It's black and white - PETHIDINE aka MEPERIDINE is a bad drug

Now a sufficient time has elapsed since the untimely death of the self-abusive and much abused Michael Jackson, we should question the availability of one of the purported agents of death, pethidine (known as meperidine in North America).

Many authorities believe that pethidine (meperidine) is a drug that has had it’s time. It no longer serves any useful purpose, it is no longer the drug or first choice (or indeed even the drug of second choice) when opioid analgesia is required. Sensibly, it is not available as a subsidised drug under the Pharmaceutical Benefits Scheme (PBS) in Australia.

THE CASE

All opioids have equi-analgesic effects when equivalent doses are given. Despite any advertising hype they all the work the same way to the same extent - although some may be shorter or longer acting than others. This enables the clinician to choose the opioid with the lowest side-effect profile. This is NEVER pethidine.

Pethidine is currently approved in Australia for:

Short term relief of moderate to severe pain not responsive to non-opioid analgesics.

Preoperative medication.

Analgesic adjunct in general anaesthesia.

Obstetric analgesia

(most literature stresses that pethidine therapy should be limited to 24-36 hours for all indications)

The following conditions are NOT indications for pethidine:

Migraine:
Pethidine is too short acting, has an addictive potential and is not as effective as specific anti-migraine treatments such as 5HT and ergot alkaloids. Indeed it is no more effective than NSAIDs or prochlorperazine.

Low Back Pain:
Intramuscular morphine, not pethidine, is the drug of choice for a single dose of opioid for treating acute lower pack pain.

Post Caesarian Pain:
Pethidine is less effective than morphine in controlling pain after Caesarian delivery.

Biliary Colic:
Despite a long held belief there is no real evidence that pethidine causes any greater increase in intrabiliary pressure than morphine.

Renal Colic:
Although renal colic is often listed as a contra-indication for morphine, there is little evidence to support this. Nor is there any evidence that pethidine is free of this side-effect.

In summary the only real indication for pethidine is in obstetric analgesia where there is no possibility of the therapy extending for more that 24-36 hours. For this indication the dose is 50–100 mg IM or SC when labour becomes regular, may be repeated 1–3-hourly (to a maximum of 400 mg)

Why is it such a crock?

Drug Interactions:
Pethidine has such a wide spectrum of serious drug interactions, (some not shared with other opioids) including:

monoamine oxidase inhibitors, selegiline, anticoagulants, seizure treatments, urinary alkalizers, barbiturates, amphetamines, phenothaizines, bromocriptine, lithium and SSRIs

It really is not a drug suitable for patients using a lot of different medications (or street drugs).

Contra-indications:
As for the drug interactions, pethidine has such a variety of contra-indications, many not shared with other opioids:

Pethidine allergy, monoamine oxidase inhibitors, selegiline, respiratory depression, emphysema, severe chronic bronchitis, kyphoscoliosis, acute bronchial asthma, chronic airway disease, status epilepticus, tetanus and strychnine poisoning, pre-eclampsia, eclampsia, cardiac arrhythmias, diabetic acidosis, acute alcoholism, delirium tremens, liver disease, hepatic encephalopathy, head injury, raised intracranial pressure, brain tumour, low platelet count, coagulation disorders, anticoagulant treatment.

Histamine Release:
All opioids occasionally cause the release of histamine from tissue mast cells through independent triggering mechanisms. This causes hypotension, tachycardia, erythema and increased adrenaline levels. Patients noted flushing of face, neck chest and extremities and a generalised sensation of warmth.

Seizures:
The active metabolite of pethidine, nor-pethidine is associated with an increased likelihood of seizures, it can also make some anti-seizure treatments less effective.

Short Duration of Action:
The effectiveness of pethidine analgesia is only two to four hours, compared with four to six hours for morphine. In a rare plus for pethidine this may be an advantage in obstetrics.

Abuse Potential:
Because it excites the nervous system as well as being a narcotic, many abusers favour pethidine over other legal opoids.

Pregnancy:
Pethidine is category C for pregnancy. Drugs in this category “have caused or may be suspected of causing, harmful effects on the human foetus or neonate without causing malformations.”

Lactation:
Maternal pethidine is secreted in breast milk, therefore pethidine administration to breastfeeding mothers is not recommended. Neonates metabolise pethidine more slowly than older persons.

Sport:
Pethidine is banned in all sports under national and international rules.

Glaucoma:
Pethidine can raise intraocular pressure.

MY VERDICT
Pethidine acts for a shorter time than morphine with no analgesic or other benefits.

Pethidine has similar side effects to morphine, including increased biliary pressure.

Pethidine can cause seizures, because it’s main metabolite, nor-pethidine, has many toxic side-effects (including convulsions).

Pethidine has many significant drug interactions.

Because other analgesics are less toxic when given at an equivalent dose pethidine is never the first line agent for treatment of severe pain. There is absolutely no case to allow a patient to self-inject pethidine.

Australian INFANTS COUGH and COLD remedies become prescription only

THE CASE
On 9/04/2008 The national Drugs and Poisons Scheduling Committee announced that all infant cough and cold preparations would be prescription only.

See "TGA announcement regarding the use of cough and cold medicines in children".

This is the correct decision but pharmacists and parents with young children won't be pleased.


THE BACKGROUND

In September 2007 the US Food and Drug Administration (FDA) announced that it was considering a ban on cough and cold medicines targeted for all children under six years. This was in response to a retrospective investigation, going back nearly 40 years, of 54 deaths associated with the ingredients pseudephedrine, phenylephrine and ephedrine. There were a further 69 deaths associated with preparations containing the antihistamines diphenhydramine, brompheniramine and chlorpheniramine. Not many deaths, admittedly, but it does indicate a pattern.

One month later in October 2007 an independent expert group advised the FDA to ban the sale of over the counter cough and cold medicines for use in infants under two years old. A majority of these experts also advised the FDA to ban the sales for all children under six.

The FDA has yet to make a final decision, but some of the more responsible drug companies such as Wyeth, and some pharmacy chains have stopped marketing them already. Medicines voluntarily withdrawn in the USA include brands commonly sold in Australia, for example some of the Dimetapp range and some of the Robitussin range.

STOP PRESS

In an extraordinary example of parallel thought, (?????) the Sydney Morning Herald (SMH) published an article on the same topic just a day and a half after I posted my original one. See "Cough syrup risk alert"

This article presented the TGA view that as these medicines are more tightly controlled in Australia, there is less risk. Sales must be personally supervised by a pharmacist. Fair enough, but decisions must be made on the basis of the evidence of the presence or absence of actual harm.

Professor Colin Robertson, director of respiratory medicine at the Royal Children's Hospital in Melbourne, said the drug regulator was "dodging the issue" and urged it to follow the lead of the FDA.

This doesn't address evidence based medicine either, it is just opinion.

MY VERDICT

In this series of articles I have highlighted a number of cases where the TGA has been slow or neglectful, such as with the anti-smoking drug varenicline with biphosphonate associated jaw osteonecrosis and even with the zolpidem pack sizes.

What bothers me about the TGA is its inertia. A statement about the issue, directed to pharmacists and other health care workers, should have been made months ago. But now they have made a good decision.


FURTHER READING

Cough and Cold Products for Children: Risk and No Benefit

http://sciencebasedpharmacy.wordpress.com/2009/05/19/cough-and-cold-products-for-children/

Weight Loss can be Dangerous

THE CASE

The Australian Therapeutic Goods Administration has placed a range of weight loss products called "Hydroxycut" on it's watch list.

It's all a bit bizarre.

The TGA is responding to the US FDA's (Food and Drug Administration) asking the supplier, Iovate Health Sciences Inc, to recall the product and advising consumers to stop using it. This follows a spate of reports of adverse reactions and even a death associated with Hydroxycut.

The Australian supplier of the Hydroxycut range has explained that the product sold here is different from the US product, and therefore is safe. A recall is not warranted. Unfortunately for them this statement flies in the face of the Australian advertising that states:

"Hydroxycut^® is America's #1 selling weight-loss supplement and is a brand name sold in over 70 countries around the world. It has been a lasting weight-loss brand. And it works!"

In other words they are saying:

1. "Buy our product - it works in the US"
2. "Don't worry about the US safety warnings, our product is different"

....Duh!!....

Most of the ingredient appear top be ordinary things found in most kitchens, such as tea, coffee and ginger (sure is an expensive way to buy these). We know what it contains, but there is not the slightest indication of HOW it works.

When will our regulators really start to regulate? All therapeutic products both mainstream and complementary must be forced to pass the following tests:

IS IT SAFE? and DOES IT WORK?

In addition products that receive any public subsidy such as by the Pharmaceutical Benefits Scheme (PBS) or by out heavily subsidised health funds need to pass another test -

IS IT AS EFFECTIVE AS EXISTING PRODUCTS?

Anyway, back to Hydroxucut. The online version of Choice, the media arm of the Australian Consumers Assocoation (ACA) has issued a warning:

"CHOICE does not believe the Therapeutic Goods Administration (TGA)’s advice to stop using Hydoxycut dietary supplements purchased online from the US provides adequate consumer protection. "

MY VERDICT

Hear Hear!

And make sure the product you are using has one of the Australian Listing numbers on the packaging. If it doesn't it is probably illegally imported with even less assurance of integrity and quality.

HOMEOPATHY for dummies

THE CASE

Homeopathy has a long history. It was invented in the late 1700s by German physician Samuel Hahnemann. He based it on treating "like with like", his theory being that a condition can be cured by a substance that produces the same signs and symptoms in a healthy person. But this is where it becomes scientifically problematic, because a necessary corollary of this is that the weaker the medicine, the more effective it becomes.

With the blossoming of physics and chemistry in the late nineteenth century it became obvious that the basic tenets of homeopathy did not stand up to scientific scrutiny. Put simply, if you keep diluting a solution there will become a time when there is no active ingredient left, and most homeopathic products can be shown mathematically to exceed this limit.

Remember the less that isn't there, then the more beneficial the homeopathic remedy!

Another problem is that homeopathy has never been shown to be any more effective than a placebo. The Lancet dated 27/08/2005 published the results of a study that concluded that there was no evidence for the effectiveness of homeopathy, and went on to say:

"doctors need to be bold and honest with their patients about homeopathy's lack of benefits"

Or as the National Advisory Council for Complementary and Alternative Medicine (NACCAM) website says:

"Overall, clinical trial results are contradictory, and systematic reviews and meta-analyses have not found homeopathy to be a definitively proven treatment for any medical condition."

It is hard to think of any other group of products that so successfully avoids the scrutiny of consumer protection legislation. Not only is there no hard scientific evidence that it works, but homeopathy actually claims to contravene the basic laws of physics and chemistry. Most homeopathy practitioners no longer pretend that the extreme dilutions they use contain any active ingredients. They instead rely on magic, claiming that the water somehow remembers the chemicals that have been diluted away, and the preparation institutes a healing process as if they were still there. The real question is, how come the water remembers the beneficial effects of the substance but forgets the side effects and the toxic effects. Water must have selective memory loss. I will reiterate, there are no laws of physics, chemistry or biology that support this highly imaginative theory.

I recently wrote:

Homeopathy is to pharmaceutics as astrology is to astronomy, in each case the former is fantasy and the latter is scientific. Time and time again homeopathy has been proven (yes proven!) to be exactly as effective as a placebo.

Usually homeopathy is just a piece of harmless junk pseudo-science. The only loss is financial, but ocasionally it gets dangerous. For example up to 2002, homeopathic "vaccines" for meningococcus, hepatitis B and influenza were being sold, these were banned by the Therapeutic Goods Administration (TGA) on 9/09/2002. This ban remains in place. The danger is that naive, well meaning parents were allowing their children to be given these non-therapeutic "vaccines" in the mistaken belief that they would be protected from diseases.

Until someone proves that dilution beyond Avogadro's number is meaningful, or can even present a cogent argument on how it could possibly be meaningful, I believe that any pharmacist who practises homeopathy is guilty of fraud, if not professional malpractice. They have the scientific training to know better. If they really must practice homeopathy, it should be away from a pharmacy so that this daft money and time waster is not given a false credibility that it does not deserve.


MY VERDICT

Please don't accuse me of having a closed mind. There have never been any reasons, of physics, chemistry, biology, logic, mathematics, or medicine, given for how homeopathy could possibly work(see below)*. Any perceived benefits are either fraudulent, imaginary or the placebo effect.

DO IT YOURSELF HOMEOPATHY

According to homeopathic principals "like treats like", so if a severe blow to the head with a hammer causes a headache, then it should be possible to treat your migraine with some very light hammer blows. Try it at home sometime, but don't blame me if it doesn't work.

*there is no support for homeopathy in physiology, pharmacology, anatomy, biochemistry, common sense, herbalism, pharmaceutics or statistics either.

FURTHER READING

The Cognitive Dissonance of Homoeopathy
http://sciencebasedpharmacy.wordpress.com/?s=homoeopathy

COSMECEUTICALS where white lies earn big money

THE CASE

About homeopathy I wrote:

"It is hard to think of any other group of products that so successfully avoids the scrutiny of consumer protection legislation."

Well, I was wrong, there is a whole industry that was specifically designed to circumvent as many consumer protection laws as possible.

About ten years ago the word "cosmeceutical" was popularised. The intention was to give cosmetics the scientific respectability of pharmaceuticals by using a semantic trick. Cosmeceuticals are cosmetics that the manufacturers claim have drug-like benefits. Examples include products that claim to reverse skin anti-aging, prevent or cure wrinkles, or reverse hair-loss. Such products are labelled with claims that superficially seem specific and credible, but on close examination are often quite meaningless.

For example, a hair product may say "makes your hair 3 times stronger". To a normal person this means that on average, before treatment, a strand of hair will support a given weight, and after treatment the same hair would support 3 times this weight.

To a cosmetic company this claim means something very, very different. A number of volunteers are paid to try the product, then asked their opinion. In this case 3 times as many users of the product thought their hair was stronger as opposed to weaker. They then claim "makes your hair 3 times stronger" By using semantics instead of science the advertisers are presenting a subjective opinion as an objective fact.

This method is also used to "quantify" essentially unquantifiable positive or negative attributes like sheen, smoothness, frizziness, vibrancy, radiance or plumpness.

Remember as Benjamin Disraeli (not Mark Twain) said:

"There are three kinds of lies: lies, damned lies, and statistics."

Decide for yourself which category this behaviour belongs to.

In most jurisdictions cosmetics and cosmeceuticals are tested for safety, but there is no corresponding testing of efficacy. In other words there are no requirements to prove that the preparations actually live up to the manufacturer's claims.

This brings me directly to the concept of "Angel Dusting". Cosmeceutical manufacturers are very fond of putting sub-therapeutic amounts of active substances in preparations then carefully wording the associated literature, making sure that it tells the truth. They say this preparation contains "ingredient X". They also say that "ingredient X" is good for treating "condition Y". But what they carefully don't claim is that their product will treat "condition Y", because it can't. There is simply not enough "ingredient X" in it. This neatly skips around all sorts of regulative hurdles in many jurisdictions. Hey! does this remind you of homeopathy?

Attendees at the 2008 annual meeting of the the Australasian College of Dermatologists were told that the multi-national skincare companies are discouraged from testing their products in scientific trials, because if they products actually worked they might be reclassified from cosmetics to prescription drugs. So basically these companies are trying to have two bob each way. As the CEO of the college Dr John Flynn says, products that are truly effective are usually prescription only.

The meeting was also told that sunscreens are the only ingredients that actually work to prevent aging. Consumers are therefore allowing themselves to be ripped off by paying hundreds of dollars for useless products. The best way to treat your skin, is a non-soap cleanser followed by an application of sunscreen each morning - and that's it.

The February 2008 edition of Cosmos magazine put it quite neatly:

So it's not just consumers being left in the dark. Not even scientists know what these products actually do. The cosmeceutical industry operates outside of accepted scientific methodology. The in-house studies of cosmetic companies have to be taken with a grain of salt, and the scientific literature that does exist doesn't seem to address the fundamental questions: do the active ingredients penetrate human skin? Do they do it in the mixtures found in creams? What concentrations do they reach? What effects do they have when they get there?

But help may be on the way, our drug regulator the TGA has put these purveyors of half truths on notice. It has issued a warning that specious claims such as "scientifically tested "and "clinically proven" should not be used unless there is real evidence based research to back them up. Thank goodness and about time!

MY VERDICT

If the claims for a product seem too good to be true, they almost certainly are. Cosmeceuticals are often homeopathic style products manufactured by multinational companies.

Go to your local pharmacy. Walk quickly past all the Clarins, L'Oreal, Estee Lauder and Clinique products (notice how they always have French names no matter where they are based). Buy a big tub of sorbolene cream, preferably without glycerine, as glycerine is a false moisturiser. Then buy bottle of non-soap cleanser manufactured by a reputable company, if in doubt always choose the one with the least number of ingredients. This way you will be able to look after your skin properly for six months for less than $20. Now spend the savings on good quality sunscreens.

BRITISH MEDICINE is rapidly heading for a new Dark Age

THE CASE

The heir to the throne His Royal Highness the Prince of Wales (appropriately and correctly written in Latin as "Princeps Wallie") is clearly not a man of the Enlightenment otherwise he would know there is no such thing as alternative medicine, there is only proven medicine or unproven medicine. Once a particular therapy satisfies the "evidence based medicine" (EBM ) criteria it becomes proven and hence mainstream.

Similarly if new evidence shows that a therapy is no longer appropriate, then it should be dropped- like chloroform and ether for anaesthesia or the poisonous arsenic containing Salvarsan for syphilis or cupping or blood-letting.

In an article published in The Times 30/12/2000 the Prince himself wrote:

The traditional herbal remedy of St John's Wort, for example, has been found to work as well as tricyclic antidepressants in treating mild to moderate depression, with fewer side effects. Admittedly, there are reservations about its interaction with particular drugs - but sufficient science-based support is there to warrant its prescription in trained hands.

Fair enough, this is all true. So although St John's Wort is a traditional herbal medicine it also satisfies the EBM criteria, therefore it is not alternate - it is proven.

Contrast this with another of the misguided Prince's advocated therapies, reflexology. Reflexologists claim it has benefited almost anything including (but not limited to) improved sleep, boosted lymphatic system, detoxified system, improved circulation, promoted body awareness, increased vitality, balanced nervous system, cured head neck and back aches, abolished muscle and joint pain, removed digestive problems including diarrheoa and constipation, cured colds and flu, stopped travel sickness, abated period pain, cured infertility. There is not a shred of evidence that it does anything except give you a jolly good foot massage. In other words this is an unproven therapy.

The problem is that these therapies are taking an ever increasing proportion of the British health budget. The National Health Service (NHS) is funding a proliferation of alternative health services. British universities are teaching more alternative health courses leading to degrees. It is hard to see how learning a totally unscientific discipline (actually anti-scientific is a more accurate adjective) like homeopathy can justify the awarding of a BSc. Homeopathy is to pharmaceutics as astrology is to astronomy, in each case the former is fantasy and the latter is scientific. Time and time again homeopathy has been proven (yes proven!) to be exactly as effective as a placebo.

Some of the finest medical academics in Britain have complained about the Prince's involvement in pushing alternative medicine. They have highlighted inaccuracies in a British taxpayer funded book endorsed by the Prince titled "Complementary Health Care: A Guide for Patients". The book makes extravagant, unproven and even dangerous claims, such as that chiropractic and homeopathy can be used to treat asthma.

While we are at it let's not legitimise unproven therapies by labelling them "alternative". The word "alternative" suggests peers amongst equals, these therapies are not a true alternative. For example ear candling is not a real alternative to proper medical treatment for an ear infection. Similarly to label them "complementary" is also an attempt to legitimise them. The main thing they complement is the bank balance of the practitioner. Don't allow proponents to get away with these weasel words, they are simply unproven.

"Either it is true that a medicine works or it isn't. It cannot be false in the ordinary sense but true in some 'alternative' sense."

(Prof. Richard Dawkins, Oxford, April 2001)

It getting worse, now the meddling Prince's Foundation for Integrated Health is proposing a "Kitemark" scheme for medical services that agree to sign a pledge to provide complementary therapies.

Silver and gold levels of membership, with more stringent levels of criteria, would then follow, and eventually a fully fledged kite-marking scheme to accredit the quality of provision.

According to the Foundation's literature to earn this stigma a practice has to:

1. Agree to provide integrated care
2. Provide at least one complementary therapy in-house
3. Have at least one partner in the practice with a specialist interest in integrating conventional and complementary medicine
4. Ensure all partners are happy to discuss complementary therapies with patients
5. In order to retain their membership after three years, members will have to conduct significant event audits, clinical care audits and seek patient views on the integrated services offered by their practice

A little knowledge really is a dangerous thing.

MY VERDICT

University money is a scarce resource and is better used for teaching true science such as physics, chemistry and biology, than populist pseudo-intellectual alternative medicine.

The precious health budget should be use for actual proven therapies, not for unproven, and unscientific mumbo-jumbo.

Complementary and alternate health care practitioners and products need to be carefully monitored, self-monitoring is not sufficient.

Please let's not fall into this trap in Australia.

Sex Test for your Baby

THE CASE

Now you can go to your favourite pharmacy and for about $95.00 buy a test kit that will accurately determine the gender of your baby as early as eight weeks - or so the manufacturers claim.

Dr. Ted Weaver the President of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists can't see how it could be accurate at eight weeks. He points out that there is no supporting evidence for the claim of 90% accuracy, nor is there any information on how it works. However anecdotal evidence indicates that the accuracy it is about 80%,

The Australian Christian lobby says it should be banned, because it will increase the demand for abortions if the sex of the baby is not what the parents want. Although abortion on the grounds of gender selection is illegal, the managing Director of the Australian Christian Lobby, Jim Wallace said "That we would allow a product that would allow eugenics to be practiced and started in the home is just unbelievable".

NSW Health Minister John Della Bosca says go to your doctor instead.

The President of the Australian Council of Natural Family Planning, Evelyn Brien, was also worried that by enabling parents to determine the sex of their babies early in pregnancy "they could decide to abort the pregnancy if it's not the sex of their choice." "Morally, that's unacceptable."

All of these people miss the point.

If you are the sort of person who sneaks around and secretly opens up Christmas presents before Christmas, then this test may appeal to you. Ask yourself why you need to know the sex of your unborn baby? Surprises are nice, do you really want to spoil the fun just so you can paint the bedroom the right colour?

The only good reason to test the sex of an unborn baby is if there is the possibility of a familial sex-linked genetic disorder such as Haemophilia or Fragile X Syndrome. Any other reason is just a type of voyerism. Even the adverts say it "bridges the curosity gap"'.

In a very muddy business here are some facts:

The adverts say go to your local pharmacy for one of these kits, but it is available in very few pharmacies.

The adverts claim 90% accuracy but offer no proof of this, beyond a few testimonials.

The adverts say it is accurate from as little as six weeks after the first missed period.

The mechanism of the test is a secret.

MY VERDICT

I wonder if it is any more accurate than the old method of putting some Drano in a urine sample. I am told that Drano turns dark in a boy pregnancy but does not change in a girl pregnancy. I have also been told that it turns blue for boys and pink for girls (no really!).

http://www.babygenderprediction.com/drano-gender-prediction.html

IATROGENIC DISEASE

The Case

The following conversation is imaginary but strongly based on a real visit to the doctor by an acquaintance of mine.

Hello Doctor...

Good morning, how can I help you today?


...I've got a terrible pain...

I suggest you take two paracetamol four times a day. That usually helps control pain.


...in my back...

Luckily, back pain often responds to manipulation, I can give you a referral to either a physiotherapist or a chiropractor whichever you prefer. If neither of these help you could try acupuncture.

...and my legs...

In that case I think I should prescribe a non-steroidal anti-inflammatory as well. And here is an antacid in case it upsets your stomach.

...sometimes it's so bad I can't even get up...

You can't get up! That’s no good; well I better give you a script for Viagra! Take one tablet and you will be up within 20 minutes. If it doesn't work we can always increase the strength.

...in the mornings, and I keep waking up all night...

You better take a course of sleeping tablets; I recommend temazepam or better still zolpidem -Take one tablet 20 minute before bedtime with a glass of warm milk.

...with shooting down my legs...

Goodness me! You’ve been in a shooting? I'll send you for a body scan to make sure there are no pellets lodged anywhere.While we are at it I better test you for lead poisoning, but don't worry the mortality from lead poisoning is quite low in adults. If the test comes back positive I'll give you chelation therapy to help remove it.

...and agonising pain...

If the pain is that bad you better take an opiod as well as the paracetamol, Here's a script. Trouble is these might make you constipated, so I'll write in some laxitives for the constipation, and also an antidiarrhoeals in case the laxitive gives you diarrhoea.

...It all started when I sneezed...

Well, sneezing is easily controlled; I'll add an antihistamine and some nose drops to your script so it won't happen again. And while you are at it I'll give you your influenza shot, and here is a script for an antiviral in case we get that swine flu epidemic.

...and I suddenly got a terrible spasm in my back...

The drug of choice for spasms is still diazepam, take one tablet up to four times a day, mind you it will make you very drowsy, so you may need to take a big dose of caffeine to counteract this. Wait a minute I'll give you a script for dexamphetamine, that should keep you alert.

...and it really hurts when I cough...

Pholcodeine is a good cough suppressant.

...and laugh...

I usually prescribe chlorpromazine or sertraline to control inappropriate emotion.

....actually, I think I better go and get a second opinion....

(goto start)

My Verdict

It speaks for itself.

How COUGH and COLD remedies work - a heretical view

THE CASE

Following up on the recently famous youtube video, I have just read an article in the New Yorker Magazine about Nicholas White, the man trapped in a lift (an elevator) for 41 hours. Bad enough, but deep in the article is an even more appalling fact:

The "Door Close" button in most lifts doesn't work.


Apparently the button's only function is to make the occupant think that they have some sort of control. Can this really be true? We get into a lift and press the required floor button then jab at the "Door Close" button a few times..... hey presto the door closes, thus reinforcing our belief that the button works. But the truth is the action and the effect are completely unlinked, it is a timer that closes the door not the button.

Similarly most pharmacists and doctors do not really believe that cold remedies work. Their only function is to make you think that you can do something. The cold will last from ten days to three weeks with or without treatment. But patients persists in buying their favourite nostrums, because just like "you press the button and the door closes", you take the remedy and the cold goes away. Again the action and effect are completely unlinked, it is the passage of time that cures the cold not the remedy.

MY VERDICT

The treatment that works is the one you were using when you got better. There is no evidence based research indicating that over the counter cough and cold treatments have any effect on shortening the duration of illness.

NOTE

To be absolutely correct the button apparently does work when the lift is in service mode, accessed by a key.

FURTHER READING

Coldfx: More Hype that Hope for Colds and the Flu
http://sciencebasedpharmacy.wordpress.com/2009/02/27/cold-fx/

SWINE FLU at work

THE CASE

Influenza is spread from person to person mainly by droplet infection - when people cough or sneeze near each other. It can also be spread by contact, when a person touches nasal secretions or saliva from an infected person, and then touch their own mouth or nose.

PREVENTING INFLUENZA SPREAD AT WORK

VACCINATION

The best way to minimise serious illness from influenza is vaccination. Everyone at risk of lower respiratory infection should be vaccinated each year. Vaccination also helps prevent your co-workers and your family from getting the flu from you.

GENERAL HYGIENE

1. Have your own mug and glass, don't share.

2. Don't share phones - either fixed phones or mobiles.

3. Don't share headsets.

4. Your keyboards and mouse can also transmit infection.

4. Wash up with hot water.

5. Don't use a tea towel, or use a clean one each time.

RESPIRATORY HYGIENE

1. Tissues, waste containers, and hand antiseptics should be available at every work station.

2. Always cover your nose and mouth with a tissue when coughing or sneezing.

3. Throw your tissue into a waste container immediately after use.

4. Disinfect, or wash your hands with soap and water immediately after discarding your tissue.

5. Consider the good Japanese custom of wearing face masks to limit droplet transmission.

HAND HYGIENE

All sink areas should have plenty of soap and paper towel available. Wash your hands for at least 15 seconds with a rubbing action with soap and warm water, rinse, and then dry with a paper towel. Use a clean paper towel to turn off the taps.

To reduce the transmission of respiratory illnesses, wash your hands:

1. After coughing or sneezing.

2. Before eating.

3. After contact with anyone with a respiratory illnesses.

EXCLUSION

1. Anyone who develop symptoms of influenza (fever, chills, sore throat, cough, headache, muscle aches) while at work should go home immediately. If this is not possible the ill person should be confined in a separate area away from others.

2. Anyone with influenza should stay at home for at least 5 to 7 days after the onset of symptoms. Don't be a hero and Don't soldier on with Codral Cold Tablets

THE WORST CASE

If you still get the "Swine Flu" despite taking all the above precautions, baby yourself, go to bed, hide away, don't exercise, drink plenty of fluids, don't go to work and if you are really unwell see your doctor. Proprietary cold and 'flu remedies will only give symptomatic relief (at best), but there are two antiviral drugs, Tamiflu and Relenza that are reported to be effective against the 2009 swine flu. These are probably worth while taking but do have some side effects, see "INFLUENZA treatments under scrutiny"

MY VERDICT

There is nothing new in this blog, just good common sense.

Don't soldier on with Codral Cold Tablets

THE CASE

We are currently being bombarded with television adverts encouraging us to take Codral Cold Tablets so that we can continue to go to work despite suffering from coughs, colds and even influenza. The implication is that by "soldiering on" you are being brave and conquering adversity, and that Codral Cold Tablets will help you win the war. In fact, you are being stupid and anti-social. As I have written before,

"there is no evidence based research indicating that over the counter cough and cold treatments have any effect on shortening the duration of illness"

they merely alleviate symptoms.

Soldiering on is very bad advice on two counts. Firstly, the symptomatic relief does nothing for the course of the viral disease, it merely allows the afflicted person to hide the illness, to function more or less normally and to infect as many healthy people as possible. Secondly, by "soldiering on" when they should really be at home looking after themselves, afflicted persons are risking secondary bacterial infections such as bronchitis, middle ear infection and even pneumonia.

If you get a cold, stay home and be kind to yourself, loaf around, get a lot of of sleep and drink plenty of fluids (non-alcoholic). You are not doing anyone any favours by going to work, you won't be very productive and will probably infect a lot of people while you are at it. Remember that colds are spread by droplet infection emitted by coughing and sneezing, so cover your mouth and nose and definitely do not spit in public. Infection can also be spread by touch so don't use the same phone as someone who has a cold, and everyone should wash their hands a lot, especially if they use shared keyboards. If you go to your doctor, don't expect a script for antibiotics. Antibiotics are ineffective against viral illnesses.

If you are a manager, do everyone a favour and send infected staff home, and don't expect ill people to come to work, and don't play the martyr and come in yourself if you are sick. Provide paper towels and encourage frequent hand-washing.

As I wrote above, cold and flu tablets, including Codral, do nothing to shorten the course of the disease as they only provide symptomatic relief. Because these cold treatments reduce the apparent symptoms the temptation is to behave normally. If you have a light head-cold with just a runny nose or watering eyes you probably will not do yourself any harm, but you will still pass it on to everyone else. However if you have generalised symptoms such as muscle aches, chills or chest infection you really should rest. Many studies have shown that physical stress delays healing, in other words your cold or flu will hang around longer, especially if you play sport or go to the gym.

MY VERDICT

Don't soldier on with Codral. It is unfair to yourself and to all your contacts. For hints on how to minimise the risk of catching colds an flu see "Swine flu at Work".


NOTE

In 2008 the Australian distributors of Codral, Johnson & Johnson Pacific spent $5.2 million dollars on the antisocial Codral "Soldier On" adverts.

Is that medicine Western or Chinese?

THE CASE

If you take imported complementary medicine or supplements, you really cannot be sure of what you are taking. There are a lot of snake-oil merchants out there. You are most likely to be sold mislabelled products in gyms, on the Internet or in Eastern medicine shops.

During 2007 the Therapeutic Goods Administration (TGA) has ordered recalls on a number of complementary medicines including:

Excite for Women and Ultimates for Men
These products were recalled on 26 April 2007 and were shown to contain a substance closely related to Viagra, a sildenafil analogue. People taking this medicine believed they were taking "natures safe alternative", when in reality they were taking a prescription only Western medicine. Sildenafil is especially dangerous for people who have heart disease, who are liable to strokes or who are taking certain other medicines. The supplier of these products, Herbal Health International, were risking their customers lives, as well as misleading them. They are still listed for sale on their website. The TGA considered this a Class I recall, that the products were potentially life-threatening and could cause a serious health risk.

Top Gun for Men Herbal Extracts 750mg tablets
Were recalled on 30 July 2007, again this product was found to contain a substance closely related to Viagra, tadalafil. The supplier, La Viva Blue Pty Ltd, put their clients at the same risks as outlined above. The TGA considered this a Class II recall, where the product could cause illness.

Physio Care Lida Dai Dai Hua Jiao Nang Slimming Capsules
Were recalled on the 29 October 2007. This product was shown to contain sibutramine, marketed in Australia as the prescription only weight loss drug Reductil. Sibutramine has a large number of contraindications and interactions with other drugs. These capsules were marketed by Mekong Grocery as Physio Care, may have only been sold in South Australia. Persons taking these capsules were under the impression that they were taking a herbal weight loss product, but were in fact taking an illegally imported and supplied Western prescription medicine. The TGA considers this a Class I recall, the product being potentially life-threatening or able to cause a serious risk to health.

Dymatize Nutrition Anabolic Meth-X 100 capsules
Were recalled on the 29 October 2007 they were found to contain ipriflavone, a synthetic bioflavanoid. Through a legislative loophole this substance is available in the US as a supplement, but this is not the case in Australia. It is marketed as an anabolic agent, but it's safety and effectiveness has never been assessed, therefore it is prescription only and should only be used under the supervision of a doctor. It was sold by Superior Supplements, and is still advertised on Australian sites on the Internet. The TGA considered this a Class I recall, that the product being potentially life-threatening or could cause a serious risk to health.

VPX 'No Shotgun' and BSN 'Cell Mass' Body Building Powders
Were recalled on the 22 October 2007. These products were marketed by Crestkey Pty Ltd through Elite Physique and contain traces of the drug coumarin. This compound has been associated with liver and kidney damage, and has been banned as a food and cigarette additive in many countries. The TGA considered this a Class I recall, because the product is potentially life-threatening and could cause a serious health risk. They are still advertised on Australian sites.


During 2008 the Therapeutic Goods Administration (TGA) has ordered recalls on a number of complementary medicines including:

Nutrex Research Lipo 6 liquid capsules

Recalled 2/10/2008 because at least some batches contained the substance yohimbine. which has long been considered an aphrodisiac. There is no evidence for this, and there is no evidence that it helps in weight loss.

Zhen De Shou 10 x 250mg capsules

These were recalled on 5/11/2008. These fat loss capsules were illegally imported and supplied. They were found to contain the prescription medicines sibutramine and Phenolphthalein .were detected in a sample. These medicines must only be used under medical supervision.They were found to contain contain sibutramine, marketed in Australia as the prescription only weight loss drug Reductil. Sibutramine has a large number of contraindications and interactions with other drugs. The label merely says

"Not applicable for woman in pregnancy and patients of cordis-vasal disease and apoplexy"

whatever all that means.


MY VERDICT
Bear in mind that the person recommending this type of product probably has no, or at best, little health care education and that they have no idea what is really in the product. Shop assistants and personal trainers have absolutely no expertise in medicines, they just pretend they have. It is immoral and cynical in the extreme to sell Western pharmaceuticals as traditional Chinese herbal remedies.

I hope the authorities responsible are monitoring Internet sites to make sure these products are still not being sold in Australia.

If you want to know all the side-effects and contraindications of any medicine ask pharmacists, they are experts.

Keeping MELAMINE at bay in Australia

Chinese workers removing milk products

THE CASE

Melamine is a relatively insoluble basic organic compound with a high nitrogen content. The name melamine is a catchy trivial name for the chemical compound 1,3,5-triazine-2,4,6-triamine also known as cyanuramide.

Melamine

It can be used to fool some of the traditional tests used to determine the protein content of food. For example if milk has melamine added to it it can then be diluted with water and still appear to contain the mandated protein level. Similarly it can be added to fish food and livestock feed to enhance the protein assay. A melamine derivative, cyanuric acid, has also been used.

The abuse of melamine by incorporating it into animal and human foodstuffs has a long and sorry history in China. In early 2007 there was an international scandal involving pet-food sourced in China that contained huge amounts of melamine.

In September 2008 melamine was detected in many brands of baby formula with high melamine content. All over China and in a number of other countries thousands babies and children were getting sick and in some cases dying. Because melamine is basic and only sparingly soluble it can crystallise in the urinary tract where it precipitates into kidney and bladder stones. Animal studies have indicated that it may even cause bladder cancer. The amount of melamine detected varied from 2.5g grams /kilogram for a Sanlu product down to an almost acceptable 1.4ppm for a Hong Kong Nestle product. Because of the wide usage of melamine based plastics a small amount (parts per billion) can often be detected in the food chain.

The Chinese authorities have known about the current baby-food scandal for at least four months, but chose to hush it up for the sake of the Olympics.

Our regulatory authority, Food Standards Australia New Zealand (FSANZ) has determined that there is no wide spread melamine contamination of milk based products in Australia. There may be small quantities of Chinese sourced products containing a small amount of melamine such as lollies being sold in Asian stores.

White Rabbit lollies

Apparently White Rabbit sweets (seven White Rabbit sweets are equivalent to one cup of milk) are being investigated.


MY VERDICT

Does this bear a scary resemblance to the heparin scandal? see

HEPARIN recall - why was the TGA not pro-active?

and

ENOXAPARIN the latest victim of the heparin debacle

The parallels are

1. The products were sourced in bulk from China

2. Somewhere in the supply chain someone thought it would be a good idea to add a contaminant to trick assay procedures.

3. The contaminant was deleterious to human health.

4. The scam continued for months before being detected.

The moral of the story is if you want to be safe, buy local.

TAKING PYGEUM may threaten the survival of the Red Stinkwood tree

INSENSITIVE "HARVESTING" OF PYGEUM

THE CASE

Pygeum has been heavily marketed in Australia, Europe and the United States as a herbal remedy for benign prostatic hyperplasia (BPH), commonly called an enlarged prostate. It is claimed to reduce the swelling and inflammation of the prostate and therefore relieve discomfort by improving urine flow. The most commonly cited clinical trial of pygeum was held in the UK and was a brief and, to some reviewers, problematic. This trial showed that pygeum provided some relief, of some of the symptoms, in some men sometimes. The evidence was hardly overwhelming.

Pygeum is prepared from the bark of the African tree Prunus africana commonly called the Red Stinkwood. Over the last 20 years the collection of bark from these trees has resulted in the species becoming endangered. This is because financial attraction of the high price of pygeum has discouraged harvesters from leaving enough bark to allow the trees to survive. For example in Madagascar, Prunus africana is now only found in very inaccessible areas. A Greenpeace source estimated that during the 1990's debarking caused an annual loss of 35,000 trees.

Prunus africana

Fortunately the high price has also made it economic to cultivate these trees.

A native of high, forested regions of Africa, pygeum is an evergreen tree with leathery leaves, deeply fissured gray or dark brown bark, and small, creamy-white flowers. Mature trees can reach heights of up to 150 feet. When ripe, pygeum fruit (technically called a drupe) looks something like a cherry. In fact, as a member of the rose family, pygeum is closely related to cherries, plums, almonds and other rose family plants in the genus Prunus. More than 200 Prunus species are distributed around the world, but pygeum (also known as African prune) is the only one native to Africa. Pygeum’s natural range includes mountainous areas of South Africa, Madagascar, Cameroon, Kenya, the Democratic Republic of the Congo, and Zaire. The plant is esteemed not only for its medicinal properties, but also for its hard, durable wood, which is used in the construction of wagons, axe handles, farm tools, dwellings, and veneers and paneling for the export market.

The endangerment of Prunus africana by pygeum collections is uncannily similar to the endangerment of Hoodia gordonii by overenthusiastic collection for the preparation of weight loss treatments.

MY VERDICT

If you have been convinced by the advertising that taking pygeum is a good idea, please firstly consider the following.

1. Consult a doctor to ensure that you really have BPH. This treatment is not suitable for treating prostate cancer and it may mask some of the symptoms of cancer.

2. Ask if the pygeum you are buying comes from a sustainable source and not from illegally debarked trees growing in national parks. They'll think you are a jerk and won't be able to tell you but it's worth asking just to publicise the cause.

NOTE

The name Pygeum, comes from the original Linnean name of the plant, Pygeum africanum. The word pygeum being a latinisation of the Greek word for buttock. This is supposedly because the two lobed fruit resembles the human buttock (think of peaches). The name was changed to Prunus africana about forty years ago.

ALCOHOL TAXATION is a victim of lobby groups

THE CASE

If the Australian Government is really serious about reducing teenage binge drinking it would approach it a bit differently. It makes more sense to treat alcohol in the same way as tobacco.

STEP 1 - TAKE A "NO FEAR OR FAVOUR" APPROACH TO ALCOHOL TAXATION

By all means tax alcohol, but tax it on just the alcohol content. The higher the alcohol content the higher the tax. Make the tax directly proportional - it's that simple! The human body makes do distinction as to the source of the alcohol, grapes or sugar cane or barley. Currently some sectors the alcohol industry receive special treatment for a variety of reasons. Their success is due to the extreme ferocity of their lobbying.

But at the same time we need to address some other issues.

STEP 2 - REDUCE THE APPEAL OF ALCOHOLIC DRINKS TO TEENAGERS

There is no doubt that the RTDs (ready to drink or alcopops) are specifically designed to appeal to younger people. Naturally the alcohol industry contests this. Figures show they have been magnificently successful.

"The 2005 national secondary schools survey showed that 47 per cent of 12- to 17-year-old girls and 14 per cent of boys had drunk pre-mixed spirits in the last week" -SMH August 6, 2007

The packaging is "now" and often deceptively resembles that of energy drinks. Drinkers get the subliminal message that not only are these products fun and cool but that they are also good for you. This is a bit hard to mandate, but the packaging constraints imposed on tobacco products could serve as a model. Without the "sexy" packaging the products should have less appeal.

The drinks themselves are a complex mixture of flavours, combined with a lot of sugar to completely mask the presence of the alcohol content.Sometimes it is not at all obvious which drinks contain alcohol and which don't as this American sample demonstrates.

So the actual alcohol content needs to be clearly displayed.

Step 3 - BAN THE INCLUSION OF STIMULANTS IN ALCOHOLIC DRINKS

Many of these drinks also contain high quantities of stimulants -either caffeine or guarana. The inclusion of these in the RTDs is extremely cynical. The normal effect of alcohol consumption is sedative, the consumer becomes drowsy and falls asleep, but an asleep person is of no use to the alcohol industry - a person needs to be awake to drink alcohol. So some bright, but unprincipled persons came up with the idea of adding stimulants to keep their drunks alert and drinking - and that is binging. An alcoholic energy drink seems to be an oxymoron to me.

MY VERDICT

Kevin Rudd, Brendan Nelson, Nicola Roxon, Joe Hockey get real! Stop playing party politics about this. Stop using alcohol as a political football and tax cow. Put a comprehensive and logical set of policies in place. (note to self - stop mixing metaphors, they are as insidious as mixed drinks)

MEDICARE AUSTRALIA - callow or incompetent over PBS changes?

THE CASE

Dispensing software is provided to all Australian pharmacies by just a handful of fiercely competitive companies. The performance and parameters of this software is regulated by a myriad of State and Federal agencies, the most important one being Medicare Australia which administers the Pharmaceutical Benefits Scheme (PBS).

In about March 2007, the previous Minister for Health, Tony Abbott, mandated changes to the pricing and structure of the PBS that are due to take effect on 01/08/2008. To allow pharmacists to dispense medicines in accordance with these changes the dispensing software vendors had to make huge, unfunded changes to their software. Having made these changes the dispensing software vendors were obliged to obtain certification (NOI - notice of integration) from Medicare Australia.

This is the problem.

To test the thousands of changes listed for 01/08/2008 Medicare provided a sample of three drugs (yes 3!), and five patients. The software vendors were not unreasonably expecting a complete file. To make matters worse these sample drugs were priced using the July formula for calculation rather than the new August pricing scheme.

But it gets even sillier.

At least some of the test patients provided had invalid Medicare numbers. Medicare Australia, of all organisations, should be able to create a valid Medicare number. Next, the SafetyNet numbers provided by Medicare expired 31/12/2006! Naturally enough the various dispensing systems just rejected this patient data.

Then the icing on the cake. The test data did not allow for testing:

Dentists Prescriptions
Optometrists Prescriptions
Section 100 drugs (Highly specific and very expensive items)
Creams and ointments prepared from scratch by pharmacists
Department of Veterans Affairs scripts for unlisted items
Medicines like children's antibiotics that the pharmacist has to make up.

So in other words, despite having more than a year's lead time, Medicare Australia could not provide adequate test data for their own initiative, but the dispensing software vendors were expected to do it in a couple of weeks. If this change goes smoothly on 01/08/2008 it is BECAUSE of the competence of the privately owned dispensing software providers and DESPITE the pathetic efforts of Medicare Australia.

MY VERDICT

Nicola Roxon please take these people out the back and bang their heads together very hard, and don't blame the dispensing software vendors is of goes horribly wrong.

NOTE

I hold documentation of all of the above.

KUDZU root hangover remedies are illogical

THE CASE

There are several preparations containing kudzu root (Pueraria lobata) on the market that claim to be "hangover cures". The instructions for one particular product are:

"For best results take 4 capsules while drinking. Alternatively take 4 capsules the morning after."

This product claims to contain the equivalent of 2.25 g of Pueraria lobata along with amino and minerals. The blurb continues:

"Great for a big night out. Contains Pueraria lobata traditionally used to relieve hangover symptoms."

Another product says:

"An alcohol protection formula that stops a hangover before it starts! ...... Unique flavonglycosides like isoflavones, diadzin, and puerarin in kudzu extract help limit alcohol's damage to the body."

The only problem is that kudzu root contains an inhibitor of aldehyde dehydrogenase, and therefore acts to increase the levels of acetaldehyde. It is acetaldehyde that produces many of the symptoms of hangover especially the flushing, and the throbbing headache. I can't find any reference to kudzu root (but see below) being used a "hangover cure" and as far as I can work out it will increase the liklihood and worsen the symptoms of a hangover.

There is a venerable Western drug on the market, disulfiram (marketed as Antabuse), that has long been used as a deterrent for alcohol abuse (called an antidipsotropic). It has a reaction named after it "The Disulfiram Reaction". Just like kudzu root, disulfiram inhibits the enzyme system responsible for the conversion of acetaldehyde to acetate. Ingesting alcohol after taking disulfiram results in raised blood acetaldehyde levels with accumulation in the tissues producing the very unpleasant and potentially dangerous "aldehyde reaction". Chronic use may cause an only partially reversible peripheral neuropathy. There is no reason to assume that kudzu root will not produce the same results if taken chronically along with alcohol.

Kudzu root is a traditional Chinese antidipsotropic medicine, like the drug disulfiram. It decreases the desire to drink by making the consequences more unpleasant, in other words behaviour modification. Therefore there are some kudzu root products that more logically claim to reduce the desire to drink. This gives rise to advertorial blurb like:

"....was developed as a direct result of the now famous 2005 Harvard Medical Center/McLean Hospital study in which participants drank significantly less alcohol when given herbal kudzu extract."

Traditional Chinese medicine (TCM) practitioners usually claim that kudzu is harmless:

"All in all, Kudzu is a benign herb with no observed toxicity, its actually a food commonly served in some Asian cuisines."

But Unfortunately there is some suggestion that kudzu ingestion may increase the risk of cancer formation.

There are two distinct kudzu preparations Radix pueraria lobata (a root extract) and Flos pueraria lobata (a floral extract). Apparently Pueraria flos does enhance acetaldehyde removal, so just may be useful for preventing or treating a hangover.

MY VERDICT
To the public:

If you really consider a kudzu "hangover cure" is worthwhile. Make sure that the one you select contains the floral extract (Flos puerariae) not the root extract (Radix pueraria). The root extract will make your hangover worse and is probably contraindicated at the same time as alcohol consumption. There is also no point in taking a medicine that is a mixture of the two, they will tend to cancel each other out.

To the regulatory authorities:

Purveyors of kudzu preparations should be required to identify their product as containing either root extracts, or floral extracts of the Pueraria lobata plant, as they have different pharmacological effects.

Herbal medicines must be marketed along with some sort of proof of efficacy, in this case kudzu can have entirely the opposite effect to that claimed, if it is derived from the wrong plant part.

NOTE

Originating in east Asia, kudzu (Pueraria lobata) is a noxious weed in many parts of the world, especially in the south- east of the United States. It was deliberately introduced into Australia in the belief that it would provide an new source of forage legume for stock. It is now becoming a problem in south east Queensland. If you see it growing, please notify the appropriate authority.

NUTRACEUTICALS sitting on the fence between food and drugs

THE CASE

Nutraceuticals are foodstuffs purporting to have health or medical benefits in addition to their normal nutritional value. They are often considered to be a subset of "functional foods" along with "medical foods" and good old fashioned "health foods", but the distinctions are blurry. The word itself, an etymologically horrible combination of "nutrition" (from Latin) and "pharmaceutical" (from Greek), is designed to give an air of scientific authority to a rather dark art.

The idea is that nutraceuticals can prevent, ameliorate or reverse disease states; in other words, food is being used as a drug. This type of therapy has great appeal for people who are suspicious of conventional medicine, or who cannot afford it, or who are in denial about their state of health or medical condition.

The January 2008 edition of Scientific American contained an excellent article "Getting to Know Nutraceuticals" that is well worth reading. The article concludes:

For many nutraceuticals, the most compelling evidence for efficacy remains anecdotal or, at best, based on hints of benefit from small or poorly controlled studies.

As I have written before, the marketers of nutritional products have done a remarkably good job in selling products there is no real need for. A good diet is all you need. Just because a small, naturally occurring, amount of a substance prevents (a deficiency related) disease, it does not mean that increasing the intake of said substance will cause good health. It just might, but there is no proof.

For example, a recent study found that vitamin C levels in the blood were a good predictor of whether or not that person was likely to have a stroke. This does not necessarily mean that vitamin C prevents strokes. It would be just as logical to conclude that strokes cause low levels of vitamin C. There is no evidence that either variable is a dependant of the other. They both may be results of a third, unknown factor.

Go to your pantry and read the claims of some nutriceutical products, you will find they tend to be very carefully worded to avoid being classified as "therapeutic goods". In Australia the Therapeutic Goods Act 1989 states that "therapeutic goods" are normally items sold for a therapeutic use defined as follows:

(a.) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals

(b.) influencing, inhibiting or modifying a physiological process in persons or animals

(c.) testing the susceptibility of persons or animals to a disease or ailment

(d.) influencing, controlling or preventing conception in persons

(e.) testing for pregnancy in persons

(f.) the replacement or modification of parts of the anatomy in persons or animals.

Foods are specifically excluded, but once an item becomes a "therapeutic good" it stops being a food, and a different, more stringent, set of rules applies. Vegemite, pictured above, does not make any claims that would make it a "therapeutic good". Contrast this with the following claims of a product chosen at random on ebay. This product specifically says it is not a "therapeutic good" within the definition of the Australian Therapeutic Goods Act..... What do you think?

"Instant Myotrophic Hyperexpansion Growth Kit
Massive Muscle Pumps
Increases Gains in Lean Muscle Mass, Strength and Stamina
Increased Vascularity Stimulates Glycogen Building in Skeletal Muscle
Maximum Vasodilation
Increased Uptake of Amino Acids and Other Nutrients
Increased Male Sexual Performance
Post Cycle Therapy Powerhouse"

In my opinion this comes clearly into (b.) above. How do they get away with it? Probably because no-one has actually examined the advertising.


MY VERDICT

The manufacturers of nutraceuticals are saying on the one hand that their products are worth taking because of the wonderful health benefits. On the other hand they are claiming they should be considered as foods so that they can escape the regulations of the Therapeutic Goods Act.

In the United States both food and drugs are controlled by the same umbrella organisation The Food and Drug Administration (FDA). Perhaps it is time that this model was considered in Australia. It would then be harder for products to be sold with specious claims.

SATIVEX the CANNABIS SPRAY one step closer in Australia

THE CASE

On the 7th of February this year I wrote about Sativex, an oral cannabis spray, being developed by GW Pharmaceuticals for use in controlling the pain and spasticity associated with multiple sclerosis. It has also been shown to be useful for relieving the nausea and vomiting associated with cancer chemotherapy and HIV. The advantage of Sativex is that it frees medical users of cannabis from many of the side effects, and the possibility of legal sanction if they are caught. At the time I expressed the opinion that:

I think it will be a long time before Australian MS sufferers will have the benefit of Sativex. Our populist press would have a great difficulty with "taxpayer funded pot" or "getting high at public expense".

The good news is that the NSW Minister FOR Health, Reba Meagher, has applied to her Federal counterpart Nicola Roxon for permission to import and trial a cannabis based drug, presumably Sativex.

To counter a possible wowser attack, the New South Wales Justice Minister John Hatzistergos said that although the State Government does not support the legalisation of marijuana, it is in favour of medical trials.


Both the Australian Medical Association (AMA) and the Cancer Council NSW have welcomed this initiative.

This is not really new news. As long ago as 2001 the "New South Wales Premier's Expert Working Party on the Use of Cannabis for Medical Purposes" recommended that appropriate regulatory and legislative changes be made to legally permit the use of cannabis for defined serious medical conditions. Two years later, in May 2003, the Premier of NSW, Bob Carr, announced a four-year trial to allow the medical use of cannabis to help control severe pain. Nothing happened.

MY VERDICT

Third time lucky? Lets hope.

Another thumbs down for GLUCOSAMINE

THE CASE

Choice magazine, the publication of the Australian Consumers Association (ACA), has just a released a study indicating that the popular alternative remedy glucosamine is ineffective in treating osteoarthritis.

The ACA researchers examined all the studies on glucosamine published before January 2005 and found that almost all showed that glucosamine was ineffective. Interestingly, the studies with positive findings were all sponsored by an Italian pharmaceutical company.


This finding mirrors the April 2007 results of the American "NIH Glucosamine/Chondroitin Arthritis Intervention Trial" (GAIT)

"Participants taking the positive control, celecoxib, experienced statistically significant pain relief versus placebo--about 70 percent of those taking celecoxib had a 20 percent or greater reduction in pain versus about 60 percent for placebo."

Overall, there were no significant differences between the other treatments tested and placebo.

"For a subset of participants with moderate-to-severe pain, glucosamine combined with chondroitin sulfate provided statistically significant pain relief compared with placebo--about 79 percent had a 20 percent or greater reduction in pain versus about 54 percent for placebo. According to the researchers, because of the small size of this subgroup these findings should be considered preliminary and need to be confirmed in further studies."

For participants in the mild pain subset, glucosamine and chondroitin sulfate together or alone did not provide statistically significant pain relief.

The GAIT study concluded

"People with osteoarthritis should work with their health care provider to develop a comprehensive plan for managing their arthritis pain: eat right, exercise, lose excess weight, and use proven pain medications. If people have moderate-to-severe pain, they should talk with their health care provider about whether glucosamine plus chondroitin sulfate is an appropriate treatment option."

The Choice study also found that some of the commercially available glucosamine preparations did not contain the amount of glucosamine indicated on the label.

MY VERDICT

All of this gets back to an old complaint of mine. There is an official double standard. Complementary medicines are not subject to the same scrutiny of safety, efficacy and good manufacturing practice as mainstream medicines. Let's not forget the Pan Pharmaceuticals fiasco.

NOTE

As an aside, there is absolutely no evidence that the sustained release glucosamine, as touted by the legendary Dawn Fraser, is any more effective than normal glucosamine. Even Bioglan, Dawn Fraser's employer, merely says

"When taken orally, many nutrients only stay available to the body for a short time. After that, they are either passed through the system or become inactive. In a Sustained Release formulation, the nutrient is release over a much longer time frame."

CRYSTAL HEALING for fun and profit

THE CASE

Crystal Therapy

Crystal Therapy uses crystals selected for specific characteristics or wavelength to treat a wide range of mental and physical conditions. It is based on a belief that the body has an energy field that can be influenced by the placement of specific crystals on specific body points. This energy field is often considered to be the same as the "aura" of the body and it's image is what is supposed to be captured by Kirlian photography. Exactly what Kirlian photograpy captures is problematic, but it has been extensively researched and can easily be explained without using the concepts of "life force" and "aura".

"Like us, the Earth is enlivened by life force. As the Earth was forming, life energy was infused into the planet’s crystalline matrices. Thus, the Earth’s gemstones came to embody and express the life force within the planet."

There is a whole industry built around the unproven concept that different crystals have different healing properties. There is not a shred of evidence that:

Amber
Lifts heaviness. Amber is great at lifting the heaviness of burdens -- allowing happiness to come through.

or

Green Fluorite
Balances Hormones. This stone has been helpful with hormonal changes such as PMT and menopause.

or

Tourmaline
Promote male balance and physical healing. It is not recommended for females, use emerald or aventurine instead.

Who writes this stuff? What happened to the poor old Enlightenment?

Electrocrystal Therapy

Electrocrystal Therapy (EleCT) is a late 20th century extension of Crystal Therapy. It was developed by British biologist Harry Oldfield in the 1980s. Working outside his original field of expertise, he extended Kirlian photography into a computer imaging technique he calls Polycontrast Interference Photography (PIP). This creates images of the body's "energetic field".

Following PIP and Electrocrystal Scanning:

"A rebalancing session consists in placing various tubes of crystals on the subject's body, while he/she is comfortably seated and relaxed, for about one hour. After the first appointment, sessions are usually given once a week, and the scanning is repeated once a month or more frequently if necessary.

There is no standard length of time required to complete the rebalancing program; each person is unique and responds differently, depending on his/her history. However, immediate benefits are almost always felt. The degree of balance achieved largely depends on one's commitment towards a long-term energy realignment and maintenance."

Apparently the treatment involves an electromagnetic generator attached to conducting tubes filled with specific types of crystals. These tubes are applied to the body, and some sort of energy is transmitted through them. As with Crystal Therapy it is purported that various types of crystals have different effects on the body. Exactly who decided which crystals do what and how is a mystery. But Electrocrystal Therapy aims to achieve better health by rebalancing the energy fields.

There is absolutely no evidence that:
1. We have an aura or energy fields apart from the four fundamental and measurable forces of physics
2. If we do have energy fields that they can get out of balance
3. Crystals can rebalance these theoretical energy fields

As usual with this type of pseudo-science, the proponents unquestioningly accept the traditional physics, chemistry and medicine that suits them, and reject the bits that don't.

Both Crystal Therapy and Electrocrystal Therapy owe a lot to traditional Tantric texts. Apparently there are supposed to be a number of "chakra points" in the body from which our psychic forces flow. "Chakra" comes from the Sanskrit "cakram" meaning wheel. In Crystal Therapy, crystals of appropriate color and energy may be placed at specific chakra points on the body to energize and to cleanse. Here is one set of chakras and the "useful" stones.
You will note that the order of the colours represents the rainbow, red orange yellow green blue indigo and violet.

Root Chakra – jasper, garnet, onyx, rubies
Second Chakra (womb) – hematite, moonstone
Third Chakra (solar plexus) – citrine, amber, topaz
Fourth Chakra (heart) – rose quartz, Chinese fluorite
Fifth Chakra (throat) – aquamarine, turquoise
Sixth Chakra (third eye) – sapphire, turquoise, amethyst
Seventh Chakra (crown) – clear quartz or amethyst

Again who writes this stuff? Where is the evidence?

MY VERDICT

There is no evidence base for these techniques, neither the safety nor the efficacy have been independently or thoroughly scientifically tested.

It is hard to think of any way that Crystal Therapy could be unsafe, excepting that ill persons may delay seeking medical help.

As Electrocrystal Therapy uses electromagnetic, electronic and electrical equipment the risks are not as clear and safety needs to be more thoroughly studied. Certainly ill persons should not rely on this therapy and delay seeking medical help.

SEXY EYELASHES can be a risky proposition

THE CASE

The purveyors of undeclared prescription items have been at it again. This time a product touted for making eyelashes sexier has been shown to contain some prostoglandins used for treating a serious eye condition.

"Jan Marini’s Australian distributors - Erase Products Management Pty Ltd - today announced that sales of their phenomenally successful product, Age Intervention Eyelash Conditioner, have been suspended in Australia.

This is at the direction of the Therapeutic Goods Administration (TGA), which has determined the product is therapeutic rather than cosmetic, and must be registered on the Australian Register of Therapeutic Goods and sold on prescription only."

The TGA medicine recall is a little more specific:

"This product contains a derivative of the prostaglandins fluprostenol and travoprost (which are prescription only ingredients) and as such the product can only be used under medical supervision."

The TGA considers this a Class I recall, the most serious category, used when:

"defects are potentially life-threatening or could cause a serious risk to health".

Travaprost is an analogue of protaglandin PGF2alpha, and is used in eye drops (Travatan and DuoTrav) to reduce the intra-ocular pressure in patients with open angle glaucoma. Listed side effects include: ocular hyperaemia; ocular discomfort; pruritus; pigment changes to the iris, around the orbit and eyelashes; dry eye, keratitis. The product information further indicates that approximately 50% of users will experience eyelash changes, such as thickening, increased profusion and darkening.


Fluprostenol is another analogue of protaglandin PGF2alpha, but it is not approved for use in Australia. Presumably it has similar effects and side-effects.

So Jan Marini Skin Research Inc have developed a product that exploits this side effect. Their advertising blurb says:

"A Stunning Technology Gives You the Lashes of Your Dreams! Your Lashes Will Appear Fuller, Thicker and More Lustrous!"

The small print also says:

"Age Intervention Eyelash Conditioner is not intended to stop, prevent, cure, relieve, reverse or reduce eyelash loss or to promote the growth of eyelashes."

But what about all the other side effects such as numbness, low blood pressure, low heart rate, sore thoroat, runny nose, skin rash, and altered sense of taste? Is the risk of these really worth while to have darker eyelashes?

MY VERDICT

How do these people continue to get away with such behaviour? The sanction for risking public health should reflect the seriousness of the transgression.

This time the TGA was awake.

NOTES

Coincidentally, or perhaps not coincidentally, the boutique pharmaceutical company, Allergan, has filed a patent protection suit against Jan Marini Skin Research Inc in the US. This forced Jan Marini Skin Research Inc to withdraw Age Intervention Eyelash Conditioner from the US market.

ROSS RIVER FEVER helped by sulfasalazine

THE CASE

Ross River Fever is a viral disease transmitted by some mosquitoes. As a fact sheet issued by the NSW Government says:

Many people who are infected with the virus will never develop symptoms.

• Some people will have flu-like symptoms that include fever, chills, headache and aches and pains in the muscles and joints.

• Some joints can become swollen, and joint stiffness may be particularly noticeable in the morning.

• Sometimes a rash occurs on the body, arms or legs. The rash usually disappears after seven to 10 days.

• A general feeling of being unwell, tired or weak may also occur at times during the illness. This may affect work performance.

The fact sheet goes on to say that there is no specific treatment for the Ross River virus.

But now there is. A team coordinated by the School of Health Sciences, University of Canberra has been working on this problem.

They have just published an article in The Journal of Infectious Diseases (23/04/2008) "Macrophage-Derived Proinflammatory Factors Contribute to the Development of Arthritis and Myositis after Infection with an Arthrogenic Alphavirus" provides some hope. The article indicates that the arthropathy associated with this virus can be treated using the relatively inexpensive drug sulfasalazine, marketed in Australia under the brand names Salazopyrin and Pyralen EN.

Although this drug does not prevent the disease it may also be useful to treat the arthritic symptoms caused by similar viral diseases especially chikungunya that reportedly affects over 6 million people anually in India, Africa, the Western Indian Ocean area, and even Italy. The research team said that this treatment could also be of use in treating the arthritis caused by many other viruses, even influenza.

MY VERDICT

This appears to be an excellent piece of research, not only will it potentially benefit millions of people annually, but the therapy uses an existing, presumably out of patent drug.


NOTE

For further information on this contact Dr. Suresh Mahalingam, School of Health Sciences, University of Canberra, Canberra, ACT 2601, Australia.

ENOXAPARIN the latest victim of the heparin debacle

THE CASE
The Australian Therapeutic Goods Administration has just (22 April 2008) announced that five batches of enoxaparin, marketed as Clexane by Synthelabo, have failed the testing for the contaminant oversulphated chondroitin sulphate (OSCS). These batches have been recalled immediately.

Dalteparin, marketed as Fragmin by Pharmacia, is the only other low molecular weight heparin available in Australia. Fortunately it has been found to be clear of contamination.

This Australian testing has been a reaction to the concerns first raised in the United States after the American drug company Baxter discovered there was a problem with it's heparin, and announced a recall on 17/01/2008, and the FDA issued a warning advisory on 11/02/2008.

The problem is thought to stem from one ore more Chinese heparin manufacturing plants, it was found that some batches of heparin contained up to 20% of OSCS when tested. This contaminant may have been deliberately introduced to bulk out the quantity of heparin - some assay tests for heparin also react to OSCS.

We are still facing a worldwide shortage of heparin, and various authorities should seriously consider shepherding unaffected batches of Clexane and heparinised saline, as well as all batches of Fragmin and heparin. This would be a sensible precaution until supply is stabilised.

MY VERDICT
Medical companies should always rigorously test any raw materials they use. They should not rely on the testing performed by the supplier. There are a lot of greedy people out there who do not care about the consequence of their actions.

Should all products containing CODEINE be PRESCRIPTION ONLY

THE CASE

Pressure has been put on the Australian National Drugs and Poisons Scheduling Committee to consider rescheduling all codeine containing compound analgesics to Prescription Only Medicines (also called Schedule 4). There is even a body of thought that these products be reclassified as Controlled Substances (Schedule 8), because of their addictive potential. They would then have the same status as morphine, dexamphetamine and methadone.

The reason given for this proposed change is that, as compound analgesics containing codeine are available over the counter (Schedule 2 or Schedule 3 depending on Australian State law), there is very little control over them and therefore there is a potential for opiate addiction. For example an addicted person can easily buy a packet of Nurofen Plus, each tablet of which contains 200 mg of ibuprofen along with 12.5 mg of codeine phosphate, but in order to placate their opiate addiction this person would need to take an effective overdose of the ibuprofen component. Unfortunately ibuprofen, along with all the other non-steroidal anti-inflammatory medicines (NSAIDs), causes gastric irritation with the potential for life threatening complications such as duodenal perforation.

Naturally, users (as opposed to abusers) of these analgesics will not be pleased with this proposed change, they will need to see a doctor to obtain a prescription for the relief of a minor, short term, self-limiting complaint. These products are especially useful for treating the severe pain associated with toothache, backache, period pain and severe headaches.

Doctors are unlikely to be pleased, they are already overworked, they do not need this extra patient load.

Pharmacists are already displeased, they are set to lose a major tool in their therapeutic armory, most of their patients who buy strong over-the-counter analgesics really do not need medical intervention.

Medicare (ultimately us taxpayers) will be a loser too. Many of the patients who will seek prescriptions for simple pain relief will be eligible for bulk billing. In addition the doctors are likely to write prescriptions for Pharmaceutical Benefits Scheme (PBS) listed items rather than the non-subsidised over-the-counter analgesics.

Pharmaceutical companies are annoyed, they will lose revenue. Currently over-the-counter medicines are priced according to the free market. But PBS listed items are priced according to a much lower Government imposed formula.


MY VERDICT

Its lose-lose-lose-lose-lose. Why bother to make this change to attempt to help an unknown but very small number of opiate addicted persons? The public benefit really does seem to be on the status quo side of the equation.

If Nurofen Plus is the particular culprit, as indicated in a blog site, then lets make it prescription only, don't generalise this to all over-the-counter mixed analgesics.

NOTES

Other products potentially affected include: Aspalgin, Codalgin, Dolased, Fiorinal, Mersyndol, and Panadeine.

HEPARIN recall - why was the TGA not pro-active?

The Changzhou SPL facility

THE CASE

The Australian Therapeutic Goods Administration (TGA) has just (20/03/2008) announced a safety warning on a heparinised saline. The pharmaceutical manufacturer Astra-Zeneca will ask the TGA for permission to recall all stocks of this drug. It is not yet certain if other heparin products, or even the low molecular weight heparins are involved.

The problem appears to stem from a Chinese heparin manufacturing plant, the Changzhou SPL facility. Apparently there is a significant amount, up to 20%, of an unexplained non-heparin contaminant, oversulfated chondroitin sulfate, in batches marketed by this facility.

Heparin is an anticoagulant, mainly used in hospitals to prevent and treat blood clots during surgery and dialysis. Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin. Although heparin will not dissolve clots that have already formed, it will prevent clots from enlarging. It is derived from cow and pig intestines. This problem is extremely serious as worldwide heparin supplies are threatened, and there are not any real alternatives.

Calcium Heparin crystals

(nothing to do with the article - but beautiful!)

My concern is, that as the American drug company Baxter first announced there was a problem, and a recall on 17/01/2008, and the FDA issued a warning advisory on 11/02/2008, that it has taken another six weeks for knowledge of the problem to seep into the TGA. This is far too long, our supposed watchdog has put Australians health and lives at risk. All of this is on the public record, if I am aware there is a potential problem, so should the TGA.

What is truly ludicrous about this is that after nearly two months of inaction, the TGA has released its warning titled "Urgent safety advisory on use of Heparin products". Ummmm...... why wasn't it urgent six or so weeks ago?

If the TGA were an effective organisation, someone would have rung their counterpart in the FDA on the 18/01/2008, the day after the problem was first publicised. Then the TGA should telephone each of the Australian suppliers of heparin to determine the source of the product. The companies should be able to answer this very quickly, either straight away or at the most within 24 hours. If the Australian distributed product had the same source as the US product, then an advisory should have been issued straight away. I can't see how this process should take more than a week.

MY VERDICT

So the TGA is working at it's customary rate. I have previously illustrated TGA shortcomings with "Influenza treatments under scrutiny" "Maybe it really does send you blind (Viagra that is)" "Zolpidem (Stilnox or Ambien), infant cough preparations", "biphosphonates" and "varenicline (Chantix or Champix)". Please, Minister Roxon, give them a good kick in the bum.

Astra-Zeneca has not behaved very well either, they would have known where their product was sourced, and could have been pro-active. Perhaps they were hoping the problem would go away. Well it didn't.

IS MELANOTAN safe to use?

MELANOTAN the BARBIE DRUG

THE CASE

Melanotan is any analog of the naturally ocurring hormone, alpha-melanocyte stimulating hormone (MSH). The main action of MSH is to stimulate the production of melanin in the skin and hair, making them darker. Melanotan has been called the "Barbie drug", because it purportedly makes you tanned, thin and horny. There are at least three synthetic melanotan compounds, called melanocortin agonists, under development.

Melanotan-I

Melanotan-I is being developed by the Australian company EpiTan, now known as Clinuvel Pharmaceuticals Ltd. It presently has the catchy name of CUV-1647. They are battling with some rules:

Regulatory approval requires that their product is demonstrated in over 1000 patients. So far they have trialled it in 167. Their struggle is that you cannot register a medicine for "sunburn" or "tanning" so they have had to seek out disorders to which it can be applied. They have chosen immuno-compromised patients susceptible to Actinic Keratosis (Solar Keratosis) which can lead to cancer.

They are also considering trialling it for rosacea. Clinuvel does not expect to achieve registration any time soon, possibly in early 2009. The company has also had to ward off imposters, importing products that infringe their copyrights. See

AUSTRALIAN CUSTOMS NOTICE NO. 2007/49 Notices of Objection to Importation Trade Marks Act 1995 epitan and Melano Tan 3/07/20007

When it is released Melanotan-I will be administered by subcutaneous implant - so don't try this at home folks.

Melanotan-II

This compound was being marketed as a sexual stimulant and for sunless tanning. It is a cyclic heptapeptide. The evidence for it's aphrodisiac efficacy was largely anecdotal, but biochemically likely. On 05/09/2007 the FDA issued a warning:

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Brian Manookian, owner of Melanocorp, Inc. in Hendersonville, Tenn. for the illegal sale and marketing of the product Melanotan II, which is not FDA-approved, on Melanocorp's Web site. FDA recommends that consumers who are currently using Melanotan II stop using this product and consult their health care provider if they have experienced any adverse events that they suspect are related to its use.

"This product is being mislabeled, marketed and sold illegally as a preventative against skin cancer and as a tanning agent," said Steven Galson, M.D., M.P.H. director of FDA's Center for Drug Evaluation and Research. "Protecting the public from unapproved products such as this that make unsubstantiated claims and may pose a health risk is a top priority at the FDA."

The FDA cautions consumers about injecting any substance, particularly products that are not FDA-approved, into their bodies without the oversight of a licensed health care provider.

In Australia the Melanotan-II website copout says

Unless otherwise stated, Melanotan-II is intended solely for in-vitro research purposes, It is the responsibility of the buyer to assure that any products purchased from Melanotan-II Australia, including Melanotan-II are approved for use by the TGA and/or their states Misuse of Drugs Act, if applicable.

It is the buyers sole responsibility to ensure that the use or application of MT-II does not breach or infringe any patent, copyright or trademark in the state or territory of the consumer.

The buyer acknowledges that there may be risks involved with consumption or distribution of these products. The listing of Melanotan II on this site does not constitute a license to its use in infringement of any patent. All buyers agree and acknowledge that through their own research and study they are fully aware and knowledgeable about the following: · Government regulations regarding the use of and exposure to Melanotan-II. · The health and safety hazards associated with the handling of Melanotan-II. · The necessity of adequately warning of the health and safety hazards associated with Melanotan II.

In other words the site acknowledges that Melanotan-II is not approved in Australia and it not been proven as fit for human use. It is unlikely that the sellers can absolve themselves from all legal action by the use of fine print - but nice try. The other drawback with Melanotan-II is that it must be injected. I certainly would not inject anything of unknown provenance into myself. At least the water is labelled!

A quick trawl around the Internet uncovered many sites selling Melanotan-II, all with the proviso that their product was not intended for human use. They also extol the virtues and give instructions for use.

MELANOTAN-II AS SOLD - in UNLABELLED VIALS!

Reported side-effects include nausea, flushing and the darkening of existing freckles and moles.

Bremelanotide

Bremelanotide is provisionally named PT-141 or "Passion". Research by Palatin Technologies was halted by the FDA on 30/08/2007, due to it's causing an unacceptably high blood pressure increase. The FDA was also not convinced that the risk/benefit ration was low enough. This compound was being mooted as the only known synthetic aphrodisiac and "the female Viagra". Palatin claims it works by stimulating the brain not the genitals.

It was intended to be used for treating sexual dysfunction in men, both for erectile dysfunction (ED) and impotence, and also for sexual dysfunction in women (sexual arousal disorder). Bremelanotide is compounded into a nasal spray. Despite the side effects the FDA has left the door open for Palatin to continue research into alternate uses for bremelanotide.

MY VERDICT

It would be nice if people who want enhance their body image, by displaying tanned skin, were able to achieve this without the dangers associated with UV exposure in sunlight or in solariums, but none of the melanotans are approved for human use yet.

These melanocortin agonists are promising, but still have a way to go before they can be recommended. Forget Melanotan-II, which presently has to be injected. Forget bremelanotide nasal spray which may cause dangerous high blood pressure. Your best bet is to wait for the Clinuvel (aka EpiTan) product. At least it will have been properly tested and evaluated.

UPDATE

On 17/03/2008 there were media reports that CUV1647 had been granted status as a "orphan drug", this means that it is given a cheaper "fast track" status in Europe, that should lead to phase III testing very soon. This approval only relates relates to it's use to treat the two very rare diseases listed above - not much of an income stream, but this will no doubt lead it to be used off-label as a tanning treatment.

NATIONAL REGISTER for all Australian health care professionals

"Hello everybody, I'm Dr Nick!"

THE CASE

The new Australian Minister for Health, Nicola Roxon is keen to develop a centralised national register for doctors and other health care professionals such as dentists, nurses and pharmacists.

One reason given to support this idea is that a centralised register will help prevent persons moving from state to state to avoid deregistration and other professional sanctions. The scheme was given legs by recent well publicised cases of medical misadventure in several states.

To most of this this seems like a terrific idea. The public could have confidence that their medical professionals were competent and trustworthy. Medical professionals should more easily be able to move from state to state. Currently medical professionals need to seek, and pay for, registration in each state to be able to practice.

But some doctor organisations are outraged. Dr Rosanna Capolingua, the President of the AMA is claiming that the national registration would not result in better patient protection. Frankly the AMA argument is a little hard to follow. I can't see how a centralised registration system can result in worse patient care. It rather looks like turf protection, and it is turf protection that has caused so many of the troubles in the state health care system in NSW and other states. The interests of patients are more important than the self-interests of officials in the AMA and the 12 medical colleges that are standing in the way of this change.

The real problem for these people is they are concerned that eventually external standards will be imposed upon them, currently medical colleges set their own standards. The system of peer accreditation (also called "the old boy network") has merits, but it also has obvious limitations. There is always the possibility (dare I say probability) of favouritism, nepotism, selective blindness, sinecures and rule bending. Most people who have worked in the public health sector will have seen examples of each of these.

The Australian Doctors Trained Overseas Association has a different view, it says that the current medical college system has stopped many overseas doctors from practising in Australia.

MY VERDICT

I wonder if dental, nursing and pharmacist organisations would be similarly discomfited by the imposition of national registration - I rather doubt it.

Judging by the tenacity and determinism of Nicola Roxon, I predict the AMA will lose this one.

FLAME retardants may snuff out Tasmanian Devils

THE CASE

More than thirty five years ago biologists and environmentalists were worried about the presence and accumulation of PCBs (poly chlorinated biphenyls) in the environment. Research into the effects of this group of supposedly inert chemicals led first to their use being highly restricted and then subsequently banned for most purposes.

But the use of the closely related PBBs (polybrominated biphenyls), went largely unnoticed for years. Major doubts about these, and the other brominated compounds used as fire retardants (BFRs), started to appear in the late nineties.

Brominated flame retardants (BFRs) are a group of chemicals added to many products, including computers, electrical equipment, furnishing fabrics and carpets, in order to reduce fire risk. The most suspect BFRs are the PBBs, the polybrominated diphenyl ethers (PBDEs) and tetrabromobisphenol a (TBBP-A).

In 2004 an article "Brominated Flame Retardants: Cause for Concern?" appeared in the journal Environmental Health Perspectives (Volume 112, Number 1, January 2004). The conclusion was that not enough was known about these compounds and that detected biological accumulation is sometimes inconsistent with the measured environmental half-lives. This means that just measuring environmental levels of these chemicals is not a satisfactory measure of the actual environmental effects.

There is a substantial amount of research into BFRs in humans, for example Food Standards Australia and New Zealand released the "FSANZ study of brominated flame retardants in food" in December 2007. They found that levels of BFRs in Australian foods were comparable to those in other countries.

The Australian Government has also released a fact-sheet "Polybrominated diphenyl ether flame retardants (PBDEs)" that outlines concerns and gives advice about the PBDEs. This is largely based on another report "Interim Public Health Risk Assessment of Certain PBDE congeners". This latter report briefly analyses the known health risks associated with PBDEs, including the induction of liver enzymes, effects of thyroid function, developmental changes and reproductive effects.

It is an entirely rational assumption that effects detected in one mammalian species (for example human beings) will also be seen in others. The authors of "A Study of the Presence of Brominated Flame Retardants in Australian Fauna" detected PBFs in Sperm Whales, Altantic Salmon, various raptors and Tasmanian Devils.

How on earth do compounds that start out in carpets and computers end up in Sperm Whales and Tasmanian Devils? Why is the concentration of PBFs in some devils so much higher than in others?

The population of Tasmanian Devils has been decimated by a transmissible cancer the Tasmanian Devil Facial Tumour Disease (DFTD). Most devils seem to be immunologically unable to resist this tumour. The question is are these two things linked. Is the devil's immune system being compromised by the environmental BFRs? Is there any correlation between the devil's PBF level and susceptibility to DFTD?

This is certainly a possibility, as it is known that these compounds may interfere with the function of all steroid hormones, anabolic, sex hormones and the adrenocorticoids. See:

Effects of Polybrominated Biphenyls (PBB) on Immune Response in Rodents Michael I. Luster, Robert E. Faith, John A. Moore Environmental Health Perspectives, Vol. 23, Apr., 1978 (Apr., 1978), pp. 227-232 doi:10.2307/3428765

"These studies indicate that PBB exposure can lead to suppression of both humoral and particularly cell-mediated immune responses."

In other words the ability to fight infections and cancers.

MY VERDICT

The sooner the Brominated flame retardants (BFRs) are removed from the market, the better, both from a human and a wildlife point of view.

UPDATE (19/03/2008)

A report has just been handed to the Tasmanian Government, demonstrating that there is no link between the tissue level of chemicals and the presence of DFTD in devils. The study compared 22 healthy devils with 23 diseased animals. The study noted that there was no detectable 1080, but that the arsenic levels warranted further investigation.

This report in no way removes the need to discontinue the use of brominated flame retardants.

SPORTS DRUG TESTING gets more invasive

THE CASE

The Australian Sports Anti-Doping Authority (ASADA) has been testing the use of Australian Medicare records as part of the new fight against drug cheats called the Pure Performance Program.

ASADA provides various agencies like Australian Customs, Medicare, the Australian Federal Police (AFP) and the Therapeutic Goods Administration (TGA) with the details of elite athletes and asks them to share information. In the case of Medicare it seems that they are searching the Pharmaceutical Benefits Scheme (PBS) records for matches between the athletes names and the use of anabolic steroids, human growth hormone and other banned drugs.

This is an invasion of privacy, but athletes are used to doing very private things in public like providing a supervised urine sample whilst totally naked. Privacy invasion needs to be seen as part of the deal of being an elite athlete.

They have to be naked while giving the sample to prevent substitution, such as tried by this jockey:

"Warrington had left the track when he was asked by Queensland Racing stewards to come back to provide a urine sample for precautionary drug testing.

Acting chief steward John Hackett became suspicious of Warrington's actions while he attempted to give a urine sample and caught him squeezing urine from a dildo concealed inside his pants." - The Age 02/03/2007

There does not appear to be anything illegal in ASADA's action, as it checks the Privacy Act provisions and the legislation governing each agency with the Australian Government Solicitor before data is extracted.

I have a different concern though.

If athletes obtain drugs legally through their doctor and the PBS, then the identity and quality of the drug is assured, and it is used in a supervised environment, so athletes know exactly what they are using. Illegally obtained drugs are much more problematic, they are often veterinary products such as stanazol, they may be contaminated, and the actual components may differ from the label. Because of the chance of forensic search of their Medicare records, athletes may now resort to the more dangerous and uncertain black market drugs.

On 02/11/2007 I wrote:

"Only yesterday a young (early twenties) man assured me that stanazol was safe to use. Studies in several countries have demonstrated that the majority of anabolic steroids bought in gyms or on the street are fake. They are sometimes veterinary medicines and sometimes not even steroids. There is even a batch going round that is labelled "Steriod" instead of "Steroid"....and people are still willing to inject the contents!"

But as "Dr Ben" writes

"There is just too much money in pro sport and amateur sport (read The Olympics) for the use of roids to go away. The public wants to see people run faster, jump higher, hit harder, grow bigger etc, etc, and this will not happen without the use of roids. The reason? For the last 30-35 years athletes have been using them and despite todays detection methods will continue to use them because they have methods of avoiding detection that will always put them one step ahead of the IOC or whichever hypocritical governing body that tries paradoxically to stamp out the very means by which the Olympics have become such a money spinning phenomenon.

There is no doubt about it, roids, hgh, and igf are all potentially dangerous drugs, as is any drug. I DO NOT support the use of black market roids in an unmonitored fashion. I FULLY SUPPORT the use of legalized roids in a medically monitored manner. There is a ton of evidence in the medical literature which shows the harm minimisation that can be achieved with sterile needle programs, regular blood tests, and physician monitoring of roid users."

MY VERDICT

Athletes with nothing to hide have nothing to fear.

But anybody associated with sport at any level will tell you that it is very easy, too easy, to obtain illegal performance enhancing drugs. Maybe "Dr Ben" is right, that performance enhancing drugs are so entrenched in sport they will never be controlled, so we need to embark on harm minimisation instead. I sincerely hope not.

BOLIVIA asks UN to legalise coca leaf but not cocaine

Coca leaf (Erythroxylon coca)

THE CASE

Most gringos travelling in the high Andes of Bolivia and Peru, will have seen and probably been offered coca leaf to chew as an antidote to altitude sickness. They probably have also been given mate de coca (coca tea). It as an acquired taste but it works. Tourists will usually see piles of coca leaf for sale in the local markets.

mate de coca

Coca (Erythroxylon coca) has been cultivated for hundreds, possibly thousands, of years in the Andes. During the Incan and Spanish rules the Quechua and Aymara Indians chewed the leaves to alleviate hunger, combat fatigue and control altitude sickness. This tradition has carried forward until present day.

In the late 1980s, at the behest of the US, the United Nations (UN) classified coca leaf along with cocaine as a controlled substance. Legal and prohibited zones for growing coca in Bolivia were mapped out, and then US funded military and paramilitary operations were mounted to destroy illegal crops.

More recently the UN called upon the Andean nations to criminalise the chewing of coca leaves, and to to establish as a criminal offence the use of the leaf to make tea, flour and other products. This will anger the many Bolivian Indians who are currently legally entitled to cultivate up to 40 square metres of coca plant for personal use.

Now the President of Bolivia, Evo Morales, has said that Bolivia will petition the UN to have coca leaf reclassified. President Morales calls coca The Sacred Leaf (hoja sagrada) and says it is not harmful and should not be confused with the drug cocaine extracted from the leaf. "Coca no es cocaína" is his catch cry. The process is said to be rather complex as the leaf usually contains only 0.2% cocaine.

We should note that President Morales is a former coca farmer, and he was re-elected last month as the head of the coca-growers association. There is nothing underhand about this, he has always campaigned for, and was elected as a representative of the coca growers.

President Morales has a massive fight on his hands. As the president of one of the worlds poorest countries, he has to take on the might of the United States. He is lobbying very hard, with the only obvious support coming from Fidel Castro of Cuba and Hugo Chávez of Venezuela.

As an aside the committee representing the coca farmers sent a resolution to the UN to demand that "international companies that include in their commercial name the name of coca refrain from using the name of The Sacred Leaf in their products".

Unsurprisingly Coca-Cola responded with a statement that its trademark "the most valuable and recognised brand in the world" was protected under Bolivian law. Well if parmesan cheese can only come from Parma in Italy and burgundy can only come from the Burgundy region of France, maybe coca can only come from the high Andes - it sort of makes sense, almost.

MY VERDICT

It is extremely culturally insensitive of the United Nations to insist on banning the traditional use of coca leaf. Any such ban would be counter-productive as it would drive the whole industry underground and into the hands of the black marketeers, as it is in Columbia. Those pressing for this ban haven't even managed a cogent case.

Remember what happened in the U.S. during the terrible prohibition years. Learn from history!

INFLUENZA treatments under scrutiny

THE CASE

The US Food and Drug Administration (FDA) and Roche pharmaceuticals met last November to discuss the incidence of psychiatric disturbances and even suicide deaths related to osteltamivir (Tamiflu). The results of these discussions have just been made public, along with recommendations that the consumer drug information be modified to include specific warnings.

Meanwhile, GlaxoSmithKline the manufacturers of the competing influenza treatment drug zanamivir (Relenza), are concerned that their product is also associated with psychiatric changes, but so far no deaths have been linked to Relenza. GlaxoSmithKline says that the evidence so far is circumstantial and does not definitely indicate a connection.

The common thread is that the neurological problems are seen mainly in children. Apparently twenty-five patients under the age of twenty-on have died, most of them in Japan. Five of these deaths were from children falling from balconies or running into moving traffic. All of the deaths were related to Tamiflu and not to Relenza, but both are associated with neurological problems.

The main difference between the two drugs, is that Tamuflu is taken orally in capsule or liquid form, while Relenza is inhaled directly into the lungs using a special inhalation device. Possibly the Relenza is mainly retained in the lungs rather than being distributed to the whole body as is Tamiflu.

Because of the patchy occurrence of these neurological side effects, other factors may be at play, such as genetic differences in the Japanese population or even that some strains of influenza may cause these behavioral changes. These need to be ruled out before the drugs are blamed.

The current Australian Consumer Medical Information (CMI dated April 2007) for Tamiflu says:

"People with influenza including those taking TAMIFLU may be at an increased risk of confusion and in rare cases accidental injury. Please ensure that you monitor how you are feeling throughout the treatment period. Your doctor should be contacted immediately if you notice any signs of unusual behavior."

The latest CMI for Relenza, dated August 2007, does not mention anything about behavioural changes.

MY VERDICT

Even though there is a paucity of information about the neurological changes caused by taking Tamiflu and Relenza, let's play it safe. The CMI for both products needs updating to include a specific warning of the potential for these drugs to cause neurological changes in children. TGA are you awake?

NOTE

Neither of these drugs are subsidised under the Australian Pharmaceutical Benefits Scheme (PBS).

IS REFLEXOLOGY more than a wallet massage?

THE CASE

The proponents of reflexology say it is a holistic therapy based on the principle that all parts of the body are reflected in the feet, hands and ears. By using a series of pressure techniques the therapists claim they can do wonderful things like restoring the flow of energy blocked by stress, illness and toxins.

Examine several different reflexology charts, and two things immediately become apparent -

Firstly, there is no rationale or proof as to why particular organs are reflected in particular places. Why, for example, is the voice on the inside of each big toe, or the bladder on the inside of each heel? Who said so? How did they find out? Where is the proof?

Secondly, different charts show the reflected organs in remarkably different places. Even if reflexology does work it must be very hard for the therapist to find the kidney or the heart, they wander around so much. Perhaps the charts are made deliberately inaccurate so that the uninitiated aren't tempted to perform the therapy themselves, or maybe they just drew the charts to look pretty.

The existence of Human Energy Flow is fundamental to reflexology, it is the same as or at least similar to Qi in Traditional Chinese Medicine - but it has never been demonstrated to exist. Reflexology proponents have developed elaborate charts or maps, and protocols of treatment without first proving or even demonstrating that there is even such a thing. Ten years ago a study concluded:

"the existence of 'human energy fields' and the ability to detect them remains extraordinarily doubtful."

A major criticism of reflexology, is that the therapists are not medically qualified, something not necessarily understood by their clients. Patients with serious or even life threatening illnesses have been known to delay proper treatment by consulting a reflexologist first.

So without Human Energy Flow, what can reflexology offer? You may get a relaxing foot or hand massage, as a result your stress levels may fall for a short while, and don't forget that the placebo effect is amazingly powerful. It is extremely unlikely that it will:

• improve your sleep


• boost your lymphatic system (except in your feet)


• detoxify your system


• affect all your body systems


• improve your circulation


• promote your body awareness (whatever that is!)


• increase your vitality


• balance your nervous system (again what does this mean?)


• abolish head, neck and back aches


• fix muscle and joint strains and aches


• overcome digestive problems such as diarrhea and constipation


• cure colds and flu


• stop travel sickness


• soothe period pains


• help infertility (unless your are really attracted to the therapist)
  

all of which are described as "proven benefits" in reflexology literature, but with absolutely no supporting evidence. In the US the National Council Against Health Fraud (NCAHF) recommended that:

"NCAHF advises practitioners and consumers of reflexology to be skeptical of therapeutic claims beyond the ability of foot massage for relaxation. Health professionals should be cautious about recommending practitioners who make, or encourage patients to believe in, unproved claims that reflexology is a valid method for assessing health status or for the treatment of diseases."

In Australia most reflexologists follow the Ingham method, which was developed mainly to help reduce tension caused by stress. As long as a patient realises that reflexology is not a substitute for proper medical diagnosis and treatment, it probably does no harm, and may even give temporary relief.

There are plenty of spin-off products emulating reflexology. There are a plethora of massage shoes, sandals and inner soles that make spurious claims such as "shoes that help improve your health and well being". There are even products that try to combine the two unproven therapies of reflexology and magnetism - nice one! These products a a tribute to human ingenuity, some of them are fun, but they are not therapeutic.

As Quackwatch says:

"Whether that is worth $35 to $100 per session or is more effective than ordinary (noncommercial) foot massage is a matter of individual choice. "

MY VERDICT

What more can I say? Reflexology may be an entertainment, but it is not a legitimate therapy.

WEAKNESSES in Australian medicine regulation

THE CASE

The Australian newspaper published an excellent article by the chairman of the Consumers Health Forum of Australia (CHF), Mitch Messer, on 01/03/2008.

As I have written before the two rules of medication are:

1. Medicines should do no harm, or at the very least the benefits should outweigh the risks.

2. Medicines should be proven to be effective in treating the conditions they purport to treat.

The article clearly explains the difference between listed and regulated products.

"The main difference in the regulatory process is that the TGA evaluates data from clinical trials to determine whether or not a registered medicine has the effects that are claimed for it. Listed products, on the other hand, are simply assessed for quality and safety. While companies are supposed to be able to provide TGA with data supporting the claims made for these products, TGA does not routinely request and assess this data."

In other words registered medicines must comply with both of the above rules, while listed medicines must only comply with "rule 1". There is some sort of weak provision for the sponsors of listed medicines to indicate that they hold evidence of effectiveness, but this is largely ignored and unenforced.

In an ideal world sponsors of new medicines should have to answer to a third rule:

3. New medicines must have demonstrable advantages over medicines already on the market.

One reason for this rule is to prevent drug companies rushing "me-too" products on to the market, that subsequently prove to have disadvantages over existing products. MSD did this when they rushed the Australian marketing of Vioxx (rofecoxib) to combat the already marketed Celebrex (celecoxib). Unfortunately Vioxx was quickly shown to increase the risk of heart attack among patients using it for more than eighteen months. This may have been known even before Vioxx was marketed in Australia.

Another example is the waste of resources by each major pharmaceutical company producing a lipid-lowering "statin" (more correctly but less conveniently called HMG-CoA reductase inhibitors). These different drugs are just variations on a theme:

• Atorvastatin
• Fluvastatin
• Pravastatin
• Rosuvastatin
• Simvastatin

are all currently available in Australia, and there is more difference in the packaging than there is in the therapeutic effect (despite what the drug reps. are programmed to tell doctors). Several other "statins" have already come and gone.

MY VERDICT

The chance of "rule 3" happening in Australia is unfortunately remote. The lobby group Medicines Australia will make sure of that.

The chances that listed medicines will be forced to comply with "rule 2" are slightly brighter.

IS HOODIA safe to take for weight loss?

THE CASE

Hoodia for weight loss, is an extract from the South African succulent Hoodia gordonii. The hype for this product says that it has been used for centuries by the Kalahari San Bushmen to reduce their craving for food in times of famine. By a leap of logic it is assumed that it will therefore help obese westerners to lose weight.

The Hoodia gordonii plant is a protected species under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). So only only Hoodia gordonii farmers with permits can grow and sell hoodia products. It is illegal to collect the wild plant as there is very little indigenous plant left in its native environment. But the plant continues to be collected for a the black-market and scam industry offering the product as a wonder drug for dieting. The plant is now considered endangered under CITES. If you buy hoodia consider that you may be contributing to the extinction of this endangered species.

Because it is protected under CITES it is generally illegal to import hoodia into Australia without matching CITES import and export permits. Shipments will be seized. See "Get the Facts on Hoodia".

Investigation of the properties of hoodia resulted in a compound named P57 being identified in 1977, this substance can purportedly reduce the need for food by up to a thousand calories daily. Some multinational drug companies including Pfizer and Phytopharm (or Unilever) then invested in hoodia research.

Hoodia is remarkably difficult and time consuming to propagate commercially, either by seed or from cuttings. After a false start by Pfizer in Kununurra Western Australia, another company is trialling hoodia near Carnarvon Western Australia. The proposal is to increase the stocks of hoodia sufficiently for commercial use in Australia and also to provide a "bank" for the eventual rehabilitation of the South African environmental population.

Hoodia gordonii

Is hoodia safe to take?

The FDA have received applications for hoodia products but say:

"The agency concluded that the information submitted did not appear to be adequate to establish that a dietary supplement containing the new dietary ingredient was reasonably expected to be safe."

That being said, I can find no well documented side effects to, or drug interactions with, hoodia.

Does hoodia work for weight loss?

There is plenty of anecdotal evidence that it does, plenty of testimonials, plenty of endorsements by the slightly famous - but not much else. An example is the late Anna Nicole Smith's endorsement of hoodia:

"It's really hard to eat, because, for me, it's like I've lost my appetite. So I have to really, really push myself to eat."

This sound more like anorexia nervosa than hoodia to me.


What about synthetic hoodia (P57)?

Pfizer dropped out when it found that synthesising the active ingredient was too difficult and expensive. So it looks like it has to be extracted from the plant.

Hoodia patches

There are many companies that market hoodia patches. They claim their products are more effective than taking it orally, because the hoodia works faster by bypassing the stomach and reaches the bloodstream directly through the skin. There are no evidence based studies to back this up, and it does not even make sense. The oral dose of hoodia recommended is usually 2,000 to 4,000 mg daily. The patches usually contain only 10 mg of hoodia. With 200 to 400 patches stuck on you would look like a well travelled suitcase.

Beware of other hoodia scams

Many (or more likely most) of the products available contain little or no hoodia. Worldwide there is simply not enough cultivated or wild hoodia to account for all the products that claim to be hoodia. One survey estimated that 80% of all hoodia products were fake.

MY VERDICT

Hoodia is probably safe to take for weight loss. It may even work, but the chance of obtaining real hoodia seems to be only about 1 in 5. Then if you do manage to get real hoodia you may be contibuting to the demise of the species Hoodia gordonii in it's natural habitat in the Kalahari Desert. Illegally collected hoodia is also denying the San Bushmen of their rightful intellectual property from which they should benefit.

The adverts sometimes claim that apart from suppressing the appetitive, hoodia also raises your mood and gives you energy. So far there is absolutely no evidence for this.

TAIPANS are less dangerous than PNG public officials

Taipan - Oxyuranus scutellatus

THE CASE

Taipans are one of the most dangerous snakes in the world. They have large amounts of very potent venom, long fangs, make accurate multiple strikes and can be very aggressive.

Before the legendary Ram Chandra helped the Commonwealth Serum Laboratories develop the first Taipan Antivenom in 1956, a taipan bite was almost certainly fatal. In fact one of the first lives saved, was Ram Chandra's own when he was bitten while demonstrating taipan handling to a group of ambulance officers in Mackay.

In an uncanny echo, New Guinea taipan expert Dr David Williams was bitten while demonstrating taipans to a television documentary camera crew, his life was saved by the only vial of antivenom left in Port Moresby Hospital.
Dr Williams has helped uncover a black market in Taipan Antivenom. He highlighted two different scams. The first involves antivenom imported through official channels from Australia, about 25% of it simply disappears. 634 vials worth at least 2 million kina remain officially unaccounted for. These stolen vials reappear, and are available for private purchase at a premium. The second scam involves the unofficial importation of antivenoms that are not designed to treat the local taipan. Dr Williams says :

"anti-venoms from other countries that are not only useless for treating PNG snake bites, but also potentially dangerous in their own right".

MY VERDICT

This man is a hero (as was Ram Chandra).

Compare his actions to the miserable low-life that steal a publicly owned resource for their own financial benefit. It is worse because the high public officials, doctors and pharmacists who are complicit in this trade are betraying their position of public trust.

These people are guilty of man-slaughter by causing the needless death of those bitten by taipans but who have been denied treatment. They really need to be exposed and charged.

THE TAIPANS

Inland Taipan or Fierce Snake - Oxyuranus microlepidotus
Eastern Taipan or Coastal Taipan - Oxyuranus scutellatus
Papuan Taipan - Oxyuranus scutellatus canni
Central Ranges Taipan - Oxyuranus temporalis

TAKING ZOLPIDEM safely using harm minimising strategies

HOW NOT TO TAKE ZOLPIDEM

THE CASE

Despite public anxiety, the Australian Therapeutic Goods Administration (TGA) decided this week (21/02/2008) not to ban Zolpidem or even reclassify it as a "Controlled Drug" also known as "Schedule 8". So be it, we are not party to the facts they considered, and for the time being let us assume they have made the right decision.

If zolpidem is to remain on the Australian market then it must be used correctly.

TO PRESCRIBERS (DOCTORS)

The official indication for zolpidem is "Short-term treatment of insomnia in adults". Don't prescribe it for continuous therapy, it isn't indicated for this nor did Sanofi test it for this.

Write prescriptions for the smallest quantities necessary. Preferably specify seven tablets or at the maximum fourteen tablets, no more. Some authorities consider that it may be malpractice to prescribe more than fourteen tablets at a time.

If you really must write repeat prescriptions then please specify the time interval before the repeat can be filled by the pharmacy.

Do not write prescriptions for large quantities in the mistaken belief you are doing patients a favour by saving them money.

The correct dose is always one tablet at night, the tablets are available as 10mg, 6.25 mg or 12.5 mg. The latter two strengths are "controlled release" tablets where the drug is released more slowly into the blood stream.

The dose for elderly or debilitated patients is 5 mg at night (half a 10mg tablet).

The patient will not gain any therapeutic benefit from taking more than one tablet at night, however the likelihood of side-effects will increase.

Remember to write "Take one tablet at night only if needed", not "Take one or two tablets at night" and definitely not "Take as directed".

Never, ever, prescribe zolpidem to children, teenagers under 18 or alcohol abusers.

Be wary with patients who have psychiatric disorders, substance abuse history, respiratory disease, liver damage, kidney disease, depression, psychosis, schizophrenia, epilepsy or who are pregnant or breastfeeding.

TO PHARMACISTS (CHEMISTS)

Everything above plus:

Don't dispense more than fourteen tablets at a time just because the doctor has written a larger quantity. It is your professional responsibility. The TGA has also recommended this.

Don't offer to save the patient money by dispensing the original prescription and the repeats at the same time, this is legally and morally wrong.

Issue a CMI available here.

Counsel the patient to store sleeping tablets safely - not within reach of the bed and preferably in a different room.

Instruct patients not to drink alcohol whilst taking zolpidem.

The correct instruction is "Take one tablet at night only if needed for sleep". If the prescriber has written a higher dose remember that you are a professional - query the dose!

TO PATIENTS

Listen to your doctor, don't request larger quantities.

Listen to your pharmacist, don't expect more than fourteen tablets at a time.

Read the information the pharmacist has provided (CMI). Available here.

Don't take zolpidem every night, it will stop working.

Don't take more than one tablet at night it won't help, and you may regret it.

Store your tablets out of reach of your bed, so your can't accidentally take multiple doses while you are drowsy.

TO THE FAMILY OF PATIENTS TAKING ZOLPIDEM

Read the information provided by the pharmacist. Available here

Don't let the patient take more than one tablet, it is dangerous.

Don't let the patient drink alcohol while taking zolpidem, it is dangerous.

Don't ignore even a single episode of bizarre behaviour, get help immediately. See here for some reported episodes.

TO INTERNET AND DISCOUNT PHARMACIES

SHAME ON YOU! A quick check on the net showed that Australian Online pharmacies are still listing multiple packs of zolpidem, despite the TGA recommendation. I found prices for Stilnox 10mg Tablets 14 x 3, Stilnox CR 6.25mg 14 Tablets x 3 and Stilnox cr 12.5mg 14 Tablets x 3. Newspaper adverts for discount pharmacies also showed these in the price lists. Just because you are offering "cheap" medicines it does not mean the rules don't apply to you. It is illegal for you to dispense the original prescription and the repeats at the same time. It is also unprofessional and immoral.


MY VERDICT

If everybody followed the advice above, zolpidem would probably be a very safe drug. However I predict that the TGA will reschedule it within twelve months.

RELATED STORIES

"Zolpidem tall tales and true make sad reading"

"Sleep drug zolpidem facing withdrawal?"

"Heath Ledger - another victim of zolpidem?"

"Further restrictions on zolpidem likely in Australia"

"Heath Ledgers cocktail - what happened to the zolpidem?"

DUROGESIC fentanyl patch withdrawal does not affect Australians

DUROGESIC RESERVOIR PATCH

THE CASE

Janssen-Cilag the makers of Durogesic pain relief patches have recalled all batches of the 25 microgram/hr patches in the US. Other companies have also recalled batches of their fentanyl patches including Sandoz and Abrika.

The reason for the recall is that it is possible that some patches:

"may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel."

The defect is a possible cut in the drug reservoir that may allow the drug gel to escape, posing the danger of a narcotic overdose to anyone touching the gel. In addition the patient may receive a sub-therapeutic dose, leading to ineffective pain control.

Anyone who comes in contact with this gel should immediately wash the area with large amounts of cool water, do not use hot water or soap.

Fortunately the patches marketed in Australia do not have a drug reservoir, they are more sophisticated matrix style patch. Therefore Australian patches do not have this problem and will not have to be withdrawn.

Fentanyl is an opoid, and Durogesic patches are indicated for chronic pain requiring opioid analgesia. It is subsidised on the Australian Pharmaceutical Benefits Scheme (PBS) for "Chronic severe disabling pain not responding to non-narcotic analgesics".

As an aside it is worth noting here the storage and handling instructions for Durogesic. The Consumer Medical Information (CMI) for Durogesic says (in part):

"DO NOT expose the patch to direct heat from electric blankets, heat pads, heated water beds, heat lamps, intensive sunbathing, hot water bottles, saunas or hot spa baths while you are using DUROGESIC. Direct exposure to such heat may cause an increase in the amount of fentanyl absorbed by the skin."

"Disposal
The contents of DUROGESIC patches may be retrieved and abused by addicts. Fold used patches so that the adhesive side of the patch sticks to itself, wrap and dispose of carefully in the garbage."

MY VERDICT

At least we don't have to worry about this recall.

I wonder if this is one of those drug company power plays. They find fault in their own product, so withdraw it from the market, and by association cause the competitors products to be withdrawn also. But they alone have an alternative product and so are able to corner the market.

In this case the all the gel reservoir style patches will be withdrawn leaving only Janssen-Cilags matrix style patch.

This is not paranoia theory at work, there are well documented cases of this in the past.

ZOLPIDEM tall tales and true make sad reading

THE CASE

Because of my recent articles highlighting the dangers of zolpidem (marketed by Sanofi as Stilnox, Stilnoct and Ambien), "Sleep drug zolpidem facing withdrawal?" "Heath Ledger - another victim of zolpidem?" "Further restrictions on zolpidem likely in Australia" and "Heath Ledgers cocktail - what happened to the zolpidem?" I have been invited to sign a petition titled "Ban Stilnox, Imovane and related sleep medications".

The case for the petition is well presented, and quite compelling. The petitioners have so far collected over three thousand signatures. Here are some unedited extracts from comments attached to the petition. Remember they are anecdotal only, they have not been tested for truthfulness, and the usual quota of "Big Pharma" haters are represented.

I had my one and only blackout after taking this awful drug- during the blackout I unknowingly took another 4 stilnox and had a fight with my then boyfriend.

He went home, took a Stilnox, then walked back past his friends home to the local railway line, waited in a tunnel and killed himself in front of the next train.

....went driving after taking Stilnox the other week and wrote off her car. Luckily she didn’t kill herself or anyone else, and woke up on the couch in the morning without remember a thing....

....sleep walking out of a hotel room - thank god it was into the corridor (albeit locking myself out of my room, in my pajamas), and not off a balcony....

I had one friend who 'came to' at his sink holding a pair of scissors and he had cut most of his hair off.

....my uncle died while using stilnox - sleep driving

My father was taking Stilnox at the time he died by jumping 83 metres to his death at Fitzroy falls, NSW. I would like his death not to have been in vain.

....my partner has been experiencing Stilnox-related parasomnia - manifesting as night-time wandering the streets, night-time bing eating and unknowingly slashing my throat.

He slept walked over his balcony plunging to his death!

MY FIRST ACCIDENTAL SUICIDE ATTEMPT I ALMOST DROVE OFF A BRIDGE WHILE DRIVING HAVING TAKEN ONLY 1 STILNOX.

As someone who has used stilnox in the past and experienced the 'sleep sex' side effect, I support the ban.

Ex-husband addicted to them. Takes then during the day, and is constantly falling, Hospitalized a week ago due to fall. He suffers memory lapses, abusive behaviour. Frightened what will happen next.

At first, the frantic ironing and making popcorn at 2 or 3am were quite funny; however he had no memory of any of this and he nearly burnt the house down when he melted a plastic comb on the popcorn maker!

I had a frightening reaction to taking this drug. Frightening because I did something that was out of character with my normal behaviour. Fortunately, I was with my family that evening who protected me from myself.

My mother was on stilnox for over 2 years culminating in a severe amnesia episode and permanent memory damage.

....Father died in car accident on the 18/12/07 as he was sleep driving due to Stilnox - Just got out of bed and went for a drive in his sleep at around 4am.

I lost my husband when he rode his motorbike under the effect of stilnox.

Last year we were prescribed Stilnox for a long international flight - 1 whole tablet for myself and husband and half each for our two teens. We had asked our doctor for a VERY MILD sleeping tablet. My husband and I were completely ''Knocked out" and were unable to be woken by cabin staff when our teens started to display unusual behaviour. Our son was crying uncontrollably whilst our daughter was hallusinating with abnesia and completely wet her pants- so much so that we had to throw out her shoes because of the stench!

I recently lost a brother to sleep-driving - he was taking Stilnox!

After taking the drug, my personality underwent a complete change where I ordered all sorts of advertised products late at night, believed I was going to join the fire brigade and more.

....i know someone who put a heater under her doona, only to be caught with her housemate finding her.

I couldn't remember what I've done. I was smsing people and could not recall.

....my body was parallaysed but I wanted to jump out of my bedroom window.

....i had server side effects amnesia, driving problems, unexplained brusing, waking up outside watering the garden....

....my brother's death in December '07 we strongly believe was due to 'sleep driving' while on the drug 'stilnox'

She suffered sleepwalking (smoking while doing so)....

My partner lost two days after taking stilnox on a thursday night.....To this day she still has no memory of the episode

My friend woke up and had lost three days; her car was parked erratically in her drive way and all of the car doors were open

If it wan't for my husband I would have been wandering the streets half naked. My husband stopped me from walking out. He also found me cooking in the middle of the night, naked on the trampoline in my back yard at 2am, stopped me driving off in our car

During taking Stilnox I binge ate at night--knew I was doing it but was unable to control it. Withdrawal was very difficult and I gained 6 kg while trying to withdraw

....Luckily my family were around and brought me inside where I began to have discussions with figures in tapestries that to me were alive.

....the family has fun repeating some of it though. like naked in front yard at 3am trying apparently to organise a party. had 3 baths overnight.

I took stilnox and walked out of my house in my pj's and drove my company car around the suburb and eventually crashed into a parked car. I still have no memory of this. I wrote of my company car and lost my job

....suddenly fell asleep while riding her bicycle. She received extensive injuries when she fell in front of a car....

....i have woken up half naked in the middle of the night km's away from my home. this itself has caused me trauma.shame and the feeling of being crazy.

....a fire started in her apartment due to sleep cooking on Stilnox.

What would you do if you received an email congratulating you on your purchase on EBAY of a motor vehicle which you had apparently successfully bid on several evenings ago, but again you have absolutely no idea of when and why you made such an online bid....

Once I found him outside in his jocks talking to the letterbox I can laugh now but at the time it was very very scary

My wife found me semi-conscious on the kitchen floor after taking it- God only knows how long l'd been there.

MY VERDICT

These comments make depressing reading, although not scientific, they do indicate a pattern. They can't all be due to a fervid imagination or from vested interests. Before I read these comments I was not in favour of banning zolpidem, just restricting its use. Now I am not so sure.

NOTES

Amongst the comments attached to the signatures there are a number of common misapprehenions that out of fairness need correcting:

Heath Ledger did not die of a Stilnox overdose, in fact the enquiry into his death found no Stilnox in his blood stream.

Stilnox has not been banned in the US or anywhere else (yet).

Stilnox is not a subsidised medicine on the Australian Pharmaceutical Benefits Scheme, and never has been.

Neither the Australian Government nor the TGA profit from the continued marketing of zolpidem (Stilnox). There is no official vested interest in it either way.

Doctors do not profit from prescribing Stilnox. There is no kickback scheme, any such scheme would contravene so many laws that it would be in neither the drug companies nor the doctors interests to be party to it.

ORAL TERBINAFINE is not a first line treatment for skin infections

THE CASE

The Therapeutic Goods Administration (TGA) has recently issued an alert for the oral antifungal drug terbinafine, sold in Australia under many brand names including Lamisil by Novartis (see NOTES below). The TGA reported that three people had died and about seventy others had suffered significant liver damage.

Terbinafine is oficially indicated to treat adults with ringworm when topical treatment has been tried not worked. It is also used to treat fungal nail infections. These are hardly life threatening conditions, so a doctor should not prescribe terbinafine lightly. Apart from sometimes (the manufacturer says rarely) causing liver problems, tebinafine also ocassionally causes a whole gamut of side-effects including blood abnormalities, raised cholesterol, skin rashes, muscle pains, headache and nausea. It might also cause kidney abnormalities and retinal abnormalities.

The conditions for prescribing terbinafine under the Australian Pharmaceutical Benefits Scheme (PBS) medicine are:

"Proximal or extensive (greater than 80% nail involvement) onychomycosis due to dermatophyte infection where topical treatment has failed. This infection must be proven by microscopy or culture and confirmed by an Approved Pathology Authority. The date of the pathology report must be provided at the time of application and must not be more than 12 months old."

Because the conditions being treated are relatively trivial, and the (addmittedly rare) potential consequences are so dire, a prescriber should consider the risk/benefit ratio every time terbinafine is prescribed. The TGA gives an example with this case:

"One patient, a 79 year old female developed agranulocytosis about 2 months after initiation of terbinafine, and died from septic shock despite treatment with granulocyte colony stimulating factor and antibiotics."

Death is a particularly unsatisfactory outcome for a patient undergoing treatment for a relatively minor skin infection. The TGA warning concludes:

"Patients taking terbinafine for longer than a month should be advised to be alert for any symptoms of possible infection/neutropenia, such as fever, sore throat or mouth ulcers. Total white blood cell count and neutrophil count should be checked if symptoms develop since a delay in diagnosis is likely to be associated with an increase in morbidity and mortality."

Other regulatory authorities around the world are now watching terbinafine following the TGA warning.

If you are taking terbinafine and develop fever, sore throat, mouth ulcers, "flu-like" symptoms (chills, aching joints, swollen glands, lack of energy) any other signs of infection tell your doctor immediately. Make sure to have any blood tests done that are ordered by your doctor, these tests are used detect side effects on your liver, kidneys and blood.

MY VERDICT

Oral terbinafine should only be used once ALL possible alternatives have been vigorously tried. It would be better for GPs to refer patients to Dermatologists than to experiment with oral terbinafine. It is simply not worth the risk.

None of this applies to the topical forms of terbinafine such as Lamisil Cream and Lamisil DermGel both also marketed by Novartis. A patient is unlikely to absorb enough terbinafine through the skin to cause systemic side-effects.

The TGA were awake this time- congratulations!

NOTES

Brands of oral terbinafine marketed in Australia are Lamisil, Tamsil, Terbihexal, Terbinafine GenRx, Terbinafine-DP, Terbinafine Pharmacor and Zabel.

AUSTRALIAN PHARMACISTS divided over medical certificates

THE CASE

As part of the dreaded "WorkChoices" package, the then Minister for Health Tony Abbott announced that all health professionals, as defined under State Law, would be entitled to issue medical certificates. It was

"a direct result of the Howard Government's 2006 WorkChoices legislation, which gives employers much greater scope to demand medical certificates than they used to."

Whilst pharmacists are without doubt the most accessible of all the health professionals, the various community pharmacy industry groups behaved exactly to script.

The Pharmacy Guild of Australia (PGA) rubbed its metophorical hands at the mere thought of dollar signs. The Guild is the association of pharmacy proprietors, its role is to look after the (mainly financial) interest of it's members.

The Pharmaceutical Society (PSA) is a largely educative organisation, dedicated to improving the professionality of all pharmacists. The Society set about developing a set of protocols and standards.

The Australian Medical Association (AMA) was so annoyed that its president called pharmacists "non-medical people", another spokesperson hinted that patients were going to die, and said pharmacists were not qualified or professional enough to decide when a patient was unfit for work. Besides which the $20 or $30 was better off in doctors rather than pharmacists pockets.

I think most pharmacists would be insulted to be labelled along with iridologists, ear candlers and astromancers as "non-medical people". Perhaps the AMA is expecting this kind of thing, "I certify that Audrey Smith is unfit to work on 14/02/2008 because Mercury is already in retrograde, and the Moon enters Gemini as the Sun trines with Mars." or more likely "Purchase cough and cold medicines to the value of $40.00 and for only $10.00 more receive a bonus personalised 2 day medical certificate!"

But the Brisbane Courier Mail reports that:

"patients are asking time-pressured GPs to write twice as many medical certificates as a decade ago, apparently to meet employers' demands."

so doctors should really consider it a blessing.

The upshot is that the Pharmaceutical Society of Australia (PSA) and the Pharmacy Guild of Australia (PGA) have issued joint guidelines that specify whether a pharmacist should write a certificate or if it is would be more appropriate to refer the patient to a doctor. The process outlined by the PSA guidelines is rigorous, professional and fairly onerous.

However the union representing employed pharmacists has recommended that its members refuse to issue them. Geoff March the President of the pharmacists division of the Association of Professional Engineers Scientists and Managers Australia (APESMA) said that pharmacists simply have neither the time nor the facilities to issue medical certificates.

A survey of pharmacist indicated that about one third would issue certificates, one third would not, and the final third were fence sitters.

MY VERDICT

See, everyone was conforming to script. The Pharmacy Guild looked forward to the profits, the Pharmaceutical Society designed protocols, the AMA says "We wuz robbed !" and the union (APESMA) wants higher wages for less hours work.

DISCLOSURE OF INTERESTS

I am not a member of any of the organisations named above.

COMPLEMENTARY HEALTHCARE COUNCIL of Australia resists sensible reforms

THE CASE

The fundamental principals of medicines are

1. They should do no harm (product safety)
2. They should be effective (product efficacy)

The Complementary Healthcare Council of Australia (CHC) is resisting the introduction of controls that would indicate whether or not alternative medicines were effective. The CHC is the peak body representing the overall complementary healthcare industry in Australia.

The idea presented to the Parliamentary Secretary for Health, Senator Jan McLucas, was that therapeutic claims for complementary medicines supported by hard scientific evidence should entitle that medicine to be identified by the consumer as being efective. The specific idea presented by Ken Harvey of the School of Public Health at La Trobe University was a green tick, similar to the National Heart Foundation's red tick.

"The industry group Complementary Healthcare Council is strongly opposed to Harvey's reforms, which include a disclaimer on product labels to explain that the "listing" process used by the Therapeutic Goods Administration to approve most alternative products does not mean that the products have been assessed for efficacy by the TGA."

The CHC is being a little disingenuous:

“Ingredients used in Listed complementary medicines have been reviewed by the Complementary Medicines Evaluation Committee and determined to be safe. Sponsors of complementary medicines are required to hold evidence of their efficacy and certify so at the time of listing. Advertising of all nonprescription medicines whether via broadcast or mainstream print is subject to pre-approval under a coregulatory process and advertising copy must conform to the strict requirements of the Therapeutic Goods Advertising Code. Dr. Harvey appears to lack understanding of the checks and balances built into the system”

The CHC addresses the issue of safety by saying that the Complementary Medicines Safety Committee reviews the ingredients - fair enough. But the words "Sponsors of complementary medicines are required to hold evidence of their efficacy and certify so at the time of listing" dodge the question of efficacy. The words imply that no-one is going to look at, or assess such evidence no matter how weak, such as "Auntie Audrey took it for a week and now she feels much better".

In 2003 the Australian Skeptics awarded the CHC "The Bent Spoon Award":

"The deciding factor was when the CCHA asked the government for several million dollars to educate the public about alternative medicines. This request was in response to the discovery that Pan Pharmaceuticals, Australia's largest manufacturer of alternative medicines, had quality control procedures which were so lax that the only facts about a product which could be accepted without question were that the bottles were made of glass and the boxes were made of cardboard."

There is a voice of dissent. Another complementary medicines industry organisation called Ethical Complementary Medicines said the regulatory system "should be changed so that the public can be told clearly whether or not there is scientific evidence to support the efficacy of a particular product". In other words good old Evidence Based Medicine (EBM).

Hear hear!

MY VERDICT

Knowingly selling ineffective products is actually stealing. It is nothing more than consumer fraud.

SIMPLE WAYS to reduce drug overdose and suicide

THE LATE MARILYN MUNROE

THE CASE

Modern medicines are very effective and surprisingly safe. However they can still be abused, either accidentally, unintentionally or on purpose. No amount of attention to labelling or drug information supplied to the patient by a pharmacist can prevent a young child from swallowing a bottle of attractively coloured capsules. Similarly a person intent on self harm is not going to stop and read the label. The recent death of Heath Ledger provided a good example of this.

Here are some very simple and obvious measures that regulatory authorities, prescribers and drug manufacturers can take.

1. Package tablets and capsules in platforms or blisters.
If it is time consuming to remove the medicine from the packaging children may become discouraged, or nauseous before they have taken a harmful doses. Adults attempting suicide have to be quite dedicated to remove a toxic dose before they start swallowing them.

EXAMPLES OF ACCEPTABLE PACKAGING

Child proof closures on conventional medicine bottles are better than nothing, but they are not good enough. Even when tightened correctly they are not child-proof, and adults often do not tighten the cap adequately when re-closing the bottle. They are no barrier to an adult intent on self harm.

NOT CHILD-PROOF JUST CHILD-DELAYING

2. Encourage doctors to prescribe non-fatal quantities.
It is simple malpractice for a doctor to prescribe huge quantities of any drug - prescribing twelve months or even six months supply is unreasonable. This is usually done with good intentions for economic reasons. This is no justification for prescribing 100 sleeping tablets or 100 strong pain killers just to save money. This is just providing the means of suicide, as for Marilyn Munroe pictured above or possibly Heath Ledger.

LOOSE TABLETS ARE NO LONGER ACCEPTABLE

3. The maximum pack size for any medicine should reflect its toxicity.
This is so obvious, and it is rarely taken into account. For example, if a fatal overdose of aspirin is somewhere between 50 and 100 300mg tablets then the maximum allowable pack size should be 50 tablets. Similarly is the aspirin tablets are 325 mg then the maximum pack should be about 40 tablets (certainly not 500 as below).

ENOUGH ASPIRIN TO KILL ELEVEN PEOPLE!

If the medicine is a liquid intended for children then the total volume in the bottle should be a non-fatal dose. For example paracetamol (acetaminophen in the US) is reported as starting to cause liver damage with a dose of about 10 grams (10,000mg), therefore the largest amount of children's paracetamol mixture allowed in a package should be less than this. One common preparation is 200mL of 240mg/5mL. This equates to 9.6 grams (9,600 mg), so this is good, responsible packaging. Of course they must have child-resistant closures.

The worst culprits of all are the Internet medicine pushers. On the pretext of providing a financial savings, they provide ludicrously unsafe quantities of medicines. I have seen Viagra in 100's and Stilnox (Ambien) in 100's advertised. There are no checks an balances on the Internet (as and aside comment medicines purchased on the Internet are often fake, you do not know exactly what you are buying).

MY VERDICT

These measures save lives, let's make all medicines as safe as possible.

It is false economy for health authorities to encourage generic prescribing and dispensing, when the generic brands are poorly packaged in bulk containers.

UPDATE on the anti-smoking drug varenicline

THE CASE

On 12/12/2007 I wrote about some psychiatric side effects of the anti-smoking drug varenicline marketed in Australia as Champix and in the US as Chantix. My complaint was that the Therapeutic Goods Administration (TGA) had allowed this new drug onto the market and the Pharmaceutical Benefits Advisory Commitee (PBAC) had approved it as a subsidised Pharmaceutical Benefits Scheme (PBS) medicine without the Consumer Medical Information (CMI) including the latest warnings about the possibility of serious psychiatric events.

see ANTI-SMOKING drug's serious side effects ignored

The FDA has just issued (01/02/2008) a Public Health Advisory on Chantix, the Agency asked the manufacturer to add some new safety warnings:

Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug's approval.

Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

Patients should immediately report changes in mood and behavior to their doctor. Vivid, unusual, or strange dreams may occur while taking Chantix. Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

Meanwhile according to press reports Pfizer is working with TGA on rewording the Australian warnings to mirror the US warnings. A quick check on the TGA web site today (11/02/2008) did not indicate that varenicline was a drug of interest to them.

MY VERDICT

Varenicline seems to be the most effective drug yet developed for aiding smoking cessation, but the merit of its efficacy does not absolve the manufacturers and authorities from making it use as safe as possible.

HEATH LEDGERS cocktail - what happened to the zolpidem?

THE CASE

Immediately after Heath Ledger was found dead in his New York apartment, it was reported in the press that he died from an overdose of zolpidem. It seems that this conclusion was reached because Heath had previously (in November 2007) said in an interview that even two zolpidem tablets only gave him an hours sleep. A container of zolpidem was also reportedly found in his bedroom, it was assumed that he had taken them just before he died.

In my article "Heath Ledger - another victim of zolpidem?" I wrote

"According to media reports the Australian born actor Heath Ledger was taking zolpidem in the months leading up to his death. Zolpidem is, and never has been recommended for more than short term use, but it seems that he was taking it more or less continuously and in higher doses than prescribed."

So it was bit of a surprise when the New York City's Chief Medical Examiner announced that the was accidental, but there was no zolpidem in his bloodstream. The announcement said:

"We have concluded that the manner of death is accident, resulting from the abuse of prescription medications"

The drugs found in Heath's bloodstream were:

Three benzodiazepines - alprazolam, diazepam and temazepam.

Two opiods - hydrocodone and oxycodone.

And doxylamine a sedating antihistamine.

First lets examine the benzodiazepines (the following applies in Australia, but it would be similar in other countries).

Alprazolam is indicated for "short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression". The product information for one brand says

"Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished and that these medications should either be eliminated or given in reduced dosage in the presence of alprazolam"

The patient information for all brands of alprazolam, instructs the patient to tell their doctor or pharmacist if they are taking other sleeping tablets, sedating antihistamines or narcotic analgesics (for example the opioids).

Diazepam is indicated for "anxiety disorders or short-term relief of anxiety symptoms; acute alcohol withdrawal; muscle spasm".

Temazepam is indicated for "adjunctive therapy in short-term management of insomnia in adults". The patient information for all brands of temazepam, clearly warns about, and lists, other medicines may increase the sedative effects of temazepam.

So although these drugs are in the same class they are marketed for different purposes. A patient could take alprazolam for anxiety, diazepam for the spasm of backache and temazepam for insomnia. This would be very inappropriate therapy as the side effects, especially the sedative side effects, are additive, even though the wanted therapeutic effects may not be.

Similarly the opiods hydrocodone and oxycodone are both indicated for "moderate to severe pain". There is absolutely no reason to take both. Again the respiratory depressant and sedative side effects are additive.

The sedating antihistamine doxylamine is available without prescription in many countries, is is indicated for the "short-term relief of insomnia" or "temporary sleeplessness". The product information for one brand says it

"produces an additive effect when administered with other CNS depressants such as opioid analgesics, neuroleptics, alcohol, hypnotics and psychotherapeutic drugs."

MY VERDICT

Health professionals can only help patients who want to be helped.

It seems that Heath Ledger was taking a potent cocktail of six drugs each with sedative and respiratory depressant side effects. The freely available patient information for each of these drugs clearly warns about mixing them. Moreover the doctors he consulted and the pharmacists who dispensed his prescriptions would have warned him IF THEY HAD KNOWN HE WAS TAKING THIS COCKTAIL. Therefore he was probably aware that the drugs interacted with each other but chose to ignore the warnings. It is even possible hat he consulted many different doctors and patronised different pharmacies, on purpose, so there was no overall record of his drug history.

This is a sad case of drug abuse. Even though all the drugs are legal drugs, legally obtained, it is still intentional drug abuse. His death may have been accidental but the drug abuse was not.

Zolpidem is off the hook for this one, but this doe not change my opinion of it as a drug. See Sleep drug zolpidem facing withdrawal? and Further restrictions on zolpidem likely in Australia.

CANNABIS SPRAY Sativex is coming slowly to a country near you

THE CASE

Sativex, an oral cannabis spray, is being developed by GW Pharmaceuticals for use in controlling the pain and spasticity associated with multiple sclerosis. Apparently it is just as effective for many other types of chronic pain including cancer.

Health Canada approved the use of Sativex in early 2005 where it is distributed by Bayer Healthcare.
In the US, GW Pharmaceuticals and Otsuka Pharmaceutical Co announced on 26/11/2007 that:

the first US Phase II/III dose-ranging trial has been initiated to evaluate the efficacy and safety of Sativex in the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.

Meanwhile the lobby group "Republicans for Compassionate Access" are trying to provide Republican legislators with information on the medical use of marijuana and make it part of the debate in the race for the presidency.

On 13/12/2007 the British Medicines and Healthcare products Regulatory Agency (MHRA) published a report called the "Public Information Report on Sativex Oromucosal Spray UK/H/961/01/DC" that effectively recommended its approval by the MHRA:

"In conclusion the safety profile is considered acceptable in principle for the proposed population and indication, providing sufficient efficacy is demonstrated. However important safety issues that as yet are not clearly quantified and occur during the week trial period. It will be necessary to demonstrate clear potential efficacy if these issues are to be outweighed so that a positive risk-benefit might be concluded."

Some doctors in Scotland, frustrated by the years of delay, have preempted British authorities and have started using it legally, by obtaining supplies directly from the manufacturer.

Coincidentally, on the 5/02/2008 a report from New Zealand was released that showed that regular smoking of cannabis causes periodontal disease, resulting in tooth loss in the worst cases. The heavier the use the worse the disease. The study was controlled for external effects such as pre-existing gum disease. And less than a week ago a team from the Department of Allergy, Immunology and Respiratory Medicine at Monash University concluded that heavy cannabis smokers get lung disease 20 years earlier than cigarette smokers.

The advantage of Sativex is that it frees medical users of cannabis from this type of side effect, and the possibility of legal sanction if they are caught.

Honest officer, it's just for personal use!

MY VERDICT

I think it will be a long time before Australian MS sufferers will have the benefit of Sativex. Our populist press would have a great difficulty with "taxpayer funded pot" or "getting high at public expense". Until then medical users will have to flout the law and set themselves up for lung and dental disease.

MAGNETIC treatment for all illnesses

THE CASE

There is an amazing array of magnetic devices on the market that purport to treat a diverse range of human (and even animal) illnesses. Browsing through the Internet revealed a range of magnetic devices that included pillows, underlays, body supports, innersoles, spas, jewellery and veterinary products. If there are so many products available, surely there must be some therapeutic benefit? Well - no, not really.

In the US the FDA considers static magnet therapy as useless but harmless, and there have been some successful prosecutions against vendors making outlandish claims of being able to treat specific conditions such as cancer.

Most rigorous studies found that magnets were of no benefit. One of the few studies that did demonstrate a benefit with magnets (and naturally the one most quoted) was discredited on the grounds that two of the researchers failed the "nul hypothesis" test, in that they had previously used magnets to treat their own pain, therefore they were not disinterested parties to the study. Moreover as this study was supposed to be the pilot study for a larger study never carried out, the results were never intended to be definitive.
Examine this diagram. It purports to show that the induced field in magnetised blood cells would cause the cells to separate. For a start there is not enough iron in red blood cells for the field from even the most powerful magnet to overcome the other forces acting on blood cells in liquid blood. Secondly even if the field did predominate, it would cause the cells to clump, as the north pole on one cell attracted the south pole on its neighbour and so on, just like iron filings. This is exactly the opposite of what is claimed.

For a history of magnetic therapy see the chapter "the Magnetisers" in the excellent book "Extraordinary Popular Delusions and the Madness of Crowds" By Charles Mackay. Although this was first written in 1841 it will give you a good idea of the culture of this industry. Not much has changed.

The following was the mode of operation: -- In the centre of the saloon was placed an oval vessel, about four feet in its longest diameter, and one foot deep. In this were laid a number of wine-bottles, filled with magnetised water, well corked-up, and disposed in radii, with their necks outwards. Water was then poured into the vessel so as just to cover the bottles, and filings of iron were thrown in occasionally to heighten the magnetic effect. The vessel was then covered with an iron cover, pierced through with many holes, and was called the baquet. From each hole issued a long moveable rod of iron, which the patients were to apply to such parts of their bodies as were afflicted. Around this baquet the patients were directed to sit, holding each other by the hand, and pressing their knees together as closely as possible to facilitate the passage of the magnetic fluid from one to the other.

This eighteenth century fad is no sillier than this item that I just found on eBay, the magnetic stirrer or magnetic wand. Unusually for this type of device it comes with a complete explanation on how it works. Unfortunately it is a load of pseudoscientific codswallop (or bunkum if you are American), and it is written in English that is almost as poor:

We are shown by physics that chemicals and water are able to change weight by being influenced by magnetic fields. There are more hydroxyl ions created in order to form bicarbonate, calcium, and other alkaline-type molecules. These molecules are what help reduce the acid from the traditional pH level of seven or greater. Magnetism also has an affect on the bonding angle between the oxygen atom in a water molecule and hydrogen. This causes a hydrogen-oxygen bond angle within the water molecule that is reduced from 104 to 103 degrees. In turn, the water molecule begins to cluster in groups of six or seven, rather than the normal level of 10 to 12. The smaller the cluster, the better the water absorption across the cell walls.

MY VERDICT

Don't waste your money.

GET CANCER in less time with Marlboro Intense

THE CASE

The think-tank at Philip Morris, the tobacco company that recently brought you the Heatbar, is at it again. They have another new and innovative product.

To help the beleaguered office bound smokers get a quick nicotine fix, Philip Morris is testing a new product in Turkey (and probably other countries) called Marlboro Intense. It is physically not as long but delivers the same amount of nicotine as a standard Marlboro Red. It is the short potent cigarette designed for busy people. Here is a table to help you:

(I refuse to rewrite this in Imperial measurements, I have my limits.)

So you don't have to spend so much time in the snow or the rain, the cold or the wind, you will soon be able to buy this mini cigarette termed "snack size" from the kind and thoughtful people at Philip Morris. If the company's predictions are correct this will be the first of a wave of similar products.

It is probably no accident that this new product has appeared simultaneously with the separation of Philip Morris from it's parent company Altria. The feeling is that

the move would free the tobacco giant's international operations of legal and public-relations headaches in the U.S. that have hindered its growth.

The separate entity, for example, would be exempt from U.S. tobacco regulations and out of reach of American litigators. Importantly, its practices would no longer be constrained by American public opinion, paving the way for broad product experimentation.

MY VERDICT

There is nothing accidental about the design of a cigarette. They are intended to addict you to nicotine quickly, and to keep you addicted. Nicotine addiction is probably the hardest addiction to overcome.

As the anti-smoking guru Professor Simon Chapman says "cigarettes are a drug delivery system".

EZETIMIBE plus simvastatin has no extra benefit - except to the makers

AUSTRALIAN PACKAGING OF EZETIMIBE

THE CASE

The drug ezetimibe is co-marketed in Australia as Ezetrol and as Zetia in the US, by Merck Sharp & Dohme and Schering-Plough. It is approved for use to treat high cholesterol. In the official product information it is described as a "cholesterol intestinal absorption inhibitor".

Ezetimibe is also marketed under the brand name Vytorin in several different combinations with the venerable lipid-lowering drug simvastatin. Vytorin became available under the Australian Pharmaceutical Benefits Scheme (PBS) on 01/02/2006. Only two months later the manufacturers became aware of a probable lack of efficacy, but neglected to publicise this information.

There was a comprehensive study of the efficacy of the various Vytorin combinations called the ENHANCE clinical trial. On 25/01/2008 the FDA issued an "Early Communication" indication that there was concern with the clinical trial results and that the FDA will be analysing the data further, before recommending any action.

"This communication is based on information that FDA has not yet fully evaluated. FDA is not advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available."

The reasons for the concern are that there was no greater lowering of the amount of cholesterol deposited with the ezetimibe/simvastatin combination than with simvastatin alone. However the ezetimibe/simvastatin combination has a greater incidence of side effects than simvastatin alone.

This is the worst possible result for the drug company. The combination appears to be adding to the potential risk to the patient without adding any benefit.

"There are no clinical studies available that demonstrate a reduction in risk of heart attack or stroke when ezetimibe is used alone or in combination with a statin, including the fixed-dosed combination drug of ezetimibe and simvastatin"

There really does not seem to be any point in taking ezetimibe with or without a "statin" such as simvastatin.

The whole episode gets murkier. In the US the House of Representatives, Committee on Energy and Commerce is holding an investigation into why Merck Sharp & Dohme and Schering-Plough withheld the results of the ENHANCE trial even though it finished in April 2006.

“In light of today’s results, which were released nearly two years after the ENHANCE trial ended, it is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data ........ It’s currently unclear whether these companies knew that adding a new expensive drug accomplished nothing more than an established, cheaper, generic."

I hope that the Therapeutic Goods Administration (TGA) in Australia is awake and takes early action on this information. The TGA website does list Vytorin as a "Drug of Current Interest".

The Pharmaceutical Benefits Advisory Committee (PBAC) needs to look at the listing of items containing exetimibe and restrict the benefit to patients already stabilised on this therapy - at least until the matter is clarified.

MY VERDICT

With behaviour like this it is no wonder that the general public is deeply suspicious of the pharmaceutical giants. There is a feeling that profits are more important than public health to these companies.

Lets not forget that it is only about three years since Merck Sharp & Dohme had to quickly withdraw it anti-inflammatory drug Vioxx (rofecoxib), because it was implicated in increasing heart attacks and strokes in long-term users.

If you are taking the ezetimibe either alone or in the ezetimibe /simvastatin called Vytorin, and you are concerned, please see your prescriber.

DRUG PROMOTION has some benefits

DEGUSTATION at the GUILLAUME RESTAURANT

THE CASE

Last year the Australian Competition and Consumer Commission (ACCC) declared that "educational" events organised by drug companies for doctors must be recorded in a systematic manner. This was a condition of the ACCC's renewal of approval of the drug industries code of practice.

The drug companies representative body Medicines Australia, previously known as Australian Pharmaceutical Manufacturers' Association, was initially opposed to monitoring and recording of these events because they were to onerous. However they have now relented and appointed an independent auditor as a monitor. The monitor, Deloitte, will report retrospectively on events from 01/07/2007 to 31/12/2007, and Medicines Australia will publish the results on its website http://www.medicinesaustralia.com.au/. The report will be available in February 2008.

On the positive side, these events are a good opportunity for doctors to receive continuing education, too keep up with the latest developments and to network. The hard pressed government health systems should be providing these educational and peer support events, but there is no real money public money available.

Medicines Australia puts it like this:

“I hope people will recognise that these events are important in educating doctors about new medicines and the quality use of medicines. I also hope that this audit gives the community confidence that the manner in which these events are conducted is closely and effectively monitored.”

Good corporate behaviour does not come naturally to multinational companies, especially the pharmaceutical giants. Drug company sponsorship of an event can mean the information provided is one sided, incomplete or even misleading. Let's face it, if they have spent squillions of dollars on developing a drug they need some return. The marketing arms are tempted to do (almost) anything to beg, cajole, bribe, blackmail, trick or even force doctors to prescribe their product. It is on public record that Roche spent $65,000 on a single night event for just 300 doctors (some media reported only 200), at the Guillaume Restaurant Bennelong Point, this is not exactly "simple and modest" as required by the industry code of conduct.

The harbourside restaurant boasts a “degustation” menu of sterling caviar, kingfish sashimi and the best of French and Australian wines. The meal was priced at more than $200 a head, and the whole night cost Roche over A$65,000. I know that for fact because a disgruntled diner leaked me a copy of the bill. “The gluttony of the whole thing was mind-blowing,”

More DEGUSTATION at the GUILLAUME

Judges on the Australian Federal Court, in June 2007, handed down a decision, against the Australian pharmaceutical industry. They found that excessive hospitality ran the risk of altering doctor's decision making and that the drug companies would not bother to offer these junkets if there was no benefit to them. This is reminiscent of the arguments for and against tobacco advertising.

MY VERDICT

Fortunately our doctors are an intelligent lot, and most of them will attend just for the free feed, the flesh-pressing and the talks. Some of them might even like the (usually tawdry) gifts, but most are probably not swayed in their prescribing, at least consciously. Subliminally, however, they may have a leaning towards the products named on their pen, or scribble pad, or from the rep that gave them a bottle of good red at Christmas. That is human nature.

In a funny sort of way the drug companies are performing a public service. They are educating our doctors at no discernible cost to the public, by holding an estimated 10,000 events each year. They are also keeping the cost of healthcare down by giving doctors free pens.

NOTE

Medicines Australia says:

If you have any concerns in relation to the activities of a prescription medicine company or wish to lodge a complaint please contact the Secretary, Code of Conduct Committee at Medicines Australia on 02 6282 6888 (9.00am – 5.00pm Monday to Friday) secretarycodecommittee@medicinesaustralia.com.au.