A tale of two health systems
Yesterday the Therapeutic Goods Administration (TGA) withdrew Prexige from Australia and ordered a national recall of the medication. The generic name of Prexige is lumiracoxib and it belongs in the same class as Vioxx, a drug that in 2004 was also precipitously removed from the world marketplace. Although they both belong to the class of COX-2 anti-inflammatory drugs, Vioxx was withdrawn for causing heart attacks while Prexige has been withdrawn for causing liver damage. The manufacturer, Novartis, has just flushed several hundred million research and marketing dollars. Novartis has supported the TGA, no doubt with clenched teeth and a sense of grim resignation, and reported the TGA’s decision to health administrations in sixty other nations.
The TGA acted after receiving information that Prexige was linked to eight cases of liver damage, including two deaths and two liver transplants from among the 60,000 Australians using the drug. The information was presented to the TGA on Friday. Yesterday, which was Saturday, as I was walking in to work, Alistair and Mark from the pharmacy next door stopped me to show the fax that the TGA circulated to all Australian pharmacies and medical practices overnight. I’m pleased to say that I have not initiated Prexige for any of my patients, but I have 16 packs of Prexige samples sitting in my cupboard unused and now unusable. I might keep them for museum pieces.
This dramatic drug recall reminded me of another story. While I was attending an obstetric and gynaecology update course, one of the speakers remarked that the last two liver transplants in Brisbane were due to a drug used to relieve menopausal symptoms called black cohosh.
Nobody knows exactly how black cohosh works, but the most likely mechanism is that it contains phytoestrogens, that is, plant molecules that mimic the effects of oestrogen in mammals. Phytoestrogens were first discovered when farmers in parts of Australia, New Zealand, and the UK noticed that their ewes were not falling pregnant at the normal time. These sheep were grazing in pastures with heavy growths of clover. The same pattern turned up in fields rich in alfalfa and dry medic that had been attacked by aphids and fungi respectively. The plants were producing chemicals that mimicked oestrogen and interfered with the reproductive hormones of the grazing sheep. The effects could be disastrous.
Norman Adams of the CSIRO wrote a key 1975 paper on phytoestrogen chemistry:
Bennetts et al. (1946) described severe clinical abnormalities in sheep grazed on highly estrogenic subterranean clover pastures. This syndrome, called “clover disease,” included very low lambing rates, prolapse of the uterus and dystocia in ewes and enlargement of the bulbo-urethral glands and death in wethers. Severe metritis, pyometron and hydrops uteri were also observed.
What this technical language means is that sheep who grazed on clover fields tended to have fewer pregnancies (this is how the contraceptive pill works in humans, so that’s no surprise), but also had problems such as having lambs get stuck in their birth canal during labour, permanent anatomical changes to their genitalia including having the uterus hanging out of the vagina, not to mention infections and sometimes big collections of pus in their uteri, and the small matter of a few deaths. Just the sort of thing we should be advising women to ingest.
Adams reported that clover fields had no effect on rams, but this was a premature conclusion. A year later, H.R. Linder reported that natural phytoestrogens from red clover caused castrated male sheep to develop “lactation, squamous metaplasia of the bulbo-urethral glands and urethral stenosis.” In plainer words, the males started leaking milk from their nipples, developed a protocancerous disease of their reproductive organs, and had severe narrowing of the outlet to the bladder. Just the sort of thing men should be taking.
Having said that, we don’t know for certain that black cohosh actually has an oestrogenic effect in the same way that clover and alfalfa do. The National Center for Complementary and Alternative Medicine (NCCAM) in the US cites nine papers to the effect that, “[t]he possibility that black cohosh exhibits estrogenic activity has been studied but the evidence is contradictory.”
One explanation of why black cohosh may has no oestrogenic effect is that it may actually be ineffective for menopausal symptoms after all, despite its popular use for that purpose. Two recent well-designed studies showed that black cohosh had no benefit. Last month, a team of Seattle researchers concluded in the journal Menopause that “none of the herbal interventions showed significant effects on any outcomes at any time point.” In December last year, the Annals of Internal Medicine published another large trial with even worse news for herbal treatments, including black cohosh:
[Symptoms measured on four scales]…did not differ between the herbal interventions and placebo at 3, 6, or 12 months or for the average over all the follow-up time points (P > 0.05 for all comparisons) with 1 exception: At 12 months, symptom intensity was significantly worse [my emphasis] with the multibotanical plus soy intervention than with placebo (P = 0.016).
So here we have a treatment, black cohosh, that is almost certainly of no benefit in reducing menopausal symptoms. If the recent studies are wrong and black cohosh does help, then it probably works in the same way as naturally-occurring compounds that were discovered because they cause serious disease and death in large mammals. Whether it works or not, black cohosh may be linked to as many cases of liver transplantation in Queensland alone as Prexige in all of Australia.
Unlike Prexige, black cohosh has not been removed from the shelves of pharmacies and health food shops. You can even buy liquid cohosh for children. Unlike Prexige, manufacturers are allowed to market black cohosh as a treatment of menopausal symptoms despite the best evidence showing it has no benefit. Unlike Prexige, black cohosh maintains supporters who do not accept the evidence and instead invent increasingly strained conspiracy theories to explain why their golden child continues to fail in well-conducted studies. (Corrupt mainstream scientists are bent on discrediting the noble complementary health industry and the National Public Radio is a “cheerleader for corporate power and war” for reporting the findings.) The NCCAM, which was ostensibly set up to evaluate alternative medicines for the public, has not included any of the recent data on its public information pages. The Menopause paper has only just been published, but the Annals of Internal Medicine paper is nine months old. Meanwhile, the NCCAM has not updated its public information webpage on black cohosh since June last year. The NCCAM was set up with informing the public as one of its explicit purposes and it is funded to the tune of over US$120 million per annum, not including donations. It is not good enough.
Interestingly, the same Australian TGA that stripped Prexige out of Australia with an urgent recall, addressed the liver concerns about black cohosh back in May. The TGA reported that black cohosh was linked to 47 cases of liver damage worldwide and nine cases in Australia, two of which resulted in liver transplants. The TGA did not recommend it be removed from sale. “Considering the widespread use of Black cohosh, the incidence of liver reaction appears to be very low.” This is a dubious conclusion as we have almost no hard data on the use of black cohosh in Australia. Black cohosh is not prescribed; it is made by many different manufacturers and sold through many different retail outlets; and there are no central records on sales let alone on actual use in the community. The TGA did however declare that black cohosh formulations would henceforth require a warning label, to read:
Warning: Black cohosh may harm the liver in some individuals. Use under the supervision of a healthcare professional.
Manufacturers of black cohosh were given twelve months to comply with the edict to place this rather mild warning on their products, a decision that the natural health industry regarded as “a tough stance” and “a gross over-reaction”. A professor of complementary medicine commented that, “There is no plausible mechanism to understand how black cohosh damages the liver, if it does.” At the same time, “If [black cohosh] is effective it is a shame that people will be deterred from using it.”
This illustrates the cognitive divide between biomedical science and complementary medicine. In complementary circles, standards of biomedical evidence are used selectively. There is no plausible mechanism for black cohosh causing liver damage, so we do not need to take the adverse findings seriously. On the other hand, there is no known mechanism for black cohosh relieving menopausal symptoms either, but that doesn’t stop the professor from recommending it. In fact, he thinks it would be a shame if women were discouraged from using black cohosh. From my point of view, I think it would be a shame if a woman developed liver failure due to a treatment of unproven benefit for a non-fatal condition.
Which raises the question of why Novartis was not permitted to continue selling Prexige with the same warning label and given twelve months grace. The answer, it seems to me, is that Australia has two health systems. One is based on research, economic practicalities, and self-appraisal while the other is based on wishful thinking, deceptive practices, and passionate disregard for evidence. Paradoxically, it is the biomedical system that is governed nearly to despair while the alternative health system is allowed to flourish — Australians spend twice as much on complementary medicine as mainstream medicine — with virtually no legal, government, or media scrutiny. Even regulatory bodies such as the TGA apply different standards to the two systems. The system that collects evidence is flogged with it while the system that shirks evidence is given free rein.
What a pity human physiology doesn’t change depending on what sort of clinic you walk into.
19 People have left comments on this post
This commentary is very perverse. One would reasonably expect the withdrawal of yet another ‘biomedical’ medicine, would be cause to question the process by which these drugs are approved. Instead, the writer attempts to distract from this issue, and remarkably, instead attacks the sale of complementary medicines. I suggest this is very fuzzy logic, and hardly an association that is helpful in addressing the issue in question. Banning Black Cohosh is not going to make one ioto of difference to the victims of Prexige, and (say) Vioxx - over 100,000 heart attacks, an estimated one third of them fatal. No matter how much the writer may try, Black Cohosh and their ilk are not in the same league.
As we all know, the reason why drugs such as Vioxx make it to market is because multinational drug companies corrupt the process - in particular their ‘influence’ on regulatory authorities. In short, big money talks. There is no manufacturer of black cohosh, or any complementary medicine for that matter, which has similar influence on the regulatory authorities. Complementary medicines exist because they have mostly been around for hundreds or thousands of years, and those that have survived have stood the test of time.
By comparison, drug companies hell bent on making overnight billions, have to pay the price of their attempts to ‘compress’ time - to pay the price for attempting to substitute, emulate and/or ’steal’ from nature that which has taken millennia to produce. As we know from the Vioxx example, conventional medicine does all in its power to bypass this process. My suggestion to the writer is as follows:
1. Focus his attention on those deficiencies in conventional medicine that lead to the Vioxx and Prexige’s of this world, and attempt to correct these deficiencies.
2. Toss the drugs away and consider instead very cheap, safe and effective natural COX2 inhibitors such as curcumin - a natural extract of turmeric. Besides, it is a lot more than JUST a COX-2 Inhibitor.
Pete
Pete, you’re quite correct. Removing black cohosh from the market will do nothing to protect victims of Prexige and Vioxx. I was thinking more along the lines of it protecting victims of black cohosh.
Chris, that may have been your intention, but it came across as a cheap shot at ‘complementary’ medicine, rather than a critical assessment of the FDA/TGA approval process - which appears to have failed in his instance.
In 2005 the Australian TGA ”reviewed the safety of Black cohosh following reports of possible liver problems internationally and in Australia.
At the time of the review, there were 47 cases of liver reactions worldwide, including 9 Australian cases. In Australia, four patients were hospitalised, including two who required liver transplantation. Although some reports are confounded by multiple ingredients, by more than one medication or by other medical conditions, there is sufficient evidence of a causal association between Black cohosh and serious hepatitis.
Considering the widespread use of Black cohosh, the incidence of liver reaction appears to be very low. Following the safety review, the TGA decided that medicines containing Black cohosh must carry the following label statement:
“Warning: Black cohosh may harm the liver in some individuals. Use under the supervision of a healthcare professional”.
Subsequently, ”The expert advisory group examined a total of 16 Australian reports of suspected liver damage and 11 were judged at least possibly related to black cohosh use, including 3 cases of liver transplantation. Following consideration of all available information, the group concluded that there appears to be an association between the use of Black cohosh and liver damage, BUT THAT IT IS VERY RARE.
It was not possible to identify, with any certainty, the strength of the association, or any particular vulnerable group, type of preparation, dose, duration of use or specific products”.
http://www.tga.gov.au/cm/0705blkcohosh.htm
I think by any reasonable assessment the warning label is the appropriate response from the TGA, or FDA for that matter - not the wholesale banning of black cohosh (impossible anyhow, right ?).
Clearly, patients who take black cohosh should have regular liver tests - as so should those (for example) taking high dose, pre-formed vitamin A. Personally, I think that should be included in the warning.
You may argue black cohosh should be withdrawn in the same manner as Pregix - and if it were a level playing field you might be right - but it aint so.
There is a greater onus of responsibility for those medicinals which are ‘mainstream’, broadly prescribed, premium priced, with the impramateur of regulatory authorities - and permission to make various claims on their label. That is, there is a price to pay for legitimizing widespread use, and thereby maximizing commercial potential.
For example, how many conventional doctors ‘prescribe’ curcumin as an anti-inflammatory ? ….virtually none. If it was a patented/proprietary product supplied at great expense by your friendly drug company it would be a different matter. If you study (for example) curcumin - you soon realise its scientific credentials are at least as sound as any latter day synthetic COX-2 inhibitor out there. So why isnt it the next ‘big’ thing ? The answer of course, is that it is naturally occurring, cant be patented, and there is no money in it.
That aside, comparing Black Cohosh and Pregix, the latter is in widespread use, it already has caused two deaths in Australia - despite being through the vigorous TFDA/TGA approval process, and it requires sustained use by patients - many who are elderly and therefore even more vulnerable. There is no way of knowing yet if there is a small subset of the population who are exposed to the risk, or all patients are exposed. Until such time as this is known, the prudent thing to do is to withdraw it, just as the prudent thing to do with black cohosh is to provide warnings for those ‘rare’ individuals the TGA have identified as being vulnerable to liver damage.
Pregix is not necessarily another Vioxx, it may only affect a small subset of the population. If that is so, I am certain it will be back on the market - with the appropriate labelling and warnings.
Pete
Curcumin
Curcumin has many valuable properties that cover multiple diseases - it is xenohormetic (activating a stress response in mammalian cells), antiseptic, anti-inflammatory, anti-oxidative, and a natural COX-2 inhibitor. Inflammation and/or oxidative stress and are involved in the aging process, cardiovascular diseases, sporadic Alzheimer’s disease (AD), sarcopenia, type II diabetes, arthrosis, arthritis and cystic fibrosis. It may therefore protect against these conditions. It also inhibits tumor formation, promotion, progression and dissemination in many animal models - including skin, oral, forestomach, duodenal, colon and tongue carcinogenesis in mice and rats.
http://ecam.oxfordjournals.org/cgi/content/full/nem043v1
http://www.aapsj.org/view.asp?art=aapsj080352
http://www.pdrhealth.com/drug_info/nmdrugprofiles/nutsupdrugs/cur_0087.shtml
Dr. Chris bemoans the ‘fact’ complementary medicine has ‘no legal, government, or media scrutiny’. …That the ‘TGA applies different standards to the two systems’. The system that collects evidence is flogged with it while the system that shirks evidence is given free rein’.
That is of course spoken by a doctor who doesnt know better - but should (not his fault, he has never been taught even the ‘basics when it comes to more natural alternatives, or preventative medicine). His former employment by the drug industry also tends to focus one’s mind - in completely the wrong direction. There is a certain hypocrisy in lauding the system that gave the green light to Vioxx, Thalidomide, the toxic pesticide Lindane as a topical medicine, and a plethora of less than less-than-effective and highly damaging chemotherapeutic agents. Now there is a genuine example of quack medicine for you.
”the overall contribution of curative and adjuvant cytotoxic chemotherapy to 5-year survival in adults was estimated to be 2.3% in Australia and 2.1% in the USA”.
Professor Graeme Morgan, Royal North Shore Hospital, Sydney.
http://www.abc.net.au/rn/talks/8.30/helthrpt/stories/s1348333.htm
http://www.cancermonthly.com/iNP/view.asp?ID=40)
Worse still, chemotherapy-induced senescent cells not only beneficially activate genes that inhibit cell division, they also non-beneficially turn on genes that stimulate, rather than prevent, the growth of neighboring cells.
Some chemotherapy non-beneficially stimulates the p21 gene. Previous studies have demonstrated that p21 turns on a host of genes linked to numerous diseases associated with old age, including Alzheimer’s, as well as senescent colon cancer cells.
That is, FDA-approved chemotherapy CAUSES cancer and other diseases, whilst only providing a 2% benefit!
I. B. Roninson, E. V. Broude, B.-D. Chang, If not apoptosis, then what? Treatment-induced senescence and mitotic catastrophe in tumor cells. Drug Resist. Updates 4, 303-313 (2001).
http://sageke.sciencemag.org/cgi/content/abstract/sageke;2002/19/nw60
And for a more current bad example see: http://www.reuters.com/article/healthNews/idUSN2421846020070725?feedType=RSS
Something to do with US Senators objecting to the efforts of ”the FDA to suppress scientific dissent and downplay safety concerns” including the sidelining of the reviewer who has been voicing safety concerns” about Avandia.
The FDA reviewer “was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia,”.
As we all know, the FDA wont let a few deaths get in the way of a raging commercial success.
Meanwhile, the breast cancer chemotherapy drug Abraxane has made its founder US-based Dr. Patrick Soon-Shiong a billionaire at $4200 per dose, or about $ 25,000 per patient. This drug exemplifies all that is wrong in Western medicine. That is, exhorbitantly expensive drugs and treatments characterized by a lack of price control or containment, no relationship to the cost of developing and producing the drug, only temporary tumour shrinkage in patients, neglible long term benefit, adverse side effects, and overhyping and overselling at the expense of other conventional and non-conventional treatments.
According to Dr. Chris, the NCCAM ‘ is not good enough’.No mention of those regulatory bodies that manage conventional medicine ?
Methinks Doctor Chris is suffering a bad case of ‘Myopic Lossofobjectivitis’.
Pete G.
[comment removed at author's request August 18th, 2007 8:14 pm]
[comment removed at Pete G's request August 18th, 2007 8:18 pm]
Pete, your comment has been up since at least Wednesdat, when I first saw it.
Nick, it turns out Pete G submitted a later comment which was picked up by the spam filter. It turned up when I searched the spam heap and it has been restored.
One cannot question the outstanding contribution of mainstream surgery and (say) vaccination to mankind. And there are contentious but nonetheless valuable contributions made by pharmaceutical companies in regards to cardiovascular and various other diseases. But when it comes to environmental/lifestyle based disease prevention, cancer treatment, and providing a universal service to patients, Western medicine is one big ugly blot on the landscape.
Who can forget Marshall’s 20 year struggle to convince a sceptical medical profession that stomach ulcers (and thereby stomach cancer) were a result of H.Pylori ? But why did it take all of 20 years ? A combination of an overworked, disinterested, uninformed and ‘glacial’ medical profession, lack of appropriate Government interventions, and the concerted and surreptitious efforts of the mainstream drug companies to discredit Marshall’s work. Their motive - pure greed of course - regardless of the effect on people’s lives (their stomach’s can burn baby, burn - nothing shall get in the way of our $billions in sales of antacids). That’s the nature of drug companies so favored by Chris. In more ways than one, there is very little between them and the Philip Morris’s of this world.
Unquestionably the duopoly of mainstream medicine and pharmaceutical companies is a curse of monumental proportions - although it doesn’t have to be so.
In regards to cancer treatment, perhaps the following can summarize its deficiencies far better than I ever could. One wouldn’t mind it so much if mainstream medicine were a little humble about it all. But instead of humility we get grandiosity, obfuscation, deceit, and concerted attacks on any sort of medicine that challenges the mainstream monopoly. Well, that’s a fairly typical defensive posture when one has a heap of unresolved inadequacies and no particular solutions at hand.
See: Ralph W. Moss, PhD.
Aug 1 2007 (Vol. 27, No. 14)
Genetic Engineering and Biotechnology News,
http://www.genengnews.com/articles/chitem.aspx?aid=2179
Chris claims the mainstream pharmaceutical industry is disadvantaged in comparison to ‘alternative’ medicines. That’s a very big joke for anyone who knows how the system really works. Until early 2007, the US FDA had no regulations precluding experts with financial ‘conflicts of interest’ from participating in the panels recommending which drugs, diagnostic tests and medical devices should be approved for use. Unfortunately, the FDA invariably accepted the recommendations of its advisory panels - often made up of experts with financial ties to the products being reviewed. This FDA/industry nexus totally corrupted the registration process. Following trenchant and sustained criticism, the FDA belatedly tightened its requirements - but without capping the number of members with conflicts of interest on advisory panels. Whilst the nexus has been partly loosened, it has evolved into a more subtle ‘consensus’ process which involves drug industry influence rather than direct involvement in the decision making process. Given these circumstances, suggesting the mainstream pharmaceutical industry is somehow disadvantaged in comparison to ‘alternative’ medicines is completely erroneous and misleading in the extreme.
Pete, you have made many comments about problems within the FDA, and I would be the first to acknowledge that the FDA and the TGA in Australia have many flawed processes. I would even go so far as to say that being bureaucratic bodies that regulate high-risk, multi-billion dollar projects, they will always be prone to inefficiencies, internal power plays, political interference from above, and even corruption. But I wasn’t arguing that the FDA was perfect or that it is above criticism. Let me ask you a few questions that are relevant to the point:
1. What regulatory body oversees alternative medicine? What disciplinary powers does it have? Is it clean of the problems affecting the FDA?
2. The “trenchant and sustained criticism” of the FDA you refer to took place within medical circles and has been amply documented in high-profile journals such as the New England Journal of Medicine. Has there ever been a sustained movement within alternative medicine to subject itself to stricter regulation and to marginalise or exclude its more dangerous practitioners? How many editorials in alternative medicine journals have recommended tightening up the industry?
3. What happens to homeopaths who tell people not to take vaccines or anti-malarials? What happens to naturopaths who tell children to stop their asthma medications?
4. Without a formal post-marketing surveillance program, how do we know what the dangers of a given alternative medicine amount to?
5. What is your interest in this? You wouldn’t happen to be involved in the alternative medicine industry, would you?
From the Denialism blog:
Chris and Nick,
Firstly let me answer Chris’s last question. It is of course completely irrelevent whether or not I am connected to alternative medicine. Either I am talking sense or talking crap. But for the record, I am nothing more than a cancer patient on a quest for self knowledge. For the most part, I am a user of mainstream medicine, but if I had my time again I would be a early user of integrative medicine (a combination of mainstream and alternative) as a means of PREVENTING my disease, and others, in the first place.
My principle objections to mainstream medicine are as follows:
1. The indiscriminate use of most chemo drugs in terminal cancer patients - which is a complete and utter fraud.
2. The poor outcomes and the excessive cost of mainstream medicine in most developed countries - esp. the USA. That is, blatant overservicing without a corresponding benefit in patient outcomes and longevity. The principal benefit of such policy resides with those providing the service - which is as intended!
3. Mainstream medicine (which encompasses the combination of doctors, drug companies, hospitals, medical insurance) effectively abandon terminal cancer patients to their fate, without exploring all possible options. That is, they merely go through the motions. The possible exception are some cancer clinics - particularly in Germany, that use a personalized, multi-faceted approach that include both mainstream and some alternative/complementary techniques.
4. The monopolistic, overly commercialized, and profiteering (http://tinyurl.com/yw48ca) aspects to modern medicine.
5. The over emphasis on treatment rather than prevention.
Far too much this conventional/alternative thing is an artificial construct created by vested interests to protect their particular intellectual and financial ‘monopoly’. I suggest patients should not get suckered into blindly following one side or the other, as they shall self-detrimentally diminish rather than expand their treatment options.
I figure, if it works, then why not employ it- regardless of labels.
Chris and Nick have deluded themselves into believing the billions of dollars spent in research, development and clinical trials somehow produces an effective, working, albeit slightly imperfect system. They imply buckets of money is the solution to the problem, rather than being the CAUSE of the problem. The contrary position, which seems to completely escape them, is the clear historical relationship between the amount of money invested in any project, and the degree of resultant corruption. And that corruption can take many forms. For example, certain ineffective, monopolistic, and costly drugs can be approved and widely deployed by mainstream medicine, whilst effective, unpatentable, non-approved more natural alternative products are rejected - and perhaps hounded out of existence by the authorities. That’s just one effect of the current system - and the $billions invested by drug companies in patenting and registering drugs. Despite their lack of efficacy, and their high cost, these are the tools of mainstream medicine - simply because of their deep pockets.
If one follows the logic of Chris and Nick’s argument, the amount of money invested in testing mainstream or alternative medicine is directly related to their effectiveness. This ignores the manipulation of the approval process by the powerful drug companies, and the manipulation of doctors in prescribing these drugs.
I have already provided examples of FDA/TGA -approved drugs that have not only been ineffective, but have made the patient worse. Here’s another, just today.
”More than 100 million prescriptions have been filled in the United States for Zetia and Vytorin since the Food and Drug Administration approved them in November 2002 and August 2004 respectively. Both drugs cost about $3 a day”.
‘This trial was designed to show that Zetia could reduce the growth of those plaques. Instead, the plaques actually grew almost twice as fast in patients taking Zetia along with Zocor than in those taking Zocor alone.
http://www.nytimes.com/2008/01/14/business/14cnd-drug.html?_r=1&oref=slogin
How may $billions is that spent by patients on this anti-cholesterol drug - you do the math.
And for what - progression (not regression) of patient atherosclerosis !
If the FDA/TGA approval system is so much more effective in comparison to alternative medicine, how did we manage to end up with an anti-cholesterol drug that increases the patiernt’s risk of atherosclerosis and heart attack/stroke ?
And another recent example.
”Older patients treated with the diabetes medications known as thiazolidinediones (which include rosiglitazone) had a significantly increased risk of heart attack, congestive heart failure and death, compared with the use of other hypoglycemic drugs, according to a study in the December 12, 2007 issue of JAMA”
http://ihealthbulletin.com/blog/2007/12/12/thiazolidinedione-medications-for-diabetes-increase-risk-of-heart-attack-death/
The following describes just part of the problem.
”The FDA approves drugs based on limited studies and cannot fully determine if a drug increases mortality or morbidity until larger groups use the medication. This means most new prescription medications are of unknown risk till long after their approval. The shocking problem is that the FDA has not required post-approval safety testing for hundreds of drugs in use today.
Sixty-five percent of the 1,231 so-called “post-marketing” drug studies that companies had pledged to carry out were still pending. Dr. Jerry Avorn, a Harvard Medical School professor and author of “Powerful Medicines,” says the numbers show the system is broken and calls the situation “scandalous” and “appalling.”
What we end up with are drugs that are just slightly more effective than an inactive placebo tablet, but pose unknown risks, some which may be mortal, that could outweigh any proposed health benefits”.
http://tinyurl.com/2kctkg
Now, in terms of patient benefit, Chris and Nick would like us to believe that THEIR drug approval system is so much more reliable and foolproof than the standards applied to alternative medicines. As should now be evident, this is not necessarily the case.
Their favored system has produced many thousands of unintended deaths. By comparison, the number of people adversely affected by natural alternative medicines is miniscule by comparison.
The mainstream medical system is a giant corruption - from the drug monopolies/cartels that manufacture and patent the drugs, to the FDA-TGA that approve and protect the drug monopolies, to the hospitals that overcharge for their services, to the medical insurance companies that exploit their patients in so many ways, to the customer-interface - the doctors that make it all possible. Medicine has evolved into a giant money-making enterprise, and much of the objection to alternative medicine relates to the perceived competitive threat they pose.
Nonetheless I happen to agree with some of Chris’s comments in regards alternative medicine - and the way they are promoted, but I dont buy his solution, and I dont buy his sheer hypocrisy.
My suggestion is he looks to improve the performance of mainstream medicine - before picking holes in alternative medicine. There is a lifetime’s work ahead of him in that aspect alone - if he truly has the best interests of patients at heart. But if he is just defensively protecting the shambolic, corrupt, disingenuous professional monopoly we have at present - then he will get no encouragement or comfort from me. I will leave that to his fellow practioners.
If either Chris or Nick want to feed their reformist zeal somewhere, how about helping reform the following:
”DRUG companies will be forced to publicly reveal details of the hospitality they lavish on doctors — such as foreign travel and expensive dinners — in a bid to slow down the pharmaceutical “gravy train” for the nation’s medical professionals.
The Australian Competition Tribunal, in a major ruling yesterday, has upheld a new set of rules for drug companies that will require their gifts to
doctors to be declared twice-yearly and posted on the internet.
The disclosures will include details such as venues used, the number and types of professionals invited, and the total cost of food, travel,
accommodation and entertainment provided.
However, in what critics have described as a weakness of the crackdown, individual doctors and others who accept hospitality from the pharmaceutical giants will not be named.
The ruling is a rebuff to the pharmaceutical industry body, Medicines Australia, which had applied to the tribunal for the disclosure rules to be disallowed.
The Australian Competition and Consumer Commission sought to impose the rules on drug makers as a condition of the industry being allowed to be self regulating.
The rules were designed to counter concerns that gifts from pharmaceutical companies could inappropriately influence the way healthcare professionals prescribed medicines.
In a strongly-worded ruling yesterday, Justice Robert French and two other members of the Competition Tribunal warned of a “real risk” that without public disclosure and regular reporting of hospitality to doctors and nurses, some drug companies “will test the boundaries and offer
inappropriate benefits”.
Melbourne oncologist Ian Haines, a prominent critic of drug company largesse, hailed the ruling as “leadership the world has been crying out
for”. But he said it was only a necessary first step to curbing drug company generosity.
Dr Haines, of Cabrini Hospital, who last year gave evidence to the court case brought by the ACCC, told The Age: “This decision is a very good first
step to dismantle this whole gravy train. It will make doctors really
strongly consider where they go, what they accept. I really think Australia is providing leadership the world is crying out for.”
Dr Haines told the court last year it was common practice for drug companies to treat doctors to expensive dinners at top restaurants such as the Flower Drum and Jacques Reymond, and to pay up to $13,000 a person for doctors’
international travel to sit at symposiums.
He warned hospitality could be unduly influencing doctors’ drug prescribing choices.
While welcoming the ruling, Dr Haines said a better system would involve doctors being named. “Every doctor should be named on the website, and everything they accept,” he said.
Ken Harvey, adjunct senior research fellow at Latrobe University’s School of Public Health, agreed, saying doctors who attended drug firm-sponsored dinners ideally should be named on the websites as well.
“Naming and shaming is a good way to go,” he said. “There’s some evidence that’s probably the best way of stopping doctors from attendance.”
But ACCC chairman Graeme Samuel said the commission had not pushed to name
doctors on websites because there was more concern about the potential source of the problem — the companies offering benefits.
“We can’t require the naming of doctors. What we can do is set a level (of disclosure) that satisfies the law that we have available to us.”
He said there was a possibility the tribunal would have rejected the ACCC proposal if it had included naming doctors.
While the code is voluntary, Mr Samuel said if companies were found to be “thumbing their noses at it” then the consequences of that might be governments or authorities responding by imposing mandatory codes.
The chief executive of Medicines Australia, Ian Chalmers, labelled the result disappointing. “While we will abide by the decision we don’t feel it
adds anything to the already large public benefit provided by our strong code of conduct,” Mr Chalmers said.
David Henry, a Newcastle University academic who has published extensive research on Australian doctor and drug company relationships, hailed the
“strong” judgement as welcome, and said he hoped it would lead to companies moderating their hospitality instead of trying to outdo one another.
The Age understands, however, that some groups of doctors have become so emboldened by a culture of lavish pharmaceutical hospitality that they threaten to refuse to prescribe certain drugs if the manufacturer does not stump up cash sponsorship for their symposiums.
“That’s just woeful,” Professor Henry said. “That’s arisen because at its heart they’ve been brought up on the teat of the pharmaceutical industry,
and they’ve become dependent on it.
“The (drug company) income supports their recreational activities, whether it’s skiing, golf days or whatever.”
Professor Henry said it was interesting that drug companies would be forced to disclose speakers’ fees at industry functions. “The drug companies and the speakers themselves are going to be quite sensitive about that information being made available on a website,” he said.
“If they get say $2000 for giving a public lecture, that information will be available for the tax authorities. Information on how many of these meetings there are, and how much they are costing will be made available to everybody, from professional groups to consumer bodies. You can be sure they will be paying close attention to what’s there.”
Professor Henry said continued self-regulation was the way to go for the drug industry “because we don’t want the police knocking on the door, asking
to check”.
”But Dr Haines said a critical nexus that still needed to be broken was the influence of drug companies on medical research. “The bigger picture is medical research is now owned by pharmaceutical companies,” he said.
“In medical publications, a lot of the authors now are employees of drug companies. In this era of evidence-based medicine, where new drugs are so
expensive, it’s very hard for independent groups to set up research to test these drugs.
“The wrong studies get done, and they’re reported in a way that’s beneficial to the drug companies. If the drug companies do 20 studies around the world, they pick one or two that look the best, and don’t publish the others 18”.
http://www.theage.com.au/news/national/drug-firms-forced-to-reveal-gifts/2007/06/27/1182623991757.html?page=fullpage#contentSwap2
Meanwhile, in the US the pharmaceutical industry spends upwards of $8 billion on journal ads, promotions and gifts to physicians each year - roughly $10,000 per physician.
http://www.amsa.org/prof/pharmfree.cfm
And dont expect all those free samples to go to the poor - they will end up where they are least needed.
http://www.physorg.com/news118658865.html
So, this is the medical system Chris and Nick so stoutly defend ? This is the system which protects us consumers, and delivers the best treatments at the lowest price ?
SHEER HUMBUG !
“Doctors prescribe medicine of which they know little, to cure diseases of which they know less, in human beings of which they know nothing.”
Voltaire (1694 - 1778)
I expect if Hippocrates were alive today, he would be arguing, ”Physicians, reform thyselves !’
More grist for the mill. How drug companies manipulate research findings so that only selective, positive impressions are created of treatments.
”Antidepressants’ benefits may be exaggerated, 17 January 2008 , Erick Turner
It’s called the “file-drawer problem”. A study fails to produce interesting results, so is filed away and forgotten - a practice that might mean antidepressants don’t work as well as doctors think.
To get approval for the 12 antidepressants that went on the market between 1987 and 2004, drug firms registered over 70 clinical trials with the US Food and Drug Administration (FDA). But when Erick Turner of Oregon Health and Science University in Portland and his colleagues combed through medical journals, they found that 23 of these studies never made it into a journal. All but one of the unpublished studies concluded that the effect of the drugs was negative or questionable (The New England Journal of Medicine, vol 358, p 252).
Consider all 70 studies and antidepressants still emerge as helpful drugs. Publication bias has exaggerated their effectiveness, Turner says, but it’s impossible to know if journals refused to publish the studies or didn’t get them in the first place.”
http://www.newscientist.com/channel/health/mg19726393.300?DCMP=NLC-nletterbanner&nsref=mg19726393.300
Vale, Heath Ledger, who paid the ultimate price of blissfully taking a combination of MAINSTREAM, FDA-approved medicines. We all hear about the stars who succumb this way, but rarely to the thousands of ordinary people.
I does not take a genius to figure out most FDA-approved insomnia ‘cures’ are far more dangerous than the condition itself.
Likewise many FDA-approved antidepressants. It is worth noting most of the more recent mass killings in the USA have been executed by individuals taking antidepressant drugs.
”Overall, about 6 percent of 1,915 patients with depression reported that they started to have suicidal thoughts while taking an antidepressant. This rate soared to 36 percent among the few patients with both of the suspect gene versions; 59 percent of the patients who had suicidal thoughts had at least one of the versions. . .
Earlier studies had shown that about 4 percent of youth treated with antidepressants experience suicidal thinking compared with about 2 percent of those taking placebos”
http://www.nimh.nih.gov/science-news/2007/genes-linked-to-suicidal-thinking-during-antidepressant-treatment.shtml
Ouch ! Genetically, 42% of those taking FDA-approved antidepressants are at an ELEVATED risk of suicide. Thats taking depression to an even higher level. Who knows how many of these combine that depression with anger/loathing of others, access to guns, and the inclination to use them.
It begs the question. How the hell did the FDA ever approve these dangerous drugs in the first place ? If we are to believe Chris, more rigid control of mostly harmless natural products is the solution to the problems of the medical world. Of course, its just a distraction from the infinitely greater necessity for greater control over mainstream medical practice. That particular issue never seems to given a passing thought by its practioners. I suppose its just a lot easier to find a convenient scapegoat.
Just some of thousands of people who die each year from FDA/TGA approved drugs.
So what’s Chris’s solution..ban MOSTLY harmless alternative medicine !
”Police investigated Mairead’s death and have referred her death to the NSW Coroner. Siobhan said one of the investigating officers told the family they did not believe it was suicide.
Z-class drugs - zolpidem, zopiclone and zaleplon - are all non-benzodiazepine hypnotics that are used as an alternative to drugs such as valium. They take effect faster but allow for a quicker recovery.
In its campaign against Stilnox, the Costigan family has created an online petition which has 2800 signatures, along with hundreds of other people’s horror stories.
A report released late last year - based on calls to a national drug helpline - said there were 13 deaths, four attempted murders and 12 suicide attempts recorded by the hotline where “zolpidem was the suspected causal agent”.
A bottle of Ambien, the US brand name for zolpidem, was reportedly among the prescription drugs found near Heath Ledger’s body when he died last month.”
http://www.smh.com.au/articles/2008/02/18/1203190740530.html?page=2
So we finally learn that for the majority of moderately depressed patients, doctors could secretly prescribe them Equal (or better still, fish oil caps) instead of antidepressents and (considering the side effects) the patients would achieve a better overall result.
So, who’s selling the snake oil then?
And why does it take a FOI request to the FDA before we finally establish the truth - from that organisation that Chris and Nick claim is so protective of patient’s interests ?
And how many other dark secrets does that organisation have - secrets designed to protect the drug industry at the expense of patients ?
http://www.theage.com.au/articles/2008/02/26/1203788345678.html
From The Melbourne ‘Age’
March 3, 2008
”Sometimes they (the drug companies) bury data that shows drugs to be harmful. This happened in the case of Vioxx and heart attacks, and SSRIs and suicidal thoughts. Such stories feel, intuitively, like cover-ups. But there are also more subtle issues at stake in the burying of results showing minimal efficacy, and these have only been revealed through the investigative work of medical academics.
One example came just in January. A paper in The New England Journal of Medicine dug out a list of all trials on SSRIs that had ever been registered with the US Food and Drug Administration, and then went to look for those same trials in the academic literature. There were 37 studies which were assessed by the FDA as positive and, with a single exception, every one of those positive trials was written up, proudly, and published in full.
But there were also 33 studies which had negative or iffy results and, of those, 22 were simply not published at all — they were buried — while 11 were written up and published in a way that portrayed them as having a positive outcome.
The new study published in PLoS Medicine analysed all the data from the FDA, using the Freedom of Information Act to obtain the results of some of the trials. That medical academics should need to use that kind of legislation to obtain information about trials on pills that are prescribed to millions of people is absurd. More than that, it breaks a key moral contract between patient and researcher.
When a patient agrees to participate in a clinical trial, they give their consent on the understanding that their information will be used to increase the sum of our knowledge about treatments, to ensure that other people in the future will be treated more effectively. Burying unwelcome results is an unambiguous betrayal of their trust and generosity.
And yet we have known about this happening for a long time. The first paper describing “publication bias” — where studies with negative results tend to get forgotten — was in 1959”
http://www.theage.com.au/news/opinion/ben-goldacre/2008/03/02/1204402269508.html
And Chris’s solution to this abomination ? Attack and increase regulation on vitamin C and natural medicine !!
Pete, Pete, Pete. I think I’ve given you long enough now. You have been unpleasant from the moment you joined this thread, but this last post has finally eroded my patience. Your own words contribute only two small sentences, and yet with that tiny effort you have managed to include a strawman fallacy, a red herring fallacy, an outright lie, a selective quotation, a bad case of cognitive bias, and a double exclamation mark.
(The lie is in saying I want to “attack and increase regulation on vitamin C.” I was talking about black cohosh if you recall. That lie feeds into a strawman fallacy; vitamin C is safe even in very high doses whereas black cohosh can cause catastrophic liver failure when used as directed. Obviously it’s easier for you to argue when you pretend I was discussing vitamin C. The red herring fallacy is that you have shouted repeatedly about the shortcomings of mainstream medicine but only as a distraction — you have yet to propose a single measure that might protect consumers from the dangers of black cohosh. The selective quotation is in your failure to include the last paragraphs of the article above in which Ben Goldacre proposed a practical solution to the problem he raised; you seem uninterested in solutions, only in vilifying medical science as part of your red herring strategy. The cognitive bias comes from quoting Ben Goldacre without realising that he is just as savage a critic of alternative medicine as I am; I heartly recommend Goldacre’s Guardian column as he attacks bad biomedical science of all stripes, whether it comes from an alternative health practitioner, a drug company, or a government office. You might have noticed this if you were using the internet as a research tool instead of as a computerised cognitive filter.)
You have filled this comment thread with your unpleasantness for months. I tried gently addressing your mistakes. I tried joking with you. I tried letting you alone. All to no avail. If you may recall, you even asked to have one of your comments removed when you figured out how bad a light you had cast yourself in. I agreed under the mistaken assumption that you might learn from the experience.
Allow me to explain something to you, Pete. This is a private blog. I pay for the upkeep. I spend many hours writing content and administrating. It is, like most blogs, open to the general public, but you should never forget that it is still a private space which I share with my fellow contributors. My role here is as host, and the general public is as guests. Like most such arrangements, there are social obligations to both the host and to the guests, and you have violated your social obligations frequently, at length, and with a great deal of self-righteous hostility.
As such I have decided to close this comment thread and banish your email address. I wish you the best of luck with your health, but I am not prepared to host any further comments from you. It occurs to me that you treat our roles not so much as host:guest but as host:parasite. Enough. Go get your own blog.
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