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REGULATORY ABUSE

16 December, 2003

..."As far as public health is concerned the available evidence is abundantly clear. Since less than 1% of dietary supplements have been found to constitute any significant health hazard there is absolutely no justification for additional safety based regulatory controls of 99% of available dietary supplements. Pharmaceutical drugs on the other hand continue to cause a huge number of adverse reactions and fatalities. According to abundant scientific evidence therefore, urgent reforms are needed to improve the safety of pharmaceutical drugs and prevent adverse reactions. To this end there should be mandatory reporting of drug reactions in death certificates and specific inclusion in official statistics. There should also be severe penalties for doctors who fail to report significant adverse reactions. Given unbiased consideration of the evidence, no other conclusion is possible."...

Extracted from: The Safety of Dietary Supplements and Pharmaceuticals

These extracts make the most obvious observation which most regulatory health bodies continue to blatantly ignore/overlook: Namely, their mandate to protect the public through the basic health improvement measures (record keeping and post injury investigations). Such behavior is inexcusable in any other industry. Imagine an aeroplane crash, or telephone, electricity service interruptions without investigation and copious and through incidence record keeping with solid future preventative measures. These basics are the corner stones of any other industry. So why not in health care? The answer - remain unaccountable by design!

Their agenda is clear, if one does not gather the basic data then one can put a spin on any discussion (with all the phoney experts) and say that their is no evidence of harm - leaving the door wide open to say and/or do what ever they please to maximize profits. With no data, it also becomes easier to attack other safer modalities that compete for their business with disease.

All the money (mainly our from our own taxes) required to set up the basic health improvement measures has and is literally being spent on protecting and creating the pharma medical Mafia monopolies through the making of useless regulations and then twisting them to suit the needs of the vested interests...

This is only possible as the regulatory bodies exploit the trust of the public. Only widespread recognition of these abuses will change the situation. Unfortunately, it may have to get much worse before real action to force a change may be possible...

Chris Gupta
http://www.newmediaexplorer.org/chris/2003/12/14/regulatory_abuse.htm


Concluding Remarks

The Pan Pharmaceuticals fiasco, according to the TGA, is the result of a shameful abandonment of quality control and the falsification of data. This is absolutely inexcusable. Pharmaceutical companies should conform to the highest quality standards and the highest ethical standards and any breaches of these standards must be severely penalised. Having said this however, safety standards and quality control standards, as distinct from efficacy standards, must be consistent and apply to all companies and all products. There should be no bias or preferential treatment. As many experts have stated, the same safety standards should be applied to both alternative medicines as well as drugs. If it is acceptable for drugs to cause thousands of fatal reactions every year, then according to this standard, with which of course I vehemently disagree, it should be acceptable for alternative medicines also.

Contrary to the impression created by the media hype, the Pan crisis confirms again the safety of dietary supplements and alternative medicines as compared to drugs. While alternative medicines were withdrawn because of fears some products may not have been true to label, Travacalm drugs on the other hand were withdrawn because there was a fear of severe or fatal reactions. Even though Pan Pharmaceuticals were producing tablets that contained up to 7 times the normal level of active ingredients, the only products to cause ill effects were drugs. In spite of the huge number of alternative medicines which were withdrawn, the only products which required a Class 1 health warning were also drugs. These facts clearly illustrate the safety of alternative medicines compared to drugs.

We should not be distracted from the real issue by those who wish to avoid responsibility and turn the Travacalm tragedy into an alternative medicine witch hunt. The real issue is the fact that people have been poisoned by drugs due to the manufacturing processes (and ethical conduct) which have been utilised in a pharmaceutical company which produced over the counter drugs as well as prescription medicines and alternative products. It is the manufacturing procedures, quality control and ethical behaviour of those in the pharmaceutical industry which is in question. In spite of these facts, the health authorities and the media have largely succeeded in creating the false perception that responsibility for the current crisis falls squarely on the shoulders of the alternative medicine industry. It is up to the industry to correct this misperception and publicise the enviable safety record of alternative medicines.

According to abundant evidence there are gross deficiencies in the pharmaceutical industry, especially in regard to ethics and quality control. There is also overwhelming evidence that prescription drugs and pharmaceuticals generally, cause far too many adverse reactions and even fatalities. Reporting systems for adverse drug reactions should be strengthened and reporting of adverse drug reactions in death certificates should be mandatory. Current proposals to encourage reporting of adverse reactions to alternative medicines should be extended to include all drugs until the drug industry has achieved a level of safety similar to that which has already been achieved by the alternative medicine industry.

The same rules of evidence should of course be applied in both instances. Any symptom, even if only vaguely related to a prescription drug, should be immediately reported and recorded by doctors and alternative practitioners. We must all strive to reduce the unnecessary suffering caused by prescription drugs. We should also strive to produce a genuine form of integrated medicine where the independence of alternative medicine is preserved, and its strengths maintained. We should never accept the use of scare tactics to justify a takeover of the alternative medicine industry.

I look forward to the time when our health care professionals no longer feel the need to indulge in insults and name calling and they begin to work together to eliminate deficiencies in our health care system for the betterment of human health.

Addendum

In keeping with the oft stated desire of authorities to establish a connection between the safety of over the counter drugs and the use of alternative medicines as a result of the Pan crisis, scientists now want consumers to be more wary about alternative medicines (but not over the counter drugs such as Travacalm) (68). According to Pengelley (68): "When the dust settles from the Pan Pharmaceuticals recall, scientists want users to be more discerning about natural medicines." Pengelley cites Geraldine Moses from the Pharmaceutical Society of Australia (68): "We have to educate people to be a bit nitpicky and stop just acting on blind faith because it's on the label. There are a lot of things that are only there for historical reasons. They've kind of been grandfathered on to the shelves. It's really true there are lots of things that get marketed but don't work."

Predictably, as a result of the Travacalm DRUG scare, government authorities have now promised to clamp down on complementary medicines. According to O'Malley (66):

"A panel of experts will be given the job of scrutinising the complementary medicines industry after the Pan Pharmaceuticals recall. Parliamentary health secretary Trish Worth said the panel would also focus on the maintenance of a responsible and viable complementary medicines industry.' The Pan Pharmaceuticals recall has highlighted the importance of preventing or deterring deliberate or reckless breaches of standards and conditions,' she said.".................."Australian Medical Association president Kerryn Phelps has welcomed the committee and urged it to focus on restoring consumer faith in evidence-based complementary medicines. 'Complementary medicines and therapies that have been shown to work should not be dragged down by the Pan scandal,' Dr Phelps said."

According to Parliamentary Secretary for Health, Trish Worth (78), "the Pan Pharmaceuticals recall has highlighted the importance of preventing or deterring deliberate or reckless breaches of standards and conditions applicable to the manufacture of medicines in order to protect the health and safety of the Australian public." As a result of these concerns about the Pan recall, Trish Worth announced the formation of a committee to conduct an inquiry into "complementary medicines" (78). Trish Worth continues (78): "the establishment of this committee and amendments to the Therapeutic Goods Act go a long way towards giving the public and all health care practitioners confidence that the Government has taken the necessary steps to examine the role of complementary medicines in the health care system."

It seems that since we have now proven that a certain pharmaceutical drug was toxic we must take urgent action to ensure the safety of vitamins and dietary supplements and we must "examine the role of complementary medicines in the health care system." Furthermore, as has been correctly pointed out by Phelps, the reputation of vitamins and supplements should not be "dragged down" simply because of the "Pan scandal". The Pan scandal, as I have indicated above, provided further evidence of the safety of alternative medicines as compared to drugs. Did I miss something? Are we having an inquiry into drugs or vitamins?

Interestingly, Professor MacLennan, who reportedly regards alternative medicines as "snake oil"(69), has been appointed to the Committee to assist in determining the role of complementary medicines in the health care system. Professor MacLennan was described by Paul Heinrichs (69) as " someone with a long-standing interest in querying the worth of alternative medicine."

But the Pan crisis is also being used to justify the control of dietary supplements in New Zealand by the Australian government (71,72,73).

According to Middleton (71):
"Up to ninety (90) percent of all traditional Chinese Herbal Medicine and as much as forty (40) percent of New Zealand, Canadian and the U.S.A made Dietary supplements will be banned from New Zealand if the New Zealand LABOUR party's proposed Trans Tasman Agency to Regulate Dietary Supplements( Chinese Herbal Medicine) is passed into law early 2003"......"The proposed Authority will be based in Canberra, set up under Australian Law, and staffed primarily by Australians . Every single herb or vitamin that is sold in New Zealand will have to be registered and licensed with this new Authority run by the Australian Therapeutic Goods administration( TGA) which is recognised internationally and by the American Nutritional Foods Association as having the most draconian regulatory regime for dietary supplements in the world , being highly restrictive, bureaucratic, cumbersome and costly."

As I have indicated above, the desire of the medical establishment to control dietary supplements has accelerated the need for increased publicity aimed at causing fear and anxiety regarding the safety of all alternative medicines (74,75,76,77). There will be an increasing number of poorly conducted and biased studies (see Dietary Supplements) which will seek to draw attention to any alleged dangers, real or imaginary, of alternative medicines. Such studies are made more urgent as scientists and doctors advise the public that anyone who does not take nutritional supplements is risking serious diseases such as heart disease and cancer (see Nutrition and Megavitamins 2, Nutrition is for the Birds,
B vitamins). As more and more doctors are themselves taking vitamins there is an increasing need to convince the public of the safety of prescription drugs and the dangers of vitamins.

Not surprisingly, as a result of the Pan crisis the Australian government is now seeking to begin a process of dramatic regulatory reform of the alternative medicine industry to enable it to take full control of the industry with greatly enhanced power to cancel licences of manufacturers of alternative products.

See the Australian Government Inquiry into Complementary and Alternative Medicine for more details of recent developments.

Read full article (one of the best) : Pan Pharmaceuticals Recall of Australian Drugs, Dietary Supplements and Alternative Medicines

 

 
 
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