I want to know all about drugs

The corporate strangle-hold on government regulation of pharmaceuticals must stop.

A recent admission by Bayer A.G. that it withheld data from the US FDA, suggesting that a heart-surgery drug is dangerous, is simply not acceptable. It is ridiculous that pharmaceutical companies have the option to withhold (read: hide) studies that do not provide favourable results of their drugs. Few other industries have the flexibility to tailor the perception and evidence of their brand (without breaking the law). Few other industries can pick and choose what evidence they can release to the public without breaking the law. The fact that Bayer is chalking this up to a "mistake on the company's part" only strengthens the need for full disclosure of all pharmaceutical studies.

Time and time again, when cases arise of pharmaceutical companies withholding unfavourable study results, the evidence eventually shows that these multi-national, multi-billion dollar corporations choose to hide the results. Often this is done by dismissing the study because it is produced by a third-party (a contractor) -- providing the pharmaceutical company time to discount the study's evidence. Often, the results only come out because of whistleblower activity.

For Bayer, right now, the drug in question is Trasylol (which has long been used in heart surgery to reduce blood loss and the need for transfusions), but last year US-based pharmaceutical Merck lost a Texas court case when the judge awarded a widow $253-million after her husband died of a heart attack as a result of taking the painkiller Vioxx. (The award was later reduced to $26-million, but Merck continues to face thousands of similar court cases over Vioxx). The year before that GlaxoSmithKline had difficulties when the New York attorney-general, Eliot Spitzer, accused it of suppressing negative results from trials on the use of its antidepressant paroxetine (Paxil) in children. The drug was never licensed for use in children, but doctors often prescribed it "off label".

The fact is pharmaceutical companies are not required, by law, to fully disclose the results of all studies. The fact is doctors are then left with a body of results that always provides favourable results for medication, regardless of whether or not these results are skewed through omission of results. The fact is, as patients, we need to demand that more regulation be created in order to protect us from the malpractice of pharmaceutical companies.

I am not alone in this sentiment.

Even Peter Goodfellow, the head of the discovery wing of the GSK, the world's second largest pharmaceutical company, believes that the pharmaceutical industry faces a huge challenge. While he describes the challenge as one of perception, I would describe the challenge as one of ethics. When large corporations stand to lose tens-of-millions of dollars on a drug because one of out four studies provide unfavourable results than there is a strong temptation (tempered with rational explanations) that the unfavourable results should be rejected.

While Goodfellow calls for full disclosure from all involved (pharmaceutical companies, doctors and academics), I place the sole responsibility on government. It is the government that needs to step in and set some firm ground rules for disclosure. It is the government that needs to enforce those ground rules. Why? Because, theoretically, the government is the people's representative and as the people's representative it is responsible for protecting the people.

Over the years there has been much debate over this issue. Natural health practitioners and victims have come out strongly in favour of non-pharmaceutical options, while the medical profession continues to support the use of medication. While I do not advocate either extreme, I do believe that full disclosure would go a long way to appeasing both sides. Full disclosure of all results for all medications would provide the medical and scholarly industries the ability to truly assess a medication -- and it would provide skeptics the option to accept or deny medication based on its merits, not on the practice of the industry. In the long run, this would go a long way to helping people...and in the end that's why the pharmaceutical industry was first established.


For more information on Bayer's recent trouble go to:
http://www.nytimes.com/2006/10/04/opinion/04wed3.html?th&emc=th

For more information on drug trials and suppression go to:
http://www.cpa-apc.org/Publications/Archives/CJP/2004/
september/procyshyn.asp
http://www.cmaj.ca/cgi/reprint/162/2/212.pdf#search=
%22pharmaceutical%20companies%20withhold%20evidence%22