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Drug industry secrets becoming public

Celebrex! Celebrex! Most of us have heard the celebratory ad that conjures up images of arthritic seniors throwing away their canes and cavorting around maypoles.  CivAb readers are among those who will not be surprised to learn that Public Citizen Health Research Group's (HRG) Companion (2002) supplement to Worst Pills, Best Pills (1999) consigns Celebrex to its Do Not Use category along with 11 other drugs that were used to fill 92.9 million prescriptions in 2001.

Vioxx takes the cake for pure inanity.  Without mentioning any symptoms, listeners are exhorted to "ask your doctor if Vioxx is right for you", suggesting that Vioxx might be good for no matter what ails them.  Then, there is the "purple pill called Nexium" that might help you with something if you can prevail upon your doctor to prescribe it.  Nexium and Vioxx also made HRG's Do Not Use list.  Altace is claimed to reduce the narrator's blood pressure but might help you "in a different way".

The message to consumers is that you would probably be better off taking one or more of these drugs regardless of what conditions you might, or might not need help with.  The HRG's position is that, extensive animal testing and a clinical trial or two have not proved these new drugs to be any more effective than existing drugs which have not harmed enough people to be taken off the market, thus giving them a safety edge over the new drugs with which their companies hope to replace them before their patents run out.           

This advertising flurry is likely to begin as soon as a purveyor receives a product approval from the Food and Drug Administration (FDA).  The purpose is to expand the conditions for which the drugs might be useful.  This amounts to making guinea pigs of the folks who take them for conditions for which they have not received approval.  Some companies encourage doctors to experiment with unsanctioned uses for their drugs in hopes of expanding their market.  In any case, the first patients to take a new drug for any condition are assuming the role of secondary test animals behind participants in the first clinical trial.  Earlier animal trials don't count because they cannot be applied to humans with any certainty.

Another ploy used by drug companies is to get ahead of the game by calling public attention to little-known diseases that might reasonably be treated with a drug they are developing or one already on the market for which they are seeking approval for new uses

In an article in Mother Jones (July-August 2002) Brendan I. Koerner describes how Cohn & Wolfe, the publicity firm hired by Smith-Kline Beecham (now GlaxoSmithKline) orchestrated general recognition of social anxiety disorder (SAD) timed to coincide with the release of its new drug Paxil.  This campaign included cobbling together an organization called Social Anxiety Disorder Coalition whose phone was answered in the offices of Cohn & Wolfe. 

Without mentioning Paxil by name, the campaign merely informed people of the existence of SAD and how hard it was for people coping with it.  One can't help but wonder how many hypochondriacs and people suffering from another undiagnosed disorder are taking Paxil because they are nervous about ordinary social situations such as meeting new people, for instance.

All the recent political hype about the high cost of therapeutic drugs also leads one to wonder how many people are actually benefiting from them and, conversely, how many people would be better off without them.  We know that adverse reactions are grossly under reported.  Estimates range as high 90%.  At the same time, the public receives only promotional advertising instead of actual results about drugs that have been helpful.  It takes trial and error to learn which drugs interact adversely with the torrent of new drugs being produced.

One encouraging development is the precautionary statement that now usually accompanies the announcement of new drugs and procedures stating that results obtained on animals may not apply to humans.  For an industry and a public imbued with the idea that the reactions of animals are a reliable indication of human responses, this is a big step in the right direction because it could lead to a more general questioning of why we bother to perform expensive animal tests at all.  The answer to that is: because the FDA requires it.

Changing FDA rules is, unfortunately, as much a politically-influenced bureaucratic decision as a scientific one.  It can be swayed by members of congress protecting industries in their constituencies and bureaucrats protecting the careers they have pursued for years.  It doesn't help that there is a frequent exchange of personnel between the industry and the agency responsible for regulation. 

Change will come when enough people face the fact that testing drugs and other products on animals is a futile exercise compared to the more scientific methods already available.

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The Civil Abolitionist

          Summer 2002  v.13 no. 2