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Drug Regulation Scandal

drug scandalsA whole slew of pharmaceutical companies in the drug industry are caught up in highly questionable act. This is the act of testing their own products to determine the products safety to the public. A simple search into the history of unsafe drugs reveals a plethora of results.

Among some of the best-known pharmaceutical companies- Dow Corning, Upjohn, Bolar, Hoffman-LaRoche, SmithKline and Syntex-were said to have failed to report data showing their drugs or products were unsafe.

 

Dow Corning is said to have withheld information about the dangers of silicone injections and breast implants; Upjohn, about violent side effects from its sleeping pill, Halcion; Bolar, for mislabeling and adulterating eight drugs.

What tripped them up? The system that permits companies, rather than the Food and Drug Administration or another group, to test the safety of drugs the pharmaceutical companies want to market. The evidence strongly suggests that drug companies often find it irresistible to doctor, or even conceal, unfavorable data-particularly if the alternative is endangering the prospects of a drug that has cost them a fortune to develop.

Free-market purists argue that the system needs no change, that it is self-correcting. They say that companies caught misleading the public will lose credibility-and business. But without oversight, it often takes decades before the public finds out about pharmaceutical wrongdoing. By then, thousands may suffer ill consequences.

There has been some interest in the news lately about studies showing that, in children and teenagers, Selective Seratonin Reduction Inhibitors (a type of anti-depressant that has been around for years) may actually cause suicidal thoughts instead of helping to prevent them. I read in a local newspaper yesterday that these results are being expanded into a study of adults.

But I will admit that I never thought to ask why the studies are now being done. As I mention, SSRIs have been around for years - in fact, Paxil and Prozac, both SSRIs, were some of the first pharmaceuticals ever marketed to the general public. Given the FDA approval process which theoretically requires certain stringent testing prior to release of a drug, why is it that we are just now hearing about this particular danger inherent in SSRIs?

 

Mr. Etzioni is right: sooner or later, results that may have been withheld will be released to the general public (simply because this type of secret has a way of spreading from person to person until someone accidentally opens his or her mouth) and, at that point, a pharmaceutical company will lose credibility and sales of the drug will fall off.

But he also raises a very valid point about each one of these pharmaceuticals, one that the thalidomide generation will remember quite well: how many people will have to suffer permanent damage first?

 

 

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