Learning from Vytorin and Zetia

Not only should we all be angry at the drug manufacturers Merck and Schering-Plough for not disclosing that Vytorin and Zetia had serious flaws, we must look at the process that allowed that to happen and try to correct it.

Current findings indicate that for two years these companies knew that while their drugs reduced cholesterol, they also increased plaque, the major cause of heart attack and strokes and thus potentially catastrophic.

They did not find this out accidentally. Medical and clinical pharmacology investigators who conducted this study established these findings. Why then did these healthcare professionals not speak out when the manufacturers did not? I would hazard a guess that they were either directly employed by Merck and Schering-Plough or had been compelled to sign a non-disclosure agreement. In either case they cast aside the basic principle of “do no harm”.

In the past studies regarding drug efficacy and safety were far more independently conducted using strict FDA protocols and results were communicated both to the manufacturer as well as to the FDA. Clearly this is no longer the case. Why? We must consider that the staggering amount of political contributions from the pharmaceutical industry to both major parties has made oversight of their activities a sham.

If the FDA had been a party to the study as it should have been, at the very least Merck and Schering-Plough would have been obliged to advise doctors what the study had determined. Conceivably the FDA could have compelled the removal of these products pending further investigation. To hide such results from government agencies and practitioners while continuing to market these products with flashy TV spots to the lay public is reprehensible and without a doubt grossly indifferent to the safety of the public.

We can only guess how many other unfavorable studies are hidden away by pharmaceutical companies far more interested in bottom line profits than in the safety and well being of the American public.

Sadly, it appears the FDA has become as political as many other parts of government whereas its mission was and should be to safeguard the public. Recently we saw a similar situation with the CDC. Surely agencies such as these should be above the petty frays of political interference.

We could of course hope that one or more of the current candidates would pledge to change these policies. Doubtful.