FDA “Oversights” and Pharmaceutical Follies
It’s no secret that the FDA has ties to the pharmaceutical industry (even if they claim that it does not effect their behavior) – consider Donald Rumsfeld, former CEO of Searle Pharmaceuticals (he was the head honcho when aspartame (NutraSweet) passed FDA approval, despite outcry from doctors who had performed research and determined that the sweetener – which is metabolized into formaldehyde, amongst other fun things – causes cancer).
The FDA, invariably, has the public interest in mind – when you see quotations from its cautious and conscientious Director of Drug Evaluation and Research, Janet Woodcock, you know that she has the best interest of patients in mind (particularly those who have been prescribed medications which are under investigation for adverse effects):
“My message to patients is this: Don’t stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”
The FDA is always ready to share its good-natured wisdom with consumer – that’s what it’s there to do, right?
Not in the case of Zetia.
Documents on the FDA Web site reveal that pharmaceutical companies Merck and Schering-Plough conducted numerous safety studies on the popular cholesterol drug Zetia but did not publish the results, which suggested that the drug may cause liver damage when mixed with statins.
Zetia is a trade name for the drug ezetimibe, also marketed under the names Ezetrol and Ezemibe. It is a major seller for Merck and Schering, and is estimated to have earned them $5 billion in 2007.
…
The trials used to secure Zetia’s FDA approval were all short-term studies, in which a total of 3,900 patients had been given Zetia for a maximum of 12 weeks. The time period covered by these studies is generally accepted to be too short for signs of liver damage to emerge in most patients. Yet even in these studies, the rate of health problems was 11 times higher among patients who took Zetia in combination with a statin than among those who took only statins. Nearly all serious health effects were liver-related.
The FDA ruled that these risks were minor, and approved the drug without any request for longer term studies.
- Liver-Damaging Effects of Cholesterol Drug Zetia Hidden by Merck, FDA Documents Reveal
I look forward to seeing a post from a public relations spammer at a pharmaceutical company – I hope that they are just as interesting as Gavin Gibbons happened to be…
No one – not your doctor and certainly not your federal regulatory agency – is watching out for you where there is money to be made at your expense.
