Dr. Bowen's 122 patients were investigated because of the heart murmurs to begin with, so I do not see it as "apparently very skewed"
it was clearly bias toward finding problems, and not general redux or fen-phen population. This does not matter, it is the nature of case series studies to try to define a problem with early and non control data. The animal studies did clearly showed the direction and provided the clues, also the European experience, and the well known and related (but minimized by both the companies and the FDA) Pulmonary Hypertension side effect (a deadly condition).
The report from the companies thenselves that prompted them to stop selling the medications involved were done in patients without signs or symptoms of heart disease and they did found something like 5% of Echo abnormalities (now I am writing from memory, do not have reports at hand). The diet centers not finding abnormal echos is higly "skewed" and understandable, they are parties to the problem.
The Editorial in the NEJM in response to the initial Mayo clinic report explained that practically the same findings occurred in Europe 10 to 15 years ago when the drugs were introduced. The companies here have a problem the size of the silicon breast scandal. The main argument is that Dow-Corning knew of leaking silicon gel from the implants long before and went ahead anyway. Here, the European experience was well known and the companies went ahead, and did not even try to discouraged the use in the non target population and contribute to the recreational use aspect (diet-centers) and festive enviroment (the more skinny women/men were getting the drug).
The lawyers are accumulating lawsuits and this is not to get couple of millions.
The jury will not be on the side of the giant drug companies, and they will not listen to the cry of "the patients asked for it", or "doctors were the reeponsible ones who prescribed against the indications", nor will they care about the "disclaimers" which by the way do not take legal responsibilities away, except in the cases of the strong vs the weak. Here is not the weak complaining, it is an avalanche of lawyers wery well trained in fighting for their money (the lawyers'money).
This is not a rosy scenario for this company. Anyway the fact that they removed the products away is high evidence of damage control
(too late).
If I remember well the large WA study was designed to follow the clue from animal evidence on behavioral side effects. It started months before the valvular problems came around. If they have another to follow the heart problems I did not know about it. But, what are they going to find? now everybody is off the drugs and conditions made change, at the least the done damage will not get worse, and some damage maybe even get better, the offending agent is not there anymore.
A new lawsuit a day is boring, but it does not sound like investment advice. |
