The very first question that someone needs to ask themselves is whether they should be taking a COX-2 inhibitor in the first place. There are many alternatives that are safer. And many studies have shown taht the COX-2 inhibitors like Vioxx are no more effective than these alternatives. But far be it from the FDA to stand in the way of this now multi billion dollar industry.
Now that Vioxx has been found to double the risk of heart attacks and strokes, doctors, researchers, and congressmen (but not the FDA???) are calling to have these drugs pulled and finally, the FDA has agreed to call for long term safety studies of all COX-2 drugs.
Is this the fault of the FDA? Is it the fault of big pharma trying to make money for stock holders over its concerns for patient safety?
Is Merck to blame? Who is responsible?
Studies show that Merck new of these problems since 2000, yet Merck continued to aggressively advertise VIoxx. They spent over $100,000,000 to put positive spin on the overwhlemingly negative data. Instead they should have spent that money warning doctors. Even one month before the recall, and even at the time of the recall, they said Vioxx was "safe." One month before, they sent out a press release refuting the heart attack connection, saying Merck stands behind the overall safety and the cardiovascular safety of Vioxx. And six months before that, they asked the FDA for permission to sell Vioxx for kids. Can you believe that???
Some want to blame the FDA. They are in a tough spot. If they don't approve drugs, then big pharms starts promoting the concept that the FDA is holding up life saving and life improving drugs. If they do approve drugs, then they look bad if they later recall them... and even worse if they don't when it is discovered how bad some drugs (liek Vioxx) really are for the health of the patients taking them. In Senate committee testimony, Dr. Graham, the whistle blower in the case of Vioxx, said that the FDA ostracized him and subjected to implied threats and intimidation.
And do we really care about blame, or just fixing this situation so it does not happen again, and compensating people who have been injured.
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