Drug companies that manage the studies can manage the message Posted by Rob Schneider at 08/24/06 01:08 PM

Merck released some news -- though not the complete results -- from a study of a painkiller. As you recall, Merck had withdrawn the painkiller, Vioxx, from the market in 2004 because of cardiovascular risks. The release of a portion of the study on the drug Arcoxia is a reminder of the power drug companies have to manage the news when they pay for the clinical trials.

The release, as reported in the NY Times today, raised concerns among some:

Some independent scientists, though, criticized the company for making its announcement without releasing the study’s full details. And they noted that the Arcoxia side effects that Merck did disclose yesterday included high blood pressure.

Vioxx was a blockbuster drug that was supposed to be a better pain reliever than other medicines and safe on the stomach. It was massively advertised, including television ads featuring Olympic ice skater, Dorothy Hamill. Sales hit about $3 billion a year and it was taken by 80 million people worldwide.

But, Merck may have know about potential serious cardiovascular risks as early as 2000, and some estimate that between 88,000 and 140,000 more cases of “serious coronary heart disease” have resulted from the use of Vioxx.

And it is the question of when Merck told the public and doctors that goes to one key piece of the controversy:

Merck is pursuing a high-risk strategy in pressing ahead with its application to sell Arcoxia in the United States, scientists said. Accusations that Merck did not tell doctors everything it knew about the risks of Vioxx have damaged the company’s reputation. Merck must now persuade skeptical regulators and doctors that it is fully disclosing Arcoxia’s potential hazards.

Given the cloud hovering over clinical trials there has been broad agreement that all clinical trial results -- not just the positive ones -- be released to the public:

Dr. Steven E. Nissen, the president of the American College of Cardiology, said Merck should have disclosed more information from the Arcoxia trial or not discussed it at all.

“The bottom line here — they didn’t really release enough data for us to make a conclusion,” said Dr. Nissen, who is overseeing a large clinical trial sponsored by Pfizer to study the heart risks of Celebrex. “It was a very carefully crafted press release.”

Merck has responded to that kind of criticism:

Dr. Sean Curtis, who heads the Arcoxia development program for Merck, said the company would disclose the study’s full results before the end of 2006, both in a peer-reviewed scientific journal and at a medical conference.

“We really want to present the entirety of the data after peer review,” Dr. Curtis said.

So why did they release the partial results? Does this study point to the need for independent study of the drugs we take?

Unless a government agency carries out a large independent trial, patients and doctors may never know which painkillers are the safest, Dr. Psaty said.

And, until there is a requirement that all clinical trial results are released to the public, the cloud over the credibility of drug companies will remain.

comments (4)

1 Posted by wendella at 08/30/06 11:25 AM

I have long thought the government ought to have a bigger role in drug studies, if only to make certain that ALL the information from the studies actually makes it out to the public. I am one of those people who regularly participates in drug studies - I have lost count of how many I have been in over the years. I do this for several reasons, not the least of which is the fact that often this is the ONLY way I am able to afford the drugs I need (another comment on our great health care system !) but I also do the studies with a sincere wish to do some good for others.
It bothers me that big drug companies can hide the parts of these studies they don't like, simply because they paid for them. We, the consumers, ought to have an ultimate right to know all of what the studies turned up. And we depend on our government to make sure we get that information, not to protect the drug companies right to hide the information from us!

2 Posted by Alendronate at 07/23/07 12:06 PM

Pfizer is one of four drug companies that have started discount cards in recent months. The cards can be helpful, if an elderly person meets the income requirement, if the drug company makes the needed medication, and if the senior even finds out about the card. Ruth Church works hard to stay informed on these things. But she didn't know about drugmaker GlaxoSmithKline's program, which discounts still another of her medications.

3 Posted by narconon vista bay at 08/06/07 08:02 AM

Well it's in their power, who is going to stop them ?

4 Posted by narconon at 08/07/07 05:53 AM

What makes you think the government doesn't have a big role in the drug related field ?