Tuesday, October 31, 2006

Burying Data, Chapter 214

OK, I'll admit the following story ain't all that surprising unless your head has been firmly planted in the sand for the past several years. That being said, I'm sure glad somebody reported it...

"There is growing criticism of Big Pharma for failing to disclose results of clinical studies; especially studies that provide information about the safety or effectiveness of medicines being taken by consumers.

Take the case of GSK and two trials of Valtrex vs Famvir, in genital herpes.

The trials finished in 1998, but the were only published last month.

The lead researcher for the studies complained she was never given a satisfactory explanation, and noted the drugmaker responsible for the delay also owns the medicine that fared poorly.

"I was given all sorts of reasons," said Anna Wald, a professor of medicine at the University of Washington, whose work comparing the two drugs was recently published in the journal Sexually Transmitted Diseases.

"It took years to receive any material," she said. "They should have moved faster."

To gain an edge, SmithKlineBeecham funded a pair of comparative studies. Such clinical trials are known as head-to-head studies, but are rarely undertaken voluntarily by drugmakers due to the expense and, in particular, the possibility that results will be unflattering. In effect, SmithKlineBeecham took a gamble in hopes of goosing sales.

There was good reason. In 1997, the drugs were in a dead heat. Valtrex sales totaled $111 million on 1.6 million prescriptions, while Famvir rang up $107 million in revenue on 1.1 million prescriptions, according to Verispan, a market-research firm.

A team of researchers led by Wald conducted the studies in 1997 and 1998, but SmithKlineBeecham never shared the results, even though Wald said she repeatedly asked for the data. As a result, Wald said she had no way of knowing SmithKlineBeecham's Famvir compared unfavorably with Valtrex.

In other words, SmithKlineBeecham lost its bet.

In 2000, Glaxo and SmithKline merged, complicating the tale. The combined company promptly sold Famvir to Novartis to satisfy anti- trust concerns. A Glaxo spokeswoman said there was no information available about how the study data were handled at that time or why the data weren't given to Wald.

By then, Glaxo's Valtrex had taken the lead. In 2001, Valtrex generated $413million in sales on 4.4million prescriptions; Famvir rang up $191million in sales on 1.5million prescriptions, according to Verispan.

After the merger, Wald said she began asking Novartis for the study data, but didn't receive anything until early last year, when the drug maker sent what she described as an "enormous box of papers." She said Novartis personnel insisted the data couldn't be located.

"There are two possible interpretations," said Wald, who is also a consultant to Novartis. "Either the data got lost as part of the transfer from one company to another. The other is that Novartis didn't want to share the data be cause it wasn't favorable (to Famvir), which might hurt the sales. I don't know which it is."

The Novartis spokeswoman also explained Famvir data were stored among 28,000 boxes sent by Glaxo, and that talks began with Wald in January 2003. But she couldn't explain the delay between 2003 and late 2005, when Wald finally received the data.”

Hat Tip: The always ecellent PharmaGossip.

P.S. Don't worry -- drug companies don't have to share data with researchers. Just ask this guy.

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