Wednesday, December 13, 2006

Medical CME and Conflicts of Interest: GSK Funds Talks About Screening Pregnant Women for Herpes

The Wall Street Journal just published an article by David Armstrong about how continuing medical education (CME) often seems to serve the interests of its commercial sponsors. The focus of the article was on how GlaxoSmithKline funds speakers who seem to favor clinical policies that just might end up increasing the use of the GSK drug valacyclovir (Valtrex) for genital herpes infections. (See our recent post about the attempted suppression of a study comparing Valtrex to Famvir here.)

The article focused on talks given by Dr Zane A Brown of the University of Washington. To quote from the article,

Addressing doctors, medical residents and students at Ohio State University Medical Center in September, Zane Brown advocated a big change in prenatal care: testing all pregnant women for genital herpes.

Widespread testing would reduce herpes infection in newborns, said Dr. Brown, an obstetrician at the University of Washington medical school.

It also would probably lead to a rise in the use of herpes drugs by pregnant women. That would be a boost to GlaxoSmithKline PLC, which sells the top-selling herpes drug -- and which paid for Dr. Brown's lecture.

Glaxo says it doesn't market its herpes drug, called Valtrex, in any way for pregnant women.

Doctors, however, aren't restricted in how they use an approved drug, nor in what they can say about it in talks to other medical professionals. And currently, about 10 doctors are fanning out across the U.S. making the case for universal genital-herpes screening of pregnant women. Glaxo funds these talks by giving grants to hospitals and other institutions that host them.

The lectures are called continuing medical education, or CME. Doctors who attend earn credits needed to maintain their medical licenses. Drug makers increasingly use lectures and articles by outside doctors to get their message across, at a time when hospitals often restrict salespeople's access. The funding reflects a broader trend of drug companies trying to influence medical practice, not always with full disclosure of their role. However, Dr. Brown, speaking to doctors in Ohio in September, mentioned Glaxo's funding of the talk.

Dr. Brown says he gives two to three lectures a week advocating universal herpes testing for pregnant women, earning $1,000 to $2,500 per talk. He says his motive isn't money but a desire to reduce the number of babies born with herpes. Because his own university lacks the funds to pay for his lectures, he says, he has a relationship with Glaxo born of necessity. 'I am using them and they are using me,' he said recently as he waited to board a flight to Tennessee for a series of lectures at hospitals there.

A Glaxo spokeswoman said the company has no 'control over the selection of speakers or the material presented' at CME lectures it funds. In the case of the Ohio State lecture, a professor who organized it, Wayne Trout, said, 'We approached [Glaxo] and said we want to bring Dr. Brown in -- can you give us some funding?' Glaxo declines to comment on specific programs.

Dr Brown is not the only one getting into this particular act.

The message doctors get in continuing-medical-education lectures and Web sites clearly favors testing and treatment of pregnant women. An example is an online CME lecture provided by Medscape LLC last March. Medscape says it picked the herpes speakers -- Dr. Brown and another pro-screening doctor, Serdar Ural of the University of Pennsylvania -- from a list provided to it by Glaxo, which funded the event. Glaxo said there's nothing wrong with providing names of potential speakers and added that CME sponsors have ultimate control over who speaks.

In the lecture, Dr. Ural advocated giving antiviral medication to all pregnant women who test positive for herpes even if they show no symptoms. He acknowledged there wasn't a lot of evidence such a strategy works but said, 'What is the downside? If she takes medication for a couple of weeks, side effects compared to placebo are about the same.' Dr. Ural said he has given 11 Glaxo-funded talks this year, declining to say how much he has been paid.

David A. Baker, a professor of maternal-fetal medicine at the medical school at the State University of New York in Stony Brook, lectures on herpes for Medscape and also for a firm called Omnia Education. Omnia receives funding both from Glaxo and from Quest Diagnostics Inc., maker of a herpes test. Dr. Baker typically discloses he is a consultant to Glaxo. In a filing with the New York State Ethics Commission, he also reported owning Glaxo stock. Asked about his stockholdings, he declined to comment, through a spokesman.

The American Journal of Obstetrics & Gynecology published a study in March that promoted the use of Valtrex in pregnant women over a generic alternative or no treatment at all. Not mentioned was that co-author Richard Whitley, a pediatrician at the University of Alabama at Birmingham medical school, is a member of the Valtrex maker's speakers bureau.

Dr. Whitley said in an interview he didn't disclose this because he hadn't yet begun his work as a Glaxo speaker. Yet his university disclosure forms indicate he has been a speaker for Glaxo since at least 2003. Asked about this, Dr. Whitley said through a spokesman that 'my omission of mentioning serving as a speaker for GlaxoSmithKline was an honest and simple oversight, made because my involvement in this role is quite minimal as a regional speaker.'
The article noted that there is no strong evidence supporting screening of pregnant women for herpes. In fact, the US Preventative Services Task Force, which usually follows the evidence-based medicine process pretty closely, suggests that screening not be done.

We just seem awash this week in conflict of interest stories. In this one, we have academic physicians whose talks, at $1000 - $2500 a pop, which suggest aggressive screening for herpes with little evidentiary justification, which presumably could lead to aggressive use of anti-viral agents for patients who test positive, just happened to be supported by a pharmaceutical company that makes those anti-viral agents.

Again, this suggests, at the least, the need for much more thorough disclosure of conflicts of interest by, in this case, all those who give CME presentations. One wonders if audience skepticism would have been increased if Dr Brown announced before each talk the amount he was paid to give it, and the total amount he received from GSK in the previous year, and made it clear that the strategies advocated in his talk would tend to increase the use of Valtrex, which just happened to be manufactured by GSK.

In lieu of such policies, doctors attending CME talks given by supposedly impartial experts (or those reading articles or guidelines written by other supposedly impartial experts) need to be very skeptical about for whom these experts actually work, and whose interests their talks, articles, and guidelines actually support.

FULL DISCLOSURE - I participate in a more or less monthly Roundtable discussion published by Medscape on the web.

1 comment:

Anonymous said...

Interesting post. I've commented on it on my Medical Conference Blog at