Friday, January 19, 2007

NIH Cancels Guideline Development Meeting After Conflicts of Interest Revealed

The Wall Street Journal just reported that the NIH cancelled a planned meeting for drafting guidelines about neonatal herpes after receiving a letter written by a group of individuals and organizations, lead by the Center for Science in the Public Interest, that raised concerns about conflicts of interest affecting many of the meeting participants. (Full disclosure: I was one of the individuals who signed the letter.)

The National Institutes of Health abruptly canceled a meeting scheduled for next month to draft guidelines for treating pregnant women and babies with herpes, after concerns were raised about conflicts of interest among a panel of experts tapped to review the issue.

The action came after a group of physicians, medical researchers and consumer and health groups urged the NIH in a letter yesterday to bar experts who are paid by drug makers from helping to draft government guidelines for how doctors treat diseases. Their action was touched off by the NIH's recent naming of five experts to present evidence at a conference next month aimed at drafting guidelines for treating pregnant women with herpes and babies born with the condition.

The five experts, including one who is responsible for coordinating the writing of the guidelines, are doctors employed at academic medical centers. Four of the five experts, including the writing coordinator, have financial ties to makers of herpes drugs, resulting in a panel that "is completely unbalanced," the letter says. The five were the only experts listed as presenters on an NIH draft agenda for the meeting.

The action comes amid concern that clinical guidelines that form the basis for how physicians and hospitals treat patients are being unduly influenced by the drug industry. In several recent cases, including one involving kidney treatment with the drug erythropoetin, guidelines composed by experts paid by drug companies have promoted treatment regimens that some other experts contended brought harm to patients while promoting wider use of a drug.

The letter was signed by 44 individuals and 16 organizations. Among the individuals were Richard Horton, editor of the British medical journal Lancet; Marcia Angell and Jerome Kassirer, both former editors of the New England Journal of Medicine; and doctors from medical schools including Harvard and Johns Hopkins. The organizations included the Center for Science and the Public Interest, the National Women's Health Network and the publisher of Consumer Reports.

The group wrote that the NIH agency 'must be an honest broker in the development of medical evidence that will inform clinical practice' and that the NIH must ensure that all members of guideline-writing committees are 'free from conflicts of interest.'

The letter writers said the scheduled meeting on herpes added to a 'sad record' at the NIH of drafting treatment guidelines using panels composed largely of experts receiving money from drug companies. They said that 2004 guidelines for treating cholesterol were drafted by a committee of nine physicians, eight of whom had financial relationships with makers of statins, which are widely given for high cholesterol.

According to a draft agenda of the Feb. 20 meeting, University of Washington obstetrician Zane Brown was to have presented information on testing pregnant women for herpes. Dr. Brown is a frequent speaker for Glaxo[SmithKline] on herpes issues. In an interview with The Wall Street Journal for a prior story on the subject, Dr. Brown estimated he gives two to three lectures a week advocating universal testing of pregnant women, earning $1,000 to $2,500 a talk.

The doctor who was slated to lead the session on writing the guidelines, Richard Whitley, is a pediatrician at the University of Alabama at Birmingham medical school who is a member of the Glaxo speakers bureau.

Also on the panel was Anna Wald, a University of Washington epidemiologist, who said yesterday she has been a consultant to Novartis AG, which makes a herpes drug, and has done research funded by Glaxo. Dr. Brown didn't respond to an email, and attempts to reach Dr. Whitley through a representative were unsuccessful.

The fourth member identified in the letter as having a conflict was Massachusetts General Hospital obstetrician Laura Riley, who is the secretary and treasurer of the American Herpes Foundation, a nonprofit largely funded by herpes drug makers. Dr. Riley says she has received a few $1,000 stipends for attending meetings of the herpes foundation, but doesn't receive a salary or other pay for her work at the organization.

See also CSPI's press release here.

Note that we recently posted 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. We also recently posted about how Amgen Inc. supported development of guidelines that might lead to aggressive use of epoetin (Epogen), which it manufactures, for anemia in patients with chronic kidney failure.

As we have said before, this is a reminder that just because a set of recommendations is called a guideline, or is written under the auspices of some august academic or scientific organization does not guarantee that its recommendations are based on the best evidence, or are not influenced by vested interests. And yet guidelines remain a buzz word for those who say they want to control health care costs, and improve quality and access. And giving guidelines teeth, otherwise known as "pay for performance," (P4P) is now the most fashionable solution to the cost, quality, and access problems. (See post here.)

At least, in the current instance, quick action, lead by the Center for Science in the Public Interest, may have stalled the development of yet another guideline that could have been unduly influenced by those wishing to promote vested interests. I am proud to have had a very minor role in this action.


Anonymous said...

Would you mind leaving a comment about this over on my Herpes Blog? I would really appreciate it very much. I just blogged about this yesterday and am quite shocked that they would cancel the meeting so quickly.

Anonymous said...

It's been interesting to note the skepticism about cost benefit analysis coming from physicians who participated in our little action this week. It's no wonder they're skeptical. Most cost benefit analyses is written by health care economists in the pay of the pharmaceutical industry, just like most medical evidence. It never ceases to amaze me how many studies come in just under the $50,000 QALY threshhold. See! Our new pill/test/device is worth it!

That's why, if you today's post on closely, you'll begin to get my thinking on why I support comparative cost benefit analysis. Take an example that I heard today. The changes in the cholesterol guidelines made by the National Cholesterol Education Project in 2004 pushed the levels requiring statin therapy to the point where it now costs $2 million per Quality Adjusted Life Year improvement. We're spending close to $20 billion a year for statins, many for people with elevated cholesterol but no other risk factors for heart disease (the worried well). Imagine, if you will, that we took even $2 billion of that expenditure and put it into a massive public health campaign (community nurses, advertising, neighborhood clinics) in communities with very high risk of heart disease . . . low income communities with untreated hypertension, out of control blood sugar and pre-diabetes, obesity, poor diet . . . and try a public health approach to reducing heart disease. I suspect we'd get a lot more bang for the buck. But no one has even done a cost effectiveness analysis of that approach, much less a comparative cost-effectiveness analysis comparing it to giving statins to marginally at risk people who are well insured.

The knee jerk response opposing CB analysis is justified because of how it's been abused. But my view, at least for now, is that it potentially, and I stress potentially, could be a useful tool for moving the health care system in a more targeted direction, and thereby getting better health outcomes at lower costs. -- Merrill

Anonymous said...

Still on the government front we learn from the WSJ via AP:

Ex-CVs Officers Are Indicted

January 19, 2007; Page C2

PROVIDENCE, R.I. -- Two former executives at drugstore chain CVS Corp. were charged in a probe into influence peddling at the Rhode Island statehouse.

John R. "Jack" Kramer, former senior vice president for corporate affairs and government relations, and Carlos Ortiz, former vice president of government affairs, were charged with one count each of conspiracy and bribery and 21 counts each of fraud for allegedly paying former state Sen. John Celona to kill legislation CVS opposed or sponsor bills the company supported.

It is very disconcerting when we learn that our government officials can be bought so cheaply and our health is hostage to the high bidder.

Steve Lucas