Looking for an Honest Broker in Health

Many physicians and hospitals in the U.S. ignore the best scientific evidence when treating patients, which helps explain why we have worse health care outcomes than other advanced industrialized nations despite spending far more. Any proposal for universal health care that wants to improve quality must include powerful incentives for moving the health care delivery system toward adopting evidence-based medicine.

It's not only key to better health care, it's the key to making health care affordable. The marketing muscle of medical suppliers like the drug and device companies encourages physicians to follow the most expensive medical practices, which often turn out to be worse for health than cheaper alternatives. Therefore, if insurers, whether Medicare or the private market, paid doctors to perform up to scientific standards (it's called pay for performance), not only would the health care system's performance improve, it would be less costly.

The key, of course, is coming up with evidence that identifies the most effective forms of prevention and medicine. Someone -- the National Institutes of Health is the most logical candidate in the U.S. -- must conduct systematic studies that compare competing modes of prevention and treatment to determine which are the most effective interventions. Just as importantly in the cost-constrained years ahead as the Baby Boom ages, someone is going to have to figure out the most cost-effective interventions. These comparative studies, distilled into evidence-based clinical practice guidelines, will be the building blocks of any new universal health care insurance system if it is going to provide quality care to everyone at a price that the rest of the economy can afford.

But where does this evidence come from? The gold standard for evidence-based medicine is derived from randomly-controlled clinical trials. When there are few trials to go by or they cannot be randomly controlled (many implanted devices or othe surgical procedures fall into this category), the evidence comes from observational studies. In a few cases, like for extremely rare diseases, the evidence comes from consensus statements issued by docs who have tons of experience in the field.

This collective wisdom is synthesized into clinical practice guidelines, which are issued by government agencies, medical professional societies and even patient advocacy organizations. These groups call together panels of physicians (sometimes they include patient representatives) to review the evidence, and distill from them a set of best practices that physicians should follow. The assumption is that by widely publicizing these guidelines (the Agency for Healthcare Research and Quality has even created a website that collects them and makes them readily accessible to physicians, patients and payers) and providing incentives for their adoption like paying doctors to adhere to them, the quality of health care in the U.S. will improve.

But for many health care observers, the questions immediately raised by efforts to move toward evidence-based medicine are: 1) How valid is the evidence and who paid for the research (we know that research sponsored by industry usually favors the sponsor's products); and 2) who evaluated that evidence.

Those were the concerns that lay behind this week's protest against a relatively minor meeting at the National Institutes of Allergy and Infectious Diseases that had been called to write clinical practice guidelines for the diagnosis and treatment herpes in pregnant women who are at risk of passing the infection to their newborn. Four of five presenters at the February meeting had financial ties to GlaxoSmithKline or a Glaxo-funded "patient advocacy" group. Glaxo makes a drug, Valtrex or valacyclovir, that suppresses herpes outbreaks. Shortly after receiving the protest letter, NIH cancelled the meeting.

While potentially devastating to the baby, neonatal transmission is a relatively rare phenomenon -- under two thousand cases a year. If a pregnant woman has herpes (and about one in five do), then careful monitoring to ensure there is no outbreak at the time of delivery can avoid the problem. If there is an outbreak, the usual treatment is delivery by cesarean section. While avoiding C-sections is desirable, the number of women getting this procedure at birth is already nearly 30 percent of the 4 million births each year. Does it really make sense to expose newborns to heavy doses of antiviral medications whose long-term health effects are unknown in the name or preventing a few thousand more C-sections?

But, as a Wall Street Journal story documented last month, Glaxo has launched a nationwide "education" campaign to convince doctors to test all pregnant women for herpes, since, once confronted by this "problem," many doctors would probably prescribe drugs to suppress an outbreak. The education program has been accompanied by a large-scale direct-to-consumer advertising campaign for the drug. Once the speakers for the NIAID's neonatal herpes guideline-writing conference in February were announced -- four or five had ties to Glaxo -- it quickly became apparent that Glaxo's marketing campaign had infiltrated that process, too.

The physicians signing the protest letter were a fairly high-powered group. They included Richard Horton, editor of the Lancet, which ran an article last fall critical of the herpes screening in pregnancy; two former editors of the New England Journal of Medicine, Marcia Angell and Jerome Kassirer; and 41 other physicians and scientists, including the head of the U.S. Cochrane Collaboration, which is an international consortium that writes clinical practice guidelines free from industry influence. As their letter pointed out, virtually every clinical practice guideline that comes out of NIH these days -- the examples cited in the letter included guidelines for hypertension, cholesterol management and pediatric AIDS -- has a majority if not a preponderance of physicians with ties to industry.

The letter also pointed to recent examples highlighted in the medical literature (Amgen's Epogen for anemia and Eli Lilly's Xigris for sepsis) where clinical practice guidelines written by physicians with ties to the drugs' manufacturers had actually increased mortality because the drugs touted in the guidelines were being used inappropriately. "Why should either practicing physicians or patients have faith in guidelines written by researcher-physicians with ties to providers whose financial well-being is driven by the content of those recommendations?" the letter asked.

The coalition asked NIH to adopt a simple agency-wide rule: Any institute or center at NIH that writes or funds a group to write a clinical practice guideline should require that the writing committee exclusively be composed of members without conflicts of interest. And those committees should seek out the full range of evidence on a subject before sitting down to write."

The stakes here are much broader than the best treatment for preventing transmission of neonatal herpes. NIH, the letter writers said, "must serve as an honest broker in the development of medical evidence that will inform clinical practice."

An NIH spokesman late Friday afternoon said the agency was still evaluating the broader demands contained in the letter, demands that have significant implications for the future of the movements for evidence-based medicine and pay-for-performance. But a high-ranking NIH official earlier in the day provided a hopeful sign that the agency may respond positively to the criticism.

If you haven't guessed already, I wrote the letter behind this campaign and, in my role as director of the Integrity in Science project at the Center for Science in the Public Interest, organized the physician-consumer coalition that sent it to NIH. After hearing late Thursday night that NIAID had canceled the herpes meeting, I decided to celebrate by taking the morning off to attend a symposium sponsored by the journal Health Affairs on "Heart Disease Prevention and Treatment."

Much of the discussion revolved around the cost-effectiveness of treatments, which isn't surprising since the journal focuses on health economics. David Cutler of Harvard argued that virtually every intervention is cost-effective and he looked forward to lots more coming out of the drug and device industries. As counterpoint, Thomas Gaziano, also of Harvard, pointed to the latest cholesterol guidelines, a product of the National Heart Lung and Blood Institute at NIH where 8 of 9 physicians had ties to statin manufacturers. Their proposals, if widely adopted, would result in spending $2 million on statin drugs for every quality-adjusted life year (QALY) improvement, which is far above the generally accepted standard that says anything over $50,000 (or $100,000 in some formulations) is not cost-effective.

That provided me with a perfect opening to jump up and ask Elizabeth Nabel, the director of NHLBI, who was also on the panel, why the medical economics literature lacked comparative effectiveness studies comparing various drugs for a single conditions or drugs versus other health care interventions, or, for that matter comparative cost-effectiveness studies. I also asked if NHLBI would be willing to fund such studies. She replied: "We see ourselves as clearly being the honest broker to provide the data to support evidence-based medicine."

Though she wasn't one of the recipients of the letter, I thought her choice of words was instructive. Sometimes building an honest broker must be done one brick at a time.

Posted by gooznews at January 19, 2007 04:31 PM