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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 10-10-2006

Report Faults FDA on Drug Safety
Washington Post, 10-10-06

Editor's Notes:

There is an old journalist's adage to the effect that if something happens all the time—"dog bites man" being the typical illustration—it isn't a story worth running. "Man bites dog," on the other hand, is page A1 material. The same theory holds true for public policy, particularly when it comes to the FDA.

When a prescription drug works exactly as intended—as they do every day for the vast majority of Americans—no one notices. Singling out rare adverse events, on the other hand, garners great press coverage and a plethora of Congressional hearings. On the heels of a recent report from the Institute of Medicine criticizing the FDA, more experts are weighing in on the perceived shortcomings of the agency:

Five experts who have advised the Food and Drug Administration on drug safety yesterday threw their weight behind mounting criticism that the agency does not adequately protect the public from unsafe drugs.

The experts, all current or former members of the agency's Drug Safety and Risk Management Advisory Committee, said FDA-mandated safety studies can miss serious problems with a drug both before and after its approval. The agency does not have the authority to pull dangerous drugs unilaterally, force changes in drug labels or sanction drug companies that skimp on safety monitoring, the experts said.

The group, which published its critique yesterday in the Archives of Internal Medicine, also contended that the FDA lacks the money and structure to insulate itself from the influence of the pharmaceutical industry.

The findings are similar to those released last month by the congressionally chartered Institute of Medicine, which found that the system for approving and regulating drugs is in serious disrepair. That report, requested by the FDA, followed two years of controversy over drug safety after the 2004 withdrawal of the arthritis drug Vioxx because of the risk of heart attack.

The FDA are certainly has problems that are worth addressing: the need for increased funding, improving the agency’s ability to monitor adverse events after a drug has entered the market, and finding more effective ways to communicate emerging safety signals to physicians and patients. Some are tough technical problems that resist quick solutions, such as finding better biomarkers for liver and kidney toxicity. The FDA has already embarked on a number of promising initiatives in many of these areas.

How good of a job is the agency really doing on drug safety? Getting the right answer to this question requires weighing the relative trade-offs between safety and benefits, because slowing down drug approvals to analyze more data or request larger and longer clinical trials inevitably lengthens the time it takes for new medicines to reach patients.

Some researchers believe that the FDA is actually too cautious—a view the authors of this thought–provoking article from the Milken Institute Review, "How safe is too safe?" hold. When it comes to the FDA, this may be the real "man bites dog" story, but is not one that we often hear.

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Lawmakers Express Distrust of CDC on Vaccine Studies
FoxNews.com, 10-10-06

Editor's Notes:

The controversy over vaccine safety—specifically that vaccines may be related to neurodevelopmental diseases like autism—is unlikely to go away because frustrated and frightened parents demand absolute answers from scientists who can only speak in terms of probabilities. Based on all of the credible evidence we have now—from the CDC and the Institute of Medicine, and from U.S. as well as foreign researchers—there is no link between vaccines and autism. That is simply all science can say that on this point—or on any other point, for that matter.

Asking science to prove a negative is a rhetorical feint that obscures the fact that no study could restore "absolute trust" in vaccines. Unfortunately, some members of Congress are blithely ignoring this fact and are preying on parent's fears for political advantage.

"Parents deserve answers," Maloney said when the bill was introduced. "As the most scientifically advanced country in the world, we should be able to conduct a comprehensive study of the health effects of vaccines to restore absolute trust in the nation's vaccine program."

...As for the CDC's focus on vaccine safety, Allen said, "We carefully evaluate allegations of harmful vaccine effects and are prepared to adjust our policies if allegations prove scientifically valid."

In 2005, Dr. Frank DeStefano, acting chief of immunization safety for the CDC told FOXNews.com, "Autism is a serious developmental disability and has a great effect on the individual and their families, and there is great impetus of need among families and society and the government to find out what is causing autism and what can be done to prevent it."

However, he said, the current body of evidence on the safety of vaccinations is strong.

"Our judgment is that vaccines are safe and the evidence today indicates that vaccines are not linked to autism," said DeStefano.

For more information on the vaccine safety debate, please see our interview with Dr. Paul Offit on vaccine development.

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States Take Lead On Health Care As Budget Pinch Forces Reform
Investor's Business Daily, 10-11-06

Editor's Notes:

America's federal structure encourages states to act as innovative laboratories for new social policies, as Justice Brandeis famously observed. Wisconsin's welfare reforms in the early 1990s, for example, eventually became the model for the landmark welfare reform legislation Congress passed in 1996. This Investors Business Daily article shows that Medicaid, the joint state–federal healthcare program for the poor and disabled, may be the next policy area in which the states lead Washington, D.C. to implement effective reforms.

States can't afford to let health spending get further out of control because they must, by law, have balanced operating budgets, said Kala Ladenheim, program director of the forum for state health policy leadership of the National Conference of State Legislatures.

States also must pay for public hospitals and half the cost of Medicaid, the federal–state program to cover health costs for the poorest.

"The states have to be very inventive," Ladenheim said.

Kentucky is breaking up its Medicaid system into four groups: the general population, children, elderly needing nursing home care, and those with disabilities needing long-term care. Funds will go to each group based on its level of health care need.

Arkansas will set up a basic insurance plan for small businesses. It also has ordered junk food and soft drinks out of schools to tackle childhood obesity and diabetes.

Minnesota has a pay–for–performance plan, called P4P, for all health care programs paid for by the state. The plan will set standards in the four costliest areas: diabetes, hospitalization, cardiac care and preventive medicine.

California has passed a law letting the state wield the purchasing power of its Medi–Cal (Medicaid) program as a club to persuade drug suppliers to lower prices for almost 6 million people.

It is too early to tell which model may turn out to be the most effective, but it is encouraging that, while Congress seems unable to pass even modest health care reforms, governors and state legislators are taking real political risks.

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A Poor Report Card
The Economist, 10-12-06

Editor's Notes:

The National Health Service in the United Kingdom was up for a national review recently, and the Economist reports that it appears to have done rather poorly:

WHETHER or not the National Health Service is granted greater independence from politicians, the vast sums of public money flowing into it demand close scrutiny. The Labour government set up the Healthcare Commission to provide an independent check on the quality of NHS services in England. On October 12th it delivered a damning indictment.

Almost half of the hospital trusts that provide acute care were rated only "fair" or "weak" on quality. Primary–care trusts, which buy health care for the patients living in their areas, did even worse, with two–thirds in the lowest two categories (see chart). A rating of "weak"—the lowest grade possible—means that the trusts have just 30 days to come up with an action plan to sort themselves out.

...The commission's report card marks a new approach to monitoring performance in the NHS. It replaces the previous "star ratings", which rolled all the indicators into just one, ranging from no stars at all for poor performance to three for excellent. Now that the results for quality have been unbundled from those for finance, trusts can no longer blame a poor overall rating on a dodgy financial performance.

The headline ratings are supposed to summarise a heap of data. The "quality of service" measure, for example, compresses indicators based on 24 core standards, 20 existing national targets, 24 new national targets and seven reviews of specific services. For the core standards alone, hospitals had to fill in a 68-page form, answering questions ranging from the general ("Please give examples of initiatives to reduce anxiety about admission and treatment for children and young people") to the very specific ("Where is the designated endoscopy washroom situated?").

Hospitals' returns were then compared with information already held by the commission, such as surveys and figures from other regulators. Where they seemed suspiciously upbeat the commission carried out further checks, which led to a downgrade for a quarter of all the standards examined. Even more worryingly, the commission also carried out some random checks, one in eight of which led to a downgrade, suggesting that trusts' self–assessments were not very reliable.

The commission hopes that its findings will be used to help patients choose between hospitals, one of the government's main policies to improve the NHS. The findings are all available online and can be searched by postcode or name of institution. Scores can be broken down into their components, and results for each standard and target examined separately.

But are the right things being measured? "The commission is faced with the problem of auditing quality without any data on outcomes," says Nick Black, a professor of health–services research at the London School of Hygiene and Tropical Medicine. "So instead it asks whether hospitals are carrying out the processes it thinks they should be."

The NHS, along with health systems throughout the developed world, are essentially trying to bring market forces and market discipline to bear in what are essentially third–party payer systems. Tinkering at the margins will undoubtedly help things along, but the biggest gains seem to come—in places like Switzerland and elsewhere—when consumers have the financial clout to drive quality improvements.

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Two doctors sound alarm on heart stents
The Miami Herald, 10-13-06

Editor's Notes:

Information technology and new statistical tools are revolutionizing the way we perceive safety in medicine, as researchers uncover ever more subtle differences in outcomes from medical treatments. For instance, sophisticated re–analysis of clinical trial data and the "real world" outcomes data that large public and private insurers collect can uncover rare safety signals—like the link between Vioxx and heart attacks—that might otherwise have escaped notice for years.

Take, for instance the growing debate over the increased possibility of death resulting from the use of drug–coated stents, rather than uncoated stents, as reported in this article from the Miami Herald.

While federal authorities sounded huge alarms after one death was caused by tainted spinach, they have done virtually nothing to reduce the more than 2,000 unnecessary deaths a year caused by drug–coated stents, alleges an editorial on the website of a major medical society. The editorial—written by two Los Angeles physicians at a website run by the American College of Cardiology—could have a major effect on Cordis, the Miami Lakes company that produces one of the stents, small metal tubes inserted in arteries to keep them open after blockages occur.

Sanjay Kaul, lead author of the editorial, told The Miami Herald that he fears the drug–eluting stents are similar to Vioxx, the heart drug that has led to thousands of lawsuits. "Like Vioxx, sometimes the signals don't emerge until later, and I think that could be the case here," said Kaul, a cardiologist and associate professor at Cedars–Sinai Medical Center in Los Angeles.

The Food and Drug Administration recently said it is convening a panel to review the safety and benefits of the stents in light of concerns. Two South Florida cardiologists who use the stents frequently believe Kaul's concerns are exaggerated, but Steven Nissen, president of the American College of Cardiology, said the matter must be examined scientifically. "There is a question here. The answer is not known with certainty, and the FDA is putting together a panel together to review this," said Nissen in a telephone interview. Nissen, the chairman of cardiovascular medicine at the Cleveland Clinic in Ohio, was the first doctor to link Vioxx to increased risks of heart attacks.

The analogy to Vioxx is instructive, as the Agency for Health Care Quality and Research (AHQR) recently published an analysis comparing the relative risks of new and old pain treatments for osteoarthritis. The analysis found that new COX–2 inhibitors, such as Vioxx, posed risks and benefits similar to those of drugs that have been on the market for decades.

The good news, when it comes to drug–coated stents or any other medical intervention, is that we are only at the earliest stages of analyzing the relative risks involved. Over the long term, medical researchers will find ways to make the diagnosis and treatment of diseases much more personalized and cost effective.

The bad news is that we have limited ability today to predict exactly which patients are most at risk for adverse effects. This uncertainty is bound to generate pressure on regulators to set blanket rules with the goal of protecting everybody, while lawyers will continue to bring litigation second–guessing every decision. Right now, the FDA seems to be taking the right approach, convening a panel to look at the evidence and sort out what we do and don’t know.

Until we make a quantum leap in diagnostics, the bottom line is that patients and doctors are going to have to keep doing what they have always done: Make educated guesses about what treatments are most appropriate on an individual basis.

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Drug Reactions Send 700,000 Yearly to ER
Baltimore Sun, 10-17-06

Editor's Notes:

The media tends to exaggerate the risks of newer, patented drugs–in part because these drugs are the most heavily advertised, and thus constantly in the public eye. But a new report from government agencies suggests that older, widely used treatments generate a vast number of adverse events.

Harmful reactions to some of the most widely used medicines—from insulin to a common antibiotic— sent more than 700,000 Americans to emergency rooms each year, landmark government research shows.

Accidental overdoses and allergic reactions to prescription drugs were the most frequent cause of serious illnesses, according to the study, the first to reveal the nationwide scope of the problem. People over 65 faced the greatest risks.

"This is an important study because it reinforces the really substantial risks that there are in everyday use of drugs," said patient safety specialist Bruce Lambert, a professor at the University of Illinois at Chicago's college of pharmacy.

Even so, the study authors and other experts agreed that the 700,000 estimate was conservative because bad drug reactions are likely often misdiagnosed.

The study found that a small group of pharmaceutical warhorses were most commonly implicated, including insulin for diabetes; warfarin for clotting problems; and amoxicillin, a penicillin–like antibiotic used for all kinds of infections.

"These are old drugs which are known to be extremely effective. We could not and would not want to live without them. But you've got to get the dose exactly right. Variations, especially on the high side, are really dangerous," Lambert said. He was not involved in the research.

Those aged 65 and older faced more than double the risk of requiring emergency room treatment and were nearly seven times more likely to be admitted to the hospital than younger patients.

The results, from 2004–05, represent the first two years of data from a national surveillance project on outpatient drug safety. The project was developed by the federal Centers for Disease Control and Prevention, the Food and Drug Administration and the U.S. Consumer Product Safety Commission. The study was published in Wednesday's Journal of the American Medical Association.

In other words, all drugs come with their own risks and benefits. The ancient Greeks knew this, and used the same word–pharmakon–for medicine as they did for poison. Still, we shouldn't panic. After all, the basic premise of medicine is not that treatment is without risks, but that the diseases we are trying to cure present greater risks.

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