In the Spotlight
Breaking the European information barrier
EU citizens won’t have real healthcare choices until better information is available
Johan Hjertqvist, Medical Progress Today, 6-16-05
Europe is integrating as never before. People, services and goods cross borders, leading to improved quality of life and economic growth.
Continue reading . . .
How Safe Are Your Drugs? Not Enough, Some Say
Investor's Business Daily, 6-13-05
There a ghost haunting the FDA: the ghost of thalidomide.
The FDA, politicians and the public are terrified by the 40-year-old specter of an apparently safe drug that caused birth defects in many patients who took it. As a result, the FDA places a premium on collecting as much information as possible regarding drugs before they are released, and much less effort on tracking the performance of drugs as they are actually used by doctors and patients.
But thalidomide doesn’t represent the central challenge facing the FDA today. Industry drug screening, often in early preclinical tests, is sophisticated enough to catch most serious common drug side effects. Consequently, the vast majority of prescription drugs used by Americans are remarkably safe. But no medicine is completely safe—and when millions of people take any medicine, some very tragic events will inevitably ensue. What are we to do, then,
…if a drug is good for some and bad for a few? That's the key question, says Dr. Jerry Avorn, professor at Harvard Medical School and author of the book "Powerful Medicines: the Benefits, Risks and Costs of Prescription Drugs..
"The problem is that drugs can affect different people in different ways," Avorn said. "We know that some drugs will be just right for some patients and really bad for others..
Calls to increase premarket testing would probably not resolve this problem. It would just add to the costs and time involved in making new medicines, without necessarily making them any safer.
The FDA is on the right track, though: it is building more relationships with insurers and providers so it can access databases that follow individual patients and specific treatments. This is the best way to balance drug safety in large populations (which is generally good) with individual safety (where we need a lot more information).
Study Links NSAIDS to Increased Risk of Heart Attack
Dow Jones Newswires, 6-10-05
While the media have battened onto the Cox-2 painkiller Vioxx as an example of everything that is wrong with the FDA, they have largely overlooked the fact that some painkillers in common use—and commonly considered safe—may also have rare side effects that pose similar risks to Vioxx. The British Medical Journal, for instance, recently published a study finding that:
Ibuprofen and other commonly used painkillers for treating inflammation may increase the risk of heart attack…
Researchers found that for those prescribed NSAIDs in the three months just before the heart attack, the risk increased compared with those who had not taken these drugs in the previous three years. For ibuprofen, the risk increased by almost a quarter (24%), and for diclofenac it rose by more than half (55%).
The newer generations of anti-inflammatoriesCox-2 inhibitorsalso were associated with increased rates of first-time heart attack. Those prescribed the drugs in the preceding three months were at 21% higher risk of heart attack if taking celecoxib, and 32% increased risk if taking rofecoxib.
This finding is significant because after Vioxx and another COX-2 drug, Bextra, were withdrawn from the market, patients have shifted to the older NSAID painkillers, assuming that they posed less risk. That may yet turn out to be true. But in the interim, we shouldn’t allow rare risks to create knee-jerk reactions to medicines—old or new—that are extremely useful and safe for the vast majority of patients.
Do these drugs need a warning? The FDA says yes, but doctors who disagree are taking their case to the AMA
Chicago Tribune, 6-9-05
The FDA has been under tremendous pressure to "get tough" on drug safety, particularly in the case of antidepressants taken by teenagers. There have been some claims that a new class of these drugs, called SSRIs, may increase suicide risk in some adolescents, and the FDA has responded by adding its most stringent warning to the drugs' labeling.
Some psychiatrists, however, contend that these risks have been exaggerated and that the FDA is doing more harm than good by frightening parents and teenagers with severe depression away from useful treatments:
The American Medical Association will consider taking a stance against a controversial Food and Drug Administration decision to add stiff warnings about antidepressant use among teens and children at its conference in Chicago this month.
Those behind the proposal say it is designed to combat a recent, rapid decline in [antidepressant] prescriptions and ensure children and adolescents are getting proper treatment for depression.…
The decline concerns Dr. David Fassler, who is on the board of the American Psychiatric Association… "I worry that it will reduce access to effective and appropriate treatment for children and adolescents suffering from depression," said Fassler, adding that he didn't feel the decision was supported by available scientific data.
An end to the party line
David Gratzer, Macleans.ca, 6-14-05
Gratzer, a Canadian physician and senior fellow at the Manhattan Institute, reviews last week's decision by the Canadian Supreme Court invalidating Quebec provincial laws that made it illegal to purchase private health insurance. Gratzer concludes that, even though the decision only applied to Quebec, it will revolutionize Canadian health care:
Writing in their opinion, Chief Justice Beverley McLachlin and Justice John Major stated: "The evidence in this case shows that delays in the public health-care system are widespread, and that, in some serious cases, patients die as a result of waiting lists for public health care" (emphasis added). The wording is clear: Canada's medicare system can kill you...
What does the ruling really mean? Medicare defenders are quick to point out that it simply applies to Quebec. And that is true. But remember: in an age of jet travel, private health care anywhere in Canada effectively means that private health care is everywhere. For the Torontonian with a bad hip or a Winnipegger looking for cataract surgery, Quebec and its private option are just a plane ticket away.
Accelerate drug approval
Robert Goldberg, Ph.D., Washington Times, 6-14-05
Goldberg, also a Manhattan Institute senior fellow, takes issue U.S. Rep. Edward Markey's criticism of a vital FDA program. Markey claimed that the FDA's accelerated approval process for life-threatening diseases is "broken" because, he said, companies marketing these drugs have completed only 50 percent of the studies they were required to complete. Goldberg responds that:
Mr. Markey uses fuzzy math to conclude that 50 percent of follow-up studies have not been completed. Actually, only 4 percent of the nearly 80 studies for drugs that have received accelerated approval are delayed, though they do take longer than anticipated in many cases.
[This is because] once breakthroughs for life-threatening diseases are on the market, it is hard to get patients to enroll in formal studies. As former FDA official Scott Gottlieb notes... "dying patients are unwilling to roll the dice on a placebo controlled trial — taking a chance they may get little more than a sugar pill — when the drugs are readily available on the market."...
A Better Prescription
Bruce Mehlman, Washington Times, 6-10-05
Mehlman reminds his readers that when world leaders are seriously ill—from King Hussein of Jordan to Ukrainian President Viktor Yuschenko—chances are they will come to the U.S. for treatment. "While great caregivers can be found all around the world, American doctors and nurses are second to none."
Why is it then, Mehlman asks, that the U.S. only ranks 24th in life expectancy and "more Americans die from preventable medical errors than from AIDS, homicides and car crashes combined?"
The answer to these questions, in large measure, is that the world's greatest doctors, armed with history's most powerful medical tools, operate within a system that is inefficient and disconnected. It's as if we're putting our best jet pilots in the cockpits of antiquated World War II fighters. …At a time when industries around the globe are tapping the power of technology to transform how they do business, our health-care system is investing less in these technologies than every sector except construction, education and mining. …
A health-care system transformed through greater use of information technology will do more than save lives and save money. It will provide you and your family the confidence of knowing that the best doctors and nurses have all the tools they need to offer the best possible care.
NSAIDs may be cardiotoxic: Hippisley-Cox and Carol Coupland, British Medical Journal
British Medical Journal, 6-11-05
As we noted above, researchers have uncovered some evidence that the entire class of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs) possesses some cardiovascular risk for certain groups of patients.
In a nested case-control analysis, Hippisley-Cox and Coupland…determined the comparative risk of myocardial infarction in patients taking cyclo-oxygenase-2 (COX 2) inhibitors and NSAIDs. All drugs in the study were associated with an increased risk of myocardial infarction, which was statistically significant for rofecoxib [Vioxx], diclofenac, and ibuprofen; no protective effect was seen for naproxen. The authors warn that this is an observational study and may be subject to residual confounding that cannot be fully corrected for.
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