In the Spotlight
European Price Controls Harm Patient Health
Robert Goldberg, Ph.D., 9-16-04
State and local elected officials from Vermont to California have been practically tripping over themselves in their zeal to help residents import prescription drugs from Canada and other countries with price controls.
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Antidepressants Urged to Have Stern Warnings: FDA Panel Recommends Forcing Drug Makers to Cite Risk of Suicidal Tendency for Youth
Wall Street Journal, 9-15-04
After two days of deliberations and testimony, an FDA advisory panel has recommended so-called "black box" labels on all antidepressants; the labels will warn patients and physicians about the risk "of increased suicidal tendencies in young people" taking these medications. The FDA usually follows the recommendations of its advisory committees.
The panel's recommendations are the result of a re-analysis of over 20 clinical trials that shows that 2% to 3% of adolescents who were treated with antidepressant drugs "displayed suicidal thoughts or behavior that could potentially be tied to the medications." There is no similar concern for adults, and none of the young people in the trials actually committed suicide.
Experts are divided on the wisdom of the warnings. Some are concerned that physicians may shy away from the drugs and note that increased supervision of patients during the first month of treatment would substantially lower any suicide risk. Others believe that the medications are over-prescribed and want to "raise the threshold for prescribing [antidepressants]" and hope that the black box labels will better inform the public about the risks involved. The FDA plans to pursue further research in this area, including pediatric trials of antidepressants that include "a comparison to a drug that works, rather than simply a placebo."
Will the new labeling requirement lead to better patient care? Only time will tell, since the data on antidepressants is open to conflicting interpretations, and suicide among adolescents has been trending downward since the mid-1990s. Ultimately, however, treatment decisions still rest where they should - with individual families and their physicians.
HEALTH JOURNAL: Custom Chemo: Some Doctors Want It, But Key Panel Says Tests Aren't Ready
Wall Street Journal, 9-14-04
It would be wonderful if, someday, a newly-diagnosed cancer patient could request a relatively quick, reliable test that would help their physician determine which chemotherapy drugs would be most effective against their disease.
Scientists are well on their way to developing such a test. The test, called a chemo sensitivity and resistance assay (CSRA), "[has] the potential to revolutionize cancer treatment by testing different chemotherapy drugs directly against a sample of the tumor to identify which is the most effective." This is an important development because even the best cancer drugs may "fail to help between 30% and 60% of patients" due to individual variations in the disease. Or, as one cancer researcher remarked, "The average treatment for the average patient can’t possibly work all the time because there are no average patients."
The American Society of Clinical Oncology wants more research done on CSRAs, but doesn't think they are quite ready for clinical use. Other oncologists disagree and already use the tests to help prescribe chemo for their patients. Two CSRAs are currently used: one that measures whether a chemo drug stops a cancer cell from growing and another that checks whether a drug kills cancer cells outright. (Some oncologists think the cell death test is the more reliable assay.)
As yet, the tests are expensive and more research needs to be done to show that the benefits they provide patients are more than anecdotal. Still, they bring oncologists closer to the day when they will be able to offer cancer patients tailored treatments rather than playing a guessing game with this deadly ailment.
Method to Turn Off Bad Genes Is Set for Tests on Human Eyes
The New York Times, 9-14-04
A handful of small studies are currently testing a new technology that aims to directly target the rogue genes that produce human disease. The trials use a new drug treatment based on RNA interference (RNAi), "a standard tool for genetic studies in the laboratory" that is moving into the real world for the first time.
Accuity Pharmaceuticals is set to test the new RNAi drug in “about half a dozen elderly people at risk of blindness” who will have the drug injected directly into the whites of their eyes. "If it works, RNAi could potentially yield a cornucopia of other drugs designed to silence errant disease-causing genes in the body, or disarm an invading virus by knocking out its genes."
Other gene silencing techniques (like gene therapy) are in various stages of testing, with mixed results. Unfortunately, what is successful in vitro often proves less successful in the complex environment of the human body. Still, RNAi could become one of the fastest medical dividends from the decoding of the human genome and a welcome boost for this fledgling science.
Canada Looks for Ways to Fix Its Health Care System
The New York Times, 9-12-04
Americans are flocking to Canada to find cheaper prescription drugs. On the other hand, droves of Canadians are heading south, looking to escape the long waiting lines in Canadian hospitals and doctor's offices. Or, as one Canadian patient put it, "If you are not bleeding all over the place, you are put on the back burner, unless of course you have money or know somebody."
Canadian health care is free at the point of service – assuming you ever get to that point. Economics dictates that subsidies drive over-consumption of commodities and hence, in the case of "free" health care, create artificial scarcity. As a result of this scarcity, Canadian confidence in their system is eroding, primarily because "doctors who do preliminary diagnostic work, refer patients to specialists, and monitor the care of chronically ill people are less and less available, especially in small towns and rural areas." New doctors are more likely to work in cities, or flee to the U.S. where they can make hefty salaries. In Canada's most populous province, Ontario, the number of communities "not adequately served by family doctors" is up 36% since 2000 (from 100 to 136). The Canadian government estimates that about 15 percent of Canadians don't have a family doctor.
Canada is in the midst of a debate over reforming its health care system, and will undoubtedly thrust billions more into health care funding. Will this fix the problem? Probably not in the long run. The current crisis results from the fact that patients have no way of rationing their use of health care in the absence of prices. In this sense, the more Canadians demand "free" care, the more scarce care becomes. Americans who like the idea of "free" health care should take note that free health care comes with its own costs.
Few Enroll in Low-Cost Drug Demonstration
The New York Times, 9-11-04
Less than 7,000 people have applied to enter the Medicare trial program that will offer low-cost prescription medications to elderly patients with cancer and other serious ailments. The Bush Administration had expected a flood of applicants, and had engineered a lottery system to choose 50,000 random enrollees from the applicant pool.
The program's current deadline for applications is Sept. 30, although Medicare officials expect that the deadline will be waived. Some outside observers have criticized the application process for the program as too complex; others have said that describing the plan as a "lottery" was unwise given that seniors are loath to take chances with their health care coverage.
Another, equally likely explanation, is that the partisan atmosphere surrounding the U.S. presidential election has tainted the program in the minds of many seniors, and raised unfair suspicions of a program that offers immense savings to Medicare recipients. Still, there is plenty of time correct the misperceptions. The Administration should act quickly to publicize the program in a high-profile medium, perhaps on television, to get the word out to its target audience.
Health Insurance Costs Keep Rising Premiums for Employer-Sponsored Plans Grew by 11.2%, Survey Finds
Washington Post, 9-10-04
Employers' health insurance premiums rose an average of 11.2% this year, the fourth annual double digit increase, although the current increase is beneath the 13.9% increase registered the previous year. Still, there are a some bright notes in the nation’s otherwise gloomy health care trends.
Large employers think that aggressive disease management plans – "the treating of long-term illnesses on an integrated, coordinated basis, rather than dealing with each problem as it arises" – would be "very effective in cutting costs."
Other experts are optimistic that health savings accounts (HSAs) will become more popular with employers and will help stem costs by giving employees financial incentives to economize on health care use.
Aetna CEO Jack Rowe observed that people increasingly "want to control health care cost increases without restricting choice" and that this trend should spur the adoption of HSAs, which maximize consumer choice. Aetna notes "that a survey of its employer-customers found that medical costs for those with consumer driven plans rose only 3.7 percent last year, compared with an 11 percent rise for employers using more conventional plans."
Anorexia: The Most Deadly Mental Illness
Anorexia is the most deadly mental illness, more deadly even than depression, schizophrenia, or bipolar disorder. Despite its lethal nature, the disease remains very poorly understood and drug treatments for it are nearly non-existent.
For as many as 90% of anorexia sufferers, the disease is curable by helping families to intervene more effectively in their children's lives by monitoring food consumption and exercise habits. "Often, parents may have to supervise their children 24 hours a day, seven days a week, in order to make sure they eat enough – as much as 4,000 calories a day to replace lost weight – and don’t exercise too much," one expert said.
The final 10%, however, who resist this formula are likely to starve to death.
There is currently no good data on any medications for treating anorexia – but some doctors are prescribing Zyprexa, an antipsychotic drug, when other interventions fail.
Off-label use of drugs is often the only option for doctors when they face poorly understood diseases like anorexia.
More research is clearly needed, and clinical trials are currently underway testing Zyprexa directly as an anorexia treatment. But the current furor over off-label pediatric antidepressant use illuminates the dilemma facing drug manufacturers, who may be unwilling to directly research cures for diseases like anorexia due to liability concerns and the public relations nightmare involved in directly marketing drugs for pediatric patients.
An IT Trojan horse ... Feds should stay out of ‘evidence-based’ medicine
Regina E. Herzlinger, Modern Healthcare, 9-14-04
Regina Herzlinger, Harvard Business School professor and Manhattan Institute senior fellow, argues that new federal regulations designed to create standard formats for electronic patient health records are really a Trojan horse for the creeping government control of medical practices and standards.
Once Washington bureaucrats have standardized data in hand, Herzlinger fears that they will use the government's enormous purchasing power to dictate the process of care rather than outcomes. She notes that "because the [health care sector] has few accepted measures for risk-adjusted quality outcomes – the death and illness rate of different providers – [policymakers will] focus instead on the process care. Those judged as low performers because they do not comply with the federally mandated processes will be financially penalized in an initiative dubbed 'pay for performance'."
Herzlinger thinks that rather then micromanaging physician practice, the government should provide risk-adjusted health information that compares outcomes at different providers, and then let consumers reward high performers with their health dollars. This approach will reward providers for health care innovation, rather than their skill at jumping over government hurdles.
Lessons of Success: What Congress Can Learn from the Federal Employees Program
Robert E. Moffit, Ph.D., Heritage Foundation, 9-14-04
Moffit suggests that the Federal Employees Health Benefits Plan (FEHBP) holds many lessons for policymakers seeking to reform Medicare and improve the nation's health care delivery system.
The FEHBP saw premium increases this year of only 7.9 percent on average, well below national trends. The program benefits from real consumer choice (members can choose among a wide variety of health care plans, including, in 2005, consumer driven plans), genuine competition (249 plans compete directly for consumer dollars) and light regulation (there is no standard benefits package and plans can offer any array of benefits to members).
Moffit hopes that Congress will look at FEHBP and see how "consumer choice, competition, and light and reasonable regulation can deliver high quality health plans, including consumer-driven options." With health care a prominent issue in the Presidential election, we hope the candidates take careful note of the principles Dr. Moffit recommends.
EDITORIAL: The drug makers' problem
The Star-Ledger, 9-13-04
The latest "drug war", according to the Star Ledger, is the proliferation of stolen medications finding their way into the nation’s legitimate drug supply chain. Last week, federal authorities arrested 17 people in New Jersey and three other states and accused them of "trafficking $56 million in stolen prescription drugs, from sinus spray to cholesterol blockers."
The criminal operation in this case involved reselling stolen drugs at large discounts to legitimate retailers, who then would sell them at full-price. Besides theft, trafficking in stolen pharmaceuticals poses a threat to public health because the drugs could have been stored improperly or expired by the time they reached consumers.
The problem facing regulators is that a small army of middlemen handle prescription drugs once they leave the manufacturer, leaving ample room for theft and fraud. The Ledger believes that drug manufacturers need to strengthen their security and background checks for wholesalers; states should also toughen regulation of drug wholesalers, including "a sizable bond" for anyone entering the business. Harsher fines, including jail time, would also help deter theft in what is a quickly growing, and highly lucrative criminal enterprise.
Bad Medicine? The data on anti-depressants and child suicide aren’t conclusive.
Sally Satel, MD, National Review Online, 9-12-04
The media's emotionally fraught coverage of how the FDA has handled the issue of pediatric suicide risk with antidepressant use is illustrative of why we have the FDA to begin with: to parse difficult, sometime contradictory data and come up with sensible recommendations as to whether or not a given medication, on balance, improves the public health.
Antidepressants undoubtedly have powerful health benefits that warrant their use, although the debate over their use in pediatric patients is highly complex and will probably remain that way for some time. Still, fear mongering or pharma bashing over the issue is likely to do more harm than good.
Satel's commentary ranks among the very best on this issue, not least for its conclusion: "Anyone looking for clear and simple answers here will be frustrated. Of course, that provides no solace to parents who have lost a child. But the emotional weight of the issue must not deform facts, drive public policy, or stymie further research. It is clear that authentic major depression in children is a serious matter. Accurate diagnosis and careful treatment will save many more lives than might be lost through the use of these drugs."
Are Free-Trade Agreements Good for Your Health?
Benedict Irvine, Andres Mejia-Vergnaud, Wall Street Journal Asia, 9-10-04
Activists have taken the U.S. to task for a number of recent bilateral free-trade agreements that protect intellectual property rights for pharmaceuticals. The authors note that the activists scare tactics are unwarranted and completely miss the point that protections for intellectual property rights are associated with increased access to new pharmaceuticals and new investment.
"By protecting intellectual property, FTAs encourage innovative product launches by local pharmaceutical industries. Since the U.S.-Jordan FTA, for example, there have been more than 30 new product launches in Jordan." In time, the authors hope, free trade might just "enable some poor countries to rise their per-capita health spending to the threshold level of about $65, above which real population health gains can be made."
MMR vaccination and pervasive developmental disorders: a case-control study
Claire Cook, Eric Fombonne, Andrew J. Hall, Lisa Heavey, Ron Pollack, Laura C. Rodrigues, Liam Smeeth, Peter G. Smith,
The Lancet , September 2004
One of the 20th centuries greatest health victories was the elimination of childhood diseases through universal vaccination programs. However, as these diseases have been eliminated, the public tends to forget their value, and the universal nature of the vaccine programs means that parents of healthy children who later become sick with poorly understood diseases may see the vaccines (with the encouragement of avaricious trial lawyers) as culprits for their children's illnesses.
The most recent case in point has been the longstanding accusation that the measles-mumps-rubella (MMR) vaccine causes autism, a childhood neurological disease which is poorly understood. Numerous studies have debunked the purported link, but have not tamped suspicion of the vaccine; as a result, vaccine coverage among children continues to fall off. Hopefully, this latest study will finally dispel the junk science surrounding the MMR vaccine; the authors note that "our findings suggest that MMR vaccination is not associated with an increased risk of pervasive developmental disorders." Until this myth is laid to rest, parents will continue to withhold critical vaccinations from their children, exposing them to real risks, as opposed to imaginary ones.
Antidepressants and the Risk of Suicidal Behaviors
James A. Kaye, MD, DrPH, Hershel Jick, MD, Susan S. Jick, DSc,
The Journal of the American Medical Association , July 2004
The use of antidepressants, particularly SSRIs, in pediatric populations has attracted much controversy over the past year. This study, a "matched case control study of patients treated in UK general practices using the UK General Practice Research Database" included 160,000 users of 4 antidepressant drugs (amitriptyline, fluoxetine, paroxetine, and dothiepin).
The study measured the "frequency of first-time exposure to [these 4 drugs] of patients with a recorded diagnosis of first-time nonfatal suicidal behavior or suicide compared with comparable patients who did not exhibit suicide behavior."
The study found that "the risk of suicidal behavior after starting antidepressant treatment is similar among [the four drugs]", and that the risk is elevated in the first month after beginning treatment, "especially during the first 1 to 9 days."
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