In the Spotlight
The Stem-Cell WarsJohn Kerry claims that President Bush, by restricting federal funding of research on stem cells from human embryos, has attacked medical progress.
Robert Goldberg, Ph.D., 8-11-04
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Strep-Throat Vaccine Passes Early Clinical Tests
Wall Street Journal, 8-11-04
Good news - but not good enough. The Canadian firm ID Biomedical Corp. has produced a strep-throat vaccine that has been shown be effective and safe in early clinical trials. This is good news since researchers have been trying to develop a safe strep vaccine for decades; research on an earlier vaccine was halted in the 1970s after test subjects developed rheumatic fever. In the wake of its successful Phase I and II trials, Biomedical will ask for FDA approval to begin testing the vaccine in children in early 2005.
This is where the good news ends. The vaccine still faces a steep uphill struggle to clear stringent regulations. As a result, the vaccine won’t reach market at least until 2009 - after much larger studies have been conducted with as many as 60,000 people. The enormous cost of drug development hinders vaccine and anti-infective research much more than other biopharmaceutical products - the market for vaccines and antibiotics is normally much smaller than for other products, and much more vulnerable shifts in government policy. As it is, the pipeline for new vaccines and antibiotics is worrisomely low. Streamlining the process would disproportionately benefit the public health - and should be a top FDA priority.
Health Plan That Cuts Costs Raises Doctors Ire
The New York Times, 8-11-04
In northwest Washington State, Whatcom County has started an innovative program that lowers costs by, among other things, “assigning nurses and creating electronic records for some patients.” The county also hopes that improved patient care will come as a result of standardized patient filing, better tracking of prescription drug utilization, and frequent follow-ups with patients to ensure that they are complying with physicians’ instructions.
Why haven’t health care providers done this before? The incentives in the American health care system all subsidize health care use - not health care quality. A case that is managed badly - resulting in increased hospitalizations or emergency room use - is more heavily compensated than cases where providers are proactive and keep their patients out of the doctor’s office. In other words, we reward waste and penalize high-performing, innovative health care institutions.
We can only hope that this program, and similar Medicare trial programs, are the leading edge of a coming revolution in American health care.
LIABILITY LAWSUITS Can FDA seal be broken? A fight is raging on whether agencys approval of medical devices or drugs can prevent litigation
The problem with state tort claims conflicting with FDA regulations arises from the fact that firms that distribute products for national markets have no way of avoiding jurisdictions that allow rogue jury verdicts.
If one state allows jury verdicts that can bankrupt a drug or device manufacturer, but 49 other states and the federal government do not, that one state can still effectively set regulatory policy for the entire nation. The FDA has adopted the commonsense policy that variations among state tort laws - or between juries in individual states - should not be allowed to set national regulatory policy for medical products. This stance may not be popular with trial attorneys - but it is the right one.
FDA Approves Drugs to Treat Internal Contamination from Radioactive Elements
FDA News, 8-11-04
In order to better protect the public health in the event of a terrorist attack using radiological dispersal devices (aka “dirty bombs”), the FDA has approved two new drugs for treating radiation exposure: pentetate calcium trisodium (CA-DTPA) and pentetate zinc trisodium (Zn-DPTA). The FDA says that both drugs are “safe and effective for treating internal contamination with plutonium, americium, or curium.”
These compounds have been used as “investigational drugs” for treating patients in radiation contamination emergencies for decades prior to official FDA approval. The impetus for the approval was the FDA’s announcement in September 2003 of a specific set of findings that would allow the drugs to be approved through the new drug application process.
The FDA’s foresight and aggressiveness in promoting medications to treat acts of terrorism and bioterrorism has been, and remains, encouraging. Hopefully, the passage of the Bioshield Act will lead to flood of similar applications.
Medicare Drug Benefit Fails to Boost Bush, Survey Finds
Washington Post, 8-11-04
The Kaiser Family Foundation and the Harvard School of Public Health have released a new survey showing that seniors view the Medicare prescription drug benefit negatively. Out of the 1,223 participants in the survey, 47 percent had an unfavorable view of the law, 26 percent had a favorable view, and 25 percent didn’t know enough to have an opinion. Still, most respondents did say that they thought the program would benefit low-income seniors and seniors with expensive drug bills - although they didn’t expect to benefit personally.
Evaluating the drug benefit at this stage, however, seems unlikely to reveal anything useful about the true value of the program since the primary benefit (actual drug coverage) won’t take effect until 2006. By then the election will be over and the “muddle” surrounding the drug discount cards will have evaporated. At that point, seniors may have a very different impression of the program.
Still, seniors’ much discussed preference for legalized Canadian drug importation or having Medicare “negotiate” with pharmaceutical companies won’t change until there is a real national debate on these issues. We hope that such a debate will be forthcoming soon.
Fake-Drug Sites Keep a Step Ahead - One Is Busted for Selling Bogus Pharmaceuticals; New Vendor Grabs Address
Wall Street Journal, 8-10-04
Five federal agencies - including the FDA, FBI, and IRS - worked together to dismantle a large Internet drug counterfeiting operation, WorldExpressRX.com. The counterfeited drugs in question - which often contained “too much active ingredients”, making them a health hazard - were manufactured in places like India, and smuggled into the U.S. through Mexico.
This is only, however, a single needle in a very large haystack. In the battle against internet counterfeiters, the federal agencies are up against an agile, technically sophisticated foe operating from foreign shores. Indeed, the profit margins in counterfeit drug trafficking are so large that legitimate Internet drug vendors often shift to counterfeiting after selling legitimate drugs. As long as the U.S. has an enormous appetite for less expensive prescription drugs, counterfeiters will be drawn into the market in droves.
Encore (A Special Report): HealthMiracle Cure? Medicare is bringing disease management to your door; Heres what you need to know
Wall Street Journal, 8-9-04
As mandated by the 2003 Medicare Modernization Act, the Centers for Medicare and Medicaid Services has begun test “disease-management programs” in ten regions that aim to cut program costs and improve patient care.
“Medicare has traditionally focused on paying more when people use more services and have more complications - when they spend more time in the hospital getting intensive procedures”, said CMMS Administrator Mark McClellan. Through this new trial program, nurses will regularly communicate with about 30,000 patients in an effort to help seniors better understand and utilize the care they receive, as well as improving overall patient health.
The trial program takes its bearings from the fact that “the average Medicare beneficiary visits seven different doctors and fills many as 20 prescriptions each year” - creating myriad opportunities for waste and confusion between providers and patients.
Worse yet, standards of care vary widely - some studies have shown that patients with chronic conditions often do not receive the right tests and medications recommended for their illnesses. Medicare officials hope that, through effective patient education and follow-up, companies who participate in the program can produce savings of 5% or more compared to what Medicare would normally spend. If a company misses the savings target it won’t get paid. “We’ll be surveying patients and providers involved to see what they think of the program”, said Dr. McClellan.
The bottom line: Medicare is trying to give providers the right incentives to coordinate patient care and reduce expenditures at the same time. This is exactly the kind of visionary reform American health care desperately needs.
Missoula firm helping seniors cut prescription costs
Associated Press Newswires, 8-8-04
Large U.S. drug manufacturers have long made free or low-cost prescription drugs available to patients without insurance coverage who can demonstrate financial need. But many Americans aren’t aware of the these programs and, even when they are, are daunted by the paperwork required for enrollment.
Thankfully, some pharmacists at Wal-Mart have seen this as an opportunity to exercise their entrepreneurial spirit in a good cause. In return for a small monthly fee ($25), a Wal-Mart pharmacist and his colleagues have started a pharmaceutical consultation service that will fill out the forms drug makers require and renew the paperwork on patients’ behalf when necessary, about every 3-6 months.
The result: pharmaceutical companies get to tout their community service programs and patients get improved health at an affordable price.
STATIN MEDICATION Sale plan a bitter pill? Cardiologists debate effectiveness, safety of cholesterol-cutting drugs being available over the counter
J&J-Merck Pharmaceuticals, a joint venture by Merck and Johnson & Johnson, is preparing an application to the FDA to sell the statin drug Mevacor over-the-counter. The National Health Service in Britain already allows Merck to sell its statin Zocor OTC.
Statins are widely considered remarkably effective and safe drugs in traditional clinical settings - and many patients who might benefit from statin therapy remain untreated. This has led some researchers and companies to press for making low-dose statins available at retail pharmacies. Still, statins can cause muscle aches and, much more rarely, muscle wasting and kidney damage. The appropriate balance between risks and benefits will do doubt continue to be debated for some time yet.
Still, regulators should note that patients are becoming more sophisticated consumers of medical advice, and are gaining wider access to home based cholesterol monitoring kits that could enable them to self-medicate effectively. British pharmacists have assumed the role of educating patients about statin use and the risks it entails; American pharmacists could play a similar role. Overall, the health care market is shifting towards a consumer-based model where issues like this one will become increasingly common; the real question is how best to help patients and physicians navigate the transition.
Price of AIDS Drug Allowed to Stand - NIH Wont Force Abbott To Reduce Cost of Norvir, Developed With Tax Dollars
Wall Street Journal, 8-5-04
There is a provision in the 1990 Bayh-Dole Act that gives the NIH “march-in authority” to ensure that “scientific discoveries funded and supported by the federal government” regardless of the degree of support, “are properly used by companies.”
Recently, the NIH declined to exercise this power on the AIDS drug Norvir even after its maker, Abbott Laboratories, set off a political firestorm by significantly boosting its price. The NIH’s decision was prudent, even if it was unpopular. Restricting Abbott’s ability to recoup its investment in Norvir would’ve sent a signal to other firms developing AIDS drugs with government grants that such cooperative ventures were counterproductive. Consequently, controlling prices today would inevitably produce fewer public-private joint ventures in the future. This would be a loss for everyone: industry, AIDS patients, and the government.
Heralded Heart Drug Has Unexpected Risks - Hospitalizations, Deaths Highlight Hazards Of Applying Study Results to Individual Patients
Wall Street Journal, 8-5-04
Drug industry critics have championed the cause of evidence-based medicine, i.e. holding large clinical trials and then limiting Medicare or VA drug formularies to those medications with the best results. Unfortunately, clinical trials can be very limited tools for determining what actually works - or doesn't work - for individual patients in the real world.
For instance, in 1999, a large clinical trial showed that a forty-year-old drug (spironolactone) significantly reduced death and hospitalization rates for patients with congestive heart failure. Physicians embraced the findings of the study, and applied its results whole-heartedly. Problems quickly surfaced, however, because the study's findings didn't hold for all patients - especially patients who were suffering from conditions like diabetes. Indeed, the New England Journal of Medicine recently published an article showing that increased use of the drug “was accompanied by a tripling of hospital admissions and of deaths resulting from dangerous elevations of potassium” - a known side effect of spironolactone use.
The NEJM highlights the dangers of making sweeping recommendations for patient care based on clinical studies - and underscores the importance of finding better mechanisms for understanding how drugs, patients and physicians interact in real world settings. After all, life doesn't come equipped with laboratory controls.
WHO drops Aids generics over safety fears
Financial Times, 8-5-04
When the U.S. last year launched its own $15 billion emergency program to treat AIDS, it demanded that generic companies manufacturing combination AIDS drugs meet the same standards for safety and efficacy as branded medications. This stricture was greeted with scorn by activists in the international AIDS community, who claimed that the U.S. was acting as a shill for pharmaceutical companies. Since then, however, the WHO has withdrawn 5 generic combination AIDS drugs from its list of approved medicines because of concerns over data submitted by generic manufacturers vouchsafing safety and efficacy. The WHO’s actions have vindicated U.S. government concerns - and helped advance the cause of AIDS patients in developing nations.
Mid-year at the FDA highlights permanent problem
Ken Howard, Nature, 8-9-04
Ongoing reform efforts at the FDA need strong leadership. The vacancy left by departing FDA commissioner Mark McClellan needs to be filled sooner rather than later.
Lower Cholesterol Without Drugs
Dean Ornish, Washington Post, 8-8-04
Before we rely more heavily on prescription medications like statins, we need to consider the benefits of health and lifestyle changes that can be just as effective - without the risk of side-effects.
Pharmaceutical Price Controls in OECD Countries
Kevin A. Hassett, Department of Commerce, 8-3-04
The U.S. is the last member of the OECD to allow market prices to prevail for pharmaceutical products. Introducing price controls into this market would have adverse affects not only for the U.S., but possibly for global health as well.
Innovative drugs cost patients less in the long run
Kerri Houston, Chicago Sun-Times, 7-31-04
Carping about the cost of pharmaceuticals misses the real question: what is their value to patients and society?
Inappropriate Prescribing for Elderly Americans in a Large Outpatient Population
Lesley H. Curtis, PhD, Peter E. Dans, MD, Steve Hutchison, PhD, Truls Ostbye, MD, PhD, Kevin A. Schulman, MD, Veronica Sendersky, PharmD, Raymond Woosley, MD, PhD, Alan Wright, MD, MPH
Archives of Internal Medicine
According to an article published in the Archives of Internal Medicine, at least 20 percent of people over the age of 65 in the U.S. are taking a medication that is contra-indicated for their age. At least 15 percent take two or more of these drugs, and 4 percent took three or more drugs that were deemed inappropriate. This should give more impetus to reformers who want to use more technological safeguards to reduce medical errors and warn doctors of potential drug complications.
Unfortunately, policymakers are more obsessed with reducing costs than they are in improving quality or promoting best practices. Until the nation focuses its health care spending on quality, tamping down costs alone will only make a dysfunctional system even more dysfunctional. The health care sector needs to renew itself by adopting the mindset of a famous American automaker: Quality is Job #1.
Genetic Mutation Linked to More Aggressive Breast Cancer Found More Often in African-Americans Cancer
Interdisciplinary International Journal of the American Cancer Society
Researchers had long assumed that higher breast cancer mortality rates in African American women were due to life-style variations, or that the disease was diagnosed at more advanced stages. Now, however, a new study has found that black women are much more likely than white women to have a genetic mutation that makes their cancers significantly more aggressive and dangerous. The gene, p53, has long been known for its involvement in a range of cancers. Hopefully, now that researchers have a better understanding of how genetics affects disease progression in this population, they will be able to develop targeted therapies that offer patients better treatment options.
Views of the New Medicare Drug Law: A Survey of People On Medicare
Kaiser Family Foundation/Harvard School of Public Health
The Kaiser Family Foundation and the Harvard School of Public Health have released a survey of American seniors on Medicare that finds that nearly twice as many respondents have an unfavorable view of the new Medicare law as have a favorable view. The survey is undoubtedly true - although perhaps not really relevant. The main reform under the law, the Medicare prescription drug benefit, won’t take effect until 2006. Other recently released studies have found that the drug discount card program in place till then is offering seniors significant savings, especially low-income seniors, who receive a $600 subsidy.
The survey also noted that most respondents thought that the law would help low-income seniors, and seniors with very high prescription drug bills, although they didn’t think it would help them personally. This seems to suggest that most seniors outside of these categories aren’t paying much attention to the bill, and may very well have a different opinion of it in 2006.
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