|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 08-03-2004
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), one of the nation's largest health care accrediting organizations, has launched a website (www.qualitycheck.org) that allows visitors to compare patient care at hospitals state- and nationwide in four areas: heart attack, heart failure, pneumonia, and pregnancy. JCAHO accredits about 16,000 health centers nationwide and hopes to offer visitors more information on non-hospital settings in the future.
This is a valuable step towards building better health care markets - especially in light of a recent RAND study that found that American patients only received recommended care about 55% of the time. Expanding patient and physician access to comparative information on provider outcomes will help to redirect patients - and funding - towards institutions that provide better treatments. (The RAND study findings are available at http://www.rand.org/publications/RB/RB9053/.)
Off-Label Treatments, New Drugs Target Mysterious, Debilitating Fibromyalgia
Fibromyalgia is a disorder that causes its victims, mainly women, to suffer from chronic bouts of debilitating pain, sleep disturbances, fatigue, and headaches. Researchers are finally getting a better understanding of the condition, and as a result are turning to drugs approved for other conditions in order to treat the disease. This is known as "off-label use" and involves taking depression, epilepsy, and even cancer drugs and using them in ways that the FDA and the manufacturer had not originally envisioned. Several off-label treatments, including the cancer drug thalidomide, are currently in clinical trials testing their effectiveness in reducing fibromyalgia symptoms. Although off-label use is something of a wild card in the medical community, it is still an important, if serendipitous, tool in the battle against rare diseases like this one.
Lilly Plans Broad Access to Results on Its Drug Trials
While in many ways the pharmaceutical industry is a victim of its own success (everyone wants access to effective prescription drugs as cheaply as possible) the industry has sustained some well-deserved criticism for its lack of transparency when it comes to industry sponsored clinical drug trials. As long as some trial data remains undisclosed the industry remains vulnerable to the charge that it places drug profits above patient health.
Finally, however, one company is taking its cue from the well-worn political adage that, when it comes to warding off potential scandals, it is always best to tell all that you know as soon as you know it. With that in mind, Eli Lilly has announced a plan to disclose almost all of its clinical trial data from marketed drugs over the last 10 years. Lilly has also promised to embrace data transparency by continuing to reveal data from all "early to late stage clinical trials, including safety information and outcomes." It will even disclose trials that test established drugs for "off-label uses." Dr. Alan Breier, Lilly's chief medical officer, said that "patient care is served best by open disclosure." Dr. Breier is right - and what is good for patient care is also good for the industry.
Combination AIDS Drugs Moving Through FDA's Approval Process
One criticism repeated ad nauseam by international AIDS activists is that the U.S. isn't serious about approving generic combination AIDS drugs for use in developing countries because it wants to protect the pharmaceutical industry. Nonetheless, the $15 billion President's Emergency Plan for HIV/AIDS Relief has promised that it will purchase the least expensive and most effective medications available - including generics. At the same time, the FDA has adopted a fast-track program for generic AIDS drugs destined for global use, even if the drugs are patented in the U.S. Once a generic manufacturer files an application, the FDA has guaranteed that it will take no more than 4-6 weeks to review it. One leading Indian generic manufacturer, Ranbaxy Laboratories, has already said that it will seek FDA approval for its generic three drug combination before the end of 2004. U.S government agencies have shown their flexibility - and their commitment to helping AIDS patients in the developing world. Perhaps someday the activists will bring themselves to give credit where credit is due.
Canada feels squeeze from drug makers; Major drug manufacturers have significantly cut back their supplies to Canadian pharmacies, hoping to curtail purchases by Americans in search of cheaper prescription medications.
Canadian pharmacies don't have enough supply to match mounting American demand, partly because pharmaceutical companies have been limiting their Canadian drug shipments to quantities for Canadian use only. Canadian pharmacies have responded by ordering drugs from places further abroad and harder for companies to monitor, for instance Europe and the Fiji Islands.
Current legislation pending in Congress would open U.S. markets to a similarly long list of international suppliers. This creates an interesting question: if the pharmaceutical companies can't monitor all the global shipments of their own drugs now, how does Congress think federal regulators would ever be able to cope?
In Drug Research, Some Guinea Pigs Are Now Human
The single largest cost in developing new drugs are those compounds that are shown to be either unsafe or ineffective during late-stage testing - i.e., after enormous amounts of money have been spent on them. "Even a small improvement in the ability to predict failures could save $100 million in development costs per drug, the F.D.A. said in a March report." The FDA and industry have responded by exploring how sophisticated new imaging technology (functional MRIs, positron emission tomography, etc.) can test early on whether or not a drug is having the expected effect in the human body. The new emphasis on early testing of drug targets in humans is called "experimental testing" and should enable researchers and companies to target their efforts on drugs that have the best possible chance of success. (For more information on these and related topics see the FDA's report Challenge and Opportunity on the Critical Path to New Medical Products at http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.)
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.
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
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.
Missoula firm helping seniors cut prescription costs
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.
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.
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