|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 04-05-2005
Smart Drug for Lung Cancer May Be Pulled From Market: Iressa Helps Small Portion of Patients
As we discussed earlier, targeted drugs will revolutionize cancer treatment. But is the FDA leading the revolution or slowing it down? The FDA “is geared toward finding drugs that work broadly across the population.” Targeted drugs that benefit small groups of patients “may be slipping through the cracks.”
The FDA’s regulatory gold standard—large placebo-controlled clinical trials—is designed to identify statistically significant outcomes. In this system, a very small difference between thousands of patients—half of whom take a drug, half a placebo—can be shrugged of as random variation. If this happens, the drug fails.
The cancer drug Iressa is the poster child for this problem. It “failed” in its pivotal clinical trial—even though physicians know that it is very beneficial for a small group of patients.
The Iressa saga…underscores the challenges the FDA and cancer doctors will increasingly face, as researchers churn out precision cancer drugs that benefit subsets of patients but do little or nothing for others, with delicate trial and error required to match the right patients with the right drugs. Pulling [Iressa] off the market could deny a helpful treatment to a subset of patients who have experienced remarkable recoveries with the drug.
The FDA shouldn’t hesitate to approve more drugs like Iressa. Market approval will spur companies to develop genetic tests that will help match the right drug with the right patient. Eventually, the FDA’s old “gold standard” will make way for a new one—truly personalized medicine.
What consumer-driven health care needs to flourish are consumers dedicated to finding the best bargains. And it would be hard to imagine a more dedicated group than expectant mothers. As maternity health care coverage becomes increasingly expensive, mothers-to-be are demanding that hospitals and obstetricians compete on price and service.
As companies boost premiums for family coverage—and in some cases drop dependents altogether—a growing group of women lack health coverage for pregnancy, one of the biggest medical costs they face. Others are in some type of consumer driven high-deductible plan, with a Health Savings Account, that gives patients incentives to shop around.
Consumers are learning that if you can bargain with a car dealer for a $30,000 Mercedes, you can bargain with a hospital for a $5,000 maternity bill. One patient received a line-item breakdown of “what her previous insurer paid for her last pregnancy” and demanded that her hospital and doctors give her the same discounts. They did. Policymakers should take note of this development and encourage it by giving consumers easy access to information on quality and costs across providers and insurers.
Directing the Poor to Free Medicine
Pharmaceutical companies are expanding access to critical prescription drugs for low-income Americans without health insurance.
The new initiative, called the Partnership for Prescription Assistance, will direct patients or people who know them to a toll-free number or an Internet site for help. After a phone interview, callers will receive forms by mail for the drugs sought, while those completing a questionnaire online can print out forms. The forms are then taken to a doctor for final approval.
Standards for the program vary depending on the company that makes the drug; “generally, the income cutoff is about two times the poverty threshold, which for a person younger than 65 was $9,827 last year.” In 2004, the industry gave away over $4 billion in drugs (wholesale cost) and is launching a national ad campaign to help expand the program.
Will this solve the problem of affordable health care? No. But America’s health care woes aren’t the fault of industry.
‘Advance Purchase Contracts’ Could be Cure for Vaccine Sellers
‘Market failure’ is term that echoes repeatedly in books and articles decrying globalization. As the example of India shows, however, capitalism is not the source of third-world woes. Rather than decrying markets, international advocates for developing nations need to think more creatively about how to leverage market forces to their advantage. Take, for instance, a new proposal on how to boost vaccine development for diseases that largely afflict poor nations.
Pharmaceutical companies that fled the high-risk, low-margin vaccine field could be lured back with “advance purchase contracts,” according to a report scheduled to be released today by the Center for Global Development. The contracts would be offered by pools of donors who would guarantee that they’d buy a volume of doses at near-market prices…. The report says donors could initially guarantee a manufacturer a price of $15 a person for a three-shot immunization for the first 200 million people immunized, for a market of about $3 billion. After that, the company would promise to drop the price to $1 or $1.50 per person. Such a program, while pleasing companies, could still create a malaria-prevention [vaccine] program that would be very cost-effective, advocates say.
Other hurdles, primarily regulatory, still abound. Vaccine development in the first-world is under severe pressure from expensive regulations and cut-rate government pricing. Cutting red tape and easing price controls would also help to spur the development of new vaccines for rich and poor nations alike.
Low Costs Lure Foreigners to India for Medical Care
This is the second article this week on the implications of India’s booming health care sector. Need hip replacement surgery not covered by your employer’s health insurance? Don’t want to wait months for life-saving angioplasty provided by the British National Health Service? Go to India, where health care price, service and technology are attracting patients from around the world.
…Europeans and Americans, looking for world-class treatments at prices a fourth or fifth of what they would be at home, are traveling to India. Modern hospitals, skilled doctors and advanced treatments are helping foreigners overcome some of their qualms about getting medical treatment in India.
Last year alone, “150,000 foreigners visited India for medical treatments.” While countries in Europe and the U.S. have enshrined patients in a web of confusing and expensive health care regulations, countries like India, Singapore and Thailand are catering to patients who don’t want one-size-fits all medicine. Policymakers in the first world should take note of this development and work harder to make health care more responsive and affordable for consumers.
Labs Turn DNA Into Personal Health Forecasts
Companies are using cutting edge DNA analysis to help consumers tweak their diets, seek out better medicines, and generally stay healthier longer.
…Genelex Corp. technician Dascena Vincent and her colleagues will conduct what they call a nutritional genetic assessment, analyzing [DNA samples from customers] for certain deficiencies. Problems in the genes that handle dietary fats? That could put you at risk for heart disease. Trouble with those that help rid your body of toxins like smoke? Cancer could be an issue later in life. And how about those associated with metabolizing vitamin D? Be watchful for signs of deteriorating bone strength. Based on the findings, the company provides recommendations on diet, lifestyle changes and categories of medications that might work best for an individual.
While tests like these are still in their infancy - and there are legitimate concerns about privacy and accuracy issues - DNA analysis does represent the future of personalized medicine. For better or worse, patients will have greater insight into and control over their own healthcare. Rather than hedging these developments, physicians and policymakers should find ways to intelligently encourage them.
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