In the Spotlight
Why the new NIH ethics rules are bad for the agency - and the public health.
Elizabeth Whelan, Medical Progress Today, 4-14-05
The National Institutes of Health (NIH) is now reconsidering the overly restrictive ethics rules it recently released for its employees - about what they can and cannot do on their own time, dictating what stocks they and their families can and cannot own. Let us hope the rules are never implemented. The restrictions would shackle researchers’ ability to pursue collaborative projects, and would jeopardize the quality of scientific work at our nation's prestigious research labs.
Continue reading . . .
Imported Canadian drugs pose security risk, report says.
The Globe and Mail, 4-13-05
A consulting firm headed by former New York Mayor Rudy Giuliani, Giuliani Partners, released a report calling for a moratorium on legislation legalizing prescription drug importation. The report, commissioned by the Pharmaceutical Researchers and Manufacturers of America, finds that
Terrorists can finance their activities by getting involved in the drug-counterfeiting business…Several Canadian mail-order pharmacies import their drugs from other countries, [the report warned], and without knowing where the drugs originated, they could have been targeted by criminals, drug traffickers, or terrorists. “Based upon what was learned about the existing system, it is not difficult to imagine a scenario in which terrorist groups could use this system to either finance their operations, or, worse, as a vehicle of attack,” the report says.
The Giuliani report lands in the midst of a heated political debate over drug importation. Many of the report’s findings, however, are uncontroversial: Canada can’t become America’s drug supplier, and current government oversight of imported drugs suffers from significant safety loopholes that can’t be closed without enormous new federal expenditures. Once shipping and regulatory costs are taken into account, savings from large scale drug importation would be very small - perhaps just a few percent at the margins. Importation is, consequently, the “Frankenstein” of policy issues - it’s a dead idea, it just doesn’t know it yet.
New Research Bolsters Tarnished MS Drug - After Withdrawal, Study Highlights Tysabri’s Efficacy
Wall Street Journal, 4-13-05
The FDA gained its mandate to ensure the safety of America’s medicines in 1938, after an antifreeze solvent used in a pediatric medicine killed 100 people. The public widely supports this basic FDA function: protecting Americans from unscrupulous or careless manufacturers. But the FDA’s role has also evolved to entail making complex safety and benefit judgments about new medicines that are inherently uncertain. For instance, as the Wall Street Journal
The withdrawal [of the multiple sclerosis drug Tysabri] was a blow to the 400,000 MS patients in the U.S., for whom other available treatments had been largely disappointing. Tysabri was also in the final stages of being tested for Crohn’s disease, a bowel disorder that affects 600,000 in the U.S., and was being studied for rheumatoid arthritis, a severe form of joint inflammation that affects about two million people. Many patients have expressed anger that the drug was pulled and say they would prefer to be allowed to weigh the risk themselves.
To be fair, drug manufacturers - like the makers of Tysabri or Vioxx - often pull drugs from the market to limit legal liability or avoid bad publicity. But their decisions are emblematic of how the FDA - and we as a society - have structured drug approval as a binary equation: available/not available. This all-or-nothing approach makes sense, if you want to keep antifreeze solvent out of medicines. It makes no sense when we are keeping valuable medicines from desperately ill patients, who may be willing to risk a very small chance of a catastrophic injury in exchange for a new lease on life.
Tysabri is just another example of why the FDA and its stakeholders need to formulate a drug safety regime that fits the realities - and nuances - of 21st century medicine.
Patients in pain keep popping pills despite FDA warning.
Chicago Tribune, 4-11-05
Imagine that you suffer from crippling arthritis pain. After years of trying drug after drug, you finally find one that helps you live a normal life. A few months later, the FDA pulls the drug from the market because 7 or 8 - or 10 - people out of a thousand may have an adverse effect after taking it. Maybe you are one of those people. But chances are, you’re not. Too bad. You will still lose access to what was, for you, a life changing treatment.
This scenario describes something of the predicament of people like Bob Starzyk, who is still taking - and hoarding - Vioxx pills months after it was withdrawn. Starzyk is a
…51-year-old truck driver from Palos Altos who says he occasionally needs Vioxx…to do his job. “I have maybe 15 to 20 left…I will take the risk to get relief,” Starzyk said. “I still have Vioxx at home, and when I get really bad I take it to keep the pain away. You can only deal with pain so much.” Starzyk is among the estimated 75 million Americans - one in four - who are living with chronic pain, according to the National Pain Foundation of Englewood, Colorado.
As we noted earlier, our current drug safety system is geared to avoid “bright line” adverse effects, rather than route patients and doctors around them, or allow them to balance their own life decisions. In an era driven by information technology and DNA testing, can’t we offer citizens like Mr. Starzyk a better way?
India Senses Patent Appeal
Wall Street Journal, 4-11-05
India is a globalization success story, and we have two articles this week chronicling how its growing economy has created new health care trends. The first article, below, notes how the Indian biopharmaceutical sector is embracing new intellectual property rights. The second chronicles India’s growing attractiveness for American and European consumers in search of inexpensive, high quality medical care.
Market-based economic reforms and an ongoing embrace of patent rights have transformed a once-poor nation into a formidable economic competitor.
Behind India’s new patent protections - which raised alarms in some quarters - is a quiet change in the country’s industry: India is becoming an intellectual-property powerhouse. The [recently enacted] amendments to India’s patent law have sparked worries that Indian companies will face chilling global competition, and that the cost of medicines would jump in poor countries now supplied by Indian generic drugs…But many of India’s most innovative companies welcome the stronger patent protections, saying they will trigger further investment and innovation in India.
It is a truism of economics that countries which persistently shield key industries from competition encourage inefficiency and waste. Countries that embrace international competition, property rights and the rule of law - like India - thrive and prosper. Europe and the U.S. should take note that India is using capitalist ju-jitsu to drive health care innovation and beat us at our own game.
‘Advance Purchase Contracts’ Could be Cure for Vaccine Sellers
Wall Street Journal, 4-7-05
‘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
The New York Times, 4-7-05
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
Washington Post, 4-7-05
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.
Medical R&D Miracle
Doug Bandow, Washington Times, 4-12-05
Bandow reminds readers why America leads the world in biopharmaceutical technology. Although they labor under enormous regulatory burdens, companies that operate in the U.S. are still allowed to profit more from their investments than anywhere else. Consequently,
Nearly $50 billion was spent last year in pharmaceutical and biotech research and development. The big drugmakers devoted $38.8 billion in finding new cures. A bevy of smaller biotech companies spent another $10.5 billion…America’s advantage is not that its citizens are smarter, better educated or nicer. Rather, America is freer. Despite manifold regulation by states as well as the federal government, it is still easier to conduct research, create products, and sell medicines in the U.S. than overseas. In contrast, Europe faces a full-scale scientific brain drain in many industries due to its stultifying economic environment.
The biggest threat to industry - and America’s position in the global economy - is from policymakers who want to inflict price controls or parallel importation on the goose that is laying the golden eggs.
The Top Ten Reasons for Medicaid Reform
Nina Owcharenko, Heritage Foundation, 4-12-05
Owcharenko’s “Web Memo” lists the most important reasons why Congress and the states should work towards serious Medicaid reform. For instance, Medicaid’s benefit setting process is outdated and it limits access to quality health care. She also posits a framework and a philosophy that should drive reform:
In reforming the welfare system in 1996, Congress established a process to move people out of dependency and into work, enabling them to participate in the mainstream economy. Medicaid reform should track the success of welfare reform, mainstreaming beneficiaries, wherever possible, into the private health care system that covers their fellow citizens. The result: a modernized and improved Medicaid program to better care for those it is intended to serve.
Data Do Not Support Ban on Silicone Breast Implants
Sally Satel, MD, USA Today, 4-11-05
Satel notes that feminist groups, long the self-proclaimed guardians of “choice” for women, have turned their back on choice and science in their stand against silicone breast implants.
Ever since women began enlarging their breasts with implants, feminists have been upset. So, predictably, when a Food and Drug Administration advisory panel begins hearings today to consider approval of silicone-gel-filled breast implants, feminist health activists will urge them to reject the devices as unsafe. But the data emphatically do not justify their concern. Unfortunately, women can't depend on such groups as the National Organization for Women to give them the facts.
Making Markets for Vaccines: Ideas to Action
Center for Global Development, 4-7-05
As mentioned above, the Center for Global Development has released a report recommending that policymakers and philanthropic organizations create an “advance market” to help spur private sector research and development of treatments for diseases that primarily afflict poor nations.
Making a commitment in advance to buy vaccines if and when they are developed would create incentives for industry to increase investment in research and development. New commercial investment would complement funding of research and development (R&D) by public and charitable bodies, accelerating the development of vital new vaccines for the developing world. This report presents the proposal from theory to practice, by showing how a commitment can be consistent with ordinary legal and budgetary principles.
Statin Use Before and After an Ischemic Event Has Better Outcomes
Researchers here present data showing that patients “who are treated with a drug in the statin class either before or shortly after an ischemic stroke are more likely to survive and go home on discharge rather than die or be transferred to an extended care facility.”
"These findings represent an important step in a growing pool of knowledge showing that statins reduce the risk of recurrent stroke and improve outcomes," said Mark J. Alberts, MD, in an interview seeking outside comment. "The study has limitations in that it is a retrospective, registry study, which means that it is susceptible to several biases, such as selection bias." Dr. Alberts is a professor of neurology at Northwestern University Feinberg School of Medicine in Chicago, Illinois, where he is director of the stroke program.
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