|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 07-11-2005
U.S. efforts to secure new drugs to defend against bioterrorism and radiological attacks have lagged due to large manufacturers’ concerns regarding profits and liability protections:
Big drug and biotechnology companies largely have shunned the [government’s bioterrorism defense] program, known as Project BioShield …amid concerns over legal liability, high costs and limited potential for profit. That has left the government highly dependent on fragile, little-known biotech companies …
Michael Friedman, chief medical officer for biomedical preparedness at PhRMA, the drug-industry trade group, warned that this could happen during House testimony on the BioShield legislation in 2003.
"It is necessary to recognize scientific, legal and economic impediments to the research and development of biodefense products," he said at the time. He noted that manufacturers could be "exposed to devastating product-liability suits." In addition, he cautioned, "The decision to divert resources from the research and development of medicines for serious illnesses like heart disease can be financially risky, especially when a countermeasure may never be purchased or used."
Companies also expressed concerns in the wake of the anthrax attacks, when then-HHS Secretary Tommy Thompson ordered the maker of Cipro, Bayer AG, to supply tablets to the U.S. government at a fraction of the regular price. That event alienated drug companies already wary of getting into the biodefense business.
Essentially, the government is asking companies to engage in expensive, blue-sky research with little assurance that their R&D investments will eventually be profitable. This is a recipe for self-sabotage. Until government offers better—and more consistent—incentives to large manufacturers, developing bioterrorism medicines will be remain a slow and haphazard endeavor.
As we saw in the case of Project BioShield, the absence of clear property rights and profits signals from the market can doom research in critical medical sectors. This also applies to promising natural medicines—which can’t be patented under current law.
In a host of studies, M.D. Anderson researchers are showing that curcumin, the pungent yellow spice in both turmeric and curry powders, has potent anti-cancer properties. They say it may prove effective for both prevention and treatment….
"Curcumin's promise is enormous," said Bharat B. Aggarwal, a professor of cancer medicine in M.D. Anderson's department of experimental therapeutics. "It appears to inhibit multiple pathways by which cancer grows, and we know it's nontoxic."
The greatest obstacle to further study of curcumin is financial. No pharmaceutical company is likely to develop a natural product that can't be patented so the only sources of funding are government agencies.
And government agencies often don’t have the expertise or financial resources to navigate potential new drugs through the hazardous and unpredictable process of drug research, development, and FDA approval.
One solution for this problem would be for governments to create patent pools for natural compounds where companies, based on sliding fees, could begin proprietary research into their development and use. Fees would be low initially, to encourage basic research, with royalties payable if and when the drug was actually approved for marketing by the FDA or its European counterpart. Creating assignable property rights is the best way to encourage research in areas that would otherwise languish without private sector investment.
Makers of Race-Based Heart Drug Warn Against Ignoring Genetics
If there are personalized medicines, are there race-based medicines? Race is an extremely slippery category; it is more accurate to talk about genes. Still, race can be used as a shorthand that can help patients ask questions about underlying genetic or familial risk factors. One new drug, BiDil, for black Americans, is helping to generate public discussion on the interaction between genes and medicine.
When a team of researchers zeroed in on studies that showed blacks responded better than whites to a heart medication, they spent another two years rechecking their work before releasing the findings.
NitroMed, the company that created BiDil, is also "examining genetic commonalities among blacks in the study who benefited from BiDil" which may reveal the genetic factors underlying drug response, and transform the drug into a race-neutral therapy that uses a simple genetic test to identify the patients who could most benefit from it.
Ex-shrimper at vanguard of 'personalized medicine'
Oncologists looking for better treatments for pediatric cancer confront the same challenge facing proponents of personalized medicine: how to best uncover the molecular roots of disease and develop the tools to fight it. This challenge is as easy to say as it is difficult to do.
Brad Margus, CEO and co-founder of Perlegen Science, knows this better than anyone. Margus' interest in personalized medicine started when he discovered that two of his three sons had a rare and fatal genetic disorder called ataxia-telegiectasia (A-T) that afflicts only about 500 U.S. children every year:
Since doctors told Margus in 1993 that his toddlers Jarrett and Quinn would soon be confined to wheelchairs and probably dead before they were old enough to vote, the Harvard Business School graduate has been on a mission to save the boys from their genetic fate. …
Perlegen helps companies personalize their medicines, matching drugs with patients' genetic backgrounds.
A lot is riding on the underlying technology. A more precise understanding of the genetic basis of disease should not only help accelerate the search for new cures, it should lower the cost of finding and testing new medicines, bringing hope to small groups of patients with rare diseases like pediatric cancer or A-T.
Industry Concerned Drug Watch Will Cause Disruptions, Lawsuits
As we've seen in articles on autism, pediatric cancer, and A-T, quantifying the underlying mechanisms of disease is extremely difficult, time-consuming, and expensive. What, then, should we make of the FDA's new public communications strategy for adverse drug events, i.e. letting the public know about potential adverse drug reactions early on, when there may be little hard evidence on whether or not the therapy or some other factor was to blame?
Communication of premature and unvalidated safety observations not only has the potential to confuse healthcare professionals, but it could also unintentionally disrupt beneficial treatment, according to Alan Goldhammer, associate vice president of regulatory affairs at PhRMA.
The pharmaceutical industry obviously is a stakeholder in this dispute, but they do have a point: correlation of a drug with an adverse event doesn't prove causation. Trumpeting potential risks will, however, spark a lot of litigation while FDA is still hashing out the science. This doesn't serve the cause of patient health or improve our understanding of real risks.
As Medicaid Balloons, Watchdog Force Shrinks
This is the second article in a well-researched series by the Times cataloguing the enormous waste and fraud riddling New York’s $44 billion dollar state Medicaid budget:
New York's Medicaid program pays more than a million claims a day, feeding a $44.5 billion river of checks to radiologists and ambulance drivers, brain surgeons and orderlies, medical centers and corner pharmacies. Many who get those checks pocket more money than they deserve, and millions of taxpayer dollars are believed to be lost every day to theft and waste. Yet the state, charged with protecting those dollars, has done little to stop them from draining away. …
Albany policymakers have used a lavish system of Medicaid spending to court votes from politically connected health care unions and other providers. Today, New York's Medicaid program is—astonishingly—more expensive than those of Texas and California combined. In response to the Times' expose, Governor Patacki has announced the creation of an independent inspector general's office to help police the program, and appointed a former federal prosecutor to recommend reforms for how the state monitors Medicaid fraud.
Manhattan Institute Senior Fellow E.J. McMahon said in response to the Governor's reforms that "There's no guarantee that a third office dedicated to policing Medicaid will accomplish anything more than the two agencies that were already supposed to be overseeing this area. What we still need, above all, are far more fundamental Medicaid reforms that would weaken the ability of providers to scam the system by giving patients themselves an incentive to spend wisely. The problem may prove to be that the state itself is far too involved in Medicaid administration and should devolve more of this responsibility to private insurers."
5 Drug-Importing States Add 2 Countries as Sources
Illinois’ Governor Blagojevich has discovered the biggest problem with legalizing drug importation: foreign countries don’t want to see their own prices rise. Canada, for instance, has repeatedly expressed its unwillingness to become “America’s drug store” out of a desire to protect its domestic drug supply.
The importation program Governor Blagojevich supports, I-SaveRx—an importation program used by 5 states, including Illinois—just added Australia and New Zealand to its list of approved countries to compensate for Canadian restrictions:
Canada has been by far the largest of the exporters, but Gov. Rod R. Blagojevich of Illinois said in a statement on Monday: "The drug companies and their allies are turning up the heat in Canada, which has been the primary point of purchase for millions of Americans. We've known for some time that a sound importation program can't rely solely on Canada."
The move comes less than three weeks after Canada's health minister announced plans to introduce legislation limiting bulk prescription drug exports to the United States. The bill is aimed at preventing medication shortages in Canada, where the pharmaceutical industry has suggested that it might counter those exports by curbing distribution.
Australia and New Zealand, however, might not have much to worry about. Since its inception, I-SaveRx has only filled about 10,000 prescriptions. This indicates that demand for imported drugs is lower than the Governor’s rhetoric would suggest, and that low-income, uninsured patients would be better served through existing public and private programs that offer access to free or low-cost prescription drugs.
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