|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 11-15-2004
Tiny Antennas To Keep Tabs On U.S. Drugs
Pharmaceutical companies and the FDA are working together on an initiative to bring inventory management technology (and the same technology underlying electronic highway toll booth systems across the country) to the drug wholesale industry in an effort to stem a rising tide of counterfeiting and theft in America’s prescription drug supply chain.
The technology, known as known as Radio Frequency Identification (RFID), is “basically a bar code that barks” – an electronic id tag that helps to make “supply chains more efficient and more secure.” “Computer chips embedded into stickers” will be inserted into selected bottles of frequently counterfeited or stolen medications like Oxycontin or Viagra. The tags then “emit numbers when prompted by a nearby radio signal.” Although the technology is still in its infancy, it will allow pharmaceutical companies that employ it to track drugs as they migrate through the drug supply chain from manufacturer to the shelf of your neighborhood pharmacy.
Prescription drug crimes are expanding as amateur thieves give way to professional syndicates. “We’ve seen organized crime start to get involved,” said William Hubbard, an associate FDA commissioner. “With some drugs costing thousands of dollars per vial, the profit potential [for criminals] is huge.” At least initially, RFID tags will only be used on a handful of medications at high risk for abuse; however, as the technology becomes less expensive it will be possible to cheaply and easily ensure that every drug Americans take is exactly as safe, effective, and legal as it claims to be.
Preparing for Vioxx Suits, Both Sides Seek Friendly Venues
Whether the Vioxx cases are won or lost depends largely on where they are held. Plaintiffs’ lawyers will try and place as many suits as possible in state courts, where they can expect a friendly reception from juries and judges in very carefully selected forums. Defendants, on the other hand, generally (although not always) prefer federal courts which tend have more experience dealing with complex litigation and are more likely to interpret rules of evidence narrowly. Where will the cases wind up? No one really knows yet. But if venue is so important to the resolution of the issues, whatever happens to the issues themselves? The utter debacle that was the breast implant litigation against Dow Chemical shows a medical liability system run amok, a system that doesn’t offer fair compensation to truly injured patients or protection for manufacturers who obey the law and operate according to detailed state and federal regulations.
Whatever the outcome of the Vioxx suits, we are long overdue for a no-fault system for the pharmaceutical industry, one of the most heavily regulated industries in the world. This system would be modeled on the vaccine injury compensation fund run by the Department of Justice, and would offer real compensation for injured victims without threatening the viability of companies that contribute mightily to the public health.
Punitive damages or tort liability could be reserved for those rare instances where there has been outright fraud on the FDA, and provide a powerful but fair incentive for companies to disclose all the known risks of a medicine or medical device as soon as they can be reliably identified.
Reuters Summit-AstraZeneca CEO urges US to spur drug innovation.
AstraZeneca CEO Tom McKillop warned the U.S. that its dominance of the $400 billion global pharmaceutical industry wasn’t assured, and that price controls or expansion of the U.S.’s unpredictable liability system could send investment fleeing the country to nascent competitors like India and China. “In a 20-year time period [we] went from eight of the top 10 pharmaceutical products being discovered in Europe to eight of the top 10 pharmaceutical products being discovered in America…That's absolutely amazing, and the U.S. is an enormous economic winner from that. If we go down the route in the U.S. that Europe went down, India and China are waiting with vastly bigger populations. They're producing more talented scientists and engineers every year than the United States, and they're going to be the next generation of winners if the U.S. moves away from innovation."
Bristol-Myers Diabetes Drug Produces Positive Test Results
Bristol-Meyers announced plans to seek FDA approval for its new diabetes drug, muraglitazar, next month after finding positive results with final stage human trials. The trials involved 4,500 hundred patients and the experimental drug showed that it significantly lowered blood sugar as well as triglycerides (fats in the blood). “It also increased HDL, or ‘good,’ cholesterol levels in patients with Type 2 diabetes.” The drug performed as well or better than other diabetes drugs on market, and showed that it helped patients control glucose for as long as 2 years. The drug also had a better side-effect profile than other diabetes drugs, which tend to cause weight gain.
Mouse Study Hints at Effects of Cox-2 Inhibitors on Heart
Dr. Garrett Fitzgerald and other researchers at the University of Pennsylvania have said that Cox-2 inhibitors “could undermine the protection against heart disease that premenopausal women get from natural levels of the hormone estrogen.” Nonetheless, Dr. Fitzgerald and his colleagues cautioned that too much could be made of their findings, since the study only focused on a mechanism of action in mice and didn’t constitute firm evidence of a clinical risk in humans. Also, “the results don’t reflect actual tests of the drugs since mice weren’t given the medicines as part of the study. Instead mice lacked a receptor for a fatty acid called prostacyclin that may yield heart-related benefits when activated by Cox-2.”
However, what Dr. Fitzgerald’s study does point to is the need for better animal models of human disease (for instance, heart disease), and for more attention to the systems biology behind drug treatment, as opposed to focusing only on “hitting” a single drug target, like the Cox-2 enzyme. Knockout mice studies like this one (so-called because a particular gene is “knocked out” of the animal being studied) can be a valuable tool in developing better drugs and understanding what adverse effects researchers and physicians should be on the lookout for.
F.D.A. Approves a Pill for Lung Cancer to Be Sold by Genentech and OSI
In one of the fastest drug approvals ever, the FDA has approved the drug Tarceva to treat advanced non-small cell lung cancer, “the most common form of the disease”, in patients who have failed to respond to at least one prior round of chemotherapy. Tarceva is a “targeted” cancer drug that blocks a protein found in tumors, epidermal growth factor receptor, and has been shown to confer a survival benefit of nearly 7 months versus 4.7 months for placebo.
Targeted cancer drugs like Tarceva typically have fewer side effects than conventional treatments. Tarceva has also shown promise in providing a survival benefit for pancreatic cancer patients, a cancer that is notoriously difficult to treat. Genentech and OSI plan to apply for an additional indication for pancreatic cancer next year.
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