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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 11-22-2004

Drug Companies Look to China For Cheap R&D
Wall Street Journal, 11-22-04

The cost of developing drugs in Western nations has risen exponentially in recent years – along with ever-tightening price controls in Europe, and the threat of price controls in the U.S. In order to ward off profit pressures, companies are increasingly looking to expand operations in low-cost countries with highly skilled populations like China. “[Companies] are finding highly educated scientists who work for a fraction of what their Western counterparts are paid, as well as vibrant and growing biotechnology businesses.” This is a critical factor, since as much as 80% of R&D costs can go toward researcher compensation. Patent protection for pharmaceuticals has been a concern in China in recent years, but with China joining the World Trade Organization, even that concern is abating.

American policymakers take note: the U.S. economy will remain a hotbed of pharmaceutical and biotech innovation only as long as we can keep regulation to a minimum and offer investors a high return on their investments. Otherwise, the U.S. will cede its high tech dominance to lower-cost, more flexible competitors.

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FDA Sets Its Priorities for Drug Safety Debate in Next Congress
Food & Drug Letter, 11-24-04

Editor's Notes:

There seems to be a developing consensus in Washington that "[the FDA can expect] effective oversight, withering oversight" from Congress in 2007 that may sap the agency's ability to deliver timely and objective management of new drug applications. Effective oversight is one thing, if Congress is intent on balancing safety and efficacy concerns. But the highly technical nature of these debates is not one that lends itself to media–driven Congressional hearings, which is what we can expect.

Hearings can be a real pain," John Kamp, executive director of the Coalition for Healthcare Communication (CHC), said, becoming "a significant distraction to senior people." The time involved makes it "hard to get real work done," he added.

Industry can also suffer from additional oversight. The more oversight hearings, the more support for legislation that industry will oppose, Adams said. Public perception is very important to the drug industry and more hearings could sully the public's view of that industry.

Importation is also likely to come up in the next Congress. The "probability of passage [of new legislation] has increased" with the election, former Senator Connie Mack (R-Fla.), a senior policy adviser at King & Spalding, told FDL. Democrats are likely to move very quickly to expand importation to include drugs from the European Union, Mark Smith, a senior government relations adviser at King & Spalding, said. Key Republicans have supported importation as well. For example, Sen. Trent Lott (R–Miss.), the new minority whip, has called for expanded importation, Smith said.

Congress is also more likely to approve broader drug importation because of Democrats' interest in lowering drug costs, CHC's Kamp added. Democrats such as Rosa DeLauro (R-Conn.) have been proponents of importation and now step into leadership positions, increasing the chances that importation reform will take place, Peter Pitts, director of the Center for Medicine in the Public Interest, said. Incoming lawmakers, including Sen. Sherrod Brown (D-Ohio), have been vocal proponents of importation, Pitts added.

In other words, Congressional criticism of the agency may be used as a forum to drive a broader political agenda on lowering drug prices and importation that may have very little to do with making drugs safer.

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Protein May Prevent Damage After Heart Attack
Wall Street Journal, 11-26-04

How do you regenerate human tissues and organs once thought irreparably damaged? Media attention on this medical front is focused on embryonic stem cell research, partly because it is a promising technology, and partly because it is ethically ambiguous and controversy sells.

However, researchers are pursuing other therapies outside the media glare, and some are now hopeful that a protein that is critical in pre-natal heart development will also prove effective as a treatment to prevent damage caused by heart attacks. “Through a series of experiments, researchers showed that – when given to mice that were induced to have heart attacks – treatment with the protein, called thymosin beta-4, protected heart muscle cells from dying and was associated with improved heart function.” Weeks after the induced heart attacks, protein treated mice had less muscle damage and stronger hearts than mice treated with saline solution.

Animal tests, no matter how encouraging, are only a first hurdle; moving from mice to man has killed many a promising therapy. Nonetheless, the lead author of an article in Nature describing the experiments has said that the results suggested that the protein could be a powerful frontline treatment, if it could be delivered to patients within a few hours after suffering a heart attack.

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Many See Hope in Parkinson's Drug Pulled From Testing
The New York Times, 11-26-04

What constitutes a failed, unsafe drug? Given the backlash against Vioxx, that answer may seem clear cut. However, in reality drug safety is a very slippery concept – drugs once thought the epitome of failure, like thalidomide, can be rehabilitated to become powerful cancer treatments. Safety issues often involve delicate risk-balancing tests, and when patients have few viable options – or have exhausted the options available to them – what looks like a bad gamble can suddenly become a good bet.

Parkinson’s is a crippling neurological disease characterized by severe motor impairment, and patients afflicted by the disease have few good options and are anxious to develop new treatments, no matter how remote the prospect of success. Adding to the challenges facing companies seeking new treatments is that the condition has a very high placebo response rate, meaning that drugs that look effective in small, early tests can fade abruptly when subjected to the rigors of placebo controlled trials.

One example of the dilemmas facing companies and regulators is the Parkinson’s drug glial cell line-derived neurotrophic factor (GDNF) developed by Amgen. GDNF showed enormous promise in early trials, but Amgen withdrew it from patients receiving it as an experimental treatment last August after the drug failed to outperform placebo in a controlled trial and some patients developed antibodies against the drug.

Patients (and some doctors) in earlier trials still swear by the drug and are begging the company to license it to another company or university for development, or at least continue providing it to clinical trial patients on a “compassionate use” basis – which the company says that it cannot do for ethical and legal reasons. Currently, The Michael J. Fox Foundation for Parkinson’s Research is holding talks with Amgen to try and work out a compromise.

Still, this is a critical side of the drug safety debate that is apt to be missed by policymakers and activists eager to find corporate scapegoats. The reality is that we don’t have any perfect tools for measuring safety or efficacy, and every decision by corporations and FDA is open to second guessing by people looking for easy answers.

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Flu Crisis Sparks Fresh Look at Vaccine Production
Washington Post, 11-27-04

Which came first, the chicken or the egg? When it comes to flu shots, it’s the egg.

For about fifty years, the U.S has relied on the same technology for its flu vaccinations: “flu shots containing liquid drawn from 11-day-old fertilized chicken eggs.” The eggs are used as tiny incubators for viruses that are then killed and used in vaccines. However, as the nation discovered recently, the process is expensive, time-consuming, and prone to contamination – a problem that prevented the British company Chiron Corporation from delivering on its promise to send 48 million flu shots to the U.S. for the current flu season.

Policymakers also fear that current technology will be unable to respond quickly in the event of a pandemic outbreak of a new virus like the avian flu, which some experts think might kill hundreds of millions worldwide if it makes the jump to human beings. Consequently, federal officials are encouraging biotech companies to develop a new technology whereby viruses are incubated in cells drawn from insects, monkeys, dogs, or even human tissues. The technology is somewhat faster and certainly less prone to the problems affecting the egg based vaccine. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, has said that he will ask Congress for $100 million to design a better national vaccine procurement process, with pilot projects focusing on cell based vaccine development methods.

Still, the technology is several years away from large scale deployment, and it may not coax new companies into the vaccine market absent one critical ingredient: higher profits. Until industry has better incentives to spend money on vaccine development, technology alone won’t solve the problem. Said one analyst, “If the profit margins are horrible, why would any company want to take that chance otherwise?”

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