HEALTH BLOG
WSJ’s blog on health and the business of health.
December 1, 2008, 9:17 am
Overseas Clinical Trials Are Under the Microscope
Posted by Victoria Knight
As the number of clinical trials conducted by western drugmakers in developing nations rises, so is the attention being paid to how they’re being run.
As the WSJ reports, regulators in India recently halted a trial of a new Wyeth vaccine after a baby died. Patient deaths and other problems in Poland have led to a delay of at least a year in the approval by European Union regulators of a bird flu vaccine being developed by Novartis.
Though neither the companies nor the experimental vaccines have been proved at fault, the problems bring to the fore longstanding concerns over whether medical and ethical practices are being adhered to in developing countries, according to the WSJ.
Lower costs, faster recruitment and patients who are less likely to take other medications that can interfere with study results make overseas trials attractive to drugmakers. Critics charge corners can also be cut. Investigators may be too eager to please. And the promise of access to life-saving drugs beyond the financial reach of many test patients may lead them to take extra risks.
Some 40% or more of trials are taking place in the developing world. And big drug companies say they apply the same standards and oversight, regardless of location. But some observers aren’t so sure. “There are standard ways of conducting clinical trials,” Sonal Singh of Wake Forest University told the WSJ. “The question is: Are they being adhered to?”
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Swiss Voters Send Mixed Messages On Heroin, Marijuana
Posted by Victoria Knight
The Swiss are known for their precision, but over the weekend voters in the Alpine nation sent a mixed message on drug use.
In a national referendum held Sunday, Swiss voters overwhelmingly said “yes” to making permanent a government-authorized heroin program for addicts, while at the same delivering a firm “no” to an initiative that would have decriminalized marijuana. The AP has the details.
Under the legalized heroin program, hard-core addicts who have tried but failed to quit, can receive daily, controlled doses of heroin produced at drop-in centers. Participants can’t take the drug home with them and have to inject it under the supervision of medical professionals at the centers. Proponents argue the government-sanctioned approach reduces crime, disease and death among addicts. Critics, including the U.S, have charged that such initiatives have the potential to fuel drug abuse, the AP writes.
While the outcome of the vote suggests the Swiss are wholeheartedly in favor of helping those who are already addicted to drugs, they remain opposed to encouraging recreational use of drugs by those who aren’t. Almost two-thirds of Swiss voters in the referendum opposed decriminalizing possession of small amounts of marijuana or growing of the plants for personal use.
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Obama Presidency Could Bring Cheaper Medicines, Universal Coverage
Posted by Scott Hensley
Some of Big Pharma’s worst fears could become reality under the Obama administration, the Chicago Tribune reports.
Changes to look for: legalization of the importation of cheaper prescription medicines, legislation clearing the way for generic versions of biotech drugs and direct price negotiations between Medicare and drugmakers.
The Bush administration has stymied some of those changes so far. But the Obama team is expected to be more supportive. Industry is digging in. PhRMA’s Ken Johnson told the the Tribune, “Clearly, we are getting prepared for anything and everything next year.”
The Los Angeles Times lays out the case for bold government action under Obama to bring universal health coverage to fruition.
A consensus in support of change is emerging among businesses, hospitals, doctors, labor unions and insurers and folks inside the Beltway. While there’s no clear view yet of the specifics on the health front, a few ideas are pretty much off the table, the LAT writes. Those include a government-run single-payer health care system on the left and, on the right, a system rebuilt largely through tax incentives to individuals for purchasing insurance on their own.
But don’t get your hopes up, reformers. It’s easy to agree on principles of change and then see the good cheer disappear when it’s time to make something happen. “Once you get into the details, the consensus is going to vanish pretty quickly, I suspect,” Stuart Butler, VP for domestic policy at the conservative Heritage Foundation, told the LAT.
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Latest Postmortem on Torcetrapib Leaves Hope for HDL Boosters
Posted by Scott Hensley
Two years after Pfizer lost its big bet on torcetrapib, an experimental booster of good cholesterol, the failure still casts a pall on researchers working on similar drugs.
Torcetrapib flamed out when more patients taking the drug in combination with Lipitor died than those taking Lipitor alone. The Pfizer drug, a CETP inhibitor, had a particularly unfortunate side effect — raising blood pressure in people with heart disease risks. The lingering question: Were torcetrapib’s problems inextricably linked to its ability to raise HDL?
Not according to a couple of papers published online during the holiday-shortened week. The work suggests torcetrapib’s problems were independent of its effects on cholesterol. “Torcetrapib’s failure is based on the drug’s off-target toxicity,” Menno Vergeer, one of the researchers, told the heartwire, which summarizes the findings. “I think that’s the most important conclusion we both arrive at.” (more…)
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Indonesia to Drugmakers: Build Factories Here, Or Get Out
Posted by Jacob Goldstein
Want to sell prescription medicines in Indonesia? Better start building a factory there.
The nation’s health ministry recently decreed that foreign drug makers will only be allowed to sell products in the country if they build production facilities there.
“I don’t think they’d dare leave,” the nation’s health minister told the Associated Press this week. “But if they do, it’s their loss.”
Of course, it might also be a loss for sick people unable to get medicine.
Thirteen companies, including giants such as Eli Lilly, Merck Sanofi-Aventis, and AstraZeneca, sell drugs in Indonesia but don’t have factories there, the AP says. The new rule isn’t set to take effect for two years.
With sales growth likely to slow in the U.S. and Western Europe in the coming years, the drug industry is looking to middle-income countries such as Indonesia as key growth markets. But there have been some bumps in the road.
Brazil and Thailand made headlines when they decided to break the patents on branded drugs.
And Indonesia itself announced last year that it would no longer share bird flu samples collected within the country with foreign researchers, on the grounds that any vaccine developed from the samples was likely to benefit the developed world more than the developing world. The country ultimately cut a deal with the WHO and started sharing the samples again.
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