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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 08-30-2006

FDA Warns Consumers Not to Buy or Use Prescription Drugs
FDA News, 8-30-06

Editor's Notes:

The Food and Drug Administration issued a press release this week warning consumers to avoid websites that offered drugs from Mediplan Prescription Plus Pharmacy or Mediplan Global Health, both Canadian firms.

The FDA took this step after reports that counterfeit drugs had been sold by these companies to American consumers.

FDA recommends that consumers who have purchased drugs from these websites not use the products because they may be unsafe. Laboratory analyses are underway for intercepted product that was destined for the U.S. market. Preliminary laboratory results to date have found counterfeits of the following drug products from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex, and Propecia. All of these medications require a prescription from a licensed health care provider to be legally dispensed.

As a general matter, FDA advises consumers to use caution when buying medical products online. Although a website may appear reputable and similar to legitimate retail pharmacy websites, many actually operate from outside the U.S. and provide unapproved drugs from unreliable sources.

For example, in August of 2005, FDA conducted an operation at New York, Miami, and Los Angeles airports which found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with "Canadian pharmacies." Of the drugs being promoted as "Canadian," based on accompanying documentation, 85 percent actually came from 27 other countries around the globe. A number of these products also were found to be counterfeit. These results demonstrated that some Internet sites that claimed to be "Canadian" were, in fact, selling drugs of dubious origin, safety and efficacy.

Consumers should remember that it is challenging enough for U.S. regulators to monitor and protect the domestic drug supply chain. The global market for prescription drugs—drugs that are sold and then resold to various retailers and wholesalers in dozens of different countries—is much more vulnerable to fraud. Let the buyer beware.

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Some patients back on Celebrex
USA Today, 8-30-06

Editor's Notes:

Cox&150;2 inhibitors like Vioxx and Celebrex were designed to offer patients who suffered serious stomach bleeding from the use of conventional painkillers a safer alternative. However, the discovery of cardiovascular risks associated with Vioxx and its withdrawal from the market in 2004 seemed to cast a pall over the entire class of Cox&150;2 drugs. That pall may be lifting with the resurgence of Celebrex, the only Cox&150;2 drug available to American patients.

Two years after safety concerns bloodied and bruised the arthritis painkiller market, Pfizer's Celebrex is making a comeback.

Annual sales are expected to top $2 billion this year after falling to $1.7 billion last year. Sales were at $3.3 billion in 2004.

In its most recent quarterly report, Pfizer (PFE) boasted of Celebrex's 17% year&150;over&150;year revenue growth, and the company earlier this year restarted consumer advertising for the drug.

That's a far different scenario than faced by Celebrex's former chief rival, Vioxx, a Merck (MRK) product. Vioxx was taken off the market in September 2004 after studies showed increased heart attack and stroke risk in some users. Merck faces 14,000 lawsuits and billions of dollars in potential damages.

Whether Celebrex will regain its former heft is another matter. The drug now carries a boxed warning, the strongest kind, about cardiovascular and stomach risks. And doctors are prescribing it less often.

"The drug has been right&150;sized," says Stephen Paget, chief of rheumatology for the Hospital for Special Surgery in New York City. "It's been pulled back to an optimal group of patients. . . who need it and who can tolerate it."

The process of "right-sizing" drugs like Celebrex isn't helped by the U.S.'s reliance on third&150;party insurers, who basically prepay consumer's use of pricey new technologies, even when they don't need them. Perhaps the most important lesson to be learned from Vioxx is that this creates a moral hazard both for companies and consumers.

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Cancer breakthrough reported
Washington Times, 8-31-06

File this under "proof of concept." An article in the journal Science this week reported that gene therapy helped two men with metastatic melanoma fight off the cancer. The men remain disease free two years after undergoing therapy.

Government scientists saved two men dying of melanoma by genetically altering their own white blood cells to attack their tumors—deemed the first major success in battling cancer with gene therapy.

Though the men appear disease–free almost two years after the experimental therapy, it wasn't a panacea. Fifteen other melanoma victims weren't helped. The National Cancer Institute is trying to strengthen the shots.

Still, specialists proclaimed the work, published today by the journal Science, an important advance—gene therapy with the potential to fight cancer's worst stage, when it has spread through the body. The NCI hopes to begin testing it soon against cancers more common than melanoma, such as advanced breast or colon cancer.

While much more research needs to be done, this is an encouraging advance for a therapy that has, until now, generated more hope than results.

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Cancer breakthrough reported
Washington Times, 8-31-06

Editors Notes:

File this under "proof of concept." An article in the journal Science this week reported that gene therapy helped two men with metastatic melanoma fight off the cancer. The men remain disease free two years after undergoing therapy.

Government scientists saved two men dying of melanoma by genetically altering their own white blood cells to attack their tumors—deemed the first major success in battling cancer with gene therapy.

Though the men appear disease–free almost two years after the experimental therapy, it wasn't a panacea. Fifteen other melanoma victims weren't helped. The National Cancer Institute is trying to strengthen the shots.

Still, specialists proclaimed the work, published today by the journal Science, an important advance—gene therapy with the potential to fight cancer's worst stage, when it has spread through the body. The NCI hopes to begin testing it soon against cancers more common than melanoma, such as advanced breast or colon cancer.

While much more research needs to be done, this is an encouraging advance for a therapy that has, until now, generated more hope than results.

[permanent link]

Study Finds Health Care Good Value Despite Costs
Washington Post, 8-31-06

Editor's Notes:

Researchers have released a new study arguing that America's health care spending, the highest in the world, may actually be money well spent.

The dramatic increase in health–care spending in the United States since 1960 is a major reason that Americans are living longer, making the world's most expensive health–care system a good value despite its high costs, according to an academic study being released today.

The study notes that a baby born in 2000 can expect to live for 76.9 years, compared with 69.9 years for a newborn in 1960. While some of the gain is because of declines in rates of smoking and fatal accidents, it is reasonable to attribute at least half of it to more and better health care, said Harvard University economist David M. Cutler, the study's lead author.

"If you want to evaluate whether we're spending too much, you have to know what we're getting for it," Cutler said in a telephone interview. "And when you look at what we're getting for it, the return actually looks to be pretty high. . . The presumption that most people have is that it's obvious that we're spending way too much."

The conclusions of the study, published in the New England Journal of Medicine, run counter to the arguments by analysts who question whether health–care costs should consume 16 percent of the nation's economic output. Such critics point out that in longevity and infant mortality, the United States ranks below other countries that spend far less.

Comparing health and health care spending is, obviously, a tricky business. Critics who lambaste U.S. health care on the basis of longevity and infant mortality statistics, for instance, ignore the fact that health is influenced by cultural and genetic factors that are independent of health care spending. Conversely, while U.S. spending may be "worth it" in the abstract, it is hard to say what spending decisions consumers would make if their own money was on the line.

Still, this study is an important contribution to America’s ongoing debate on health care spending and the value of medical innovation.

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