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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 08-10-2006

TV Ads for Prescription Drugs Fuel Further Debate
Lexington-Herald Leader, 8-10-06

Editor's Notes:

Critics of prescription drug advertising claim that the high volume of ads, particularly for "lifestyle" drugs like the sleep aid Lunesta, are causing a surge in the number of patients demanding treatment for symptoms that would be better treated through non–medical means and driving up the nation's health care bill.

Advertising [can promote] the use of expensive prescription drugs by otherwise healthy people, critics say. Some users of Pfizer's Viagra and other drugs to treat erectile dysfunction are taking them simply to facilitate certain lifestyles.

Doctors, the ultimate gate keepers, are often too busy to argue with forceful patients or to spend much time diagnosing non–life–threatening conditions such as insomnia, medical experts said.

"Doctors have only a few minutes with most of their patients and they will usually find the path of least resistance, especially if a drug probably won't do much harm and may do some good," said Larry Levitt, a spokesman with Kaiser Family Foundation, which studied the tie between advertising and sales of prescription drugs. The study found that each additional dollar spent in consumer advertising yielded an additional $4.20 in drug sales.

That adds to the country's health–care bill, the critics say. Americans spend $190 billion in prescription medicines a year, according to the Kaiser Family Foundation. It is only about a tenth of the entire health care bill, but it is increasing faster than other categories, including physician and hospital bills, which account for about 20 percent and 30 percent of the health–care bill, respectively.

The elimination of direct–to–consumer advertising is not the solution to rising health care costs. Rather, policymakers should focus on building a consumer driven health care system that gives patients the information and the financial incentives to spend their own health care dollars wisely.

For instance, if a patient knows that a $10 or $15 co-pay will cover the latest drug for insomnia, they may not think twice about demanding a prescription. However, a patient who had an HSA attached to a high–deductible insurance plan would have to consider if buying Lunesta at its full price was better than making other health changes. Consumer–driven health care will empower patients to control costs without depriving them of the information they need to make informed choices.

[permanent link]

Congress to Probe Policies at NIH
Los Angeles Times, 8-10-06

Editor's Notes:

The National Institutes of Health is under renewed pressure from Congress to tighten its conflict of interest policies as a result of an article in the Los Angeles Times alleging that Thomas Walsh, a senior NIH researcher, did not disclose his industry ties when serving on a FDA advisory committee.

U.S. conflict–of–interest law generally prohibits a federal employee from representing an outside party before a government agency. Walsh, in earlier comments to the newspaper, said that he appeared before the FDA not as a company representative but "as a government scientist providing information and/or evaluation" regarding clinical trials...

In their letter to the NIH director, the four congressional leaders requested a wide range of documents, including all internal financial–disclosure reports filed by Walsh from 1995 to 2005.

The letter also requested copies of any related policy that "permits [NIH] scientists as part of their official duties to assist drug companies with presentations to FDA advisory committees or FDA staff."

This is not the first time that the Times has alleged serious conflict of interests at the NIH—an earlier investigation found isolated violations of NIH regulations, but not the widespread problems asserted by Times reporters. The problem with these allegations is that, rather than alleging specific wrongdoing—like fabricating or withholding data—they tend to attribute guilt by association. Researchers who have any ties to industry—and industry is bound to seek out the best experts it can when developing new products, a process that is very much in the public's best interest—are automatically presumed to be suspect in their professional duties. This is bad logic, and it is likely to lead to bad policy.

The better solution is that researchers should simply declare all significant financial interests, and recuse themselves when companies they consult for (or their competitors) are implicated in important regulatory decisions. We should rely on peer review and clinical judgment to vet medical information—not leering into the minds of researchers searching for hidden bias.

[permanent link]

New Tests May Help Treat Lung Cancer
Wall Street Journal, 8-10-06

Editor's Notes:

A recently released study in the New England Journal of Medicine holds promising news for patients suffering from lung cancer. The study found that researchers can use genetic markers to better predict the best treatment options for patients suffering from non–small–cell lung cancer.

Patients who suffer from this type of cancer had previously been unable to receive insurance coverage for adjuvant chemotherapy immediately after surgery because it was thought that the treatment didn't provide tangible benefits. This study found that patients who had a specific gene expression profile were more likely to relapse and were therefore more likely to benefit from chemotherapy to treat the disease in its early stages. A similar study in the same issue found that genetic patterning may also help physicians decide when to use chemotherapy for certain breast cancer patients.

In light of the findings, the Duke researchers have already approached health insurers, asking them to cover chemotherapy for early–stage lung–cancer patients, depending on the progress of a forthcoming clinical trial. They say health insurers are already aware of the gap in coverage because many early–stage patients sign up for clinical trials that include chemotherapy just to receive more aggressive treatment.

Later this year, Duke will begin a clinical trial, funded by the NIH, of 1,200 early–stage lung–cancer patients in the United States and Canada. The trial, which steers high–risk patients into chemotherapy, is being funded by NIH. Centers for Medicare and Medicaid Services, which typically sets insurance standards, has told researchers that if the trial shows a benefit for early–stage patients, coverage will be likely, Duke says. In a statement, CMS said yesterday that "it's unlikely that contractors would choose to change standard practice without some evidence that chemotherapy actually works better than surgery."

This finding comes too late for David Grant. Diagnosed with early–stage lung cancer in 2001, he underwent surgery to remove his tumor and then expected to have chemotherapy. Instead, three oncologists told him that chemotherapy was "not the protocol" for his case. Two years later, his cancer came back. Now the Army veteran and retired Radio Shack manager, who achieved his dream of building a Wisconsin log cabin for himself and his wife, has advanced, stage 4 cancer. When he heard about the test, he says, "My first thought was, I wish I'd known about that when I had my first surgery," says Mr. Grant, adding that he's glad the test will help other patients.

The researchers' findings herald the significant shift in cancer treatment known as personalized medicine, in which doctors tailor treatment to the genetic characteristics of each person's cancer.

[permanent link]



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