Senator Moves to Block Medical Ghostwriting

A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products.

Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.

Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington.

With a letter last week, a senator who helps oversee public funding for medical research signaled that he was running out of patience with the practice of ghostwriting. Senator Charles E. Grassley, an Iowa Republican who has led a long-running investigation of conflicts of interest in medicine, is starting to put pressure on the National Institutes of Health to crack down on the practice.

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Federal Court Upholds Drug Privacy Law

A federal appeals court in Boston on Tuesday dealt a setback to the pharmaceutical industry and companies that collect prescription data for use in drug marketing.

Ruling in support of a New Hampshire law, the court upheld the right of states to prohibit the sale of doctor-specific prescription drug data that is widely used in pharmaceutical marketing.

The case is a defeat for two large data-mining companies, IMS Health and Verispan. They sued in 2006 to block implementation of the New Hampshire law, which prohibited the sale of computerized data showing which doctors were prescribing what drugs.

The law was intended to cut down on state health care costs by eliminating the tool used by drug sales representatives in promoting brand name drugs. By purchasing the data describing which doctors prescribe what drugs, pharmaceutical sales forces are better able to identify which doctors might use their products and be receptive to their sales pitches. They can also focus on persuading doctors who do not write many prescriptions for their products to change their minds.

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Lilly Will Take $1.42 Billion Charge in Zyprexa Probe (Update1)

Eli Lilly & Co. said it is having ``advanced discussions'' to settle investigations by U.S. and state authorities over marketing the antipsychotic Zyprexa and will take a $1.42 billion charge in the third quarter.

The charge will amount to $1.29 a share and reflects Lilly's ``currently estimable exposure'' to investigations into whether it promoted Zyprexa for unapproved uses, the Indianapolis-based company said today in a statement.

Investigations by the U.S. Attorney's Office for the Eastern District of Pennsylvania and more than 30 state Medicaid fraud units focus on Lilly's marketing to U.S. doctors and the drugmaker's payments to consulting physicians and other advisers. The announcement follows Lilly's Oct. 7 settlement of consumer fraud investigations by 32 states and the District of Columbia into the company's marketing of Zyprexa, its top-selling drug.

``The government's investigation of Zyprexa has been ongoing for five years and we now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues,'' said Robert A. Armitage, Lilly's general counsel, in the statement. The company is cooperating with the investigations, Lilly said.

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Pharmaceutical Payola-Drug Marketing to Doctors

Last week, a Congressional committee properly raked Big Pharma over the coals for misleading advertising of pharmaceuticals.

A hearing of the House Energy and Commerce Committee's oversight subcommittee focused on advertising campaigns for three drugs, including the remarkable case of Robert Jarvik. Jarvik is featured in endlessly re-run ads for Pfizer's blockbuster cholesterol drug Lipitor. Known as the inventor of the Jarvik artificial heart, he is not a cardiologist, not a licensed medical doctor and not authorized to prescribe pharmaceuticals. He's shown in the ads engaged in vigorous rowing activity, but in fact he doesn't row. Pfizer pulled the ads in February after controversy started brewing.

Among industrialized countries, only the United States and New Zealand permit drug companies to market directly to consumers. It's a bad idea, it drives bad medicine, and it should be banned.

But although it has the highest profile, direct-to-consumer advertising is a small part of Pharma's marketing machine.

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Solving The US Drug Price Crisis, Experts Propose Solution

The mounting U.S. drug price crisis can be contained and eventually reversed by separating drug discovery from drug marketing and by establishing a non-profit company to oversee funding for new medicines, according to two MIT experts on the pharmaceutical industry.

Stan Finkelstein, M.D., senior research scientist in MIT's Engineering Systems Division, and Peter Temin, Elisha Gray II Professor of Economics, present their research and detail their proposal in their new book, "Reasonable Rx: Solving the Drug Price Crisis."

Finkelstein and Temin address immediate national problems--the rising cost of available medicines, the high cost of innovation and the 'blockbuster' method of selecting drugs for development--and predict worsening new ones, unless bold steps are taken.

"Drug prices in the United States are higher than anywhere else in the world. Right now, the revenues from those drugs finance research and development of new drugs. We propose to reduce prices, not at the expense of innovation, but by changing the way innovation is financed," said Temin, also the author of "Taking Your Medicine: Drug Regulation in the US."

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F.D.A. Seeks to Broaden Range of Use for Drugs

When federal drug regulators approve a medicine for sale, they limit how drug makers sell it. A drug approved to treat only breast cancer cannot be marketed for lung cancer even if some studies suggest that the medicine may save lung patients.

But the Food and Drug Administration proposed guidelines Friday that would change this, and advocates on both sides of the issue say that lives are at stake.

The rules would allow drug and device makers to provide doctors with copies of medical journal articles that discuss product uses that have not been vetted or approved by the F.D.A. The rules also say that drug companies do not have to promise to adequately test the unapproved use discussed in the article.

Advocates of the rule say the F.D.A. is so slow in assessing drug and device benefits that companies need to be able to hand out medical journal articles so that doctors can learn immediately about life-saving uses.

“The consequence of rapid disclosure of these benefits could be measured in lives,” said Dr. Scott Gottlieb, a former F.D.A. deputy commissioner.

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