PHARMACY

DTC ads criticized by Congress, AMA

BY Drew Buono

WASHINGTON Direct-to-consumer ads took another hit yesterday when lawmakers and the American Medical Association said that they should be limited and/or monitored in an effort to control deceptive marketing from reaching consumers, according to published reports.

A moratorium should be placed on ads for newly approved drugs until doctors are educated and regulators have signed off on the messages, the medical association, said yesterday at a House subcommittee hearing on drug advertising. Representative Bart Stupak said Congress should consider new restrictions on ads.

“Congress needs to decide whether the US should continue to be one of two countries in the world that allow DTC ads, and if we continue to allow such advertising, whether any further limits to DTC ads should be required,” said Stupak, D-Mich., head of the Energy and Commerce Subcommittee on oversight and investigations. “It appears that we need to enforce significant restrictions on DTC ads.”

Drug makers spent $5.4 billion last year on DTC advertising, according to market research firm Nielsen Monitor-Plus. That’s a fivefold increase in the decade since rules about the disclosures required in television ads were changed, allowing drug makers to more easily air commercials. Lawmakers said the ads gloss over risks and may cause overprescribing of expensive medicines.

Companies that were targeted at the meeting was Merck and Schering-Plough for marketing of their cholesterol drug Vytorin, Pfizer for using a doctor, who does not practice medicine in their ads for their cholesterol drug Lipitor and the anemia drug Procrit by Johnson & Johnson.

Pfizer senior director James Sage defended his company’s role in using Dr. Robert Jarvik, who isn’t a practicing physician but who helped design the artificial heart, in its TV ads for Lipitor.

“Although not a practicing physician, he has devoted his entire career to medical science related to the human heart,” Sage said. “An important objective of the Jarvik advertising campaign for Lipitor was to highlight the importance of diet and exercise in reducing cardiovascular risk.”

Sage, and officials from the other companies, all said they submitted the ads, after they began running, to the Food and Drug Administration for comments. Sage said the company made several changes to its ads for Lipitor, including weakening claims about its ability to lower cholesterol as compared to other drugs.

FDA officials were not invited to participate.

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Anthem BC/BS allows doctors to access EMRs via cell phone

BY Drew Buono

MANCHESTER, N.H. Anthem Blue Cross and Blue Shield in New Hampshire has unveiled new technology that will enable physicians to have secure access to online patient medical records and claims information from their mobile phones.

“Now all licensed New Hampshire practitioners who are part of our e-prescribing program are also able to access both medical records and claims data on Anthem members, anytime, anywhere by using their web-enabled cell phone,” said Richard Lafleur, medical director, Anthem Blue Cross and Blue Shield in New Hampshire, who added that participants could also access the new program from their office or home computer.

The addition of the new technology, known as Member Medical History, further enhances the e-prescribing tool by delivering an unprecedented amount of clinical information to the physician wherever he or she may be. Now the doctor looking to generate an electronic prescription is able to quickly access their Anthem patient’s medical history, getting valuable information on medical conditions and the patient’s most recent care, test results, or diagnoses by other clinicians.

“Putting even more comprehensive information in the physician’s hands at the time care decisions are being made improves quality and efficiency,” said Charles Kennedy, vice president of health information technology for Anthem. “E-prescribing and MMH are good examples of how Anthem can use technology to create a community benefit for all patients while still delivering unique value for our members.”

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Study shows metformin as effective as insulin injections during pregnancy

BY Drew Buono

BOSTON According to a new study, metformin, the generic version of Bristol-Myers Squibb’s diabetes drug Glucophage, is just as effective as insulin injections in treating women who develop diabetes during pregnancy, researchers in New Zealand and Australia reported yesterday.

Gestational diabetes appears in 1-in-20 pregnant women, and there has been concern that metformin might affect a fetus because the drug can cross the placenta.

But the study, led by Janet Rowan of the Auckland City Hospital in New Zealand, found that the risk of complications such as respiratory distress, birth trauma and newborn hypoglycemia, or low blood sugar, was no different for the 363 women who received metformin and the 370 given conventional insulin shots.

After delivery, nearly 77 percent of the metformin recipients said they would want to stay with the pill if they developed diabetes during pregnancy again, even though 46 percent still needed supplemental insulin injections at some point. On the other hand, only 27 percent of those who got insulin shots felt the same way.

But doctors may still be cautious, the researchers said. “Clinicians may remain circumspect about using metformin until follow-up data for offspring are available,” they wrote. The children born during the study are being tested when they reach their second birthday.

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