PHARMACY

Actor testifies to Congress on pre-emption debate

BY Drew Buono

WASHINGTON In front of Congress yesterday, actor Dennis Quaid asked the legislative branch to preserve patients’ rights to sue drugmakers for injuries, recounting how his newborn twins nearly died from an accidental drug overdose, according to Reuters.

At a the hearing, the actor said victims of harm from medicines should be able to seek damages from manufacturers in state court. Drug and medical-device makers argue that the Food and Drug Administration approval should preempt state liability suits in many instances, and the Supreme Court backed that view in a recent device case.

“I believe if preemption of lawsuits is allowed to prevail, it will basically make all of us, the public, uninformed and uncompensated lab rats,” Quaid said at a House of Representatives committee hearing. He urged Congress to pass legislation to protect patients’ ability to sue drugmakers if the Supreme Court further restricts the suits.

“FDA believes that the important decisions it makes about the safety, efficacy and labeling of medical products should not be second-guessed by state courts,” said FDA Deputy Commissioner Randall Lutter. Patients still could sue if companies sold devices that failed to meet FDA conditions of approval, Lutter said.

But Rep. Henry Waxman, D-Calif., called the FDA’s current view a “radical legal doctrine” that departed from the agency’s previous stances and would be harmful if allowed to stand. Waxman has said he will back legislation to reverse the Supreme Court’s ruling.

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Study finds more than half of Americans regularly take prescription meds

BY Alaric DeArment

FRANKLIN LAKES, N.J. For the first time, a majority of Americans with health insurance have some kind of chronic health condition, and young people have experienced the largest increases.

According to research released Wednesday by Medco Health Solutions that examined the prescription claims of around 2.5 million Americans, 51 percent of insured Americans took prescription drugs to treat chronic health problems in 2007. While the elderly still constitute the largest demographic such medications, nearly half of women aged 22 to 44 and a third of men in the same age bracket were also using them. Men and women in that age group experienced a 20 percent increase in use of drugs to treat chronic conditions between 2001 and 2007.

Among men in the 20 to 44 age bracket, drugs to treat hypertension and cholesterol were among the top four, showing an increase in heart disease in this group. Nearly 30 percent of children aged 19 and younger also took chronic medications, mostly to treat asthma, allergies, depression and attention deficit/hyperactivity disorder.

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Avastin/Lucentis study may reverberate through industry

BY Drew Buono

NORWALK, Conn. According to IMS Health, a new clinical trial that began this year by a research institute may change the relationship between payers and the pharmaceutical industry, the Financial Times reported.

The National Eye Institute has sponsored a $16 million head-to-head trial of Genentech’s drugs Avastin and Lucentis. Lucentis is approved to treat age-related macular degeneration and Avastin is used to treat cancer but, both drugs are very similar and physicians have been using Avastin off-label for AMD.

The problem with the off-label use is the cost, as a single dose of Lucentis costs $2,000 while a bottle of Avastin can be split up to cost only $40-$75 per injection.

IMS argues that if CATT, the Institute’s study, shows Avastin to be as safe and effective for AMD as Lucentis, it may pave the way for an increasing number of payers to take comparative drug studies out of the hands of the pharmaceutical companies, especially as databases of patients make it much easier to conduct such tests.

But it warns that the move may create a disincentive for companies to study such areas, and creates untested areas of who would approve Avastin for AMD following a late-stage Phase 3 clinical trial which was conducted without any of the usual early-stage testing regulators usually require.

The study is expected to conclude in 2010 and has no involvement with Genentech.

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