Bitter Pills for Big Pharma to Swallow

His telephone comments to NJBIZ came in the wake of probes of incidents ranging from celebrity endorsements of Pfizer’s cholesterol drug Lipitor to the delayed release of data about Merck and Schering-Plough’s Vytorin cholesterol treatment.

“If we are not careful, there are going to be less and less [new] products,” says Tauzin, a former Louisiana congressman who chaired the House committee that oversees the drug industry before retiring from politics in 2004. “Many patient groups are impatiently waiting” for treatments, he says. “There are 2,000 drugs in the pipeline, and the rate of [regulatory] approval is dropping.

“This is an election year,” adds Tauzin, “and in election years Congress generally does more investigative work than legislating.” Moreover, he says, while people may assume that federally approved drugs “are perfectly safe, the truth is every drug has certain side effects and certain concerns.”

Hollie Gilroy, spokewoman for the HealthCare Institute of New Jersey, a Bridgewater-based lobby group that represents about two dozen pharmaceutical and medical technology companies, attributes the stepped-up scrutiny to factors that include tightened federal regulations and recent scandals involving counterfeit drugs from China.

“Safety is always paramount when you have an influx of new drugs coming on to the market,” says Gilroy. “If we made greeting cards, I don’t think anyone would care,” she says, “but scrutiny—fair or unfair—goes with the territory of what we do.”

Much in the pharmaceutical industry needs fixing, says Rep. Bart Stupak, a Michigan Democrat who has been pursuing Big Pharma. “Whether we’re talking about deceptive advertising with [Pfizer’s] Lipitor, questionable clinical trials with [Merck’s and Schering-Plough’s] Vytorin, or fraudulent data with [Sanofi-Aventis’s antibiotic] Ketek , we’re currently looking at a number of examples where pharmaceutical companies have put the interest of investors before the well-being of their customers.”

Stupak says drugmakers have a “moral, ethical and legal obligation to the American public,” since “doctors and patients often have to rely” on the companies’ products.

Last month, Stupak colleague John Dingell, who chairs the House Committee on Energy and Commerce that Tauzin once ran, sent letters questioning Merck Chairman Richard Clark and Schering-Plough Chairman Fred Hassan about Vytorin.

At issue were statements from the American Heart Association (AHA) and the American College of Cardiology (ACC) in support of Vytorin. The medical groups spoke up the day after a study showed that Vytorin had failed to reduce plaque formation more effectively than a generic cholesterol treatment. “We are curious as to whether Merck and/or Schering-Plough may have had direct input into the AHA and ACC statements,” wrote Dingell.

Stupak says the overburdened Food and Drug Administration regulates “more than $1 trillion in consumer products or close to 25 cents of every U.S. consumer dollar spent.” Yet the agency “lacks the resources to properly protect the American people from unsafe food and drugs,” he says, which is a problem that calls for increased funding.

Meanwhile, Congress has been pressing drugmakers about their direct-to-consumer advertising. Last month, Dingell’s committee sent a letter to Pfizer CEO Jeffrey Kindler about the company’s commercials for the cholesterol drug Lipitor featuring Dr. Robert Jarvik, inventor of the the Jarvik-7 artificial heart.

Among the details the letter sought were “all financial records relating to Dr. Jarvik’s association with Pfizer, including how much money he or any member of his family or any business entity associated with him or any member of his family has ever received from Pfizer, its subsidiaries, contractors or subcontractors.”

In a related statement, Stupak said, “Americans with heart diseases should make medical decisions based on consultations with their doctors, not on paid advertisements during a commercial break,” and added Jarvik isn’t licensed to practice medicine in the United States.

E-mail to shankar_p@njbiz.com