Sunday, April 19, 2009

Drugmakers Boost Lobbying to Police Drug Comparisons (Update1)

U.S. drugmakers are working to ensure that President Barack Obama’s move to encourage cheaper medical care doesn’t end up dictating treatments to doctors and insurers.

Already the biggest spender on influencing policy, the drug industry, including Merck & Co. and Eisai Co., is relying on well-known individuals, some with stories of personal battles against disease, to promote its views. They include Tony Coelho, a former U.S. House Democratic leader who has epilepsy; Andrea LaRue, counsel to Tom Daschle when he was Senate Democratic leader; and the firm of Democratic fundraiser Tony Podesta, brother of Obama adviser John Podesta.

Makers of drugs and other health-care products say they support side-by-side studies of medical products as a tool for doctors and patients, not as a way to stop medical professionals from prescribing a more expensive drug if they’re convinced it will work better. The industry has already recorded one victory, supporting the removal of language concerning costs from a $1.1 billion funding provision for such studies included in the Obama stimulus package passed in February.

“The companies fear that older generic drugs might very well turn out to be better than the newer advertised drugs, which bring in much more of a profit,” said Julian Zelizer, a history and public affairs professor at Princeton University in Princeton, New Jersey. “In difficult economic times, the drug companies don’t want to take any risks, so they are bringing out the biggest lobbyists in the business.”

Crucial Savings

Carving savings out of the health-care system is crucial to Obama’s goal of providing health insurance to more Americans. Senate lawmakers have pledged to have legislation ready by June to get all Americans affordable medical coverage.

More than half of medical care may be based on insufficient evidence of effectiveness, the Congressional Budget Office said in March. The Health and Human Services Department says all medical spending will probably rise this year to $2.5 trillion, or 18 percent of the economy.

Merck backs comparative effectiveness research to figure out what works best, said Jane Horvath, senior director for public policy at Merck, based in Whitehouse Station, New Jersey.

“We aren’t stepping up a fight with President Obama,” Horvath said in a telephone interview today. “Merck continues to encourage Congress to pass a more permanent comparative effectiveness research structure and process. Presenting valid research that people can trust can be a valuable tool for the health-care system.”

U.K. System

Opponents to the inclusion of cost as a factor in comparing the effectiveness of treatments cite the U.K.’s National Institute for Health and Clinical Excellence, or NICE, which looks at the cost and benefit of medical treatments in deciding what should be covered by national health insurance.

The U.K. agency said March 5 that Tykerb, sold by GlaxoSmithKline Plc of London, is too expensive for routine use in women with advanced breast cancer. Given with chemotherapy, Tykerb costs about $35,000 a year for each patient, the agency said.

Indianapolis-based WellPoint Inc., the second-largest health insurer by revenue, and Philadelphia-based Cigna Corp. are backing Obama with a lobbying push of their own through their Washington-based support organization, America’s Health Insurance Plans.

‘Need More Information’

“We need more information about which drugs, treatments and technology are more effective and we need to put that information in the hands of consumers and providers,” said Robert Zirkelbach, a spokesman for the trade group. “That will go a long way to improve the quality of care and bring down health-care costs across the board.”

Merck and Schering-Plough Corp.’s cholesterol pill Vytorin may face tougher competition from generic simvastatin if federally funded studies show it no more effective at unclogging arteries. Vytorin prescriptions dropped by a third last year after a study found the pill, a combination of simvastatin and Kenilworth, New Jersey-based Schering-Plough’s Zetia, worked no better than the generic pill alone. Vytorin costs about four times as much as simvastatin.

The president’s Federal Coordinating Council for Comparative Effectiveness Research, formed last month, includes Ezekiel Emanuel, brother of White House Chief of Staff Rahm Emanuel, to oversee the studies. The council’s first report to Obama and Congress, containing recommendations of what treatments should be studied, is due June 30.

Advancing Cost?

“We need to compare whether some of these new ideas are really advances or more costly alternatives to what we know will work,” said Henry Waxman, a California Democrat and chairman of the House Energy and Commerce Committee, in an interview.

Soon after Obama won November’s election, the Pharmaceutical Research and Manufacturers of America, the trade group known as Phrma, helped create the Partnership to Improve Patient Care, which last month hired Coelho, 66, who was chairman of Al Gore’s unsuccessful presidential bid and helped win passage of the 1990 Americans With Disabilities Act.

Coelho’s group also includes the American College of Cardiology, a Washington-based trade group for heart doctors, and Easter Seals, the 90-year-old advocacy group for disabled people. The organization, based in Chicago, claims a million members.

“I have no problem with research determining what is bad, what is good,” Coelho said. “But all of us have different bodies and all of us react differently to different types of medication. Don’t make it into a cookie-cutter process.”

Easter Seals

Easter Seals will use its newsletter, Web site and annual convention in October to mobilize supporters, said Katy Neas, a lobbyist for the organization.

“As the debate goes forward, and after this much- anticipated research, things are going to start heating up,” Neas said.

Another Coelho ally is Phrma President Billy Tauzin, 65, a former Republican chairman of the House Energy and Commerce Committee.

Tauzin had intestinal cancer. He and Coelho use personal stories to argue that Obama’s plan runs the risk of stopping government health plans and insurers from paying for lifesaving treatments deemed more expensive than alternatives that may not work as well for everyone.

Coelho said he’s worried that government studies will lead to restrictions on antiseizure drugs. He said he needed four drugs, though some plans would only pay for two. And substituting lower-cost generics can hurt patients, Coelho said.


“On a lot of us, if you do that switch, you can cause me to have seizures,” Coelho said. “It’s criticism from my point of view as a patient.”

Tauzin said he used an experimental drug to cure his cancer, a medicine he might not have gotten if insurers consider cost to determine coverage.

“They’ll show medicines work better for some people on average,” Tauzin said. “You may not be average. Suppose you’re the patient for whom Drug B doesn’t work.

“The irony is science is taking us in the direction of precision medicine, where we can figure out from your genetic code exactly what medicine works for you.”

Backers of comparative research say there’s no conflict.

Where It’s Working

“It’s not whether it works or not, but in whom it is working or not,” said Marcus Wilson, president of HealthCore, a WellPoint subsidiary that conducts comparisons and is seeking federal money for research, in an interview. “We look at it as helping us get much closer to personalized medicine than we are today.”

Individual drug companies, which have said they support comparative effectiveness as a concept, have been keeping watch in Washington. Tokyo-based Eisai, which developed the Alzheimer’s drug Aricept, hired the Podesta Group in January.

Comparative effectiveness “should not be used by the public or private payers as a reason to deny access to specific therapies to specific patients,” said Lynn Kenney, an Eisai spokeswoman.