Drug Industry Pledges New Openness

The powerful new head of the pharmaceutical industry's biggest lobbying group is calling for changes, but critics remain skeptical.

Billy Tauzin, the new CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), says drug companies have lost Americans' confidence and that the industry would begin working to "regain the nations' trust."

Meeting formally with reporters for the first time, Tauzin unveiled a series of steps intended to foster openness from an industry known up to now for secrecy about how it tests and prices drugs used by millions of Americans.

But consumer advocates, many of them longtime drug industry critics, still express disappointment that the plans don't address prescription drug costs that have priced medications out of the reach of millions of Americans. They also raised ethical questions about Tauzin, a former congressman for Louisiana who until a year ago led a powerful committee that was heavily lobbied by the group he now represents.

"The industry has found, I think correctly so, that the country has come to resent our industry," Tauzin says. "We've got a problem and we need to cure it."

Tauzin says PhRMA would expand the amount of clinical trial information in its online database, a move designed to give the public more access to the results of drug testing. Companies have in the past suffered criticism for disclosing results that cast their products in a favorable light while sometimes guarding findings that suggest a lack of safety or effectiveness.

Companies will also be encouraged to quickly alert the public when they detect safety problems in drugs already on the U.S. market, he says. Such "post-market" safety monitoring is now under scrutiny in the wake of the recall of the popular painkillers Vioxx and Bextra that were pulled from pharmacy shelves after being linked to heart attacks and strokes.

"If there are indications of that, these indications ought to be known early, and that ought to be communicated," he says.

'It's About Doing the Right Thing'

Tauzin says his group's members, some of the world's largest drug manufacturers, are also close to finalizing new, voluntary ethical standards on direct-to-consumer drug advertisements that many blame for possible overuse of medications, including Vioxx. He says the guidelines, whose details he would not disclose, would call for ads to be "serious and educational."

The group also plans to promote insurance access for Americans who now lack it as well as step up long-standing programs delivering discounted or free drugs to low-income persons.

"It's not about P.R.; it's about doing the right thing. It's not about buying respect, it's about earning it," Tauzin says.

Public relations is by no means left out of PhRMA's strategy, however. Tauzin last week appeared on the daytime Montel Williams talk show to discuss, in part, how pharmaceuticals helped drive his recent bout of small intestine cancer into remission.

In addition to improving companies' public image, the moves are also designed to satisfy lawmakers eager to enact new safety regulations because of problems with Vioxx and other drugs. Tauzin says improved clinical trial disclosures should prove to Congress that tighter regulation by the FDA is unneeded.

Critics Skeptical

Consumer groups remain largely skeptical of PhRMA's plans, noting that they do little to address rising U.S. drug prices, already the highest in the world.

"I think there is a tremendous amount of anger on the part of average Americans for the manipulation people have experienced and for the high prices they've been charged," says Gail Sharer, senior health policy analyst at Consumer's Union.

"If PhRMA led the way to fairly priced pharmaceuticals, that would buy them a lot of good graces. You can talk a good game, but if you can't deliver with fair prices, I think Americans are going to remain skeptical," she tells WebMD.

Shearer says that PhRMA has "an obligation" to consider lowering drug prices by directly negotiating with Medicare when the program starts paying part of seniors' drug costs in January 2006. The Medicare Modernization Act of 2003, which Tauzin helped author as the Republican chairman of the House Energy and Commerce Committee, specifically forbids the government from negotiating lower drug costs with manufacturers.

The Battle Over Drug Costs

Drugmakers have long argued that the high cost of bringing new drugs to market is what drives inflated U.S. prices. Tauzin says a disproportionate share of drug costs "is being borne by Americans." Still, he vowed to remain steadfast against Medicare negotiations that drugmakers say would amount to price controls capable of hobbling their industry.

Instead, PhRMA would work to prevent patent abuses in Europe, where drug prices are on average significantly lower than in the U.S., Tauzin says.

Members of Congress who become lobbyists are barred by ethical rules from discussing policy issues with lawmakers for one year after taking their new jobs. Tauzin said he has not discussed Medicare prices or other issues affecting drug makers with any lawmakers since taking over PhRMA four months ago.

Ron Pollack, head of the consumer health group Families USA, still attacked Tauzin for lobbying on behalf of an industry that stands to make tens of billions of dollars from the Medicare bill he helped write and shepherd through Congress.

"It has a horrendous appearance. Irrespective of whether it violated any law or existing ethical standards, it has an odor to it," he says.

Tauzin maintains that his ongoing experience as a cancer patient is a stronger influence on his leadership of one of the Washington's most powerful lobbying groups than his 25 years as a member of Congress.

"I welcome that scrutiny, any scrutiny anyone wants to give me," he says.

By Todd Zwillich, reviewed by Michael W. Smith, MD

SOURCES: Billy Tauzin, president and CEO, Pharmaceutical Research and Manufacturers of America. Gail Shearer, senior health policy analyst, Consumers Union. Ron Pollack, director, Families USA.