Pharmaceutical Industry Faces Increased Pressure

The U.S. pharmaceutical industry faces intensifying political and scientific attacks that risk further undermining its credibility just as Washington is gearing up to renew challenges to the industry's business practices.

All the leading Democratic presidential candidates and, on the Republican side, Arizona Sen. John McCain, support importing less-expensive drugs from Canada. Democrats also back allow Medicare, the federal health care insurance program, to negotiate with the industry over pharmaceutical prices.

New York Sen. Hillary Clinton has supported new legislation that would allow the U.S. Food and Drug Administration to approve generic versions of biotech drugs — something the agency generally can't do now.

Over time, that could push down prices for often-costly biotech drugs.
While it isn't certain how much Congress will do in an election year, some lawmakers are gearing up investigations and hearings that could shed a harsh light on the industry.

Rep. Rosa DeLauro, the Connecticut Democrat who heads the House appropriations subcommittee that oversees FDA funding, compares the drug makers to the tobacco industry. “We have to have the same kind of scrutiny,” she says.

The prospect of a rough year on Capitol Hill could hardly come at a worse time for big pharmaceutical companies. As the drug makers struggle to refill weak new-product pipelines and prop up sagging stock values, they are increasingly relying on the government for revenue.

The implementation of the Medicare drug benefit, for example, increased the portion of retail prescription-drug purchases paid for by government sources to 34 percent last year, from 28 percent in 2005. That growing role could make the industry more vulnerable to shifting political winds.

Democrats' plans to expand health care to more Americans, though they could add customers to the drug companies' rolls, also risk granting Washington even more influence over the industry's revenue.

A recent volley attacks on drug companies' marketing, research and information-disclosure practices give the industry's political opponents more ammunition.

Billy Tauzin, chief executive of the Pharmaceutical Research and Manufacturers of America, says “we've got a thick skin,” and “we can handle” attacks. Tauzin says he wants to continue to foster a marketplace that rewards his member companies for their $60 billion in annual research spending. “We accept the notion that change is inevitable,” he says.

In just the past few weeks, pharmaceutical makers have been hit by a series of blows. Schering-Plough Corp. and Merck & Co. released the results of a study about Vytorin, part of a cholesterol-drug franchise that generates $5 billion a year, raising questions about whether the pill is better than a less-expensive generic.

A new analysis published in the New England Journal of Medicine found many antidepressant drugs aren't as effective as they have publicly appeared, because less-successful studies haven't always been published.

Finally, the FDA recommended against using certain over-the-counter cough and cold medicines to infants younger than 2 years old, the latest inflection point in a lingering controversy over widely marketed products that may not have helped young children.

On the campaign trail, Sen. Clinton told a crowd recently at the California State University Northridge campus that she wants to “give Medicare the opportunity to bargain to get cheaper drug prices.” The New York Democrat added, “We pay for clinical trials ... and then we end up paying the highest cost in the world because other countries drive a better bargain.”

Her rhetoric echoed similar attacks by her Democratic rivals, and even McCain, in a debate on Jan. 5, asked, “Why shouldn't we be able to reimport drugs from Canada?” answering himself, “It's because of the power of the pharmaceutical companies.

” When former Massachusetts Gov. Mitt Romney urged him not to cast the drug makers as the “big bad guys,” Sen. McCain countered, “Well, they are.”

Tauzin calls the recent confluence of bad news a “perfect storm.” His trade group has formed a task force to consider overhauls to industry-marketing practices. “We think some of the criticisms are valid and we ought to address them,” he says.

The industry will consider major changes, he says: “Nothing is a sacred cow.”

Indeed, drug makers have parried past criticism with voluntary initiatives, including a registry of clinical-trial results and submitting commercials to the FDA for review before they air. Under pressure from medical journals, they also are registering trials before they are performed. A new law will make such efforts mandatory.

Merck and Schering-Plough have defended their handling of the Vytorin study and said they are cooperating with the committee's investigation.

After scrutiny of the children's cold medicines mounted, a number of their makers voluntarily withdrew the products aimed at kids younger than age 2, though they have said there is evidence they work in older children.

The makers of the antidepressant drugs said they had made their study results, including negative ones, public in various ways, including databases.
The House Energy and Commerce Committee, led by Michigan Democrat John Dingell, is examining the marketing of drugs including Vytorin, Pfizer Inc.'s Lipitor, Johnson & Johnson's Procrit and Amgen Inc.'s Aranesp.

Democratic Rep. Henry Waxman of California, Senate Finance Committee Chairman Max Baucus of Montana and ranking Republican Charles Grassley of Iowa also are investigating the industry.
“We see puffing, advertising based on untrue facts or facts that can't be substantiated, medically, ethically or legally,” says Michigan Democratic Rep. Bart Stupak, chairman of the Energy and Commerce investigations subcommittee.

The efforts are fueled by a growing genre of investigative research by physicians focused on industry influence and the reliability of medical literature. Catherine DeAngelis, editor in chief of JAMA, the Journal of the American Medical Association, says she has more articles on the drug industry's role in research coming soon.

“I want to show how they manipulate the data and why we have to be so cynical about them,” she says.

In the case of the recent antidepressant analysis, the New England Journal said in a statement that “it is critically important that physicians have all the available data,” and patients who participated in unpublished studies “should not be left on the cutting room floor to make a drug look better than it really is.”

Source : www.theday.com

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