"Just Say No" to bad drugs

A Pfizer study released today suggested an increased cardiovascular risk for Celebrex, a drug in the same "cox-2 inhibitor" group as Vioxx, a drug that was withdrawn by Merck in September over similar concerns. The Pfizer statement:

As reported to Pfizer by the Data Safety and Monitoring Board, one of the studies (the APC cancer trial) demonstrated an increased cardiovascular risk over placebo, while the other trial (the PreSAP cancer trial) revealed no greater cardiovascular risk than placebo,” the statement said.

“These clinical trial results are new. The cardiovascular findings in one of the studies (APC) are unexpected and not consistent with the reported findings in the second study (PreSAP). Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world,” said Hank McKinnell, Pfizer chairman and chief executive officer.

At the same time, reports are also coming to light that almost 20% of FDA scientists surveyed in 2002 feel that they

"were pressured to approve or recommend approval of a medicine despite their reservations about the drug's risks or effectiveness, according to documents made public on Thursday."

The article goes on to decry this apparent problem of oversight:

"Also, two-thirds of the scientists questioned by the Department of Health and Human Services' inspector general said they lacked full confidence in the FDA's ability to monitor side effects of prescription drugs after they hit the market.

The survey shows at least some government scientists backed accusations last month by FDA safety officer Dr. David Graham, who told a Senate hearing he had felt pressured to water down safety concerns about Merck & Co. Inc.'s painkiller Vioxx. The drug was pulled from the market Sept. 30 over links to heart attacks and strokes."

Although the FDA agreed with Mr. Graham, he went on to point out:

"...the survey "confirms that the FDA is more interested in taking care of business clients than it is in taking care of the American people." Safety "is not given the priority it deserves" while the agency focuses on approving drug company applications to market new medicines, he said."

This report did not come from some "liberal" think-tank; it was released by the Department of Health and Human Services Inspector General.

During the second Bush-Kerry debate, President Bush emphasized what he called his priority for safe drugs. Discussing reimportation of drugs from Canada, he stated:

"I just want to make sure they're safe. When a drug comes in from Canada, I want to make sure it cures you and doesn't kill you. And that's why the FDA and that's why the surgeon general are looking very carefully to make sure it can be done in a safe way. I've got an obligation to make sure our government does everything we can to protect you."

Clearly, protecting the consumer is not the highest priority for this Administration.

The Cato Institute, a well-known conservative think-tank, has expressed the philosophy about FDA regulation in a recent article where it was written:

"The next greatest regulatory cost, according to Conover, is imposed by the Food and Drug Administration, which regulates medicines and medical devices. The FDA has long been criticized for delays in approving new medicines and for preventing patients from trying new therapies. Conover estimates those delays impose a net annual cost of $41.8 billion.

A sensible way to cut down on unnecessary delays would be to let independent private agencies certify the effectiveness of new medicines, just as they now certify effectiveness for new uses of existing medicines. Yet neither Bush nor Kerry has issued a proposal that would reduce the lives lost to the FDA's delays or reduce the costs the FDA builds into the prices of prescription drugs."

Clearly, the "neocons" would like to see less regulation, less oversight, and quicker approval of medications for the market-place.

Beyond this, a major failing of this Administration has been to appoint lobbyists for those industries to regulatory positions regulating those very same industries. Nothing could be closer to the foxes guarding the hen-house with this President. As reported by the Denver Post, more than 100 industry lobbyists are filling regulatory positions in this Administration. As they reported:

"Daniel E. Troy, lead counsel for the U.S. Food and Drug Administration, extended the government's help in torpedoing certain lawsuits. Among Troy's targets: claims that medications caused devastating and unexpected side effects.

Pitch us lawsuits that we might get involved in, Troy told several hundred pharmaceutical attorneys, some of them old friends and acquaintances from his previous role representing major U.S. pharmaceutical firms.

The offer by the FDA's top attorney, made Dec. 15 at the Plaza Hotel, took the agency responsible for food and drug safety into new territory."

The article goes on to report:

"The FDA is now in the business of helping lawsuit defendants, specifically the pharmaceutical companies," said James O'Reilly, University of Cincinnati law professor and author of a book on the history of the FDA. "It's a dramatic change in what the FDA has done in the past."

Troy's switch from industry advocate to industry regulator overseeing his former clients is a hallmark of President Bush's administration."

An absolute disgrace.

As the article points out regarding Mr. Troy:

"As a lawyer in private practice, Troy repeatedly sued the FDA, arguing that it had only limited ability to regulate drug companies. He filed those suits through the Washington Legal Foundation, a group funded by businesses, including drug companies. Donors include charitable foundations run by Pfizer Inc., Procter & Gamble Co. and Eli Lilly & Co.

Troy also represented Pfizer through his firm, Wiley, Rein & Fielding. Troy said in an e-mail to a reporter that his Pfizer work was mainly communications and insurance law, and averaged only 80 hours a year.

At the FDA, Troy still is fighting for causes that benefit drug companies."

And what about John Kerry? What his position on all of this?
In an article (re-reported in the Milwaukee Journal Sentinal) from Nature magazine, Kerry stated:

"As president, I will ensure that the FDA has the resources it needs to approve drugs in a safe and timely manner. In the U.S. Senate, I sponsored and supported legislation that requires drug manufacturers to pay fees to the FDA and allows the agency to hire more reviewers and significantly accelerate drug reviews and approvals.

Under the Prescription Drug User Fee Act, new drugs are being approved rapidly by the FDA - and I believe that more should be done to assure the safety of those drugs once they are marketed.

The biggest threat to our success in expanding patient access to medical breakthroughs is the Bush administration's ideological approach to scientific decision-making. When it comes to the safety of our medicines and food supply, the public health is taking second place to special interests and ideological agendas.

John Edwards and I support a return to sound science at the FDA and throughout the federal government."

A return to sound science. That doesn't sound liberal or Democratic to me. That just sounds like honesty and common-sense.

America and the World needed John Kerry in 2004. But we shall have to wait for 2008.

Bob