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Monday, May 22, 2006

BUSH USES FDA TO SHIELD BIG PHARMA FROM LAWSUITS---PART III................


This is Part III and the conclusion to this OpEd article.


....To put the number of injuries into perspective, Dr. Graham told members of the committee that instead of side-effects from a drug, to think of it as if they were talking about jetliners.

"If there were an average of 150 to 200 people on an aircraft," he said, "this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky."

"This translates to 2-4 aircraft every week," he advised, "week in and week out, for the past five years."

"If you were confronted by this situation," Dr. Graham asked the panel, "what would be your reaction, what would you want to know and what would you do about it?"He noted the problems with the FDA's reliance on a 95% paradigm. In other words, he said, a drug is considered safe "until you can show with 95% or greater certainty that it is not safe."

The scientist condemned the FDA's failure to acknowledge the Vioxx risks sooner. "I strongly believe that this should have been, and largely could have been, avoided," Dr. Graham told the committee.

Ms. Menziess often cites his testimony to demonstrate that the FDA's position on preemption is wrong and states: "Dr. Graham's testimony illustrates why FDA approval and subsequent post-marketing acquiescence should have no preemptive effect."

The Vioxx matter caught the attention of the Senate Finance Committee basically because of the drug's cost to government programs like Medicaid and Medicare. The committe is responsible for oversight of the two programs.

At the November 18, 2004 hearing, Senator Max Baucus discussed the high-costs related to the drug: "In the 5 years that Vioxx was on the market, Medicaid spent more than $1B on the drug," he said.

In addition to the prescription costs, government programs are now paying for the damage caused by Vioxx. "Medicaid bears the cost of an additional medical care necessary when drugs cause injury," Senator Baucus pointed out.

By far, the Vioxx debacle is the most serious public health failre to occur since the FDA took on the authority for safe oversight of medical products in 1938.

On September 3, 2005, Shane Ellison, a former pharmaceutical chemist turned whistleblower and author of the book, "Health Myths Exposed," gave an interview to Crusador Magazine and discussed Vioxx and the problems within the FDA.

According to Mr. Ellison, the FDA and Merck knew about the dangers of Vioxx for at least 4 years before it was pulled off the market. "Instead of removing the drug immediately," he said, "they kept it on the drug market for matters of wealth not health."

Mr. Ellison says compliant politicians have "democratized" the industry. "This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary," he reports. "Science and choice no longer prevail at the FDA or at pharmaceutical companies," he added.

"To go against the 51% means losing your career," Mr. Ellsion explains. "Therefore, the majority of scientists choose to please drug companies, not the general public."

To substantiate this allegation, Dr. Ellsion points to Dr. Curt Furberg, a member of the FDA's drug safety advisory committee. Dr. Furberg went public with findings that Bextra also caused heart attacks and strokes and said studies "showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information," in the British National Journal.

"Immediately thereafter," Mr. Ellison said, "Dr. Furberg was barred from serving on the panel that was responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."

"The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes---not science," he told Crusador.

Another relevant, but little-mentioned fact, is that many FDA officials end up working for Big Pharma. "The old joke is that the FDA is sort of like a showcase for a future job in the drug industry," Robert Whitaker, author of Mad In America, said in an August 2005 interview with Street Spirit.

"You go there, you work awhile, then you go off into the drug industry," he said, "the progression that people make, in essence they're making good old boy network connections, so they're not going to be harsh on the drug companies."

In addition, when leaving office many federal employees and members of Congress go to work for Big Pharma in one area or another. For instance, of the 1,274 people registered to lobby in Washington for drug companies in 2003, according to an April 2005 report by the Center for Public Integrity, 476 are former federal officials, including 40 members of Congress.

Critics say the Prescription Drug User Fee Act, is in large part to blame, for the current problems with the FDA. The Act allows the agency to collect a fee from a drug company seeking approval for a new drug. In return, the FDA is expected to complete the review process within 12 months.

User fees now account for about 40% of the approval process, which means the FDA is dependent on drug companies for nearly half of its funding. This situation creates a major conflict of interest according to Dr. Graham: "This culture views the pharmaceutical industry it is supposed to regulate as it s client. It overvalues the benefits of the drugs it approves, and seriously undervalues, disregards and disrespects drug safety," he told members of Congress.

Another problem he said is that even when the FDA does try to take measures to limit harm, the agency lacks the authority to force drug companies to comply. For example with Vioxx, he said, it took more than 2 years to get Merck to add the increased risk of heart attacks and stroke on the label.

Then there is the matter of the conflicts of interests involving the FDA panels that advise the agency on which drugs should be approved, what their warning labels should say, and how studies should be conducted.

The approximately 300 experts on the 18 committees make decisions that affect billions of dollars in sales and with very few exceptions the FDA follows their advice.

Members of the panels are supposed to be free of conflicts of interest relating to products they consider but they rarely are. For example, in February 2005, when the hearings were held to determine whether the COX-2 inhibitors should be allowed to remain on the market, a panel mired with conflicts was exposed. Out of the 32 voting members, ten had served as consultants to Merck and Pfizer in recent years.

This revelation prompted Senator Mike Enzi (R-WY), the chairman of the Health, Education, Labor and Pensions Committee, along with Senators Edward Kennedy (D-MA) and Richard Durbin (D-IL), to ask the General Accounting Office to look into the FDA's practice of letting scientists serve on panels when they have conflicts of interest.

"We are concerned about the process that supports FDA's decisions to waive conflicts of interest rules for scientisits with financial ties to the manufacturers of the products under consideration, or their competitors," said their letter to the GAO in September 2005.

"These practices appear to have undermined the public's faith in the objectivity and fairness of FDA's advisory committees," they wrote. The Senators specifically referred to the conflicts among the panels that studied the Cox-2 inhibitors like Vioxx.

According to Ms. Menzeiss, "The FDA's preemption argument, if successful, would take away the sole means by which American consumers may obtain compensation for drug-induced injuries caused by a drug company's failure to warn."

"Civil lawsuits uncover internal company documents to which not even the FDA has access," she explains.

"The tort system provides an important check on the regulatory process and on drug companies' compliance with law."

"Preemption," Ms. Menzeiss warns, "would close off one of the few avenues by which we learn of safety and efficacy information that pharmaceutical companies do not publish or hide from FDA."


Source: OpEd News
Story By: Evelyn Pringle
May 13, 2006

*Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

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