Article: The Bush Administration's FDA

Since the Bush administration took control of the FDA, editorial pages in the major newspapers, along with respected medical journals, have broadcast outrage over the agency's failure to protect the public from an industry focused on profits only.

According to a May 2006, poll conducted by the Wall Street Journal and Harris Interactive, the majority of adults in the U.S. think the FDA's most important function is to ensure the safety and efficacy of new prescription drugs.

However, the poll found that the public has come to doubt the FDA's ability to do its job, with 7 out of 10 adults giving the agency a negative rating and a large majority saying the FDA's decisions are influenced more by politics than science.

Experts from all over the country have been openly expressing their concerns about the FDA and urging lawmakers to act. On October 9, 2006, Dr. Curt Furberg, of Wake Forest University Baptist Medical Center, was one of five current and former members of the FDA's Drug Safety and Risk Management Advisory Committee, who called on Congress to change how the FDA polices Big Pharma, in the Archives of Internal Medicine.

Because of the FDA's poor performance in regulating the industry, Dr. Furberg said, "new drugs are introduced on the market with inadequate safety documentation."

"Serious adverse drug reactions are later reported from the marketplace, and a large number of patients are unnecessarily injured before the drugs are withdrawn or better managed," he stated.

And a number of current and former FDA employees have come forward to say that the politically appointed officials at the top of the agency have sold out to the very industry that it is supposed to regulate.

One does not have look far back in history to substantiate that allegation. Two months after the last FDA commissioner, Lester Crawford, was confirmed, MSNBC ran the headline, "Embattled Food and Drug Administration Commissioner Lester Crawford abruptly resigned Friday, telling his staff that at age 67 it was time to step aside."

"As late as 2004, former Food and Drug Administration head Lester Crawford or his wife owned stock in companies that make or distribute products regulated by the agency," the Wall Street Journal reported on October 26, 2005.

Six months later, on April 29, 2006, the New York Times announced that Mr. Crawford was under investigation by a federal grand jury over allegations of financial improprieties and making false statements to Congress, quoting his lawyer Barbara Van Gelder.

On October 16, 2006, the Associated Press reported that Mr. Crawford had agreed to plead guilty to charges of failing to disclose a financial interest in firms regulated by the FDA and that the Justice Department accused him in court papers, "of falsely reporting that he had sold stock in companies when he continued holding shares in the firms governed by FDA rules."

Representative, Maurice Hinchey (D-NY), led the call last year for an investigation into Mr. Crawford's sudden resignation with a focus on potential financial conflicts of interest. On October 16, 2006, he released a statement saying, "Senior officials at the FDA have led the agency down a dark road into a state of crisis."

"By blatantly ignoring the law on financial holdings and conflicts of interest," Rep. Hinchey stated, "Lester Crawford used his position as the head of the FDA to send all the wrong signals to other FDA employees and the American public."

"It is not possible for the FDA to fairly and impartially regulate the food and drug industries," he said, "when the commissioner of the agency has a vested financial interest in the results."

"The days of letting the FDA treat the pharmaceutical industry as a client rather than a regulated entity," Rep. Hinchey stated, "must come to an end."

After leaving the FDA, Mr. Crawford went directly to a new job with a firm called Policy Directions. On its Web site, the firm states, "PDI has longstanding relationships with key personal and committee staffs in Congress, as well as with critical players at important agencies within the Administration."

Looking back with hindsight, that statement certainly appears to be truthful.

A few of the firm's listed accomplishments for clients are: (1) achieved FDA advisory committee support for a product originally voted down; (2) Interceded when FDA failed to provide final approval for client's product and product was approved; (3) created a coalition of six biotechnology firms to promote legislation advantageous to client and meet with agency officials to prevent onerous rulemaking; (4) wrote industry-coalition draft of legislative authority for a regulatory agency included in final bill; (5) led coalition of universities, research institutions, pharmaceutical and biotechnology companies to lobby Congress to stop a federal agency from costly and ineffective rulemaking; and (6) led coalition that stopped negative amendments to agriculture/FDA appropriations bills.

Under the circumstances, the firm should now inform potential clients that with Mr. Crawford on board, it now has the unprecedented benefit of inside information about every drug, device, and company regulated by the FDA.

The other reasons for the overall decline in trust for the FDA are many. The agency's attempts to protect drug company profits by suppressing scientific dissent and muzzling its own scientists have gained wide publicity over the past few years. For instance, in February 2004, the FDA held an advisory committee meeting to discuss whether there was a link between SSRI antidepressants, and suicidality in children and Dr. Andrew Mosholder, the FDA's expert on the issue, conducted a study and reported that there was.

However, it has since been learned that his superiors suppressed his findings, canceled his presentation to the advisory committee, and gave Dr. Moshlder a script to read if he were asked why he was no longer making a presentation before the committee.

Similarly, in February 2005, FDA scientist, Dr. David Graham, conducted a study on patients taking COX-2 inhibitors that resulted in negative findings on Vioxx and he was also told that he could not present his study at an upcoming advisory committee meeting.

And this was not the first attempt to muzzle Dr. Graham. Several months before the committee meeting, he went public about the FDA's mishandling of the Vioxx disaster and his superiors tried to prevent the publication of his paper in the Lancet medical journal.

According to Dr. Graham, senior FDA officials also attempted to intimidate him so that he would not testify before the Senate Finance Committee in November 2004, about the adverse effects of Vioxx but he refused to be intimidated.

FDA employees brave enough to speak out about wrongdoing have formed a strong alliance with Senator Chuck Grassley (R-Iowa), the outgoing chairman of the Finance Committee, who has been one of the FDA's most out-spoken critics since the Vioxx and SSRI debacles, and has called for a "major overhaul and a culture change at the highest levels" of the FDA.

In July 2006, the Senator even wrote a letter to Daniel Levinson, the Inspector General at HHS, asking for an investigation into whether Dr. Brian Harvey of the FDA, conspired against Dr. Graham by providing Merck with the details about his Vioxx presentation before the hearing in November 2004, to help Merck refute Dr. Graham's testimony.

"It is no secret that Dr. Graham was and is a critic of the FDA," Senator Grassley wrote. "However, that does not mean the FDA should scheme with drug sponsors to discredit its own employees," he said.

Houston attorney, Robert Kwok, also condemns these types of attempted cover-ups. "I saw this kind of thing in a multi-million dollar case I won against a railroad," he says.

"Companies and governments try to go back and change or cover up the facts," he explains, "but juries are smart and can sniff out this kind of behavior."

"That's why I believe a few high-profile cases could expose and sink what the FDA is trying to do," he says.

In another example of top officials catering to the industry, in July 2005, the FDA approved the Vagus Nerve Stimulation (VNS) Therapy System, a device designed to treat depression, even though FDA scientists could not determine whether the device worked.

But instead allowing the scientific process to proceed, a senior FDA official overruled more than 20 scientists, medical officers, and management staff who recommended against approval of the VNS, based on their evaluation of the device maker's application.

The approval of the antibiotic, Ketek (telithromycin), is another example where the FDA accommodated a drug company, and in this case, despite the fact that the company submitted fraudulent studies to support Ketek's application for approval and repeatedly provided incomplete safety information on the drug.

Internal FDA emails that came to light during Congressional investigations reveal that the FDA was fully aware of the serious problems caused by liver failure associated with Ketek before it was approved, and that at least four safety officials, Dr. David Graham, Dr. David Ross, Dr. Charles Cooper, and Dr. Rosemary Johann-Liang had expressed serious concerns about the safety of the drug.

"It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned," Dr. Graham wrote in a later email calling for the "immediate withdrawal," of Ketek.

Former FDA employees have told Senator Grassley, that while he was acting FDA commissioner, Dr Andrew von Eschenbach used sports metaphors during a meeting to hint that FDA employees would be retaliated against or kicked off the team if they discussed their complaints about Ketek outside the agency.

Top FDA officials have not only disregarded warnings from the agency's own scientists, they have also pressured scientists to change their findings regarding the safety and efficacy of pharmaceutical products. Most notably, Dr. Mosholder and Dr. Graham, were pressured to alter their findings regarding SSRIs and Vioxx, but the practice appears to be more wide-spread than previously thought.

A July 20, 2006, report by the Union of Concerned Scientists (UCS) and the Public Employees for Environmental Responsibility (PEER), said that approximately one-fifth of the nearly 1,000 FDA scientists who responded to a survey stated that they had been asked, for nonscientific reasons, to alter or exclude technical information or conclusions.

And, one-fifth said that they have been asked explicitly by FDA decision-makers to provide incomplete, inaccurate or misleading information to the public, industry, the media and government officials.

The UCS also cited an earlier survey by the HHS Office of Inspector General in which nearly one in five scientists said they had been pressured to approve or recommend approval of a new drug despite concerns about its safety, effectiveness, or quality.

Although the FDA claims that there are procedures in place to resolve disagreements, employees continue to say that they experience intimidation and reassignments when they raise issues about the integrity of the FDA's work. In fact, the UCS survey found that over one-third of the scientists said they could not openly express any concerns about public health within the FDA without fear of retaliation.

Congressman Hinchey released a statement on June 24, 2006, in response to the report, which he said, "shed light on the serious and widespread problems at the FDA."

"One of the more disturbing findings of the study," he said, "is that more than half of the scientists at the FDA said their job satisfaction has decreased over the past few years during President Bush's time in office."

"Under this president," he noted, "the FDA has decided to let politics overrule science."

We saw it with the way in which Vioxx, Bextra, and other drugs were mismanaged, Rep. Hinchey stated, and "in the agency's repeated efforts to preempt state law in order to minimize drug company accountability under former Counsel Daniel Troy."

"We must end the financial link and inappropriately close relationship between the drug industry and the FDA, eliminate conflicts of interest on FDA advisory committees, and vastly improve the agency's post-market drug safety operations," he advised.

"We must return the FDA to a time," he said, "when science was the only consideration for approving a drug, not politics."

FDA employees have also complained that they are under constant pressure to approve drugs within deadlines set by the Prescription Drug User Fee Act, and that as a result, patient safety takes a back seat to the fast approval process of products.

In fact, during a Senate Finance Committee investigation into the delay in labeling changes regarding the risk of blindness associated with Viagra, a safety evaluator told committee staff that the Office of New Drugs is under such pressure to quickly approve drugs that safety concerns were often "fit in" wherever they could be.

Families seeking legal advice for infants born with birth defects to mothers who were prescribed Celexa during pregnancy can contact Robert Kwok & Associates, LLP at (713) 773-3380; http://www.kwoklaw.com/about.php

Evelyn Pringle
evelyn-pringle@sbcglobal.net

(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)

(This article is written as part of a series on pharmaceutical litigation and is sponsored by Robert Kwok & Associated, LLP)