Grassley Pushes FDA: Transparency, Accountability & Independence / Whistleblowers are essential Witnesses

Wed, 8 Jun 2005

The FDA has once again demonstrated bad faith when it appointed an industry biased panel to monitor drug safety. The Washington Post reports that FDA safety officer Dr. David Graham, who blew the whistle on FDA’s failure to protect the public from lethal drugs such as Vioxx, reviewed the makeup and structure of the new FDA Drug Safety Oversight Board, and concluded that the panel is “severely biased in favor of industry” and that “the FDA cannot be trusted to protect the public or reform itself.”

Senator Charles Grassley wrote a critical letter to FDA commissioner, Lester Crawford, pushing for the establishment of an independent drug safety board. Grassley notes that 11 of the 15 drug panelists convened by the FDA are from the Center for Drug Evaluation and Research (CDER), the division that approved the drugs whose safety the board is supposed to monitor. That presents a conflict of interest.

Merrill Goozner makes a distinction between whistle blowing and leaking. However, not everyone has the stamina to be a heroic whistleblower or an outspoken critic of his / her professional colleagues. Some, whom Goozner calls leakers, provide information behind the scenes. But their contribution and the risks they take also deserve recognition. Without people of conscience who provide information about wrongdoing, our society would be even in worse shape.

Contact: Vera Hassner Sharav
212-595-8974

For Immediate Release
June 8th, 2005
GRASSLEY CONTINUES PUSH FOR TRANSPARENCY, ACCOUNTABILITY AND INDEPENDENCE AT FDA

WASHINGTON – Sen. Chuck Grassley is questioning the make-up of the new drug and safety board set up by the Food and Drug Administration to provide independent review of FDA-approved medicines.

In a letter sent to the acting commissioner of the nation’s drug safety agency, Grassley asked for assurances that the board could act in an unbiased way given its composition and said the deliberations of the panel should be more transparent in order to improve accountability at the Food and Drug Administration.

Grassley has conducted oversight of the Food and Drug Administration since early last year based on concerns about how the agency resisted making public information about suicide risks for teenagers using antidepressants and cardiovascular risks associated with the painkiller Vioxx. Grassley is chairman of the Senate Committee on Finance, which is oversees the Medicare and Medicaid programs. Medicaid has spent more than $1 billion on Vioxx. Medicare will offer a new prescription drug benefit beginning in January. Grassley has advocated administrative and legislative reforms to make the Food and Drug Administration’s work more transparent.

In April, Grassley and Sen. Christopher Dodd introduce a bill (S.930) to set up an new, independent Center inside the Food and Drug Administration to review drugs and biological products once they are on the market. In February, Dodd and Dodd and Grassley introduced a separate bill (S.470) to make clinical trial results publicly available to researchers, doctors and consumers. Both pieces of legislation have been endorsed by consumer and health groups including the Center for Medical Consumers, the Consumer Federation of America, Consumers Union, the National Women’s Health Network, Public Citizen, and the U.S. Public Interest Research Group.

The text of Grassley’s letter regarding the FDA’s new Drug Safety Oversight Board follows here.

June 6, 2005

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Crawford:

On May 18, 2005, the Food and Drug Administration (FDA) announced the members of its new Drug Safety Oversight Board (DSB). According to the FDA’s policies and procedures manual for the DSB, one of the purposes of this board is to provide independent oversight and advice to the director of the Center for Drug Evaluation and Research (CDER) regarding drug safety issues.

The new board, however, is established within CDER and has no authority to pull a drug from the market if it determines that the drug is harmful to patients. Of particular concern to me is the makeup of the DSB. The FDA states that the DSB will “enhance the independence of internal deliberations and decisions regarding risk/benefit analyses and consumer safety.” But, I do not believe that this is the case for several reasons. First, a majority of the DSB members are senior managers within CDER, the center responsible for drug approvals. In fact, CDER officials hold 11 out of a total of 15 voting positions on the DSB. Even more interesting regarding the make-up of the board is the fact that only three of the 11 DSB CDER officials come from organizational subunits not directly involved in the review of new drug applications. Moreover, two of these three originally came from the Office of New Drugs, which is charged with getting new drugs on the market in the first place. So, what we have here is nothing more than the status quo. My question to you, Dr. Crawford, is: Where are the people responsible for post-marketing surveillance who have allegiances only to post-marketing safety and the public’s well-being and not to the drugs that they helped put on the market in the first place?

In addition, according to FDA Week (May 20, 2005), the FDA announced in early May that the deliberations of the DSB will be private, unlike decisions that are made by FDA’s advisory committees. It is surprising to me that the FDA has chosen to make DSB deliberations private at a time when the agency should be making every effort to improve transparency and accountability.

As Chairman of the Committee on Finance, I request that the FDA explain in detail how it will ensure that the DSB is truly independent and objective. In addition, please describe in detail any actions the FDA will take to assure the public that decisions made by the DSB will be unbiased.

I look forward to hearing from you regarding the issues and concerns set forth in this letter and would appreciate a response to my inquiries no later than July 1, 2005.

Sincerely,
Charles E. Grassley
Chairman

washingtonpost.com
Drug Safety Panel Is Criticized
Efforts to Protect Consumers at Risk, Say Senator, FDA Official
By Marc Kaufman
Washington Post Staff Writer
Wednesday, June 8, 2005; A05

The new drug safety board established by the Food and Drug Administration to restore confidence in the nation’s drug supply will actually set back efforts to improve the safety of the medications Americans take and will not make it any easier to take dangerous drugs off the market, an FDA whistle-blower and a key senator said.

FDA safety officer David Graham said that after reviewing the makeup and structure of the Drug Safety Oversight Board, he concluded that the panel is “severely biased in favor of industry” and that “the FDA cannot be trusted to protect the public or reform itself.”

“Ironically, drug safety in the U.S. is worse off today than it was in November,” Graham added in an interview. That was when Graham, a longtime FDA safety reviewer, sharply criticized his agency’s record during a Senate Finance Committee hearing into the abrupt withdrawal of the arthritis painkiller Vioxx after a study found it had harmful heart effects.

Today, committee Chairman Charles E. Grassley (R-Iowa) plans to issue his own critique of the board. In a letter to acting Commissioner Lester M. Crawford, Grassley said that the makeup of the safety oversight panel led him to conclude that “what we have here is nothing more than the status quo.”

Grassley’s and Graham’s criticisms indicate that Congress may not be satisfied with the FDA’s steps and may press for action on pending legislation to create a more independent drug safety office.

The FDA announced the 15-member board last fall in part to identify and review emerging drug safety issues that Graham and others said were not being treated seriously enough; it was formally established last month. It consists largely of FDA managers, with some input from officials of the National Institutes of Health and of the Department of Veterans Affairs.

The attacks on the panel come as a steady flow of bad news about safety problems with popular drugs has given rise to competing initiatives designed to reassure the public. The congressionally chartered Institute of Medicine is holding a public meeting today to begin an FDA-requested study of its safety procedures, and Congress is considering bills that would more aggressively address drug safety.

Other administration officials have also proposed their own ideas. Last week, Medicare Administrator Mark B. McClellan floated a plan to use billing and health care information collected from Medicare beneficiaries to create a more effective surveillance system for prescription drugs on the market.

The current voluntary system for reporting serious drug reactions is believed to capture only 10 percent of actual cases. FDA officials said the initiative looks promising and that they are working with Medicare on it.

Janet Woodcock, FDA acting deputy commissioner for operations, declined to respond to Grassley’s letter or Graham’s comments, but she defended the safety board as useful and independent. “The safety board will be able to meet quickly, deliberate and make some strong recommendations if needed,” she said. “They will be moving issues up and down on the scale of urgency.”

For Grassley and Graham, the big problem with the safety oversight board is who will sit on it. In his letter, Grassley said 11 of the 15 voting positions on the board are filled by senior managers of the FDA’s Center for Drug Evaluation and Research, the same office responsible for reviewing and approving new drugs. The safety board was established, in part, to make the safety review process more independent of the new drug review process — an acknowledgment of sorts that officials who approve a drug for sale may be reluctant to see it taken off the market because they tend to be more focused on the potential benefits new drugs can bring.

Woodcock said the board will not include any decision makers involved with individual drug approvals and only a few of the supervisors who oversee them. She said its members will not be beholden to the drug center and will have little to do with new drug approvals.

In his letter, however, Grassley asked: “Where are the people responsible for post-marketing surveillance who have allegiances only to post-marketing safety and the public’s well-being, and not to the drugs that they helped put on the market in the first place?”

He and Graham also criticized FDA’s decision to keep most of the board’s safety deliberations private, especially “at a time when the agency should be making every effort to improve transparency and accountability,” Grassley said.

Graham noted that before he testified in November, he turned down an invitation from Crawford to play a central role in reorganizing the drug safety program, fearing that it would constrain his ability to criticize the agency.

A posting on the FDA Web site last month confirmed that most of the board’s members will come from the center that evaluates new drugs, and its executive director will be appointed by the center’s director. Any office can refer a drug safety issue to the board’s director, who, in consultation with the center’s deputy director, will decide whether and when the board should address it.

The operating procedures of the board require at least a two-thirds vote by its members to recommend that the FDA take action.

Grassley and Sen. Christopher J. Dodd (D-Conn.) have introduced a bill that would give drug safety oversight responsibility to a board that would have considerably more independence from FDA. Opponents of the proposal, including the trade association for the drug industry, say that they worry that an independent board will focus exclusively on a drug’s risks and disregard its potential benefits.

© 2005 The Washington Post Company

http://www.gooznews.com/archives/000152.html
MERRILL GOOZNER
Whistleblowing v. Leaking

There’s a big difference between blowing the whistle and being a leaker. Whistleblowers take responsibility for their actions and suffer the career consequences, as today’s news amply points out.

The White House war on global warming science suffered another damaging blow today thanks to Rick S. Piltz, a former high official in the government’s Climate Change Science Program. He resigned in March after a former petroleum industry lobbyist now working for the Bush administration watered down his office’s reports on the need for near-term action to halt global warming.

Piltz could have remained in the shadows and leaked his information to the press. But instead he went to the Government Accountability Project, which provides legal assistance to government employees who want to go public with knowledge about government wrongdoing. In today’s New York Times story documenting his allegations, Piltz not only attached his name to the allegations that Philip Cooney, a non-scientist who previously lobbied for the American Petroleum Institute, added equivocating language to a 2002 global warming report, but he provided the documents that proved the allegations.

The movement to improve the Food and Drug Administration’s safety record is also benefiting from the actions of a courageous whisteblower. David Graham, who testified before Congress late last year on the problems with Vioxx and a number of other potentially unsafe drugs, is still working at the agency. In today’s Washington Post, Graham attacks the independence of the FDA’s new Drug Safety Oversight Board, claiming it contains too many officials with ties to the agency’s new drug approval arm – an institutional conflict of interest. He and Sen. Chuck Grassley, chief sponsor of the bill that would make the safety arm of the agency independent, sent a letter to the FDA protesting the oversight board’s make-up.

The FDA asked Graham to serve on the new oversight board, but he turned down the offer. According to the article, he feared it would limit his ability to criticize the agency.

Like Piltz, Graham was assisted by the Government Accountability Project. While GAP often counsels would-be whistleblowers not to go public because legal protections for public employees have been all but eliminated by the courts, in these cases the stories were so compelling and the individuals involved so intent on getting their stories known that they ignored that legal advice in favor of serving the public interest.

If legal protections are ignored in the public sector, they are virtually non-existent in the private sector, as the sad tale of Pfizer vice president Peter Rost in today’s New York Times shows. Rost appeared on 60 Minutes last Sunday to repeat his claims that the drug industry consistently overcharges for its products, games public sector agencies like Medicare, Medicaid and the IRS, and has essentially lied about the safety problems of imported drugs.

His reward inside Pfizer has been near total isolation. Though he’s still on the payroll at $600,000 per year, the marketing executive’s employees have been taken away and he has no authority. Pfizer even locked him out of its corporate email system for a brief time this week until the New York Times reporter called to inquire about the move. “I guess everybody’s waiting for me to get fired,” he said.

The article speculates that the only thing keeping him on the payroll is a federal investigation into the marketing of a Pfizer drug that Rost used to manage.

These whistleblowers’ actions stand in stark contrast to the methods of anonymous leakers. In this week’s New Yorker , legendary investigative journalist Seymour Hersh recounts his own experiences with anonymous sources during the Watergate years. It wasn’t just Mark Felt, the 91-year-old former number two man at the Federal Bureau of Investigation who came out last week as Deep Throat. The Nixon White House couldn’t control the unraveling cover-up “because of the wealth of information, including documents, that reporters got from sources within the Administration. Many reporters also had sources on the various congressional investigating committees and in the Justice Department and other agencies,” he wrote. “Anonymous sources were essential to the Watergate story.”

They talked because they were “outraged by the sheer bulk and gravity of the corrupt activities they witnessed in the White House . . . some feared that the government might fall, and some talked to reporters about their concern that the President, facing impeachment, might try to hold on to his office by defying the Constitution.”

These anonymous sources, most of whom dealt with national security secrets, had their “worst fears confirmed by the revelation” that Nixon was taping their conversations. Presumably, this dictated their need to stay anonymous.

Scientists concerned about the fate of the planet and the safety of common medicines somehow found the courage to put their careers at risk to unmask administrative wrongdoing by high government officials. But when the fate of the Republic was at stake, top government officials – who had been entrusted with the nation’s highest secrets – felt the need to stay anonymous to bring serious malfeasance to the public’s attention. The system may have worked during Watergate, but I still say it set a bad precedent. Posted by gooznews at June 8, 2005 08:59 AM

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