October 26

FDA Smoke & Mirrors Musical Chairs

FDA Smoke & Mirrors Musical Chairs

Wed, 16 Feb 2005

Amidst widespread public criticism of the FDA’s role as facilitators in the marketing of lethal drugs that killed thousands of people, the Administration made several announcements incorporating terminology (such as: “we’re in an era of openness” “transparency”). But politically correct words will not calm the storm – mere Band-Aids will not cure a disease requiring major surgery.

On Monday, Lester Crawford, acting director of the FDA, was nominated to be its official head – despite his record of failure to take steps to improve drug safety. Consumers Union is calling upon the Senate to “vet the vet” before confirming him.

On Tuesday, the FDA announced it would establish a drug safety board to monitor drugs after they have been approved by the FDA. However the board would be composed mainly of FDA staff from its center of drug evaluation (CDER) division – the very division whose iron fist rule has led to the current debacle.

“I’ve been in practice for 30 years, and I’ve never seen such a mess,” Michel Dubois, director of the New York University Pain Management Center, told the Associated Press.

Neither announcement addresses the substantive flaws in the current system that have rendered the agency incapable of protecting the public from unsafe, even lethal drugs. FDA’s actions have demonstrated a knee jerk inclination to protect the pharmaceutical industry by hiding the risks – no matter how many lives are sacrificed.

Crawford’s statement to the press: “We’re in an era of openness” is belied by the muzzling of Dr. David Graham, the agency’s safety officer whose ‘going public’ with evidence of the hazards of Vioxx and the other COX2 painkillers was the catalyst for this hearing. FDA’s actions demonstrate the agency’s unyielding culture of denial.

Three articles and an editorial in The New England Journal of Medicine add fuel to the fire: given the risks of heart attacks posed by COX2 inhibitors, “It is reasonable to ask whether the use of the drugs can now be justified?”

Contact: Vera Hassner Sharav

FDA chief chosen amid troubles
President Bush taps acting commissioner Lester Crawford, as the agency faces criticism for handling of popular drugs.
By Gregory M. Lamb Staff writer of The Christian Science Monitor

With the heat turned up on the Food and Drug Administration regarding its failings as a consumer watchdog, the Bush administration has decided that the man already in place is the one to battle the blaze. The White House announced it was nominating Lester Crawford, who has served as acting commissioner of the FDA since March 2004, for the post.

Critics were quick to express disappointment that the administration hadn’t turned to an outsider to show it was serious about addressing the agency’s shortcomings. Though Dr. Crawford is expected to be confirmed by the Senate, the process will undoubtedly provide yet another forum for critiquing the embattled agency.

“I was hoping for someone who could actually redirect the agency to what its legal and legislative mission is: to protect the public from unsafe drugs,” says Vera Hassner Sharav, president of the Alliance for Human Research Protection and a longtime FDA critic. “Instead, the agency is in the business of fast-tracking the approval of drugs even before they’ve been found to be safe.”

Drug safety and the clamor for change

In recent months, a simmering stew of issues has kept the FDA under constant scrutiny. Concerns that antidepressant drug use among children could increase their risk of suicide in turn raised cries for a more open policy on publication of clinical trials by drug companies, and spurred questions on the FDA’s role in promoting that openness.

Last fall, the FDA seemed to be caught by surprise when half of the annual supply of flu vaccine, about 40 million doses, was declared tainted and unsafe for use. As the public fretted and waited in long lines for the existing doses, the government scrambled to find new supplies. In the end, a mild flu season has left the nation with an oversupply of doses.

Wednesday an advisory panel to the FDA begins three days of hearings on heavily marketed and highly popular painkillers known as Cox-2 inhibitors.

One, with the brand name Vioxx, has been voluntarily removed from the market by its manufacturer, Merck. Two others, Celebrex and Bextra, made by Pfizer, remain on the market. In a number of studies, the drugs have been implicated in higher incidences of fatal heart attacks and other cardiovascular problems.

Critics have questioned why the FDA has taken so long to recognize the problem and take action. The agency could ask for strong warnings on the products or demand their removal from the market. David Graham, a whistle-blower within the FDA, will be allowed to testify, but has said he does not feel free to present new unpublished data about the drugs.

In an editorial released Wednesday, accompanying three more studies linking Cox-2 drugs to heart problems, Jeffrey Drazen, editor of the New England Journal of Medicine, wrote that “It is reasonable to ask whether the use of the drugs can now be justified” and said that the same zeal that had suggested the drugs offered new benefits to patients had not been applied to ensuring that they were safe.

A changing science

The press reports have sent patients and doctors fleeing from the drugs. Sales of Cox-2 drugs dropped 43 percent in December from a year earlier, according data released by IMS Health in Plymouth Meeting, Pa. “I’ve been in practice for 30 years, and I’ve never seen such a mess,” Michel Dubois, director of the New York University Pain Management Center, told the Associated Press.

Tuesday, the FDA announced it would be establishing an independent drug-safety oversight board to help ensure the safety of drugs already in the marketplace. A number of critics had been calling for such a step as part of revamping the FDA. “Dr. Lester Crawford is an outstanding choice for Commissioner of the Food and Drug Administration,” said Mike Leavitt, Secretary of Health and Human Services, in announcing the nomination Monday. “Dr. Crawford has dedicated his career to advancing the nation’s public health and will lead the way as we enter a new era of individualized medicine and rapidly developing science. With Dr. Crawford’s leadership, the FDA will provide the world’s safest drugs and empower citizens with the tools they need to make informed choices about their health.” Crawford’s background is in veterinary medicine and pharmacology. Before joining the FDA he worked in the food industry for the National Food Processors Association.

Among the topics likely to be discussed at his Senate hearing is the FDA’s proposed budget. Though overall funding would increase about 4.5 percent under the president’s budget proposal, the plan also calls for the FDA to cut the number of inspections of food-processing plants, blood banks, and foreign drug plants, USA Today reported Tuesday. New funding would be put into fighting bioterrorism and establishing the drug-safety office.

Material from wire services was used in this report.

Cox-2s safety summit sees FDA scientist censored
By Katherine Griffiths in New York and Stephen Foley in London
16 February 2005

David Graham, the high-profile scientist at America’s Food and Drug Administration, has been banned from presenting new information about a controversial type of painkiller at a three-day summit on their safety starting today.

Dr Graham, who works in the FDA’s office of drug safety, said yesterday that he had been “threatened with being called insubordinate” by the FDA when he said he wanted to include the findings of an unpublished study he has completed as part of his testimony on Cox-2 inhibitors.

The FDA has organised the series of hearings, which will include evidence from drug makers and scientists, in Washington in response to mounting concerns about Cox-2s and to allegations that the agency has been too slow to deal with possible dangers associated with the drugs. Last September, the US pharmaceuticals giant Merck withdrew Vioxx after a study showed the blockbuster increased the risk of heart disease five-fold in patients on a high dose.

In an attempt to head off further criticism of the FDA, the US Secretary of Health and Human Services, Mike Leavitt, announced a new independent Drug Safety Oversight Board would be created within the FDA to monitor medicines once they are on the market and to update physicians and patients with emerging information on risks and benefits.

Dr Graham, who has accused the FDA of ignoring worrying evidence about Vioxx when it was still on the market, said he wanted to include in his testimony tomorrow details of a study he completed with Gurkirpal Singh of Stanford University School of Medicine.

This study “talks about the risks of Cox-2 agents and other drugs that are widely used,” he said. “We think the findings are important. The committee might not think so, but it should have the opportunity to consider it,” Dr Graham said. As well as Vioxx, drugs which will be scrutinised at the meeting are Celebrex and Bextra, two Cox-2s made by Pfizer. The hearings will be monitored closely by the UK’s GlaxoSmithKline, which has stopped work on its own Cox-2 pending clarification of the requirements for large-scale human trials.

The FDA is not expected to ban Cox-2s outright, and GSK is unlikely to abandon work on its drug, codenamed 381. The company says it had always expected trials involving thousands of patients would be required and that it had budgeted for increased expenditure since Vioxx was withdrawn. It has already done extra work on the existing data, and says the effect Vioxx appears to have on blood pressure is not found with 381.

GSK believes head-to-head trials against Celebrex, the market leader have proved that 381 is a superior drug, and the outcome of this week’s FDA hearings and more talks with the agency this spring will determine how long it takes to bring the product to the US market. The FDA panel is thought likely to demand that manufacturers increase the level of warning on bottles, and perhaps carry out trials into the long-term impact of the drugs when they are on the market. It could order that trials are designed to generate more data on high-risk patients.

Relations between Dr Graham and his employer have been strained since he spoke out against the way the FDA handled Vioxx, which he said caused heart problems in up to 140,000 patients. Last November, the FDA publicly repudiated comments by Dr Graham naming five drugs, including AstraZeneca’s cholesterol lowering pill Crestor and GSK’s asthma drug Serevent, that he thought could be too dangerous for use. The agency argued that it has struck the right balance of benefits and risks when assessing new drugs for launch, but it has been accused of being too close to the drug industry and has faced political calls to split its safety monitoring functions into an agency separate from the drug approvals process.

February 16, 2005, A-1
F.D.A. to Create Advisory Board on Drug Safety

WASHINGTON, Feb. 15 – Responding to widespread criticism of the government’s handling of drug safety problems, the Food and Drug Administration announced Tuesday that it was creating a board to advise it on drug complications and to warn patients about unsafe drugs.

Dr. Lester M. Crawford, the acting commissioner of the drug agency, said the board would be made up of scientists drawn from throughout the federal government. The board, which is to make its conclusions public on a Web page, will not have independent power to force the withdrawal of drugs but will simply advise the F.D.A., Dr. Crawford said. In addition, he said, the agency will soon tap into large databases, including those at the Medicare agency, to uncover dangerous side effects in drugs already on the market. The agency said it would increase the number of fact sheets that patients receive with prescriptions.

The announcement comes as Congressional committees are investigating the agency’s ability to discover drug dangers. It also comes on the eve of a landmark three-day advisory panel hearing into the safety of the pain pills Celebrex, Bextra and Vioxx, a hearing that could prove embarrassing to the agency.

Michael O. Leavitt, the secretary of health and human services, who made the announcement with Dr. Crawford at the agency’s headquarters, said the measures were “a response to a widely held concern both inside and outside Congress.” Dr. Crawford, who was nominated Monday by President Bush to become the permanent commissioner of the F.D.A., noted that the agency had tended to keep secret potentially damning information about drugs until it decided what to make of it.

“Our culture, which has received some criticism in recent months, is not to alarm the public when we get a signal,” Dr. Crawford said. “That era is sort of past. What the public, we think, is demanding is to know as soon as we know what’s going on. And they’re fully prepared and adult enough to interpret whether or not this is a final decision.” Like many of the

F.D.A.’s recent actions, this one immediately drew criticism from advocates for drug safety and from academics. The Office of Drug Safety at the agency now has about 109 employees and tries to uncover unknown drug dangers largely by poring over miscellaneous and haphazard injury reports sent in by doctors and drug companies. If a drug causes a reaction that is an otherwise common malady – like a heart attack – the Office of Drug Safety is almost powerless to uncover it. The office is part of the agency’s drug review center.

Advocates have been calling for a more muscular drug safety center with far more employees that would be independent of the F.D.A. or at least independent of its drug review division. Neither characterizes the agency’s board.

“It’s being done as a substitute to fundamental change in the Office of Drug Safety, so it’s unlikely to make any difference,” Dr. Sidney M. Wolfe, a director of the consumer advocacy group Public Citizen, said. “It’s a cruel hoax and a frantic reaction to Congressional disapproval.”

Dr. Alastair Wood, an associate dean at Vanderbilt University who has long advocated an independent safety review board structured like the National Transportation Safety Board, said he was disappointed. “This is not my concept of what an independent drug safety board would be,” Dr. Wood said. “This is a reshuffling of the deck.” He added, “It’s a huge opportunity that’s been lost to introduce transparency and restore confidence in the system.”

Academics say that tapping into large health databases to uncover drug dangers would probably cost tens of millions of dollars each year. The administration’s 2006 budget proposal includes no additional money for such an expense. An agency spokesman said the money “would come from existing resources.”

Senator Charles E. Grassley, Republican of Iowa, who has been investigating the F.D.A. for a year, said that Dr. Crawford’s initiative, while welcome, did not go far enough. Mr. Grassley said legislation was needed to make the Office of Drug Safety independent of the drug review center, which approves drugs before marketing. “I’m drafting legislation to clearly establish this independence and provide the office the authority needed to do its job,” Mr. Grassley said.

Senator Edward M. Kennedy, Democrat of Massachusetts, said the F.D.A. needed to do more. “It is critical that F.D.A.’s resources to monitor drugs be dramatically increased, and the F.D.A. must be given the authority to require drug companies to initiate and complete appropriate safety studies,” Mr. Kennedy said.

The lack of new financing for drug safety efforts disappointed researchers who use databases to uncover unknown dangers of drugs. Dr. Richard Platt of Harvard Medical School, one of the nation’s premier drug safety experts, said a comprehensive drug safety system would be costly. “A single complex study can cost over $2 million,” Dr. Platt said.

The safety oversight board could nevertheless become an important avenue for earlier disclosures about potential problems with drugs on the market. The F.D.A. is required to keep secret much of the information it receives from drug companies about their products. But this information is often made public in advisory panel meetings, and such disclosures could become common with the drug oversight board.

“We need to find reasons to make the information available rather than simply saying we can’t reveal trade secrets,” Dr. Crawford said. “We’re in an era of openness.” Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, said the drug industry “supports efforts to address the quality of information used by the agency, health-care professionals and patients.” The trade association will study the F.D.A.’s initiative carefully, Mr. Trewhitt said.

The announcement on Tuesday was delivered by Dr. Crawford at a meeting of several hundred employees at the agency’s offices in Rockville, Md. The meeting was called in part to welcome Mr. Leavitt on his first visit to the agency. Both men received a warm reception. After telling the crowd a bit about his three terms as governor of Utah, Mr. Leavitt said the F.D.A. needed to become more transparent and independent and to improve its use of information technology to husband its resources. His statement drew murmurs of agreement. F.D.A. medical officers have watched the mounting criticism of the agency with dismay. Most believe that the agency is filled with dedicated public servants who perform difficult jobs well, and many feel that constraints on the agency’s public pronouncements have ill-served its image.

Mr. Leavitt said he did not agree with critics who say the agency’s drug safety office should be independent of the F.D.A. or its drug review center. “We understand their point of view, but having it inside the agency and inside the government creates a number of advantages that we think can’t be replicated outside,” he said. “The F.D.A. is the best in the world at what they do. Drug safety is their job, it’s their accountability.”

Dr. Crawford also said that the agency at this point had no plans to ban consumer drug advertising. “We believe it does useful things,” Dr. Crawford said. “My wife first found out about new therapies about migraine headaches from direct-to-consumer advertising.” But he promised to crack down on misleading drug advertisements.

“We will continue to be extremely vigilant, but the industry needs to meet us halfway,” he said. “We need some improvement on the type and character of these advertisements.” The number of warning letters on misleading advertisements issued by the agency has steadily declined in recent years. The F.D.A. will be under scrutiny for the rest of the week at an advisory panel meeting that will explore the safety of Celebrex, Bextra and Vioxx and how the agency regulated them. Merck, the maker of Vioxx, withdrew the drug from the market in September after a trial showed that it doubled the risk of heart attacks and stroke. Recent tests of Celebrex and Bextra, both made by Pfizer, have shown that those drugs may also hurt the heart. Currently, the F.D.A. is wholly reliant on voluntary efforts by drug makers to assess the safety of medicines once they are already being marketed.

Copyright 2005 The New York Times Company

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