FDA Commissioner Nominee told Senate He’s Open to Independent Safety Unit / Avonex Warning

FDA Commissioner Nominee told Senate He’s Open to Independent Safety Unit / Biogen issues Avonex Warning

Fri, 18 Mar 2005

It would be impossible to gain insight into Lester Crawford’s confirmation hearings by the Senate Health, Education, Labor and Pensions committee if one read only one news report.

The Los Angeles Times report (below) zeroed in on Crawford’s concession: “An independent office of drug safety is something I am certainly open to discussing.”

The LAT notes: “Such a watchdog office would go beyond fixes that the Bush administration had announced to deal with concerns that the FDA was failing to detect deadly side effects in drugs approved for widespread use.

And it would fulfill a key goal of congressional reformers, who contend the FDA had created a conflict by requiring the office that monitored the safety of approved drugs to report to the branch that granted approval in the first place.”

The Wall Street Journal focused on Crawford’s concession about conflicts of interest: he indicated that the FDA would revamp the disclosure process for FDA advisory committees.

The New York Times headline focused attention on a political issue rather than safety concerns: “F.D.A.’s Role in Delaying Contraceptive Is Criticized”

See: http://www.nytimes.com/2005/03/18/politics/18fda.html?

The Associated Press reported that three consumer groups–Consumers Union, Consumer Federation of America and the U.S. Public Interest Research Group–criticized the nomination in a joint letter to the committee. They contended the FDA’s “high profile missteps and failure to take timely action” in protecting the public against unsafe prescription drugs raise questions about Crawford’s “leadership, his ability to manage interagency conflicts and willingness to act in the best interest of consumers.”

Every newspaper reported that Crawford rejected the assertion that the FDA failed to live up to its mandate and he also rejected the charge that the agency’s image has suffered in the past year.

“I don’t think we’ve been tarnished,” Crawford said. “I don’t want to see that happen. The specter has been raised in the past few months.. I don’t want the FDA to be tarnished in any sense.”

Underscoring Crawford’s dilemma–his denial notwithstanding–are ongoing indicators that the system is failing to protect the public from unsafe drugs. The FDA allows drug manufacturers to market and widely advertise drugs which have not been tested to detect deadly but rare side effects.

And when potentially lethal effects have been detected in the FDA’s post-approval database containing reports voluntarily submitted by physicians, FDA officials dismissed the concern of its medical officers, stating that “spontaneous reports are not scientific” evidence.

But the headlines provide compelling evidence demonstrating the unreliability of FDA’s failure to put safety before commerce:

1. An announcement by Biogen and the FDA that Biogen’s second multiple sclerosis drug, Avonex, might cause severe liver damage. See: Biogen and F.D.A. Issue Drug Warning By Andrew Pollack The New York Times, March 17, 2005: http://www.nytimes.com/2005/03/17/business/17drugs.html

2. FDA’s approval of Symlin (pramlintide), a diabetes drug, has raised safety concerns because it is tied to an increased risk of hypoglycemia, or low blood sugar.

In 2001, an FDA advisory committee rejected the drug for these reasons.

Dr. Sidney Wolfe, of Public Citizen had warned about the drugs lethal effects–including, severe hypoglycemia with automobile driving-related adverse events including crashes and confusion while driving (statistically significant); most people required paramedic intervention, ER visits and IV glucose administration; there was one death in an auto crash in a patient getting pramlintide.” Dr. Wolfe went on to say the drug’s hazards preclude further testing: “This drug deserves to be put out of its misery before any more patients are injured or killed in any further clinical trials.” See: http://www.citizen.org/publications/release.cfm?ID=6786

The Wall Street Journal reports that since 2001, “the agency said, new data clarified conditions under which Symlin posed a risk and the approval came with provisions to minimize safety issues. Along with stringent labeling that recommends use by a limited population of patients, the drug will have no direct-to-consumer ads.”

Do the scientifically proven benefits outweigh these serious risks?

3. On Feb 3, 2005, the FDA deleted a key sentence from the newly issued warning labels of antidepressant drugs: “A causal role for antidepressants in inducing suicidality has been established in pediatric patients.” The unprecedented label change was done without any explanation or any supporting new evidence to back it up. Did the FDA yield to commercial pressure and withholding from physicians the science-based rationale for the black box suicide warning?

Whose interests are being served?

Contact: Vera Hassner Sharav
212-595-8974

http://www.latimes.com/news/nationworld/nation/la-na-fda18mar18,1,515384.story?coll=la-headlines-nation

THE LOS ANGELES TIMES
It’s a Maybe for Drug Safety Unit
Nominee to head FDA, pressed by senators, says he’s open to discussing an independent office.
By Ricardo Alonso-Zaldivar
March 18, 2005

WASHINGTON – President Bush’s nominee to head the Food and Drug Administration told a Senate panel Thursday that he would consider setting up an independent drug safety unit within the beleaguered agency, as some critics have demanded.

Such a watchdog office would go beyond fixes that the Bush administration had announced to deal with concerns that the FDA was failing to detect deadly side effects in drugs approved for widespread use.

And it would fulfill a key goal of congressional reformers, who contend the FDA had created a conflict by requiring the office that monitored the safety of approved drugs to report to the branch that granted approval in the first place.

“An independent office of drug safety is something I am certainly open to discussing,” acting FDA Commissioner Lester M. Crawford told the Health, Education, Labor and Pensions Committee, which is considering his nomination.

“An independent drug safety office within the FDA . is a critical step in restoring the public’s trust in the phrase ‘FDA-approved,’ ” Sen. Christopher J. Dodd (D-Conn.) said after the hearing. Dodd introduced legislation last week calling for such an office.

Crawford’s nomination could run into stiff opposition unless he can convince senators that he would follow through with changes at the FDA.

He faced sharp questioning Thursday from committee Democrats over drug safety and the FDA’s delay in deciding whether the morning-after pill should be available without a prescription. Crawford said the FDA was weeks away from a decision on the contraceptive, which would involve resolving the question of whether it could be used safely by women younger than 16.

Crawford, a veteran government manager who holds doctorates in pharmacology and veterinary medicine, tried to defend the FDA while simultaneously pledging to transform its internal culture.

“I don’t think we’ve been tarnished,” Crawford said. “I don’t want to see that happen. The specter has been raised in the past few months.. I don’t want the FDA to be tarnished in any sense.”

Crawford was referring to recent controversies over how the FDA had dealt with the suicide dangers associated with antidepressants used by adolescents and the heart risks of a popular painkiller. In both cases, FDA scientists had unsuccessfully tried to warn their superiors of emerging problems.

Last fall, the FDA belatedly issued a strong warning that taking antidepressants could prompt suicidal thoughts and actions among some teenagers. That was followed by Merck’s withdrawal of its arthritis painkiller Vioxx, after a study confirmed suspicions that it increased chances of heart attacks and strokes.

“There is a crisis of confidence over drug safety in the public mind and even among some clinicians,” said Sen. Barbara A. Mikulski (D-Md.).

Sen. Edward M. Kennedy (D-Mass.) asked Crawford whether he felt there were any lapses in the agency’s handling of Vioxx. Crawford responded that the painkiller’s effects on the heart “could not have been anticipated.” That prompted an exasperated reaction from Kennedy.

” ‘Couldn’t be anticipated’ is a rather ominous response,” Kennedy said. “I’m trying to detect whether it’s going to be business as usual. I’m not sure the American people are going to be satisfied by [Crawford’s saying] there are a number of situations that can’t be anticipated, and therefore that’s the way it should be.”

The Democratic critics have an influential Republican ally in Sen. Charles E. Grassley of Iowa. He heads the Finance Committee, which has jurisdiction over healthcare programs, although not the FDA.

After Thursday’s hearing, Grassley released a list of 30 questions he wanted answered before he made up his mind on Crawford’s nomination. Grassley accused the FDA of withholding information from Finance Committee investigators.

The Bush administration acknowledges that the FDA needs to improve its oversight of drugs on the market. It has increased the budget of the FDA’s drug safety office and pledged to warn the public promptly about suspected or emerging risks. The FDA also is setting up a drug safety board, composed of government and independent experts, to advise the commissioner. But under the administration’s plan, the drug safety office, where FDA scientists and reviewers work, would remain part of the branch that approved new drugs.

“It needs to be independent of the whole bureaucracy, reporting only to the commissioner,” Mikulski told Crawford.

A committee vote on Crawford’s nomination is set for mid-April. The FDA has been without a permanent commissioner for a year.

http://www.nytimes.com/aponline/national/AP-FDA-Crawford.html
March 18, 2005
Bush FDA Choice Rattles Advocacy Groups
By THE ASSOCIATED PRESS

WASHINGTON (AP) — President Bush’s nominee to head the Food and Drug Administration sidestepped allegations from Senate Democrats that something was awry at the agency, but he promised he would improve its drug safety reviews. Lester Crawford, acting FDA commissioner and Bush’s choice to become commissioner, spoke Thursday at his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions. Several Democrats, citing the recall of the painkiller Vioxx last September and the flu vaccine shortage, asked him to acknowledge that the agency had problems.

“I’m trying to detect whether this is going to be business as usual out of the FDA or whether you’re setting up kind some of system to flag these issues,” said Sen. Edward Kennedy, D-Mass. “Personally, there has to be recognition that there is a serious problem.”

Crawford, who has been acting or deputy FDA commissioner for the past three years, did not accept the assertion that the FDA failed to live up to its mandate. He also rejected the charge that the agency’s image has suffered in the past year.

“I don’t think we’ve been tarnished,” he said, but then added: “I promise to you to do everything in my power to stem the tide and do the right thing.”

Crawford said he would institute a drug safety board that would advise the agency on issues involving drugs already approved for the market. The board’s deliberations would be public. He also said he also wanted decision-making within the agency to be more transparent.

“It is true that within the culture of the FDA there is a lot of give-and-take on these decisions based on science,” he said. “We want to honor that, and also to report the minority’s” view.

The FDA regulates about $1 trillion worth of products a year and is charged with ensuring the safety and effectiveness of all drugs, medical devices, animal drugs and feed.

Sen. Jeff Sessions, R-Ala., defended Crawford, saying he has a difficult balancing act: If the agency waits too long to approve a drug, thousands of lives can be put at risk, but if it acts too quickly, the same result is possible.

“Your challenge is to identify in advance what would work, what would not work, and make those decisions that are best” Sessions said.

Crawford, elevated to acting FDA director a year ago, said he’s committed to addressing concerns about the safety of medical products as well as food. “I remain focused on bioterrorism and minimizing the threat of terrorist attack both through heightened food security and through the development of new medical countermeasures,” he said.

Three consumer groups criticized the nomination in a joint letter to the committee. They contended the FDA’s “high profile missteps and failure to take timely action” in protecting the public against unsafe prescription drugs raise questions about Crawford’s “leadership, his ability to manage interagency conflicts and willingness to act in the best interest of consumers.”

The groups, Consumers Union, Consumer Federation of America and the U.S. Public Interest Research Group, focused on the FDA’s response to concerns about Vioxx.

Before Merck, the manufacturer, withdrew the drug last September, an FDA scientist had found an increased risk of heart attack and strokes in patients taking the pain killer. Three weeks before Merck pulled the drug, the agency had approved it for use by children.

Democrats asked Crawford to update them on the status of an oral contraceptive application before they vote on his confirmation. The drug — Plan B oral contraceptive — is available with a prescription, but some senators say it should be available over-the-counter, as recommended by an FDA advisory committee. They said the agency has taken too long to review the application.

Crawford said the application was complex and unique, but declined to be more specific in public. He offered to discuss the issue privately with senators. He also said he expected a decision in weeks.

Copyright 2005 The Associated Press

http://online.wsj.com/article/0,,SB111110670374383253,00.html
THE WALL STREET JOURNAL
FDA to Revamp Disclosure Process
By ANNA WILDE MATHEWS
Staff Reporter of THE WALL STREET JOURNAL
March 18, 2005; Page A10

The Food and Drug Administration plans to revamp its process for disclosing potential conflicts of interest among members of its advisory committees, acting commissioner Lester Crawford said.

At his confirmation hearing to be the permanent head of the FDA, Dr. Crawford said the agency will change disclosure procedures. “There should be easier disclosure,” he told the Senate Committee on Health, Education, Labor and Pensions. Later, a spokeswoman said the FDA is “reviewing ways to make our current process for providing disclosures more transparent and readily available to the public.”

Responding to Democrats’ queries about a bid by Barr Pharmaceuticals Inc. to sell emergency contraceptive Plan B over-the-counter, Dr. Crawford said the agency would make a decision within weeks.

The FDA gave details of its approval of Symlin, a diabetes drug that had raised safety concerns because it is tied to an increased risk of hypoglycemia, or low blood sugar. In 2001, an FDA advisory committee rejected the drug, made by Amylin Pharmaceuticals Inc., largely because of such concerns, though it did find the medication helped to control diabetics’ blood sugar.

Since then, the agency said, new data clarified conditions under which Symlin posed a risk and the approval came with provisions to minimize safety issues. Along with stringent labeling that recommends use by a limited population of patients, the drug will have no direct-to-consumer ads.

David Orloff, who directs the FDA division overseeing diabetes treatments, said Symlin, “while clearly benefiting some patients…is not for all patients.” Daniel Bradbury, chief operating officer for Amylin, San Diego, said the company “believes that these provisions provide a very comprehensive platform for managing risks associated with the product and at the same time providing the benefit.”

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