Safety fears plague US drug system

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Safety fears plague US drug system

By Christopher Bowe

Published: November 25 2004 18:25 | Last updated: November 25 2004 18:25

http://news.ft.com/cms/s/32bb3886-3f0c-11d9-8e70-00000e2511c8.html

 

US drugs regulators made two trips to Capitol Hill last week to defend

themselves before Congress. They are likely to return soon, after their

efforts to reassure lawmakers and the public on the US drug safety

system fell flat, triggering calls for reform of the system.

 

The Food and Drug Administration faces withering scrutiny and increasing

pressure to restructure in an effort to provide a more adversarial

industry safety monitor.

 

Proposals are afoot to create an independent drug safety office, removed

from regulators who work with companies to approve medicines. Critics

complain these regulators defend their own wisdom to approve a drug too

often, siding with industry at the expense of safety.

 

Both internal and external reviews have been ordered at the FDA.

Momentum is also building for a public clinical trials registry, to

which drug makers would post all drug study data.

 

The pharmaceuticals industry argues that the FDA is the “gold standard”

in world drug safety. It worries that increased vigilance could add

costly changes and delays in the drugs business, with over-emphasis on

risk rather than benefits for treating sick people.

 

The FDA is under siege after the withdrawal of Vioxx, Merck's popular

pain drug, in September. The US group removed the drug with

$2.5bn-a-year sales from the market after an internal study found it

doubled risk of heart attack and strokes after 18 months. The move

confirmed critics' concerns that Vioxx showed warning signs four years ago.

 

Last week, the controversy widened when Dr David Graham, a 20-year FDA

safety expert, told a Senate committee hearing that US patients were

“virtually defenceless” against more regulatory safety lapses.

 

He said five drugs on the market needed closer review of safety risks.

He named AstraZeneca's Crestor, for cholesterol; Pfizer's Bextra, a pain

drug similar to Vioxx; Abbott Laboratories' obesity treatment Meridia;

GlaxoSmithKline's Serevent for asthma; and Roche's severe acne treatment

Accutane.

 

Moreover, Dr Graham said the FDA's bureaucratic hierarchy favoured drug

makers and downplayed researchers with safety concerns. He said the

agency's umbrella group, Centers for Drug Evaluation and Research

(CDER), allows the new drugs office to overrule safety concerns, while

the drug safety office management is toothless.

 

Dr Graham added that this system actively suppressed safety researchers'

conclusions. He fought to release a study in August on Vioxx's dangers

linking it to 28,000 heart attacks and deaths, before Merck pulled the

drug. Dr Andrew Mosholder, his FDA colleague, this year was told he

could not publicly present research suggesting that antidepressants

could increase suicidal behaviours in children.

 

“In these situations, the new drug reviewing division that approved the

drug in the first place and that regards it as its own child, typically

proves to be the single greatest obstacle to effectively dealing with

serious drug safety issues,” Dr Graham told the Senate finance committee

hearing.

 

Senator Charles Grassley, Republican chairman of the finance committee,

wants to restructure the FDA with legislation to make an independent

drug-safety watchdog.

 

“I intend to put in some legislation making the Office of Drug Safety

very much independent of the Office of New Drugs,” Mr Grassley said this

week. Mr Grassley also asked the US General Accounting Office to study

the FDA's regulatory system, safety monitoring and relationship with big

drugs companies.

 

This follows the influential Journal of American Medical Association's

call on Monday for an “independent drug safety board” outside of the

FDA. The British Medical Journal made the same request. It is unclear

what form a separate drug-safety office would take. If it were outside

the FDA, as some propose, it could be in federally funded institutions

such as the National Academies of Science or the Institute of Medicine

(IOM).

 

Separately, Dr Bruce Psaty, medicine professor at University of

Washington, is proposing that the US adopt a European practice of

reassessing drugs after five years, as well as a separate drug-safety

office.

 

The FDA disagrees with critics, defending its safety system and saying

there is hearty debate between all scientists. “No one group or person

makes a decision about a recall of that kind,” the FDA says.

 

The agency also says a misperception exists about the safety office. It

says the Office of New Drugs and Office of Drug Safety have separate

structures and operations that report independently to CDER.

 

PhRMA, an industry lobby group, agrees with the regulator. “The FDA

remains the gold standard for safe and effective treatment with

medicine,” says Jeff Trewhitt at PhRMA.

 

Sensing growing unrest over Vioxx, the FDA this month also ordered the

IOM to study the US drug-safety system, particularly the monitoring of

drugs after approval. In addition, it announced a programme to appoint

an ombudsman, and guidelines to handle “differences in professional

opinion” with significant public health consequences. It also said it

would find a director for the office of drug safety.

 

Another political factor weighs on the FDA. It has been without a

commissioner for a year, after Mark McClellan left to head Medicare, the

federal health plan for the elderly. The Bush administration could “make

finding a permanent FDA commissioner a high priority”, but that remains

a hard task with Senate democrats staunchly opposing an industry

friendly candidate, says Paul Heldman, analyst at Citigroup.

 

The IOM report, set to be completed in six months, could influence

legislation to restructure the FDA. For now, Mr Grassley estimates he

does not have enough votes to pass a new drug safety watchdog. But he

plans to continue pushing the cause in Congress. FDA officials will

undoubtedly be talking safety again on Capitol Hill.

 

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