Calls Mounting for FDA Revamp / Americans Are the most medicated population in the world – DHHS

Calls Mounting for FDA Revamp / Americans Are the most medicated population in the world – DHHS

Sun, 26 Dec 2004

A government survey by the U.S. Department of Health and Human Services, confirms that Americans are the most medicated population in the world – 44 percent of Americans had taken at least one prescription drug in the prior month when surveyed in 1999 and 2000 compared to 39 percent during the 1988-1994 period. "The nation’s growing reliance on medications carries a hefty price tag and ranks as the fastest growing part of the $1.6 trillion spent on health care in the United States in 2002"

The drugs most prescribed were antidepressants, anti-inflammatories and drugs designed to control cholesterol and blood sugar levels. But evidence shows that these drugs pose lethal risks which the FDA failed to detect. This failure has brought the agency under public spotlight.

FDA officials are scrambling as Congress is looking for ways to overhaul FDA’s drug approval and monitoring system. The momentum for FDA overhaul is driven by the recent parade of drug problems dominating the nation’s front pages, including antidepressants that trigger suicidal behavior among children, and painkillers–Bextra, Celebrex, and Vioxx–increase the risk of heart attacks or strokes.

The agency’s antiquated computer system which cannot even bring up the data on Celebrex and Vioxx and compare them, underscores how low safety issues are among the agency’s priorities. Dr. Raymond Woosley, vice president for Health Sciences at the University of Arizona, who has trained FDA staffers, and was a top candidate to become FDA commissioner in 2002, called FDA’s failure to make adverse drug effect data accessible to its safety officers, "criminal.”

The Boston Globe reports (below) that Dr. Curt Furberg, professor at Wake Forest University School of Medicine, and a drug safety adviser who was accused by FDA’s deputy director of the Center for Drug Evaluation and Research, Dr. Sandra Kweder, of having an "intellectual conflict of interest," because he examined the Bextra safety data, said: Like Merck & Co with Vioxx and Bayer AG with Baycol, Pfizer Inc. ”suppressed or ignored” problems with Bextra that it knew about last spring. Pfizer ”didn’t talk to anyone, until some of us started raising questions about it in October, six months later.”

The Globe notes that calls to reform the FDA are fuelled by criticism that the agency is "too cozy with the drug industry it regulates and unwilling to act when red flags are raised." US Senator Charles Grassley, an Iowa Republican, will introduce legislation to create an office of drug safety independent of the FDA.

Given the FDA’s dismal record of approving drugs before their safety had been established, and its failure to monitor the safety of widely marketed drugs – even as reports of lethal effects were surfacing – two options present themselves. Either the drug safety division is separated from the drug development division – as Senator Grassley recommends – or the agency’s top brass should be fired, and replaced by scientists who have no ties to the drug industry, and for whom public safety is the single priority. An obvious choice for the drugs safety position is Dr. David Graham.

Moreover, the FDA is facing a people’s revolt over the industry’s price gouging and the agency’s siding with industry. Reuters reports (below) that "More and more states are standing up and accusing the FDA of doing little more than attempting to protect the profits of the pharmaceutical companies it is supposed to be regulating. In fact, it is blatantly obvious to anyone familiar with the situation that the FDA’s mission here is to protect pharmaceutical profits and not to protect public health." Vermont has filed suit against the FDA to allow the importation of prescription drugs from Canada.

Contact: Vera Hassner Sharav
212-595-8974

http://www.boston.com/business/articles/2004/12/25/calls_are_mounting_for_revamp_of_fda/

The Boston Globe
Calls are mounting for revamp of FDA
By Diedtra Henderson, December 25, 2004

Just as the Enron scandal triggered an overhaul of corporate accounting practices, the nation’s prescription drug crisis may prompt a sweeping revamp of the way the Food and Drug Administration ensures drug safety, some say.

The momentum for FDA overhaul is driven by the recent parade of drug problems dominating the nation’s front pages, including antidepressants that heighten suicidal thoughts and behaviors among children, and the painkillers naproxen, Bextra, Celebrex, and Vioxx increasing the risk of heart attacks or strokes.

”Each one of these drugs has affected another large group of Americans and, collectively, the spotlight is now shining on the FDA — more than any other federal agency — as one in need of reform,” said US Representative Edward J. Markey, Democrat of Malden. ”I think Congress will be forced to act in the same way that Enron and MCI Worldcom forced an overhaul of the accounting industry in America.”

On Thursday, the FDA issued a public health advisory cautioning doctors to restrict Bextra and Celebrex prescriptions to fewer patients, including those at high risk for gastrointestinal bleeding. From January through October this year, doctors wrote 30.7 million prescriptions for those drugs, according to IMS Health, a pharmaceutical information company. The agency did not change either drug’s label or remove either drug from the market.

The agency’s action came the same day the New England Journal of Medicine published a letter from Vanderbilt University School of Medicine staffers urging doctors to write fewer Bextra prescriptions because cardiovascular risks linked to the drug ”constitute a potential imminent hazard to public health and thus require action.”

C. Michael Stein, a Vanderbilt clinical pharmacologist and one of three coauthors of the letter, said the FDA’s prescription restrictions pending review of Bextra and Celebrex risks are ”a move in the right direction.”

Fueling calls to reform the FDA, headed for much of the Bush administration by an acting commissioner, is criticism that it is too cozy with the drug industry it regulates and unwilling to act when red flags are raised.

As drug companies absorb the latest body blow — heart safety questions raised by the painkiller naproxen that crippled a government-funded national study — some already plan to transform concerns over drug safety into congressional action.

Specialists inside and outside the FDA say at least three changes are needed before the public can be assured that drugs are safe: naming a permanent FDA commissioner; increasing the agency’s budget to permit meaningful surveillance of the safety of drugs after they are approved for use by consumers; and adding regulatory muscle to require that companies complete promised postmarketing studies. The White House is said to be considering a short list of candidates for a permanent FDA commissioner, and a decision is likely by mid-2005.

And US Senator Charles Grassley, an Iowa Republican, will introduce legislation to create an office of drug safety independent of the FDA. Markey is eyeing ways to speed the slow pace of safety studies that drug companies promise in exchange for swift FDA approval.

US Senator Edward M. Kennedy, a Democrat working with Republican US Senator Michael B. Enzi of Wyoming, is contemplating widespread FDA changes to bolster the safety of drugs once they’re used by millions of Americans. The legislation, still under discussion, would increase the FDA’s budget to conduct stepped-up drug safety surveillance. Epidemiologists would scour massive databases — such as health records kept for 8.2 million members of Kaiser Permanente, the nation’s largest HMO — to track side effects as drugs are used widely. When the epidemiologists spot a worrisome trend, as they did with Vioxx, targeted studies would look to find the drug’s role in causing that side effect. In addition, Kennedy is keen to add the force of law, so the FDA can require postmarketing safety studies that companies promise, but few complete.

”Reform is urgently needed,” Kennedy said. ”It is time for the administration to end its business-as-usual, head-in-the-sand posture toward this healthcare crisis.”

How effective is the FDA’s decision-making on drug safety issues? The question, posed by the Government Accountability Office in dozens of interviews for two congressional committees, cuts to the heart of what millions of patients want to know.

”Much of this can be fixed by strong leadership,” said David A. Kessler, FDA commissioner from 1990 to 1997. ”You don’t need a change in statute to give greater prominence to drug safety review. An FDA commissioner on his or her own could give greater independence to an office of drug safety . . . overnight.”

The current system puts drug companies in charge of monitoring side effects. That system is derided as too crude to pick up subtle increases in common health woes.

But the agency also lacks money for nuts-and-bolts spending. Until recently, new drug applications were logged in a three-ring binder, said Raymond Woosley, vice president for health sciences at the University of Arizona Health Sciences Center. FDA staffers trained by Woosley tell ”horror stories,” he said.

”No one at the agency can sit down at a computer and bring up the data on Celebrex and Vioxx and compare them,” he said. ”Their computer systems are so antiquated, it’s criminal.”

The proposal garnering the most support is Grassley’s plan to create an independent drug safety office to keep drug companies honest.

Absent that, drug safety details trickle out from lawsuits, congressional hearings, and academic meetings.

Curt Furberg’s data linking Bextra to doubled heart risks among patients with heart disease were presented at the American Heart Association annual meeting in early November.

Like Merck & Co. with Vioxx and Bayer AG with Baycol, Pfizer Inc. ”suppressed or ignored” problems with Bextra that it knew about last spring, said Furberg, a Wake Forest University School of Medicine professor and drug safety adviser. Pfizer ”didn’t talk to anyone, until some of us started raising questions about it in October, six months later,” he said.

The firm says it shared information with the FDA in a ”timely manner.” The trial data Pfizer disputed in November were published this month on Bextra’s label, with a warning that the painkiller should not be used immediately after coronary artery bypass graft surgery.

And an independent safety board would have had the teeth to require Merck to conduct more tests when safety issues arose with Vioxx, said David Campen, Kaiser Permanente medical director in pharmacy operations. ”That would put the clear responsibility of the agency back where it truly, truly belongs . . . to serve the safety of the American consumer,” he said.

Critics call withdrawing drug approval an ”atomic bomb” the FDA rarely hurls. And drug label changes are a ”powder puff” solution that does not slow a drug’s use. The push is on for Congress to add more regulatory options.

Dr. Alastair J.J. Wood, a Vanderbilt University Medical Center associate dean, said drug firms should earn the right to corner a market in exchange for safety studies with solid goals. That exclusivity keeps generics at bay, guaranteeing profits to offset research expenses.

”Losing exclusivity doesn’t remove the drug from people who might want to take it,” Wood said. ”It removes the pricing advantage for the company, so they will move heaven and earth to make sure that doesn’t happen.”

Diedtra Henderson can be reached at dhenderson@globe.com.

© Copyright 2004 The New York Times Company

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NewsTarget.com

Source: http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=6981845

Friday, December 24, 2004

Americans are the most medicated population in the world by Paul Simau

Overview:

  • Americans, long considered one of the most medicated peoples in the world, are swallowing more pills than ever, according to a report released on Thursday by the U.S. government.
  • A total of 44 percent of Americans had taken at least one prescription drug in the prior month when surveyed in 1999 and 2000, compared to 39 percent during the 1988-1994 period, according to the U.S. Department of Health and Human Services.
  • The popularity of antidepressants, anti-inflammatories and drugs designed to control cholesterol and blood sugar levels helped fuel increased prescription use among all adult age groups, the HHS said in its annual report on Americans’ health.
  • “Americans are taking medicines that lower cholesterol and reduce the threat of heart disease, that help lift people out of debilitating depressions and that keep diabetes in check,” HHS Secretary Tommy Thompson said.
  • In the case of antidepressants, one of the most common types of drugs handed out by doctors, prescription use among adults nearly tripled between the 1988-1994 and 1999-2000 periods.
  • Pharmaceutical giant Merck withdrew its blockbuster arthritis drug Vioxx from the market in September after a study showed it doubled the risk of heart of heart attack and stroke.
  • A recent analysis by the U.S. Food and Drug Administration, for instance, suggested a link between some antidepressants and suicidal thoughts and behaviors in children and teenagers.
  • There are also fears in public health circles that the growing tendency of Americans, especially seniors, to have more than one prescription in their medicine cabinet could lead to a surge in drug interactions.
  • The nation’s growing reliance on medications carries a hefty price tag and ranks as the fastest growing part of the $1.6 trillion spent on health care in the United States in 2002.

If you enjoy this article, you may also be interested in an article entitled ‘Senior FDA officials suppressed initial findings on suicide link to antidepressant drugs

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http://www.reuters.com/newsArticle.jhtml?type=domesticNews&storyID=6023414

NewsTarget.com

Friday, December 24, 2004

Vermont defies the FDA and sues to allow the importation of prescription drugs from Canada

Vermont now joins five other states who are defying the FDA with a plan to import prescription drugs from Canada to lower the costs of prescription drugs for its state employees and retirees. In fact, Vermont has sued the U.S. Food and Drug Administration and is seeking a court order that will require the adoption of regulations allowing Vermont’s prescription drug importation plan.

The FDA, of course, continues to insist that prescription drugs from Canada are somehow far more dangerous than the very same drugs from the United States, even though Canadian pharmacies have been studied and shown to meet or exceed the very same safety requirements recognized by U.S. pharmacies.

Clearly, the momentum here is against the FDA. More and more states are standing up and accusing the FDA of doing little more than attempting to protect the profits of the pharmaceutical companies it is supposed to be regulating. In fact, it is blatantly obvious to anyone familiar with the situation that the FDA’s mission here is to protect pharmaceutical profits and not to protect public health. If the FDA were really interested in helping the public, it would find ways to allow the importation of more affordable drugs from other countries rather than seeking to block them and effectively monopolize the U.S. drug market.

This is why the FDA is now grasping at straws and coming up with ridiculous claims such as the one that says terrorists will somehow target prescription drugs from Canada. I’m not making this up — the FDA has actually made this claim as part of its argument that prescription drugs should not be allowed to be imported from other countries, thereby forcing U.S. consumers to pay exorbitant prices for such drugs in the United States.

Of course, importing prescription drugs is really only a stop-gap measure to fighting the skyrocketing costs of health care (or “sick-care”) in the United States. Until we actually start investing in disease prevention, we will never reign in the rising costs, no matter how cheaply we can source these prescription drugs. Remember that for every dollar that’s currently being spent on prescription drugs, we as a nation could have spent one penny on prevention and avoided the whole disease in the first place.

Overview:

  • Vermont sued the U.S. Food and Drug Administration on Thursday over the agency’s opposition to the state’s plan to help its employees and retirees import cheaper prescription drugs from Canada.
  • Vermont is the first of many states interested in importing drugs to sue the federal government, which says buying medicines from abroad may pose health risks.
  • “Vermont will not sit back and watch as the cost of health insurance and prescription drugs continues to rise,” Vermont Republican Gov.
  • The state is seeking a court order that will require “prompt adoption” of regulations allowing importation and “appropriate consideration” of Vermont’s plan, the governor’s office said.
  • The rising cost of prescription drugs is a major election year issue as the elderly and others without insurance struggle to pay for their medications.
  • FDA officials say they are particularly worried about drugs bought over the Internet that purport to be from Canada but actually originate in Thailand, China or other countries.
  • Vermont has said its plan would include safeguards, such as requiring prescriptions to be filled by licensed Canadian pharmacies.
  • The FDA’s stance has mirrored that of the pharmaceutical industry, prompting critics to charge the agency with trying to protect drug company profits.
  • Five states already have defied the FDA by setting up plans to help residents import medicines, mainly from Canada where prices for many drugs are lower than in the United States.
  • The FDA argues that buying medicines from abroad is risky because there is no guarantee they are safe and effective.
  • FDA officials were not immediately available to comment on Vermont’s lawsuit.

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