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Three Questionable FDA policies: drug factory inspection rules/ clinical trials/ Paxil ads

Thu, 22 Aug 2002

Three news items highlight questionable FDA policies that are in conflict with consumer health interests.

1) Poor quality control standards in American drug and vaccine manufacturing plants is a disgrace.

The Associated Press reports that "just last week, the FDA ordered a Georgia tissue bank to recall soft tissue grafts because it couldn't guarantee they were free of bacterial contamination. Drug maker Schering Plough recently agreed to a $500 million FDA fine for quality-control violations; Eli Lilly & Co. last month said factory problems could delay as many as five drugs under FDA review; and Abbott Laboratories in 1999 paid a $100 million fine in agreeing to clean up its plants."

But rather than accelerating inspections and enforcement to ensure quality control, FDA reduced its factory compliance inspections from 4,300 in 1980 to just 1,600 last year. Fewer inspections produce fewer critical report findings, but fewer inspections mean that American consumers are at increased risk of contaminated medicines.

Now FDA announced a plan that is welcomed by PhRMA, the drug industry representatives. A plan to automate pill production and to minimize FDA inspections. http://www.nytimes.com/aponline/health/AP-Drug-Quality.html

2) Evidence demonstrating that in the rush to bring new drugs to market human subjects are exposed to increased risks of harm in clinical trials-- even before their safety has been shown in animals.

A news report in the British Medical Journal (below) about a diabetes drug trial in 32 countries raises concerns about the FDA's failure to comply with its own human subject protection standards.

A requirement under The Nuremberg Code, the Declaration of Helsinki, and FDA's own "Investigational New Drug" requirement (Ch.9) --is that tests be conducted on animals before a clinical trial on human subjects is allowed to go forth.

But Indian researchers have complained that humans tests were being conducted at the same time as animal tests --and that animal tests revealed the drug caused tumors, first in rats, then in mice. http://bmj.com/cgi/content/full/325/7360/353/a

3) FDA is using its muscle --together with the Justice Department--in an effort to interfere with a court order to stop advertisements for the drug Paxil, an antidepressant drug that, like Prozac, has been the center of multiple lawsuits in which it is claimed the drug caused severe withdrawal symptoms. FDA's move led Karen Barth, the attorney in the case to state:

"The fact that the FDA is now trying to step in and advocate on the side of the pharmaceutical company is disgusting to me.'

The Guardian reports that in the brief, filed Tuesday, the FDA acknowledged that "there were often side effects when patients stop taking certain medications "abruptly,'' but the agency labels drugs as habit-forming only when such drugs "cause drug-seeking behavior, often with the user escalating the dose for psychological or physical gratification.'' http://www.guardian.co.uk/uslatest/story/0,1282,-1962372,00. html

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http://www.nytimes.com/aponline/health/AP-Drug-Quality.html THE NEW YORK TIMES FDA to Revamp Drug Making Rules By THE ASSOCIATED PRESS

WASHINGTON (AP) -- The Food and Drug Administration is poised to revamp rules for safe drug manufacturing for the first time in 25 years, reacting in part to companies' desire to automate pill production and the government's own inability to inspect factories as rigorously as it once did.

The FDA's planned update comes even as numerous major medical factories have repeatedly failed to meet current standards of quality manufacturing.

Just last week, the FDA ordered a Georgia tissue bank to recall soft tissue grafts because it couldn't guarantee they were free of bacterial contamination. Drug maker Schering Plough recently agreed to a $500 million FDA fine for quality-control violations; Eli Lilly & Co. last month said factory problems could delay as many as five drugs under FDA review; and Abbott Laboratories in 1999 paid a $100 million fine in agreeing to clean up its plants.

The FDA said its changes will modernize the way it inspects medical factories -- ultimately focusing most on those that make the riskiest products -- and allow pharmaceutical companies to make better use of new technology that could improve quality.

"There's a tremendous scientific and technological opportunity here, and we need to embrace that and help the industry embrace it,'' FDA drug chief Dr. Janet Woodcock said Wednesday.

For example, she cited fully automated manufacturing systems that some U.S. drug makers use in factories in Europe and other countries -- but not here -- that contain sensors embedded in different steps. Those sensors could tell if a batch of pills or powders has an ingredient wrong, for example. So can FDA-required laboratory testing of a few pills here and a few pills there, but a sensor may provide continuous, immediate quality control, Woodcock said.

The FDA likes the promise of that technology, but drug makers recently told agency officials that they believed the government's 25-year-old manufacturing rules made it too hard for them to adopt it in their U.S. factories. As a first step in its planned update of "good manufacturing practices,'' the FDA already has begun streamlining how companies can adopt such technology, Woodcock said.

The Pharmaceutical Research and Manufacturers of America, the industry's trade group, welcomed Wednesday's announcement, saying FDA's development of new manufacturing standards "will help ensure that patients continue to benefit from timely access to high-quality'' drugs.

But Larry Sasich of the consumer advocacy group Public Citizen called the plans "very, very troubling.''

He questioned whether FDA was loosening some standards simply because it has run out of money to inspect medical factories frequently, and asked how technology could really be transforming the industry when so many factories have recently run into trouble. "It just doesn't add up.''

Last year the FDA inspected 1,600 factories for compliance with good manufacturing practices, down from 4,300 in 1980, Woodcock said. The reason: Even as the number of drugs FDA oversees has increased, Congress has not increased funding for regular inspections to ensure those medications aren't contaminated and contain the proper, safe level of ingredients in each batch.

The FDA's update won't loosen standards but strengthen them so "we'll be able to allocate inspections better based on risk,'' said enforcement chief John Taylor.

The update is expected to take several years to complete; companies must follow the old rules until then.

Copyright 2002 The New York Times Company

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http://bmj.com/cgi/content/full/325/7360/353/a British Medical Journal

BMJ 2002;325:353 ( 17 August ) News Researchers question ethics of diabetes drug trial Ganapati Mudur, New Delhi

Indian scientists have questioned the ethics of clinical trials of a candidate drug for diabetes conducted by the European company Novo Nordisk in 32 countries, including India, before the drug was fully tested in animals.

Novo Nordisk suspended clinical trials of the new molecule ragaglitazar in July after it discovered that several rats and one mouse treated with the drug had developed urinary bladder tumours. The company said it was suspending the trials until the cause of the tumours had been determined. The drug had been discovered by an Indian company, Dr Reddy's Laboratories, and licensed to Novo Nordisk.

The clinical trials across Asia, Europe, the United States, and Latin America had been approved in each country, said Mike Rulis, a spokesperson for Novo Nordisk. He said short duration toxicity tests on animals had been completed before the human trials started.

For drugs that treat chronic conditions such as diabetes, it is permissible to conduct long duration toxicity tests on animals in parallel with human clinical trials, he said.

But a senior official of the Indian Council of Medical Research said that Indian regulations insist that results of toxicity studies on drugs for chronic diseases are available before phase III clinical trials begin. "We do not know on what basis the drug control agency here approved the trials," the official said.

The company said that US and European health authorities had not questioned the continuation of clinical trials when they were told of the tumours in the rats earlier this year. It was only when tumours were detected in a mouse, that the trials were suspended.

"It is unethical for human trials to run concurrently with chronic toxicity tests on animals," said Pushpa Bhargava, founder director of India's Centre for Cellular and Molecular Biology and member of the ethics panel at the Nizam Institute of Medical Sciences, Hyderabad.

"This may be justified for drugs against life threatening conditions like cancer for which no drug exists at all, but this is not the case for diabetes," he said.

He added there was suspicion that countries like India are favoured for trials that might not gain approval in developed countries. Last year, an Indian hospital admitted conducting unapproved trials of a new cancer drug developed in a US university (BMJ 2001;323:299)[Full Text]. ~~~~~~~~~~~~~~~~~~~~

http://www.guardian.co.uk/uslatest/story/0,1282,-1962372,00.html

The GUARDIAN (UK) Fda Faults Ruling On Paxil Ads Thursday August 22, 2002 2:20 AM

LOS ANGELES (AP) - A federal judge was wrong to ban national TV commercials that claim the anti-depressant Paxil is not habit-forming, the Food and Drug Administration said in a new court filing.

The FDA's "statement of interest'' brief asked U.S. District Judge Mariana Pfaelzer to rescind a decision that grew out of a civil lawsuit. FDA officials said they were worried the ruling improperly interferes with the way the agency regulates drugs and drug companies.

"The FDA is concerned about the ruling,'' agency spokesman Lawrence Bachorik said Wednesday. "This is not about a single product or a single company but about FDA's authority over prescription drug advertising.''

The television commercials were reviewed in advance by the FDA and the agency "had no objections,'' according to the brief.

Pfaelzer's preliminary ruling against Paxil producer GlaxoSmithKline comes about a year after a lawsuit was filed on behalf of 35 patients who claimed they suffered withdrawal symptoms such as nausea, fever, and "electric zaps'' to their bodies.

The plaintiffs' attorney, Karen Barth, said the judge "was well within her jurisdiction'' in making the ruling.

"The fact that the FDA is now trying to step in and advocate on the side of the pharmaceutical company is disgusting to me,'' Barth said.

In the brief, filed Tuesday, the FDA said there were often side effects when patients stop taking certain medications "abruptly,'' but the agency labels drugs as habit-forming only when such drugs "cause drug-seeking behavior, often with the user escalating the dose for psychological or physical gratification.''

Pfaelzer found that in other countries, labels on the drug warn of adverse reactions when use of the drug is discontinued.

The commercials were "misleading and created inaccurate expectations about the ease of withdrawal from the drug,'' Pfaelzer ruled Monday.

The judge's ruling is preliminary and comes at an early state of the court proceedings. A hearing is set for Oct. 7 to decide whether the lawsuit should be converted to a nationwide class-action, Barth said.

In the meantime, company attorneys are appealing the judge's decision.

"The U.S. Food and Drug Administration - and not the courts - has the expertise and responsibility for reviewing and regulating pharmaceutical ads,'' David Stout, president of U.S. Pharmaceuticals at GlaxoSmithKline, said in a statement.

Surging U.S. sales of Paxil and the asthma drug Advair led to a 15 percent increase in second-quarter profits for London-based GlaxoSmithKline PLC. Global sales of Paxil grew 29 percent.

Guardian Unlimited Guardian Newspapers

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