SEC Focusing on Drug Makers Disclosure_ Continuing Medical Ed Changes

Tue, 28 Sep 2004

Evidence showing that drug manufacturers and the FDA concealed negative clinical trial data and deceived physicians, consumers, and shareholders about failure to demonstrate the safety and effectiveness of SSRI antidepressant drugs has caught the interest of the Securities and Exchange Commission.

The Boston Globe reports: “The SEC’s Boston office has made the biotech industry a new focus because of the concentration of companies in the area and the possibility that selective disclosure could seriously harm investors, say lawyers and company officials.”

Another positive development: Continuing medical education courses, the hotbed for off-label prescribing encouragement by influential doctors with financial ties to the companies whose drugs they recommend, is about to undergo change.

The Associated Press reports that the Accreditation Council for Continuing Medical Education (ACCME), which gives its stamp of approval for CME classes will announce sweeping changes today “to limit the influence of doctors with financial connections to the pharmaceutical industry.”

ACCME recognizes that disclosure of conflicts of interest is not enough: doctors will no longer be given a free hand in their CME presentations, nor will they be allowed to make recommendations that are not backed up by hard evidence. “Now, a third party with no ties to the drug company would have to tell the doctor what kind of recommendations he or she could make. Anecdotal observations would be replaced by results of systematic clinical trials. Any review of journal literature would have to include negative, as well as positive, studies.”

Such changes are long overdue-inasmuch as the public has been harmed by dangerous drugs promoted as “safe and effective” for a myriad of off-label uses.

We agree completely with Dr. Bernard Carroll who has recognized the malaise and has called for reforms: “Wherever there is a competing financial interest, there is a potential conflict. And wherever there is a potential conflict, you ought to find somebody else to do the job. Money corrupts and lots of money corrupts absolutely.”

Contact: Vera Hassner Sharav
Tel: 212-595-8974

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The Boston Globe
SEC focusing on drug makers: Full disclosure of tests called key
By Jeffrey Krasner, Globe
September 27, 2004

The Securities and Exchange Commission is scrutinizing biotechnology companies as part of a wider effort to ensure that companies don’t mislead investors by covering up negative results of clinical trials.

The SEC’s Boston office has made the biotech industry a new focus because of the concentration of companies in the area and the possibility that selective disclosure could seriously harm investors, say lawyers and company officials.

“We won’t comment on any particular matter,” said Walter Ricciardi, district administrator of the SEC in Boston, “but speaking generally, we’d note that when companies speak, they must do so truthfully and accurately. Misrepresentations about the status of a product in development can be very damaging to investors.”

The heightened interest comes amid a flurry of Boston-area cases involving disclosure of clinical trial information.

In December, the SEC sent so-called Wells notices to Biopure Corp., its chief executive, and a former official, indicating they were likely to be sued. Four other Biopure officials received such notices in the spring. The Cambridge company said the SEC is looking at whether it misled investors when it failed to tell them the Food and Drug Administration had blocked clinical trials because of safety concerns.

In July, Transkaryotic Therapies Inc. said the SEC had recommended seeking penalties against the Cambridge company and its former chief executive. The commission is investigating company disclosures surrounding its drug Replagal for Fabry disease.

And in August, Cubist Pharmaceuticals Inc. said it is under investigation by the SEC, which is looking at whether the Lexington firm disclosed the results of a clinical trial with a drug candidate in a timely fashion in Jan uary.

Drug companies’ prospects are determined in large part by their success in winning FDA approval for new treatments. For most investors, the way to track drugs in the pipeline is to follow the human clinical trials, which take place over years.

But there are no hard-and-fast rules as to how and when companies must disclose such trial results. Some are published in medical journals or presented at medical conventions. Others are publicized in news releases. Sometimes, companies extract and disseminate specific information from a larger trial, such as disclosing results from a single location.

Regulators have become increasingly concerned that drug companies may be highlighting successful trials while burying the results of failed trials.

In June, New York Attorney General Eliot Spitzer sued GlaxoSmithKline, alleging the drug giant had engaged in “repeated and persistent fraud” by failing to disclose clinical trial information about its antidepressant Paxil. In particular, Spitzer alleged, Glaxo had suppressed trials showing that Paxil was not effective in treating depression in children and adolescents.

“The attorney general’s office has an ongoing interest and concern with respect to the pharmaceutical industry,” said Marc Violette, a spokesman for Spitzer. “I cannot comment on biotech.”

Violette said that, to the best of his knowledge, “this office is not involved in a review of the biotech industry.”

Spitzer’s action has already sparked a small revolution in the medical publishing world. A group of editors of prestigious medical journals, including the New England Journal of Medicine, said this month that they would publish results only from trials that are registered in a central database. The move is intended to prevent the journals from unknowingly highlighting only positive results.

“The drug companies want to tell you the good news, but they want to bury the bad news,” said Dr. Jeffrey M. Drazen, in a recent interview with the Globe.

The disclosure of trial information is particularly important to biotech companies, which tend to be younger and smaller than pharmaceutical firms. Biotech firms often depend on a single promising drug candidate. Share prices often plunge when a biotech firm discloses a clinical setback for that one product.

Because biotechnology firms have fewer products, the threshold for materiality — whether information has enough impact on a firm’s results to require disclosure to investors — is lower for their clinical trial results.

“The larger the company and the more drugs in the pipeline, the less likely the information is going to be considered material,” said Derek M. Meisner, an attorney with Kirkpatrick & Lockhart LLP in Boston and a former SEC enforcement attorney. “If the drug’s success is crucial to the company’s bottom line or scientific credibility, then disclosure may be warranted.”

Meisner said he is advising biotech firms to develop explicit policies to notify their lawyers when trial results are imminent. Company lawyers need to be able to “react to prevent innocent but embarrassing and perhaps even legally actionable” statements by the company, he said.

The new focus on clinical trials began in February, when SEC enforcement director Stephen M. Cutler said the commission would be working more closely with the FDA. One step: The FDA, which has tremendous reservoirs of clinical trial data, will take steps to share “nonpublic information” more quickly with the SEC.

C Copyright 2004 The New York Times Company

http://www.cnn.com/2004/HEALTH/09/28/offlabeldrugs.ap/index.html
CNN
Group seeks limits on drug-financed doctors
Tuesday, September 28, 2004 Posted: 8:03 AM EDT (1203 GMT)

WASHINGTON (AP) — Doctors who receive drug company funding would be limited in what they could teach other physicians under new rules being proposed by accreditors.

The Chicago-based Accreditation Council for Continuing Medical Education, which gives its stamp of approval for such classes, was to announce sweeping changes Tuesday to limit the influence of doctors with financial connections to the pharmaceutical industry.

The nation’s 750,000 physicians stay up to date on medical advances through mandatory participation in thousands of continuing education activities per year.

In the past, a doctor teaching such a course would disclose his or her financial relationship with any drug company, say as a paid member of the company’s speakers’ bureau or a grant recipient. Once that was out in the open, the physician might then talk glowingly about anecdotal experience with that company’s drug.

Now, a third party with no ties to the drug company would have to tell the doctor what kind of recommendations he or she could make. Anecdotal observations would be replaced by results of systematic clinical trials. Any review of journal literature would have to include negative, as well as positive, studies.

“So this whole thing about just saying ‘I’ve got a conflict of interest. And I’ve got a relationship. And I’ve got a personal opinion. And I’m probably biased. But, I’m going to tell you anyways,’ that’s not allowed,” said Murray Kopelow, chief executive of the accreditation council.

Doctors who balk at the new rules will be barred from presenting or teaching at continuing medical education conferences.

The changes were endorsed by the council’s seven members, including the American Medical Association. Kopelow could not say how many doctors would be affected. Earlier this month federal advisers endorsed highly visible “black-box” warning labels linking antidepressants to heightened suicidal thoughts and actions among children. The vast majority of American children who are prescribed antidepressants are taking drugs that have never been proved to ease depression among youngsters.

Pharmaceutical companies are prohibited by law from promoting such off-label use of the drugs. Doctors, however, have faced few similar restrictions. Dr. Norm Fost, a member of the Food and Drug Administration’s Pediatric Ethics Subcommittee, said many doctors are learning about off-label prescriptions during continuing medical education activities. He had no data, though, to support his hunch.

“In 23 studies, none of them has been shown to have any efficacy in children, other than Prozac. And there’s all this increasing noise level about toxicity,” Fost said. “Why would physicians make millions of prescriptions a year? Where would they get that idea?

“Usually, where they get it is from one of three sources. One: pharmaceutical companies. Two: pharmaceutical companies. And three: pharmaceutical companies.”

A Pharmaceutical Research and Manufacturers of America attorney dismissed the notion of “stealth marketing” by drug companies.

“All of the PhRMA member companies know that if they are, in fact, trying to influence the content of an individual speaker’s presentation, they’re risking FDA enforcement,” said Marjorie Powell, PhRMA senior assistant general counsel. “All the companies have to work with FDA all the time.”

One observer called the rule changes “enlightened and refreshing,” but late. “Wherever there is a competing financial interest, there is a potential conflict. And wherever there is a potential conflict, you ought to find somebody else to do the job,” said Bernard J. Carroll, a semiretired psychiatrist who has lobbied for transparency. “Money corrupts and lots of money corrupts absolutely.”

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