Obama HHS/FDA Torpedo Public Safety, Again: Useless Studies, Real Harm

AHRP has;

Useless Studies, Real Harm

Monday, 01 August 2011

The Obama Administration has embarked on an aggressive course of action that will accelerate the pace at which the integrity of American medicine--is sullied beyond repair.

Commercially-driven biomedical research--in particular, research involving prescription drugs, vaccines, and medical devices---has corrupted the entire field of medicine, both academic research and clinical practice. Americans' health is being undermined by expensive, defective, all-too often, treatments that, at best, are useless. A worst, they kill or cause serious permanent damage.

A sobering OpEd piece in The New York Times by Carl Elliott, MD, PhD, "Useless Studies, Real Harm," provides a window to the extent to which biomedical research has been degraded by commercially-driven clinical trials,

Rather than addressing the spreading problem, the Obama Administration has embarked on an aggressive course of action that will accelerate the pace at which the integrity of American medicine--is sullied beyond repair.

1. The Obama Administration has proposed massive changes in regulatory oversight governing research with human subjects.

The proposed regulatory changes to 45 CFR 46--in particular, (1) the elimination of local institutional review board oversight from multi-site clinical trials, and (2) the broadening of expedited review of clinical trial protocols, would significantly worsen both the safety of human subjects in research, and would further erode the scientific integrity of clinical trials.

If adopted, the proposed changes-- delineated in a 92 page document-- would, in effect, dismantle existing federal protections under 45 CFR 46.

2. Bloomberg News reports that FDA Commissioner, Margaret Hamburg, told Public Citizen that the 2008 conflicts of interest policy governing FDA advisory panels would be loosened. (below)

3. In June, HHS submitted a proposal to conduct a trial to test the highly controversial, hazardous anthrax vaccine in children.

Read AHRP's letter to Secretary Kathleen Sibelius outlining the legal and moral prohibitions against exposing healthy children to research involving risks of harm with no direct benefit to justify the risk. Furthermore, without concrete evidence--rather than hypothetical scenarios--it is immoral to expose children to the documented severe risks linked to the anthrax vaccine.

**AHRP has requested an extension of at least 120 days from the 60 day period allotted to public comment:

"Given the size of the document (HHS-OPHS-2011-0005) and the extensive proposed changes to the existing federal human research protection regulations, the 60 day period for public comment is simply inadequate to the task of a careful examination of the proposed changes and a thoughtful consideration of the ramifications of such proposed changes.

Therefore, the Alliance for Human Research Protection respectfully requests an extension of at least 120 days for the public comment period."

** We suggest YOU request an extension as well.

To request an extension go to: http://www.regulations.gov/#!home It will say, "Enter keyword or ID" type: HHS-OPHS-2011-0005

The first item is HHS-OPHS-2011-0005-0012, click "Submit Comment"

and you will then be asked to insert your name and org. and comment:

Vera Hassner Sharav

Bloomberg News

Conflict-of-Interest Rules May Be Relaxed in 2012, Hamburg Says

By Jeffrey Young - Jul 25, 2011

Conflict-of-interest rules restricting scientists with financial ties to drug and device- makers from advising U.S. regulators may loosen next year, said Food and Drug Administration Commissioner Margaret Hamburg.

A 2008 policy limiting researchers who were paid by manufacturers from serving on advisory panels may be curtailing feedback the FDA receives, Hamburg told the advocacy group Public Citizen in Washington today. Changes may come through a renewal of the law letting the agency receive fees from companies such as Pfizer Inc. (PFE) for product reviews.

“We have to be sure that FDA has subject-matter experts that we need for our important decision making,” Hamburg said, adding that the agency also must “prevent inappropriate influence or distortion of information” that may compromise reviews. Patient-advocacy groups and academic researchers have expressed “valid concerns” about the conflict-of-interest policy, prompting an agency rules review, she said.

Republicans in Congress and manufacturers have criticized the pace of FDA reviews as too slow, blaming unanticipated requests for safety information from FDA staff and advisers.

Representative Fred Upton of Michigan, the chairman of the Energy and Commerce Committee, said this month the conflict-of- interest rules are slowing new product approvals because advisory committees lack sufficient qualified members. Twenty- three percent of the seats on the FDA’s advisory committees weren’t filled as of March, with 608 positions occupied and 138 vacant, according to the agency’s website.

Congressional action on product-review fees has created a “renewed sense of interest” and will provide critics of the policy with an opportunity to petition for fewer restrictions on participation on FDA advisory committees, Hamburg said.

The rules shouldn’t be changed because financial interests influence the way products are evaluated, said Robert Weissman, president of Public Citizen. “We need stronger protection rather than less,” he said after Hamburg’s remarks.

To contact the reporter on this story: Jeffrey Young in Washington at jyoung89@bloomberg.net.

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net

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THE NEW YORK TIMES

July 28, 2011

Useless Studies, Real Harm

By CARL ELLIOTT

Minneapolis

LAST month, the Archives of Internal Medicine published a scathing reassessment of a 12-year-old research study of Neurontin, a seizure drug made by Pfizer. The study, which had included more than 2,700 subjects and was carried out by Parke-Davis (now part of Pfizer), was notable for how poorly it was conducted. The investigators were inexperienced and untrained, and the design of the study was so flawed it generated few if any useful conclusions. Even more alarming, 11 patients in the study died and 73 more experienced “serious adverse events.” Yet there have been few headlines, no demands for sanctions or apologies, no national bioethics commissions pledging to investigate. Why not?

One reason is that the study was not quite what it seemed. It looked like a clinical trial, but as litigation documents have shown, it was actually a marketing device known as a “seeding trial.” The purpose of seeding trials is not to advance research but to make doctors familiar with a new drug.

In a typical seeding trial, a pharmaceutical company will identify several hundred doctors and invite them to take part in a research study. Often the doctors are paid for each subject they recruit. As the trial proceeds, the doctors gradually get to know the drug, making them more likely to prescribe it later.

In an age of for-profit clinical research, this is the new face of scandal. Pharmaceutical companies promote their drugs with pseudo-studies that have little if any scientific merit, and patients naïvely sign up, unaware of the ways in which they are being used. Nobody really knows how often companies conduct such trials, but they appear with alarming regularity in pharmaceutical marketing documents. In the marketing plan for the antidepressant Lexapro for the 2004 fiscal year, Forest Laboratories described 102 Phase IV trials — the classification under which seeding trials fall — in a section labeled “Marketing Tactics.”

Oversight bodies like the Food and Drug Administration generally don’t view seeding trials as research scandals: seeding trials are not illegal, and the drugs in question have already received F.D.A. approval. But even after particularly egregious seeding trials have been exposed, the F.D.A. has not issued sanctions. Take the notorious Advantage study, a seeding trial of the pain reliever Vioxx conducted by Merck. According to a 2008 report in the Annals of Internal Medicine, litigation documents show that the Advantage study was conceived and managed by Merck’s marketing department. Three subjects died in the Advantage trial; five more subjects experienced heart attacks. Oversight bodies should treat the Advantage study as a violation of research ethics.

How can studies that endanger human subjects attract so little scrutiny? Forty years ago, when most clinical research took place in academic settings, the main dangers to research subjects came in service to genuine scientific aims. A large regulatory apparatus was developed to protect human subjects from the ambitions of overweening academic researchers. In the early 1990s, however, pharmaceutical companies realized that it was faster and less expensive to conduct trials in the private sector, where the driving force is not knowledge, but profit. And the regulatory apparatus designed for the old era has proved woefully inadequate for the new one.

The main source of protection for research subjects is a patchwork system of ethics committees known as institutional review boards, or I.R.B.’s. These are small, federally empowered bodies that review research proposals before they are carried out, to ensure that the studies are ethically sound. But they don’t typically pass judgment on whether a study is being carried out merely to market a drug. Nor do most I.R.B.’s have the requisite expertise to do so. Even worse, many I.R.B.’s are now themselves for-profit businesses, paid directly by the sponsors of the studies they evaluate. If one I.R.B. gets a reputation for being too strict, a pharmaceutical company can simply go elsewhere for its review.

Last week, the federal government announced that it was overhauling its rules governing the protection of human subjects. But the new rules would not stop seeding trials. It is time to admit that I.R.B.’s are simply incapable of overseeing a global, multibillion-dollar corporate enterprise. They should be replaced with an oversight system that is financially and administratively independent of the research it oversees. The system must have the power to impose sanctions, and its responsibilities must extend to fraud, bribery and corruption.

Many patients volunteer for research in the hope that the knowledge generated will benefit others. When a company deceives them into volunteering for a useless study, it cynically exploits their good will, undermining the cause of legitimate research everywhere.

Carl Elliott teaches bioethics at the University of Minnesota and is the author of “White Coat, Black Hat: Adventures on the Dark Side of Medicine.”

*Dr. Elliott holds dual professorships at the University of Minnesota Medical School: Professor, Department of Pediatrics, and Professor, Department of Philosophy. His wide ranging scholarly interests include the ethics of enhancement technologies, research ethics, the philosophy of psychiatry, and the work of Ludwig Wittgenstein and Walker Percy. His articles have appeared in The Atlantic Monthly, The London Review of Books, The Believer, The American Prospect and Dissent. Dr. Elliott is the author or editor of six books, including A Philosophical Disease: Bioethics, Culture and Identity (Routledge, 1999) and Better than Well: American Medicine Meets the American Dream (Norton, 2003.) White Coat, Black Hat: Adventures on the Dark Side of Medicine (Beacon Press, 2010.)

Thank You AHRP