Conflict of Interest

Conflict of Interest: Profits vs Safety

Congressional Investigations

US Senators Pharmaceutical industry holdings, 2004: http://www.consumerwatchdog.org/resources/SenPharma.pdf

Oct 12: How Did the Vioxx Debacle Happen? USA Today / Lancet

Oct 4: Op Ed: Psychiatry on the Ropes–WP / Evidence-based Psychiatry

Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception

Sep 30: GSK Sales Reps told NOT to Divulge Paxil Data / Merck Withdraws Vioxx

Sep 28: SEC Focusing on Drug Makers Disclosure_ Continuing Medical Ed Changes

Sep 16: Black Box Warnings for Antidepressants – What’s Next?

Sep 16: Tell the Truth About Antidepressants On Drug Labels & in Medical Journals

Sep 14: AHRP Press Briefing Re: Antidepressant Drug Risks

Sep 8: FDA Forced Wyeth to REMOVE Suicide Warning from Effexor Label

Sep 2: Antipsychotic Drug Use Doubled since 1996 in Tennessee Children – Why?

Aug 13: Time for a Drug Test Registry_Marcia Angell_Why NIH is Not Up to the Task

Aug 13: Bradshaw cancels appearance after SSRI-Citizen Press Release Announced Protest

Aug 5: Spitzer Expands drug Probe: Johnson & Johnson / New FDA analysis Confirms SSRI Risks to Kids – WSJ

Aug 4: FDA Approves Lilly’s Cymbalta for Depression Despite Risk of Suicide

Aug 3: Drug safety Hearings-Sept-Congress/ FDA – Lilly Plans to Disclose Data

Jul 27: Bill Moyers: the Real Show…Congressional hearing was abruptly cancelled

Jul 26: Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits – NYT

Jul 22: Concealed Drug Trial Results Mislead Doctors & Put Children’s Lives at Risk – NYT

Jul 21: Cong Greenwood’s version

Jul 21: Hearing on Antidepressants Canceled – Washington Post

Jul 20: Corruption of Cong by Pharma: Greenwood offered job / drops Pharma hearing

Jul 19: Clinical Trials Controversy Spotlights Flawed System – Psychiatric News

Jul 14: Statin-Cholesterol Guidelines–Industry influenced?

Jul 9: FDA Squelches an Article Raising Doubts on Safety Of Device to Repair Artery – WSJ

Jul 9: Paxil for Children: Safety, Efficacy Aren’t Established – Letter WSJ

July 7, 2004: Pharma Influence: Penn Psychiatrist Files Whistleblower Lawsuit – Investigtion Confirms Medicare Chief Lied to Congress

Jul 6: FDA Failed to Enforce Law Requiring Drugmakers to Disclose Test Data – WashPost

June 30,2004: NYS AG Expands Pharmaceutical probe – Forest Labs

June 30, 2004: Response to Washington Post Editorial "Missing Drug Data"

Jun 28. 2004: Scientists Decode Secret of Getting NIH Grants – WSJ

Jun 27, 04: NIH Under Fire: Longtime Favorite of Congress – Wash Post / WSJ

Jun 26, 2004: Forest Labs Admits Concealment of data – Congressional Probe Expands

Jun 23: AHRP: Published NIMH Funded Prozac Trial Report Concealed Suicide Attempts by Teens

Jun 21: Antidepressants – USA Today Editorial / AHRP OpEd/ WSJ Editorial Bashes Spitzer

Jun 20: HMO physician applauds Spitzer’s focus on information bias / NYT blind spot

Jun 7, 2004: Paxil induced suicides in US quantified – Glaxo Faces criminal action in UK over “suicide” pills – Times

Jun 6, 2004: NY Times Editorial Gets it Right: When Drug Companies Hide Data

Jun 5: “Black Hole” of medical research–Negative Results Don’t get Published – JAMA, WSJ

Jun 2, 2004: NYS Attorney General files suit against GlaxoSmithKline

Jun 2: NY Times Does it Again – Drug Advertisers Get Front Page Coverage to Boost SSRI Market

May 25, 2004: FDA role in suppressing damaging data – WSJ

May 24, 2004: More than 100 top regulatory officials represented industry as lobbyists, lawyers – Denver Post

May 18, 2004: Lawmakers accused leaders of the NIH of encouraging “the option of corruption.”

May 17, 2004: Paxil Sales Plummet in UK (372K PDF)

May 16, 2004: Pfizer Admits Guilt in Promotion of Neurontin–Agrees to Pay $430 Million

May 7, 2004: NIH Panel Recommendations Fail to Resolve Conflicts of Interest

May 6, 2004: Interview with Shannon Brownlee (NPR)

Apr 13, 2004: Doctors Without Borders: Why you can’t trust medical journals anymore

Mar 25, 2004: Antidepressant Controversy: Media Conflicts of Interest – New York Times

Mar 2, 2004: Ethics Policy Announced for NIH Officials – LAT

Jan 29, 2004: Antidepressant Makers Withhold Data on Children – Washington Post

Jan 25, 2004: ACNP Summary Report Criticized as “Junk Science”

Jan 21, 2004: ACNP – a pharmaceutical industry funded association of psychiatrists – claims SSRI Antidepressants don’t increase suicidal behavior

Jan 7, 2004: FDA Sham Conflicts of Interest Policy

Dec 7, 2003: Stealth Merger: Drug Companies and Medical Research at NIH – LAT

Aug 15, 2003: Almost 1/2 of faculty on IRBs have ties to industry – Harvard Partners

Aug 3, 2003: Psychiatrist’s Undisclosed Financial Ties Prompt Reproval – NYT

June 20, 2003: Time to put drug giants on trial – Scotsman (UK)

April 5, 2003: AHRP Comments: DHHS COI Guidance for Human Subject Protection

March 30, 2003: CNN: Drug Argument Embroils Psychiatrists, Pharma Companies

March 19, 2003: Conflicts of Interest Taint UK Gov panel investigating SSRI

November 22, 2002: Tonight PBS Is Science for Sale?

September 30, 2002: Ritalin Outrage: Congress_ Big Media Under the Influence of Big Drugs

August 25, 2002: Integrity in Scientific Research : Peer review ineffective – Institute of Medicine / Lancet / Science

August 1, 2002: Randomized Controlled Trials: Evidence Biased Psychiatry, an original article by David Healy MD, MRCPsych,  in which he challenges the scientific assumptions about the value of evidence obtained from randomized controlled clinical trials.

July 15, 2002: The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration. By Irving Kirsch, Thomas J. Moore, and Alan Scoboria and Sarah S. Nicholls.

A meta-analysis of efficacy data submitted to the U.S. Food and Drug Administration for approval of the six most widely prescribed antidepressants approved between 1987 and 1999. They report that, although the difference in drug versus placebo response was statistically significant, approximately 80% of the medication response was duplicated in the placebo control. The accompanying expert commentaries reflect the broad range of reactions that such findings provoke. http://journals.apa.org/prevention/volume5/pre0050023a.html

Response to the commentaries Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions http://journals.apa.org/prevention/volume5/pre0050033r.html

July 15, 2002: Short Drug Tests, Fatal Flaws. Thomas J. Moore. Op Ed. Boston Globe

July 14, 2002: Corporate influence on medicine, budgets & investors

June 13, 2002: When Money Corrupts Medicine – Deaths Occur

June 13, 2002:

In 1984 the NEJ M became the first of the major medical journals to require authors of original research articles to disclose any financial ties with companies that make products discussed in papers. In accordance with the NEJM policy, editorial reviewers could have no financial ties to the companies. In 2002, Dr. Jeffrey Drazen, the journal’s new editor, abandoned the Journal’s policy of containing conflicts of interest, claiming "it is becoming tough to find doctors to write such articles." The change, Drazen wrote in the June 13, 2002 issue of the Journal, is designed "to enhance the depth and breadth of the journal’s content while ensuring that the articles we publish are not influenced by financial interests.” The Boston Herald indicated that Drazen claimed: "We’re strengthening the journal.” But Dr. Jerome Kassirer, former editor of the NEJM, blasted the new policy. http://www.bostonherald.com/news/local_regional/nejm06132002.htm

June 8, 2002: Fraudulent Conduct that Takes Lives: Why Criminal Prosecution of Medical Researchers with Financial Conflicts, Who Fabricate Safety Data, has Become an Essential Component of Regaining the Integrity of Device and Drug Research in the United States

By James J. Neal, Copyright 2002

"Giant corporations are locked in a life and death struggle to provide one of a kind instrumentation with which a given operation ‘must’ be done." Editor, Michael Baggish M.D., Journal of Gynecologic Surgery.

"Rare is the disinterested researcher. It is a phenomenon found in every medical treatment using devices." "If you can’t trust the studies, what happens to the profession and what happens to patients." John Wasson, M.D., Dartmouth, New York Times.

"We’ve lost our way. We’ve terribly, terribly lost our way. Science has been lost in the rush for money." Steven Nissen, M.D., Cleveland Clinic, New York Times.

"Organs punctured include bile ducts, bowel, small intestine, liver and arteries and veins. Data shows high morbidity." Pennsylvania Medical Society, comments on "hi tech" surgical devices.

Summary: In recent years, surgical instrument companies working through surgeons with concealed equity interests in devices, have created new procedures, to promote the sale of equipment. Corporations have created demand for new surgical procedures "through massive advertising campaigns to convince the public of [their] necessity." Rutkow, IRA, The Socioeconomic Tyranny of Surgical Technology. Archives of Surgery. Leading surgical researchers, with equity interests have fabricated surgical research to demonstrate the safety and efficacy of new procedures with device costs of $2,000-$5,000 per operation. One sales rep described his companies’ philosophy as "dollars per procedure." Although the device industry has generated tens of billions of dollars in revenue using these tactics, serious surgical morbidity from many new device dependent operations has multiplied. Treating MD’s and patients need law enforcement’s assistance in deterring fabricated research data published by research surgeons with concealed equity interests in expensive medical devices, and new drugs. The question raised in this analysis is whether fraudulent medical research is taking lives, and if so, how many.

For complete article go to: http://www.redflagsweekly.com/new_frontiers/2002_june08.htm

June 5, 2002: APA Under the Influence of PhaRma

June 13, 2002: Vermont to Require Drug Makers to Disclose Payments to Doctors
By MELODY PETERSEN
The New York Times

Vermont follows Minnesota in its efforts to contain the cost of medicine by requiring public disclosure of conflicts of interest. A law will require drug companies to disclose the gifts and cash payments they make to doctors. We have not heard of similar moves by states that have major medical centers such as: New York, Massachusetts, Maryland or California. http://www.nytimes.com/2002/06/13/business/13DRUG.htm

May 30, 2002: Bitter Medicine: Pills, Profit & the Public Health – ABC News

May 23, 2002: FDA -Conflicts of Interest to be expanded – Washington Post

May 21, 2002: Bitter Pill for David Healy: academia under pharma influence

May 6, 2002:  "Conflicts of Interest in Clinical Trials", a presentation by Vera Hassner Sharav before the U.S. Army Medical Department and Henry M. Jackson Foundation for Advancement of Military Medicine on Conflicts of Interest in Medical Research.

September 24, 2001: The American Prospect.

Pharma Buys a Conscience By Carl Elliott, MD, PhD

The issue of corporate money has become something of an embarrassment within the bioethics community. Bioethicists have written for years about conflicts of interest in scientific research or patient care yet have paid little attention to the ones that might compromise bioethics itself. Arthur Caplan, the director of the University of Pennsylvania Center for Bioethics, counsels doctors against accepting gifts from the drug industry. "The more you yield to economics," Caplan said last January, "the more you’re falling to a business model that undercuts arguments for professionalism." Yet Caplan himself consults for the drug and biotech industries, recently coauthored an article with scientists for Advanced Cell Technology, and heads a bioethics center supported by Monsanto, de Code Genetics, Millennium Pharmaceuticals, Geron Corporation, Pfizer, AstraZeneca Pharmaceuticals, E.I. du Pont de Nemours and Company, Human Genome Sciences, and the Schering-Plough Corporation.

By no means does Caplan’s center stand alone in its coziness with industry. The University of Toronto houses the Sun Life Chair in Bioethics; the Stanford University Center for Biomedical Ethics has a program in genetics funded by a $1-million gift from SmithKline Beecham Corporation; the Merck Company Foundation has financed a string of international ethics centers in cities from Ankara, Turkey, to Pretoria, South Africa. Last year the Midwest Bioethics Center announced a new $587,870 initiative funded by the Aventis Pharmaceuticals Foundation. That endeavor is titled, apparently without irony, the Research Integrity Project.

Bioethics appears set to borrow a funding model popular in the realm of business ethics. This model embraces partnership and collaboration with corporate sponsors as long as outright conflicts of interest can be managed. It is the model that allows the nonprofit Ethics Resource Center in Washington, D.C., to sponsor ethics and leadership programs funded by such weapons manufacturers as General Dynamics, United Technologies Corporation, and Raytheon. It also permits the former president of Princeton University, Harold Shapiro, to draw an annual director’s salary from Dow Chemical Company while serving as chair of the National Bioethics Advisory Commission. Dow, of course, has been the defendant in a highly publicized lawsuit over the Dow Corning silicone breast implants as well as in numerous legal actions involving disposal of hazardous waste.

Part of the problem is aesthetic. It is unseemly for ethicists to share in the profits of arms dealers, industrial polluters, or multinationals that exploit the developing world. But credibility also is an issue. How can bioethicists continue to be taken seriously if they are on the payroll of the very corporations whose practices they are expected to assess?

Read complete article (free): http://www.prospect.org/print/V12/17/elliott-c.html

May 18, 2000. The New England Journal of Medicine.

Is Academic Medicine for Sale?

By Marcia Angell, MD – Vol. 342, No. 20

Finding an editorialist to write about the article presented another problem. Our conflict-of-interest policy for editorialists, established in 1990, ( ) is stricter than that for authors of original research papers. Since editorialists do not provide data, but instead selectively review the literature and offer their judgments, we require that they have no important financial ties to companies that make products related to the issues they discuss. We do not believe disclosure is enough to deal with the problem of possible bias. This policy is analogous to the requirement that judges recuse themselves from hearing cases if they have financial ties to a litigant. Just as a judge’s disclosure would not be sufficiently reassuring to the other side in a court case, so we believe that a policy of caveat emptor is not enough for readers who depend on the opinion of editorialists.

..

In this editorial, I wish to discuss the extent to which academic medicine has become intertwined with the pharmaceutical and biotechnology industries, and the benefits and risks of this state of affairs. Bodenheimer, in his Health Policy Report elsewhere in this issue of the Journal, provides a detailed view of an overlapping issue — the relations between clinical investigators and the pharmaceutical industry.

The ties between clinical researchers and industry include not only grant support, but also a host of other financial arrangements. Researchers serve as consultants to companies whose products they are studying, join advisory boards and speakers’ bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company-sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the companies.

Read complete article (for pay) : http://www.nejm.org/content/2000/0342/0020/1539.asp

May 18, 2000. The New England Journal of Medicine.

"Uneasy Alliance — Clinical Investigators and the Pharmaceutical Industry"

By Thomas Bodenheimer, MD, MPH. Vol. 342, No. 20

How much influence does industry have over the work and products of the research community? Can practicing physicians trust the information they receive about the medications they are prescribing? Does the shift from the academic to the commercial research sector give industry too much control over clinical drug trials?

In this report, I discuss some of the problems raised by pharmaceutical-industry funding of drug trials, problems that may deepen as trials are increasingly conducted by commercial organizations. I interviewed 39 participants in the process: 6 pharmaceutical executives, 12 clinical investigators, 9 people from university research offices, 2 physicians with CROs, 8 people who have studied the process of clinical drug trials, and 2 professional medical writers. Each interview consisted of standard questions plus an opportunity for the interviewees to discuss the industry-investigator relationship in a general way. Several interviewees preferred not to allow the use of their names in the article.

Read complete article (for pay): http://www.nejm.org/content/2000/0342/0020/1539.asp

May 22, 1999: This smashing NY Times editorial (below) should awaken the public and its elected policy makers to the need for reform our Federal human subject protection regulations so that patients don’t become unwitting commodities.

THE NEW YORK TIMES

EDITORIAL

May 22, 1999

Patients for Hire, Doctors for Sale

People go to doctors because they assume the doctor will tell them what they need to do to stay healthy or get well. But in articles

published in The Times on Sunday and Monday, the reporters Kurt Eichenwald and Gina Kolata have opened the door on a practice of medicine that few of us knew existed – a warped world in which patients have become commodities, lured into research projects for the profit of their doctors.

In pushing to create a supermarket of new pills, the pharmaceutical industry has created a frantic competition for patients on whom new drugs must be tested before they can be approved. A bounty system has evolved in which doctors are paid by drug companies to enroll research subjects with certain kinds of problems: $1,200 from Bayer for a patient with vaginitis; $2,955 from Merck for one with hypertension; $4,410 from SmithKline Beecham for a willing diabetic.

The devil’s bargain is that the doctor knows that enrolling the patient is worth money, but the patient does not. It is a recruiting system with the potential to corrupt either the drug companies, because they are forced to outbid each other for patients, or the doctors, because they are tempted to enroll patients who may not be medically appropriate.

The articles reveal a whole research universe slipping out of control. A review by The Times of more than 300 recent drug studies, and more than 200,000 government research request files, found hundreds of thousands of patients involved and indications that some doctors make $500,000 to $1 million a year in recruitment bounties.

One Southern California doctor now in prison forged his patients’ medical records and test results on a massive scale to boost his income.

In the past, most clinical trials of drugs were conducted by doctors at medical research institutions. But that system proved too slow at recruiting patients, so the drug companies and their contractors turned to doctors in private practice, tripling their number since 1990.

Meanwhile, the monitoring systems to protect patient welfare, already under fire for past performance, have shown no interest in the ethical conflict of doctors being paid to recruit their own patients.

Dr. Nancy Dickey, president of the American Medical Association, says that the bounty system is unethical by A.M.A. standards and that the organization will work with Federal regulators to try to end the practice.

They need to act expeditiously. The patient search has now begun to tap the poor populations of South America, threatening to corrupt the practice of medicine even more widely.

© The New York Times

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available to advance understanding of ecological, political, human rights, economic, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior general interest in receiving similar information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use copyrighted material for purposes of your own that go beyond ‘fair use’, you must obtain permission from the copyright owner.