Date: Thu, 13 Jun 2002 09:31:03 -0400
Subject: When Money Corrupts Medicine - Deaths Occur

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
www.researchprotection.org
Contact: Vera Hassner Sharav

FYI

The Boston Globe reported that the family of Roger Darke who died in a gene therapy experiment conducted by the late Dr. Jeffrey Isner, has filed a lawsuit against his estate and the hospital at which the experiment was conducted. The investigator was considered a "rainmaker" by the research hospital. But the subjects didn't know about the financial interests of the chief researcher and the hospital. "As lay people we assume doctors in research are doing this for the betterment of mankind," said Susan Darke. "But in this case there were billions of dollars that could have been made. That was something I felt we had a right to know." The family claims Mr. Drake was used by Dr. Isner as "a guinea pig to amass great wealth for himself." To gain insight and a perspective on the scope of the abuse and the calamitous consequences for patients when their doctors have significant financial conflicts of interest, see, a riveting SPECIAL REPORT on this week's Redflaggs Weekly:
http://www.redflagsweekly.com/new_frontiers/2002_june08.html (summary below)

part one:

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.

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WRONGFUL-DEATH SUIT ASSERTS GENE THERAPY FACTS WITHHELD
Boston Globe
Saturday, May 18, 2002
By: Alice Dembner, Globe Staff
Page: B1

The widow of a man who died while participating in a nationally debated gene therapy experiment at St. Elizabeth's Medical Center in Brighton has filed a wrongful death suit against the hospital, three of its doctors, and the companies that funded the experiment. The Suffolk Superior Court suit, apparently the first against the hospital arising from its gene therapy experiments, alleges that study leader Dr. Jeffrey Isner used Roger Darke of Peabody as "a guinea pig to amass great wealth for himself."

Isner died of a heart attack seven months ago just as the hospital was preparing to expand its gene therapy experiments. Darke was 59 and suffering from severe heart disease when he agreed to participate in Isner's study. He died in May 1999 only hours after a gene was injected into his heart to promote growth of new blood vessels. In the suit, Susan Darke says that her husband would never have agreed to the surgery had he known that another participant had died a few months earlier and that Isner and the hospital had a financial stake in the study's outcome. The suit argues that Roger Darke, an electrical engineer, could instead have been treated with a repeat of the bypass surgery he'd had in 1993. "As lay people we assume doctors in research are doing this for the betterment of mankind," said Susan Darke. "But in this case there were billions of dollars that could have been made. That was something I felt we had a right to know." Isner, chief of cardiovascular research, had joined with the hospital and two companies to form Vascular Genetics in 1997 to support his gene therapy research. The suit says Isner or his heirs own 20 percent of the company, the hospital owns another 20 percent, Cato Holdings Co. of Durham, N.C., owns 40 percent, and Human Genome Sciences Inc. of Rockville, Md., owns 20 percent. Previously, hospital officials said their share was actually less than 10 percent and Isner's was well below 20 percent. The suit names Vascular Genetics, Cato Holdings, and a related company, Cato Research, as defendants. Officials at Vascular Genetics and Cato Holdings did not respond to requests for comment. Sonya Hagopian, a spokeswoman for St. Elizabeth's, said, "The medical center is confident that all appropriate procedures were followed with respect to Mr. Darke." Previously, Isner and officials of the hospital and Vascular Genetics had insisted that gene therapy did not cause the death of Darke or of the other patient, Mary E. Lucier of Milford. Isner said the stress of surgery might have contributed to their deaths, but that the patients' underlying illnesses were the root cause. Although the Food and Drug Administration shut down Isner's studies in February 2000, saying he failed to report Lucier's death to the hospital's safety committee and endangered others by improperly enrolling them in the study, neither the FDA nor other regulators faulted him for the patients' deaths. Other patients have credited Isner with saving or enriching their lives. Isner and the hospital have also maintained that their financial interest did not bias their research, but they eventually agreed to disclose that interest to study participants. Last year, they got permission to resume gene therapy experiments and a $10 million federal grant to help fund them. Darke said she doesn't oppose all gene therapy research, but wants to send researchers the message that it's not right to withhold important information from research participants. "We all want cures, we all want people to get well, but I don't want any other family to go through what we did." In the suit, she also alleges that Isner and two of his colleagues "traded upon the Darkes' anxiety about Mr. Darke's illness and the all too human desire for a miracle cure" in getting them to agree to the study. After her husband's death, she says, the doctors tried to "spin the evidence to create the impression that the death was caused by chronic heart failure." She also alleges that the gene injected, a vascular endothelial growth factor, was defective or "unreasonably dangerous." While the suit asks for unspecified financial damages, a cover sheet filed at the court lists $10 million.

CAPTION:
PHOTO
1. Susan Darke (left) lost her husband, Roger, during a gene therapy experiment and is filing a wrongful death suit.
2. Dr. Jeffrey Isner (right) was leader of the experiment at St. Elizabeth's Medical Center in Brighton.
Copyright (c) 2002, Globe Newspaper Company
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