Dishonest Medical Research - Will Transparency Bring Integrity?

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National Institutes of Health Director Elias A. Zerhouni has bowed to congressional pressures and public criticism announcing a drastic set of new anti-corruption rules for thousands of scientists and indeed all employees of the institution. No more stocks, consulting fees or other income from pharmaceutical companies, is the simple prescription.

How deep seated the culture of unethical and fraudulent medical experimentation has become is perhaps exemplified by a recent report in the New York Times which reveals that in experimental cancer studies, performed at the Stratton Veterans Affairs Medical Center in Albany, patient records were falsified in the recruiting process endangering veterans' lives.

How to remedy the situation? Transparency is essential, believes NIH director Zerhouni who, after the internal reforms designed to decrease pharmaceutical influence on scientific activity, has now asked that researchers receiving NIH grants should publish their papers in the Pub Med central database run by the National Library of Medicine. According to a Reuters article, the move is seen as a challenge to scientific journals which normally publish such research. The article mentions Science, Nature and The New England Journal of Medicine.

Certainly making more research openly accessible would be a good start, and if the promise of pharmaceutical companies to publish their studies on websites ever does come through, we might see some much needed changes.

It seems that historically, the British Medical Journal has been considered "a tough nut to crack" by pharmaceutical firms, saying it is difficult to obtain publication of research favourable to this or that drug. In a comment to the BMJ, Stefan Kruszewski, a psychiatrist from Harrisburg, Pennsylvania, implores the journal to

"expose published studies whose conclusions are not corroborated by the research results; where statistical analysis is simply a means to achieve a positive result rather than a meaningful analysis of benefit and reward; and when sloppy and uncontrolled clinical research designs merit neither statistical analysis nor publication."

Kruszewski is a whistleblower, fired for exposing abuses of psychiatric patients in the Pennsylvania Department of Public Welfare.

Vera Hassner Sharav of the Alliance for Human Research Protection is skeptical about the new developments at the National Institutes commenting that

"greed and corrupt research practices have engulfed the NIH. And much as 'Stratton officials turned a blind eye to unethical cancer research practices and punished those who spoke out against them' so did NIH administrators."

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ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
www.ahrp.org

Paul H. Kornak pleaded guilty to fraud, making false statements and criminally negligent homicide in the death of an Air Force veteran, James DiGeorgio—one of the patients he used as subjects in medical experiments that he conducted at  the Veterans Affairs Medical Center in Albany. Kornak admitted that he had conducted such medical experiments without an MD license, had falsified patients’ records, and exposed patients to hazardous experimental treaments. Kornak was convicted of homicide and is awaiting sentencing in May.

Kornak’s lawless research conduct was facilitated by a failed system: "Research violations were a way of life at Stratton for 10 years," said Jeffrey Fudin, a pharmacist at the hospital. "Stratton officials turned a blind eye to unethical cancer research practices and punished those who spoke out against them.”

The New York Times reports that according to the F.D.A., “patients' medical records were altered in at least five experimental drug studies, enabling veterans like Mr. Steubing to be enrolled in studies for which they were either too sick or too healthy to qualify. A patient with coronary disease, for instance, was enrolled in a study that excluded heart patients because of a risk of hemorrhages. A patient with impaired renal function was administered a drug toxic to kidneys that probably contributed to his death, the agency said.”

Veterans at the Albany VA facility are pretty much a captive population, having no alternative treatment options outside the system. The case, however, is a demonstration of systemic failure--not only at VA facilities. Patients at prestigious academic medical centers are also not protected from experiments that expose them to undisclosed risks--their  welfare and best interest are often disregarded, as local institutional review boards (IRBs) rubber stamped their approval. Vulnerable patients are often enrolled in experiments not designed to protect their welfare or to serve their best interest.

For example, critically ill patients in intensive care units at some of the nation’s most prestigious hospitals were recruited into a federally funded, multi-site experiment conducted by the ARDSNet affiliated hospitals. The subjects of the experiment were withdrawn from the individualized treatment prescribed by critical care specialists, and randomly assigned to one of two extreme treatment methods for pumping oxygen into their lungs.  The patients’ condition, in most cases, precluded their ability to give or withhold informed consent. They were conscripted without consent, without full disclosure of the risks or alternative treatment available—the number of patients who may have died who might have lived had they remained on the individually selected treated outside of the research protocol, is in dispute. See: http://www.ahrp.org/infomail/0902/25.php

The Times observes: “In the 1990's, because of a marathon of new drug development, the field of clinical research grew into a multibillion-dollar industry, overwhelming the systems developed to protect human research subjects. The ethical model for those systems was born in 1947 after German physicians were convicted for performing crippling and deadly medical experiments on concentration camp prisoners. But the Nuremberg Code did not stop unethical research.”

Kornak, the NY Times points out, was “a certified clinical research professional who had passed an examination covering such ethical topics as informed consent and clinical fraud.” Just about anyone can become an NIH certified “clinical research professional.” I personally took an online exam administered by NIH and passed within 6 minutes. Such pro-forma “certification” is testimony to the low standards required by NIH for “ethical research certification” demonstrates the cynicism underlying the current “research protection system.”

As recent investigative reports in the Los Angeles Times and the Associated Press have revealed, greed and corrupt research practices have engulfed the NIH. And much as "Stratton officials turned a blind eye to unethical cancer research practices and punished those who spoke out against them” so did NIH administrators.

See: Willman, D. The National Institutes of Health: Public Servant or Private Marketer? The Los Angeles Times
 
See: Solomon, J. NIH AIDS Research Chief Rewrote Safety Report – Associate Press

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

New York Times - February 6, 2005

IN HARM'S WAY

(original here)

Abuses Endangered Veterans in Cancer Drug Experiments

By DEBORAH SONTAG

ALBANY - Carl M. Steubing, a decorated Battle of the Bulge veteran whose experience of war made him a pacifist but also instilled in him a zest for living life at full tilt, took his diagnosis of gastroesophageal cancer in 2001 as a challenge. With a thatch of white hair and a rich baritone voice, Mr. Steubing, at 78, was not ready to succumb to illness. A retired music educator and wedding photographer, he remained active as a church choir director, expert cook, painter, golfer and fisherman. He was married to a woman 24 years his junior, and they had seven children and three grandchildren between them.

Mr. Steubing jumped at the chance to participate in an experimental drug study at the Stratton Veterans Affairs Medical Center in Albany, believing it offered him the hope of surviving longer. The research coordinator, Paul H. Kornak, told Mr. Steubing that he was "just a perfect specimen," with the body of a man half his age, according to Jayne Steubing, Mr. Steubing's widow. He was not, though. Because of a previous cancer and poor kidney function, Mr. Steubing was not even eligible to participate in the experiment, according to government documents. Mr. Kornak, however, brushed that obstacle aside. He altered Mr. Steubing's medical records, according to prosecutors, and enrolled him in the study. He also posed as a doctor. In 2001, Mr. Steubing endured about six periodic treatments with an aggressive three-drug chemotherapy combination. Each infusion made him violently ill and forced his hospitalization. He died in March 2002.

Last month, at the federal courthouse in Albany, Mrs. Steubing glared at Mr. Kornak, 53, as he pleaded guilty to fraud, making false statements and criminally negligent homicide in the death of an Air Force veteran, James DiGeorgio. When Mr. Kornak admitted to falsifying the medical data of "subject initials CMS" - Carl M. Steubing - Mrs. Steubing's face crumpled. Mr. Kornak, who is scheduled to be sentenced in May, also agreed to cooperate in a widening investigation of the hospital's cancer research program. From 1999 to 2003, when he worked there, scores of veterans were, at the least, put at risk. But allegations of carelessness, fraud and patient abuse in the hospital's cancer research program predated Mr. Kornak, and employees say that administrators not only dismissed their concerns, but harassed them for standing up for the veterans