VA Drug Study Deaths under Criminal Investigation in NY_BNA

[Guest guest]

http://www.researchprotection.org/infomail/0203/06.html

 

VA Drug Study Deaths under Criminal Investigation in NY_BNA

 

Thu, 6 Feb 2003

 

Alexander Otto of the Bureau of National Affairs (BNA) has uncovered a criminal

investigation at the VA Medical Center in Albany, NY following the deaths of 5

patients who were inappropriately enrolled in a cancer drug trial. The Albany VA

experiment was part of a nationwide trial involving 450 patients funded by Ilex

and the National Cancer Institute.

 

" Dr. James Holland, former chief of oncology at the Albany center, and Paul

Kornak, former research assistant in the hematology and oncology department,

could face involuntary manslaughter charges. " Veterans Affairs spokesman John

Wooditch confirmed the criminal investigations.

 

According to BNA, FDA found substantial problems in 54 of the 55 patient charts

prepared by Holland and Kornak that it reviewed during its own early-January

investigation. "

 

BNA reports that the pair are accused of fabricated data, improperly enrolling

patients, failing to report adverse events, altering medical charts, and other

serious acts of research misconduct in drug company studies involving almost 100

patients. " The actions probably caused one death and may have caused at least

four more. "

 

This case sheds light on the culture in which medical research is currently

conducted in the US. Patients are at high risk when they participate in clinical

trials. There are no effective safeguards to protect their health and welfare.

 

As one Albany observer put it: Researchers " may be too incentivized to recruit

patients. They may be too incentivized to get results. "

 

This is not an isolated instance of research abuse or preventable research-

related deaths. In 2000 research at the West Los Angeles VA, Duke University and

Johns Hopkins were shut down for similar abuses. Most cases of research

violations are covered up by the institution involved.

 

This is not an example of a few " bad apples. The entire research enterprise has

been hijacked and corrupted by financial conflicts of interest. These

intertwined financial interests now undermine patient safety, the integrity of

research , and scientifically valuable research, that may not have immediate

market value is being derailed. Medical institutions and their faculty have come

to regard clinical research as a cash cow.

 

Who are the watchdogs and what actions do they take to hold violators

accountable?

 

The Office of Research Compliance and Assurance (ORCA), was established in 1999

as an independent watchdog office within the VA specifically to enforce human

research protection rules. It did so and shut down some research until

safeguards were in place. Instead of encouraging ORCA to conduct an

investigation of the Albany VA, the bureaucracy at VA central tried to shift the

blame on ORCA. In mid-January, Dr. Robert Roswell, Under Secretary for Health,

abolished ORCA.

 

Oversight agency actions are inconsistent and are, therefore, no deterrent to

misconduct. [see: AHRP Infomail, Dec. 16 at:

http://www.ahrp.org/infomail/1202/16.html]

 

It appears that neither the safety of human subjects nor the integrity of

research is a priority for officials at FDA and the VA. Unless the free press

investigates, the public would be kept in the dark about research crimes and

misconduct.

 

~~~~~~~~~~~~~~~~~~~~~~

 

Medical Research Law & Policy Report Copyright 2003, The Bureau of National

Affairs, Inc.

 

Human Subject Protection Researchers Under Criminal Investigation For VA Drug

Study Deaths in New York

 

By M. Alexander Otto

 

Two medical researchers are under criminal investigation for the deaths of at

least five patients in drug studies at the Stratton Veterans Affairs Medical

Center in Albany, N.Y., BNA has learned, as VA officials take action to address

study safety issues the incidents have uncovered. Dr. James Holland, former

chief of oncology at the Albany center, and Paul Kornak, former research

assistant in the hematology and oncology department, could face involuntary

manslaughter charges if federal investigators determine they were at fault in

the deaths of patients enrolled in the studies, sources close to the case said.

 

Either Holland or Kornak or both allegedly fabricated data, improperly enrolled

patients, failed to report adverse events, altered medical charts, and committed

other serious acts of research misconduct in drug company studies involving

almost 100 patients. The actions probably caused one death and may have caused

at least four more, according to Stratton's preliminary investigation.

 

Veterans Affairs spokesman John Wooditch confirmed the criminal investigations.

 

The Albany center dismissed Holland in early January and Kornak on Jan. 31,

Arthur K. Wu, staff director of the House Veterans' Affairs Subcommittee on

Oversight and Investigations, told BNA Feb. 3.

 

Some of the patients signed up for the pair's studies allegedly were not

appropriate candidates for the experimental drugs given. Taking them could have

at least contributed to patients' deaths, said Wu, who helps advise the House

Committee on Veterans' Affairs on VA research issues.

 

The Albany center released a press statement Feb. 4 admitting the misconduct

probe. A VA press officer acknowledged the move was a response to BNA's

investigation and breaking of the story that morning. " The medical center has

taken the necessary steps to ensure that all ongoing research studies strictly

adhere to regulations and procedures, and that the interests of all study

participants are protected, " according to the Feb. 4 statement, which gave few

details. Albany had declined to talk to BNA previously.

 

Link to Drug Companies. VA medical centers conduct a vast amount of medical

research involving veterans. As at university medical centers, a great many of

those studies are funded by the pharmaceutical industry.

 

Financial ties between drug companies and researchers increasingly have been

called into question by regulators who suspect the ties encourage some

researchers to fabricate data and take other steps to help companies get new

products approved by the Food and Drug Administration (see related item in the

News section).

 

Typically, each patient enrolled in a trial earns an investigator $1,000 or more

in recruitment fees. Holland was paid by drug firms to enroll patients, but Wu

was uncertain of the amount.

 

Researchers " may be too incentivized to recruit patients. They may be too

incentivized to get results, " he said.

 

A string of research deaths and other mishaps in recent years have put medical

researchers under fire from patient advocates and others. The VA anticipates

significant coverage when the Albany deaths break in the general interest media.

lland and Kornak could not be reached for comment.

 

Nationwide Research Review. The problems were first uncovered about a year ago

by staff at Ilex Oncology Inc. of San Antonio who noticed discrepancies in data

submitted by Holland and Kornak. The pair had been studying Ilex's experimental

bladder cancer drug, eflornithine, in four Stratton patients.

 

The Albany study was part of a nationwide trial involving 450 patients funded by

Ilex and the National Cancer Institute. The drug, also known as DFMO, is being

studied for several cancer uses and long has been used to treat tropical

parasite infections.

 

The discrepancies triggered an internal investigation by Albany. Federal

investigators from the VA and from the U.S. attorney's office started looking

into the matter in the fall.

 

FDA found substantial problems in 54 of the 55 patient charts prepared by

Holland and Kornak that it reviewed during its own early-January investigation.

Federal authorities have confirmed Stratton's original conclusions.

 

Ilex originally refused to talk to BNA about the Albany investigations, but

after the story broke Feb. 4 spokesman Barry Cohen explained that " Ilex

continues to cooperate with the investigation " and that the company " has been

advised that it is not a target of the investigation. "

 

Ilex excluded the Albany data and shut down its DFMO study there when problems

emerged, he noted. ohen said he was unsure whether the compound was studied at

other VA centers.

 

Federal law enforcement workers are reviewing " the entire universe of research

touched by " Holland and Kornak, Wu said. Albany also has reviewed all of its

studies " with a microscope, " he explained.

 

A nationwide review of how research is conducted at VA medical centers could

follow the Albany investigation; VA investigators have been convicted of

criminal research misconduct in the past, Wu said. But he was quick to note that

the kinds of problems suspected at Albany have occurred in non-VA research

programs as well.

 

Washington Fallout. The situation already has had political consequences at the

VA's Washington, D.C., headquarters.

 

In mid-January, VA Under Secretary for Health Dr. Robert Roswell announced that

the office that polices the safety of patients in VA studies had been abolished

for failing to inform VA administrators quickly enough about the Albany deaths,

Wu said.

 

Roswell planned to put the VA office that funds and promotes research in charge

of study safety, a scheme prominent researchers told BNA was unworkable. At

times, measures to protect patients can delay or even derail trials.

 

Dr. Greg Koski, who until his resignation in November 2002 oversaw patient

safety in the housands of human studies funded each year by the National

Institutes of Health, told BNA the abolition of the office was a " big step

backward " in patient protections.

 

A VA research safety officer at a Northeast VA center said she was " shocked " by

the suddenness of the move and the fact that there was no official announcement.

" This is not good and we are not happy about it, " she said, noting that the

office had a reputation for " handling things fairly. "

 

Rep. Steve Buyer (R-Ind.), a House Committee on Veterans' Affairs member,

shelved the move in a Jan. 27 letter obtained by BNA, and asked VA Secretary

Anthony J. Principi to reconsider and further justify the plan.

 

The body, known officially as the Office of Research Compliance and Assurance,

was established in 1999 as an independent watchdog office within the VA

specifically to allow it the freedom to enforce human research protection rules.

 

" To get rid of ORCA " because it should have detected the Albany deaths earlier

" is ludicrous, " Wu said. He noted that no enforcement agency can prevent an

individual from deciding to do something criminal.

 

Several observers suspected ORCA was " taking the fall " for the deaths, and noted

that there long has been resentment among some VA research administrators

against an independent body to police study safety. In the past, ORCA has halted

research at centers it thought were not adequately protecting research subjects.

 

A Jan. 30 subcommittee meeting revealed that ORCA may well have kept VA staff

informed of the Albany situation, Wu said. Roswell has since told BNA the

abolition of ORCA no longer was a " done deal, " but would not elaborate.

 

Copyright 2003, The Bureau of National Affairs, Inc., Washington, D.C.

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.

 

 

Gettingwell- / Vitamins, Herbs, Aminos, etc.

 

To , e-mail to: Gettingwell-

Or, go to our group site: Gettingwell

 

 

 

 

Send Flowers for Valentine's Day