Chairman Filner, and honorable members of the House Veterans’ Affairs Committee, on behalf of Eilhys England Hackworth, Chairperson of the Board of Trustees of Soldiers For The Truth Foundation, I am humbled to appear before your committee as you carry out your responsibilities under the Constitution to exercise congressional oversight of the Department of Veterans’ Affairs.

Recent events show that this oversight is critical to ensure that the well being of our veterans is in fact the highest priority of the VA. These events demonstrate very clearly that without congressional oversight, true concern for the well-being of our veterans can deteriorate into mere lip service of an indifferent and self-serving bureaucracy.

I note that you have scheduled a most impressive group of experts on various medical and ethical issues related to human subject experiments as conducted by the VA.

I do not bring their expertise to this hearing.

What I do bring is the experience of a career Marine Corps officer who believes that our nation has a sacred responsibility to care for those who have manned the ramparts of freedom on our behalf.

I also bring the skepticism of a journalist who for 18 years has investigated misconduct by various federal agencies in the areas of defense and national security.

Let me now turn to the question that serves as the title for today’s hearing. “Why Does the VA Continue to Give a Suicide-Inducing Drug to Veterans with PTSD?”

While studying the experience of Army combat veteran James Elliott, I was struck by three major questions which I believe this committee’s investigation should consider.

My first question relates to the Hippocratic Oath and a physician’s first responsibility, “to do no harm.”

How then did the VA physicians involved in planning and conducting this drug study fulfill their duties under this pledge?

Here are some “follow-up” questions I suggest you and your committee staff might also consider:

• Would these physicians have subjected their own sons or daughters to such a high-risk drug study?
• And, would they have failed to inform their own children of the substantial risks this study entailed?

My second question relates to the Nuremberg Code, and the fact that informed consent of all human subject medical experiments is an absolute requirement under this code.

As you may recall, it was the exposure of the most heinous and gruesome medical experiments by Nazi doctors that led to enacting the Nuremberg Code.

Our country’s own history has, unfortunately, too many examples of medical experiments on unwitting subjects. The infamous Tuskegee syphilis experiment is perhaps the best known of such shocking violations by physicians of their Hippocratic Oath.

I have attached to this statement a Knight Ridder press report dated July 7 that describes the latest legal action in a federal criminal prosecution of a former VA staff physician at the Stratton VA Medical Center in Albany, New York. The federal prosecutor asked the court to sentence this former VA physician, and I now quote from the press report, “to spend a year in prison for his role in a drug-research scandal that killed at least one veteran and victimized dozens more.”

If it pleases the Chairman, I respectfully request that this article be included in the record.

My last question for your consideration involves the participants themselves, the veterans with PTSD, who were recruited by VA staff to become the subjects of this drug study.

Why were members of a group, who by the VA’s own diagnoses were struggling to return to mental health normality, selected for this study?

The mental health of these veterans was known to have been, in various degrees, what a layman would term “fragile.” Special caution and prudence should have been invoked before exposing them to a drug study where by definition “unknown” factors might further damage their mental health.

Instead, the very VA physicians trusted to help the vets regain a more normal mental condition enticed the vets to join a game of mental-health roulette, while withholding critical information that would have permitted true “informed consent” to have been given.

Sir, this concludes my prepared statement. I stand ready to respond to any questions the committee members may offer.

Doc in VA Drug Study Scam May Get Jail
July 07, 2008
Knight Ridder

ALBANY -- Federal prosecutors want a former Stratton VA Medical Center oncologist to spend a year in prison for his role in a drug-research scandal that killed at least one veteran and victimized dozens more.

A year in jail is the maximum punishment that Dr. James A. Holland, 50, faces under his guilty plea last year to a misdemeanor charge in which he admitted failing to protect his patients from a rogue researcher who falsified medical records to enroll them in drug studies.

Holland's sentencing had been scheduled to take place in May, but was delayed as federal prosecutors and his attorney have made formal arguments about what punishment he should face. A new sentencing date has not been set.

"This crime was committed over a three-year period, with many obviously altered documents involving a large number of cancer patients needing careful attention because of the gravity of their conditions," assistant U.S. Attorney Grant C. Jaquith wrote in a memorandum to U.S. District Senior Judge Frederick J. Scullin, Jr.

Jaquith argues in court papers that the high number of victims and significant financial losses to the drug companies and Department of Veterans Affairs warrants a maximum prison term.

Holland has placed blame for the scandal on Paul H. Kornak, 56, a former research coordinator at Stratton who posed as a doctor while advising patients and their families on life-or-death medical decisions. Kornak had a felony criminal record for lying on a medical license application when he was hired at Stratton. He never finished medical school and falsified his college transcripts to get there, records show.

Kornak was sentenced in November 2005 to a six-year prison term for his guilty plea to felony counts of mail fraud and negligent homicide in connection with the death of James J. DiGeorgio, a 71-year-old Air Force veteran from Brunswick.

Another 64 veterans were harmed by the forgeries, which involved manipulating their medical backgrounds so they would qualify for drug studies that were lucrative for the hospital and had furthered the researchers' careers.

Federal authorities claim the research violations took place over about three years, beginning in May 1999. But VA workers have said the cancer program's problems, including the endangering of patients, stretched back years and involved other researchers.

Kornak blamed his actions on hospital officials, including Holland, claiming they urged him to enroll as many patients as possible in drug studies.

Gaspar M. Castillo, Holland's attorney, has cast Holland as a victim of Kornak and blames hospital administrators who allowed Kornak to masquerade as a physician.

"The defendant assumed, and it was reasonable for him to have assumed, that the VA had conducted appropriate background checks of Mr. Kornak," Castillo wrote last month in a letter to Scullin. Holland's guilty plea in April 2007 has not derailed his medical career. He works for a cancer program at Archbold Medical Center in Thomasville, Ga.

Holland and Kornak were fired by the hospital in 2002 after a private drug company investigator noticed problems with the medical records of patients. Authorities have never offered a clear motive for the forgeries.

A Times Union investigation found that Stratton's cancer research program was the target of internal complaints dating to the mid-1990s. Hospital staffers said they were harshly retaliated against for warning hospital administrators as early as 1994 that cancer patients were being placed at risk and being enrolled in drug studies without signing consent forms indicating they knew the risks.

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