- The Washington Times - Sunday, December 28, 2008

Service members returning from Afghanistan and Iraq increasingly are suffering from mental trauma that dampens their homecomings, hobbles their re-entry into civilian life and imperils their continued military service - a situation the Department of Veterans Affairs (VA) has sought to address with treatment, counseling and even drug experimentation.

But even as the VA has worked to provide quality health care for millions of veterans at its facilities across the country, it has endured a series of failures - from not notifying test subjects about new drug warnings to ignoring safeguards during experiments. Those failures have damaged the reputation of the agency charged with supporting vulnerable veterans.

But it also has compromised the speedy recovery of those vets.

President-elect Barack Obama, who has named retired Gen. Eric K. Shinseki as incoming VA secretary, will have to deal with those long-standing discrepancies in the agency, as well as seek out new solutions to remedy the mental health problems plaguing an ever-growing population of veterans.

“Wars are supposed to end when the last shots are fired, but some of our new veterans will unfortunately have to cope with internal demons that may last their lifetime,” said Joe Davis, spokesman for the Veterans of Foreign Wars.

The Washington Times has focused throughout the year on the VA and scrutinized the agency’s handling of human subject drug tests using veterans, its treatment of veterans and the impact it has on service members and their families.

An often disturbing picture of a bureaucratic health care system that is disconnected from its charges has emerged.

The situation at the VA is becoming more urgent, though. A recent study by the Rand Corp. shows that one in five veterans returning from theater in Iraq or Afghanistan will suffer from depression or post-traumatic stress disorder (PTSD).

Mr. Obama’s pledge to draw down some 146,000 troops from Iraq over the next sixteen months will increase the VA’s burden to diagnose those returning soldiers who are suffering from PTSD and to provide treatment.

It also will increase pressure on the federal government to conduct even more questionable clinical trials on this vulnerable population to find a cure for the elusive psychological trauma.

“Despite heightened risks in trying to study drugs in a vulnerable population like recently returned vets with PTSD, the currently available treatments are not especially useful or efficacious,” said Arthur Caplan, medical ethicist and director of the Center for Bioethics at the University of Pennsylvania.

“So more studies will surely be undertaken,” he said. “This means those charged with human subjects protection will have to be especially vigilant.”

In a joint investigation, The Times and ABC News first reported June 16 that the federal government is using thousands of military veterans suffering from PTSD for voluntary clinical trials; several test psychotropic drugs linked to suicidal behavior.

The trend likely will continue. Soldiers returning from Iraq and Afghanistan are increasingly being recruited for new experiments.

“Medical research is vital to understanding and treating such maladies, but equally important is that research subjects know what they’re getting into,” Mr. Davis said.

“Military veterans have already voluntarily done more for their country than virtually everyone else. They must not be used unwittingly for the sake of science,” Mr. Davis said.

Drug testing on vulnerable veterans, failures by the VA to notify study participants when new drug warnings were issued and high suicide numbers among the retirees dominated the agenda of veteran support groups and Democrats on Capitol Hill this year.

Gen. Shinseki will be responsible for shaping the future of medical research conducted on veterans with PTSD and to develop new and innovative treatments including stricter ethical standards.

Rep. Bob Filner, California Democrat and chairman of the House Veterans’ Affairs Committee, told reporters and editors at The Times after the election in November that he hopes the new administration will implement “tight controls” on future research. Mr. Filner said mental health care for veterans, “from every conflict and each generation, must remain a high priority.”

Although Mr. Obama’s transition team has not yet released his position on the future of clinical testing, Mr. Obama expressed his displeasure with the current administration’s failure after The Times’ report.

“I was very concerned to read this morning’s Washington Times and learn that the VA has yet again failed to take appropriate steps to safeguard the health and well-being of veterans participating in drug trials,” Mr. Obama said in a June 17 letter to VA Secretary James B. Peake.

“I understand that clinical research is a vital mission of the VA,” Mr. Obama said.

“However, as I am sure you would agree, the VA has a special responsibility to maintain the most rigorous standards when conducting research on such a vulnerable population. Those trials should only be conducted when VA fully informs patients of the risks of the drugs they are taking, and adequately monitors the patients for side effects. These requirements are especially important when dealing with vulnerable patients such as veterans suffering from PTSD.”

Mr. Obama, Mr. Filner and other lawmakers on both sides of the aisle called for an investigation into a smoking cessation study, which Mr. Peake immediately initiated.

The experiment tracked 240 veterans taking the drug Chantix to examine which forms of counseling were more beneficiary - smoking clinics or through a separate counselor. James Elliott, an Army infantryman who was wounded in Iraq, says the drug caused him to experience a mental breakdown and a showdown with police who used a Taser to subdue him in February.

Mr. Elliott said the VA didn’t warn him about new FDA concerns that Chantix was linked to psychotic behavior and nearly 40 suicides until nearly a month after his disturbing incident occurred earlier this year.

The internal investigation confirmed that Mr. Elliott was not alone. It took medical professionals involved in the study anywhere from 16 to 134 days to notify participants taking Chantix about the new warnings.

The Office of Research Oversight said the “long delays” were “unacceptable failures to maximize safeguards for the veterans who had volunteered to participate in” the study.

The investigation also discovered there was no agencywide system in place to notify everyone involved in human testing, including the participants, when new or emerging medical safety information is released. Mr. Peake pledged to create such a system to keep participants informed of new dangers.

“Our problem wasn’t the fact that Chantix was being used in the smoking cessation research; our problem was that the researchers and doctors knew but never told their patients of the potential side effects until The Washington Times forced them to,” said Mr. Davis, of the Veterans of Foreign Wars.

“Everybody knew except the people swallowing the pill. The VA is the largest medical system in the U.S. and maybe the world. They provide an unmatched medical service to veterans and an invaluable teaching facility for medical universities. What they must not forget in all their largeness is that the VA exists for one reason and for one reason only: To serve America’s veterans,” Mr. Davis said.

According to an Oct. 23 report by the Institute for Safe Medical Practices, Chantix, also known as varenicline, “accounted for more reported serious injuries than any other prescription drug for a second quarter, a total of 1,001 new cases, including 50 additional deaths.”

Since it was approved in 2006, the institute said the drug has accounted for 3,325 reported serious injuries in the U.S., including 112 deaths.

“FDA is currently undertaking a review of the serious psychiatric reactions that can occur with use of varenicline,” FDA spokeswoman Karen Riley said.

In the United Kingdom, the Medicines and Healthcare Products Regulatory Agency reported in its November Drug Safety Update some new drug safety advice on varenicline.

“Psychiatric disorders are the most commonly reported suspected adverse reactions for varenicline in the UK,” the report said. “Depression and suicide-related events have been reported in patients using varenicline who are trying to stop smoking. Patients who are taking varenicline who develop suicidal thoughts or who develop agitation, depressed mood, or changes in behavior that are of concern for the doctor, patient, family, or caregiver should stop their treatment and contact their doctor immediately.”

As of Sept. 29, the advisory said that 3,541 reports were received on suspected adverse reaction to the drug, including sleep disorders and gastrointestinal reactions.

“The most frequently reported psychiatric disorders are depression or depressed mood, and suicidal ideation,” said the report, which also stated that nicotine withdrawal can cause various psychiatric conditions.

Meanwhile, the overall number of such ongoing behavioral experiments declined significantly this year, down from 300 in June to 67 clinical trials listed by the National Institutes of Health in December.

But the focus is sharply shifting from the general veteran population to those returning from battle in Iraq and Afghanistan to determine the effects of war on mental health and the long-term effects on mood, stress, thinking and reaction skills.

Some tests are examining new therapies to treat chronic insomnia, nightmares, and whether counseling by telephone can “prevent chronic mental illness and associated disability among our newest generation of veterans.”

Other experiments are using questionable drugs to treat hyperarousal, depression and smoking cessation.

In addition, an experiment using 40 Gulf War veterans recruited from the Bronx Veterans Medical Research Foundation is testing the drug mifepristone, also known as RU-486, to treat chronic multisymptom illness. The drug was approved by the Food and Drug Administration to induce abortions by blocking progesterone that is needed to sustain pregnancies.

Aimee Fitzgerald took her 74-year-old husband Joe to the VA hospital in the Bronx last year for diagnosis and treatment after he suddenly started losing motor skills. He was immediately admitted to the hospital, underwent some tests and was told that if he enrolled in a clinical study of Alzheimer’s study he could be diagnosed quicker. When he declined, Mrs. Fitzgerald says her husband was immediately dismissed from the hospital without a diagnosis or treatment.

Less than a month later, Mr. Fitzgerald died of Creutzfeldt-Jakob disease, the human form of mad cow disease.

After a review of the Fitzgerald case this year, the VA denied that the study recruitment efforts had anything to do with Mr. Fitzgerald’s dismissal from the VA hospital.

However, Mr. Peake apologized to the family in an Aug. 26 letter to the editor at The Times.

“I can only apologize that Mrs. Fitzgerald perceived a sense of callousness or a sense that there was some additional diagnostic or other measures to be offered,” Mr. Peake said. “It will renew our emphasis to VA staff about sensitivity in communicating.”

“I can only apologize for the family’s perception in this tragic case and to let them know that it will serve as a systemwide reminder about the importance of clear and compassionate communication,” Mr. Peake said.

The VA halted all new experiments involving human subjects at the Central Arkansas Veterans Healthcare System in Little Rock this summer after an investigation by its inspector general.

Rampant violations in human experiments were uncovered, including missing consent forms, clandestine HIV testing and failure to report more than 100 deaths of veterans participating in various studies.

Entire consent forms were missing or signatures missing and research officials failed to obtain witness signatures in one study using veterans with dementia. Patients were tested for AIDS without their knowledge or permission.

In a review of several cancer studies involving 1,400 veterans, investigators randomly sampled the files of 105 patients and could only find 20 consent forms.

In West Virginia, several families of Iraq War veterans demanded a congressional investigation after their loved ones died at home in their sleep. All were taking medication for drugs described for post-traumatic stress disorder.

A review of two of the cases gave the families little comfort, but confirmed that the deaths were caused by “combined drug intoxication” of three prescribed psychiatric medications - paroxetine, clonazepam and quetiapine.

Stan White, whose son Andrew was taking the cocktail of medications and died in his sleep, is leading the charge to get answers from Washington for his and other families whose loved ones have mysteriously died after serving a tour in Iraq.

“Several soldiers I know who have taken that combination have died,” Mr. White said. “Almost all of them had another drug that they had been prescribed for pain, oxycontin, morphine derivatives. Some of the others, they found methadone in their system. But all of them, the common thing they had was the three drugs,” Mr. White said.

In Van Lear, Ky., in the shadows of country singer Loretta Lynn’s hardscrabble birthplace, Cheryl Endicott is still awaiting answers from the VA concerning her son Jason’s untimely death on Dec. 20, 2006, just weeks after the Marine lance corporal returned home from a tour of duty in Iraq.

Like the West Virginia veterans, Jason died quietly in his sleep. His autopsy did not reveal an overdose of medication, but it did reveal a regular dose of methadone, which was prescribed for him by the VA, Mrs. Endicott said.

Studies have examined methadone as a possible treatment for PTSD, but Mrs. Endicott said she is not aware of whether the VA diagnosed her son with PTSD.

“Nobody told me and I can’t say that he had PTSD, I never saw any paperwork, but he had the symptoms,” Mrs. Endicott said. “Jason couldn’t handle seeing body parts, people laying in the streets. It really got to him.”

Mrs. Endicott is now working with Mr. White to get answers from the VA, but so far, all they have released are a few sheets of paper delivered in a regular-size envelope, with no explanation as to why methadone was prescribed to her only child.

“I know there has to be a lot more than that,” Mrs. Endicott said. “It’s been very difficult. I think they are covering up a lot.”

Andrea Billups contributed to this report.

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