Tuesday, December 11, 2007

VA starts Caregiver assistance Program

http://www.emilitary.org/article.php?aid=12999

VA Announces $4.7 Million to Help Caregivers
Department Enhancing Education, Training and Resources2007-12-11
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WASHINGTON – The Department of Veterans Affairs (VA) today announced it will provide nearly $4.7 million for “caregiver assistance pilot programs” to expand and improve health care education and provide needed training and resources for caregivers who assist disabled and aging veterans in their homes.
“This funding will enhance support and training for the family members and other caregivers who sacrifice to care for disabled and aging veterans,” said Acting VA Secretary Gordon H. Mansfield. “At VA, we’re committed to looking after caregivers who dedicate their own time and well-being to take care of loved ones who are veterans.”
The pilot programs will support eight caregiver projects across the country. In addition, VA provides support and assistance through a variety of programs such as care management, social work service, care coordination, geriatrics and extended care, and through its nationwide volunteer programs.
Among the key services provided to caregivers are transportation, respite care, case management and service coordination, assistance with personal care (bathing and grooming), social and emotional support, and home safety evaluations.
Education programs teach caregivers how to obtain community resources such as legal assistance, financial support, housing assistance, home delivered meals and spiritual support. In addition, caregivers are taught skills such as time management techniques, medication management, communication skills with the medical staff and the veteran, and ways to take better care of themselves.
Many of the projects use technology, including computers, Web-based training, video conferencing and teleconferencing to support the needs of caregivers who often cannot leave their homes to participate in support activities.
The VA pilot programs announced today include:
At the Memphis (Tenn.) and Palo Alto (Calif.) VA medical centers, a project will provide education, support and skills-building to help caregivers manage both patient behaviors and their own stress. This intervention will be provided in 14 Home-Based Primary Care (HBPC) programs across the country and also to caregivers in non-HBPC settings at the Palo Alto VAMC.
At the VA medical center in Gainesville, Fla., caregivers will take part in a Transition Assistance Program to provide skills training, education and supportive problem solving using videophone technology.
At the VA Healthcare System of Ohio, headquartered in Cincinnati, caregiver advocates will be available around the clock to coordinate between VA and community services.
At the VA Desert Pacific Network and the VA Sierra Nevada Healthcare System, VA will work with a community coalition to provide education, skills training and resources for caregivers of veterans with traumatic brain injury using computer-based telehealth, including Web, telephone and videoconferencing.
At the VA medical center in Albany, N.Y., a pilot project will convert a three-hour workshop developed by the National Family Caregivers Association called “Communicating Effectively with Health Care Professionals” into a cost-effective multimedia format.
At the Atlanta VA Medical Center, use of computer-based technology will provide instrumental help and emotional support to caregivers who live in remote areas or to those who cannot leave a patient alone.
The Tampa VA Medical Center and the Miami VA Healthcare System are working on a collaborative project. In the Tampa area, the current program will be expanded to provide 24-hour in-home respite care to temporarily relieve caregivers up to 14 days a year. In Miami, the program will coordinate comprehensive community-based care services, including respite, home companions, adult day care and use of emergency response system.
The VA Pacific Islands Health Care System will use the “medical foster home” model of care, in which caregivers in the community take veterans into their homes and provide 24-hour supervision. This program will take place on the islands of Kauai, Hawaii, Maui and rural areas of Oahu.
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I am not enthused by the level of VA healthcare today, over the past five years I have watched it degrade from excellent care to now where it just barely provides enough.

Examples when I started PTSD counseling I was seen monthly from Jan 2003 - May 2005 then it went to every 3 months May 2005 - May 2006

May 2006 they switched me to every 4 months, I started having problems, my wife talked to my shrink and he went back to every 3 months, this last visit I was informed they were going to every six months for med reviews since I am 100% P&T. I am not happy with this.

Regular Medical care since I am a chronic and severe patient with multiple extensive medical problems considered severe and life threatening I started out being seen every 3 months by primary care, I have CHF, a failed triple by pass, a stroke, COPD, GERD, PTSD, Hyperstension, autoimmune problems, I am in a power chair due to the severity of my heart disease ejection fraction of LVEF of 25%, when DR Duquette left in 2005, they started switching my primary care doctors about every 6 months, and ended up arguing with all of them when they tried changing my meds to generics that did not work, and would have to go to patient advocates and complain and chief of clinics to get Prevacid rewritten it's the only med that actually works on my GERD. My cardioligists and my Primary Care doctors agreed that due to the severity of heart diseae and the fact they can NOT operate on the blockages, that I should stay on Plavix but the VA pharmacy rewrote the rules that you could only get it for a year after a hreat attack or stent placement. It keeps blood slippery so it doesn't clot, it gave me a feeling of comfort that it was less likely that a clot would form and cause me another heart attack, hey after 7 of them you worry about #8 take my word for it.

The most ludicrous idea they came up with, the cardiac clinic wanted me to agree to have an http://http//aolsearch.aol.com/aol/redir?src=websearch&requestId=ed38c0077c78808f&clickedItemRank=2&userQuery=ICD&clickedItemURN=http%3A%2F%2Fen.wikipedia.org%2Fwiki%2FImplantable_cardioverter-defibrillator&title=%3Cb%3EImplantable+cardioverter-defibrillator%3C%2Fb%3E+-+Wikipedia%2C+the+free+%3Cb%3E...%3C%2Fb%3E&moduleId=matchingsites.jsp.M&clickedItemPageRanking=2&clickedItemPage=1&clickedItemDescription=WebResults

implanted, instead of refilling the Plavix. I asked them about the risks, they minimized them and finally admitted when pressed that yes, in about 5-6 years it would have to be taken out and a new one put in. I asked what the cost of this would be, the VA doctor estimated about 50-60,000 every 5 years, yet the VA refuses to pay for a mdeication that would run about 1800 a year that keeps my blood thin, go figure that nonsense? I have never had a problem with irregular heart beat, my heart attacks have been caused by clots and stress not an out of whack muscle.

The VA would save a hell of a lot of money issuing those portable defib machines for the home and car that run about 2,000 and when the vet dies, have the family turn them back into the VA and ressiue them to another veteran, now that makes fiscal sense. Why waste a 100,000 or more on a machine I will more than likely never need. Now to me this is waste.

Instead of getting me into one of the caregiver programs to more closely monitor my failing health, I was told yesterday that instead of seeing my primary care doctor every six months, it is now being switched to every 8 months, they are just adding more patients to each doctor so the vets will have to wait longer between appointments, this is not getting to be better treatment, it is getting worse.

The VA employees are oberworked and stressed out and they have every right to be, they have managers wanting more work for no extra pay, they have veterans mad at them bedcause healtcare is getting worse, and vets are dying from missed cases of cancers, lung problems, PTSD, and suicide because no one is listening.

they are blowing in the wimds...........


Sphere: Related Content

Charles Kelley's Dec 11 Letter from 2/94th Bulletin

Blue Water Navy and other


At the bottom - VA medical compared to Nazi Germany

"Hundreds of documents alleging negligence by the Department of Veterans Affairs, and comparing the scandal to Nazi experiments on humans during World War II.

The sad part is this was way before Walter Reed and Congress and the Media really did nothing or even address it. You see it was against our own Veterans not the enemy they seemed to want to protect while doing nothing to protect us from VA abuses. That includes the lying ass media also.

Join the military and get treated like we hanged folks for and Congress for the most part just says but gee we gave you more money. What else do you want?

Yet, this kind of backroom stuff goes on daily at the VA and the answer is give them more money? I think not. The answer is a responsible caring government for their protectors of which we do not have.

Need a new one? You bet we do in all areas of executive branch as well as congress.

But it will all be taken care of by Peake as he like so many have promised to fix the problems.


Ironically just out is a pilot program to have VA do the compensation exams for the DoD and as you read below VA will provide the professionals to do the exams. Now lets not forget that the folks contracted (outsourced) to do this exams is a company called QTC and our soon to be new Veterans Affairs secretary is as it just so happens a director on the board of QTC. And it just so happens when that a billion dollar award was given to QTC, Secretary Principi was the COO of this company. And it ,the BS, just keeps on getting thicker and thicker.............and thicker and deeper and deeper......and deeper.

VVA: VA News Release - VA/DOD Commence Single Disability Pilot Program
FOR IMMEDIATE RELEASENovember 29, 2007VA/DOD Commence Single Disability Examination Pilot Program for WoundedWarriors Evaluation to Provide Smoother Transition to DisabilityBenefits and CompensationWASHINGTON -- The Department of Veterans Affairs (VA) and the Departmentof Defense (DoD) this week began a pilot program to test a new singledisability evaluation system for wounded warriors at the three majormilitary medical facilities in the Washington D.C. area.
This initiative is designed to eliminate the duplicative and oftenconfusing elements of the current disability processes of the twodepartments. Key features of the disability evaluation system (DES)pilot include one medical examination and a single-sourced disabilityrating.
The single disability examination pilot is another improvement as aresult of the President's Commission on Care for America's ReturningWounded Warriors (Dole/Shalala) and is aimed to simplify health care andrehabilitation for injured service members and veterans.
This pilot program will seek to ease the transition of wounded servicemembers through the disability evaluation system to reentry into thecivilian community with more efficient delivery of disabilitycompensation at the time they leave military service.
VA is providing the medical professionals performing the examinations.The pilot is being conducted for service members at the Washington,D.C., VA Medical Center, Walter Reed Army Medical Center in Washington,D.C., the National Naval Medical Center in Bethesda, Md., and theMalcolm Grow Medical Center at Andrews Air Force Base, Md., and will runfor one year. Throughout the pilot, VA and DoD officials will monitorprogress to determine potential expansion into other locations.
The pilot includes all non-clinical care and administrative activities,such as case management and counseling requirements associated withdisability case processing from the service member's initial referral toa Military Department Medical Evaluation Board to VA's compensation andbenefits program.


blue Water Navy

From Norm

The below RAO Bulletin segment tells how the VA intends to circumvent the court's decision to extend the presumption of Agent Orange/defoliant exposure to all veterans with a Vietnam Service Medal (the CAVC rescinded the "boots-on-the-ground" rule). The VA offers us a brief period to submit objections, but we all know that if the Bush-appointed VA heads can defy the CAVC, they are sure as hell not going to back up for a few old veterans.

As I read the law, the VA cannot write regulations that contradict laws and rescind court decisions even when the VA acts on behalf of the president to cut veterans' entitlements.

I think we need to push this in the faces of our representatives, our media, our judges et al. Let's see who supports the law, the people and the courts and who belongs to King George and the petro-chemical crones. If Bush appointees can defy the courts and re-write the law, our representative democracy and our Constitution are history. Nc


From RAO Bulletin 01 December 2007, p. 9:
Agent Orange Lawsuits Update 11: On 19 NOV Acting VA Secretary Mansfield approved a notice for publication in the Federal Register to rescind provisions of its Adjudication Procedures Manual, M21-1 that were found by the U.S. Court of Appeals for Veterans Claims (CAVC) not to have been properly rescinded. The notice can be reviewed in the 27 NOV issue (Volume 72, Number 22

7) Page 66218-66219. The notice in effect says that since a 2001 change to the manual’s 1991 provisions has been ruled illegal by the CAVC it would be further changed if the VA lost their appeal to this ruling. The provision in question allowed veterans who received the Vietnam Service medal and served offshore in Vietnam during that war the presumption of exposure to Agent Orange in accordance with a 1991 ruling of the Veterans Court. The VA subsequently changed the rules in their M-21 manual in 2002 taking away this right which brought on the Haas v. VADC-Nicholson lawsuit which the VA lost and is currently appealing. Now the VA is seeking to correctly alter the M-21 provisions by giving notice and a time for comment as required when an agency makes a “substantive change”.

The VA is in effect trying to wipe out both the 1991, and 2002 M-21 manual provisions laying the groundwork for a new provision which will allow the VA to continue denying Blue water Navy the same rights as their fellow veterans who received the Vietnam Service medal. And at the same time they say that if they win their appeal to the Federal Courts, they will withdraw this change and keep the M-21 change of 2002 which denies presumption of exposure. Bottom line either way NO COMPENSATION for Blue Water Navy veteran’s Agent Orange related disabilities. Veterans are encouraged to exercise their right to comment on the change. Written comments must be received by VA on or before 28 JAN 08. They may be submitted through online at http://www.Regulations.gov; or by mail or hand-delivery to the Director, Regulations Management (00REG), Department of Veterans Affairs, 810 Vermont Ave., NW. Room 1068, Washington, DC 20420; or by fax to (202) 273-9026. Comments should indicate that they are submitted in response to “Rescission of Manual M21-1 Provisions Related to Exposure to Herbicides Based on Receipt of the Vietnam Service Medal.” Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 08-1630 M-F (except holidays). To review call (202) 273-9515 for an appointment. In addition, during the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at http://www.Regulations.gov.

[Source: http://www.valaw.org
Editor Ray B Davis Jr. 27 Nov 07 ++]



It looks like (Conflict of Interest) Peake is in and will win senate support hands down. Another executive branch federal agency puppet making decisions for the executive branch and not science, medicine, and statistical facts. Backed up by the "less than prestigious IOM. "

From retired Master Guns McCartney

VA Secretary Nominee Gets Favorable Senate HearingMichael PosnerCongressDaily
December 5, 2007 http://www.govexec.com/dailyfed/1207/120507cdpm2.htm\
Retired Lt. Gen. James Peake, President Bush's nominee for Veterans Affairs secretary, breezed through a Senate confirmation hearing today with bipartisan support. Members of the Veterans' Affairs Committee praised Peake, 63, a highly decorated veteran with 38 years of Army service including time in Vietnam and two years as its surgeon general. They also told him his task ahead would be difficult if confirmed."You have a tremendous challenge facing you," Veteran Affairs Committee Chairman Daniel Akaka, D-Hawaii, told Peake. "Indeed it may be one of the most daunting tasks in or out of government."Akaka and other senators said returning Iraq war veterans have problems different from other veterans, including mental health difficulties. A significant number of returning veterans suffer from traumatic brain injuries, other wounds and post traumatic stress disorders, Akaka said.In testimony, Peake said veterans' mental health issues may be his biggest challenge in the job."I appreciate the universal concern that PTSD and traumatic brain injury may be less apparent than some of the horrendous physical wounds that we see fresh from the battlefields," he said, adding that "PTSDs are real wounds of war and ought to be treated." He said PTSD and traumatic brain injuries "are likely to become the signature injury of this conflict."Peake pledged to work on getting veterans health care claims adjusted faster. So has every other head of Veteran Affairs so what?
"A veteran should not need a lawyer to figure out what benefit is due, or get that benefit," Peake said. So has every other head of Veteran Affairs so what?
He also vowed to address problems with the transition of veterans from active duty to veteran status. So has every other head of Veteran Affairs so what?"I don't think you could have better prepared for this job if you had planned it," commented Veterans Affairs ranking member Richard Burr, R-N.C. His conflict of interests prepared him greatly for this puppet mission.But Sen. Patty Murray, D-Wash., told him "a strong resume is not enough." She called on Peake to have "the fortitude, the backbone, and the courage to stand up to the administration, to be honest and upfront about our veterans' current and future course." That folks including integrity ain’t going to happen!Akaka criticized former Veterans Affairs Secretary Jim Nicholson for not advocating more funding for the VA, but Peake promised to work for adequate funding. The committee has not set a date for a confirmation vote.

It all comes back to funding, which is bull crap. INTEGRITY AND TRUTH ARE MORE IMPORTANT!

From a Marine Corpsman

THE WAR IN THE SAND BOX AND OTHER AREAS OF THE GLOBE IS NOT WINNABLE. ESP. THE SAND BOX. THE ONLY COUNTRY THAT CAN PUT A SHORT LEASH ON N. KOREA AND OTHER MUSLIM IDIOTS IN THE FLIP ISLANDS; THE INDOCHINA; AND THE MALAY AND INDONESIA IS CHINA.

WE NEED TO WITH DRAW ALL TROOPS FROM AS MANY PLACES AS POSSIBLE AND LET THEM KILL EACH OTHER; NO RE-ENLISTMENTS; THEY'RE GETTING THE SHAFT, FROM THE DOD AND THEIR RESPECTIVE MILITARY ORGS. WE ONLY NEED TO SUPPORT ISRAEL IN COUNTRY WITH WHAT EVER THEY NEED AND MOST OF THAT MONEY DOES NOT COME FROM THE FEDS BUT JEWISH NATIONALS OR AMERICANS IN THE USA.

THEIR ARE MANY WAYS TO NEUTRALIZE HOSTILE COUNTRIES WITHOUT NUCLEAR FALLOUT; WE HAVE IT IN NON-NUKE AND NON-RADIATION NUKES AND SHOULD USE IT. THEN WITH DRAW TO CONUS AND USE THE TROOPS WE HAVE AND PLANES AND SHIPS TO DEFEND OUR SHORES FROM ALL DIRECTIONS. IT IS VIABLE. I KNOW WHAT I'M TAKING ABOUT CONCERNING NON RADIATION NUKES AND BOMBS SO POWERFUL THEY ACTUALLY GIVE OFF SOME RADIATION; NOT MUCH BUT SOME. WE NEVER USED THOSE.

THE DOD WILL HAVE TO RE-INSTATE THE DRAFT AND WHEN THAT IS DONE; THE LINE WILL BE DRAWN IN THE SAND. IT'S THAT SIMPLE.
THIS ALSO INCLUDES DEFENDING US FROM CUBA AND SOUTH AMERICA AND MEXICO AS WELL AS SOME GAPS IN CANADA.

I HAVE KIDS THAT HAVE BEEN ON BOTH SIDES OF THE GLOBE FOR 16 YEARS NOW. ENOUGH IS ENOUGH.

THE VA IS SO CORRUPT IT CAN'T EVER BE FIXED.

THE HOTDOGS GO TO BETHESDA WHILE I TROOPS GO TO AN OUTDATED WALTER REED HOSPITAL. OUR BODY CONGRESS GETS THE BEST CARE IN THE BEST PLACE FOR FREE WHILE OUR TROOPS GET THE WORST. TIME TO BRING THEM HOME AND PUT THEM ON THE BORDERS AND SHIPS OFF SHORE TO PROTECT OUR COUNTRY. THE CANDIDATES FOR OFFICE WILL SAY ANYTHING TO GET YOUR VOTE.

UNLESS OF COURSE THEY'RE BUSTED BEFORE THE ELECTIONS FOR HITTING ON KIDS OR PEOPLE IN PUBLIC RESTROOMS. PEDOPHILES AND QUEER BAIT OVER PAID ASSHOLES. WHO GET A BIG COLA BASED ON THEIR SALARY PLUS THE ANNUAL BONUS EACH JULY FOR THE BODY CONGRESS; OVAL OFFICE AND SUPREME COURT.

IT SUCKS.

I COULD QUOTE WILL ROGERS ALL DAY LONG ON POLITICIANS.

EACH OF US KNOWS OUR RUNNER'S WILL LIE TO GET ELECTED; THE CHOICE IS TO VOTE FOR THE MOST INCOMPETENT. OBAMA IS A TRAITOR. HE WON'T COVER HIS HEART DURING THE ANTHEM NOR WILL HE SALUTE THE FLAG; NOR WILL HE Sing THE NATIONAL ANTHEM.

THE TIME HAS LONG LAST COME AND GONE WHERE THE ITALIAN MAFIA HAS MORE INTEGRITY THAN OUR OWN CONGRESSIONAL ELECTED, COURT AND OVAL OFFICE. AT LEAST THE MAFIA KEEPS THEIR WORD; CHARGES A FAIR PRICE AND DELIVERS.

From a Nam Vet on Burying the VA
One hell of a great idea because as all veterans know, the VA will "never" get caught up with their back logged claims no matter what they say or do. So we might as well just add more fuel to the fire and let them see what it feels like to have the heat put on them for a change.

Right off the top of my head I can think of roughly five or six different claims I can submit that I would have normally just forgot about. One may be a first for us Nam veterans and that being - I will file a claim for TBI. After all, those in Iraq are doing it and all it amounts to is being around loud explosions that rattle your brain. I think a mortar round that exploded right next to me, strong enough to blow me off my feet and caused me to come down with migraine headaches, just might be enough to prove my brain was injured. I haven't heard of a Nam vet having his claim adjudicated in his favor for submitting a claim for TBI so that will be the first one I fire off to the VA. Then my teeth falling out, diabetic, sore on left big toe, both knees, a CUE on my low back, oral surgery needed. Yea, I can keep somebody in the VA busy for a long time. And none of these claims can ever be viewed as submitting a claim where the VA can accuse me of fraud.

I have fought the rotten VA system for over twenty years. Additionally during those twenty years I assisted veterans in filing their claims for service connected disabilities against the VA AND Social Security.

I'd much rather prefer to go out dying while I'm typing up a claim or an appeal rather than just sitting in my recliner or wheel chair, day after day, staring at the walls.
One thing I would pass on again as to what the State VA worker told me. Do not allow the VA or the VSO to force you or to even recommend signing a form 9 requesting a BVA. These are crooked and once out of the local office there is nothing the state or state workers can do to help you. You will not be allowed to present a case as they tell you - trust me. In addition they can hold these for decades without so much as one decision and as I am finding out even when they are remanded there is nothing you can do bring them back to the local level to get some help. As a matter of fact I was told to tell all Veterans that little bit of information - do not allow the claim to leave the local level - keep filing notices of disagreements (NOD's) as they deny your claims.
Once inside 495 you can just about forget it for at least five years minimum.


In the above issues it just so happens I was being waited on a young man that was to enter the Navy shortly. The only thing on his mind was the enlistment bonus so he could get a motorcycle. I informed him he would be better off finding another way to obtain what he wanted. I then went on to tell him what VA and DoD is doing to Veterans in all areas including paying back of the bonus if they could not complete their term of conditions. Not only did they say it was not their policy; but they were doing it any way on unsuspecting Veterans and families, as long as they could get away with it.

I informed him if was he was hurt for any reason he would be left out in the cold with a fight on his hands that would be easier to fight the enemy than our government and in fact the government did not care whether he served or not or what happened to him. How they minimize or lie about disorders and then appoint a man that whose company is in charge of rating Veterans in charge of Veterans.

I informed him he would lose all guaranteed constitutional rights as a citizen and as a human if he enlists and become the property of Veterans Affairs the rest of his life.

Now I did give him my phone number and told him that if his dad or his lying ass recruiter wanted to argue the issues please call me.

The recruiter had told him he would not be in harms way joining the Navy. I told him that was so much crap and once he was in all that shit was by the way side.

Maybe I convinced him – maybe not – that motorcycle was foremost in his mind and his now indestructible body and wanting to believe his unscrupulous recruiter.

As I said, I am glad for what we have now but these boys signing up for motorcycles must be told the real facts and the truth as we have lived them; before he signs on that life changing dotted line.

DoD is not going to do that.

e-mail from Naval Aviation

Thanks, Bro, for the updates on efforts to bring the VA to its knees - to really start serving all of us. The high rate of suicides among returning Iran and Afghanistan vets hit the news last month. It was no surprise to us, but news anchors across the nation appeared "surprised."

I remember a couple of VA doctors examining me for my C & P case, trying to get me to "fess up" to alcoholism as the cause of my neuropathy. It would have been a feather in each of their caps. Sad for them and good for me, it turned out that alcohol is an impossible cause for my afflictions. So they knocked me off the table by stating that "I had not filed in time." I refuse to go through all that crap of 10 years putting together my C&P case myself. When I finally ended up at the Federal Bldg. in LA for the interview, the American Legion Rep. looked at me in wonder.

His statement was: "Most disabled vets give up after a few years of fighting. What makes you keep going?" Not that he didn't defend me with all he had. He simply reflected the fact that the VA manages to dig us all into the ground so heavily that we do give up. The word from the vets I know is that now the VA is just waiting for all of us Viet vets to die off. Look at the "Taps" section of any military magazine. They are right.

We are lucky, as a group, to make it to age 55 (the average number of years of life for a Vietnam vet). Blessings to you and yours for the holidays.

Veterans affairs compared to Nazi Germany

Court papers detail dark chapter at VA

By BRENDAN J. LYONS, Senior writer First published: Sunday, December 9, 2007

Albany -- The veterans and their spouses called it the drip room.
It was a grim place, located on the first floor at Stratton Veterans Affairs Medical Center just past the cashier's office and the pharmacy. Hard plastic seats spilled into the hallway, with relatives who waited hours for their loved ones to get the cancer drugs that offered them hope.
The spacious room, with its IV-friendly lounge chairs and a row of beds for the patients who got nauseous, began filling to capacity about nine years ago.
The crowds were in large part caused by experiments on dozens of desperate cancer patients who were given powerful mixtures of drugs that were being tested for their marketability.
In September 2001, as the number of cancer drug studies at Stratton tripled to more than 20, two nurses warned a VA oversight board that conditions were unsafe and patients were at risk. No one took action.
Yet that bustling business was only a symptom of a systemic breakdown in which veterans were being pushed into poorly run drug studies for which they didn't medically qualify. They also were the victims of fraud and deception, and top hospital officials privately suspected that as many as five veterans, and possibly more, died prematurely from the fallout.
New information surfaced last month in hundreds of pages of depositions and internal reports filed in a lawsuit by several widows of veterans who died after enrolling in Stratton's drug studies, providing a spotlight on a government research program that had spiraled out of control.
Attorneys in the case declined comment.
The federal court documents, which include confidential investigative reports never made public, indicate that about 70 percent of Stratton's former cancer research patients were victimized in the scandal, which triggered nationwide hiring reforms in VA research programs. In early 2002, at the time it began unfolding, 91 veterans were involved.
Allegations include:
Cancer patients were pres into joining experimental studies in which they and their families did not want to be enrolled.
A nurse who still works for a VA hospital received only a reprimand for issuing pre-signed prescriptions for controlled substances without doctor approval.
Three research coordinators were ordered to enroll as many people as possible in drug studies by a physician who said their salaries and job security were at stake.
Paul H. Kornak, a convicted felon who never completed medical school, was hired as a research coordinator and fraudulently posed as a doctor when supervisors knew of his background.
Research coordinators were allowed to illegally use a physician's electronic signature and computer access codes to perform functions for which they were not qualified.
Kornak and the former cancer research director, Dr. James A. Holland, continued working for months after their scientific misconduct was discovered.
Stratton's Institutional Review Board, which monitors research studies, "did not adequately protect the rights and welfare of human subjects."
Glenn McGee, a bioethics expert at Albany Medical College enlisted as an expert witness by the attorneys for the widows, characterized the situation as a "systematic deception by clinicians in plain violation of medical and research ethics across 3,000 years of the development of such principals."
"The clinical trials conducted at the VA involving the plaintiffs and their loved ones in this case violated the standards and regulations governing the conduct of clinical trials in this country and throughout the world," McGee wrote in a report filed in the case.
The case is pending in U.S. District Court in Albany. The hospital is being defended by Justice Department attorneys from Massachusetts because federal prosecutors in Albany oversaw the prosecutions of Kornak and Holland, both of whom were convicted of federal crimes related to research fraud.
At a hearing scheduled for Monday, the government's attorneys are expected to argue for a dismissal of the class action lawsuit on the grounds there is no proof the experimental drugs caused more than one death. They have also argued that since the participants were terminally ill cancer patients their deaths were already likely, and their pain and suffering from the experimental drugs cannot be quantified.
The widows' attorneys have filed hundreds of documents alleging negligence by the Department of Veterans Affairs, and comparing the scandal to Nazi experiments on humans during World War II.
The fraud at Stratton was discovered in December 2001 by a monitor for a Texas drug company who visited Stratton and began scrutinizing the records of a cancer patient. The monitor, whose job was to check the integrity of drug studies, found a forged radiological report and confronted Kornak, the study coordinator.
Kornak, 56, who had been working at Stratton for two years, got into a shouting match with the monitor and they had to be physically separated, according to sworn depositions of witnesses.
It wasn't the first time Kornak had argued with a drug company monitor, witnesses said. This time, Kornak's behavior and the discovery of the forged medical record further raised the suspicions of co-workers who were already unsettled by the fact he was allowed to wear a name tag with "M.D." on it. He also was introduced to patients and their families as a doctor and carried VA-issued business cards that listed him as a medical doctor.
Kornak was not a doctor. He was a convicted felon who never finished medical school and had tried more than once to use forged transcripts to obtain a medical license, according to federal court records. Fifteen years ago in Pennsylvania, Kornak pleaded guilty to federal mail fraud charges and was sentenced to probation after admitting he lied on a medical license application, the records show.
After the drug company's monitor confronted Kornak, he told Holland what had happened. Holland responded by writing a memorandum to his research staff affirming their ethical obligations. On May 28, 2003, some five months after it was first discovered, Kornak and Holland reported the incident to Dr. Donald Pasquale, the chief of research and head of the hospital's Institutional Review Board for research.
Pasquale initiated an internal probe, but the investigation began slowly and Kornak continued working.
At that time, hospital officials were apparently unaware of the scope of the scandal or that nearly three-fourths of their cancer research patients had been subjected to fraud.
Despite the fact that Kornak had admitted "scientific misconduct," and also that top hospital officials had begun questioning his credentials, he was allowed to continue working for almost 10 months, and he continued to commit more fraud.
Hospital officials defend their actions, noting that Kornak was removed from caring for "sensitive patients" and his computer access was limited.
"I strongly feel that our (system) functioned adequately," a high-ranking Stratton physician said during an interview at the newspaper last week. The physician declined to be identified on the grounds he or she is not authorized to talk about the case.
Kornak was finally barred from Stratton's premises in October 2002 after a clerk in the cancer unit reported he'd tried to get her computer access code to hack into the system, according to court records.
On Nov. 2, 2002, Pasquale and Dr. Eina Fishman, who was chief of staff at Stratton, met for two hours in Fishman's office with Holland. The meeting, which is characterized in the court documents as a "conversation," was tape recorded.
According to a transcript of the meeting, Holland admitted he was overwhelmed with work and had relied on his three research coordinators, none of them physicians, to carry out many of his duties. Most notably, he said, the researchers took the lead in getting cancer patients to sign consent forms that would enroll them in drug studies.
Still, Holland blamed Kornak.
"This is so black and devious," he said in the meeting. "There's got to be a lot more to this and he's put all of our jobs at risk. And he put my medical license at risk. ... If I was (not) a calmer person, I would've strangled him."
The infusion suite, where the drugs were administered, became so busy nurses were "pounding me ... this is not safe," Holland said. He recounted a case in which a patient could have died because of a prescription mishap that wasn't caught until the nurse who was supposed to administer the drugs noticed a problem.
"That was cutting it really close; it should have never have gotten that far," Holland said.
As for the high number of patients, Holland said he often felt "rushed" to treat them and under pressure from the drug companies to get more veterans in studies. Yet, he also said Kornak was pushing people into studies who didn't qualify, claiming Kornak's motive was to earn overtime pay from the added work.
Looking back, Holland said at the time, he was concerned that at least four deaths may have been linked to Kornak's fraud and forgeries. Holland specifically cited the case of James J. DiGeorgio, an Air Force veteran from Rensselaer County who died during a drug study. Kornak would later be convicted of negligent homicide for DiGeorgio's death.
Four deaths involving veterans on drug studies, including DiGeorgio, bothered Holland as he reflected on the circumstances of their cases, he said in the interview.
Another veteran, George Hunt, died after being infused with experimental drugs that required subjects have no history of heart disease in order to qualify for them. In Hunt's case, his EKGs (electrocardiograms) used as criteria for admission to study had been handled by Kornak.
"I was told that Paul had altered some EKGs, and I was hoping I saw the right EKG at that particular point," Holland said of his decision to order a drug infusion. "I'm afraid, hoping he wasn't the one that the EKG had been altered beforehand. ... Next thing I know, I come back in the morning and the guy had coded in the middle of the night."
Hunt died later that day.
In a deposition on Jan. 16 at the federal prison in Ohio at which he is serving a 71-month prison sentence, Kornak invoked his Fifth Amendment right against self-incrimination four times as he was pressed by an attorney for the widows about the extent of his crimes.
Kornak cast blame on Holland, saying the former researcher knew Kornak lacked a medical license and that Holland encouraged staffers to push patients into the drug studies.
"There was a blackboard or a marker board in the office areas that listed all the studies and he would urge that more patients be placed on the study that was less than fulfilled," Kornak said. "He told me there was no reason why a patient shouldn't be placed on a study ... that is the mantra that he lived by at the VA."
Between 1998 and 2002, the number of studies at Albany's VA hospital jumped from five to nearly 30, Kornak said.
"He opened up every study he could and decided to fill them to their capacity," Kornak said. "It seemed to me that he wanted me to take over more of his duties."
Lori Megherian, another research coordinator, backed Kornak's version.
In a seven-page affidavit given to investigators with the Food and Drug Administration, Megherian recounted Holland's drive to get patients enrolled.
Holland would say "we need to get patients on the studies and our salaries are based on enrollment, on how much money we were bringing in," Megherian said.
In January 2003, 13 months after the fraud was discovered, hospital officials began drafting letters to the families of research patients to notify them there was a problem.
Fishman said she chose to personally attempt to contact the families of five veterans, including DiGeorgio and Carl M. Steubing, both of whose widows are plaintiffs in the lawsuit.
"I had a concern that the deaths may have been related to the documentation issues," said Fishman, who no longer works at Stratton.
Brendan J. Lyons can be reached at 454-5547 or by e-mail at blyons@timesunion.com.
* Independent audit of Stratton research program: "Subjects were consented, enrolled, and examined by an individual posing as a medical doctor.... The Internal Review Board did not adequately protect the rights and welfare of human subjects."
* Karen Sutton, whose father, Charles G. Merritt, a World War II Army veteran, died Aug. 10. 1999: "I remember my father saying he understood the importance of experimental chemo but he didn't want to do it. He was overmedicated and things got kind of out of control there for him. He was hallucinating. They falsified his records and Dr. Holland coerced him into signing the paper."
* Interview of Dr. James Holland by VA officials, Nov. 8, 2002: "I was told that Paul had altered some EKGs and I was hoping I saw the right EKG -- I'm afraid, hoping he wasn't the one that the EKG had been altered beforehand -- I come back in the morning and the guy had coded in the middle of the night."
Scandal in the making
1990: Paul H. Kornak is denied a medical license in New Jersey for falsifying documents in his application.
1992: Kornak, who never completed medical school and forged his college transcripts, is convicted of federal mail fraud in Pennsylvania for lying on a medical license application. He is sentenced to probation and fined $2,500.
1995: Stratton Veterans Affairs Medical Center pharmacist Jeffrey Fudin warns hospital officials of corruption in Stratton's cancer program that he said is resulting in "needless premature patient suffering and/or death."
1998: A review of Stratton's cancer program by other VA oncologists determines it is in disarray and patient care is poor. Dr. James A. Holland is hired by Stratton VA.
1999: Kornak is hired as a laboratory technician at Stratton through nonprofit Albany Research Institute.
2000: Holland appointed head of Stratton's cancer program, including research. Despite lying on his application, Kornak gets a government job at Stratton as a human research coordinator.
2001: Two nurses complain to Stratton's research oversight board that patients are at risk because of an overtaxed research department. One of the nurses is later reprimanded for issuing presigned prescriptions for controlled substances to patients. The cancer program's research studies have swelled from five in 1998 to more than 20. A monitor for Ilex Oncology, a Texas company funding a drug study at Stratton, discovers fraud in a patient's file at Stratton.
2002: FDA investigators report serious record-keeping flaws in Stratton's cancer research program, including alteration of patient medical tests. A federal criminal investigation is launched. Kornak and Holland are suspended and later terminated.
2003: Legislation is introduced in Congress creating an independent oversight office to keep tabs on medical research programs at Veterans Affairs hospitals nationwide.
Dr. Thomas Ferro, a former pulmonary physician at Stratton who was appointed to lead the 1995 internal investigation of Fudin's allegations, tells the Times Union that he took part in a cover-up designed to "thwart the truth."
Quintiles Consulting, an independent clinical site auditor hired by Stratton, discovers fraud in 70 percent of Stratton's cancer research patients' files. The confidential report concludes the hospital's human experiments "lack adequate oversight" and that an Institutional Review Board, which monitors research protocols, "did not adequately protect the rights and welfare of human subjects."
A federal grand jury hands up a 48-count indictment against Kornak, including charges of negligent homicide.
The first of seven widows of veterans, all of whom died after being enrolled in experimental drug studies at Stratton, files what is now a class-action lawsuit against the U.S. Department of Veterans Affairs, Kornak and Holland.
2005: Under a plea and cooperation agreement, Kornak pleads guilty to three felony counts and is sentenced to 71 months in federal prison.
2007: Holland pleads guilty in federal court to a misdemeanor count of failing to keep accurate records on research patients. He continues to practice medicine. His sentencing is pending.
Compiled by Senior writer Brendan J. Lyons Sources: Interviews; U.S. Department of Veterans Affairs; federal court records; U.S. attorney's office


Kelley



These are Kelly's opinions and I am just posting them for wider reading I suggest you do other research and discover for yourself the facts of these different areas of discussion. Mike

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Sunday, December 9, 2007

A flood of stressed vets is expected great article by C.W. Nevius


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A FLOOD OF STRESSED VETERANS IS EXPECTED -- "I was
driving to Reno. I was literally going to kill myself. I kept thinking,
I should have stayed in Iraq. I should have died over there."


For more about veterans and PTSD, use the VA Watchdog search engine...click here... http://www.yourvabenefits.org/sessearch.php?q=ptsd&op=andvabenefits.org/sessearch.php?q=ptsd&op=and
Story here... http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/12/09/BALQTQEO0.DTLcgi-bin/article.cgi?f=/c/a/2007/12/09/BALQTQEO0.DTL
Story below:
-------------------------
A flood of stressed vets is expectedC.W. Nevius
Last May, Tim Chapman was sitting in his car on the edge of a cliff, weeping. If he took his foot off the brake, he would go over the edge - to silence, to peace, and to death."It was a truck stop in Truckee," Chapman said. "I was driving to Reno. I was literally going to kill myself. I kept thinking: I should have stayed in Iraq. I should have died over there."The 23-year-old National Guardsman, just six months back from a tour in the combat zone, sat on the brink for two hours. Even today, he isn't sure why he didn't launch himself over the side.Instead, he backed off the cliff and drove himself to a hospital in Roseville. Within three days, he was in the psych ward at a Veterans Affairs hospital. Today, after extensive therapy, he thinks his life is beginning to make sense again.

It's a wrenching story. But this isn't the end of it. It is just the beginning.First a few facts. Bobby Rosenthal, regional manager for homeless programs at the Department of Veterans Affairs, estimates that one third of the more than 6,000 homeless people - about 2,100 - in San Francisco are veterans.And no wonder the number is so high. California leads the nation in homeless veterans by a mile, according to the National Coalition for Homeless Veterans. The 2006 numbers showed 49,724 homeless vets in California. The next nearest state was New York with 21,147.Now here's the scary part. Compared with what's coming, that's nothing.Roughly 750,000 troops served in the wars in Iraq and Afghanistan, often with multiple tours of duty. Many are only now returning home. But unlike Vietnam veterans, who didn't begin to demonstrate post-war trauma until five or 10 years after they left the war, this group seems to be on a fast track."Everything is speeded up," said Michael Blecker, executive director of San Francisco's Swords to Ploughshares program. "What we're seeing in San Francisco is guys in their 20s with the kind of stress and trauma that makes it impossible to go on with their lives."It's been called a health care tsunami. Because not only are the Iraq vets prone to post-traumatic stress disorder (something Chapman has battled) but with improved battlefield health care, far more are surviving traumatic injury. On one hand, that's good news, but it also means many more vets who are severely disabled, having lost arms and legs. Both factors increase the chances that the returning troops will join the sad ranks of homeless veterans.Cities all over the country are bracing themselves, although some, like San Francisco, are bound to be hit harder. Mayor Gavin Newsom says that at a recent conference of mayors, the group passed a resolution asking the VA "to tell us what you are going to do.""It's great lip service," Newsom said, "but show me the money."If history holds, the mayors shouldn't hold their breath. If anything, benefits for veterans have been restricted. To take one example, many of us think of the World War II G.I. Bill as a shining example of a reward for service, paying for college for vets. But Blecker, of Swords for Ploughshares, says the current version "is in no way, shape, or form near enough" to pay for a degree.As Newsom says, "Yeah, support the troops - as long as they are young, healthy and a great photo op."For San Francisco, the potential impact could be huge. An influx of traumatized, battle-scarred veterans presents a scary future. Consider the case of Scott Kehler, a veteran of the first Gulf War, who needed years to work through his demons. He recalls passing burned bodies and the constant fear that an explosion would suddenly erupt in the street."It was the things I didn't want to see at night when I closed my eyes," Kehler said. "I didn't know what PTSD was. I only knew my dreams, my shame, my guilt, was all coming together."Kehler spent almost 16 years kicking around the country. He lived in shelters in San Francisco and ate in free kitchens until a friend suggested he get in contact with Ploughshares. He checked into the group's transitional housing, a 60-person unit on Treasure Island, and began to find himself.Today he has been hired by the organization as a residence manager. He's lived there 18 months, which doesn't sound like much until you hear him say, "This is the longest I have lived in one place since 1990."Kehler, who is mentoring Chapman, is testimony to the effectiveness of the Ploughshares slogan - "veterans helping veterans.""Especially now that we've got our veterans coming home from Iraq," said Ploughshares counselor Tyrone Boyd, "we're going to need people that have been in combat so they know what they are talking about."The challenges are unique. Wanda Heffernon, a program and clinical counselor for Ploughshares, said they had a new inductee who slept in the closet. It was the only place he felt safe.It's the sudden transition that gets them."One day they are fighting in a war," said Kehler. "The next day they are sitting at their mother's kitchen table."Is it any wonder they end up on the street? Kehler battled alcohol abuse, but Chapman is part of the new breed, who turn to methamphetamine. Married when he returned, he lost his wife and all contact with his parents. Eventually he ended up sleeping in an alley. Now drug-free, living at Treasure Island housing, holding down a full-time job, and reconnected with his mother, he is testimony to the idea that peer counseling seems to work. Ploughshares has earned support from Sens. Dianne Feinstein and Barbara Boxer and House Speaker Nancy Pelosi.Imagine the impact it would have on the San Francisco homeless problem if one third of those on street were able to get help and housing.But what the vets don't have is funding."Why isn't the federal government doing something about this? Why isn't the Veterans Administration doing something?" Blecker asks. "The irresponsibility of our leaders, not to address this, makes me want to tear my hair out."The VA's Rosenthal - who gets high marks from local leaders - says the problem is not being ignored."It's a whole new set of challenges," she said. "The VA is looking at it. Let's hope we've learned our lesson from Vietnam."We can only hope."You know what scares me?" asks Boyd. "I haven't heard a plan (from the federal government) about what they are going to do when the troops come home. What's the plan?"Well?
C.W. Nevius' column appears Tuesday, Thursday, and Sunday. His blog C.W. Nevius.blog can be found at SFGate.com. E-mail him at cwnevius@sfchronicle.com.
------------------------- Larry Scott --
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How to package a new VA Secretary?

PACKAGING PEAKE -- How a former Army Surgeon General with

ties to the Walter Reed scandal and one-time executive with a

company raking in VA contracts worth hundreds of millions

of dollars was sold to Congress and vets as a good guy

who can save the Department of Veterans' Affairs.







Story below:

-------------------------

Packaging Peake

How a former Army Surgeon General with ties to the Walter Reed scandal and one-time executive with a company raking in VA contracts worth hundreds of millions of dollars was sold to Congress and vets as a good guy who can save the Department of Veterans’ Affairs.



commentary by Larry Scott



It went like this:

Jim Nicholson, Secretary of the Department of Veterans’ Affairs (VA), announces his resignation. It’s July of 2007. Nicholson says he will leave the VA no later than October 1. A collective sigh of relief can be heard all over Capitol Hill. The press won’t have the bumbling Nicholson to kick around any more. But, who will be the new VA Secretary? Who could be passed-off as a savior of the VA working to make all the nagging problems go away?

Many thought the miter would pass to Deputy Secretary Gordon Mansfield. But, on October 1, when Mansfield automatically became Acting Secretary, we knew that was not to be. Why not Mansfield? Many insiders feel Mansfield is too “veteran-friendly” because of his years of service at the Paralyzed Veterans of America.

So, who, then? Who would meet all the requirements of staunch political ally (sometimes called a hack) and a yes-man, but could be packaged to appear to be a benign benefactor? Let’s see…we’ll need a veteran, decorated, of course. And, of high rank…none of this enlisted stuff. Three stars? That's enough. Hey…how about a doctor? We’ve never done that before. Just make sure he still has his license and didn’t have anything to do with those experiments at Edgewood Arsenal. And, to round it out, a business executive who knows how to make hundreds of millions of dollars from VA contracts but can plausibly deny any wrongdoing.

On October 30, LIVE from the Roosevelt Room at the White House, we got our man. Dr. James Peake. Decorated veteran. Three-star general. Physician. Highly-paid executive with QTC Management, Inc., a company that makes hundreds of millions of dollars giving C&P exams to veterans. (Peake has since resigned from QTC to avoid the appearance of “conflict.”)

The packaging had begun. The lighting was perfect. The camera work brilliant. The president smooth and deliberate in his praise. He described Peake as an “end of a chow line officer,” who “devoted his career as an Army doctor to improving care for our wounded servicemen and women.” The president’s remarks went on and on…building a package of perfection around Dr. Peake.

The next layer of packaging came from the veterans’ service organizations (VSOs). The American Legion’s national commander said, “I’m pleased with Pres. (George W.) Bush’s nominee to lead the Department of Veterans Affairs.” From the VFW: “…he certainly has the prerequisite credentials and organizational skills to lead the second largest federal department.” And, the DAV caved-in and assumed that Peake would be confirmed: “The DAV stands ready to assist the new Secretary in any way possible to help fulfill our nation’s sacred obligation to veterans.” Now, the veterans’ community was primed to accept Peake as VA Secretary, although few stopped to realize that the VSOs would give the nod to any nominee who didn’t have a Dishonorable Discharge.

The next step in the packaging came in the disclosure statements Peake sent to the Senate Committee on Veterans’ Affairs in answer to their questions. Peake said even though he was Surgeon General of the Army from 2000-2004, he had no “direct” knowledge of the problems at Walter Reed hospital. How about “indirect?” Did anybody ask that? No. Peake also said he will terminate any connection with QTC. Does that mean he will have no contact at all with the chairman of QTC, former VA Secretary Anthony Principi? Probably not. “Hey, Tony, just called to chat about the budget.” Not likely. And, Peake promised to keep an open mind on mandatory funding for VA healthcare, something none of his predecessors, or the White House, has done.

Now, the packaging is almost complete. We are just a few days away from the December 5, 2007 confirmation hearing before the Senate Committee on Veterans’ Affairs and Peake has said all the right things. Will the Committee buy it? Will they become true believers? Before the hearing even begins, we find out that the packaging has worked. In a news story the day before the hearing, Committee Chair Sen. Daniel Akaka (D-HI) indicated that he would like to see Peake approved by the full Senate later in the month, indicating that it is a done deal. Sen. Patty Murray (D-WA) said she plans tough questions but expects him to be confirmed.

Then, the day of the hearing, we realize that the packaging is complete when Peake sits down at the witness table flanked by Sen. Daniel Inouye (D-HI), a World War II hero and recipient of the Medal of Honor and former Sen. Bob Dole, another World War II hero.

The message comes through loud and clear, not as an endorsement from two respected warriors but as a threat to the Committee: “This is our boy you see surrounded and protected by these courageous World War II heroes. No hard questions, or there will be political consequences.” The appearance of Inouye and Dole made Peake bullet-proof. The message was received. Sen. Larry Craig (R-ID) called Peake “our new Secretary.” Sen. Arlen Specter (R-PA) said to Peake, “Thank you for taking this job.” The blatantly-political move of shielding Peake with war heroes had worked.

DISAPPOINTMENT: Sen. Akaka indicating Peake would be confirmed before the hearing was even held.

BIGGER DISAPPOINTMENT: Sen. Barack Obama (D-IL) not showing up for the hearing. Obama’s loudly proclaimed pro-veteran stance must have been forgotten for the day. Or, maybe, he was out with Oprah.

BIGGEST DISAPPOINTMENT: Sen. Patty Murray rolling over, playing dead, scrupulously avoiding the tough question, and finally saying, "I am likely to confirm your nomination..."

Now we know for sure that it’s not who you are or what you do, but how well you are packaged. We never heard in-depth questioning about the Walter Reed scandal. And, Peake was there in the chain of command. We never heard reasonable answers about QTC and how they grabbed huge VA contracts. And, we never even heard a whisper of the allegation that Peake may have provided mental health professionals to aid interrogators at Guantanamo.

But, we sure have a pretty package. A nice ornament to hang on the tree, if you will.

Dr. James Peake WILL be confirmed as VA Secretary. His nomination should move out of Committee to the full Senate before the Christmas recess.

Then, veterans get to hold their breath and hope that this political hack is just a little bit better, a little smarter, a little more caring than the previous political hacks.

-------------------------

Larry Scott --



Don't forget to read all of today's VA News Flashes (click here)

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Dark Chapter at Albany VA, patients lives risked

COURT PAPERS DETAIL DARK CHAPTER AT ALBANY VA --

Veterans were being pushed into poorly run drug studies for

which they didn't medically qualify and top hospital officials

privately suspected that as many as five veterans, and

possibly more, died prematurely.







For more about the cancer drug studies at the Albany VA, use the VA Watchdog search engine...click here... http://www.yourvabenefits.org/sessearch.php
?q=albany+cancer+drug+study&op=and

Story here... http://www.timesunion.com/AspStorie
s/story.asp?storyID=645743&category=REGION&newsdate=12/9/2007

Story below:

-------------------------

Court papers detail dark chapter at VA

By BRENDAN J. LYONS, Senior writer



Albany -- The veterans and their spouses called it the drip room.

It was a grim place, located on the first floor at Stratton Veterans Affairs Medical Center just past the cashier's office and the pharmacy. Hard plastic seats spilled into the hallway, with relatives who waited hours for their loved ones to get the cancer drugs that offered them hope.

The spacious room, with its IV-friendly lounge chairs and a row of beds for the patients who got nauseous, began filling to capacity about nine years ago.

The crowds were in large part caused by experiments on dozens of desperate cancer patients who were given powerful mixtures of drugs that were being tested for their marketability.

In September 2001, as the number of cancer drug studies at Stratton tripled to more than 20, two nurses warned a VA oversight board that conditions were unsafe and patients were at risk. No one took action.

Yet that bustling business was only a symptom of a systemic breakdown in which veterans were being pushed into poorly run drug studies for which they didn't medically qualify. They also were the victims of fraud and deception, and top hospital officials privately suspected that as many as five veterans, and possibly more, died prematurely from the fallout.

New information surfaced last month in hundreds of pages of depositions and internal reports filed in a lawsuit by several widows of veterans who died after enrolling in Stratton's drug studies, providing a spotlight on a government research program that had spiraled out of control.

Attorneys in the case declined comment.

The federal court documents, which include confidential investigative reports never made public, indicate that about 70 percent of Stratton's former cancer research patients were victimized in the scandal, which triggered nationwide hiring reforms in VA research programs. In early 2002, at the time it began unfolding, 91 veterans were involved.

Allegations include:

Cancer patients were pressured into joining experimental studies in which they and their families did not want to be enrolled.

A nurse who still works for a VA hospital received only a reprimand for issuing pre-signed prescriptions for controlled substances without doctor approval.

Three research coordinators were ordered to enroll as many people as possible in drug studies by a physician who said their salaries and job security were at stake.

Paul H. Kornak, a convicted felon who never completed medical school, was hired as a research coordinator and fraudulently posed as a doctor when supervisors knew of his background.

Research coordinators were allowed to illegally use a physician's electronic signature and computer access codes to perform functions for which they were not qualified.

Kornak and the former cancer research director, Dr. James A. Holland, continued working for months after their scientific misconduct was discovered.

Stratton's Institutional Review Board, which monitors research studies, "did not adequately protect the rights and welfare of human subjects."

Glenn McGee, a bioethics expert at Albany Medical College enlisted as an expert witness by the attorneys for the widows, characterized the situation as a "systematic deception by clinicians in plain violation of medical and research ethics across 3,000 years of the development of such principals."

"The clinical trials conducted at the VA involving the plaintiffs and their loved ones in this case violated the standards and regulations governing the conduct of clinical trials in this country and throughout the world," McGee wrote in a report filed in the case.

The case is pending in U.S. District Court in Albany. The hospital is being defended by Justice Department attorneys from Massachusetts because federal prosecutors in Albany oversaw the prosecutions of Kornak and Holland, both of whom were convicted of federal crimes related to research fraud.

At a hearing scheduled for Monday, the government's attorneys are expected to argue for a dismissal of the class action lawsuit on the grounds there is no proof the experimental drugs caused more than one death. They have also argued that since the participants were terminally ill cancer patients their deaths were already likely, and their pain and suffering from the experimental drugs cannot be quantified.

The widows' attorneys have filed hundreds of documents alleging negligence by the Department of Veterans Affairs, and comparing the scandal to Nazi experiments on humans during World War II.

The fraud at Stratton was discovered in December 2001 by a monitor for a Texas drug company who visited Stratton and began scrutinizing the records of a cancer patient. The monitor, whose job was to check the integrity of drug studies, found a forged radiological report and confronted Kornak, the study coordinator.

Kornak, 56, who had been working at Stratton for two years, got into a shouting match with the monitor and they had to be physically separated, according to sworn depositions of witnesses.

It wasn't the first time Kornak had argued with a drug company monitor, witnesses said. This time, Kornak's behavior and the discovery of the forged medical record further raised the suspicions of co-workers who were already unsettled by the fact he was allowed to wear a name tag with "M.D." on it. He also was introduced to patients and their families as a doctor and carried VA-issued business cards that listed him as a medical doctor.

Kornak was not a doctor. He was a convicted felon who never finished medical school and had tried more than once to use forged transcripts to obtain a medical license, according to federal court records. Fifteen years ago in Pennsylvania, Kornak pleaded guilty to federal mail fraud charges and was sentenced to probation after admitting he lied on a medical license application, the records show.

After the drug company's monitor confronted Kornak, he told Holland what had happened. Holland responded by writing a memorandum to his research staff affirming their ethical obligations. On May 28, 2003, some five months after it was first discovered, Kornak and Holland reported the incident to Dr. Donald Pasquale, the chief of research and head of the hospital's Institutional Review Board for research.

Pasquale initiated an internal probe, but the investigation began slowly and Kornak continued working.

At that time, hospital officials were apparently unaware of the scope of the scandal or that nearly three-fourths of their cancer research patients had been subjected to fraud.

Despite the fact that Kornak had admitted "scientific misconduct," and also that top hospital officials had begun questioning his credentials, he was allowed to continue working for almost 10 months, and he continued to commit more fraud.

Hospital officials defend their actions, noting that Kornak was removed from caring for "sensitive patients" and his computer access was limited.

"I strongly feel that our (system) functioned adequately," a high-ranking Stratton physician said during an interview at the newspaper last week. The physician declined to be identified on the grounds he or she is not authorized to talk about the case.

Kornak was finally barred from Stratton's premises in October 2002 after a clerk in the cancer unit reported he'd tried to get her computer access code to hack into the system, according to court records.

On Nov. 2, 2002, Pasquale and Dr. Eina Fishman, who was chief of staff at Stratton, met for two hours in Fishman's office with Holland. The meeting, which is characterized in the court documents as a "conversation," was tape recorded.

According to a transcript of the meeting, Holland admitted he was overwhelmed with work and had relied on his three research coordinators, none of them physicians, to carry out many of his duties. Most notably, he said, the researchers took the lead in getting cancer patients to sign consent forms that would enroll them in drug studies.

Still, Holland blamed Kornak.

"This is so black and devious," he said in the meeting. "There's got to be a lot more to this and he's put all of our jobs at risk. And he put my medical license at risk. ... If I was (not) a calmer person, I would've strangled him."

The infusion suite, where the drugs were administered, became so busy nurses were "pounding me ... this is not safe," Holland said. He recounted a case in which a patient could have died because of a prescription mishap that wasn't caught until the nurse who was supposed to administer the drugs noticed a problem.

"That was cutting it really close; it should have never have gotten that far," Holland said.

As for the high number of patients, Holland said he often felt "rushed" to treat them and under pressure from the drug companies to get more veterans in studies. Yet, he also said Kornak was pushing people into studies who didn't qualify, claiming Kornak's motive was to earn overtime pay from the added work.

Looking back, Holland said at the time, he was concerned that at least four deaths may have been linked to Kornak's fraud and forgeries. Holland specifically cited the case of James J. DiGeorgio, an Air Force veteran from Rensselaer County who died during a drug study. Kornak would later be convicted of negligent homicide for DiGeorgio's death.

Four deaths involving veterans on drug studies, including DiGeorgio, bothered Holland as he reflected on the circumstances of their cases, he said in the interview.

Another veteran, George Hunt, died after being infused with experimental drugs that required subjects have no history of heart disease in order to qualify for them. In Hunt's case, his EKGs (electrocardiograms) used as criteria for admission to study had been handled by Kornak.

"I was told that Paul had altered some EKGs, and I was hoping I saw the right EKG at that particular point," Holland said of his decision to order a drug infusion. "I'm afraid, hoping he wasn't the one that the EKG had been altered beforehand. ... Next thing I know, I come back in the morning and the guy had coded in the middle of the night."

Hunt died later that day.

In a deposition on Jan. 16 at the federal prison in Ohio at which he is serving a 71-month prison sentence, Kornak invoked his Fifth Amendment right against self-incrimination four times as he was pressed by an attorney for the widows about the extent of his crimes.

Kornak cast blame on Holland, saying the former researcher knew Kornak lacked a medical license and that Holland encouraged staffers to push patients into the drug studies.

"There was a blackboard or a marker board in the office areas that listed all the studies and he would urge that more patients be placed on the study that was less than fulfilled," Kornak said. "He told me there was no reason why a patient shouldn't be placed on a study ... that is the mantra that he lived by at the VA."

Between 1998 and 2002, the number of studies at Albany's VA hospital jumped from five to nearly 30, Kornak said.

"He opened up every study he could and decided to fill them to their capacity," Kornak said. "It seemed to me that he wanted me to take over more of his duties."

Lori Megherian, another research coordinator, backed Kornak's version.

In a seven-page affidavit given to investigators with the Food and Drug Administration, Megherian recounted Holland's drive to get patients enrolled.

Holland would say "we need to get patients on the studies and our salaries are based on enrollment, on how much money we were bringing in," Megherian said.

In January 2003, 13 months after the fraud was discovered, hospital officials began drafting letters to the families of research patients to notify them there was a problem.

Fishman said she chose to personally attempt to contact the families of five veterans, including DiGeorgio and Carl M. Steubing, both of whose widows are plaintiffs in the lawsuit.

"I had a concern that the deaths may have been related to the documentation issues," said Fishman, who no longer works at Stratton.



Brendan J. Lyons can be reached at 454-5547 or by e-mail at blyons@timesunion.com.



* Independent audit of Stratton research program: "Subjects were consented, enrolled, and examined by an individual posing as a medical doctor.... The Internal Review Board did not adequately protect the rights and welfare of human subjects."

* Karen Sutton, whose father, Charles G. Merritt, a World War II Army veteran, died Aug. 10. 1999: "I remember my father saying he understood the importance of experimental chemo but he didn't want to do it. He was overmedicated and things got kind of out of control there for him. He was hallucinating. They falsified his records and Dr. Holland coerced him into signing the paper."

* Interview of Dr. James Holland by VA officials, Nov. 8, 2002: "I was told that Paul had altered some EKGs and I was hoping I saw the right EKG -- I'm afraid, hoping he wasn't the one that the EKG had been altered beforehand -- I come back in the morning and the guy had coded in the middle of the night."

Scandal in the making

1990: Paul H. Kornak is denied a medical license in New Jersey for falsifying documents in his application.

1992: Kornak, who never completed medical school and forged his college transcripts, is convicted of federal mail fraud in Pennsylvania for lying on a medical license application. He is sentenced to probation and fined $2,500.

1995: Stratton Veterans Affairs Medical Center pharmacist Jeffrey Fudin warns hospital officials of corruption in Stratton's cancer program that he said is resulting in "needless premature patient suffering and/or death."

1998: A review of Stratton's cancer program by other VA oncologists determines it is in disarray and patient care is poor. Dr. James A. Holland is hired by Stratton VA.

1999: Kornak is hired as a laboratory technician at Stratton through nonprofit Albany Research Institute.

2000: Holland appointed head of Stratton's cancer program, including research. Despite lying on his application, Kornak gets a government job at Stratton as a human research coordinator.

2001: Two nurses complain to Stratton's research oversight board that patients are at risk because of an overtaxed research department. One of the nurses is later reprimanded for issuing presigned prescriptions for controlled substances to patients. The cancer program's research studies have swelled from five in 1998 to more than 20. A monitor for Ilex Oncology, a Texas company funding a drug study at Stratton, discovers fraud in a patient's file at Stratton.

2002: FDA investigators report serious record-keeping flaws in Stratton's cancer research program, including alteration of patient medical tests. A federal criminal investigation is launched. Kornak and Holland are suspended and later terminated.

2003: Legislation is introduced in Congress creating an independent oversight office to keep tabs on medical research programs at Veterans Affairs hospitals nationwide.

Dr. Thomas Ferro, a former pulmonary physician at Stratton who was appointed to lead the 1995 internal investigation of Fudin's allegations, tells the Times Union that he took part in a cover-up designed to "thwart the truth."

Quintiles Consulting, an independent clinical site auditor hired by Stratton, discovers fraud in 70 percent of Stratton's cancer research patients' files. The confidential report concludes the hospital's human experiments "lack adequate oversight" and that an Institutional Review Board, which monitors research protocols, "did not adequately protect the rights and welfare of human subjects."

A federal grand jury hands up a 48-count indictment against Kornak, including charges of negligent homicide.

The first of seven widows of veterans, all of whom died after being enrolled in experimental drug studies at Stratton, files what is now a class-action lawsuit against the U.S. Department of Veterans Affairs, Kornak and Holland.

2005: Under a plea and cooperation agreement, Kornak pleads guilty to three felony counts and is sentenced to 71 months in federal prison.

2007: Holland pleads guilty in federal court to a misdemeanor count of failing to keep accurate records on research patients. He continues to practice medicine. His sentencing is pending.

Compiled by Senior writer Brendan J. Lyons Sources: Interviews; U.S. Department of Veterans Affairs; federal court records; U.S. attorney's office

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Larry Scott --



Don't forget to read all of today's VA News Flashes (click here)

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My thoughts and opinions on VA PTSD treatment

I know opinions are like azzholes, everyone has one and most people don't want to hear them. But given I have been very involved with PTSD treatment since 2003 on a personal basis, so I have views from another states VA treatment, and despite DR Nussbaums thoughts that what is happening in Tampa is an abnormal situation, is he is mistaken, this is happening across the nation, I have experienced it myself, in Georgia and South Carolina. So if it is happening in these three states, then it is more likely than not happening in other states as well.

I have had 2 C&P exams for PTSD and neither of them lasted more than 15 minutes, they were done by residents and the C&P clinics MD had to sign off on them to make them legitimate. Would anyone consider these 2 exams well done? They also refuse to allow your spouse in the room for PTSD exams, why? My wife attends all my VA psych appointments because I have a really bad memory and the regular treating shrink asks her whats really going on every session, which is good. It's when he lets the interns interview me that they don't like her being there.

There is a lot of room for improvement in the treatment of PTSD and the C&P exams need a major overhaul.

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VA Watchdog.org Article on PTSD and DR Nussbaum

UPDATE: TAMPA VA PSYCHOLOGIST TELLS OF MORE

MISMANAGED MENTAL HEALTH PROGRAMS -- C&P exams for

PTSD take just 15-20 minutes and are given by residents with little,

if any, training. PTSD treatments try to fit people into a mold

that disregards the individual's needs. And, there's more...






Dr. Brian Nussbaum, Psychologist, Tampa VA



Story below:

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On December 5, 2007, I posted a story from the St. Petersburg Times headlined: COMPLAINT CHARGES TAMPA VA USING UNLICENSED PSYCHOLOGISTS. That story here...
http://www.vawatchdog.org/07/nf07/nfDEC07/nf120507-5.htm

In the story, VA psychologist Dr. Brian Nussbaum told of a complaint he has filed with the state of Florida regarding the VA's use of unlicensed psychologists.

Shortly after that, Dr. Nussbaum contacted me and we exchanged a series of communications. Dr. Nussbaum outlined problems he sees in the mental health care programs at the Tampa VA.

I have decided to use Dr. Nussbaum's own words instead of trying to write an article about this. That way, there is no room for error or interpretation.

Dr. Nussbaum's remarks are below in quotes and italics.

NOTE: In Dr. Nussbaum's remarks he says he feels the problems he sees at the Tampa VA are not widespread. Anecdotal evidence indicates otherwise. Many veterans write me about the problems they have getting a mental health appointment and the quality of care when they are seen.


ON C&P EXAMS FOR PTSD:

"At the James A Haley VA [Tampa, FL] Compensation and Pension exams for PTSD last 15-20 minutes and are completed by medical residents with little, if any, training in the assessment of PTSD, yet they are making such important decisions. VA published a Best Practices manual on C&P exams for PTSD that states an initial exam is likely to require four hours or more and include psychological testing. They don’t follow this manual. I have not seen board certified psychiatrists doing C&P exams in my five+ years in the Tampa VA system."



ON PTSD TREATMENT AND CURES:

"The VA is promoting two 'evidence based' treatments for PTSD that they claim are well supported in the literature. These are based on exposure therapy models that involve very brief, but intensive, therapy lasting 10-14 weeks. They claim that many of these patients are 'cured' after this treatment. Although these can be important tools in a therapist’s toolbox, they are one of many important resources in recovering from trauma. Additionally, nearly all of the research studies were done on female civilians and veterans with sexual trauma, not male combat veterans (the predominant population it is being promoted for in VA).

"Many experts in PTSD, especially those familiar with combat veterans, understand that it takes time to develop trust and a therapeutic relationship with patients. Additionally, although you may make progress in dealing with the combat trauma, these treatments essentially ignore the co-morbid diagnoses that accompany PTSD in about 80% of cases, such as depression, panic disorder, marital/relationship problems, and substance abuse. What about the anger Vietnam vets often express related to their country rejecting them upon their return, or the five marriages and 30 jobs we often hear many have gone through? These are not a part of these brief treatments.

"Most concerning is that the treatments are manualized and try to fit people into a mold that disregards the individual's needs and personal goals for treatment. When I raised this issue, I was told, 'Sometimes what a patient wants isn’t what they need'. As a consumer of healthcare, I would hope that my providers would take my personal goals into consideration and not impose the 'flavor of the month' intervention because they find it interesting.

"Those of us who have expressed a need for the VA to provide a wide range of services from support groups to intensive treatments have been dealt uncomfortable reprisal or just flat out been ignored. The truth is we don’t know what the complex factors are that lead to PTSD and we don’t know which treatments work for all patients. However, we do know that we are all unique individuals and our soldiers and veterans who have borne the battle deserve personalized, not manualized, care that addresses that person’s unique needs."



ON INEXPERIENCED STAFF:

"In recent months, several of the Tampa PTSD clinic’s most qualified and experienced experts have been removed and replaced with less experienced staff. Many of these staff have little experience with PTSD and/or are unlicensed and not appropriately supervised per state and VA regulations. My attempts to get an audience with the Chief of Mental Health, Dr. Glenn Catalano, have repeatedly been ignored, yet he is often seen [in meetings] with the less experienced, unlicensed staff members who he has empowered to develop and oversee the programs in place for our returning Iraqi and Afghanistan soldiers/veterans."



ON WORK SCHEDULES:

"All three of the unlicensed psychologists in the PTSD clinic have requested to work a compressed work schedule (e.g. four 10-hour days). All were approved and all were allowed to take Friday as their day off. This is in an effort to provide evening/extended hours of care to better meet the needs of Iraqi/Afghanistan veterans. Yet it leaves serious gaps on Fridays. How is this improved coverage?"



ON EMPLOYEE ASSISTANCE PROGRAM:

"Of the few members of the mental health staff that are providers for the Employee Assistance Program (EAP), one is an unlicensed psychologist. I suppose licensed psychologists were not available to provide this service. Yet, I don’t recall ever being asked if I was interested."



CONCLUDING THOUGHTS:

"These issues and more are extremely concerning. I do not believe they are widespread throughout VA. I believe they are the result of a relatively few people at the local facility who are…well…you fill in the blank. These are not difficult issues to fix. VA has a wonderful approach to recruiting, hiring, retaining, and continually evaluating the performance of career staff. They just aren’t utilizing these procedures at the busiest VA in the country.

"From a mental health standpoint, I believe the resources are adequate, they are simply mismanaged. Reorganizing with the help of an outside consulting agency might help rapidly remedy these problems.

"And hopefully they will allow me to continue to be around and be a part of this positive change."

Dr. Brian Nussbaum

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Larry Scott --

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