WSU to Study Iraq Toxins' Effect
Spokesman-Review
by Bert Caldwell
Research to examine how exposure might damage offspring of soldiers
Washington State University scientists will use a $1.7 million grant to study what multi-generation genetic damage might be done by toxins U.S. troops could encounter in Iraq.
The research using laboratory rats, not humans, will be the first for the military to examine the epigenetic effects of pesticides, herbicides and other compounds, said lead scientist Michael Skinner, director of the university's Center for Reproductive Biology.
Previous studies have looked at the health effects of other substances, notably the Agent Orange used to defoliate jungles in Vietnam, on the soldiers directly exposed, he said, not on their children or grandchildren.
"The science really had not caught up with the trans-generational stuff," said Skinner, one of several WSU pioneers in the field of epigenetic, or multi-generational, inheritance.
Besides herbicides and pesticides – which and in what combinations has not been determined – the study also will look at the effects of explosives residues, he said.
The four-year study will allow researchers to see how any changes in genetic chemistry that develop are passed along through two subsequent generations of rats, he said, noting that only the first two years of research have been funded.
Among the problems that might develop are kidney disease, or changes in the male and female reproductive organs, he said.
If any genetic markers are identified in rats, Skinner said, follow-up research could look at whether they might show up among members of the military as well.
That would be of particular interest to Dave Holmes, interim chief operating officer of the Institute for Systems Medicine, which was awarded the U.S. Department of Defense grant passed through to Skinner.
Holmes' son, Tim Hammond, did two tours in Iraq with the U.S. Marine Corps.
"They sprayed all kinds of stuff on them," Holmes said.
Although the grant money, the first awarded ISM, will fund work in Pullman, he said the organization's supporters hope any subsequent clinical studies will be done in Spokane.
"There's a lot of excitement about making it happen," he said.
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VA, Tricare to get millions from settlement
NAPLES, Italy — Federal agencies including the Department of Veterans Affairs and Tricare stand to share more than $300 million following settlement of a fraud case brought by the Department of Justice against pharmaceutical company AstraZeneca.
The case centered around AstraZeneca’s marketing strategy for its anti-psychotic drug Seroquel, which was only approved by the Food and Drug Administration for use in treating bipolar disorder and schizophrenia, according to the justice department.
AstraZeneca, however, sold the drug to health care providers for a multitude of other conditions, including post-traumatic stress disorder, anger management, anxiety, sleeplessness, dementia, depression and others, according to the settlement agreement.
The company settled the suit for $522 million. In addition to the VA and Tricare, settlement funds go to state Medicaid programs, according to the justice department.
Tricare officials said their agency will get about $4.7 million of the settlement, which will be returned to the general Tricare Benefit fund.
"A small percentage of the fines and penalties is returned to Department of Justice to support further fraud efforts, a portion goes to the HHS-OIG fund to support fraud investigations and the remainder goes to the Medicare Trust Fund," said Tricare spokesman Austin Camacho.
Doctors can prescribe drugs for uses other than what the FDA has approved. This is a fairly common practice, according to the DOD pharmacy agency, which cites a report on its Pharmacoeconomic Center website indicating "some 40% to 60% of all prescriptions are for uses the FDA has not approved."
Marketing drugs for uses that haven’t been approved by the FDA is known is "off-label" use. While off-label prescriptions are legal, off-label marketing isn’t.
"It’s fraud," Charles Miller, a Justice Department spokesman, said on Wednesday. "It is a matter of overbilling, in the sense that [drug companies] are seeking and receiving reimbursement for (uses of) a drug that was not FDA approved."
The suit also contended AstraZeneca paid doctors to pose as authors of medical articles that were actually ghostwritten by company agents touting the efficacy of Seroquel for non-FDA approved uses, according to the settlement agreement. The government also charged the company for violating the federal Anti-Kickback Statute by paying doctors to travel to resort areas where they would advise the company about off-label marketing for the drug, according to the agreement.
According to the terms of the agreement, AstraZeneca admits no wrongdoing, but has to enter into a five-year Corporate Integrity Agreement that forces closer scrutiny of company practices.
Under the agreement, the company must notify doctors about the settlement, and post information on its website about travel, lodging and gratuity payments made to doctors. Non-compliance with the agreement could result in the company’s exclusion from doing business with federal health care programs.
