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Dr. Raymond Schinazi played a leading role developing a drug that cures hepatitis C while working seven-eighths of his time for the VA| By amynordrum

Hepatitis C drug costing VA, DoD millions
By Patricia Kime, Staff writer
We're looking at a company who is milking a cash cow for everything it's worth," Sanders said. 

VA to outsource care for 180,000 vets with hepatitis C
Dennis Wagner, The Arizona Republic 12:27 a.m. EDT June 21, 2015

VA to outsource care for 180,000 vets with hepatitis C
, The Republic | 11:51 a.m. MST June 19, 2015
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Michael Volpe Contributor ...According to a memo — the entire region has been forced to stop all “non-VA care” referrals due to a budget shortfall.
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Did Shots Cause Hepatitis C? Officials Downplay Concerns
(Star Tribune)

- Star Tribune intern Andrew Atkins contributed to this report.
Copyright 1997 Star Tribune.
Greg Gordon; Staff Writer, Did shots cause hepatitis C? Officials downplay concerns., Star Tribune, 07-28-1997, pp 01A

When a test was developed three years ago to detect the potentially deadly virus hepatitis C, researchers at the Food and Drug Administration (FDA) made a disturbing discovery. They found the genetic fingerprint of the virus in batches of a blood-plasma product that has been used for decades to inoculate U.S. soldiers and other Americans against hepatitis A and B before they travel to Third World nations.

Officials at the FDA and the Centers for Disease Control and Prevention (CDC) say that despite the finding, there is no need to worry about the safety of those inoculations. Even if the virus got into the inoculants, the officials contend, its genes were damaged during the manufacturing process or otherwise neutralized.

Some scientists aren't so sure.

And FDA and CDC officials acknowledge that there has been no definitive research on whether the inoculants could have transmitted hepatitis C, a disease estimated to have infected 3.9 million Americans.

A number of public-health experts say more studies are needed to prove that the inoculations were safe and didn't put soldiers and travelers at risk of contracting the slow-moving, blood-borne virus that is a leading cause of liver disease.

In a recent report, the General Accounting Office quoted an anonymous FDA official as saying that although there are no known instances in which the shots have transmitted the disease, "this is a very scary situation."

Last year, after the FDA ordered that immune globulin inoculants undergo testing for hepatitis C as a "fail-safe measure," all private manufacturers pulled their products from the market. Some of these companies, including Pennsylvania-based Centeon, which was the military's principal supplier, said they soon will seek FDA approval to add steps to their production processes that inactivate the virus. The pharmaceutical industry also recently developed a vaccine for hepatitis A that eliminates much of the need for the immune globulin.

But Sen. Richard Shelby, R-Ala., has asked the Pentagon to look further into the possibility that the inoculants may have spread the disease.

In a letter to the Defense Department in May, Shelby said that since the inoculants weren't virally inactivated, "it is possible that military personnel sent to Somalia, Panama, Haiti, the Persian Gulf and other theaters were exposed to hepatitis C through the . .injections."

In a 1993 Army study, blood tests were taken on 513 soldiers before and six months after they were inoculated with immune globulin and deployed in Somalia. The study found that none was infected by the shots, said coauthor James Writer, an epidemiologist at the Walter Reed Army Institute of Research. But Writer and other experts said the study's methodology wouldn't pass scientific muster, in part because it wasn't known whether the soldiers received tainted inoculants.

After a different immune globulin product was found to have transmitted the disease in 1994, the CDC tested about 100 civilian travelers who had received immune globulin shots from lots known to contain hepatitis C genes. None was infected, said Jay Epstein, the FDA's director of blood research and review, who vouches for the inoculants' safety.

Dr. John Penner, a Michigan State University hematologist who sits on the FDA's Advisory Committee on Blood Safety and Availability, said he cannot recall "any really good studies" on whether immune globulin shots can transmit hepatitis C.

"It probably needs to be looked at . . . more carefully," he said. However, if low amounts of the virus in the products infected a small percentage of people, "we might have a hard time uncovering it," he said.

Former Surgeon General C. Everett Koop said more research is needed on all possible transmission routes for hepatitis C - including immune globulin inoculations.

A Mystery

The inoculants have been considered a possible suspect in part because most scientists view the virus' spread as somewhat of a mystery. As many as 44 percent of its victims typically report no risk factors - such as having had a blood transfusion, having shared intravenous needles or having held a health-care job.

Also, until recently, it has been easy to contaminate immune globulins. It takes 10,000 to 25,000 blood donations to produce one dose, which can be tainted by a single infected donor. After tests to detect hepatitis C were developed in 1990, manufacturers began screening donors for the virus.

Federal health officials and spokesmen for makers of immune globulin inoculants say that, despite these factors, the products always have been safe because the manufacturing process kills the virus.

"Intramuscular immune globulin is safe and has never transmitted hepatitis C or any other infectious disease as licensed in the United States," said Miriam Alter, the CDC's chief hepatitis epidemiologist.

She said that although many victims reported having no risk factors, follow-up interviews with a sample group established that all but 1 percent of them had "high-risk drug and sexual behaviors." Alter said her agency had "miscommunicated" by failing to publicize that follow-up data, thus leaving the impression that the disease spreads in unknown ways.

Other scientists, even federal officials who say that immune globulins are safe, are skeptical of such sweeping conclusions. Edward Tabor, director of the FDA's Division of Transfusion-Transmitted Diseases, said he is "a little bothered" by the deduction that anyone who has the virus and has used drugs got it from an infected needle. In many cases, he said, "you're talking about somebody who experimented with drugs once."

Centeon spokesman Jimmy Hendricks said that since 1992, 11 people have contended that the company's globulin gave them hepatitis C and that FDA and company inquiries exonerated the product in each case.

Not Tested

If immune globulin inoculants carried the hepatitis C virus in the past, the military would be a good place to look for victims. The Pentagon ordered 481,000 doses of the inoculants from 1992 to 1996; the number of those doses actually administered was unavailable.

Capt. David Trump, an official of the Defense Department's Office of Health Affairs, said that troops aren't routinely tested for hepatitis C and that no statistics on the number of infected soldiers exist. But, he said: "We really don't have any evidence that the military population in general is different from the civilian population when it comes to hepatitis C infection."

Army epidemiologist Writer said a 1992 study of random blood samples from 15,124 active duty personnel found that 1.3 percent tested positive for hepatitis C - below the national infection rate of 1.5 percent. Rider didn't know how many of those tested had received globulin shots.

Shelby, a member of the Senate defense appropriations subcommittee, has inserted language in this year's appropriations bill calling for the Defense Department to study the rate of hepatitis C among personnel who received globulin inoculations.

At a warehouse in Rockville, Md., the department has stored millions of frozen blood samples taken during physical examinations of Army, Navy and Marine Corps personnel since the mid-1980s to test troops for AIDS. Air Force blood samples were added recently.

Former Surgeon General Koop said the military should begin screening troops for hepatitis C. "You've got a demon on your hands," he said. "You'd better find out where that's coming from if you can."

Immune serums (immune globulin) are starter material for vaccines that provide passive immunity to infectious disease. Treatment is recommended for Rh-negative children and women of childbearing age who received Rh-positive red cell containing components The protection will be of rapid onset, but of short duration (1-3 months). Immune sera are obtained from pooled human plasma of either general population donors or hyperimmunized donors. It may be administered either by intravenous (IV) or intramuscular (IM) injection.

Intramuscular immunoglobulin preparations are prepared according to the Cohn fractionation process, which separates the fraction containing antibodies that neutralize various infectious agents. The resulting preparations are highly concentrated (16% in solution and containing 160 mg of protein/mL). Other manufacturing procedures do not ensure the same safety

Cohn's method number 6 was particularly amenable to largescale use. This method results in five major fractions: fraction I (fibrinogen), fractions II and III (gamma globulins), fraction IV (alpha and beta globulins), and fraction V (albumin). As expected, differences in fractionation and purification processes between manufacturers exist ...

However, the role of partitioning of viruses cannot be taken in isolation; when antibodies to HCV were removed following the introduction of screening, the amount of recoverable HCV-RNA in the various Cohn fractions changed dramatically as a result of the virus no longer being complexed with antibody. 28 ...As Cohn–Oncley fractionation is not sufficient to remove lipid-coated viruses, additional antiviral inactivation steps are required.