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.
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.
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."
- 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.
Thank you for your letter dated June 1, 1998, regarding Mr. (Deleted) concerns about the use within the Department of Defense (DoD) of jet injectors for immunization.
We have no evidence that service members have acquired bloodborne infections (such as hepatitis B, hepatitis C, or human immunodeficiency virus) as a result of DoD's use of jet injectors. Concerns about the safety of jet injectors, however, have prompted us to discontinue the routine use of jet injectors within DoD. We are very interested in the development of new multi-dose, needle-free injectors that have no risk for transmission of bloodborne infections.
Hepatitis B, hepatitis C, and human immunodeficiency virus infections do occur among military members but at rates that are lower than those seen in civilian populations of the same age. Risk factors for acquiring these infections include: injecting illegal drugs (low in the military because of drug screening); unsafe sexual practices, including having multiple sexual partners; receiving blood transfusions in the years before donated blood was tested for these infections; and occupations, such as health care, involving exposure to blood and body fluids.
Jet injectors that use the same nozzle tip to vaccinate more than one person have been used worldwide since 1952 to administer vaccines when many persons must be vaccinated with the same vaccine within a short time period. The jet injector developed and most widely used by the military has never been implicated in transmission of bloodborne infections. However, there is concern that use of jet injectors may pose a potential risk for translating bloodborne infections to vaccine recipients. In 1985 there was an outbreak of hepatitis B caused by non- standard use of another type of jet injector in a civilian weight loss clinic. Laboratory studies in Brazil and the United Kingdom suggest that bloodborne transmission theoretically could occur with use of jet injectors. Recent U.S. Centers for Disease Control and Prevention and World Health Organization reviews of these issues highlight that worldwide jet injectors have been generally considered safe and effective for delivering vaccines if used properly by trained personnel. Both organizations, however, strongly encourage the development of new multi-dose, needle-free injectors with no risk of transmission of bloodborne infections.
Although DoD has used jet injectors for many years, a DoD Medical Quality Assurance System Device Alert on December 9, 1997, recommended that use of all jet injectors be discontinued. This action was taken in response to a letter from Ped-O-Jet International, the manufacturer of the jet injector product most commonly used in DoD. The manufacturer notified us that they were discontinuing producing and servicing their product. Although their product never had a reported case of cross-contamination and has had an exemplary record, they "strongly urged the Armed Forces to discontinue use of the product" until studies conclude that no risk is present for bloodborne disease transmission. The Armed Forces Epidemiological Board (AFEB), a civilian scientific advisory board, reviewed DoD's action to discontinue use of jet injectors within the Department. The AFEB noted the highly probable safety record of the use of jet injectors in the military, but found that "there are no current data to counteract the current recommendation that jet injectors not be used within the DoD for routine immunization."
We hope that this information has been informative. Thank you for your continued interest in the health and welfare of the men and women in uniform who serve our Nation.
Sincerely,
Dr Sue Bailey
Author: DIMACHE G, CANTACUZINO INST, BACTERIAL VACCINES LAB, SPLAIUL INDEPENDENTEI 103,POB 1-525, BUCHAREST 70100, ROMANIA Source: VACCINE 1997 JUN;15(9):1010-1013
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