By KAREN GULLO Associated Press Writer.

WASHINGTON (AP) - Thousands of university researchers buy cocaine, heroin and other street drugs with government grant money for studies on addiction but are almost never monitored by federal agents to make sure the narcotics are put to proper use.

Even when there evidence of abuse arises, the government doesn't always check up. A University of Minnesota researcher died of a cocaine overdose shortly after he bought a fresh supply of the drug with grant money. University officials told The Associated Press the Drug Enforcement Administration never investigated. DEA officials would not discuss the Minnesota case or any other investigation. But they said DEA lacks the staff to do regular checks on the 4,500 researchers registered by the agency to buy drugs for experiments. Instead, it relies on universities and state agencies that license researchers for primary oversight. Agents perform background checks when researchers apply for registration, review research proposals and visit laboratories before granting permission. About 535 of those registered are authorized to conduct research with the most dangerous drugs, including heroin, morphine and LSD.

The drugs must be kept under lock and key, their use carefully recorded, the DEA said. The drug-fighting agency also tracks researchers' drug purchases, but it rarely conducts surprise checks because it lacks sufficient staff. Just 400 agents monitor drug manufacturers, distributors, analytical laboratories, pharmacies and doctors. Thus, they ordinarily don't check a researcher unless they receive a report of a problem.

``Monitoring is a local issue,'' said Dr. Alan Leshner, director of the National Institute of Drug Abuse, which provided $250 million in grants last year for researchers to study heroin, cocaine and marijuana. Between 1,500 and 2,000 of the institute's grant recipients employ street drugs in their research.

Researchers undergo rigorous federal screening before they receive

government grants. Research proposals are carefully scrutinized, and experiments are monitored by institutional review boards.

``There's an entire infrastructure in place to oversee research,'' said Leshner. Researchers say they must follow strict rules about storage and account for the drugs used in experiments.

``It would be tough to trick the system,'' said David Self, a Yale

University researcher who has administered cocaine to rats in a federally funded study on addiction. ``But it has happened in my field.'' Dr. Keith Kajander, who ran a University of Minnesota dental school lab on pain research, fatally overdosed on cocaine in April shortly after he used federal grant money to buy a fresh supply from a California distributor. Kajander, 45, bought at least 80 grams (almost 3 ounces) of cocaine with federal money since 1996 even though his grant proposals did not mention the drug, police reports show. His DEA registration allowed him to buy the cocaine. The university receives $70 million annually in federal grants for medical research, half of which involve controlled substances, and has more than 1,000 researchers working with drugs. Yet the DEA never investigated the school after Kajander's death, said Dr. Richard Bianco, assistant vice president of the academic health center. The university has strengthened its policies on drug buys.

Kajander's death wasn't the university's first problem with research drugs. In 1998, burglars stole almost $4,000 worth of ketamine, a PCP-type ``club drug'' used as an anesthetic for humans and animals. And in 1991, a campus janitor stole heroin, cocaine and other drugs from a laboratory and died of an overdose. Other states also report problems. Legislative auditors in Montana are investigating the 1998 theft of painkiller drugs from an animal laboratory at the University of Montana.

Twelve of the 2,413 drug cases under investigation by the DEA's office of diversion control in the last fiscal year involved researchers. Seven remain open. The closed cases resulted in letters of admonition or administrative hearings, officials said.

Although the DEA said it relies on state and university officials for primary oversight, some states, like the DEA, lack the capacity to do regular inspections.

And Dale Cooper, compliance officer at the University of Minnesota, said his survey of 26 universities found only three with written policies for research use of controlled substances.

``The universities tend to dump it off on a compliance office,'' said Cooper. ``They don't tend to take it on as an institutional responsibility.''

~*~*~*~*~*~*~*~

by Caroline Decker

Contact:

Washington University School of Medicine in St. Louis Caroline Decker 314-286-0109

Anecdotal reports of illness by some women with silicone gel breast implants eventually led the federal Food and Drug Administration in 1992 to ban their use pending a safety review. However, researchers still do not know why some women with implants, and not others, develop symptoms suggestive of an illness. Now, a study by researchers at Washington University School of Medicine in St. Louis concludes that genetic factors may play a role.

The study found that women with breast implants who had debilitating symptoms such as chronic fatigue, burning breast pain, muscle or joint pain were more likely to share genetic characteristics that differentiate them from women with breast implants who have no symptoms.

"To our surprise, we found that some women with implants may be genetically predisposed to develop symptoms," said lead researcher Leroy Young, M.D., a plastic and reconstructive surgeon at Washington University School of Medicine.

Moreover, the researchers found that women with breast implants and symptoms also were more likely than others in the study to produce autoantibodies against their B cells. B cells are a key component of the immune system, and high frequencies of such autoantibodies are clearly abnormal, Young said.

"Autoantibodies to B cells may hold clues that will help explain why some women with breast implants develop symptoms," he said. The team reported its findings in the journal of Plastic and Reconstructive Surgery in December 1995.

Since the FDA ban, researchers have tried to explain the origin of symptoms reported by some women with breast implants. The lack of a recognized disease in these patients and the failure to find a cause for their symptoms prompted Washington University researchers to conduct the study.

The researchers studied the genetic characteristics of 199 women 77 with breast implants and symptoms, 37 with implants and no symptoms, 54 healthy women without implants and 31 women diagnosed with fibromyalgia, a disease defined by pain in connective tissues such as muscles, tendons and ligaments. Fibromyalgia is not known to be immune-mediated and has no known cause.

Women with fibromyalgia were included in the study to determine whether women with breast implants are prone to develop the rheumatological disorder. Symptoms of fibromyalgia are similar to those experienced by women with breast implants who develop symptoms. "At first, we thought implants might trigger fibromyalgia," Young said.

To be considered symptomatic, women with breast implants had to have one or more of the following: burning breast pain, chronic fatigue, vague upper body pain, muscle or joint pain. Their symptoms must have persisted for at least four months and have interfered with daily activities, particularly with the ability to maintain a job.

Women with breast implants and those with fibromyalgia averaged 46 years of age; those in the healthy comparison group were slightly younger, averaging 37 years of age. Virtually all women in the study were white. Genetic characteristics were determined by analyzing blood samples. The researchers zeroed in on a group of proteins encoded by a collection of genes called the major histocompatibility complex (MHC), which is known to play an important role in immune response. They wanted to find out whether the MHC molecules of symptomatic women with breast implants differed from those of women with breast implants who did not have symptoms.

The investigators used HLA (human leukocyte antigen) typing to analyze blood samples; organ transplant teams use the same procedure to assess genetic similarities between organ donors and recipients.

They found that both women with implants and symptoms and women with fibromyalgia were significantly more likely to have an HLA molecule called DR-53. The molecule was present in 68 percent of symptomatic breast implant patients and 65 percent of fibromyalgia patients, compared with 35 percent of the asymptomatic implant patients. Fifty-two percent of the healthy women also had the DR-53 molecule, which is similar to its natural frequency among white women. DR molecules play a critical immunoregulatory role because they control the interactions among the immune system's T cells, B cells and antigen-presenting cells.

Young and his colleagues initially suspected that women with breast implants and symptoms actually had fibromyalgia. But when they looked closer, they found that 42 percent of symptomatic women with breast implants formed antibodies against their own B cells. Only 2 percent of healthy women formed autoantibodies, compared with 14 percent of asymptomatic women with breast implants and 19 percent of fibromyalgia patients.

More striking, however, was the observation that 81 percent of the

patients with implants who produced autoantibodies were DR-53 positive. This compares with 33 percent of fibromyalgia patients who were positive for both autoantibodies and DR-53.

"There's clearly a link between DR-53 and autoantibodies," Young said. "But we won't know what it means until we find out why these women are forming autoantibodies at such a high rate."

Women with symptoms had had their breast implants for an average of 12 years, compared with asymptomatic women who had had their implants for an average of 10 years. So it's possible that the latter group may develop symptoms over time. "This may be especially true for those asymptomatic women who are DR-53 positive or who have produced autoantibodies to their own B cells," Young said.

Young and his co-workers are now trying to find out what is triggering the production of autoantibodies. If they are formed in response to silicone gel or one of its components, then the asymptomatic implant group also might be expected to have high frequencies. On the other hand, if the autoantibodies are somehow related to the presence of DR-53, the fibromyalgia patients might be expected to have higher frequencies of B cell autoantibodies.

"We can't fully explain the highly statistically significant formation of autoantibodies to B cells, but their presence suggests the activation of an immune-mediated process that is related to DR-53 and breast implant exposure," Young said.

If the study's results are confirmed, DR-53 could be viewed as a marker for individuals who may be predisposed to develop an immune-mediated response or hypersensitivity reaction following silicone breast implants. But Young cautioned that it is too early for the information to be used clinically and that women with implants should not rush to their doctors and request HLA tissue typing, a test that costs about $1,300. "The test is useful as a research tool but would not be helpful in making clinical decisions," Young explained. "However, women with breast implants need regular follow-ups with their physicians."

~*~*~*~*~*~*~

HILARY Magazine Online! -

Breast Implants - Food for Thought

Very Interesting website ~ A must visit!

http://www.homestead.com/siliconecity /webring

http://implants.clic.net/tony/Smoke/index.html

http://www.homestead.com/siliconecity/index.html

http://implants.clic.net/tony/Smoke/index.html

http://implants.clic.net/tony/Myrl/index.html