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September 2007 Updates

Texas A&M Safety Manager Quits on the Day of Critical CDC Report

By R.A. Dyer
Star-Telegram Staff Writer
September 6, 2007

The environmental health and safety manager at Texas A&M University abruptly resigned last week on the same day that federal regulators issued a report faulting the institution for multiple safety failures involving dangerous bioweapons agents.

The resignation, confirmed Wednesday by university officials, was effective Aug. 31. In his resignation letter, Environmental Health and Safety Manager Brent S. Mattox wrote, "I no longer can effectively perform my duties in the present environment."

His departure corresponds with findings by the Centers for Disease Control and Prevention last week that the university allowed unauthorized access to bioweapons agents, maintained poor records of those agents and had lab workers handling the agents with unapproved equipment.

The CDC also advised A&M officials that a ban on biodefense research at the university will remain in place until inspectors can be certain that the institution can be trusted to handle the dangerous materials.

"I feel it is in my best interest to terminate my employment with Texas A&M at this time," wrote Mattox in his brief resignation note. "I do this with regret, and will dearly miss my staff. I was proud to have led them in making Texas A&M a safer place to work."

Edward Hammond, the director of a nonprofit that first raised the safety concerns, said Mattox would have been responsible for making sure that lab operations were performed safely.

But he said that it's clear from a review of documents that Mattox was not a powerful official in the safety system. "I'm sorry for Mr. Mattox -- but I'm not impressed that this is a step that's going to fix things," Hammond said.

Mattox could not be reached for comment. An A&M spokeswoman said a university official will answer questions during a conference call today.

Texas A&M manages the National Center for Foreign Animal and Zoonotic Disease Defense, which is financed through an $18 million biodefense research grant from the Department of Homeland Security. Word of safety lapses there first began leaking out to the media after an investigation by Hammond's Austin-based group, known as the Sunshine Project.

In the ensuing controversy, another top official responsible for biodefense research left his post, although he has remained in the university's mathematics department. The chancellor has also repudiated actions at the labs.

The Aug. 31 CDC report found safety lapses, and faults the university for allowing unauthorized experimentation with toxic agents and not providing documentation that deficiencies found during inspections had been corrected, among other things.

The report was the result of a four-day CDC inspection in late July.

Sunshine Project researchers had uncovered documents showing that three people at A&M were exposed to the so-called Q fever organism last year. The group also reported an incident in which a researcher became ill from Brucella, another biological-weapons agent.


Keep Monsanto Out of Our Milk

By Michael Hansen and David Wallinga
The Providence Journal
September 10, 2007

The recent announcement by Kroger stores that it will no longer use the genetically engineered growth hormone rbST (also known as rbGH) in its private label milk brand is part of a nationwide trend among dairy processors, retailers and farmers. Starbucks, Tillamook, Safeway and Chipotle Restaurants have already begun to discontinue the hormone and California Dairies Inc., which produces nearly 10 percent of the nations milk, announced it went rbST-free Aug. 1.

Each of these companies affirms that the chief impetus for its actions comes from rising consumer demand for hormone-free dairy products. Those consumers cite legitimate health concerns, including increased cancer risks and antibiotic resistance.

Facing dwindling sales of rbGH, Monsanto, its sole manufacturer, is trying to thwart informed consumer choice by pressuring the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) to restrict labeling of such products as rbGH-free. Monsanto claims there are no differences in the milk and that consumers are somehow misled by these labels.

Of course, consumers know exactly what rbGH-free means, just as they recognize the meaning of No preservatives, No artificial colors and No artificial flavors. These labels are important tools consumers use to make educated choices about products they buy, including additional labeling about how animals are treated in meat, egg and dairy production.

Regardless of the claims of Monsanto and its supporters, there are significant differences in rbGH-treated cows and their milk. Treated cows experience higher rates of 16 harmful medical conditions, including pregnancy problems, diarrhea and mastitis, which Monsantos own package insert acknowledges. Virtually every animal protection agency in the country, including the Humane Society of the United States and Humane Farming Association, criticizes use of this synthetic hormone.

Elevated mastitis rates lead to increased treatment with antibiotics. Bacteria resistant to these antibiotics may pass into humans through milk, air, water or soil, or through ground meat, increasing antibiotic resistance. According to the Centers for Disease Control and Prevention, overuse of agricultural antibiotics is a significant contributor to food-borne, antibiotic-resistant infections in humans, a multibillion-dollar problem in the United States

There is also no doubt that rbGH use in cows increases the level in cows milk of another growth hormone found in both cows and humans, IGF-1. While a certain level of IGF-1 is needed for normal development and daily functioning, elevated levels are strongly implicated with increased risk of breast, prostate, colon and other cancers. Advocates of rbGH claim that the amount of IGF-1 taken in from dairy products is not hazardous, but numerous scientists believe that even small amounts of additional hormone exposure can be significant. Its simply common sense to avoid a higher risk of getting cancer when the source of that risk is completely unnecessary.

Government leaders, scientists and farmers alike criticized the FDAs controversial decision to approve rbGH in 1993. In contrast, most industrialized nations of the world, including Canada, Australia, New Zealand, Japan and all 25 members of the European Union, have disallowed its use.

The Codex Alimentarius, the United Nations main food safety body, twice decided that it could not endorse the safety of rbGH for human health.

Hospitals across the country are also taking action. Health Care Without Harm, an international coalition of over 440 health-care and public health organizations dedicated to improving health and safety in hospitals, formally declared its opposition to rbGH in 2005. Since then, leading hospitals and hospital systems, such as Catholic Healthcare West, the largest Catholic health-care system in the country, have begun purchasing rbGH-free dairy products.

Monsanto's attempt to pressure the FDA and FTC to restrict rbGH-free labeling is a self-serving attempt to save its falling profits. We need our government to reject this assault on the right of businesses to inform consumers and the right of all citizens to make informed choices about what they eat.

Michael Hansen, Ph.D., is a senior scientist at Consumers Union ( David Wallinga, M.D., is food and health director for the Institute for Agriculture and Trade Policy and Health Care Without Harm ( This piece originated at, published in a collaborative agreement with The Providence Journal.


Woman's Death Calls Gene Therapy into Question

By Carla K. Johnson and Lindsey Tanner
The Associated Press
September 16, 2007

Jolee Mohr died three weeks after experimental treatment using a virus

TAYLORVILLE, Ill. - A few hours before she died this summer at the age of 36, Jolee Mohr lay in a Chicago hospital so swollen by internal bleeding and her failing kidneys that her husband decided against bringing their 5-year-old daughter to say goodbye. The girl wouldn't have recognized her mother.

Robb Mohr couldn't bring himself to watch her die and he spent his wife's last hours talking with her helpless and puzzled doctors. One vowed to get to the bottom of the illness, and there were several clues to go on.

The most unusual was this: Jolee Mohr fell ill the day after her right knee was injected with trillions of genetically engineered viruses in a voluntary experiment to find out if gene therapy might be a safe way to ease the pain of rheumatoid arthritis. She was dead three weeks later.

The sponsor of this nationwide experiment, Targeted Genetics Corp. of Seattle, has halted the work and more than 125 patients are being evaluated, according to a company spokeswoman. No other problems have been reported, and the company believes patients were adequately informed of the treatment's risks.

U.S. health officials are investigating Mohr's death, and the case is expected to be discussed Monday by advisers to the National Institutes of Health. There's a lot at stake, including answers for Robb Mohr, and the interests of Targeted Genetics. But there are also questions about how medical studies are done and how much study volunteers are told of the risks.

"To me, it's an avoidable death," Mohr said during an interview at his home amid the cornfields of central Illinois. "And you're going to have to really show me a lot of stuff to convince me that it wasn't."

5,000 patients involved in studies

There have been more than 800 gene therapy studies involving 5,000 U.S. patients since the NIH approved the nation's first human gene transfer study in 1989. Yet there are no approved therapies despite 17 years of research, and the only major success - a cure for the rare inherited immune disorder known as "bubble boy disease" - came with a high cost: leukemia linked in 2003 to the virus that delivered the treatment.

Still, the 1999 death of Arizona teenager Jesse Gelsinger is the only reported fatality definitively linked with a U.S. gene therapy study, an NIH spokesman said. And Dr. Theodore Friedmann, who once headed the NIH committee that oversees gene therapy experiments, said developments in medicine often come with problems, even death.

Even if gene therapy is found to be the cause of Jolee Mohr's death, Friedmann said, the method remains promising.

"There's no question that this event is tragic for the family and the woman involved," he said. "It does simply point to the fact that we have a lot more to learn."

Living with the pain

When Dr. Robert Trapp of the Arthritis Center in Springfield told Jolee Mohr about the gene therapy study, she had lived with rheumatoid arthritis for 14 years, her husband said. She kept the pain, stiffness and swelling in her joints under control with medication.

Mohr seldom missed any work at her full-time data entry job for the Illinois secretary of state. She went to church and volunteered at the county fair. She loved to read and work in her garden. She and Robb had just bought a boat and were planning to build a new house. Their only child, Toree, was getting ready for kindergarten.

To enroll in the study, every patient had to have some form of inflammatory arthritis. Jolee Mohr had faith in Trapp, her doctor for seven years, her husband said.

"You trust your physician. He's your doctor. You trust him like you do your minister," Robb Mohr said.

Jolee Mohr thought the experimental treatment might relieve the chronic pain in her right knee, her husband said, though this stage of the study was simply to find out if the treatment was safe. Bioethicists talk of a "therapeutic misconception" - a belief among patients in early-stage research that they will get better.

Robb Mohr said his wife believed.

Jolee Mohr signed a 15-page consent form Feb. 12. "Knowing her, she probably didn't read through it," her husband said.

Chilling risks

The form mentioned some scary possibilities. It said that the genetically altered viruses in the study - called tgAAC94 - "could spread to other parts of your body. The risks of this are not known at this time."

"We have seen this type of spread in animal studies when tgAAC94 has been given by injection into the joint," the form said.

Altered viruses can "damage the DNA in the cells of your body by inserting itself into your genes," it went on. "If this happens, it could put you at risk for developing cancer in the future."

And on page 9, it said unknown side effects could result in "pain, discomfort, disability or, in rare circumstances, death."

The study used a virus that can infect cells without causing human disease. In simple terms, the genetically engineered virus is used as a vehicle to carry a new gene into the body. Targeted Genetics hopes the new gene will help the body make a protein that would ease arthritis pain.

Dr. Trapp made a brief note in Mohr's chart after her visit: "Discussed participation in clinical trial. Consent form received and I answered her questions."

Mohr got the first shot of the test drug two weeks later. She was randomly assigned to get the highest dosing level on both injection dates.

By all accounts, everything was fine after the first shot. But she got sick the day after her second injection, vomiting and running a fever.

Recalling the sequence of events, Robb Mohr removed his wife's calendar from the kitchen wall and carried it to the dining room table. He tapped his finger on key dates, stabbing harder on July 2.

"She got the injection on the second, we were in the emergency room on the seventh, she was admitted on the 12th," Mohr said. He pointed to July 18, the date of his wife's 200-mile ambulance ride from a Springfield hospital to Chicago; July 23, when he agreed to a "do not resuscitate" order and, finally, July 24, the date she died.

No obvious cause

Jolee Mohr was brought by ambulance to the University of Chicago Medical Center shortly after midnight on July 19. Doctors in Springfield had thought she might need a liver transplant and the Chicago hospital had transplant expertise.

Dr. Kyle Hogarth treated her in the intensive care unit that morning and grew increasingly concerned. After learning that Mohr had gotten sick following the July 2 injection, he reported her condition to the Food and Drug Administration as a possible serious side effect related to the study.

While a transplant wasn't deemed necessary, Hogarth saw signs of a possible infection and that "got us very concerned about the possibility that this virus that wasn't supposed to replicate" somehow might have spread throughout her body.

Jolee Mohr was in respiratory failure, her kidneys were shutting down and she was septic, meaning she was suffering from a life-threatening immune system reaction that can result from infection. She needed a ventilator to help her breathe, and she was put on kidney dialysis. A fungus infection was discovered throughout her body - it did not respond to medication - and Mohr developed a pool of blood in her abdomen that grew to the size of a watermelon, crushing against her spleen and kidney.

Hogarth has seen many patients that sick, but he found Mohr's case unusual because there was no obvious cause. That made her difficult to treat, and her condition worsened.

"As she was accumulating more problems and we were making no headway, her family came to us and said she's been through a lot ... this is not what she would have wanted," Hogarth recalled. Already unconscious, Mohr was given drugs to sedate her even further, lifesaving equipment was removed, and she died a day later.

"The human side to this is awful - it bothered everybody on the team," Hogarth said. "We've all unfortunately been around it, but this one just seemed even sadder, because she didn't have a life-threatening illness to begin with."

"To see someone who is otherwise young and otherwise healthy - that I think is the part that is really bothersome," he said.

No disciplinary action

Details about the experiment's other volunteers have not been released by Targeted Genetics. The government says the study recruited people through doctors in small cities -Springfield, Willow Grove, Pa., Glendale, Ariz., Ocala, Fla., and Coeur d'Alene, Idaho.

Tom Murray, president of the Hastings Center, an independent, nonprofit research institute on medical ethics, said seeking patients through smaller clinics tends to save money compared with doing the work at major medical centers.

"The good thing is more research is done at lower costs. The bad thing is you may not have the same depth of protections that the academic centers provide," he said.

Trapp, who did not respond to several requests for an interview, enrolled "seven or eight" patients in the gene therapy study, according to his attorney, David Drake. He described Trapp's enrollment procedures only as "standard", and he declined to comment on how much money Trapp's clinic received from Targeted Genetics, fees meant to reimburse costs.

Trapp, 59, has not faced state disciplinary action and his license is active. In 2002, he settled out of court with a patient who sued him for negligence after she developed eye problems known to be a side effect of an arthritis drug he had prescribed.

The investigation into Mohr's death has steep consequences for Targeted Genetics. The company, which employs 70, has no products on the market and several years ago cut workers and several of its programs.

"A very exciting lead product with the possibility to meet significant unmet need could be jeopardized," said CEO H. Stewart Parker when asked what was at stake for the company. "A program we've spent years on, one where there is a tremendous amount of preclinical data supporting it, is under examination."

She said the company believes the study was done with the "highest level" of responsibility and that it followed federal guidelines. She said there's never been any rush to get the study drug tested and on the market.

Parker also noted that key tests have not yet been done that could link Mohr's death to the gene therapy study. A spokesman at the University of Chicago, which is conducting the tests, said they are under way but that several are needed to determine the cause of death.

Targeted Genetics believes Mohr might have died of a fungal infection that could be blamed on anti-arthritis drugs she was taking, Parker said.

The study included a Chicago site where Dr. Eric Ruderman of Northwestern University was in charge. He said none of the patients experienced any problems with the injections.

Ruderman also said the company paid him to cover the research costs at his site, as is customary in clinical research. He declined to disclose the amount.

"There are no bonuses for enrolling a specific number of patients or keeping patients in for the full study. Even if a sponsor were to offer this, I would not accept it," he said.

Patients' parking costs were covered, roughly $20 each, but they otherwise weren't paid to participate, he said.

Industry involvement in gene therapy research is virtually a necessity, since experiments can cost millions of dollars, Friedmann said.

"It's certainly an added complication when there's an issue of transparency and profit issues that industry has to keep in mind," Friedmann said.

Ruderman said he worries the public has the wrong impression about gene therapy research.

"I'm hopeful that people will look at what happened and realize that's why you do a safety study, and not say, well, this kind of therapy is out the window," he said.

Wondering why

Mohr's family asked the University of Chicago to lead the investigation into her death, but the FDA is also investigating, spokeswoman Karen Riley said.

"If there are any implications for the safety of other gene therapy trials, we will take whatever actions that may be needed," she said.

The NIH began developing guidelines on gene therapy in the mid-1970s and formed the Recombinant DNA Advisory Committee to review studies, procedures and safety.

Mohr's death tops the agenda for the committee's regularly scheduled quarterly meeting Monday at the NIH campus in Bethesda, Md. University of Chicago doctors will present autopsy results, though the cause of death and what role the gene therapy might have played are not expected to be ready by then.

Robb Mohr will be there.

"I think it's great that there's companies out there wanting to help people, but I also think there's companies out there that are trying to make millions of dollars on people before they can truly understand what's going on," he said.

Two days before she fell ill, the family went boating. The last family snapshot of Jolee was taken on the boat by Toree, and Jolee beams at the young photographer.

"My wife has never looked so beautiful," Robb Mohr said.

"She had nothing to gain from this study," he said. "Why would a 36-year-old mother of a 5-year-old that's going to kindergarten want to participate in something just to see how safe it is on her body? Nothing adds up."

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