GenoMed in the News
GenoMed has been quoted recently in the prestigious journals Nature and Health Affairs
1. Nature
nature.com
News
Published online: 28 October 2004; | doi:10.1038/news041025-17
Vaccine shortage fuels clinical trials
Helen Pearson
US public seeks alternative sources of flu protection.
For some, clinical trials are the only way to get vaccinated.
© Punchstock
The dearth of flu vaccine in the United States is having one small, unforeseen benefit: people are flocking to join clinical trials of new ways to defeat the disease and, perhaps, fuelling advances in protection.
Since a manufacturing hitch unexpectedly halved the country's vaccine supply earlier this month, remaining stocks are being reserved for infants, the elderly and others at high risk. But even individuals in these groups are struggling to find supplies and reports abound of long lines outside clinics.
Despite the shortage, some research groups are still able to run clinical trials that aim to figure out how best to use the existing vaccine. And some are testing experimental drugs or vaccines for the future. For healthy adults, "it's the only way such a person could be vaccinated," says flu researcher John Treanor at the University of Rochester, New York.
We've had a record pace in the last few weeks.
Pedro Piedra
Baylor College of Medicine, Texas
New recruits
One trial, headed by virologist Pedro Piedra at Baylor College of Medicine in Houston, Texas, is testing whether the spread of the influenza virus can be curbed by blanket vaccination of all school-age children in a local area. Children are the most likely to get infected and to pass on the disease to others, so the researchers hope to discover whether it makes sense to target this group with vaccines in the future.
Because the trial is pretty much the only way many families can find a jab for their kids, Piedra says the group has immunized around 3,000 children in ten days, a process that would normally take over six weeks. "We've had a record pace in the last few weeks," he says.
The interest in clinical trials is also helping those testing experimental vaccines, such as those that are grown in cells cultured in the laboratory rather than in hen eggs. Researchers are particularly keen on testing and refining these vaccines, because they can be produced quickly, avoiding the hold-up of having to order eggs many months in advance.
Treanor is recruiting around 400 healthy adults below the age of 49 who are willing to receive a syringe-full of a vaccine grown in insect cells, which was tested in the elderly last year. With the current shortage, "it's certainly going to be easier to recruit subjects," he predicts.
At least one company is willing to take any number of healthy people into their trial. GenoMed, based in St Louis, Missouri, wants to test whether drugs that are commonly used to treat high blood pressure, called ACE inhibitors, can also fight flu. The company already has preliminary evidence that the therapy wards off West Nile virus, and the opportunity to test it on flu during the current shot shortage "was too good to pass up," says GenoMed chairman, David Moskowitz.
Trial by e-mail
ACE inhibitors bind receptors on the cells of disease-fighting white blood cells, which swamp the body during a flu infection. They trigger the cells to commit suicide, which damps an overactive immune response and can actually ease symptoms, Moskowitz believes.
Anyone interested can enrol by printing a form from the company's website and taking it to their doctor in order to get a prescription for the drugs; the company then sends follow-up e-mails to check on subjects' progress. About 100 people have shown an interest so far. Although the approach is experimental, Moskowitz says the drugs are widely used and safe enough to pose little risk.
Scientists in the field say they are unsure whether the surge of interest in these new techniques, from both the public and policy-makers, will last if next season's vaccine supply arrives without a hitch. But for now, Treanor says, "I can't imagine it'll do anything but stimulate research."
2. Health Affairs
content.healthaffairs.org
Electronic Letters to:
Cathy Schoen, Robin Osborn, Phuong Trang Huynh, Michelle Doty, Karen Davis, Kinga Zapert, and Jordan Peugh, Primary Care And Health System Performance: Adults’ Experiences In Five Countries, Health Affairs Web Exclusive, October 28, 2004
Electronic letters published:
Genomics and Primary Care: Eve of the Revolution
David W. Moskowitz, M.D. ( 29 October 2004 )
Genomics and Primary Care: Eve of the Revolution 29 October 2004
David W. Moskowitz, M.D.,
CEO and CMO
GenoMed, Inc.
Send letter to journal:
Re: Genomics and Primary Care: Eve of the Revolution
E-mail David W. Moskowitz, M.D.
It is not a surprise that primary care is the stepchild of American medicine. Blue Cross and Blue Shield, the first health plans, were established by surgeons in the 1920s to make sure they got paid for the operations they performed.
Health plans have remained tied to hospitals ever since. The only way to spend 70% of health care dollars in the last 12 months of a patient's life, as we do in the U.S., is to spend it in the hospital, especially the ICU. Health plans simply pass on the costs; it's not their money. As long as every health plan does business the same way, health plans don't lose market share despite raising their premiums.
In fairness, the hospital traditionally has been the place where medicine has joined battle with disease. That's all changing now with medical genomics.
Medical genomics, the science of which genetic variations are responsible for which diseases, will provide an early warning system for each patient and make possible "personalized medicine." More importantly, it will make possible "preventive molecular medicine." For the first time, preventive medicine will be significantly more effective.
Like hospital-based medicine, preventive medicine has so far been pretty underwhelming in terms of patient outcomes. Vaccines are less than perfect. Even with nicotine patches, only 25% of smokers quit. Obesity is notoriously hard to treat. But knowledge of a single gene may be able to delay or prevent as many as 150 common diseases. Imagine what will happen when we can accurately predict who's at high risk for the top 200 common diseases!
Of course, it will be the PCP who will be running the show. Patients will be kept healthy and out of the hospital.
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