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IN THIS ISSUE:

Common Blood Pressure Drug Reduces Progressive Muscle Degeneration in Mice
Helium Helps Patients Breathe Easier, Study Finds
Lab Disaster May Lead To New Cancer Drug
'Hot' Patients Setting Off U.S. Radiation Alarms
Study Tests Oral Insulin to Prevent Type 1 Diabetes
Cervical Cancer Vaccine Meeting Roadblocks
New HIV Test May Predict Drug Resistance
Believe It Or Not
News From MedWatch
Research Update
Recently Approved Drugs/Indications
FDA Recalls and Safety Alerts in the Past 60 Days
Drug Shortages
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Common Blood Pressure Drug Reduces Progressive Muscle Degeneration in Mice

Scientists supported in part by the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and National Institute of Neurological Disorders and Stroke (NINDS) have found that that the commonly prescribed blood pressure medication losartan improves muscle regeneration and repair in a mouse model of Duchenne muscular dystrophy (DMD), a devastating disease characterized by rapid progression of muscle degeneration in boys and young men. The research is based on similarities in the mechanism of DMD and another rare disease — Marfan syndrome — and the discovery that losartan is effective in blocking the key mechanism in animal models of both diseases. Further studies of the drug, scientists emphasize, are needed to assess its value in patients.
Marfan syndrome is a heritable connective tissue disorder affecting many organ systems, resulting in dislocation of the lens of the eye; progressive dilation of the aorta, which puts the aorta at risk of rupture; and small, weak muscles, says Harry C. Dietz, M.D., an author of the study in the February 2007 edition of Nature Medicine. Until recent years, scientists believed that Marfan syndrome was caused by weakness of tissues, says Dr. Dietz, the Victor A. McKusick professor of genetics in the McKusick-Nathans Institute of Genetic Medicine at the Johns Hopkins University School of Medicine and director of the William S. Smilow Center for Marfan Syndrome Research. But research by Dr. Dietz and his colleagues, and funded by the National Heart, Lung, and Blood Institute, NIAMS and others, has shown that the disease is the result of excessive activity of a growth factor called TGF-beta in the muscles. “We found that muscles were abnormal; they had very small fibers and excess fibrosis — excessive connective tissue, or scarring — between the fibers. What we learned was that high TGF-beta levels were preventing a process called muscle regeneration.”
Normally, when a person damages their muscle or when they exercise and send a signal to the muscle to get bigger, the muscle is able to mobilize a population of muscle stem cells that proliferate and then fuse to each other and to damaged muscle fibers to rapidly accomplish muscle repair or muscle growth. In the presence of too much TGF-beta, however, the cells simply do not get the signal to accomplish this regenerative process, says Dr. Dietz. “We learned that simply blocking TGF-beta in a mouse model of Marfan syndrome could rescue muscle regeneration, normal architecture and muscle function.”

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Helium Helps Patients Breathe Easier, Study Finds

It makes for bobbing balloons and squeaky voices, but now helium is also helping people with severe respiratory problems breathe easier.
Researchers at the University of Alberta in Edmonton, Canada have discovered that by combining helium with 40 per cent oxygen allowed patients with chronic obstructive pulmonary disease (COPD) to increase their exercise capacity by an average of 245 per cent. COPD is a disease of the lungs caused by smoking and includes the conditions of emphysema and chronic bronchitis.
This was the first study to demonstrate that helium-hyperoxia (40 per cent oxygen, 60 per cent helium) improves the exercise tolerance of COPD patients to a greater extent than oxygen alone, which is currently used for treating patients with this disorder. People with severe COPD typically struggle for every breath while exercising and any improvements that could be made to their ability to perform exercise could have significant clinical implications.
The results of the study were published recently in the American Journal of Respiratory Critical Care Medicine.

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Lab Disaster May Lead To New Cancer Drug

Her carefully cultured cells were dead and Katherine Schaefer was annoyed, but just a few minutes later, the researcher realized she had stumbled onto a potential new cancer treatment.
Schaefer and colleagues at the University of Rochester Medical Center in New York believe they have discovered a new way to attack tumors that have learned how to evade existing drugs.
Tests in mice suggest the compound helps break down the cell walls of tumors, almost like destroying a tumor cell's "skeleton".
The researchers will test the new compound for safety and hope they can develop it to treat cancers such as colon cancer, esophageal cancer, liver and skin cancers.

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'Hot' Patients Setting Off U.S. Radiation Alarms

When 75,000 football fans pack into Dolphin Stadium in Miami for the Super Bowl on February 4, at least a few may want to carry notes from their doctors explaining why they're radioactive enough to set off "dirty bomb" alarms.
With the rising use of radioisotopes in medicine and the growing use of radiation detectors in a security-conscious nation, patients are triggering alarms in places where they may not even realise they're being scanned, doctors and security officials say.
Nearly 60,000 people a day in the United States undergo treatment or tests that leave tiny amounts of radioactive material in their bodies, according to the Society of Nuclear Medicine. It is not enough to hurt them or anyone else, but it is enough to trigger radiation alarms for up to three months.
Since the September 11 attacks, the U.S. Department of Homeland Security has distributed more than 12,000 hand-held radiation detectors, mainly to Customs and Border Protection agents at airports, seaports and border crossings. Sensors are also used at government buildings and at large public events like the Super Bowl that are considered potential terrorist targets.

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Study Tests Oral Insulin to Prevent Type 1 Diabetes

Researchers have begun a clinical study of oral insulin to prevent or delay type 1 diabetes in at-risk people, the National Institutes of Health (NIH) announced today. Type 1 Diabetes TrialNet, an NIH-funded network of researchers dedicated to the understanding, prevention, and early treatment of type 1 diabetes, is conducting the study in more than 100 medical centers across the United States, Canada, Europe, and Australia.
“Our goal is to prevent type 1 diabetes or to delay it as long as possible. If diabetes can be delayed, even for several years, those at risk will be spared the difficult challenges of controlling glucose and the development of complications for that much longer,” said TrialNet study chair Jay Skyler, M.D., of the University of Miami.
In the study, researchers are testing whether an insulin capsule taken by mouth once a day can prevent or delay diabetes in a specific group of people at risk for type 1 diabetes. An earlier trial suggested that oral insulin might delay type 1 diabetes for about four years in some people with autoantibodies to insulin in their blood. Animal studies have also suggested that insulin taken orally may prevent type 1 diabetes. Some scientists think that introducing insulin via the digestive tract induces tolerance, or a quieting of the immune system. Insulin taken orally has no side effects because the digestive system breaks it down quickly. To lower blood glucose, insulin must be injected or administered by an insulin pump.

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Cervical Cancer Vaccine Meeting Roadblocks

Girls jumping rope chant "one less, one less," in TV commercials for the new cervical cancer vaccine Gardasil, vowing they will be one less cancer patient.
But in the real world, Gardasil is getting used less than doctors would like. Pediatricians and gynecologists from Arizona to New York are refusing to stock Gardasil because of its $360 price for the three doses required and "totally inadequate" reimbursement from most insurers.
Pediatricians, in particular, are rebelling, fed up after years of declining insurance reimbursement for vaccines, an explosion of new vaccines and fast-escalating vaccine prices. (Texas governor orders girls to be vaccinated. )
Many practices must tie up $50,000 or more in vaccine inventory, run multiple refrigerators, insure the vaccines and spend lots of time on inventory management. They also must absorb the cost of broken or wasted vials and say that's not possible with most insurers reimbursing at just $2 to $15 over the $120 per dose charged by Gardasil's developer, Merck & Co. of Whitehouse Station, New Jersey.
"Doctors are drawing a line in the sand on this. They're either not giving it or requiring a surcharge," said Dr. Daniel Schwartz of Broadway Pediatrics Associates in Westport, New Jersey, which charges patients a $25 surcharge per shot.

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New HIV Test May Predict Drug Resistance

Researchers at Duke University Medical Center have developed a highly sensitive test for identifying which drug-resistant strains of HIV are harbored in a patient's bloodstream.
The test may provide physicians with a tool to guide patient treatment by predicting if a patient is likely to become resistant to a particular HIV drug, said one of its developers, Feng Gao, M.D., associate professor of medicine. Drug resistance is one of the most common reasons why therapy for HIV, the virus that causes AIDS, fails.
The test, which detects genetic changes, or mutations, in HIV, also may help scientists understand how the constantly evolving virus develops drug resistance, Gao said. He said such knowledge ultimately may result in the development of new treatments designed to evade resistance.
The findings will appear online on Sunday, Jan. 7, 2007, in the journal Nature Methods, as well as in the journal's February 2007 print edition. The work was supported by the National Institutes of Health and the Duke Center for AIDS Research.

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Believe It Or Not

Pot-running Arizona granny gets 3 years

A 62-year-old grandmother who prosecutors said ran drugs to support her bingo habit has been sentenced to three years in prison and a $150,000 fine.
Acting on a tip, state police stopped Leticia Villareal Garcia near Bisbee in southeast Arizona in February 2005 and found 214 pounds of marijuana stuffed into the trunk of her car.
Garcia has maintained her innocence, telling the judge at her sentencing Friday that she was unaware of the grass as she headed for a bingo game.
"I never, never had any knowledge of that car being loaded when I went to Tucson," the Bisbee resident told Cochise County Superior Court Judge Wallace Hoggatt.
Garcia testified at her trial in November that her son's godfather had borrowed her car the day before. Her lawyer, Robert Zohlmann, said she had been used as a "blind mule" to unknowingly haul drugs.
Garcia said she often played bingo, occasionally winning several thousand dollars at a sitting, although her only regular income was a $275 monthly welfare check she received for caring for a granddaughter.
"The underlying issue is that she's got a bingo problem, which explains why an otherwise nice person might get sucked into something like this," prosecutor Doyle Johnstun told the jury.
Garcia faced as much as 12 1/2 years in prison, but Johnstun asked for just four years, agreeing with her lawyer that her age and lack of a record called for the lesser sentence.

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News From MedWatch

Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by CLICK HERE

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Recently Approved Drugs/Indications

Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs CLICK HERE

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FDA Recalls and Safety Alerts in the Past 60 Days:

To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE

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Drug Shortages:

As many of you are aware, many drugs in the US are either unavailable or in short supply. To view a list of these drugs CLICK HERE

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Edmund M. Hayes, R.Ph., M.S., Pharm.D.
Departments of Pharmacy and Medicine
Stony Brook University Hospital
State University of New York at Stony Brook
Stony Brook, New York, 11794
631 444-2668

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