FDA Would Give Patients More Access to Experimental Drugs
New rules that would provide easier access to experimental drugs for seriously ill patients who have no other treatment options are being proposed by the U.S. Food and Drug Administration.
The proposed regulatory changes would also clarify the circumstances and costs for which drug makers could charge for an experimental drug.
"FDA hopes this proposal will increase awareness in the health-care community of the range of options available for obtaining experimental drugs for seriously ill patients," Dr. Janet Woodcock, FDA's deputy commissioner for operations, said in a prepared statement.
"By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for health-care practitioners in obtaining them," Woodcock said.
In order for an experimental drug to be approved for patients, the FDA would have to be satisfied that the potential benefits of the drug outweigh the risks.
The proposed changes, released Monday, are subject to comment for 90 days.
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'Inkjet' System Directs Stem Cell Growth
U.S. scientists have created an "inkjet" system that can direct how and where stem cells grow. This technology may enable the creation of multiple types of tissue from a single population of stem cells, researchers said Sunday at a meeting of the American Society for Cell Biology.
The scientists, from the University of Pittsburgh and Carnegie Mellon University, used this inkjet method to direct muscle-derived stem cells from mice to grow into both muscle and bone cells, CBC News reported.
Using a "bio-ink" that's able to stimulate or inhibit growth factors in stem cells, the scientists sprayed a complex pattern onto protein slides. Depending on the bio-ink that the stem cells interacted with, they grew into either bone or muscle cells.
"Previously, researchers have been limited to directing stem cells to differentiate toward multiple lineages in separate culture vessels," said Phil Campbell, research professor at the Institute for Complex Engineered Systems at Carnegie Mellon University. "This is not how the body works; the body is one vessel in which multiple tissues are patterned and formed."
The study authors said that being able to manipulate stem cells to grow into desired patterns and types of cells is essential if scientists want to engineer replacement tissues for use in treating trauma injuries, diseases, or genetic abnormalities, CBC News reported.
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Experts Assess Bird Flu Situation
While there are still sporadic outbreaks, the bird flu situation around the world is relatively quiet and scientists are trying to determine what's changed since earlier this year when there were serious concerns about the possibility of a pandemic.
Some experts suggest that weather may be one factor, the Associated Press reported. One possibility: The bird flu virus survives longer at cooler temperatures and therefore is more likely to spread in colder months of the year.
"Many of us are holding are breath to see what happens this winter," Dr. Malik Peiris, a microbiology professor at Hong Kong University, told the AP. "H5N1 spread very rapidly last year. So the question is, was that a one-off incident?"
Other experts suggest that poultry vaccinations may be obscuring detection of the bird flu virus. Vaccination does reduce the amount of virus in circulation. However, low levels of the bird flu virus may still be causing outbreaks, but not the bird deaths that would trigger an alert.
Despite the fact that there has been no pandemic, experts say the risk is still there, the AP reported.
Since 2003, bird flu has killed 154 people and prompted the slaughter of hundreds of millions of fowl worldwide.
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E. coli Suspected in Taco John's Outbreak
Nearly three dozen people became ill after eating at a Taco John's restaurant in Cedar Falls, Iowa. Health officials said the customers' symptoms were consistent with infection by E. coli bacteria. Results of tests to determine whether E. coli was responsible were expected Monday, the Associated Press reported.
Fourteen of the sick customers had to be hospitalized. All suspected food ingredients have been removed from the menu and the restaurant has been sanitized. A representative for the company, based in Cheyenne, Wyo., has been sent to review the Cedar Falls restaurant's food storage and cooking procedures and to check cleaning reports and worker health records.
Taco John's is not associated with Taco Bell. Health officials have confirmed 61 cases of E. coli-related illness in people in five states -- New Jersey, New York, Pennsylvania, Delaware and South Carolina -- who ate at Taco Bell restaurants.
On Sunday, the New York City Health Department said a Staten Island resident was the first person in the city to become ill with the same E. coli strain that caused the other confirmed cases. The person was admitted to a hospital Nov. 24 after eating at a Taco Bell, but has since recovered, the AP reported.
Scallions were the likely source of E. coli at the Taco Bell restaurants, the company said. It has switched produce suppliers. The company said independent laboratory tests confirmed all other ingredients on the Taco Bell menu were safe and that there were no plans to use green onions again.
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Cruise Ship Hit by Second Outbreak of Illness
For the second straight cruise, there's been an outbreak of gastrointestinal illness on Royal Caribbean's Freedom of the Seas, the world's largest cruise ship.
U.S. health officials said the ship should delay its next scheduled departure and remain in port in Florida for a thorough cleaning. In addition, two doctors and 45 extra cleaning staff will be on the ship when it leaves for its next voyage. The departure is scheduled for Tuesday, the Associated Press reported.
On the latest cruise, 97 passengers and 11 crew members became ill due to norovirus. On the previous voyage, more than 380 passengers and crew were sickened by the same virus. The ship was cleaned after that cruise.
Another cruise ship, Princess Cruises' Sun Princess, also had an outbreak of illness. When the vessel docked at Port Everglades, Fla., on Sunday, it had 97 sick passengers. Cleaning crews were scouring the ship, the AP reported.
Norovirus -- a group of viruses that can cause stomach cramps, vomiting and diarrhea -- can be spread through contact with contaminated surfaces or through contaminated food or liquids.
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