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WEDNESDAY, Jan. 10 (HealthDay News) -- U.S. officials are notifying pharmaceutical companies about more than 1,100 generic and brand-name drugs that might have been approved or are awaiting approval based on faulty testing.

In letters sent Tuesday by the U.S. Food and Drug Administration, companies are being asked to identify any pharmacokinetic studies conducted by MDS Inc. between 2000 and 2004 so that FDA officials can decide whether audits, new analyses or retesting might be required. The studies measure the level of a drug in a person's blood, and can be used to support approval of a drug.

Officials stressed, however, that individuals taking any of the drugs in question were not believed to be at any extra risk.

"Patients who use the products are not believed to be at any increased safety risk," said Joseph Famulare, deputy director of the Office of Compliance at the Center for Drug Evaluation and Research (CDER) of the FDA. "We are requesting confirmation of these analyses of bioequivalency studies simply as a precaution because of a pattern of irregularities at two MDS sites. FDA believes that all of the drugs involved continue to be safe and effective."

Famulare, who spoke at a Wednesday news conference, would not reveal the names of any of the drugs, citing confidentiality issues.

The Associated Press reported that FDA officials have identified all 217 generic drugs that either have won or are seeking federal approval and that included MDS studies in their applications. For brand-name drugs, the FDA isn't sure which companies relied on testing done by MDS. As a result, the agency is notifying all brand-name drug makers that submitted the more than 900 applications received since 2000 to review their files to find out.

The FDA has been concerned with the quality of tests performed at MDS for years. The company is known as a contract company, hired by various pharmaceutical firms to conduct testing on drugs. It is one of the larger players in the field, Famulare said.

Regular on-site inspections of two MDS facilities in Canada revealed potential problems with laboratory analyses used for pharmacokinetic studies. Further inspections narrowed it down to laboratory analyses completed from 2000 to 2004 and submitted to the FDA to support generic and new drug applications.

"A number of unexpected results in tests conducted during that time period prompted concerns that all laboratory tests were accurate," Famulare said.

To date, the FDA has conducted four inspections and issued three letters to the company; the most recent was dated Aug. 31, 2006. MDS committed to a five-year retrospective audit of the time period 2000 to 2004 but that was considered inadequate, Famulare said.

"We did not receive enough assurances through that audit that all the issues we had brought up were addressed," Famulare said. "The issues involved a variety of issues, such as reporting inaccurate drug level data, not investigating unexpected values, and lack of reproducibility."

So, FDA officials have identified all of the approved generic and brand-name drugs that were submitted for approval from 2000 to the present day, and is notifying those companies about the potential for faulty testing. More than 900 brand-name drugs and 217 generic drugs were identified.

The actual number of affected drugs is likely to be much lower, however.

"It's a very broad net we're casting," said Dr. John Jenkins, director of the Office of New Drugs at CDER. "It's a very comprehensive search strategy we're taking to make sure we're touching the entire universe of potentially affected products, but it's much broader than the actual universe that included MDS studies."

Once companies have identified any studies conducted by MDS, the FDA "will determine what actions are needed," Famulare said. This may include validating the data through audits, new analyses or repeating the tests.

Companies have six months to get the information to the FDA. Drugs which are currently pending approval may take longer to be approved, said Gary Buehler, director of CDER's Office of Generic Drugs.

Potential deficiencies that were identified and reevaluated have turned out not to be problems after all, Buehler added.

In a company statement released Wednesday night, Stephen P. DeFalco, president and CEO of MDS Inc., said, "While we are disappointed in the time and effort that it has taken to get to this course of action, we believe that it will benefit everyone involved to have a crisp path forward to resolve this issue. We will fully support our clients with data and information from their studies to help bring this issue to a rapid and complete resolution."

The statement also noted that the company has ended its retrospective review of the tests in question, and will instead support its clients with independent audits.

More information

The FDA has more on this issue.

THURSDAY, Jan. 11 (HealthDay News) -- Early to bed and early to rise might make you healthy, wealthy and wise, but it's likely the result of a gene mutation, researchers report.

For some time, scientists led by Dr. Louis J. Ptacek, a professor of neurology at the University of California, San Francisco, have been studying several families with a unique sleep problem. These so-called "morning larks" have a condition known as familial advanced sleep phase syndrome (FASPS). People with this condition have a gene mutation that causes them to go to sleep -- in the most extreme cases -- at four or five in the afternoon and wake up at one in the morning, he said.

"FASPS is not hugely common, but it's not rare," Ptacek said. "About 0.3 percent of the population has the mutation."

In its latest research, Ptacek's group has determined how the gene causes the condition, by transplanting the gene into mice to create rodents with FASPS.

"They get up and start running on their running wheels four to six hours before other mice, and they also stop running on their running wheels four to six hours earlier than normal mice," Ptacek said.

In the studies of these FASPS mice, Ptacek's team found that the mutant version of the Period 2 (Per2) clock gene, which is needed to reset the body's central clock in response to light, cannot be chemically changed by an enzyme that controls it. This leads to a reduction in the number of copies of the Per2 gene, and the shift in sleep patterns, the researchers said.

Ptacek thinks these findings may eventually lead to ways to reset humans' internal time clocks and provide new drugs to help deal with sleep problems caused by factors such as shift work or jet lag.

"Very little is known about the human clock," Ptacek said. "Only once we understand what all the gears in the clock are will we be in a position to make decisions about how we might advance or delay our own clocks when we work the night shift or when we travel across time zones."

Ptacek noted that people with FASPS react to the condition differently. Some see it as a problem, while others enjoy being morning larks, he said. "This underscores that FASPS is behavior. Whether you see it as positive or negative depends on your perspective," he said.

The findings are published in the Jan. 12 issue of Cell.

The researchers are also studying people who are night owls and finding there appears to be a genetic link as well, Ptacek said.

One expert thinks that modifying internal clocks -- called circadian rhythms -- is possible but difficult.

"These findings suggest that there are other components of the clock that are not known, that account for different sleep patterns," said Dr. Emmanuel Mignot, a professor of psychiatry and behavioral sciences and director of the Center for Narcolepsy at Stanford University School of Medicine. He co-wrote an accompanying editorial in the journal.

But, other factors also influence sleep and biological clocks, Mignot said. "We know that everything is not genetic," he said. "For example, as people age, they become more and more early birds. That's a natural progression of most people. That's not genetic, because the genes don't change with age."

Mignot said it might be possible to develop drugs that can change the speed of the clock. But, developing a drug that has no other effect than to act on a particular enzyme for a specific purpose may be tough to do. "It's not going to be easy, but it's not impossible," he said.

More information

The National Sleep Foundation can tell you more about sleep  .

TUESDAY, Jan. 9 (HealthDay News) -- Skin cells that have been genetically altered may be able to help artificial skin fight infection in burn patients, a new study found.

People with severe burns often receive cultured skin substitutes, which are grown in a laboratory using the burn patient's own skin. The skin cells are cultured, expanded and combined with collagen to make skin grafts that can be reattached to the burn wound.

"Cultured skin substitutes are improving the lives of many burn patients, but they also have limitations -- including an increased susceptibility to infection," Dorothy Supp, the study's lead researcher and an adjunct research associate professor at the University of Cincinnati, said in a prepared statement.

The study findings are published in the January issue of the Journal of Burn Care and Research.

Currently, doctors manage cultured skin graft infections by continually wrapping the wound in drug-soaked dressings during the early healing period. While this protects the skin grafts, said Supp, it can also lead to drug-resistant strains of bacteria.

Supp and her research team isolated a protein known as human beta defensin 4 (HBD4) from donated tissue samples and transferred it into surface skin cells. HBD4 is one of a class of proteins that helps the body fight off infection.

When the researchers infected the skin cells with pseudomonas aeruginosa, a type of bacteria common in hospitals, they found that the genetically altered cells containing HBD4 were more resistant to infection than unaltered cells.

"If it proves effective in additional testing, this type of gene therapy could be a promising alternative infection control method for burn wounds," Supp said.

Researchers hope to begin testing these altered skin grafts in animals early this year.

More information

The Johns Hopkins Burn Center has more about burns  .

FRIDAY, Dec. 29 (HealthDay News) -- Robots are increasingly coming to the rescue for humans undergoing delicate surgeries, say experts at Johns Hopkins University in Baltimore.

Engineers and computer scientists at the university's National Science Foundation Engineering Research Center for Computer-Integrated Surgical Systems and Technology are working closely with physicians to build robotic tools that can enhance the surgeon's skills.

The tools include a snakelike robot that could allow surgeons to manipulate surgical instruments in narrow spaces such as the throat region. The robotic assistant would help surgeons make incisions and tie sutures with greater dexterity and precision.

Another tool being developed and tested is the steady-hand robot, which can grasp a needle and work in tandem with a surgeon's movements, reducing hand tremor that can complicate microsurgery. This robot could allow surgeons to inject drugs into tiny blood vessels in the eye, dissolving clots that can damage vision.

"We're not trying to replace or automate surgeons," said Russell H. Taylor, a professor of computer science and director of the center, in a prepared statement. "Human hands are remarkable, but they have limitations. There are times when it would be useful to have a 'third hand,' and we can provide that," he said.

The new medical tools also enable the surgeons' work to be recorded. This would allow doctors to analyze how well patients respond to treatment and learn which techniques and procedures are most effective.

"We could provide the equivalent of a flight-data recorder for the operating room," Taylor said.

These robotic devices will require about five more years of testing and improvements in a lab environment before they find their way into operating rooms.

More information

The Cleveland Clinic Foundation has more about robot-assisted surgery  .