Medical Beat

---

Osteoarthritis drugs can stay on the market.
WASHINGTON - The popular painkillers Celebrex, Bextra and Vioxx all pose a risk of heart trouble, but should be available to those who need them, advisers to the Food and Drug Administration said Friday.

The panel strongly favored keeping Celebrex on the market, split over Bextra and favored Vioxx - which is currently not on sale - by a vote of just 17-16.

``The data is very compelling,'' Vioxx is substantially worse than the others, meeting chairman Alistair J.J. Wood of Vanderbilt University School of Medicine said.

The panelists voted 31-1 to keep Celebrex on sale and, after a revote, favored Bextra 17-13 with two abstaining. The FDA is not required to follow the recommendations of the panel, but generally does so.

At the opening of the three-day meeting, FDA officials promised a prompt response to the panel's suggestions, which it requested after studies began showing problems with the drugs.

The panelists were unanimous in saying the drugs, known as Cox-2
inhibitors, pose risks of heart trouble. Studies of Bextra were limited, but showed a greater risk than Celebrex, the committee noted.

The advisers suggested restrictions on the drugs such as placing a severe ``black box'' warning on them, including more patient information with the drugs, restricting which patients could get the drugs and possibly banning direct-to-consumer advertising for the products.

Meeting Chairman Alistair J.J. Wood of Vanderbilt University Medical School said it is important to find some way to help the public better understand the nature of risk.

``People worry about crime and then drive drunk,'' he said, indicating they don't really understand relative risks.

Dr. Steven Nissen, medical director of the heart center at the Cleveland Clinic said ``What we really want is to make sure it's available for patients that need it and is unavailable to patients who whom it's inappropriate.''

The FDA's arthritis and drug safety advisory committees, concluding three days of meetings to assess the risks of three popular painkillers called Cox-2 inhibitors, were to address Vioxx and Bextra later in the day. All three drugs have been approved for sale by the government.

The advisers also were set to frame recommendations to the FDA
about whether further testing is needed for the drugs and any special warnings or limits placed on them.

``We need to find the unique patients that will benefit from this drug and work out what they need to be told,'' said Wood.

The committees were asked to assess the drugs after Merck & Co. pulled Vioxx from the market last fall because of health concerns. Since then questions have been raised about Bextra and Celebrex, both made by Pfizer Inc.

The excess risk from Celebrex varied in different studies and the panel didn't seek to determine just how much more hazard a user faces than someone on another drug.

However, the panel was told that no cardiovascular problems were seen at the normal prescription dose of 200 milligrams. Heart trouble began to appear in colon polyp study patients who took 400 milligrams.

Earlier in the meeting, Wood said the safety problems reported in connection with Cox-2 inhibitors exceed those of products that have been withdrawn from the market.

However, since the side effect involving heart attacks, irregular heartbeat and stroke is a relatively common problem, that makes it harder to pin it to the drugs than if it were a rare side effect.

Dr. Peter S. Kim, president of Merck Research Laboratories, had told the FDA committees earlier that new studies indicated the side effects aren't unique to its product.

``There are unique benefits to Vioxx,'' he said. ``The science has progressed and we need to take that science into consideration.''

While the committees heard evidence that all drugs in the group can increase the risk of heart attacks, irregular heart beat and strokes, it noted that Vioxx seemed to have more such reports than the other drugs.

On the other hand, Kim said, Vioxx is the only one of the drugs approved for people with certain allergies and did better at preventing the stomach and intestinal problems often caused by over-the-counter painkillers.

Dr. Robert Temple, director of medical policy for the FDA's Center for Drug Evaluation and Research, told the committees on Friday that ``the idea of doing a large new study has weight.''

``There are some data we'd all like to have, that we don't have,'' Temple said, including the blood pressure and other effects of the various drugs.

He said a new study might include more than just the Cox-2 drugs, possibly adding such widely used painkillers as ibuprofen, naproxen and diclofenac.

``My main point is that there is a very important need for more
information on many of these drugs,'' Temple said.

Your spit might put you in jail. Your spit might save your life.
WASHINGTON - Detecting illegal drug use may one day become as simple as testing spit on a sponge.

Researchers on Thursday said techniques now being developed for analyzing saliva may in the future replace many of the blood and urine tests that now are used to detect drug abuse and disease.

Some law enforcement agencies in Europe already test drugged drivers using saliva and the technique is gaining acceptance in the U.S., said Edward Cone, a Maryland researcher developing equipment for using oral fluids to screen for drug abuse.

``There are a lot of advantages to using oral fluid or spit,'' he said Thursday at a news conference of the national meeting of the American
Association for the Advancement of Science. ``It is easily accessible,
noninvasive and not embarrassing. You don't have to greet an employee with a urine cup.''

Most people produce more than a quart of saliva a day. Researchers have found the oral fluids accurately mirror the proteins that are found in blood and urine. This means that simple spit could provide a diagnostic window on the body in tests not requiring a needle or the embarrassing collection of urine.

Cone said experiments have already shown that spit can be even more reliable than urine tests for drug use screening.

``Drug users have learned how to beat the urine test in a variety of ways,'' said Cone, an organic chemist who heads up firm near Annapolis, Md. ``We haven't found any way to beat the oral fluids test.''

At the news conference, researchers said saliva tests also are being developed to detect virus and bacterial infections, and there is the possibility that some cancer tests one day will be based on spit chemistry.
``It has been known for decades that what is in the blood is also present in the saliva,'' said David Wong, a researcher at the University of California, Los Angeles, Jonsson Cancer Center. He said the National Institutes of Health are now financing studies to develop oral fluids tests that could detect infection and some types of cancer.

First, though, Wong said, science is studying saliva from healthy people.
The oral fluid is a complex collection of many proteins, and researchers want to develop an accurate profile of the compounds present in the mouths of normal patients.

Then, he said, researchers will search for the chemical differences that may reflect disease.

``We'll look in the oral fluids for the chemical signature of a disease process,'' said Wong.

A technique is now being refined, he said, that can detect the telltale
proteins produced by oral cancer. Daniel Malamud of the University of Pennsylvania said his research team has developed a sponge-tipped wand that can collect saliva from a patient and then transfer it to an analyzer that can identify DNA, antibodies and other compounds linked to virus and bacterial infections.

He said laboratory experiments show the technique can detect evidence of infection from the HIV virus and from a bacteria similar to anthrax.
Eventually, he said, science will learn how use saliva to find evidence for
any type of virus or bacteria present in the bloodstream.

Seaweed may help in the fight against cancer.
Researchers recently found kelp seaweed supplements lowered levels of Estradiol in female rats. Estradiol is the estrogen possible linked to breast cancer in women. Even though this study was in the rodents, researcher say in Japan, where kelp makes up about 10 percent of the diet, women have lower rates of breast cancer than in the United States.

More Bay Area Stories

• FDLE: Condoms, smokes, beer bought on govt's dime
• Weather blog: Anniversary of the nation's worst tornado
• Tampa Bay On Demand's tour of Irish pubs
• Your Web Poll Comments
• Traffic reporter tests Google Maps' new biking routes
• St. Patrick's Day Quiz Wrong Answer
• St. Patrick's Day Quiz Answers
• Do you have 'Luck of the Irish'? St. Patrick's Day QUIZ
• Blog: Chuck asked, and you answered

For current FLU conditions enter your zip code:

  

Select the size text you want to use to view www.baynews9.com from the choices below.

• Listen live
• Employee blogs
• Twitter page

• Breaking alerts
• RSS news feed
• Upload video