OVERDOSES LEAD TO SEARCH FOR SAFER PAINKILLERS

In the face of increasing deaths from overdoses of prescription
painkillers, several pharmaceutical companies are trying to bring to
market drugs they say are abuse resistant.

Last year, about 2,000 Floridians in the Tampa Bay area fatally overdosed on
prescription drugs. The vast majority of the lethal drugs were opioid
painkillers like oxycodone, hydrocodone and morphine.

Pharmaceutical companies say many of the people dying are abusing the
drugs by crushing, biting, snorting or injecting time-released pills.
This provides a powerful, heroinlike high.

The Food and Drug Administration has encouraged manufacturers to study
ways to make their drugs less susceptible to abuse.

Several companies are seeking approval of new formulas this year. Some
of the drugs are rubbery or gel-like and can't be crushed. Others have
substances embedded in the pills that offset the euphoric affects of
the drug if it is crushed or manipulated.

"Our goal is to address a public health concern," said Dr. Joseph W.
Stauffer, chief medical officer at Alpharma Pharmaceuticals, which
hopes to have an abuse-resistant morphine pill on the market by next
year.

But this month, a panel of FDA advisers expressed skepticism about an
abuse-resistant form of OxyContin. Panelists said OxyContin maker
Purdue Pharma hadn't provided enough evidence that its new product
would deter abuse.

"I'm fascinated with the poor scientific rigor" of the data presented
by Purdue, FDA panel member Jeffrey R. Kirsch said. "It's almost insulting."

Purdue said in a statement it would continue working with the FDA on
the product.

Larry Golbom of Pinellas County spoke against FDA approval of the new
drug during the panel meeting in Maryland. Golbom is a pharmacist with
a family member who become addicted to prescription drugs. He hosts a
radio show about prescription drug addiction on Sunday nights on
WGUL-AM 860.

"There is no logical sense to making more of this product available on
our streets," Golbom said. "To present the concept that this is a
safer drug would be a tremendous disservice to the medical profession
and the American public."

Golbom believes most of the people who die of painkiller overdoses
don't snort or inject the drug, but swallow the pills whole.

The St. Petersburg Times analyzed the autopsy reports of nearly 800
prescription drug deaths over a two-year period for a series published
in February. The analysis found there is no way to be certain if the
fatal drugs were swallowed or taken another way.

Golbom worries that FDA approval of additional drug types would give
doctors a false sense of security.

"The fact is that oxycodone is a highly addictive drug in the same
category as heroin," Golbom said. "The reality is that pain relief is
a side effect of this drug."

Last year, Purdue agreed to pay $634-million to settle criminal
charges that it misled doctors about the risks of OxyContin, which had
more than $1-billion in sales last year.

Golbom said the drugs proposed by other companies also should be
scrutinized. He said the FDA needs to better define when opioid
painkillers should be prescribed.

But Stauffer said the indications are clear. He said the new drugs
will help ensure that drug abuse is deterred, while those who need
painkillers can continue to receive them. "There are dual public
health issues at stake here," he said.

Stauffer said only a small percentage of people prescribed painkillers
become addicted. He said the drugs help far more people than they hurt.

Alpharma's abuse-resistant drug has gone through trials that have
found it to be safe and effective, Stauffer said. The pills are
embedded with a substance that blunts the euphoric high users would
receive if the pills were crushed.

King Pharmaceuticals also hopes to submit by June an application for
its abuse-resistant oxycodone drug, Remoxy.

The gel-like Remoxy, which has successfully completed trials, does not
lose its time-release mechanism if crushed, said James E. Green,
King's executive vice president of corporate affairs.

Green acknowledged there is no way to ensure drug abusers won't find
some way to defeat the abuse-resistant features of the new drugs.

"I don't know that you'll ever have anything that is tamper-proof,"
Green said. "You just don't want it to be easy for people to tamper
with."

The drugs could mean billions of dollars for the companies.

Last year, sales of opioid painkillers totaled $6.37-billion in the
United States, a 52 percent increase over 2002.

Dr. Lynne Columbus, a Palm Harbor pain physician, said the
abuse-resistant pills are a good idea.

"I think they will help a lot," she said. "It will give us a
medication we can prescribe and sit back and relax and know people
can't bite it and overdose."

Information from Bloomberg News, Dow Jones Newswires and the
Associated Press was used in this report.