Re: GSK peddling more death

June 7, 2002

I guess they didn't kill enough people the first time around!!!

June 7, 2002

I guess they didn't kill enough people the first time around!!!

June 7, 2002

Interesting article. What I get from this is re-affirmation of my

belief that the FDA doesn't care 2 cents for public health.

We need to realize that the government today is there to keep the

people in line and to provide a friendly environment for corporations

to maximize profits.

I for one have no use for the FDA. FDA approval simply gives a false

sense of safety to drugs. I myself will probably never take another

drug that hasn't been around for 20 years so I can read after the

fact what the drug really does.

June 7, 2002

Interesting article. What I get from this is re-affirmation of my

belief that the FDA doesn't care 2 cents for public health.

We need to realize that the government today is there to keep the

people in line and to provide a friendly environment for corporations

to maximize profits.

I for one have no use for the FDA. FDA approval simply gives a false

sense of safety to drugs. I myself will probably never take another

drug that hasn't been around for 20 years so I can read after the

fact what the drug really does.

June 7, 2002

Interesting article. What I get from this is re-affirmation of my

belief that the FDA doesn't care 2 cents for public health.

We need to realize that the government today is there to keep the

people in line and to provide a friendly environment for corporations

to maximize profits.

I for one have no use for the FDA. FDA approval simply gives a false

sense of safety to drugs. I myself will probably never take another

drug that hasn't been around for 20 years so I can read after the

fact what the drug really does.

June 7, 2002

Interesting article. What I get from this is re-affirmation of my

belief that the FDA doesn't care 2 cents for public health.

We need to realize that the government today is there to keep the

people in line and to provide a friendly environment for corporations

to maximize profits.

I for one have no use for the FDA. FDA approval simply gives a false

sense of safety to drugs. I myself will probably never take another

drug that hasn't been around for 20 years so I can read after the

fact what the drug really does.

June 7, 2002

How unfortunate...

When will we, as a society, wake up??? Will we forever go for the " quick

fix " instead of taking responsibility for our own health? The truth of the

matter is that we will reap what we sow...

The Avenging Angel

>From: " Buggy " Reply-SSRI medications " SSRI

>Crusaders " Subject: GSK peddling more death Date: Fri, 7

>Jun 2002 22:16:20 -0400

>

>glitter, our favorite company's at it again...

>http://www.nytimes.com/2002/06/08/health/08DRUG.html June 8, 2002 U.S. Lets

>Drug Tied to Deaths Back on Market By DENISE GRADY

>

>or the first time, the Food and Drug Administration is allowing a drug to

>go back on the market after it was removed for safety reasons. The drug,

>Lotronex, a prescription treatment for irritable bowel syndrome, will be

>available again in several months, GlaxoKline P.L.C., its

>manufacturer, said. Lotronex was taken off the market in November 2000,

>less than 10 months after it was approved, because it was linked to severe

>intestinal problems and several deaths. GlaxoKline, based in Britain,

>withdrew the drug voluntarily at the F.D.A.'s request when the two could

>not reach an agreement on marketing restrictions intended to reduce adverse

>reactions. But thousands of patients protested the withdrawal, saying

>Lotronex was the only treatment to have aided them. Their pleas helped to

>persuade the agency and manufacturer to find a way to reinstate it.

>Lotronex will return, the agency said â€” with restrictions. The new rules

>leave considerable responsibility with doctors, pharmacists and patients to

>use it correctly and to watch for early signs of intestinal problems, which

>can be fatal. Dr. Victor Raczkowski, deputy director of the F.D.A. office

>that evaluates gastrointestinal drugs, said that the return of Lotronex was

> " not part of any overall F.D.A. strategy to bring back withdrawn drugs. "

>Rather, he said, it was a unique case in which the agency took an unusual

>action to help desperate patients who had no other effective treatment.

>Larry Sasich, a pharmacist and research associate at Public Citizen Health

>Research Group, a consumer advocacy group, called the plan disappointingly

>lax. " We're concerned that we're going to see patients hurt again from this

>drug, " he said. Before Lotronex was pulled from the market, a month's

>supply cost $175. A GlaxoKline spokeswoman said the price would rise

>because of the costs attached to the new marketing plan. GlaxoKline's

>shares rose 2.8 percent in London trading yesterday. Lotronex was first

>approved in February 2000 to treat women who had chronic diarrhea caused by

>irritable bowel syndrome, a condition that causes abdominal pain along with

>diarrhea or constipation, or both. The condition affects millions of people

>â€” more women than men â€” and earlier treatments did not work very well.

>Lotronex was the first drug shown to be effective specifically for

>irritable bowel syndrome. When it was first marketed, some financial

>analysts predicted Lotronex would become a blockbuster treatment for

>GlaxoKline. But it did not get the chance to become one and is

>unlikely to do so now, some analysts say, because of the restrictions. At

>its sales peak, about 275,000 people used Lotronex. But it was withdrawn

>after 70 patients developed severe constipation or ischemic colitis, a lack

>of blood flow to the bowel. Some needed surgery. Three deaths were linked

>to Lotronex use. More reports came in later. The F.D.A. said yesterday that

>as of March 8, it had been notified of 84 cases of ischemic colitis and 113

>cases of serious complications from constipation. Of those with ischemic

>colitis, 54 were hospitalized, 11 needed surgery and 2 died. Of the

>constipation cases, 83 were hospitalized, 34 had surgery and 2 died. Even

>so, many other Lotronex users said that they had essentially been homebound

>by pain and severe diarrhea, and that Lotronex had enabled them to live

>normal lives for the first time in years. Doctors who studied the drug said

>it greatly helped some patients, did little or nothing for many, and

>greatly harmed others. But it was impossible to predict into which group a

>patient would fall. Under the new rules set by the F.D.A., doctors who want

>to prescribe Lotronex will have to enroll in a program run by

>GlaxoKline that requires them to " self attest " that they know how to

>diagnose and treat irritable bowel syndrome, how to prescribe Lotronex and

>how to recognize and treat complications. The doctors must also agree to

>explain the drug's risks and benefits to patients, give them the company's

>informational pamphlet and report serious adverse effects to

>GlaxoKline or the F.D.A. Any doctor can get into the program by self

>attesting. Those who do not feel qualified to prescribe the drug can take

>an as yet undeveloped course from GlaxoKline. Patients who want

>Lotronex must sign an agreement acknowledging its risks, which include a

>1-in-1,000 chance of serious constipation problems and a 1-in-350 chance of

>ischemic colitis. Patients must also pledge to call their doctors

>immediately if they develop any symptoms considered to be dangerous,

>including constipation, new or worse bowel pain or blood in their stools.

>Doctors in the program will be given special stickers to apply to

>prescriptions for Lotronex, and the drug's labeling will alert pharmacists

>not to fill prescriptions that lack stickers. Pharmacists will also be

>instructed not to allow refills or prescriptions that are telephoned or

>faxed in, to insure that patients keep in contact with their doctors. The

>new plan also cuts the dose in half, to one milligram a day. Lotronex was

>first approved for women with chronic diarrhea from irritable bowel

>syndrome, but it is now recommended only for a narrower group: women with

>very severe cases that have not responded to other drugs. The group amounts

>to less than 5 percent of all people with irritable bowel syndrome, and is

>estimated to be about 185,000 women. Mr. Sasich of Public Citizen

>disparaged the self-attesting plan for doctors, saying no one was checking

>on their competence. He added that only gastroenterologists should be

>allowed to prescribe the drug. He and Dr. Sidney Wolfe, the director of the

>health research group, had argued that Lotronex should be treated as an

>experimental drug, with data collected on each patient. At a minimum, Mr.

>Sasich contended, a registry now ought to be created to track patients who

>use the drug and pharmacists who sell it. But many patients were pleased by

>the F.D.A.'s decision. " I was pretty nonfunctional without this

>medication, " said Zargo, 42, of Brookfield, Conn., who urged an

>F.D.A. advisory panel in April to recommend the drug's return. " When it was

>pulled, I was devastated. It's been a long battle and it's finally coming

>to an end. "

>

> " All Truth passes through Three Stages: First, it is Ridiculed... Second,

>it is Violently Opposed... Third, it is Accepted as being Self-Evident. " -

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June 7, 2002