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May 6, 2002

EFFECTIVELY TREATING SYMPTOMS OF IRRITABLE BOWEL SYNDROME

NO NEED TO RELY ON A TOXIC DRUG

By Meryl Nass, MD

In March 2000, The Lancet published a favorable clinical trial of the GlaxoWellcome anti-diarrhea drug Lotronex. It had been licensed a month earlier. By November 2000, Glaxo voluntarily withdrew the drug following reports of five deaths. Yet soon thereafter, the FDA leadership worked closely with the manufacturer to bring the drug back, and set up an advisory committee meeting to do so last summer.

In May 2001, before the meeting took place, The Lancet’s editor, Horton (angered that his journal had published a misleading study of the drug) wrote a strong commentary on the drug and the FDA’s review process. He noted that the FDA’s own scientists reported that "a risk management plan cannot be successful that will eliminate deaths, colectomies, ischemic colitis and complications of treatment that were never seen previously in the management of Irritable Bowel Syndrome."

Furthermore, he carefully documented the existence of a two-track process for approval of the drug at FDA: one "official and transparent, one unofficial and covert, contrary to FDA’s stated policy." Basically, the FDA leadership was secretly working with Glaxo to control the deliberations of its advisory committee and bring the drug back, in opposition to the advice of its own scientists.

The Advisory Committee meeting was delayed until April 2002, when it supported reapproval of the drug.

Being ‘dissed’ by one of the world’s top medical journals apparently made no lasting impression on FDA or its parent agency HHS.

One reason given was the demand by patients for the drug. Several said their life had been ruined by chronic diarrhea until Lotronex came alone. Glaxo had given money to patient support groups, by the way. Is that unusual?

PR firms set up dummy patient support groups (and dummy experts) as cheering squads for specific drugs. Sometimes the process is quite complex, so that it is almost impossible to identify the manufacturer’s involvement.

Entirely left out of the discussion of this drug is the fact that chronic diarrhea can be treated safely and effectively without Lotronex. No one need be forced to choose between being a prisoner of their house or possibly losing their colon or their life.

Doctors can successfully treat chronic diarrhea with the understanding that there are many causes. Irritable Bowel Syndrome (IBS) is a diagnosis of exclusion, which means when doctors have ruled out other causes, everything left is called IBS. It is a common condition in fibromyalgia, Gulf War Syndrome and other poorly understood conditions.

Diarrhea is, in general, a tough condition for doctors. The small intestine is like a "black box" which can only be viewed at its very beginning or very end. Its chemistry and physiology are complex and only partially understood. The large intestine (or colon) can be seen in its entirety, but we do not completely understand how the motility of either is controlled. Furthermore, the stool that appears at the anus may not contain the organism causing problems higher up, or reflect the process causing disease

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> May 6, 2002

>

> EFFECTIVELY TREATING SYMPTOMS OF IRRITABLE BOWEL SYNDROME

>

> NO NEED TO RELY ON A TOXIC DRUG

>

>

My daugher, now 33, was dxd with this

as a child, and as a teenager. It became

worse after her saline implants at

age 20. She was again dxd at age 30 at

Stanford and was told it was becoming

ulcerative colitis. Last year, because

of something I read re blood types, she

decided to try eliminating wheat--BINGO!

It not only took a few short weeks to

determine, but she has not had to

watch her weight since. Many things

contain it--even your average white bread--

so check ingredients before purchasing.

Health food stores carry lines of

gluten/wheat-free breads and pastry and

they can be found on-ine also. Many with

silicone illnesses developed or discovered a

gluten allergy. So I have to agree with this

physician--that is one thing that can cause it.

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