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Home Journal Excerpts Lotronex and the FDA
Lotronex and the FDA
fdaThis story reveals not only dangerous failings in a single drug's approval and review process but also the extent to which the FDA, its Center for Drug Evaluation and Research (CDER) in particular, has become the servant of industry.

Comment:

The Lancet is one of the leading medical journals in the world and this scathing article reveals the depth of corruption in the FDA and medical industry. Both are more concerned with getting a product to market and making a profit that they are in ensuring the safety of the public. The FDA is a "servant of industry" and should be disbanded for creating an illusion of a government agency that protects the public. Instead of protecting the FDA often times creates a rubber stamp that only lulls people into thinking a drug has been somehow been approved that is safe and effective. If not disbanded all together, then the people in both the FDA and the drug companies involved in the drug approval process should be held responsible for drugs that injure or kill people. A possibility of a manslaughter conviction in the event of delivering a deadly drug to market would ensure that drugs go through stringent testing procedures before entering the market. And what is shocking is that the FDA is now allowing this killer bowel back on the market (http://www.sickofdoctors.addr.com/articles/lotronex.htm). And again after people die no one at the FDA or in GlaxoSmithKline will be held responsible.


Lotronex and the FDA: a fatal erosion of integrity PDF Print E-mail
Saturday, 19 May 2001 00:00
"Lotronex was licensed by the US Food and Drug Administration (FDA) in February, 2000. By November, GlaxoWellcome had voluntarily withdrawn Lotronex from the market. At least five people had died after taking the drug. Yet many within the FDA's leadership now want to bring Lotronex back. An advisory committee meeting set up to do so is being planned for June or July. This story reveals not only dangerous failings in a single drug's approval and review process but also the extent to which the FDA, its Center for Drug Evaluation and Research (CDER) in particular, has become the servant of industry."

"Glossy six-page advertisements in specialist medical journals claimed that Lotronex had "a favorable safety profile and [was] generally well-tolerated". The advertisements did, however, mention the problem of ischaemic colitis, although the warning emphasized that a casual connection between the drug and this adverse event was uncertain. By July 2000, concerns about the balance of risk and benefit were being voiced. Between February and June that year, seven patients had developed serious complications of constipation, three of whom required surgery. Eight further cases of ischaemic colitis were reported. The FDA had an opportunity then to take stock of its earlier position. The clinical data confirmed the substantial and potentially life-threatening risks hinted at during the pre-approval review. But instead of withdrawing Lotronex and calling for more evidence, the FDA issued a medication guide designed to warn patients of escalating risks, while keeping the drug on the market."

"This decision was to prove fatal. On Nov 28, GlaxoWellcome withdrew Lotronex from the market after the deaths of five patients taking the drug. There had been 49 cases of ischaemic colitis and 21 of severe constipation, including instances of obstructed and ruptured bowel. In addition to the deaths, 34 patients had required admission to hospital and then need surgery. A letter from Janet Woodcock, director of CDER, declared the "FDA is committed to working with pharmaceutical sponsors to facilitate the development and availability of treatment options for patients with IBS". There was no word of sorrow or regret for the families of those who had died."
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