Exactly! Why? They (the FDA) did the same thing with aspertame (nutra-sweet) that is put in diet soft drinks -- breaks down into toxic substances at 87 degrees farenheit. Had skids of this poisonous crap sitting out in the sun during Desert Storm for our troops to consume. Their mysterious symptoms do correlate to aspertame poisoning. But then the FDA also approved the vaccines too ... didn't they~! What a double whammy! Robert
----- Original Message ----- From: Judith Thamm <[email protected]> To: <[email protected]> Sent: Thursday, November 16, 2000 7:09 PM Subject: CS>Re:Another deadly drug [fwd] > >Date: Mon, 13 Nov 2000 22:19:20 -0600 (CST) > >From: Circare <[email protected]> > > > >From: Vera Hassner Sharav, President > >CIRCARE: Citizens for Responsible Care & Research, > > A Human Rights Organization > > Tel. 212-595-8974 FAX: 212-595-9086 > > [email protected] > > > >FYI > > > >"Why, given the warnings of potentially fatal ischemic colitis for a > drug > >that is not lifesaving itself, did the FDA approve Lotronex?" > > > > >From the number of deadly drugs approved by the FDA, one wonders > whether > >making them affordable is in the public interest??? > > > >The Los Angeles Times reports that within the last 3 years, the FDA > has > >struck out 9 times by approving deadly drugs in an approval process > that is > >corrupted by industry affiliated FDA advisory panels. > > > >" The FDA officials disregarded the significance of concerns > raised by > >an agency medical officer who examined the drug before its approval. > They > >chose a paid consultant to Glaxo to serve with an advisory committee > that > >recommended approval of the drug." > > > > If the FDA relies the advice of drug company representatives who > want their > >company's drugs approved--and ignores warnings from its own unbiased > >experts--WHY DO WE NEED THE FDA? > > > >~~~~~~~~~~~~~~~~~~~~~~~ > > > ><http://www.latimes.com/RealMedia/ads/click_lx.ads/www.latimes.com/ne > ws/nati > >on/updates2/lat_lotronex001102.htm > > > >LOS ANGELES TIMES > >Thursday, November 2, 2000 | > > > >FDA Minimized Issue of Lotronex's Safety > > > > Health: Times study finds officials sided with drug maker on > regulatory > >concerns. Agency reevaluation is underway. > > > >By DAVID WILLMAN, Times Staff Writer > > > > WASHINGTON--In the drug's first eight months on the market, > five people > >who took it died. Several others underwent bowel surgeries--one had a > colon > >removed. A total of 49 patients developed ischemic colitis, a > potentially > >life-threatening complication. > > > > As a result, the Food and Drug Administration is now > > "reevaluating" the > >safety of Lotronex, a drug intended to treat women with a nonfatal > disorder, > >irritable bowel syndrome. But a Los Angeles Times investigation of > the FDA's > >handling of Lotronex found that over the last year agency officials > >repeatedly played down questions about the drug's safety while siding > with > >the manufacturer, Glaxo Wellcome Inc., in important regulatory > decisions. > > > > The FDA officials disregarded the significance of concerns > raised by an > >agency medical officer who examined the drug before its approval. > They chose > >a paid consultant to Glaxo to serve with an advisory committee that > >recommended approval of the drug. They agreed with Glaxo not to place > a > >highly visible "black-box" warning on the label of Lotronex. Rather > than > >wait for Glaxo to conduct a major new study of the drug's link to > ischemic > >colitis, the agency approved the pill on a condition that the study > would > >take place after the drug entered the market. The study has yet to > begin. > > > > And for the last several months, the officials have declined, > in the > >face of data gathered by FDA epidemiologists, to seek withdrawal of > the > >drug. > > > > The FDA's handling of Lotronex is the latest example of how the > >pressure to get new drugs to market can clash with the agency's > mandate to > >protect public health and safety. Since 1993, the agency has > dramatically > >stepped up approvals of new drugs submitted by the $100-billion > >pharmaceutical industry, with fortunes rising or falling on sales of > a > >single medication. > > > > In the last three years, the FDA has been forced to withdraw > nine drugs > >from the market after reports of deaths and injuries linked to the > >compounds. > > > > An FDA administrator, Dr. Florence Houn, on Wednesday defended > the > >agency's decisions on Lotronex but added, "FDA is concerned about the > >serious adverse event reports of ischemic colitis and severe > constipation > >associated with Lotronex." When the agency approved Lotronex, Houn > said, > >officials suspected that the ischemic colitis seen with the drug was > >nonfatal and reversible. > > > > 3 Deaths Not Linked to Drug, Firm Says > > > > A representative of Glaxo, Dr. Allen Mangel, said the company > has > >investigated three of the five deaths and believes those events were > not > >caused by Lotronex. Mangel said Glaxo has not been able to adequately > probe > >the remaining two deaths. He said the company "will absolutely want > to meet > >with the FDA very soon" to discuss the drug's future. > > > > As for Glaxo's pledge to launch the major new study regarding > ischemic > >colitis and Lotronex, Mangel said the company and the FDA are still > >negotiating details of how to conduct the research. > >A spokeswoman for Glaxo, Ramona Dubose, said the company stands > behind > >Lotronex. > > "We have complete confidence in the safety profile of this > drug," > >Dubose said. "We believe that any risks can be managed." > > > > The FDA takes into account whether other treatments are > available when > >deciding whether to approve or withdraw drugs. For irritable bowel, > there > >are five drugs on the U.S. market, including Lotronex. Doctors say > that none > >is effective at easing all symptoms of the disorder, which can > include > >abdominal pain, diarrhea and constipation. However, a search by The > Times of > >records maintained by the FDA since 1993 found that only Lotronex has > been > >cited as the "suspect" in a case of ischemic colitis. > > > > It was last November when an FDA medical officer named John > Senior > >tried to sound an alarm about Lotronex. Time was short. The FDA had > agreed > >to conduct a "fast-track" review of Lotronex, on the basis that it > would > >treat a "serious" disease. Dr. Senior, while stopping short of > recommending > >rejection or approval of Lotronex, deplored Glaxo's approach to the > safety > >concerns > >surrounding the drug. > > > > "It is very disturbing that the applicant has chosen to > downplay so > >strongly the important issue of constipation, induced commonly and > >predictably by [Lotronex], and has totally ignored the [problems] of > >ischemic colitis," Senior, a bowel specialist, wrote in his review. > > > > Senior identified four cases within Glaxo's clinical studies of > >ischemic colitis--the potentially lethal complication that results > from > >inadequate blood flow to the colon. He noted that no patient taking a > >placebo had developed it. > > > > "This finding represents a signal of a potentially serious > problem," > >Senior warned in his review, adding that drug-induced ischemic > colitis can > >be "mild and transient" but can also result in gangrene of the bowel > and > >death. > > He found that 27% of the patients taking Lotronex experienced > >constipation. > > > > Improvement in Patients Cited > > > > As for the drug's potential benefits, the FDA medical-review > staff > >concluded that 10% to 20% of patients in Glaxo's clinical studies > gained > >improvement in their symptoms that could be attributed to Lotronex. > The drug > >is intended for women whose predominant irritable-bowel symptom is > diarrhea. > >Once a drug is approved by the FDA, doctors can prescribe it for > anyone or > >any purpose they deem appropriate. > > > > After Senior apprised the Gastrointestinal Drugs Advisory > Committee of > >patients' risk for ischemic colitis, Dr. Houn asked panelists whether > more > >safety studies "should be performed prior to approval, or after > approval?" > > > > The question was crucial to Glaxo because withholding approval > until > >more safety data could be examined would have knocked Lotronex off > the fast > >track and delayed, if not dimmed, sales. Only one committee > participant, Dr. > >Arnold Wald of Pittsburgh, responded directly to Houn's question: > > > > "I think we could approve the drug with the caveat that we > monitor it > >very carefully. . . . So I would not hold up the approval pending > that > >data," said Wald, who recalled that he participated at the meeting as > a > >temporary special government employee paid by the FDA. > > Wald, it turns out, was no stranger to Lotronex or Glaxo, > according to > >FDA records and interviews. > > > > Wald at the time of the meeting had a grant from Glaxo, the > panel's > >secretary announced, "on a matter unrelated" to Lotronex. He also had > helped > >conduct one of the early studies of Lotronex on Glaxo's behalf, as an > >intestinal specialist at the University of Pittsburgh. > > > > In an interview, Wald acknowledged that it was also around > November > >1999--the same month as the FDA advisory meeting--that he and several > >faculty colleagues began teaching a series of courses for Glaxo's > sales > >representatives, honing their familiarity with irritable bowel > syndrome. > > > > The Gastrointestinal Drugs Advisory Committee voted unanimously > to > >recommend prompt approval. The FDA formally approved Lotronex on Feb. > 9, > >completing a review that took seven months. Securities analysts > predicted > >Lotronex would generate sales for Glaxo of up to $2 billion within > five > >years. > > > > When the FDA approved Lotronex, Glaxo retained Wald to make > >presentations to physicians who might prescribe the drug. Wald said > that his > >financial ties to Glaxo did not taint the advice he > >gave to the FDA. > > > > "We do have that relationship," Wald said of his work with > Glaxo. > >"That's a potential conflict. But personally, it wouldn't be enough > to > >misrepresent the drug in terms of my professional reputation." > > Wald said that he holds no regret about advising the FDA to > approve > >Lotronex quickly--instead of waiting for additional safety data > concerning > >the drug's capacity to induce ischemic colitis. > > "They proved their efficacy; it seemed to be safe," Wald said, > adding: > >"I don't really have any concerns about the drug." > > > > Lotronex began arriving on pharmacy shelves in March. And in > April, the > >FDA received the first voluntarily filed reports of serious side > effects > >among the new patients, according to records reviewed under the > Freedom of > >Information Act. In one case, a 59-year-old woman was hospitalized > and the > >health professional who filed the report listed Lotronex as the > "primary > >suspect" drug. > > > > By early June, a total of eight new ischemic colitis cases had > emerged. > >Six other Lotronex patients were hospitalized with > constipation-related > >complications, and three of them required surgery. > > > > On June 27--less than five months after the FDA approved > Lotronex--the > >agency convened a special meeting of the advisory committee. > > > > Another FDA medical officer, Dr. Hugo Gallo-Torres, told the > advisory > >committee that "there is a causal relationship" between Lotronex and > both > >ischemic colitis and constipation. Gallo-Torres a few months earlier > had > >recommended approval of Lotronex, despite saying it was "a hard to > >explain/accept coincidence" that no patient taking placebos in the > clinical > >studies suffered ischemic colitis. > > > > 'Black-Box' Warning Opposed by Glaxo > > > > Glaxo representatives suggested that preexisting medical > complications > >or patients' use of other drugs may have caused some of the > >hospitalizations. A company executive, citing competitive > considerations, > >said Glaxo opposed the FDA staff's proposal to place a "black-box" > warning > >in the drug's labeling. This black-bordered feature signifies > pronounced > >risk and is more noticeable to patients and their physicians. > > > > "We don't feel . . . that this drug is a dangerous drug and > merits a > >black box," said Dr. Richard S. Kent, Glaxo's chief medical officer > and vice > >president. > > > > With a black box, Kent said, "patients and physicians may end > up making > >inappropriate decisions around whether to use this drug. I think > there is a > >duty to warn that we all have; I think there is a great duty not to > >over-warn. We have to put the risks and benefits of all these > products in > >proper perspective." > > > > The FDA dropped the proposal for a black-box warning. > > > > The first fatality of a Lotronex patient was reported to the > FDA on > >July 17, a 50-year-old woman who suffered "mesenteric occlusion," a > severe > >blockage of blood to the colon. This report, filed voluntarily by a > health > >professional, identified Lotronex as the "primary suspect" drug in > the > >death. Glaxo denies that Lotronex caused this death. > > > > On Aug. 24, the FDA and the company announced a safety-labeling > change. > > > > In a letter to doctors and pharmacists, Kent acknowledged > reports "of > >serious complications of constipation, including obstruction, > perforation, > >impaction, toxic megacolon, and secondary ischemia, in patients > treated with > >Lotronex. In some cases these complications have required intestinal > >surgery, including colectomy," the removal of the patient's colon. > > > > Records kept by the FDA show that, through Oct. 30, the agency > had > >received 93 reports of patients being hospitalized after taking > Lotronex. In > >each of the reports, the doctor or other party cited Lotronex as the > >"primary suspect" drug in the event. > > > > In an interview on June 30, the FDA's drug center director, Dr. > Janet > >Woodcock, cited Lotronex as an example of what she termed a fresh > commitment > >to pro-actively monitor the risks of newly approved drugs. She > praised a > >leaflet, called a "medication guide," that the FDA and Glaxo had > agreed to > >develop for Lotronex patients. > > > > Why, given the warnings of potentially fatal ischemic colitis > for a > >drug that is not lifesaving itself, did the FDA approve Lotronex? > > "We can't not approve drugs because they have certain side > effects," > >Woodcock said. "They're all going to have side effects. We have to > >determine, are they going to be adequately managed?" > > > > Lotronex generated $42.1 million in sales through August for > Glaxo, > >according to IMS Health, an information-services firm. During this > period > >334,000 prescriptions were written, some to the same patients. > > > >--- > > Times researchers Janet Lundblad in Los Angeles and Sunny > Kaplan in > >Washington contributed to this story. > > > >Copyright 2000 Los Angeles Times > > > >Kid Fever > ><http://www.latimes.com/RealMedia/ads/click_lx.ads/www.latimes.com/ne > ws/nati > >on/updates2/lat_lotronex001102.htm/29623/Bottom/IH-KidFever001/kf_Ban > ner_468 > >.gif/63306138643531333339626363653030> > > > > > > > -- > The silver-list is a moderated forum for discussion of colloidal silver. > > To join or quit silver-list or silver-digest send an e-mail message to: > [email protected] -or- [email protected] > with the word subscribe or unsubscribe in the SUBJECT line. > > To post, address your message to: [email protected] > Silver-list archive: http://escribe.com/health/thesilverlist/index.html > List maintainer: Mike Devour <[email protected]> >
