Fred A. Baughman, Jr., M.D. and Craig Hovey See book keywords and concepts | Documents obtained under the freedom of information Act reveal that two months before Prozac was approved for use in adults in 1987 there had already been 27 deaths during the clinical trials alone—and the first prescription had not even been written yet! 15 deaths were by suicide, 6 by overdose, 4 by gunshot, and 2 by drowning. All were confirmed to be directly related to Prozac. An additional 12 deaths were reported but could not be linked to Prozac with absolute certainty. | Mike Adams, the Health Ranger See article keywords and concepts | It was uncovered through a freedom of information Act (FOIA) request that uncovered a 2002 Human and Health Services survey asking FDA scientists questions about the agency. Their answers reveal an astonishing lack of confidence at the Fraud and Drug Administration, not to mention the bullying of scientists by FDA bureaucrats to get drugs approved even though they were dangerous. Let's take a closer look at the results of this survey.
The survey involved 846 FDA scientists with a near-50% participation rate. | Mike Adams See book keywords and concepts | Through a freedom of information Act request of all FDA-consumer correspondence for the past ten years relating to monosodium glutamate and hydrolyzed protein, I obtained several letters from FDA officials advising MSG-sensitive people to avoid hydrolyzed proteins. The standard form letter response that was sent to consumers stated that symptoms of MSG reactions are generally "mild and transient."
In December of 1989, at a meeting with top FDA officials, I informed them of my concerns as a physician about adverse reactions to MSG. | Jeffrey M. Smith See book keywords and concepts | Crist submitted several freedom of information (FOI) requests to the FDA and CDC in 1998 and again in 2001. Crist said, "In 1998, responses were received from FDA and CDC, but none of the specific documents and/or information requested were supplied. In 2001, FDA FOI staff said that the information requested either 'was lost' or 'could not be found,' and that the people who were involved at that time (1989-90) had all left FDA. | | He filed a freedom of information Act Request for the study, but was refused. He appealed within the FDA and, surprisingly, the request went to the same people who had initially refused him. Not surprisingly, Cohen lost again. The reason for the FDA's denial stated, "Release of the information would cause substantial competitive and financial harm to the company (Monsanto)."6 Cohen was determined to get his hands on the study. He filed a lawsuit in Federal Court. | | We're the country of freedom of information."40 He introduced labeling legislation in the House in 1999, and Senator Barbara Boxer tried the same in the Senate, but the bills never came up for a vote.
A handful of citizens from Oregon decided to take matters into their own hands. Taking advantage of voter laws in their state, they collected over 100,000 signatures on their petition and placed a labeling bill on the ballot in November 2002. Measure 27, as it was designated, would have required any food containing an ingredient with more than 0.1 percent GM content to be labeled. | | While the FDA and Monsanto said that they saw only a handful of cows develop udder infections, documents obtained through the freedom of information Act revealed that 9,500 cows from 500 farms were infected. In addition to omissions of data, dubious statistics were applied that further masked the drug's effects.
Burroughs, who was the only one in the unit who had real dairy herd experience, was involved with the rbGH approval process for nearly five years. When he saw what he considered to be unacceptable compromises on safety, he made his opinions known. | Marcia Angell, M.D. See book keywords and concepts | An unpublished internal document produced by the NIH in February 2000, which was obtained by Public Citizen through the freedom of information Act, revealed similar percentages. The NIH had selected the five top-selling drugs in 1995 (Zantac, Zovirax, Capoten, Vasotec, and Prozac) and found that sixteen of the seventeen key scientific papers leading to their discovery and development came from outside the industry. (Eli Lilly had sponsored one of the four key studies leading to the development of Prozac. | Katharine Greider See book keywords and concepts | He used a freedom of information request to obtain studies submitted to the FDA for approval of the six most widely prescribed antidepressants approved between 1987 and 1999—Prozac, Paxil, Zoloft, Effexor, Serzone, and
Celexa. On average, about 80 percent of the response to medication was duplicated in the placebo groups, Kirsch reports. On a commonly used fifty-point scale measuring symptoms of depression, people getting active medicine improved an average of two points more than placebo patients. | Marion Nestle See book keywords and concepts | Showa Denko demanded prepublication copies of the studies under the freedom of information Act (most scientists would find this intimidating as well as a nuisance) and used a carefully selected advisory committee to argue that the studies were done poorly and could not be reproduced.
Furthermore, the company sponsored its own research studies, organized a conference to announce the results, and paid for publication of the conference papers as a supplement to the Journal of Rheumatology. | | Center for Food Safety, obtains freedom of information Act information that Aventis knew in 1999—and told EPA in January 2000—that farmers were selling StarLink for use in human food.
December
Canada reports that keeping StarLink out of its food supply cost its government nearly $1 million.
2002
March
Federal judge approves $9 million settlement of farmers' class-action suit against companies involved in StarLink production and distribution.
June
Bayer completes purchase of Aventis CropScience; forms Bayer CropScience; divests interests in Starlink. | Marcia Angell, M.D. See book keywords and concepts | Using the freedom of information Act (a law that allows citizens to obtain government documents), the authors obtained FDA reviews of every placebo-controlled clinical trial submitted for initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999—Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor (all but the last two are SSRIs).23 As is typical, most of the forty-two clinical trials lasted for just six weeks.
Their findings were sobering. On average, placebos were 80 percent as effective as the drugs. | Philip Yam See book keywords and concepts | Web site, referred to the unit as the BSE Swat Team when he described the report after obtaining it via the freedom of information Act (the report is posted on the USD As Web site). Subsequently, the team created T-shirts that actually say "BSE SWATTEAM" on the back.
25 Department of Agriculture, "Bovine Spongiform Encephalopathy (BSE) Response Plan Summary," (Washington, DC, October 1998).
26 R. | Kevin Trudeau See book keywords and concepts | How can America, a country that presents itself to the world as a bastion of free speech, free expression of ideas, freedom of choice, freedom of information and free enterprise, be faced with such draco-nian restrictions of these freedoms when it relates to our health and medical choices? Operation Cure All is part of a new set of rules being implemented to restrict and limit access to health information, food supplements, and natural therapies on a worldwide basis. | Robert Whitaker See book keywords and concepts | This story is revealed in FDA documents obtained through freedom of information requests.
The scientific background to the clinical trials of the atypical drugs is, in some ways, a confusing one. On the surface, the trials appeared to straightforwardly compare the atypicals to placebo and to haloperidol. But surface appearances can be deceiving. In the first place, there was no true placebo group in the trials. The same "abrupt withdrawal" design that put patients at great risk also produced a placebo group that could be expected to fare poorly. | Katharine Greider See book keywords and concepts | Two years and numerous interviews and freedom of information requests later, Hall reported in the New York Times Magazine, "The little white pill was easy to swallow and had to be taken only once a day. There was just one problem: it didn't work." Hall had discovered that in studies submitted to the FDA for approval of the drug, Claritin patients reported relatively modest improvements in symptoms. At the same time, as is often the case in studies of allergy medicines, those on placebo had done quite well. | | One company issued a freedom of information request that demanded "all records related to study design and methodology, study protocols), individual data for all study results and data, data sets, statistical calculations, methodologies, and analyses" as well as meeting minutes and correspondence from researchers, staff, or oversight committees. This, from an industry that likes to keep its own minutes and data tapes to itself. | Mike Adams, the Health Ranger See article keywords and concepts | I actually filed a freedom of information Act Request and got a Watergate tape -- March 23, 1971, we find Richard Nixon taking $3 million dollars cash in the White House. John Connelly walks in there afterwards and is recorded saying, "These men are militants, they're adamant, they're going to place a lot of money into political activities," and they had $3 million cash! You know what Nixon did the next day? | Ann Blake Tracy, Ph.D. See book keywords and concepts | | The following information is taken from the freedom of information Office, Center for Drug Evaluation and Research dated June 18, 1992 and contains only those reports filed on these drugs since 1985: (The big question is,"If all depressed people are at risk of suicide attempts", as Lilly puts it, why are there so few attempts made on the other drugs as compared to the ones on Prozac? As you can see the deaths linked to Prozac outnumber the others by an extraordinarily wide margin, even if the number of deaths associated with all the other drugs were combined. | Rhonda D. Orin See book keywords and concepts | Consider filing a freedom of information request, if necessary. At least you'll have the information for next year.
It can be very frustrating to get information about a health plan's fee schedule, but it's well worth the effort. And remember, you're not the only person looking for this information. So when you get a few answers, unless you're bound by some negotiated requirement of confidentiality, you may even consider posting them on the Internet. You may help someone else and, someday, they may find a way to help you.
3. DEDUCTIBLES
Deductibles seem very straightforward. | John Lauritsen See book keywords and concepts | Anyone who requests government documents under the freedom of information Act should be aware that he's in for a hard time. If the requested documents are completely innocuous, then the government will probably lose them through incompetence. If the documents are not innocuous, then dilatory tactics of every kind will be employed, on top of the usual incompetence. If the documents should eventually be found and released, they will be heavily censored. | Joseph Glenmullen, M.D. See book keywords and concepts | Those interested in the matter only learn about it by obtaining a copy of the transcript of the hearing from the FDA through the freedom of information Act.
Why were the stakes so high for Prozac, for the soon-to-be released Zoloft and Paxil, and for psychopharmacologists, the subspecialists of psychiatry who only prescribe pills and do not provide psychotherapy? Why was there so much concern about creating public doubt about the safety of psychiatric drugs? So much concern that even a warning was voted down? | John Lauritsen See book keywords and concepts | There can be no legal justification for this kind of censorship, and it is clearly in violation of the principles of the freedom of information Act. I have sent a letter of protest to the FDA, demanding to be given the complete and uncensored report.6 I shall now describe, by category, the major violations that were uncovered by Spitzig in her investigation of the Boston center. | | On 12 December 1991 I filed my request with the FDA's freedom of information Staff, asking for various documents pertaining to the multi-center Phase II AZT trials conducted in 1986. My requests comprised the "Establishment Inspection Report" on the Boston center, written by FDA investigator Patricia Spitzig, and two sets of minutes, written by Jackie Knight and Mary Gross. Three weeks after filing my request I got an acknowledgment. When I called the woman who sent it to me, she said that all three of my requests had been found, and I would get them soon. | | Take Duncan Campbell, for instance, a Left-wing journalist prominent in the freedom of information movement.... He demands freedom of speech for himself, but seeks to gag others. He is currently taking me to the Press Council for calling him a shirt-lifter. He says this term is offensive.
It was MEANT to be offensive. I find Campbell offensive. I wanted to offend him. It worked.
But it is his hypocrisy I find offensive, not his homosexuality. | | Another highly critical review of the Phase II trials was written by Joseph Sonnabend, "Review of AZT Multicenter Trial Data Obtained Under the freedom of information Act by Project Inform and ACT-UP", AIDS Forum, January 1988.
And then there is the matter of symptoms — both the symptoms that qualified for entry into the study and the symptoms that were interpreted as meaning that the subject had gotten sicker. The NTAID press release didn't list the symptoms in each category, and the NIAID spokeswoman didn't know what they were. | | There are many indications in FDA documents, released under the freedom of information Act, that sicker patients were placed in the Placebo group.5 For example, according to an FDA analyst: "Two patients (both ARC patients) died
5Lawrence R. Hauptman, Ph.D., "Statistical Review and Evaluation" of NDA 19-655. very early in the study, one at 10 days and one at 21 days. It is arguable that these patients were sick enough at entry that they should not have been included in the study." Both patients just happened to be in the placebo group. | Stephen Fried See book keywords and concepts | I called the FDA to find out what it had available on Floxin and Omniflox and was told I had to file a written freedom of information (FOI) request to get anything. In the United States much of the paperwork submitted on a drug becomes "public" under the Freedom of
Information Act when the product gets approved. That is how journalists, lawyers and competing drug companies get much of their information about drug products. | Kenny Ausubel See book keywords and concepts | We had to file twice through the freedom of information Act to get Hoxsey records from the FDA, which apparently still considered these documents a threat to national security. We also tracked down obscure private collections across the country and searched all public and court records. At the completion of the film, the National Library of Medicine requested our research as a donation to its archives.8
We did manage to find a surprising number of individual players from the Hoxsey drama still alive. | | I think we should have freedom of information and freedom of choice. It should be made available to the public, and then let them choose what route they're going to take. We're all adults in charge of our own destiny, and we should be allowed to go whatever route we think would be best for us. Of course I'm angry. I can't even put it into words. I keep writing letters trying to contact people. They should burn in hell for what they're doing to the people of the world. I think really we need anarchy in the streets. Then maybe we'll get something done. |
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