Jeffrey M. Smith
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 There is evidence of heavy metals in GM soybean oil.
3. fda scientists also said that toxins in GM feed might concentrate in milk or meat.
4. GM DNA fragments were found in milk.
5. While very little research has been done on this, small amounts of Roundup may be retained in the body of animals and affect sperm quality.
6.
The overuse of Roundup and Liberty herbicides on GM crops magnifies these types of risks. |
Kevin Trudeau
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 A previously unpublished internal survey of fda scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs. The internal secret survey showed that the FDA does not adequately monitor the safety of prescription drugs once they are on the market, and the majority of fda scientists do not believe that the labeling decisions adequately address key safety concern. It also showed that an alarming percentage of fda scientists themselves were not confident that the final decisions adequately addressed the safety of drugs. |
Mike Adams, the Health Ranger
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 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, the Health Ranger
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 David Graham and other fda scientists who have gone to Congress as whistleblowers to save American lives, it was an "acid-test" vote on who is truly on Big Pharma's payroll. Click here to see how your senators voted.
The other key vote came on the Durbin amendment #1034. This amendment sought to prevent Big Pharma from placing "experts" on FDA Advisory Committees -- which make the final decisions on the safety of drugs. |
Dr. Timothy Scott
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 Today, close personal friendships are commonly seen among the fda scientists and the drug company scientists assigned to getting a company's new drug approved. Informal contact occurs daily, and formal meetings with drug company representatives occur over one thousand times a year.51
FDA scientists and occasionally FDA administrators admit to the pressure they feel to approve drugs and to do so quickly. |
Mike Adams
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 A few of the more disturbing reports from the fda scientists include:
18.4% have been asked to exclude or alter their information or conclusions in FDA reports for non-scientific reasons
40% of the fda scientists fear retaliation for voicing safety concerns in public
** 61% knew of cases where political appointees inappropriately injected themselves into FDA determinations or actions
You can read the full press release, include a suggested course of action, at www.UCSUSA.org.
"Before approving a drug, the FDA does no research on that drug. |
Kevin Trudeau
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 Three fda scientists advise against approval of Nu-traSweet and aspartame stating on the record that Searle tests are unreliable and are not adequate to determine the safely of aspartame. These fda scientists believe that aspartame is responsible for brain tumors and other major health concerns.
July 15, 1981. In one of his first official acts, the new FE'A commissioner actually does the unthinkable; he personally overrules the Public Board of Inquiry's findings, ignores the recommendations of his own internal FDA team, and he personally approves NutraSweet and aspartame!
October 15,1982. |
Jeffrey M. Smith
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| Internal documents show that fda scientists were concerned. They repeatedly asked Calgene to provide additional data in order to resolve what they regarded as outstanding safety questions. The director of FDA's Office of Special Research Skills wrote that the tomatoes did not demonstrate a "reasonable certainty of no harm,"11 which is the normal standard of safely. The Additives Evaluation Branch agreed that "unresolved questions still remain,"12 and the staff pathologist stated, "In the absence of adequate explanations by Calgene, the issues raised by the Pathology Branch ... |
| They then spiked the milk with powdered hormone—146 times the naturally occurring levels—heated that 120 times longer than normal, and were then able to destroy 90% of the hormone.221 fda scientists reported that 90% of the hormone was destroyed during pasteurization.222
Documents revealed that in order to show that rbGH injections did not interfere with fertility, industry researchers allegedly added cows to the study that were pregnant prior to injection. |
| Case Study: Irregularities marred evaluations of Monsanto's GM drug, recombinant bovine growth hormone (rbGH)
Several claims made by fda scientists in defense of rbGH have not held up under scrutiny. For example, they said that bovine growth hormone does not increase substantially in milk from treated cows. The study they cited, however, shows a 26% increase in the hormone. Furthermore, those researchers injected cows with only a 10.6 mg daily dose of rbGH compared to the normal 500 mg bi-weekly dose used by farmers. |
| In July 2006, the Union of Concerned Scientists and Public Employees for Environmental Responsibility distributed a 38-question survey to nearly 6,000 fda scientists. Nearly 1,000 scientists responded, disclosing that 61% knew of cases in which "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions," and 60% knew of cases "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal, or modification of FDA determinations or actions. |
| For instance, fda scientists at the Division of Food Chemistry and Technology and the Division of Contaminants Chemistry called for mandatory review, stating that 'every transformant should be evaluated before it enters the marketplace.'10 Dr. Samuel Shibko, Director of the Division of Toxi-cological Review and Evaluation, recommended 'a limited traditional toxicological study with the edible part of the plant,' as well as 'limited studies in humans' and in vitro geno-toxicity tests. |
Too Profitable to CureBrent Hoadley, Ph.D.
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| The fda scientists who evaluate applications are handicapped. They must use data submitted by the company seeking approval. While they can ask for additional information, or even require further trials, they cannot independently verify the data —the FDA is not empowered to conduct its own trials or tests. FDA officials rely on the corporation seeking approval to submit valid, truthful, pertinent, and complete data.
The recent Enron and WorldCom debacles have shown corporations' willingness to manipulate information in the quest for profits. |
Mike Adams, the Health Ranger
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 A full 90 percent of fda scientists are actually dedicated, caring people who applaud the actions of whistleblowers like Dr. David Graham (also an FDA drug safety scientist).
I've met people from all of these companies over the years, and that includes people from Merck and Eli Lilly and even the FDA, and I've never run across a person that I would characterize as evil or overtly destructive. The people that I've met have always been positive people, even while they work for organizations that I believe are ultimately causing untold human suffering and creating a negative impact on society. |
Peter Rost
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 The survey also revealed that 18 percent of fda scientists had been "pressured to approve or recommend approval for a [new drug application] despite reservations about the safety, efficacy, or quality of the drug."
36 percent of the scientists in the survey said they were only somewhat confident or not confident at all in the FDA's decisions regarding drug safety. Finally, when it came to drug effectiveness, 22 percent of scientists said they were only somewhat confident or not confident at all in the agency's decisions. |
Mike Adams, the Health Ranger
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 Plus, there's the FOIA document that surfaced, showing that two-thirds of the FDA's own scientists don't think the agency can protect the safety of Americans, and nearly 1/5th of fda scientists say they have been pressured to approve a drug they thought was unsafe.
In light of the recent drug safety scrutiny, the FDA is treading lightly. But don't worry, as soon as all this scrutiny blows over, they'll get right back to rubber-stamping dangerous drugs and padding the profits of Big Pharma. That is, if serious FDA reform doesn't dismantle the agency first. |
Ray Moynihan and Alan Cassels
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 By then, even though the drug had been on the market for around one year and then off the market for eighteen months, there were over two hundred reports of serious complications and seven reports of deaths, deemed by fda scientists as probably linked to the drug. Given that only a tiny proportion of serious complications are ever reported to the FDA, it was possible that anywhere between two thousand and twenty thousand women had been made seriously ill, and perhaps scores had died due to complications associated with a drug whose benefits were the subject of serious scientific doubt. |
| For him that meeting sent a powerful signal to the young fda scientists present, and it was symptomatic of a much bigger malaise. He felt it was sending the message that "we don't argue with drug companies; we listen to their distortions and omissions of evidence and we do nothing about it."13 One of the senior officers at the meeting, Dr. Janet Woodcock, directly rejected Stolley's view. "The FDA wanted to determine a course forward, not to argue the details," she said. |
Greg Critser
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 Reports from patients, hospitals, and physicians indicated that Lotronex caused ischemic colitis — constipation that was so profound as to become life-threatening — and led several fda scientists to recommend that the drug be recalled. But Glaxo believed that the side effects could be ameliorated with a recommendation for increased physician monitoring. In the midsummer of 2000, the company sent a team of "reg affairs" people to the FDA to make their case. They prevailed. Instead of recalling the drug, the FDA simply issued a medication management guideline. |
| Despite the guideline's failure to address the FDA scientists' concerns — that "pain" as a symptom that something was going wrong was a symptom that came too late in the potentially fatal ischemic colitis process to do anyone any good — Lotronex would stay on the market.
Three months later, after five patients died and dozens more were admitted to emergency rooms for ruptured bowels, Glaxo withdrew the drug from the market.
Yet right away its reg affairs people began working on a way to get it back on the market, which they succeeded in doing by mid-2002. |
Mike Adams, the Health Ranger
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 It is time to hold FDA decision makers accountable for the chemical warfare they have waged against the American public, and at the same time set free the honest fda scientists so they can tell the truth without fear of being silenced.
Scientific fraud is routine at the FDA
Because right now, many of those scientists are being routinely intimidated to alter their conclusions in order to fit the political agenda of top FDA officials. A shocking 18.4 percent of scientists surveyed report that they "... |
Kevin Trudeau
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| One of the first fda scientists to review the aspartame data states that "The information provided is inadequate to permit an evaluation of the potential toxicity of aspartame." She says in her report that in order to be certain that aspartame is safe further clinical tests are needed.
July 26, 1974. Miraculously, the FDA grants aspartame approval for restricted use in dry foods. To this day no one knows how or why this approval was granted since the data was so inconclusive and suggested major negative side effects.
August 1974. |
| These fda scientists believe that aspartame is responsible for brain tumors and other major health concerns.
July 15, 1981. In one of his first official acts, the new FE'A commissioner actually does the unthinkable; he personally overrules the Public Board of Inquiry's findings, ignores the recommendations of his own internal FDA team, and he personally approves NutraSweet and aspartame!
October 15,1982. Searle files a petition to have aspartame approved as a sweetener in carbonated beverages and other liquids. |
Mike Adams
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| From a 2002 Human and Health Services survey asking fda scientists questions about the agency:
Of those who responded, 66 percent said they lacked confidence in the agency's ability to "adequately monitor the safety of prescription drugs once they are on the market."
*" Only 12 percent of the scientists surveyed were completely confident that the FDA labeling decisions adequately address safety concerns.
<•* Nearly one in five scientists, 18 percent, said that they have "been pressured to approve or recommend approval" for drugs that they thought weren't proven safe. |
| FDA reports for non-scientific reasons
40% of the fda scientists fear retaliation for voicing safety concerns in public
** 61% knew of cases where political appointees inappropriately injected themselves into FDA determinations or actions
You can read the full press release, include a suggested course of action, at www.UCSUSA.org.
"Before approving a drug, the FDA does no research on that drug. Instead, the FDA evaluates studies handed to them by the pharmaceutical company that created the drug. |
| FDA scientists fear retaliation for voicing safety concerns in public. ¦ ¦
-Union of Concerned Scientists Survey, July 2006
The Ephedra ban: FDA tyranny at its worst
After reviewing the history of FDA action on Rezulin, it is worthwhile to examine the agency's contrasting actions on Ephedra. As you read this, ask yourself: Is the FDA really interested in protecting the public, or does it seem to act out of a different, hidden agenda?
Ephedra is an herb that's been used in Chinese medicine for more than 5,000 years. |
Kevin Trudeau
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| The internal secret survey showed that the FDA does not adequately monitor the safety of prescription drugs once they are on the market, and the majority of fda scientists do not believe that the labeling decisions adequately address key safety concern. It also showed that an alarming percentage of fda scientists themselves were not confident that the final decisions adequately addressed the safety of drugs. |
Dr. Timothy Scott
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| But human nature is such that when a neighbor invites us over for a meal, we aren't apt to leave until we say, "Well, we will be sure and have you over soon." fda scientists know who pays for their meals. That was evident when Dr. Woodcock noted the discomfort she feels when she considers rejecting a company's drug. As she noted, it might mean an immediate loss of $150 million or more in development costs.53 Of course, $150 million is nothing compared to the potential loss to the industry that could result if the FDA declared antidepressants and antipsychotics unsafe. |
Mike Adams, the Health Ranger
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| In this environment of such scientific fraud, reported first-hand by fda scientists, to imagine that our system of drug approvals has anything to do with "evidence-based medicine" is nothing short of preposterous. All the billions of dollars in advertising, propaganda, donations to politicians and bribery of doctors can't cover up the sobering truth: The drug industry today is a massive criminal enterprise operating in broad daylight, and the FDA is its chief enforcer. |
| David Graham and other key fda scientists would be more than willing to testify at such a trial, if the nation could ever find the courage to subject the FDA to the scrutiny of real justice.
Personally, I don't understand why Americans continue to tolerate tyranny in medicine. They witness the events of September 11 and rally for war on somebody -- anybody -- but when our own drug companies kill a hundred times as many Americans right here at home, all they do is sign up in droves for the latest Medicare discount drug sham. |
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