Mike Adams, the Health Ranger
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 My staff investigators continue to hear from fda employees who believe in their agency and ... want to do the right things, but experience intimidation, suppression and reassignments when they raise concerns about the integrity of the FDA's work."
Grassley and House Energy and Commerce Committee Chairman Joe Barton, R-Texas, requested an investigation by the Government Accountability Office (GAO) into the FDA's drug oversight practices after hearing complaints that the FDA was sluggish to pull harmful drugs -- like Vioxx -- off the market. |
Jeffrey M. Smith
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 Other fda employees sent an anonymous letter complaining of "fraud" and "conflict of interest" in relation to the drug's approval. They claimed, for example, that a Monsanto-re-searcher-turned-FDA-employee raised allowable levels of antibiotics in milk one-hundredfold, to pave the way for rbGH approval.23 And when Canadian government scientists analyzed how the FDA approved rbGH, they wrote that the "evaluation was largely a theoretical review taking the manufacturer's conclusions at face value. No details of the studies nor a critical analysis of the quality of the data was provided. |
Mike Adams, the Health Ranger
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 As a Morale Officer, your job will be to keep all fda employees in line as a way of boosting overall morale and work efficiency. It's good for the economy!
To enforce proper morale among fda employees, especially those involved in drug safety operations, you will be granted insider access to top-secret FDA technologies currently under development, including our "Graham buster" verbal silencer (patents pending) and a building-wide subliminal program broadcast system. "All profitable drugs are safe... All profitable drugs are safe..."
Salary: $85,000 plus free unlimited cable television. |
Dr. Timothy Scott
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 The Unique Problem of Evaluating Mind Drugs
Now let's return to the FDA and the drug approval process, and let's imagine that every clinical trial was registered, that drug manufacturers did not provide any of the funding for FDA employees' salaries and did not give grants, honoraria and consulting fees to any of those sitting on FDA advisory panels. Could the FDA then make wholly objective judgments about the drugs they are asked to approve? The FDA and its expert committees make their decisions based primarily on the results of the research they examine. |
Mike Adams, the Health Ranger
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 It is only with the threat of criminal prosecution that the remaining fda employees will come to their senses and start doing the jobs they were supposed to do in the first place, which is to regulate the pharmaceutical industry, not protect it and promote it.
At the same time, it is important that this new Department of Internal Affairs, or whatever it ends up being called, is staffed with people who do not have financial ties to the pharmaceutical companies themselves. Because that's the problem with the FDA today. |
Mike Adams, the Health Ranger
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| To enforce proper morale among fda employees, especially those involved in drug safety operations, you will be granted insider access to top-secret FDA technologies currently under development, including our "Graham buster" verbal silencer (patents pending) and a building-wide subliminal program broadcast system. "All profitable drugs are safe... All profitable drugs are safe..."
Salary: $85,000 plus free unlimited cable television.
Canada Basher
Do you share our hatred for those snooty Socialist Canadians? |
Dr. Timothy Scott
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| But for the average American, it is hard to believe that the research studies used to get these drugs approved were purposely designed to get the desired results, that the FDA drug approval process relies on the studies provided to them by the drug companies, not by independent or government-sponsored research, or that some fda employees involved in approving these drugs have been paid huge sums by the very drug companies they are supposed to be regulating. |
Mike Adams, the Health Ranger
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 The vast majority of fda employees -- especially in the drug safety office -- actually agree with most of this and they back the idea of radical FDA reform that would take the bureaucrats out of power.)
There is apparently no limit to the number of people that a drug can kill in order for the FDA to consider it to be dangerous. You have to wonder, with this class of drugs killing more Americans than were killed in the Vietnam war and killing vastly more Americans than have ever been killed by terrorists, at what point does the FDA become more dangerous than terrorism? |
Mike Adams
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 This resulted in the conviction of four fda employees and, most significantly, loss of public trust.
New England Journal of Medicine report reveals that health care information companies have been purchasing prescription records from pharmacies and other sources since the early 1990s. These companies then compile that data with individual physicians' information licensed from the American Medical Association and sell those physicians' prescribing data to pharmaceutical companies, compromising patient privacy in the process. |
| My staff investigators continue to hear from fda employees who believe in their agency and ... want to do the right things, but experience intimidation, suppression and reassignments when they raise concerns about the integrity of the FDA's work.
-U.S. Senator Charles Grassley, R-IOWA
The results of the experiment led to the conclusion that "... [direct-to-consumer] advertisement-driven requests (along with general requests) dramatically boost prescribing. |
| Generalizations aren't always right
The next criticism that's likely to be leveled against this book is that I make huge, sweeping generalizations about pharmaceutical companies, doctors, fda employees, and so on. Even though it is true that I use many generalizations throughout the book, in no way do I intend to mean that such statements apply to every single individual in that group. For example, when I say that doctors are nutritionally illiterate, I don't mean every single doctor practicing medicine today is ignorant about nutrition. There are a few who actually have studied nutrition. |
Kevin Trudeau
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 These two efforts indeed revealed misconduct by Simmons as follows:
1) Simmons is held in low esteem by the vast majority of the Cincinnati office fda employees, and many regard him as an unfit supervisor and public official.
2) Many of Simmons' employees were outraged by the Nancy's Bread atrocity and indicated that it was widely held that the actions taken at Simmons' direction were excessive, unnecessary and a waste of taxpayers' money. |
Jeffrey M. Smith
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 Burroughs acknowledges that the science in the studies was well outside the expertise of fda employees. Rather than admit that they were in over their heads, Burroughs says, "the Center decided to cover up inappropriate studies and decisions." Officials "suppressed and manipulated data to cover up their own ignorance and incompetence."
As with other drug approvals, the FDA did not carry out its own tests on rbGH. Rather, the biotech industry performed the tests, summarized the data and presented it to FDA reviewers. |
Ralph W. Moss, Ph.D.
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 In particular, the auditing arm of Congress found that 150 fda employees were owners of stock in twenty-seven FDA-regulated companies. In addition, 203 fda employees simply had not filed financial disclosure statements, while several had ignored FDA requests that they divest themselves of their personal investments in drug companies (New York Times, January 20, 1976).
Improper and illegal stockholding is one of the ways in which the drug industry may influence policy decision making at FDA. |
Mike Adams, the Health Ranger
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 Quite clearly, Big Pharma is a highly corrupt industry, and it is backed and promoted by a federal agency that needs to be wiped clean and rebuilt from scratch (along with a new office of Internal Affairs that would investigate fda employees for precisely these sort of crimes).
Regardless of what happens next, it's evidence that the public trust in the FDA has been destroyed. "...the most important legacy of this episode," writes Dr. Horton, "is the continued erosion of trust that public-health institutions will suffer. |
Marcia Angell, M.D.
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 Since the act was passed, about a thousand new fda employees have been added to handle new drug applications, and another five hundred are called for in the 2002 renewal. Altogether, these industry-paid employees constitute more than half of the FDA staff involved in approving drugs.17 Yet the faster the approval process, the more likely it is that dangerous drugs will reach the market. Indeed, over the decade since the Prescription Drug User Fee Act was enacted, a record thirteen prescription drugs have had to be withdrawn from the market—after they caused hundreds of deaths. |
Mike Adams, the Health Ranger
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| These actions represent a pattern of criminal behavior on the part of fda employees and drug company executives. Promoting these toxic drugs, distorting the clinical trials, and burying the negative evidence are criminal actions and should be treated as such. In a sane world, the FBI would march into the FDA offices tomorrow and arrest these white-collar felons for the crimes they have committed. Executives at Merck should do prison time -- plus pay billions in fines -- for the pain, suffering and death they have unleashed upon the population. |
Mike Adams, the Health Ranger
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 In one case, a bus load of American senior citizens was detained and searched by fda employees for drugs. Not illegal drugs, mind you, but prescription drugs.)
8. All felons serving time in prison would be set free. Why? The FDA would claim that no particular felon could be considered dangerous, since all felons are dangerous. (Explanation: The FDA defends the safety of obviously dangerous drugs by explaining that all drugs are dangerous. Therefore, the thinking goes, you can't single out any particular drug as being especially dangerous, so they should all remain on the market. |
Marion Nestle
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 The GAO reviewed more than 40,000 pages of documents, interviewed 54 people, and evaluated the financial disclosures and conflict-of-interest statements of all fda employees involved in the rBGH approval. Although the GAO concluded "there were no conflicting financial interests," its report raised discomfiting questions. One FDA employee, Dr. Margaret Miller, worked for Monsanto from 1985 to 1989 as a laboratory supervisor responsible for evaluating tests that measured rBGH and IGF-i levels in cow blood, tissues, and milk. |
Elaine Feuer
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 KESSLER'S REIGN OF TERROR
David Kessler became FDA Commissioner shortly after the 1989 generic drug scandal, which involved the conviction of four fda employees for taking illegal bribes from pharmaceutical companies. In a 1994 "60 Minutes" interview, Kessler explained, "We had to win back the trust of the American people."
Kessler seems to have planned his political career early on. He studied for a medical and law degree simultaneously, followed by a pediatrics residency at night while working on food and drug legislation in Senator Orrin Hatch's Capitol Hill office during the day. |
| It is thus not surprising that in 1975, the General Accounting Office Study of FDA Officials reported that 150 FDA officials owned stocks in the companies they were supposed to be regulating, or that allegations of insider-trading of pharmaceutical stocks by fda employees have been reported to the U.S. Securities and Exchange Commission.
DRUGS VERSUS NUTRIENTS
Scientists and government regulators refuse to recognize the differences between drugs and nutrients:
Drugs are foreign to the body, and the body begins to detoxify and eliminate them immediately after they are ingested. |
Ralph W. Moss, Ph.D.
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| It anticipated that several fda employees and six drug companies would be indicted (ibid.). This may not have directly affected FDA's decision, but it certainly reinforces the impression of an agency under siege.
In any case, Dr. Burzynski has gotten his foot in the door. Antineoplastons still represent a powerful challenge to toxic chemotherapy. It remains to be seen if the FDA, or anyone else, will be able to slam that door shut again.
1996 Update: The focus of the cancer alternative controversy has increasingly become centered on Dr. Burzynski and his treatment. |
| In addition, 203 fda employees simply had not filed financial disclosure statements, while several had ignored FDA requests that they divest themselves of their personal investments in drug companies (New York Times, January 20, 1976).
Improper and illegal stockholding is one of the ways in which the drug industry may influence policy decision making at FDA. Another is the "revolving door"—the process by which government officials are recruited by industry or sent from industrial positions into regulatory posts. |
Stephen Fried
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 By the late 1980s the FDA was embroiled in a generic drug scandal, much of which was played out in the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, chaired by Michigan Democrat John Dingell. fda employees were accused (and were later convicted) of taking bribes to push through the applications of certain generic firms faster than others; the generic business is based on speed, and whichever firm gets the first low-priced generic out there has a big advantage. At the same time, several firms were found to be making substandard generic medicines. |
| There were also quite a few disgruntled former fda employees who had been pushed out as deadwood in an attempt to streamline the agency. Together, they attacked Kessler relentlessly, demanding a privatized, defanged regulatory apparatus that would basically trust industry to police itself and allow market forces to root out substandard products. They were calling for a moratorium on any new government regulations, no matter how necessary they might be.
The whole situation was painful to watch. |
Elaine Feuer
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| Within three weeks, the FDA began investigating his clinic: fda employees checked the dumpster periodically for evidence of vitamin products with foreign labels, and visited the clinic posing as patients.
Nothing could have prepared Dr. Wright for the morning of 6 May 1992 when twelve FDA agents in flak vests and ten King County policemen knocked down the doors of his Tahoma Clinic in an armed
"commando-style" raid. Bursting into the clinic from three directions, police officers and FDA agents pointed guns at the staff, ordering, "Get your hands up! |
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