Health Supreme by Sepp Hasslberger

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June 10, 2003

The FDA and the drug companies are getting awfully cozy...

With virtually no public debate, Congress has passed a law that dramatically increases the FDA's dependence on large drug companies for its funding. It's an expansion of a law passed in 1992 intended to speed up the approval process for new AIDS medications.

But this time the emergency was of a different sort. The FDA was running out of money to keep its new employees. Going before Congress and asking for more money amidst a war on terrorism was going to be a tough fight. And the drug companies offered an easier solution.

The Food and Drug Administration is at it again. It has recently become dependent on the multibillion-dollar drug industry that it's supposed to be policing.

With virtually no public debate, Congress has passed a law that dramatically increases the FDA's dependence on large drug companies for its funding. It's an expansion of a law passed in 1992 intended to speed up the approval process for new AIDS medications.

But this time the emergency was of a different sort. The FDA was running out of money to keep its new employees. Going before Congress and asking for more money amidst a war on terrorism was going to be a tough fight. And the drug companies offered an easier solution.

Negotiate a deal in secret, attach it to the widely popular bioterrorism bill, and the drug companies would pay for the FDA's new employees and more.

Article published on

The FDA and the drug companies are getting awfully cozy...

The details of discussions leading to this "solution" were never made public. According to a recent article in the Washington Post, the program was created in private meetings between the industry and the FDA. It was never debated or voted on in either chamber before going to the negotiators. And it's moving forward before a General Accounting Office review of the current program can be finished and made public.

According to the Post, the user fees from pharmaceutical and biotechnology companies would add almost 500 employees to the FDA centers that review proposed new drugs. That would bring the FDA workforce funded by the drug industry to at least 1530. And that would constitute more than 55 percent of the FDA staff involved in reviewing drug applications.

"What was the price of the FDA sellout? $1.2 billion over the next five years.

The report that's due from the GAO is supposed to tell us how well the public has faired under the current smaller program of drug company support for the FDA's drug approval process. But the truth probably won't come out:

Over the last 10 years, the FDA has approved nine drugs that proved to have deadly side effects.

The Journal of the American Medical Association estimates that 125,000 Americans die each year from the side effects of FDA approved drugs.

The FDA approved the sale of Baycol (later found to cause fatal rhabdomyolysis) and continues to approve the use of other "" to lower cholesterol that are also associated with this deadly side effect.

Beefed up by drug company funds, the FDA has aggressively suppressed natural alternatives to drugs. Red yeast rice, for example, known to be a safe and effective alternative to cholesterol-lowering drugs, was banned by the FDA
in 2001.

The next time you are offered a drug, ask questions. Why do I have to take it? If I take it, what's the plan to get me back off? Are there alternatives? What are the side effects? How can I get more information?

Most importantly, keep yourself healthy. If you need help to get back to good health, choose as natural a therapy as possible. You will be less vulnerable to these dangerous products of a questionable approval process.

Addition (11 June 2003)

There has been some discussion over whether red yeast rice (it's actually called red rice yeast) was indeed banned in the United States or not, as one expert from industry maintains. The following is a quote from a lengthy e-mail which I post here because it clearly explains what did happen and why, with red rice yeast.

Under DSHEA an enormous number of botanicals, nutrients and special natural agents were grandfathered (October, 1994) if they were in commerce. However, after DSHEA went into law regulations were promulgated by the FDA according to Congresses' desire, such as 21 CFR 190.6, which deals with "New Dietary Ingredients." If you read this statute you will see that it states that "a dietary supplement that contains a new dietary ingredient shall be deemed adulterated unless it meets one of two requirements. One requirement is that `the dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.' The alternative requirement is that: 'There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.' "

Taking a natural product such as red rice yeast and standardizing it around a percentage of statins would make this grandfathered product a new dietary ingredient (NDI). As a NDI anyone offering this standardized red rice yeast would have to send to FDA a submission BEFORE going to market documenting its safety as noted above. That was not done in the case of the standardized red rice yeast that was sold for its statin content after the passage of DSHEA, and whose marketers presented marketing material that the US Courts affirmed was presented as a drug, not a dietary supplement, because the marketer made drug claims for the product and did not submit safety data under a NDI without first getting permission as required by law.

There is nothing to preclude or limit any company in the United States in selling red rice yeast, as long as it is not standardized around a particular percentage of statins. If anyone wants to do the latter, the law does not prohibit doing so. It only requires that adequate safety data be presented to the FDA 75-days before going to market. If the data is insufficient or inadequate to support a claim of safety for the product, then the agency specifies what the deficiency is in the submission and awaits amended information to meet those deficiencies. Once they have been met, the company is free to proceed to market with the product. By the way, gathering such data does not cost millions, or even hundreds of thousands of dollars. We have worked on many such NDI's and sometimes have supplied the agency with the information at hand, including traditional usage data, and had it allowed to go to market. At other times, toxicological studies were needed because there was no other evidence of safety, and when these were done, they were also adequate according to the agency for the intended use designated for the product. Knowing how these NDI submissions should be prepared requires skill, nevertheless.

The importance of this approach, which Congress voted for in 1994 makes sense. For example, if you take a botanical found in nature, it will have some variations in its pharmacoactive principles. If a standardized extract of that botanical was in commerce at the time of the passage of DSHEA, it is allowed and protected as a grandfathered product. If after passage of DSHEA you desire to create and market an entirely new botanical extract with say significantly higher percentages of the botanical's actives than before, and which of course is not found in nature, and of course also could not have traditional usage as evidence of safety, then it would have to go through the NDI submission process.

See also:

March 2005 - Medscape: U.S. Senator Says FDA Too Cozy With Drugmakers It Regulates
WASHINGTON (Reuters Health) Mar 10 - The U.S. Food and Drug Administration has grown too close to the drug companies it regulates, raising questions about whether its acting director should be given a permanent job, a top Republican Senator said Thursday.

The Role of the FDA
The Claim There is "No Scientific Evidence" for Alternative Treatments...

The Truth About the Drug Companies
The Once-Solid Foundations Of The Big Pharma Colossus Are Shaking says Marcia Angell, a former editor of the New England Journal Of Medicine in her upcoming book...

Drug safety has its own side effects - By Al Lewis - Denver Post Business Columnist
What you hear before taking prescription drugs versus what you learn afterward may make you feel like a lab rat.
Before: Bayer's Baycol lowers cholesterol. After: But it also may cause muscle and kidney damage.
Before: Vioxx stops arthritis pain. After: It may cause strokes and heart attacks.
Before: Antidepressants will curb your kid's emotional problems. After: They also may promote overwhelming suicidal urges. But, hey, at least the kid won't be depressed anymore.


posted by Sepp Hasslberger on Tuesday June 10 2003
updated on Tuesday December 7 2010

URL of this article:


Related Articles

In the FDA we trust?
..."Last Daily Dose, I spilled a story that many in the medical mainstream (and the drug companies they're slaves to) would no doubt love to keep under wraps: A possible link between antidepressant drugs and suicide in depressed juveniles. But the ironic part of the story was that the red flag on this potential link is being hoisted not by a marquis medical journal, some big-name investigative reporter, or even... [read more]
January 03, 2004 - Chris Gupta

FDA - Monsanto: dangerous relations
Monsanto Corporation has been aggressively developing and pushing genetically modified seeds and their logical toxic counterpart, Roundup herbicide, now less damaging for some superweeds that have learned to survive the toxic onslaught by accepting genes from their GM cousins. The company has also developed a widely sold sweetener - Aspartame - which, has been called toxic by a number of researchers and according to some, is implicated in an epidemic... [read more]
November 30, 2003 - Sepp Hasslberger

FDA Shenanigans
FDA Shenanigans ..."Of course, what we're witnessing in all of this is some of the most cynical cronyism you can imagine. Congressmen, regulators, and lobbyists accommodate one another as they please, but when it comes to the needs of citizens, or cities and states struggling in the current economic climate, we're given restrictions and left to our own devices. A couple of centuries ago a certain tea party in Boston... [read more]
December 19, 2003 - Chris Gupta

FDA Misses Risky Business
The FDA is charged with controlling the safety and efficacy of drugs before marketing, but judging from available statistics, pharmaceutical drugs have become more of a problem than a help in achieving good health. John Hammell, president of the International Advocates For Health Freedom contends the FDA is not able to independently evaluate possible dangers of new pharmaceuticals to be approved. Researchers of the agency are often pressured into changing... [read more]
November 15, 2003 - Sepp Hasslberger

Neurontin Suicides: FDA Still Turning A Deaf Ear Charges Rep Hinchey
Maurice Hinchey, Representative of the 22nd Congressional District of New York is calling for a thorough examination of the link between Neurontin, an anti-epilepsy drug that has been made a block-buster seller by off-label marketing, and suicides. The lawmaker blasted the FDA's failure to act in this matter in a letter to FDA acting Commissioner Lester Crawford dated 7 September 2004. According to a report by the Alliance for Human... [read more]
October 11, 2004 - Sepp Hasslberger

Vioxx Shows: FDA Unable To Protect Public From Deadly Medical Drugs
According to recent congressional testimony, "the FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenceless," said David Graham, associate director of the agency's Office of Drug Safety. The quote is from an article published in South Africa, titled Doctor: FDA is too cosy with drug firms. The FDA is the national food and medicines regulatory agency of the US but it has been... [read more]
November 23, 2004 - Sepp Hasslberger




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