FDA BS…

Please visit this page to read the entire article FDA VIOLATION OF THE RULE OF LAW [1] By Jonathan W. Emord

I meant to just copy out parts that were interesting….but…that was pretty much the whole article. :/

The FDA is an executive branch agency, the beneficiary of vast legislative powers delegated to it by Congress. It is also the repository of powers not delegated by Congress that FDA has usurped beyond the limits of its enabling statute throughout its 68 year history. The Commissioner of FDA sits at the pleasure of the President. The FDA is one of the largest and most powerful federal bureaucracies. It regulates over $1 trillion dollars of goods. The products under its jurisdiction account for 25 cents of every dollar spent by American consumers. FDA has approximately ten thousand employees and 26 district offices across the United States. The United States Attorneys and federal marshals are at its disposal and can obtain search and seizure warrants to be exercised without any advance notice against any company that sells a food, dietary supplement, drug, or medical device in the United States.

From 1787 until 1937, the constitutional law of this country prohibited administrators from possessing combined legislative, executive, and judicial powers, but for the last 69 years, the Separation of Powers doctrine has been largely abandoned in favor of oligarchic rule by the independent regulatory commissions. That rule has produced rights violations, massive transfers of wealth from private to public hands, government protectionism for industry leaders over new market entrants, vast corruption, and explosive growth in the size and scope of the federal government. The independent regulatory commissions, and the FDA in particular, are destroying free enterprise and individual liberty in America.

Federal drug regulation was fairly non-existent till 1937. Massengill reformulates sulfa drug into liquid form that now included DIEthylene glycol (ANTI-FREEZE). 107 children DIE. Roosevelt administration call for adoption of Food, Drug, and Cosmetic Act of 1938. Companies now have to submit tests on safety and recommended dosage….called NDAs (New Drug Applications). NOTE: NDAs were AUTOMATICALLY APPROVED AFTER 60 DAYS, UNLESS FDA determined testing ‘insufficient’.

Before 1962 FDA regulated drug safety, but not drug efficacy.

1961: Thousands of deformed newborns appear across Europe. Victims of the sedative THALIDOMINE.

1962: FDA powers expand (1962 Act). Unlike the 1938 Act were drugs were automatically passed unless the FDA “acted” to deny them. The new 1962 Act drugs were now automatically DENIED, unless the FDA acted to pass them. The previous 60 day  approval process, is changed to 6 months (or more). Cost from discovery to approval rise from a few million dollars to $1.6 billion per drug. 1962 Act also transfers drug advertising from FTC (Federal Trade Commission) to FDA.  Same year, FDA acquires vast new powers to regulate drugs, and begins to counter the (competitive) THREAT of dietary supplements (eg: vitamins and minerals). Without the slightest grant of legislative authority from congress…FDA publishes regulations, setting a minimum and maximum potency level for all dietary supplements! The regulations were later withdrawn after strong public protest! But….can easily see that a government protected monopoly is already in place, and acting in it’s own best interests.

1966: FDA sneaks back on the subject, and again…without any grant of legislative authority, they publish a RULE that ANY dietary supplement exceeding 150% of the RDA for a vitamin or mineral would be AUTOMATICALLY regulated (by them) as a DRUG! Of course, that meant that once a potent supplement is declared a drug….the FDA then had the power to make it ILLEGAL for sale in the US. Dietary Supplement Industry challenges rule in federal court + public outrage = On April. 22, 1976 (after intense public lobbying against the rule) Senator William Proxmire introduces an amendment to the Heart and Lung Act, and the amended Act becomes LAW! Prohibits the FDA from classifying a vitamin or mineral as a drug based on POTENCY.

1970: FDA TRIES AGAIN! Claiming vitamins on a case by case basis were adulterated based on potency. Federal courts refused to cooperate. FDA then declares supplements be unapproved FOOD ADDITIVES. Under the FDCA “no food additive may be sold unless the manufacture PROVES is safe to the FDAs satisfaction”! An attempt to make things so difficult, that it would drive supplement manufacturers out of business. The FDAs basis, was that the “gelatin” capsule containing the supplement was considered a “food”. Courts called this approach “nonsensical”.

1980: FDA returns, this time proposing an “over the counter” drug monograph for vitamins and minerals, declaring potency above RDA, fall within the scope of the monograph. Public opposition kills this proposal.

FDA repeatedly working to exceed it’s limits of statutory authority, and work to protect durg companies from any competition. Many times coming at the cost of human life. Courts have occasionally held FDAs actions unlawful. FDA either ignores court rulings, or adopts new rules and policies to achieve it’s desires.

1987: FDA supervisor Charles Chang received “gifts” from drug company lobbyists in exchange for making sure their drugs were assigned to subordinates Chang knew to be quick reviewers. Chang manipulated the approval schedule to the advantage of those who gave him bribes. Department of Justice and FBI uncover corrupt practices. Chang lands in federal prison, along with 42 others, and 10 companies being convicted on charges of fraud and corruption. Scandal shakes congress and public. FDA commissioner Frank Young resigns 1989. FDA Commissioner David Kessler turns on Barr Laboratories (that had informed FBI of corruption), calling for repeated inspections of their facilities, and delayed approvals for their drugs. Just another way that their competitive bureaucracy hurts people (waiting on drug approval).

1997: REZULIN is approved by the FDA for treatment of type 2 diabetes over objections of several FDA officers, claiming that it SIGNIFICANTLY increased liver enzyme levels to the point of failure and death. Robert Misbin (FDA Officer) resigns claiming that “politics reigned over science”. He knew people would die from the lethal approval, and didn’t want to be around for what was coming…He stated to Congress…”I don’t want to sit idly by while bodies pile up”. FDA retaliates against Misbin with his first negative job performance review, and an internal investigation against him. Doctors involved in the testing of Rezulin (Gueriguian and Lutwak) retire from the FDA, rather then face investigation. Both doctors claim that the FDA told them to downplay any problems with the drug. Tests for the drug showed liver enzymes 6 TIMES NORMAL, but Warner-Lambert reported levels of 2-3 times normal; a figure the company later acknowledged to be incorrect.

Rezulin is withdrawn from the market after being associated with 391 deaths. 63 from liver failure. Dr. G. Alexander Fleming, a senior FDA official, offered to “ease out” ANY FDA medical officer how EXPOSED doubts about the safety of Rezulin.

1999: FDA approves GlaxoSmithKline’s Lotronex for the treatment of irritable bowel syndrome (IBS), once again over objections from several safety officers.

2000: Glaxo withdraws the drug from the market, after reports of several deaths. Despite Lotronex’s safety problems, FDA works with GSK to get the drug back on the market..despite studies showing the drug increased risk of a life-threatening condition called Ischemic Colitis.

In 1995 the FDA approved 60 percent of all new drugs applications. By the end of the decade, and to present…the agency approves over 80% of all NDAs.

2003: British Medicines and Healthcare Products Regulatory Agency (England’s equivalent to the FDA) warns physicians not to prescribe anti-depressants: Zoloft, Lexapro, Celexa, Luvox, Effexor, Serzone, Remeron, or Paxil to any patients 18 years or younger, due to an increase in violence, hostility, and suicidal behavior. FDA lead expert on anti-depressants, Dr. Andrew Mosholderx agrees with the claims, with his own research showing children 1.89 times more likely to commit suicide on these drugs, as opposed to a placebo. When he voiced these concerns to the FDA, he was removed from the 2004 advisory panel, and was made the subject of criminal investigation. Facing adverse publicity, FDA forms a second advisory panel seven months later, and recommends adding a simple ‘warning label’. FDA REFUSES TO THE TAKE THE DRUGS OF THE MARKET for juveniles and young adults, despite mounting evidence that the drugs are ineffective and dangerous.

2004 (November): Dr. David J. Graham (FDAs Associate Director of Drug Safety), testifies under the Whistle Blower’ Act, before the Senate Finance Committee…explaining that the largest drug companies in the world exercised undue influence over FDA senior management. He insisted that despite safety objections from staff, the FDA approved unsafe drugs for market.

Dr. Graham, along with other senior safety officers oppose passing Vioxx (an arthritis drug manufactured by Merck), because it substantially increases the risk of heart attack, and stroke. FDA approves the drug, and some 20 million Americans are prescribed Vioxx. An estimated 140,000 people suffer heart attacks, and of those, 60,000 die. Dr. Graham testifies that the FDA made attempts to keep him from testifying before Congress about their decision to put Vioxx on the market, despite it’s KNOWN lethal effects. The day before testifying, FDA Commissioner, Lester A. Crawford, urges Dr. Graham to take a newly created position at a higher pay grade, rather then appear before Senate. Graham declined. Later a campaign was orchestrated by the FDA to prove Graham inept.

Serevent, a drug for asthma, still on the market, was the subject of significant objection by safety officers, yet the FDA passed it, despite it showing a four-fold increase in death from asthma (check mkhlawyers.com for more details about the cases of wrongful death).

Arava, a drug for rheumatoid arthritis, also on the market, was recommended against approval, because it substantially increased the risk of acute liver failure.

2004 (April): FDA approves Ketek, a Sanofi-Aventis antibiotic, Despite warnings from four safety officers that there was evidence supporting the drug was highly-suspicious. They found that Sanofi failed to disclose safety dangers, and were intentionally withholding data. Ketek has been implicated in 14 incidents of liver failure, including 4 liver failure deaths. It still remains on the market.

A study by the National Research Center for Women and Families, evaluated advisory committee meeting transcripts from January 1998 through December 2005, and found:

  • Many advisory committees recommended approval for almost every product they review, usually unanimously.
  • Committee members describe pressure to conform and to recommend approval, and htey candidly admit to their votes for approval may not be consistent with their concerns about the safety and effectiveness.
  • The FDA almost always approves products recommended for approval, but also often approves products that advisory committees reject.

2006: The Union of Concerned Scientists reveal the results of a survey of senior scientists at the FDA. 18.4% of 997, said they had been asked for non-scientific reasons to inappropriately exclude or alter technical information on their conclusions of FDA documents. 61% knew of cases where HHS or FDA political appointees had inappropriately injected themselves into FDA determinations or actions. Only half believed the “FDA is acting effectively to protect public health”. 20% said they had been asked directly by FDA decision makers to provide INCOMPLETE, INACCURATE, or MISLEADING data to the public, regulatory industry, media, or elected senior government officials.

Worse, FDA Center for Drug Evaluation and Research is now PRINCIPALLY funded by the very drug companies it is suppose to regulate! Since 1992 over 50% of the funding for FDAs drug center has come from the drug companies themselves, via fees paid under the Prescription Drug User Fees Act. Dr. Graham stated, “When Congress passed this law, I suppose it’s possible that it didn’t realize that PDUFA would lead to the FDA becoming a captive of the industry it’s supposed to regulate. However, that is what has happened, and to a disastrous end.”

The pharmaceutical lobby not only affects FDA regulation of drugs, but food and dietary supplements as well. TRUTHFUL speech concerning disease treatment effects of dietary supplements is CENSORED by the FDA, which is evident in thousands of holistic, herbal, and nutritional websites it shut downs regularly, not to mention the unyielding harassment of supplement companies to the point of bankruptcy. In1990, COngress passed a NUTRITION LABELING and EDUCATION ACT. This Act provided foods and dietary supplements could make claims concerning the effects of their ingredients on disease, without having to obtain FDA approval. From 1990 to 1999, the FDA REFUSED to implement the NLEA health provision, case after case. Among the claims that the FDA censored, was that folic acid reduced the risk of neural tube defect births. And estimated 2,500 preventable neural tube defect births occurred each year from 1991-1993, before this information became public. In a lawsuit, similar to Xarelto lawsuits, brought by Dr. David Kessler, plus public pressure, the claim was allowed. FDA had refused this claim for folic acid, despite the fact that the Center for Disease Control and Prevention, and the Public Health Services each recommended publicly, that women of childbearing age consume 400 micrograms of folic acid daily before becoming pregnant, to reduce their risk of having NTDB.

1999: United States Court of Appeals for the D.C. Circuit held FDAs censorship of 4 nutrient-disease relationship claims as UNCONSTITUTIONAL under the First Amendment. These were a folic acid claim/neural tube defect birth claim; an antioxidant vitamin/cancer risk reduction claim; a fiber/colorectal cancer risk reduction claim; and an omega-3 fatty acid/heart disease claim. The Court ordered FDA to FAVOR disclosure of nutrient-disease information over its suppression, and to allow claims if they could be rendered non-misleading with disclaimers. FDA works to overturn this at all possible cost.

On remand, FDA refused to allow any of the claims the Pearson court held unconstitutionally suppressed. Four federal court decisions later, all against the FDA, the claims have finally been allowed along with a half dozen others. Many well-backed claims, like the glucosamine and chondroitin sulfate/osteoarthritis claim, have been suppressed by the FDA to protect the makers of non-steroidal anti-inflammatory drugs from competition.

The only way these claims are allowed, is when the FDA accepts the classification of the supplement as a “drug”. At $1.6 billion a pop for NDA testing and approval, this is an economic impossibility.

The author of this article, Jonathan W. Emord, suggests the following, so long as the FDA exercises control over drug approvals…its decision makers should be held PERSONALLY liable for decisions that result in the infliction of disability and death.

(1) The Tort Claim Act should be amended to permit wrongful death and gross negligence actions to be filed against FDA management, personally whenever someone suffers permanent disability or death, as a result of a decision by the FDA management to overrule recommendations against drug approval made by FDA scientific reviewers.

(2) Drug review panels should be chosen by a statutorily created, independent advisory body, NOT by the FDA. Members should be screened to exclude those who have conflicts of interest, including ties to the pharmaceutical industry, or the FDA. The members should be paid for their services, NOT by the FDA, but by the United States Treasury directly.

The FDA should have NO authority to recommend panel members, or to influence advisory panel meetings, or modify advisory panel recommendations. All questions posed to the advisory panel should be submitted by FDA to the Department of Justice and modified by the Justice as needed, to ensure that none reveals a bias in favor of drug approval. FDA should be prohibited from acting contrary to a panel recommendation if that recommendation is against drug approval, and if any FDA safety officers have also recommended against drug approval.

Long-term, Congress should end FDA censorship of nutrient-disease treatment claims by passing the Health Freedom Protection Act, H.R. 4282. In addition, Congress should amend the FDCA to remove from FDA, the power to evaluate and approve new drugs. Instead, by statute, criteria should be established for drug evaluation to be conducted by government funded  academic teams at universities qualified to do so who have NO financial ties, either to the pharmaceutical industry or the FDA. Drug applications should be blinded so that reviewers are unaware of the company sponsors. The recommendations of these independent reviewers should be deemed final determinations, and the FDA should be required by law to follow those determinations.

[1] © 2006 Jonathan W. Emord. All rights reserved. Reproduction in whole or part without the express written consent of the author is strictly prohibited. Delivered September 23, 2006 at the Health Freedom Expo in Richmond, Virginia

Original article can be read in full here: http://www.emord.com/Read-FDA-Violation-of-the-Rule-of-Law.html

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