December 01, 2004

The most surprising aspect of the recent ballyhooed recall of the arthritis drug Vioxx from the prescription drug market by its manufacturer, Merck & Company, is that there was absolutely no involvement by either the Food and Drug Administration or the Federal Trade Commission. This is in and of itself almost miraculous! What are brainwashed Americans to conclude other than the high level of ethics on the part of the humongous crony corporations of the pharmaceutical industry?

But if one were to read Kevin Trudeau's book, "Natural Cures ‘They' Don't Want You to Know About," a lot more clarity would surface as regards this wondrous event. Trudeau is an FDA-maligned crusader in the shaping battle of those mustering in defiance of the growing federally-supported threat of the American drug cartel: the FDA, FTC, pharmaceutical industry, Madison Avenue, and of course, that great nemesis of an American free society, the media. The FDA has promoted fraudulent disinformation in contending that cheaper drugs from Canada are unsafe, obviously to protect the interests of the pharmaceutical industry as opposed to those of the American consumer.

The book is somewhat sophomoric in launching Trudeau's case – I found two glaring typos in the first twenty-five pages. And Trudeau's rock-solid arguments are painfully redundant. But his analysis is flawless and right on the money, and indeed a sobering revelation. His case is born out and proven accurate by precisely such events as the Vioxx recall by Merck. The book was written before the Vioxx caper, reinforcing both its analysis and conclusions all the more.

Reporting on the Vioxx pullback, Washington Post reporters Marc Kaufman and Brooke A. Masters open their November 18th article, "FDA Is Flexing Less Muscle – Some Question Its Relationship With Drugmakers," with a delivery duplicating somewhat the more assertive and strident theme in Trudeau's book: "In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects, records show, leading some lawmakers, academics and consumer advocates to complain that the agency is focusing more on bolstering the pharmaceutical industry than protecting public health."

Elaborating, the article continues: "From 2001 to 2004, three important drugs were taken off the market, compared with 10 that were recalled from 1996 to 2001. Two of the three were withdrawn in the very early months of the Bush administration. The third, the blockbuster arthritis drug Vioxx, was pulled in September at the initiative of its maker, Merck & Co., without FDA involvement. In the same period, the number of warning letters sent by the FDA's drug marketing office challenging misleading or dishonest drug advertising also plummeted. From 1996 to 2001, the agency issued about 480 cease-and-desist letters. Over the past four years, the total has been about 130."

Trudeau makes the case, both in his book and in the many infomercials he's recently been seen in on several cable TV channels, that the FDA protects the pharmaceutical industry from scrutiny and investigation, allows fraudulent advertising by drug companies on TV, including free and false advertising in the form of media "news reporting," collaborates with the industry and the FTC, and blocks natural health cures from ever seeing the light of day. But his most serious charge is that the FDA protects pharmaceutical companies, even when it can be shown that drug companies, just as in the case of the tobacco companies our government persecuted and prosecuted so successfully, knew their products were dangerous, improperly tested, and in some cases resulted in deaths.

"The decrease in FDA enforcement has come despite a steadily rising number of reports of potentially harmful side effects from approved drugs. From 1996 to 2004, the annual number of these ‘adverse events' almost doubled," echoes the Washington Post article.

One of Trudeau's fiercest contentions is the heavy funding required by a 1992 law hastily passed by Congress on the premise of urgency in addressing the AIDS epidemic. Kaufman and Masters offer: "Few doubt the FDA remains the world's gold standard for drug regulation, and the agency fiercely defends its record. Nonetheless, Steven Galson, acting director of the FDA Center for Drug Evaluation and Research (CDER), said his agency ‘has learned some important lessons in the past year and will make some changes' based on an upcoming Institute of Medicine study and its own reviews. The agency has ‘taken the criticism to heart,' he said.

He added, however, that some of the falloff in recalls may be the result of a decline in new drug approvals. Concerns about the FDA's safety monitoring have been growing ever since Congress required in 1992 that the industry assume a significant share of the costs of evaluating new drugs. These ‘user fees' now pay for more than half of CDER's annual budget of almost $500 million, and the percentage is growing steadily."

The CDER funding is clearly a conflict of interest – the pharmaceutical industry foots half the bill of an agency operation that is supposed to monitor and regulate it. And in the true tradition of a government bureaucrat with an overstaffed agency with a bloated budget, it is doubtful if either the director or anyone in his agency takes any "criticism to heart."

According to Trudeau, when he and his associates had allegedly repeatedly written to, phoned, e-mailed, and contacted the FDA, and asked for guidance and input, they gave their continued approval and blessing for the group's marketing and introduction of a natural coral calcium supplement on the American market. Trudeau offers, "Suddenly, and without any warning, the FDA struck and charged him and his company with illegally providing an unlicensed and untested drug, and also with false advertising." Trudeau offers that it is a natural product, and therefore not patentable. He offers that the FDA waited a year to pounce on him and his operation to allow it to earn revenue that could be confiscated.

Of course, and as usual, a Congressional investigation was scheduled on the heels of the Vioxx debacle. And again as usual, more money will be thrown at the problem. The real issue, however, as Trudeau consistently points out in his book, is that the real drug crimes are being committed by the FDA in blocking known, natural, and in many cases, permanent cures and treatments from the market in precisely the manner described in Trudeau's coral calcium case. Trudeau offers, "The big guys are never treated that way! Drug companies are not motivated to make you healthy or to offer a permanent cure; they need you to keep buying more of their products." And the FDA's falsehoods concerning alternative foreign drugs reinforce this assertion that the FDA favors the major drug producers.

It is clear that the direction of both the Congress and the bureaucratic apologists for the growing FDA safety failures and "incompetence" is that the agency needs even more powers than they are already over-abusing; or, that the agency needs "restructuring," the latter the most often touted dog-eared and time worn cure-all for an ineffective and failed government operation or bureau.

What is really needed is truthful and factual information made available to the public, information that bypasses a profiteering media that earns billions from drug advertising, hopefully followed by the public outcry for a severe curtailment of the FDA and the FTC's unlimited and frightening power to kick down the doors of small and medium size companies and marketing groups, "with drawn guns," to seize assets and records, and health-beneficial inventories of safe natural products that compete with the poisonous offerings of the rich and powerful drug cartels they are protecting.

Theodore E. Lang

Editor's Note: There is no way to "curtail" government agencies. The most compelling lesson of history is that government always increases in size and power until they are destroyed, either from within or without. They never get smaller or less intrusive. Never. What a shame that so many good people delude themselves with the idea that they can tame this ravening beast.

Far, far better is the necessary condition for liberty: each person taking complete responsibility for their own life and the consequences of their decisions. It's up to you. If you want to believe the commercials, nobody can stop you, not even the FDA.

© THEODORE E. LANG 7/12/04 All rights reserved

Ted Lang is a political analyst and a freelance writer. Visit his new website soon

Archives

A Secret No More! - The Lone Star Ranger Unmasked

TSA: A Continuing Government Disaster! - Controlling Congress

Defeat The Press - The State Silences Dissent!

Gun Control = CSI -- Victimology And Government Investigations

America’s First Jewish President - Putting Israel First

Another Police State Killing

Election Electives - Choices In Spite Of None

Lost in a Crowd - Always A Threat To Freedom

Election Reflection and Beyond - The House Bush Built

Triple Indemnity - Who Dies And Pays?

US Media Propaganda-Phase II- Preparations For Attack On Iran

MAD Tax Beyond Squander Dome

Lead Blockers - Someone's Got To Do It!

Complete Archives for Ted Lang

Visit Etherzone for other articles by Ted Lang