You'd have to be visiting from another planet not to have figured out by now how thoroughly riddled with corruption the federal government of 2007 is. From the White House to the lowly janitor mopping out the toilet stalls of Congress, "you scratch my back, and I'll scratch yours" is the rule of business.
Maybe we can all live with a deadbeat janitor paying himself for hours he never worked, or stealing the occasional roll of toilet paper, but other areas of the federal government are a matter of life and death. Such a life-and-death agency is the Food and Drug Administration, or the FDA, whose stamps of approval directly effect hundreds of millions of lives.
Since 1906 the FDA has been standing like a granite rock in a world of deception. They are here to safeguard Americans from the greed and corruption of corporate snakes. It's this image that inspire most Americans to take for granted that the agency does its job while they ingest virtually anything sitting on food or pharmacy shelves. So much for fairy tales.
Most of you on this side of ancient may remember the thalidomide disaster of the late 50s and early 60s. During its pathetic heyday, thalidomide was marketed as a sedative and anti-inflammatory medication and sold in almost fifty countries under at least forty different brand names. It was also sold as a antiemetic to combat morning sickness during pregnancy. The catastrophic result on pregnancies was that approximately 10,000 children were born with hideous birth defects, such as flippers in place of arms and feet. Granted, the FDA had never approved the drug, but neither did it keep it from being used in clinical testing, where it was given by doctors to pregnant women who didn't know they were being used as human guinea pigs. As a direct result of this tragedy, in 1962 John F. Kennedy approved the Kefauver-Harris drug amendments to the Food, Drug, and Cosmetic Act to ensure that any drug or therapeutic device on the market is safe and effective for its intended use.
That sounds good—a dangerous loophole in the way the FDA did business had been filled, and it only cost 10,000 babies! But when it comes to the FDA, the old saying that time heals all things must be a motto because in 1998 the agency approved thalidomide for usage in the U.S. The fact that such a damnable drug is back on the market with FDA approval is a testament to the clout of the giant pharmaceutical companies and their partner in $$$—the United States Food and Drug Administration!
If you plan on reaching retirement age alive, never doubt for a moment that the FDA is in business to protect the drug and junk food industry, Americans be damned! A case in point is a drug called the COX-2 inhibitor.
The Cox-2 inhibitor is a non-steroidal anti-inflammatory drug (NSAID) that directly targets COX-2, which is an enzyme responsible for inflammation and pain. Marketed under the trade names Vioxx (produced by drug giant Merck, 2003 annual sales of $2.5 billion) and Bextra (produced by the infamous drug giant G. D. Searle, which was eventually bought out by Pfizer) COX-2 inhibitors were unleashed in 1999 on the American public. With tens of millions of slick advertising dollars, it was hyped in prime time television, big name magazine ads, and full-page newspaper ads as an arthritis and menstrual pain reliever. As usual, doctors received generous kickbacks for over-prescribing the medication, when simple over-the-counter painkillers would have been just as effective—or better yet, whole food concentrates made from cherries, blackberries and other fruits, which have proven results in pain relief, but which the FDA does not allow to be sold for that purpose because of "insufficient" clinical testing. (See the Associated Press article "A cherry a day . . . not so fast, FDA says" by John Flesher, Monday, March 20, 2006.) The result of the ad campaign was that the drug rapidly became the most frequently prescribed new drug in the United States. By late 2000 its US sales exceeded 100 million prescriptions per year for $3 billion in revenues.
Behind all the media hype and paid-for medical enthusiasm was the deliberately suppressed knowledge that the COX-2 inhibitor was a deadly poison. Before the corporate greed was stemmed, an estimated 28,000 to 160,000 people were systematically killed by COX-2 inhibitor medications.
Okay. Tens of thousands of corpses mean lawsuits, and if there's one thing worse than a greedy drug pusher, it's a greedy lawyer. And so, Merck's management voluntarily removed its COX-2 inhibitor from the market and started fending off some thousands of lawsuits. Later, the FDA (under pressure over the Merck decision) ordered Pfizer to pull its billion-dollar poison, Bextra. What is surreal is that the FDA left Pfizer's other COX-2 inhibitor on the market.
Released in 1999, Celebrex was promoted in every prime media market in the U.S. as nothing short of a miracle pain reliever. By 2001 its sales topped $3.1 billion, and 2002 saw some 23 million prescriptions for the FDA-approved stuff bing written. (100 capsules sell between $75 and $100!) Even better for the company, with its own Bexta off the shelves, as well as rival Vioxx, Celebrex has the run of the COX-2 inhibitor marketplace. Even better than better is that the good old FDA is still giving its stamp of approval for Pfizer's Celebrex. In fact, the FDA recently approved Celebrex for treating juvenile rheumatoid arthritis, and in December 2006 Pfizer met with the FDA seeking approval to use the drug on toddlers as young as two years!
Despite evidence published in peer-reviewed medical journals like the British Medical Journal showing the COX-2 inhibitor to be a deadly drug, the FDA's continued endorsement smacks of corruption at the highest levels. This becomes crystal clear when FDA insider and "whistleblower" Dr. David J. Graham, the associate director for science at the Office of Drug Safety at the FDA, produced evidence that the FDA knew in advance of COX-2 inhibitor's release to the public market that the drug was unsafe, and potentially deadly. Cutting through all the couched words, and what Dr. Graham indeed revealed was that the FDA is a partner in crime with the profit-minded, don't-give-a-damned-how-many-people-die, drug companies.
Recalling former FDA Commissioner Dr. Arthur Hull Hayes, Jr. and his connection with drug giant G. D. Searle and Donald Rumsfeld in the aspartame scandal, we see that the FDA's complicity in the marketing of the COX-2 inhibitor is not surprising. Throughout its farcical career the FDA has virtually always sided with big money drug companies, even suppressing its own findings and punishing those in its own agencies who try to work for the public good. In the case of Dr. Graham and the COX-2 inhibitor, the FDA tried to prevent his findings from being made public, and when failing this, released a statement that read, in part: "Dr. Graham's views expressed in the accompanying editorial are his own, and do not reflect the official positions of the FDA. Dr. Graham provides his personal views on the issue of what NSAID he would recommend to patients in need of long-term use of an analgesic, however, the FDA does not believe the available data rise to the level required to support an official FDA regulatory decision regarding comparative safety and efficacy of the available COX2-selective and non-selective NSAIDs."
Given the corrupt history of the FDA, the above statement yet another indictment against the leadership of this nation and FDA—only one of the many corrupt government agencies now strangling the life out of this country.
The fact is that conflicts of interests is business as usual for the panels that advise the FDA on matters such as which drugs should be approved, what their warning labels should say, and how safety studies should be conducted.
Some three hundred "experts" on eighteen committees decide on billion dollar drugs, and the FDA routinely follows their recommendations. Although committee members are supposed to be free of conflicts of interests, the FDA usually waives this requirement if the member's "expertise" is deemed to outweigh a risk of a conflict of interest. This was the case with the COX-2 inhibitors manufactured by both Merck and Pfizer. This fact came to light in February 2005 when highly publicized hearings were held about the safety of the COX-2 inhibitors when it was revealed that out of the thirty-two FDA advisors voting on the matter, ten had previously served as consultants to Merck and/or Pfizer.
Specifically noting the apparent conflicts of interests of the panels that studied the Cox-2 inhibitors like Merck's Vioxx, a September 2005 letter to the General Accounting Office, signed by Senators Mike Enzi, (R-WY), the chairman of the Health, Education, Labor and Pensions Committee, and Senators Edward Kennedy (D-MA), and Richard Durbin (D-IL) said: "We are concerned about the process that supports FDA's decisions to waive conflicts of interest rules for scientists with financial ties to the manufacturers of the products under consideration, or their competitors . . . These practices appear to have undermined the public's faith in the objectivity and fairness of FDA's advisory committees."
In March 2005 Senator Charles Grassley (R-Iowa), Chairman of the Senate Finance Committee, bluntly accused the FDA of suppressing studies in order to protect pharmaceutical industry profits and the careers of certain FDA officials: "The Vioxx example showed that the FDA and Merck were too close for comfort," Senator Grassely told Health News on March 12, 2005; "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck." Sen. Grassley pointed out that based on a trial that took place in 2000, both the FDA and Merck were aware that heart attacks were five times more likely in patients taking Vioxx than among those taking a similar drug. But even with the corpses stacking up the FDA did nothing to change the labeling on the drug for nearly two years, while Merck aggressively marketed its product on nightly TV.
Senator Grassley had the goods, since it was he who held hearings on Vioxx back in November 2004, when he had Dr. David Graham testify that Vioxx may have been responsible for tens of thousands of heart attacks and strokes but that his superiors had pressured him to keep silent about his findings. Graham told Grassley's committee that "The estimates range from 88,000 to 139,000 Americans." Of these, "30 to 40 percent probably died. . . . For the survivors, their lives were changed forever."
To make his statements more comprehensive, Dr. Graham told committee members that instead of considering the serious side-effects of a prescription drug, to think of the situation as if they were talking about jetliners: "If there were an average of 150 to 200 people on an aircraft, this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky. This translates to 2-4 aircraft every week; week in and week out, for the past 5 years." Dr. Graham went on to condemn the FDA's failure to acknowledge the dangers that Vioxx posed to millions of people in the five years the FDA allowed it to remain on the market: "I strongly believe that this should have been, and largely could have been, avoided."
Vioxx came to the attention of the Senate Finance Committee because of the related costs to government programs like Medicaid and Medicare. (The committee is responsible for oversight of the two programs.) At the November 2004 hearing, Senator Max Baucus informed the public that "In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug. And Medicaid bears the cost of any additional medical care necessary when drugs cause injury."
What all this boils down to is that a drug bearing "FDA approved" should be seen as nothing more than the skull and crossbones of the old iodine labels! The full hypocrisy of the FDA seems to be woven into an unwritten rule that when it comes to natural foods, herbs and nutritional supplements, there's never enough clinical evidence to prove them safe for public consumption, and therefore they're unfit for FDA approval; but when it comes to billion-dollar drug companies and their chemical drug-poisons, if there's not enough evidence to prove they're dangerous, then let them loose on the American public! Indeed, it seems that virtually all drugs approved by the FDA are safe until proven deadly. But even when proved deadly—as many as 160,000 dead when it comes to the COX-2 selective inhibitor—the FDA seems to need numbers approaching a holocaust before it will even consider taking a stand against the big-money drug pushers.
Maybe the key here is the little-known fact that not only does the FDA get a lot of its funding from the drug industry, but that many former FDA employees wind up taking high paying jobs in the pharmaceutical industry—such as former FDA Commissioner Dr. Hayes, who was hired by Burson-Marsteller, drug giant G. D. Searle's public relation firm. In an August 2005 interview with the website Street Spirit, Robert Whitaker, author of Mad In America, said: "The FDA's funding changed in the 1990s. An act was passed in which a lot of the FDA's funding came from the drug industry: the PDUFA Act, or Prescription Drug User Fee Act. Basically, when drug companies applied for FDA approval they had to pay a fee. Those fees became what is funding a large portion of the FDA's review of drug applications. So all of a sudden, the funding is coming from the drug industry; it's no longer coming from the people. As that act comes up for renewal, basically the drug lobbyists are telling the FDA that their job is no longer to be critically analyzing drugs, but to approve drugs quickly. And that was part of Newt Gingrich's thing: Your job is to get these drugs to market. Start partnering with the drug industry and facilitating drug development. We lost this idea that the FDA had a watchdog role.
Also, in a human way, a lot of people who work for the FDA leave there and end up going to work for the drug companies. The old joke is that the FDA is sort of like a showcase for a future job in the drug industry. You go there, you work awhile, then you go off into the drug industry. Well, if that's the progression that people make, in essence they're making good old boy network connections, so they're not going to be so harsh on the drug companies. So, that's what really happened in the 1990s. The FDA was given new marching orders. The orders were: 'Facilitate getting drugs to market. Don't be too critical. And, in fact, if you want to keep your funding, which was coming now from the drug industry, make sure you take these lessons to heart.' "
Yes indeed. The FDA is a national disgrace; but the depths of its shame has yet to be plumbed. In January of 2006 the agency let it be known that it was going to try and shield drug companies from lawsuits filed by victims of its greed.
In a new sheer naked protective policy aimed at protecting the profits of drug giants, the FDA announced that people who have been injured by FDA-approved drugs should not be allowed to sue drug companies in state courts: "We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
The FDA's stand was immediately denounced by trial lawyers and members of Congress as another effort by the Bush administration to limit the public's ability to bring and win lawsuits. "Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety," said Ken Suggs, president of the Association of Trial Lawyers of America. He added, "The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process." (Washington Post Jan. 19, 2006.) In his response to the FDA's announcement, Senator Edward "Ted" Kennedy issued a statement that said: "It's a typical abuse by the Bush Administration—take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry."
We agree Teddy, even though we place lawyers and politicians in the same category as that of drug-pushing corporations!
We have all heard or read of cases in which someone poisons another person by pouring anti-freeze in their drinks. Usually the convicted person finds no mercy in the courts—and well they shouldn't! But when it comes to killing tens of thousands of Americans with poisoned drugs for nothing more than corporate profits, nary a charge is filed! In fact, the culprits go on to bigger and better poisonings! A case in point is the following notice from the Wednesday, February 23, 2005 edition of the Washington Post (page A01) by Rick Weiss, when he reported that the National Institutes of Health cleared most of its researchers in a conflict-of-interest probe:
"Most of the 100 or so National Institutes of Health researchers who the agency has said are under investigation for allegedly engaging in secret deals with pharmaceutical and biotechnology companies have been cleared by NIH investigators, according to agency officials. The unexpected finding that as much as 80 percent of the seeming improprieties were actually the result of errors by government investigators, has undermined the rationale behind NIH Director Elias A. Zerhouni's recent decision to impose severe restrictions on the personal activities and finances of all of the agency's more than 5,000 employees, said scientists and NIH officials upset about the new rules."
So, the National Institutes of Health cleared the National Institutes of Health of any wrongdoings over "alleged" secret deals with pharmaceutical and biotechnology companies to kill off god-knows-how-many Americans for corporate profits! Ain't "business-as-usual" America wonderful!
