Bureaucratic Oligarchy Rules at the FDA
Emord, Jonathan W., USA TODAY
"The [Food and Drug Administration], like many other Federal agencies, wields way too much authoritarian power. The bureaucracy has become sovereign, governing in a manner not unlike the absolute monarchs who were detested for rights abuses by America's revolutionary leaders."
THE U.S. NO LONGER is a republic; it is a bureaucratic oligarchy. A republic depends on the consent of the governed; elected representatives to make laws; a separation of legislative, executive, and judicial powers; and limits to government that prevent it from violating the inalienable rights of the people. A bureaucratic oligarchy arises when unelected officials make the laws while possessing the combined powers of all three branches of government, and they enact each measure without having to account for their actions to the courts, Congress, or the people.
This transformation has occurred incrementally since 1938, as Congress has delegated ever more governing power to independent regulatory commissions, and as the Supreme Court has not struck down any Congressional delegation of lawmaking, enforcement, or adjudication power to the agencies as a violation of the separation of powers. Indeed, so profound is the Court's failure to defend the separation of powers deemed indispensable to liberty by America's Founding Fathers that U.S. Court of Appeals Judge Douglas Ginsburg has described that doctrine as part of a "Constitution in exile." With the growth of unaccountable government has come corruption, rights violations, and abuse of power, just as our nation's Founders predicted. There perhaps is no greater Federal government example of those combined ills than the Food and Drug Administration.
In Thoughts on Government (1776), John Adams warned, "A people cannot be long free, nor ever happy, whose government is in one assembly ... because a single assembly possessed of all the powers of government would make arbitrary laws for their own interest, execute all laws arbitrarily for their own interest, and adjudge all controversies in their own favor." Drawing from Montesquieu's explanation in Spirit of the Laws (1748) that liberty only can be preserved by a government of separated powers, the Founders of the American republic--George Washington, Alexander Hamilton, Thomas Jefferson, James Madison, and John Adams--warned that, if ever our national government were to devolve against the Constitution's design into "one assembly" for the creation, enforcement, and adjudication of laws, there would be an end of liberty and a birth of tyranny. Some 221 years later, this unfortunate reality has come to fruition. Today, more than 90% of all Federal law is not the product of our elected representatives who are given the exclusive power to make laws in the Constitution, but of unelected heads of Federal agencies. Based on the testimony and correspondence of more than a dozen FDA medical reviewers turned whistleblowers, the agency is a captive of its principal regulatee, the pharmaceutical industry, resulting in the approval of unsafe drugs onto the market.
Most Americans are shocked to learn that the FDA is not mandated to test any proposed new drug to determine if it is safe. Instead, the FDA relies on the drug companies to inform it if they find evidence of safety. Characteristic of just how entrenched drug company control is over the agency, the FDA presumes drugs under its review to be safe unless the sponsoring drug company informs the agency of evidence indicating otherwise. In addition, FDA medical reviewers do not have the first or last word on the prudence of approving a drug; that decision is made by the agency's political appointees--the agency's management, its head of the Center for Drug Evaluation and Research, and, ultimately, its commissioner, whose decrees are absolute.
Physician Richard Besser, ABC News' senior health and medical editor, well described the biased safety review process performed by the industry--that the FDA condones--when he observed: "Drug trials are sponsored by industry--and it's been clearly shown that industry sponsored trials are more likely to show a positive result.... Not only are trials being sponsored by industry, the data [is] being collected by industry ... analyzed by industry, and written up by industry. For many trials ... the lead author doesn't even get to see the primary data. They see the result tables and write up and sign their name on it."
Adds David Graham, the FDA's associate director of Drug Safety, "... When there are unsafe drugs, the FDA is very likely to err on the side of industry. Rarely will it keep a drug from being marketed or pull a drug off the market.... When it looks at safety ... the FDA assumes the drug is safe and now it's up to the company to prove that the drug isn't safe.... Safety flaws are discovered after the drug gets on the market."
Drug industry control over the FDA is no secret. It is the consistent theme present when agency medical reviewers testify as whistleblowers before Congress. Indeed, as Graham has stated, the "FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drags as it can, regardless of whether the drugs are safe or not.... As a result, thousands of Americans [have] died."
Graham is not alone in this view. On Jan. 7, 2009, nine physicians and scienlists in the agency's Center for Devices and Radiological Health wrote a letter to Pres. Barack Obama and his chief of staff, John Podesta, excoriating the agency for elevating politics favoring drug approvals over science: "Managers have ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions, and recommendations in violation of law ... and to accept clinical and technical data that is not scientifically valid."
FDA medical reviewers complain repeatedly that the agency is the handmaiden for the largest pharmaceutical companies in the world. "Industry has become FDA's client," states former FDA Medical Reviewer David Ross. "People at FDA know that they have to be careful about upsetting the industry.... Even if a product doesn't work ... there is pressure on managers that gets Wansmitted down to reviewers to find some way of approving it." Another former FDA medical reviewer, the late Robert I. Misbin, once stated, "One of my superiors said something to me that I have never forgotten--that we have to maintain good relations with the drag companies because they are our customers."
A 2006 Union of Concerned Scientists' survey (to which 997 FDA scientists responded) revealed that 61% of those surveyed knew of cases in which FDA "political appointees [had] inappropriately injected themselves into FDA determinations or actions." Twenty percent charged they had "been asked, for nonscientific reasons, to inappropriately exclude or alter technical information or their conclusions in FDA scientific documents." Less than 50% thought the FDA provided patients "complete and accurate information" concerning FDA approved drugs.
In a 2009 Department of Health and Human Services Inspector General survey of 400 FDA scientists, 66% maintained they lack confidence that the FDA adequately monitors the safety of prescription drugs. Eighteen percent of those surveyed stated they were pressured by FDA management to approve or recommend a drug despite their reservations about its safety, effectiveness, or quality.
Under the Prescription Dmg User Fee Act, the drug industry pays for the government's review of its drags. This, Graham complains, has increased drug company undue influence over the process. "He who pays the piper," explains Graham, "calls the tune."
Drag industry influence is not limited to the FDA. For instance, the point man in Congress for Bush Administration approval of the Medicare Part D bill (the prescription drug benefit) was then-Chairman of the House Energy and Commerce Committee--Billy Tauzin. He and his staff" fought vociferously to retain in the bill a provision that prohibited the Federal government from negotiating down the per unit price of drugs bought in bulk for all Medicare beneficiaries. In other words, with this provision in place, whatever price the drug industry demands for its drugs the Federal government must pay. In reflecting on this welfare benefit for the drug industry, former Solicitor General Dan Walker testified that, unless Medicare Part D were scaled back significantly or eliminated, it would bankrupt the U.S. (and he made that observation before the onset of the current recession). Tauzin resigned from Congress and became the head of the Pharmaceutical Research and Manufacturers Association (the group whose lawyers principally wrote the Medicare Part D bill), earning an estimated $2,500,000 annually.
Over the past decade, the drug industry has spent in excess of $1,000,000,000 lobbying Congress. Rep. Dan Burton (R.-Ind.) has stated that, if the industry wants a bill passed "bad enough," Congress will pass it. "When [the drug companies] push real hard to get something accomplished in Congress ... they can get it." Drug industry money fills the coffers of Republicans and Democrats on the Hill. Regardless of party stripe, the head of the Energy and Commerce Committee usually receives the most drug industry money. That person has direct FDA oversight and chairs the House committee most responsible for regulating the health care industry, including the drug industry. Although current Energy and Commerce Committee Chair Henry Waxman condemns conflicts of interest on FDA drug review panels--the FDA routinely waives financial conflict of interest to permit those conflicted to review drug safety--Waxman himself receives huge financial contributions from the industry his committee regulates. According to the Council for Responsive Politics, Waxman received more than $286,000 in campaign contributions between 2009-10 from entities regulated in the health care sector. Since becoming chair of Energy and Commerce in 2008, he has received more money than any other member of Congress from the industry his committee regulates.
Despite direct evidence of drug company control over the FDA, Congress has done nothing material to remove lifts undue influence. Perhaps the greatest example of that corruption comes in the form of the FDA's 2004 approval and defense of the Merck drug Vioxx. In Merck's application for approval, it presented a clinical trial comparing Vioxx to another pain killer, Naproxen. One of the anomalies present was an apparent threefold increase in the comparative risk of heart attack disfavoring Vioxx. Merck explained away the apparent increase in risk with what Graham regarded as a nonsensical answer, it was not that Vioxx increased the risk of a heart attack, it was that Naproxen somehow lowered the risk of heart attack and thus gave the false appearance of an increased risk from Vioxx. Graham subsequently told his supervisors that his research revealed high-dose prescriptions of Vioxx tripled the risk of heart attack. The acting director of the Center for Dmg Evaluation and Research, Steven K. Galson, denigrated Graham's evaluation, referring to it as 'junk science." Moreover, Galson dispatched an e-mail to the editor of The Lancet, a prestigious peer-reviewed British medical journal, calling into question Graham's "integrity." Various FDA managers then began a general campaign to discredit Graham and control the negative publicity created when word was leaked as to the heart attack risk.
In early August of 2004, Graham presented to his supervisors a large epidemiologic study he had performed on Vioxx with Kaiser Permanente in California. The study revealed that high-dose Vioxx significantly increased the risk of heart attacks and sudden death. Graham had intended to make a similar presentation at the International Conference on Pharmacoepidemiology in Bordeaux, France. He recommended that the agency warn against prescription of high doses. In response, senior FDA officials ordered Graham to change his conclusions and recommendations and threatened that, if he did not, he would not be permitted to present findings at the Bordeaux conference. An e-mail from the director of the Office of New Drags explained that the FDA was "not contemplating" a warning against use of high dose Vioxx and that Graham's conclusions should be changed.
In mid August, the FDA announced that it approved the drug for use in children with rheumatoid arthritis, leaving several FDA medical reviewers incredulous. Vioxx caused an estimated 140,000 heart attacks and 60,000 deaths; the death count is comparable to the number of Americans who died in the Vietnam War. Lester Crawford, the man ultimately responsible for approving Vioxx, resigned from the FDA shortly after being approved by Congress to serve as commissioner. (He served as "acting" commissioner before that time.) Crawford failed to reveal ownership interests in large food and drug company stocks on Federal disclosure forms that he signed under penalty of perjury. Despite repeated invitations from the FBI to correct his responses, Crawford insisted that he responded truthfully. He was charged with making false statements to the government, pied guilty, and paid a fine--but was not incarcerated. Instead, he went to work for the Washington, D.C., lobbying firm Policy Directions, Inc., which includes among its clients, Merck, the maker of Vioxx.
It is not at all uncommon for senior agency officials to leave the agency and go to work for the very companies that they assisted while in government. Indeed, every decisionmaker at the FDA well knows that, if they avoid offense to industry and help achieve its aim of drug approvals, their post-government employment prospects will be particularly bright. For instance, Crawford's chief counsel, Dan Troy, intervened on behalf of the FDA in products liability lawsuits confronting GlaxoSmithKline, achieving dismissals of the suits. In one such case, Troy argued against plaintiffs alleging addiction that the drug Paxil, represented to be "non habit-forming" by Glaxo was labeled accurately. Troy contended that patients who ceased taking the drug did not suffer from "withdrawal symptoms" but from a "discontinuation syndrome." Based on the FDA's intervention, the Federal court withdrew a temporary restraining order against Glaxo. After leaving government service in September of 2008, Troy became the senior vice president and general counsel of GlaxoSmithKline.
Safety don't mean a thing
I have identified some 32 drugs that have been approved by the FDA for marketing over the safety objections of the agency's own medical reviewers. In his testimony before Congress, Graham identified six drugs that he said were approved by the FDA over grave safety concerns: Vioxx; Crestor (a cholesterol lowering drug linked to kidney failure and myopathy, including cardiomyopathy); Meridia (a weight loss drug linked to increased risk of heart attack and stroke); Bextra (a pain killer linked to increased risk of heart attack and stroke); Accutane (an acne drug linked to birth defects if used by pregnant women); and Serevent (an asthma drug linked to increased risk of death from asthma).
Other drugs deemed too unsafe for marketing-yet approved--include the type 2 diabetes drag Avandia (linked to heart attack by FDA Medical Reviewer Robert Misbin and likewise so identified in a meta-analysis published in the New England Journal of Medicine); the antibiotic Ketek (inked to liver damage by FDA Medical Reviewer David Ross, who testified that the drug "could kill people from liver damage"); and the antidepressant drugs Paxil, Zoloft, and Effex or (linked to increased risk of suicidality by FDA Medical Reviewer Andrew Mosholder).
To solve this problem requires significant public action to remove from office those members of Congress who have condoned these acts--which includes virtually every individual in the House and Senate with the notable exceptions of Reps. Burton, Ron Paul (R.-Tex.), and Peter DeFazio (D.-Ore.). In addition, Congress must pass a simple bill I wrote for Paul that would restore the separation of powers--called the Congressional Responsibility and Accountability Act. Under it, no agency regulation can be enforced unless enacted into law by Congress.
However, the FDA likely will remain hopelessly corrupt, as no reform can pass that would eliminate undue drug company influence over its decisionmaking, although I have recommended a new statute for drug approval that would enable university departments of biochemistry and pharmacology--whose faculty and staff have no conflicts of interest--to review in secret new drug applications for safety and efficacy. Those departments actually would test the drugs and would follow statutory criteria for evaluation. New applications would be filed with the Department of Justice, not the FDA. The Justice Department would eliminate from the applications all reference to the drug company sponsors, and the sponsors would be forbidden, under Federal criminal law, from identifying themselves publicly as the sponsor of the drugs in question or from attempting to influence evaluations at university testing centers. Testing center determinations presumptively would be final. Challenges could be brought by the drug companies in Federal court, but a reversal would entail not approval, but resubmission of the application for evaluation through a new (and once again blinded) university testing center.
The drug industry pleads that anything other than a rapid FDA approval process will keep from the market numerous life-saving drugs that are discovered each year. The problem with this argument is that it presumes something that is false. Life saving drugs are a rarity. Most drugs approved by the FDA either already have been approved for one indication and are being approved for another or have nothing to do with saving or even prolonging life. As Graham observes: "A very small proportion of drugs represents a new drug that hasn't been marketed before. Most of those drugs are no better than the ones that exist. [Only about one or two drugs a year truly are new] and most of them aren't breakthroughs and aren't lifesaving."
The FDA, like many other Federal agencies, wields way too much authoritarian power. The bureaucracy governs in a manner not unlike the absolute monarchs who were detested for fights abuses by America's revolutionary leaders. To ensure individual sovereignty will require a restoration of the separation of powers and a return to our constitutional republic, together with its limitations on government power and its defense against use of that power to deprive our citizens of their lives, liberties, and property.
Jonathan W. Emord is a free speech attorney and principal of Emord and Associates, Clifton, Va. He has defeated the Food and Drug Administration seven times in Federal court. The author of The Rise of Tyranny, he is the 2007 recipient of the Cancer Control Society's Humanitarian Award and the only nonscientist ever appointed to the Certification Board for Nutrition Specialists.…
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Publication information: Article title: Bureaucratic Oligarchy Rules at the FDA. Contributors: Emord, Jonathan W. - Author. Magazine title: USA TODAY. Volume: 139. Issue: 2786 Publication date: November 2010. Page number: 62+. © 2009 Society for the Advancement of Education. COPYRIGHT 2010 Gale Group.
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