The FDA and HCFA (Part II): Unconstitutional Regulatory Agencies
James A. Albright, MD
In regard to the deleterious changes that have taken place in the field of medicine, the regulatory agencies that have had the most damaging effect on the Constitution are the FDA and HCFA. Indeed, the history of the government's involvement in medical care provides a textbook example of the natural history of a command (a managed or collective) economy. In a command economy, power is centralized, which means it is an authoritarian system. Furthermore, when power is centralized, rules and regulations to control the system, particularly costs, inevitably become increasingly oppressive, due to the lack of incentives for self-control that exist in a market economy. For example, most physicians know that the measures implemented by the government (HCFA) to control Medicare have become more onerous each year. In fact, it has reached the point where most physicians know that severe penalties, even imprisonment, can be imposed if they bill too much and, as incredible as it may seem, even if they bill too little.(1) It is no surprise that few physicians actually know the details of what is and is not permitted, nor what the penalty might be for any given infraction.
Most physicians are well aware of the day to day agitations which result from government policies, and many have heard about some of the more sensational problems which occur.(2) The basic issue concerns the regulatory agencies in general. For example, in 1994, the estimated cost of economic, social, and environmental regulation topped $647 billion (as much as $6,457 per family), according to the General Accounting Office.(3) The FDA is one of these regulatory agencies and, in fact, it may be the most unaccountable of them all. Over the past 30 years, the FDA has inflated its powers so much that regulatory gridlock is now a greater menace to public health than thalidomide ever was.(4) The presumed "protection" provided by the system is illusory.
The misadventures of the device section of the FDA are well-known.(5) Some of the more memorable cases include the Bjork-Shiley heart valve implanted in 86,000 patients between 1979 and 1986, with a success rate of 99.5 percent. But it was pilloried by the government because it fractured in 0.5 percent. In other words, it saved the lives of 191 individuals for every valve that fractured. This raises the question of whether perfection is a reasonable standard for any mechanical device, a standard that the 51,000 patients who were still alive in 1992 might question.
Other infamous cases include a defibrillator made by Physio Control, which functioned properly more than 99.995 percent of the time. This product was the victim of scurrilous reporting by the news media, combined with heavy-handed tactics from Congress and the FDA.
The most recent, widely reported fiasco was that of breast implants. In spite of multiple epidemiological studies showing no relationship between breast implants and either connective tissue disease or carcinoma of the breast, FDA Commissioner David Kessler precipitated actions which resulted in a $43 billion legal settlement in 1994. Then, in the absence of data showing any link between breast implants and the alleged ailments, an FDA spokesman, Bruce Burlington, head of the Center for Devices and Radiological Health (CDRH), said the agency would maintain the same course it had set before the studies were reported. A Wall Street Journal editorial stated, "This, after billions of dollars have been put up to pay off the Plaintiffs' lawyers, after mastectomy patients have been terrorized, and after companies and careers associated with the implants have needlessly washed over the falls."(6)
Orthopaedic surgeons received an overnight education on the FDA from pedicle screws. Numerous research studies have shown that pedicle screws provide the strongest possible fixation in the spine. In fact, a non-medical observer, even an astute school child, could look at a vertebra and immediately recognize where the strongest part is. This explains why pedicle screws are often used clinically for certain problems.(7,8) Clearly, they provide optimum treatment for certain conditions. Yet, for many years, the FDA refused to approve pedicle screws. Because there was no logical explanation for this position, a neutral observer might conclude that the underlying purpose was to transfer funds into the hands of plaintiffs' lawyers since the actions of the FDA precipitated a massive class-action lawsuit.(9) The defendants included physicians and professional organizations such as the American Academy of Orthopaedic Surgeons, the Scoliosis Research Society, the North American Spine Society, the Orthopaedic Trauma Society, the Orthopaedic Research and Educational Foundation, the American Association of Neurological Surgeons, and the Congress of Neurological Surgeons, as well as countless individual physicians and major companies that manufacture the devices. (One company, Sofamore Danek, had approximately 3,000 lawsuits filed against it.) The professional societies and their members were accused of fraud and illegal collusion with orthopaedic companies by sponsoring academic meetings where scientific papers on pedicle screw devices were presented. Ironically, the companies that manufacture pedicle screws and the physicians who use them should be commended, not condemned.
After inflicting such enormous costs on society, both monetarily in legal costs and professionally in patient care, in 1998 the FDA reversed course and reclassified pedicle screw spinal systems from Class III to Class II for certain indications,(10) i.e., after countless years of resisting undeniable evidence, the FDA reluctantly admitted a serious error. Whatever the reasons, there is little question that the effect of the FDA's actions had an adverse effect on patients in this country.
Although this discussion has focused on actions of the device section, the drug section has a similar, if not more alarming history.(11)
It is now obvious the basic structure of the regulatory system needs to be changed or abolished. To simply put on the brakes by restructuring HCFA and the FDA either by reordering their priorities or by legislation, might work for awhile. However, as long as these agencies continue to exercise unconstitutional legislative and/or judicial power, the current problems and dangers to society will persist. The reason is that the history of authoritarian systems is well-known.(12-14) Examples of such systems have been repeatedly demonstrated over the past 60 years, not only in Nazi Germany and the former Soviet Union, but also in most of the underdeveloped countries in the world. There is little question that the FDA and HCFA are exhibiting the same dangerous attributes that are inherent in authoritarian systems.
The current question is: "What can be done to change the FDA and HCFA into organizations that have a positive, rather than a negative, effect on society?" There are several possibilities.
Constructive change could come from Congress, but we should not expect a revolution because Republicans now face the same political incentives and restraints previously faced by the Democrats and, unfortunately, they are beginning to act similarly. Thus, the most desirable solution would be for the United States Supreme Court to take the lead and re-establish the authority of the Constitution as the Supreme Law of the Land.
Numerous proposals have been offered to change the structure of the FDA. These range from a plan to provide funding strictly from royalties derived from products approved by the agency, to limiting its function to the determination of safety. One of the more sensible suggestions would alter its mission to that of product certification. No longer would it engage in excruciatingly detailed rule-making and law enforcement. Consumers, therefore, would be free to purchase products lacking FDA certification, and sellers would be free to sell uncertified products without government interference.(15)
Defenders of the current system claim that such a "drastic" change would be too dangerous because charlatans and imposters would flood the market with ill-devised and harmful "remedies." But such a response is irrational, because the evidence suggests otherwise. The prime example presented by defenders of the status quo is thalidomide. Yet, it is now known that the market had already solved that problem prior to the government-imposed sanctions. In effect, the government simply provided another example of what Professor E.G. West termed the "galloping horse" phenomenon.(16) In reality, market forces and their ramifications, including our legal system, provide the most effective methods of protecting the public from harmful drugs and devices. Enforcement of the Constitution, together with more sensible guidelines, would unleash the most effective controls.
In the final analysis, as stated by Ludwig von Mises in 1927, "The ultimate outcome in the struggle between libertarianism and totalitarianism will not be decided by arms, but by ideas. It is ideas that group men into fighting factions, that press the weapons into their hands, and that determine against whom and for whom the weapons shall be used. It is they alone, and not arms, that, in the last analysis, turn the scales."(17) It is ideas that led to the fall of the Soviet Union. Although some state that it was predetermined and that it was merely a matter of time before it fell, nothing is predetermined. The course of events is influenced by unexpected forces and directed by men of vision and resolve.
In the recent past, for example, the determination and wisdom of Ronald Reagan set the course in world affairs, which led to an outcome which was nothing less than the fall of the "Evil Empire." We can benefit from this lesson if we set our sights on the ultimate triumph of individual rights over totalitarian forces, whatever form they may take. We must attack this issue on a philosophical basis, while at the same time maintain pressure at every level. Therefore, it is imperative that we look beyond our next transaction and not lose sight of the ultimate goal, which is the triumph of liberty. If we remain steadfast in this resolve, the future is clear. By choosing this path, we cast our lot with those who would preserve high quality medical care, together with those who would guarantee liberty for every citizen.
It is one thing to claim that the function of government is to determine whether or not a given product is safe or not safe for citizens to use. But in a free society, there is no justification for forcing people to do what the government states is best for them. To do so is tyranny. Peter McWilliams succinctly calls it, "The absurdity of consensual crimes in a Free Society."(18) The absurdity hits home with the realization that any adult with a terminal illness who is given up as a hopeless case by the medical establishment can be put in jail for trying certain alternative therapies because the FDA has determined that such treatment might prove harmful.
The historic and continuing struggle of citizens against government oppression must be fought at several levels. Vigilance in opposing specific actions that infringe on citizens' rights is critical. However, the battle will not be won at that level alone. Our major focus must address the philosophic issue by concentrating on the concept of Constitutional Supremacy and the rule of nondelegation to expose the unconstitutional structure and actions of the FDA and HCFA (and other regulatory agencies). Equally important, we must pressure our "public servants" at all levels of government to simply adhere to the vows they take when sworn into office. At that time, they promise to uphold the Constitution. It is a travesty that most of them break this vow immediately after swearing to uphold it. Justice Joseph Story had strong opinions on this issue. He felt that if a judge departs from the original meaning of the Constitution, he acts on his own personal opinion of the public good or wise policy --- i.e., he usurps powers not given to him by the people through their Constitution. Therefore, he is no longer interpreting the Constitution, but amending it in a manner contrary to what the document itself permits.(19)
Justice John Marshall's driving interest was to establish the Constitution as the supreme law of a tripartite system. What does this mean in practical terms? Is it relevant or is it simply a concept of theoretical interest only? For much of the 20th century, we failed to honor constitutional principles and the executive branch has increasingly exercised legislative powers. However, in recent decisions the court has begun to address this issue, so we, as Benjamin Franklin, may be viewing a rising, not a setting, sun.(20)
Most dramatic was the recent case where the court firmly declared that the line item veto was unconstitutional.(21,22) The decision was based on the separation of powers. It was emphasized that Congress has no authority to delegate legislative power to the executive branch. Indeed, Alexander Hamilton in rejecting the idea that Congress could delegate its authority to any other power stated: "There is no question which depends on clearer principles than that every act of a delegated authority, contrary to the tenor of the commission under which it is exercised, is void. No legislative act, therefore, contrary to the Constitution can be valid."(23)
More recently, in Washington Legal Foundation v. Friedman, Federal District Court Judge Royce C. Lamberth ruled that the FDA could not prevent pharmaceutical companies from informing physicians of valuable off-label (not FDA approved) actions of drugs.(24) The decision was based on First Amendment rights. This decision was followed by an Act of Congress on November 21, 1998: The FDA Modernization Act (FDAMA) which attempted to overrule the Friedman court decision by legalizing the FDA's unconstitutional regulations.(25) This law was enacted to amend the Federal Food, Drug and Cosmetic Act.(26) In response to an appeal by the government, the court reconsidered its decision made in July 1998, with an opinion on July 28, 1999.(27) The court stated that the FDA's claims were "preposterous" and akin to "constitutional blackmail." The decision firmly upheld the court's decision in 1998 and the FDAMA was ruled unconstitutional. The ruling states that the "Defendants shall not in any way prohibit, restrict, sanction or otherwise seek to limit any pharmaceutical or medical device manufacturer or any other person" ...from publicizing any information on off-label uses of drugs or devices "...previously published in a bona fide peer-reviewed professional journal." It would be reasonable to expand these same criteria for the initial approval of a drug or device.
Most recently, the Supreme Court ruled that the FDA's attempt to regulate tobacco was unconstitutional.(28) It was a bold and much needed, if belated, decision. More serious is the court's continuing failure to recognize that many and probably most "laws" (regulations) written by regulatory agencies are unconstitutional.
The recent decisions of the Supreme Court, together with the fact that the unconstitutional actions of the FDA and HCFA have deprived American citizens of optimum medical care, point toward the next logical step: A constitutional challenge must be made in the form of a legal case. To have standing in court, the plaintiff must be an individual, or a body, who was damaged by an unconstitutional action of either HCFA or the FDA. This could either be a physician, or a patient, or even an institution. The recent announcement that the Association of American Physicians and Surgeons (AAPS) is considering such a case is very encouraging. For maximum benefit, the case must be one which not only will receive a favorable opinion from a District Court, but one which the Supreme Court will elect to accept for consideration, rather than simply accepting the District Court's opinion.
In recent years, the Supreme Court has accepted far fewer cases than in previous years. Yet, this fact should in no way discourage the development of such a case, because the court's powers are limited and it may simply be waiting for a suitable case (or series of cases). The court has no legislative power, so it can only make decisions on cases presented to it. There is a real possibility that a suitable case has never appeared.
The unique value of our Constitution is the balance of power it establishes between three equal branches of government. Once discovered by our Founding Fathers, this concept immediately captured their imagination, and it became the central driving issue during the Constitutional Convention in 1787. The Founders understood the danger that results when any two of the three powers are exercised by a single branch: When the lawmaker also becomes the enforcer, or the accuser becomes the executioner. As a result, the Founding Fathers specifically created a Constitution that separated these three powers between three equal divisions of government.
Likewise, there no longer is any doubt that the regulatory agencies, including the FDA and HCFA, now have legislative, as well as executive, powers. Such imbalance was defined by James Madison as tyranny, because power is transferred from the people to the government. Thus, the concentration of power in the hands of regulatory agencies has resulted in an authoritarian system where power has been extracted from the people and centralized by the government.
The first step toward recovery is recognition of the problem.
1. Orient JM. Can "health care fraud"
be ended? Medical Sentinel 1998;3(4):124-130.
2. Trasby TR. What has government done to our health care? Cato Institute, Washington, DC, 1992.
3. Crews CW, Kerrigan K. Here's a winning issue. Wall Street Journal, editorial page, March 7, 1996.
4. Driscoll JA. Cure for FDA-induced pain. Wall Street Journal, editorial page, February 8, 1996. Regulatory gridlock should not be compared with the much ballyhooed "government gridlock" which is actually the system of checks and balances the framers created to prevent runaway government.
5. Higgs R. Wrecking ball: FDA regulation of medical devices. Policy Analysis #235, Cato Institute, Washington, DC, August 7, 1995.
6. Higgs R. Hazardous to our Health? FDA Regulation of Health Care Products. Oakland, CA, The Independent Institute, 1995, pp. 64-66.
7. Dick, W. Internal fixation of thoracic and lumbar spine fractures. Lewiston, NY, Hans Huber Publication, 1989.
8. Berkman EF, Cruse RN, Mukherjee DP, Sadasivan KK, Albright JA. A comparative biomechanical evaluation of the thoracolumbar burst fracture in human and canine spine. Orthopaedic Transactions 1994;18(2):77.
9. White JS. The pedicle screw lawsuits: Can CME finally come out of the shadows? Medical Economics, September 1998, pp. 40-46.
10. Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems. Federal Register, July 27, 1998, Vol. 63, No. 143, pp. 40025-40041.
11. Higgs, Hazardous to our Health? op. cit., pp. 13-27.
12. Albright JA, Bleck, EE, Ricardo-Campbell R. Health care in the United States: What we should keep and what we should change. Essays in Public Policy, Hoover Institution, Stanford University, 1994, p. 9.
13. Hayek F. The Road to Serfdom. Chicago, IL., University of Chicago Press, 1944, p. 100.
14. Bastiat F. The Law. The Foundation for Economic Education, Irvington-on-Hudson, NY, 1950. Translation of 1850 Edition.
15. Higgs, Hazardous to our Health? op. cit., pp. 97-101.
16. Seldon A. Capitalism. Basil Blackwell Ltd, Oxford, UK, 1990, p. 258. When the solution to a problem is already in place, but not widely recognized, "the occupational disease of politicians is to succumb to the inducements of the political process to 'interfere' by putting themselves at the head of 'prospering systems' in order to win credit for their wisdom and public spirit but often to end by obstructing them. Professor West accused the politicians of jumping onto 'a galloping horse.' " Almost invariably, the outcome is a progressive deterioration of the program at issue.
17. Mises L. Liberalism: The Classical Tradition. The Foundation of Economic Education, Inc. Irvington-on-Hudson, NY, 1996. Translation of 1927 edition, translated by Ralph Raico, p. 51.
18. McWilliams P. Ain't Nobodies Business If You Do. Los Angeles, CA, Prelude Press, 1993.
19. Story J. A Familiar Exposition of The Constitution of the United States, 1840. Reprinted by Regency Books, Lake Bluff, IL, 1986, pp. 68-70. Forward by Edwin Meese III, p. 12.
20. Madison J. Notes of Delegates in the Federal Convention of 1787. Reissued by Norton & Co., NY and London, 1987, p. 659. At the conclusion of the Federal Convention in 1787, while the last members were signing the Constitution, Madison reported that Doctor Franklin looked toward the President's chair at the back of which a rising sun had been painted. He was heard to say that painters found it difficult to distinguish between a rising and a setting sun. He said he often looked at that sun but due to the "vicissitudes of his hopes and fears" during the convention, he was unable to tell whether it was rising or setting. But now, he said, "... I have the happiness to know that it is a rising and not a setting sun."
21. City of New York v. Clinton and Snake River Potato Growers v. Rubin, 985 F Supp. 168, p. 169. (D.D.C.) February 12, 1998. The court held that "...the Line Item Veto Act violates the procedural requirements ordained in Article I of the United States Constitution and impermissibly upsets the balance of powers so carefully prescribed by its Framers. The Line Item Veto Act therefore is unconstitutional."
22. Clinton v. City of New York, WL 333013 (U.S.) p. 14, 1998. Supreme Court of the United States, June 25, 1998. The court held that the Line Item Veto Act "...would authorize the President to create a different law - one whose text was not voted on by either House of Congress or presented to the President for signature." Furthermore, "such change must not come by legislation but through the amendment procedures set forth in Article I of the Constitution." Therefore "The judgment of the District Court is affirmed."
23. Hamilton A, Madison J, Jay J. The Federalist Papers. New York, New American Library, No. 78, p. 467.
24. Washington Legal Foundation v. Friedman, 13F. Suppl. 2d 51 (D.D.C.) July 30, 1998).
25. FDA Modernization Act. Dissemination of Information on New Uses. Public Law 105-115 (S. 830). Title IV, Section 401, November 21, 1998.
26. Federal Food, Drug, and Cosmetic Act Section 554(d), as amended 21 U.S.C.A. Section 360aaa-3(d), 1999.
27. Washington Legal Foundation v. Henney and Donna Shalala. 1999 WL 557679, *2, *6 (D.D.C.) July 28, 1999. The Court held that "...the FDAMA largely perpetuates the policies held unconstitutional by the court on July 30, 1998 and therefore may not be applied or enforced by FDA." The court held that the Central Hudson Test (447 U.S. 557, 1980) applied: "If the speech is truthful and nonmisleading, the government must demonstrate a substantial interest that is directly advanced by the regulation without burdening substantially more speech than necessary."
28. Food and Drug Administration, et al., v. Brown and Williamson Tobacco Corporation 153 F. 3d 155 (98-1152) USC, March 21, 2000.
Dr. Albright is Professor and Chairman of the Department of Orthopedic Surgery at Louisiana State University Medical Center in Shreveport, Louisiana. His e-mail is firstname.lastname@example.org.
Dr. Albright does not have a conflict of interest with any of the products discussed in this article, although as an orthopedic surgeon, he has performed numerous laboratory studies on pedicle screws and associated implants.
Originally published in the Medical Sentinel 2000;5(6):205-208. Copyright © 2000 Association of American Physicians and Surgeons (AAPS).