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Who Should Choose? Patients and Doctors or the FDA? by Doug Bandow

Good ideas in Congress rarely have a chance. Rep. Fred Upton (R-Mich.) is sponsoring legislation to speed drug approvals, but his initial plan was largely gutted before he introduced it last month.

Congress created the Food and Drug Administration in 1906, long before prescription drugs became such an important medical treatment. The agency became an omnibus regulatory agency, controlling everything from food to cosmetics to vitamins to pharmaceuticals. Birth defects caused by the drug Thalidomide led to the 1962 Kefauver-Harris Amendments which vastly expanded the FDA’s powers. The new controls did little to improve patient safety but dramatically slowed pharmaceutical approvals.

Those who benefit the most from drugs often complain about the cost since pills aren’t expensive to make. However, drug discovery is an uncertain process. Companies consider between 5,000 and 10,000 substances for every one that ends up in the pharmacy. Of those only one-fifth actually makes money—and must pay for the entire development, testing, and marketing processes.

As a result, the average per drug cost exceeds $1 billion, most often thought to be between $1.2 and $1.5 billion. Some estimates run more.

Naturally, the FDA insists that its expensive regulations are worth it. While the agency undoubtedly prevents some bad pharmaceuticals from getting to market, it delays or blocks far more good products.

Unfortunately, the political process encourages the agency to kill with kindness. Let a drug through which causes the slightest problem, and you can expect television special reports, awful newspaper headlines, and congressional hearings. Stop a good drug and virtually no one notices.

It took the onset of AIDS, then a death sentence, to force the FDA to speed up its glacial approval process. No one has generated equivalent pressure since. Admitted Richard Merrill, the agency’s former chief counsel:  “No FDA official has ever been publicly criticized for refusing to allow the marketing of a drug.”

By 1967 the average delay in winning approval of a new drug had risen from seven to 30 months after the passage of Kefauver-Harris. Approval time now is estimated to run as much as 20 years.

While economist Sam Peltzman figured that the number of new drugs approved dropped in half after Kefauver-Harris, there was no equivalent fall in the introduction of ineffective or unsafe pharmaceuticals. All the Congress managed to do was strain out potentially life-saving products.

After all, a company won’t make money selling a medicine that doesn’t work. And putting out something dangerous is a fiscal disaster. Observed Peltzman:  the “penalties imposed by the marketplace on sellers of ineffective drugs prior to 1962 seem to have been enough of a deterrent to have left little room for improvement by a regulatory agency.”

Alas, the FDA increases the cost of all medicines, delays the introduction of most pharmaceuticals, and prevents some from reaching the market. That means patients suffer and even die needlessly.

The bureaucracy’s unduly restrictive approach plays out in other bizarre ways. Once a drug is approved doctors may prescribe it for any purpose, but companies often refuse to go through the entire process again to win official okay for another use. Thus, it is common for AIDS, cancer, and pediatric patients to receive off-label prescriptions. However, companies cannot advertise these safe, effective, beneficial uses.

Congress has applied a few bandages over the years. One was to create a process of user fees through the Prescription Drug User Fee Act. Four economists, Tomas Philipson, Ernst Berndt, Adrian Gottschalk, and Matthew Strobeck, figured that drugmakers gained between $11 billion and $13 billion and consumers between $5 billion and $19 billion. Total life years saved ranged between 180,000 and 310,000. But lives continue to be lost because the approval process has not been accelerated further.

Criticism and pressure did lead to creation of a special FDA procedure for “Accelerated Approval” of drugs aimed at life-threatening conditions. This change, too, remains inadequate. Nature Biotechnology noted that few medicines qualified and “in recent years, FDA has been ratcheting up the requirements.”

The gravely ill seek “compassionate access” to experimental drugs. Some patients head overseas unapproved treatments are available. The Wall Street Journal reported on those suffering from Lou Gehrig’s disease who, “frustrated by the slow pace of clinical drug trials or unable to qualify, are trying to brew their own version of an experimental compound at home and testing it on themselves.”

Overall, far more people die from no drugs than from bad drugs. Most pharmaceutical problems involve doctors misprescribing or patients misusing medicines. The deadliest pre-1962 episode involved Elixir Sulfanilamide and killed 107 people. (Thalidomide caused some 10,000 birth defects, but no deaths.) Around 3500 users died from Isoproterenol, an asthmatic inhaler. Vioxx was blamed for a similar number of deaths, though the claim was disputed. Most of the more recent incidents would not have been prevented from a stricter approval process.

The death toll from agency delays is much greater. Drug analyst Dale Gieringer explained:  “The benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties per decade or 10,000 per decade for worst-case scenarios.  In comparison … the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade.”

According to the Competitive Enterprise Institute, among the important medicines delayed were ancrod, beta-blockers, citicoline, ethyol, femara, glucophage, interleukin-2, navelbine, lamictal, omnicath, panorex, photofrin, prostar, rilutek, taxotere, transform, and vasoseal.

Fundamental reform is necessary. The FDA should be limited to assessing safety, with the judgment as to efficacy left to the marketplace. Moreover, the agency should be stripped of its approval monopoly. As a start drugs approved by other industrialized states should be available in America.

The FDA’s opinion also should be made advisory. Patients and their health care providers could look to private certification organizations, which today are involved in everything from building codes to electrical products to kosher food. Medical organizations already maintain pharmaceutical databases and set standards for treatments with drugs. They could move into drug testing and assessment.

No doubt, some people would make mistakes. But they do so today. With more options more people’s needs would be better met. Often there is no single correct treatment decision. Ultimately the patient’s preference should control.

Congress is arguing over regulatory minutiae when it should be debating the much more basic question: Who should decide who gets treated how? Today the answer is Uncle Sam. Tomorrow the answer should be all of us.

Doug Bandow

Doug Bandow is a senior fellow at the Cato Institute and the author of a number of books on economics and politics. He writes regularly on military non-interventionism.

The 6 Things You Need to Know About The Human Care Complex

This is the first in a series of columns on America’s human care system. With the Affordable Healthcare Act now the law of the land, it is time to understand six things: the who, what, where, when, why and how we got here.

In 1976, the great critic of 20th-century society, Ivan Illich, wrote: “Modern medicine is a negation of health. It isn’t organized to serve human health, but only itself, an institution. It makes more people sick than it heals.”

In 1961 President Dwight D. Eisenhower warned America about a growing government-industrial complex.

During his farewell speech Eisenhower warned, “In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the military industrial complex. The potential for the disastrous rise of misplaced power exists and will persist.” [Emphasis mine]

Since 1961 the military-industrial complex has been surpassed by the political power of the government/human care complex.

Eisenhower said, “The prospect of domination of the nation’s scholars by federal employment, project allocations, and the power of money is ever present and is gravely to be regarded. Yet, in holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy could itself become the captive of a scientific technological elite.” [Emphasis mine]

The human care “scientific technological elite” is now in the hands of the National Institute of Health (NIH). The NIH human care system, in some cases, is not about improving health. The NIH human care system may ultimately result in increased cases of pain, suffering and death.

Since passage of the Affordable Healthcare Act, there has been a battle raging over the control of human care. The battle is between the producers and consumers of human care — or as Illich and others have described it: sickness or  illness care. There are a growing number of consumers being cared for by the Social Security, Medicare and Medicaid systems. Estimates are that ten thousand Americans daily are entering the federal human care system.

A growing number of doctors and think tanks are recognizing that the human care system is not designed to make people healthy; rather, it is designed to grow and be sustained by ever more illness care. This is accomplished via human care standards called “protocols.”  The illness care providers are ultimately responsible for human care medical guidelines becoming protocols.

The human care system has become a government/industrial complex controlling over 17% of America’s GDP. In comparison, the military is less than 4% of GDP.

Patients believe human care providers are acting in their best interests.

However, like any other producer of products or services, the human care system is focused on keeping competition down, increasing scarcity of services with the objective of keeping costs and thereby profits high. The human care system is by definition a cartel. A cartel is defined as, “A combination of independent business organizations formed to regulate production, pricing, and marketing of goods by the members.”

Add to the “human care cartel” government at every level and you have a powerful force, which few are willing to confront.

Dr. Barbara Starfield, MD, MPH, looked at the human care system in her landmark study, “Is US health really the best in the world?”, published in the July 2000 edition of the Journal of the American Medical Association. Dr. Starfield came to the following conclusions:

Every year in the US there are:

  • 12,000 deaths from unnecessary surgeries;
  • 7,000 deaths from medication errors in hospitals;
  • 20,000 deaths from other errors in hospitals;
  • 80,000 deaths from infections acquired in hospitals;
  • 106,000 deaths from FDA-approved correctly prescribed medicines.
  • The total of medically-caused deaths in the US every year is 225,000.

According to Dr. Starfield, “This makes the medical system the third leading cause of death in the US, behind heart disease and cancer.”

In 2010 Dr. G.R. Greenwell, MD, FACSM, began examining the US human care system. According to Dr. Greenwell, “Chronic noncontagious illnesses such as diabetes, arteriosclerosis  and hypertension have been continually increasing since the Office of Disease Prevention and Health Promotion (ODPHP) was established in 1976.”

“From 1976 to 1987 the number of diabetics in the United States increased by 25%. In 1995 the methodology for decreasing the incidence and severity of diabetes by more than 58% was demonstrated. Since that time the ODPHP has failed to require demonstrations and research projects to utilize that methodology in order to receive grants or funding. Consequently the percentage of people living in the USA suffering with diabetes has increased over 107% since 1995. The number of people in the United States with diabetes has increased 138% since 1995,” notes Dr. Greenwell.

Dr. Greenwell reports, “In 2006, approximately 65,700 non-traumatic lower-limb amputations were performed on people with diabetes. During the first 10 years of the War on Terror the total number of lower limb amputations of active-duty armed forces personnel was only 1,621.”

Dr. Greenwell points out, “The number of lower limb amputations due to diabetes and vascular disease during 2006 was 109,500. It’s been proven that if an optimum aerobic exercise program had been included in the treatment of these patients, approximately 80% of these amputations would have been precluded from becoming necessary (see page 8 of the 2011 National Diabetes Fact Sheet).”

The human care cartel is more dangerous than any other cartel because taken to its ultimate end it can contribute to the pain, suffering and deaths of those to whom it purports to serve.

Part II will look at the who and what is behind America’s human care system.

RELATED LINK: The National Council for Aging Care’s information regarding Health and Well Being