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FDA's compassion for desperate drug companies.

FDA's Compassion for Desperate Drug Companies

The twentieth century opened with an expose of the meat packing industry that prompted almost immediate action to establish the Food and Drug Administration (FDA) to protect consumers from unconscionable industrial practices. Although Upton Sinclair's The Jungle (1906) was meant as a rallying cry for socialism to replace a rigid class system based on "wage slavery," it was the ten pages on meat packing practices in Chicago of the 300-plus page book that attracted worldwide attention and indignation, rather than the story of how Jurgis Rudkus and his family and friends were ruthlessly exploited in the stockyards. As Sinclair wrote about the response, "I aimed at the public's heart and by accident I hit it in the stomach."

As the twentieth century closes, attention is again being focused on the FDA, but this time free enterprise is being given a boost by clamors to "deregulate" the drug approval process, and concern about the food supply has been manifest mainly in hysterical stories such as the poisoning of two grapes from Chile. It is often alleged that AIDS is driving the FDA to modify and even reverse safety and efficacy standards that have been in place since the thalidomide disaster of the early 1960s. But neither the Reagan nor the Bush administrations have shown much concern for the suffering of people with AIDS and even less for gays, IV drug users, and minorities. AIDS is the cover story, the real story is the drug industry.

The anti-regulation Reagan and Bush administrations and the gay rights community probably have only one interest in common: deregulating the drug approval process. The gay community had adopted the administration's position as summed up in ACT UP's (AIDS Coalition to Unleash Power) slogan: "A Drug Trial is Health Care Too." The truth is otherwise: a drug trial is research designed to test a hypothesis, not to help individual patients. This strange alliance has little to do with shared love for those suffering with AIDS, but rather is attributable to federal administrations composed largely of free market advocates, and the deregulation lobbying of drug companies that see the AIDS epidemic as an opportunity to further their own interests.

The Administration's position is that drugs should be permitted to go on the market faster and that dropping approval and licensing prerequisites for marketing would help accomplish this. While still Vice-President, George Bush urged the FDA to develop procedures to expedite the marketing of new drugs intended to treat AIDS and other life-threatening illnesses. In his first debate with Democratic nominee Michael Dukakis, Bush said that in response to his efforts the FDA has "speed up bringing drugs to market that can help." However, he did caution that "you've got to be careful here because there's a safety factor." The policy question is whether the safety factor should be ignored or radically lessened when the research subjects have a fatal illness for which there is no cure. Although the AIDS epidemic is new, the question is not. The FDA has faced it squarely before.

The Laetrile Precedent

In the 1970s, thousands of cancer victims travelled to Mexico and Canada to obtain laetrile, a substance derived from apricot pits. The drug was not available in the United States and was not even studied in experimental trials. In 1975, a group of terminally ill cancer patients and their spouses sued the federal government to enjoin it from interfering with the interstate shipment and sale of laetrile. The FDA vigorously opposed making laetrile available in the United States, even to terminally ill cancer patients, because "there were no adequate well-controlled scientific studies of laetrile's safety or effectiveness."

In 1979, the United States Supreme Court, in United States v. Rutherford,[1] upheld the FDA's position, noting, among other things, that " [1] implementing the statutory scheme, the FDA has never made exception for drugs used by the terminally ill." The Court also agreed with the FDA that safety is relevant to the terminally ill, stating that "[f]or [them] as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeautic benefit."

Changing the Rules

Since 1979, the FDA's public position on the use of unproven drugs and devices in clinical setting has shifted. In 1985, for example, the FDA decided to encourage the use of temporary artificial hearts, even though their use in clinical settings outside of a planned research project could generate no scientifically useful information about these devices. The justification offered was that the FDA should not stand in the way of a physician using an unapproved medical device in an "emergency." In 1987, seemingly in response to increasing political pressure to make experimental AIDS drugs more widely available, the FDA issued new regulations that permit the treatment use and sale of an investigational new drug (IND) that is not otherwise approved for treatment and sale, while the drug is still in clinical trials, if:

(i) The drug is intended to treat a serious or immediately life-threatening disease;

(ii) There is no comparable or satisfactory alternative drug or other therapy available to treat that stage of the disease in the intended patient population;

(iii) The drug is under investigation in a controlled clinical trial under an IND in effect for the trial, or all clinical trials have been completed; and

(iv) The sponsor of the controlled clinical trial is actively pursuing marketing approval of the investigational drug with due diligence. [2]

According to S. Jay Plager, then counselor to the Undersecretary of Health and Human Services, the purpose of these new rules was to give "desperately ill patients' the opportunity to decide for themselves `whether they would rather take an experimental drug or die of the disease untreated.' [3]

In July 1988, FDA Commissioner Frank E. Young announced that the FDA would permit United States citizens to import unapproved drugs from abroad for their personal use. In attempting to justify this policy, the Commissioner said that "[t]here is such a degree of desperation, and people are going to die, that I'm not going to be the Commissioner that robs them of hope." [4]

In mid-1989 the FDA announced a plan to develop a "parallel track" under which people with AIDS who are unable to enroll in certain drug trials would be able to obtain the experimental drug as a treatment. In the words of James R. Allen, director of the National AIDS Program in the Public Health Service:

In exceptional circumstances, a life-threatening disease such as AIDS, we are to give the responsibility to the patient and the patient's physician, while still monitoring them under stringent controls. [5]

And most recently, in October 1989, the FDA reached agreement with Burroughs Wellcome to make AZT, which is still undergoing clinical trials to establish safety and efficacy in children, available free to children not currently in the trials. The New York Times was properly confused enough by this announcement to equate the experimental drug with treatment:

From 200 to 300 children now get AZT in clinical trials, but because Federal approval was lacking until now, children who did not take part in the experiments went largely without treatment. [6]

What's Wrong with Those Actions?

The first thing wrong with these actions is that the arguments the FDA used in Rutherford to justify its central role as a consumer protection agency are correct. All patients, particularly terminally ill patients, deserved protection from profit seekers who want to prey on their desperation. People with AIDS have a lot to lose, including their health, lives, dignity, and money. They can be and have been viciously exploited. Because many victims of AIDS are members of disenfranchised groups that have traditionally been rightfully suspicious of government's view of them, they may be at risk for exploitation by those who proclaim that the government and orthodox medicine are in a conspiracy to deny them treatment.

Second, encouraging the use of unproven drugs is bad public policy because this encourages people to pretend that quack remedies are real treatments, and this an only provide temporary false reassurance. The FDA and other federal agencies (like the Centers for Disease Control) have recognized this in almost all other aspects of the AIDS epidemic. For example, rather than continue to deny that teenagers are engaging in sexual activity, condom use and "safe sex" practices have been recommended to help prevent the spread of AIDS. Similarly, education about the science and epidemiology of AIDS has been used as the major weapon to fight fear and prejudice against those infected by others who would deny them education, housing, employment, and insurance. The scientific facts have been seen as the most powerful weapon against fear bred by ignorance. It is thus at least ironic that attention to scientific facts seems to have been jettisoned when it comes to research on AIDS drugs. It is not compassionate to hold out false hope to terminally ill patients so that they spend their last dollar on unproven "remedies."

By making experimental drugs available to AIDS patients outside of organized clinical trials we are doing little, if anything, for people with AIDS. We are merely comforting ourselves with the illusion that something is being done to combat death - an illusion that is all the more satisfying because it does not call for any additional government funding. But we will pay a high price for this comfortable illusion if it is used as an excuse to abandon the distinction between experimentation and therapy and to transform the FDA from a consumer protection agency into a drug promotion agency.

Third, making unproven drugs available is also poor public policy because if unproven remedies are made easily available it will be extremely difficult if not impossible to conduct scientifically valid trials of new drugs. Many with AIDS will be unwilling to participate in randomized clinical trials, and those who are randomized to an arm of the study they do not like may take the drugs they "believe in" on the sly, making any valid finding from the study impossible. This will delay, not speed up, the discovery and distribution of safe and effective drugs.

FDA's new positions are essentially contradictory and ultimately hypocritical. The sole justification for the parallel track and useless drug import policies, for example, is that adults should be able to "take chances" with their own lives. But no such rationale can explain why infants and children should be denied the protection of institutional review of boards and informed consent. It seems fair to conclude that the compassion is not for the people with AIDS at all, but rather for the drug industry itself, which has been lobbying for decreased regulation for decades. Instead of accepting its responsibility as a consumer protection agency, the FDA seems only too willing to abdicate it. Yet as one community activist put it, in another context: "Even if you have a supply of complaint martyrs you have to infuse your trials with some ethical validity."[7]

When the FDA Commissioner says that the FDA "has a heart as well as a mind," it is fair to ask whether the FDA's role is to provide emotional support for the drug industry or scientific protection to the public. All consumer protection legislation is to some degree paternalistic; in this case it is also realistic. FDA certification of the safety and efficacy of drugs recognizes that the public is in no position to judge the value or usefullness of many medications and that many are dangerous and have serious side effects (which is one reason we also license physicians and require that some drugs be available only upon a physician's prescription). Drug manufacturers have a different social role: to create and sell new products. Their role is not consumer protection.

Libertarians and those with extreme views on individual autonomy, and even some free marketers, object to FDA regulation, equating "pursuit of quackery" (and of unwholesome meat products?) with "life, liberty, and the pursuit of happiness." But autonomy requires adequate and accurate information upon which to base decisions. This is simply impossible in the absence of responsible scientific study and properly designed clinical trials. It is appropriate to concentrate energies and resources in the time of an epidemic. It is also appropriate to assign AIDS drug testing a very high priority and to assure adequate governmental funding for the development and testing of drugs that might be effective. It is also appropriate for NIH and FDA to work together more closely and to develop better dispute resolution systems when disagreements persist that delay drug research. But it is not appropriate or ultimately helpful to use the AIDS epidemic as an excuse to rush inadequately tested drugs to market. The thalidomide episode taught us all that lesson; and our experience with suramin, HPA-23, dextran sulfate, and Compound Q to name just a few, should have reinforced it.

The FDA's Role

The FDA has been the focus of much criticism for not producing a cure for AIDS. But this is not its responsibility. The FDA does not develop, manufacture, or test new drugs for marketing; it approves as "safe and effective" drugs that are made and tested by others who seek to market them in the United States. Its role is not to further the interests of drug companies, but to protect the public. It does this by insisting on strict standards in drug testing. Shortcuts that undermine these standards risk the health of all who later use a drug that has been too hastily approved. The excuse that patients are dying without treatment and have "nothing to lose" is not persuasive. Terminally ill patients can be harmed, misused, and exploited. Realistic discussion of death and accurate education about the status of unproven AIDS drugs and the reason randomized clinical trials are needed is in order. It is not compassionate to make quack remedies easily available to those who can pay for them or to supply dying patients with false promises. True compassion demands that we allocate the money and staff necessary to conduct meaningful scientific research expeditiously, and that when valid clinical trials demonstrate a therapy is "safe and effective," we make it available to all who need it regardless of their ability to pay.

A familiar rhyme in the U.S. in 1906 was:

Mary had a little lamb,

And when she saw it sicken,

She shipped it off to


And now it's labeled chicken.[8]

The drug industry of the late twentieth century may not be as ruthlessly profit-centered as the meat packing industry at the beginning of the century. But with pretax profits of 23 percent of sales in the first half of 1989 (compared to 8% for all manufacturing) and pretax earnings of 43 percent of shareholders' equity (compared to 22% for all manufacturing), it is one of the most profitable sectors of the economy.[9] As the number of prescriptions written in the U.S. has stabilized at 1.5 billion since 1982, new profits will primarily be made either by raising prices on existing drugs, or by replacing existing drugs with new and more expensive ones.[10] In such a climate it is not surprising that the drug companies would want an easier road to marketing new drugs. But labelling experimental drugs "therapy" no more changes their nature than labelling diseased lamb "chicken."


[1] 424 U.S. 544 (1979). [2] 21 C.F.R. sec. 312.34. [3] Robert Pear, "U.S. to Allow Use of Trial

Drugs for AIDS and Other Terminal Ills,"

New York Times, 21 May 1987, Al. [4] Philip M. Boffey, "FDA Will Allow AIDS

Patients To Import Unapproved Medicine,"

New York Times, 24 July 1988, 1. [5] Milt Freudenheim, "Sick Get Experimental

Drugs Free," New York Times, 21 October

1989, 35. [6] Philip J. Hilts, "AZT to Be Widely Given Out

To Children With AIDS Virus," New York

Times, 26 October 1989, Al. [7] Joseph Palca, "AIDS Drug Trials Enter New

Age," Science, 6 October 1989, 19. [8] Robert D. Downs, "Afterword," in The Jungle,

Upton Sinclar (New York: New American

Library, 1960.) [9] Milt Freudenheim, "Price Revolt Spreading

on Prescription Drugs," New York Times, 14

November 1989, D1, D6. [10] Freudenheim, "Price Revolt."
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Title Annotation:U.S. Food and Drug Administration
Author:Annas, George J.
Publication:The Hastings Center Report
Date:Jan 1, 1990
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