AIDS TREATMENT NEWS No. 058 - June 3, 1988
John S. James

Red Tape For the Dying: The Food and Drug Administration and AIDS recommends fundamental reform, in clear language anyone can understand:

"Something clearly is wrong when a regulatory program aimed at protecting the health of Americans sends thousands of its supposed beneficiaries into covert action to obtain potentially effective drugs. What is needed is fundamental reform of the FDA. The agency's power to block new drugs should be eliminated. While FDA should continue to certify drugs that it finds safe and effective, licensed physicians should be allowed, with the patient's informed consent, to prescribe drugs that are not so certified."

The report, which applied to all serious diseases not just AIDS, is published by The Heritage Foundation, 214 Massachusetts Avenue NE, Washington, D.C. 20002, (202) 546- 4400. For a copy, send $2. to this above address; be sure to ask for their "backgrounder number 644".

Why It's Important

* The report is accessible to anyone who can read a newspaper; no special background is required. Yet it has enough substance that we learned much from it, despite our familiarity with the subject.

* The paper provides an excellent overview of what is wrong with the current FDA system, and how and why the problems developed. It summarizes previous ineffective attempts at reform, such as the "treatment IND" regulations announced last year, and explains why they failed.

* It is full of authoritative references--for example to government reports, The New York Times, The Wall Street Journal--which individuals and organizations can use to support their case.

* It arrives at a critical time when interest in drug regulatory reform is stronger than ever.

* It has its own momentum which the AIDS community can build on.

For Example: Explaining Unbalanced Judgment by FDA

Two kinds of error by the FDA--wrongly approving a drug, or wrongly denying or delaying approval--can cost lives. Yet there is so great an institutional bias toward fear of the first kind of error that the second kind is hardly considered at all. The report explained why.

First it quoted a former FDA commissioner:

" '...in all of FDA's history, I am unable to find a single instance where a Congressional committee investigated the failure of the FDA to approve a new drug. But, the times when hearings have been held to criticize our approval of new drugs have been so frequent that we aren't able to count them. The message to FDA staff could not be clearer. Whenever a controversy over a new drug is resolved by its approval, the Agency and the individuals involved likely will be investigated. Whenever such a drug in disapproved, no inquiry will be made. The Congressional pressure for our negative action on new drug applications is, therefore, intense. And it seems to be increasing...'

Then the report suggested that "in large part this is due to the fact that the victims of a mistakenly approved drug are often highly visible, while the victims of a wrongfully delayed drug rarely even realize that they have been injured."

The report listed some consequences of this imbalance. U.S. drug innovation fell by 50 percent after the FDA obtained its current powers in 1962. England, for example, has four times as many new drugs which are not available in the U.S., as the U.S. has which are not available in England. In cardiovascular, respiratory, and gastrointestinal medicine, U.S. drug development has all but stopped; almost all the new drugs are available in England (and elsewhere) but not to Americans, except those who make periodic trips abroad to pick up personal supplies.

And according to an article in The Washington Post, quoted in the report, unjustified FDA delays in approving the heart- attack drug TPA caused three thousand needless deaths in the United States.

An Objection, and Our Reply

Objection: "The proposal would allow unsafe and ineffective drugs to be marketed to desperate people, for profit."

Reply: The proposal would apply only with a prescription, a prominent warning, and informed consent. It would in no way weaken the laws against false or unproven claims, or other forms of fraud.

We should be very careful of the idea that seriously ill persons are "desperate" and therefore unable to decide properly for themselves. Even a decision to try a dubious therapy is often the best, most rational choice among the unattractive options available to that person. The efforts to disempower those seriously ill may stem less from efforts to protect them, than from the fact that persons facing major illness or death may free themselves from the constraints of conventional structures--structures which have evolved to reflect the interests of the most powerful groups (here drug companies, bureaucrats, and professionals) much more than those of the patients, who in the past have not had a seat at the negotiations through which the conventional structures developed.

In other words, persons seriously ill are deprived of the right to make their own decisions, not to protect them, but rather to control them for the benefit and protection of powerful vested interests.

FDA Media Note

You may have noticed the FDA much in the news recently, in its favorite role of hero and protector. The agency has an impressive ability to generate press attention when necessary to divert the thrust of widespread calls for reform.

Don't be misled--no one wants to end the legitimate and necessary consumer protection functions of the FDA. That isn't the issue. Instead, we need reforms to give patients and their physicians final say in an emergency, final say when the agency doesn't know best or has not had the time or resources to get around to making a decision, final say when commercial or bureaucratic empire building would override the best interest of the patient.

Consumer protection has nothing to do with sending thousands of people to their deaths in order to safeguard the FDA's regulatory process, or the market shares and profits of the giant corporations which know best how to work the system and have the contacts and money to do so.

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