Subject: Consumer Protection Could Kill AIDS Patients 
Date: Published: 3/6/91 (100 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Consumer Protection Could Kill Aids Patients
    ----
    By James Driscoll

    Many AIDS activists are coming to the realization that the
 fastest way to develop new treatments is through regulatory
 reform and research incentives for the pharmaceutical
 industry.  Rep. Henry Waxman, chairman of the House
 subcommittee on health and the environment, apparently hopes,
 however, to sidetrack those activists by reintroducing in
 this session of Congress his "consumer protection" amendments
 to the Orphan Drug Act.  Mr. Waxman maintains that his
 amendments will curb excessive corporate profits; in fact,
 they will curb the development of new AIDS treatments.
    Where AIDS activists seek the bread of new treatments, Mr. 
 Waxman has offered them the stone of his anti-research and
 anti-business amendments to the Orphan Drug Act.  "Orphan
 drugs" are unpatented drugs that treat rare diseases.  The
 Orphan Drug Act allows companies to recoup the costs of
 researching orphans by granting them a patent -- like seven
 year market exclusivity.  People with AIDS need orphan drugs
 because their weakened immune systems leave them vulnerable
 to an array of rare opportunistic illnesses.  The incentives
 in the act have made possible many valuable drugs, including
 aerosolized pentamidine, which prevents pneumocystis carinii
 pneumonia, a devastating illness often fatal to AIDS
 patients.
    Mr. Waxman has apparently entrenched himself in a
 1970s-style "consumer protection" ideology.  As he sees it,
 the enemy is greedy, powerful drug companies; Congress's role
 is to badger the FDA to resist company attempts to hurry the
 licensing of new drugs.  As AIDS activists have cried out
 against being "protected to death" and demanded faster drug
 review, Mr. Waxman has tried to divert their attention with a
 red herring -- his charge that those drug companies that do
 invest in AIDS research make "too much" profit.
    Mr. Waxman, rather than being happy with pentamidine's
 success in saving lives, is so angry about the profits its
 manufacturers have made that he wants to gut much of the
 Orphan Drug Act.
    President Bush took a longer view last fall when he pocket
 vetoed Mr. Waxman's first attempt to amend the act.  Mr. Bush
 argued that, since orphan drugs usually produce low profits,
 drug companies will simply avoid them altogether if they are
 penalized whenever they develop a profitable orphan.
    In seeking support for this year's rerun of his
 amendments, Mr. Waxman hopes to persuade AIDS activists that
 drug companies, which are expected to develop new treatments
 to keep AIDS patients alive, should not profit from their
 efforts.Mr. Waxman's claim that the purpose of his amendments
 is to help AIDS patients by lowering orphan drug prices
 collapses under scrutiny.  Even if the amendments have the
 effect of temporarily lowering some drug prices, an unlikely
 outcome, the chief beneficiaries would not be people with
 AIDS but rather public and private health insurers.  In any
 case, the high drug prices needed to spur research are
 ultimately a bargain because new drugs will save everyone
 money by keeping AIDS patients out of the hospital.
    Two of Mr. Waxman's amendments do especially grave harm.
 One retroactively cancels the market exclusivity of an orphan
 drug when epidemic conditions raise the theoretical patient
 population above 200,000.  The other denies orphan status if
 epidemic forecasts raise the theoretical patient population
 above 200,000 within three years.  Such rules send the drug
 companies a discouraging message:  Avoid AIDS drugs because
 Congress will change the rules in the middle of the game for
 strictly political reasons.  This is not bad just for orphan
 drugs; it undermines all AIDS research.
    AIDS activists, especially the pragmatic California
 species, are comprehending that stable incentives are needed
 to make sure new drugs for AIDS are developed.  We are worried
 that drug companies will look at potential AIDS drugs and
 decide not to develop them because the incentives are
 undependable, while the political hassles are a sure bet.  We
 are concluding that the country cannot afford ideological
 legislation that removes incentives from drug companies that
 step forward to help.
    Orphan Drug Act amendments that single out AIDS drugs for
 disadvantages are not what we want from Congress.  Instead, we
 want regulatory reform, such as that proposed by the National
 Commission on Approval of New AIDS and Cancer Drugs.
 Supporting private sector incentives for AIDS drug research
 and expediting approval of those drugs may well cut against
 the grain of Mr. Waxman's old-style consumer protectionism.
 But we hope that he will update his thinking and begin, now,
 to help rather than hinder the struggle to get new treatments
 to patients who desperately need them.
    ---
    Mr. Driscoll, a member of ACT UP Golden Gate in San
 Francisco, is a founder of Path Project, an organization that
 promotes development of new AIDS treatments.

[This article is made available here by Dow Jones Co. for the 
personal and non-commercial use of callers to this bbs, in the 
hope that it will be of some help to those who are suffering 
from the disease and others who are seeking to help them.]