Copyright 1999 Federal Document Clearing House, Inc.
Federal Document Clearing House Congressional Testimony
July 22, 1999
SECTION: CAPITOL HILL HEARING TESTIMONY
LENGTH: 1854 words
HEADLINE:
TESTIMONY July 22, 1999 PETER LAURIE MD,MPH HOUSE GOVERNMENT
REFORM US ROLE IN COMBATING HIV/AIDS
BODY:
Statement of Peter Lurie., MD MPH Public Citizen's Health Research Group
Before the Committee on Government Reform Subcommittee on Criminal Justice, Drug
Policy, and Human Resources US House of Representatives July 21, 1999 Recently,
the pharmaceutical industry has questioned compulsory
licensing' and parallel importS2 on the grounds that these measures
might 1. lead to the development of strains of the human immunodeficiency virus
(HIV) that are resistant to currently available medications; and 2. result in
decreased pharmaceutical company research and development (R&D). This
testimony will address these two claims in turn. The Viral Resistance Argument
Tom Bombelles, Assistant Vice President International for the Pharmaceutical
Research and Manufacturers of America (PhRMA) has recently asserted: "Just
giving people drugs without the proper treatment can create drug-resistant
strains of HIV. It can make people sicker, not better. And that threatens
AIDS patients everywhere around the world."' The potential
development of resistance to anti-HIV drugs is a serious public health concern,
one that threatens to undermine the enormous gains that have been made in
treatment for HIV infection in this country. But before one can address the
validity of the HIV-resistance argument directly, one must acknowledge the
following aspects of compulsory licensing and parallel
importing that transcend viral resistance: The compulsory
licensing and parallel import proposals do not require any country to
engage in these practices. Rather countries are left to decide for themselves if
they wish to use these mechanisms. But preventing compulsory
licensing and parallel imports in blanket fashion robs developing
countries of that choice. - The compulsory licensing and
parallel import mechanisms proposed by South Africa, for
example, do not only involve AIDS drugs or those for infectious
diseases. The "resistant strain" argument is thus being used to prevent improved
access to lifesaving drugs for even non- infectious diseases such as heart
disease and cancer. Drugs like simvastatin, to lower cholesterol, and
ranitidine, for ulcers, could be dramatically reduced in price. - Fluconazole is
a drug that treats an often-fatal complication of HIV infection, cryptococcal
meningitis, rather than HIV itself. Its price could be dramatically reduced by
either compulsory licensing or parallel importing. Two 150 mg
fluconazole tablets sell for $23.50 in Italy, where its patent is protected,
compared to $0.95 in India where the patent is not recognized. Let me now turn
to the HIV-resistance argument directly. For a patient to be worse off due to
the development of viral resistance, one would have to believe that a patient
who develops a resistant HIV strain due to partial adherence to anti-HIV therapy
is worse off than one who is not treated with anti-HIV drugs at all. But there
is no evidence to support that assertion. First, many patients do not develop
antiviral resistance. Resistance to zidovudine, the first anti-HIV drug to be
approved, has been estimated at 0% to 10% in Europe and North America. Even for
those who develop resistance, there is no reason to believe that the mutations
necessary to confer resistance will be associated with those that confer greater
aggressiveness, as these are separate genetic phenomena. A recent review points
out that in the absence of therapy, "wild-type primarily non- resistant strains
may have a replication advantage over resistant strains that dominates over
time."' There is also some evidence that HIV strains resistant to zidovudine are
more difficult to transmit. The decision to prescribe or not prescribe effective
medication is a matter between a patient and his or her doctor. Two authors,
writing in the American Journal of Public Health have argued that, "it would be
very difficult to justify denial of access to protease inhibitors specific drugs
for HIV infection in the face of expressed patient preference for treatment
except in the presence of clear and compelling evidence that a patient could not
or would not be adherent."' But opposing compulsory licensing
and parallel imports is a blunt instrument indeed: because of high costs,
physicians and patients would be unable to make that case-by-case assessment'
and patients would instead be denied drug simply on the basis of their
residence. The solution to the development of drug resistance due to patient
difficulty in adhering to the often-complex AIDS drug regimens
is not denial of drug, but rather interventions to improve adherence. Such
interventions have had substantial success with tuberculosis in developing
countries,' including with HIV- infected populations." Has anyone suggested
leaving tuberculosis or malaria patients untreated to prevent the development of
resistance? - 0ne should not write off the entire developing world with a
broad-brush stroke. Clearly there are enormous differences between developing
countries and within them. For example, very impoverished African countries such
as Zimbabwe, Zambia, Uganda, Botswana, Senegal and Cote d'Ivoire are planning to
provide anti- HIV drugs for HIV-positive women to prevent HIV transmission to
their infants. " Other countries, such as Brazil, provide complex anti-HIV drug
regimens to their HIV-positive populations. - It is true that pharmaceutical
company pricing practices are not the only reason that anti-HIV drugs are
unavailable in most developing countries. The lack of health care infrastructure
is a very important impediment to drug delivery. But pricing is an important,
and in this case partially correctable, part of the problem. One reason that the
HIV counseling and testing infrastructure in developing countries is weak is
that, in the absence of affordable therapies, there are only limited reasons to
improve it. But, if effective therapy were more widely available, there would be
an incentive to improve the infrastructure. - Adherence is a problem in the
United States as well. Even in the controlled setting of a clinical trial,
non-adherence rates of 25% have been observed. 12 Should we therefore apply the
same logic to some US populations? Imagine if someone tried to make that
argument with respect to all drug users or particular socioeconomic sectors of
the United States. - Is the real concern that resistant strains from the
developing world will enter the US? If so, is the pharmaceutical industry really
arguing that Africans should remain untreated so that Americans can live longer?
In sum, on both policy and virological grounds, the possible emergence of
drug-resistance strains provides no support for arguments against
compulsory licensing and parallel imports. The R&D Scare
Card Tom Bombelles of PhRMA has also asserted that "compulsory
licensing creates an active disincentive to research-based
pharmaceutical industry involvement in the international effort to improve
public health in developing countries, as countries will choose not to develop
medicines which will not be patent- protected. Such disincentives are more
likely to drive patients and the availability of medicines further apart."" This
seems to argue that patients in developing countries should wait patiently
without existing drugs while companies develop other drugs that may eventually
be affordable in developing countries. The history of international drug
development teaches us that this is likely to be an empty promise. Once again,
the pharmaceutical industry is playing its R&D Scare Card. This is an empty
threat: pharmaceutical company R&D expenditures almost doubled between 1990,
when Congress imposed price restraints on Medicaid drugs, and 1995." R&D
represented a median of 11.4% of sales for the top 10 pharmaceutical companies
(ranked by revenue) in 1998. " In contrast, profit (net income) represented a
median of 18.6% of sales by those same companies in 1998. Furthermore, the
pharmaceutical industry is the most profitable in the United States, whether
measured by return on sales, assets or equity. 16 Since 1989, pharmaceutical
company return on equity has been at least 1.7 times the median of all U.S.
industries. 1 7 Given the extraordinary profits generated by the pharmaceutical
industry, and its failure to make many critical medications affordable for
developing country patients, we urge you to call the R&D Scare Card bluff.
Conclusion Neither the viral resistance nor the R&D scare card arguments
provides support for opposing legal trade measures such as compulsory
licensing and parallel importing. The explanation for the
pharmaceutical companies' opposition is to be found elsewhere: in their desire
to not have their irrational pricing practices exposed. We suggest that
providing potentially lifesaving drugs to residents of developing countries
should take a higher priority. 1.Compulsory licensing allows
local production of patented medications with a royalty to be paid to the patent
holder. 2. Parallel importing allows countries to find the lowest price for a
particular drug on the international market, rather than being required to
purchase from the manufacturer at a higher price. 3.World News Tonight with
Peter Jennings (6:30 PM Eastern Time), July 8, 1999 (rush transcript). 4.Yerly
S, et al. Prevalence of transmission of zidovudine- resistant viruses in
Switzerland. Schweiz Med Wochenschr 1996;126:1845-88. 5.Hirsch MS, et al.
Antiretroviral drug resistance testing in adults with HIV infection:
implications for clinical management. JAMA 1998;279:1984-91. 6.Wahlberg J, et
al. Apparent selection against transmission of zidovudine-resistant human
immunodeficiency virus type 1 variants. J Infectious Disease 1994; 1 69:611-4.
7.Bayer R, Stryker J. Ethical challenges posed by clinical progress in
AIDS. Am J Public Health 1997;87:1599-602. 8.Bangsberg D, et
al. Protease inhibitors in the homeless. JAMA 1997;278:63-5. 9.Wilkinson D, et
al. Directly observed therapy for tuberculosis in rural South
Africa, 1991 through 1994. Am J Public Health 1996;86:1094-7.
10. Davies GR, et al. Twice-weekly, directly observed treatment for HIV-infected
and uninfected tuberculosis patients: cohort study in rural South
Africa. AIDS 1999; 13:811-7. 11. Lauie M, et al. Denying
effective antiretroviral drugs to HIV- positive pregnant women -- the national
government's flawed decision. S Afr Med J 1999;89:621-3. 12.Kastrissios H, et
al. The extent of non-adherence in a large AIDS clinical trial
using plasma dideoxynucleoside concentrations as a marker. AIDS
1998; 12:23 05-1 1. 13.Bombelles T. Remarks before Presidential Advisory Council
on HIV/AIDS, Washington, DC, June 7, 1999. 14.Pharmaceutical
Research and Manufacturers Association. Pharmaceutical Industry Profile 1999,
Washington, DC 1999. 15.Based on 1998 Annual Reports. 16.Fortune 500. Fortune
Magazine, April 26, 1999, p. F-27. 17.Sager A, Socolar D. Winning affordable
prescription drugs for all Americans: problems, causes and solutions. Access and
Affordability Monitoring Project, Boston University School of Public Health, 28
June, 1999.
LOAD-DATE: July 26, 1999