a. Websites
www.thebody.com/govt/developing.html
An index of articles on "Treatment Policy in the Developing World" provided by The Body, an AIDS and HIV resource. Articles include the following and some older ones:

1.) www.thebody.com/poz/columns/10_99/publiceye.html
Ireland, Doug. "Veep Show: AIDS-drugs-for-Africa protests dog Gore, divide advocates and drive issue." October 1999. From POZ.
2.) www.thebody.com/atn/326.html#gore
James, John S. "Activists Block Gore's Office to Protest Terms of Africa Deal." September 3, 1999. From AIDS Treatment News.
3.) www.thebody.com/poz/columns/9_99/sos.html
Strub, Sean D. "S.O.S.: The moral of this story? Activism still works, and needs you." From POZ. September, 1999
4.) www.thebody.com/wa/summer99/president.html
"No Matter Who's President, AIDS Is Still a Worldwide Crisis." Summer, 1999. From Women Alive, et al.
5.) www.thebody.com/iapac/edit899.html
Nary, Gordon. "Sloppy Homework." August, 1999. On activism, Al Gore, and AIDS in Africa. From the International Association of Physicians in AIDS Care (IAPAC).
6.) www.thebody.com/atn/322.html#africa
James, John S. "Africa, Access, and Patents: Moving Fast." AIDS Treatment News. Issue #322 July 2, 1999.
7.) www.thebody.com/poz/columns/7_99/calltoarms.html
Jackson, Jr., Jesse. "Keep HOPE Alive: Here's what you can do for Africans with AIDS." From POZ. July, 1999.
8.) www.thebody.com/poz/columns/7_99/publiceye.html
Ireland, Doug. "License to Kill: Gore guns for Third World countries trying to make cheap AIDS drugs." From POZ. July, 1999
Clinton/Gore, compulsory licensing, and countries attempting to make cheap AIDS drugs
9.) www.thebody.com/atn/319.html#africa
James, John S. "Hundred Million Dollar Program for Public-Private AIDS Research and Outreach in Africa." AIDS Treatment News. Issue #319. May 21, 1999

www.catholic.org.uk/stop_press/Archives/1998/February%2098/stop_1_010298.htm

From Stop Press. "Free drugs for the poor give donors a PR tonic." The Observer. 1 February 1998. Drug donations to third world countries are just to boost pharmaceutical companies' images and have been bungled.

www.ucsf.edu/daybreak/1998/04/0422_pan.htm
"Controlling the HIV/AIDS Pandemic in the Third World." from UCSFs electronic daily. 1st appeared 4/22/98.

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b. articles
"New Hope." Time. August 14, 1989, 134: 56.
Abstract: Many doctors have long suspected that the drug azidothymidine, or AZT, could benefit the estimated 100,000 to 200,000 Americans who are infected with the acquired immunodeficiency syndrome (AIDS) virus but who have not yet developed full-blown symptoms. Last week a federal study showed that they were right. The research, conducted by a division of the National Institutes of Health, shows that AZT dramatically slows the multiplication of the AIDS virus in people with mild symptoms of the disease, such as diarrhea, thrush (a fungal infection of the mouth), or a chronic rash. Until now, AZT was thought to be effective only in patients with more advanced cases of AIDS. Currently, the drug is the only medication licensed by the Food and Drug Administration (FDA) as a treatment for the disease. Doctors and advocates for AIDS victims were elated at the breakthrough. Many hoped that the news would motivate people who are at high risk for infection--homosexual men and intravenous drug users--to get tested for the disease and seek counseling. But the high cost of AZT--$7,000 to $8,000 a year--will make it difficult for any but the wealthy or the well insured to receive the drug. Some state Medicaid programs pay for AIDS treatment only when the disease is far advanced. People who take AZT to stall the onset of AIDS may not be covered. Burroughts Wellcome Co., which manufactures AZT, is now seeking FDA clearance to use the medication in pre-AIDS patients. If the Federal Government permits the number of consumers to go up, presumably the price will come down.

Dowell, William. "Ethics and AIDS Drug." Time. July 12, 1999, 154: 49.
Abstract: The latest drugs to combat the acquired immune deficiency syndrome (AIDS) virus can cost $15,000 a year per patient. Their use may downgrade AIDS from an inevitable death sentence to a chronic disease. Developing countries are responsible for 90% of new human immunodeficiency virus (HIV) infection. How will countries like Africa and Thailand afford the outrageous cost of the newest drug cocktails? The hottest debate is in South Africa, where 3.5 million of the 40 million citizens are HIV-infected, more than three times the U.S. rate. Africa has 50,000 new HIV cases per month. Drug prices in Africa are high, a holdover from apartheid when price premiums were needed to encourage foreign companies to override sanctions. South Africa passed a law in 1998 that gives the Ministry of Health the power to authorize compulsory licensing. This allows for local production of essential drugs exempt from patent restrictions, and parallel importing, which in turn allows for the purchase of the drugs in a country where they are cheaper. However, 40 drug companies, one-third of them American, filed a suit that has kept the law tied up. Vice President Al Gore has been the target of public debate when AIDS activists accused him of siding with the drug companies. Gore said he supports compulsory licensing and parallel importing as long as they are done in a consistent way within international agreements. Out of a population of 60 million, Thailand has been experiencing a similar struggle. There are approximately 1.5 million HIV infections. Thailand has begun producing its own drugs. Until 1998, Flucanazole, an antibiotic used to fight a fatal form of meningitis that accompanies AIDS, cost $7.36 a tablet. Thais began manufacturing the drug locally and the price dropped to $1. After Thailand started producing its own drugs, pharmaceutical companies began to reduce their prices. Pharmaceutical companies claim that the high prices are necessary to finance new drug development. However, the recent breakthroughs in AIDS research have been paid by U.S. taxpayers. The drug AZT (azidothymidine) was discovered by the National Cancer Institute and given to Burroughs Wellcome. DDI (didanosine) was developed by the National Institutes of Health and licensed to Bristol-Myers Squibb. Bristol-Myers has offered to give $100 million to fight AIDS in five African countries over the next 5 years. A large portion of the money will bring African doctors to the U.S. so that they can be trained to carry out research. Activists believe that the better solution would be for drugs to be available at a price that those in developing countries could afford.

Littlehales, Crispin. "The Price of a Pill." Modern Drug Discovery. January/February,
1999: 21-30.
Abstract: Genzyme's drug Ceredase is a blessing for patients suffering from Gaucher's disease. However, at $150,000 per patient per year, it seems like a classic case of what the public perceives as the pharmaceutical industry's greed, especially since Genzyme's annual profit per patient using the drug is a staggering $31,200. However, pharmaceutical industry insiders say the pricing of Ceredase and other drugs simply reflects the risky business of bringing a new drug to market. In an unprecedented move, Genzyme published a detailed breakdown of how drug pricing for Ceredase is formulated--a breakdown that reflects the pricing system for most new drugs. "Materials" represent less than one-third of the price of the drug, while corporate overhead, sales, state and federal taxes, distribution, and after-tax profit account for more than one third. The rest of the cost is made up of Medicaid rebates, manufacturer's labor and overhead, free samples, and bad debt allowance. The biggest cost in creating a new drug, say manufacturers, is the cost of research and development (R&D), which may take over a decade. The average cost of R&D for a single new drug is currently about $500 million. Just one out of three new drugs, however, ever recoups its average R&D costs. Meanwhile, the cost of R&D has steadily risen over the past 2 decades. While companies spent $4.1 billion on overall R&D in 1985, they now spend an average of $21.1 billion. Nearly one-fifth of the industry's revenues is pumped back into to research. By contrast, the electronics industry returns just 6.4% to R&D efforts. The most intensive R&D is conducted in the area of biotechnology. Biotechnology companies may spend more than three times as much on R&D as the average pharmaceutical companies do. Outside factors that influence the price of a new drug include input by healthcare payers and systems, how much money the drug will save through its use (reduction in hospitalizations, improved productivity of patients, for example), the price of competing drugs, corporate and investor revenue projections, and the number of users the drug is likely to have. Another key factor is the pressure exerted by the largest two consumers of new drugs: health maintenance organizations (HMOs) and the U.S. government (Medicaid, Medicare, and the Veterans Administration). These groups drive tough bargains in an effort to keep drug expenditures down, and they demand detailed cost-effectiveness data on new medicines. Finally, at the level of the local drug store, the price charged to a consumer for the same drug may vary widely from store to store--by as much as 50%, according to one study. In the final analysis, says Robert J. Rubin, M. D., president of the Lewin Group, Pricing.is an area of art, science, and magic. It's closely guarded because the marketplace is fiercely competitive and every product warrants a different strategy."

Thomas, Clare. "False Economies Breed Superbugs." New Scientist. June 8, 1996, 150(2033)
Abstract: Cost-cutting in hospitals may be the cause of the growing problem of antibiotic-resistant bacteria, according to Jerome Schentag, director of the Clinical Pharmacokinetics Laboratory at the Millard Fillmore Health System of the University of Buffalo in New York, who reported on studies to the American Society for Microbiology. Schentag claims that limiting antibiotic treatments to a few less expensive medicines is contributing to drug resistance in bacteria. Schentag's study included 100 U.S. hospitals and found that most prescribe one drug at a time which allows bacteria to develop resistance. Schentag has found that using several antibiotics to wipe out infections before bacteria have a chance to evolve resistance to any one drug is more effective. Schentag claims that existing doses of antibiotics are often inadequate because studies show that dosing is too low to keep blood concentration of the antibiotic at the minimum inhibitory concentration for 80% of the time--resulting in resistance. Schentag recommends "cycling' between different drugs, as well as using multiple antibiotics to make it harder for bacteria to develop resistance. Schentag recommends that during the three days it takes to culture the bacteria for identification, a patient should be given general antibiotics. Once the bacteria is known, the patient could be given drugs which are particularly effective against the microorganism. Schentag also advises switching from intravenous to oral therapy as a cost saving strategy, once the bacterium has been identified. Other researchers argue that switching from an intravenous agent to an oral agent might work in some settings, but research is needed. David Hooper, an infectious diseases expert at the Massachusetts General Hospital in Boston argues that the idea of concentrating on antibiotics that are particularly effective against the bacterium may not work because some bacteria acquire new genes from other microorganisms which might not be wiped out by a narrowly selective antibiotic.

Cohen, Jon. (August 4, 1995). "Bringing AZT to Poor Countries." Science. 269(5224): 624-626.
Abstract: 1994 saw a breakthrough in acquired immunodeficiency syndrome (AIDS) research. It was found that the drug AZT can reduce by almost 70% the risk of an infected mother transmitting the disease to her baby. A campaign is underway to inform U.S. women about the findings and urge them to seek human immunodeficiency virus (HIV) testing and appropriate treatment. Poor countries, though, will have a hard time applying this breakthrough because of several obstacles. Developing countries can afford neither the drug AZT nor the clinics required to administer it. The breakthrough trial, called by its protocol number 076, requires that women have repeated doses of AZT during pregnancy. This regimen would seem to be unfeasible in poorer countries. Another obstacle is that Trial 076 requires infant formula feeding in place of breast milk to avoid spreading the virus. Both the World Health Organization and UNICEF have encouraged women in developing countries to breastfeed their infants because of the lack of formula and unsanitary conditions in these places. Researchers are, however, attempting to apply the findings of Trial 076 to poorer countries by devising less complicated methods. There is one unanswered question that will affect simpler methods: At what point in the pregnancy is AIDS transmitted? Most researchers now believe that the virus is transmitted shortly before or during labor. If this is accurate, one method of controlling the transmittal of AIDS from mother to baby in poor countries may be to administer shorter treatment schedules of AZT near the time of labor, rather than throughout pregnancy. About six trials are now being started in developing countries using this method of administering AZT. Another requirement for applying the results of 076 in poorer countries is to limit the cost of AZT. In some countries, the amount spent per person on health care is about two dollars, or the cost of two AZT capsules. Lowering the drug's cost and finding ways to deliver it to remote areas are necessary if the breakthrough findings of Trail 076 are to be applied in developing nations.

Wallich, Paul. (March 1995). "The Many Costs of Drug Testing." Scientific American. 272: 54.
Abstract: When researchers test a new drug, pressures from many quarters converge on the clinical trial. The Food and Drug Administration (FDA) must worry about whether the trial will adequately answer questions about the drug. A drug company must decide whether sales will repay the cost of studies, and patients worry about getting the best treatment for their illness. Now, as the FDA rethinks how drugs should be studied, the balance among other parties may also shift. Experts have estimated that, depending on what one includes in the estimates, the cost of testing a typical compound in people ranges between $12.5 and $93 million. But regardless of which of these extremes is closer, drug companies definitely do abandon some compounds for lack of a market rather than lack of therapeutic promise. One economics expert points out that "orphan" drug legislation enacted in 1983, which gives companies 7 yr. of exclusive marketing rights, has had some impact on bringing useful but economically marginal products to market. At the same time, some companies have reaped windfalls by winning orphan status for drugs that later turned out to be immensely popular, among them human growth hormone. Researchers do not charge for administering experimental therapy and recording clinical data, but most others concerned with the trial do: a hospital stay while the drug is being administered, blood tests to check for side effects, even long-term care if the patient has a disabling reaction. Additionally, participation in a study generally precludes patients from suing for injuries a new therapy may cause. At one time, insurance companies covered parts of experimental therapies, but lately they have shied away from paying charges that patients receiving ordinary treatment would not incur. (Paradoxically, for some diseases such as cancer and acquired immunodeficiency syndrome, research progresses so rapidly that clinical trials are an almost routine avenue for care). Some are concerned not only of the potential inequity of limiting advanced treatments to the few that can afford them but also for the way that scientific results may be skewed by testing drugs in a tiny, unrepresentative slice of the population. As pressure to contain health care spending increases, however, there are no obvious alternative candidates willing to foot the bill.

Koff, Wayne C. (1995). "The Next Step Toward a Global AIDS Vaccine." Science. 266(1589):
1335-1337.
Abstract: The human immunodeficiency virus (HIV), the virus that causes AIDS, (acquired immunodeficiency syndrome) continues to spread uncontrollably throughout the world, despite efforts to combat the epidemic through promotion of education and behavior modification. The World Health Organization estimates that by the year 2000, at least 40
million people will be infected with HIV, and thus the development of a safe, effective vaccine has become an urgent public health priority. The first generation of vaccine was produced in the
late 1980s when there was optimism that a vaccine similar to the recombinant vaccine produced for hepatitis B could be made for HIV. These AIDS vaccines were predominantly based on HIV's envelope glycoprotein, which is the principal target for neutralizing antibodies. The vaccines focused on AIDS prevention in North America and Europe by targeting a subtype of HIV that predominated in these regions. Optimism has waned as new information about the AIDS virus has emerged: multiple serotypes circulate at the same time in different parts of the
world; the virus has the capacity to infect by cell-free and cell-associated forms; the envelope glycoprotein has the potential to induce infection-enhancing responses; and the early vaccines failed to evoke an effective level of immunity. The National Institutes of Health AIDS
Advisory Committee voted in 1994 to delay efficacy trials of candidate vaccines, believing there was little likelihood of their proving successful. Criteria for an ideal AIDS vaccine have been laid out by scientists and policy makers. They state that the vaccine must be safe; elicit a protective immune response in a high proportion of vaccinated individuals; stimulate both cellular and antibody components of the immune system (since HIV is transmitted via different routes); protect against different variants of the virus; induce long-term protection; induce local immunity in the genital or rectal mucosa; and be practical for worldwide delivery and administration. The development of a single "ideal" vaccine achieving all these goals may be unrealistic, but an effective vaccine that approaches these criteria is a distinct possibility. There are four areas where successful development of a safe and globally effective AIDS vaccine could be accelerated significantly. These include providing incentives for expanded investment in vaccine development. Currently, less than 10% of the total dollars spent on AIDS research is targeted for vaccine development. Commercial manufacturers face considerable disincentives, such as liability and low profit margins, compared with production of therapeutics. To expand biopharmaceutical investment, government funding should be increased, with tax incentives for AIDS vaccine development, guaranteed purchase of licensed AIDS vaccine, orphan drug categorization and assistance with patent protection, and exclusion from pharmaceutical price control legislation. An international regulatory consensus of criteria for licensure of an effective vaccine should be established. An effective but less than "ideal" vaccine could still have dramatic public health benefits. The international capabilities to evaluate the efficacy of the best candidate vaccines should be expanded, in view of the enormous logistical complexities involved in worldwide testing. Such factors as prevalence of HIV in a population, the strain(s) of HIV present, and the level of vaccine efficacy sought--all must be taken into account in designing trials. The cost of vaccine trials also necessitates major investment. International cooperation is essential for conducting successful trials. Improving mechanisms to facilitate information transfer from researchers to manufacturers could also expedite development. Currently, manufacturers must often wait to review data until it has been presented at a scientific meeting or published in a journal, which may result in delay of a year or more. Information flow to manufacturers could be improved without jeopardizing the potential for researchers to publish their findings.

Adams, Paul. (1994). "On the Road." Ford Foundation Report. 25: 25-27.
Abstract: Nigeria, with a population of 88.5 million, is the most populous country in West Africa. It was affected by acquired immunodeficiency syndrome (AIDS) later than many of its neighbors, but is catching up fast. It is estimated that 5% of pregnant women attending prenatal
clinics in Nigeria have human immunodeficiency virus (HIV), and statistics indicate that the number of AIDS cases is doubling every 9 mo. About 100,000 AIDS cases are projected for 1995 and 150,000 in 1996. Nigeria is ethnically and religiously diverse, and communications among factions are often poor. Thus the logistics of a national campaign against AIDS are difficult. Further, the government is severely restricted in what it can allocate to AIDS education because of a budget crisis due in part of falling oil revenues and rising debt obligations. Some assistance has been provided by the U.S. and the United Kingdom, but political uncertainty--there have been four cabinets and three heads of state in the last 24 mo.--has seriously hindered administration of Nigeria's AIDS programs. In an effort to broaden the government's AIDS education program, support was authorized for non- government organizations such as STOPAIDS. Funding for STOPAIDS came almost entirely from the Ford Foundation. Research has shown that long-distance truck drivers are among the groups in West Africa most at risk from HIV, and STOPAIDS has established field offices at several truck stops to address this problem. Much of STOPAIDS' work is aimed at male drivers, but the Society for Women and AIDS in Nigeria (SWAAN) focuses on educating women between the ages of 15 and 45 yr. to causes and effects of AIDS. Two high-risk groups that Nigerian AIDS prevention programs largely discount are drug abusers and homosexuals. Homosexuality is a taboo subject, and there is sensitivity about the drug issue, since the U.S. State Department decided to classify Nigeria among the world's top drug-trafficking countries--which led Washington to cut its assistance to the country. According to non-governmental AIDS organizations, drug abuse is spreading fast, and the cost of illegal drugs is forcing many into prostitution.

Pollner, Fran. (1993). "Battling the High Cost of Drugs." Harvard Health Letter. 18(9-Spec.
Sup.): 9-12.
Abstract: To fight the high cost of drugs, some health maintenance organizations (HMOs) and state Medicaid programs are promoting generics, or negotiating bulk discounts with manufacturers. More and more people are buying their medicines from mail-order discount houses, and key congressional leaders have begun investigations of the pharmaceutical industry's pricing practices. Price- trimming strategies will also surely be part of the Clinton administration's blueprint for health-care reform. Drug companies claim that this will result in a decline in the inventiveness that makes the U.S. pharmaceutical industry a world leader. They say that profits from the occasional compound that makes it to the market must also cover the research and development costs for those that failed. But critics counter that drug companies spend considerably more on promotion than on research and development. Some analysts also challenge the idea that companies need patent protection--17 yr. in the U.S.--to recoup development costs and underwrite more research.
Recent surveys show that increasing drug prices are especially hard on senior citizens, not only because they often receive prescriptions for chronic health problems but also because they are less likely than younger persons to have insurance that pays for many prescription drugs. And despite general awareness that generics are less expensive copies of brand-name medications, only 32% of surveyed consumers over age 45 had ever asked their physician or their pharmacist for the generic version of a drug. Various groups have encouraged people to help contain their health-care costs by asking for generic drugs whenever possible, and in 12 states the law requires pharmacists to substitute generic drugs whenever they are available, unless the doctor specifically orders otherwise. Powerful physicians groups such as the American Medical Association have spoken against automatic generic substitution on the basis that it interferes with the physician's ability to prescribe as he or she sees fit. Just as physicians treasure the ability to prescribe whatever they want, consumers apparently cherish their freedom to shop around. A recent attempt by a Massachusetts HMO to set up a mail-order prescription program and a network of approved pharmacies where participants would be required to fill prescriptions was met with outrage by many members. It is far more difficult to imagine balancing costs, quality, and choice for a diverse population of 260 million and coming up with a system that makes both medical and economic sense. Many, however, have embraced the task, and change is inevitable.

Purvis, Andrew. "Forging a Shield Against AIDS." Time. April 1, 1991, 137(13): 64-65.
Abstract: In more than 60 laboratories around the world, researchers are working with at least 40 different concoctions in pursuit of a most urgent goal: development of an acquired immunodeficiency syndrome (AIDS) vaccine. But while some doubts still exist that an ideal vaccine can actually be created, some researchers believe that enough good candidates now exist to warrant selecting the most effective experimental vaccines for major trials in humans. Last month, health officials and scientists began to lay groundwork for trials in the U.S. and other
nations, and researchers from the World Health Organization (WHO) will begin in April to visit countries in Africa, Asia, and Latin America in order to locate groups in which studies might be conducted. The basic principle behind such human testing is to inoculate several thousand people at high risk for the disease. The experimental agent, most likely an altered version of the AIDS virus or some portion of it, should not be dangerous enough to cause the disease, but should
confer immunity by triggering the production of antibodies and other components of the immune system. Subjects will then be monitored to see if they have a better record of avoiding infection than others who were not vaccinated. However, the epidemiology of AIDS is such that disturbing issues about the conduct of trials have already been raised. In particular, populations at highest risk include drug abusers, prisoners, and prostitutes in the U.S., and truck drivers and military recruits in some African countries--groups not ideal for a structured scientific trial. Further, study participants will hopefully produce antibodies in human immunodeficiency virus (HIV), and, being HIV-positive, could suffer the same discrimination--in getting health insurance or a job--that plagues people with AIDS. Still another problem is that many of the subjects in the Third World may not fully comprehend the risks of participating in these trials. The delicacy of these tests requires cooperation between the drug companies that ordinarily finance much of the cost of vaccine research and various government and inter-government agencies; yet such cooperation has been sporadic at best. Researchers at the National Institutes of Health worry that drug companies will be too inclined to stay with their own projects rather than to pool their resources. Perhaps the most difficult ethical question is the cost of the vaccine. A successful but high-priced vaccine would be of little use to most Africans, and it would be grossly unfair if Africans helped develop the vaccine by taking part in the trials only to see it priced out of the reach of their countrymen. One recently proposed possibility is that Congress offer drug companies an extension on exclusive marketing rights for other lucrative drugs in exchange for keeping the price of an AIDS vaccine down.

"An Aim and a Hope." World Health. June-July-August, 1990 (0043-8502): 8-9.
Abstract: At the beginning of 1990, the World Health Organization (WHO) created a Tropical Diseases Control Division which will work closely with the Special Program for Research and Training in Tropical Diseases (TDR). Dr. Ralph H. Henderson, Assistant Director-General of WHO, oversees TDR and the new control division, in addition to his other duties. During a recent interview he described how research and control of tropical diseases could be part of a greater effort to translate the ideal of primary health care into a worldwide reality. One problem cited by Dr. Henderson is the need for more applied research in cases where control programs experience difficulties in using the tools provided by research. An example is ivermectin, a new drug for river-blindness. The drug, manufactured by Merck and Company, is offered at no cost to countries with river-blindness. But delivery to the people costs about five U.S. dollars a person, and most developing countries can't afford this. Thus, too few countries are taking advantage of Merck's offer. A possible solution is to study how the drug can be matched with other products to produce an overall health package. Such a package, containing a dozen or so of the most essential health items, might not cost much more than delivering a single drug like ivermectin. Such an effort will require coordination between researcher (those who develop the drugs and vaccines) and the control personnel (those who have to use the drugs and vaccines). Dr. Henderson points out that the buildup of individual programs such as the immunization capability and diarrheal disease control initiative has yielded a mass of managerial skills at the national level, able to deliver technologies where they are needed. Upon being asked about what can be done to contain diseases like malaria, Dr. Henderson admitted that malaria is a growing problem which will continue to expand until a universal tool such as a vaccine becomes available. Until then, he suggests, thoughts of controlling malaria will have to be put aside in favor of reducing drastically the number of deaths from the disease. The aim should be to provide children with antimalarial drugs as soon as they become sick, to help them get over their first infection and build up some degree of immunity to subsequent attacks.

Stevens, Tim. (1996). "The big squeeze (high costs of drug research)." Industry Week.
245(17):61
Abstract: The national emergence of managed health care, which has caused government and employers to apply budget pressures and cost controls, has led to a sharp decline in sales for the pharmaceutical industry. This decline led to a steady rise in the cost of drug research, which has tripled since 1986. (full text on Infotrac, previously SearchBank)

Freudenheim, Milt."Costs of drug research seen as overestimated. (Office of Technology
Assessment questions research costs proposed by pharmaceutical industries)." New York
Times, April 30, 1991 v140 pC7(N) pD5(L) col 5

McCarthy, Michael. (1999). "US promises to help poorest nations get needed drugs." Lancet.
354(9195):2061 (full text on infotrac)

Roberts, T.W. "Cost of drugs to the Third World." Times (London), Dec. 10, 1999. Features. (full text on Lexis-Nexis)

Yamey, Gavin. "Cost of drugs to the Third World." Times (London), Dec. 10, 1999. Features. (full text on Lexis-Nexis)

Russell, Sabin. "World Trade Showdown / Activists, Industry Split Over AIDS Drugs /
manufacturers fight affordable access." San Francisco Chronicle. Nov 24, 1999
Abstract: Allied with AIDS activists and Doctors Without Borders (the recent winner of the Nobel Peace Prize), Love's organization developed a strategy to invoke little-known WTO rules that permit poor countries to manufacture drugs ordinarily protected by patents. Combinations of newly developed antiviral drugs have helped cut the U.S. AIDS death rate in half since 1996. But at a cost of more than $1,000 a month, such therapies are hopelessly out of reach for Third World countries, where 90 percent of the world's people with AIDS reside. Although South Africa has yet to carry out any plan to make cheaper AIDS drugs, Thailand's Government Pharmaceutical Organization said on November 12 that it intended to seek a compulsory license to make the AIDS drug ddI from patent-holder Bristol-Myers Squibb. The same WTO rules that permit compulsory licenses also require negotiation of royalties payments to the drug patent holder.
Thailand would have become the first nation to take that step.

Berndt, Ernst R.; Iain M. Cockburn; Douglas L. Cocks; Arnold M. Epstein; Zvi Griliches.
(1998). "Prescription drug prices for the elderly." Monthly Labor Review. Sept 1998:23
(full text on Infotrac)

Studt, Tim. (Jan 1991). More restructuring needed to offset high pharmaceutical R&D costs.
R & D. 33(1): 19.

Hamilton, Robert A. (1990). "History of the Orphan Drug Act." FDA Consumer. 24: 10.
Abstract: FDA set up the Office of Orphan Product Development in 1982 to focus on drugs, medical devices, foods for medical purposes, and biologics such as immune globulin for rare disorders. The Act became law on Jan. 3, 1983, and it guarantees the developer of an orphan drug 7 yr. of market exclusivity and 50% tax credit for certain clinical research expenses. Initially, the act applied only to patient populations when it could be shown there was little hope of recovering development costs from sales in the U.S. A later amendment to the act defined an orphan product as one with a potential patient population of fewer than 200,000 people. Under the Orphan Drug Act, FDA makes grants for drug development, assists the drug developer in designing the clinical studies required for marketing, and can speed up the drug approval process. Since enactment of the Orphan Drug Act, 41 drugs for rare diseases have been developed and brought onto the market. Activity in orphan products--which, in addition to drugs, can include biologics, medical devices, and foods marketed for medical purposes--is reaching an all-time high. According to Marlene Haffner, FDA's director of Orphan Product Development, FDA has designated as orphans 375 drugs, and at least 150 are being actively developed or are going through the approval process. The federal monies available to fund orphan drug development have increased steadily--from $500,000 in 1983 to $7.5 million in 1990. The term "orphan drug" refers to a drug that will serve so few patients that it will be commercially impractical for a manufacturer to sponsor it. Orphan drug also refers to compounds in the public domain for which there can be no patent protection once a company goes through expensive efficacy tests and gets FDA approval, so that a competitor could immediately begin producing a generic copy at a fraction of the cost.

Asbury, Carolyn H. (1991). "The Orphan Drug Act: The First Seven Years." Journal of the
American Medical Association. 265: 893-897.
Abstract: The 1983 Orphan Drug Act sought to increase market incentives and decrease regulatory barriers for products used to treat rare (orphan) diseases. Major provisions included market exclusivity, tax credits, and regulatory process clarifications. Analysis of government and industry data revealed that in the 17 yr. prior to passage of the Act industry sponsored 34 marketed and 24 experimental orphan drugs. The major disincentives which limited commercial interest in orphan products during this period were small market size relative to development expenses, lack of product patents (which confer a 17-yr. period of exclusive marketing protection for a product), and product liability. Since passage of the law, orphan product development has increased significantly; industry has sponsored 39 of 42 marketed orphan products in the 7 yr.
since the Act, and an additional 301 experimental products have orphan designation. Recently, controversy has arisen over whether the law's market exclusivity provision is resulting in unexpected costs to competing sponsors and to patients or their insurers. While 25 of 40 marketed orphan products reportedly had annual sales of less than $1 million annually. This suggests that exclusivity has unnecessarily conferred monopoly benefits on profitable rare disease products and has led to pressure to amend the Act because of the products' therapeutic importance and the large stakes involved. The marketing exclusivity issue has also sparked controversy over whether closely related products can be distinguished.
A second unanticipated situation has also revealed the potential need to amend the Act. Experience has now shown that development of new applications for already approved orphan drugs and growth in the numbers of the target population (as with AIDS) can expand the market
for these drugs in excess of the 200,000 patient limit set for orphan drugs. In 1990, Congress passed a bill to amend the Act so as to address the issues of expanded patient populations and marketing exclusivity. The President, however, quickly vetoed the bill on the grounds that weakening the exclusivity provision would discourage development of orphan drugs and that retroactively changing the population limit rule would send a troublesome signal of unilateral rule change to developers. If major changes in the Act are proposed in the future, their effects on costs and benefits to companies, patients, and the public should be closely examined.

Henkel, John. (1999). "Orphan Drug Law Matures into Medical Mainstay." FDA Consumer. 33:
29-30, 32.
Abstract: An orphan disease is any medical condition affecting less than 200,000 people in the U.S. Currently more than 5,000 of these diseases fall into this category. Because of the relatively low profits to be gained from any drug to help or cure these diseases, few pharmaceutical companies have invested in drug development research for these conditions, making few treatments available for most of these diseases. To help rectify this problem, the Orphan Drug Act of 1983 was passed. This law has allowed significant incentives to be given to any company willing to "adopt" an orphan disease and develop drugs for it. Of the 1,252 applications for orphan disease classification, the Food and Drug Administration (FDA) has approved 917. In 1998, 18 new products from this act were FDA approved. Some of the diseases treated include leprosy, sickle cell anemia, and a pneumonia that affects HIV-infected patients. Incentives included in the Orphan Disease Act now also cover the development of needed medical devices. Even so, big drug companies only comprise about 15% of the applications for orphan disease drug development. As a result, many small biotechnology companies have been started to develop orphan drugs through the incentive program. These companies, due to patent law regulations, have 7 years exclusive rights to the marketing of any new drugs developed. The exclusive rights, along with the orphan incentive program, has allowed American biotechnology to flourish.
There are three ways in which the orphan drug law induces a company to apply for incentives: research grants allotted now add up to $11.5 million/year; the FDA works with the company in designing the research itself; and up to 50% of clinical trial costs can be claimed as credit against owed taxes. Overall, the program has proved beneficial to both orphan disease patients and the companies that develop therapies for them.

Brody, Robert. (Oct 1982). "Orphan drugs." Science Digest, 90:26

Miller, Roger W. . (1980). "Rx for orphan drugs." FDA Consumer. 14:15

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