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Africa Access: Moving Fast, Outcome Uncertain

February 23, 2001

Two years ago almost nothing was being done about access to medical treatment in Africa and other developing countries; today so much is happening that nobody could make a complete list. Powerful people and institutions are looking for a path forward. Clearly, workable solutions are within reach -- and providing this treatment could be much less costly than generally believed. But even though it is feasible to distribute AIDS drugs in developing nations, there is no guarantee it will happen.

The biggest problem now is lack of leadership on this issue by governments and other major institutions. So the immediate need is to find enough consensus among the different stakeholders to induce governments to exercise responsible leadership. But with most of the pharmaceutical industry long opposed to any workable plan for widespread access to treatment in developing countries, finding consensus may be difficult. [For a fascinating and appalling history of the global decisions not to provide HIV/AIDS treatment to the poor, see Barton Gellman, "An Unequal Calculus of Life or Death," Washington Post, December 26, 2000.]


Solutions Are Possible

The bottom line for any program on treatment access is whether it actually makes treatment available. It is not enough to generate press releases and heartwarming media stories alone, as if to satisfy public demand until the world's attention turns to something else. By this standard there has been only one success so far: generic drug manufacture and distribution, as in Brazil, and generic competition to bring prices down. Pharmaceutical-company discounts which still leave the drugs unaffordable, or company "charitable" type programs which treat a select few if they treat anybody at all, have not worked so far (although these approaches cannot be ruled out for the future).

But generic manufacture and competition will not solve the problem by itself. Brazil can afford to treat its AIDS patients at generic drug prices. But many African countries, with much less money per person and a far higher proportion of their population infected, cannot.

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Jeffrey D. Sachs, a leading economist at the Harvard University Center for International Development, recently told the annual Retroviruses conference in Chicago, and other forums as well, that government leadership is key, and that without it, pharmaceutical-company programs could not be expected to succeed on their own. He showed that the resources required for assisting African and other poor countries in controlling the epidemic (including access to treatment, which is now recognized as a key element of HIV prevention campaigns) would be a minor expense for the world. He has outlined a solution in which pharmaceutical companies follow through on their promises to drop prices sufficiently in developing counties, governments respect the companies' property rights, and rich countries together contribute several billion dollars a year to buy the drugs at the discounted prices. (You can hear Dr. Sachs' talk to the Retroviruses conference at http://www.retroconference.org -- select "Hear the Lectures," then select his address, "From Talk to Action in Fighting AIDS in Developing Countries," and click the button to start playback.)

There is no quick or total solution to making HIV or other medical treatment available to everyone in the world. But the AIDS community and others must urge governments and other major institutions onto a path that will bring steady improvement, by supporting doctors and others who are doing the work, giving them the tools they need to be more successful.


Why Treatment Will Cost Less Than It Seems

Until recently it was popular to estimate the cost of providing HIV treatment to the 90% of people with AIDS now denied it, by multiplying the price of the drugs (usually $10,000 or $15,000 per year) by the number of persons estimated to have HIV in developing countries -- resulting in a figure of hundreds of billions of dollars per year in drug cost, which of course could not be raised, thereby ending discussion. This multiplication was never realistic, for several reasons.

First, most people with HIV do not know they are infected, and are not seeking medical care (and for many with asymptomatic HIV, antiretroviral drugs would not be recommended immediately even if cost were no obstacle). There is no way around the fact that during the foreseeable future, any treatment-access program contemplated for the poorest countries will mostly treat those who are symptomatic and come in for care. So already the cost of providing treatment is reduced to a fraction of what had been computed.

Even more important for limiting cost, the prices of the drugs in poor countries can be reduced about 30 times or more from current U.S. retail prices. On February 6, the Indian generic manufacturer Cipla offered to sell a triple-combination HIV treatment (d4T, 3TC, and nevirapine) for less than a dollar a day to MSF (Doctors Without Borders); it offered a price of $600 per year to governments. So on top of the reduced number of patients comes an approximately 30-fold reduction in drug costs. The offer itself has changed public awareness and generated much discussion.

And the $350 price is available today. By the time much of Africa is being treated there will have been huge scale-ups in the manufacturing, resulting in further drug price reductions.

In addition, researchers are now testing intermittent schedules, such as one week on and one week off for certain antiretroviral regimens, in the hope of reducing side effects as well as drug cost; a team at the U.S. National Institutes of Health reported early results at the recent Retroviruses conference (Dybul M., Fauci A.S., and others, "Short-Cycle Intermittent HAART: A Pilot Study," 8th Conference on Retroviruses and Opportunistic Infections, Chicago February 4-8, 2001, Abstract #354). Unfortunately nevirapine probably could not be used in this way, because it has a long half life in the body and would remain present at low levels after the other drugs were eliminated, creating conditions for HIV to develop nevirapine resistance; a protease inhibitor might be used instead.

Another huge cost reduction is less obvious and has been largely overlooked. On February 23 the Wall Street Journal reported that there was no great rush by governments to take up the Cipla offer of treatment at $600 per patient per year ("Economy: Offer to Sell AIDS Drugs at a Discount in Africa Is Met with Caution, Uncertainty.") That is not really news; there was no reason to expect a rush. At previous prices (around $10,000 per year per patient), the issue was never on the table for African governments. And providing AIDS treatment to a population which has not had it is more than a matter of deciding to buy drugs; professional and public education, training, management of side effects, and many other infrastructure problems need to be addressed. Until now there was no reason to develop this infrastructure, since access was hopeless anyway due to the prices of the drugs. Now planning can begin; but doctors, officials, organizers, activists, and others need to hear about the new availability and development treatment and distribution plans to put on the table for their governments, which then need to act. All this does not happen in 17 days (the time between the Cipla announcement and the Wall Street Journal article).

So in addition to the other factors which greatly reduce the cost of providing AIDS treatment to poor countries, there is the slow scale-up -- which not only delays expenses, but also eliminates some of them, since mistakes and inefficiencies can be found and corrected while programs are relatively small.

And finally, though it is hard to calculate, the remaining costs of treatment must be offset against the costs of not providing it. Opportunistic infections, hospitalization or other care, faster spread of HIV, faster spread of tuberculosis and other diseases, sick time, funeral leaves for workers (sometimes for services many miles away), loss of teachers, the need to replace trained workers, care of orphans, the list goes on.


Who Will Negotiate?

How will the different stakeholders work together toward serious government leadership on the AIDS epidemic? This is the most difficult issue.

We have followed developing-country treatment access for years, but it has been hard to find anyone in industry to talk to about it. Pharmaceutical-company officials have been either uninformed about the issue or unwilling to address it, or fanatically committed to defending their intellectual-property rights to the exclusion of everything else (including the tens of millions of people being left to die). The obvious group to address this issue, PhRMA (the Pharmaceutical Research and Manufacturers of America), has been even more fanatical than the companies it represents -- still denying that intellectual property is an issue, even while thousands of patients die for no other reason except that fluconazole and other drugs are patented and priced completely out of reach of their doctors, who cannot buy affordable generics in India or elsewhere because of patent laws. (PhRMA cites other problems, such as infrastructure and corruption, which are also real -- though less able than intellectual property to stop discussion cold and take everything off the table).

Reading African press reports on these struggles shows a different world from that painted by pharmaceutical-company statements released for rich country public consumption. Even when patent and trade laws technically allow exceptions, pharmaceutical companies and their money have been active behind the scenes, in the superpower government, the local governments, international agencies, the business community, and elsewhere, to block solutions they see as any possible symbolic threat to patent rights in rich countries. (They care little about lost sales in poor countries, since their markets there are negligible; they do care about precedents, ideas, or information that might erode patent rights or prices elsewhere.)

Also, who will speak for the AIDS community? Industry might do what it has done in other areas -- create a hand-picked, kept community of organizations which have names or numbers, but have not been involved in international treatment access, or are financially dependent on industry, or which otherwise can be controlled. Today the kept community is becoming a standard public-relations strategy, and AIDS treatment activists are alert to prevent it from happening here.

A result of industry rigidity on intellectual property vs. treatment access in developing countries is that activists have had little opportunity for industry dialog, and no way to act except through opposition. It has long been clear that industry would not cooperate meaningfully on treatment access in poor countries (this might or might not change in the future). The only possibility of success was the development of a public insistence too strong to be stopped.

We are mostly optimistic as the current confusion sorts itself out. A key organization will be MSF (Doctors Without Borders). It has credibility on this issue, and credibility in the larger world as well -- although it could do better in explaining this issue to the public. It might become the cornerstone of a forum where the different interests come together to discover what common ground could be found.


An Impossible Dream?

Recently a reporter mentioned the possibility that the pharmaceutical industry could "get religion." As strange as it seems, we cannot see any economic or other reason why it would be impossible.

Under the current system, now being imposed around the world by the WTO treaty, governments must give pharmaceutical companies monopolies over life and death treatments, so that the companies can charge high prices for patented drugs in order to pay for research, and reward investment. Society demands nothing from the industry beyond quality control, and general obedience to the law. So companies are free to use their money to corrupt medical research, medical publishing, medical practice, patient advocacy, governments at all levels, and international institutions. They are not even expected to maintain adequate supplies of life-critical medications in rich countries, let alone research diseases that affect mostly poor regions, or give any thought or plan for access to life-critical medicines outside of lucrative markets. There is also no control over "incestuous drugs," even in rich countries -- the mis-design of clinical trials to promote a manufacturer's products instead of testing the treatments which are best for patients. In the last year this system has changed little, but the public has become much more aware of it, through in-depth reports in leading national newspapers and medical journals. These issues are not going away; and if the pharmaceutical industry will not change voluntarily, it is likely to have changes imposed.

Pharmaceutical patents are different from most patents not only because the product can be essential to life. They are also different because human beings have risked their health or their life in clinical trials to get these products tested. (This should be remembered when the United States threatens other nations with economic retaliation if they use publicly available clinical-trial data to approve drugs competing with those of U.S. companies, on the grounds that registration data is proprietary, and its use to approve drugs within those countries is an unfair trade practice.)

Would it be possible to change public opinion and business and legal practice, so that holding a patent on a life-critical medical treatment would be regarded as a calling, as well as a business? There is a precedent in the traditional role of the physician, who until recently was also well rewarded, but with the understanding that the practice of medicine was not only a business, but involved more than just making of a buck.

Could we ask that proprietary pharmaceutical companies be the leaders in the public interest around the use of their patented medicines -- be out in front of everybody else in advocating their best use, not just maximum sales?

Such a social contract would be expressed partly in law, as it has been with physicians. But widely shared, less formal expectations can also be effective. A pharmaceutical company cannot be successful without the cooperation of many people -- including investors, doctors, scientists, corporate partners, politicians, and regulatory officials. If any social contract is serious, then how well or how badly a company fulfills its obligations will be weighed by many people in deciding whether or not to do business with the company.

Public-interest leadership need not cost money. Last week in New York, about 60 ACT UP New York and other activists visited a GlaxoSmithKline meeting for investors, to protest the company's role in the March 5 pharmaceutical-industry lawsuit against South Africa to block its medicines reform law; about 20 of them entered the room. Later, financial analysts were asked about the issue, and were quoted as saying that Glaxo could sell its drugs in Africa at cost without losing money.

But sometimes profit motive and public interest would conflict -- as when a marketing department wants to use a questionable or unethical promotional campaign. How could incentives be designed to handle this situation?

One possibility is that companies large enough to own FDA-approved patented pharmaceuticals would be expected to have a public-interest department reporting directly to top management -- not to marketing. This department would focus on creative ways of advancing the public interest, more than on saying No to company projects. But sometimes it would say No, and then the issue would go to management to make the decision -- and be responsible for it.


ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.


Back to the AIDS Treatment News February 23, 2001 contents page.



  
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This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.
 
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