Saturday, February 11, 2012

Deadly Monopolies by Harriet A. Washington

“I don’t see why special effort should be demanded from the pharmaceutical industry. Nobody asked Renault to give cars to people who haven’t got one.”-Bernard Lemoine, director of the French National Pharmaceutical Industry Association.

“The plea of impossibility offers itself at every step, in justification of injustice in all its forms.”- Jeremy Benthham

What has this book’s catalog of greed, imperiled health, failures, infuriating injustices, and inspiring visions taught that can help us forge a better system of incentives and rewards for needed medical research and healthcare? Perhaps we should first take a step back.

The monopolies enabled by the Bayh-Dole Act and related laws of the 1980s have successfully allied for-profit corporations and universities. This pharmaceutical-academic alliance through patents certainly did succeed by some measures. It provided a way to more quickly develop the university innovation that lay fallow by allowing academia to transfer patents and licenses to private corporations.* The number of these developed patents has soared beyond five thousand, and hundreds of biotechnology firms sprouted as technology-transfer offices proliferated and earned their institutions at least $45 billion. This innovation has been a huge financial success, making tens of billions in profits for both universities and corporations: until recently, pharmaceutical firms constituted the most profitable industry on the planet.

But the relationship proved asymmetrical: when corporations bought and licensed university patents and funded post-patent research and development, they also began to dictate the terms under which these patents were developed to generate income, giving for-profit corporations sway over the means, timing and methods of U.S. medical research itself, to say nothing of their ability to determine which research would be carried out and what research directions would be ignored. In this manner they usurped the traditional role – and the traditional cultural values, directed at the public weal – of university medical research.

The system has failed for U.S. patients, who pay more for health care and receive less. Too often, they cannot afford the industry’s very expensive medications. Moreover, the bodies and body parts of Americans have been appropriated for marketable tissues and mined for their genes. Recently, Americans have even been given over to non-consensual research with a profound lack of transparency.

In place of the collegial collaboration that marked pre-1980’s research, today’s investigators find silence imposed on them that strictly prohibits sharing data, theories and findings at conferences. Data sharing, which was once the norm, is even criminalized. Some researchers see their drug trials brought to an abrupt end by a drug maker’s insistence that the drug be a financial blockbuster as well as a medical success. Others, such as investigators seeking better breast cancer, Hepatitis C, and hemochromatosis treatments, are prevented by a patent from pursuing their research. Drug companies go to court to gain exclusive control of tissue samples vital to research on drugs to combat diseases such as Alzheimer’s, liver and prostate cancer.

Today, profit-driven medical monopolies also present problems for physicians and hospitals, who are sometimes sued for treating patients in strict compliance with the law but against the monopolistic interests of patent holders such as Bayer Healthcare. Other physicians cite a fear of lawsuits as a deterrent to giving necessary tests.

Monopolistic medical research has not worked out for the poor in the developing world, either, because the system has neither pursued nor provided remedies for the diseases of poor people. Instead, it profits hugely from its ability to conduct cheap, rapid research with relatively poorly informed subjects who live amid a health-care vacuum that causes them to grasp desperately at any proffered medical straw, even a medical-research study without the usual Western protections of informed consent and without the provision of standard treatment for control groups, risks usually unacceptable but sometimes practiced in minority communities in the developed world.

Frankly, though, aside from the very limited focus of preserving colonial subjects’ fitness for work, the medical needs of poor people in the developing world were never a priority of Western health care, even before 1980. However, the need to maximize patent profits and ‘intellectual’ property rights has spurred pharmaceutical firms to offer a legitimizing discourse for this long-standing indifference, blaming ‘poverty, not patents’ for the medical misery of those for whom it chooses not to develop desperately needed drugs.**

The current systems failures for all these groups should be quite enough to spur us to create a new paradigm, but there is one more group that seems to be faltering: the pharmaceutical companies themselves. They have lost their fiscal primacy. They still earn billions profits are falling despite their flouting of FDA laws and their perversion of the medical-publication process by ghost-writing, faux medical journals, payola to drug evaluators and prominent medical ‘thought-leaders’. The artificial “clinical trials” aimed at selling pills in volume, the courting of customers via direct-to-consumer advertisements, the churning out of cheap doppelganger “me too” drugs and other strategies to extend the life of their patents by decades have not saved the pharmaceutical companies from losing ground.

For years, the $1-billion-a-year blockbuster drugs have been drying up, falling off the ‘patent cliff’ with little innovation in the pipeline to replace them. Pharmaceutical firms’ widespread strategy of buying up biotechnology companies to supply the missing innovation is unproven, and, frankly, it smells of desperation. Whether most firms will admit it or not, this particular patent-based system is no longer working for them either.

So what will work to attain the dream of affordable medical innovation for all without rendering universities and pharmaceutical companies destitute and unable to function, and without sacrificing medical progress?

What has been abandoned in the wake of the Bayh-Dole Act is patient primacy and altruism. Researchers once derived their satisfaction from the prospect of becoming a famous benefactor by devising the means of healing many people. They also desired the intellectual challenge and the fame of achievement, and were motivated by such rewards instead of merely by money. To return such motivations to center stage we should uncouple the conduct of medical research from the pressure to protect monopolies at all costs that is exerted on researchers today by their institutions and sponsoring corporations.

Placing the welfare of patients first is the responsibility of the government that funds the initial research on which the drug makers’ patents rest. U.S. medical research is possible only because of the taxpayers’ huge investment in colleges and universities, so it is the business of the federal government to ensure this investment goes into generating medications that Americans really need – and can afford. We have a moral responsibility to the developing world to provide the same for them, especially because they now supply the means to conduct research that produces medications more cheaply and efficiently than we can do ourselves.

We must explore the remedy of eliminating the influence of corporate lobbyists in the development of health care legislation and explore the possibility of badly needed drug-price controls. We should also restructure the manner in which pharmaceutical companies contribute to the FDA budget in order to eliminate the obvious conflicts of interests that are currently embodied in that agency’s approval process. Pharmaceutical companies and medical investigators should be required to report all their data, not selectively cherry-pick positive findings so that ‘the appellation ‘peer-reviewed’ regains its authority.

The patent system itself could benefit from fine-tuning, for example, to curtail excessive patent protections which injure the public health or prevent important research from going forward. We could, for example, build in a six-month “comment period” during which anyone can criticize or applaud the awarding of a patent and make a case for its revocation or permanent adoption. This would free millions of dollars now gobbled up in patent suits for research and development.

In recent years some progress against the abuses of the last three decades has been made. Patents can only be obtained on materials and processes which are novel ( previously unknown) and this represents a significant opportunity for the practitioners of Open Medicine to publish their findings gratis on the internet and thus prevent their use in the construction of commercial monopolies. Alternative models to compensate drug companies in proportion to their products effect in ameliorating pressing health concerns and reducing disease are in development. Various groups like Harvard’s Partners in Health and the Gates Foundation have been instrumental in bringing health care to deprived counties. In fact, in 2011, following the Gates foundation Advanced Market Commitment initiative , major pharmaceutical firms shattered expectations when they announced that they were slashing prices on vaccines to save the lives of desperately poor children in countries such as Brazil, Nigeria and rural India. These reductions are estimated to save the lives or benefit as many as $250 million children by 2015.

The means to rectify the abuses of the past and initiate substantially positive reforms in the health and healthcare of people not only in the U.S. but through-out the developing world are at hand. It would be much better for the drug companies themselves if they got on the band-wagon instead of fighting tooth and nail to maintain their monopoly profits.

*Public Citizen, Merrill Goozner, and the TB Alliance accounting of the Research and Development costs for new drugs brought to the market between 1994 and 2000, based on PhRMA’s own data, range from $71 million to $150- million ($250 million for the atypical NMEs.) The $800 million figure so widely touted by the drug companies is just a thinly disguised advertisement for the pharmaceutical industry to justify continued price-gouging.

**While some analysts and virtually all pharmaceutical companies blame poverty, not their patents and the resulting high drug prices, for the preventable deaths and plummeting life expectancies of poor foreign nations, the data tell a different tale. To be sure, health improved and life expectancy first extended in developed countries as the result of the better nutrition and sanitation, such as cleaner water supplies that resulted from higher incomes. As a result, death rates in the U.S. fell most precipitously between 1700 and 1910, at an adjusted rate of 70 percent, before the advent of important medications. But poor countries today are governed by a different dynamic, where life expectancy has increased dramatically when access to medications and medical technology has improved, even while poverty has remained static.

Harriet Washington is the author of the award-winning (National Book Critics Circle, 2007 PEN Oakland, 2007 American Library Association Black Caucus Non-Fiction) Medical Apartheid

She has been a fellow at the Harvard Medical School, Harvard School of Public Health and a senior research scholar at the National Center for Bioethics at Tuskegee University.

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