[Ip-health] Patients Before Profits--A Profile of Rachel Kiddell-Monroe and the Access to Medicines Movement--Commonweal magazine
quigley2 at iupui.edu
Tue Jun 28 05:53:02 PDT 2016
Patients Before Profits
A Profile of Rachel Kiddell-Monroe and the Access to Medicines Movement
By Fran Quigley
The Altiero Spinelli building of the European Parliament in downtown Brussels exudes modernity. Its steel-and-glass structure houses high-ceilinged hearing rooms with perfect lighting, blonde wood, and state-of-the-art audio and video technology. These spaces seem to embody technocratic competence and calm deliberation, but on a chilly afternoon last December, one of these hearing rooms was the setting for a scathing denunciation of the global system for developing and distributing medicine.
In recent years, this system has come in for an increasing amount of criticism, much of it from the United States. In the past year alone, patients and politicians in this country have been outraged by the young pharmaceutical CEO Martin Shkreli, who arbitrarily raised the cost of a toxoplasmosis drug by over 5,000 percent overnight. Meanwhile, state Medicaid programs and the U.S. Veterans Administration strain to afford the $1,000-per-pill price of a critical Hepatitis C drug, developed with government funding but now under patent by a private corporation. The cost of manufacturing these pills? About a dollar each. In August 2015, 118 cancer physicians co-authored an article in the prestigious Mayo Clinic Proceedings condemning a system that has pushed the average cancer patient's drug costs to over $100,000 per year, leading about 20 percent of patients not to fill their prescriptions. "What we're fighting is the greed," the article's lead author told the Wall Street Journal.
The panelists gathered in the European Parliament building were just as unhappy. An editor at a French drug-industry publication lamented, "If the current pharmaceutical innovation model is our patient, our patient is very sick." She noted the lack of transparency when it comes to how much it costs drug companies to develop new medicines. That criticism was quickly echoed by a Spanish physician who has served on the board of the World Health Organization. He cited the example of the drug to treat Hepatitis C, priced at anywhere from $500 to $84,000, depending on the country where it is sold. "The real reason for high costs is that governments give the companies monopolies through patents," he says. "And then the companies charge whatever the market can bear."
As the discussion proceeded, the complaints piled up. A representative for the German health-insurance system pointed out the substantial government investment in medicine development-about 30 percent of the overall cost, and an even higher percentage for the most valuable medicines. But that public investment is not reflected in the high prices governments pay for these same medicines. Governments were thus accused of playing the role of incompetent venture capitalists: pouring big investments into drug research and development, and then paying far above the costs of production for the final product. A foundation executive on the panel called it "socialized risk, privatized profit."
A second panel was called up, and Rachel Kiddell-Monroe took her seat facing the audience. Casually dressed, her long blonde hair pulled back in a ponytail, Kiddell-Monroe remained silent as her fellow panelists made their points. Finally the moderator asked her a question about drug development. Smiling, she promised to return to the question-"but first let me backtrack," she said. "With all due respect to the members of the previous panel, I have to disagree with the core of what has been said. I think the system is actually very successful." She paused a moment for effect, and then continued. "Look, it's time we realized that this current system is very well-designed to do exactly what it does: create maximum profits for pharmaceutical companies. And it has been incredibly resilient to every challenge we make to it. The day we realize all that is the day we end twenty years of fighting for small changes."
Kiddell-Monroe cited the example of the Trans-Pacific Partnership trade agreement, which will expand the reach of medicine patents in a pact covering 40 percent of the world economy. The TPP is intended to serve as a template for future trade agreements. "It's time for civil society to stop focusing on mopping up the mess," said Kiddell-Monroe. "Let's just say the current system has nothing to do with the needs of patients, and move on to create something new."
KIDELL-MONROE GREW UP in London, but her mother is French and each summer the family would visit her maternal grandparents in Chateau-la-Valliere in central France. Kiddell-Monroe's grandfather, Romain Pimbert, had been a member of the French Resistance during World War II and participated in dangerous missions to shepherd Allied pilots back to England. When Pimbert told his granddaughter stories about his wartime experiences, there was always a moral: the duty to fight injustice wherever one found it. The lessons took. By age eleven, Kiddell-Monroe had started a school Amnesty International chapter; she got a group of her classmates to write earnest letters to dictators, demanding the release of political prisoners. Eventually, she studied law at Southampton University, hoping for a career in human rights but ending up at a corporate law firm.
One year while she was at the law firm, Kiddell-Monroe spent her vacation backpacking in Indonesia. There she was invited to visit an island called Siberut, where logging companies were successfully lobbying to have the indigenous Mentawai people forcibly removed from their ancestral homes. A Mentawai man in one village tugged on Kiddell-Monroe's sleeve and said something to her in his language. The interpreter explained that the man was the village leader. "You have to help us," he had said. "We are going to die."
Upon her return to London, Kiddell-Monroe started an organization called S.O.S. Siberut. She raised money and partnered with Indonesian activists in England and Indonesia. Frustrated by the limitations of working from afar, she obtained a leave from her law firm and returned to Indonesia, where she soon became involved in the East Timorese independence movement. She escorted native people into the cities to confront government leaders. She hid political dissidents in her basement. She saw children in remote villages who were dying from common illnesses like chicken pox because they lacked access to basic treatment. She told her law firm in London that she would not be coming back.
After a few years of working in Indonesia, Kiddell-Monroe found her way to the international humanitarian organization Médecins Sans Frontières-Doctors Without Borders-where she served in several administrative positions in Africa and Latin America. In the mid-1990s, she visited an African hospital that Médecins Sans Frontières had been asked to take over. She was shown the pediatric ward, the surgery rooms, the internal medicine section. But she noticed that her guides kept passing by a large area behind closed doors. Only after Kiddell-Monroe insisted did her guides grudgingly show her into the room. Inside lay dozens of emaciated, vacant-eyed patients, all lying nearly motionless. They were all presumed to have HIV/AIDS and were on the brink of death. "There is nothing you can do for these people," she was told. Kiddell-Monroe just nodded. She was confident that things would change once Médecins Sans Frontières was in charge. But they didn't. "Do you know how much it costs to treat just one patient with HIV/AIDS?" she was asked when she called her bosses. The answer was $11,000 a year, for the rest of a patient's life. At the time, Médecins Sans Frontières typically served in a transitional role, moving from one crisis to the next. Even if it could somehow afford to begin HIV treatment, what would happen to HIV-positive patients once the organization left? "So we basically just had to do what we could to make their deaths comfortable," Kiddell-Monroe says.
The image of that hospital ward stayed with her, as did the sight of children dying from other treatable diseases. Where she worked, such sights were common. If the drug development process is a pipeline, the impoverished patients treated by Médecins Sans Frontières are at the dry end of it, where only a few drops trickle out. Our profit-based pharmaceutical system has produced a wide variety of medicines for erectile dysfunction, acne, and other maladies of special concern to first-world consumers. But for many of the world's most deadly diseases, the system is a dismal failure. In the past fifty years, only one drug has been developed for tuberculosis, which kills half a million people every year. "The R&D incentive is virtually nonexistent," World Health Organization director-general Margaret Chan admitted in 2014. "A profit-driven industry does not invest in products for markets that cannot pay."
In the current research system, pharmaceutical companies devote a lot of resources to "me-too" drugs, which are developed in order to grab a share of the lucrative market for blockbuster medicines. Over 70 percent of medicines brought to market in the past two decades provide no new therapeutic benefit but instead compete with products that are already available. Meanwhile, many of the most important drugs that have been developed recently aren't reaching some of the people who need them most: 10 million people die annually for lack of access to medicine. "My experience in the field was that people were not able to afford the medicines they needed, if the medicines had been developed at all," Kiddell-Monroe says. After more than a decade on the front lines of global health, Kiddell-Monroe did not see the situation getting any better-with the exception of one disease and one set of medicines. That single exception was enough to give her hope.
BY THE LATE 1990s, medicine had been developed that would work for the people who lay dying of AIDS in African hospitals. New antiretroviral drugs were so potent that they triggered what was known as the Lazarus Effect, allowing AIDS patients who had been near death to lead long and active lives. At the turn of the century, antiretrovirals had already been widely prescribed and used in the United States and Europe for several years. But the drugs were under patent, and their high cost meant that only one in a thousand Africans infected with HIV was receiving treatment. The patents were protected by a recently signed international trade deal, the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS. Under TRIPS, nations had committed to a minimum of twenty years of patent protection for medicines, as well as to provisions that enable corporations to fight off generic competition for even longer periods.
More than 2 million Africans were dying from AIDS every year, but the cost barrier for patented drugs caused even global-health advocates to be fatalistic. "It's so politically incorrect to say so, but we may have to sit by and just see these millions of people die," one unnamed global-health official told the Washington Post in early 2001. The pandemic raged with such abandon that in 2000 more South Africans died in their thirties and forties than in their sixties and seventies.
In some of the countries hit hardest, activists began to fight back. In response to public pressure, Brazil's government created a national program of antiretroviral treatment, which relied on domestic manufacture of generic medicines that were patented elsewhere. South African activists, emboldened by the example of aggressive HIV/AIDS advocacy by groups like ACT UP, flouted the TRIPS agreement by illegally importing generic antiretroviral medicine and pushed their government to follow Brazil's example. When the South African government took steps to do so, the drug companies struck back with lawsuits, and the U.S. government threatened trade sanctions against both Brazil and South Africa. But an international coalition of activists ramped up the pressure, holding protest marches, fighting the corporations in court, and heckling drug-company executives and politicians.
One of the most unlikely activists in that coalition was a twenty-six-year-old Yale Law School student named Amy Kapczynski. At a meeting of women AIDS activists in South Africa, Kapczynski was startled by the realization that, whereas the biggest challenge for the HIV-positive women from the United States and Europe was coping with drug side effects, the HIV-positive women from South African would likely be dead in a few years. So, when she began her studies at Yale, Kapczynski also began a campaign with Médecins Sans Frontières. They demanded that the drug d4T-first developed at a Yale lab and branded for HIV treatment as Zerit by the patent-holder Bristol-Myers Squibb-be made available for low-cost generic production in South Africa.
At first, officials from Yale, which received $40 million a year for the medicine under its licensing deal with Bristol-Myers Squibb, said their hands were tied. But Kapczynski and fellow students circulated petitions, reached out to the media, and gained the support of faculty-including the drug's inventor, Dr. William Prusoff, who told the New York Times, "People shouldn't die for economic reasons, because they can't afford the drug." Soon thereafter Bristol Myers-Squibb announced it would no longer enforce the d4T patent in South Africa.
This was the first time a major pharmaceutical company had willingly relinquished its patent rights. It heralded a cascade of similar decisions by other drug companies, leading to a drop of over 90 percent in the price of HIV drugs in just one year. Front-line antiretrovirals that once cost $1,000 a month now cost as little as $99 a year. Today, 16 million people are on the medicine.
The Yale case quickly became the basis for a new strategy. Most important new medicines and nearly all vaccine and biotechnology breakthroughs can trace their lineage back to university laboratories. Unlike pharmaceutical corporations, universities are accountable to the kind of people (students, faculty, taxpayers) who may demand that their institutions respect a broad set of values and not just seek to maximize profit. The model of advocacy invented at Yale quickly spread to other campuses and inspired a new organization: Universities Allied for Essential Medicines. Under the UAEM banner, students secured commitments from major universities like Harvard and Brown to ensure that the drugs developed in their labs were made available to the world's poor. UAEM also worked closely with Médecins Sans Frontières, which launched an access-to-medicines program after it won the Nobel Peace Prize in 1999. Soon after this program was created, Kiddell-Monroe left her field work, moved to Canada, and devoted herself full time to the cause of making urgently needed medicine affordable throughout the world.
AS PRESIDENT OF UAEM, Kiddell-Monroe was an immediate hit with students in the movement. When Sandeep Kishore first met Kiddell-Monroe, he was an MD/PhD student at Cornell and the leader of the university's UAEM chapter. "Many student leaders reach a stage where they are getting a little jaded: they have learned about all the horrible things going on in the world, and they get overwhelmed. They start to question if they can really make a difference," Kishore says. "But Rachel has a way of articulating the path to justice so clearly, and with such passion, that she infects you with her point of view. It is her gift."
Kiddell-Monroe won't allow younger activists to imagine that success will be easy. After the successes of the HIV/AIDS-treatment campaign at the turn of the century, the access-to-medicine struggle has too often been relegated to the sub-paragraphs of international trade agreements. The Holy See and various Catholic organizations, including the Maryknolls and NETWORK, are among many faith-based advocates who have expressed concern about the effects that trade agreements like the Trans-Pacific Partnership will have on access to medicines. But arguments over complicated trade-agreement terms and obscure interpretations of intellectual-property law have not been easily translated into grass-roots activism. "The problem we have is that there are only about eight people in the world who understand what we are talking about," one leading activist confesses.
Kiddell-Monroe admires the existing advocacy groups, such as Knowledge Ecology International, Public Citizen, and even her own Médecins Sans Frontières. (She is no longer on staff at MSF, but serves as an elected member of the organization's board of directors.) "These are wonderful people who work morning to night every day of the week on the cause, but they are so focused on the constant, immediate challenges to medicine access that they struggle to be proactive," Kiddell-Monroe says. "We need to expand this movement beyond the geeky access-to-medicines folks-and, of course, I consider myself among that group!"
The students she works with agree on the need to expand the movement. Manuel Martin, a British medical student who is one of the European coordinators of UAEM, is a member of a group Kiddell-Monroe convened called "The Blue Sky Project." The aim is to imagine an entirely new approach that breaks through the constraints of patents and international trade agreements. "Sometimes, a little naïveté can help. We students see the issue as black and white: people are denied the fundamental right to health because medicines are unaffordable," Martin says. "So maybe we can challenge the status quo in a way that people working on the issue for a long time may struggle to do. Rachel encourages that from us. She says we are not to think outside the box-we are to assume there is no box at all."
Kiddell-Monroe has been doing her own "blue sky" thinking. Last year, at the invitation of the Open Society Foundation, she and others were invited to submit their views on the economics of pharmaceutical innovation. Kiddell-Monroe seized on that opportunity to write a piece that described access-to-medicine activists as dancing the "Pharma Foxtrot." It is a dance, she wrote, where the steps lead to the conclusion that medicines are a market commodity like DVDs or cars. Kiddell-Monroe proposed instead a "Citizen's Samba," based on the notion of medicine as a public good and open access to information as the norm. In such a system, profit would be "relegated to a modest by-product of the activity rather than a deliberate goal."
This approach is not new; in fact, it was the norm until recently. The Agreement on Trade-Related Aspects of Intellectual Property Rights was only finalized in 1994. It was the product of corporate lobbying and strong-arm pressure by the United States, where half the world's top pharmaceutical companies are based. Before TRIPS, most nations either did not allow patents for medicines or placed strict limits on them. To many, the very idea of treating life-saving medicines as a market commodity is simply immoral. Jonas Salk famously refused to pursue a patent for the polio vaccine, saying the patent belonged to the people. "Would you patent the sun?" he once asked an interviewer.
Kiddell-Monroe's default manner is genial, but at one point during the discussion at the European Parliament, she appeared to lose her patience. Shortly after she called for a different approach to medicine access, the discussion turned back to the details of intellectual-property policies. Someone used the term "value" to refer to the market price of a drug. Kiddell-Monroe jumped in. "You are talking about the drug's value. Let's talk about the value of human beings, shall we?" She was leaning close to her microphone now, her voice rising for the first time. "Consider the Ebola crisis. It is not like we did not have a vaccine. We had a vaccine. It was sitting on a shelf in Canada. No one developed it because there was no profit in it. We lost eleven thousand people in West Africa. That is the reality of this system."
Our profit-based system for developing medicine devotes just 10 percent of its resources to illnesses that account for 90 percent of the global disease burden. That imbalance became horribly visible in the Ebola tragedy: promising vaccines and treatments languished in preclinical development, while drugs to treat male pattern baldness were being rushed to market. As soon as it seemed the disease might spread from West Africa to wealthier countries, Ebola began to capture global attention and the lack of an effective treatment was suddenly seen as an urgent problem. As public-health advocate Greg Gonsalves put it, once Ebola "cleared customs," it struck fear in the hearts of Americans.
Now the broader access-to-medicines crisis has cleared customs, too. When U.S. cancer physicians are moved to issue a call to action, as they did in their Mayo Clinic Proceedings article, it means that the problem has crossed the border not just from poor countries to wealthy ones, but also from infectious diseases to noncommunicable ones. Malaria or even HIV may now seem to many Americans like exotic maladies that happen to other people in faraway places. Women dying of breast cancer because they can't afford treatment is a tragedy that hits closer to home.
Activists hope that we are now approaching a tipping point, as the public in rich countries becomes more familiar with the cruelties imposed by the current system. In November, UN Secretary-General Ban Ki-moon created a body called the High-Level Panel on Access to Medicines. The UN is notorious for convening ambitious-sounding committees that do no more than issue dense, ineffectual reports. But this panel includes several outspoken critics of the current profit-based system, including Stephen Lewis, the former Canadian ambassador to the UN and the UN's special envoy for HIV/AIDS in Africa. Lewis, a friend of Kiddell-Monroe's, is quick to point out that he has seen a lot of similar bodies come to nothing. But he thinks this time may be different. "Access to medicines has become one of humankind's greatest crises, perhaps right behind climate change," he says. "This has become a problem for the developed world alongside the developing world, and I think that means great changes are coming."
IN APRIL 1994, Kiddell-Monroe-then just twenty-nine years old-was serving as head of mission for MSF in Goma, Zaire, now the Democratic Republic of Congo, on the northwestern border of Rwanda. Over the next three months, eight hundred thousand Rwandans were killed, including scores of Kiddell-Monroe's MSF colleagues who were trapped inside the country. The river flowing into Goma became choked with headless, machete-butchered corpses. A few bodies in better shape belonged to victims who had paid their killers one dollar to be shot with a bullet. Kiddell-Monroe and other witnesses struggled to attract the international community's attention to the ongoing slaughter. "It seemed the world was looking the other way, and there were just a few of us who were there saying, 'You've got to look at this, you've got to see what's going on.'"
Today she finds herself searching for a way to focus the world's attention on another kind of human-rights crisis-one that kills as many people every month as were killed in the entire Rwandan genocide. She says there needs to be less talk about the intricacies of intellectual-property law and more talk about social justice and common decency. "If I try to explain to my neighbor or my kids what I work on, and I talk about patent law or trade agreements, their eyes roll up in their heads," she says. "We need to be able to describe a system that reflects our basic values, and say we are working to make that a reality."
There are already plenty of ideas about what such a system might look like. UAEM has counted eighty-one different proposals to motivate innovation and distribute drugs outside the for-profit system. Some plans would involve a buyout of existing patents. Others would offer prizes to reward drug research, like the Longitude Prize for antibiotics. The not-for-profit Drugs for Neglected Diseases Initiative has already developed several new drugs for a fraction of the cost that private corporations claim is necessary. Kiddell-Monroe and UAEM have been at the center of a push to build on these alternative approaches by adopting a sweeping global-research-and-development agreement. The proposal calls for all governments to make a contribution to drug research proportional to their national income. An international coalition of physicians, scientists, and economists have signed on to a public letter-"Make Medicines for People, Not Profit"-demanding that the World Health Organization move the agreement forward.
Proponents of a global-research-and-development agreement say it would achieve significant savings by eliminating the inefficiencies of the for-profit system, which absorbs both large profits and equally imposing marketing costs. The economist Dean Baker, one of the signers of "Make Medicines for People, Not Profit," describes the current system as "an unambiguously terrible way to support research." Governments are already paying massive amounts of money for medicine-first by supporting the research required to develop new drugs and then by purchasing the drugs from pharmaceutical companies. The goal would be to cut out some of the middle-men and marketing. "I do not believe there is a lack of money to make drugs available for all the world," Kiddell-Monroe says. "I think it is only a question of how we choose to distribute the resources we already have."
In Rwanda, Kiddell-Monroe could only stand by and witness the carnage from across a border. In the medicines struggle, she is in the thick of the action, and she expects a better outcome. "I've been privileged to talk with people all over the world, and I think there is a common morality that cuts across nationalities and religions and ethnic groups," she says. The problem in Rwanda, she insists, wasn't that the international community did not agree about what was right. The problem was that people of good will turned away so they would not have to confront the injustice. "We know that it is wrong to let people suffer and die needlessly," she says. "We just need to be willing to look at it-and then act."
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