Vaccine Policy

Vaccine Policy

Revolution

11-19-2005

Conn Hallinan & Carl Bloice

For too long, the development and manufacture of vaccines and antiviral drugs has been of limited interest to drug companies”

–editorial, The Lancet

Oct. 1, 2005

Dr. Don Francis’ office at Global Solutions for Infectious Disease (GSID) is a museum of his family’s long war with disease.

His grandfather and parents’ medical degrees are next to a California State Legislative Resolution thanking him for his “outstanding” service in the battle against AIDS. A small trophy from the Hemophilia/HIV Peer Association celebrates him as a “Warrior for Justice,” and a plaque on the wall thanks him for helping to eradicate smallpox in India. He has just returned from trying to beat back polio in the Indian state of Bihar, and he is preparing to leave for Africa.

But if his office is crowded with laurels, the rest of GSID in Brisbane, Ca. is a study in minimalism. The wall-to-wall carpet is rarely broken by furniture, and the place feels blank and cavernous. Asked why it looks so bare, Development Manager Ian Francis—a nephew—looks up from his laptop: “No money,” he shrugs.

Indeed, until recently, Francis and his partner paid the rent out of their own pockets, forgoing any salary. And while GSID has an AIDS vaccine ready to go into its final testing phase, it doesn’t have the money to move it into the field.

It is a bind Francis finds deeply aggravating. “Vaccines have had the biggest impact on health of any product ever made,” says Francis. “With biotechnology we now have a revolution in our ability to make vaccines, but we are only beginning to take advantage of it because we don’t value what they do.”

GSID’s mix of poverty, combined with veterans in the battle against humanities great killers—malaria, AIDS, dysentery—sums up the problem and the potential of medicine’s new kid on the block, Public-Private Partnerships (PPPs).

PPPs are non-profit organizations that meld pharmaceutical companies, non-governmental organizations, charitable foundations, universities, and national and international institutions like the Center for Disease Control (CDC) and the World Health Organization (WHO) into coalitions. Their goal is to stimulate research and figure out how to deliver vaccines and medicines to people too poor to afford them.

Started in the mid-1990s, such PPPs as Roll Back Malaria (RBM) and the Global Alliance for Vaccines and Immunization (GAVI) are leading campaigns against the so-called “neglected diseases” that inflict millions of deaths each year, particularly among the poor, and especially in sub-Saharan Africa.

According to Doctors Without Borders, between 1973 and 1997, out of 1450 new drugs, only 13 were for the “ignored diseases, and the number of vaccine developers declined from 26 in 1967 to five today.

That may be changing. A Wellcome Trust study by the London School of Economics suggests that PPPs are successful in generating new drugs. Since 2000, some 63 new drugs aimed at these diseases are in the pipeline, 18 of them in clinical trials.

Some even see vaccines as a growth industry. According to a study by the investment bank, Morgan Stanley, “Vaccines are one of the most overlooked new opportunities in phrarma/biotech.”

Which some people see as a problem.

“We have gone from people seeing vaccines as something that is for the public good and that should reside in the public sector, to something that makes profits,” says Dr. Anthony Robbins of Tufts University, adding “We haven’t changed the behavior of the private sector, we are just financing it.”

Robbins is a former president of the American Public Health Assn. (APHA), directed several state public health programs, and is the former director of the U.S. National Institute for Occupational Health and Safety.

Figures on PPPs tend to bear Robbins out. According to a study by the South Asian health and environmental magazine, Down To Earth, the public sector, including WHO and the U.S. National Institute for Health (NIH), underwrites about 88 percent of PPP budgets. The private sector contributes about 10 percent, and philanthropy picks up the rest.

Philanthropic contributions, led by the Bill and Melinda Gates Foundation with its $29 billion endowment, more than doubled from 2002 to 2004. Gates accounts for 75 percent of philanthropic donations and recently announced an infusion of $258.3 million to malaria research.

In contrast, private sector contributions appear to have fallen. Drug and biotech companies donated $68 million last year, $31 million less than in 2004.

The annual WHO budget is $1.65 billion.

While pharmaceutical companies contribute only a small part of PPPs research and development money, they reap the patents The AIDS drug AZT was developed by Yale University on a grant from NIH, but GlaxoSmithKline ended up with it.

Drug companies also fiercely defend intellectual property laws. “Our ability to invest such huge sums in R&D (research and development) depends on strong patent protection,” says Richard Sykes, former CEO at Glaxo Wellcome. A patent lasts 20 years.

The companies claim it costs between $500 and $800 million and 12 to 15 years to develop a drug.

But those are industry-generated figures. No outside agency has ever examined drug company books, nor has Congress ever subpoenaed such records. Critics claim the costs are overblown, and that non-research and development costs, like marketing, administration and lobbying, are folded into that $500 to $800 million figure.

According to health researcher Hannah Plumb in “Putting a Price on Life,” advertising costs are more than double R&D. In 2000, Merck spent $6.2 billion on marketing and advertising (M&A), and $2.3 billion on R&D. Pfizer spent $11.4 billion on M&A and $4.4 billion on R&D. And BristolMyersSquibb spent $5.6 billion on M&A and $1.9 billion on R&D.

In comparison, of R&D money spent for an AIDS vaccine in 2004, 67 percent was spent on pre-clinical research, 32 percent on clinical trials and development, and 1 percent on advocacy.

The companies also write off 46 cents for every $1 spent on R&D, a deduction they conveniently ignore when they add up bottom line figures for drug development.

Profits have never been a problem for drug companies, which posted gains four times greater than the average Fortune 500 company in 2000, out performing even mega-empires like Microsoft.

This private-public alliance is not always a comfortable one, and public health advocates like Dr. Victor Sidel are “very suspicious” of the private side’s motivations, since their “bottom line is to make money.”

Sidel, a former president of the APHA and Distinguished University Professor at Montifiore Hospital in New York, has recently co-authored a book with Dr. Barry Levy,” Social Justice and Public Health.”

For instance, because the private sector is only willing to underwrite vaccines that can be patented, the use of older vaccines is declining at a time when a combination of growing poverty and an explosion of urbanization is increasing the disease burden in the Third World.

A UNICEF study found that in 1990, 80 percent of the world’s children were immunized against the main childhood diseases: diphtheria, tetanus, whooping cough, measles, polio and tuberculosis. By 2000 that had fallen to 75 percent. In 19 African countries only 50 percent were vaccinated for the “big six.” The price those children pay for going unvaccinated is a heavy one: about 1.5 million under the age of five die each year.

While vaccines past their 20-year patent date go a-begging, Sanofi-Pasteur is pouring tens of millions into developing a dengue fever vaccine. According to a 2002 GAVI report, 63 percent of its resources are slotted for new vaccines, vaccines, that is, which can be patented.

A major focus of vaccine R&D is malaria. It is an ancient disease that plagued the Greeks, and was a major problem in Southern Europe and the American South until well into the 1940s. It consumes nearly 40 percent of the public health spending in Africa and cuts a grim swath through children under the age of five. There are at least 500 million cases of malaria a year.

“It is a moral outrage,” Richard Feachem, professor of Public Health at the University of California, Berkeley and director of the Global Fund, told the New Yorker magazine. “This is an utterly preventable holocaust, and numbers are far higher than the WHO says. They have put the dead at one million (a year) for years, and now it is really three million in terms of deaths to which malaria might have contributed.”

And the situation is getting worse, as conditions that favor malaria—from increasing urbanization to global warming—widen the disease’s reach. Currently, 50 percent of the world’s population is exposed to malaria, an increase of 10% over the past decade. “More people have suffered from malaria in the past 50 years,” says Feachem, “than in the history of mankind. It is a remarkable march backward.”

At the same time, fewer and fewer drugs are effective against it. The plasmodium that causes the disease is complex and, in terms of developing a resistance to drugs and insecticides and fooling the body’s immune system, devilishly clever.

Part of the problem is that the developed world eliminated malaria by the mid-1950s, easing the pressure to develop a vaccine. With the exception of the military’s interest in a vaccine, research funds dried up. Abandoned by wealthy nations, and unable to pay for the R&D themselves, Third World countries have increasingly relied on philanthropy to help them control the disease.

But how that money is spent is fraught with controversy. For example, the Gates Foundation, the largest of these philanthropies, is strongly biased toward the development of new technology. Almost half of the Foundation’s recent grant will go toward a malaria vaccine being developed by two drug companies, Rixensart of Belgium and the British giant, GlaxcoSmithKline.

A malaria vaccine is certainly a worthy goal, particularly since the disease has long resisted one, and with new biotechnology techniques, it may be possible to finally develop one. A GlaxoSmithKline vaccine, largely bankrolled by Gates, is presently being tested in Mozambique and reportedly reduces severe malaria in children by 58 percent.

But a number of public health advocates argue that what is needed is not so much new technology, as the ability to deliver things like mosquito nets and medicine. “I think we need not put our hopes in magic bullets when we have an arsenal to make such an impact now,” argues David Schellenberg from the London School of Hygiene & Tropical Medicine. “What we need are magic guns, not magic bullets. We need to be able to deliver what we already have.”

The influential British medical magazine, The Lancet, recently editorialized that “The eradication of disease and the alleviation of suffering depends more on developing the skills of talented people than on technology,” and suggested that PPPs consider underwriting medical training.

Canadian health economist Anne-Emanuelle Birn is also critical of the “technology” solution. “In calling on the world’s researchers to develop innovative solution targets to ‘the most critical scientific challenges in the global health’ the Gates Foundation has turned a narrowly conceived understanding of health as a product of technological interventions divorced from economic, social and political contexts.”

A number of PPP advocates argue that reducing the disease burden on the Third World will be an important ingredient toward lifting populations out of poverty. But the link between poverty and disease is a complex and tangled one.

Shortly after World War II, on a grant from the Rockefeller Foundation, anthropologist Peter Brown examined what effect eliminating malaria in Sardinia would have on poverty. It turned out, very little. Brown found that while malaria consumed 4.6 percent of its victim’s caloric intake, landlords swallowed up 62 percent of the island’s calories.

Regardless of the critiques, however, PPPs appear to be one of the few games in town. “PPPs are the result of people realizing that returns on investment isn’t going to be the the model that drives forward the development of needed vaccines,” says Dr. David Olson, medical advisor of Doctors Without Borders (DWB). “PPPs are seeking a way to bring together scientists, donors and industry to focus on particular problems. They also keep someone responsible for keeping their eye on the ball.”

Even those who are leery of PPPs admit that creating alternatives is, as Sidel puts it, a “long-term” project.

For warriors like Francis, battling AIDS, polio, and diseases that are little heard of in the First World but extract a deadly tithe in the Third, “long-term” is a luxury. “Time is money in the private sector, but in vaccines, time is death and suffering. For every day we don’t have vaccine ‘Y,’ so many people die,” he says.

His view of Bill and Melinda Gates? “Bless them,” he says.

Sidel agrees that “in the short run” Francis is probably correct about PPPs, but that the long-term project of building a public sector vaccine industry, where profit is not the bottom line, needs to be done. “And in so far as they (PPPs) delay the buildup of a public sector,” they can be problematical, he says

Tuft’s Robbins says there is a long history of successful government intervention to solve problems, “like landing people on the Moon. No one thought the private sector would do that, the government did it.”

There is certainly precedent for government intervention in health. Popular campaigns in India, Thailand and China forced governments to manufacture cheap generics to treat HIV.

A similar movement in Brazil pushed the government to withdraw from the World Trade Organization because of its objections to patenting generic anti-virals. Not only were the Brazilian generics five to six times cheaper, but under market pressure, Merck dropped the price of the antivirals Indiarvir by 65 percent and Rfavirencz by 59 percent. From 1996 to 2001, AIDS treatment costs in Brazil fell 73 percent.

Olson argues that governments need to see that just because disease is somewhere else, doesn’t mean is shouldn’t be their concern. “Take, for instance, Botswana where there is a possibility that the existence of the country is at stake, that the AIDS crisis could get so large as to make the country non-functional.” He says that possibility should be seen as a “security concern,” and that governments need to realize “that their countries will be affected in the long run—if not the short run.”

While drug companies argue that profit has been the driving force behind vaccine creation, profit has not always been the motive, even in the most successful vaccine campaigns. Jonas Salk and Albert Sabin refused to patent their polio vaccines, and Alexander Fleming rejected patenting penicillin. The discoverer of insulin handed his patent over to the University of Toronto for $1.

Relying on drug companies to find cures for “neglected diseases” in the Third World has not worked very well, although PPPs have helped make progress in this area. Ultimately, however the bottom line for drug companies is profit. “The private sector is not much concerned with countries or people without disposable income,” Robbins points out.

Indeed, when it comes to vaccines, profit may be part of the problem. “Vaccines are almost treated like orphan drugs,” says Francie Wise, RN, MPH, the Contra Costa County director of public nursing and an expert on communicable diseases. “There is not enough profit in them.”

Francis agrees that vaccines are not profitable because of the very nature of the drugs themselves. “From the drug manufacturers point of view, the ideal drug is one that doesn’t cure, is defective, in a sense, but good enough to keep taking for years.” Vaccines, he says, are generally given only once or twice.

The global shortfall is also about haves and have-nots, illustrated by the Global Forum for Health Research’s “10/90 gap”: 10 percent of the world’s resources are directed at diseases that are responsible for 90 percent of the world’s disease burden.

Put another way, North America, Europe and Japan constitute 23 percent of the world’s population, but account for 80 percent of the world’s drug market. Only 0.3 percent of the money spent on medical research goes to malaria, unarguably the biggest killer on the planet. Sixteen times that amount goes into researching and treating diabetes, a dangerous disease, but hardly comparable to malaria.

Poor countries fear that in the advent of a flu pandemic, wealthy countries will hoard any vaccines that are developed. Markos Kyprianou, health and consumer protection minister for the European Union, recently called for “Rich and powerful countries” to share vaccines and antivirals drugs with “poor and affected ones.”

Poverty and unequal access to health care, however, is not just a Third World problem. The U.S., is the wealthiest country in the world, but it is 29th in life expectancy and 38th in infant mortality. A child born in the upper East Side of New York City has a one in 600 chance of dying before the age of one. A child born 20 blocks further uptown in Harlem has a one in 50 chance. As hurricane Katrina demonstrated, the Third World can exist in the heart of the First World.

And lastly there are politics.

“We live in a world where people have decided that government doesn’t have a role,” says Robbins, something he thinks needs changing. One suggestion he has is for the United Nations to establish a vaccine cartel. He understands the impulse behind PPPs, but doesn’t believe they are the solution in the long run. “We have to rescue these dedicated scientists from a trap not of their own making.”

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