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The rabbit hole is deep, deep, deeper than Atlantis. Deeper than the sea floor traveled by the mantis. With apologies to the Wachowski Brothers and X-Clan (and Alice in Wonderland), the quest for bio-chemical information, access and profits is of staggering dimensions. Experiments which began in the early part of the last century are part of a continuum. Today, clinical trials involving 40,000 Malian adults are high-risk experiments where the payoff must be questioned. Tests to assess the responsiveness of 2,000 Mozambican children or 2,500 Malawian children are being conducted by scientists with deep pocketed donors. And everyone has a history – from the top to the bottom. At the bottom of all this empirical research is “the cell.”
(I am not a scientist by trade or training. I am a historian. As such, it’s easier for me to gather the pieces quickly than to process them and “interrogate” my sources against solid references. For that reason, I’ve been particularly cautious in advancing claims I could not defend. (That’s not anything new – but I have a heightened awareness of being on unfamiliar ground here.) Lacking the depth of scientific background required to lay bare some of these complex issues, I have instead sought to leave those arguments to the professionals – and in the context they intended.)
Immortal cell lines
The historic relationship between the Rockefeller Institute and the Johns Hopkins University in Baltimore has points of intersection. In Part I, I discussed Simon and Abraham Flexner. Abraham, the younger brother, was a student at Hopkins who would eventually lead the Institute for Advanced Study. Simon, the elder, studied briefly at Hopkins and would become director of the Rockefeller Institute. Pioneering work on keeping cells alive for study began in the early 1900’s at both the Rockefeller Institute and Johns Hopkins University. In fact, one of the leading scientists at Johns Hopkins, Dr. Alexis Carrel, was one of Simon Flexner’s first hires at Rockefeller. The immunology research to identify viable cells went on for decades before scientists were able to isolate the cells that would support Dr. Jonas Salk’s research on polio (April 1955).
The story of this brand of immunology research, however, is the story of a Black woman born during a time – and in a part of the nation (Halifax County, Virginia) – when my own great grand mother and her siblings were coming of age. It is not inconceivable that they knew one another or that our families sat in the same church pew or shopped in the same stores or rode on the back of the same buses or worked for small shares on the same plantations. The woman’s name was Henrietta Lacks.
In July of 2006, The Scientist (Terry Sharrer) wrote about Ms. Lacks and the immortal cells which carry her name in a modified form. The form was modified to shield her identity.
By January 1951, while a new war in Korea was propelling the local economy, Lacks made a troubling discovery: abnormal vaginal bleeding. She consulted William Wade, a family practitioner, who referred her to the women’s clinic at Johns Hopkins Hospital. There, Howard Jones made the preliminary diagnosis of cervical cancer, then the leading cause of cancer deaths among women. Lawrence Wharton Jr. performed a cone biopsy, which confirmed the diagnosis and noted its advanced stage.
When Wharton took the biopsy specimen on February 9th, he had sent a portion of it to George Gey, director of the Tissue Culture Research Laboratory in the hospital’s Department of Surgery. Gey had been trying for some time to grow tumor cells in vitro but had failed repeatedly. It was his laboratory assistant, Mary Kubicek, who first noticed that Lacks’ cells remained alive in a nutrient solution of chicken plasma. They not only survived, but after six weeks the cells were dividing every twenty hours, much faster then they grew in vivo.
Gey was only secondarily interested in cancer research; tissue culture for growing poliovirus topped his agenda, and the now designated HeLa cell line suited that work perfectly. In 1953, the National Foundation for Infantile Paralysis set up a production facility for polio virus at the Tuskegee Institute, using HeLa cells that Gey provided, thus opening the way for Jonas Salk’s killed virus polio vaccine. Gey also sent Lack’s cells to medical researchers, pharmaceutical companies, and biologists studying the effects of zero gravity in space. When President Nixon signed the National Cancer Act in 1971, initiating the so-called war on cancer, HeLa cells provided the living context for many discoveries about cancer genetics and tumor viruses.
Surely there are millions of Americans who would never warm to the idea that the critical cancer research which saved their lives was predicated upon the cells of a Black woman. Perhaps more than that is the disturbing truth that Lawrence Wharton, Jr. took a culture from Ms. Lacks without her knowledge or permission. Her family was never informed and only came to the information by happenstance.
From the New York Times, November 17, 2001:
Deborah Lacks closed her eyes as a young cancer researcher opened the door of his floor-to-ceiling freezer. She stood clutching the ragged dictionary she uses to look up words like ”DNA,” ”cell” and ”immortality.” When the icy breeze hit her face, she opened her eyes slowly, and stared into a freezer filled with tiny vials of red liquid. ”O God,” she gasped, ”I can’t believe all this is my mother.”
Fifty years ago, when Deborah Lacks was still in diapers, her 30-year-old mother, Henrietta Lacks, lay in a segregated ward of Johns Hopkins Hospital in Baltimore. The resident gynecologist sewed radium to her cervix in an attempt to knock out the cancer that was killing her. But before he finished, and without telling her, he took a small sample of her tumor and sent it downstairs to Dr. George Gey (pronounced guy), head of tissue culture research at Hopkins. Dr. Gey had spent almost 30 years collecting cancerous human cells and trying to make them grow, but until Ms. Lacks came along, they never did. Though Henrietta died a few months after her radium treatments, her cells are still living today.
Henrietta’s cells — named HeLa after the first letters in Henrietta and Lacks — became the first human cells to live indefinitely outside the body. They helped eradicate polio, flew in early space shuttle missions and sat in nuclear test sites around the world. In the 50’s, HeLa cells helped researchers understand the differences between cancerous and normal cells, and quickly became a standard laboratory tool for studying the effects of radiation, growing viruses and testing medications. HeLa is still one of the most widely used cell lines; in fact, this year’s Nobel Prize in Physiology or Medicine was awarded for research in which HeLa cells played a pivotal role.
Yet it was not until nearly two decades later — just before magazines like Jet and Emerge started writing stories about a black family whose mother had made important contributions to science without their knowledge — that anyone in Ms. Lacks’s family knew what had happened. Ms. Lacks, 52, doesn’t remember how she heard, but she’ll never forget her reaction: ”I went into shock,” she said. ”Why didn’t they just ask if they could use her cells?”
If the issue of using patient tissue without permission wasn’t a pressing one in the 50’s, informed consent has certainly become a heated topic today.
”In 1951, they wouldn’t have felt like they needed to ask,” said Ruth Faden, executive director of the Johns Hopkins Bioethics Institute. ”It’s a sad commentary on how the biomedical research community thought about research in the 50’s, but it was not at all uncommon for physicians to conduct research on patients without their knowledge or consent.”
Today, when patients go in for surgery, they’re usually asked to sign a form saying whether their tissues can be used for research. But, said Lori Andrews, a professor at Chicago-Kent College of Law and co-author of ”Body Bazaar: The Market for Human Tissue in the Biotechnology Age,” that practice doesn’t solve an important problem.
”All of us have blood or tissue on file somewhere,” Ms. Andrews said. ”Today, every drop of blood taken from people, every organ or biopsy removed by a surgeon, is in the pipeline toward research and commercialization. Since the 60’s, every newborn in the U.S. has been tested for genetic disorders, and many of their samples are still on file for use in later research. There are no rules governing who has access to these samples.”
The Times continues by outlining the awful consequences of how scientists have communicated their “role” in the evolution of immortal cell lines:
Within a few years of learning about HeLa cells, the Lacks family began getting letters from researchers, asking them to donate blood so scientists could find genetic markers to help identify Henrietta’s cells. But Ms. Lacks remembers differently: ”It was a typed letter, stating we need samples of the Lacks family to check her blood cells with theirs, to see if anybody has the same thing that she had,” she said. Ms. Lacks was in her late 20’s and had always worried that she might die at 31, just like her mother.
”I cried and cried,” she recalled. ”I had my two children, they was babies at the time, and I said ‘O God, am I going to make it past 31?’ ” She dodged the researchers at first, because she didn’t want to know whether she had cancer. When she finally decided to take the tests, she thought she’d get a phone call telling her whether she was going to live or die. She never heard back from the researchers and soon had the first of what would become several breakdowns.
Ms. Faden said: ”This could have been a very innocent misunderstanding. But this is why researchers have to be as straightforward as possible, because the expectation is that when a doctor wants to do something to you, it’s for your benefit. Physician-researchers need to make this clear by saying, ‘I’m not doing this to help you, I’m doing it to advance science.’ ”
Bobbette Lacks, Henrietta Lacks’s daughter-in-law, says that if researchers had told them about HeLa cells, then informed them of future research, her family would have cooperated. But not now. ”I would never subject my kids to that,” Bobbette Lacks said.
This year, the 50th anniversary of Henrietta Lacks’s death, some scientists wanted to honor her contribution. The National Foundation for Cancer Research had invited Deborah Lacks onstage to thank her for her mother’s cells. But the conference had been scheduled for Sept. 13 and was canceled after the terrorist attacks. So for now, Ms. Lacks is back to learning about her mother on her own.
Until Ms. Lacks looked into that freezer filled with vials earlier this year, she had only read about her mother’s cells; she had never seen them.
These are the immortal cells of Henrietta Lacks.
Here are pictures of the doctors who led the research on Ms. Lacks in the 1950’s and also misdiagnosed her condition:
Lawrence Richardson Wharton:
George Otto Gey (pronounced “guy”):
The importance of immortal cell lines cannot be underestimated. Nor, however, can we underestimate the extent to which scientists (for more than 10 decades since the founding of the Rockefeller Institute) have operated with the sense that human beings (especially Africans) are not much more than chattel.
The Purpose of US Vaccination Efforts on Malaria
Listen to Major General Lester Martinez-Lopez (April 25, 2002):
“Our goal is to produce a vaccine that will protect military personnel in malaria endemic regions, but it’s clear that this vaccine candidate also holds tremendous potential for children,” said Major General Lester Martinez-Lopez, commanding general of the U.S. Army Medical Research and Materiel Command, which oversees WRAIR’s work. “With MVI adding critical support for these trials, we all can move that much faster toward our respective goals.”
From the Seattle Times (February 6, 2008):
With an unprecedented infusion of cash and a businesslike approach, the Bill & Melinda Gates Foundation has kicked the quest for a malaria vaccine into high gear. Since 1999, no single government agency or organization has spent more on the effort. Of all the diseases the foundation has tackled, only AIDS gets more money than the $1.14 billion committed to malaria so far — and Bill Gates vows to keep the funds flowing.
“This is the time period where malaria can be largely conquered,” he said in an interview. “Whatever it takes, we’re just going to stay at it.”
The Gates Foundation has almost single-handedly revitalized malaria research, says retired Maj. Gen. Philip K. Russell, a medical doctor who oversaw the Army’s malaria research for more than 15 years. “It was not on anybody’s agenda until Gates put it there.”
No one has ever developed a vaccine against a human parasite. The current version is the most advanced in the world, but in early trials it kept only about a third of children from getting sick.
According to a New York Times article from July 7, 1913, a University of North Carolina professor, Dr. Wade Brown, conducted experiments funded by the Rockefeller Institute and determined the causative factor in malaria as early as 1912. Given the history of this disease (it was treated with quinine in the 1640’s), one wonders why a man as smart as Bill Gates would focus his efforts on finding a vaccine which may be one day or one century in the offing. Is this akin to trying to outdo Steve Jobs with more vulnerable, proprietary software? If this approach reflective of a truly modern open-source approach to resolving issues on the ground?
The article continues:
Many clinics in Africa don’t have refrigerators. Roads are often no more than rutted tracks. Villagers who travel days to visit a doctor may find no one there because health workers are fleeing for better-paying jobs. And while Gates has committed nearly $350 million to develop a vaccine, it will cost billions to manufacture and distribute it in countries where most people live on less than $2 a day.
Critics who fault the Gates Foundation for its faith in technological solutions say the shelves are already groaning with drugs and devices that never reach poor Africans because of these “downstream issues.”
Dr. Regina Rabinovitch, leader of the foundation’s infectious-disease programs, is well aware of the stakes. “We know our job is not finished when the vaccine is done,” she says. “It doesn’t do any good if it doesn’t get out there.”
In Part III, I sought to establish the close connection between systems of clean water and sanitation as causes for disease. Here, the Gates Foundation acknowledges that in addition to water and sanitation, transportation and energy (electricity, solar, or other) are also of critical concern in delivering the product. The work of the foundation, however, does not address these critical areas. The work of the Clinton Foundation does not address these areas either. Still, the idea of opening African markets to private investment lies at the heart of this endeavor — after identifying a vaccine that will protect the American military.
Clinical Trials, Mandatory Testing and Guaranteed Demand
The global community of non-governmental organizations (NGOs) have developed new terminology to define many of the unique actions in which they are engaged. In Part III, I provided some historical context and mainstream links on the nature of the business mapped by the Bill and Melinda Gates Foundation. Simply, the BMGF is engaged in the business of triage. The term which is now widely circulated by European and US-based NGOs (and the US government) is “child survival.” The US government has even established what is known as the US Coalition for Child Survival.
“Child survival” is part of a broader paradigm which focuses, essentially, on improving the survival rates of women and children. Critics of the paradigm have argued the donor inattention to the basic, but more expensive, requirements for clean water, sanitation, and transportation undermine the entire effort. Moreover, there is little mention of the place of African men in this paradigm (more on this in future installments).
The US Coalition reports that 27 million children, under the age of five, die each day from various conditions. The leading causes of death are, in order, malnutrition, neonatal causes, pneumonia, diarrhea, malaria, measles and finally, the myriad diseases classified as AIDS.
Large multinational pharmaceutical firms are continuing the work by leading clinical trials in Africa.
- Merck in South Africa (September 24, 2007)
- From the New York Times (May 9, 2007):
“Jeffrey L. Sturchio, a vice president at Merck in New Jersey, says his company strives to balance providing the broadest possible access to AIDS drugs while maintaining financial incentives to attract companies to conduct research and development on new drugs.
Brazil and Thailand have overridden Merck’s patent on the AIDS drug efavirenz, an ingredient of the new, improved first-line AIDS therapies. Merck had been charging Brazil $577 annually per patient, a price it agreed to drop to $400 a year after Brazil said it was considering overriding the patent. The Clinton Foundation’s new price for the generic drug is $164.”
How was the former President able to secure these price reductions? By guaranteeing that the United States Armed Forces (remember the Presidential Decision Directive from 1996) would implement mandatory testing in EVERY African nation with a high prevalence of infection.
From the Financial Times (April 25, 2006):Bill Clinton may no longer be an elected politician, but the outspoken former US president has stepped into an ethical quagmire by expressing support for the controversial idea of mandatory HIV testing in countries with a high prevalence of infection.Speaking to a group of journalists in London recently, he endorsed Lesotho’s pioneering programme launched last November to offer universal testing, and suggested other countries and companies should launch extensive efforts to diagnose HIV.His comments come at a time when several countries have raised concerns that although they are scaling up Aids treatment, they are still losing the battle to reduce rates of HIV infection, which are causing widespread economic damage.For a long time, the idea of widespread diagnosis made little sense in the developing world, where confirmation of HIV was simply a death sentence, with no prospect of treatment. But that has changed significantly since the turn of the millennium.Malawi, which has significantly increased its HIV treatment in recent months, has toyed with an “opt-out” system to identify infection during patient check-ups unless they specifically refuse.Kevin de Cock, head of the World Health Organisation’s HIV/Aids programme, said he supported such an “opt-out” system, but only on condition that it was voluntary and linked to patients being able to get treatment if found to be HIV positive. “That is a valid type of informed consent,” he said. Lesotho’s programme does just that in principle, with the aim of providing universal treatment by 2007, although some observers suggest that social pressure may mean voluntary agreement is in practice partly coerced.Mr Clinton suggested he might support programmes that went still further, explicitly requiring mandatory testing and even compulsory disclosure of positive HIV results to the partners of those found to be infected.
Asked about the ethics of such compulsion, he argued that it could be justified in countries with high infection rates, on condition there was guaranteed diagnosis, treatment and anti-discrimination measures put in place. “In a population with extremely high rates of infection, [mandatory testing] overcomes other reservations,” he said, warning of the “social wreckage” devastating poorer countries with widespread HIV incidence.
Cuba launched mandatory programmes for Aids testing and treatment in the 1980s, triggering substantial international criticism at the time, although it appears to have been able to successfully maintain very low rates of HIV infection since.
Its model may attract new interest at a time when the battle against Aids elsewhere remains tough. The latest United Nations figures suggest that despite a sharp rise in international funding, just 1.3m people are currently receiving anti-retroviral treatment for HIV in the developing world, compared with 6.5m estimated to need it.
The Clinton Foundation itself has contributed to an acceleration in treatment by negotiating sharp reductions in the cost of HIV medicines and diagnostic tests in developing countries, as well as launching efforts to strengthen healthcare structures.
However, about 40m people around the world are now living with HIV – the highest number ever, and those newly infected rose last year by another 5m, suggesting that prevention efforts continue to lag behind treatment.
In that context, politicians continue to float more extreme measures. Public officials in the Indian state of Goa became the latest to propose one such initiative – compulsory HIV testing ahead of marriage, for example – although it is unlikely to be implemented.
Richard Coker, a reader at the London School of Hygiene and Tropical Medicine, argues that it is ethically justified for doctors to protect the partner of someone found to be HIV positive by informing them of the diagnosis if their patient refuses.
But he criticises the idea of mandatory testing. “Coercive measures don’t work. If you have to launch mandatory programmes, that suggests the person is not persuaded of the benefits and you would have to isolate them or force them into treatment.”
He argues that such an approach would be both unethical and counterproductive, since it would probably lead to poor compliance with treatment and discourage people from coming forward for testing.
Many countries in the developing world are still far from achieving any significant coverage of HIV patients with treatment, suggesting it will be a long time before they can justify more aggressive testing programmes backed up with the incentive of drugs.
But as the leaders of the Group of Eight industrialised nations consider how to meet their pledge at last year’s Gleneagles summit to try to give HIV treatment to all who need it by 2010, the continuing growth in infection means they will face the still more difficult political and ethical challenges in tackling prevention.
Mandatory and universal testing requirements ensure demand for the manufacturers of generic, lower cost drugs. They’re for everyone. Everyone. Everyone!!!!
Clinton has made agreements with two firms in India – and has provided (with Bill Gates) the leverage for these firms to provide these drugs which continue to require trials to ensure their efficacy. After 100 years of lab-research on malaria by John Rockefeller, the US Army and Bill Gates, mosquitoes continue to impose their will. And yet, today, there are questions about whether or not the story has been overstated.
The All-American Raison D’Etre
Chinese demands for energy are driving the US to pursue new relationships in Africa. The guise of humanitarian aid must be viewed within the context of the Defense Department’s critical role in the advance of US-Africa relations. And, perhaps most disastrously, it must be borne in mind that at precisely the point when Gilead Sciences (a leader in HIV vaccination research) was making its most headway, the chairman of its board was none other than Donald Rumsfeld (more in Part V).
From Reuters (February 28, 2008):
LOS ANGELES, Feb 28 (Reuters) – A safety board has recommended that certain AIDS patients taking part in a study of GlaxoSmithKline Plc’s (GSK.L: Quote, Profile, Research) Epzicom consider switching to Gilead Sciences Inc’s (GILD.O: Quote, Profile, Research) Truvada, sending Gilead’s shares up about 4 percent on Thursday.
The National Institute of Allergy and Infectious Disease’s AIDS Clinical Trials Group, a unit of the National Institutes of Health, is comparing the two drugs in a head-to-head trial involving 1,858 patients.
The unit said on Thursday that an independent Data and Safety Monitoring Board recently found that for patients with high levels of HIV virus, treatment regimens containing Epzicom were less effective at controlling the virus than regimens containing Truvada.
The board also found that patients with high levels of HIV virus treated with Epzicom developed side effects such as body aches and high cholesterol more quickly.
Glaxo said in a statement that the NIH study did not routinely exclude patients at risk for a known reaction with Epzicom, which might have accounted for some adverse events.
The trial recommendation applies to about half the patients being treated with the Glaxo drug and, if translated to real world usage, could mean a 20 percent market share gain for Gilead’s Truvada and Atripla, Morgan Stanley analyst Sapna Srivastava said in a research note on Thursday.
Remember Tamiflu and the avian flu virus? That was also Gilead Sciences.
The stakes in the energy game are very high. In 2006, China’s president visited Saudi Arabia, Morocco, Nigeria and Kenya. Today, the United States of America imports more oil from Africa than from Saudi Arabia. The US has protected the House of Saud from all comers and precluded other nations from breaking up the dollar-oil peg which prevails in Saudi Arabia. No such arrangements exist on the ground in Africa…and yet – the US is proposing to establish its first military command. China’s strategy for African partnership centers on infrastructure.
Beijing plans to invest $4 billion in Nigeria’s infrastructure, including a Nigerian state-run oil refinery, a railway line and power plants. Two Chinese telecommunication companies will install rural telephone services financed by $200 million in loans from Beijing.
On the eve of Hu’s visit, the China National Offshore Oil Corporation (CNOOC) paid $2.7 billion for a 45 percent stake in a Nigerian oil field due to start production in 2008. Last year, Nigeria agreed to provide 30,000 barrels of oil per day for five years to China’s largest state-owned oil company, PetroChina, in a deal worth $800 million.
Oil was also top of the agenda in Kenya on April 27-30. In Nairobi, the Chinese president signed an agreement for licenses to allow CNOOC to explore six possible oil blocks off the coast of Kenya. Last year, China provided $36.5 million in aid to Kenya, mainly to upgrade its power stations.
China’s deals with Nigeria and Kenya, as well as other African countries, are direct challenges to the traditional domination of the continent’s oil by American and European companies. (See Western concern at China’s growing involvement in Africa)
China’s energy diplomacy was spelled out by Yang Peidong, a foreign ministry consultant, in a recent edition of China Economic Weekly. Beijing is now focusing on “the extension of trade and the promotion of energy, resources and technology cooperation” as the heart of China’s foreign policy, he wrote.
China’s strategy is to offer infrastructure projects to the resource-rich countries in Middle East, Africa and Latin America to facilitate, and in exchange for, the export of minerals to China. China is now the world’s sixth largest engineering contractor, with its new contracts up 24 percent to $39 billion last year. In some cases, China has also financed and even armed regimes, such as in Sudan and Zimbabwe, in order to protect its resource interests.
In comments to Reuters during Hu’s visit, former Nigerian foreign minister Bolaji Akinyemi attempted to play down possible tensions with Washington. “In the Middle East, the US regards China’s incursion with alarm, but Nigeria is more virgin territory for suitors and Washington should not be too worried,” he said.
The Bush administration, however, regards China’s moves in Africa as far from benign. Its recently published National Security Strategy openly states US concerns over China as “expanding trade, but acting as if they can somehow ‘lock up’ energy supplies around the world or seek to direct markets rather than opening them up—as if they can follow a mercantilism borrowed from a discredited era; and … supporting resource-rich countries without regard to their misrule at home or misbehaviour abroad of those regimes.”
The West has not directed itself to resolving the infrastructure crisis across the continent precisely because they are architects of that crisis.
For more information on the complexity of dealing with malaria (for example, in contrast to HIV), check out this link.