Are US Researchers And Pharmaceutical Companies Conducting Human Experimentation in Africa?

By Farid Zakaria (not the famous one)

November 7, 2011 "PBFC" --  A new policy brief faults prominent institutions and drug companies like Pfizer, Columbia University, Johns Hopkins University, and Population Council, for their involvement in unethical and illegal human experimentation in Africa.

The report is titled “Non-Consensual Research in Africa: The Outsourcing of Tuskegee” in reference to the illegal human experiment conducted in Tuskegee, Alabama, between 1932 and 1972 by the US Public Health Service. In that experiment, some 600 impoverished African-American men were observed in a study on the progression of untreated syphilis. Some of the men were intentionally infected with the disease and all of them were denied the cure. Regrettably, the report notes, no one was held accountable for this crime against humanity.

The new report details human experiments led by US researchers and drug companies on Africans who are typically undereducated, poor, and lack full understanding of their rights. The human subjects often are led to believe that they are receiving medical treatment from governmental health services or health ministries.

These practices hearken back to the appalling experiments carried out by US researchers in Guatemala in the 1940s where hundreds of Guatemalans were deliberately infected with sexually transmitted diseases without information or consent. President Obama formally apologized to Guatemala for these experiments last year.

Human experimentation in the United States is regulated by the Office of Research Integrity and various Ethical Research Institutional Boards. Many African countries lack these institutions. Even when they exist, they lack independence and are controlled by corrupt government officials.

In one experiment on HIV sponsored by Gilead Sciences, the Centers for Disease Control, and the Bill and Melinda Gates Foundation and operated by Family Health International, Cameroonian subjects were given details about the experiment in English even though many spoke only French and were illiterate. Five women were allegedly infected with HIV in the experiment but were not given antiretroviral drugs.

In another experiment in Nigeria led by Pfizer physicians, researchers injected children with an antibiotic called Trovan during a meningitis outbreak without providing their families with informed consent forms that fully disclose the side effects and purpose of the experiment. Eleven children died and many were left paralyzed.

In South Africa and Namibia, mothers with HIV/AIDS are routinely sterilized without their informed consent. Countries that perform these procedures are known to receive funding in the form of grants and incentives from USAID and other aid organizations.

The report explains that US researchers and drug companies violate the laws and protocols of the Declaration at Helsinki (1964) and the Belmont Report which provide ethical guidelines on human experimentation.

Moreover, the results of unethical and fraudulent experiments are laundered in the United States and Europe through the peer-review system. Many of the “peers” who review these experiments are themselves involved in the same unethical conduct. Others are concerned about the possibility of professional alienation if they speak out.

The authors make several demands so that these practices are ended. They include holding congressional hearings so that the matter is brought to the public’s attention and enacting new legislation to ensure that drugs are not approved by the FDA unless the research on which they are based comply with ethical research principles.

Farid Zakaria is a recent law school graduate and is interested in the intersection of law, technology, and society. He currently lives in Los Angeles.

No to Obama's pharma in Asia

Bangkok Post
2/11/2011


There is trouble on the horizon for all hopeful members and would-be joiners of the Trans-Pacific Partnership Agreement (TPP). The TPP is a US-led initiative, started by President Barack Obama at the end of 2009. Its rather lofty aim is to bring free trade to the entire Asia-Pacific region, in stages. A Pacific free-trade zone is the almost mythical goal of the Asia-Pacific Economic Cooperation group. The theory is that if the United States and eight other disparate countries can agree on free trade, then all the other nations will quickly join.

That is a good theory, but after two long years and nine high-level negotiating sessions, the TPP is far closer to falling apart than coming together. The basic reason is simple: free trade pacts depend upon excruciatingly detailed contracts, appendices, exceptions and side agreements. In the last two negotiating sessions, the US delegation has almost entirely reversed its liberal policies on intellectual property protection, specifically on medical drugs and pharmaceutical products. That is bad news for the TPP, terrible news for Thailand. This very likely will derail the TPP talks or even cause them to fail entirely.

Free trade agreements always are sold by their promoters as win-win propositions. This is misleading at best. There are many winners in free trade, and in general consumers and businesses gain. The public gets generally lower prices and companies get opportunities to expand trade abroad. Free-trade advocates are correct that opening up borders to commerce produces far more winners than losers. But that is a stark admission that free trade also produces losers. This is why negotiating FTAs must be meticulous.

President Obama launched the TPP talks as a repudiation of sorts against his predecessor. The Obama administration vowed that "We are back" in Asia, after what it claimed was years of neglect by the Bush government. But George W Bush had taken the US into a far more liberal stance on copyrights, trademarks and patents. Mr Obama is now rolling back the Bush-era stance on medical patents. Mr Bush basically acceded to demands from developing countries, led by Thailand, for access to affordable medicines. It was Mr Bush who backed down when challenged by the Ministry of Public Health over drugs for Aids and heart disease. He accepted that the right to affordable medicine trumped strict patent enforcement. The new policy under Mr Obama specifically returns the right of "big pharma" to retain and expand its patent rights. That means a monopoly on any "new" drug and on all marketing. US negotiators at the past two TPP sessions threw these proposals on the table nonchalantly, as if they meant nothing. Civil society groups leapt on the issue, putting the entire TPP proposal at risk.

Of course, pharmaceutical firms have the legal right to protect their massive investments in developing helpful new drugs. Under Mr Bush, the US did not completely back the drug firms, meaning they were subject to public pressure. Mr Obama has fundamentally reversed that. Any country trying to challenge drug firms will find themselves doing battle with US diplomacy and trade sanctions.

Opposition abroad and among NGOs is near-unanimous. Medicins Sans Frontieres calls the US policy reversal "a dangerous new standard" that will deny drugs to millions. Peter Maybarduk of Public Citizen says the Obama administration is forcing developing countries to trade away their access to medicines. This is a bad decision by the US and Mr Obama should drop that requirement immediately.