In Vanity Fair, Donald Barlett and James Steele have devoted more than 6,000 words to chronicling the gaping holes in the global pharmaceutical industry, particularly as pertains to the globalization of clinical trials. Even if you’re familiar with many of the specific incidents covered, their cumulative effect, driven home with forceful and authoritative prose, is brutal. Each paragraph holds another tale of trials gone wrong, children killed and bad results that somehow never came to the attention of American regulators.
It used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards. The free market has changed all that. Today it is mainly independent contractors who recruit potential patients both in the U.S. and—increasingly—overseas.
They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns. The people doing the work on the front lines are not independent scientists. They are wage-earning technicians who are paid to gather a certain number of human beings; sometimes sequester and feed them; administer certain chemical inputs; and collect samples of urine and blood at regular intervals. The work looks like agribusiness, not research.
After neatly setting up each pin with demonstrations of how international the pharmaceutical industry has become, then proceed to knock them all down with examples of industry impunity and FDA weakness.
The F.D.A., the federal agency charged with oversight of the food and drugs that Americans consume, is rife with conflicts of interest. Doctors who insist the drug you take is perfectly safe may be collecting hundreds of thousands of dollars from the company selling the drug. … Quite often, the F.D.A. never bothers to check for interlocking financial interests. In one study, the agency failed to document the financial interests of applicants in 31 percent of applications for new-drug approval. Even when the agency or the company knew of a potential conflict of interest, neither acted to guard against bias in the test results.
Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.
Today’s program features sessions about people with HIV and tuberculosis; prevention of mother-to-child transmission; HIV testing; the role of families in prevention, treatment and care; policies and measure ins Europe and more.
The Foundation is offering webcasts of sessions and interviews with newsmakers, as well as daily observations from Science magazine reporter Jon Cohen.
The conference website include slides, audio synched to the slides, rapporteur reports, links to abstracts and webcasts.
In related news, health journalists have been discussing an embargo break on a study that was presented at the conference. AHCJ board member and Reuters Health Editor Ivan Oransky has covered the situation here and here on his Embargo Watch blog.
The guide devotes sections to diseases/issues (HIV/AIDS, Malaria, Tuberculosis, Neglected Tropical Diseases, Maternal and Child Health, Water-Related Diseases, Food Insecurity), U.S. funding of global health efforts (Obama’s Global Health Initiative), relevant policy issues and policymaking. It also catalogues and explains related multinational and NGO efforts and lists news-making events.
The Chicago Tribune‘s Tom Hamburger reports that several global health advocacy organizations, including Doctors without Borders and OxFam International, have criticized the Obama administration for not helping to remove Bush-era impediments (primarily regarding pharmaceutical patent enforcement) to cheaper drugs overseas. Advocates claim officials are unwilling to confront major pharmaceutical companies at a time when their cooperation is needed in negotiations surrounding health care reform. For their part, administration officials point out that language in their reports has softened somewhat from that of the previous administration.