Petrelis Files

New York Times Omits Drug Company Role in HIV Trial; NEJM Doesn't

January 26, 2007

Byron Calame
Public Editor
The NY Times

Dear Mr. Calame,

I wish to inquire as to why the NY Times in a January 11 story about a drug trial related to AIDS didn't provide full transparency in regards to the involvement of two pharmaceutical companies.

The Times duly reported on a recent study in the New England Journal of Medicine about nevirapine's apparent benefit of preventing a fetus from contracting HIV from an infected mother. AIDS experts were quoted, findings were cited and a breakthrough seems to be on the horizon, and I don't have a problem with any of that.

However, I do have a qualm over the Times omitting the fact that the maker of nevirapine, Boehringer Ingelheim, donated doses of the drug to the researchers, which was noted in the footnotes of the NEJM article:

Supported by grants from the National Institute of Child Health and Human Development (R01 HD44391 and R01 HD37793) and the Fogarty International Center (D43 TW00004), by UNICEF, by Boehringer Ingelheim (which provided the single doses of nevirapine and placebo for the parent Mashi Study), and by GlaxoSmithKline (which provided zidovudine prophylaxis for the parent Mashi Study).

On the one side, I'm not saying the study or the findings are necessarily suspect just because Boehringer Ingelheim provided its drug to the research effort.

But on another side, I do think Times readers should have been informed of the pharmaceutical giant's involvement with the study, which I imagine will be used to prescribe vast amounts of the drug to hundreds of thousands of pregnant women, and those prescriptions in turn will equal increased profit for the drug company.

Obviously the NEJM knows the importance of disclosing any competing interests on the part of investigators and authors, along with any funding or support from a pharmaceutical company or diagnostics firm, which why such information is disclosed in NEJM articles.

But my question for you is, What is the responsibility of Times reporters to report on competing interests or donations from drug companies when the paper runs stories on clinical trials and their impact on public health?

Is there a standard way the Times handles such matters? Maybe the reporters and editor decide to include or omit competing interests or donations made on a case-by-case basis.

I would hope the Times does maintain a policy of including that information, and if the paper lacks a hard rule requiring such information make it into the story, then I will ask the science editors to revisit this policy with an eye open to putting the information in future articles.

A prompt reply is requested and would be appreciated.

Sincerely,
Michael Petrelis
San Francisco, CA

Excerpts from the article in question:

AIDS Drug to Protect Fetus Is Safe for Infected Mothers, Study Finds

By DONALD G. MCNEIL JR.
Published: January 11, 2007

Women can take the anti-AIDS drug nevirapine to protect their unborn children without endangering their ability to undergo life-saving antiretroviral treatment later on, a new study has found.

The results are good news for poor women in Africa, Asia and Latin America who must take nevirapine, an inexpensive first-line drug that often prevents the transmission of H.I.V. from mother to child.

The drug lingers in the blood up to three weeks, and if the mother has the virus that causes AIDS, its presence encourages the growth of nevirapine-resistant strains. That has led to fears that any antiretroviral drug cocktail containing nevirapine would be useless.

But the new study, published today in The New England Journal of Medicine, finds that such a cocktail is still effective if women simply delay it for six months after taking the protective dose of nevirapine.

The study was done by Harvard researchers working in Botswana but has implications for poor women everywhere. Early reports of data gathered in the study, along with evidence from similar ones, influenced the World Health Organization's new AIDS treatment guidelines last year, helping to keep nevirapine in the arsenal of first-line AIDS drugs.

''This is a real glimmer of hope,'' said Dr. Catherine Hankins, chief scientific adviser for Unaids, the United Nations AIDS agency. ''There was real concern that single-dose nevirapine was blowing the use of that whole class of drugs.'' [...]

The Botswana study concludes that waiting six months after single-dose nevirapine allows the nevirapine-resistant strains to disappear from the body.