December 18, 2004

Making Sense of The Recent African AIDS Treatment Stories

There have been many reports this week about AIDS treatment in Africa, with all sorts of dramatic headlines. I’ve gone through them and I will seek to make sense out of them here.

An alternate title for this post might be, “An Error Made By Jesse Jackson Threatens Lives in South Africa.” It would be difficult to find a clearer-cut example of someone on the Left claiming moral outrage in pursuit of a goal which threatens the lives of the very people that person is ostensibly trying to help.

WHAT IT’S ALL ABOUT
Here’s the deal. The vast majority (70%) of the people in the world who have HIV live in a specific region of Africa:

Some 70 percent of the 45 million people worldwide infected with HIV live in sub-Saharan Africa.

There’s a terribly serious circumstance there: in childbirth the disease may be passed from the mother to the infant. A drug, nevirapine, has been found, that greatly reduces this danger:

Studies have shown that a single dose of nevirapine to an infected woman during labor and another dose to her newborn can reduce the chances of HIV transmission by up to 50 percent. Nevirapine is also used in combination with other drugs to prolong the lives of AIDS patients.

Subsequent research has confirmed the safety and efficacy of nevirapine in protecting newborns, according to the World Health Organization. ...WHO recommends nevirapine be used in combination with other drugs where possible — a strategy that has reduced transmission to less than 1 percent in wealthier countries.

America has been providing this drug to people in Africa:

President Bush launched a 2002 plan to distribute the drug in Africa.

Additional details:

In June 2002, Bush announced a three-year, $500 million initiative to reduce mother-to-child HIV transmission in Africa and the Caribbean with nevirapine as the plan’s “centerpiece,” the AP/Globe reports (AP/Boston Globe, 12/14).

The initiative aimed to provide treatment to one million HIV-positive pregnant women annually to reduce vertical HIV transmission by 40% in target countries within five years or less (Kaiser Daily HIV/AIDS Report, 6/19/02).

The program is considered to have saved lives:

...the drug [is] credited with protecting thousands of African babies from catching HIV from their mothers.

So what we have here is an impressive story of American generosity saving lives in Africa, of which we would all be extremely proud, if anyone here ever heard about it from our biased Liberal media. Of course, the mainstream media tries to avoid printing anything that makes America look good. MSM only mentions this sort of thing when there’s a way of using it to make America look bad.

In keeping with which, earlier this week, this headline appeared:

Pregnant Woman in NIH Study Died of Liver Failure Likely Caused by Nevirapine

Sounds like evidence that normal use of the drug is dangerous, doesn’t it? However, it turns out the drug was improperly administered:

...NIH documents obtained by the Associated Press show that Hafford could have survived if doctors had ceased administering nevirapine when her bloodwork indicated liver problems two weeks before her death, the AP/Sun reports.

The U.S. government has publicized the dangers of incorrectly administering the drug for over four years:

Since 2000, the government has warned that nevirapine can cause lethal liver damage or rashes in patients who take the drug in multiple doses over extended periods of time.

There is a one serious possible side-effect of using the drug to save the lives of the infants:

...there’s evidence women who receive a single dose during pregnancy can develop resistance to the drug that can compromise their future AIDS treatment.

QUESTIONS ABOUT THE INITIAL STUDY
However, initial testing of the drug in Africa was not satisfactorily completed:

NIH in 1997 began studying the use of nevirapine in single doses among HIV-positive pregnant women in Uganda to determine the drug’s ability to prevent vertical HIV transmission. The initial results showed that the drug prevented HIV transmission to newborns in as many as 50% of births.

However, by early 2002, medical safety specialists and an auditor with NIH as well as Boehringer all cited “widespread problems” with the research in Uganda—including a failure to receive participants’ consent about changes in the study, administration of incorrect doses, and delays and underreporting of “fatal and life-threatening” reactions to the drug, according to the AP/Globe. Because of the reported problems, NIH suspended the research for 15 months from spring 2002 to summer 2003 in order to “review the science and take corrective actions,” according to the AP/Globe.

Investigators found that the research was “riddled” with poor record keeping and could not be sure from records which participants received nevirapine, the AP/Globe reports. Therefore, researchers had to use blood samples to confirm the doses used in the study, according to the documents obtained by the Associated Press.

That “fatal and life-threatening” phrase appears to be quite serious. However, in all the articles I’ve reviewed at this time, the only “fatal and life-threatening” reactions to the drug are associated with administration of the drug that is contrary to the official procedures for its use. No articles quoted in this post report any life-threatening consequences associated with correct use of the drug.

Okay, so the initial study had a lot of sloppy record-keeping and was poorly admistered; since then in actual practice the drug has (per the quotes at the top of this post) been found effective, and no deaths have been observed from the correct use of the drug, but only from use of the drug in ways that are contrary to officially approved procedures.

QUESTIONS ABOUT THE HANDLING OF THE INITIAL STUDY BY A GOVERNMENT AGENCY

Dr. Tramont, director of the National Institute of Allergy and Infectious Diseases Division of AIDS, was aware of the poor administration of the initial study, and did not consider this serious enough to report to the FDA:

The documents show that Dr. Edmund Tramont, director of the National Institute of Allergy and Infectious Diseases Division of AIDS, and other NIH officials regarded the problems with the trial as “overblown” and did not immediately report safety concerns about the drug to FDA, according to the AP/Globe.

Dr. Tramont’s evaluation appears to have been justiifed by actual results of use of the drug.

So yesterday, AP ran an article with the headline, “S. Africa Attacks U.S. Over AIDS Drug”:

President Thabo Mbeki’s ruling party published a stinging attack Friday on top U.S. health officials, accusing them of treating Africans like “guinea pigs” and lying to promote a key AIDS drug.

The article, published in the online journal ANC Today, was responding to Associated Press reports this week that U.S. health officials withheld criticism of a nevirapine study before President Bush launched a 2002 plan to distribute the drug in Africa.

...”Dr. Tramont was happy that the peoples of Africa should be used as guinea pigs, given a drug he knew very well should not be prescribed,” the article said. “In other words, they entered into a conspiracy with a pharmaceutical company to tell lies to promote the sales of nevirapine in Africa, with absolutely no consideration of the health impact of those lies on the lives of millions of Africans.”

Paragraph 6 of the AP article casts doubt on the statements in paragraph 1. Paragraph 1 says that “President Thabo Mbeki’s ruling party” is responsible for the allegations, but per paragraph 6:

Smuts Ngonyama, an African National Congress spokesman and editor of the journal, said the article was an opinion piece by a member and didn’t reflect official party policy. He wouldn’t identify the author.

However, the AP article does report that the doctors using the drug feel it is effective and fear to have the use of it curtailed:

The criticism reinforces fears of doctors and activists that new questions about the testing of nevirapine could halt use of the drug that’s credited with protecting thousands of African babies from catching HIV from their mothers.

Okay, so there were concerns about the initial study, which Dr. Tramont did not feel were serious enought to stop the use of this life-saving drug. Dr. Tramont’s views appear to have been justified by the actual use of the drug. The doctors and activists using the drug in Africa have found it to be effective and fear to lose access to it.

WHICH BRINGS US AT LAST TO THE REVEREND JESSE JACKSON
Here’s what Jesse Jackson had to say about all this:

In the United States, the Rev. Jesse Jackson called for a U.S. congressional investigation and demanded nevirapine no longer be distributed in Africa.

“This was not a thoughtful and reasonable decision, but a crime against humanity,” Jackson said Thursday in Chicago. “Research standards and drug quality that are unacceptable in the U.S. and other Western countries must never be pushed onto Africa.”

That’s right. The Reverend Jesse Jackson demands that the drug no longer be distributed. In the name of high moral authority he demands the very thing that would cause lifelong suffering and even death to the very people he purports to defend.

Update 12-19-04: Instapundit questions the propriety of Dr. Tramont’s actions:

IF A DRUG COMPANY DID THIS it would be a huge scandal. But it’s the government, so it’s okay!

It doesn’t appear to me that Glenn has stated a conclusion on this yet, although he well may by the time you read this. It’s a very interesting controversy. Dr. Tramont’s actions got the drug to the people sooner and saved lives. But in less honorable hands the procedures he used could have been used for wrongful purposes. Do we sanction Dr. Tramont? Or do we give him credit but keep a more watchful eye out for such things in the future?

2nd Update 12-19-04: Welcome, Instapundit readers. Thanks Glenn, for the link to this post.

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