Untitled Document

Slicko

Pharma PR Campaigns Spin the Limitations of Approved Drugs Away from the Eyes of Patients.

Left Field by Patricia Nell Warren

As I write this, Michael Moore’s latest blockbuster documentary Sicko is cleaning up at the box office. If I had the dough and the Hollywood clout, I’d produce my own documentary titled Slicko, to portray the slick PR jobs that float so many things in the pharmaceutical industry. The aim: to convince the American public that all is well—that the academic and corporate scientists who produce pharma products are all brimming with integrity, that all the research behind all drugs and vaccines is 100 percent honest and reliable. Last but not least, that the National Institutes of Health and the FDA do their job as watchdogs every minute of the day.

I’m sure there are still some scientists and corporate executives out there who give a hell about medical ethics. But during the last few years, many Americans are angry over some of the clear violations of ethics behind the Slicko Curtain. It’s not nice to find out you’ve been lied to about the safety and efficacy of medicines that you put into your own body, or those of your family and loved ones. During the last few years, certain antidepressants, and weight-loss drugs, and sex enhancers, and other drugs, have been in the news, because they turned out to be more toxic and lethal than we were told. Today the liars can include your own doctor. According to The New York Times, payments by pharmaceutical companies to medical doctors and psychiatrists, to get them to prescribe their products, are now so common that the Times called for a national database to be established, where such payments would be mandatorily disclosed. This way, you and I can see if our personal healthcare professional is on the take.

But most Americans appear to be less angry about controversies around AIDS drug safety. Why? Because they don’t hear much about it. I’m fascinated at the slick effort done by the AIDS establishment to keep bad news off the six o’clock news as much as they can. Example: the decade-long effort to manage the growing PR problems for nevirapine. While the wire services have done some landmark reporting on this subject, this drug has been kept away from the screaming TV visibility gotten by, say, the Vioxx scandal.

Nevirapine (brand name Viramune) was first sold in 1996 by Boehringer Ingelheim. Here in the U.S., everybody looked for it to be a HAART workhorse. Then, starting in 1997, there were growing reports of liver failure and severe-to-life-threatening skin rash, notably in healthy HIV-negative healthworkers who had received prophylactic treatment following needle sticks. Since the healthworkers’ reactions couldn’t be conveniently dismissed as AIDS-related, it became clear that nevirapine is more toxic than the trusting public (including people with HIV/AIDS and their loved ones) had been led to believe. For a while the AIDS establishment retreated on huckstering HAART in the U.S., and in 2000 the FDA strengthened warnings on the drug.

Shortly, however, HAART came creeping quietly back—along with a plan to launch nevirapine as a global workhorse, aiming to cut the rate of mother-to-child transmission of HIV with a single-dose treatment. Many advocates of mother-child treatment were looking for a slick and simple approach—nevirapine is cheaper than AZT, therefore more attractive for distribution in developing countries. Studies were said to prove that the single-dose treatment was safe for mothers and babies. It looked like a walk in the park.

But more PR problems started popping up. In South Africa in 2000, there were reports of liver-toxicity deaths during a series of sixteen Triangle Pharmaceuticals trials across the country that involved nevirapine. The AIDS establishment bitterly criticized the South African government for giving credence to these reports, but the company itself saw fit to halt recruitments for the trials. Then, in 2004, a high NIH official was caught red-handed rewriting a report on a Ugandan clinical trial, including the suppression of some statistics on severe side effects of nevirapine. According to an AP report, nevirapine had caused “thousands of severe reactions, including deaths” of Ugandan women and babies in this study. The AP added that opportunity for informed consent had not been provided to some of the Ugandan women enrolled in the study.

Reacting quickly, the establishment circled the wagons around nevirapine, with various AIDS-industry publications insisting that the suppressed statistics didn’t change the study’s results—that nevirapine is still safe, and that anybody saying otherwise was helping to kill babies all over the world. AIDS Treatment News said: “Many experts fear that the emotions released by the worldwide misinformation will result in many HIV-positive mothers getting no treatment and unnecessarily infecting their children with HIV.”

Despite the scandal, the Bush administration plowed ahead with the global launch. Then more queasy reports started coming in from African and Asian studies. It was now being discovered that nevirapine was prompting resistance mutations in a significant number of mothers and babies, whether used by itself or in HAART. At a 2005 conference, the CDC had to admit a growing problem with the cherished single-dose therapy—a majority of pregnant HIV-positive women who received nevirapine in a single dose were developing resistance. Worse, according to Medscape Today, “Some recent studies have questioned the safety of nevirapine when used as part of HAART regimens during pregnancy.”

By 2004 the FDA had finally put a black box warning on Viramune, and in 2005 the agency directed a belated cautionary at women. It turns out that women are three times as likely as men to develop liver toxicity during nevirapine treatment. The agency also admitted that women who have T-cell counts above 250 are twelve times more likely to develop liver toxicity than women with T-cell counts below 250. Not only that, but the effectiveness of birth control pills may be decreased for women who are on nevirapine treatment.

The related effort to persuade HIV-positive women in developing countries that they should not breast-feed their babies was also running into trouble. Establishment champions of formula feeding were having to face the fact that infant mortality is greater among children of HIV-positive women who use formula. In these countries, clean water is often not available for formula preparation, so infants are at risk of dying from fulminating diarrhea.

Not surprisingly, after ten years of cloudy news and controversy, a dogged effort is still being made to salvage nevirapine for targeted use. The manufacturer claims to have donated a million single doses so far. According to Medscape Today, “While additional treatment regimens are being studied for reduction of MTCT, nevirapine will continue to constitute one of the major drugs for HIV prevention in this field.”

Today, as they have for twenty years, the slickos are still telling us that nobody should question any item of AIDS science—that the public should believe and obey every pronouncement made by the powers-that-be. Yet the record shows how the slickos backtrack when earlier policies and approaches are proven dangerous or questionable. Putting a powerful chemical into the human body is never a simple thing, no matter how simple and convincing the political reasons for doing so may look. In the last analysis, the slickos make it hard for the rest of us to exercise any real informed consent—to get accurate and unbiased information on a drug, and decide for ourselves if its benefits are greater than its risks.