Reversing a six-month-old decision, the National Institutes of Health announced last week that it will test a controversial AIDS drug that has been widely promoted within the black community.
Officials of the National Institute of Allergy and Infectious Diseases (NIAID) agreed to conduct clinical trials to determine if low doses of the drug, oral alpha-interferon, can be used by people infected with the human immunodeficiency virus (HIV) to help delay the onset of the disease.
The announcement came after a daylong closed meeting during which scientists from NIAID met with members of the National Medical Association, an organization of minority doctors.
The prime force behind the use of low-dose alpha interferon was the black religious group Nation of Islam, which insisted that its doctors and clinics -- as well as its version of the drug -- be used in the clinical trials.
"It seems that large numbers of individuals are opting to take low-dose interferon and declining to take therapy that, from our perspective, has been proved beneficial in good, sound clinical trials," said Jack Killen, deputy director of the division of AIDS at NIAID. "This controversy must be resolved so that people with HIV disease, and those who care for them, know what is best."
The new study will evaluate low-dose interferon in HIV-infected people to see if the drug is safe and effective. Officials estimate that several hundred patients have been treated with low doses of interferon. Physicians who prescribe the drug report that it seems to make HIV-positive people feel better.
At the same time, there is no scientific evidence that the drug can attack the AIDS virus in the body or prevent the onset of the disease. Low-dose interferon is not approved for general use by the Food and Drug Administration but can be obtained on a case-by-case basis with a doctor's prescription.
The NIH decision caps an emotionally charged debate about the role that the drug might play in treating AIDS. Many AIDS researchers are skeptical of this form of interferon, a drug which in high doses is effective against certain cancers and hepatitis B. But the Nation of Islam, which is led by Louis Farrakhan, launched a nationwide campaign to highlight low-dose interferon for HIV patients.
One leading advocate is Abdul Alim Mohammad, medical director of the Abundant Life Clinic Foundation, a nonprofit organization affiliated with the Nation of Islam. Mohammad said that the Abundant Life Clinic Foundation also runs Perankh Laboratory, the exclusive marketer of a type of low-dose alpha interferon, formerly called Immunex and now known as Immuviron. The drug sells for about $1,500 for a six-month supply.
Interest in low-dose alpha interferon stems from AIDS research in Kenya with a drug called Kemron, which is marketed by the Amarillo Cell Culture Co. Inc. of Texas. Similar to Immuviron, Kemron has been used in the U.S. black community for several years. Because it is an investigational drug, there is no charge for Kemron.
Kemron, which includes nine kinds of interferon, is approved for experimental use, and physicians report their results to FDA officials.
Doctors at the Abundant Life Clinic began using Immuviron about a year ago. Immuviron, which contains 16 kinds of interferon, is not approved for experimental use by the FDA but can be prescribed for individual patients.
Muhammad and Barbara Justice, a physician who runs an Abundant Life Clinic in New York, became supporters of the drug after a trip to Kenya. They visited the laboratory of researcher Davy Koech, who first developed low-dose alpha interferon for AIDS patients. "We did a tour of hospitals," Mohammad said in an interview this week. "We talked to physicians, patients and the like. We were really convinced after 10 days that it was very effective."
Interferon is one of the new breed of drugs called biologics, which are made from compounds produced normally in the body in minute amounts. Genetic engineering has enabled the production of mass quantities of these disease-fighting agents so that they can be used as therapy. Interferon is now approved by the FDA for several diseases, including a rare form of leukemia and Kaposi's sarcoma, a type of cancer that afflicts many AIDS patients. These forms of interferon, however, are taken by injection in very large doses and are expensive, running up to $270 per day for treatment.
The interferon drug to be studied by NIH is much less potent and contains several types of interferon. It is administered in low-dose tablets or lozenges that are held in the mouth for several minutes and then discarded.
No one knows how low-dose alpha interferon given orally works in the body. The drug is inactivated in the stomach, but by placing interferon in lozenges, it is thought that it could be absorbed by cells lining the mouth. The theory is that the drug might then somehow signal nearby immune cells to activate the entire immune system and fight the HIV infection.
Six months ago, the NIH reviewed all available scientific data on low-dose alpha interferon, including studies conducted by the World Health Organization. The NIH concluded that further trials for treating HIV-positive people were unwarranted and noted that there was no evidence to support claims that low doses of Kemron boosted HIV-infected patients' immune systems by increasing levels of white blood cells or had other benefits.
Officials also said then that they had no evidence to support claims by African researcher Koech that the drug could reverse the course of the infection and leave the patient cured.
Proponents of the drug sharply criticized the NIH decision and accused the NIH of racism for dismissing the African research. "There has been a lot of controversy, even within the black community, about this drug," said Wayne Greaves, associate professor of medicine in the division of infectious diseases at Howard University. Howard and other black institutions, Greaves said, have been criticized by many community leaders for not being more supportive of the drug's use. "But we felt that the scientific data were not overwhelming," he said. "We felt that there needed to be involvement of NIH in this effort."
When the NIH made its decision last spring not to pursue clinical testing of low-dose alpha interferon, Mohammad and Justice began giving lectures to other physicians about the drug and lobbying for its use. The Final Call, the Nation of Islam newspaper, also ran stories publicizing their efforts, including one published last month, headlined "The Plot to Stop AIDS Cure."
Faced with the growing use of alpha interferon in the black community, the House of Delegates of the National Medical Association in August called for more studies. That in turn, led to the meeting last week with NIAID.
"Patients have heard about it through the black media," said Henry Francis, associate professor of medicine and infectious diseases at the Johns Hopkins Medical Institutions in Baltimore. "Black health professionals are the same way. They want to understand the drug and its past research history and what the current assessment is of its efficacy."
Wilbert Jordon, director of the AIDS Clinic at the King-Drew Medical Center in Los Angeles, has studied Kemron in his private practice. He found that it helped increase appetite and energy for many HIV-positive patients and raised white-cell counts for some. It may be, he said, that Kemron could be used to keep patients healthier and delay having them take stronger, more toxic and more expensive drugs, such as AZT.
Whatever the results of the clinical trial, the carefully designed study is seen by most AIDS researchers as the only way to settle the debate.
"You don't have to be racist to treat medical claims about AIDS drugs coming from anyplace -- Kenya or Chicago -- with great skepticism," said Mark Smith, vice president of the Kaiser Family Foundation. "Most of us doing this work for a while have seen these drugs come and then unfortunately go. There has continued to be a residual skepticism about this drug."
If the drug proves effective, Smith said, "we need to get it to whoever can benefit from it as soon as possible and as widely as possible." But if clinical trials show that the medication has no benefit then, he said, "we want to keep people from wasting their time, money and hope on something that is not of value."