“This year, Allah willing, the Ministry of Health will HIV test every member of the Nation as ordered by the Honorable Minister Louis Farrakhan….Individuals who are HIV-positive will be offered treatment with the low-dose alpha interferon currently the subject of NIH-sponsored clinical trials.”
The Nation of Islam (NOI)’s minister of health, Dr. Abdul Alim Muhammad, hyped interferon in a column he authored in the Feb. 18, 1997, issue of the Final Call, NOI’s national weekly newspaper. NOI began promoting and selling the unlicensed drug in the U.S. soon after a Kenyan doctor announced in 1991 that a type of interferona naturally occurring protein in humanshad cured some patients of HIV infection. Thirteen subsequent trials failed to replicate the claims, so mainstream medicine lost interest. But a vocal group of black AIDS specialists who were affiliated with NOI and the National Medical Association (NMA), the largest group of black doctors in the country, remained convinced that interferon had real potential.
In 1992, the pro-interferon lobby managed to pressure the National Institutes of Health (NIH) to settle the debate by conducting a clinical trial of a low-dose oral form of the drug. Years of political haranguing ensued, but the controversial trial finally began in April 1996. Muhammad’s D.C.-based Abundant Life Clinic (ALC) is one of the 14 clinics participating in the trial.
Opposition to the trial goes beyond skepticism about interferon’s effectivenessAIDS activists suggest that NOI’s and ALC’s devotion to interferon represents a clear conflict of interest because the clinic sells the drug at a profit, and a version of the drug called Kemron is distributed by Perankh Laboratories Inc., a for-profit company of which Muhammad is an officer.
Financial conflicts aside, the $1.5-million trial of several low-dose versions of alpha interferon is on the brink of collapse because of low enrollment of patients nationally.
“From what I’ve seen so far the trial is in pretty serious jeopardy,” says Jack Killen, director of the National Institute of Allergy and Infectious Disease (NIAID)’s division of AIDS, which is overseeing the trial. “It may be that this is no longer a study of interest to patients,” he speculates, as almost one year into the trial only one-third of the required 560 patients have been recruited. “If the community is flat-out not interested, it will not be possible to fix it.” Originally, the trial was designed to be completed in 18 months.
The trial is faltering in part because attention has turned to a new generation of AIDS drugsthe much-ballyhooed protease inhibitorsthat have armed physicians and patients for the first time with an effective weapon against HIV. Even though medical events seem to have surpassed interferon, ALC continues to receive hundreds of thousands of dollars a year in federal and local subsidies for its operation, and Muhammad continues to prescribe alpha interferon to his patients, sometimes in lieu of conventional AIDS therapies that have been proven to extend life.
Critics suggest that devoting $1.5 million of NIH’s $68-million budget for AIDS clinical trial groups to interferon studies is politicized science of the worst sortin effect an attempt to mute criticism from the black community that NIH has ignored interferon. They say that if the trial is falling apart, that should indicate that it’s not a good place to spend time and energy.
“The drug deserved a fair trial. It got a fair trial. It didn’t work. It’s time to move on,” says Carlton Hogan of the University of Minnesota’s community clinical research programs on AIDS.
At the Million Man March on Oct. 16, 1995, Muhammad and Farrakhan paraded onto the podium a man they believed to be a living testament to the wonders of interferon. The crowd on the Mall listened as Demetrius X. Haskins, a 28-year-old father of three and NOI member, recounted how he had checked into ALC in 1992 after he had been diagnosed as HIV-positive and how he subsequently became HIV-negative (“sero-deconverted”) while taking interferon at ALC.
“We actually think it’s a cure for these particular patients,” Muhammad says, referring to Haskins and one other patient who he claims sero-deconverted under his care. He says that of the few hundred other patients he’s treating at the clinic, there are a “large number threatening to sero-deconvert.”
But few people outside NOI buy Haskins’ story. To be sure, it hasn’t swayed AIDS authorities or captured any attention from the mainstream media. “There are no success stories with Kemron; they don’t exist,” says Steve Michael of ACT UP Washington. “Somebody has to say it.”
The larger concern is that hundreds or even thousands of people may be relying solely on interferon when better care is now available. The effects of the protease inhibitors are so dramatic that almost no one in the field except Muhammad and his affiliates would even dream of treating AIDS patients solely with alpha interferon.
“No one is using any kind of monotherapy if they’re being really aggressive in fighting the disease,” says Wilbert Jordan, director of the AIDS program at the King-Drew Medical Center in Los Angeles, another trial site.
“Personally, I would not recommend [monotherapy with alpha interferon],” says NIAID’s Killen. “I don’t think that would be right.”
ALC, however, is bucking scientific consensus
by clinging to alpha interferon as the treatment
However, not all of Muhammad’s patients have raved about NOI’s official AIDS treatment. A former ALC patient who asked not to be identified took the alpha interferon therapy and watched as her T-cell counta critical measure of AIDS progressionwent through the floor. Despite the patient’s worsening condition, Muhammad declined to prescribe conventional medicine that he said was “bad for me,” recalls the patient. After a year of ALC treatment, her T-cell count hit the red zone, plummeting below 100. When she began treatment with protease inhibitors, her T-cell count rebounded above 200 during the first month of treatment. A count between 800 and 1,200 of these critical immune cells is considered normal.
“Our basic approach is we use what works,” maintains Muhammad, a nonpracticing surgeon, who says he does occasionally prescribe protease inhibitors to selected patients with extremely high viral loads.
Even though the trial began just last year, in 1991 ALC and affiliated physicians began selling alpha interferon to patients without FDA approval. The drug costs $70 for a 30-day supply at ALC, although the Carl Vogel Foundation, a Washington buyers’ club, sells a comparable amount for $40. Only about one or two customers purchase the drug each month, the club reports.
Some AIDS specialists believe that interferon helps patients even though the claims about sero-deconversion are dubious.
“No one ever really claimed it was a cure,” says Jordan of the King-Drew Clinic. He claims that the drug has produced measurable results in a study of 126 patients conducted at his clinic over the past four years. Patients on combination therapy with AZT and alpha interferon, Jordan says, showed more energy, greater appetites, and more stable white blood cell counts than patients who took AZT alone. “My patients really like it, and that’s what matters,” he says.
But Patricia Hawkins, associate executive director of the Whitman-Walker Clinic in D.C., says, “[I haven’t] heard of any positive impact to come out of these trials.” Hawkins allows that alpha interferon may act as a placebo in reducing stress in AIDS patients, a benefit that is thought to boost the immune system.
Former ALC patients say the clinic has lost its cachet even among its core constituency: black HIV-positive patients who live in the District. “At one timea couple years backeverybody was talking about Abundant Life and going there for treatment, but now nobody is even talking about going to Abundant Life,” says one former patient. “There comes a time when you have to forget about the culture and customs and ways of your people, because what’s first and foremost is your life. It doesn’t do much good to be a dead, loyal person. If Abundant Life was the answer, then everybody in would be flocking there, but people are going other places for treatment in the District,” she says.
The trial itself has been controversial from day one. Although NIH agreed in 1992 to conduct a clinical trial to ascertain whether the drug deserved federal approval for treating HIV and AIDS, it stalled over controversial statements made by NOI leaders that suggested that the federal government had a hand in spawning the epidemic. Many in the science community remained opposed to the clinical trials as well. Reviews by the World Health Organization and NIH of 13 other trials of the drug around the world in 1992 found that no one had been able to duplicate the results that prompted all the hype in the first place. However, small trials without control groups concluded that patients on alpha interferon felt better and had improved appetites. In early February 1995, the Community Program for Clinical Research on AIDS (CPCRA), a Washington NIH advisory panel, sent NIAID’s Killen a letter opposing the trials, citing insufficient scientific justification.
After much discussion and debate, NIH finally went forward with the trial last April, to “examine whether [the drug] therapy is effective in reducing the symptoms of AIDS,” a meager goal compared to most AIDS therapies, which attack the virus itself. NIH included ALC as one of 14 study sites.
“What we’re advocating here is knowledge, and that’s no different than what we usually do,” says Killen, explaining that it’s time to find out once and for all whether low-dose alpha interferon made people with HIV and AIDS feel better. “That’s the reason we’re in this.”
“The main worry now is that we won’t be able to finish the trial,” Killen says. “If you don’t get over the hill, you never do. After a period of a year or two it becomes harder and harder,” he says. Enrollment at the three Washington-area study sites, which hovers around 50 patients, has been lower than expected.
NIH officials say they are “not clear” as to why the trial isn’t filling up as quickly as they originally estimated. “There are a lot of reasons why this may be happening, and we don’t know any of them definitely,” says NIH trial administrator Beverly Alston of the agency’s opportunistic infections research branch.
“Community-spearheaded trials are always hard to get going,” says Howard University’s Wayne Greaves, who admits that he was reluctant to get involved himself. “If leading AIDS researchers at Ivy League schools [had] been interested, it would have gotten off the ground right away.”
Muhammad charges that the trial was set up to fail from the get-go because NIH failed to provide funding to build an adequate infrastructure. “In essence, community-based clinics are being asked to finance the trial,” he says. “You can’t make bricks from straw.” While Killen acknowledges that some of the clinics were ill-equipped to run a large-scale trial, he doesn’t think any more funding is forthcoming.
The clinic’s fight to uphold the standing of its franchise drug is just one front of the war Muhammad claims is being waged against ALC. The clinic’s viability is now under siege from a fusillade of IRS claims.
A few weeks before the NIH press conference on the trial, the IRS placed a lien of about $30,000 against the clinic and froze its bank accounts. And in the past six months, the IRS has filed four new liens totaling more than $420,000 against ALC, according to D.C. records. The recent liens penalize the clinic for nonpayment of federal payroll taxes among other things, according to Dom Laponzina, chief of communications in the IRS District office. The clinic, which Muhammad founded in August 1986, employs fewer than 50 workers and has gross annual earnings of under $1 million, according to its NIH clinical-trial application.
Muhammad says IRS liens are based on phony numbers and are part of a campaign to sabotage the clinic.
“We don’t accept the various figures. We don’t know where they came from,” he says in frustration. “How can we financially afford to do this?” A report in the Final Call suggested that the liens have undercut the clinic’s ability to treat patients, pay staff, and keep therapies and supplies in stock. Muhammad told the Final Call that the IRS’s actionswhich included freezing more than $120,000 in reimbursements from the District governmentcreated “a negative feeling in the community. Most people think that we have been shut down,” he says.
Many point to the availability of new and powerful drugs as the real explanation for ALC’s problems. “The timing was bad when the trial was launched. That’s when the news broke about the protease inhibitors, so it was hard to get people to enroll, or you had to wait for them to be stabilized on the drugs first before starting with alpha interferon,” says King-Drew’s Jordan.
The thorny question of whether the trial should go forward will be answered in the upcoming months. If enrollment doesn’t step up briskly, NIH officials are likely to shut it down. Most credit Muhammad’s political acumen for getting him as far as he has gotten. “Frankly, the trial was undertaken largely due to the persuasiveness of Dr. Muhammad and the National Medical Association,” Greaves says.
From behind the desk of his office suite in a low-income housing complex known as Paradise Manor, Muhammad expresses his dissatisfaction with the level of funding that has flowed into the trial he is conducting.
“It’s not a fair trial, but it’s a trial,” he says.
The phone on his desk has inexplicably been disconnectedagaineven though Muhammad says the for-profit clinic paid its bill on time. The phones were similarly cut off the day after NIH announced it was finally going ahead with the trial last April. The problem with the phones is just one form of “political harassment and repression” the clinic at 3708 Hayes St. NE has faced along the road to the trial, alleges Muhammad, clad in a trademark bow tie and immaculate white doctor’s coat.
Muhammad remains confident, however, that “if [the trial] goes to completion, we’ll prove what we already know.”
Muhammad may be alone in his beliefs about the efficacy of alpha interferon, but not in his ambition to complete the trial. A fair number of investigators and NMA still back his pursuit. “Enrollment alone would not be a reason for closing down a study,” says Dr. Keith Rawlings, coordinator of NMA’s AIDS and infectious disease program. “There are several [AIDS clinical] trials that have had trouble enrolling.”
Even ALC detractors support the trial in the hope that it will improve relations between the medical establishment and the black community. And they believe that a fair trial could settle the controversy for good. “We’re spending a couple million dollars on a trial knowing it’s not going to work. I support that. But when NIH’s findings are that it doesn’t work, they are still going to promote the stuff,” ACT UP’s Michael says.
For a growing number of AIDS authorities and observers, however, pursuing the trial at this point is beyond absurd. “It’s ludicrous whether you’re an AIDS activist or you’re a top-rated researcher, or whether you’re a taxpayer, to continue spending money on a drug when it has failed in 13 trials and there are so many other important questions,” the University of Minnesota’s Hogan says. “The people who are working the hardest are the people participating in the trial. We need to appreciate that and not waste their time with drugs that are not the most promising.”CP