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Issue #247: September 17, 1999
FASTFAX is available by fax in the 215 and 610 area codes at no cost, by mail anywhere for 20.00 per year, by calling 215-545-6868, and on the fastfax index page. Information in fastfax is drawn mostly from secondary sources; people living with HIV/AIDS should share information of interest to them with their primary care provider before making treatment choices. For more information on HIV medications and treatments, contact Kiyoshi Kuromiya of the Critical Path AIDS Project, 215-545-2212 or by email to The presence of the name or image of any individual in fastfax should not be construed as an indication of their HIV status or sexual preference unless specifically stated. Questions or comments should be directed to Editor, fastfax, 425 S. Broad St., Phila., PA 19147-1126 or by email to
In This Issue:
Drug companies 'suspend' S. Africa lawsuit
Africa an AIDS "killing field"
HAART too complicated for long-term: docs
CA Senate approves weakened needle bill
Court ruling on medical marijuana hailed
FIGHT plans adherence seminar for providers
Claiming that they detect a weakening of South Africa's efforts to provide cheaper versions of AIDS drugs to its citizens, the Pharmaceutical Manufacturers Association (PMA) says it is "suspending" legal action which claims that the actions violate patent rights of U.S. drug companies.
S. Africa and other African nations say that the high prices of U.S. AIDS drugs makes it impossible for them to get the drugs for their people who have AIDS. The drug companies say that allowing foreign countries to produce their own, generic versions of the drugs is against international patent law and will undermine the profitability of their companies.
PMA said it was taking the action after a S. African government announcement that it was "reviewing" the 1997 law which had led to the lawsuit. The dispute has become a major issue in the 2000 presidential campaign of Vice President Al Gore, who is seen by AIDS advocates as a supporter of the drug companies in efforts to force African companies to pay high prices for AIDS drugs.
Some activists charged that the South Africans were finally bending to enormous pressure from the U.S. in agreeing to review the regulation which permitted the production of generic versions of U.S. AIDS drugs in the country. They said that the suspension of the lawsuit was an indication that the S. African government itself intended to back down in the international controversy.
However, the South African government has issued a press release saying that it still intends to license cheaper versions of the AIDS drugs as allowed by the 1997 law, even though a 1998 revision -- which is silent on the issue -- is still making its way through a complicated adoption process. The 1998 revision, which is the law it has announced it will "review," left open the drugs issue for later resolution because of the PMA lawsuit.
If the suspension of the PMA lawsuit becomes permanent, S. Africa could restore formally the provisions which have so angered U.S. drug companies. On the other hand, if S. Africa uses the suspension as a reason for reinforcing its right to produce or license cheaper versions of the AIDS drugs, the PMA could renew its lawsuit.
In any case, the government says that the PMA suit is not behind its decision to move ahead with the review of the 1998 act. "There are currently no negotiations with the PMA with respect to any litigation that the PMA has brought against the Government of South Africa," the statement said. "With respect to the litigation, the only acceptable position to the Government of South Africa would be the total withdrawal by the PMA and others, of the litigation against the Government of South Africa with regard to medicines legislation....The Government of South Africa will continue to build its legal defense in this case, and hope to conclude the case as rapidly as the courts will allow.
The statement concluded with a restatement of S. Africa's willingness to buck the pressure of the U.S. and the drug companies. "The policy position of the Government of South Africa is that, as allowed by the [1997 Act] and international trade agreement, it may issue compulsory licenses for, or parallel import medicines, in the public interest."
Meanwhile, officials and scientists gathered at the 11th International AIDS in Africa Conference in Lusaka heard reports indicating that AIDS, not war, has turned Africa into a "killing field" and will wipe out enough adults to create 13 million orphans in the next 18 months. That cataclysmic estimate was made by a representative of UNICEF , the United Nations children's agency.
Many at the conference urged African governments, which generally spend more on their militaries than on public health, revise their priorities in the face of the genocidal impact of the epidemic on the continent.
Africa is home to two-thirds of the world's 31 million HIV-infected people. Last year, AIDS killed two million Africans, outstripping deaths from armed conflicts on the continent 10-1, said UNICEF.
In 15 years, AIDS has killed 11 million Africans, more than 80% of the world's AIDS deaths.
"By any measure, the HIV-AIDS pandemic is the most terrible undeclared war in the world, with the whole of sub-Saharan Africa a killing field," UNICEF executive director Carol Bellamy said on the conference's third day.
Africa is also home to 90% of the world's AIDS orphans and most suffer "alarmingly higher rates of malnutrition, stunting and illiteracy," UNICEF said.
In many southern African countries up to 25% of adults are infected with HIV -- the highest prevalence in the world.
Also at the conference, the World Bank, which provides financing for projects in developing countries, announced that it will allocate up to $3 billion every year to support AIDS efforts in sub-Saharan Africa.
While the announcement was greeted as good news, some at the conference cautioned that much of the money might never reach the people with AIDS who most need it.
Former Nigerian health minister Olikoye Ransome-Kuti accused some African governments of corruption and stealing the bulk of funds meant for the purchase of medical drugs.
He told the conference that due to inefficiencies and the waste of drugs, only 12 US dollars worth of drugs eventually got to the patient out of every 100 dollars, according to World Bank estimates. Kuti said many of the HIV/AIDS patients could be saved and the epidemic effectively controlled in the region if governments valued the lives of their people and looked critically at the ways funds were being spent.
He added that it would not be helpful to appeal for international aid towards the procurement of drugs when the money was being stolen by the governments.
"Donors no longer listen to our whines. I am also sure they will respond promptly when our countries demonstrate a determination to care for the people. Even now, out of a total expenditure of 141 million dollars on AIDS reported from 25 sub-Saharan African countries in 1996, the countries contributed only 13 million dollars - 9 percent of the total, whilst 91 percent came from donors," Kuti observed.
He said people were now tired of hearing repeated messages of gloom, doom, and impossibility from their leaders and governments. What was needed now was "a change in tone."
"Our countries are notorious for wasteful spending, corruption and stealing of public funds by those in authority over us. Perhaps the worst of them is the country I know best (Nigeria), known for its enormous financial, material and human wealth, yet has been reduced to one of the poorest in the world," Kuti added.
He said he was convinced that Nigeria, for example, could afford to spend large sums of money on the AIDS control program considering that it had spent 200 million dollars on the war in Liberia and Sierra Leone.
"I have seen 300 million dollar presidential palaces, 350 million dollar cathedrals and enormous teaching hospitals in the midst of ill-health, poverty and destitution among our people in various African countries," Kuti charged. (Associated Press/Reuters/Africa News)
HAART too complicated for long-term: docs
Three years after new medications revolutionized the treatment of AIDS, many people with AIDS are backing off their therapies because of side effects and the daily burden of taking dozens, even scores of pills.
Doctors say few patients are abandoning their drugs altogether, but acknowledge that many are missing or tapering their doses even if it means lowering their expectations of long-term survival. Some patients, with or without their doctors' approval, are taking "drug holidays" to gain relief from side effects.
Some, like restaurant manager Tim Leist, took about 50 pills a day to keep his infection in check. But the drugs, he said, caused intestinal and psychiatric problems that, at times, made it next to impossible to drive or get out of bed. Like many patients, he became resistant to one drug after another, forcing his doctors to prescribe new medications whose effects were also short-lived.
Now, with his doctor's blessing, he is taking about a third as many pills and is feeling better than he has in years, though he recognizes the virus may seize the chance to rebound.
"I'm probably on the lightest drugs I've been on in five years," said Leist, 38, who attends the AIDS clinic at Johns Hopkins Hospital. "My philosophy on this illness is that as long as I feel good day-to-day, I don't worry about the long term."
Faced with these problems, doctors are adopting a sober view of today's therapies for acquired immune deficiency syndrome -- saying it may not be realistic to expect patients to continue for many years on complicated drug schedules. The problem, they say, underscores the need for new treatments that are less toxic and simpler to take.
"It's one thing to take these drugs for a week or six months; it's another to do it for four or five years," said Dr. Robert Redfield, director of AIDS care at the University of Maryland Medical Center. "This is not a sustainable therapy for the majority of individuals."
Dr. Joel Gallant, director of the outpatient AIDS clinic at Johns Hopkins Hospital, said he remains optimistic about the ability of his most committed patients to stay on complex therapies for years. But he acknowledged that less than half the patients at Hopkins and other inner-city clinics can take their drugs faithfully and keep the virus at bay.
Since 1996, when doctors started using a class of drugs called protease inhibitors, AIDS deaths have steadily declined. The drugs, used in combination with other medications, enabled thousands of patients to return to work and stay out of hospitals. Many gained weight, lost their sickly pallor and rediscovered wells of energy.
Nationally, deaths dropped 25 percent in 1996 and 40 percent in 1997. But last year, the decline was 20 percent, triggering a recognition that drug therapy had its limits. Doctors said it would have been naive to expect the death rate to continue its steep decline without new breakthroughs in treatment.
"It can't keep going down and down," Dr. Douglas Richman, an AIDS specialist at the University of California San Diego, said in Baltimore recently at a conference organized by the University of Maryland's Institute of Human Virology. "We need better drugs and new things to supplement drugs."
Doctors who championed the new treatments made no secret that the medications posed problems. But today, many acknowledge that they underestimated the difficulties and were probably wrong to expect some patients to keep up with dosing schedules.
Patients often are required to swallow large amounts of pills at intervals throughout the day. Some pills must be taken with meals, others without. Some patients carry electronic timers that alert them to the next dose. But for many, the task is too complex. To make matters worse, patients who miss doses are more likely to develop resistant strains. Side effects include nausea, diarrhea and fatigue. Protease inhibitors can also raise cholesterol to dangerous levels and change the way fat is distributed on a person's body. Some patients get skinny arms and legs, distended stomachs and fat deposits called "buffalo humps" on the upper back.
Doctors decided that, for some patients, it is better to use drugs sparingly -- but consistently -- than to prescribe complicated regimens they are unlikely to take.
"The worst thing you can do is give these drugs to a lot of patients who can't take them," he said. "We're not only contributing to an epidemic of drug resistance but we don't do the patients any favors. We have to individualize therapy and not be afraid to withhold therapies in some cases."
Though the practice is controversial, some doctors have agreed to plan "drug holidays," brief periods when patients take a break from the drugs that are bothering them.
"I don't tell a patient to please take a drug holiday," said Redfield. "But in the third year of combination therapy, some are very honest. They need a rest. So they get a rest and then they come back enthusiastically into therapy."
Carefully conceived, he said, holidays can be taken without giving the virus a chance to evade treatment. Other doctors, including Gallant, said the practice is dangerous and should be encouraged only when patients are suffering intolerable side effects.
Patients who are thriving on the drugs say they have no choice but to structure their lives around medication schedules.
"My compliance may not be 100 percent, but it's 98 percent," said James Ball, a Hopkins patient on combination therapy. "It is frustrating, and I wouldn't be honest if I didn't admit that. It's part of your life, and you've got to treat it as a normal requirement."
Leist, the restaurant manager, says he used to have a swimmer's body but has developed a "beer belly" and "chicken legs" since taking protease inhibitors. These, he says, are mere annoyances compared to the intestinal problems and paranoia that overcame him when he was taking high doses of anti-viral drugs.
Now on simpler regimens, Leist says he has learned to enjoy every good day. "The only thing I can make sure of is that I take my meds, eat right and get enough sleep. The rest will take care of itself," he said.
For children, life on anti-viral drugs can be daunting. Many want to spit out their pills and capsules. Liquid medications can taste bitter and metallic. But the biggest problem, according to some doctors, is the parents.
Dr. Douglas Watson, a pediatric immunologist at the University of Maryland Medical Center, said most of the youngsters are the children of drug addicts who suffer from AIDS. Many can't be trusted to make sure their kids swallow their pills.
In a recent study, Watson found that 42 percent of the children don't take their medications because their parents don't get the prescriptions filled. Though the hospital works with the parents, it sometimes fights to have the children placed in group homes or foster care.
"I have a legal obligation to report medical neglect to the state," Watson said. "The bottom line is that after a certain point, the parent doesn't have a choice of whether to give their child medication." (Baltimore Sun)
CA Senate approves weakened needle bill
After the rejection by Gov. Gray Davis of a bill which would have authorized needle exchange programs throughout California, the state senate has adopted a revision of the legislation which would permit the programs but require constant reauthorization by the counties in which they are located.
Davis had criticized the earlier bill because the approval to operate the programs would have been open-ended. Under the new bill, the programs would have to be reauthorized every two or three weeks.
Regina Aragon, public policy director for the San Francisco AIDS Foundation, called the amended version "a significantly more cumbersome process for some communities" But a spokesman from the governor's office noted that governments running their own programs might have less difficulty meeting the new requirement.
Current state law prohibits providing or possessing hypodermic needles unless prescribed by a physician. Four cities -- Berkeley, Los Angeles, San Francisco and Santa Cruz -- have already adopted emergency ordinances to allow needle exchanges to operate in their communities.
Seriously ill patients may have the right to use medical marijuana despite federal narcotics laws, a federal appeals court has ruled.
The 9th U.S. Circuit Court of Appeals told a federal judge on Monday to review his 1998 order that closed the Cannabis Cultivators Club in San Francisco, the Oakland Cannabis Buyers' Cooperative and other Northern California clubs, and to consider an exemption for patients who face immediate harm without the drug and who have no alternatives.
Though it will not immediately open the doors of any local marijuana clubs, the ruling constitutes a victory for patients who say marijuana is the only drug that will ease their suffering.
"I'm ecstatic," said Dennis Peron, founder of the Cannabis Cultivators Club and author of the 1996 medical marijuana initiative, Proposition 215. He said the federal government may finally be moving toward the realization that availability of medical cannabis is a life- and-death issue for some users. The ruling reviews U.S. District Judge Charles Breyer's decision last year to shut down the Cannabis Cultivators Club in San Francisco and several other clubs.
The government "has yet to identify any interest it may have in blocking the distribution of marijuana to those with medical needs," and "has offered no evidence to rebut (a marijuana club's) evidence that cannabis is the only effective treatment for a large group of seriously ill individuals," the court said in a 3-0 ruling.
In their decision, the judges seemed to recognize the "medical necessity" defense for federal marijuana prosecutions, which says a person can violate the law when it is the only way to prevent a greater harm.
"For the first time, we have a clear ruling that the federal Controlled Substances Act is not an absolute bar to the distribution of medical cannabis," said Gerald Uelmen, a Santa Clara University law professor and lawyer for the Oakland Cannabis Buyers' Cooperative, which was the appellant in the case.
The Justice Department has maintained that no claim of necessity can justify the use of a drug that is classified by Congress to be among the most dangerous substances, with no approved medical purposes.
Avram Goldstein, professor emeritus of pharmacology at Stanford, said the issue of medical marijuana should be left for medical science, not the courts, to decide.
"I really don't think judges ought to get into the medical business," Goldstein said. "They don't know anything about it."
Prop. 215, passed by California voters in 1996, allowed patients to legally possess and grow marijuana for a variety of medical conditions, including AIDS and cancer, if recommended by a doctor.
But the initiative clashed with federal laws against distributing the drug, and the Justice Department sued six Northern California clubs. Breyer issued an injunction in May 1998 barring the clubs from distributing marijuana.
Club lawyers presented their "necessity" defense to Breyer a few days after that ruling, but he rejected the argument, and the clubs appealed. Monday's ruling sends the "necessity" defense back to Breyer, asking him to reconsider.
The opinion says the government relied "exclusively on its general interest in enforcing its statutes," without addressing the arguments in favor of giving pot to the seriously ill.
"It simply rests on the erroneous argument that the district judge was compelled as a matter of law to issue an injunction (that follows the statute)."
The 9th District represents nine states. Five of those states * California, Arizona, Oregon, Washington and Alaska * have laws that provide at least limited protection from state prosecution for medical marijuana users. Those who want marijuana can still find it through informal clubs, including several in San Francisco, and through private cultivation and street sales. The Oakland club, which served 2,000 patient-members, has been allowed to reopen for hemp distribution and patient support.
State Attorney General Bill Lockyer announced in March that he would not interfere with medical marijuana providers, as long as they operate discreetly. (Associated Press/San Francisco Chronicle)
FIGHT plans adherence seminar for providers
Philadelphia FIGHT will host a discussion on "What To Do When Your Clients Stop Taking Their Medication" as part of its Frontline Information Series on Wednesday, October 27th, at St. Luke's and the Epiphany Church, 330 S. 13th Street, from 3:00-5:00 p.m.
The seminar will discuss ways of working with clients on deciding when to start drug therapy and whether they be able to take the drugs as needed.
The issue has become increasingly important as the effectiveness of AIDS drugs has improved, but the burden of taking the pills as required has discouraged some patients from using the treatments. Case managers and caregivers are being encouraged to find ways to support people with AIDS in making sure they take their medications as required.
Some doctors have said that they will refuse to prescribe the new treatments if they believe the client won't follow the drug regimen, since they might then develop a resistance to later effectiveness of treatment.
Federal officials recently alerted communities receiving Title I AIDS funds that Title I funds cannot be used too support physicians who refuse to allow patients to make their own decisions about whether to start the treatment regimens.
Speakers at the FIGHT seminar include Jody Gilmore, CRNP, from Presbyterian Hospital and Ramona Christian, RN, CCM Medical Coordinator and HIV Case Manager for the Temple University Outpatient Clinic.