Gilead Sciences And Janssen Therapeutics Agree To Lower AIDS Drug Prices For ADAPs – Gilead Sciences and Janssen Therapeutics (a division of Johnson & Johnson) have reached agreements with the ADAP Crisis Task Force (ACTF) to further reduce the prices for antiretrovirals purchased by state AIDS Drug Assistance Programs (ADAPs), which provide free antiretrovirals to low-income people with HIV. Due to state budget crises and an increase in the number of people requesting assistance, many states have tightened eligibility requirements or implemented waiting lists for ADAPs. According to ACTF, there were 6,595 people on ADAP waiting lists nationwide as of November 17. For more information, please see the press releases from ACTF (pdf) and the AIDS Healthcare Foundation.

GeoVax Begins Phase 1/2 Trial Of Therapeutic AIDS Vaccine; Still Recruiting Participants – Biotechnology company GeoVax Labs announced today that the first patient has received a dose of its investigational therapeutic HIV vaccine as part of a Phase 1/2 trial. The company is testing the safety and efficacy of the vaccine in controlling HIV replication in people already infected with the virus; participants will stop taking antiretrovirals for 12 weeks as part of the trial. The company also noted that it is still recruiting participants for the trial. Eligible participants must be HIV-positive and have started antiretrovirals within 18 months of their last negative HIV test; or have had a negative HIV test within the past 18 months and not yet started antiretrovirals. For more information, please see the GeoVax press release (pdf) or the U.S. Clinical Trials Registry.

Governors Push For Legalization Of Medical Marijuana – The governors of Rhode Island and Washington states have petitioned the federal government to legalize use of marijuana for medicinal purposes. Both states have legalized medical marijuana, and the governors argue that the change in federal law is necessary so that state employees are not prosecuted for distributing the drug. The U.S. Justice Department had previously sent letters to state governments warning of prosecution if they continued to distribute medical marijuana (see related AIDS Beacon news). The federal Drug Enforcement Agency rejected a request to reclassify the drug as acceptable for medicinal use in June; however, the governors argued that the evidence used for that rejection is several years old and that the medical community has since changed its stance on marijuana. For more information, please see the article in the New York Times.

Government Creates New Website To Fight Discrimination Against People With HIV – The Department of Justice has created a new website to help fight discrimination against people with HIV and AIDS, which is illegal under the federal Americans with Disabilities Act (ADA). The website provides information about HIV’s coverage under the ADA and instructions on how to file a complaint, as well as information on past legal settlements against companies found guilty of discrimination. The ADA prohibits discrimination against people with disabilities in employment, education, healthcare, and housing, among others. For more information, please see the Department of Justice’s ADA AIDS website.

New Jersey Will Implement Medical Marijuana Program – New Jersey governor Chris Christie announced yesterday that he will lift the suspension on the state’s plans to dispense medical marijuana. The governor last month delayed implementing the law to request assurance from the federal government that it would not prosecute state officials for dispensing the drug. However, despite not receiving such assurances, Governor Christie said yesterday that the state can move forward with its plans. Governors of several states have reassessed medical marijuana laws in light of recent letters from the U.S. government threatening to prosecute state employees under federal drug laws (see related AIDS Beacon news). Marijuana is not legal under federal laws, although several states have legalized it for medicinal use. For more information, please see the article in Bloomberg.

Armenia Lifts HIV Travel Ban – Armenia last week became the latest country to lift its ban restricting people with HIV from entering the country. Namibia, China, South Korea, and the U.S. have all lifted travel bans since 2010, although restrictions remain in 48 countries, territories, or areas worldwide. The United Nations Programme on HIV/AIDS (UNAIDS) praised the move, stating that travel bans are discriminatory and have no health or economic justifications. For more information, please see the UNAIDS press release.

Massachusetts Considers Legalizing Medical Marijuana – Lawmakers in Massachusetts have sponsored a bill that would legalize medical marijuana in the state. The proposed bill would allow patients suffering from certain medical conditions, including HIV and AIDS, to legally carry four ounces of marijuana or keep up to 24 plants in a secure, locked facility. The bill would also require users to register with the state’s Department of Public Health and would provide for the creation of 19 state-regulated dispensaries. For more information, please see the article in the Boston Herald.

AIDS Healthcare Foundation Asks FDA Not To Approve Truvada For HIV Prevention – The AIDS Healthcare Foundation (AHF), a California-based AIDS activist and treatment group, has sent a letter to the U.S. Food and Drug Administration (FDA) asking it not to approve the drug Truvada (tenofovir/emtricitabine) for prevention of HIV transmission. The drug has been shown to reduce infection risk when taken daily by HIV-negative men who have sex with men. AHF argues that the drug is not effective enough and that approval would encourage more risky sexual behavior and promote the spread of drug-resistant HIV. For more information, please see the article in the PharmaLetter.

Bristol-Myers Squibb Signs Agreement To Bring Reyataz To Sub-Saharan Africa And India – Bristol-Myers Squibb announced this week that it has signed an agreement with Matrix Laboratories Limited to allow Matrix to produce the protease inhibitor Reyataz (atazanavir), as well as the older drugs stavudine (Zerit) and didanosine (Videx), in sub-Saharan Africa and India. The agreement will include provisions for pediatric dosages of didanosine and Reyataz. The agreement is part of Bristol-Myers Squibb’s “Global Access Program,” which is intended to expand access to HIV drugs in developing countries. For more information, please see the Bristol-Myers Squibb press release.

Low-Income South Carolina HIV Patients Must Try Generic Drugs First – Senators in the state of South Carolina voted last week to require low-income patients on Medicaid who need cancer, HIV/AIDS, and mental illness drugs to use generic drugs first if available. Generic HIV drugs include didanosine (Videx), stavudine (Zerit), and zidovudine (Retrovir). If a doctor subsequently determines that generic drugs are not sufficiently effective, he or she may prescribe brand name products. For more information, please see the Associated Press article.

Several States Are Reviewing Medical Marijuana Laws – Several states have begun reassessing their medical marijuana policies after the federal government issued warnings to these states. The warnings stated that licensed growers and regulators, including state employees, could be subject to prosecution. In response to the letter, Governor Chris Gregoire of Washington state vetoed a proposal to create medical marijuana dispensaries and has said states should instead work to change federal marijuana laws. Other states included in the warning letters are California, Colorado, Montana, and Rhode Island. For more information, please see the Associated Press article.

FDA and FTC Target Anti-STD Products Making False Claims – The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced last week that they would take steps to remove fraudulent products from the market that claim to treat or cure sexually transmitted diseases (STDs), including HIV. These products include Disintegrate Formula and Detox Formula, sold by MasterPeace; and Colloidal Silver and Essaic Tonic Liquid Drops, sold by the International Institute of Holistic Healing. Letters have been issued to the manufacturing companies stating that their products break federal law, as none of them have been evaluated by the FDA for safety and efficacy. Some of the products are marketed as dietary supplements, but under the Federal Food, Drug and Cosmetic Act they are all considered drug products. For more information, please see the FDA website.

Abbott Laboratories Cleared In Norvir Pricing Lawsuit – A jury has cleared Abbott Laboratories of claims that it deliberately raised the price of Norvir (ritonavir) to discourage competition. However, Abbott was forced to pay GlaxoSmithKline (GSK) $3.5 million over allegations that Abbott breached a contract allowing GSK to promote the use of its HIV drugs with Norvir. GSK claimed in its lawsuit that Abbott’s price increase for Norvir, from $1.71 to $8.57 per 100 mg pill, unfairly favored Abbott’s protease inhibitor Kaletra (lopinavir/ritonavir), which already contains Norvir, over other protease inhibitors. GSK stated that the price increase resulted in losses of over $570 million on sales of its protease inhibitor Lexiva (fosamprenavir). Norvir is commonly used as a boosting agent to enhance the efficacy of other HIV drugs, particularly protease inhibitors. For more information, please see the Bloomberg Businessweek website.

Arizona Releases Final Rules On Medical Marijuana Dispensaries – The Arizona State Health Department has released its rules regarding the formation of medical marijuana dispensaries in the state. According to the rules, the number of dispensaries will be proportionate to the number of pharmacies, likely between 120 and 126 throughout the state. The rules specify that dispensary agents must create a business plan and apply for a registration certificate as well as an operating license. The dispensaries are a result of a November vote legalizing marijuana for treatment of certain medical conditions, including HIV. The medical marijuana program will start on April 14, when the state will begin accepting patient applications. For more information, please see the article in The Arizona Republic.

Former Surgeon General Koop Recounts Early Days Of The AIDS Epidemic –The Annals of the Forum for Collaborative HIV Research has published an article, “The Early Days of AIDS, As I Remember Them,” by former Surgeon General Dr. C. Everett Koop. Dr. Koop was the Surgeon General responsible for managing the nation’s response to AIDS when the disease first began appearing in the United States. His paper recounts the details of what occurred in the early days of the AIDS epidemic and the public health challenges the country faced. For more information, please see the press release from The Annals of the Forum for Collaborative HIV Research.

AIDS Healthcare Foundation Offers Free HIV Drugs To People On Florida ADAP Waiting Lists – The AIDS Healthcare Foundation (AHF), a California-based treatment and advocacy group for people with HIV and AIDS, announced today that it will provide up to $1 million in free HIV drugs to people who have been placed on an AIDS Drug Assistance Program (ADAP) waiting list in Florida or have been removed from the program due to new, stricter eligibility requirements. ADAPs are programs that provide anti-HIV medications to low-income people with HIV. The offer from AHF is expected to benefit about 2,850 people and is intended to allow time for them to transition to private patient assistance programs without interrupting treatment. The HIV drugs will be distributed by AHF’s pharmacies throughout the state. For more information, please see the AHF press release.

Maine Now Requires Registration Cards For Medical Marijuana Use – A new state law that went into effect January 1 now requires registration for people in Maine who wish to use medical marijuana. Previously, the state only required a doctor’s permission for marijuana use. Applications for a registration card can be found on the Maine Department of Health and Human Services website; cards cost $100 ($75 for patients in the state’s Medicaid program, MaineCare). The new law also restricts the amount of marijuana a person can carry to 2.5 ounces and limits the number of marijuana plants a patient or their caregiver is allowed to grow. In addition, it provides for new medical marijuana dispensaries, which are expected to open in March or April. Medical marijuana has been legal in Maine since 1999 for treatment of symptoms related to specific conditions, including HIV and AIDS. For more information, please see the article at the Portland Press Herald.

In fact, the monkeys were less likely to die early, experienced small reductions in their viral loads, and had slightly better retention of body mass. However, the study authors stated that the results are too preliminary to suggest marijuana might slow the progression of HIV.

“In terms of viral replication, disease progression, and immunological parameters, chronic use of cannabinoids may not be detrimental to the infection,” said Dr. Patricia Molina, lead author on the study.

However, she added, “It is too premature to claim that this also reflects protection or improvement of disease in HIV-positive [patients], or how this would play out in the presence of antiretroviral therapy.”

Studies have estimated that about a quarter to a third of people with HIV use marijuana to ease symptoms from HIV infection or antiretroviral therapy. Tetrahydrocannabinol (THC), the primary drug in marijuana, is available in two forms: the marijuana plant itself and two different pills, which are available by prescription.

Marijuana, which is usually smoked, is not approved by the United States Food and Drug Administration (FDA) and is illegal according to federal law. However, 15 states and Washington, D.C. have legalized use of marijuana for people with HIV.

In addition, Marinol (dronabinol), which contains THC, and Cesamet (nabilone), which contains a synthetic version of THC, are available by prescription. Marinol is approved by the FDA for the treatment of HIV-associated anorexia, while Cesamet is approved for use in treatment of anorexia and wasting in people with HIV.

Most research has shown that using marijuana or prescription THC can help ease common symptoms and side effects of antiretroviral therapy in people with HIV (see related AIDS Beacon news). However, some research has suggested that marijuana and THC may have harmful effects on the immune system, which could lead to more illnesses and faster HIV disease progression.

In this study, researchers set out to determine whether regular THC use causes faster disease progression in monkeys infected with SIV, the monkey equivalent of HIV.

Four monkeys were injected twice daily with THC starting approximately one month prior to being infected with SIV. Another four monkeys were infected with SIV but did not receive THC.

After infection, the researchers monitored immune system markers, CD4 (white blood cell) counts, and viral loads (amount of virus in the blood) over the course of 6 months. The monkeys receiving THC continued to receive the drug twice daily throughout the study period.

Contrary to the researchers’ expectations, results showed that regular THC administration did not increase viral load or lead to faster disease progression.

In fact, infected monkeys receiving THC had slightly lower viral loads than infected monkeys that did not receive THC, although the difference was too small to be significant. CD4 counts also dropped more slowly in monkeys receiving THC.

In addition, among the infected monkeys receiving THC, the first death did not occur until 11 months after infection. In that time, three of the four infected monkeys not receiving THC died: two about 5 months after infection and a third after 7 months.

Results also showed that monkeys receiving THC lost less weight 3 to 6 months after infection than monkeys not receiving THC, although the difference was too small to be significant.

The authors noted that their study was small, which means individual differences between monkeys could have played a role. Nonetheless, they concluded that THC does not increase disease progression and, in fact, regular administration of THC may actually delay SIV disease progression, possibly by reducing inflammation and weight loss.

Dr. Molina stated that additional follow-up studies on the monkeys are planned. “There are many things we are interested in pursuing, such as what happens with a longer period of exposure to THC prior to infection, can we eliminate the psychoactive effects of THC and still see protection, does THC interfere directly with viral entry into the cell, etc.,” said Dr. Molina.

The authors also plan to study the effects of THC in female monkeys (all the monkeys in this study were male) and what the biological mechanism of THC’s effects on disease progression might be.

Dr. Molina stated that they would like to replicate the results in human studies, but that this presents some challenges.

“These are difficult studies, and finding the right cohort of patients is quite complex,” said Dr. Molina. “Questions arise as to whom do we study? People on antiretroviral therapy plus cannabinoids? Do we add cannabinoids to the therapy? Do we study cannabinoid users?”

“We are interested in pursuing it, just not at that stage yet,” she added.

For more information on the study, please see the article in AIDS Research and Human Retroviruses.

New Jersey expects to start distributing medicinal marijuana in July 2011.

People with HIV or AIDS qualify for medicinal marijuana use in New Jersey if they suffer from severe or chronic pain, severe nausea, vomiting, or wasting syndrome – an involuntary and unavoidable loss of weight – due to their illness or treatment.

Scientific studies have demonstrated that marijuana helps treat some of these symptoms, though it might also result in faster HIV progression and its effects on patients’ immune system are controversial (see related AIDS Beacon news).

Physicians will be able to register for the program starting this month. Upon approval of their credentials, they may submit a list of patients they recommend for medicinal marijuana use.

To submit a patient’s name for the program, the physician must either have treated the patient for a year or more, seen the patient at least four times for their condition, or must assume responsibility for a patient’s care after a thorough medical assessment and review of his or her medical records.

Patients whose names have been submitted by their doctor can start registering next month to obtain a mandatory photo ID. The program registration fee amounts to $200 every two years. Patients who qualify for state federal aid programs will pay a reduced $20 fee.

Patients may receive a monthly maximum of two ounces of medicinal marijuana. Medicaid will not cover its cost.

New Jersey’s rules are stricter than in other states. Patients will not be allowed to cultivate their own marijuana, and caregivers will need to pass a criminal background check to be able to pick up marijuana for a patient.

Medicinal marijuana will be available at Alternative Treatment Centers throughout the state. These centers will serve as cultivating and dispensary locations and will be chosen through a competitive process. The state expects to make applications for locations available this month. Only non-profit organizations will be allowed to grow and distribute marijuana.

New Jersey will schedule a public hearing on the proposed draft rules after they have been published in the New Jersey Register.

New Jersey’s legislature voted to legalize medicinal marijuana earlier this year. It was the 14th state to do so; medicinal marijuana has previously been legalized in Alaska, California, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont, and Washington.

For more information, please the New Jersey Department of Health and Senior Services website.

Arizona Considers Legalizing Medical Marijuana – Voters in Arizona will decide November 2 whether to legalize medical marijuana in the state. Proposition 203 would allow licensed physicians in Arizona to recommend the drug to patients with certain medical conditions, including HIV/AIDS. This is the fourth attempt to legalize medical marijuana in Arizona. Medical marijuana is not currently approved by the United States Food and Drug Administration, but several states have legalized it to provide relief for patients with serious illnesses. For more information, please see the article on The Arizona Republic website.

Governor Paterson Vetoes Rent Relief For AIDS Patients In New York – Governor David Paterson vetoed a bill last week that proposed additional rent subsidies for approximately 11,000 New Yorkers with HIV/AIDS. Under the terms of the bill, people who receive housing assistance from New York’s HIV/AIDS Services Administration would have had to spend no more than 30 percent of their income on rent. Paterson vetoed the bill because he believes it would strain New York’s tight finances. Paterson stated that he will support the bill if the Legislature makes clear how the costs, estimated at $20 million, would be covered. For more information, please see the article on The New York Times website.

Research has mostly shown that using medical marijuana helps ease common symptoms and side effects in people with HIV. However, there are also potentially serious risks, some of which are specific to people who are HIV positive.

Studies have estimated that about a quarter to a third of people with HIV use medical marijuana to ease their symptoms.

The active ingredient in marijuana, called tetrahydrocannabinol (THC), is actually available in two forms: the cannabis plant itself, which is usually smoked, and two different pills, which are available by prescription.

The cannabis plant, known simply as marijuana, is not approved by the United States Food and Drug Administration (FDA) and its use, possession, and cultivation are illegal according to federal law. However, the government has said it does not plan to pursue medical marijuana users or their caregivers (see Part 1 of this series).

The two prescription drugs are Marinol (dronabinol), which contains THC, and Cesamet (nabilone), which contains a synthetic version of THC.

Marinol and Cesamet are approved by the FDA and are legal when prescribed by a doctor. They also are swallowed, not smoked, which may be preferred by some users.

Some patients have argued that the dosages in the pills last longer and are harder to control. Studies have shown that smoked marijuana takes effect more quickly (about 20 minutes, versus two hours for pills) and does not stay in the body as long.

Benefits Of Medical Marijuana

Kris Hermes, Media Specialist for Americans for Safe Access (ASA), an organization that promotes legalization of medical marijuana, told The AIDS Beacon in an interview that there are a variety of reasons people with HIV use medical marijuana.

“One main reason is relief of side effects from antiretroviral therapy,” said Hermes, “which can make patients better at taking their medications.”

“Many users also say it helps reduce symptoms from other illnesses, such as hepatitis C, that are common in people with HIV,” he added.

Reduced Nausea And Increased Appetite. The ability of marijuana to reduce nausea and vomiting and stimulate the appetite has been well established. Most studies and clinical trials have been done with cancer patients undergoing chemotherapy, but results appear to extend to people with HIV as well.

A study published in the Journal of Pain and Symptom Management (pdf) in 2005 asked HIV-positive medical marijuana users in a survey whether the drug helped decrease nausea and other symptoms. Of those who responded, 93 percent said the drug helped: 56 percent said their nausea was “much better,” while 37 percent said it was a “little better.”

A small, placebo-controlled 2007 study in JAIDS found that either smoking marijuana or taking Marinol successfully stimulated the appetites of people with HIV. The study authors reported that the drug resulted in a weight gain of about 2.5 pounds over four days of treatment.

Reduced Depression And Anxiety. Relief of anxiety and depression are among the most common reasons people with HIV take marijuana. According to the study published in the Journal of Pain and Symptom Management, 93 percent of marijuana users reported that it helped decrease anxiety, and 86 percent said it helped with depression.

The study published in JAIDS also found that marijuana slightly increased the amount of time users were able to sleep and how well they slept.

Reduced Muscle And/Or Nerve Pain. People with HIV can have damage to nerves or muscles that causes tingling, numbness, or pain.

The study published in the Journal of Pain and Symptom Management found that 90 percent of marijuana users reported a reduction in nerve pain, and 94 percent said they had less muscle pain.

A 2007 placebo-controlled study published in Neurology (abstract) confirmed that marijuana reduced pain twice as much as a placebo. Furthermore, 52 percent of marijuana users reported at least a 30 percent reduction in their pain, compared to 24 percent of patients taking the placebo.

Drawbacks And Side Effects Of Medical Marijuana Use

Using medical marijuana is not risk-free, particularly for people with HIV. Marijuana may have some harmful effects on the immune system, which can lead to more illnesses and faster disease progression. There are also some additional unwanted side effects of the drug.

Immune System Effects. The effect of marijuana on the immune system is still unclear. Animal studies have shown that marijuana can affect the immune system, and a 2003 study in the Journal of the American Medical Association found that people who smoked marijuana had lower numbers of certain types of immune cells.

Some older studies from the 1980s and 1990s have also linked marijuana smoking to faster disease progression and increased risk of illnesses, such as pneumonia and Kaposi’s sarcoma.

On the other hand, several short-term studies have found no effects of marijuana on the immune system. Some scientists have also argued that if marijuana use helps people with HIV take their antiretroviral medications, which help the immune system heal, the effects of marijuana could be positive overall.

Cancer Risks. The risks of cancer in HIV-positive marijuana smokers are also uncertain.

Marijuana smoke is similar to tobacco smoke, which can cause severe breathing problems, respiratory infections, and lung cancer.

However, a study published in 2006 in Cancer Epidemiology, Biomarkers & Prevention found that a history of heavy marijuana usage was not associated with a risk of lung or upper respiratory cancer.

Scientists will need to do more studies to make sure this holds true for people with HIV as well. HIV-positive individuals are already at higher risk for cancers, including lung cancer.

Additional Side Effects. Finally, like any drug, medical marijuana has side effects. These include a “high” that can affect the ability to drive, concentrate, or think clearly. In addition, 47 percent of medical marijuana users in the 2005 Journal of Pain and Symptom Management study reported memory deterioration.

Marinol, which is taken in pill form, has also been reported to cause mental cloudiness and confusion.

As with any drug, patients are advised to talk with their doctor before starting or stopping medical marijuana.