Articles tagged with: Medical Marijuana
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Norvir Prescribing Information Updated To Include Risk Of Life-Threatening Skin Condition – The U.S. Food and Drug Administration (FDA) has approved updated prescribing information for Norvir (ritonavir) to warn of the possibility of toxic epidermal necrolysis, a rare, life-threatening reaction to medications in which the top layer of skin detaches from the bottom layer and dies. The new prescribing information also notes that when Norvir is taken with the cancer drugs Tasigna (nilotinib) or Sprycel (dasatinib), used to treat certain forms of leukemia, or the painkiller fentanyl (Duragesic, Actiq), dose adjustments of these drugs may be necessary. For more information, please see the FDA press release.
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.
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EMA Approves Victrelis For Hepatitis C In Europe – The European Medicines Agency (EMA), which provides marketing authorization for drugs for the European Union, announced this week the approval of Victrelis (boceprevir) for the treatment of hepatitis C in people who are previously untreated or who failed treatment in the past. Victrelis, marketed by U.S. pharmaceutical company Merck (known as MSD outside the U.S.), was approved for use in combination with the current standard hepatitis C treatment, peginterferon alfa (PegIntron or Pegasys) plus ribavirin (Copegus, Rebetol). Victrelis received approval in the U.S. in May, along with Incivek (telaprevir), a second new hepatitis C treatment in the same drug class. For more information, please see the Merck press release.
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.
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New Jersey Assembly Votes To Restore ADAP Funding – New Jersey’s state Assembly has passed a bill to reverse earlier state restrictions on income requirements for its AIDS Drug Assistance Program (ADAP). The bill would restore eligibility to people with HIV whose incomes are five times the federal poverty level, or $55,150. The previous budget, signed last June, restricted the program to people whose incomes were three times the poverty level, or $32,490. The bill must still be signed by Governor Chris Christie before it can become law. For more information, please see the related article at NorthJersey.com.
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.
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New Website Helps People With HIV Maintain Heart Health – A new website created by the American Heart Association and the American Academy of HIV Medicine provides guidance to HIV-positive patients regarding heart health. Heart disease is now a major cause of death among HIV-positive individuals. At www.hivandyourheart.org, patients will find videos, personal stories, an HIV checklist, and quizzes regarding HIV and heart health. The website also has applications for the iPhone, iPad, and iPod Touch that help people set health-related goals and track their progress. For more information, please see the American Heart Association 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.
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American Civil Liberties Union Sues Alabama Over Treatment Of HIV-Positive Inmates – The American Civil Liberties Union has filed a lawsuit against the state of Alabama for its treatment of HIV-positive inmates. The lawsuit claims that Alabama discriminates against inmates with HIV by separating them from other inmates, forcing them to wear armbands identifying their status, and barring them from participating in certain jobs and programs. The lawsuit also claims that the policies concerning HIV-positive inmates in Alabama violate the Americans with Disabilities Act and the Rehabilitation Act, which forbid discrimination against people with disabilities, including HIV. The lawsuit was filed on behalf of 10 HIV-positive inmates from Alabama and cited the Governor of Alabama, the Alabama Department of Corrections Commissioner, and four wardens as defendants. For more information, please see article in The Birmingham News.
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.