Health Journal Online

Tag: HIV

  • Doctors Pushed HIV Meds On Patients in Exchange For Lavish Meals, Trips, and Cash: Prosecutors

    Doctors Pushed HIV Meds On Patients in Exchange For Lavish Meals, Trips, and Cash: Prosecutors

    A pharmaceutical company that allegedly paid doctors kickbacks to push their HIV/AIDS drugs has agreed to pay a fine of more than $200 million to settle a civil lawsuit filed by federal prosecutors.

    The government alleged that Gilead had induced doctors to prescribe a slew of HIV/AIDS drugs in exchange for honoraria payments, meals, and travel expenses to healthcare practitioners. Prosecutors said the company created a scheme where healthcare practitioners who spoke at or attended Gilead speaker events, and used the events as a a way to deliver kickbacks.

    “For years, Gilead unlawfully sought to increase sales of its HIV drugs, by using its speaker programs to funnel kickbacks to doctors. As alleged, Gilead spent tens of millions of dollars on these programs, including over $20 million in speaking fees and millions more in exorbitant meals, alcohol and travel, all in an effort to induce doctors to prescribe Gilead’s HIV drugs and drive up sales,” U.S. Attorney Jay Clayton said.

    “With this settlement, Gilead has taken responsibility for its conduct and agreed to pay a significant financial penalty. The message is clear, companies that illegally drain taxpayer dollars from federal healthcare programs will be held accountable,” he said.

    The government also alleged that the scheme led to false claims for the Gilead HIV Drugs being submitted to and paid for by federal healthcare programs. Because of this, more than $176 million of the fine will go as compensation to the government, with the remainder being distributed to several states.

    One HIV speaker, who received over $300,000 in total honorarium payments, wrote prescriptions for Gilead HIV Drugs that resulted in over $6 million in Medicare, Medicaid, and TRICARE payments.

    The Gilead HIV antiretroviral drugs are expensive, with Medicare paying more than $1,000 for a one-month supply of Complera®, for example. From 2011 to November 2017, the company conducted HIV speaker programs, ostensibly for educational purposes.

    However, prosecutors say many of the events had little educational value and that Gilead would invite the same physicians over and over to the same program. The events were often held at fancy restaurants in New York including at James Beard House, Del Posto, Asiate, Palma, Vaucluse, Ilili, and Limani.

    Other desirable locations for the events included Hawaii, Miami, and New Orleans. Prosecutors noted that sometimes the location was selected in response to an HIV speaker’s request to be booked for a program in that city.

    Originally published on Lawyer Herald

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  • New drug shows promise in clearing HIV from brain

    New drug shows promise in clearing HIV from brain

    An experimental drug originally developed to treat cancer may help clear HIV from infected cells in the brain, according to a new Tulane University study.

    For the first time, researchers at Tulane National Primate Research Center found that a cancer drug significantly reduced levels of SIV, the nonhuman primate equivalent of HIV, in the brain by targeting and depleting certain immune cells that harbor the virus.

    Published in the journal Brain, this discovery marks a significant step toward eliminating HIV from hard-to-reach reservoirs where the virus evades otherwise effective treatment.

    “This research is an important step in tackling brain-related issues caused by HIV, which still affect people even when they are on effective HIV medication,” said lead study author Woong-Ki Kim, PhD, associate director for research at Tulane National Primate Research Center. “By specifically targeting the infected cells in the brain, we may be able to clear the virus from these hidden areas, which has been a major challenge in HIV treatment.”

    Antiretroviral therapy (ART) is an essential component of successful HIV treatment, maintaining the virus at undetectable levels in the blood and transforming HIV from a terminal illness into a manageable condition. However, ART does not completely eradicate HIV, necessitating lifelong treatment. The virus persists in “viral reservoirs” in the brain, liver, and lymph nodes, where it remains out of reach of ART.

    The brain has been a particularly challenging area for treatment due to the blood-brain barrier — a protective membrane that shields it from harmful substances but also blocks treatments, allowing the virus to persist. In addition, cells in the brain known as macrophages are extremely long-lived, making them difficult to eradicate once they become infected.

    Infection of macrophages is thought to contribute to neurocognitive dysfunction, experienced by nearly half of those living with HIV. Eradicating the virus from the brain is critical for comprehensive HIV treatment and could significantly improve the quality of life for those with HIV-related neurocognitive problems.

    Researchers focused on macrophages, a type of white blood cell that harbors HIV in the brain. By using a small molecule inhibitor to block a receptor that increases in HIV-infected macrophages, the team successfully reduced the viral load in the brain. This approach essentially cleared the virus from brain tissue, providing a potential new treatment avenue for HIV.

    The small molecule inhibitor used, BLZ945, has previously been studied for therapeutic use in amyotrophic lateral sclerosis (ALS) and brain cancer, but never before in the context of clearing HIV from the brain.

    The study, which took place at the Tulane National Primate Research Center, utilized three groups to model human HIV infection and treatment: an untreated control group, and two groups treated with either a low or high dose of the small molecule inhibitor for 30 days. The high-dose treatment lead to a notable reduction in cells expressing HIV receptor sites, as well as a 95-99% decrease in viral DNA loads in the brain .

    In addition to reducing viral loads, the treatment did not significantly impact microglia, the brain’s resident immune cells, which are essential for maintaining a healthy neuroimmune environment. It also did not show signs of liver toxicity at the doses tested.

    The next step for the research team is to test this therapy in conjunction with ART to assess its efficacy in a combined treatment approach. This could pave the way for more comprehensive strategies to eradicate HIV from the body entirely.

    This research was funded by the National Institutes of Health, including grants from the National Institute of Mental Health and the National Institute of Neurological Disorders and Stroke, and was supported with resources from the Tulane National Primate Research Center base grant of the National Institutes of Health, P51 OD011104.

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