California Man sentenced for illegally distributing Serostim, an HIV drug.

CONCORD, NEW HAMPSHIRE: Thomas Lavery, of Irvine, CA, was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork. Judge McAuliffe also entered an order of forfeiture against Lavery for the sum of $1,009,460.

Previously, on September 4, 2007, Lavery pleaded guilty to a forty-four count Indictment charging him with wire fraud conspiracy and wire fraud, money laundering, and conspiracy to engage in unlicensed wholesale distribution of prescription drugs, and false statements in a matter under the jurisdiction of the U.S. Food and Drug Administration.

The scheme, in which Lavery was found by Judge McAuliffe to be a leader and organizer, involved purchasing large quantities of Serostim from illegitimate sources in Palm Springs and Los Angeles, California at prices significantly below the price that the manufacturer charges pharmacies. Specifically, the Serostim was purchased from HIV infected patients and then reintroduced into the wholesale distribution chain by using false documentation to make it appear that the Serostim had come from legitimate licensed wholesalers when in fact it had been previously dispensed to HIV infected patients.

In furtherance of the scheme, Lavery purchased the Serostim from suppliers who had in turn purchased the Serostim directly from the HIV infected patients. Lavery worked with Beth Handy of Milford, NH who has also pleaded guilty to similar charges in U.S. District Court in Concord and is now awaiting sentencing. During the time frame of the scheme, Handy was licensed by the New Hampshire Board of Pharmacy as a wholesaler of prescription drugs doing business in the State of New Hampshire. Handy solicited licensed wholesalers of prescription.

Read the complete report at the U.S. Attorney's Web site.

Neuropathic Pain in HIV Could Be Eased With Medicinal Marijuana (Cannabis)

In a double-blind, placebo-controlled clinical trial to assess the impact of smoked medical cannabis, or marijuana, on the neuropathic pain associated with HIV, researchers at the University of California, San Diego School of Medicine found that reported pain relief was greater with cannabis than with a placebo. The study, sponsored by the University of California Center for Medical Cannabis Research (CMCR) based at UC San Diego, will be published on line, August 6 in the journal Neuropsychopharmacology.

Led by Ronald J. Ellis, M.D., Ph.D., associate professor of neurosciences at UCSD School of Medicine, the study looked at 28 HIV patients with neuropathic pain not adequately controlled by other pain-relievers, including opiates. They took part in the controlled study as outpatients at the UCSD Medical Center. The proportion of subjects achieving pain reduction of 30 percent or more was greater for those smoking cannabis than those smoking the placebo.

“Neuropathy is a chronic and significant problem in HIV patients as there are few existing treatments that offer adequate pain management to sufferers,” Ellis said.

“We found that smoked cannabis was generally well-tolerated and effective when added to the patient’s existing pain medication, resulting in increased pain relief.”

Each trial participant participated in five study phases over seven weeks. During two five-day phases, randomly selected participants smoked either cannabis or placebo cigarettes made from whole plant material with cannabinoids (the psychoactive compound found in marijuana) removed, both provided by the National Institute on Drug Abuse. Outcome was tested by standardized tests measuring analgesia (lessened pain sensation), improvement in function and relief of pain-associated emotional distress.

Using verbal descriptors of pain magnitude, cannabis was associated with an average reduction of pain intensity from ‘strong’ ‘to mild-to-moderate’ in cannabis smokers, according to Ellis. Also, cannabis was associated with a sizeable (46% versus 18% for placebo) proportion of patients reporting clinically meaningful pain relief.

The study’s findings are consistent with and extend other recent research supporting the short-term efficacy of cannabis for neuropathic pain, also sponsored by the CMCR.

“This study adds to a growing body of evidence that indicates that cannabis is effective, in the short-term at least, in the management of neuropathic pain,” commented Igor Grant, M.D., professor of psychiatry and director of the CMCR.

The CMCR coordinates and supports cannabis research throughout the state of California. Research focuses on the potential medicinal benefits of cannabis for diseases and conditions as specified by the National Academy of Sciences, Institute of Medicine Report (1999) and by the Workshop on the Medical Utility of Marijuana, National Institutes of Health (1997).

Grant noted that this is the fourth CMCR sponsored study to provide convergent evidence that cannabis can help in relieving these types of pain. The previous studies were conducted with CMCR support by Donald I. Abrams, M.D., Professor of Clinical Medicine at UCSF, who reported efficacy in short-term treatment of HIV neuropathy (Neurology, 2007, 68:515-521); by Mark Wallace, M.D., Program Director for the UCSD Center for Pain Medicine, who found that normal volunteers subjected to chemically induced pain which mimics neuropathy also responded to medium doses of cannabis (Anesthesiology, 2007, 107(5):785-796); and by Barth Wilsey, M.D., Director of the UC Davis Analgesic Research Center, who also reported benefit from smoked cannabis in a group of patients with neuropathy of multiple origins (Journal of Pain, 2008 Jun;9(6):506-21).

Additional contributors to the study, all from the UCSD School of Medicine, include Will Toperoff, RN, FNP, Department of Neurosciences; Florin Vaida, Ph.D., Family and Preventive Medicine; Geoff van den Brande, RN, Medicine; J. Gonzales, Pharm.D., Pharmacy; Ben Gouaux, Heather Bentley, CCRA, and J. Hampton Atkinson, M.D., Psychiatry.

Tags: Medicinal Marijuana, Cannabis, HIV, Medical Research, HIV Drug, Pain Relief, Neuropsychopharmacology, San Diego School of Medicine, cannabinoids

FDA Approves New HIV Drug After Priority Review

FOR IMMEDIATE RELEASE January 18, 2008

Media Inquiries: Christopher Kelly, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Approves New HIV Drug After Priority Review
Etravirine tablets used in combination with other antiretroviral agents

The U.S. Food and Drug Administration today approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.

Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme which HIV needs to multiply. The drug was approved to be used in combination with other anti-HIV medications. Sold under the trade name Intelence, etravirine received a priority review by the FDA.

Development of etravirine was triggered by the observations of in vitro anti-HIV activity of etravirine against mutant, NNRTI-resistant HIV strains.

"This is another significant new product for many HIV-infected patients who are NNRTI –resistant and whose infections are not responding to currently available medications," said Debra B. Birnkrant, M.D., director of the FDA's Division of Antiviral Products.

When used with other active anti-HIV medicines and when taken as prescribed, etravirine reduces the amount of HIV in the blood and increases white blood cells that help fight off other infections. In addition, etravirine may reduce the risk of death or infections that can occur with a weakened immune system.

The FDA's approval of etravirine is based primarily on data from 599 adults who received etravirine in two randomized, double-blind, placebo-controlled trials. After 24 weeks of treatment, more of the patients who received etravirine along with background therapy experienced reductions in the level of HIV in their blood than did those who received a placebo and background therapy.

The most common adverse events reported were rash and nausea. Patients developing a rash while taking etravirine should contact their doctor. To avoid drug interactions, patients starting etravirine treatment should tell their prescribers and pharmacists about all the medications they take. Information about drug interactions is contained in the etravirine package insert.

In the overall development program for etravirine, rare cases of serious skin reactions such as Stevens-Johnson syndrome and erythema multiforme were reported. Patients taking etravirine may develop infections, including opportunistic infections or other conditions that may develop in patients living with HIV infection. The long-term effects of etravirine are not known, and its safety and effectiveness in children ages 16 years and younger has not been studied.

Etravirine also has not been studied in pregnant women. Women who are taking HIV medications when they become pregnant are advised to consult their physician or other health care professional about use of etravirine during pregnancy and about registering with the Antiviral Pregnancy Registry.

Etravirine is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., based in Bridgewater, N.J.

FDA and its work in HIV/AIDS

tag: FDA Approval, Drug Approval, HIV Drug, antiretroviral agent, Etravirine, NNRTI, Intelence, AIDS Drug, Ortho Biotech Products, Tibotec Therapeutics,