Pharma companies discontinue giveaways to doctors and agencies
AIDS denialist Christine Maggiore dies at 52
Viread more effective at treating HBV than Hepsera, study finds
New dosing recommendations of Prezista and Ziagen approved for use in children and adolescents
Pharma companies discontinue giveaways to doctors and agencies
Pharmaceutical Research and Manufacturers of America (PhRMA), an industry group based in Washington, recently introduced new voluntary industry guidelines in an effort to quell perceptions that gifts to doctors – such as branded pens, staplers, flash drives, paperweights and calculators – have influence over their prescribing habits.
According to IMS Health, a health care information company, pharmaceutical companies spent more than $6 billion in 2007 on drug representative sales activities including branded pens and other handouts as well as meal-time presentations. In addition, nearly $16 billion in free drug samples were given away to doctors in that same year.
“We have arrived at a point in the history of medicine in America where doctors have deep, deep financial ties with the drug makers and marketers,” said Allan Coukell, director of policy for the Prescription Project, a nonprofit group in Boston working to promote evidence-based medicine (Singer, New York Times, 12/30/2008). “Financial entanglements at all the levels have the potential to influence prescribing in a way that is not good.”
The new guidelines also reiterate a previous code established by PhRMA which prohibits more expensive goods and services, such as tickets to professional sports games and junkets to resorts, and asks companies that financially support medical courses, conferences or scholarships to distance themselves from the selection of study material and scholarship recipients.
Nearly 40 drug makers have signed on to the code, and representatives from several other pharmaceutical companies have stated that they will also comply.
For more details, go to www.phrma.org
AIDS denialist Christine Maggiore dies at 52
AIDS denialist Christine Maggiore died late last month, possibly of AIDS-related complications. Diagnosed with HIV in 1992, Maggiore worked as a volunteer for several AIDS service organizations in the Los Angeles area – including AIDS Project Los Angeles, L.A. Shanti, and Women at Risk – speaking about the risks of HIV at local schools and health fairs.
In 1994, intrigued by University of California, Berkeley biology professor Peter Duesberg’s well publicized views on AIDS (which claim that its symptoms are not caused by HIV), Maggiore started Alive & Well AIDS Alternatives, a non-profit that challenges the common knowledge about the disease. From what she learned with regards to the underlying science of the virus, Maggiore came to believe that positive test results could be caused by flu shots, pregnancy and common viral infections.
Maggiore espoused her views on national television and in her book titled What if Everything You Thought You Knew About AIDS Was Wrong? She refused to take anti-HIV medications, and proceeded to breastfeed both of her children in spite of the known risks of doing so.
While her pre-teen son remains HIV-negative, her daughter died at the age of three from what a Los Angeles County coroner determined to be AIDS-related pneumonia. Maggiore protested the findings and went on to sue the county, claiming that the autopsy report did not contain proper scientific evidence to support the declared cause of death. The case is still pending. Maggiore herself had been treated for new pneumonia in the six-month period prior to her death.
Viread more effective at treating HBV than Hepsera, study finds
According to 48-week data from two Phase 3 clinical studies designed to evaluate the safety and efficacy of once-daily Viread (tenofovir) for the treatment of chronic hepatitis B (HBV) infection in adults, the drug (also widely used to treat HIV) is more effective against the virus than one of the current most commonly used treatments.
The two studies, published in the December 4, 2008 issue of The New England Journal of Medicine, compare Viread to Hepsera among patients with chronic hepatitis B and compensated liver disease. Results at week 48 demonstrate that participants who received Viread experienced superior efficacy compared to those receiving Hepsera, with 71% of patients in the Viread group achieving HBV viral load levels below 400 copies compared to 49% in the Hepsera group.
“Chronic hepatitis B is a long-term, life-threatening disease that may result in tremendous complications if left untreated,” said Patrick Marcelling, MD, the principle investigator of Study 102 and one of the lead authors of the published paper. “Hepsera represented an important advance in the treatment of chronic HBV, but these findings demonstrate that Viread can result in an even greater antiviral response.”
Both Viread and Hepsera were generally well tolerated by patients in both studies, and consistent with the known safety profiles of these drugs in patients with HIV and HBV.
It is estimated that 400 million people worldwide are affected by HBV. Viread was approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic HBV in adults in August of 2008.
New dosing recommendations of Prezista and Ziagen approved for use in children and adolescents
The FDA recently approved new dosing recommendations for a 75 mg Prezista (darunavir) tablet for use in patients ranging from 6 to 18 years of age, to be used in combination with other antiretroviral drugs.
This new dosing is based on 24-week analyses of HIV viral loads and T-cell counts from a Phase 2 clinical study in treatment-experienced HIV-positive young people between the ages of 6 and 18 years. The average viral load of the study participants at baseline was 40,000 copies/mL, and the average T-cell count was 330 cells/mm3.
At week 24, 64% of the participants achieved viral loads less than 400 copies, and 50% had less than 50 copies. The average increase in T-cells from baseline was 117.
Adverse drug reactions experienced in patients age 6 to 18 years of age using Prezista boosted with Norvir were similar to those observed in adults taking the same combination, and include vomiting, diarrhea, abdominal pain, headache, rash, nausea, and fatigue. Once-daily dosing with pediatric patients is not recommended.
In addition, a 300 mg scored Ziagen (abacavir) tablet has been approved for use in pediatric patients greater than 3 months of age and weighing more than 14 kg (30.8 lbs.). Children should be assessed for the ability to swallow tablets before prescribing Ziagen tablets, and the oral solution should be prescribed in the event that a child is found unable to reliably swallow the tablets. The side effects of this pediatric dosing of Ziagen are similar to those for the dosing of Prezista mentioned above.
