FDA grants approval for Intelence
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to...
BMS raises prices, Fair Pricing Coalition responds
Britsol-Myers Squibb (BMS) – the makers of Zerit, Sustiva, Reyataz, and co-developer...
Study shows drug-resistant strain of MRSA spreading through MSM communities in San Francisco and Boston
According to a study published online in the journal Annals of Internal Medicine, a...
HIV infection rates rise among young MSM in NYC
A recent report released from the New York City Department of Health and Mental...
Track the presidential candidates on health care
According to the Kaiser Family Foundation’s latest poll on “health and the 2008...
FDA grants approval for Intelence
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Intelence (etravirine), or TMC-125, the first non-nucleoside reverse transcriptase inhibitor (NNRTI) proven to be effective in people who have developed resistance to the other drugs in that class.
“NNRTIs have been used in HIV combination therapy for more than a decade, but their use has been limited by cross-resistance within the class. Resistance to one NNRTI generally meant resistance to all NNRTI’s,” said Richard Haubrich, M.D., Professor of Medicine in the Division of Infectious Diseases at the University of California, San Diego. Haubrich was also an investigator in the Phase III DUET studies of the drug. “Etravirine breaks new ground in the NNRTI class, and provides a new option to thousands of treatment-experienced patients with NNRTI-resistant HIV.”
Intelence was studied in clinically advanced, treatment-experienced adults and is indicated for people within this group who have a detectable viral load and virus that is resistant to an NNRTI and other HIV drugs. The most common side effects seen in the studies of the drug were rash and nausea.
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BMS raises prices, Fair Pricing Coalition responds
Britsol-Myers Squibb (BMS) – the makers of Zerit, Sustiva, Reyataz, and co-developer of the once-daily combo pill, Atripla – recently announced price increases ranging from 6.9 to 9% for its HIV drugs. The Fair Pricing Coalition (FPC), an independent community group that works to contain the prices of drugs used to treat HIV, is outraged.
According to the FPC’s Martin Delaney, the increases “are well beyond any increases in the Consumer Price Index and above the increases taken by any other company.” Delaney also points out that these drugs, with the exception of Atripla, have been on the market for several years and that BMS has long since recovered the development costs of them.
“There is no justification for this kind of increase,” Delaney says.
BMS is one of the few drug companies who, for the past several years, has refused to take part in pricing discussion with the FPC, which acts on behalf of the interests of hundreds of community groups.
“This is exactly the kind of behavior that gives the pharmaceutical industry such a bad name with the public,” says Lynda Dee of the AIDS Treatment Activists Coalition (ATAC) and AIDS Action Baltimore. “This action makes it clear [that] they don’t care what their customers think or need.”
Paul Dalton, of Project Inform as well as the FPC, says that the group is concerned that BMS’s actions could prompt other drug-makers to increase their prices as well.
“The last thing we need right now is a round of excessive price increases for these drugs, which are already extremely expensive and burdening the health care system,” Dalton says. “Even though the increase to government payers is limited to the increases in the Consumer Price Index, these increases affect the co-pays that patients must pay out of pocket. The price hikes also put pressure on other companies to levy similar increases, triggering round after round of price escalation.”
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Study shows drug-resistant strain of MRSA spreading through MSM communities in San Francisco and Boston
According to a study published online in the journal Annals of Internal Medicine, a drug-resistant strain of MRSA (methicillin-resistant staphylococcus aureus) is being seen in men who have sex with men (MSM) in Boston and San Francisco. The San Francisco Chronicle reports that HIV-positive people “seem especially prone” to this infection.
A review of the charts of 183 people treated for MRSA at San Francisco Hospital’s Positive Health Program, an outpatient program for HIV-positive people, and of 130 people at Fenway Community Health Clinic in Boston was conducted by University of California-San Francisco researcher Binh Diep and colleagues.
The researchers found that MSM between the ages of 18 and 35 were most likely to have the infection, with a statistical analysis showing that one in 588 people in San Francisco’s Castro neighborhood may be infected, compared with one in 3,800 people in the city as a whole. The analysis also concluded that MSM in San Francisco were 13 times more likely than other city resident to contract the infection.
MRSA is most often spread through anal intercourse, but can also be spread through casual skin-to-skin contact or by touching surfaces contaminated with the bacteria. There are a wide array of potential symptoms of MRSA, including abscesses and skin ulcers, flesh-eating bacteria, pneumonia, heart damage, and blood infections. Researchers say that the most effective way to prevent transmission of MRSA is to wash areas that may have been exposed with soap and water, particularly after sex.
This particular strain of MRSA, known as USA300, is resistant to six major antibiotic classes and two of the three alternative MRSA treatments recommended by CDC and the Infectious Diseases Society of America, as well as mupirocin.
Shelly Gordon, an infectious disease specialist at California Pacific Medical Center, says that USA300 is “more virulent than standard staph,” and recommends that emergency department physicians test for drug resistance to avoid using the wrong antibiotic and fueling further resistance. USA300 has been found in 44 states and is beginning to spread through Europe.
“Once [the strain] reaches the general population, it will be truly unstoppable,” says Diep. “That’s why we’re trying to spread the message of prevention.”
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HIV infection rates rise among young MSM in NYC
A recent report released from the New York City Department of Health and Mental Hygiene revealed that new HIV infection rates among NYC men who have sex with men (MSM) who are under the age of 30 increased by 32 percent between 2001 and 2006.
In addition, the study also found that the rate of new HIV infections among its youngest participants, those between the ages of 13 and 19, had doubled. City officials cite the increase of alcohol and drug use among young MSM as a contributing factor, as the use of such substances makes sex without barriers more likely.
Infection rates among MSM over age 30 who participated in the study, however, declined by 22 %. It is believed that factors such as maturity and awareness of the devastating effects of the disease may explain the difference.
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Track the presidential candidates on health care
According to the Kaiser Family Foundation’s latest poll on “health and the 2008 campaign,” health care remains a top domestic issue that the public wants to hear the candidates talk about, second to Iraq.
With the campaign now in full swing, Kaiser has launched a new website at www.health08.org, which offers resources for following health care developments during the campaign season. The website serves as a hub of information about health and the elections, and includes original content produced by Kaiser and easy access to health-related resources from the campaigns, other organizations, and news outlets. It also features an interactive tool for side-by-side comparisons of the candidates’ health care proposals, allowing users to compare up to four candidates’ positions on health care coverage, cost containment, quality of care, and financing.
For more details, or to sign up for free weekly e-mails highlighting the most recent addition to the site, visit www.health08.org.
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