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Thursday, 27 March 2014

Anti-Seizure Drug May Guard Against Some Cancers

MONDAY, March 24, 2014 (HealthDay News) -- A drug used to treat seizures may reduce the risk of head and neck cancers, a new study suggests.

Valproic acid (Depakote) is prescribed to prevent seizures and also to control mood, but it is also being investigated for cancer prevention because it inhibits genetic changes that can lead to cancer.

The new study included nearly 440,000 U.S. veterans, including about 27,000 who were taking valproic acid for bipolar disorder, post-traumatic stress disorder (PTSD), migraines and seizures. Overall, veterans who took the drug for at least one year were 34 percent less likely to develop head and neck cancers than those who didn't take the drug, the investigators found.

The risk appeared to be even lower in those who took it in higher doses or for longer periods of time, according to the study published online March 24 in the journal Cancer.

Veterans who took valproic acid did not have a reduced risk for lung, bladder, colon or prostate cancers, said team leader Dr. Johann Christoph Brandes, of the Atlanta Veterans Affairs Medical Center and Emory University in Atlanta, and colleagues.

"A 34 percent risk reduction for the development of head and neck cancer with [valproic acid] use could result in the prevention of up to approximately 16,000 new cases and 3,000 to 4,000 annual deaths in the U.S. alone," Brandes said in a journal news release.

"Head and neck cancer is an important global health crisis, and low cost and low toxicity prevention strategies like [valproic acid] use have a high potential impact on pain, suffering, costs, and [death] associated with this disease," he added.

Although the study found an association between valproic acid use and reduced risk of certain cancers, it did not prove cause-and-effect.

-- Robert Preidt MedicalNews
Copyright © 2014 HealthDay. All rights reserved. SOURCE: Cancer, news release, March 24, 2014

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Thursday, 24 October 2013

Scientists Uncover Breast Milk's Potential Secret Weapon Against HIV

MONDAY, Oct. 21 (HealthDay News) -- Experts have long suspected that breast milk may have the power to prevent babies from getting infected with HIV, and new research gives insight into why that might be so.

Researchers say they've discovered a component of breast milk that appears to kill the virus that causes AIDS, potentially preventing some babies from becoming infected by their mothers.

"Even though we have anti-retroviral drugs that can work to prevent mother-to-child transmission, not every pregnant woman is being tested for HIV, and less than 60 percent are receiving the prevention drugs -- particularly in countries with few resources," study senior author Dr. Sallie Permar, an assistant professor of pediatrics at Duke University, said in a university statement. "There is still a need for alternative strategies to prevent mother-to-child transmission, which is why this work is important."

According to UNICEF, an estimated 330,000 children worldwide in 2011 became infected by their mothers during pregnancy or birth.

The protein the researchers pinpointed, known as Tenascin-C or TNC, wasn't previously suspected to have germ-fighting abilities. The researchers reached their conclusions after testing samples of breast milk from uninfected women to see if it could combat HIV strains.

"TNC is a component of the 'extracellular matrix' that is integral to how tissues hold themselves together," Permar said. "This is a protein involved during wound healing, playing a role in tissue repair. It is also known to be important in fetal development, but its reason for being a component of breast milk or its antiviral properties had never been described."

Future research should examine whether the protein works with other components of breast milk to fight HIV, she said.

Dr. Barton Haynes, director of the Duke Human Vaccine Institute, added: "The discovery of the HIV-inhibiting effect of this common protein in breast milk provides a potential explanation for why nursing infants born to HIV-infected mothers do not become infected more often than they do."

"It also provides support for inducing inhibitory factors in breast milk that might be even more protective, such as antibodies, that would completely protect babies from HIV infection in this setting," Haynes said.

The study was published Oct. 17 in the journal Proceedings of the National Academy of Sciences.

-- Randy Dotinga MedicalNews
Copyright © 2013 HealthDay. All rights reserved. SOURCE: Duke University, news release, Oct. 21, 2013

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For Uninfected Partner, Antiretroviral Drugs May Shield Against HIV

TUESDAY, Sept. 10 (HealthDay News) -- Antiretroviral drugs can provide a high level of protection against HIV for uninfected people in heterosexual couples in which the other partner has HIV, according to a new study.

The study included more than 1,100 HIV-uninfected people in Uganda who had a partner with HIV, the virus that causes AIDS. The participants were given antiretroviral drugs and received counseling support throughout the study to help them adhere to their drug regimen.

The drug adherence rate was 97 percent to 99 percent in the study, which was published Sept. 10 in the journal PLoS Medicine.

After an average follow-up period of 11 months, just 14 of the participants became infected with HIV, according to a journal news release.

The findings provide further proof that strict adherence to what is called antiretroviral pre-exposure prophylaxis offers high levels of protection to uninfected people, said Jessica Haberer, of Harvard Medical School, and colleagues.

The researchers said several previous studies in various groups (such as men who have sex with men, or women at high risk for HIV) have shown that taking antiretroviral drugs provided uninfected people with varying levels of protection against HIV. One possible explanation for the range of findings is different levels of adherence to the antiretroviral drugs, the researchers said.

"Proper support and assessment of adherence will be critical for determining efficacy of [pre-exposure prophylaxis] outside of clinical trials," the study authors wrote. "This data will be important for guiding ethical decisions about resource allocation for both prevention and treatment of HIV."

The Bill & Melinda Gates Foundation funded the study.

-- Robert Preidt MedicalNews
Copyright © 2013 HealthDay. All rights reserved. SOURCE: PLoS Medicine, news release, Sept. 10, 2013

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Nail Fungus Drug Might Help Against HIV, Study Suggests

MONDAY, Sept. 23 (HealthDay News) -- A common drug used to treat nail fungus may hold promise against HIV, the virus that causes AIDS, according to a new study.

In laboratory research, the anti-fungal drug Ciclopirox allowed HIV-infected cells to get killed off by blocking the cells' mitochondria -- their powerhouse. In addition, Ciclopirox eliminated HIV from cell cultures, and the virus did not return when the anti-fungal drug was stopped, the study authors said.

This does not occur with currently available anti-HIV drugs, which must be taken for the rest of a patient's life, said study leaders Michael Mathews and Hartmut Hanauske-Abel, of the Rutgers New Jersey Medical School.

The effectiveness of Ciclopirox against HIV needs to be confirmed in human clinical trials. But because the drug is already approved by the U.S. Food and Drug Administration for treatment of fungal infection and is considered safe, the clinical trial process for this treatment could be quicker and less costly than usual, the researchers said.

The study is published in the current edition of the journal PLoS One.

The use of combination antiretroviral drugs have vastly improved HIV treatment, the study authors said in a Rutgers news release. These so-called drug cocktails are effective at keeping HIV under control, but they never completely eradicate the infection.

HIV's persistence is partially due to its ability to disable a cell's so-called suicide pathway, which is normally triggered when a cell becomes infected or damaged.

View the original article here

Tuesday, 25 June 2013

Supreme Court Nixes State Suits Against Generics

By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- Makers of generic drugs cannot be sued under state law for side effects of their products, the Supreme Court ruled Monday, angering patients' rights advocates.

In a 5-4 decision, the justices overturned a multimillion dollar award to a woman who suffered damages from a generic medication, noting that federal law prohibits drugmakers from making changes in their warning labels without the approval of the FDA.

The case, Mutual Pharmaceutical v. Bartlett, involves a woman who, in 2004, was prescribed Clinoril, the brand name for the nonsteroidal anti-inflammatory drug sulindac. The pharmacist dispensed the generic version manufactured by Mutual. The woman developed an acute case of epidermal necrolysis and sued Mutual seeking damages for the severe disfigurement she developed. A jury awarded her $21 million, an award that was later upheld by a circuit court.

But the Supreme Court said the federal Food, Drug, and Cosmetic Act allows only the FDA to make labeling changes and supersedes state law -- including the one in New Hampshire where this case originated -- that tries to force drugmakers to make labeling or design changes when safety issues arise.

"Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac's label or composition and its state-law duty to either strengthen the warnings on sulindac's label or change sulindac's design," Justice Samuel Alito wrote for the majority.

The High Court said Monday the First Circuit Court of Appeals' ruling was flawed. The lower court said Mutual could have stopped selling sulindac if the drugmaker knew it was unsafe.

It was not until 2005 that the FDA ordered new labeling on all NSAIDs to include a warning for the condition.

The Generic Pharmaceutical Association, the Washington-based trade group of the generic-drug industry, hailed the decision, saying it reaffirms the FDA's authority to oversee the safety of drugs.

"When it comes to decisions on safety and approval of prescription medicine, the FDA is best equipped to make judgments that affect patients," Chief Executive Ralph Neas said in a statement. "The experts at FDA alone have the scientific knowledge, regulatory experience, and complete data to make these decisions."

Monday's decision frequently cited the 2011 case Pliva v. Mensing, which found that generic drugmakers were preempted in state failure-to-warn cases challenging the generics' safety because federal law prohibited changes to generic drug labels without changes to the branded drug's labeling.

"Generic-drug manufacturers' inability under current regulations to update the labeling of their products poses a threat to the safety of prescription drugs, creating unnecessary risks to patients," Michael Carome, MD, director of Public Citizen's Health Research Group, said in a statement.

The consumer advocacy group Public Citizen released a report Monday noting that many safety issues aren't recognized drugs until years after a drug receives FDA approval and are available in a generic form. According to the report, at least 53 drugs approved by the FDA more than 10 years ago have required new black box warnings in the past 5 years.

Public Citizen called on lawmakers and regulators to update post-marketing regulations to bring generics more in line with the safety requirements of their branded counterparts.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.