FDA nears ruling on HIV-prevention pill

By Deena Beasley — An advocacy group concerned about costs and possible health problems related to a drug being considered to help stop the spread of HIV infection to healthy people has asked U.S. regulators to delay or deny its approval.

Los Angeles-based AIDS Healthcare Foundation (AHF) has petitioned the Food and Drug Administration on the grounds that studies have shown that the pill, Truvada, made by Gilead Sciences, is only partially effective in preventing transmission. The drug is already approved to treat people infected with the human immunodeficiency virus that causes AIDS.

Because Truvada must be taken every day, protection from the virus will falter if, as is likely in everyday life, a dose is missed, the AHF said.

"Any approach that relies on adherence for people who don't have a disease is going to fail," AHF President Michael Weinstein said at a press conference on Thursday.

The Fenway Institute, which advocates for lesbian, gay, bisexual and transgender people, and several other HIV organizations are in favor of using antiretroviral medication, along with risk reduction counseling and condoms, to prevent HIV transmission.

A coalition of 25 health organization in January contacted the FDA expressing their support for the Truvada application.

Officials at Gilead declined to comment.
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A decision by the FDA, which granted an expedited review of the company's application, is expected by June 15 and a panel of experts will review the issue in May.

AHF estimates the cost of Truvada for preventing transmission of HIV at $14,000 a year.

Gilead is seeking permission for Truvada -- a combination of its HIV drugs Emtriva, also known as emtricitabine, and Viread, or tenofovir -- to be used as a form of "pre-exposure prophylaxis," often shortened to PrEP.

Results from a PrEP trial involving 4,758 heterosexual Kenyan and Ugandan couples presented this week at the Conference on Retroviruses and Opportunistic Infections found that 82 HIV infections occurred, 17 in patients treated with tenofovir, 13 in patients given Truvada, and 52 among those treated with a placebo.

"People who take PrEP even haphazardly will consider themselves protected" and could well let up on safe-sex measures, such as condoms, said AHF General Counsel Tom Myers.

The AHF said Truvada is associated with kidney problems and that use of the drug by healthy people could cause them to become resistant to it, complicating treatment if they contract HIV.

"Expanding the use of antiretrovirals to include pre-exposure prophylaxis will increase the risk of resistance, which is already a serious problem," British medical journal Lancet said in an editorial last year. "HIV is a rapidly evolving virus and development of resistance creates the need for ever-changing regimens of drugs in various classes."

Scientists are exploring a variety of tactics for using AIDS drug formulations to prevent HIV infection, including long-acting injections, gels and vaginal rings.

"There are very good scientific arguments in favor of treatment as prevention," said Daria Hazuda, vice president for infectious disease discovery at Merck & Co. "It's an issue of timing, cost and do you have the right intervention."

An estimated 1.2 million Americans have HIV, according to the Centers for Disease Control and Prevention.

In preliminary guidelines issued last year, the CDC said only high-risk gay and bisexual men should use a daily AIDS pill to protect themselves from the virus.

Diabetes,statins meds may be available over counter

WASHINGTON — Prescription drugs to treat some of the most common chronic diseases, such as high cholesterol and diabetes, may become available over the counter under a plan being considered by U.S. regulators.

In what would be a major shift in policy if finalized, the Food and Drug Administration is seeking public comment until Friday on a way to make these medications more readily available. It will also have a meeting about the proposal at the end of March.

The goal is to ensure people take drugs as needed, while still understanding safety issues.

Experts say the unwillingness of people to take certain medications as prescribed has undermined effective treatment of conditions including high blood pressure, raising the cost of healthcare in the United States.

About one in three U.S. adults has high blood pressure, which contributes to heart disease and stroke. The condition cost the United States about $76 billion in 2010, according to the Centers for Disease Control and Prevention.

The FDA said about a third of those with high blood pressure stop taking their medication.

The problem with making these drugs available without a prescription is that many require patients to understand complex aspects of their disease, or exactly when to take a drug to ensure safe use.
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A typical over-the-counter drug generally treats short-term conditions with easily recognized symptoms such as a headache or runny nose, and comes with only a factbox or pamphlet.

But taking cholesterol-lowering drugs called statins requires knowledge about a person's elevated or abnormal levels of fat in the blood, known as lipids.

"We've had several applications already to switch statins to over the counter, and they have failed because consumers can't determine their lipid status," Janet Woodcock, head of the FDA's drugs center, told reporters on Wednesday.

The FDA rejected Merck & Co Inc's bid in 2008 to sell its Mevacor statin without a prescription. FDA advisers said patients would not be able to decide for themselves whether they were appropriate candidates for the medicine.

New technology may help change that calculus.

The FDA said it met with drugmakers to discuss ways to help people understand drug risks when they go to a pharmacy, such as using self-serve kiosks, touchscreen pads or interactive videos.

The FDA emphasized that consideration of any over-the-counter change is still in the initial stages.

The FDA will discuss its proposal at the public meeting before developing further guidance. Drugmakers would then have to apply for each drug to be in a new category.

Copyright 2012 Thomson Reuters. Click for restrictions.

Teen smoking an 'epidemic,' new report finds

CHICAGO — Smoking among America's youth has reached epidemic proportions, starting them on the path to a lifetime of addiction, the U.S. surgeon general's office said in its first report on youth smoking since 1994.

Almost one in five high school-aged teens smokes, down from earlier decades, but the rate of decline has slowed, the report said. Because few high school smokers are able to quit, some 80 percent will continue to smoke as adults, according to the report released on Thursday.
"Today, more than 600,000 middle school students and 3 million high school students smoke. We don't want our children to start something now that they won't be able to change later in life," Surgeon General Dr. Regina Benjamin said in the report, which details the scope, health consequences and influences that lead to youth tobacco use.

An estimated 3,800 kids pick up their first cigarette every day and 9 in 10 current smokers started before the age of 18. Some 99 percent of all first-time tobacco use happens by the age of 26, exposing young people to the long-term health effects of smoking, such as lung cancer and heart disease.

Smoking kills more than 1,200 people every day, and every tobacco-related death is replaced by two new smokers under the age of 25, the report said.

"This report highlights the urgent need to employ proven methods nationwide that prevent young people

from smoking and encourage all smokers to quit, including passage of smoke-free laws, increases in tobacco excise taxes and fully funded tobacco prevention programs," John Seffrin, chief executive officer of the American Cancer Society and the American Cancer Society Cancer Action Network, said in a statement.

The report criticized tobacco companies for targeting youth, saying the industry spends more than $1 million an hour -- over $27 million per day -- in marketing and promoting tobacco products.
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Advertising messages that make smoking appealing to young people are widespread, and advertising for tobacco products is prominently displayed in retail stores and online.

"Targeted marketing encourages more young people to take up this deadly addiction every day," U.S. Department of Health and Human Services Secretary Kathleen Sebelius said in a statement. "This administration is committed to doing everything we can do to prevent our children from using tobacco."

Tobacco companies were quick to defend their practices.

Altria Group, parent of companies Philip Morris USA, U.S. Smokeless Tobacco and John Middleton, said it markets to adults who use to tobacco through age-verified direct communications and in retail stores.

"The vast majority of our marketing expenditures come in the form of price promotions," the company said in a statement.

Altria said its tobacco companies worked to help enact the Family Smoking Prevention and Tobacco Control Act of 2009, noting it was one of the few tobacco companies that did.

But U.S. public health officials said more is needed to curb youth smoking.

"We can and must continue to do more to accelerate the decline in youth tobacco use," Dr. Howard Koh, assistant secretary for health at HHS said in a statement. "Until we end the tobacco epidemic, more young people will become addicted, more people will die and more families will be devastated by the suffering and loss of loved ones."

The report also recommended anti-smoking campaigns and increased restrictions under the U.S. Food and Drug Administration's authority to regulate tobacco as other ways to prevent adolescents and young adults from using tobacco products.

Benjamin did not point fingers on why youth tobacco use continues in the U.S. Instead, she wants to see how the nation as a whole can best address the issue, she said.

"I don't want to focus on blame, I want to focus on prevention," she said. "I want to make sure we're doing everything that we can to prevent kids from ever starting to smoke or use tobacco products."

The full report can be found at www.surgeongeneral.gov

HIV-positive man who intentionally infected ‘thousands’ of partners turns himself in

Michigan health officials issue alert, encourage possible victims to get tested immediately

Hundreds of Michigan residents -- and others -- may have been infected with HIV by a man who told police he’d been on a three-year mission to transmit the disease to as many people as he could, MSNBC reports.

Police arrested David Dean Smith, 51, last week after he turned himself in -- and admitted he had unprotected sex with "thousands" of partners with the intention of killing them by infecting them with the virus.

Only two possible victims have yet been identified.

Smith's mission to sicken his lovers likely stretched to other states including anyone he may have seduced via Yahoo! Personals, as he did with the one of two victims who came forward.

"He's charming," the alleged victim, who didn't want to be identified, told 24 Hour News 8. "He's very charming."

Records from Pine Rest Christian Mental Health Services, where Smith had been admitted recently because he was "suicidal," indicated he is "sexually aroused by causing pain to females," according to court documents.

The woman, who was diagnosed with HIV in October 2008, told the TV station that Smith told her there were 3,000 victims including men and women.

"He hits drifters," said the alleged victim. "He hits people who are young. He hits young women, and from what I understand, he hits men too. Those are his targets."

Health officials released an alert to residents of Kent County Michigan that "possibly hundreds have been exposed to HIV," and encouraged possible victims to come forward and be tested.

Kent County Health Department spokesperson Lisa LaPlante said this is the first time they have seen someone deliberately trying to spread HIV to so many people.

"We want to make sure that anyone who may have injected drugs with , who may have had sex with him, does come forward and get tested," LaPlante told the TV station. "We want to make sure that they're not spreading the virus to anyone else."

Before his arrest, Smith reportedly texted the alleged victim: "Turning myself into the law, my life is over. Take care. Always love you."

Smith, currently at Kent County Jail where he is being held in lieu of $100,000 bond, has been charged with two felony counts of failure to disclose HIV status to a sexual partner, a charge carrying a four-year jail sentence and a $5,000 fine.

Smith's attorney, Richard E. Zambon, told MSNBC he is "exploring all options" in his client's defense, and specified "I am concerned about his mental health.

5 surprising things that could make your seasonal allergies worse

Fruits and vegetables, air filters, fresh air, procrastination, and self-medication may be culprits
Allergists in the US reveal five surprising seasonal allergy triggers, including eating certain kinds of fruits and vegetables.

If you suffer from springtime allergies, there are five surprising ways you may be aggravating your suffering -- fruits and vegetables, air filters, fresh air, procrastination, and self-medication.

"People with spring allergies often don't realize how many things can aggravate their allergy symptoms so they just muddle along and hope for an early end to the season," said Myron Zitt, M.D., past president of the American College of Allergy, Asthma and Immunology (ACAAI), in a release last week. "But there's no reason to suffer. A few simple adjustments in habits and treatment can make springtime much more enjoyable."

What not to do if you have seasonal allergies:

1. Eat certain fruits and vegetables - While this rarely makes a "what not to do" list, if you suffer from seasonal allergies, you may also suffer from pollen food allergy syndrome, "a cross-reaction between the similar proteins in certain types of fruits, vegetables (and some nuts) and the allergy-causing pollen," noted the statement. For instance, if you are allergic to birch or alder trees, you might react to celery, apples, or cherries. Grass allergies? Then tomatoes, potatoes, or peaches may bother you. Talk to your allergist.

2. Use the wrong air filter - Studies show inexpensive air conditioning filters and ionic electrostatic room cleaners aren't helpful, and that the ions released in the latter can be irritants. Look to whole-house filtration systems but change the filters regularly.

3. Open your windows - To keep pollen from drifting inside your house and settling into carpet and furniture, keep your windows shut during allergy season. Also, keep your car windows closed, since pollen can settle into car upholstery as well.

4. Procrastinate - If you have a history of seasonal allergies, get a jumpstart on the condition and begin taking your medications before the season gets underway, stated the ACAAI.

5. Self-medicate - Rather than trying to resolve the problem yourself, talk to an allergist, who can help you determine what is triggering your symptoms and suggest the proper treatment plan.


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Bat flu could pose risk to humans Evidence of virus proving not all animal flu had been discovered

Scientists have found evidence of flu in bats, reporting a never-before-seen virus whose risk to humans is unclear.

For The first time, scientists have found evidence of flu in bats, reporting a never-before-seen virus whose risk to humans is unclear.

The surprising discovery of genetic fragments of a flu virus is the first well-documented report of it in the winged mammals. So far, scientists haven't been able to grow it, and it's not clear if — or how well — it spreads.

Flu bugs are common in humans, birds and pigs and have even been seen in dogs, horses, seals and whales, among others. About five years ago, Russian virologists claimed finding flu in bats, but they never offered evidence.

"Most people are fairly convinced we had already discovered flu in all the possible" animals, said Ruben Donis, a Centers for Disease Control and Prevention scientist who co-authored the new study.

Scientists suspect that some bats caught flu centuries ago and that the virus mutated within the bat population into this new variety. Scientists haven't even been able to grow the new virus in chicken eggs or in human cell culture, as they do with more conventional flu strains.

But it still could pose a threat to humans. For example, if it mingled with more common forms of influenza, it could swap genes and mutate into something more dangerous, a scenario at the heart of the global flu epidemic movie "Contagion."

The research was posted online Monday in the journal Proceedings of the National Academy of Sciences.

The CDC has an international outpost in Guatemala, and that's where researchers collected more than 300 bats in 2009 and 2010. The research was mainly focused on rabies, but the scientists also checked specimens for other germs and stumbled upon the new virus. It was in the intestines of little yellow-shouldered bats, said Donis, a veterinarian by training.

These bats eat fruit and insects but don't bite people. Yet it's possible they could leave the virus on produce and a human could get infected by taking a bite.

It's conceivable some people were infected with the virus in the past. Now that scientists know what it looks like, they are looking for it in other bats as well as humans and other animals, said Donis, who heads the Molecular Virology and Vaccines Branch in the CDC's flu division.

At least one expert said CDC researchers need to do more to establish they've actually found a flu virus.

Technically, what the CDC officials found was genetic material of a flu virus. They used a lab technique to find genes for the virus and amplify it.

All they found was a segment of genetic material, said Richard "Mick" Fulton, a bird disease researcher at Michigan State University.

What they should do is draw blood from more bats, try to infect other bats and take other steps to establish that the virus is spreading among the animals, he continued. "In my mind, if you can't grow the virus, how do you know that the virus is there?"

Donis said work is going on to try to infect healthy bats, but noted there are other viruses that were discovered by genetic sequencing but are hard to grow in a lab, including hepatitis C.