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Update July, 2019


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Health & Wellbeing
 

Vaccine no match against flu bug that popped up near end

In this Jan. 12, 2018, file photo, a medical assistant at a community health center gives a patient a flu shot in Seattle. U.S. health officials say the flu vaccine has again turned out to be a disappointment. (AP Photo/Ted S. Warren, File)

Mike Stobbe

Atlanta (AP) — The flu vaccine turned out to be a big disappointment again.

The vaccine didn’t work against a flu bug that popped up halfway through the past flu season, dragging down overall effectiveness to 29%, the U.S. Centers for Disease Control and Prevention reported Thursday.

The flu shot was working well early in the season with effectiveness put at 47% in February. But it was virtually worthless during a second wave driven by a tougher strain, at just 9%.

There was “no significant protection” against that strain, said the CDC’s Brendan Flannery.

Flu vaccines are made each year to protect against three or four different kinds of flu virus. The ingredients are based on predictions of what strains will make people sick the following winter.

This season’s shot turned out to be a mismatch against the bug that showed up late.

That pushed down the overall effectiveness to one of the lowest in recent years. Since 2011, the only season with a lower estimate was the winter of 2014-2015, when effectiveness was 19%. A mismatch was also blamed then.

Vaccines against some other infectious diseases are not considered successful unless they are at least 90% effective. But flu is particularly challenging, partly because the virus can so quickly change. Overall, flu vaccine has averaged around 40%.

Flu shots are recommended for virtually all Americans age 6 months or older. Officials say the vaccine is still worthwhile since it works against some strains, and it likely prevented 40,000 to 90,000 hospitalizations over the winter flu season.

The CDC bases vaccine effectiveness on preventing cases bad enough to send someone to the doctor.


Vaccine panel gives nod to HPV shots for men up to age 26

Mike Stobbe

Atlanta (AP) — A vaccine against cervical and other cancers should be recommended for both men and women up to age 26, a U.S. government advisory panel decided Wednesday.

The vaccine protects against HPV, a virus that is commonly spread through sex and can cause certain cancers and genital warts.

The Advisory Committee on Immunization Practices’ vote in Atlanta raises the recommended vaccination age for men from 21 to 26, making it the same as the existing recommendation for women. The Centers for Disease Control and Prevention almost always accepts the panel’s recommendations and uses them as guidance for U.S. doctors.

The HPV vaccine is usually given to 11- and 12-year olds, to protect them before their first exposure to sexually transmitted viruses.

Women as old as 26 had been recommended to get a “catch-up” vaccination if they missed the shots in pre-adolescence. For men, the catch-up recommendation had applied only up to age 21, because research indicates males tend to be exposed to sexually-transmitted viruses earlier.

The panel decided Wednesday to equalize the age recommendations to make it easier for doctors.

The CDC estimates that roughly half of Americans ages 18 to 59 had some form of genital HPV. Vaccinations against it first became available in 2006 and each dose now costs $216.

The vaccine is approved for people up to age 45, but the same panel declined a proposal to recommend it for people older than 26.

Instead, it settled on a weak endorsement for adults between 26 and age 45, meaning patients and doctors can make the decision together.

It’s not clear how many cancers would be prevented in that age group or whether the cost is worth the public health benefit, experts at the meeting said.


Daily HIV prevention pill urged for healthy people at risk

Studies released on Tuesday, June 11, 2019 show the anti-AIDS treatment also cuts the chances that someone who’s still healthy becomes infected from risky sex or injection drug use. But with nearly 40,000 new HIV infections each year in the U.S., only a fraction of people who could benefit are prescribed the drug for prevention. (AP Photo/Jeff Chiu, File)

Lauran Neergaard

Washington (AP) — Doctors should offer a daily HIV prevention pill to healthy people who are at high risk of getting infected with the virus, an influential health care panel recommended Tuesday.

The new guidelines aim to help cut the nearly 40,000 new HIV infections in the U.S. each year.

Screening people for the HIV virus also is critical. The U.S. Preventive Services Task Force reiterated its long-standing advice that everyone ages 15 to 65 — and anyone who's pregnant — should be regularly screened, a step to early, life-saving treatment.

But the latest recommendations went a step further.

Studies show that if people who are still healthy take certain HIV drugs every day, it dramatically reduces their chances of being infected by an HIV-positive sexual partner or from injection drug use.

The approach is called PrEP, or preexposure prophylaxis. One brand — a two-medication combo pill named Truvada — so far is approved for preventive use in the U.S.

The task force said PrEP is only for people at high risk of infection. That includes anyone with an HIV-positive sex partner; who has sex without a condom with someone at high risk of HIV; or who shares needles while injecting drugs.

The recommendations were published in the Journal of the American Medical Association. Other medical groups also urge Truvada for prevention, yet just 17 percent of people who might benefit were prescribed it last year, according to an accompanying editorial.

Private insurers follow task force recommendations on what preventive care to cover, some at no out-of-pocket cost under rules from former President Barack Obama's health care law.

"How this recommendation will be implemented is of critical importance because cost is a major barrier," Drs. Diane Havlir and Susan Buchbinder of the University of California, San Francisco wrote in JAMA Internal Medicine. They weren't part of the task force.

Without insurance, the average monthly retail cost is nearly $2,000, they noted.

For the uninsured, the federal government last month announced that Truvada maker Gilead Sciences Inc. had agreed to donate PrEP doses for up to 200,000 people a year.

Some 1.1 million people are living with HIV in the U.S. The Trump administration has set a goal of ending the nation's HIV epidemic within 10 years.


New drug to boost women's sex drive approved in US

This image provided by Amag Pharmaceuticals in June 2019 shows packaging for their drug Vyleesi. The medication OK'd Friday, June 21, 2019 by the U.S. Food and Drug Administration is only the second approved to increase sexual desire in a women, a market drugmakers have been trying to cultivate since the blockbuster success of Viagra for men in the late 1990s. (Amag Pharmaceuticals via AP)

Matthew Perrone

Washington (AP) — U.S. women will soon have another drug option designed to boost low sex drive: a shot they can give themselves in the thigh or abdomen that raises sexual interest for several hours.

The medication OK'd Friday by the Food and Drug Administration is only the second approved to increase sexual desire in a women, a market drugmakers have been trying to cultivate since the blockbuster success of Viagra for men in the late 1990s. The other drug is a daily pill.

The upside of the new drug "is that you only use it when you need it," said Dr. Julia Johnson, a reproductive specialist at UMass Memorial Medical Center who was not involved in its development. "The downside is that it's a shot — and some people are very squeamish."

The drug's developer, Amag Pharmaceuticals, could also face some of the same hurdles that have plagued the lone pill previously approved for the condition, including unpleasant side effects and limited insurance coverage. The company declined to release price information.

The FDA approved the new drug, Vyleesi (pronounced vie-LEE'-see), for premenopausal women with a disorder defined by a persistent lack of interest in sex, causing stress. The most common side effect in company studies was nausea. The approval was based on women's responses to questionnaires that showed increases in sexual desire and decreases in stress related to sex. The women didn't report having more sex, the original goal for the drug.

"Women are not desiring more sex. They want better sex," said Dr. Julie Krop, Amag's chief medical officer.

Flushing, injection site reactions and headache are other common side effects.

Women with high blood pressure or heart disease should not take the drug because increases in blood pressure were observed after injections, the FDA said. It also could interfere with oral naltrexone, a drug for people with alcohol and opioid dependence, the FDA said.

Because so many factors affect sexual desire, doctors must rule out other causes before diagnosing the condition, including relationship issues, medical problems and mood disorders. The condition, known as hypoactive sexual desire disorder, is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.

Still, the pharmaceutical industry has long pointed to surveys — some funded by drugmakers — suggesting that it is the most common female sexual disorder in the nation, affecting roughly 1 in 10 women. Amag estimates nearly 6 million U.S. women meet the criteria for the drug.

Cynthia Pearson, executive director of the National Women's Health Network, urged women to avoid using the drug "until more is known about its safety and effectiveness." She noted in a statement that Amag had not yet published full clinical trial results.

The search for a pill to treat women's sexual difficulties was once a top priority for many of the world's biggest drugmakers, including Pfizer, Bayer and Procter & Gamble. Those companies and others studied and later abandoned drugs acting on blood flow, testosterone and other targets.

Vyleesi acts on receptors for a brain-stimulating hormone called melanocortin, which is associated with sexual arousal and appetite in both men and women.

Waltham, Massachusetts-based Amag plans to pitch the drug to consumers through social media, including a website called unblush.com that tells women that low sex drive "is nothing to blush about."

Amag's campaign has some of the hallmarks that helped launch the first female libido drug, Addyi, a once-a-day pill approved in 2015. The FDA decision followed a contentious four-year review that included a lobbying effort funded by Addyi's maker, Sprout Pharmaceuticals, which framed the lack of female sex drugs as a women's rights issue.

Women taking Addyi showed a slight uptick in "sexually satisfying events" per month and improved scores on psychiatric questionnaires. Those results were only slightly better than what women taking a placebo reported, but they were significant enough to meet FDA effectiveness standards.

The pink pill — originally developed as an antidepressant — was ultimately approved with a bold warning that it should not be combined with alcohol, due to risks of fainting and dangerously low blood pressure.

Most insurers refused to cover the drug, citing lackluster effectiveness, and many women balked at the $800-per-month price. Last year, Sprout slashed the price to $400. It was prescribed just 6,000 times last year, according to investment analyst data.

UMass's Johnson said drugs should not be the first choice for treating women's sexual problems. Instead, she recommends counseling to help women "separate all the stresses of life" from their sex life.

"But if that doesn't work, having a medication that may help is worth trying," she said.

  


HEADLINES [click on headline to view story]

Vaccine no match against flu bug that popped up near end

Vaccine panel gives nod to HPV shots for men up to age 26


Daily HIV prevention pill urged for healthy people at risk


New drug to boost women's sex drive approved in US