EPA reverses approval for poison traps used by ranchers


The Environmental Protection Agency on Thursday reversed its preliminary decision allowing continued use of deadly sodium cyanide traps, blamed for injuring people and pets as well as their intended targets of coyotes and other predators.

EPA head Andrew Wheeler said in a statement he had decided the agency needed to do more analysis and consulting regarding the so-called M-44 traps, devices embedded in the ground that look like lawn sprinklers but spray cyanide when triggered by animals attracted by bait.

“I look forward to continuing this dialogue to ensure U.S. livestock remain well-protected from dangerous predators while simultaneously minimizing off-target impacts on both humans and non-predatory animals,” Wheeler said.

Environmental groups had blasted the agency’s preliminary decision last week reauthorizing the cyanide traps, saying they were impossible to use safely.

Federal officials decided against using the devices in Idaho after a then 14-year-old boy was injured in 2017 when he encountered an M-44 with his dog on federal land near his house on the outskirts of Pocatello. His Labrador retriever died.

The U.S. Department of Agriculture’s Wildlife Services uses the devices to kill coyotes and other livestock predators, mostly in the Western U.S.

In 2018, M-44s killed about 6,500 animals, mainly coyotes and foxes. That was down from about 13,200 animals in 2017.



Source link

Is pot safe when pregnant? Study seeks answer, draws critics


An increase in U.S. women using pot during pregnancy has prompted new government-funded research aiming to resolve questions about whether it might harm the fetus and lead to brain damage.

One of the studies is at the University of Washington in Seattle. Researchers there are enrolling women who are already using pot early in pregnancy. At 6 months, their babies will have brain scans to be compared with scans of infants whose moms didn’t use pot.

For government and university authorities, it’s worthy research that takes advantage of a booming trend. But critics contend it is bogus research that endorses drug use and needlessly endangers fetuses.

Ethicists say the dispute shows why studying how drugs affect pregnant women and babies can be so challenging.



Source link

E-cigarette giant Juul's campaign donations favor Democrats


E-cigarette giant Juul Labs gave nearly $100,000 to members of Congress during the first half of 2019 as the company faced the bulk of the blame for a surge of underage vaping and calls for tighter government regulation of the industry.

The donations from Juul’s political action committee represent a sharp increase over last year’s total, according to a Federal Election Commission report released Thursday that shows most of the money went to Democrats.

The boost in contributions is the latest sign of the company’s expanding influence operation in Washington and around the country. An explosion of underage vaping has put Juul in the crosshairs of a number of Democrats, who have accused the company’s early advertising and marketing of leading to the current wave of vaping by American teens.

Juul is ramping up its political giving as Congress considers legislation to raise the minimum age to purchase all tobacco and vaping products from 18 to 21.

Juul and cigarette maker Altria — which controls 35% of the vaping company — have backed a Senate bill that raises the age nationally. The bill does not include additional measures that anti-tobacco groups say are needed to curb youth use, such as banning flavored products and online sales.

Ted Kwong, a spokesman for Juul, said in a statement the company strongly prefers to support bills to raise the purchase age that are free of additional provisions, “as we believe it is one of the most effective ways to prevent underage use.”

The new FEC figures show that Democrats, who won control of the House during last year’s elections, received $74,000 from Juul’s PAC between Jan. 1 and June 30 while Republicans received $22,500.

Kwong said the company “strives to support candidates on both sides of the aisle” as part of its mission to “improve the lives” of smokers and “combat underage use.”

Juul contributed $2,500 to Rep. Sanford Bishop, D-Ga. Bishop has co-sponsored legislation to exempt most e-cigarettes on the market from health reviews by the Food and Drug Administration.

Rep. Cedric Richmond, D-La., received $7,500, the largest donation to a single lawmaker. Richmond is co-chairman of Democratic presidential candidate Joe Biden’s campaign and a former chairman of the Congressional Black Caucus.

The company gave $5,000 each to the Congressional Black Caucus and the Congressional Hispanic Caucus’ political action committees. The company also gave $2,500 to the ASPIRE political action committee that raises money for Asian American candidates for Congress.

Juul donated $5,000 each to Sens. Kyrsten Sinema, D-Ariz., and Jeanne Shaheen, D-N.H. Shaheen has called e-cigarette companies the “culprits of this epidemic” of underage vaping. Legislation introduced by Shaheen would force manufacturers to fund anti-vaping education and prevention efforts for teenagers through federal user fees.

The company reported giving $2,500 to a left-leaning group called VoteVets. But Jon Soltz, chair of VoteVets, said the organization didn’t accept the money. Sen. Catherine Cortez Masto, D-Nev., also didn’t want Juul’s donation. Ryan King, the senator’s spokesman, said Friday her campaign did not accept the $5,000 contribution “and has promptly returned the check.”

Juul executives have said the company never intended its e-cigarettes to be adopted by underage teenagers. During a congressional hearing last week, Juul co-founder James Monsees testified that Juul developed its blockbuster vaping device and flavor pods for adult smokers who want to stop. “Combating underage use” is the company’s highest priority, Monsees added.

Most health experts say that e-cigarettes are probably less harmful than traditional paper-and-tobacco cigarettes, which can cause cancer, lung disease and strokes. But neither Juul nor any other e-cigarette has yet been approved by the FDA to help smokers quit.

Juul has assembled an extensive network of lobbyists amid mounting concern over e-cigarettes and warnings from the FDA that regulatory steps may be inevitable to combat what public health officials and anti-smoking groups have described as an epidemic of youth vaping.

The company also has become a generous political donor, giving tens of thousands of dollars over the last 18 months to candidates for state and national offices as well as political organizations, according to the FEC data and state campaign finance records.

During the first half of 2019, Juul spent $1.9 million on lobbying Congress, the White House and the FDA as the company expanded its pool of Washington insiders with ties to Republicans and Democrats in positions of authority.

Among those lobbying on Juul’s behalf are Jim Esquea, who worked during the Obama administration as an assistant secretary at the Department of Health and Human Services, and Ted McCann, who was a top policy aide to former House Speaker Paul Ryan. Juul hired Fulcrum Public Affairs in January, adding to its lobbying ranks former aides to Obama-era Labor Secretary Hilda Solis and Rep. Maxine Waters, the California Democrat who chairs the House Financial Services Committee.

In California, where Juul is headquartered, the company has donated close to $99,000 since early last year to members of the state legislature, political action committees and committees set up to influence the outcome of ballot measures.

About a third of the money went to Assemblymember Adam Gray, a Democrat from Merced who chairs the powerful Governmental Organization Committee. Gray’s reelection campaign received $8,800 from Juul, and the company gave $25,000 to Valley Solutions, Gray’s ballot measure committee.

Legislation introduced by Gray and other assemblymembers earlier this month to curb youth use of vaping products was criticized by the American Cancer Society’s Cancer Action Network as an industry-friendly measure that should be called the “Juul Market Share Protection Act.”

Gray said in a statement sent by his spokesman that the financial support he receives “plays zero role in how I represent my district or how I make decisions on public policy.”

Despite Juul’s public commitment to keeping its products out of teens’ hands, the company has fought in California and other states against legislation that anti-tobacco groups have argued would help to move toward that goal.

Juul and the Vapor Technology Association, a trade group that lists Juul as a platinum member, opposed a California bill that would have banned flavored tobacco products, arguing such a prohibition would only hurt adults trying to quit smoking.

Juul and Altria lobbyists in Arizona supported legislation to raise the minimum buying age for tobacco products and e-cigarettes to 21 but which included language that would bar cities and counties from imposing regulations on tobacco and e-cigarettes. Local governments often impose stricter rules than the state does. Kwong said this was the only bill that had a hearing and “provided us an opportunity to publicly support.”

In Montana, Juul opposed measures to require convenience stores that sell e-cigarettes to keep them behind the counter and to apply the state’s tobacco tax to e-cigarettes. Juul didn’t testify against the tax measure in Montana, but several Montana vape shop owners did.

“Taxing a product that helps people? I don’t see the point in that,” said Ron Marshall of Freedom Vapes.



Source link

Saudi Arabia suspends visas to people from Congo over Ebola


Saudi Arabia has stopped issuing visas to people from Congo while citing the Ebola outbreak there, even as the World Health Organization recommends against travel restrictions.

Some Muslims in Congo had planned to take part in the annual hajj pilgrimage in Saudi Arabia next month. A letter from the Saudi foreign ministry to Congo’s embassy in Riyadh, obtained by The Associated Press and dated Wednesday, says the kingdom made the decision to protect pilgrims and others.

The letter refers to the WHO decision this month to declare the year-long Ebola outbreak in eastern Congo a global health emergency. More than 1,700 people have died in the second-worst Ebola outbreak in history.

Saudi Arabia also suspended visas during West Africa’s Ebola outbreak a few years ago in which more than 11,000 people died.

The new decision affects anyone coming from Congo, including non-citizens.

Congo’s government has not responded publicly.

———

Follow Africa news at https://twitter.com/AP—Africa



Source link

AP sources: Trump officials weigh delay of abortion curbs


The Trump administration has told federally funded family planning clinics it is considering a delay in enforcing a controversial rule that bars them from referring women for abortions. That comes after clinics had vowed defiance.

Two people attending meetings this week between the Department of Health and Human Services and clinic representatives told The Associated Press that officials said the clinics should be given more time to comply with the rule’s new requirements. The people spoke on condition of anonymity because they weren’t authorized to speak publicly before any decision has been announced.

HHS said Friday that its policy has not changed.

On Monday, agency officials announced that the government would immediately begin enforcing the rule, catching the clinics off-guard and prompting an outcry. Planned Parenthood said its 400 clinics would defy the requirement. Some states, including Illinois and Maryland, backed the clinics. The family planning program serves about 4 million women a year, and many low-income women get basic health care from the clinics.

The administration’s abortion restrictions, cheered by social and religious conservatives, are being challenged in court by groups representing the clinics, several states, and the American Medical Association. The litigation is still in its early stages. An enforcement pause may allow for a clearer indication of where the court cases are headed.

The people who spoke to AP said that HHS Office of Population Affairs Director Diane Foley told representatives of the clinics the administration is considering rewinding the clock on enforcement. Instead of requiring immediate compliance, the administration would issue a new timetable and start the process at that point.

Some requirements would be effective in 60 days, others in 120 days, and others would take effect next year.

The clinics had complained to HHS that the agency gave them no guidance on how to comply with the new restrictions, while expecting them to do so immediately.

The rule bars the family planning clinics from referring women for abortions. Abortion could still be discussed with patients, but only physicians or clinicians with advanced training could have those conversations. All pregnant patients would have to be referred for prenatal care, whether or not they request it. Minors would be encouraged to involve their parents in family planning decisions.

Under the rule, facilities that provide family planning services as well as abortions would have to strictly separate finances and physical space.

Known as Title X, the family-planning program funds a network of clinics, many operated by Planned Parenthood affiliates. The clinics also provide basic health services, including screening for cancer and sexually transmitted diseases. The program distributes about $260 million a year in grants to clinics, and those funds cannot be used to pay for abortions.

The family planning rule is part of a series of Trump administration efforts to remake government policy on reproductive health to please conservatives who are a key part of its political base.

Other regulations tangled up in court would allow employers to opt out of offering free birth control to women workers on the basis of religious or moral objections, and grant health care professionals wider leeway to opt out of procedures that offend their religious or moral scruples.

Abortion is a legal medical procedure, but federal laws prohibit the use of taxpayer funds to pay for abortions except in cases of rape, incest, or to save the life of the woman.

Planned Parenthood is also the nation’s leading abortion provider, and abortion opponents see the family-planning money as a subsidy, even if federal funds cannot be used to pay for abortions.

Planned Parenthood is in the midst of a leadership upheaval, after its board abruptly ousted the organization’s president this week. Leana Wen, a physician, had sought to reposition Planned Parenthood as a health care provider. In her resignation letter, she said the organization’s board has determined the top priority should be to “double down on abortion rights advocacy.”



Source link

Competition to grow medical marijuana in Utah heats up


The wide metal barn on the Utah alfalfa farm owned by Russell and Diane Jones will host their youngest son’s wedding next month. By September, they hope the structure will be full of marijuana plants.

The Joneses are fourth-generation farmers, members of The Church of Jesus Christ of Latter-day Saints, and among 81 applicants for one of a handful of coveted spots as a licensed medical marijuana grower in conservative Utah.

Though leaders of their faith once opposed the bid to legalize medical marijuana, Russell Jones says he researched the drug’s pain-relieving benefits as he battled Hodgkin’s lymphoma. Now he and his wife want to be part of an emerging industry that some doubted would ever come to the state.

“This is groundbreaking for Utah,” Diane Jones said. “Who doesn’t want to make history?”

Others hoping to win licenses include larger operations that grow hemp, and a handful of out-of-state growers. State officials are expected to begin awarding up to 10 licenses later this month.

The state recently opened the licensing process to out-of-state growers, a change that makes locals like hemp processor Darren Johnson nervous.

“Does it bode well for me? No, but they want it to be seamless. They don’t want hiccups. And I get that,” he said.

Some applicants worry the process stacks the deck against local growers in favor of “Big Weed,” or companies that have successfully grown cannabis in other states where the crop is legal. The application requires a $2,500 fee, and submissions are hundreds of pages long. Those who get a license pay $100,000 every year to keep it, in addition to buying tools and facilities that can cost millions.

Department of Agriculture officials said they are awarding extra points to applicants with community ties as they review applications. Eight applications came from out-of-state growers. The state is looking for farmers able to expand operations as demand increases while keeping costs low and growing plants free of mold and pesticides.

At an indoor facility in North Salt Lake, Troy Young tends to rows of hemp plants under the harsh, purple glow of LED lights designed to nurture growth. Young grows industrial hemp, a nonpsychoactive cousin of marijuana legalized in Utah last year.

He is among a number of ambitious growers who have invested in equipment and set aside money hoping to receive a license to grow medical marijuana.

Cannabis in its various forms is challenging to grow and requires a lot of experimentation, he said.

“It’s fun for me. I get to be a mad scientist,” Young, 52, said. He has a personal stake in marijuana legalization. Young lost his mother to an opioid addiction. If she had access to a less destructive pain-relieving drug, like marijuana, he said, maybe she’d still be alive.

Marijuana has been shown to help ease chronic pain, and studies have suggested medical marijuana laws may reduce opioid prescribing.

“There’s a real need for it. It’s not just about the high,” Young said.

Johnson, the hemp processor, has a spacious warehouse in Salt Lake City with a team of technicians and equipment primed to grow medical marijuana. One room is filled with large beakers. Sticky hemp drips through paper filters and into the glass to extract CBD oil.

Hemp is his side business. Johnson works full-time in construction but views cultivating marijuana as a smart, long-term investment.

“Once (medical marijuana) becomes less taboo and people opt for that over an opiate-based drug, we’re going to see more demand and a stronger market,” he said.

Revenues from the state’s medical cannabis program are projected to reach $5.4 million in 2020 then grow to $16.2 million in 2021, said Richard Oborn, director of the state health department’s Center of Medical Cannabis.

Utah joined 33 states in legalizing medical marijuana after voters approved a new law last year.

Leaders of the state’s predominant faith originally opposed the push to ask voters to approve medical marijuana but eventually struck a compromise with some advocates to allow medicinal use of the drug with more regulation.

Whoever wins the state’s 10 grower licenses will have to grow the cannabis in Utah. The state also will choose licensed processors to make medical marijuana products to be sold in dispensaries expected to open next year.



Source link

US customs agents seize rat meat at Chicago's O'Hare Airport


Officials say U.S. Customs and Border Protection agents at Chicago’s O’Hare International Airport thwarted a man’s attempt to import several pounds of African rat meat.

Customs spokesman Steve Bansbach said Tuesday that the man declared the 32 pounds of meat on June 26 when his flight arrived from the Ivory Coast. The meat was confiscated and destroyed.

Bansbach says the man did not face a fine and continued on his journey because he was forthcoming about what he was bringing into the country. He says customs officials prohibit the entry of African meats to prevent the spread of African swine fever.

The Department of Agriculture says the highly contagious and deadly viral disease affects domestic and wild pigs and is not a threat to humans. The department says it has never been found in the U.S.



Source link

Justices won't revive Alabama ban on abortion procedure


The Supreme Court won’t revive Alabama’s attempt to ban the most commonly used procedure in second-trimester abortions after the measure was blocked by lower courts.

The justices on Friday rejected the state’s appeal and declined to review a lower court ruling that blocked the law. The 2016 Alabama law sought to ban the abortion procedure known as dilation and evacuation, a procedure Alabama referred to in court filings as “dismemberment abortion.”

Lower courts have blocked similar laws in Kansas, Oklahoma, Louisiana, Texas and Arkansas, but this was the first case to go before the Supreme Court, according to the American Civil Liberties Union, which challenged the Alabama law.

Court records show 93% of abortions in Alabama occur before 15 weeks of pregnancy. For the 7% of abortions that occur later, almost all are by dilation and evacuation.

Randall Marshall, executive director of the American Civil Liberties Union of Alabama, said the ban would have effectively ended access to second trimester abortions in Alabama if it had been allowed to take effect.

“We are not surprised by the Supreme Court’s decision to deny reviewing this case. In doing so, they are upholding the Supreme Court’s own precedent in protecting a woman’s right to access the healthcare she needs. A woman’s health, not Alabama politicians, should drive personal medical decisions,” Marshall said.

Planned Parenthood said the decision was a victory for abortion access in the state, but warned of the continuing push to enact new restrictions on abortion.

“This is a major victory for Alabamians and people everywhere. The courts have for now protected our constitutional right to access abortion. But the fight is far from over,” said Staci Fox, CEO and president of Planned Parenthood Southeast.

Justice Clarence Thomas, who supports overturning the Roe v. Wade decision that first declared abortion rights, did not dissent from the decision to pass on the Alabama case, but described the abortion procedure at issue as “particularly gruesome.”

“The notion that anything in the Constitution prevents States from passing laws prohibiting the dismembering of a living child is implausible,” Thomas said.

Alabama Attorney General Steve Marshall said he was disappointed in the court’s decision not to hear the Alabama case, and added “I believe that the day of reckoning for Roe is coming.”

“I am disappointed that the United States Supreme Court has decided not to hear Alabama’s appeal of a lower-court decision that invalidated our state law, enacted in 2016, prohibiting dismemberment abortion — a method of killing an unborn child that cannot be described in even the most clinical of terms to hide its monstrosity and gruesomeness,” the Alabama attorney general said.

Two Alabama abortion clinics and the ACLU had challenged the 2016 law in court.

U.S. District Judge Myron Thompson found the law was amount to a virtual ban on abortion in the state after 15 weeks of pregnancy. The 11th U.S. Circuit Court of Appeals affirmed Thompson’s ruling blocking the law, but two of the three judges on the panel said they voted to affirm only because they are bound by past Supreme Court decisions in support of abortion rights.

The state will now have to pay attorney fees to the ACLU and other plaintiff lawyers in the case.

The Friday decision comes as some conservative states are seeking to enact far-reaching restrictions on abortion.

Alabama lawmakers this year passed a law that would ban almost all abortions in the state, in the hopes of sparking a new court case that might prompt justices to revisit Roe. That near-total abortion ban, which is slated to take effect in November, is facing a challenge in court.

Marshall said the Friday decision on the procedure ban is perhaps a sign that justices, “are not ready to go in and make sweeping changes.”

The Supreme Court still is likely to hear an election year case involving abortion, a challenge to a Louisiana law that requires doctors who perform abortions to have admitting privileges at nearby hospitals. A district judge who barred the state from enforcing the law found it would close one or two of the state’s three abortion clinics.

The 5th U.S. Circuit Court of Appeals upheld the law and would have let it take effect pending a Supreme Court appeal. But the justices kept the law on hold in a 5-4 vote in February, pending a full review of the case.

Louisiana was among 21 states that urged the high court to hear the Alabama case. The other states, like Louisiana, have passed sweeping abortion restrictions, including an abortion ban as early as six weeks when a fetal heartbeat can be detected.

———

Chandler reported from Montgomery, Alabama.



Source link

WSOP review: Korea win a second series bracelet; Baris overcomes Cain online


Sejin Park became the second South Korean to win a World Series of Poker bracelet this series after taking down the COLOSSUS, and Nicholas Baris overcomes a 70% heads-up chip deficit to win a $1,000 No-Limit Hold’em event.

wsop-review-korea-win-a-second-series-bracelet-baris-overcomes-cain-online

[Image credit: WSOP]

On Monday, South Korea’s military sent fighter jets scurrying into the sky to investigate an ‘unidentified flying object’ flying near the North Korean border, a day after the North Korean leader Kim Jong-un met with the U.S. President, Donald Trump.

The military later told the South Korean press than the UFO was nothing more than a flock of 20 birds, but our sources at CalvinAyre.com inform us with some accuracy that the UFO was Sejin Park, who was still flying high after his victory in Event #61: COLOSSUS – $400 No-Limit Hold’em.

Park, a cash game grinder from Macau, was visiting the World Series of Poker (WSOP) for the first time when he flicked in the $400 and took down the $451,272 first-prize after conquering a field of 13,109-entrants. He becomes the first Korean to win a WSOP bracelet, in an open event, and the second of the series after Jiyoung Kim won the ladies event earlier this summer.

Speaking to PokerNews after his win, Park said that he didn’t expect much from this tournament given the size of the field, before thanking Kim, for supporting him on the rail, alongside his other buddy.

“I would talk strategy during the break with them, and it was a tremendous help,” said Park.

The most recognised face at the final table was Andrew Barber who won the $10,000 H.O.R.S.E Championship in 2015. Barber is an ambassador for Raising for Effective Giving (REG), the meta-charity created to reduce suffering in the world, but that didn’t stop him from suffering when he hit the rail in the fifth position.

To win the bracelet, Park had to overcome Georgios Kapalas in heads-up action. The South Korean began with a 2:1 chip lead, and used it to treat Kapalas like a pumpkin seed rolling around a mortar and pestle, grinding him down to nothing after Kd2c flopped trips when all-in against the slightly superior As3h.

Final table results

1. Sejin Park – $451,272
2. Georgios Kapalas – $278,881
3. Ryan Depaulo – $208,643
4. Juan Lopez – $157,106
5. Andrew Barber – $119,072
6. Norson Saho – $90,838
7. Patrick Miller – $69,757
8. Maksim Kalman – $53,925
9. Diego Lima – $41,965

Three other stars of the game who wore kimonos, pipes and slippers late into this thing were bracelet winners Jeremy Ausmus (35th), Nicholas Haynes (52nd) and Tom McEvoy (93rd).

Nicholas Baris wins Event #68: $1,000 WSOP.com ONLINE No-Limit Hold’em Championship.

The online fields at the WSOP continue to swell like teenage gums with Event #68: $1,000 WSOP.com ONLINE No-Limit Hold’em Championship pulling in a field of 1,750-entrants.

Two names stood out amongst the pack with David ‘Bakes’ Baker making his second final table of the series (he finished 5/996 in $2,500 No-Limit Hold’em), and the 2017 WSOP Player of the Year, Chris ‘Jesus’ Ferguson, also making his second final table after finishing 3/116 in the $10,000 Razz Championship (Ferguson played on his iPad whilst also competing in a $1,500 No-Limit Hold’em event).

Bakes and Ferguson may have the star power, but it was Tara Cain who looked the likeliest to win this thing for most of the final table. Cain has. World Series of Poker Circuit (WSOPC) online gold ring somewhere in her jewellery box, and in 2017, she finished runner-up to Thomas Cannuli in the 424-entrant $3,333 No-Limit Hold’em Online High Roller.

Cain would have been desperately trying to avoid a second crushing disappointment, especially when she began heads-up with Nicholas Baris, holding 70% of the chips in play. Poker can send you into North Korean airspace, but it can also drop you deep into graveyard silence, and that’s what happened to Cain, as Baris chipped away, doubling up with tens against ace-nine before queens beat nines for all the chips, all the chops and the bracelet.

Final table results

1. Nicholas “Illari” Baris – $303,738.75
2. Tara “bertperton” Cain – $187,530
3. William “TheBurrSir” Lamb Harding – $113,332.50
4. David “YoungPitts” Baker – $96,092.50
5. Jason “LuckDuck” Lawhun – $69,991.25
6. Jack “Mr. Yang” Maskill – $51,703.75
7. Chris “Camdi” Ferguson – $38,736.25
8. Ryan “PlzCumAgain” Jones – $29,260
9. Antonio “karma007” Guerrero – $22,443.75

Comments



Source link

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


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.

———

Follow Matthew Perrone on Twitter: @AP—FDAwriter

———

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.



Source link

Sex Education, Gambling and other News