Judge to rule if pharmacies must sell "Plan B" pills


TACOMA, Washington |
Wed Feb 22, 2012 2:24pm EST

TACOMA, Washington (Reuters) – A federal judge was expected to rule on Wednesday on whether Washington state can compel pharmacy owners to carry and sell the emergency contraceptive known as Plan B despite their personal religious objections to the drug.

The case stems from a lawsuit brought by a family-owned pharmacy and two licensed druggists claiming their constitutional rights to the free exercise of religion is violated by a state rule requiring pharmacies to stock and dispense all medications for which there is a demonstrated community need.

The rule at issue, adopted by the Washington State Pharmacy Board, includes emergency contraceptives, also known as the “morning-after” pill.

The pharmacists challenging the regulation object to being required to furnish the medication because of their view that it destroys human life, which they believe begins at conception.

Plan B, which is used to prevent pregnancy when taken within 72 hours of unprotected sexual intercourse, prevents ovulation and may interfere with implantation of a fertilized embryo on the uterine wall, according to the Food and Drug Administration.

Available by prescription since 1999, Plan B was approved as an over-the-counter emergency contraceptive for women aged 18 and older in 2006 by the FDA.

The state pharmacy board voted in 2006 to allow pharmacists who objected to dispensing Plan B for reasons of conscience to refer their customers to other drug stores that stock the pills.

But the rule was amended in 2007 to require druggists with religious qualms to find another pharmacist in the store who would dispense the medication, rather than sending the customer to another outlet.

Lawyers for plaintiffs claim the stricter rule was adopted under political pressure from Governor Christine Gregoire, a Democrat.

They also have noted that state regulations still allow pharmacies to refer customers to other stores under various non-religious business exemptions, such as low demand.

NATIONAL ATTENTION

The case in Tacoma, Washington, has potential national implications as a test of the broader objections raised by some healthcare providers to providing certain kinds of medical treatment or drugs on religious grounds.

That issue has been at the heart of a highly charged debate over a provision in the 2010 U.S. healthcare overhaul act mandating free contraception coverage in employer-based health plans.

The Obama administration has exempted houses of worship from the rule but requires birth control coverage to be made available to employees of religiously affiliated organizations such as hospitals and universities, a mandate opposed by the Roman Catholic Church.

U.S. District Judge Ronald Leighton issued an injunction barring enforcement of the pharmacy board’s 2007 rule, siding with plaintiffs in finding that it would infringe on their religious freedom.

But the 9th U.S. Circuit Court of Appeals overruled Leighton in 2009, saying he applied the wrong legal standard. The appeals court said the rule appeared to pass constitutional muster because it did not single out the practice of religion but was rather aimed at increasing access to all prescribed medicines.

Late last year, Leighton held a trial to hear further testimony and legal arguments in the case, and indicated he would rule in such a way as to set the stage for further review of the matter by higher courts.

(Additional reporting by Laura L. Myers; Writing by Steve Gorman; Editing by Dan Burns)

Article source: http://feeds.reuters.com/~r/reuters/healthNews/~3/8qv5lHPI0Zk/us-usa-contraceptives-court-idUSTRE81K24W20120222

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Supreme Court sends back California Medicaid cuts case


WASHINGTON |
Wed Feb 22, 2012 12:55pm EST

WASHINGTON (Reuters) – The Supreme Court sent back to a lower court a case on whether Medicaid recipients and medical providers can sue California for cutting reimbursement rates in the healthcare program for low-income Americans.

The high court said on Wednesday that after it heard oral arguments in the case on October 3, federal government officials approved the state’s statutes as consistent with federal law.

Justice Stephen Breyer said in the majority opinion the case was sent back to a U.S. appeals court based in California to determine whether the recipients and providers may sue in light of the changed circumstances of the federal government’s approval.

In sending the case back, the justices set aside a ruling by the appeals court that had blocked the cuts for violating federal law.

The case involved a plan by California’s lawmakers in 2008 to slash Medicaid payments to doctors, hospitals and other medical providers to help reduce the state’s massive budget deficit.

The providers sued to stop the cuts from taking effect on the grounds it would violate federal law. The cash-strapped state said the cuts of up to 10 percent would save more than $700 million.

The state and the Obama administration argued that only the U.S. government can enforce the federal law and private citizens have no right to sue.

The Supreme Court cases are Douglas v. Independent Living Center, 09-958, Douglas v. California Pharmacists Association, No. 09-1158 and Douglas v. Santa Rosa Memorial Hospital, No. 10-283.

(Reporting By James Vicini; Editing by Tim Dobbyn)

Article source: http://feeds.reuters.com/~r/reuters/healthNews/~3/QJ_AvI_94no/us-usa-court-medicaid-idUSTRE81L1M620120222

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More troops on smokeless tobacco after deployment


NEW YORK |
Wed Feb 22, 2012 12:39pm EST

NEW YORK (Reuters Health) – U.S. troops sent to Iraq or Afghanistan are more likely to start a smokeless tobacco habit than their comrades who stay home — especially if they see combat, a new study finds.

The findings, reported in the journal Addiction, follow other studies that have tied deployment and combat to health risks, including higher rates of smoking and drinking.

“This adds to the list of things we’re learning are associated with combat,” said lead researcher Dr. Eric D.A. Hermes, of the Yale University School of Medicine in New Haven, Connecticut.

It’s not fully clear why some troops take up smokeless tobacco after deployment. But Hermes suspects stress is involved.

That’s because deployment with combat exposure was linked to a higher risk than deployment alone. And troops with symptoms of post-traumatic stress disorder (PTSD) also had an increased risk.

The findings come from the Millennium Cohort Study, an ongoing government project looking at the health effects of military service.

Of more than 45,000 personnel followed from 2001 to 2006, 2 percent started using smokeless tobacco during that time. Another 9 percent had already developed the habit, and kept it up.

Overall, troops who were deployed but did not see combat were almost one-third more likely to take up a smokeless tobacco habit than their non-deployed counterparts. Those odds were two-thirds to three-quarters higher for troops who were in combat or who deployed multiple times.

According to Hermes, those different levels of deployment can be seen as stand-ins for different levels of stress.

So it’s possible that stress plays a role, he said.

Another finding gives weight to that idea. “We also saw a relationship with PTSD symptoms,” Hermes said.

Just under 4 percent of all troops had PTSD symptoms, based on a standard questionnaire. And they were 54 percent more likely to start using smokeless tobacco than troops without symptoms, Hermes and his colleagues found.

There are other factors that, along with stress, might push some deployed troops toward tobacco, according to Hermes.

“You’re not at home, you have more exposure to smokeless tobacco, you’re around more people doing it,” Hermes said. “Maybe it’s all these little things coming together.”

MILITARY TOBACCO USE STILL HIGH

Past studies have found that while tobacco use in the military is declining, it’s still higher when compared to the U.S. public as a whole. In 2005, almost 15 percent of military personnel said they’d used smokeless tobacco in the past year — versus just three percent of Americans overall.

“Smoking is the thing that everyone talks about,” Hermes said. “But there’s also smokeless tobacco, and it seems to be related to the stress of combat.”

Whether some troops are “treating” their stress with tobacco, or whether the tobacco somehow feeds the stress is not entirely clear, according to Hermes. “There’s still a chicken-and-egg question,” he said.

But the findings suggest that doctors treating military personnel should ask not only about smoking habits, but any use of the smokeless forms of tobacco, Hermes said.

Tobacco products are widely available at U.S. military bases. A 2009 study commissioned by the Pentagon and the Department of Veterans Affairs recommended a phased-in ban on tobacco on military property. But whether that will ever happen remains up in the air.

SOURCE: bit.ly/yHczjq Addiction, online January 23, 2012.

Article source: http://feeds.reuters.com/~r/reuters/healthNews/~3/k7YW6zAw6_M/us-troops-smokeless-idUSTRE81L1KZ20120222

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Gender "non-conformity" tied to abuse: study


Tue Feb 21, 2012 7:36pm EST

(Reuters) – Girls who dress or act like boys, and boys who act more feminine, may be more likely to be abused and end up with post-traumatic stress disorder, according to a U.S. study.

Researchers whose findings appeared in Pediatrics said that parents or other adults who are uncomfortable with so-called gender non-conformity may treat children differently, sometimes violently, or be convinced they can change their feelings and behavior.

“In some cases, they believe they’re helping the child, that gender non-conforming won’t be accepted by other people,” said Andrea Roberts, from the Harvard School of Public Health in Boston, who worked on the study.

“But of course, abuse is never protective.”

Roberts and her colleagues analyzed data from a long-term study on children and teens that looked at more than 16,000 children, who recalled their favorite toys, roles they took on during play, and feelings of femininity or masculinity at age 11.

The participants were also asked about instances of abuse — from kicking and grabbing, to threatening, to forced sexual contact — that happened either before that time or during their adolescent years.

The researchers found that children who were the most gender non-conforming were between 40 percent and more than twice as likely to report any kind of childhood abuse as those who did confirm to typical gender roles.

They also reported more symptoms of PTSD, which include jumpiness, trouble sleeping and flashbacks.

Roberts said that while the findings can’t prove that parents abused boys because they acted like girls, and vice versa, the study did hint that gender non-conformity in younger children predicted abuse during the teenage years.

A separate study that also appeared in Pediatrics reported on the experience of doctors from Children’s Hospital Boston in treating 97 children and teens with gender identity disorder. This disorder goes beyond not conforming to gender norms and includes children who are very bothered by their physical gender and identify as the opposite sex.

Forty-three of those treated at the Children’s Hospital clinic had a history of psychiatric problems, including 20 who had self-harmed and nine that had attempted suicide.

Researchers pointed out that in children who are already going through puberty and are serious about treatment to switch to the opposite gender, intervening at an early stage can keep them from developing secondary sex characteristics like facial hair and breasts, which may head off some of their distress.

“If the kid is unhappy, depressed, troubled about their own body, that’s probably (a sign) the parents could use some help,” said Roberts.

She added that while adopting some opposite-gender behavior is relatively common, far fewer children will be seriously bothered by their gender — possibly about 1 in 1,000, though researchers don’t have a full grasp of the extent of gender identity disorder in children.

Those are the children who may be at the highest risk of abuse and psychological problems, researchers said, adding that the most important thing for non-conforming children, including those who are seriously questioning their own gender, is to get support from their families and schools. SOURCES: bit.ly/xm2tBB and bit.ly/xyRShP

(Reporting from New York by Genevra Pittman at Reuters Health,; editing by Elaine Lies)

Article source: http://feeds.reuters.com/~r/reuters/healthNews/~3/wCV7k7brA9o/us-abuse-gender-idUSTRE81L02720120222

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Johnson & Johnson CEO Weldon to step down in April


NEW YORK |
Tue Feb 21, 2012 7:33pm EST

NEW YORK (Reuters) – Johnson Johnson Chief Executive William Weldon will step down from his post in April after a series of recalls called into question the quality of the healthcare giant’s products, from artificial hips to infant Tylenol.

Weldon, 63, will remain chairman, the company said on Tuesday. He has held both roles for nearly 10 years, after three decades spent working his way through the company from his first job as a sales representative at JJ’s McNeil consumer division.

Vice Chairman Alex Gorsky, 51, will become CEO at the next board meeting on April 26, making him the ninth person to lead the company since JJ’s founding in 1886.

Under Weldon’s tenure, JJ expanded a sprawling business comprising more than 250 companies, from prescription drugmakers to a medical devices division and units that make personal care products.

JJ shares are up less than 2 percent since Weldon took over a decade ago, but have recovered about 14 percent since August 2010 when the company was mired in product recalls.

In the past two years, the company that long prided itself on a credo of high quality has seen its reputation tarnished by massive recalls for products that were poorly manufactured or failed at a higher-than-expected rate.

“Gorsky is inheriting a company with a better pharmaceutical pipeline than it had 5 or 6 years ago,” Morgan, Keegan Co analyst Jan Wald said. “He is inheriting a consumer division that’s still embroiled in problems and he is getting a medical device business that he needs to refresh and restructure and get it to grow again.”

“He’s got a lot of work to do and it is going to be very hard to affect anything in the short-term,” Wald said.

The quality control problems at JJ’s McNeil consumer healthcare unit — which makes over-the-counter medicines like painkillers Tylenol and Motrin — were deemed so pervasive that U.S. health regulators took over supervision of three manufacturing plants in March.

Under a consent decree that the McNeil unit was forced to enter into, the U.S. government will oversee those errant plants for at least five years, an independent expert was retained to inspect manufacturing facilities and the U.S. Food and Drug Administration can levy fines up to $10 million annually if it feels the agreement has been violated.

The consumer products recalls cost the company nearly $1 billion in 2010 sales.

Last month, the company said it would take a $3 billion charge, mostly to cover costs for its recall of metal artificial hips by its DePuy Orthopedics unit. The company also had to recall contact lenses, heart devices, such as stents, and insulin pump cartridges.

The latest trouble came just last Friday, when JJ recalled the entire U.S. supply — 574,000 bottles — of its infant Tylenol soon after the product had returned to pharmacy shelves.

Weldon was called before Congress in late 2010 to address the recalls, including an incident in which JJ hired contractors to pose as customers and buy defective bottles of Motrin at drugstores rather than alert the general public.

“This was not one of our finer moments,” Weldon said at the time.

TWO-WAY RACE

Gorsky is the latest in a long line of CEOs to come from within the company, although he left in 2004 for a four-year stint as Novartis’ head of pharmaceuticals in North America before returning to JJ.

“Any time you change the hand at the tiller, it’s liable to liven things up a bit,” said Piper Jaffray analyst Matt Miksic.

Miksic said he does not expect to see great rapid changes, but added, “resolution of the succession question and an energized new CEO rising to the challenge is a good thing for the company.”

Gorsky began his JJ career in 1988 as a sales representative with the Janssen Pharmaceutica unit. In 2001, he was appointed president of Janssen, and in 2003, Gorsky became group chairman of Johnson Johnson’s pharmaceuticals business in Europe, the Middle East and Africa. After returning to the JJ fold he became global chairman of the Surgical Care Group.

Investors had expected Weldon would be succeeded by Gorsky or co-Vice Chairman Sheri McCoy, who were promoted to the shared post in December 2010. McCoy will report to Gorsky and continue to lead the company’s pharmaceuticals and consumer groups.

JJ’s planned $21 billion purchase of Swiss medical device maker Synthes, its largest ever, may have helped tip the decision in Gorsky’s favor, some said.

“Medical devices has now become their biggest division by sales and earnings and is going to be even bigger when the Synthes deal closes, and that’s obviously Alex Gorsky’s background,” said Jeff Jonas, co-portfolio manager for the Gabelli Healthcare and Wellness Trust, which holds JJ stock.

Jonas said he’d like to see JJ buy back more of its stock going forward, a move not likely before the company closes on the Synthes deal. JJ shares were nearly unchanged after the announcement.

He noted that JJ has new promise with a pipeline of medicines including blood clot preventer Xarelto, developed with Bayer AG, and prostate cancer drug Zytiga.

“He’s done a good job for most of the business but obviously the consumer business is sort of a big black eye,” Jonas said of Weldon. “He chose good managers.”

(Additional reporting by Anand Basu in Bangalore and Susan Kelly in Chicago; Editing by Richard Chang, Bernard Orr, Phil Berlowitz)

Article source: http://feeds.reuters.com/~r/reuters/healthNews/~3/H0FJqL1BZwk/us-johnsonjohnson-idUSTRE81K1YO20120222

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