Healthcare News and Research

[Kobi]

(Reuters) - Boston Scientific Corp on Monday was set to face its first federal trials in two courts over claims from women who say they were injured by the company’s transvaginal mesh devices.

One, in Charleston, West Virginia, involves allegations from four women over the company's Obtryx device, used to treat stress urinary incontinence. The other, in Miami, concerns women implanted with the Pinnacle, which treats pelvic organ prolapse.

Boston Scientific has been hit with more than 23,000 suits in U.S. state and federal courts over the devices in the six years since concerns were first publicly raised over the devices. Federal cases against it and six other companies have been consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.

Since then, transvaginal mesh has become one of the most sued-over medical devices in U.S. history. Goodwin has said he'll resort to creative tactics, like grouping similar plaintiffs for trial, to keep the cases from dragging on for decades, as litigation for other mass torts like asbestos and tobacco did.

It won't be easy. Together, the three biggest defendants - Boston Scientific, Johnson & Johnson's Ethicon Inc unit and C.R. Bard Inc - face more than 72,000 claims in federal and state courts, according to the companies' regulatory filings.

The U.S. Food and Drug Administration in April said it was considering requiring the makers of products used to treat pelvic organ prolapse to submit additional safety data to remain on the market.

Plaintiffs say the devices were poorly designed, made from substandard material and can lead to injuries ranging from infection and pain to bleeding and nerve damage.

Ethicon and Boston Scientific have both denied liability and said in statements to Reuters that they believe mesh is an important treatment option. C.R. Bard declined to comment.

The nine cases that have gone to trial so far, against Boston Scientific, Ethicon and C.R. Bard, have produced mixed results, with defendants winning some and plaintiffs others. One company, Endo International’s American Medical Systems, announced recently that it would set aside $1.6 billion to settle “substantially all” mesh claims.

The three trials faced by Boston Scientific in state courts have also led to varying outcomes. Two cases in Massachusetts resulted in wins for the company, while a third in Texas ended with a $73 million verdict for the plaintiff, which was later reduced to $34 million under a state law capping damages.

The group trials starting Monday are part of Goodwin's plan to speed up the cases' progress. He has also ordered Boston Scientific and C.R. Bard to each prepare hundreds of cases for trial in courts across the United States starting as early as next year.

While Goodwin originally scheduled a series of single-plaintiff bellwether, or test, trials for the federal litigation, he scrapped those plans earlier this year and instead consolidated claims from multiple women into a single trial. Doing so, he said, would help save courts' time and resources, and “may facilitate settlement” by giving Boston Scientific and plaintiffs a clearer picture of the strengths and weaknesses of their cases.

While not unprecedented, it is unusual for personal-injury cases involving medical devices to proceed with more than one plaintiff at a time, given that individuals may have different medical histories and product experiences.

Boston Scientific fought vigorously against the consolidated trial plan, saying in court filings that each woman’s issues would be obscured by the group setting and prejudice jurors against the company.

A company spokeswoman, Kelly Leadem, declined to comment specifically on the litigation but said in a statement that Boston Scientific is committed to patient safety.

Several plaintiffs’ lawyers for the women headed to trial Monday did not return requests for comment.

Fidelma Fitzpatrick, an attorney at Motley Rice who has represented plaintiffs in other mesh trials against Boston Scientific and Ethicon, said the outcome from the group trials could help Boston Scientific and plaintiffs move closer to a resolution.

“I think that Goodwin has been working hard to try to find an end game for this litigation,” Fitzpatrick said. “The reality is, one case at a time when you’re trying four or five cases a year against a manufacturer isn’t enough to truly put pressure on the defendants."

https://ca.news.yahoo.com/boston-sci...--finance.html

[SleepyButch]

A third of Fortune 500 companies now cover transgender health care

A new report highlights dramatic changes in how corporations treat trans employees.

By Liz Goodwin


The number of Fortune 500 companies willing pay for sex reassignment surgeries and other transgender-related healthcare has gone from zero in 2002 to 169 this year, according to a new report from the Human Rights Campaign.


The report, which ranks corporations on their treatment of gay, lesbian, bisexual and trans employees, also found that more than half of corporations with more than 500 employees that participated in the survey now cover the procedures. That’s 418 firms.

Some of the biggest names in corporate America are among those who have signed up to cover the procedures, at up to $75,000 per employee. Facebook Inc., Visa, Starbucks Corp., CVS Health Corp. and Anheuser-Busch Companies Inc. are just some of the firms that decided this year to begin covering the procedures for their workers for the first time.

“The jump in terms of employers adopting transgender benefits has been the most dramatic of any single aspect of the Corporate Equality Index in its entire history,” said Deena Fidas, the director of the Human Rights Campaign’s Workplace Equality Program, which has been producing the report for more than a decade.

Ratings in the Corporate Equality Index are derived from a look at five major areas, including: recruiting efforts, whether firms have explicit gender identity and sexual orientation anti-discrimination protections, and if they have extended health care and other benefits to same-sex partners.

While the vast majority of Fortune 500 companies now have nondiscrimination policies that explicitly protect employees from being fired for their gender identity or orientation, companies have moved much more slowly when it comes to covering transgender health care

“Across a lot of the businesses, very well-meaning people were quite anxious about these benefits,” Fidas said. “They wondered if there’d be murmurings among the workforce.”

It took many “uphill conversations” to convince some big employers that transition-related health care is not elective or cosmetic for transgender people, Fidas said.

Such health care can include: sex reassignment surgery, breast augmentation or mastectomy, hormone therapy, short-term leave and counseling.

The vast majority of health insurance plans explicitly ban the coverage of any transition-related care, grouping those procedures with elective cosmetic surgery.

This has slowly begun to change as mainstream medical organizations, including the American Medical Association, have announced new positions in recent years stating that sex reassignment surgery is not elective for some transgender people. (The American Medical Association said in 2008 that “gender dysphoria” is a “serious medical condition” that can result in “suicidality and death” without proper treatment.)

“Transition-related care is absolutely essential to trans people who are seeking to be themselves,” said Lisa Mottet, deputy executive director of the National Center for Transgender Equality. “In many cases, this care is actually life-saving.”

Not every transgender person wants surgery, but having it as an option is crucial, she said.

Some state officials are also beginning to move in that direction. Eight states have banned insurance companies from explicitly excluding surgeries for transgender people, and a handful of states even offer coverage for the procedures through Medicaid.

The Human Rights Campaign says that businesses that have decided to provide the care have not had to increase insurance premiums. The cost has been “so small it’s not quantifiable,” Fidas said. That might be in part because so few people in the country are transgender. The Williams Institute at UCLA estimates the transgender population at one third of one percent.

“There’s not one number that will tell you how many people are transgender in corporate America,” Fidas said. “We’re on the brink of seeing more people being able to be visible in their jobs and to be able to be more open about the fact that they’re transgender.”

Nancy Kelly, the director of compensation and benefits at the Federal Reserve Bank of Atlanta, said larger companies can no longer remain competitive if they are not offering transgender benefits. The bank decided this year to begin to cover transition-related health care services as of Jan 1. Kelly said she is not sure if any of the bank’s 1,200 employees are transgender or will want to access the new benefits when they become available. The Federal Reserve banks of Boston, Cleveland and Richmond also decided to offer the benefits this year.

“It was not a particular employee request, it was more about diversity and inclusion and being a competitive employer,” Kelly said.

A CVS spokeswoman said the company changed its health coverage to include sex reassignment surgery to "provide all colleagues with meaningful choices regarding their health care."


http://news.yahoo.com/a-third-of-for...142740785.html

[*Anya*]

Lisa Kaplan Gordon

A common antimicrobial agent called triclosan causes liver fibrosis and cancer in laboratory mice through mechanisms also relevant to humans, researchers at the University of California, San Diego School of Medicine have found

Triclosan's broad use in consumer goods -- including liquid hand soaps, toothpastes, shampoos, cosmetics, plastics, yoga mats, cutting boards and ice cream scoops -- presents "a very real risk of liver toxicity for people, as it does in mice," said Robert H. Tukey, a UC-San Diego professor and co-author of the study, published Monday in Proceedings of the National Academy of Sciences.

Triclosan, a synthetic, broad-spectrum antibacterial chemical, is coming under fire because of its links to endocrine disruption that could cause infertility, impaired muscle function and now increased cancer risks.

It's All Around

The UC-San Diego study showed that mice exposed to triclosan for six months (roughly equivalent to 18 human years) had more and larger chemical-induced liver tumors than mice not exposed to the antimicrobial. Researchers believe triclosan may interfere with the protein responsible for detoxifying foreign chemicals in the body, thereby causing liver cells to proliferate and, over time, become cancerous tumors.

Studies have found traces of triclosan in 97 percent of breast milk samples from lactating women and in the urine of nearly 75 percent of people tested, according to a statement by UC San Diego Health System. Triclosan is also one of the seven most frequently detected compounds in streams across the United States, the statement says.

"We could reduce most human and environmental exposures by eliminating uses of triclosan that are high-volume, but of low-benefit, such as inclusion in liquid hand soaps," said Bruce D. Hammock, professor at University of California, Davis. "Yet we could also for now retain uses shown to have health value -- as in toothpaste, where the amount used is small."

Colgate-Palmolive (CL) recently came under fire because its Total toothpaste contains triclosan. A recent Care2 petition, asking Colgate to remove triclosan from its toothpaste, so far has received almost 68,000 signatures.

Triclosan is already under scrutiny by the U.S. Food and Drug Administration. On its website, the FDA says, "Triclosan is not currently known to be hazardous to humans. But several scientific studies have come out since the last time FDA reviewed this ingredient that merit further review."

http://www.dailyfinance.com/2014/11/...ew-study-says/
__________________________________________________ ______________

National Biomonitoring Program

Triclosan

Triclosan is a chemical with antibacterial properties. For more than 30 years, it has been used in consumer products such as detergents, soaps, skin cleansers, deodorants, lotions, creams, toothpastes, and dishwashing liquids. Triclosan can be added to other materials, such as textiles, to make them resistant to bacterial growth.

How People Are Exposed to Triclosan
People may be exposed to triclosan when they use consumer products containing triclosan. When using these products, a person can absorb small amounts of triclosan through the skin or the mouth.

How Triclosan Affects People's Health
The human health effects from exposure to low environmental levels of triclosan are unknown. Skin products containing triclosan rarely have caused irritation. More research is needed to assess the human health effects of exposure to triclosan.

Levels of Triclosan in the U.S. Population
In the Fourth National Report on Human Exposure to Environmental Chemicals (Fourth Report), CDC scientists measured triclosan in the urine of 2,517 participants aged six years and older who took part in the National Health and Nutrition Examination Survey (NHANES) during 2003–2004. By measuring triclosan in urine, scientists can estimate the amount of triclosan that has entered people's bodies.

Triclosan was detected in the urine of nearly 75% of the people tested.

Finding measurable amounts of triclosan in urine does not imply that the levels of triclosan cause an adverse health effect. Biomonitoring studies on levels of triclosan provide physicians and public health officials with reference values so that they can determine whether people have been exposed to higher levels of triclosan than are found in the general population. Biomonitoring data can also help health scientists plan and conduct research on exposure and health effects.

http://www.cdc.gov/biomonitoring/Tri...FactSheet.html

Additional Resources

Environmental Protection Agency Triclosan Facts

http://www.epa.gov/oppsrrd1/REDs/fac...iclosan_fs.htm

[*Anya*]

Yale researchers reverse type 2 diabetes and fatty liver disease in rats

By Ziba Kashef

February 26, 20

Yale researchers developed a controlled-release oral therapy that reversed type 2 diabetes and fatty liver disease in rats, according to a study published on Feb. 26 by Science.

Existing therapies for type 2 diabetes, and the closely associated conditions of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), have had limited success at treating the root causes of these diseases.

Building on earlier research, the Yale team — led by Dr. Gerald I. Shulman, the George R. Cowgill Professor of Physiological Chemistry, and professor of medicine and cellular & molecular physiology at Yale School of Medicine — decided to investigate whether an agent that had originally been used for weight loss more than 70 years ago could be reformulated to safely treat NAFLD/NASH and type 2 diabetes in rodent models of these diseases.

Based on their earlier studies, the researchers determined that toxicity associated with the agent — mitochondrial protonophore 2,4-dinitrophenol (DNP) — was related to its peak plasma concentrations. They discovered that DNP’s efficacy in reducing liver fat and liver inflammation could be achieved with plasma concentrations that were more than a 100-fold less than the toxic levels.

“Besides reversing fatty liver disease in a rodent model of NALFD, a low-dose intragastric infusion of DNP that was 100-fold lower than toxic levels also significantly reduced blood glucose, triglyceride, and insulin concentrations in a rodent model of NAFLD and type 2 diabetes”, said Shulman, who is also an investigator with the Howard Hughes Medical Institute.

In the next phase of the study, Shulman and his team developed a new oral, controlled-release form of DNP, known as CRMP, which maintained the drug at concentrations that were more than a 100-fold lower than the toxic threshold. Administered once daily, CRMP delivered similar positive results, reversing fatty liver, insulin resistance, and hyperglycemia in rat models of NAFLD and type 2 diabetes, as well as liver inflammation and liver fibrosis in a rodent model of NASH, with no adverse effects.

“Given these promising results in animal models of NAFLD/NASH and type 2 diabetes we are pursuing additional preclinical safety studies to take this mitochondrial protonophore approach to the clinic” said Shulman.

Other Yale authors include Rachel J. Perry, Dongyan Zhang, Xian-Man Zhang, and James L. Boyer.

This research was supported by grants from the National Institutes of Health (R01 DK-40936, R24 DK-085638, U24 DK-059635, T32 DK-101019, P30 DK-45735, P30 DK-34989 and UL1 TR-000142) and the Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.

Citation: Science

http://news.yale.edu/2015/02/26/yale...r-disease-rats

[*Anya*]

HealthDay News -- A new study finds that treating moderate to severe depression with antidepressants may have an added bonus: reducing cardiovascular risks.

People who took antidepressants alone had a 53% lower risk of death, coronary artery disease, and stroke over three years than those who did not take antidepressants or statins, according to Heidi May, PhD, MSPH, a cardiovascular epidemiologist at the Intermountain Medical Center Heart Institute in Salt Lake City. She and colleagues analyzed health data from 5,311 people in Utah with moderate to severe depression.

Taking a statin, either alone or with antidepressants, did not significantly reduce the risk, the researchers found. The level of depression appeared to be key, May said in an ACC news release. Although antidepressant therapy didn't seem to boost the heart health of people with little or no depression, it did have an effect on those with more serious depression.

The study couldn't prove that the use of antidepressants helped cause a lowering of cardiovascular risks. However, depression is a known risk factor for heart disease, May said.

Her team also did not examine how antidepressants might prevent heart disease. But May theorized that as depressive symptoms ease, people's behaviors might change in ways that help their hearts.

"For example, people who are having depressive symptoms may not be as inclined to exercise, practice good health habits, or comply with health advice," she said. "Using an antidepressant to reduce depressive symptoms might also help people better take care of their heart health."

The findings are scheduled to be presented March 15 at the annual meeting of the American College of Cardiology (ACC), held from March 14 to 16 in San Diego.

http://www.clinicaladvisor.com/treat...rticle/402142/

[*Anya*]

The fight over Medicaid funding for Planned Parenthood moved to Texas this week.

Three days after Gov. Greg Abbott announced his decision to end Medicaid funding for Planned Parenthood, state health department investigators showed up on Thursday at Planned Parenthood health centers in Houston, Dallas, San Antonio and Brownsville with orders to turn over thousands of pages of documents, including patients’ records and employees’ home addresses and telephone numbers.

Some, but not all, of the extensive records sought by the state related specifically to abortion.

For example, Planned Parenthood South Texas was told to produce five years of records — whether electronic, paper or ultrasound — concerning any patients billed to Medicaid who had an abortion in which any part of the fetus was removed or preserved for research use. Planned Parenthood Gulf Coast was to turn over a complete copy of certain patients’ records, including doctors’ orders, nursing notes and lab tests, as well as the center’s appointment books, patient sign-in sheets and contracts.

“We’re concerned about the breadth and depth of what they’re asking for,” said Sarah Wheat, a spokeswoman for Planned Parenthood of Greater Texas.


Rest of article found at:

http://www.nytimes.com/2015/10/24/us...-abortion.html

[*Anya*]

Health | Thu Nov 12, 2015 4:40am ESTRelated: HEALTH
U.S. maternal mortality rate is twice that of Canada: U.N
GENEVA | BY TOM MILES

Women are twice as likely to die from causes related to pregnancy or childbirth in the United States than in Canada, a new global survey of maternal mortality published by the United Nations and the World Bank showed on Thursday.

The United States was also one of only 13 countries to have worse rates of maternal mortality in 2015 than in 1990 - a group that also includes North Korea, Zimbabwe and Venezuela.

The survey, led by the World Health Organization, aims to track progress against the U.N. Millennium Development Goals. It estimated there would be 303,000 maternal deaths globally this year, down from 532,000 in 1990.

The U.N. target is to get the global average number of maternal deaths below 70 per 100,000 live births by 2030, with no country averaging worse than 140.

The United States and other developed countries are already far ahead of the target, but the U.S. average has slipped from 12 deaths to 14 per 100,000 live births over the past 25 years, while Canada's is where it was in 1990, at seven.

Over the same period Belarus has cut its maternal death rate from 33 to four, making it one of the safest places to have a baby, just behind the world leaders - Iceland, Finland, Poland and Greece - where only three mothers die for every 100,000 births.

The world average is 216 deaths, ranging from 12 in rich countries to 546 in sub-Saharan Africa.

http://www.reuters.com/article/2015/...zC0OG4OzBic.97