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After roughly 40 years, U.S. health regulators are seeking data to see if the cocktail of ingredients in antiseptics used in hospitals, clinics and nursing homes are as safe and effective as they were once considered.

The Food and Drug Administration said on Thursday it is asking manufacturers for more data, including on absorption, potential hormonal effects and bacterial resistance of thehe 'active' ingredients in antiseptics, to see if they are still appropriate for use in a health care setting.

Since the review of health care antiseptics in the 1970s, things have changed, the FDA noted, alluding to a shift in frequency of use, hospitals' infection control practices, technology and safety standards. (1.usa.gov/1EUrzCd)

An independent panel of experts to the FDA raised similar concerns last year. In 2013, the regulator issued a warning to manufacturers, saying it was aware of at least four deaths and multiple infections caused by over-the-counter antiseptics. (1.usa.gov/1DNxOSp)

Commonly used active ingredients in health care antiseptics include alcohol and iodine. Data suggests that, for at least some of these ingredients, the systemic exposure is higher than previously thought, the agency noted.

"We're going to try to answer their questions in great detail as called for, but we believe the FDA already has sufficient data on these products," said Brian Sansoni, a spokesman for American Cleaning Institute (ACI), a trade association for the cleaning products industry.

The FDA said no health care antiseptics were going to be pulled off shelves as of now, and that their review excluded home-use antiseptics such as antibacterial soap and hand sanitizers.

The new data request relates only to health care antiseptics covered by the over-the-counter monograph, a kind of "recipe book" covering acceptable ingredients, doses, formulations and labeling. Once a final monograph is implemented, companies can market their product without having to go through the FDA.

Companies will have one year to submit the data, which the FDA will evaluate before determining if the OTC monograph needs to be revised.

"We're concerned if the FDA takes maybe a too narrow view regarding the safety and effectiveness data – depending how the final rule ends up – they could take effective products or ingredients off the shelves," Sansoni said.

Medicine has changed a lot in the past 100 years. But medical training hasn't — until now. Spurred by the need to train a different type of doctor, some top medical schools around the U.S. are tearing up the textbooks and starting from scratch.

Most medical schools still operate under a model pioneered in the early 1900s by an educator named Abraham Flexner.

"Flexner did a lot of great things," says Dr. Raj Mangrulkar, associate dean for medical student education at the University of Michigan Medical School. "But we've learned a lot and now we're absolutely ready for a new model."

Michigan is one of many med schools in the midst of a major overhaul of their curricula.

For example, in a windowless classroom, a small group of second-year students is hard at work. The students are not studying anatomy or biochemistry or any of the traditional sciences. They're polishing their communication skills.

In the first exercise, students paired off and negotiated the price of a used BMW. Now they're trying to settle on who should get credit for an imaginary medical journal article.

"I was thinking, kind of given our background and approach, that I would be senior author. How does that sound to you?" asks Jesse Burk-Rafel, a second-year student from Washington state.

His partner, also a second-year student, objects; he also wants to be senior author. Eventually they agree to share credit, rotating whose name comes first on subsequent papers related to the imaginary research project.

It may seem an odd way for medical students to be spending their class time. But Dr. Erin McKean, the surgeon teaching the class, says it's a serious topic for students who will have to communicate life and death matters during their careers.

"I was not taught this in medical school myself," says McKean. "We haven't taught people how to be specific about working in teams, how to communicate with peers and colleagues and how to communicate to the general public about what's going on in health care and medicine."

It's just one of many such changes, and it's dramatically different from the traditional way medicine has been taught. Flexner's model is known as "two plus two." Students spend their first two years in the classroom memorizing facts. In their last two years, med students shadow doctors in hospitals and clinics. Mangrulkar says Flexner's approach represented a huge change from the way doctors were taught in the 19th century.

"Literacy was optional, and you didn't always learn in the clinical setting," he says. Shortly after Flexner published his landmark review of the state of medical education, dozens of the nation's medical schools closed or merged.

But today, says Mangrulkar, the two-plus-two model doesn't work. For one thing, there's too much medical science for anyone to learn in two years. And the practice of medicine is constantly in flux.

What Michigan and many other schools are trying to do now is prepare future doctors for the inevitable changes they'll face throughout a long career.

"We shouldn't even try to predict what that system's going to be like," he says. "Which means we need to give students the tools to be adaptable, to be resilient, to problem-solve — push through some things, accept some things, but change other things."

One big shift at many schools is a focus on how the entire health system works — rather than just training doctors how to treat patients.

Dr. Susan Skochelak, a vice president with the American Medical Association, is in charge of an AMA project that is funding changes at 11 schools around the country. She says the new teaching focus on the health care system has had an added benefit: Faculty members are learning right along with the students about some of the absurdities.

For example, she says, only because they have to guide students through the system do they discover things like the fact that some hospitals schedule patients for MRI and other tests around the clock.

"And one of my patients had to come and get their MRI at 3 a.m.," Skochelak says. " 'How do they do that?' " she says a faculty member asked her. " 'Do they have kids?' "

Physicians aren't always the best teachers about how the system works.

Doctors tend to focus on patient care, since that's what they know. However, Skochelak says, "If you hook [students] up with a clinic manager when you want them to learn about the system and what the system does, then the clinic manager focuses on the system."

Another major change to medical education aims at helping future doctors work as team players, rather than as the unquestioned leaders.

In a classroom at the University of California, San Francisco, several groups of students practice teamwork by working together to solve a genetics problem.

Joe Derisi, who heads the biochemistry and biophysics department at UCSF, is guiding more than teaching when he gently suggests a student's tactic is veering off course. "I would argue that it may not be as useful as you think," he tells the student. "But I'm obliging."

Onur Yenigun, one of the students in the class, says that working with his peers is good preparation for being part of a team when he's a doctor.

"When I'm in a small group I realize that I can't know everything," Yenigun says. "I won't know everything. And to be able to rely on my classmates to fill in the blanks is really important."

The medical schools that are part of the AMA project are already sharing what they've learned with each other. Plans are in the works, as well, to begin sharing some of the more successful changes with other medical schools around the country.

Jonathan Winston Jones

The disconcerting news was the doctor had to Google the issue first to figure out the best medical advice.

"My provider just did a Web search to figure out what dose of hormones I should be on, and put me on the highest dose," Sallans said. That could have been a dangerous choice. "Starting too high of a dose too quickly can cause a lot of health problems, particularly to cardiovascular health."

Fortunately, Sallans didn't have any health complications.

But his experience left him with a mission. He volunteers to speak with medical institutions, as well as with businesses and colleges, to urge them to be more LGBT inclusive. 

While a growing number of medical schools are teaching future doctors how to address health concerns that can be specific to the lesbian, gay, bisexual and transgender communities, studies show current doctors only get about five hours of training, if they get any at all.

For members of the LGBT community who live in more rural and conservative areas like Nebraska, the struggle to get good, or at least up-to-date, medical care may be even more difficult. 

In general, legal protections and institutional supports for LGBT Nebraskans are already thin, spotty or nonexistent.

On March 2, the United States District Court struck down Nebraska's ban on marriage for same-sex couples, but that ruling is on appeal. 

Without the legal institution of marriage, LGBT Nebraskans typically lack family health benefits, unless their employers provide them to same-sex partners.

A 2014 study from the Williams Institute at the University of California Los Angeles found that states without LGBT legal protections in place see lower rates of health insurance coverage for LGBT residents than states with protections.

That plays out in Nebraska. 

A 2014 study from researchers at the University of Nebraska Omaha found that LGBT residents in the rural parts of the state have lower rates of health insurance coverage than their counterparts in urban areas. 

Even when LGBT Nebraskans have health insurance, they struggle to find providers versed in lesbian, gay, bisexual and transgender heath care needs. 

Research shows that LGBT individuals often experience health issues linked to being regular targets of discrimination or social stigma. Discrimination has been linked to higher rates of substance abuse, suicide and stress-related illnesses, which can include heart problems, obesity, eating disorders and cancer. 

If the available doctors are not familiar with the increased rates of these issues, they may provide inadequate care.

Patients who find their doctors do not understand their issues may also delay treatment, often with bad health outcomes, said Jay Irwin, an assistant professor of sociology at the University of Nebraska-Omaha and a researcher in LGBT health. 

Sometimes patients are turned away by providers who don't want to treat LGBT patients, particularly if there are no laws to prohibit such discrimination. 

Irwin has completed studies that focus on the health care challenges of lesbians in rural areas and found that many people feel isolated and are afraid to come out -- or risk discrimination in the medical office.

Nebraska's sheer size doesn't help. Sixteenth largest in the nation by geography, members of its LGBT community often live far from large cities with significant LGBT populations and with teaching hospitals with staff members who have experience working with members of that community.

The Human Rights Campaign's 2014 Healthcare Equality Index named four Nebraska health care facilities, all in Omaha, as leaders in LGBT health care equality. 

Omaha is on the state's eastern border with Iowa. LGBT residents in western Nebraska -- for instance, places like North Platte -- have to travel 270 miles in either direction, to Omaha or Denver, Colorado, to reach facilities designated as leaders by the Human Rights Campaign. 

People who work within the health care system have seen some improvement when it comes to treating members of the LGBT community. 

Jill Young is the client services manager at Nebraska AIDS Project's Scottsbluff, Nebraska, office in the western part of the state.

She recalled when she started working there in the late 1990s she saw medical staff refuse care to LGBT people with HIV/AIDS. 

"We had nurses, for example, who said they wouldn't serve patients with HIV/AIDS," Young said. "But we've come a long way since then." 

Young has seen more hospitals in the region adopting policies that are supportive of LGBT residents, including one that just started recognizing same-sex partners' wills as legal documents that will allow them access to their partners when they are being cared for in areas restricted to immediate family only.

But she said she still sees too many LGBT residents traveling great distances to get care and she still sees too many patients who don't seek medical care until it is too late. 

"We still go to the hospital," she said, "and see people who are days away from dying."

Eric Yarwood, 44, has more experience than he would like with Nebraska's health care facilities. 

He spent over 100 days last year at hospitals in Omaha for complications related to germ cell cancer.

He had nine rounds of chemotherapy, three stem cell transplants, his third surgery two weeks ago and five more days for followup last week. 

For all but four of the days he was in the hospital, his partner, Aaron Persen, 36, was at his side every evening. "Aaron and I are a unit," Yarwood said. "I can count on my fingers the number of times he didn't come." 

While the couple has found the overwhelming majority of physicians and medical staff to be "genuinely supportive" of their relationship, there still were a few instances when they felt uncomfortable and unaccepted, once with a physician and another time with a nurse. 

"I'm not sure how often the medical staff works with gay couples or receives training on how to work with gay couples," Yarwood said. 

Yarwood's prognosis is good, and the couple looks with optimism to a future of having more access to LGBT-inclusive health care facilities and a more inclusive state overall. 

"Hopefully, by the time we get through the cancer and save a little money," Persen said, "Nebraska will follow most other states and allow our relationship to be legally recognized."

Source: www.cnn.com

By Anna Reisman