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Experimental Stem Cell Treatment Leaves 3 Women Blind

An experimental treatment — which blinded three women after stem cells from abdominal fat were injected into their eyes — was advertised on a government-run clinical trial website but lacked proper safeguards, researchers reported Wednesday.

The report in the New England Journal of Medicine notes that the procedures were part of a national rise in the number of clinics harnessing stem cells from fat to treat a variety of diseases — even though many have not been proven to work. Two of the women thought they were getting treatment as part of a clinical trial because they learned about the procedure on clinicaltrials.gov, a database run by the National Library of Medicine that features thousands of studies, many of which are sanctioned by research organizations and have regulatory oversight.

Jeffrey Goldberg, professor and chairman of ophthalmology at the Byers Eye Institute at Stanford University and co-author of the study, said the report aims to highlight the ethical implications of how clinical research is defined for the public and the dangers of poorly regulated trials.

“I would emphasize it’s a challenge and we can’t expect patients to fully vet these options,” he said. “And that’s where the ethics of the doctors and oversight of regulatory agencies need to play a role in the public health of our community.”

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The women featured in the report sought treatment in 2015 for age-related macular degeneration, a common, progressive eye condition characterized by blurriness in the center field of vision. Their ages ranged from 72 to 88, the report said, and they paid $5,000 for the procedure. Each had both eyes treated at the same time, a protocol that is “both atypical and unsafe,” according to the researchers.

The report did not name the clinics involved in the study or its sponsor. Researchers said in a press release accompanying the study that the clinic is no longer performing the procedures but is still treating patients.

Clinicaltrials.gov shows the trial referenced in the article was sponsored by a stem cell company based in Sunrise, Fla., called Bioheart Inc., now known as U.S. Stem Cell. Dr. Shareen Greenbaum served as the trial’s principal investigator, according to the company’s press release. She is an ophthalmologist working at the Hollywood Eye Institute in Cooper City, Fla.

According to the journal report, clinicians used cells extracted from fat, and treated them with enzymes to obtain the stem cells. Blood was also drawn from the patient and then platelet-dense plasma was extracted. The cells were then mixed with plasma and injected into both eyes.

Within days, the three patients sought medical care for complications related to the procedure. Two patients suffered bleeding and each had retina detachments. The researchers said they are not expected to regain their sight.

The analysis said that the consent forms signed by the women did not mention a clinical trial. It also noted that the patients paid for the procedure and both eyes were treated at the same time, a protocol that is “both atypical and unsafe.” The patients paid for procedures “that had never been studied in a clinical trial, lacked sufficient safety data and was performed in both eyes on the same day,” the researchers wrote.

State insurance records show insurers for Greenbaum, U.S. Stem Cell and a registered nurse paid out more than $3 million in 2016 to patients harmed by stem cell procedures, although it is not clear if those patients are the same ones detailed in the study. U.S. Stem Cell said in a statement Wednesday that it could not comment on these cases but it is committed to “research and development of effective cell technologies.” The statement noted that the company has “successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions” since 2001. Greenbaum did not return calls for comment.

Stem cells have unique properties that researchers believe may hold promise for new treatments for a host of diseases such as diabetes and arthritis. These cells have the ability to change into different types of specialized cells and act as a repair system for tissues throughout the body.

Hundreds of stem cell clinics have sprung up across the nation offering therapies. But many of these medical interventions have not been vetted through federal protocols for safety and effectiveness. Because stem cells are harvested from the patient who will receive the treatment, many of these clinicians say they do not need the Food and Drug Administration’s approval, said Karen Maschke, a research scholar at the Hastings Center, a bioethics research institute.

In the journal report, the authors hypothesize the adverse effects of the treatment were caused by stem cells transforming into myofibroblasts, or cells that can lead to scarring. Enzymes used to extract the stem cells could have also contaminated the solution.

But the report said even if the treatment had caused no adverse effects, there’s little evidence showing that it would have worked.

Formal clinical trials have several safeguards to protect participants against adverse effects, said Maschke. Biomedical trials are overseen by an institutional review board that is responsible for reviewing the study’s research protocol to ensure participants are being protected. Patients are also required to sign consent forms that outline the risks associated with the experiment.

For large clinical trials, a separate oversight group called a data safety monitoring board conducts reviews throughout the trial to assess the risks and benefits of the experiment, Maschke said. Smaller and less dangerous trials rely on the research team and chief investigators to notify the IRB of any safety issues. Participants can also report their concerns to the Office for Human Research Protections within the Department of Health and Human Services.

Dr. Thomas Albini, one of the co-authors and an associate professor of clinical ophthalmology at the University of Miami, warned consumers that clinical trials with a fee should be carefully reviewed. “I’m not aware of any legitimate research, at least in ophthalmology, that is patient funded,” he said in the press release accompanying the study.

The government website recently expanded its requirements for clinical trials wishing to register on the site. However, Maschke said she isn’t sure whether the new rules will lead to a more rigorous vetting process for prospective listings.

“It’s unclear whether or not anyone is enforcing required postings and what’s supposed to be in them,” she said.

Categories: Cost and Quality, Public Health, Syndicate

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Health Exchange Enrollment Misses Obama Administration’s Goal, But Stays Steady

An estimated 12.2 million people signed up for health insurance through the Affordable Care Act for 2017, federal officials reported Wednesday, down slightly from the 12.7 million who signed up for 2016.

It was also fewer than the 13.8 million people the Obama administration predicted would sign up last fall.

But supporters of the law argue that final enrollment was held down by Republicans when they took over the White House in January. They also maintain that the law is not in danger of collapse, as both President Donald Trump and GOP leaders in Congress claim.

The administration had no immediate comment on the enrollment numbers.

“I think the discrepancy from last year is almost entirely explained by the lack of a final push in marketing and outreach and promotion,” said Topher Spiro, vice president for health policy at the liberal-leaning Center for American Progress. “We were on track to exceed enrollment,” he said, referring to a late rush to sign up in December for coverage that began Jan. 1.

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However, the Trump administration, which took over just 10 days before the end of the three-month enrollment period for the health law, immediately canceled the final round of ads encouraging people to sign up. In each of the health law’s previous enrollment periods, a huge rush came at the end, particularly among the younger, healthier adults whom insurers covet. That did not happen this year.

Still, enrollment among those ages 18 to 34 held basically steady, at 27 percent, down from 2016’s 28 percent.

Despite that, enrollment remained strong in states that were already doing well under the program, including California, which signed up more than 1.5 million people for coverage. Even Arizona, which had some of the largest premium increases in the nation, saw enrollment drop only slightly, from 203,000 in 2016 to 196,000 this year.

As in previous years, the vast majority of those who signed up on the health exchanges — 83 percent — had incomes low enough to qualify for tax credits to help them pay their premiums. More than half — 58 percent — got additional subsidies to help cover deductibles and other out-of-pocket costs.

Even before the numbers were released, the Congressional Budget Office, in its report on the Republican replacement for the bill, found that the individual market “would probably be stable in most areas under either current law or the [GOP] legislation.”

Spiro said he agrees with that but worries that the continual dire predictions being made by Trump and Republican leaders could become “a self-fulfilling prophecy” by creating so much uncertainty for both insurance companies and consumers.

“You have to ask how many more would have enrolled if there weren’t this cloud hanging over the law and if the president was not saying that the markets are imploding or collapsing. If you’re a consumer, that does not sound like something you want to be a part of,” he said.

Categories: Insurance, Repeal And Replace Watch, Syndicate, The Health Law

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Where You Live May Determine How You Die. Oregon Leads The Way.

Americans who want to ensure they have a say in how they die should examine the lessons of Oregon, a new analysis suggests.

Seriously ill people in that state are more likely to have their end-of-life wishes honored — including fewer intensive-care hospitalizations and more home hospice enrollments — than those living in neighboring Washington state or the rest of the country.

In 2013, nearly two-thirds of Oregonians who died did so at home, compared with fewer than 40 percent of people elsewhere in the U.S., according to the report published Wednesday in the New England Journal of Medicine. Previous research had shown that more than 85 percent of Americans say they’d prefer to die at home.

“Obviously, if you’ve spent decades trying to improve your end-of-life care, it’s pretty rewarding to see that something changes,” said Dr. Susan Tolle, director of the Center for Ethics in Health Care at the Oregon Health & Science University in Portland, who co-led the study.

The review analyzed Medicare fee-for-service claims data from 2000, 2005 and 2013, and it compared end-of-life care in Oregon and Washington — a nearby state with similar demographics and attitudes toward end-of-life care — with the rest of the U.S., excluding those two states.

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It found that in 2013, ICU use in the last 30 days of life was about 18 percent in Oregon, compared with 23 percent in Washington and 28.5 percent in the rest of the U.S. Nearly three-quarters of patients in Oregon hospitalized in the last month of life were discharged to home, compared with slightly fewer than two-thirds in Washington state and a little more than half — 54.2 percent — in the rest of the U.S.

More than 40 percent of patients in Oregon were enrolled in home hospice in 2013, compared with about 30 percent in Washington and fewer than 20 percent in the rest of the U.S, the analysis found.

Oregon, which enacted the nation’s first death-with-dignity law and led the way on implementing portable medical orders for treatment at the end of life, may be reaping the results of those and other efforts, said Tolle’s co-author, Dr. Joan Teno, a professor of medicine, gerontology and geriatrics at the University of Washington in Seattle.

“When you look at the patterns, it’s very different than the rest of the United States,” she said. “It’s even different than a borderline state.”

Pat Duty, 64, who ran a Portland floor-covering business with her husband, Jimmy, for years, said Oregon’s palliative care culture helped guide treatment decisions after his 2013 diagnosis of lung cancer and dementia. Jimmy Duty wanted limited medical interventions; he had a do-not-resuscitate order, plus a request to avoid the ICU.

“He was very clear that quality of life was his first choice,” Pat Duty recalled. “We knew we needed to discuss these things while he could make decisions for himself. We wanted to give him the dignity and grace he deserved for his final couple of years.” He died in October 2015 at age 74.

Pat Duty of Portland, Ore., cared for her husband, Jimmy, after a diagnosis of lung cancer and complications that led to his death at age 74 in 2015. The couple discussed end-of-life treatment options and palliative care, part of Oregon’s integrated system that sets it apart from other states. (Photo courtesy of Pat Duty)

Creating such a culture is much harder than it looks, Tolle and Teno argued. Oregon has successfully integrated awareness of end-of-life care at all levels, from state government and emergency care to individual decisions made by patients and their doctors.

“If patients’ goals are not linked to actionable care plans that are supported by local health care systems and state regulations, many patients who wish to remain at home will die intubated for all the reasons the current system fails them,” they wrote.

Across the U.S., there’s been a push to promote ways to indicate end-of-life treatment preferences, including advance directives, which provide guidance for future care, and Physician Orders for Life-Sustaining Treatment, or POLST, portable medical orders authorizing current care. Twenty-two states now have POLST programs and others are working on or considering them, said Tolle, who co-led the creation of POLST in the early 1990s.

But the researchers warned that, while POLST efforts are important, simply filling out the forms is not enough.

“We were highlighting that there’s no simple answer,” Tolle said. “You can’t just do one thing and think that you will change the culture of end-of-life care. It is a whole lot of work.”

Dr. Scott Halpern, a medical ethics and health policy expert at the Perelman School of Medicine at the University of Pennsylvania, has been a chief critic of POLST efforts, contending that there’s little evidence that the medical orders improve quality of life near death.

The new analysis by Tolle and Teno doesn’t fill the gap, he said. But he agreed with the authors’ contention that a focus on single interventions ignores the complexity of end-of-life decisions.

“Good end-of-life care involves physicians eliciting patients’ values, hopes and fears and making treatment decisions that align,” Halpern said.

The new analysis, which was funded by a grant from the Robert Wood Johnson Foundation, underscores that families and patients outside of Oregon must be vigilant to ensure they receive the care they want, Tolle said.

“The level of care you receive near the end of life depends more on the state you live in and the systems they have in place than your actual wishes,” she said.

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.

Categories: Cost and Quality, Mental Health, States, Syndicate

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Sticker Shock Forces Thousands Of Cancer Patients To Skip Drugs, Skimp On Treatment

John Krahne received alarming news from his doctor last December. His brain tumors were stable, but his lung tumors had grown noticeably larger.

The doctor recommended a drug called Alecensa, which sells for more than $159,000 a year. Medicare would charge Krahne a $3,200 copay in December, then another $3,200 in January, as a new year of coverage kicked in.

For the first time since being diagnosed 10 years ago, Krahne, now 65, decided to delay filling his prescription, hoping that his cancer wouldn’t take advantage of the lapse and wreak further havoc on his body.

With new cancer drugs commonly priced at $100,000 a year or more, Krahne’s story is becoming increasingly common. Hundreds of thousands of cancer patients are delaying care, cutting their pills in half or skipping drug treatment entirely, a Kaiser Health News examination shows.

One-third of Medicare patients who were expected to use Gleevec — a lifesaving leukemia medication that costs up to $146,000 a year — failed to fill prescriptions within six months of diagnosis, according to a December study in the Journal of Clinical Oncology.

Researcher Stacie Dusetzina and her colleagues at the University of North Carolina found that patients with private health insurance with relatively high monthly copayments ($53 or more) were 70 percent more likely to stop taking Gleevec or take fewer doses than prescribed, according to a 2014 study.

Leukemia patients aren’t the only ones rationing care.

A 2013 study in The Oncologist found that 24 percent of all cancer patients chose not to fill a prescription due to cost, while about 20 percent filled only part of a prescription or took less than the prescribed amount. A February study published in Cancer had similar findings, with about 10 percent skipping medication or taking less than prescribed, and 14 percent delaying filling a prescription.

Given that more than 1.6 million Americans are likely to be diagnosed with cancer this year, that suggests 168,000 to 405,000 ration their own prescription use.

“Patients are being harmed daily” by high treatment costs, said Dr. Hagop Kantarjian, a leukemia specialist and professor at Houston’s MD Anderson Cancer Center. “It’s causing more deaths than necessary.”

Stopping drugs like Gleevec could be cutting years from some patients’ lives. Instead of dying in five to seven years, patients with chronic myeloid leukemia who take Gleevec and similar drugs can survive nearly as long as anyone else, and with a good quality of life, Kantarjian said.

Given that his lung cancer has grown slowly over the years, Krahne’s doctor thought it would be safe to wait until January to begin his new medication.

“We hope it doesn’t hurt my chance of cure,” said Krahne, from Santa Rosa, Calif. “It was an educated risk that we didn’t take lightly.”

Krahne made repeated calls to patient-assistance programs throughout January, trying to find help with his out-of-pocket costs.

“The anxiety during those days or weeks was probably almost as bad as the day I was diagnosed with cancer,” Krahne said.

Doctors have a term for Krahne’s problem: “financial toxicity.”

“We’re talking about huge numbers of patients,” said Dr. Scott Ramsey, director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Center in Seattle. “It’s an epidemic. And it’s not going away.”

Even patients with good insurance can face a financial crisis when trying to pay for cancer therapy. Medicare pays for the bulk of cancer care in the United States because 59 percent of cancer patients are older than 65. And, although it covers a high percentage of the cost, copays for patients such as Krahne can easily reach $10,000 a year, Dusetzina said.

Krahne and his wife, Audrey, sit in their kitchen at home in Santa Rosa, Calif. “We hope it doesn’t hurt my chance of cure,” Krahne said of his decision to delay filling his prescription. “It was an educated risk that we didn’t take lightly.” (Robert Durell for Kaiser Health News)

Unlike many commercial plans, Medicare doesn’t set an upper limit on what patients pay out-of-pocket. Patients with chronic lymphocytic leukemia who begin oral medications this year, for example, can expect to have lifetime out-of-pocket costs of $57,000, according to a January study published in the Journal of Clinical Oncology.

High drug costs are a particular problem for the elderly, half of whom have $13,800 or less in available assets, and many have more than one expensive chronic condition, such as heart disease, diabetes or emphysema. The median income for people on Medicare was $24,150 in 2014, according to the Kaiser Family Foundation.

Medicare patients with cancer spend an average of 11 percent of their income on treatment, according to a November study in JAMA Oncology. Patients who don’t have supplemental insurance, which pays for treatment not covered by traditional Medicare, spend 23 percent of their income on cancer care. Ten percent of elderly patients without supplemental insurance spent 60 percent of their income on cancer expenses.

In John Krahne’s case, persistence finally paid off. After making repeated calls to patient-assistance programs in January, Alecensa’s manufacturer, Genentech, agreed to help pay Krahne’s out-of-pocket costs. He began taking the drug Jan. 27, six weeks after it was first prescribed.

It’s impossible to know whether Krahne’s health will be affected by the delay, said Ramsey.

“Most oncologists are OK with delays of up to a month, but after that they start getting anxious that further delays will harm chances for survival,” Ramsey said.

When thinking about having to find the money for more than $10,000 in cancer treatment a year, Krahne said: “Hopefully, I won’t have to do this year after year.”

Yet Krahne acknowledged that paying high prices is the cost of surviving cancer today. “So, hopefully, I will have to do this year after year.”

Big-Ticket Designer Drugs

While cancer has always posed a financial hardship for patients, the jaw-dropping costs of new cancer medications have led to widespread criticism of the pharmaceutical industry, on Capitol Hill and beyond.

List prices for oral cancer drugs doubled from 2011 to 2016, rising from an average of $20 for a day’s supply to $40, according to Express Scripts, a pharmacy benefit manager. Six of the 39 cancer drugs on the market in 2010 doubled or tripled in price by 2016; one quadrupled in price; one drug’s price increased eightfold.

Treating melanoma patients with the highest dose of Keytruda, an immune therapy that has led to long-term remissions in some patients, could cost more than $1 million a year.

Such costs are leading to soul-searching by doctors, who often struggle to help patients decide if drugs are worth the consequence of depleting their life savings, or going into debt or even bankruptcy.

“My job is to prescribe the best treatment,” said Dr. Yousuf Zafar, associate professor of medicine and public policy at the Duke Cancer Institute in North Carolina. “But I’m not doing my job if I prescribe a drug and walk away and leave them with tens of thousands of dollars in immediate debt.”

In a statement, the Pharmaceutical Research and Manufacturers of America, an industry group, noted that drug costs are only one part of the problem. “Many factors contribute to financial hardship for cancer patients … physician services, transportation expenses, and the inability to work, among other medical and non-medical factors, drive the cost burden on patients. We have also seen a rapid rise in the number of health plans with high deductibles for medicines.”

In a statement, officials at Gleevec’s manufacturer, Novartis, noted that the company provided financial aid to 130,000 patients last year, including those struggling to pay for Gleevec.

“We price our medicines to reflect the value they bring to patients and society,” said Novartis spokesman Eric Althoff. “We also continue to invest in new treatments so that we can find ways to make more cancers survivable.”

Patients Go For Broke

The high cost of cancer medications can burden patients for years even after they finish treatment.

Liza Bernstein, 52, was diagnosed with breast cancer three times from 1994 to 2009. She emptied her savings account after her second diagnosis and gave up her apartment because she couldn’t pay her rent. Bernstein sold some belongings and put the rest in storage, where they remain. She has been living with friends and relatives ever since.

“People say ‘Call this foundation or that foundation,’” for help, said Bernstein, a freelance designer and patient advocate in Los Angeles who was unable to work for several years due to her illness. People don’t understand “the cognitive and emotional exhaustion of trying to manage this and wrap your brain around everything you need to do.”

Cancer often limits patients’ ability to hold down a job. Four years after diagnosis, one-third of previously employed breast cancer survivors were unemployed, according to a 2014 study. Patients who lose a job don’t just lose a paycheck; they often lose their health insurance.

Liza Bernstein (Courtesy of Christopher Kern)

In a 2012 study of 284 colorectal cancer patients, 38 percent reported one or more financial hardships as a result of treatment, such as being forced to sell or refinance their home or losing more than 20 percent of their income, even though nearly everyone in the study was insured. Seventeen percent borrowed money from family or friends, at an average of more than $14,000.

Twenty-three percent were in debt 20 months after their diagnosis, with an average debt of $26,860, according to the study. Even patients without severe hardship saw their fortunes change due to cancer, as they sold stocks and drew on savings.

About 3 percent of patients with cancer declare bankruptcy, said Ramsey, whose 2013 study found cancer patients are 2.7 times more likely to file for bankruptcy than those who’ve never been diagnosed.

Although Bernstein considered declaring bankruptcy, she said she couldn’t afford the $500 to $600 it would have cost for a lawyer and filing fees.

Bankruptcy isn’t just financially devastating.

Mortality rates among cancer patients who filed for bankruptcy are, on average, 79 percent higher than those of other patients, according to Ramsey’s 2016 study in the Journal of Clinical Oncology. Bankruptcy is associated with an especially high risk of death for certain cancers. For example, mortality rates are 2.5 times higher among patients with colorectal cancer who filed for bankruptcy compared with patients who didn’t file.

The financial stress takes a toll on survivors as well. A study published last year in the Journal of Clinical Oncology found that patients with more financial strain had worse overall health and more pain, depression and impairment compared with those with more resources.

Financially stressed patients may skip pain medications and miss doctor’s appointments. And those who skip taking drugs to relieve nausea and vomiting, Ramsey said, can die from dehydration.

Krahne, right, and his friend Don Stranathan, who also has lung cancer, walk near Krahne’s home. The cancer drug Krahne was prescribed sells for more than $159,000 a year. (Robert Durell for Kaiser Health News)

A 2011 study found that breast cancer patients who stopped taking hormonal therapy earlier than scheduled, or who took less than the prescribed amount, were more likely to die.

Some patients “have to choose between paying their meds and heating their home,” said Carla Tardif, chief executive officer at Family Reach, a New Jersey charity that provides financial aid to families dealing with cancer. “I went into a home and there were two sleeping bags on the kitchen floor. The mom said, ‘We sleep by the stove because I can’t afford the heat.’”

Molly MacDonald (Courtesy of The Pink Fund)

Molly MacDonald, who was diagnosed with breast cancer at age 54, when she was a divorced single mother of five, opted not to undergo reconstructive surgery because of the cost. She worried about the increased risk of infection and hospitalization, which she knew she could not afford.

“All of my decisions were based on cost,” said MacDonald, of Beverly Hills, Mich. “We sold things. I cut the kids’ hair myself. Friends brought food. Then I found myself in line at the food bank. I used to have groceries delivered. It was interesting to find out how quickly someone can find themselves in a place of need.”

In October 2006, after MacDonald got back on her feet, she began soliciting donations for a nonprofit she created called The Pink Fund, which helps to pay breast cancer patients’ bills. The fund now pays about $65,000 in bills a month. “We’ve helped people who are living in storage units, living with their families, living in cars.”

MacDonald often draws from her experience when offering financial advice. Consider selling your house to prevent it from being taken away, she suggests. Remember, that as bad as the situation is, it’s not permanent. But she also asks clients, “What in your house can you sell?”

KHN’s coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation and coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.

Categories: Cost and Quality, Health Industry, Insurance, Pharmaceuticals, Syndicate

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By The Numbers: Trump’s Choice For FDA Chief Is Versatile, Entrenched In Pharma

President Donald Trump’s pick to lead the Food and Drug Administration has deep ties to the pharmaceutical industry as a consultant, investor and board member. Scott Gottlieb, 44, also has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals.

“It seems like the main question is, ‘Which Gottlieb are we going to get?’” said Dr. Robert Califf, who stepped down from his position as the commissioner of the Food and Drug Administration in January.

Here’s a look at Gottlieb’s career, by the numbers:

188 Companies

New Enterprise Associates, the venture capital firm where Gottlieb is a partner, is currently or has been invested in 188 health care companies.

8 Boards Of Directors

Gottlieb serves or served on eight boards of directors, according to his LinkedIn profile. The firms include pharmaceutical companies Gradalis and Tolero Pharmaceuticals, which are developing cancer treatments, among other things; and Glytec, which offers glycemic management tools for patients with diabetes.

8 Drug And Device Companies

Eight pharmaceutical companies disclosed payments to Gottlieb in 2015, according to the open payments database: Vertex Pharmaceuticals, GlaxoSmithKline, Daiichi, Valeant, Pfizer, Millennium, SI-BONE and E.R. Squibb & Sons. Payments included travel to Philadelphia, San Francisco and London.

9 Recusals

In a memo, Gottlieb wrote that he had a consulting relationship with nine health care companies before his stint as the FDA’s deputy commissioner for medical and scientific affairs during the George W. Bush administration. Those ties disqualified him from dealing with matters concerning those companies for at least a year. The firms included Eli Lilly, Roche and Sanofi-Aventis.

The recusals generated some headlines during the avian flu scare because Gottlieb had to recuse himself from some of the planning efforts around vaccines.

7 Years

Starting in 1997, Gottlieb spent seven years as a staff writer for BMJ, the British Medical Journal. BMJ is one of the top medical journals in the world. And he was an editor at the Pulse section of JAMA, the Journal of the American Medical Association, from 1996 to 2001.

Gottlieb also spent the past seven years as an adviser to drugmaker GlaxoSmithKline’s product investment board, according to his LinkedIn page.

33 Years Old

Gottlieb was 33 when he got the No. 2 job at the FDA in 2005. He had done a short stint at the agency a few years earlier, but was considered a controversial pick because of his ties to Wall Street. He stayed until 2007.

“He has done a lot of thinking about how FDA should be managed — his operational sophistication is going to be a great asset,” said former FDA attorney Coleen Klasmeier, who worked with Gottlieb and co-authored articles with him. “He also has very strong relationships among career FDA personnel and will be able to hit the ground running on a range of important initiatives.”

18 Times Before Congress

Gottlieb testified before Congress as an expert witness 18 times. He has spoken about drug prices, revamping the FDA approval process and the vaccine supply.

“Most people watching at the FDA would breathe a sigh of relief,” Dr. Joshua Sharfstein, who served as the FDA’s principal deputy commissioner until 2011, said of Gottlieb’s impending nomination. He added that Gottlieb is “not someone who has expressed antagonism to the core principles of the agency.”

36,000 Twitter Followers

More than 36,000 people follow Gottlieb on Twitter, though he follows only 845 people, as of Tuesday. He has tweeted at least 10,400 times, lately about different strains of the flu.

72 Percent

Almost three-fourths of the 53 drug companies surveyed by Mizuho said they’d prefer Gottlieb to head the FDA.

$414,000

Pharmaceutical companies paid Gottlieb nearly $414,000 from 2013 through 2015, according to federal open payments data, for speeches, consulting, travel and meals.

That included $65,780 from a pharmaceutical company to promote a controversial cystic fibrosis drug called Kalydeco. Only one other doctor received more money toward promoting the drug.

The drug’s price tag was controversial because the nonprofit Cystic Fibrosis Foundation kicked in $150 million toward finding a cure for the fatal disease and got a rich $3.3 billion payday for selling its rights to royalties for the drug. Vertex Pharmaceuticals priced Kalydeco at more than $300,000 a year.

Nearly $30,000

Gottlieb has contributed nearly $30,000 toward Republican political campaigns and joint fundraising committees from 2005 to 2014. He has donated toward the presidential runs of Mitt Romney and Sen. John McCain. He also donated more than once to Speaker Paul Ryan.

Gottlieb contributed the most money toward Republican Sen. Ben Sasse of Nebraska, spending $2,600 in the primary and $2,600 again in the general election in 2013. Sasse was a vocal anti-Trump supporter, penning an open letter in February 2016 about how he could not support Trump, who was “dividing” the nation, in his view.

“But have you noticed how Mr. Trump uses the word ‘Reign’ — like he thinks he’s running for King?” Sasse asked in the post.

Categories: Health Industry, Pharmaceuticals, Syndicate

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Americans Not Sold On Cost And Coverage Claims In GOP’s Health Bill

A majority of the public is skeptical the Republican health plan would be an improvement over the Affordable Care Act, with widespread concerns that insurance costs would increase while people lost coverage, according to a poll released Wednesday.

The dour public assessment, from interviews with 1,206 adults conducted March 6-12, came before the Congressional Budget Office released its projections on Monday. The nonpartisan budget analysts predicted that the GOP’s American Health Care Act would leave 24 million people without insurance as it retracted Medicaid coverage for the poor and made premiums too high for many older people to afford.

The Kaiser Family Foundation poll found that 48 percent of the public thought the GOP plan would decrease the number of people who have health insurance. Another 30 percent expected the insured rate would stay the same, and 18 percent thought the number of covered people would increase. (Kaiser Health News is an editorially independent program of the foundation.)

One-fifth of Republicans think their party’s plan will lead to fewer people with insurance, the poll found. (Kaiser Family Foundation)

The public doubted pledges from President Donald Trump and Republicans that the proposal would lower the costs of coverage for people who buy their own insurance. Forty-eight percent thought policies would become more expensive, while 23 percent thought they would drop. The rest thought insurance costs would stay the same.

People were also dubious that deductibles would get smaller: Only a quarter of people thought so. Respondents also were doubtful the GOP plan would be a boon even for the wealthy. About the same number of people expected the plan would increase costs for high-income people as those expecting a decrease.

For all the suspicion about the GOP approach, the public remained ambivalent about the ACA, with 49 supportive and 44 percent opposed. The public was also split about whether the ACA should be repealed.

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Republicans, not surprisingly, were more optimistic than Democrats that the GOP plan would have positive effects. But it was not unanimous: 1 in 5 thought their party’s plan would lead to fewer people with insurance. A fifth of Republicans also said they expected insurance costs to rise under the plan.

Provisions of the GOP plan that would change women’s health care have strong opposition, including its ban on federal funds for Planned Parenthood to help it provide birth control and other non-abortion care to lower-income people. Three-quarters of the public thought Medicaid should continue to fund Planned Parenthood’s non-abortion services. The law already prohibits Medicaid spending for abortion, but the pollsters found that only a third of the public is aware of that.

The poll reported that 4 of 5 Americans strongly support provisions in the ACA that prohibit private insurers from denying coverage to pregnant women and from charging women more than men for policies, as well as those that require mammograms and cervical cancer screenings be provided with no out-of-pocket costs. Nine of 10 Americans support the ACA’s requirement that insurers pay for maternity care.

The poll’s margin of error was +/- 3 percent.

Categories: Insurance, Repeal And Replace Watch, Syndicate, The Health Law

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Two Words Can Soothe Patients Who Have Been Harmed: We’re Sorry

When Donna Helen Crisp, a 59-year-old nursing professor, entered a North Carolina teaching hospital for a routine hysterectomy in 2007, she expected to come home the next day.

Instead, Crisp spent weeks in a coma and underwent five surgeries to correct a near-fatal cascade of medical errors that left her with permanent injuries. Desperate for an explanation, Crisp, who is also a lawyer, said she repeatedly encountered a white wall of silence: The hospital and her surgeon refused to say little more than “things didn’t go well.” Crisp spent years piecing together what happened. “I decided I was going to find out even if it takes the rest of my life,” she said.

Jack Gentry said he “went into the hospital a patient and came out a victim.” In 2013, the retired Baltimore police officer suffered a catastrophic spinal cord injury during disk replacement surgery at MedStar Union Memorial Hospital that left him a quadriplegic.

But unlike Crisp, Gentry and his wife, a nurse, were immediately told what had gone wrong by his surgeon, who apologized for the error. The hospital covered Gentry’s rehabilitation and other major expenses and paid an undisclosed amount in compensation, all without litigation.

“When hospitals mess up, they need to do the right thing,” Gentry said. “MedStar did.”

For patients and their families killed or maimed by medical errors, Crisp’s experience — in which doctors clam up and hospitals deny wrongdoing and aggressively defend their care — remains standard operating procedure in most institutions.

But spurred by concerns about the “deny and defend” model — including its cost, lack of transparency and the perpetuation of errors — programs to circumvent litigation by offering prompt disclosure, apology and compensation for mistakes as an alternative to malpractice suits are becoming more popular. Researchers at Johns Hopkins University in Baltimore recently estimated that medical mistakes kill 251,000 Americans annually, which would make them the third-leading cause of death. Traditionally, the only way for patients to find out what went wrong has been to sue.

A blueprint for the approach used in Gentry’s case is being promoted by the federal Agency for Healthcare Research and Quality. Called CANDOR, an acronym for Communication and Optimal Resolution, the approach is modeled on a long-standing program pioneered at the University of Michigan. It was tested in 14 hospitals around the country, including MedStar’s Washington Hospital Center and Georgetown University Hospital.

Although they differ, these programs — which typically feature prompt investigation of errors whose findings are shared with the victims, as well as an apology and compensation for injuries — are operating at the University of Illinois at Chicago, Stanford and eight hospitals and outpatient groups in Massachusetts. Despite fears that the new approach would encourage lawsuits, the opposite has proved true. In Michigan, the number of lawsuits was cut nearly in half, and the hospital system saved about $2 million in litigation costs in the first year after the new model was adopted in 2001.

“The whole point of this isn’t to drop malpractice costs, it’s to drive patient safety,” said Richard Boothman, the University of Michigan Health System’s executive director of clinical safety and chief risk officer, who launched the program after a career defending doctors and hospitals. “We need to hard-wire as quickly as possible the lessons of these cases.”

In most hospitals, Boothman said, patient safety experts do not routinely talk to risk managers who handle malpractice claims. As a result, valuable information about preventing errors is lost.

Donna Helen Crisp spent weeks in a coma and underwent five surgeries after a near-fatal cascade of medical errors. (Courtesy of Rebekah Lee Crisp)

In The Dark

Most patients never learn they are victims of a medical error. A landmark 1991 Harvard study found that only 2 percent of people harmed by errors file a lawsuit. Those who do face daunting odds: Patients lose 80 percent of malpractice cases. Huge litigation costs, combined with laws that have reduced damage awards in many states, have left many unable to find an attorney because plaintiffs’ lawyers are paid on contingency. Malpractice cases typically take three or more years to resolve. In the interim, many injured people struggle to pay for care.

Litigation “is a tortuous process for patients and health care workers,” said Beth Daley Ullem, who spent five years seeking answers about the 2003 death of her newborn son from a Chicago hospital that denied any wrongdoing.

“We later learned that this had happened to a family before us and another seven months after,” said Daley Ullem, a former McKinsey & Co. consultant whose ruptured uterus went untreated for an hour. She said she received a $4 million settlement before trial, which she offered to give back to the hospital to fund safety improvements. The hospital refused.

Disclosure efforts also face stiff resistance from doctors, insurers and lawyers, including defense attorneys for whom speedier resolution means fewer billable hours.

Despite laws in most states that prevent apologies from being used against doctors in lawsuits, many worry that it will make patients more likely to file suit, said Thomas Gallagher, a University of Washington professor of medicine who has written extensively about disclosure. A recent study found that 77 percent of 300 primary-care doctors would not fully disclose a delayed breast cancer diagnosis to a patient.

Doug Wojcieszak — who founded an Illinois-based disclosure advocacy group called “Sorry Works!” — said one Iowa doctor told him that if he started apologizing when things went wrong, “he’d be doing nothing else all day long.”

Insurers are also leery, said Brian Atchinson, president of Physician Insurers Association of America, the trade association for liability insurers, which was involved in the development of CANDOR. “Some states are more conducive to this than others,” he said. “But there are those who don’t believe the benefits outweigh the risks.”

Lawyer Joanne Doroshow, director of the Center for Justice & Democracy at New York Law School, expressed worry that disclosure programs may take advantage of vulnerable patients who are not represented by a lawyer. “The hospitals are in control of it, and it’s still in their interest to try and limit compensation to patients,” she said.

Jeffrey Catalano, a Massachusetts plaintiffs’ lawyer who is president of the state bar and a participant in that state’s disclosure program, says that patients should be represented early in the process. “I think if there’s a good attorney present, there’s no way a client is going to be shortchanged,” he said. “Good attorneys know this: Medical malpractice cases are hard to take to trial. If a client can get $1 now rather than risking getting nothing [at trial] for the prospect of $1.50 later, it may be better to take the $1 now.”

Doing The Right Thing

The country’s first disclosure program began 30 years ago with a doctor’s desire to do the right thing.

Pulmonologist Steve Kraman, newly named as chief of staff for what is now the Lexington Veterans Affairs Medical Center in Kentucky, said he faced a problem in 1987: how to handle the death of a middle-aged woman caused by an “undeniable error,” a massive overdose of potassium.

“If we had said nothing, [the family] never would have known a thing,” said Kraman, who was also the hospital’s risk manager. “We never would have gotten sued. But I just didn’t feel that was right.” So he suggested to the hospital’s lawyer that they come clean to the patient’s two adult daughters, from whom she was estranged.

“I sat down and told them exactly what happened, that we were responsible for it, that they should hire a lawyer and we were going to negotiate a payment,” he recalled. Two months later, the family was paid $250,000.

From then on, Kraman said, all cases involving errors were handled similarly. “We paid out for things that nobody could have sued for in their wildest dreams,” said Kraman, who is now a professor at the University of Kentucky. Some patients declined the cash, he said, because they feared it would “ruin their relationship with the doctor.” Kraman said he refused to pay a dime in cases where no injury could be proved. “That just alienates doctors and nurses who feel like you’re throwing them under the bus.”

Kraman said he had several advantages: Doctors were employed and insured by the VA system. Payments, which averaged $16,000, were made from the U.S. Treasury, not the hospital coffers. And the program had the support of the hospital’s director and lawyer as well as the U.S. attorney for Kentucky.

“This has to be done from the top down” or it won’t work, Kraman said. “The message has to be ‘This is how we do business.’”

When Boothman arrived at the University of Michigan in 2001 — after two decades defending doctors, including an orthopedic surgeon who had been sued 21 times — he decided to try a similar approach. That included encouraging staff to report errors and bad outcomes; reports jumped from 2,400 a year to more than 34,000.

“You have to normalize honesty,” Boothman said, “to create a culture of continuous improvement.” Applying the lessons gleaned from those errors, he said, has helped make care safer.

“Litigating a case for three years and telling everybody, ‘Don’t talk about it and don’t change anything,’ is immoral and counterproductive,” he added. “I don’t serve my organization well by defending care we shouldn’t be defending.”

“Today we’re often at the bedside as soon as things happen,” he said. Patients and their families are interviewed as part of the hospital’s investigation of the facts, something that does not happen in traditional litigation.

Like Kraman, Boothman said he worries that some hospitals are using disclosure to cherry-pick small or unwinnable cases, not as a standard approach.

A Test Case

Orthopedic surgeon P. Justin Tortolani remembers with sickening clarity the moment he realized that a device he was installing had gone too far, penetrating Jack Gentry’s spine. The 60-year-old retired police officer, who once had hiked the entire Appalachian Trail, was instantly paralyzed from the neck down.

“You can’t really believe it’s happening,” said Tortolani, Union Memorial’s director of spine surgery. Summoning his years of training, the surgeon formulated a plan and steeled himself to tell Teresa Gentry what had happened. It was the first of many conversations about the accident that he would have with the family.

“We didn’t want to go through litigation, we didn’t need to go through litigation,” said Larry Smith, MedStar’s vice president for risk management. MedStar uses CANDOR in about a dozen cases with substantial damages annually.

MedStar executives “told me what had happened, why it happened, that it was directly or indirectly their fault and that whatever I needed I should ask for,” Gentry recalled. MedStar paid for five months of inpatient rehab — Gentry’s insurance would have covered only two weeks — modifications to the couple’s home, a $45,000 wheelchair and a new wheelchair-accessible van. It provided a case manager, a home-care nurse and $15,000 for incidental medical expenses.

“Because of the nature of Jack’s injury, we would have had to mortgage everything to pay for his care” otherwise, Teresa Gentry said.

Early on, Gentry said, his older brother, a Baltimore malpractice lawyer, expressed bafflement at MedStar’s approach. “He said as long as we were getting what we needed, to just go with it,” Gentry recalled.

At the end of two years, the case was settled with a confidential payment negotiated by lawyers for the couple, MedStar and the device manufacturer.

“I felt like it would take care of Jack for the rest of his life,” said Teresa Gentry, adding that the couple had been prepared to file a lawsuit if an agreement could not be reached. “Did I get enough to pay for everybody’s pain and suffering and trauma? No.”

“I was very skeptical in the beginning of this whole process,” she recalled, but she said she believes it has worked well, as does her husband.

Tortolani said he feels “remorse, guilt and sorrow for Jack and his family. This shakes you to your core,” he said. MedStar officials have been “unbelievably supportive,” Tortolani said, and he remains deeply grateful to the Gentrys. “My relationship with Jack has never been stronger.”

Donna Helen Crisp says she thinks she would have been less traumatized had the North Carolina hospital and her surgeon not stonewalled her. “I would have been deeply depressed that I had such a bad experience, but I could have moved on with my life,” said Crisp, who has written a book about her experience entitled “Anatomy of Medical Errors: the Patient in Room 2.” Being denied the truth left her with “no way to put it into perspective.”

Categories: Health Industry, Public Health, Syndicate

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