Category Archives: Medical

Creating a supervirus in your kitchen?

CRISPR gene editing kits can now be mail ordered to your home. Could amateurs create a bug that could destroy civilization?

That is a question examined by a writer for Scientific American who ordered a kit herself.  She details what she did with her kit and the question of whether anyone with an expert knowledge of gene research thinks something useful might come out of any home users and their.  That writer also talks to scientists familiar with CRISPR and asks whether a nightmare scenario of a harmful bug created with CRISPR is possible.

Writer Annie Sneed notes: 

“Honey! Look what I created in the garage with CRISPR!”

As for my bigger question—could untrained DIY-ers actually achieve scientific breakthroughs?—I asked academic researchers what they thought. Dana Carroll, for his part, believes amateurs could make meaningful discoveries. “In the professional science community, people keep coming up with new ways to use this technology—people are really only limited by their imagination,” he explains. “It’s possible that people working in their garages or their kitchens will come up with a novel application or a solution to a problem that professionals just haven’t gotten around to.” And Carroll says it would be easy for a DIY-er to share any discoveries with researchers, by attending their talks or simply by contacting them through their Web sites. Yet he notes that the DIY community faces limitations, because amateur scientists likely would lack the necessary resources. “It’s unlikely they will bring a major application all the way to fruition,” he says, “But they could certainly get started on something.”

As to the possible dangers, Sneed writes:

Finally, what about the nightmare scenario: Is CRISPR so easy to use that we need to worry about biohackers—either accidentally or intentionally—creating dangerous pathogens? Carroll and others think that the danger of putting CRISPR in the hands of the average person is relatively low. “People have imagined scenarios where scientists could use CRISPR to generate a virulent pathogen, ” he says. “How big is the risk? It’s not zero, but it’s fairly small.” Gersbach agrees. “Right now, it’s difficult to imagine how it’d be dangerous in a real way,” he explains, “If you want to do harm, there are much easier and simpler ways than using this highly sophisticated genetic editing technique.”

But that is all at the end of the article. If you are a science nerd at all, the entire article makes for interesting reading. 

I have also included a video from the renowned Broad Institute about CRISPR, which is part of a short FAQ from the Broad about CRISPR.

Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial

A screenshot of U.S. researcher William Halford’s blog, where he posted updates about the St. Kitts offshore clinical trial. Pictured here with Halford, right, is his business partner, Agustín Fernández III.

Controversial drug trial which broke all the rules on patient safety has among its investors Trump supporter — and FDA critic — Peter Thiel.

As 20 Americans and Brits flew to a Caribbean island for a controversial herpes vaccine trial, many of them knew there were risks.

The lead U.S. researcher, William Halford, openly acknowledged he was flouting Food and Drug Administration regulations in the consent forms they signed. He would be injecting them with a live, though weakened, herpes virus without U.S. safety oversight.

Still, many of them felt upbeat when they arrived on St. Kitts and Nevis in the spring of 2016. They had struggled for years with debilitating, painful herpes. Halford, the creator of the vaccine, sounded confident.

Maybe they could be cured.

“It felt like paradise,” one of the participants recalled. “Or therapy combined with vacation.”

A year later, their optimism has turned to uncertainty. Memories of kicking back in a Caribbean hotel during the trial have been overshadowed by the dread of side effects and renewed outbreaks.

But they can’t turn to Halford, a Southern Illinois University professor. He died of cancer in June.

They also can’t rely on his university, which shares in the vaccine’s patent but says it was unaware of the trial until after it was over. Because the FDA didn’t monitor the research, it can’t provide guidance. Indeed, there is little independent information about what was in the vaccine or even where it was manufactured, since Halford created it himself.

At a time when the Trump administration is pushing to speed drug development, the saga of the St. Kitts trial underscores the troubling risks of ambitious researchers making their own rules without conventional oversight.

“This is exactly the problem with the way the trial was conducted,” said Jonathan Zenilman, an expert on sexually transmitted diseases at Johns Hopkins Bayview Medical Center in Baltimore. “These people are supposed to have rights as human subjects, but now there’s nowhere for them to go. We may never know if this vaccine worked, didn’t work or, even worse, harmed anyone.”

Rational Vaccines, the U.S. company co-founded by Halford, still hopes to market the vaccine. It touted success online and to other researchers, prompting millions of dollars of recent investment, including from a company run by Peter Thiel, a backer of President Donald Trump.

Thiel, a PayPal co-founder who has excoriated the FDA as too bureaucratic, declined to answer questions about his investment, which occurred after the trial had ended.

Kaiser Health News interviewed five of the 20 participants in the clinical trial and several associates of Halford.

The participants agreed to speak on condition of anonymity because they don’t want to be known as having herpes. Most also said they feared retaliation from Halford’s company but hoped by speaking out some of their concerns might be addressed.

Their accounts, along with documents, a video and emails obtained by KHN from the offshore trial, pointed to what experts said were serious irregularities:

Halford did not rely on an institutional review board, or an “IRB,” which monitors the safety of research trials. The company has said it doesn’t know where Halford manufactured the vaccine, so it isn’t known whether he followed U.S. government guidelines when transporting it. Halford offered booster shots of the unapproved vaccine inside the United States. FDA regulations prohibit such injections.

“The FDA goes after these types of violations,” said Holly Fernandez Lynch, a lawyer and assistant professor who specializes in medical ethics at the University of Pennsylvania’s Perelman School of Medicine. “[Researchers] can be prosecuted.”

SIU, however, did little to discourage Halford. The university, which has a financial interest in the patent, said it learned of “the concerns” only after his death. In August, after KHN asked about the trial, the medical school’s IRB launched an investigation into whether Halford violated U.S. regulations or university rules.

In a statement to KHN, Rational Vaccines acknowledged that Halford “discussed a myriad of concerns … including the potential need for booster shots.”

“Unfortunately, Dr. Halford is no longer with us to address all the ways in which he may have investigated his concerns …,” stated the company. It added, “We nevertheless wholeheartedly intend to continue his line of investigation in a clinical setting to international good clinical practice standards.”

Racing Against Time

Halford first broke with scientific protocols in 2011, shortly after he was diagnosed with nasal cancer and treated with chemotherapy and radiation, according to an account he later posted on his blog.

By then, Halford was in his 40s and had worked almost a decade at SIU’s School of Medicine.

Halford, who did not have herpes, realized his cancer might not give him much time. If he submitted to the FDA’s oversight, it would take years, he reasoned in his account.

He decided to become his own research subject, injecting himself more than two dozen times with the vaccine.

“There is an ongoing herpes pandemic that demands the scientific community’s attention today, not tomorrow,” he wrote in his blog, which by his count received thousands of hits.

The experiments on himself, Halford believed, demonstrated the vaccine was safe.

In 2015, Halford set his sights on launching an offshore clinical trial.

However, his unorthodox approach made some of his peers recoil.

“He sat in my kitchen and tried to convince me to join him,” said Terri Warren, a nurse practitioner in Oregon who was approached by Halford in 2016 to help with the trial. “He believed so firmly in his vaccine. He said, ‘Think of all of the herpes patients who are suffering.’”

Warren had previously worked with Halford on a different, IRB-approved trial studying a new blood test to diagnose herpes. This time, she said, she became concerned about his methods, including how he was selecting his participants.

“I told him absolutely not,” she recalled. “I didn’t want anything to do with it. I felt bad for him because he was dying, but I thought he had lost perspective.”

But Halford did find backers, including Hollywood filmmaker Agustín Fernández III, whose credits include action films and an award-winning documentary.

Fernández recently declined to respond to questions. But in an earlier interview this year with KHN, he said he initially contacted Halford to try to help someone he knew who was battling the disease. He said he didn’t have herpes, or a background in science.

Fernández, however, became such a believer in Halford, he said, he allowed Halford to inject him with the vaccine. In 2015, he co-founded Rational Vaccines with Halford and invested his own money into the company. That same year, the company licensed two patents related to the vaccine from SIU.

“I felt like Bill had the answer, and we had to make sure he got a chance to prove it,” Fernández said.

‘Finally … Someone Who Cared’

As soon as news began spreading in the tight-knit herpes online community that Halford may have a cure, he began hearing from the most desperate who asked to be included in any future research.

For many, herpes is a mild disease that can be controlled by antiviral medicines. However, for some, it becomes a life-altering disease that destroys any hope of intimate relationships.

To several of the participants, Halford was an empathetic scientist who refused to give up on finding a cure.

“After dealing with doctors who had no answers, it felt like you were finally talking to someone who cared and could help,” said a participant in his 30s from the South who had described the trial as “paradise.”

There were other perks as well.

Rational Vaccines told some participants they would be reimbursed for their flight and hotel expenses. If they got through the entire trial, they would be given an extra $500.

As Halford organized two groups of 10 participants, he instructed them on drawing their own blood for the trial, according to a video filmed in a medical lab.

He proceeded with the trial from April to August 2016, giving participants three shots over three months.

Once in St. Kitts, many of them quickly bonded with one another and Halford. Even though they ranged in age from their 20s to 40s and came from different regions, they had the disease in common. They commiserated about how herpes had wreaked havoc on their lives.

“It was a relief to meet people who understood what we were talking about,” the Southerner said.

But other participants now say they noticed some troubling signs.

They received the injection in a house in St. Kitts, not a medical clinic.

Halford, whose gaunt frame made his cancer apparent by then, at times appeared disoriented.

Fernández, a constant presence, was introduced to them by name and made some of them uncomfortable when they socialized over drinks and dinner.

Some patients became anxious about their participation soon after receiving the vaccine.

One, a web developer in his 20s, felt ill after receiving just one dose.

“I experienced tiredness and ringing in my ears,” said the web developer, who reported the feelings along with “disequilibrium and slurred speech” continue to this day.

He said he decided not to return to St. Kitts for follow-up shots after Halford dismissed his symptoms as arising from a common cold.

Another participant, a Colorado woman in her 40s, said she told Halford she experienced flu-like aches and pains and tingling and numbness soon after the second shot. The symptoms were followed by an “excruciating” 30-day outbreak of herpes.

“I have new symptoms every day,” that woman later wrote Halford in an email exchange provided to KHN. “This is terrifying.”

Halford initially dismissed her symptoms, speculating they were caused by a mosquito-borne virus, she said.

She returned for the third shot but had her doubts. Halford and Fernández met her at a café to talk about her concerns, she recalled.

“[Fernández] kept saying, ‘You signed the consent form. You knew the risks,’” said the Colorado woman, who said Halford then removed her from the trial.

Another participant, a Californian in his 30s, said he went through with all three shots despite feeling a “terrible pain in my stomach.”

Halford then told him he had noticed in his research of mice that another version of the virus entered the gut of the mice and killed them, the participant said.

“I then thought maybe this is dangerous,” said the Californian, whose pain went away but his outbreaks did not.

Warren, the nurse practitioner in Oregon, said two participants tracked her down as a herpes expert. She said that they described possible side effects from the vaccine.

Halford had told participants he would follow up on their reactions to the vaccine for a year, according to the consent form. But he stopped sending questionnaires to the two participants who said they had been dropped from the trial.

Warren said that even when researchers stop administering a vaccine because of possible side effects, known as adverse events, they have a duty to track the subjects’ reactions.

“There is no doubt that these were adverse events that should have been reported,” Warren said.

Rational Vaccines did not respond to questions about the complaints. In previous public statements, it acknowledged that one of the 20 participants was concerned about possible side effects.

Some participants also wonder where Halford made the vaccine and how he transported it to St. Kitts.

Halford told his business partner he had made it outside of the United States, without disclosing where.

After the trial ended, some participants began complaining that the vaccine hadn’t worked. Halford and Fernández offered booster shots, according to four participants.

One participant, a man in his 40s who was also from California, declined to get the booster. He said he decided to go back to antiviral drugs when his outbreaks returned.

The Southerner said he agreed to allow Halford to give him booster shots at an office in Springfield, Ill., where Halford worked.

“It was between me and him,” said the participant. “He was doing me a favor.”

“I don’t know if it was a different strain or what, but he gave me a set of double boosters at the same time, one in each leg,” recalled the Southerner, who said he didn’t have records of the injections. He said he received them as Halford continued to collect data for the trial.

Months later, he said, he returned a second time for another set of boosters.

Courting Support Without Results

Halford, meanwhile, tried to persuade a U.S. scientific journal to publish a lengthy manuscript detailing the results of both his experiments on himself and his offshore trial. Halford put the cover letter on SIU letterhead.

In December 2016, only months after the trial had ended, Halford’s paper was rejected by the journal.

“This manuscript is partly a vision, partly science, and partly wishful thinking …,” said one reviewer for the journal. “Neither safety nor efficacy has been demonstrated by the data presented.”

Halford asked his former doctoral adviser, Daniel Carr, to attend a Rational Vaccines advisory board meeting. Carr, a University of Oklahoma Health Services Center professor, said he and other invitees heard glowing reports about the trial.

Carr agreed in May to present the trial data at a conference of herpes experts in Colorado.

A published summary of the event listed Carr as a lead author, though he said he wasn’t involved in the research.

“I just did it to help him out,” said Carr, who asked for his university’s permission to be on Rational Vaccines’ advisory board and is waiting for word on federal funding to study another version of Halford’s vaccine. “I also presented it because I thought that the scientific community would find it interesting.”

Despite its patent agreement reached in 2015, SIU said it was in the dark about Halford’s offshore activities until October 2016 — months after the trial had ended.

Halford, meanwhile, promoted his work at events attended by university officials.

In October 2016, Halford was a keynote speaker at an SIU-sponsored technology and innovation event to discuss his vaccine work.

Then, in April 2017, Halford and Rational Vaccines held a press conference to trumpet an investment pledge by Thiel’s company, according to materials handed out at the event. University officials, including SIU’s medical school dean, were invited speakers.

The university’s IRB is continuing its investigation, which includes scrutinizing whether Halford used university resources.

“If there are areas of concern, SIU will report those findings promptly to Department of Health and Human Services,” said SIU spokeswoman Karen Carlson. “We will also communicate our findings with the scientific community and the public.”

FDA spokeswoman Lauren Smith Dyer declined to comment on the trial except to say the FDA does not have jurisdiction over offshore trials that don’t seek agency approval.

Dyer, however, added that the export from the United States of an unapproved vaccine for research use and the injection of it on U.S. soil would be within the agency’s jurisdiction.

Even so, some participants don’t regret taking part in the trial.

“When you feel like a disease has ruined your life, you become desperate,” said the Southerner, who believes the boosters have lessened his outbreaks. “Some people contemplate suicide. You’re willing to do almost anything.”

Other participants still hope for some sort of accountability.

“I feel like without a doubt that my symptoms were vaccine-related,” said the Colorado woman. “I feel like it triggered something that I’ll have for the rest of my life.”

No matter what, experts said, the university has a responsibility to conduct an in-depth investigation. So far, the university has not reached out to participants who spoke to KHN.

“This researcher went rogue,” said Fernandez Lynch, the lawyer who specializes in medical ethics. “It’s true that universities can’t stand behind their researchers watching their every move. But when one of their own goes rogue, a university should launch an aggressive investigation, interview the participants and make sure it never happens again.”

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

Reminder when GOP tries to change the subject

The Congressional Budget Office may release numbers on the GOP’s ACA replacement as early as 4 PM EDT today. Just remember who appoints the CBO’s leader as the Republicans try to backpedal and say the numbers are biased when the CBO estimates just how many poor  and middle class people are going to lose health care coverage under Trump and the GOP.

Drug addiction treatments in peril

Facing Pressure, Insurance Plans Loosen Rules For Covering Addiction Treatment, But That Could Reverse Itself

Aetna, one of the nation’s largest insurance companies, will remove a key barrier for patients seeking medication to treat opioid addiction. The change will take effect in March and apply to commercial plans, a company spokeswoman confirmed, and will make it the third major insurer to make the switch.

Specifically, Aetna will stop requiring doctors seek approval before prescribing particular medications ― such as Suboxone ― that are used to mitigate withdrawal symptoms, and typically given along with steady counseling. The insurance practice, called “prior authorization,” can result in delays of hours to days in getting a prescription filled.

The change comes as addiction to opioids, which include heavy-duty painkillers and heroin, still sweeps the country. More than 33,000 people died from overdosing on these drugs in 2015, the most recent year for which statistics are available. And it puts Aetna in the company of Anthem and Cigna, which both recently dropped the prior authorization requirement for privately insured patients across the country. Anthem made the switch in January and Cigna this past fall.

Both companies took the step after facing investigation with New York’s attorney general, whose office was probing whether their coverage practices unfairly barred patients from needed treatment. They made this adjustment as part of larger settlements.

It sounds like just a technicality ― a brief delay before treatment. But addiction specialists say this red tape puts people’s ability to get well at risk. It gives them a window of time to change their minds or go into withdrawal symptoms, causing them to relapse.

“If someone shows up in your office and says, ‘I’m ready,’ and you can make it happen right then and there ― that’s great. If you say, ‘Come back tomorrow, or Thursday, or next week,’ there’s a good chance they’re not coming back,” said Josiah Rich, a professor of medicine and epidemiology at Brown University and doctor at Providence-based Miriam Hospital, who frequently treats patients with opioid addictions. “Those windows of opportunity present themselves. But they open and close.”

As these major carriers drop the requirement, treatment specialists hope a trend could be emerging in which these addiction meds become more easily available. In New York, for instance, the attorney general’s office will be following up with other carriers who still have prior authorization requirements, an office spokesperson said. The office would not specify which carriers it will next examine.

Meanwhile, though little research pinpoints precisely how widespread this coverage practice is for drugs that treat opioid addiction, experts say it’s a fairly common practice.

“Just think of any big health insurance company that hasn’t recently announced they’re doing away with this, and it’s a pretty safe bet they’ve got prior authorization in place,” said Andrew Kolodny, a Brandeis University senior scientist and the executive director of Physicians for Responsible Opioid Prescribing, an advocacy group.

Aetna will stop requiring doctors seek approval before prescribing particular medications such as Suboxone. (Wikimedia Commons)

How does the problem manifest? Take Boston Medical Center, located in a region that’s been particularly hard hit by opioid addiction. Doctors there wanted to launch an urgent care center focused on this patient population. Less than a year old, the program’s treated thousands of people.

But prior authorization requirements have been intense, said Traci Green, an associate professor at Boston University’s School of Medicine and deputy director of the hospital’s injury prevention center. To help people get needed care ― before it was too late ― the center hired a staffer devoted specifically to filling out all the related insurance paperwork.

“It was like, ‘This is insanity,’” Green said, adding that “navigating the insurance was a huge problem” for almost every patient.

But defenders of the requirement maintain that such controls have value. Insurance plans using prior authorization may view it as a safeguard when prescribing a potentially dangerous drug. “[It’s] not a tool to limit access. It’s a tool to ensure patients get the right care,” said Susan Cantrell, CEO of the Academy of Managed Care Pharmacy, a trade group.

Other large insurance carriers ― such as United Healthcare and Humana ― list on their drug formularies a prior authorization requirement for at least some if not all versions of anti-addiction medication. A spokesperson from Humana said the practice is used “to ensure appropriate use.”

Also, though, it is generally agreed that the practice is used to control the prescribing of expensive medications. Per dose, the cost of these drugs varies based on brand and precise formulation, but it can go as high as almost $500 for a 60-pack dose, which can last a month.

Regardless of intent, critics say, those extra forms and hoops do make it more difficult for patients in need to get these medications ― ultimately, they say, doing more harm than good.

“If you would like a physician to not do a particular treatment, put a prior authorization in front of it,” Rich said. “That’s what they’re used for.”

Meanwhile, addiction treatment advocates and health professionals are hoping to build on what they see as new momentum.

Earlier this month, the American Medical Association sent a letter to the National Association of Attorneys General, calling for increased attention to insurance plans that require prior authorization for Suboxone or other similar drugs.

Minnesota’s attorney general has written to health plans in the state, asking they end prior authorization for addiction treatment. New York has also heard from other states interested in tackling the issue, the attorney general spokesperson said. And another project, called Parity Track, is soliciting complaints from consumers.

They’re arguing based on a requirement that insurance plans, thanks to so-called “parity laws,” must cover addiction treatment, and cover it at the same level as they do other kinds of health care.

The prior authorization requirement “doesn’t meet the sniff test for parity,” said Corey Waller, an emergency physician who chairs the American Society of Addiction Medicine’s legislative advocacy committee. “It’s a first-line, Food and Drug Administration-approved therapy for a disease with a known mortality. Every other disease with a known mortality ― the first-line drugs are available right away.”

But the justification for legal cases like New York’s could get weaker. The 2010 health law, which lawmakers are working to repeal, included requirements that mental health and addiction treatment be considered an “essential health benefit.” If that disappears, robust coverage for addiction could be less widely available, several noted.

Meanwhile, the stakes are substantial, Rich said. He recalled a patient who was taking a version of buprenorphine ― the active ingredient in Suboxone ― who had a brief relapse with heroin. That led to complications in the paperwork for renewing his prescription for treatment.

“Now he’s out of the office, in the street, using more,” Rich said of that case. “Incumbent upon [effective treatment] is the ability to get people started right away. If there’s prior authorization? It’s infuriating.”

Influence Of GOP Doctors Caucus Grows As Congress Looks To Replace Health Law

“Their views are driven more by political affiliation,” said Mona Mangat, an allergist-immunologist and chairwoman of Doctors for America, a 16,000-member organization that favors the current health law. “It doesn’t make me feel great. Doctors outside of Congress do not support their views.”
 
Tom Price, a member of the GOP Doctor’s Caucus on Capitol Hill. at his confirmation hearings as Secretary of Health and Human Services. (Photo: NPR)

The confirmation of Tom Price, the orthopedic surgeon-turned-Georgia congressman, as secretary of Health and Human Services represents the latest victory in the ascendancy of a little-known but powerful group of conservative physicians in Congress he belongs to — the GOP Doctors Caucus.

During the Obama administration, the caucus regularly sought to overturn the Affordable Care Act, and it’s now expected to play a major role determining the Trump administration’s plans for replacement.

Robert Doherty, a lobbyist for the American College of Physicians, said the GOP Doctors Caucus has gained importance with Republicans’ rise to power. “As political circumstances have changed, they have grown more essential,” he said.

“They will have considerable influence over the considerable discussion on repeal and replace legislation,” Doherty said.

Price’s supporters have touted his medical degree as an important credential for his new position, but Price and the caucus members are hardly representative of America’s physicians in 2017. The “trust us, we’re doctors” refrain of the caucus obscures its heavily conservative agenda, critics say.

“Their views are driven more by political affiliation,” said Mona Mangat, an allergist-immunologist and chairwoman of Doctors for America, a 16,000-member organization that favors the current health law. “It doesn’t make me feel great. Doctors outside of Congress do not support their views.”

For example, while the American College of Obstetrics and Gynecology has worked to increase access to abortion, the three obstetrician-gynecologists in the 16-member House caucus are anti-abortion and oppose the ACA provision that provides free prescription contraception.

While a third of the U.S. medical profession is now female, 15 of the 16 members of the GOP caucus are male, and only eight of them are doctors. The other eight members are from other health professions, including a registered nurse, a pharmacist and a dentist. The nurse, Diane Black of Tennessee, is the only woman.

On the Senate side, there are three physicians, all of them Republican.

While 52 percent of American physicians today identify as Democrats, just two out of the 14 doctors in Congress are Democrats.

About 55 percent of physicians say they voted for Hillary Clinton and only 26 percent voted for Donald Trump, according to a survey by Medscape in December.

Meanwhile, national surveys show doctors are almost evenly split on support for the health law, mirroring the general public. And a survey published in the New England Journal of Medicine in January found almost half of primary care doctors liked the law, while only 15 percent wanted it repealed.

Rep. Michael Burgess, R-Texas, a caucus member first elected in 2002, is one of the longest serving doctors in Congress. He said the anti-Obamacare Republican physicians do represent the views of the profession.

“Doctors tend to be fairly conservative and are fairly tight with their dollars, and that the vast proportion of doctors in Congress [are] Republican is not an accident,” Burgess said.

Price’s ascendancy is in some ways also a triumph for the American Medical Association, which has long sought to beef up its influence over national health policy. Less than 25 percent of AMA members are practicing physicians, down from 75 percent in the 1950s.

Price is an alumnus of a boot camp the AMA runs in Washington each winter for physicians contemplating a run for office. Price is one of four members of the caucus who went through the candidate school. In December, the AMA immediately endorsed the Price nomination, a move that led thousands of doctors who feared Price would overturn the health law to sign protest petitions.

Even without Price, Congress will have several GOP physicians in leadership spots in both the House and Senate.

Those include Rep. Phil Roe of Tennessee, the caucus co-chairman, who also chairs the House Veterans Affairs Committee, and Burgess, who chairs the House Energy and Commerce subcommittee on health. Sen. Bill Cassidy of Louisiana sits on both the Finance and the Health, Education, Labor and Pension Committees. Sen. John Barrasso of Wyoming chairs the Senate Republican Policy Committee.

Roe acknowledges that his caucus will have newfound influence. Among his goals in molding an ACA replacement are to kill the requirement that most people buy health insurance (known as the individual mandate) as well as to end the obligation that 10 essential benefits, such as maternity and mental health care, must be in each health plan.

He said the caucus will probably not introduce its own bill, but rather evaluate and support other bills. The caucus could be a kingmaker in that role. “If we came out publicly and said we cannot support this bill, it fails,” Roe said.

The GOP Doctors Caucus has played a prominent role in health matters before Congress. For example, in 2015, when former House Speaker John Boehner needed help to permanently repeal a Medicare payment formula that threatened physicians with double-digit annual fee cuts, he turned to the GOP Doctors Caucus. It got behind a system to pay doctors based on performance — the so-called doc fix.

“When the speaker had a unified doctors’ agreement in his coat pocket, he could go to Minority Leader Nancy Pelosi and show that, and that had a lot to do with how we got this passed,” Roe said.

But not all doctors are unified behind the caucus. Rep. Raul Ruiz, one of the two physicians in the House who are Democrats, said he worries because few doctors in Congress are minorities or primary care doctors.

Ruiz, an emergency room physician from California who was elected in 2012, said he is wary about Price leading HHS because he is concerned Price’s policies would increase the number of Americans without insurance.

Indeed, many doctors feel the caucus’ proposals will not reflect their views — or medical wisdom. “My general feeling whenever I see any of their names, is that of contempt,” said Don McCanne of California, a senior fellow and past president of the Physicians for a National Health Program. “The fact that they all signed on to repeal of ACA while supporting policies that would leave so many worse off demonstrated to me that they did not represent the traditional Hippocratic traditions which place the patient first.”

Christina Jewett contributed reporting. This story also appeared on National Public Radio (NPR).

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Abortion foe admits they want to outlaw contraceptives

An anti-abortion activist gets cornered into admitting the movement ultimately wants to make contraception, including the pill, illegal. But we knew this already. They usually only admit to it when they are speaking to an audience of their own and think nobody else is listening.

This is but one among the very good reasons why you should care about abortion even if you or someone you know will never need one. 

Because if they get their way with that issue alone, they will go for any pharmaceutical or medical procedure with which they disagree.

And then they’ll come after you. Because these people — and I can tell you this from many years of experience — will never rest until your life adheres to their capricious rules.

Does a government or private entity help pay your Obamacare premiums?

Insurers, Hospitals Clash Over Help Paying Obamacare Premiums

In many locales, private for-profit insurers are fighting against the practice because it allows sick low income people to afford private insurance, driving up costs for the private insurers.
Mercedes Nimmer, who lives outside Madison, Wis., gets help paying for her Obamacare insurance premiums from HealthConnect, a program run by the local United Way organization. (Phil Galewitz/KHN)
Mercedes Nimmer, who lives outside Madison, Wis., gets help paying for her Obamacare insurance premiums from HealthConnect, a program run by the local United Way organization. (Phil Galewitz/KHN)

MADISON, Wis. — Having health insurance is vital for 21-year-old Mercedes Nimmer, who takes several expensive prescription drugs to manage multiple sclerosis. So Nimmer was thrilled to get health insurance last year through the Affordable Care Act’s marketplace and qualify for a federal subsidy to substantially lower her cost.

Yet, the government assistance still left her with a $33 monthly premium, a hefty amount for Nimmer, who makes $11,000 a year as a part-time supply clerk.

Nimmer, though, doesn’t have to worry about even that expense thanks to a United Way of Dane County program that has provided premium assistance to about 2,000 low-income people since 2014. The program, called HealthConnect, is funded by a 2013 gift of $2 million from UW Health, a large academic hospital system connected to the University of Wisconsin that also runs its own marketplace health plan.

“Oh my gosh, this is a big deal for me to get this help,” Nimmer said, noting the insurance is vital to cover her medications. The money she saves from the assistance program goes to help pay for gas to get to work, she said.

HealthConnect is one of several community-based programs across the United States helping thousands of lower-income Americans with their Obamacare marketplace premiums. Similar efforts operate in Texas, Oregon, Washington, North Carolina and South Carolina.

But premium assistance programs have come under fire from insurers. They argue that it is not fair for hospitals, other health providers and disease advocacy groups financed by providers to try to steer people who could be covered by Medicare or Medicaid into marketplace plans with higher reimbursement rates.

The federal government has banned hospitals from directly subsidizing patients’ health insurance premiums. But America’s Health Insurance Plans, the industry’s lobbying group, wants the Obama administration to prohibit all premium assistance programs that are funded directly or indirectly by hospitals and other providers with a financial interest in the patient’s care.

“In many cases these practices are harming patients and undermining the individual market by skewing the risk pool and driving up overall health care costs and premiums,” AHIP said in Sept. 22 letter to Andy Slavitt, the acting administrator of the Centers for Medicare & Medicaid Services. The letter notes specific concerns about plans assisting patients requiring kidney dialysis. It says one insurer saw its spending on those patients rise from $1.7 million in 2013 to $36.8 million in 2015 when the number of patients with serious kidney disease rose from 28 to 186.

AHIP officials also said patients could face consequences if the third-party groups stop paying premiums or the government determines patients are receiving a federal subsidy for which they are not eligible.

America’s Health Insurance Plans wants the Obama administration to prohibit all premium assistance programs that are funded directly or indirectly by hospitals and other providers.

In response, CMS says it is considering new rules for third-party payment programs.

Nonetheless, insurers are taking action. Aetna, which announced this summer that it was scaling back its marketplace offerings, said that third-party groups steering patients to the individual market had contributed to an unhealthy mix of customers in its marketplace plans.

Blue Shield of California in July filed suit in a state court against CenCal Health, which manages the Medicaid program in Santa Barbara and San Louis Obispo counties. Blue Shield alleges that CenCal was avoiding millions of dollars in medical care claims by enrolling around 40 of its very ill members in Blue Shield’s individual health plans and paying the premiums on their behalf. CenCal denied the allegations in lawsuit, saying it paid the patients’ monthly Blue Shield insurance premiums so they could afford private insurance. It has since discontinued the practice.

UnitedHealthcare filed a lawsuit in federal court in July against kidney dialysis provider American Renal Associates, accusing it of encouraging patients in Florida and Ohio who were eligible for Medicaid or Medicare to move to the insurer’s commercial plans to extract up to 20 times more than the $300 or so that the federal programs pay in reimbursements. American Renal Associates has said the suit is without merit.

The suit alleges that the patients’ premiums were paid by the American Kidney Fund, an advocacy group for patients.

AHIP officials note that the fund is supported by dialysis providers who stand to benefit financially from patients gaining marketplace coverage over payments from Medicaid or Medicare.

The nonprofit American Kidney Fund has helped more than 6,400 people with their marketplace premiums. The fund’s officials said it’s not trying to steer people away from government coverage but trying to help those who otherwise couldn’t afford coverage.

“It is critically important to emphasize that people with disabilities in general — and with end-stage renal disease in particular — should not be broadly excluded as a class from the insurance marketplace if they are unable to afford their health insurance premiums,” LaVarne Burton, the fund’s CEO, said in a statement.

Some patient advocates, like those at HealthConnect in Wisconsin, say third-party payers have an important role in helping low-income customers afford their coverage. UW Health said in a statement that HealthConnect helps all providers, including UW Health, by reducing the number of uninsured patients and potentially helping people seek care earlier in their illness.

The program pays an average of $109 monthly per person in premium assistance. For every dollar spent, HealthConnect generates $2.26 in federal subsidies, said Krystal Webb, a spokeswoman for United Way of Dane County.

United Way said it structured HealthConnect to avoid a conflict of interest. Eligible people first buy their policy, which can be any of several silver-level plans on the federal marketplace. After that, they can apply for a HealthConnect subsidy. The program is administered by United Way, and UW Health plays no role in patients’ choice of health plan, although its marketplace plan, Unity Health, refers people who may be eligible there.

Despite AHIP’s concerns, some health insurers in Dane County say HealthConnect is filling a need, according to interviews with several plans. “We support United Way’s HealthConnect efforts as a way to provide affordable insurance options to the residents of Dane County,” said a spokesman for Dean Health Plan, one of the larger marketplace plans in the county.

In Texarkana, Texas, Christus St. Michaels Health System donated $200,000 last year to an assistance program serving 138 people with marketplace coverage. The program is run by a local government agency called the Ark-Tex Council of Governments, and Christus has no control over who enrolls or what plan they choose.

“Our mission is to help the poor and this is certainly one of the ways to do that, and it gives people the opportunity to have health coverage when they normally wouldn’t,” said Mike Hargrave, the hospital’s manager of employee assistance and community outreach services. People with incomes between 100 and 150 percent of the federal poverty level (about $11,880 to $17,820 for an individual) are eligible.

Hargrave doesn’t deny the hospital could benefit when more people gain insurance, but he notes other hospitals in the region benefit, too.

The insurance industry is also troubled by premium assistance programs funded by anonymous donors since they could be hospitals looking to protect their identity, said AHIP spokeswoman Clare Krusing.

For example, PremiumHealth.org, run by United Way of the Greater Triangle in North Carolina helps more than 850 people with incomes between 100 percent to 175 percent of the federal poverty level in Durham, Orange and Wake Counties.

An anonymous donor provided $1.2 million in funding for the program, said Melanie David-Jones, a senior vice president for United Way. She would not say why the donor wished to remain anonymous.

Noel Pitsenbarger, 48, of Durham, said the program made it possible for him to have health insurance this year by covering the $200-a-month premium for his Blue Cross Blue Shield of North Carolina policy. With insurance, he said, he got a colonoscopy, physical exam and help paying for several medications. And it saved him from having to pay a $1,000 bill after he cut his finger and had to go to the emergency room.

“It’s been extremely beneficial,” he said.

Protecting yourself from hospital infections

Graphic: CDC
Graphic: CDC

Sometimes the biggest danger in a hospital, nursing home or home care setting is not your or loved one’s original illness. It’s infections that can be transferred to you due to sloppy health care practices.

This tidbit appeared on ScienceBlogs.com regarding the nasty bug that is often found in long-term care situations, including hospitals and nursing homes: 

As the name implies, Clostrodium difficile (C. diff.) bacterial infections are difficult to treat because of antibiotic resistance. The problem with C. diff is that these bacteria release toxins that cause inflammation and diarrhea. In fact, C. diff is the number one cause of infectious diarrhea in hospitals as well as long-term care facilities. Studies have shown that probiotic yeast may help prevent C. diff infections. While these studies are exciting, much of this prior research has not looked at strains of C. diff that are commonly involved in outbreaks.

A new study published in the American Journal of Physiology – Gastrointestinal and Liverexamined whether a probiotic yeast (Saccharomyces boulardii CNCM I-745) could be used to prevent common outbreak-associated C. diff infections or their complications. The research team found that administering live yeast 5 days prior to a C. diff infection reduced the toxic effects of the bacteria in the gut of hamsters. The authors concluded that probiotic yeast may therefore help prevent outbreaks of C. diff.

I was hospitalized recently for six weeks. I entered with septicemia from a blood infection — which they had under control until I came down with a case of C.diff. Soon my stay stretched past six weeks. And every time someone walked into my room they had to wear a gown and gloves.

So it is good news that they might have another way of treating C.diff or preventing the worst of its symptoms.

But I am using this as a stepping off point for a larger issue: infection control procedures in health care settings. 

I think most people who work in hospitals are appropriately cognizant of how important it is to wash their hands and take appropriate steps to avoid spreading infections from one patient to another.

Yet even the best ones can cut corners if they seem super busy or tired. And then there are the ones who don’t seem to take these infection control steps seriously at all. People on the night shift appear, from my experience, to be more careless than day shifters.

I finally reported to the night shift nurse one person who was particularly bad. Soon my complaint had gone up the chain of command to the head of the department where phlebotomists work. The next afternoon that supervisor came in and took a report. 

The next time that phlebotomist came in to draw blood a few days later, she was very good at her job. 

Then, when I first got home, I had a home health nurse who came to show me how to set up IV infusions at home. Yet he walked into my apartment and started handling all the IV equipment without even washing his hands or wearing gloves.

Who knows what was on his hands from the outside world? I called him on it (nicely) and although initially he was a little put off by my questioning him, he has been very good ever since.

The most important thing you need to remember is this: do not be afraid to nicely bring up these issues if you see someone being sloppy about infection control steps. Suggest that the person needs to wash their hands and wear gloves before handling anything this goes into body. Don’t let them place IV needles onto unsanitary surfaces before using. The ends of all IV equipment should be wiped with an alcohol pad once unsheathed and before being connected to any tubing or connectors.

Do this for incapacitated loved ones, especially if they are in a nursing home facility where they might be afraid to speak up. If you ever see someone not follow infection control procedures you should speak up for your loved ones. If you do not get the impression that the facility takes this seriously, you might consider another placement if that is an option.

What else can be done? Look at the graphic below from the CDC for some ideas.

Source: CDC
Source: CDC

Taxpayers also pay when drug companies price gouge

epipen

Even as the cost of EpiPens dramatically rose, so too did the number of prescriptions written for patients in Medicare, sending spending by the program skyrocketing nearly 1,100 percent from 2007 to 2014, a new report shows.

During the same period, the total number of Medicare beneficiaries using EpiPens climbed 164 percent, from nearly 80,000 users in 2007 to more than 211,000 in 2014, according to the analysis by the Kaiser Family Foundation. While the report does not delve into what’s behind the increase, factors could include increased awareness among people with allergies, marketing efforts and access to insurance coverage.

The abrupt rise is notable because many people think that life-threatening allergies are less common among the elderly. In addition, epinephrine — the active ingredient in EpiPens — can pose greater risks to older adults. Food and Drug Administration labeling urges caution when prescribing to this age group.

“That level of increase gives me pause,” said Martha Twaddle, senior medical officer for Illinois at Aspire Health, which provides home-based supportive care for people with serious illness.  She did not work on the study. Epinephrine — the active ingredient in EpiPens — can cause side effects including chest pain, rapid increase in blood pressure or irregular heart rhythms, which could be fatal, for people with certain medical conditions, including heart disease.

The foundation study comes amid ongoing scrutiny — including congressional testimony Wednesday by Mylan CEO Heather Bresch — over EpiPen price increases. (Kaiser Health News is an editorially independent program of the Foundation.)

EpiPens are used in cases of severe allergic reactions. Costs for a two-pack of the pens has gone from about $94 in January 2007 to $609 in May of this year. In response to criticism of its price increase, Mylan announced in late August that it would make a generic version and price it at half of its current brand name price.

The new numbers from Medicare could add fuel to the debate over these price increases and voters’ demands that Congress take action to roll back the cost of the popular medication.

The health insurance program for senior citizens and disabled people spent about $6.4 million on the devices in 2007, but spent $75.3 million in 2014, with sharp price hikes by the manufacturer driving much of the increase. Those figures reduce the amount spent based on estimates of how much Medicare saved in rebates from manufacturers, although the agency would not disclose the exact amounts.

Still, when patients show up in emergency rooms with life-threatening allergic reactions, epinephrine is a first line of defense, said Robert Glatter, emergency room physician at Lenox Hill Hospital in Manhattan. Those whose allergic reaction isn’t immediately life threatening would more likely get a mix of steroids and antihistamines, he said.

All patients with suspected severe allergic reactions — even the elderly — are given either a prescription or an actual epinephrine auto injector upon discharge, he said.

“We tell them to have it and use it if they have a lip or tongue swelling, shortness of breath, a skin rash [or other symptoms] of a problem,” said Glatter, adding that adults tend to become more susceptible to food allergies as they age.

Increased awareness among doctors and patients about the importance of epinephrine could account for some of the increase seen in the study, said Richard Lockey, a past president of both the World Allergy Organization and the American Academy of Allergy, Asthma & Immunology.

“Most people survive an allergic reaction … the people who don’t survive are those who don’t get epinephrine or don’t get it soon enough,” said Lockey, who says it is necessary to balance this idea with the possible risks epinephrine poses for older patients. “It’s a matter of clinical judgment.”

Although Medicare is generally thought of as the government health program for older people, about 16 percent — or 9.1 million beneficiaries — are younger than 65. They are generally disabled or have kidney problems requiring dialysis. According to foundation researchers, although the majority of users were older than 65, a disproportionate share – 35 percent — of the EpiPen users were younger than 65. Additionally, 26 percent were between 65 and 69. Use fell off with age, with only 15 percent of the users being between ages 75-85.

“You can come up with a ton of reasons why the under-65 population might see an increase in EpiPen use,” said James Goodwin, an expert in geriatric medicine at the University of Texas Medical Branch in Galveston. He did not work on the study.

As for the overall increase, Goodwin said there are likely many factors and it isn’t necessarily evidence of overutilization. Still, Goodwin says he specializes in patients older than age 80 and has never prescribed an EpiPen, nor had three of his colleagues, who work with slightly younger elderly patients.

One geriatrician said he has patients who are on it with prescriptions from their allergists, who weigh the pros and cons of having the drug. Those physicians “are the ones to say your allergy is serious enough to potentially become life threatening.”

At the American Geriatrics Society, epinephrine is not included on the organization’s list of potentially inappropriate medicines, said Nicole Brandt, a professor at the School of Pharmacy at the University of Maryland.

“When you look at in context of someone having a severe anaphylactic reaction, which is life threatening, you want access to treatment,” said Brandt. She said doctors should caution patients about the appropriate use of the devices and encourage them to seek additional medical attention if they experience side effects.

She suggested the increase in Medicare prescriptions seen in the study reflects access to insurance more than overuse.

Since Medicare drug plans cover part of enrollees’ total drug costs, beneficiaries in prescription drug plans pay less that the full retail price. But beneficiaries still paid significantly more of their own money for EpiPens during the seven-year period studied in the report. Average out-of-pocket spending for beneficiaries with Medicare drug coverage nearly doubled for each EpiPen, from $30 to $56. The report does not include price increases beyond 2014.

Still, those costs are far less than what some people with private insurance might pay, particularly those with high deductibles. As a result, at least one doctor — geriatrician David Barile from Princeton, New Jersey — who did not work on the study, speculated that the rise in Medicare use of EpiPens might simply be older people getting them for their grandchildren.

Mylan's embattled CEO Heather Bresch is shown here (right) speaking at Fortune Magazine's at a meeting for Wall's Street's most powerful women.
Mylan’s embattled CEO Heather Bresch is shown here (right) speaking at a Fortune Magazine meeting for Wall’s Street’s most powerful women.

Liz Szabo contributed to this report.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

First time for everything: child euthanasia in Belgium

euthanasia

I’m not usually one for slippery slope arguments because they can ignore the nuances of any argument and they are often used as a rhetorical Hail Mary pass when all other arguments have been exhausted.

But I do think they have merit when it comes to physician-assisted euthanasia. Take a look at this:

A terminally ill 17-year-old in Belgium became the first minor euthanized after the country lifted age restrictions for voluntary euthanasia in 2014. The identity of the teenager and date of his or her death have not been released, though a Belgian official confirmed the euthanasia happened within the last week.

My intense opposition to widely available euthanasia is nearly the only thing on which I agree with Catholic teaching.

I just spent six weeks in the hospital with no insurance due to an unfortunately timed lapse in my health insurance coverage. So all six-plus weeks of uncovered hospital care, including a stay in an ICU, are only my responsibility.

I’m single. I have no dependents and no giant nest egg to which I can leave any possible dependents even if I had them. But if I had a spouse who depended on our savings, or children who could watch their inheritance disappear with a long-term hospital stay or at-home debilitation, might I have felt differently when I was asked on the second day of my hospital stay to sign a paper saying how much of an effort I wanted them to exert if my heart stopped? (I told them I wanted them to make every effort to revive me if that happened.) Might I have experienced subtle or overt pressure from family members if they had a stake in my estate?

I’ve been around families where one or both parents were in nursing homes or hospitals and the bills were mounting quickly. Those scenarios can bring out the worst in people who have been counting on an inheritance. That’s cruel, I know. But it happens in the best of families. Death and money can bring out people’s inner demons.

Coupled with the general sense of alienation one can feel in circumstances of long-term incapacitation and I can see many patients thinking they had nothing to live for, even if there was some chance later they might pull out of it. Being disabled, even for a short period, is to have occasional bouts of intense loneliness and a feeling of not being in control of your life.

We live in a society where health care is seen as a privilege and not a right. Health care is treated as a commodity. There is also a general devaluing of the aged in America. I’m not sure I can ever trust this country with widely available euthanasia under those circumstances.

I do not know the circumstances of this case. Perhaps the child was brain dead. Perhaps he faced a life of intractable pain. 

It would be a tough call then. But it should always be a tough call, and not something that becomes commonplace.