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Mayo Pain Expert: Holistic Approach Helps Patients Ditch Opioids

Kaiser Health News:Insurance - August 29, 2017

Each year, more than 300 patients with chronic pain take part in a three-week program at the Pain Rehabilitation Center at Mayo Clinic in Rochester, Minn. Their complaints range widely, from specific problems such as intractable lower-back pain to systemic issues such as fibromyalgia. By the time patients enroll, many have tried just about everything to get their chronic pain under control. Half are taking opioids.

In this 40-year-old program, that’s a deal breaker. Participants must agree to taper off pain medications during their time at Mayo.

More than 80 percent of the patients who enroll stay for the entire program, said Wesley Gilliam, the center’s clinical director, and many previous opioid users who finish the treatment report six months later that they have been able to stay off opioids. Just as important, he added, they have learned strategies to deal with their pain.

Insuring Your Health

KHN contributing columnist Michelle Andrews writes the series Insuring Your Health, which explores health care coverage and costs.

To contact Michelle with a question or comment, click here.

This KHN story can be republished for free (details).

But such a program is not for everyone. Insurers might disagree that the intensive, interdisciplinary approach is medically necessary for some patients or simply not cover the program’s billing codes, he said. Mayo’s insurance team sometimes advocates on patients’ behalf if they’re good candidates for treatment, but success isn’t assured.

Mayo’s program isn’t the only one to address the emotional, social and psychological aspects of pain, and other programs also focus on reducing patients’ reliance on addictive medications to manage their pain. But as the nation weathers an opioid epidemic, there are too few programs like these around the country to address the need, Gilliam said.

Gilliam, a clinical psychologist with a specialty in behavioral pain management, talked with me about the program.

The transcript has been condensed and edited for clarity.

Q: How do pain medications work? By blunting the pain?

Wesley Gilliam, the clinical director of the Mayo Clinic’s pain rehabilitation center, says the use of medication and relaxation exercises can help relieve pain. (Courtesy of the Mayo Clinic)

They blunt some of the pain. Opioids are very effective for acute problems, but they were never designed to be used chronically. They’re not effective in the long term.

Opioids are central nervous system depressants. They soothe people who are in distress. Many people aren’t demonstrating improved functioning when they take opioids; it’s calming their nerves. It’s chemical coping.

Q: In treating pain, does it matter what’s causing it or how severe it is?

Pain is pain. The fundamental approach to self-managing it doesn’t change based on the cause or severity of the pain. 

Q: How does someone wind up at a program like yours?

Virtually all of our patients have tried and exhausted primary and secondary treatment options for pain.

[In] primary care, a patient comes in with a complaint, and a treatment plan is developed. It generally involves encouraging the patient to be active, to stretch, maybe the doctor initiates a non-opioid medication like a non-steroidal anti-inflammatory (NSAID) or an antidepressant.

If the patient continues to complain of chronic pain, the primary care provider will step up to level two and refer someone to a neurologist or maybe a pain psychologist or pain anesthesiologist.

If patients don’t respond, they start to think about step three, which is a pain program like Mayo.

Q: How does the Mayo program work?

People come to us every weekday from 8 a.m. to 4 p.m. for three weeks.

We don’t take a medical approach. It’s a biopsychosocial approach, [which] acknowledges not only the biological aspect of pain, but also recognizes that psychological and social variables contribute to how people experience pain.

That is not to say that pain is imagined, but rather how people experience pain is influenced by mood, anxiety and how that person’s environment responds to the person’s symptoms.

A more medical approach tends to focus on targeting and eliminating symptoms at the expense of the recognition of individual differences.

Q: What does that mean for the patient who’s in pain?

People need to accept that they have pain and focus on their quality of life. Some approaches reinforce in patients that the only way you can function is if you reduce your pain, as measured on a pain scale from zero to 10.

We focus on how to get you back into your life by focusing on function instead of eliminating symptoms and pain. When I refer to functioning, I mean getting back into important areas of your life such as work, social activities and recreation. If you’re waiting for pain to go away, you’re never going to get back into your life. When that happens, people get despondent, they get depressed.

Q: So how do you help people manage it?

When you’re in chronic pain and it’s poorly managed, the nervous system can get out of whack. Your body behaves as if it’s under stress all the time, even when it’s not. Your muscles may be tense and your heart and breathing rates elevated, among other things.

With meditation and relaxation exercises, we’re trying to teach people to learn to relax their bodies and hopefully kick in a relaxation response.

If I have low-back pain, for example, during periods of stress muscular tension is going to exacerbate the pain in my back. We focus on helping people to disengage from their symptoms.

By learning to relax in response to stress, muscular tension can be diminished and the experience of pain eased. This doesn’t require a medication or a procedure, just insight and implementation of a relaxation skill.

Relaxation/meditation training is one component of a much broader treatment package. All aspects of our treatment — cognitive techniques for managing mood, anxiety and anger, physical therapy, occupational therapy — are all designed to settle the nervous system.

Q: Does insurance typically cover the program? 

Insurance companies may want to see patients complete more conservative treatment approaches before approving an interdisciplinary pain rehabilitation program like ours.

There are patients whose policies don’t cover our billing codes. If we deem a patient a good candidate, we’ll write letters saying they should be accepted.

There are a very select few who have paid out-of-pocket for our program. This is a significant minority, however. The program can cost up to $40,000 for someone with other complicated medical problems in addition to chronic pain.

There are studies that show these programs do save money over the long term in health care costs and reduced health care utilization.

If we’re going to manage this chronic pain problem, we have to look at it for what it is: multifaceted. You can’t just treat the symptom, you have to treat the whole person.

Please visit khn.org/columnists to send comments or ideas for future topics for the Insuring Your Health column.

HHS establishing medical shelter to aid those affected by Hurricane Harvey

HHS Gov News - August 29, 2017

Thousands of Texans sheltering at the George R. Brown Convention Center in Houston will have medical care on-site through a 250-bed Federal Medical Station established by the U.S. Department of Health and Human Services (HHS) at the request of the State Department of Health. The Federal Medical Station is scheduled to be operational Wednesday.

HHS also is helping evacuate hospital patients to healthcare facilities outside the impacted area.

“We are committed to supporting state and local agencies in meeting the healthcare needs emerging from this devastating storm,” said Secretary of Health and Human Services Tom Price, M.D. “The Federal Medical Station we are setting up and staffing in Houston will provide vital care to Texans affected by Hurricane Harvey, and we stand ready to devote additional resources as needed.”

The Federal Medical Station at the convention center will be staffed by members of HHS’ National Disaster Medical System and U.S. Public Health Service Commissioned Corps. 

HHS has additional Federal Medical Stations available for patient care in Texas, and has positioned two 250-bed Federal Medical Stations in Baton Rouge ready to be deployed in Louisiana should state officials determine they are needed.

HHS has more than 500 personnel on the ground to assist those affected by Hurricane Harvey and 1,300 more on standby.

HHS also has helped local public health officials address the needs of those who rely upon electricity-dependent medical equipment. Using its emPOWER tool, HHS has provided information to local public health officials about the number of Medicare beneficiaries in each impacted area who rely on 14 types of life-maintaining and assistive equipment, ranging from oxygen concentrators to electric wheelchairs, as well as data on the number of people who rely on dialysis, oxygen, and home health services. These citizens are among the most vulnerable in their communities and most likely to need life-saving assistance in prolonged power outages.

HHS has activated its Disaster Distress Helpline, a toll-free call center, that is available at 1-800-985-5990 to aid people in coping with the behavioral health effects of the storm and help people in impacted areas connect with local behavioral health professionals.

In addition to full-scale coordination across the federal Cabinet agencies, HHS remains in regular contact with Texas and Louisiana health officials to maintain awareness of the local situation and stands ready to augment support to the states as the situation unfolds. 

Critical updates will also be available at:

HHS’ NDMS consists of approximately 5,000 medical, public health, and emergency management professionals from communities nationwide and serve as Federal government employees when activated as part of a coordinated federal response.

HHS Secretary Price declares public health emergency in Louisiana due to Hurricane Harvey

HHS Gov News - August 29, 2017

Following the lead of President Trump's disaster declaration for Louisiana, Health and Human Services Secretary Tom Price, M.D., today declared a public health emergency in Louisiana in response to Hurricane Harvey. In addition, he has taken action that gives HHS’ Centers for Medicare & Medicaid Services’ (CMS) beneficiaries and their health care providers greater flexibility in meeting emergency health needs.

“As Louisiana and Texas contend with the historic flooding caused by Hurricane Harvey, HHS is committed to doing all that we can to ensure that those affected by this storm receive the vital assistance and support they need,” said Secretary Price. “The people of Louisiana who rely on Medicare, Medicaid, and CHIP for their healthcare needs can be confident that this declaration will allow their care to continue despite the toll this disaster has taken in their communities.”

Many CMS beneficiaries have evacuated to neighboring communities where receiving hospitals and nursing homes may have no health care records, information on current health status or even verification of the person’s status as a Medicare beneficiary. Due to the emergency declaration and other actions taken by HHS, CMS is able to waive certain documentation requirements to help ensure facilities can deliver care.

In addition to increasing the flexibility in providing assistance for CMS beneficiaries, HHS has deployed approximately 550 personnel to affected areas to help state and local authorities respond to communities’ medical needs, and additional staff is on standby to assist.

Today’s declaration of a public health emergency for Louisiana follows a similar emergency declaration for Texas that Secretary Price signed on Saturday to help residents affected by Hurricane Harvey. Secretary Price acted under his authority in the Public Health Service Act and Social Security Act.

These actions and flexibilities are effective retroactively to August 27, 2017.

Public health and safety information for Hurricane Harvey can be found at https://www.phe.gov/emergency/events/harvey2017/Pages/default.aspx

Offshore Human Testing Of Herpes Vaccine Stokes Debate Over U.S. Safety Rules

Kaiser Health News:Marketplace - August 28, 2017

WASHINGTON — Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians, including a prominent Donald Trump supporter, are backing the offshore testing of an experimental herpes vaccine.

The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.

Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks. Most of the 20 participants were Americans with herpes who were flown to the island several times to be vaccinated, according to Rational Vaccines, the company that oversaw the trial.

This KHN story also ran in The Daily Beast. It can be republished for free (details).

“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. “There’s a reason why researchers rely on these protections. People can die.”

The risks are real. Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected. Genital herpes is caused by two viruses that can trigger outbreaks of painful sores. Many patients have no symptoms, though a small number suffer greatly. The virus is primarily spread through sexual contact, but also can be released through skin.

The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.

“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”

American researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.

Robert Califf, who served as FDA commissioner in the Obama administration until January, said he couldn’t think of a prior instance in which American researchers did not set up an IRB abroad.

“There’s a tradition of having oversight of human experimentation, and it exists for good reasons,” he said. “It may be legal to be doing it without oversight, but it’s wrong.”

However, Rational Vaccines downplayed safety concerns, asserting there was little risk the participants would be harmed because they had herpes already. Agustín Fernández III co-founded­ Rational Vaccines with tenured SIU professor William Halford. He said Halford, the lead investigator, took the necessary precautions during the trial conducted from April to August in 2016. Halford died of cancer in June.

The university backed its professor’s work by posting a glowing article on its website about the vaccine. SIU is one of the patent holders of the vaccine and set up a business account to collect donations for the work.

Nonetheless, Southern Illinois University officials said they had no legal responsibility to ensure safety measures were in place because the university has an arms-length relationship with Rational Vaccines. Fernández said the company licensed two patents related to the vaccine from the university.

“SIU School of Medicine did not have any involvement in Rational Vaccines’ clinical trial,” said Karen Carlson, the university’s spokeswoman. “But we are confident that as the chief scientific officer of Rational Vaccines, Dr. Halford followed safety protocols appropriate to the clinical trial.”

But other researchers said they were appalled by what they described as the university’s complicity in ignoring more than 70 years of safety protocols. Scientists called for more rigorous clinical trial oversight in the wake of Nazi atrocities involving human experiments in the 1940s.

“You can’t just ignore human-subject protections that have evolved since the end of the Second World War,” said Zenilman, who served as a technical consultant to the presidential commission on bioethical issues during the Obama administration.

Zenilman, an expert on sexually transmitted diseases, cited U.S. government research in the late 1940s that deliberately infected study participants in Guatemala with sexually transmitted diseases without their consent.

In 1974, Congress passed sweeping regulations aimed at protecting human subjects, requiring IRBs in government-funded research. Later, an advisory committee to the U.S. government wrote of the need for safety review committees to ensure that “basic ethical principles” were in place to protect human subjects from harm. The 1979 Belmont Report also urged researchers to balance the risk to the human subject against the benefit of any breakthrough in medicine.

While the FDA declined to comment on the herpes vaccine trial, spokeswoman Lauren Smith Dyer said “the FDA believes that the oversight of clinical investigations, including review by an IRB, is critically important and is a regulatory requirement for clinical investigations subject to FDA regulations.”

Despite Gottlieb’s stance on the need for FDA streamlining, many researchers are skeptical that he would approve a vaccine based on trials that did not follow American regulations or traditional safety rules for its experiments.

Even so, Fernández, a former Hollywood filmmaker, said he and his investors plan to submit the trial data to the FDA in hopes of getting the vaccine approved for treatment. If the FDA does not respond favorably, he said, the company will continue its trials in Mexico and Australia. Fernández said he hopes to set up an IRB for these next trials. No matter what, he plans to manufacture the vaccine offshore. However, without U.S. approval, the challenges to market such a vaccine in the United States remain significant.

A Thiel representative said the billionaire was not available to answer questions by email or in an interview. Thiel, who rose to prominence as co-founder of PayPal, reportedly advised Trump on possible FDA nominees after donating $1.25 million to his presidential campaign. Thiel has been a vocal critic of the FDA, claiming in an interview that its approval process was so unwieldy “you would not be able to invent the polio vaccine today.”

Fernández said he hoped the trials would put political pressure on the FDA to give the vaccine a closer look. He said his vaccine would be initially aimed at helping patients who experience the “worst of the worst” symptoms. He believed the vaccine eventually would be shown to be effective in preventing the spread of the disease. According to the CDC, about 1 in 6 people ages 14 to 49 have genital herpes.

“I will not stop,” said Fernández, who described the trials as his personal mission. “Too many people are suffering.” Before the trial, Halford tested the vaccine on himself and Fernández. After he failed to secure federal funding and an IRB, Halford moved ahead with the trial offshore.

Other researchers said they feared that desperate herpes patients would seek to be test participants or get the vaccine without being informed properly of the risk.

Researchers at several universities and private clinical research centers are working on two different herpes vaccines under FDA and IRB oversight. One is expected to undergo final trials by 2018 before being submitted to the FDA for final approval. In addition, the National Institutes of Health has conducted a first trial of a third potential vaccine.

Califf said drugs and vaccines are often costly to bring to market simply because they initially don’t work or are shown to be unsafe.

“The FDA is not the problem,” Califf said. “The issue is that there are so many failures.”

The vaccine’s researchers told KHN the St. Kitts trial showed the vaccine is safe and highly effective in preventing outbreaks in herpes patients.

The results have not been published in a peer-reviewed journal and Halford’s previous attempt to publish was rejected. Reviewers of the paper said they were concerned by the lack of safety and said they were skeptical about his scientific approach.

Yet some herpes patients, who are part of a tight-knit online community, have followed the project with hope and enthusiasm.

One American participant said he decided to go public with his experience despite the condition’s stigma. Richard Mancuso said he was recruited for the trial on Facebook and grew to be friends with Halford, whom he described as a “hero.”

Richard Mancuso participated in an offshore experiment for a controversial herpes vaccine, which he says has prevented his severe outbreaks. (Courtesy of Richard Mancuso)

Mancuso said the vaccine has stopped his severe outbreaks. “This has saved my life,” he said.

Fernández of Rational Vaccines said another SIU professor, Edward Gershburg, an associate professor in the university’s Department of Medical Microbiology, Immunology and Cell Biology, has agreed to become the company’s chief technical officer.

But Kayte Spector-Bagdady, who leads the University of Michigan Medical School’s Research Ethics Service, said the St. Kitts trial could be seen as a violation of SIU’s commitment to the Department of Health and Human Services.

SIU voluntarily agreed to follow U.S. safety requirements and set up an IRB for all research involving human subjects, according to records. Many universities make such a commitment to HHS, even if the experiments are abroad and don’t rely on federal grants.

Rational Vaccines was established in February 2015 and the company entered into its patent agreement with the university later that year, Fernández said.

But when asked about its commitment to HHS, Carlson, the university spokeswoman, said the university first learned about the trial in October 2016 — after it had ended. Carlson said Halford didn’t need to bring the trial to SIU’s IRB because the trial wasn’t overseen by the university.

However, after a reporter raised questions about the lack of an IRB, Carlson added that the university would “take this opportunity to review our internal processes to assure we are following best practices.”

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

HHS continues support in Texas and Louisiana in response to Hurricane Harvey

HHS Gov News - August 28, 2017

As torrential rainfall continues to pour on the Gulf Coast, the Department of Health and Human Services is providing support as local officials are continuing to assess communities’ health care infrastructure and medical needs. A list of the latest HHS actions is below:

  • An EMS contract managed by HHS has been utilized to evacuate 182 patients via 70 ambulances from three hospitals in Victoria, Texas.
  • HHS has deployed an additional 53,000 pounds of medical equipment and supplies to support the medical needs of those impacted in affected areas.
  • HHS has activated the AABB Blood Disaster Task Force for Hurricane Harvey in order to evaluate the need for nation-wide blood donations to replenish cancelled blood drives in the impacted area.
  • As announced earlier, HHS also has more than 500 personnel on the ground and 1,000 more on alert, and HHS Secretary Tom Price, M.D. has declared a public health emergency.

The Disaster Distress Helpline, a toll-free call center operated by SAMHSA, the Substance Abuse and Mental Health Services Administration, continues to be available at 1-800-985-5990, to aid people in coping with the behavioral health effects of the storm and help people in impacted areas connect with local behavioral health professionals.

In addition to full-scale coordination across the federal Cabinet agencies, HHS remains in regular contact with Texas and Louisiana health officials to maintain awareness of the local situation and to coordinate efforts to assist their rescue and recovery work as the situation unfolds. 

Information on health safety tips during and after the hurricane will be provided by the Office of the Assistance Secretary for Preparedness and Response and will be available at www.phe.gov/harvey.

Those interested in donating blood may contact the following organizations to find a local blood drive and to schedule an appointment:

Critical updates will also be available at:

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