Medical Treatments – APRA

Teen Girls Don’t Need Routine Pelvic Exams. Why Are Doctors Doing So Many?

Peter Hunt — Thu, 30 Jan 2020 20:09:48 +0000

By Emily Vaughn, NPR Shots, Jan 09, 2020.

An estimated 1.4 million adolescent girls and young women in the U.S. might have received an unnecessary pelvic exam between 2011 and 2017, according to a new study. And an estimated 1.6 million might have received an unnecessary Pap test. The authors of the study, which was published this week in the journal JAMA Internal Medicine, say the overuse of these procedures — which can cause false-positives and anxiety — led to an estimated $123 million annually in needless expenses in 2014 alone.

The study was based on data from 3,410 respondents to the National Survey of Family Growth, between the ages of 15 and 20. The study authors assessed whether the Pap test or bimanual pelvic exam given to each respondent had been in accordance with current clinical guidelines. They found that more than half of the pelvic exams administered, and nearly three quarters of the Pap tests, might have been unnecessary.

Bimanual pelvic exams and Pap tests used to be standard parts of annual gynecological checkups, but leading professional associations no longer recommend them for most younger patients.

Dr. George Sawaya, a professor of obstetrics at the University of California, San Francisco, and the lead investigator on the study, says that the results indicate that health care providers are not paying close enough attention to current best practices.

“Medical practice is very slow to change,” Sawaya says. “For many years there’s been a very ingrained idea about what young women and girls should have as a part of gynecological care. A lot of what we’re seeing is a holdover of doctors who are just not aware of the guidelines.”

The Pap test is a screening for cervical cancer that involves inserting an instrument into the vagina and removing cervical cells to check for abnormalities. It is no longer recommended that most women under 21 receive Pap tests by default. Sawaya explains that the minimum age was raised from 18 to 21 because the incidence of cervical cancer in that age cohort is extremely low and did not justify the risks such as “a high likelihood of false alarms.”

In a bimanual pelvic exam, the physician places several fingers of one hand inside the patient’s vagina, and the other hand on the patient’s abdomen. The pelvic exam was traditionally used to screen asymptomatic women for STDs, the study says, but that practice is now mostly “outdated” as urine-based tests have become widely available. The pelvic exam is no longer a recommended routine procedure for women under the age of 21.

That’s welcome news to many young patients, says Dr. Catherine Cansino, an associate clinical professor of obstetrics and gynecology at the University of California, Davis, who was not involved in the study.

“Young women, to a certain extent, are fearful of coming to the OB/GYN because they think they’re going to get a pelvic exam,” she says. If they avoid or delay appointments, she says, that can have an adverse effect on their overall health.

Cansino emphasizes that young women should still make annual wellness appointments with their health care provider — even if a Pap test and pelvic exam aren’t a part of the visit — to discuss things like pregnancy intentions, sexually transmitted infection and its prevention, vaccinations, and intimate partner violence.

According to Cansino, current guidelines from the American College of Obstetricians and Gynecologists would only recommend a pelvic exam for the age group in the study if a patient has persistent symptoms, like abnormal bleeding patterns. Cansino says that physicians are now placing greater emphasis on clinicians and patients having conversations and arriving at treatment decisions jointly.

Especially for younger patients, who may not have been to a gynecologist before, or may be first-time patients at a new clinic, Cansino says “we really want to emphasize that there should be a conversation between physicians and their patients about why a pelvic exam is important, and when is it important,” rather than treating a bimanual pelvic exam as a default part of the visit.

Dr. Melissa Simon, the vice chair of clinical research at the Department of Obstetrics and Gynecology at the Northwestern University Feinberg School of Medicine, says that the numbers in the study are high, but not surprising.

“It’s really hard for health care providers to unlearn things that they’ve been doing for years, let alone decades,” she says. Simon wrote an invited commentary on the study that was published in the same journal issue, and she was not involved in the study.

Simon explains that the guidelines for pelvic exams might be hard to keep up with, because different professional associations and governmental agencies have each changed their guidelines at different times in recent years, and with slight variations. She says it’s a skill for a medical practitioner to keep track of the changing guidelines and know when it’s time to make a change in how they practice — a skill that medical training programs could be doing more to help students develop.

Sawaya says the high percentage of possibly unnecessary exams sends a message to physicians and educators that “we have a lot of educating to do.” He hopes that the study will cause physicians to “be a little shocked — and then be reflective about their own practice.”

Colonoscopy May be Linked to Increased Risk of Appendicitis

Peter Hunt — Mon, 18 Nov 2019 16:40:02 +0000

By STEVEN REINBERG, HEALTHDAY, FEB 08, 2018.

A colonoscopy can save your life by detecting and removing colon cancer, but it might also trigger appendicitis, a recent study suggests.

Experts aren’t sure exactly why that happens, and, fortunately, it’s rare. And it shouldn’t stop you from getting a colonoscopy, according to lead researcher Dr. Marc Basson.

“Having a colonoscopy, or something about a colonoscopy, predisposes you to have appendicitis in the next week,” said Basson, senior associate dean at the University of North Dakota School of Medicine and Health Sciences.

Though the appendicitis risk is small, it’s at least four times higher the week after a colonoscopy than in the 51 weeks that follow, the study found. And by some measures, the increase is 12 times higher.

A colonoscopy involves advancing a flexible instrument through the rectum to the colon, or large intestine, to detect polyps or precancerous growths.

The appendix is a small, tube-shaped sac attached to an opening into the large intestine. Appendicitis occurs when it gets infected, causing intense abdominal pain, often on the right side. Treatment usually involves surgery to remove it, though sometimes antibiotics are enough.

Most cases of appendicitis occur in children and young adults. The older one gets, the rarer it is, Basson said.

He said he has seen a number of patients who experienced appendicitis after a colonoscopy, but this study is the first to go beyond anecdotal evidence to gauge the risk.

“Colonoscopy is generally a safe test, and the risk of having appendicitis is lower than the risk of having some of the other complications,” Basson said.

More common complications of a colonoscopy include an allergic reaction to the sedative, bleeding from the site where a polyp was removed and a tear in the colon.

Using data from the Fargo Veterans Affairs Health Care System, Basson’s team reviewed medical information on nearly 393,000 veterans nationwide who had a screening colonoscopy between January 2009 and June 2014.

Exactly how a colonoscopy leads to appendicitis isn’t clear, Basson said. He thinks it might stem from preparations for the procedure. Those preparations clear the bowel, which can cause changes in gut bacteria that could result in an infected appendix, he said.

Or, Basson said, pressure created in the bowel by the procedure itself might trigger an appendicitis attack.

Basson said doctors should be on watch for appendicitis after a colonoscopy, especially if a patient complains of continued abdominal discomfort.

One specialist says some patients may already be suffering from mild appendicitis, which the colonoscopy aggravates.

“There are potential biological reasons for why this association was found. It is possible, however, that this association may be due to an artifact of the data,” said Dr. Andrew Chan, a professor of medicine at Harvard Medical School.

For example, it could be that some people are having a colonoscopy to evaluate abdominal symptoms associated with mild appendicitis that may only be diagnosed after the exam, he said.

“Thus, it may only look like the incidence of appendicitis is higher immediately after a colonoscopy,” said Chan, who was not involved with the study.

The report was published online earlier this year in the journal JAMA Surgery.

Surgery for Blocked Arteries Is Often Unwarranted, Researchers Find

Peter Hunt — Sat, 16 Nov 2019 22:07:54 +0000

Drug therapy alone may save lives as effectively as bypass or stenting procedures, a large federal study showed.

By Gina Kolata, The New York Times, Nov. 16, 2019.

The findings of a large federal study on bypass surgeries and stents call into question the medical care provided to tens of thousands of heart disease patients with blocked coronary arteries, scientists reported at the annual meeting of the American Heart Association on Saturday.

The new study found that patients who received drug therapy alone did not experience more heart attacks or die more often than those who also received bypass surgery or stents, tiny wire cages used to open narrowed arteries.

That finding held true for patients with several severely blocked coronary arteries. Stenting and bypass procedures, however, did help some patients with intractable chest pain, called angina.

“You would think that if you fix the blockage the patient will feel better or do better,” said Dr. Alice Jacobs, director of Cath Lab and Interventional Cardiology at Boston University. The study, she added, “certainly will challenge our clinical thinking.”

This is far from the first study to suggest that stents and bypass are overused. But previous results have not deterred doctors, who have called earlier research on the subject inconclusive and the design of the trials flawed.

Previous studies did not adequately control for risk factors, like LDL cholesterol, that might have affected outcomes, said Dr. Elliott Antman, a senior physician at Brigham and Women’s Hospital in Boston. Nor did those trials include today’s improved stents, which secrete drugs intended to prevent opened arteries from closing again.

With its size and rigorous design, the new study, called Ischemia, was intended to settle questions about the benefits of stents and bypass.

“This is an extraordinarily important trial,” said Dr. Glenn Levine, director of cardiac care at Baylor College of Medicine in Houston.

The results will be incorporated into treatment guidelines, added Dr. Levine, who sits on the guidelines committee of the American Heart Association.

The participants in Ischemia were not experiencing a heart attack, like Senator Bernie Sanders, nor did they have blockages of the left main coronary artery, two situations in which opening arteries with stents can be lifesaving. Instead, the patients had narrowed arteries that were discovered with exercise stress tests.

With 5,179 participants followed for a median of three and a half years, Ischemia is the largest trial to address the effect of opening blocked arteries in nonemergency situations and the first to include today’s powerful drug regimens, which doctors refer to as medical therapy.

All the patients had moderate to severe blockages in coronary arteries. Most had some history of chest pain, although one in three had no chest pain in the month before enrollment in the study. One in five experienced chest pain at least once a week.

All participants were regularly counseled to adhere to medical therapy. Depending on the patient’s condition, the therapy variously included high doses of statins and other cholesterol-lowering drugs, blood pressure medications, aspirin and, for those with heart damage, a drug to slow the heart rate. Those who got stents also took powerful anti-clotting drugs for six months to a year.

Patients were randomly assigned to have medical therapy alone or intervention and medical therapy. Of those in the intervention group, three-quarters received stents; the others received bypass surgery.

The number of deaths among those who had stents or bypass was 145, compared to 144 among the patients who received medication alone. The number of patients who had heart attacks was 276 in the stent and bypass group, compared with 314 in the medication group, an insignificant difference.

Dr. Judith Hochman, senior associate dean of clinical sciences at N.Y.U. Langone Health and chair of the study, had expected that those with the most severe chest pain and blockages would benefit from stents or bypass.

But “there was no suggestion that any subgroup benefited,” she said.

Ischemia’s results are consistent with current understanding of heart disease. Researchers have learned that a patient with a narrowed artery may have plaques not just in a single blocked area, but throughout the coronary arteries.

There is no way to predict which of those plaques will break open and cause a heart attack. Stents and bypass treat only areas that are obviously narrowed, but medical therapy treats the entire arterial system.

Yet when a cardiologist sees a blockage, the temptation for doctor and patient alike is to get rid of it quickly, said Dr. David Maron, director of preventive cardiology at Stanford University, the study’s other co-chair.

When an exercise stress test indicates a narrowing, most doctors send patients to a cardiac catheterization lab to look for blockages, Dr. Maron said. If there is a blockage, the usual practice is to open it with a stent.

If stenting is not feasible — because of the configuration of the patient’s arteries, for example — bypass surgery is usually the next step.

Patients with abnormal stress tests should talk to their doctors about the options, Dr. Maron said. If a patient has chest pain despite taking recommended medications, a stent or bypass might help improve quality of life.

Still, he said, patients have time to make considered decisions.

“You don’t have to rush to the cath lab because, OMG, you will have a heart attack soon or drop dead,” Dr. Maron said. “If you have had no angina in the last month, there is no benefit to an invasive strategy.”

Stenting costs an average of $25,000 per patient; bypass surgery costs an average of $45,000 in the United States. The nation could save more than $775 million a year by not giving stents to the 31,000 patients who get the devices even though they have no chest pain, Dr. Hochman said.

But the conventional wisdom among cardiologists is that the sort of medical therapy that patients got in Ischemia is just not feasible in the real world, said Dr. William E. Boden, scientific director of the clinical trials network at VA Boston Healthcare System, who was a member of the study’s leadership committee.

Doctors often say that making sure patients adhere to the therapy is “too demanding, and we don’t have time for it,” he said.

But getting a stent does not obviate the need for medical therapy, Dr. Boden noted. Since patients with stents need an additional anti-clotting drug, they actually wind up taking more medication than patients who are treated with drugs alone.

About a third of stent patients develop chest pain again within 30 days to six months and end up with receiving another stent, Dr. Boden added.

“We have to finally get past the whining about how hard optimal medical therapy is and begin in earnest to educate our patients as to what works and is effective and what isn’t,” Dr. Boden said.

Common Joint Pain Treatment May be More Harmful Than Thought

APRA — Tue, 15 Oct 2019 20:03:27 +0000

The shots may speed up the progression of arthritis and hasten the need for surgery.

By Jacqueline Stenson, NBC Health News. Oct. 15, 2019.

A common therapy for joint pain may not be as safe as experts believed, according to a new report published Tuesday.

Corticosteroid injections are often given to reduce pain and inflammation from osteoarthritis.

But these injections may do more harm than good: The report found corticosteroid shots in the hips and knees may accelerate the progression of osteoarthritis and potentially even hasten the need for joint replacement surgeries in the long run, said lead author Dr. Ali Guermazi, a professor of radiology at the Boston University School of Medicine.

“The intra-articular corticosteroid injections in the hips and knee are not as safe as we thought,” Guermazi, whose paper is published in the journal Radiology, said.

It’s estimated that more than 30 million Americans have osteoarthritis, a chronic condition that causes cartilage loss, joint inflammation, pain, swelling and, in severe cases, bone destruction, according to the Arthritis Foundation.

Corticosteroid injections into the hips and knees are a common treatment for patients in significant pain; in one study of more than 16,500 patients who underwent knee or hip joint replacement, half had received corticosteroid injections in the prior two years. The injections often are covered by insurance.

In the new paper, Guermazi’s team reviewed existing literature on corticosteroid injections for osteoarthritis, and also looked at data on 459 patients at Boston Medical Center who received one to three corticosteroid injections in the hip or knee in 2018. The researchers found that 8 percent of patients developed complications, including cartilage loss, stress fractures, bone deterioration and joint destruction, in the two to 15 months following the injections.

The rate of complications surprised Guermazi, who added that the figure may actually be an underestimate because 218 of the patients did not have follow-up imaging tests to assess the health of their joints.

While patients may report temporary pain relief from the corticosteroid injections, he said, the injections may be detrimental in the long run. “They may actually harm your knee or your hip,” he said.

An exact explanation for the findings is unclear, Guermazi said, but there is some evidence that corticosteroid injections, which typically are combined with an anesthetic, can be toxic to cartilage, and more studies are needed to understand their effects and clarify their benefits and risks.

Dr. Antonia Chen, an associate professor of orthopaedic surgery at Harvard Medical School and a spokesperson for the American Academy of Orthopedic Surgeons, said corticosteroid injections can help relieve pain in some, but not all, patients for as long as days or months. But patients should be informed that the injections carry risks, as the new paper and others have shown, which is why it’s recommended the injections be given no more frequently than every three months, she said.

“There are definitely benefits and there are definitely risks, and these risks must be mentioned to patients,” Chen said. “Some patients will say they don’t want to undergo temporary relief and they don’t want to have the chance of progressing their arthritis, and some say they need some sort of pain relief to just live day to day.”

But before turning to injections or other medications, Chen recommends that patients with osteoarthritis first talk with a physician about noninvasive approaches, such as exercise, physical therapy and weight loss.

Guy Eakin, senior vice president of scientific strategy for the Arthritis Foundation, agreed, telling NBC News that a healthy lifestyle remains the key to managing osteoarthritis.

“Exercise is really one of the best things that can be done,” he said.

Indeed, research indicates that exercise helps ease pain, improve mobility and strengthen muscles around the joints. Stretching activities such as yoga and tai chi may help increase flexibility and reduce joint stiffness. Exercise also can aid in weight loss to reduce pressure on the joints.

While arthritis patients in chronic pain may try to get relief from pain relievers or injections of corticosteroids or hyaluronic acid, there is no cure for the condition. Patients who ultimately end up with bone rubbing against bone may be in such severe pain and have such difficulty moving that they opt for a total joint replacement.

From Hope to Medical Nightmare

APRA — Mon, 07 Oct 2019 21:42:41 +0000

Despite FDA warnings, state boards lag in taking action on controversial MS treatment

By John Fauber of the Milwaukee Journal Sentinel and Kristina Fiore and Matt Wynn of MedPage Today. March 28, 2018.

In 2012, James McGuckin Jr. performed a risky, unproven procedure for multiple sclerosis on Theresa Leipzig at his North Carolina medical facility.

It was not the first time McGuckin, who holds licenses in more than a dozen states, did the controversial procedure.

In one state alone, Washington, he performed it more than 200 times.

As McGuckin snaked a catheter from Leipzig’s leg to a kidney vein, he placed a stent that propped open a blood vessel. Then he placed another stent in the jugular vein in her neck, all with the intent of relieving her multiple sclerosis.

But such treatments had never been proven to work, had not been approved by the U.S. Food and Drug Administration and were being challenged by the medical community. What’s more, McGuckin knew he was under investigation for performing the procedure by regulators in the state of Washington.

At the time, interest in the purported treatment was fueled by social media, with hundreds of testimonial videos posted by patients on YouTube and shared within the MS community. In some cases, doctors did their recruiting seminar-style in hotel ballrooms.

Multiple sclerosis, which has no cure, affects an estimated 400,000 people in the U.S. Symptoms can include trouble walking, loss of balance, vision problems, fatigue and tremors, all of which generally worsen over time. The disease leaves some patients desperate for hope.

Yet experts say there is little reason to expect the vein-opening procedure would work. After all, multiple sclerosis is considered an autoimmune and neurodegenerative disease, not one caused by a lack of blood flow through veins.

It was the third time in a year Leipzig had been to McGuckin to have veins opened. This time, there were problems.

Less than two weeks after the procedure, a stent dislodged and traveled to her heart, requiring emergency open-heart surgery.

“I almost died,” said Leipzig, 47. Looking back, she believes her condition left her vulnerable to persuasion.

“Then comes a shred of light: Doctors performing a procedure that shows promise and hope,” she said. “No one would ever imagine the doctor’s words would turn into a life-threatening medical nightmare.”

McGuckin is one of about 30 doctors who performed the unproven procedure — with some requiring patients to pay as much as $10,000 up front. They say the procedure treats what is termed “chronic cerebrospinal venous insufficiency,” or CCSVI, a condition supposedly linked to MS.

Even after FDA warnings, doctors have been allowed to continue practicing in many states with clean licenses, leaving patients in the dark about their troubled pasts, a Milwaukee Journal Sentinel/MedPage Today investigation found.

One California doctor, Michael Arata, acknowledges doing the procedure 2,000 times and has been the subject of three FDA letters alleging violations of federal regulations. But no public action has been taken against his license by medical boards in any of the three states where he is licensed to practice.

The cases illustrate how an outdated regulatory morass allows troubled doctors to continue to work, putting patients at risk. Often, malpractice histories are shielded from the public in online listings and ignored by state licensing boards. Some doctors continue to collect money from Medicare even after being cited by the FDA.

In some cases, the Journal Sentinel/MedPage Today investigation found, it took years before any licensing action was taken. Some states have not acted at all.

One reason: A lack of communication between the FDA, which oversees medical research, and state medical boards, which regulate the practice of medicine.

The day after the stent was placed in Leipzig’s kidney vein in May of 2012, the FDA issued a safety alert saying the procedure was linked to serious injuries and deaths.

It also said there was no reliable evidence of its effectiveness and that promotion of it may lead people with MS to make treatment decisions without being aware of the risks.

One potential mishap the FDA cited: stents migrating through the body to places such as the heart.

“There is no scientific or medical legitimacy to it all,” said Steven Novella, an assistant professor of neurology at Yale School of Medicine. “I think it is completely unethical to offer treatment to a patient that is not valid and gives them false hope.”

Technique found ineffective

The supposed underlying condition — CCSVI — was identified in 2009 by Italian doctor Paolo Zamboni. But several studies conducted in the years since have found no proof that it causes multiple sclerosis or that the treatment works.

Even Zamboni has changed his view.

In a follow-up trial, he found the technique was largely ineffective and should not be recommended for people with MS. It was published in November in the journal JAMA Neurology.

From the beginning, doctors did angioplasty to treat the condition, propping open veins with devices designed for arteries. In some cases, they implanted stents. Over time, variations developed, going by names such as “liberation therapy” and “transvascular autonomic modulation (TVAM).”

Leipzig, who lived in South Carolina at the time, had gone to McGuckin to have the procedure done at his clinic in Durham, N.C. She now lives in Burlington.

She has been battling MS since she was diagnosed in 2008, three years before the first procedure performed on her by McGuckin. A former salon manager, she has been unable to work since 2010 and now walks with a cane.

She said she felt more clear-headed after the procedures, though that only lasted a couple weeks. In retrospect, she said, that feeling may have been because of how badly she wanted the procedure to be successful.

She sued McGuckin in 2015 and the case was resolved on a confidential basis in 2017. The lawsuit noted another stent — one placed in her right jugular vein in an earlier procedure — also had moved.

That stent is at risk of moving to another location, such as her heart, but surgeons say it would pose a greater risk if they tried to remove it.

In 2012, the same year Leipzig had the procedure done a third time, Karen Crowson, 62, who has had MS since about age 20, underwent the procedure twice at McGuckin’s clinic in Washington state, paying him a total of $17,000.

Crowson, who lives in Hawaii, said the procedure did not help her.

“It’s MS, I never expect miracles,” she said in an interview. “You try things and take your gambles.”

In 2016, she got a refund after an investigation of McGuckin by the state of Washington medical commission. The commission ordered him to repay patients who had to put up their own money for procedures performed after May 10, 2012. Those whose procedures paid by private insurance companies or Medicare were not included in the order.

Washington fined him and ordered him to stop performing the procedure.

The commision said he had performed the procedures as part of a study without ensuring that the research had received FDA approval. In its order, the commission cited McGuckin’s “substandard practices,” but noted in the cases it reviewed there was no evidence the procedures had caused serious injuries.

McGuckin is listed as the CEO of Vascular Access Centers, which has facilities in eight states. He did not respond to emails, telephone calls or a registered letter.

But in a document filed in 2016 in connection with the Washington case, McGuckin noted an earlier study had suggested the procedure held promise for MS patients and had encouraged more scientific study. He said he had relied on another doctor who ran the study to get FDA approval, but acknowledged it was his responsibility to make sure that had been done.

McGuckin wrote he acted with a sincere desire to help patients.

“I continue to live and practice under the daunting auspices of the Hippocratic Oath, which means more to me today than the day I swore it,” he wrote. “I am proud to be a physician treating patients daily while at the same time training students and fellow endovascular physicians.”

First performed in 2009

Patients began having problems with the procedure from the beginning.

Michael Dake, a doctor at Stanford University, was among the first in the country to perform it. Dake did the procedure roughly 40 times, according to an article in the Stanford Daily, a campus newspaper.

One of Dake’s patients died from a brain hemorrhage, though Dake has questioned if the stents were the cause. Two others claimed life-altering conditions, from sleeping problems to chronic pain to a blocked stent one patient feared could migrate to his heart.

After the complications, and after meeting with the Stanford medical dean and Stanford lawyers, Dake wrote in an email to his colleagues that “after deep soul searching” he had decided to stop performing the procedure.

He did not respond to multiple efforts to reach him.

In the years that followed, the procedure grew in popularity. Between 2009 and 2011, some 1,800 videos about it were posted on YouTube, according to one study examining the phenomenon.

In one video, a patient said: “I was resigned to the fact that I would spend the rest of my life fighting this awful disease. These last few days have been a liberation.” In other videos, patients claimed dramatic results: increased strength, regaining the use of limbs, decreased swelling and more.

A follow-up study found the number of new videos dropped dramatically after 2011 and the testimonials became more tepid — a result, researchers believed, of declining interest due to increasing evidence the procedure had no effect.

Arata, the California doctor, has claimed the procedure improves energy levels and cognitive ability and that improvements lasted as long as three years.

In a video on the Synergy Health Concepts website, Arata recalled a woman who could not move her legs or arms, could not speak and had great difficulty eating. He said he walked into the recovery room 15 minutes after the procedure and the woman was holding a sandwich in one hand and talking to her family on the phone with the other.

“I was overwhelmed,” he said. “I actually started crying myself. … It was just amazing to see this young woman whose life literally was taken away by this disease be a normal woman again.”

‘A dog and pony show’

Frank Lamb of Calgary said his wife, Maralyn Clarke, bought into the promise after seeing posters advertising a presentation by Arata to be held at a hotel convention hall in Canada.

Clarke, an X-ray technician, was diagnosed with MS in the 1980s. She had been unable to walk at times and was eager to stop the disease from progressing.

She and Lamb went to the meeting. The hall was packed.

“A dog and pony show is what it is,” Lamb recalled. “Give us your $12,000 and everybody will live happily ever after.”

Arata made it sound so positive, Lamb recalled, despite the cost and the fact the treatment would require surgery. MS is typically treated with drugs. After much thought, Clarke decided to go ahead with the procedure and flew to Los Angeles.

At 11 a.m. on April 13, 2011, she went into the operating room.

By 1 p.m., she was in a coma.

She never woke up.

Arata showed up a few times while Clarke was comatose, Lamb said. Eventually, Lamb decided to take his wife off life support.

“We’ll look after you, we’ll take care of you,” Lamb remembers Arata saying. “Yeah, bullshit. They gave us nothing, not even a refund.”

In 2012, the FDA issued a warning letter to Arata saying he had failed to obtain FDA approval before allowing patients to take part in clinical research that used devices posing the potential for serious risk and ordered him to submit an application to the agency.

A firm representing Arata argued the FDA had no jurisdiction to review the studies. The agency rejected that contention, noting its role is to protect human research subjects from undue hazard.

That underscores the state-federal regulatory gap.

The FDA could intervene in the cases of Arata and McGuckin because it had not approved their research. However, doctors are able to perform the procedure without federal scrutiny if there is no research involved. It is viewed as akin to the “off-label” use of a drug, in that the stent devices were approved for use in arteries, not veins.

That loophole has existed for years, said Diana Zuckerman, who has done research on the FDA and its regulation of medical devices.

Even when the FDA does act by sending warning letters to doctors, often no action is taken, said Zuckerman, president of the National Center for Health Research.

“That’s par for the course with the FDA; they don’t enforce,” she said.

In 2016, another FDA letter said Arata had repeatedly and deliberately violated regulations governing clinical studies, including failing to get approval for research involving people. The agency threatened to disqualify Arata from doing clinical research.

A follow-up letter in 2017 threatened to withdraw his eligibility as a clinical researcher to receive investigational products, such as drugs and devices that might be used in clinical trials.

In March 2017, the FDA issued a broader warning against one of the procedures, specifically citing Arata as one of its practitioners.

In an email, the FDA would not comment on what, if anything, it has done since 2017.

“As this is an ongoing enforcement matter, we are not able to provide any updates at this time,” said spokeswoman Stephanie Caccomo.

Despite the FDA warnings, California has not taken any public action against Arata. In fact, Arata’s California license indicates that no actions have been taken against him by anyone — including the federal government. His license in Michigan also does not list the FDA action. Nor does his license in New York.

California disciplined McGuckin, citing his unapproved research involving the same procedure. State regulators wouldn’t confirm or deny whether they were investigating Arata. A spokeswoman said the medical board reviews any information it receives from any source.

Meanwhile, a spokesman for the Michigan Department of Licensing and Regulatory Affairs noted that Arata’s license in California is clear, but said the state could take action if California does.

Under federal law, doctors can be excluded from the Medicare program if they provide unnecessary or substandard services to Medicare or Medicaid patients.

Yet, Arata collected more than $1.2 million in Medicare money in the first three years after the first FDA warning against him, according to a Journal Sentinel/MedPage Today analysis of federal data. It was not known how much, if any, of that involved using vein-opening procedures to treat multiple sclerosis or CCSVI.

A staff person at Arata’s medical office in California — Arata Medical — said the doctor would not comment for the story.

Doctor ordered to repay patients

In 2015, the state of Washington found McGuckin had performed the procedure on 233 patients in the state between 2010 and 2013. He was ordered to stop and repay patients who had used their own money.

The Journal Sentinel and MedPage Today obtained hundreds of pages of records from the state of Washington investigation, which took the unusual step of having outside doctors review the medical records of seven McGuckin patients.

In an email to state investigators, neurologist James Bowen, medical director of the Multiple Sclerosis Center at the Swedish Neuroscience Institute in Seattle, wrote:

“In the MS neurology world, I do not know of a single MS specialist that believes that CCSVI exists. We get these unusual treatments springing up in MS every few years, but this is the 1st one being driven by social media.”

Bowen also raised concerns to investigators about possible insurance fraud, writing that many places around the country were charging $10,000 to treat MS. He said they may have billed the procedure as one for vascular disease, not as a treatment for MS.

“In other words, lying about the diagnosis in order to get a $10,000 procedure paid for,” he wrote.

Washington found McGuckin engaged in unprofessional conduct. It said and that by performing an experimental procedure — one that created an unreasonable risk of harm — he failed to meet the basic standard of patient care.

McGuckin agreed to the order, which included a fine of $17,500.

Florida, Illinois, North Carolina, Pennsylvania and California were among states that used Washington’s action to bar McGuckin from performing the procedure. But two other states did not act until after the Journal Sentinel and MedPage Today began asking questions about the case.

Georgia ordered McGuckin to stop in December — two years after the action by Washington state. New Jersey issued a similar order in September.

In 2013, four years earlier, the FDA had sent a letter to McGuckin’s office in Trenton, N.J., accusing him of conducting an unapproved clinical study involving the procedure and citing other violations.

Among the violations was his failure to report serious complications experienced by three people who had been in the unauthorized study.

But there is little communication between the FDA and state medical boards.

The medical board in New Jersey has no record of ever receiving the FDA order, said spokeswoman Lisa Coryell. Washington state officials uncovered the letter only after asking McGuckin to supply all communications with the FDA.

Ethics course required

As part of his Washington punishment, McGuckin was required to take an ethics course and write an essay reflecting on his behavior.

In his first attempt, in March 2016, he suggested Washington’s Medical Quality Assurance Commission needed better oversight.

The essay was rejected. An evaluator said it “does not demonstrate a capacity to think ethically about why he is being held to account.”

McGuckin failed the course.

In July 2016, he took it again. In that essay, McGuckin wrote that the investigation had a profound impact on him, including having to temporarily resign as medical director at more than 15 clinics, incurring legal costs to defend himself in 20 states where he had licenses, losing admitting privileges at three hospitals and the loss of insurance affiliation that cost him millions in uncollected revenues.

“More than anything it cost me my innocence and trust,” he wrote.

That essay, too, was deemed to suffer from “persistent justification and defense” of his conduct.

Rather than take the class again, the company handling his ethics courses set up one-on-one tutoring sessions for McGuckin.

In December 2016, more than a year after his punishment was handed down, he turned in a third essay. While they still had reservations, evaluators were more understanding.

“Dr. McGuckin demonstrated in his tutorial sessions that he has developed a capacity to consider his actions from an ethical perspective and an ability to think more deeply about why the Commission should care about one of its licensees who behaved as he did,” an evaluator wrote in her final report to the Washington health department.

“However, the carelessness — both in the manner in which the essay was written and as a prevalent feature in the conduct for which he is being held to account — may be an area for additional investigation.”

McGuckin remains licensed to practice in more than a dozen states, including New Jersey, New York, Indiana, Maine, Tennessee, Texas, Florida, Georgia, Louisiana, North Carolina, California, Maryland, Virginia, and Pennsylvania.

Hormone Therapy During Menopause Raises Breast Cancer Risk for Years, Study Finds

APRA — Fri, 20 Sep 2019 14:20:42 +0000

By Megan Thielking, STAT News, Aug 29, 2019.

A sweeping new analysis adds to the evidence that many women who take hormone therapy during menopause are more likely to develop breast cancer — and remain at higher risk of cancer for more than a decade after they stop taking the drugs.

The study, published Thursday in the Lancet, looked at data from dozens of studies, including long-term data on more than 100,000 women who developed breast cancer after menopause. Half of those women had used what’s known as menopausal hormone therapy, or MHT. The longer women took the medicine, the more likely they were to develop breast cancer. Experts say the findings could shape how women and their health care providers decide how to manage symptoms of menopause.

“This is a consensus of many researchers and many studies all around the world. These are important new results,” said Valerie Beral, a cancer epidemiologist at the University of Oxford and one of the lead authors of the new study.

Women have long been prescribed synthetic versions to replace the hormones that decline during menopause. The medications — usually delivered in a pill, but sometimes in a patch, gel, or injection — provide women either estrogen or a combination of estrogen and progesterone. For many women, they help to tamp down symptoms of menopause, including osteoporosis.

For years, research has suggested a potential link between MHT and an increased risk of breast cancer. In 2002 and 2004, the Women’s Health Initiative released reports that showed women who used combination MHT were more likely to develop breast cancer. MHT use fell after the reports received widespread coverage. That was followed by a decline in breast cancer rates.

But there wasn’t much information on whether that risk persisted, or how it differed based on the type of MHT a woman took. So, an international group of researchers pulled together data from dozens of studies — published and unpublished — to examine the issue more closely. They took a woman’s age at first use of MHT, how long she used the medication, and the time elapsed since she last used it into account. The mean age of women starting menopause was 50, which was also the mean age at which women started using MHT.

The researchers found that compared with women who never used MHT, women who did had a significantly higher risk of developing invasive breast cancer. They estimated that 6.3% of women who never used MHT developed breast cancer, compared to 8.3% of women who used the combination drug continually for five years. That’s roughly one extra cancer diagnosis for every 50 users.

The longer women used MHT, the greater their risk of breast cancer. Women who were no longer using MHT had a lower relative risk than women who were currently using it — but they remained at an elevated risk for more than a decade after they stopped taking the drug. The level of risk was dependent on how long a woman took MHT. The study also found that women who took the combination drug were more likely to develop cancer than women who took the estrogen-only drug.

“The findings are significant,” said Joanne Kotsopoulos, a breast cancer researcher at Women’s College Research Institute in Toronto. “The longer you use it, the higher the risk,” added Kotsopoulos, who wasn’t involved in the research but wrote a commentary on the study, also published in the Lancet.

The new analysis doesn’t show that MHT directly causes breast cancer. But researchers suspect the association has to do with the hormonal changes of menopause. The level of hormones produced by the ovaries dramatically drops during menopause. Going into menopause early is thought to lower the risk of breast cancer. But using MHT might keep women in something like a pre-menopausal state, keeping them from getting the protective benefits of menopause on cancer risk.

“Estrogens stimulate activity in the breast and increase the risk of breast cancer. [MHT] is just putting that stimulus, which had gone after menopause, back,” said Beral.

The caveat: The findings, broadly speaking, apply to women of average weight in developed countries. The researchers found that MHT didn’t have a significant adverse effect on women who were obese, though obesity is also a risk factor for breast cancer after menopause.

For now, experts say patients and providers should carefully consider when the potential benefit of using MHT outweighs the risks. Alternatives to MHT — like taking vitamin D and calcium supplements or keeping rooms cooler — should be a part of that conversation, experts said. It’s also critical for doctors to check in with women on MHT about whether the medication is actually easing their symptoms — and if it isn’t, clinicians should consider taking them off the drugs.

“It’s a balance. Every woman is different,” said Kotsopoulos. “But the risk is high for breast cancer, so they need to take a very serious approach.”

Doctors Sound an Alarm Over Leg-Stent Surgery

APRA — Sat, 14 Sep 2019 14:34:48 +0000

Johns Hopkins researchers analyzing Medicare data say they’ve detected physicians performing what look like unnecessary vascular procedures.

Source The Wall Street Journal, Sept. 10, 2019

Now that unnecessary heart stent procedures happen significantly less often, doctors are flagging a new area of concern: unnecessary leg stents

Johns Hopkins researchers analyzing Medicare data say they’ve detected physicians performing what look like unnecessary vascular procedures.

Some physicians are stenting leg arteries and removing plaque at alarming rates, these doctors say. The often-avoidable procedures could put patients at risk of complications and worsening disease.

Stem Cell Company Persuades Employers To Steer Workers Toward Controversial Therapy

APRA — Fri, 28 Jun 2019 14:45:54 +0000

By Liz Szabo, Kaiser Health News.

A Midwestern grocery chain, Hy-Vee, is taking an unusual — and highly controversial — approach to reducing health care costs.

Before employees in certain cities can undergo knee replacement, they first must visit a stem cell provider. Hy-Vee has contracted with one of the United States’ leading stem cell companies — Regenexx, based in Des Moines, Iowa — that claims injections of concentrated bone marrow or platelets can help patients avoid expensive joint surgery.

Regenexx has persuaded over 100 employers to include its services in their health insurance plans. In a marketing booklet, Regenexx, whose injections range in price from $1,500 to $9,000, notes that its treatments cost a fraction of major surgery. A single knee replacement, for example, ranges from $19,000 to $30,000 in the U.S.

The benefits of stem cells are hotly debated in the medical community, and federal regulators have warned the public to beware of clinics that peddle unapproved injections as a cure-all. Many doctors and ethicists say they fear the public is being misled about how well stem cells work — and whether the procedures save their money or waste it.

“This definitely is not a high-quality, proven treatment,” said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center.

Knee Pain and the Bottom Line

Health insurance typically doesn’t cover stem cell injections, with the exception of certain accepted treatments, such as bone-marrow transplants for cancer and aplastic anemia. Aetna, the United States’ third-largest health insurer, dismisses stem cells and platelet injections as experimental; Anthem, the country’s second-biggest health insurance provider, classifies the injections as “not medically necessary.” Without insurance coverage, patients are forced to pay out-of-pocket or forgo treatment.

So instead of dealing with disapproving insurance executives, Regenexx appeals directly to employers large enough to fund their own health plans. These businesses have the freedom to customize their plans, covering services that aren’t part of a standard insurance package. Over half of U.S. workers insured through their jobs belong to such plans, according to the Employee Benefit Research Institute, a D.C.-based nonprofit.

Perhaps Regenexx’s best-known corporate client is Des Moines-based Meredith Corp., which owns multiple TV and radio stations, as well as magazines such as Better Homes & Gardens. (Meredith owned Time magazine until September 2018.)

In a statement, Regenexx said its goal is to “replace more invasive surgical orthopedics” with nonsurgical options, noting that recent research has found many joint operations are ineffective. On its website, Regenexx claims its procedures “repair and regenerate damaged or degenerated bone, cartilage, muscle, tendons, and ligaments.” In a bone marrow stem cell procedure, for example, a doctor withdraws bone marrow cells from a patient’s hip, concentrates them, then reinjects them into a problem area, such as an arthritic knee. Doctors target the exact location in the joint using ultrasound. For a “platelet-rich plasma” treatment, doctors draw blood, concentrate the platelets, then inject them into the target area.

Regenexx, previously known as Regenerative Sciences, is one of the oldest stem cell companies in the U.S. When it opened its doors in 2005, it had only a handful of competitors. Today, there are more than 1,000 stem clinics in the U.S., said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics, who has published a series of articles describing the stem cell market.

At times, Regenexx has clashed with the Food and Drug Administration. In 2010, for example, Regenexx sued the FDA, claiming the agency lacked the authority to regulate its procedures, which involved culturing stem cells before reinjecting them into patients. Regenexx lost its case and was countersued by the FDA, which charged that Regenexx was marketing an unapproved drug. In 2014, the U.S. Court of Appeals in Washington sided with the FDA, forcing Regenexx to stop performing the controversial procedures. Today, Regenexx performs this procedure only in the Cayman Islands, where the government allows it. The Cayman Islands, where there is less government regulation of health care, has become known as a medical tourism destination, Turner said.

Regenexx says that the treatments offered at its U.S. clinics comply with FDA regulations, which require that cells injected into patients undergo no more than “minimal manipulation.”

On its website, Regenexx lists more than two dozen studies led by its doctors. For example, its chief medical officer, Dr. Chris Centeno, published a small study last year that found patients with knee arthritis who received bone marrow and platelets fared better than those randomly assigned to exercise therapy. Regenexx says it tries to be transparent about its results, noting that it posts data on patient results. In a statement, the company said most patients it treats for knee pain have good functioning five years later.

A Regenexx marketing booklet says 70% of orthopedic surgeries “can be completely avoided with a Regenexx procedure” — a claim Fu called “silly.”

“There is zero evidence that you can replace 70% of surgeries with stem cells,” he said.

Recent research suggests stem cells and platelets may work no better than placebos, Fu added. In a recent analysis, over 80% of patients with knee arthritis experienced a noticeable improvement in pain after receiving simple saltwater injections, writes Dr. Benjamin Rothrauff, a postdoctoral fellow who works with Fu at the University of Pittsburgh.

There’s also no definitive evidence stem cells and platelets can regrow lost cartilage, Fu said. A 2018 review concluded platelets have “marginal effectiveness,” and experts note that most published studies are so small or poorly designed that their results aren’t reliable.

Is Regenexx Actually Saving Employers Money?

If Regenexx treatments worked as well as the company claims, insurance companies would rush to cover them, Turner said. But the notion that Regenexx will save employers money hasn’t been proven and is “a boastful claim with no clinical merit,” said Henry Garlich, director of health care value solutions and enhanced clinical programs at Blue Shield of California, who has reviewed Regenexx’s publications.

“The problem is that we don’t have enough data. When a company does not have this type of evidence, then they will go direct to the consumer market,” Garlich said. “Some vulnerable individuals, including companies that want to reduce their health care costs, may buy what they’re selling.” If Regenexx procedures don’t work, Garlich said, an employer could end up paying twice — once for stem cells and once for knee replacement.

Some employers are, in fact, skeptical. The Des Moines Public Schools has opted not to add Regenexx to its employee health plan, said Catherine McKay, director of employee services for the school system. She said a salesman for a local stem cell clinic, which has since merged with Regenexx, told her the treatments could save the school system lots of money. McKay wasn’t sold.

“My experience with them has not been great, in terms of marketing and sales. They’re very, very pushy,” McKay said. “They claim they can get people back to work earlier” than surgery. “But if I still need knee surgery a year down the road, that doesn’t cut my costs.”

The Des Moines school system has agreed to consider covering Regenexx procedures as part of its workers’ compensation program on a case-by-case basis, McKay said. The school system has not signed a contract with Regenexx, however, and hasn’t included Regenexx in its health plan.

McKay said she knows of two school employees who have tried Regenexx. While one employee was satisfied with the results, McKay said, another “went through a couple procedures and ended up needing surgery anyway.”

Corporate executives have become some of Regenexx’s biggest boosters. Hy-Vee’s former chairman and CEO, Ric Jurgens, appears in a Regenexx marketing brochure and says that he turned to Regenexx because of heel pain. The brochure, which was removed from a Regenexx website after Kaiser Health News began reporting this story, quotes Jurgens as saying, “I knew that giving our employees the chance to explore options besides surgery was in their best interest.”

Hy-Vee did not make Jurgens or other employees available to interview.

Steve Lacy, Meredith’s former CEO and current board chairman, said he underwent a Regenexx procedure two years after his company began covering stem cell treatments. He had been facing knee surgery and thought stem cells were worth a try. The procedure got him back to doing everything he wants to do, Lacy said, even running several days a week. He also has done daily physical therapy for over two years. “The rehab and recovery is far less onerous” with the Regenexx procedure than with surgery, Lacy said. “If the procedure doesn’t work for an individual, there’s no harm.”

Meredith has spent about $400,000 in four years on 85 employees who have had Regenexx treatments, or about $4,700 a patient, said Meredith spokesman Art Slusark. That’s a small share of the roughly $75 million a year that Meredith spends on its medical plan, he said.

At its headquarters, Meredith has promoted Regenexx procedures through email, posters and “lunch-and-learn” sessions in the office, said Jenny McCoy, Meredith’s corporate communications director.

McCoy herself has become a poster child for Regenexx’s benefits. She and two other Meredith employees appear with Lacy in a marketing video on the Regenexx site. Although McCoy had begun to experience knee and hip pain during exercise, she said in an interview that her pain was not severe enough to need surgery. McCoy underwent platelet injections two years ago and is pain-free today, she said.

“I thought, ‘If Meredith is covering it, I might as well have it done early before [the pain] causes me too many problems,’” said McCoy, 52. Given the price tag, she said, “I would not have done it otherwise. I wouldn’t have even known about it.” In the Regenexx marketing video, Lacy is shown saying stem cells saved Meredith roughly $700,000 in one year. Lacy said he estimated that number by comparing what Meredith spent on Regenexx with what it would have spent on hip and knee replacements.

But Slusark said Meredith hasn’t examined employee medical records to determine how many were eligible for surgery or how many needed joint surgery after trying Regenexx. “We don’t spend a lot of time calculating savings,” Slusark said.

Without that medical information, Meredith can’t accurately estimate how much money it saved, if any, Fu said. He noted that relatively few people with joint pain undergo surgery, which doctors typically view as a last resort for patients who have exhausted all other treatment options. Although 14 million Americans have knee arthritis, the Arthritis Foundation estimates that doctors perform only about 757,000 knee replacements each year.

Before recommending joint replacement, doctors often tell patients to try exercise, physical therapy, weight loss, supportive shoe inserts or steroid injections, Garlich said. Physical therapy, in particular, helps many patients, said Fu; it’s possible that PT, and not the stem cell injections, should get the credit for Lacy’s recovery.

How the Patients Feel

Regenexx has posted video interviews of dozens of satisfied customers on its website, including a refinery worker treated for a non-healing wrist fracture, a snowboarder who had stem cell therapy in his knees and an avid weightlifter with multiple shoulder problems. All say Regenexx helped them.

Other Regenexx patients say the treatments wasted their time and money. Several patients who posted online reviews of the company agreed to be interviewed for this article.

One is Amanda Lynch, a 42-year-old Australian trapeze artist who lives in Montreal. Lynch said she spent $7,700 last year to treat an injured ligament at a Regenexx clinic in Colorado. Doctors administered a series of injections in her knee over several days, including platelets and her bone marrow, Lynch said. She shared copies of the emails she exchanged with the clinic, a bill from Regenexx and a document in which doctors evaluated her candidacy for treatment.

But within a few months, Lynch had to undergo surgery in Montreal for both knees, she said, paying an additional $16,100, according to her medical bill. Because Lynch is Australian, she was not eligible for free care in the Canadian health system and had to pay out-of-pocket.

Roland Jersevic, a 67-year-old lawyer living in Saginaw, Mich., said he needed knee replacement after his stem cell treatments failed to relieve his arthritis. Jersevic said he went to a Regenexx clinic in Toledo, Ohio, in 2015 to get help with severe arthritis in his knees, which had caused his legs to bow. “The pain was horrendous all the time,” he said. Jersevic’s medical bills, obtained for this article, show that he paid the clinic $7,500 out-of-pocket because his insurance wouldn’t cover stem cell therapy. “They told me they were going to regrow my cartilage,” he said, referring to Regenexx. “I wanted it to work.”

Although the fat and bone marrow injections may have given Jersevic a “little bit” of temporary relief, his pain soon returned, he said. Regenexx offered to administer more injections, at an additional cost, Jersevic said. “At that point, I had lost all faith in what they were doing. To spend more money on a booster — what for? It wasn’t working.”

Jersevic had both knees replaced in summer 2016, his medical records show, and his insurance paid most of the bill. His knee pain is gone, and Jersevic said he felt well enough to return to track-and-field competitions — including hurdles and pole vaulting — in 2017.

“When your knees are that bad, it’s not going to work for you,” Jersevic said. “They should tell you it’s not going to work for you. But they want the cash.”

In response, Regenexx noted that many patients who undergo knee surgery are also unhappy with the results. Research suggests that up to one-third of those who have knees replaced continue to experience chronic pain, while one-fifth report that they are dissatisfied with the results of their surgery.

“We are disappointed to learn of any patients who didn’t have a positive outcome,” Regenexx said in a statement. “Our goal at Regenexx is to achieve the best possible clinical efficacy, and we are actively researching to find out why some patients respond better than others.”

June 20, 2019

Fecal Transplant Is Linked to a Patient’s Death, the F.D.A. Warns

APRA — Fri, 21 Jun 2019 17:08:12 +0000

By Denise Grady, The New York Times.

Two patients contracted severe infections, and one of them died, from fecal transplants that contained drug-resistant bacteria, the Food and Drug Administration reported on Thursday.

As a result, the agency is halting a number of clinical trials until the researchers conducting them can demonstrate that they have procedures in place to screen donated stool for dangerous organisms, said Dr. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research. In an interview, he did not specify how many trials would be suspended, but said it was “not just a few.”

Fecal transplants have come into increasing use to treat severe intestinal disorders, particularly an infection caused by a bacterium called Clostridium difficile, which can be deadly and tends to occur in hospitalized patients who have been heavily treated with antibiotics. The idea behind the transplants is to use stool from a healthy donor to restore the normal balance of bacteria and other organisms in the intestine, the microbiome.

In some cases, the transplants have worked quickly and saved the lives of patients who were wasting away with uncontrollable diarrhea. But the procedure is not approved by the F.D.A. and is considered experimental.

In the newly reported cases, both patients’ immune systems were already compromised at the time of the transplant, the F.D.A. said. The agency would not explain why they were immuno-compromised, why they were given the transplants, who performed the procedures or when or where the cases occurred.

Both transplants came from the same donor’s fecal matter. The report does not state whether the fecal material was given in liquid form as an infusion into the digestive tract or swallowed as pills.

Other samples from the same donor were tested after the patients got sick. The samples were found to harbor the same dangerous germs found in the patients, known as multi-drug-resistant organisms. They were E. coli bacteria that produced an enzyme called extended-spectrum beta-lactamase, which makes them resistant to multiple antibiotics. The stool had not been tested for the germs before being given to the patients.

The F.D.A. on Thursday issued a warning to researchers that stool from donors in studies of fecal transplantation should be screened for drug-resistant microbes, and not used if those were present. It is also warning patients that the procedure can be risky, is not approved by the agency and should be used only as a last resort when C. difficile does not respond to standard treatments.

Dr. Marks said the agency was trying to strike a balance between giving patients who need the treatment access to it while also establishing safeguards to protect them from infection. In a statement, he said, “While we support this area of scientific discovery, it’s important to note that fecal microbiota for transplantation does not come without risk.”

The patients received treatment as part of a clinical trial, and the researchers conducting the trial reported the cases as adverse events to the F.D.A., which they are required to do. But the rules governing this kind of experiment prohibit the F.D.A. from revealing details about the treatment or who provided it.

June 13, 2019

Beware of Worthless Procedures and Epidural Steroids for Your Back Pain

APRA — Fri, 01 Mar 2019 20:30:15 +0000

By CATHRYN JAKOBSON RAMIN, for CONDITIONS.

An excerpt from Crooked: Outwitting the Back Pain Industry and Getting on the Road to Recovery.

Near my office, there’s a breakfast-and-lunch joint where strangers sit down at shared tables. When Joseph, an attorney in his early seventies, heard that I was writing a book about the back pain industry, he started asking questions.

That afternoon, he was scheduled to have the first of three epidural spinal injections meant to relieve the symptoms of spinal stenosis, a condition in which the spinal cord narrows to the point where it squeezes the nerves. The weakness and cramping in his legs were so bad that he couldn’t walk a long city block without stopping to recover.

The injections were his best hope, he said, making it even harder for me to break the news. A few months earlier, in a 2015 review of the medical literature, the Agency for Healthcare Research and Quality had found no evidence that epidural steroid injections were effective in treating symptoms of spinal stenosis or typical lower-back pain. Even in the presence of a recent disc herniation and ensuing sciatica, the benefits of injections were small and not sustained over time. That news followed on the heels of an FDA statement warning that injection of the active medication in these shots, glucocorticoids — a class of corticosteroids — into the epidural space of the spine could result in rare but serious neurological problems, including loss of vision, stroke, paralysis and death. Based on those and other findings, the Journal of the American Medical Association ( JAMA) advised physicians to refrain from recommending injection therapy to patients with any kind of chronic back pain.

That news did not go over well with the doctors known as “interventional pain physicians,” who make a living performing such procedures. In the United States, more than ten million epidural steroid injections are delivered each year, a number that makes them the bread and butter of interventional pain management practices.

I was not surprised that my lunch partner didn’t have the facts. Primary care physicians who ordered the shots were rarely informed about the lack of evidence and the risks of treatment. Even young, healthy people, explained anesthesiologist James Rathmell, the chair of the Department of Anesthesiology, Perioperative and Pain Medicine at Boston’s Brigham and Women’s Hospital, could go in with manageable low-back-pain symptoms and come out with catastrophic neurological injuries. “The bottom line,” said Rathmell, “is that if you come into my clinic with chronic axial back pain, you’re not going to get epidural steroid injections — because they don’t work.

“People should get the best evidence-based treatment they can,” he added. “As a rule of thumb, if you pay practitioners to do stuff, they will do more stuff. Frankly, what’s happened in interventional pain management is just a microcosm of what’s happened in all of medicine.”

As I explained these things to Joseph, he paled. Why would his doctor advise him to undergo a worthless and risky procedure?

Three decades ago, anesthesiologists had no trouble getting jobs in hospital ORs. On a busy morning, they could run five cases at once, and get paid for them all, while depending on registered nurses to keep an eye on individual patients. Starting in the early 1990s, cost-conscious health management organizations (HMOs) realized that the nurses could manage without supervision, and they stopped paying fees to doctors who at best were marginally present. Many anesthesiologists found themselves underemployed. They knew little about treating musculoskeletal disorders or how to address the feelings of depression, anger, and isolation that often afflict back pain patients, but when they retooled, they set up pain management practices.

Torpedoed into entrepreneurship, the most successful interventional pain physicians offered an ever-expanding menu of injections, including facet and sacroiliac joint blocks, selective nerve blocks, discography, needle electromyography, radio-frequency and thermal facet ablations, botulinum toxin, and trigger point injections. They implanted intrathecal drug delivery pumps and spinal cord stimulators and cemented together vertebral compression fractures. They used medical lasers to heat, shave and slice soft tissue. By the turn of the new millennium, interventional pain management, which a decade before had barely existed, had become one of the most profitable aspects of spine care.

There are, indeed, people who undergo one perfectly targeted epidural steroid injection and hit the golf course the next morning, completely cured. In the more typical scenario, however, the first injection — if in fact, it provides any relief at all — is only briefly effective. Then the numbing medicine and the anti-inflammatory effect of the glucocorticoid wear off, and the pain returns.

Generally, the shots are ordered in a series of three, although no expert I asked could say why, and the American Society of Anesthesiologists’ guidelines do not advise the administration of a specific number. “You always do three, even if the first two do no good at all,” wisecracked neurosurgeon Charles Burton, who publicly questioned the safety and effectiveness of the procedure, long before JAMA and the FDA got on board. Some doctors construed the “rule of three” to mean that, in a single visit, they could give three shots at each affected vertebral level, thereby exposing a patient to a colossal dose of glucocorticoid. In fact, when Colorado researchers mined an insurance company’s database, they found that one doctor had billed a single patient for fifty-one such injections in one year. The same database showed that a New Jersey patient had received thirteen shots in a five-month period and had subsequently developed kidney failure.

The FDA had been issuing cautionary statements about epidural steroid injections since 1981. But in 2014, the agency took a further step compelling pharmaceutical manufacturers that produced the injectable glucocorticoids to clearly state the risks on every vial’s label, advising that “serious neurologic events, some resulting in death, have been reported with epidural injection,” and that the “safety and effectiveness of epidural administration of corticosteroids have not been established.” The FDA stopped short of requiring manufacturers to notify physicians or their purchasing departments that things had changed, and most did not notice. One pain physician, Cleveland Clinic’s Richard Rosenquist, told Bloomberg reporter David Armstrong that because he’d used such drugs for his entire career, unless he was alerted to do so, he was “unlikely to go back and spend time reading the package insert.”

The implications were significant: Properly “consented,” a patient who was about to receive an epidural steroid injection would hear about specific risks, including damage to the dura mater (the sturdy sleeve surrounding the spinal cord), nerve root injury, elevated cholesterol levels, vertebral fractures, the death of muscle and bone tissue, staph infection, epidural abscess, immune system deficits, stroke and death. But in reality, if this information was conveyed at all, it was in boilerplate format, which the patient signed after only a cursory glance.

There are two dominant techniques for administering epidural steroid injections. In the first, known as “interlaminar,” the needle is directed into the epidural space, around the spinal nerves. In the second approach, referred to as “transforaminal,” the needle is inserted at an angle, which places it closer to the targeted nerve but also in the vicinity of vessels and arteries. Incorrectly placed, the needle can sever an artery or deliver medication into the blood vessels, clogging them and preventing adequate blood flow to the brain. The result, in either case, may be stroke or paralysis.

Whether the approach is transforaminal or interlaminar, research shows that a quarter of epidural steroid injections miss their targets. In “blind” injections, performed without fluoroscopic guidance, the needle is incorrectly placed in up to half of epidural steroid procedures.

In roughly six percent of epidural steroid injections (a number that sounds small but is not, because thousands of injections are delivered every day), the needle nicks the dura mater, the sturdy sleeve surrounding the spinal cord, allowing cerebrospinal fluid to leak out. Typically, this is not terribly serious. It results in a severe headache, which goes away after the patient lies flat for a couple of days. Sometimes, another procedure, known as a “blood patch,” is used to stop the leak of cerebrospinal fluid.

But when the needle actually punctures the dura mater, it’s a different story. Then the payload of glucocorticoid and anesthetic may be delivered into a region of fragile nerve tissue called the subarachnoid space. From there, the cerebrospinal fluid, bearing its toxic load, circulates to the brain, where the cortisone solution efficiently strips the insulating (and essential) myelin layer of neurons. One result is “adhesive arachnoiditis,” a condition so grossly debilitating that neurologist Dewey Nelson described it as akin to “having a blowtorch up your rectum. It binds the nerves, like gunky cooked spaghetti, and the result is unrelenting pain that may last for a lifetime.”

Cathryn Jakobson Ramin is an investigative journalist and author.

APRIL 29, 2017

FDA Warns Epidural Corticosteroid Injection Associated with Serious Neurologic Problems

FDA Food and Drug Administration, Washington, DC.

The Food and Drug Administration (FDA) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.

The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use, including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.

To raise awareness of the risks of epidural corticosteroid injections in the medical community, the FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized. The FDA will convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.

April 23, 2014.

Editor: Although the publication date of an article may not be current the information is still valid.