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Saturday, April 13, 2019

One-third of cancer patients use complementary and alternative medicine

A stunning one-third of people with a cancer diagnosis use complementary and alternative medicines such as meditation, yoga, acupuncture, herbal medicine, and supplements.
UT Southwestern Medical Center’s Dr. Nina Sanford made the discovery that’s now drawing renewed attention to habits she said cancer patients must disclose during treatment. Dr. Sanford is an Assistant Professor of Radiation Oncology who specializes in and treats cancers of the gastrointestinal tract.
Herbal supplements were the most common alternative medicine and chiropractic, or osteopathic manipulation, was the second most common, according to Dr. Sanford’s analysis of data from the Centers for Disease Control and Prevention’s National Health Interview Survey. Her findings were published in the journal JAMA Oncology.
“Younger patients are more likely to use complementary and alternative medicines and women were more likely to, but I would have thought more people would tell their doctors,” Dr. Sanford said, referring to the finding that 29 percent of people who use complementary and alternative medicine did not tell their physicians. Many survey respondents said they did not say anything because their doctors did not ask, or they did not think their doctors needed to know.
Dr. Sanford and other cancer specialists agree this is concerning, especially in the case of herbal supplements.
“You don’t know what’s in them,” Dr. Sanford said. “Some of these supplements are kind of a mishmash of different things. Unless we know what’s in them, I would recommend patients avoid using them during radiation because there’s likely not data on certain supplements, which could interfere with treatment. With radiation specifically, there is concern that very high levels of antioxidants could make radiation less effective.”
Dr. David Gerber, a lung cancer specialist and a Professor of Internal Medicine and Population and Data Sciences at UTSW, said physicians need to know if their patients use herbal supplements because they can completely throw off traditional cancer treatments.
“They may interact with the medicines we’re giving them, and through that interaction it could alter the level of the medicine in the patient,” he said. “If the levels get too high, then toxicities increase, and if the levels get too low, the efficacy would drop.”
Nancy Myers wanted to use supplements during her 2015-2017 cancer treatments, but she ran it by her doctors first.
“I would ask the physician, ‘Could I?’ and everyone said, ‘No, we don’t know how that interacts with your conventional medicine,’ so I respected that,” the 47-year-old mother of four said. Only after treatment did she start taking turmeric, omega-3, vitamin D, and vitamin B6.
“I have plenty of friends in this cancer journey who I’ve met who take supplements. A lady I met recently takes 75 supplements a day. It takes her two hours to package her supplements every week,” she said.
Ms. Myers said every person in her cancer support group uses some kind of alternative medicine. In addition to supplements, she practices meditation and yoga with guidance from a smartphone app.
“It’s what we can control. We can’t control the whole cancer,” she said. “It helps because it takes your mind off just thinking about it.”
She said she knows of some people with cancer who use only alternative medicine — and no traditional medical treatments. Dr. Sanford said this is a dangerous approach that could be fatal. The most famous case of this was Apple founder Steve Jobs, who reportedly used special diets, acupuncture, and other alternatives after receiving a diagnosis of pancreatic cancer. He turned to traditional medicine late in his battle with cancer and died in 2011.
While doctors are highly cautious about the use of herbs and other supplements during treatment, they are much more open to meditation and yoga as practices that can help patients cope with the shock of a cancer diagnosis and the stress of chemotherapy, radiation, and surgery.
“We strongly advise patients to stay active and engage in exercise during treatment,” Dr. Sanford said. “A common side effect of radiation is fatigue. I let the patients know that the patients who feel the most fatigue are the ones who are the most sedentary and that those who are doing exercise are the ones who frequently have the most energy.”
Belindy Sarembock, 53, of Dallas, said she practiced yoga during her treatments for breast cancer. She started the classes with skepticism and quickly became convinced of the benefits.
“I was one who would have laughed at yoga before breast cancer, but now it just helps me so much,” she said. “It’s just so relaxing, I just feel so good after I leave. It’s just so peaceful. For your body, I can’t think of anything better than that.”
She said she had neuropathy or nerve damage from chemotherapy, and yoga almost immediately took the pain away.
“I couldn’t get onto my toes. After the second time of going to yoga, I was able to go onto my toes,” she said. “I wish I would have known about the yoga earlier. It was just such a benefit and helped me so much. I highly recommend it to anyone.”
Story Source:
Materials provided by UT Southwestern Medical CenterNote: Content may be edited for style and length.

Journal Reference:
  1. Nina N. Sanford, David J. Sher, Chul Ahn, Ayal A. Aizer, Brandon A. Mahal. Prevalence and Nondisclosure of Complementary and Alternative Medicine Use in Patients With Cancer and Cancer Survivors in the United StatesJAMA Oncology, 2019; DOI: 10.1001/jamaoncol.2019.0349

Migraine Drug Developer Biohaven Is Said to Explore Sale

Biohaven Pharmaceutical Holding Co., a developer of migraine treatments, is exploring options including a possible sale of the company after attracting interest from potential bidders, according to people familiar with the matter.
The drugmaker, which is working with a financial adviser, is in the early stages of considering a sale or partnerships and the talks may not lead to a deal, said the people, who asked not to be identified as the details aren’t public.
Biohaven shares rose 12 percent to $54.39 at 11:34 a.m. in New York. The company’s shares have almost doubled in the last year as of Thursday’s close, giving it a market valuation of $2.17 billion.
A representative for Biohaven declined to comment.
Analysts have pointed to Biohaven as a target for potential partnerships or deals. The company is gearing up to launch a migraine product, which is under consideration for approval at the U.S. Food and Drug Administration. The migraine market has gotten a boost as drugmakers like Amgen Inc., Eli Lilly & Co. and Teva Pharmaceutical Industries Ltd. have introduced new products in recent years.
Biohaven’s experimental drug acts on the same target as some of those companies’ new drugs. Its treatments are designed to both prevent and treat acute migraines.
Biohaven is also doing research in Alzheimer’s disease, inflammation and neurodegeneration. The company may be attractive to buyers in part because it’s one of the few still focused on this line of research.
Some large drugmakers are exiting neuroscience research projects after a series of high-profile failures. Last month, Biogen Inc. announced a late-stage study of its main Alzheimer’s drug was unlikely to succeed, losing as much as $18 billion in market value in one day.

Mount Sinai medical school to cap debt at $75K for students with financial need

The Icahn School of Medicine at Mount Sinai will begin capping debt at $75,000 for students with a demonstrated financial need during the next academic year, making it the latest institution to address the massive debt burden that often accompanies medical education.
Students who qualify will take out no more than $18,750 per year in loans to cover costs such as tuition, housing, food and books.
The initiative follows NYU School of Medicine’s decision to offer free tuition for all medical students and a move by Columbia University’s Vagelos College of Physician and Surgeons in 2017 to offer scholarships that cover 100% of students’ financial needs.
Mount Sinai’s strategy is unique in that it applies not just to tuition but to living expenses. Tuition for the current academic year is nearly $53,000, but the school estimates the cost of attendance, which includes expenses such as rent and health insurance, will run students an additional $25,000 to $35,000 a year. Three-quarters of medical students nationwide finance their education with some debt, and the median amount for the class of 2018 was $194,000, according to the Association of American Medical Colleges.
“Doing just tuition would still leave students with $110,000 to $120,000 of debt. That’s an unacceptable level,” said Dr. David Muller, the medical school’s dean for medical education. “We need to whittle away at the real number, and the real number is cost of attendance.”
Muller said the institution has been working on a plan to lower students’ debt burden for the past five years. It has received $25 million to $30 million in pledges from donors to jump-start a fund that will support the scholarships, which it expects to provide at least some aid to 40% of students. He said the school’s strategy is most similar to that of Yale School of Medicine, which set an annual debt limit of $15,000 for the next school year.
The program won’t benefit all students. It will award money based on a student’s expected family contribution, which is determined through federal and private financial aid applications. A first-year student with an expected family contribution of $79,000, which is above the cost of attendance, wouldn’t receive any aid, for example.
The news was shared with students via email Wednesday and wasn’t met with unanimous praise. One student, who doesn’t expect to qualify but will graduate with about $200,000 in debt, said it was “honestly a little bit of a disappointment” because many middle-class students won’t be eligible.
“This is good for low-income students, and it will help Sinai stay competitive with those students and underrepresented minority students. This is not a fundamental reimagining of the financing of medical education,” said the student, who asked not to be identified to avoid damaging relationships with the school’s administrators. “It is just a glorified scholarship. I don’t think it really helps a lot of the middle-class kids that are here.”
Accounting for need is a way for medical schools to make their programs accessible to low-income students, Muller said.
“For us, that’s just a way of distributing what we all know is limited resources,” Muller said. “There has to be justice in any initiative that takes on student debt. Some students have accumulated all sorts of privileges over their lives, and some students have accumulated none of those advantages.”
The program does not, as some do, compel students to enter specialties such as family medicine and pediatrics or to work in underserved areas. Muller said it hopes that encouraging more people with limited means to apply might draw students from underserved areas, who may be inclined to return home to provide care. Surveys show students’ debt does not influence the specialty they choose to practice.
“That’s the key for these programs: to get people who otherwise wouldn’t to go ahead and apply,” said Julie Fresne, senior director of student financial and career advising services at the Association of American Medical Colleges. “That is the main benefit that could come out of this.”

Fears of Medicare for All, drug rebate overhaul feed health insurer stock selloff

Publicly traded health insurer stocks took a hit this week amid fears that Medicare for All momentum and the federal government’s proposal to nix drug rebates to pharmacy benefit managers could threaten their business models or even their existence.
The stock price of the largest publicly traded insurers were all trading down on Friday and for the week, with Anthem taking the biggest hit, falling almost 14%. Meanwhile, the S&P 500 stock index was up.
Ana Gupte, managing director at SVB Leerink, said the sell-off is largely driven by news about the proposed changes to drug manufacturer rebates and spread pricing. Lawmakers have also been grilling PBMs in a series of hearings about their role in rising prescription drug prices.
The CMS proposal unveiled in January would essentially block drug manufacturer rebates from going to PBMs and health plans that serve Medicare and Medicaid patients, starting next year. The change could squeeze insurer and PBM revenue, though some insurers have been quick to dismissconcerns.
“We see it very likely that the HHS proposal to move rebates to the point of sale is implemented Jan 2020,” Gupte said in an email.
Cigna and UnitedHealth Group each own major PBMs, and insurer Aetna is now owned by CVS Health, which operates one of the largest PBMs, called Caremark. Anthem is slated to launch its in-house PBM in 2020 in collaboration with CVS.
Beyond the tumult surrounding the future of PBMs, the latest Medicare for All proposal from Sen. Bernie Sanders, along with the legal challenge to the Affordable Care Act brewing in a Texas federal appeals court, are also contributing to the decline in insurers’ share prices, Gupte noted.
Sanders’ revised Medicare for All legislation, introduced on Wednesday, would largely eliminate private medical insurance—including the employer-sponsored insurance system that serves more than 150 million Americans—and public programs Medicaid and Medicare. Americans would transition into a new universal plan run by the federal government.
Most observers doubt that a single-payer health care system would pass in the near term, given the Republican-controlled Senate and White House. Still, momentum for healthcare system reform is growing, and some policy experts and analysts no longer see a big expansion of the role of government programs in healthcare as unrealistic. The impact on health insurers of such an expansion would vary depending on the proposal (there are at least eight) and the type of business mix an insurer serves.
There’s an overriding fear or sentiment among investors that’s driving the decline in stock prices, said David Windley, managing director at investment firm Jefferies. That’s despite the low likelihood of Medicare for All passing or the ACA being tossed out, and the fact that insurers are performing well financially.
“If anything, company-specific updates have improved in the last few months and reinforce an environment of enrollment growth (particularly in government books), disciplined pricing, and tame utilizaton,” Windley wrote in a research note Friday.

Candida auris – a dangerous drug resistant fungi on the rise

Candida auris – a fungus, is one of the newest organisms to plague humans with its resistant nature. It is as present resistant to the available antifungal agents and is emerging as a threat around the world.
C. auris – Epidemiology and features of infection
The fungus is capable of entering into the blood stream and can cause life threatening infections. It was first isolated and identified in 2009 in a Japanese patient. A 70 year old woman admitted at a hospital in Tokyo was found to have an oozing infection of the ear that was difficult to treat with conventional antifungals. C. auris was isolated from the infection. It was named “auris” meaning related to the ear by microbiologists Kazuo Satoh and Koichi Makimura.
Candida auris fungi, emerging multidrug resistant fungus, 3D illustration. Image Credit: Kateryna Kon / Shutterstock
Candida auris fungi, emerging multidrug resistant fungus, 3D illustration. Image Credit: Kateryna Kon / Shutterstock
Over years there has been an advent in its spread and it has been commonly found in hospitals and nursing homes. According to the Centers for Disease Control and Prevention (CDC), there have been 587 cases of confirmed C. auris infection in the United States from New York, New Jersey and Illinois. The infection has spread to around 15 countries including India, Pakistan, Spain, South Africa and Venuzuela.
The major problem with C. auris infection is its resistant nature. It can resist major antifungals available for treatment. At present over 90 percent of the C auris infections are resistant to at least one antifungal agent and around 30 percent are resistant to two or more antifungal agents. This means infection with the fungus is difficult to treat and once detected at a facility, it is difficult to eradicate.
C. auris commonly affects the elderly, infants or neonates and mainly people who have a weak immune system. These individuals are also more likely to struggle to fight off the infection. Healthy normal individuals are less likely to get C. auris infection. The infection commonly manifests as fever, body ache, chills, tiredness etc.
C. auris threat
CDC has now put this fungus in a ‘serious threats’ list saying that candida is a common fungus but this species can be life threatening. They have said that nearly 50 percent of the cases infected with C. auris succumb to the infection within 90 days of contracting the infection. Dr. Tom Chiller, head of the mycotic infection section of CDC said, “It is a creature from the black lagoon. It bubbled up and now it is everywhere.” No public announcement was made over the years for fear of panic.
C. auris history
According to a study titled “Multiple introductions and subsequent transmission of multidrug-resistant Candida auris in the USA: a molecular epidemiological survey,” published last year in The Lancet Infectious diseases, transmission of C auris was reported between May 11, 2013, to Aug 31, 2017. The study was funded by the CDC.
The authors led by Dr. Nancy Chow performed a molecular epidemiological survey looking at the genes of the isolates of C. auris from patients in ten US states to understand its spread and its genetic diversity. The states from where isolates were obtained were “California, Connecticut, Florida, Illinois, Indiana, Maryland, Massachusetts, New Jersey, New York, and Oklahoma.” Other countries from where isolates were found included “Colombia, India, Japan, Pakistan, South Africa, South Korea, and Venezuela”.
They got a total of 133 cases including 73 clinical cases and 60 screening cases. Of these the picture was;
  • 66 (90%) cases were from south Asian isolates
  • Five (7%) cases from South American isolates
  • One (1%) case from African isolates
  • One (1%) case from east Asian isolates
Of the clinical cases, 60 (82%) were from New York and New Jersey. Genetically these were similar but distinct from south Asian isolates. Those from USA were similar genetically to the isolates from four global regions write the authors of the study. They speculated that while transmissions could have occurred due to travel, there seemed to have been local transmissions as well that led to the genetic diversity.
Yet another news release from last year states that C. auris outbreak was connected to the reusable temperature probes or thermometers. This news in the BMJ in 2018 showed that a cluster of patients in an Intensive Care Unit of a UK hospital was affected with the infection due to contaminated thermometers.
Lead researcher David Eyre of Oxford University Hospitals NHS Foundation Trust had said in a statement, “Our results indicate that reusable patient equipment may serve as a source of healthcare associated outbreaks of infection with C auris.”

Reducing smoking in Medicaid recipients by 1% could result in $2.6B savings

Reducing smoking, and its associated health effects, among Medicaid recipients in each state by just 1 percent would result in $2.6 billion in total Medicaid savings the following year, according to new research by UC San Francisco.
The median state would save $25 million, ranging from $630.2 million in California (if the smoking rate dropped from 15.5 percent to 14.5 percent) to $2.5 million in South Dakota (if the rate dropped from 41.3 to 40.3 percent), the research found.
The study, by Stanton A. Glantz, PhD, director of the UCSF Center for Tobacco Control Research and Education, is published April 12, 2019 in JAMA Network Open.
“While 14 percent of all adults in the U.S. smoke cigarettes, 24.5 percent of adult Medicaid recipients smoke,” said Glantz. “This suggests that an investment in reducing smoking in this population could be associated with a reduction in Medicaid costs in the short run.”
Total Medicaid costs in 2017 were $577 billion.
“There is no question that reducing smoking is associated with reduced health costs, but it’s commonly assumed that it takes years to see these savings, which has discouraged many states from prioritizing helping smokers quit,” said Glantz.
“While this is true for some diseases, such as cancer, other health risks such as heart attacks, lung disease and pregnancy complications respond quickly to changes in smoking behavior. So reducing the prevalence of smoking would be an excellent short-term investment in the physical health of smokers and the fiscal health of the Medicaid system,” he said.
Glantz derived state-by-state percentages of Medicaid recipients who smoke based on data from the 2017 Behavioral Risk Factors Surveillance System, which provides the percentage of smokers among the population of each state, and the 2017 National Health Interview Survey, which identifies Medicaid recipients in four major regions in the United States (Northeast, Midwest, South and West).
He then estimated potential Medicaid savings based on a previous research finding which showed that a 1 percent relative reduction in smoking prevalence is associated with a reduction of 0.118 percent in per capita health care spending.
Glantz noted that the study looked only at the potential savings from reducing the total number of Medicaid recipients who smoke. But even if each smoker just smoked less, there would be additional reductions in health care costs, he said.
Cost reductions from reducing smoking would continue and likely grow over the long term.
“Because some health risks linked with smoking, such as cancer, can take years to fully manifest, these savings would be likely to grow with each passing year,” Glantz said.
The paper shows predicted reductions in Medicaid costs by each state.

Combo Therapy With ‘Entry Inhibitor’ Latest Hope in Treating Hep D

A first-in-class “entry inhibitor” for hepatitis D virus (HDV) infection suppressed viral RNA in most treated patients, phase II trial data reported here indicated, especially when combined with interferon.
Eight of 15 patients randomized to treatment with 2 mg of Myrcludex B (MyrB, also known as bulevirtide) in combination with pegylated interferon α 2a (PEG-IFNα) had undetectable HDV RNA, even 24 weeks after stopping treatment, reported Heiner Wedemeyer, MD, of Essen University Hospital in Germany.
At a press conference at the International Liver Conference, the annual meeting of the European Association for the Study of the Liver (EASL), moderator Markus Cornberg, MD, a member of the EASL Scientific Committee, and a researcher at Hannover Medical School in Germany, explained that HDV is a “neglected disease.”
“We need to do something because we do not have good therapies for this besides interferon so far,” he said.
Wedemeyer described HDV — which only occurs simultaneously with hepatitis B — as “the most severe form of chronic viral hepatitis.” He further characterized various hepatitis infections to emphasize his point:
“[Hepatitis] E stands for emerging, C stands for ‘mission completed’ … and D stands for devil,” he said, adding that the virus is associated with a “higher likelihood to develop liver decompensation and also increase the likelihood of developing liver cancer.”
There is no approved therapy for hepatitis D, but it is recognized by the FDA and European Medicines Agency (EMA) as an orphan disease, Wedemeyer noted.
MyrB blocks HBV and HDV viral entry into host cells, he said. Prior studies of the drug found that it induced HDV RNA declines and improved alanine aminotransferase (ALT) levels.
This study (MYR203) randomized 60 patients — 15 to each of four regimens:
  • PEG-IFNα only
  • 2 mg MyrB + PEG-IFNα
  • 5 mg MyrB + PEG-IFNα
  • 2 mg MyrB only
Patients were treated for 48 weeks, followed by a 24 week follow-up period. MyrB was given once daily, and PEG-IFNα once weekly, both as subcutaneous injections. The study’s primary endpoint was undetectable serum HDV RNA at week 72.
Treatment arms experienced a “continuous linear decline” of hepatitis D RNA, but patients then experienced a rebound in HDV RNA at the end of therapy, Wedemeyer said. But the “big surprise” in this trial was the combination arm with 2 mg of MyrB, which experienced a much smaller rebound than even the 5 mg MyrB combination arm or the MyrB monotherapy arm.
“Not only was there an additive response, but a profound decline of HDV RNA, and many cases stayed HDV RNA negative 24 weeks after the end of therapy,” Wedemeyer said.
Secondary endpoints included a normalization of ALT levels, which was achieved in seven of 15 patients in the 2-mg MyrB combination arm and five of 15 in the 5-mg combination arm at week 72. Another secondary endpoint was a reduction of hepatitis B surface antigen (HBsAg), and indeed, six patients in the 2-mg combination arm experienced >1 log decline in HBsAg, and four patients had undetectable HBsAg at week 72.
Examining safety, there were no serious adverse events related to the study drug during the treatment period, and two serious adverse events not related to the study drug occurred during the follow-up period (anal fistula and proctitis). Wedemeyer noted an increase in bile salts in MyrB and PEG-IFNα-treated patients, though patients did not report any symptoms related to an increase in bile salts, and when the drug was stopped, it was “completely reversible,” he said.
The majority of adverse events came from PEG-IFNα treatment, the authors noted, though Wedemeyer defended the safety of interferon therapy.
“Interferon may cause side effects, but we’ve been using it for 15 years in hepatology and it’s current practice, so it’s not special,” he told MedPage Today.
Wedemeyer said the plan would be for a longer-term phase III study with MyrB monotherapy for patients with more severe disease, and combination therapy for those that could tolerate interferon.
The study was funded by Myrcludex B’s developer, MYR Pharmaceuticals. Wedemeyer disclosed support from Abbott, AbbVie, BMS, Boehringer Ingelheim, Eiger, Gilead, JJ/Janssen-Cilag, Merck/Schering-Plough, MYR, Novartis, Roche, Roche Diagnostics, and Siemens.
Cornberg disclosed support from AbbVie, Biogen, BMS, Gilead, Janssen-Cilag, Merck Sharp & Dohme, Roche, Spring Bank, and Falk.