How A Drug Company Under Pressure For High Prices Ratchets Up Political Activity

Business looked challenging for Novo Nordisk at the end of 2016. As pressure mounted over the pharma giant’s soaring insulin prices, investors drove its stock down by a third on fears that policymakers would take action, limit prices and hurt profits.

Then things got worse. A Massachusetts law firm sued the company and two other pharma firms on behalf of patients, claiming that high insulin prices of hundreds of dollars a month forced diabetics to starve themselves to minimize their blood sugar while skimping on doses. At least five states began investigating insulin makers and their business partners.

As scrutiny rose, Novo Nordisk engaged in what analysts say is a time-honored response to public criticism. It aggressively ratcheted up spending to spread its influence in Washington and to have a louder say in the debates over drug prices.

The drugmaker’s political action committee spent $405,000 on federal campaign donations and other political outlays last year, more than in 2016 — an election year — and nearly double its allocation for 2015, data compiled by Kaiser Health News show.

“We remain committed to being part of the discussion,” said Tricia Brooks, head of government relations and public affairs for Novo Nordisk, acknowledging scrutiny over insulin prices but saying the company has many other issues to work on with policymakers. “I don’t want us to run away from it and hide or keep our head down and wait for it to roll over.”

Novo Nordisk also spent $3.2 million lobbying Congress and federal agencies in 2017, its biggest-ever investment in directly influencing U.S. policymakers, according to the Center for Responsive Politics.

Part of that surge included summoning more than 400 Novo Nordisk employees to contact lawmakers and their staffs on Capitol Hill, “a huge increase from anything we’ve ever done before,” Brooks said.

Taken together, the increases represent a “major corporate policy shift” for the company and appear to be a classic business response to growing political risk, said Kent Cooper, a former Federal Election Commission official who has tracked political money for decades.

The pharma industry as a whole has behaved similarly, cranking up political contributions and lobbying. Meanwhile, despite much talk about change, Congress and the Trump administration have done little to control drug prices or threaten drug-company profits.

Pharma businesses overall made political donations of $12.1 million last year, down from a $13.6 million election-year surge in 2016 but 9 percent higher than the haul for 2015, according to the KHN analysis. Pharma industry lobbying expenses surpassed $171 million last year, the highest level since 2009, during negotiations over the Affordable Care Act, according to CRP.

“It’s been hot in the health care arena for — how many years now?” said Steven Billet, who teaches lobbying and PAC management at George Washington University. “Anybody in this world now is sitting there thinking, “When I go back to the board next year, I’m going to ask for 15 percent more in my [lobbying and campaign finance] budget. Because this isn’t going away.’”

Like most big corporations, Novo Nordisk runs a political action committee, or PAC, which solicits employee donations and gives the proceeds to political candidates’ campaigns. The company is Danish. Only workers who are U.S. citizens or permanent residents are allowed to support the PAC.

Like many PACs, Novo Nordisk spreads money to both parties, concentrating on powerful committee members and other leaders. Since 2013 it has given $22,500 to House Speaker Paul Ryan, a Republican, and $20,472 to South Carolina’s James Clyburn, a member of the Democratic House leadership.

Brooks gave the PAC $4,370 last year, the data show. Some employees gave as little as $20 or $30.

The firm’s influence-seeking has grown along with its U.S. sales, which went from hundreds of millions of dollars in the early 2000s to some $9 billion last year. Its biggest business is diabetes, including various types of insulin whose list prices have more than doubled in recent years.

The wholesale list price for a vial of Novo Nordisk’s Levemir, a long-acting insulin, went from $144.80 in 2012 to $335.70 in January, when the price rose 4 percent, according to Connecture, a research firm.

Even Alex Azar, a former Eli Lilly executive who became Health and Human Services secretary in January, said in his confirmation hearing that “insulin prices are high, and they’re too high.” Along with Novo Nordisk and Sanofi, Lilly is one of the three big insulin makers under investigation by state attorneys general for price increases that seem suspiciously similar in size and timing.

Sanofi and Lilly both spent more last year on political donations and federal lobbying than Novo Nordisk. Lilly’s political spending was $548,100 for 2017, up 12 percent from 2015, the previous off-election year, the data show. Sanofi’s was $527,200, down from 2015.

But potential insulin price limits threaten Novo Nordisk more than those companies because diabetes-related drugs account for an exceptionally big portion of its business, analysts said. Several proposals under consideration by Congress could lower insulin prices or limit future increases.

One would allow the Medicare program for seniors to negotiate prices for covered drugs, thus lowering the cost.

Other proposals would make it easier for competing, “biosimilar” alternatives to break through the thicket of patents created by sellers of complex drugs such as insulin. Others would bring more transparency, requiring companies to publish and justify price increases.

None of the proposals has made it out of congressional committees. In the face of inaction by Washington, Novo Nordisk’s stock has recovered much of the ground it lost in 2016.

Novo Nordisk rejects suggestions that it coordinated price increases with competitors. So do Sanofi and Lilly.

List prices such as those tracked by Connecture don’t reflect what patients or their insurers ultimately pay, said Novo Nordisk spokesman Ken Inchausti. Growing discounts and rebates substantially reduced the reported list price, he said.

Even including discounts, however, the company’s net profit margin for 2017 was 34 percent, its highest since at least 2000, when it was half that high.

Official filings show Novo Nordisk lobbyists have been weighing in on numerous measures related to drug prices, including proposals to import less expensive drugs from Canada.

The company lobbies Washington on a wide range of issues including diabetes prevention, budget matters, chronic disease and making obesity an accepted medical disease that insurers will pay to prevent, Brooks said.

But last year’s increase in campaign donations and lobbying doesn’t look like business as usual for Novo Nordisk, said Billet, a former AT&T lobbyist who directs GWU’s Legislative Affairs program.

“I’m not surprised,” he said. “They’ve obviously had some issues recently. This is maybe a predictable enough element in their strategy.”

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

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Tax-Funded Mental Health Programs Not Always Easy To Find

Back in 2008, Mary Hogden was homeless, living on the streets of Berkeley, Calif.

“I got beat up really badly out there,” says Hogden, 62. “It’s not a safe place for women.”

She landed in the hospital and then in a boarding home for adults with mental illness. But her big break came when she started volunteering for a mental health program called the Pool of Consumer Champions, run by Alameda County.

Participants, who offer each other support, also advise the county’s behavioral health division on how to better meet consumers’ needs. The county has adopted some of the group’s recommendations, Hogden says.

“People rallied around me when I was unstable and struggling with my mental health,” Hogden recalls.

She didn’t know at the time that the program was paid for by the state’s Mental Health Services Act (MHSA). But after two years as a volunteer, she became a paid staffer and learned that the program wouldn’t exist without that funding.

“I wouldn’t be where I’m at in my wellness and recovery had it not been for the Mental Health Services Act,” Hogden says.

In 2004, Californians approved the act, originally known as Proposition 63, which imposes a 1 percent tax on personal income over $1 million to help counties expand mental health care services.

The tax has raised billions, and Gov. Jerry Brown expects it will bring in roughly $1.8 billion in the coming fiscal year.

“Counties were able to take Mental Health Services Act dollars and either revamp existing programs or completely create new programs that didn’t exist at all,” says James Wagner, deputy director of Alameda County Behavioral Health Care Services.

The act has been “wildly successful” at improving the ability of counties to respond to the mental health needs of their residents, he says.

But counties and the state have faced criticism from the Little Hoover Commission, an independent state oversight agency, and others for their implementation of the law. In February, a state audit accused counties of hoarding the mental health money — and the state of failing to ensure the money was being spent.

Still, there’s no question “these programs have helped hundreds of thousands of people,” says Heidi Strunk, president of the California Coalition for Mental Health.

A 2016 compilation of MHSA-funded programs across the state lists page after page of offerings that address homelessness, suicide, caregivers, veterans, children and dozens of other topics and populations, including scholarships for college students pursuing degrees in mental health.

But what’s available — and to whom — depends on your county. For instance, most programs are for low-income residents, but that’s not true across the board. Unfortunately for consumers, researching county programs and determining whether you or your loved ones qualify may not be easy.

“It’s so hard for individuals and families to know what kind of services are available, especially because there’s no statewide standard,” says Jessica Cruz, CEO of NAMI California, an advocacy group for individuals, and their families, who have been affected by serious mental illness.

“Access is an issue,” Cruz says. “There’s not one singular place to look and see what’s available.”

Strunk’s coalition is advocating for a statewide, interactive map that will allow you to click on your county and see its Mental Health Services Act programs. NAMI California, which compiled the 2016 list of programs statewide, is working on an update, but that won’t be out until this summer, Cruz says. (Check NAMI California’s website at namica.org for the update.)

“We’re still trying to resolve issues with how to get information to the public,” Strunk says.

Until there’s a central information source, you will have to use your research skills, plus a little telephone work.

To get started, Strunk suggests Googling your county’s name and the term “MHSA coordinator.” Then call that person. You can also find your county’s MHSA plan online.

Some counties have toll-free hotlines that will help connect you with appropriate programs based on your needs. (In Orange County, for example, it’s 855-625-4657. In Alameda County, dial 800-491-9099. Riverside County residents can call 800-706-7500.)

“Each county webpage looks different,” Strunk warns. “Some counties have super user-friendly landing pages, for some counties it’s buried, and some you can’t find at all.”

MHSA programs primarily serve recipients of Medi-Cal, California’s version of the federal Medicaid program for low-income residents, and uninsured people with serious mental illnesses. But there are also services for a broader range of the population.

About 20 percent of Mental Health Services Act dollars are earmarked for “prevention and early intervention,” and these are more likely to serve a wider cross section of people.

Sharon Ishikawa, Orange County’s Mental Health Services Act coordinator, points to OC ACCEPT as one example. The program provides counseling, vocational support and other services to people — and their families — who are confronting challenges related to sexual orientation and gender identity.

“It is open to anybody with or without insurance,” says Dawn Smith, a program manager who oversees several of the county’s MHSA-funded services. “They might have a really high deductible and don’t have a way to pay that or they might not be able to afford the copay.”

But the majority of participants are uninsured, Smith says.

NAMI, which has chapters across the state, operates some MHSA-funded programs on behalf of counties, and eligibility is not based on insurance status, Cruz says.

“For us, anybody’s eligible. Anybody can come to a family-to-family class. Anybody can come to a support group. You don’t have to be referred by the county,” she explains.

NAMI Orange County runs the MHSA-funded Peer Connector program, says Diana Fernandez, one of the peer mentors.

The program is for people, regardless of income, who have a family member or friend who is struggling with mental illness, a learning disorder or a behavioral problem. Participants can have a one-hour phone call each week for up to 12 weeks with peer mentors who have had personal experience finding help for themselves or loved ones, Fernandez explains.

Fernandez has five children, and two have struggled with dyslexia and attention deficit hyperactivity disorder (ADHD).

Last week, Fernandez spoke with a man who told her he felt suicidal. She stayed on the phone and connected him with the county’s crisis assessment team, then waited until she knew he was on his way to the hospital.

That situation was unusual, she says. More typically, Fernandez helps parents of children who are struggling in school, or caregivers who are emotionally and physically spent.

“We assure clients that they are normal and typical for what they’re going through,” she says. “That gives them a feeling of hope they may not have had before.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

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FDA clears Pluristem radiation treatment for emergency use

HAIFA, Israel (Reuters) – Pluristem Therapeutics Inc, a developer of placenta-based stem cell products, said the U.S. Food and Drug Administration has cleared the emergency use of its therapy to treat acute radiation exposure in a nuclear event.

FILE PHOTO – Biologists work in a laboratory at Pluristem Theraputics in Haifa, Israel March 6, 2016. REUTERS/Baz Ratner

Pluristem said it will start preparations to keep an emergency stock of PLX-R18 on hand for use in such events.

Full approval of the drug will depend on the results of a Phase III clinical trial. Pluristem said on Monday it is in discussions with the FDA and several U.S. agencies to clear the path for such a large final-stage study.

The U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases sponsored and completed a mid-stage study of PLX-R18 in the treatment of acute radiation syndrome (ARS) in animals via the FDA’s “animal rule pathway” as ARS cannot be tested in humans. PLX-R18 will be provided up to 96 hours following radiation exposure.

It is also being studied by the U.S. Department of Defense to support the armed forces as a treatment prior to, or within the first 24 hours of radiation exposure.

“We are increasing the survival rate following high-level radiation exposure,” Arik Eisenkraft, Pluristem’s director of homeland defense projects, told Reuters. “We see improvement in all three blood lineages – red cells, white cells and platelets.”

PLX-R18 is injected into the muscle twice, a week apart.

FILE PHOTO: A laboratory worker removes cells from a storage unit at Pluristem Theraputics in Haifa, Israel March 6, 2016. Picture taken March 6, 2016. REUTERS/Baz Ratner/File Photo

It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes, including ARS and certain cancers or cancer treatments.

“We think that the everyday use of the compound will be for bone marrow failure of any cause,” Eisenkraft said.

Pluristem said its cells can be administered to patients without the need for tissue matching. One placenta makes 20,000 treatments.

Pluristem is conducting advanced Phase III trials in the United States and Europe of another product, PLX-PAD, to treat patients with the end-stage of peripheral artery disease, to prevent the need for amputation.

“In Europe, we are hoping to open data at the end of 2019 and in the U.S. a year later,” co-CEO Zami Aberman said.

That treatment has also been approved for a Phase III trial, to begin in the next few months, in patients with the most common form of hip fracture, in which the cells are injected during surgery, he said.

Reporting by Tova Cohen, editing by Louise Heavens

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CMS Encourages Eligible Suppliers to Participate in Expanded Medicare Diabetes Prevention Program Model

April 30
by Centers for Medicare & Medicaid Services

By CMS Administrator Seema Verma

Nationally expanded performance-based payment model now enrolling service suppliers

The Centers for Medicare & Medicaid Services (CMS) in April expanded the Medicare Diabetes Prevention Program (MDPP), a national performance-based payment model offering a new approach to type 2 diabetes prevention in eligible Medicare beneficiaries with an indication of pre-diabetes. For the first time, both traditional healthcare providers and community-based organizations can enroll as Medicare suppliers of health behavior change services. This innovative model promotes patient-centered care and continues to test market-driven reforms to drive quality of care and improve outcomes for America’s seniors, more than a quarter of whom have type 2 diabetes.

CMS recognizes that prevention is a critical part of creating an affordable healthcare system that puts patients first, and we encourage eligible suppliers to partner with us on this shared goal by participating in the national expansion of the MDPP.

As the CMS Innovation Center’s first preventive services model test to expand nationally, the MDPP is a key example of how we’re putting innovation to work. The model launched in 2012 as a small, voluntary model test at 17 sites across the country in partnership with the YMCA-USA, Centers for Disease Control and Prevention (CDC), and other public and private partners. Now, CMS is expanding this set of services nationwide based on promising results. In the initial model test, 45 percent of beneficiaries met the 5 percent weight loss target, which translates to a clinically meaningful reduction in the risk of developing type 2 diabetes.

Through the MDPP, trained community health workers and other health professionals empower beneficiaries at high risk of developing type 2 diabetes to take ownership of their health through curriculum-driven coaching and proven behavior change strategies for weight control. As a new preventive service for qualifying Medicare beneficiaries, MDPP services are available without a referral or co-payment.

The MDPP is not only a good value for our beneficiaries. Investing in prevention through performance-based payments and market-based incentives, this promising model will save the Medicare program more than $180 million by keeping beneficiaries healthy and averting new cases of diabetes[i].

One of the critical innovations in the MDPP is its approach to care delivery: For the first time, community-based organizations can enroll in Medicare to provide evidence-based diabetes prevention services after achieving preliminary or full recognition through the CDC. These organizations can enroll in Medicare to become an MDPP Supplier today, and CMS will continue to accept supplier applications on a rolling basis. Eligible organizations can begin the screening and enrollment process to become an MDPP Supplier by using the Provider Enrollment Chain and Ownership System (PECOS) or submitting the paper CMS-20134 Form. For information on the steps to enrollment, please refer to the MDPP Enrollment Fact Sheet.

Diabetes exerts an unacceptable toll on our beneficiaries, their families, and the Medicare program, which spends more than $104 billion every year treating patients with this preventable disease. The Medicare Diabetes Prevention Program is leveraging innovation to bring valuable preventive services to our beneficiaries, and I urge eligible organizations across the country to enroll today in this exciting performance-based payment opportunity.

[i] Federal Register. Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program; Final Rule. November 15, 2017. [pg. 53355 – 53356] https://www.gpo.gov/fdsys/pkg/FR-2017-11-15/pdf/2017-23953.pdf

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Improving the Diagnosis of Cardiac Sarcoidosis

April 30, 2018

An interview with Dr. Nadera Sweiss, MD, FACR, conducted by Kate Anderton, BSc

What is cardiac sarcoidosis?

Cardiac sarcoidosis is an inflammatory disease of the heart that results in various clinical manifestations. It is characterized by the presence of granulomas in the heart, which may be the first manifestation of sarcoidosis.

Credit: Liya Graphics/Shutterstock.com

How often is sarcoidosis present in other areas of the body in addition to the heart?

Sarcoidosis as an inflammatory disease that commonly involves various organs in the body, basically from head to toe. Patients quite often show signs of sarcoidosis in the brain, lungs, heart, liver and joints.

The commonest organ is the lung, but we are not sure how common this is in relation to cardiac sarcoidosis. There haven’t been many studies to give us a clear answer about the exact prevalence and the occurrence outside the heart. This is often because we’re comparing various studies from various parts of the world, so the numbers vary quite a bit.

So, the exact answer to your question is we really do not know. It depends on the organ, the center, where do you practice, and what kind of specialty you do, and how extensively do you look to find sarcoidosis in other organs.

How is cardiac sarcoidosis currently diagnosed?

The guidelines have changed over the past couple of years and are likely to change again but currently, the gold standard for accurately diagnosing cardiac sarcoidosis is the presence of signs and symptoms, as well as evidence from a cardiac PET/CT scan, and/or a cardiac MRI.

It is likely that in the future, there will be hybrid machines that will combine both. But the way we most often diagnose it at our center is using a cardiac PET/CT scan. This is because many patients have metal in their body, such as a pacemaker or defibrillator, which are not compatible with MRI. There are now MRI machines that are compatible with metal, and newer devices that are MRI-friendly, but not every institution or patient has these.

In patients where we cannot perform a cardiac MRI, we do the cardiac FDG PET/CT but in an ideal world, we’d love to be able to do both tests together.

What is FDG?

FDG is an abbreviation for Fludeoxyglucose, a glucose analog that we give to patients prior to a PET scan. It is taken up by organs with a high demand for glucose, such as the heart or cancer cells, instead of physiologic glucose. It acts as a radioactive dye that allows us to visualize abnormalities and diagnose sarcoidosis in the heart, for example.

Why is a high-fat, low-sugar diet recommended when diagnosing cardiac sarcoidosis via FDG-PET?

If you do not deplete the body of glucose a few days before the test, the results may be affected by the normal physiologic uptake of glucose in the heart. This could make it look like as if the patient has sarcoid in the heart, when in reality, the observations are due to poor preparation. This is known as a false positive result.

Most centers recommend a high-fat, low-sugar diet for at least 24 hours before an FDG-PET. However, this technique hasn’t been validated. We currently use the 72 hour preparation based on our recent study utilizing this technique, and found that the three-day diet leads to much clearer images. Ho

Why is it important to combine FDG-PET scanning with CT scanning?

Computer tomography (CT) scanning is a good way of detecting lesions in the heart, such as granulomas in cardiac sarcoidosis. It helps us to see the size and location of any lesions but doesn’t tell you anything about the activity of the lesion.

FDG-PET can tell you whether the lesion is active or inactive, whether there is physiologic uptake of the glucose in the sarcoid, or whether it is something else entirely. When you combine these tests, you’re able to see the physiologic and pathologic uptake of glucose in the tissue, in addition to evaluating the size of the nodule or the inflammation in the lung.

Having said that, we sometimes carry out the FDH-PET with a perfusion study, which allows us to make sure that if we can see something in the heart, we don’t misdiagnose it as sarcoid when it is, for example, due to a decrease in blood flow to the heart, or another issue.

Credit: sfam_photo/Shutterstock.com

Please describe your recent research into the diagnosis of sarcoidosis.

As previously mentioned, we published in January 2017 where we looked at the use of an FDG-PET/CT scan to diagnose cardiac sarcoidosis.

Our hypothesis was that the myocardial physiologic uptake of FDG is unpredictable, so if we put patients on a 72 hour pre-test high-fat, high protein, and very low carbohydrate diet, which we referred to as HFHPVLC, it could suppress the physiologic uptake of the FDG, and thus help us identify active cardiac sarcoidosis.

Although it was a retrospective study, we had a large number of patients; 215 patients underwent an FDG PET/CT test. The results suggested that if patients are subjected to the pro-longed 72 hour diet, the FDG-PET/CT scan was more sensitive and was a more accurate method of diagnosing active cardiac sarcoidosis than the 24 hour diet previously used.

Our study changed standard practice around the world, with most institutions now using the 3 day diet. However, I believe a larger study is needed, to validate our results fully. We then looked at using a PET scan to stage the disease. We wanted to find out whether we could use the PET scan of the heart to diagnose sarcoidosis outside the heart.

We took the same patients as our previous study who had been diagnosed with cardiac sarcoidosis and looked at the images again. We tried to define sarcoidosis outside the heart, and to our surprise, we found 20 scans that were positive for cardiac sarcoid among the 188 patients (around 40%).

This number needs to be validated, as I suspect that it will vary from 20% to 60%, depending on the center. So, the answer to our research question was, yes, the PET scan useful to diagnose at sarcoidosis outside the heart, but it needs validation.

What projects are you currently working on?

We were recently awarded a grant from the National Institute of Health. The principal investigators on the grant are Dr. Patricia Finn, the Earle M. Bane Professor of Medicine and Head of the UIC Department of Medicine, and Dr. David Perkins, Professor of Medicine, Surgery, and Bioengineering at UIC. I am one of the co-investigators. It will be used to fund research into the microbiome and the host’s immune response in sarcoidosis.

Our hypothesis is that the microbiome is altered in patients with sarcoidosis, affecting their immune responses. We will hopefully correlate our results with PET scan images as well, in order to improve diagnoses.

On the clinical side, we are current conducting some clinical trials into new therapies for sarcoidosis. Our main area of interest is cardiac sarcoidosis and over the next year, we hope to study the macrophages  and T cells in cardiac sarcoidosis, and how they relate to other types of sarcoidosis.

We’re going to look at lung sarcoid, heart sarcoid, kidney sarcoid, and most likely liver sarcoid too, and compare the results to normal controls, to try to further our understanding of the pathophysiology and the immunology of cardiac sarcoidosis.

Where can readers find more information?

Dr. Sweiss’ Academic Profile

About Dr. Nadera Sweiss

Dr. Nadera Sweiss is a specialist in rheumatology, the study of chronic and acute conditions that cause inflammation and sees a wide variety of patients with autoimmune diseases.

Dr. Sweiss directs the Bernie Mac Sarcoidosis Translational Advanced Research (STAR) Center, which she helped establish together with the Bernie Mac Foundation at the University of Illinois Hospital & Health Sciences System in 2012.

The STAR Center conducts research into new treatments for sarcoidosis, and also provides clinical services for patients with sarcoidosis. She is also director of the UI Health Cold Hand Clinic.

Sweiss is a principal investigator of numerous clinical trials that focus on finding treatments for sarcoidosis, scleroderma, Raynaud’s phenomenon and rheumatoid arthritis when these disorders do not respond to traditional therapies.

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Obesity associated with more rapid progression of disability in rheumatoid arthritis patients

April 30, 2018

In a study of adults with rheumatoid arthritis, those who were severely obese experienced more rapidly progressing disability than patients who were overweight. This was not explained by features of their arthritis, including the amount of inflammation in their joints. In the Arthritis Care & Research study, weight loss after enrollment was also associated with worsening disability, possibly as a sign of frailty.

To examine the effects of obesity in patients with rheumatoid arthritis over time, Joshua Baker, MD, MSCE, of the Perelman School of Medicine at the University of Pennsylvania, and his colleagues examined information on 23,323 patients with rheumatoid arthritis from the National Data Bank of the Rheumatic Diseases and 1697 from the Veterans Affairs RA registry.

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Severe obesity was associated with more rapid progression of disability. The study also found that patients who lost weight tended to become disabled more quickly, especially in those who were already thin. “We believe that this is because when people get older and acquire illnesses, they tend to lose weight. Therefore, the important weight loss in this study is unintentional,” said Dr. Baker. “So, this study suggests that patients with rheumatoid arthritis and obesity would benefit from intentional weight loss through a comprehensive management strategy; however, when we see that someone is losing weight without trying, it’s probably a poor prognostic sign, especially if they are already thin.”

The findings are especially relevant when considering the rising rates of obesity in recent years. “While patients and rheumatologists may be focused mostly on disease activity, we should also consider this common condition, which can contribute to problems that are usually attributed to the arthritis itself,” said Dr. Baker. “In addition, unintentional weight loss should alert us that the patient may be becoming frail and is at risk for developing new disability.”

As new therapies and approaches to weight loss become available, these results will help promote their use in patients with arthritis, to help prevent disability over the long-term. The findings may also encourage health providers to recognize unintentional weight loss as a poor prognostic sign and refer patients for strength training, physical therapy, and other interventions to prevent disability.

Source:

http://newsroom.wiley.com/press-release/arthritis-care-research/obesity-may-hasten-disability-patients-rheumatoid-arthritis

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Best Reads Of The Week From Brianna Labuskes

Happy Friday! If you’re like me, you’re hooked on the The Golden State Killer case, where investigators used a genealogy website to hunt down their suspect. (And if you’re also a health wonk like me, you’ll want to check out this story on what privacy concerns the investigators’ strategy sparked.)

On to the rest of the best from the week.


Dr. Ronny Jackson’s alleged misconduct (like how he was called “the candy man” and oversaw a hostile workplace) has dominated the headlines. But behind the theatrics of the failed nomination process lies a crucial but leaderless agency — the Department of Veterans Affairs — that’s caught in the midst of a fierce battle over privatization. There has been a recent legacy of turmoil and scandal at the VA, and veterans’ health care is at stake. “This is complete and total chaos after years of complete and total chaos,” said Paul Rieckhoff, with Iraq and Afghanistan Veterans of America.

• The Washington Post: ‘What Makes It Stop?’ Veterans Lament the Ongoing Turmoil Surrounding Trump’s Pick for VA Secretary


Do drug companies see rare-disease patients as human jackpots? A deep dive into the money flow for charities that are, in theory, set up to help those patients pay for expensive drugs reveals that pharma may not be donating to the organizations out of the goodness of their hearts. (Go ahead, feign surprise.)

• The Washington Post: Why Drug Companies See Rare-Disease Patients As Human Jackpots

• USA Today: Drug copay groups: Critical patient charities or fronts for drug makers?

Don’t forget our new KHN patient advocacy group database, “Pre$cription for Power,” which tracks the donations of some of the country’s biggest drugmakers to hundreds of patient groups. It was a resource for the USA Today story and is available for all to use.


Short-term plans are back in the news because the comment period for the proposed extension was Monday. Lots of people in the industry spoke out against them for obvious reasons — they know healthy and young consumers are likely to jump ship to these enticingly cheap plans leaving the population buying individual coverage sicker and older, on the whole. Also, they warn, those young and healthy consumers may well find that the plans don’t offer good coverage if they get sick.

• The Washington Post: Trump Proposal Could Mean Healthy People Save on Insurance While Others Get Priced Out


In the new trend of transparency as a fix for high health prices, the Centers for Medicare & Medicaid Services wants to require hospitals to post their prices online in an easily accessible format for patients. But experts say that while the idea sounds good in theory, it’s not actually going to help most consumers because list prices aren’t what people end up paying. And there’s the big question: Does CMS really have the legal authority to make them do this?

• Modern Healthcare: CMS Proposal for Hospitals to Publish Prices Raises Tricky Issues

• Politico Pro: Legal Barriers Await Medicare’s Price Transparency Work


There was a lot of movement in women’s health this week: The administration is favoring abstinence-focused programs with its teen pregnancy prevention funds; a judge has blocked cuts to Planned Parenthood grants; and an executive order banning Title X funding for Planned Parenthood is apparently in the pipeline for next month.

• The New York Times: Trump Administration Pushes Abstinence in Teen Pregnancy Programs

• The Associated Press: Judge Prevents Trump From Cutting Planned Parenthood Grants

• Modern Healthcare: Trump Could Ban Title X Funding for Planned Parenthood


The research on needle exchanges is crystal-clear. They cut deaths, curb spending and reduce disease without increasing drug use. But in the midst of a raging opioid epidemic, public health leaders just can’t quite convince the public that they’re a good idea.

• The New York Times: Why a City at the Center of the Opioid Crisis Gave Up a Tool to Fight It

And a drug distributor absolves itself of responsibility in the opioid crisis — but, uh, it doesn’t really work that way.

• Bloomberg: McKesson’s Board Clears Itself of Fault on Opioid Oversight


In the miscellaneous file: In Oregon, the criminally insane get better mental health services than people who don’t commit a crime; oncologists wonder if the slimmest chance of a therapy working justifies offering the treatment to terminal patients or if it’s better to keep their mouths shut;  and a reporter offers a heartbreaking look at West Virginia’s long history of broken promises over black lung disease.

• Stateline: What Care for the Criminally Insane Can Teach Us About Mental Health Treatment

• The New York Times: ‘Desperation Oncology’: When Patients Are Dying, Some Cancer Doctors Turn to Immunotherapy

• ProPublica: Covering West Virginia’s Long History of Broken Promises


Have a great weekend! And let me know what you think of this doctor who is pushing the idea of “regifting” kidneys as a way to solve the country’s organ shortage.

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Ninety-eight now sick from romaine lettuce-linked E. coli: CDC

(Reuters) – Fourteen more people fell ill from an E. coli outbreak linked to romaine lettuce, U.S. health officials said on Friday, bringing the number of people affected to 98 across 22 U.S. states.

Romaine lettuce grows near Soledad, California, U.S., May 3, 2017. REUTERS/Michael Fiala

The reported strain of E. coli, which produces poisonous substances known as Shiga toxins, can cause severe abdominal cramps, bloody diarrhea and vomiting.

The outbreak that began last month is now the largest multi-state Shiga toxin-producing outbreak since 2006, the U.S. Centers for Disease Control and Prevention (CDC) said.

Forty-six people have been hospitalized, including 10 who had developed a type of kidney failure, the CDC said in its latest update on the outbreak. No deaths have been reported.

Three more states — Mississippi, Tennessee, and Wisconsin — reported people falling sick.

“We do expect more reports of illnesses since there is a two-to-three week delay between the time that a person is sick and between the time they can be confirmed as part of the outbreak,” Matthew Wise, deputy branch chief for Outbreak Response at the CDC, said at a media briefing.

Eight cases in Alaska were linked to a farm in Yuma, Arizona, the CDC said.

“Most of the illnesses linked to the Romaine outbreak are not linked to the Romaine lettuce from (the Yuma) farm. We are investigating dozens of other fields as potential sources of the chopped Romaine lettuce,” a U.S. Food and Drug Administration official said at the briefing.

The CDC repeated its advice that people not eat or buy romaine lettuce, which is commonly used in salads, unless they can confirm it is not from the Yuma growing region.

Reporting by Manas Mishra in Bengaluru; Editing by Sai Sachin Ravikumar

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Allergan migraine drug succeeds in second late-stage trial

NEW YORK (Reuters) – Allergan Plc on Friday announced positive results from a second Phase III trial for the 50 milligram dose of its drug for acute migraine, reproducing results from the previous trial.

The Allergan logo is seen in this photo illustration November 23, 2015. REUTERS/Thomas White/Illustration/File Photo

A lower dose of the drug, ubrogepant, failed to meet one of the study’s two main goals, the company said.

Wall Street is focused on the company’s pipeline of drugs in development as Allergan faces new, cheaper competition for its Restasis eye treatment and Namenda XR for Alzheimer’s disease. Allergan has said that it believes the migraine drug could reasonably bring in $500 million a year.

In February, the drug company reported positive results for the 50 and 100mg doses of the pill in another late-stage trial.

This trial backs up those results for the 50mg dose, David Nicholson, Allergan’s Chief Research and Development Officer said in an interview.

“You have to show that a drug reproducibly demonstrates benefit in the population that you intend to treat. We now have two adequate and well controlled studies clearly demonstrating the benefit of ubrogepant in the acute treatment of migraine,” Nicholson said.

In the trial of more than 1,300 patients, 21.8 percent were pain-free two hours after taking the 50mg dose versus 14.3 percent on placebo. About 39 percent in the 50mg group also reported the absence of their most bothersome symptom (MBS), such as nausea or sensitivity to light or sound, compared with 27.4 percent for placebo. Both results were deemed statistically significant.

The 25mg dose, while providing pain relief, was not significantly better than placebo on the MBS measure.

The treatment belongs to a class of migraine drugs also being developed by Eli Lilly, Amgen and Alder Biopharmaceuticals that target a protein associated with pain signaling called CGRP.

Some of these are injected therapies designed to prevent chronic migraines. Ubrogepant is intended to relieve migraine pain and other symptoms after their onset.

Allergan said it is still on track to file for U.S. approval next year, and believes it will be the first oral CGRP on the market. It has two longer-term safety studies to complete this year.

There have been some concerns about liver toxicity with drugs in this class. Allergan is confident that its drug does not cause liver problems for patients.

“We have no reason to believe that ubrogepant has any propensity to induce liver injury,” Nicholson said.

Reporting by Michael Erman; Editing by James Dalgleish

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Dissecting the rhetoric vs. reality of Trump’s tough talk on drug prices

April 27, 2018

Trump promised a speech on prescription drug prices, and it’s expected anytime.

Here’s a look at the rhetoric thus far versus the results.

You’ll be seeing drug prices falling very substantially in the not-too-distant future, and it’s going to be beautiful.

Trump, March 19, 2018, at Manchester (N.H.) Community College

What’s Happening:

The White House and administration leaders, including Health and Human Services Secretary Alex Azar and Food and Drug Administration Commissioner Scott Gottlieb, say increasing competition is a priority. Gottlieb — whom Trump has called a star — said the FDA has approved a record number of generic drugs and eliminated a backlog in approvals.

The agency is looking for ways to boost price competition for biologics, which are made from natural sources and are among the most expensive drugs on the market. Currently, pharmacists cannot substitute a lower-cost “biosimilar” version when the doctor prescribes a biologic. FDA has proposed “interchangeability” rules that could change the status quo.

The Outlook:

Driving down drug prices through competition may take awhile. That’s because even after gaining FDA approval, generic drugs often have trouble being launched, according to Chip Davis, president of the Association for Accessible Medicines, a trade group for makers of generics and biosimilars. Only three of nine biosimilars approved are available for patients, largely due to patent protections.

We have to get the prices of prescription drugs way down and unravel the tangled web of special interests that are driving prices up for medicine and for really hurting patients.

Trump, Jan. 29, 2018, during Azar’s swearing-in ceremony

What’s Happening:

To say health care is complicated is an understatement. The system that dictates how patients get prescriptions and what they pay includes an array of buyers and payers, such as insurance companies and pharmacy benefit managers. In February, the White House pitched the idea of passing on the discounts and rebates negotiated by PBMs, the financial middlemen between insurers and drugmakers, to seniors who buy drugs through Medicare Part D. This idea, first floated under President Barack Obama’s administration, would mean seniors would pay less out-of-pocket but could also increase premiums if insurers took on added costs.

The Outlook:

Late last year, the administration released a request for public comment on this idea, and pressure is building for the administration to take action. “It’s the one thing you could say that has immediate benefit to consumers,” said John Rother, president of the National Coalition on Health Care. But House Minority Leader Nancy Pelosi said she isn’t convinced much will really change: “At this point, no one is surprised that President Trump has found another reason not to act on prescription drug costs,” Pelosi said in a statement to Kaiser Health News. “While President Trump is making more excuses, Democrats will be discussing real solutions.”

I have directed my administration to make fixing the injustice of high drug prices one of our top priorities for the year. And prices will come down substantially. Watch.

Trump, Jan. 20, 2018, State of the Union address

What’s Happening:

The White House has pitched moving drugs covered under Medicare Part B into the popular Part D program. Part B is the bucket of Medicare that covers drugs that are administered in hospital outpatient settings and doctor’s offices, including expensive chemotherapy and rheumatoid arthritis infusions. Insurers compete for business in Part D and negotiate prices for their members, but there is no such price negotiation in Part B. Total drug spending in the Part B program was about $26 billion in 2015, and the upward trend is ominous.

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The Outlook:

While providers and insurers are likely to fight it, there’s no reason the idea wouldn’t work, said Tom Scully, the former Centers for Medicare & Medicaid Services administrator who designed the Medicare prescription drug programs in the early 2000s. He worked closely with HHS’ current leader, Azar, who was then general counsel for HHS. “There’s no reason to have Part B,” said Scully, adding that moving the drugs under Part D would require price negotiation. “If you really want to drive down drug prices, you have to put somebody’s money at risk other than the taxpayers’.”

For Medicare, for Medicaid, we have to get the prices way down, so that’s what we’re going to be talking about.

Trump, Jan. 31, 2017, while holding a listening session with pharmaceutical industry leaders

What’s Happening:

When the White House announced Trump’s forthcoming speech, it also noted that it would coincide with a formal request for information from Health and Human Services on various drug-pricing ideas. The request leaves the door wide open for proposed changes in Medicare and Medicaid. Several experts predict the administration will test payment models through demonstrations under the broad authority of the Center for Medicare & Medicaid Innovation, or CMMI.

The Outlook:

Ideas such as moving drugs to Part D as well as allowing certain states to create drug lists under their Medicaid formularies, as Massachusetts has requested, and other value-based pricing models would be possible under a CMMI demonstration, said Andrea Harris, who leads the health care team at Height Capital Markets. Still, this process could take awhile, and Harris said, “I don’t think anything will meaningfully impact drug-related stocks between now and the midterms [elections].”

Prescription drug prices are out of control. The drug prices have gone through the roof. … The drug companies, frankly, are getting away with murder.”

Trump at Oct. 16, 2017, Cabinet meeting

What’s Happening:

While there has been no direct proposal that would force the pharmaceutical industry to lower the launch price of its drugs, the industry lost a battle last month when Congress reduced how much seniors would pay for prescription drugs in Medicare. It was a rare loss and signaled that the powerful industry may be in a defensive position. And Trump has another card to play with the Federal Trade Commission.

The Outlook:

Trump has nominated Joe Simons, a Washington antitrust lawyer, to lead the FTC. During his nomination hearings in February, he said he’s “very concerned” with price increases for prescription drugs. The agency, which polices anticompetitive behavior, has several vacancies to fill.

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

Kaiser Health NewsThis article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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