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Monday, April 22, 2019

No one knows what Joe Biden thinks about health care

Trying to figure out what Joe Biden thinks about health care is not an easy task.
Most other prominent Democrats, including those vying for the nomination, are out stumping for single-payer. Even Biden’s former boss, Barack Obama, has described Medicare-for-all as one of the “good new ideas” that Democrats are running on.
The former vice president has stayed pretty mum on the topic. He has not endorsed Medicare-for-all, nor has he disavowed the idea. His spokesperson did not respond to a request for comment on Monday on Biden’s views on health care.
The best we can do, then, is look back at the vice president’s historical health care record.
When Biden ran for president in 2007, he did have his own health care plan. He proposed expanding programs that cover low-income children, letting older Americans (those above 55) buy into Medicare, and creating a new government program that younger, uninsured Americans could purchase.
This was a pretty different, pre-Obamacare era. It was a time when a plan like that would have seemed a lot more disruptive and radical than it does right now. In the past decade, the politics of health care have shifted significantly to the left among Democrats — and Biden has not said anything about whether he is part of that shift.
Serving as vice president, Biden ended up cautioning President Barack Obama against trying to tackle health care at the start of his presidency.
This was a big debate within the White House: Should a new president really tackle a massive policy push just at the moment the country was digging out of a recession? In his book The Promise, journalist Jonathan Alter describes how Biden sided with Chief of Staff Rahm Emanuel in cautioning against taking on major reform and instead pursuing more incremental steps:
Whether or not to pursue major health care reform in the first year had been a furious topic of debate going back to the transition. …
[Biden] said in a meeting during the transition that the Americans he and Obama had met on the campaign trail would understand if health care reform had to be delayed because the government was busy avoiding a depression. “They’ll give you a pass on this one,” he told the president. Liberal Democratic senators like Chuck Schumer and Byron Dorgan strongly urged Obama to hold off and focus on the economy.
We of course, in hindsight, know how this story ends. President Obama did decide to pursue a major health reform bill — and Vice President Biden becomes an ardent supporter of Obama’s push, as made clear by the f-bomb he accidentally dropped within range of a podium.
Since leaving office, Biden has criticized the Trump budget for making deep cuts to Medicare and Medicaid. He’s spoken at rallies defending the Affordable Care Act as Republicans were trying to repeal the law (and, according to one Washington Post report, even lobbied Sen. John McCain (R-AZ) to vote against repeal).
But he hasn’t talked much at all about what a Biden health care agenda might look like. I think it’s safe to say from his 2007 presidential plan that he would, at minimum, be likely to support a Medicare buy-in for older adults. This would be similar to the Medicare buy-in that Sen. Debbie Stabenow (D-MI) has introduced in the Senate, and which you can read a bit more about more on Vox.com.
It’s notable to me that the Biden Foundation, a nonprofit helmed by the former vice president, has a section on the various issues it considers “pillars.” That includes things like “advancing community colleges” and “strengthening the middle class.” But there isn’t a mention of health care in sight.
Wall Street, for what its worth, seems bullish on the idea that Biden won’t take on Medicare-for-all. Health care stocks have been having a tough week lately, as more talk of Medicare-for-all plans heats up. A plan like Sanders’s, which all but eliminates private health insurance, would obviously be quite bad for private health insurers and their investors.
But there is something that would help those health care stocks, J.P. Morgan analyst Gary Taylor wrote in a note (first reported by Axios) to investors last week. “How could the news get better?” he starts. “Biden wins the Democratic nomination without changing his current view against single payer.”
Taylor, in my view, overstates Biden’s position a bit — I don’t think we’ve seen him come out as anti-single payer yet. Still, his general view seems to be right: When you look out at the field of Democratic contenders, Biden right now is positioning himself as the candidate who isn’t jonesing to go big on health care.
And that, as one former vice president might say, is a big fucking deal.

How biopharma companies use NIH and vice versa

An argument has been brewing on Capitol Hill and elsewhere that boils down to the theory that US taxpayers are fronting billions of dollars’ worth of public research that translates into early-stage products that are later sold to companies, go on to win FDA approval and then reap millions or billions in sales, although the government never sees a dime of those earnings.
With the help of a new Congressional Research Service (CRS) report published Friday and some other materials, Focus can break down what’s happening.
1. Do taxpayers pay for billions in research?
Yes. In FY 2018, the National Institutes of Health (NIH) had a budget of more than $34 billion to support more than 300,000 scientists and research personnel working at over 2,500 institutions across the US and abroad. And from FY 1998 to FY 2003, Congress doubled the NIH budget. The total NIH appropriation for FY 2019 is $39 billion.
2. Does NIH research translate into early-stage products?
Sometimes. And here’s where the quantification of NIH’s work gets tricky.
As the CRS report notes, over 50% of NIH funding supports basic research, meaning, “NIH funded research is, to a greater extent, indirectly involved—by generating scientific knowledge and innovations that aid in pharmaceutical development. For example, important basic advances in research, such as recombinant DNA, can lead to the development of whole new classes of drugs.”
But drugs with a patent held by NIH or NIH-funded researchers represent a small portion of all approved drugs by the US Food and Drug Administration (FDA). A Health Affairs study from 2011 found that 9% of the new drugs approved by FDA from 1988 to 2005 were based on a patent held by either a government agency or a nongovernmental institution that had received government support.
Another study from the New England Medical Journal in 2011 found that of the 1,541 drugs approved by FDA from 1990 through 2007, 143, or 9.3%, resulted from work conducted in public sector research institutions, including all universities, research hospitals, nonprofit research institutes and federal laboratories in the US.
But when the direct and indirect impact of NIH funding is considered, the results show a larger NIH impact. For instance, a PNAS study from 2018 found that NIH was “directly or indirectly associated with every one of 210 NMEs [new molecular entities] approved from 2010-2016.”
Similarly, 2018 study determined that NIH investments in a particular research area increase subsequent private sector patenting in that area—a $10 million increase in NIH funding for a research area results in 2.7 additional patents.
But as NIH’s Steven Ferguson noted in the Journal of Commercial Biotechnology in 2012, it’s not as if NIH can take these early-stage products to market. And as with biopharma companies, the number of failures continues to heavily outnumber the approvals. Ferguson said: “Because many, if not most of the technologies developed at the NIH and FDA, are early stage biomedical technologies, the time and development risks to develop a commercial product are high.”
3. Does NIH make money from its early-stage products?
Yes. From 1988 to 2004, NIH entered into almost 2,500 license agreements and generated more than $500 million in royalty revenues. More recently, royalties have amounted to more than $100 million per year.
NIH’s Office of Technology Transfer FY 2014 annual report explains how royalties collected on product sales, primarily drugs and biologics, account for 84% of the $138 million in royalties collected in 2014. And the three best-selling products utilizing technology licensed from NIH that year were Janssen’s Prezista, a novel protease inhibitor for the treatment of HIV-1 in patients who are non-responsive to existing antiretroviral therapies, Merck’s Gardasil, a vaccine to protect against cervical cancer, and AstraZeneca’s Synagis, a monoclonal antibody for the treatment of Respiratory Syncytial Virus (RSV) in infants.
4. What else is coming?
Other questions are mounting now, including whether the royalties that NIH and other government agencies reap from its early-stage products are adequate, and whether NIH should be able to step in and lower the price of a product that it helped to develop.
Late last month, some are questioning why the CDC is not reaping profits from patents it has on a licensed HIV drug brought to market by Gilead. Gilead, however, contends that the patents are invalid.
More recently, the National Institute of Standards and Technology (NIST) is looking into the idea of clarifying that the government cannot unilaterally set prices for certain pharmaceuticals. The issue at hand concerns whether certain regulations (never used by NIH), under the Bayh-Dole Act, should be altered so the government cannot control the price of some pharmaceuticals it helped to develop. Several groups, including Doctors Without Borders, are pushing back on those NIST changes.
CRS Report on NIH

STERIS awarded $393.78M Defense Logistics Agency contract modification

STERIS has been awarded a maximum $393.78M modification exercising the third one-year option period of a five-year base contract with three one-year option periods for integrated operating room, or IOR, components, system options & accessories, upgrades, training, maintenance services and turnkey installation. This is a fixed-price with economic-price-adjustment, indefinite-delivery/indefinite-quantity contract. Location of performance is Ohio, with an April 24, 2020, performance completion date. Using customers are Army, Navy, Air Force, Marine Corps and federal civilian agencies. Type of appropriation is FY19 through FY20 defense working capital funds. The contracting activity is the Defense Logistics Agency Troop Support.

Cut Your Odds for an Aortic Aneurysm

People at risk for an aortic aneurysm should get screened for the life-threatening condition, an expert says.
Aortic aneurysms are balloon-like bulges that can develop anywhere along the aorta, which runs from your heart through your chest and abdomen. An untreated aneurysm can grow until it ruptures or causes a tear between the layers of the artery, also called a dissection.
“Most people with aortic aneurysms don’t have symptoms until a tear or rupture has occurred, which is usually accompanied by sharp, sudden pain,” said Dr. Brett Carroll, medical director of the Aortic Center at Beth Israel Deaconess Medical Center in Boston. “But with proper screening, we can monitor its growth and intervene before a complication occurs.”
An aortic aneurysm that occurs in the chest is called a thoracic aortic aneurysm.
“These aneurysms are usually age-related, occurring most commonly in people ages 65 and older,” Carroll said.
Other risk factors for this type of aneurysm include high blood pressure, family history of aortic aneurysm, and connective tissue disorders.
An aneurysm that occurs in the abdomen is called an abdominal aortic aneurysm. It occurs most often in men aged 65 and older. Other risk factors include: history of tobacco use, high blood pressure, high cholesterol, history of other aneurysms in the body, and a family history.
“If you meet any of the criteria, you should ask your doctor about having an aortic aneurysm screening,” Carroll said in a medical center news release.
Your doctor can do the simple screening test, and it’s covered by insurance if you’re between 65 and 74 years of age and have a family history of an abdominal aortic aneurysm; or if you’re a man who has smoked more than 100 cigarettes.
“If your doctor sees a concerning finding, s/he can refer you to a specialist,” Carroll said.
More information
The U.S. National Heart, Lung, and Blood Institute has more on aortic aneurysm.
SOURCE: Beth Israel Deaconess Medical Center, news release, April 8, 2019

Evidence Grows for an HPV-Heart Disease Connection

Human papillomavirus, or HPV, is the most common sexually transmitted infection in the country.
In several studies, it’s also linked to the nation’s leading cause of death — cardiovascular disease.
There are more than 150 strains of HPV, including the ones responsible for cancers of the cervix, penis, anus and the back of the throat.
In a study published earlier this year in Circulation Research, researchers found that Korean women infected with these “high-risk” strains of HPV were 22 percent more likely to develop heart disease or have a stroke than women not infected with the virus. The risk was calculated after adjusting for other common cardiovascular risk factors, including smoking, physical activity and body mass index.
A 2011 study also connected HPV with heart attacks and strokes in women. “But at this stage, we’re not completely clear on what the link is,” said Dr. Christine Jellis, a cardiologist at The Cleveland Clinic.
Jellis said HPV may encourage chronic inflammation in the body, which can contribute to atherosclerosis, or the hardening of fatty plaque along the lining of arteries.
“But there may be some other social factors that make people both more prone to developing coronary artery disease — atherosclerosis — and also HPV,” she said. “At the moment, we don’t have that information but this … definitely warrants further evaluation.”
The link between HPV and cardiovascular risk is not restricted to women.
A 2017 study of mostly men tied HPV to an increased risk of stroke in people who received radiation therapy for head and neck cancer.
Dr. Tomas Neilan, the lead author of that study published in the Journal of the American Heart Association, said the results show HPV infection has consequences beyond the cervical lesions and cervical cancer typically associated with the virus.
“Specifically, and importantly, this also has implications for men beyond transmission” of the virus, said Neilan, director of the cardio-oncology program at Massachusetts General Hospital in Boston.
HPV is such a common virus that an estimated 80 percent of the population will be infected at some point in their life, according to the Centers for Disease Control and Prevention. About 14 million Americans, including teens, become infected with HPV each year. Most infections go away on their own, but those that don’t can lead to certain types of cancer.
That’s where prevention can help, Neilan said.
HPV vaccines, which have been available for females since 2006 and for males since 2009, have proven effective in decreasing HPV incidence and preventing precancerous growths or infections.
The CDC recommends all girls and boys get two doses of the vaccine before they turn 13. Children who start the vaccine series on or after their 15th birthday need a third dose for complete protection.
Jellis hopes to see more research about the HPV connection to cardiovascular disease, as well as other types of studies that look beyond the factors already known to contribute to heart attacks and strokes.
“We certainly see patients who don’t have any of the traditional cardiovascular risks, but they still have atherosclerotic disease,” she said. “So, whether they have additional genetic factors or additional lifestyle factors, for those patients, maybe these other things like a presence of HPV will end up being the reason why they are at higher risk.”

Medical Marijuana Use Rising Among Cancer Patients

Americans with cancer are more likely to use marijuana and prescription opioids than those without cancer, and the use of medical marijuana by this group is on the rise, new research shows.
Pain is common among cancer patients, but many do not get adequate pain relief, the researchers noted.
The new study looked at more than 800 adults with cancer who took part in the U.S. National Health and Nutrition Examination Survey between 2005 and 2014. The patients were compared with about 1,650 adults without cancer.
The findings showed that 40% of the cancer patients had used marijuana within the past year, compared with 38% of those without cancer.
People with cancer were also more likely to use prescription opioids than those without the disease — nearly 14% versus just over 6%, respectively.
When analyzing rates of marijuana and opioid use among more than 19,000 survey respondents, including those with and without cancer, the investigators found increasing rates of marijuana use over the 10-year study period, probably because legislative changes increased its availability.
More clinical trials are needed to asses just how effective medical marijuana is against cancer-related pain, said co-lead author Dr. Kathryn Ries Tringale, of the University of California, San Diego.
Prescription opioid use remained stable among cancer patients, the study authors said.
A cancer diagnosis did not significantly affect the odds of substance abuse between 2005 and 2014, according to the study published online April 22 in the journal Cancer.
Study co-author Dr. Jona Hattangadi-Gluth, noted that legalization of medical marijuana has been associated with a drop in hospitalizations for opioid abuse or dependence. If patients are substituting marijuana for opioids, it may be an opportunity for reducing opioid-related illness and death, she suggested.
“Of course, it will also be important to identify risks and adverse effects of marijuana, which has not previously been studied on large randomized clinical trials, given its scheduling as a class 1 controlled substance,” Hattangadi-Gluth said in a journal news release.
More information
The American Cancer Society has more on cancer pain.
SOURCE: Cancer, news release, April 22, 2019

Many U.S. Kids Don’t Drink Enough Water, and Obesity May Be the Result

On any given day, 1 in 5 American youngsters don’t drink any water at all, a new survey shows.
And those who don’t end up consuming almost twice as many calories from sugar-sweetened beverages.
That, investigators warn, translates into an extra 100 calories per day, which over time can raise the risk for becoming overweight or obese.
“Drinking water is the healthiest beverage to drink,” said study author Asher Rosinger, director of the Water, Health and Nutrition Laboratory at Pennsylvania State University. “Water is an essential nutrient that is critical to proper physiological and cognitive functioning.”
By contrast, sugary drinks “are problematic because they have been linked to many negative health conditions, such as weight gain, dental caries [cavities], and type 2 diabetes,” said Rosinger. He noted that current guidelines recommend limiting daily intake of added sugars to less than 10% of all calories consumed.
“Kids should drink water every day, and it should be the first option [parents] go to when their kids are thirsty,” Rosinger said.
In the study, data was collected from the U.S. National Health and Nutrition Examination Surveys between 2011 and 2012 and between 2015 and 2016.
About 8,400 children (aged 2 to 19) reported whether they drank water each day (although amounts were not quantified), and how much of sugar-sweetened beverages they routinely consumed.
The latter included all non-diet sodas, sweetened fruit juices, sports drinks, energy drinks, and/or presweetened tea and coffee drinks. (Zero-calorie diet sodas and drinks, 100% fruit juices, and/or unsweetened coffee and teas were excluded.)
Among the 1 in 5 who didn’t drink any water daily, sugared-drink calories totaled 200, on average, compared with 100 calories a day among water drinkers.
Sugared-drink habits varied somewhat by race, however. For example, white non-water drinkers were found to consume more additional calories from sugared drinks than Hispanic non-water drinkers (123 extra calories per day versus 61 extra calories per day).
Regardless, are such relatively low amounts of excess calories really a big deal? Yes, say investigators, who point out that taking in an extra 3,500 calories means packing on an extra pound. That breaks down to just a little more than a month of 100 extra calories per day.
Rosinger did note that sugary drink consumption among American children has dropped over the last 15 years. But he added that “there are still pockets and sub-populations that have high consumption levels. [So] it’s critical to identify which kids are particularly at risk for high sugar-sweetened beverage intake, since this can lead to these negative health effects.”
On that front, Rosinger noted that water insecurity due to contamination “is a growing problem in the U.S., so we need to keep that in mind as important context, especially when it comes to parents who may be giving their kids soda or juice because they distrust the water. Therefore, it’s critical to ensure that everyone has access to safe, clean water.”
The findings were published April 22 in the journal JAMA Pediatrics.
Lona Sandon is program director in the department of clinical nutrition at the University of Texas Southwestern Medical Center at Dallas. She said the findings “confirm what I have seen in practice: If someone is not drinking water, they are drinking something else, likely soft drinks or other sugary drinks.” She was not involved with the study.
Sandon’s advice to parents? “Provide water and low-fat plain milk at the table. Keep flavored milk only for special occasions. Avoid purchasing soft drinks or other fruit juice-type drinks that are laden with added sugar. Try no-calorie, flavored seltzer water instead. Make a no-soft drink or other sugary drinks rule in the household. Save them for special occasions. Keep 100% fruit juice to 1 cup per day. Keep sports drinks for sports, not with meals, and only if the child will be exercising for more than an hour.”
And dump the energy drinks, Sandon concluded. “Kids do not need them.”
More information
The U.S. Office of Disease Prevention and Health Promotion offers more on healthy diet guidelines.
SOURCES: Asher Rosinger, Ph.D., M.P.H., assistant professor, biobehavioral health and anthropology, and director, Water, Health and Nutrition Laboratory, Pennsylvania State University, University Park; Lona Sandon, Ph.D., R.D.N., L.D., program director and associate professor, department of clinical nutrition, School of Health Professions, University of Texas Southwestern Medical Center at Dallas; April 22, 2019, JAMA Pediatrics