Health Care Reform Articles - September 19, 2018

Medicare for All Is 'Not Just Pie in the Sky': Alexandria Ocasio-Cortez

by Andrea Germanos - Common Dreams - September 14, 2018

New York congressional candidate and democratic socialist Alexandria Ocasio-Cortez defended a key (and widely supported) pillar of her progressive platform—Medicare for All—on Sunday, saying such systems are "not just pie in the sky" but have been proven in other Western democracies and would be "good for our future."

Ocasio-Cortez made the comments on CNN's "State of the Union" when pressed by host Jake Tapper about how she proposes to fund a platform that also includes a federal jobs guarantee, tuition-free public college and trade school, and student loan debt cancellation.

She stressed that "one of the things that we need to realize" is that "Medicare for all would save the American people a very large amount of money."

"And what we see as well is that these systems are not just pie in the sky." She noted that "many of them are accomplished by every modern, civilized democracy in the Western world." For example, she said, "the United Kingdom has a form of single-payer health care, Canada, France, Germany."

"What we need to realize is that these investments are better and they are good for our future. These are generational investments... they're not short-term Band-Aids, but they are really profound decisions about who we want to be as a nation... and how we want to act as the wealthiest nation in the history of the world."

She went on to acknowledge the "political realities" the prove barriers to needed reforms. "They don't always happen with just the wave of a wand. But we can work to make these things happen."

Ocasio-Cortez addressed the same issue last month with CNN's Chris Cuomo. "People talk about the sticker shock of Medicare for All—they do not talk about the sticker shock of the cost of our existing system," she said.  

"We only have empty pockets when it comes to the morally right things to do," she said at the time, "but when it comes to tax cuts for billionaires and when it comes to unlimited war, we seem to be able to invent that money very easily."

https://www.commondreams.org/news/2018/09/17/medicare-all-not-just-pie-sky-alexandria-ocasio-cortez

Editor's Note:

The following post is Don McCanne's "Quote of the Day" for September 14, 2018. Click on the link at the end to see the Powerpoint presentation that illustrates the statistics.

-SPC

Texas Medical Center Health Policy Institute

The Nation’s Pulse: Year Four

  Survey completed June-July 2018

  4,020 national participants

Support for Medicare for All U.S. Adults

Are you in favor of the federal government providing Medicare insurance coverage for all U.S. adults?

59%  All

71%  Democrats

46%  Republicans

55%  Independent

===

Comment by Don McCanne

Although this question asks about providing Medicare insurance coverage for all U.S. adults without mentioning children, nevertheless it still shows strong support for Medicare for all, including close to one-half of Republicans.

Efforts are being made to discredit these surveys by tacking on questions such as "even if it means the government raising your taxes," or "even if it means losing your choice of health plans," or "even if it means they take away your insurance through your work." Inevitably these questions slightly reduce polling support for Medicare for all.

Polls that we don't see are those that would tack on questions that would increase the credibility of the Medicare for all model. Instead of threatening an increase in taxes, suppose they were asked, "even if it meant that all but the very wealthiest would end up paying on average less overall for health care." Instead of threatening loss of choice of health plans, suppose they were asked "even if it meant that you would no longer be limited to a list of physicians and hospitals dictated by the insurer but rather you had complete free choice of your health care professionals and institutions." Instead of threatening loss of your health plan through work, suppose they were asked, "even if it meant that you would never have to worry about health insurance again because you would automatically have full comprehensive coverage for life."

Obviously we could go further. "Even if Medicare for all meant that we would save hundreds of billions of dollars in administrative waste." "Even if Medicare for all meant that nobody would ever have to go without care because they couldn't afford it." "Even if it meant that wherever you are in the country, you would never have to worry whether your insurance is good." "Even if it meant that you would never have to busy yourself with insurance paperwork because coverage and billing is automatic." "Even if it meant that you would not have to worry about whether you could afford the care you are about to receive since out-of-pocket costs would be eliminated for all essential health care services."

Well, the good news is that people are gaining a better understanding of the benefits of the Medicare for all single payer model. Republican voters are realizing that the Republican promise of a better replacement for Obamacare proved to be false, and yet they understand that we need more than what the Affordable Care Act brought us. Democratic voters largely understand the benefits of single payer, but they are just beginning to realize that some Democratic politicians are using the Medicare for all rhetoric deceptively to maintain the status quo that caters to the insurers and pharmaceutical firms. It is no wonder that we are seeing an increase in independent voters who are wary of both major parties but who also seem to understand that Medicare for all seems to be a much better option than our current dysfunctional system.

We need to keep on with what we're doing, except do a whole lot more of it. Maybe those of us who are octogenarians will no longer have to say, "but not in my lifetime."

http://www.tmc.edu/health-policy/wp-content/uploads/sites/5/2018/08/08_31_FINAL-US-SLIDES.pdf

No. 1 Aim of Democratic Campaign Ads: Protect Pre-existing Conditions

Not so many elections ago, Obamacare was a cudgel for Republicans to use against their opponents.

by Margot Sanger-Katz - NYT - Sept. 17, 2018

In years past, Obamacare was the stuff of Republican attack ads. No more.

This cycle, even Democrats running in red states are unapologetically putting health care at the center of their campaign messages. There’s a reason: Republican efforts to overhaul the health care system last year were deeply unpopular.

A lawsuit brought by several states imperils the health law’s protections for people with pre-existing health conditions, the law’s most popular provision. Recent polls show growing numbers of Americans rank health care as a top issue, and coverage for pre-existing conditions as an important policy.

A recent analysis from the Wesleyan Media Project showed that health care was the most common subject of televised campaign advertisements by Democrats in both the House and the Senate. “This is the uniform issue across a lot of the states, and then these candidates will talk about things that are particular to their constituents,” said Lauren Passalacqua, the communications director for the Democratic Senatorial Campaign Committee. 

Some ads focus on a personal connection to the issue, like the health history of a candidate or a candidate’s relative. Some focus on an opponent’s role in the lawsuit. Many House campaigns are using health care as part of attack ads against Republican incumbents who voted last year for the American Health Care Act, which would have unwound major parts of the Affordable Care Act. Some ads talk about the Affordable Care Act directly, but many gesture at it more obliquely, with talk of pre-existing conditions alone.

Health care still comes up in some Republican ads. But unlike in past cycles, when ads promising to “repeal and replace” Obamacare were standard fare, health care has been pushed down the priority list, behind taxes and immigration. (Obamacare figures in only 1 percent of Republican ads, according to the Wesleyan count.) Here are what some of the new Democratic health care ads are saying, and what they’re leaving unsaid:

The Democratic candidate: Senator Joe Manchin is running for re-election in West Virginia, a state President Trump won by more than 41 points.

The ad: Reprising a 2010 special election ad in which he shot a hole in a cap-and-trade climate bill and promised to “repeal the bad parts of Obamacare,” he now shoots a hole in a lawsuit that could eliminate the protections for pre-existing conditions that are part of the Affordable Care Act. His opponent, the state’s attorney general, Patrick Morrisey, is a party to the lawsuit. “That’s just dead wrong, and that ain’t going to happen,” Mr. Manchin says, before firing.

The strategy: In 2010, Mr. Manchin’s pro-West Virginia iconoclasm meant standing up to his party’s leadership. Now, it means protecting a core provision of the Affordable Care Act. The words “Affordable Care Act” don’t appear in the ad — neither does Obamacare. But the Manchin campaign has bet big that health care politics in the state have changed. Instead of vowing to repeal part of Obamacare, he’s promising to protect its most popular provision. In fact, West Virginia has benefited more than nearly every other state from the health care law, and it’s the state with the largest share of residents with pre-existing health conditions, according to estimates from the Kaiser Family Foundation. 

The Democratic candidate: Clarke Tucker, a state legislator and lawyer, is running against French Hill, a two-term incumbent in Arkansas’s Second Congressional District. Mr. Tucker was treated for bladder cancer last year.

The ad: Mr. Tucker takes viewers on a brief tour of important places in his life, with stops at the baseball field, the church where he was baptized, his Little Rock high school, a farm where he grew up, the State House, and the cancer hospital where he was treated. He describes himself as “one of the million Arkansans with a pre-existing condition.”

The strategy: Even in a strictly biographical ad, Mr. Tucker gestures at health policy. When he got sick, Arkansas political observers thought his career would stall. Now, he presents his pre-existing health condition as a qualification for office.

The Democratic candidate: Senator Heidi Heitkamp is running for re-election in North Dakota, in what is expected to be a tough race against Kevin Cramer, the state’s three-term congressman.

The ad: A constituent, Denise Sandvick, chops vegetables in her kitchen as Ms. Heitkamp’s voice explains how both the constituent and the candidate have pre-existing conditions. Then Ms. Sandvick speaks to the camera, expressing her disappointment that Mr. Cramer voted for the Republican health bill last year. “I know Heidi would never do that,” she says.

The strategy: Ms. Heitkamp highlights her own history of breast cancer and establishes empathy with a constituent with a similar history. Like Mr. Manchin, Ms. Heitkamp declines to mention the Affordable Care Act directly, describing Mr. Cramer’s vote simply as a choice to overturn protections for pre-existing conditions. The truth is a bit more complicated. The bill, which did not become law, could have substantially weakened pre-existing protections, but only in states that chose to do so. The bill would have also made major cuts to Medicaid and to subsidies that help middle-income Americans buy health insurance.

The Democratic candidate: Elissa Slotkin, a former intelligence analyst who worked for the C.I.A. and the Defense Department, is running to unseat the incumbent, Mike Bishop, in Michigan’s Eighth District.

The ad: Ms. Slotkin describes her mother’s breast cancer, a later loss of a job and of health insurance, and then her ovarian cancer, in the years before the Affordable Care Act became law. “It could be about anyone’s mom,” Ms. Slotkin said, while criticizing Mr. Bishop’s vote for a bill last year that would have unwound large parts of the Affordable Care Act.

The strategy: Ms. Slotkin has said Republican efforts to overturn the Affordable Care Act inspired her to run for office, and her ad, which includes footage of her ailing mother delivering a toast at Ms. Slotkin’s wedding, is focused on the personal stakes of the policy debate. She is one of several Democratic candidates using family stories about illness and insurance coverage to explain their commitment to consumer protections.

The Democratic candidate: Senator Claire McCaskill of Missouri is running for re-election against Josh Hawley, the state’s attorney general, in a state President Trump won by more than 18 points.

The ad: “Two years ago I beat breast cancer,” Ms. McCaskill says, talking directly into the camera. “Like thousands of other women in Missouri, I don’t talk about it much.” She links her own pre-existing condition to the current anti-Obamacare lawsuit, where Mr. Hawley is a litigant.

The strategy: As a senator, Ms. McCaskill has tended to focus on consumer protections in health care. This summer, she began asking constituents at campaign events to stand up if they had pre-existing conditions. And her campaign has begun a series of 30 video interviews with supporters who have pre-existing conditions (Here’s one.) She tries to link Mr. Hawley’s support for the lawsuit to industry — the “insurance companies” — rather than ideology. Like many other Democrats in Republican territory, she is not pledging broad support for Obamacare, but focusing on its most popular provision.

The Democratic candidate: Senator Joe Donnelly is running for re-election in Indiana, another state Mr. Trump won handily. His opponent, Mike Braun, is the C.E.O. of a distribution company and a former state legislator.

The ad: Mr. Donnelly shuffles papers around in a copy shop, as he praises the work ethic of his constituents and his own work on their behalf. A voice-over notes his support for President Trump’s proposed border wall and for “protecting health care for Hoosiers with pre-existing conditions.” Then, a worker in the shop tells him his “break’s over.”

The strategy: As with Mr. Manchin, Mr. Donnelly’s overall strategy has been to appear pragmatic and nonpartisan, distant from Democratic leadership. On the issue of the wall, he’s in Trump’s corner. But on health care, he highlights his vote against Republican attempts to repeal and replace Obamacare last year. The contrast reveals how he thinks the issues are likely to play in a red state.

The Democratic candidate: Jacky Rosen, a congresswoman representing Nevada’s Third District, is running to unseat Dean Heller, one of the most vulnerable Republican senators this cycle.

The ad: Ms. Rosen walks amid retractable dividers defining an empty, snaking line, leading to an unmanned reception desk. She notes that Mr. Heller initially promised to oppose a Senate bill to overhaul Obamacare, while ultimately voting for its final version. Her description is interspersed with footage of Mr. Trump joking with Mr. Heller and news footage describing his change of heart. “Dean Heller got back in line,” she says.

“I’ll work to fix Obamacare, and I won’t walk the party line,” she says, opening up the divider tape and heading for the exit.

The strategy: Ms. Rosen is unusual in stating her support for Obamacare specifically, though she says that she wants to “fix” it, not preserve the status quo. Mr. Heller’s various positions on the Republican repeal effort, which he initially warned would harm the state, are the focus of this ad, and another, in which Ms. Rosen’s campaign compares him to an inflatable tube man, bending in the wind.

The Democratic candidate: Kim Schrier, a pediatrician, is running for an open seat in Washington’s Eighth District. The seat is held by Dave Reichert, who is retiring. Her opponent, Dino Rossi, is a former state senator.

The ad: Footage of Dr. Schrier shaking hands in a diner, talking to people around a table and examining a child while wearing a white coat and stethoscope is interspersed with black-and-white clips of Republicans voting on the American Health Care Act. “When D.C. politicians voted to gut health care for people with pre-existing conditions, I decided to run for Congress myself,” she says.

The strategy: Dr. Schrier is one of the candidates who say they were motivated to run by the recent G.O.P. attempts to overhaul health care. Her ad presents her as an outsider — a doctor, not a “D.C. politician.” She pledges not to accept corporate PAC donations so she can be free to stand up to health industries. Her message is less about fixing health care than protecting current programs. But she still never mentions Obamacare.

https://www.nytimes.com/2018/09/17/upshot/democrats-campaign-ads-pre-existing-conditions.html?

Financial Conflicts of Interest in Medicine

Readers discuss disclosure ... and the lack thereof.

Letters to the Editor - NYT - Sept. 13, 2018

To the Editor:

Re “A Top Doctor Didn’t Disclose Corporate Ties” (front page, Sept. 9): Let’s stipulate that Dr. José Baselga is a brilliant and innovative cancer doctor; that his work has helped thousands; and that in his research, clinical work and advice to others in the field he has been motivated only by the desire to advance knowledge and to cure millions.

According to your article, for all of this he received a salary in 2016 (the most recent data available) of more than $1.5 million from the Memorial Sloan Kettering Cancer Center, where he is the chief medical officer. This is a princely sum, which, given the work he does, no one should begrudge him. 

But it appears he also earns uncounted millions more in consulting fees, director’s fees and ownership interests from businesses directly involved in the areas of his expertise, and he is criticized for not fully disclosing this in his professional writings evaluating the products of some of the companies that pay him large sums. 

But I would ask another question: Why isn’t $1.5 million enough? Surely there is value and a satisfaction in being able to say: I advise anyone who has a promising idea, who cares about restoring cancer patients to health; these efforts and judgments are driven only by the good I think they will do; this advice, these judgments are free, and when I give them it is public and open. Such a stance would all by itself be a model and a public good.

Charles Fried
Cambridge, Mass.
The writer is a Harvard law professor.

To the Editor:

Breast cancer patients are tired of “breakthrough” therapies that do not extend life for even a day but do bring millions of dollars to industry, medical institutions and the doctors who care for us. 

Your article says, “Asked if he planned to correct his disclosures,” Dr. José Baselga “asked reporters what they thought he should do.” He should be asking patients; in fact, the entire health care industry should. And the answer is clear: Just stop circling the wagons, focusing on financial gain and fame. Become accountable, and not just by issuing “standards” that no one pays attention to.

Frances M. Visco
Washington
The writer is the president of the National Breast Cancer Coalition.

To the Editor:

Dr. José Baselga’s lapses in disclosure represent a breach in the procedural ethical norms that govern medical research, and for this he is being publicly chastened. 

But these norms, enacted in the 1980s in response to the burgeoning medical-industrial complex, are based on some magical thinking — the pretense that by disclosing these conflicts of interest the truth about these drugs will be revealed. The sad fact is that the current system of medical research and care conducted by physician-scientists like Dr. Baselga is fundamentally flawed and does an extreme disservice to patients, who deserve an unbiased accounting about the true worth of potential treatments.

Daniel J. Brauner
Chicago
The writer is a geriatrician and an ethicist at the University of Chicago.

To the Editor:

Undisclosed financial conflicts of interest are pervasive in medicine. A paper published in The New England Journal of Medicine in 2009, for instance, observed that 29 percent of payments from prosthesis manufacturers went unreported by physicians who presented or served on a board or committee at a large orthopedic conference. When asked, most claimed the conflict was not relevant to their presentation or position, or that they had misunderstood the disclosure requirements.

Even when physicians do disclose financial conflicts of interest at academic meetings, it has become common practice for presenters to quickly move past financial disclosure slides and to play down conflicts when they are acknowledged.

Financial conflicts of interest seem inevitable, since for-profit industry relies on the knowledge and advice of academic experts when developing important new products. We can begin to mitigate the potential bias only if we are aware that a conflict exists, so doctors should always err on the side of disclosure.

Kirk D. Wyatt
Rochester, Minn.
The writer is a physician.

https://www.nytimes.com/2018/09/13/opinion/letters/doctors-conflicts-of-interest.html?

Top Sloan Kettering Cancer Doctor Resigns After Failing to Disclose Industry Ties

by Katie Thomas and Charles Ornstein - NYT - September 13, 2018

Dr. José Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, resigned on Thursday amid reports that he had failed to disclose millions of dollars in payments from health care companies in dozens of research articles.

The revelations about Dr. Baselga’s disclosure lapses, reported by The New York Times and ProPublica last weekend, have rocked Memorial Sloan Kettering, one of the nation’s leading cancer centers, in recent days. Its top executives scrambled to contain the fallout, including urgent meetings of physician leaders and the executive committee of its board of directors.

In his resignation letter released Thursday, Dr. Baselga, who also served as the physician-in-chief, said he feared that the matter would be a distraction from his role overseeing clinical care and that he had been “extremely proud” to work at Memorial Sloan Kettering.

“It is my hope that this situation will inspire a doubling down on transparency in our field,” he said, adding that he hoped the medical community would work together to develop a more standardized system for reporting industry ties.

In an email sent to the staff Thursday evening, Dr. Craig B. Thompson, the hospital’s chief executive, said that Dr. Baselga had made “numerous” contributions to Memorial Sloan Kettering, patients and cancer treatment. Dr. Lisa DeAngelis, the chairwoman of the neurology department, will take over as acting physician-in-chief until Dr. Baselga’s successor is hired.

The resignation was effective immediately, and he will have no continuing role at the cancer center, although he will stay for two weeks to ease the transition, said Christine Hickey, a spokeswoman for the cancer center.

Dr. Thompson echoed comments he made to the hospital staff on Sunday, saying that the cancer center had “robust programs” in place to manage employees’ relationships to outside companies, but that “we will remain diligent.” He added, “There will be continued discussion and review of these matters in the coming weeks.”

Dr. Baselga, a prominent figure in the world of cancer research, omitted his financial ties to companies like the Swiss drugmaker Roche and several small biotech start-ups in prestigious medical publications like The New England Journal of Medicine and The Lancet. He also failed to disclose any company affiliations in articles he published in the journal Cancer Discovery, for which he serves as one of two editors in chief.

All told, ProPublica and The Times found that Dr. Baselga had failed to report any industry ties in 60 percent of the nearly 180 papers he had published since 2013. That figure increased each year — he did not disclose any relationships in 87 percent of the journal articles that he co-wrote last year.

In an interview and later statement, Dr. Baselga said he planned to correct his conflict-of-interest disclosures in 17 journal articles, including in The New England Journal and The Lancet. But he contended that in dozens of other cases, no disclosure was required because the topics of the articles had little financial implication. He also said his failed disclosures were unintentional and should not reflect on the value of the research he conducted.

Dr. Baselga and Memorial Sloan Kettering said that he had disclosed his industry relationships to the cancer center.

Those journals, as well as professional societies like the American Society of Clinical Oncology and the American Association for Cancer Research, said they were conducting reviews of Dr. Baselga’s disclosure practices after inquiries from The Times and ProPublica. Dr. Baselga was president of the A.A.C.R. in 2015 and 2016 and appears to have violated disclosure rules for reporting conflicts of interest during that period.

In his statement Thursday, Dr. Baselga said that he took full responsibility for his disclosures and that he had already submitted updates to medical journals “and will continue to do so until the record is complete.”

A spokeswoman for The New England Journal, Jennifer Zeis, said in an email Thursday that Dr. Baselga had submitted changes to his disclosures but that editors had questions for him before the articles could be corrected. A spokeswoman for the A.A.C.R. said that organization was continuing to review Dr. Baselga’s disclosures.

Dr. Baselga, 59, is an expert in breast cancer research and played a key role in the development of Herceptin, which was developed by Genentech, a subsidiary of Roche. He came to Memorial Sloan Kettering in 2013 after serving as chief of hematology and oncology at Massachusetts General Hospital in Boston. Before that he was a leader at the Vall d’Hebron Institute of Oncology in Barcelona, Spain.

Medical journals and professional societies have imposed stricter rules about reporting relationships to industry after a series of scandals a decade ago in which prominent physicians failed to disclose payments from drug companies. But medical journals have said they don’t routinely fact-check authors’ disclosures, and much is left to the honor system.

Ethicists say that outside relationships with companies can shape the way studies are designed and medications are prescribed to patients, allowing bias to influence medical practice. Reporting those ties allows the public, other scientists and doctors to evaluate the research and weigh potential conflicts.

Jeffrey S. Flier, who was dean of the Harvard Medical School from 2007 to 2016, said medical leaders should be held to a higher standard.

“The higher you are in the organizational structure, the more important it is that you fulfill those obligations,” he said. “You’re not just another faculty, you’re also a faculty to whom other people look up and your reputation is tied to the institution’s reputation.”

That said, he added, relationships between academic faculty members and the health care industry are essential to developing new drugs.

Dr. Baselga has extensive ties to a range of companies, including sitting on the board of the large pharmaceutical company Bristol-Myers Squibb and serving as a director of Varian Medical Systems, which sells radiation equipment and for whom Memorial Sloan Kettering is a client.

Dr. Baselga has served on the boards of at least four other companies since 2013, and the positions required him to assume a fiduciary responsibility to protect the interests of those companies, even as he oversaw the cancer center’s medical operations. Dr. Baselga and Memorial Sloan Kettering have said the cancer center has put firewalls in place to prevent any conflicts.

Dr. Baselga received nearly $3.5 million in payments from drug, medical equipment and diagnostic companies from August 2013 through 2017, according to Open Payments, a federal database that tracks payments to physicians from health care companies. Most of that amount, about $3 million, involved a payment from Genentech for Dr. Baselga’s ownership interest in a company it acquired, Seragon Pharmaceuticals, in 2014.

But the $3.5 million in the Open Payments database does not include payments from companies that don’t have products approved by the Food and Drug Administration. Such companies are not required to report their payments under federal law.

For instance, Infinity Pharmaceuticals, a start-up with no approved drug, paid Dr. Baselga nearly $250,000 in cash and stock options for serving on its board from 2015 to 2017. He declined to disclose how much he received from such companies.

Dr. Baselga was one of the highest-paid staff members at Memorial Sloan Kettering, earning more than $1.5 million in 2016, the most recent year for which the nonprofit’s financial filings are available.

https://www.nytimes.com/2018/09/13/health/jose-baselga-cancer-memorial-sloan-kettering.html?

Transparency Hasn’t Stopped Drug Companies From Corrupting Medical Research

by Marcia Angell - NYT - September 14, 2018

On Thursday, Dr. José Baselga resigned from his position as chief medical officer at Memorial Sloan Kettering Cancer Center. Earlier this month, ProPublica and The New York Times revealed that he’d received millions of dollars from drug and device companies whose fortunes he stood to affect. He also sat on the board of at least six companies, where his fiduciary responsibility to them might conflict with his obligations to the cancer center. Most of his outside income was not disclosed to the journals in which he published, in violation of their requirements.

Although his case is extreme, these kinds of conflicts of interest are virtually universal in the upper levels of academic medicine.

I was an editor of The New England Journal of Medicine for over two decades, and was there in 1984 when we became the first major medical journal to institute a policy that required authors of research articles to disclose all financial ties to companies that could be affected by their research. We had become aware that academic researchers were receiving large payments from drug companies and that it was distorting their work. For example, I once phoned the senior author of a paper submitted to us to ask why he had neglected to mention the side effects of a potent new drug he was testing. Without any apparent embarrassment, he said that the sponsor wouldn’t let him. We didn’t publish the paper, but another journal did.

In order to get prescription drugs approved by the Food and Drug Administration, companies must conduct clinical trials to show that the drugs are safe and effective. But drug companies don’t have direct access to human subjects, so they’ve always contracted with academic researchers to conduct the trials on patients in teaching hospitals and clinics. Traditionally, they gave grants to the institutions for interested researchers to test their drugs, then waited for the results and hoped that their products looked good. The grants were at arm’s length; the companies didn’t design or analyze the studies, they didn’t own the data, and they certainly didn’t write the papers or control publication.

That began to change in the 1980s, partly as a result of a new law that permitted researchers and their institutions, even if funded by the National Institutes of Health — that is, the taxpayers — to patent their discoveries and license them exclusively to drug companies in return for royalties. That made them business partners, and the sponsors became intimately involved in all aspects of the clinical trials.

It also gave the drug companies direct access to highly influential physicians, like Dr. Baselga, known to the industry as key opinion leaders. These are the people who write textbooks and medical journal articles, issue practice guidelines, sit on the F.D.A. and other governmental advisory panels, head professional societies and speak at the innumerable meetings and dinners where clinicians are taught about prescription drugs. Having key opinion leaders on the payroll is worth every penny a drug company spends.

What do they get for their money? First, there are the intangibles. It’s human nature to feel warm toward people with whom one collaborates closely, particularly when they’re so generous, and key opinion leaders become a sort of informal sales force.

Second, there’s good evidence that drug company involvement biases research in ways that are not always obvious, often by suppressing negative results. A review of 74 clinical trials of antidepressants, for example, found that 37 of 38 positive studies — that is, studies that showed that a drug was effective — were published. But 33 of 36 negative studies were either not published or published in a form that conveyed a positive outcome.

Bias can also be introduced through the design of a clinical trial. For example, the sponsor’s drug may be compared with another drug administered at a dose so low that the sponsor’s drug looks more powerful. Or it can be compared with a placebo, when the relevant question is how it compares with an existing drug. In short, it’s often possible to make clinical trials come out the way you and your sponsors want.

Disclosure is better than no disclosure, but it does not eliminate the conflict of interest. It’s simply a way of saying caveat emptor, and leaving it to readers to decide whether the research was biased. But most people — even doctors and science reporters — aren’t really equipped to make those judgments, particularly when data are suppressed.

I would suggest two reforms. First, researchers at academic medical centers should not accept any payments other than research support from drug companies, and that support should have no strings attached — no control over the design, interpretation and publication of trial results. We should go back to arm’s length grants.

Second, doctors should not accept gifts from drug companies, even small ones, and they should pay for their own meetings and continuing education, as is standard in other professions. They can afford it. 

In the meantime, those of us who read these studies should remain skeptical about them until several different trials reach the same result.

The indignation about Dr. Baselga is justified. But the fact that other physicians disclose their myriad conflicts of interest does not solve the underlying problem. Collaboration with industry can lead to important scientific contributions, but we should not let drug companies buy the hearts and minds of researchers. The cost of this is high, and not just in drug prices. It means both doctors and patients believe prescription drugs are better and safer than they really are.

https://www.nytimes.com/2018/09/14/opinion/jose-baselga-research-disclosure-bias.html

Medicine’s Financial Contamination

by The Editorial Board - NYT - September 14, 2018

The fall from grace last week of Dr. José Baselga, the former chief scientific officer of Memorial Sloan Kettering Cancer Center, illuminated a longstanding problem of modern medicine: Potentially corrupting payments by drug and medical device makers to influential people at research hospitals are far more common than either side publicly acknowledges.

Dr. Baselga, a giant in cancer research whose work led to the discovery of the lifesaving drug Herceptin, resigned on Thursday after The New York Times and ProPublica reported that he had repeatedly failed to properly disclose millions in industry payments.

Decades of research and real world examples have shown that such entanglements can distort the practice of medicine in ways big and small. Even little gifts have been found to influence doctors’ prescribing habits and their perceptions of a given company’s products. Larger payments have been shown to affect the design of clinical trials and the reporting of trial results, among other things. And such financial entanglements have proved devastating to individual patients — and to society at large. The opioid epidemic, to take one recent example, was partly spread by doctors who were persuaded to ignore warning bells and prescribe these drugs liberally by companies that showered them with gifts and consulting fees.

Dr. Baselga’s lapses may not have touched off a drug epidemic, but they have damaged the reputation of a leading cancer hospital in which tens of thousands of patients place their trust every year. Medical institutions should prize that trust at least as much as they prize profits. They should work aggressively to keep themselves beyond such reproach. And they should hold leaders of Dr. Baselga’s rank to an especially high standard, because leaders more than rule books set the example that others will follow. 

The latest scandal marks an especially sad failure to meet those ideals. In statements to industry analysts and the American Association for Cancer Research, Dr. Baselga praised two drug trials that many of his peers considered failures, without mentioning that the trials’ sponsor, Roche, had paid him millions of dollars. He also withheld his financial conflicts from dozens of publications, including at least one journal that he edited.

Those conflicts touched his own institution directly, in that several of the companies he advises have business with Memorial Sloan Kettering. Both Varian Medical Systems, which sells the hospital radiation equipment, and Bristol-Myers Squibb, which sells it medications, pay him several hundred thousand dollars a year for his role on their boards of directors. Likewise, Juno Therapeutics and Paige.AI, both tapped Dr. Baselga to serve as a chief adviser after securing exclusive rights to data and technology developed by the hospital. Neither Juno nor Paige are required to disclose exactly what they’ve paid Dr. Baselga, because neither has brought a product to market yet. But if those payments are on par with what he’s receiving from other companies, it would come out to hundreds of thousands of dollars for each. And if his compensation from these companies includes stock, he stands to profit personally, and handsomely, from intellectual property that belongs to the hospital.

Sloan Kettering’s other leaders were well aware of these relationships. The hospital has said that it takes pains to wall off any employee involved with a given outside company from the hospital’s dealings with that company. But it’s difficult to believe that conflicts of this magnitude could have truly been worked around, given how many of them there were, and how high up on the organizational chart Dr. Baselga sat. It also strains credulity to suggest that he was the hospital’s only leader with such conflicts or with such apparent difficulty disclosing them. After the initial report, but before Dr. Baselga’s resignation, the hospital sent a letter to its entire 17,000-person staff acknowledging that the institution as a whole needed to do better. It remains to be seen what additional actions will be taken — and by whom — to repair the situation. 

Financial conflicts are hardly confined to Sloan Kettering. A 2015 study in The BMJfound that a “substantial number” of academic leaders hold directorships that pay as much as or more than their clinical salaries. According to other surveys, nearly 70 percent of oncologists who speak at national meetings, nearly 70 percent of psychiatrists on the task force that ultimately decides what treatments should be recommended for what mental illnesses, and a significant number of doctors on Food and Drug Administration advisory committees have financial ties to the drug and medical device industries. As bioethicists have warned and as journal publishers have long acknowledged, not all of them report those ties when and where they are supposed to.

Medical journals and professional organizations have also told The Times that they are looking for ways to streamline the disclosure process for doctors and to better track those disclosures themselves. Those are good first steps, but if institutions charged with curing the sick are serious about finally stopping the corruption of medicine by money, they’ll need to do much more than that. 

Ban paid appointments to outside boards. Research hospitals are troves of valuable intellectual property and bastions of innovation. Several F.D.A.-approved medications began as research projects at Sloan Kettering, and many more are doubtless in the works. Outside board appointments can be a valuable part of that process. But when those appointments come with payments that meet or exceed a doctor’s existing salary, the process is almost certain to be corrupted, and public trust is sure to be undermined. Doctors should be prohibited from accepting money for these collaborations, just as innumerable other professionals (judges, journalists, government officials) are prohibited from accepting similar arrangements.

Create uniform reporting standards. Doctors might have an easier time abiding by the rules if they were the same everywhere. Right now, reporting requirements vary by journal, institution, federal agency and private organization. To simplify matters, all potential conflicts should be reportable on the federal site, and that site should then be checked by institutions and by journal editors as a matter of course. As Forbes has pointed out, it defies logic that payments already logged in one corner of this matrix would escape the attention of several other corners. Institutions that have not already created standing committees to evaluate potential conflicts should do so. And in cases where the person being evaluated is very senior, those committees should appoint members from outside the institution.

Establish real consequences for violations. For too long now, the only penalty for failing to disclose industry ties has been that you have to go back and correct the record. Dr. Baselga’s resignation has the potential to send a different message: Even at the highest levels of academia, there are consequences for ignoring the rules. Going forward, institutions should make honest disclosure a condition and expectation of employment, just as other types of scientific integrity are. And journals should make good on standing rules to ban violators from publishing for a certain period of time. (This rule exists at some publications, but it is hardly ever enforced.)

Build a culture of transparency. The desire to avoid a professional penalty or a public shaming should not be the only reason doctors have for minding — and ideally, minimizing — their financial conflicts. They should recognize the real potential of those conflicts to color their thinking and their work, and they should want legitimate checks and balances against that possibility. There are ways to foster that kind of collective awareness and shared desire. High-profile information campaigns, like the ones that got doctors and nurses to cut infection rates just by washing their hands more often, come to mind. Research hospitals might consider launching a similar campaign, condemning financial conflicts of interest, before the next public outing.

https://www.nytimes.com/2018/09/14/opinion/medicines-financial-contamination.html

Editor's Comment:

If you click on the link above to access the article on the NYT website, and go to the reader comments on this editorial, you will be surprised at the uniformity of opinion about the issue of corruption in medicine.

-SPC

A Crazy, Murky System for Pricing H.I.V. Drugs

by Tina Rosenberg - NYT - September 18, 2018

A new gold-standard triple therapy for H.I.V. has just made its debut in Africa. It costs $75 a year. In the United States, many people with H.I.V. take an almost identical therapy. It costs $39,000 a year.

The United States is infamous for its high cost of health care — and H.I.V. medicines are a big part of that. Plenty of drugs carry outrageous prices: EpiPens, insulin, cancer treatments, even some antibiotics. But no class of medicines is more scandalously expensive than for H.I.V. These medicines are by far the largest item in Medicaid’s drug budget, the third largest for the insurance exchanges and the fifth largest for commercial insurers.

What do we get from spending so much? Not enough. H.I.V. therapy aims to suppress the virus to the point where it is undetectable in a patient’s blood. Patients with suppressed H.I.V. are healthy and noncontagious. Just under half of all people living with H.I.V. in the United States have achieved that. That’s not only way below countries like Britain and France; it’s worse than Zimbabwe, Kenya and Malawi.

The high cost of drugs contributes to this failure. Our big problem in America is that too many people with H.I.V. don’t know they have it. Drugs can’t solve that. It requires humans — to find people, win their trust, bring them into the health care system and help them deal with other issues (such as substance abuse) so they can handle getting tested. “We have a trade-off,” said Demetre Daskalakis, deputy commissioner for disease control in the New York City Department of Health and Mental Hygiene. “New York City and New York State are a bit of a wonderland — we’re resourced very well compared to other places. But even we have limits to what we can do — because of spending on drugs.”

What does it cost to make each year’s supply of that $39,000 therapy? Well, the generic manufacturers Aurobindo and Mylan, which supply the drug in Africa, make a profit when they sell it to the United States’ President’s Emergency Plan for AIDS Relief and to the Global Fund to Fight AIDS, Tuberculosis and Malaria — two organizations that buy drugs for low-income countries. So logic says it must cost less than $75.

“Whenever I hear that, I pretty much have a seizure,” said Dr. Daskalakis. “That we are going to be able to scale up all over the world is amazing. But in the meanwhile, people in the U.S. have problems staying on medicines because of our crazy system.”

The crazy system exists because until very recently, there has been virtually no price competition in H.I.V. drugs. But we are seeing the first attempts to control the galloping cost of treating H.I.V.

Next year for the first time, Express Scripts, which is one of the country’s largest pharmacy benefits managers, with coverage of 25 million people, is kicking an H.I.V. medicine, Atripla, off its list of covered drugs. It will exclude Atripla because there’s now another drug that is essentially identical and costs 40 percent less. (They differ in one piece of their triple therapy, but the World Health Organization and the United States government consider those drugs to be interchangeable.)

UnitedHealthcare, one of the biggest insurance companies in America, is experimenting with a different way to control costs. Beginning this fall, it will encourage patients it covers to choose a less expensive H.I.V. therapy. In its My ScriptRewards program, patients who choose the cheaper H.I.V. regimen will have no co-pay or co-insurance costs, and can get $500 in gift cards to use for other health care expenses.

Why now? “There are new options in the market,” according to Lida Etemad, who is vice president for pharmacy management services at UnitedHealthcare. “There are recommended regimes at a lower cost than we’ve seen.”

She’s talking about new drugs from Mylan — the generic manufacturer that achieved infamy for the $600 EpiPen in 2016. Mylan is the world’s biggest manufacturer of generic H.I.V. drugs. This year the company brought out three new H.I.V. medicines in the United States, with prices pegged at 40 percent below the equivalent brand-name drugs.

UnitedHealthcare is giving patients incentives to choose Mylan’s two-drug combination of Cimduo instead of its pharmacological equivalent Truvada, which costs $19,700 a year. (Prices quoted are from the government’s survey of what pharmacies pay. Price secrecy elsewhere along the chain of purchases — from manufacturer to insurers and ultimately to patients — leaves doctors totally in the dark about the cost of what they prescribe, and patients as well. That’s true even for Medicare and Medicaid, where tax dollars pay the bills. 

Mylan also makes three-drug combos, Symfi (equivalent to Atripla, which costs $32,000) and lower-dose Symfi Lo. At 40 percent less, the two Symfi combinations cost $19,200.

“Lower cost” is relative — obviously, these prices are pretty far from $75. But generic competition slashes prices only when there are many competitors. The usual price drop with the first generic is small — 15 percent or less. (The Mylan drugs are not technically generics, because they are new single-pill combinations of existing generic drugs, not exact copies of existing drugs.)

The United States spends about $20 billion a year on H.I.V. drugs. Anil Soni, the head of global infectious diseases for Mylan, said that if generics and lower-cost H.I.V. medicines — made by Mylan and other companies — were incorporated into treatment regimens, America could save between $3 billion and $5 billion, with about $1 billion of that savings accruing to Medicare and Medicaid.

Mr. Soni has experience in public health unusual for a drug company executive. He was the chief of staff to the first leader of the Global Fund and later chief executive of the Clinton Health Access Initiative. At Mylan, he negotiated the agreement to supply the $75 therapy in low-income countries.

“We should be planning in a smart way to make these switches when they become possible,” said Mark Harrington, executive director of the Treatment Action Group, which works globally to help people get medicines for H.I.V., tuberculosis and hepatitis C. “If this were a rational world, this would set in play a dynamic series of negotiations between buyers and manufacturers, trying to bid around for the lowest price,” he said.

But what an irrational world it is! What’s new about Mylan’s Cimduo is that it combines two medicines available in generic form: tenofovir and lamivudine. If Cimduo is interchangeable with Truvada, then so are these drugs. The difference? Cimduo is two pills (taken together) instead of one. Oh, and the price — together the two generics add up to $1,635 per year.

Someone might say: Let’s prescribe both generics and we’ll save $18,000 off the cost of Truvada!

The same is true for Mylan’s three-drug combos. The cost of the three generic drugs in Symfi and Symfi Lo is $12,000. Prescribing those individual drugs instead of Atripla would mean taking three pills instead of one — and saving $20,000.

No one has.

This isn’t an accident. H.I.V. drug pricing is a mess because drug companies have so much sway over government policy. For example: Medicare is not allowed to negotiate with drug companies on price — although 92 percent of Americans think it should. If Medicare could get the same prices that, say, the Department of Veterans Affairs gets, it would save nearly $3 billion a year on just the 20 most-prescribed drugs, according to a study by Senate Democrats.

Pharmaceutical companies have built a system in which no one in a position to limit costs wants to do so.

The federal panel on antiretroviral guidelines now does include references to drug costs, said Dr. Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital and a guidelines panel member. “But the first-line regimens recommended still favor the absolute best — and often most expensive — drugs available. It’s ‘if this were my dad, what would I want him to have?’” she said.

Insurers should care about price. But it’s hard for them to refuse to cover a recommended drug, and they can pass their costs along in the form of higher premiums.

Taxpayers should care about price; after all, health care represents 18 percent of the national economy. But the industry has proved too powerful.

Drugmakers have designed a system in which parties that would otherwise campaign for cheaper drugs actually have an interest in high prices. For example, clinics that serve H.I.V. patients also, perversely, benefit from high prices. Their pharmacies can buy drugs at Medicaid prices. But if a patient has commercial insurance, they can bill the insurer at commercial prices.

This arbitrage is very profitable. “Lots of the dollars that come back fund case management, social work, nutritional programs and peer outreach,” said Tim Horn, the director of medication access and pricing at Nastad, the organization of state public health officials who work on H.I.V./AIDS. “They really do help to subsidize a lot of H.I.V. care.”

Most important are the distorted incentives for patients. Super-organized, savvy patient groups all over the world banded together to make H.I.V. medicines affordable in poor countries.

But in the United States, virtually no one on antiretrovirals has to pay for them. For those without private insurance, Medicare or Medicaid, the Ryan White AIDS Drug Assistance Program steps in. No other disease has such a program.

If patients have high out-of-pocket costs, such as co-pays and co-insurances, makers of brand-name H.I.V. drugs help patients. (Mylan is doing this, too, with its new drugs.) It’s smart business — small payments that increase sales of very expensive drugs.

It’s good for patients — and rather unusual in the American health care system — that they needn’t worry about paying for expensive drugs. It’s also good for everyone else: If people couldn’t afford their meds, we’d have many more deaths, huge hospital bills and an uncontrollable H.I.V. epidemic. But insulating patients from costs has greatly reduced patient pressure for lower prices. And it neutralizes a powerful potential adversary of the drug companies.

Generic medicines don’t normally come with co-pay assistance. So patients could end up paying more out of pocket for a $1,000 generic than for a $30,000 brand-name drug. Along with the inconvenience of multiple-pill regimens, this is a big reason generics aren’t much used.

Mr. Horn believes things are changing. “Cost considerations are becoming considerable factors in H.I.V. care,” he said. “It’s high time. We’re on the cusp of something.”

That something, however, carries perils, he said. “There’s a complex patchwork in place. We want to make sure everybody continues to have access to prescription drugs and services.”

https://www.nytimes.com/2018/09/18/opinion/pricing-hiv-drugs-america.html?

Medicaid supporters urge federal agency to ignore LePage letter, approve expansion

by Joe Lawlor - Portland Press Herald - September 18, 2018

An advocacy group for low-income Mainers urged the U.S. Centers for Medicare and Medicaid Services on Tuesday to disregard a letter from Gov. Paul LePage asking the agency to reject the state’s plan for expanding Medicaid.

“Expanding the Medicaid program is by federal law a step that Maine is entitled to take, and the choice to take that step is now the established law of the state of Maine,” wrote Charles Dingman, an attorney representing Maine Equal Justice Partners, the advocacy group that sued the LePage administration for failing to implement expansion.

LePage – a staunch opponent of expansion – submitted a plan, called a State Plan Amendment, in September to the federal agency after he was ordered by a court to do so, but at the same time he asked the federal government to reject the plan.

Rep. Chellie Pingree of Maine, D-1st District, and Democratic Maine House Speaker Sara Gideon also submitted similar letters this week asking the federal agency to approve an expansion that would make about 70,000 Mainers newly eligible for free health insurance.

The Maine Department of Health and Human Services, after being forced to do so by the courts, filed a State Plan Amendment with Medicaid on Sept. 4 that was accompanied by a letter from LePage urging the federal agency to reject the application. Medicaid is a federal program operated by the states under federal oversight, and is funded with a blend of state and federal money.

Under Medicaid expansion, a key component of the Affordable Care Act, the federal government pays 90 percent of the costs of expansion. Thirty-four states, including Maine, have expanded Medicaid. Mainers earning up to 138 percent of the federal poverty level, or $34,638 for a family of three and $16,753 for a single person, would be eligible. About 273,000 Maine residents are already covered by Medicaid.

Mainers voted to approve Medicaid expansion by a 59 percent to 41 percent margin in November 2017, but the LePage administration has so far been unwilling to implement it.

LePage has argued that the Legislature did not adequately fund the expansion, although lawmakers approved $60 million for expansion this summer that LePage vetoed. LePage, who is termed out and will be out of office by January, claimed the $60 million included one-time budget gimmicks and was not “sustainable.”

“Mainers have already enacted this law. Every step along this process we have a governor who is using the power to obstruct,” said Robyn Merrill, executive director of Maine Equal Justice Partners. “The court is going to have to hold the executive branch accountable for not following the law.”

Merrill said that even if the federal government approves the plan, the LePage administration may still refuse to implement the expansion. Getting Medicaid implemented may require a court order, or if enough time has passed, the issue will fall to the new governor, she said.

Democrat Janet Mills, Maine’s attorney general, Republican businessman Shawn Moody and independents Terry Hayes, the state treasurer, and businessman Alan Caron are running in the November election to succeed LePage. Mills, Hayes and Caron have committed to implementing the expansion, while Moody has not.

In August, the Maine Supreme Judicial Court ordered LePage to submit the plan, and referred most other matters to a lower court, the Superior Court.

LePage, in his letter asking the Centers for Medicare and Medicaid Services to reject the application, wrote that “if the SPA is approved, the state will become obligated under federal law to fund the full range of Medicaid services to tens of thousands of additional individuals. Until the necessary funding is in place, however, the federal government can take no assurance that Maine will be able to pay for its share of costs under the program.”

But a letter from Gideon and state Rep. Drew Gattine, D-Westbrook, said the money is available for the expansion, even though LePage vetoed the funding bill, because of surpluses in the state budget.

“Maine does have ample funds to meet its legal obligations to expand MaineCare (the state’s name for Medicaid) to over 70,000 Mainers who need health care and who are entitled to receive it under the law,” said the letter signed by Gideon and Westbrook.

Merrill said a federal agency stepping into a state budget fight would be “unprecedented.”

Pingree’s letter this week also urged the Centers for Medicare and Medicaid Services to approve the amendment.

“It is clear that the choice of Maine’s citizens to ensure that more low-income people have access to health coverage has been lawfully made, notwithstanding the political motivations of Maine’s governor to the contrary. Accordingly, the governor’s statement accompanying the SPA should be disregarded in its entirety,” Pingree wrote.

Some Mainers have applied for Medicaid under the expansion and have been denied, and Maine Equal Justice Partners argues that by law, they were eligible for Medicaid starting on July 2.

It’s unknown how many have applied even though the LePage administration refuses to implement the expansion. Merrill said about 800 have used an online screening tool set up by Maine Equal Justice Partners to help determine eligibility, but it’s not known how many of the 800 applied for Medicaid.

When asked Tuesday about the number of people who have tried to sign up, Maine DHHS spokeswoman Emily Spencer said she could not comment because of the pending lawsuit.

https://www.pressherald.com/2018/09/18/advocacy-group-democrats-urging-medicaid-to-approve-maine-expansion-plan/