PNHP

Medicare is the patriotic, prudent, medically vital thing to do

Medicare is the patriotic, prudent, medically vital thing to do

By Ed Weisbart, M.D.
Deseret News (Salt Lake City), Sept. 22, 2015

We need to improve Medicare and provide that to all Americans. It’s the patriotic, prudent and medically vital thing to do.

I appreciate the serious tone that Sally Pipes took in presenting her Koch-funded arguments against single-payer national health insurance (“Government single-payer health coverage may be nation’s future,” Sept. 20). I particularly appreciate that she accurately represented my own comments; that I, along with at least 59 percent of physicians in the U.S., believe the evidence is overwhelming that single-payer would be the most efficient way to finance high quality health care for all Americans.

Our current system produces mediocre results, with the result that the CIA World Fact Book identifies Americans as ranking 51st in life expectancy at birth. Less widely recognized is that our world ranking in life expectancy changes drastically after we hit the age of Medicare eligibility. According to the Institute of Medicine, our life expectancy before age 65 ranks the worst out of 17 modern nations. Once we hit age 65, our life expectancy ranking rapidly climbs to a position nearly the best in the world. As proud Americans, we should honor the fact that we have a world-class publicly financed health care system — Medicare.

The beleaguered Veterans Administration (VA) system does not represent the only possible model for an American single-payer system. Critics of the VA should realize that our recent years of increased military service have led to vastly increased demands on the VA, without a concomitant adjustment in resources for these new patients. Although significant service problems exist, their clinical outcomes have long been among the best in the nation. Pointing out the VA’s challenges, while intentionally not pointing out that the same issues exist in our private insurance industry, is only meant to be inflammatory and misleading. And it has little to do with questions about national health policy.

Fortunately, there is a robust North American experiment in single-payer versus private insurance: Canada vs. the USA.

Up until 1971, both of our nations were spending roughly the same 7 percent of our GDPs on health care, and had been following the same general cost trend curves. Our life expectancies were within a year of each other.

In 1971, Canada fully implemented its national health insurance. That same year, President Richard Nixon signed the HMO Act into law.

After beginning with a system performing very similarly to our own, Canada now spends roughly half of what we spend, and its life expectancies are now two and a half years longer than ours. Health care is far from perfect in Canada, but it’s dramatically better.

According to the National Bureau of Economic Research, 14 percent of Americans now report having unmet health needs. One percent of us have this problem due to waiting lists or unavailability of a service, 8 percent due to cost issues and 5 percent from an assortment of other reasons. Compare this to the 11 percent of Canadians with unmet health needs: 6 percent of Canadians report the problem as a result of waiting lists or unavailable services, 1 percent due to cost and 4 percent from other reasons. Yes, Canadians have longer waiting lists than we do, but their problem pales in comparison to the number of Americans who never even make it to our waiting lists and have unmet needs due to the cost of care. The key driver of Canadian waiting lists is their decision to fund a system at 50 percent of our own.

Today, 45 years into this Grand North American Experiment, Canadians spend half, have 20 percent less unmet health needs and live 2.5 years longer.

It’s time to call off this experiment. We need to improve Medicare and provide that to all Americans. It’s the patriotic, prudent and medically vital thing to do.

Ed Weisbart M.D. is a family physician and chairs the Missouri chapter of Physicians for a National Health Program. He volunteers at a variety of safety net clinics in St. Louis, Missouri, and across the nation.

http://www.deseretnews.com/article/865637288/Medicare-is-the-patriotic-prudent-medically-vital-thing-to-do.html?pg=all

Bassett calls race a critical factor in public health

By Dan Goldberg 
Politico New York, Sept. 1, 2015

Last week, New York City’s health commissioner gathered her staff in their Long Island City headquarters.

It was part of a regular brown-bag series Bassett offers for the staff. Usually she brings in outside speakers, but last Monday she decided to give the talk herself. She decided to explain how racial inequality fits into her vision of public health.

Health disparities, she said, are not the result of income inequality alone. An understanding of public health requires an understanding of how persistent racism has impacted the health and well-being of people of color in specific geographic areas.

“Neighborhoods that are disadvantaged need [to] correct a historic injustice,” Bassett told POLITICO New York. “The framing matters.”

Bassett believes her department should view public health issues, in part, through the lens of racial injustice, on the premise that health inequalities won’t be solved simply by offering new services, and can’t always be addressed with new regulations.

For example, for years health department officials have warned that sugary drinks contribute to obesity and heart disease, and blacks in New York City have higher rates of both when compared to whites. To tackle that problem, Bassett said, it’s imperative to understand how and why sugary drinks are more often marketed to black and Latino youth, and to counter such messages by having teens talk to peers in their neighborhoods about healthy eating.

“When I joined the health department [as commissioner], everyone talked about income inequality — no one would talk about race,” she said. “The first step toward solving anything is bringing it into the public discourse.”

She explained to her staff how she feels racism and public health fit together, and how physicians and public health officials have a role to play in the #blacklivesmatter debate, which has been part of the national discourse since the deaths of Michael Brown in Ferguson, Missouri, and Eric Garner on Staten Island after encounters with police officers.

“With the death of Eric Garner, everyone asked the question, how are we tackling racism,” said Bassett, who wrote a commentary in The New England Journal of Medicine explaining how she felt physicians should engage with the movement.

“There is great injustice in the daily violence experienced by young black men,” she wrote. “But the tragedy of lives cut short is not accounted for entirely, or even mostly, by violence.”

Her presentation to staff last week included slides that showed how life expectancy in East Harlem is nine years less than it is in Murray Hill, and how the maternal mortality rate for black women is 11 times higher than for white women. 

Bassett’s more expansive view of public health counts racism as a social determinant. It means universal pre-K and affordable housing are as much public health issues as immunization rates. It also means gun violence and police violence are just as much a public health concern as cigarettes and sugary drinks. 

It’s an opinion Bassett has voiced for decades but one that remains controversial throughout much of the country.

(Surgeon general Vivek Murthy had his confirmation held up for months because he tweeted that guns were a public health issue.)

Bassett did not criticize the New York Police Department, opting instead to focus on police violence as a broader national issue, but it is hard to separate her broader criticisms from current conditions on the ground. Broken windows policing, championed by police commissioner Bill Bratton, is now decried by many leaders in the African American community, who accuse the department of systematically harassing young black men. Garner’s death didn’t just spark a debate over racism in America. It led to a spate protests over how police officers treated black men and women. 

Mayor Bill de Blasio has tried — often unsuccessfully — to sympathize with both the protesters who want police reform and the police officers trying to do their jobs.

Bassett avoided explicitly addressing the politics, but said it is crucial to know the numbers, praising The Guardian’s “The Counted” series, which tracks people killed by U.S. law enforcement officers in 2015. 

Viewing racism as both a social justice issue and a public health issue has been a cause of Bassett’s since the mid-1980s, when she challenged liberals to do more than simply acknowledge socioeconomic factors.

“Racism disproportionately concentrates blacks into the lower strata of the working class and further causes blacks in all class strata to be racially oppressed,” she wrote in 1986.

But even as she talks about how deeply ingrained race is as a factor in the system, Bassett also makes it clear that she doesn’t view the problems as unsolveable. 

One of her slides showed how infant mortality rates for black babies declined after the Jim Crow era ended in the south, and how they quickly aligned with those in the north. 

Jim Crow was a far more overt form of racism than anything New York City sees today, but the larger point Bassett tried to impress upon her staff is that racial factors do play an outsize role in health outcomes.

That is why Bassett, in a break from her predecessors, focuses so much attention on neighborhood initiatives.

Her theory, supported by census data, is that because New York City is such a segregated city, geographically targeting department resources is critical in achieving health equity. 

“We can use our data to both learn more and highlight the issues, and contribute to critical research that lends to a better understanding in which race contributes to poor health outcomes,” she said.

http://www.capitalnewyork.com/article/city-hall/2015/09/8575583/bassett-calls-race-critical-factor-public-health

PNHP note: Dr. Bassett is a member of the board of PNHP’s New York Metro chapter.

Drug Goes From $13.50 a Tablet to $750, Overnight

By Andrew Pollack
The New York Times, Sept. 20, 2015

Specialists in infectious disease are protesting a gigantic overnight increase in the price of a 62-year-old drug that is the standard of care for treating a life-threatening parasitic infection.

The drug, called Daraprim, was acquired in August by Turing Pharmaceuticals, a start-up run by a former hedge fund manager. Turing immediately raised the price to $750 a tablet from $13.50, bringing the annual cost of treatment for some patients to hundreds of thousands of dollars.

“What is it that they are doing differently that has led to this dramatic increase?” said Dr. Judith Aberg, the chief of the division of infectious diseases at the Icahn School of Medicine at Mount Sinai. She said the price increase could force hospitals to use “alternative therapies that may not have the same efficacy.”

Turing’s price increase is not an isolated example. While most of the attention on pharmaceutical prices has been on new drugs for diseases like cancer, hepatitis C and high cholesterol, there is also growing concern about huge price increases on older drugs, some of them generic, that have long been mainstays of treatment.

Although some price increases have been caused by shortages, others have resulted from a business strategy of buying old neglected drugs and turning them into high-priced “specialty drugs.”

Cycloserine, a drug used to treat dangerous multidrug-resistant tuberculosis, was just increased in price to $10,800 for 30 pills from $500 after its acquisition by Rodelis Therapeutics. Scott Spencer, general manager of Rodelis, said the company needed to invest to make sure the supply of the drug remained reliable. He said the company provided the drug free to certain needy patients.

In August, two members of Congress investigating generic drug price increases wrote to Valeant Pharmaceuticals after that company acquired two heart drugs, Isuprel and Nitropress, from Marathon Pharmaceuticals and promptly raised their prices by 525 percent and 212 percent respectively. Marathon had acquired the drugs from another company in 2013 and had quintupled their prices, according to the lawmakers, Senator Bernie Sanders, the Vermont independent who is seeking the Democratic nomination for president, and Representative Elijah E. Cummings, Democrat of Maryland.

Doxycycline, an antibiotic, went from $20 a bottle in October 2013 to $1,849 by April 2014, according to the two lawmakers.

The Infectious Diseases Society of America and the HIV Medicine Association sent a joint letter to Turing earlier this month calling the price increase for Daraprim “unjustifiable for the medically vulnerable patient population” and “unsustainable for the health care system.” An organization representing the directors of state AIDS programs has also been looking into the price increase, according to doctors and patient advocates.

Daraprim, known generically as pyrimethamine, is used mainly to treat toxoplasmosis, a parasite infection that can cause serious or even life-threatening problems for babies born to women who become infected during pregnancy, and also for people with compromised immune systems, like AIDS patients and certain cancer patients.

Martin Shkreli, the founder and chief executive of Turing, said that the drug is so rarely used that the impact on the health system would be minuscule and that Turing would use the money it earns to develop better treatments for toxoplasmosis, with fewer side effects.

“This isn’t the greedy drug company trying to gouge patients, it is us trying to stay in business,” Mr. Shkreli said. He said that many patients use the drug for far less than a year and that the price was now more in line with those of other drugs for rare diseases.

“This is still one of the smallest pharmaceutical products in the world,” he said. “It really doesn’t make sense to get any criticism for this.”

This is not the first time the 32-year-old Mr. Shkreli, who has a reputation for both brilliance and brashness, has been the center of controversy. He started MSMB Capital, a hedge fund company, in his 20s and drew attention for urging the Food and Drug Administration not to approve certain drugs made by companies whose stock he was shorting.

In 2011, Mr. Shkreli started Retrophin, which also acquired old neglected drugs and sharply raised their prices. Retrophin’s board fired Mr. Shkreli a year ago. Last month, it filed a complaint in Federal District Court in Manhattan, accusing him of using Retrophin as a personal piggy bank to pay back angry investors in his hedge fund.

Mr. Shkreli has denied the accusations. He has filed for arbitration against his old company, which he says owes him at least $25 million in severance. “They are sort of concocting this wild and crazy and unlikely story to swindle me out of the money,” he said.

Daraprim, which is also used to treat malaria, was approved by the F.D.A. in 1953 and has long been made by GlaxoSmithKline. Glaxo sold United States marketing rights to CorePharma in 2010. Last year, Impax Laboratories agreed to buy Core and affiliated companies for $700 million. In August, Impax sold Daraprim to Turing for $55 million, a deal announced the same day Turing said it had raised $90 million from Mr. Shkreli and other investors in its first round of financing.

Daraprim cost only about $1 a tablet several years ago, but the drug’s price rose sharply after CorePharma acquired it. According to IMS Health, which tracks prescriptions, sales of the drug jumped to $6.3 million in 2011 from $667,000 in 2010, even as prescriptions held steady at about 12,700. In 2014, after further price increases, sales were $9.9 million, as the number of prescriptions shrank to 8,821. The figures do not include inpatient use in hospitals.

Turing’s price increase could bring sales to tens or even hundreds of millions of dollars a year if use remains constant. Medicaid and certain hospitals will be able to get the drug inexpensively under federal rules for discounts and rebates. But private insurers, Medicare and hospitalized patients would have to pay an amount closer to the list price.

Some doctors questioned Turing’s claim that there was a need for better drugs, saying the side effects, while potentially serious, could be managed.

“I certainly don’t think this is one of those diseases where we have been clamoring for better therapies,” said Dr. Wendy Armstrong, professor of infectious diseases at Emory University in Atlanta.

With the price now high, other companies could conceivably make generic copies, since patents have long expired. One factor that could discourage that option is that Daraprim’s distribution is now tightly controlled, making it harder for generic companies to get the samples they need for the required testing.

The switch from drugstores to controlled distribution was made in June by Impax, not by Turing. Still, controlled distribution was a strategy Mr. Shkreli talked about at his previous company as a way to thwart generics.

Some hospitals say they now have trouble getting the drug. “We’ve not had access to the drug for a few months,” said Dr. Armstrong, who also works at Grady Memorial Hospital, a huge public treatment center in Atlanta that serves many low-income patients.

But Dr. Rima McLeod, medical director of the toxoplasmosis center at the University of Chicago, said that Turing had been good about delivering drugs quickly to patients, sometimes without charge.

“They have jumped every time I’ve called,” she said. The situation, she added, “seems workable” despite the price increase.

Daraprim is the standard first treatment for toxoplasmosis, in combination with an antibiotic called sulfadiazine. There are alternative treatments, but there is less data supporting their efficacy.

Dr. Aberg of Mount Sinai said some hospitals will now find Daraprim too expensive to keep in stock, possibly resulting in treatment delays. She said that Mount Sinai was continuing to use the drug, but each use now required a special review.

“This seems to be all profit-driven for somebody,” Dr. Aberg said, “and I just think it’s a very dangerous process.”

A version of this article appears in print on September 21, 2015, on page B1 of the New York edition with the headline: Once a Neglected Treatment, Now an Expensive Specialty Drug.

Rent seeking by drug barons

Drug Goes From $13.50 a Tablet to $750, Overnight

By Andrew Pollack
The New York Times, September 20, 2015

Specialists in infectious disease are protesting a gigantic overnight increase in the price of a 62-year-old drug that is the standard of care for treating a life-threatening parasitic infection (toxoplasmosis).

The drug, called Daraprim, was acquired in August by Turing Pharmaceuticals, a start-up run by a former hedge fund manager. Turing immediately raised the price to $750 a tablet from $13.50, bringing the annual cost of treatment for some patients to hundreds of thousands of dollars.

Turing’s price increase is not an isolated example. While most of the attention on pharmaceutical prices has been on new drugs for diseases like cancer, hepatitis C and high cholesterol, there is also growing concern about huge price increases on older drugs, some of them generic, that have long been mainstays of treatment.

Although some price increases have been caused by shortages, others have resulted from a business strategy of buying old neglected drugs and turning them into high-priced “specialty drugs.”

Cycloserine, a drug used to treat dangerous multidrug-resistant tuberculosis, was just increased in price to $10,800 for 30 pills from $500 after its acquisition by Rodelis Therapeutics.

Doxycycline, an antibiotic, went from $20 a bottle in October 2013 to $1,849 by April 2014, according to the two lawmakers.

Martin Shkreli, the founder and chief executive of Turing, said that the drug is so rarely used that the impact on the health system would be minuscule and that Turing would use the money it earns to develop better treatments for toxoplasmosis, with fewer side effects.

“This isn’t the greedy drug company trying to gouge patients, it is us trying to stay in business,” Mr. Shkreli said.

This is not the first time the 32-year-old Mr. Shkreli, who has a reputation for both brilliance and brashness, has been the center of controversy. He started MSMB Capital, a hedge fund company, in his 20s and drew attention for urging the Food and Drug Administration not to approve certain drugs made by companies whose stock he was shorting.

In 2011, Mr. Shkreli started Retrophin, which also acquired old neglected drugs and sharply raised their prices. Retrophin’s board fired Mr. Shkreli a year ago. Last month, it filed a complaint in Federal District Court in Manhattan, accusing him of using Retrophin as a personal piggy bank to pay back angry investors in his hedge fund.

Daraprim, which is also used to treat malaria, was approved by the F.D.A. in 1953 and has long been made by GlaxoSmithKline. Glaxo sold United States marketing rights to CorePharma in 2010. Last year, Impax Laboratories agreed to buy Core and affiliated companies for $700 million. In August, Impax sold Daraprim to Turing for $55 million, a deal announced the same day Turing said it had raised $90 million from Mr. Shkreli and other investors in its first round of financing.

Daraprim cost only about $1 a tablet several years ago, but the drug’s price rose sharply after CorePharma acquired it.

With the price now high, other companies could conceivably make generic copies, since patents have long expired. One factor that could discourage that option is that Daraprim’s distribution is now tightly controlled, making it harder for generic companies to get the samples they need for the required testing.

The switch from drugstores to controlled distribution was made in June by Impax, not by Turing. Still, controlled distribution was a strategy Mr. Shkreli talked about at his previous company as a way to thwart generics.

http://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html

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The Price of Inequality

By Joseph E. Stiglitz
W. W. Norton and Company

The term “rent” was originally used to describe the returns to land, since the owner of the land receives these payments by virtue of his ownership and not because of anything he does. This stands in contrast to the situation of workers, for example, whose wages are compensation for the effort they provide. The term “rent” then was extended to include monopoly profits, or monopoly rents, the income that one receives simply from the control of a monopoly. Eventually the term was expanded still further to include the returns on similar ownership claims.

Not all rent seeking uses government to extract money from ordinary citizens. The private sector can excel on its own, extracting rents from the public, for instance, through monopolistic practices and exploiting those who are less informed and educated, exemplified by the banks’ predatory lending. CEOs can use their control of the corporation to garner for themselves a larger fraction  of the firms’ revenues. Here, though, the government too plays a role, by not doing what it should: by not stopping these activities, by not making them illegal, or by not enforcing laws that exist.

http://books.wwnorton.com/books/detail.aspx?id=4294967848

***

Comment:

By Don McCanne, M.D.

The pharmaceutical industry has run amok, and we are all suffering as a result. We are paying higher taxes and higher insurance premiums to create “rents” for the likes of Martin Shkreli. (You’ll understand what this means if you simply read the excerpts above.)

We should all be outraged, not only with the barons in the pharmaceutical industry, but even more with our own government, which, as Joseph Stiglitz tells us, is “not doing what it should.”

One of our candidates for president says that he “can’t do it alone. We have got to do it together through a strong grassroots movement. We have got to think big.”

Start thinking big.

(PNHP does not endorse any political candidates nor their political parties, though some candidates do endorse policies advanced by PNHP.)

White Coats for Black Lives: Medical Students Responding to Racism and Police Brutality

By Dorothy Charles, Kathryn Himmelstein, Walker Keenan, and Nicolas Barcelo, for the White Coats for Black Lives National Working Group
Journal of Urban Health, Sept. 17, 2015

Last fall, Black people and their allies took to social media and the streets to assert that, despite the non-indictment of officers responsible for the deaths of Michael Brown and Eric Garner, Black lives matter. While these protests sparked national dialogue about racism and violence against communities of color, our medical school campuses remained silent and detached. As medical trainees invested in the lives and well-being of people of color, we felt called to action by the #BlackLivesMatter movement. Medicine is not immune to the racism that pervades our education, housing, employment, and criminal justice systems. Moreover, racism and police brutality damage the health and lives of people of color, particularly Black people, and must be addressed as a public health crisis.

Initially, students at different medical schools initiated conversations and planned separate actions to engage with larger, national struggles for racial justice.

Full article:
http://link.springer.com/article/10.1007/s11524-015-9993-9

Community health centers seeing more underinsured patients

At community clinics, underinsured replace uninsured

By Mark Zdechlik
MPR News, September 16, 2015

A few years ago, community health clinics routinely offered care to people with no health insurance. Today, offering care to people who have insurance — but still can’t afford care — is becoming more common.

At the Sawtooth Mountain Clinic in Grand Marais, Minn., more people coming through the doors have a health plan, as required under the Affordable Care Act. But the plans with the lowest monthly premiums tend to have high deductibles.

Clinic CEO Rita Plourde said that for many clients, the problem now is being underinsured. They have health insurance but cannot afford the out-of-pocket costs.

In Coon Rapids, Nucleus Clinic gets some referrals from conventional clinics when patients are having difficulty with out-of-pocket expenses. Becky Fink, who runs the community reproductive health clinic, said that many patients with a high deductible health plan find it less expensive to bypass the insurance and pay cash.

Fink expects the growing demand for subsidized clinic services from people enrolled in health plans will continue despite the signature promise of Obamacare.

It’s frustrating to see insured people who can’t afford to pay for health care, Fink said. People need to know that the Affordable Care Act is pushing more people toward community health centers, she said, not decreasing the need for them.

http://www.mprnews.org/story/2015/09/16/underinsured-community-clinics

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Comment:

By Don McCanne, M.D.

As we celebrate the successes of the Affordable Care Act, it is sobering to realize that the increasing prevalence of underinsurance is leaving many patients dependent on community health centers, much as they were before, when they were uninsured.

It is fortunate that our legislators, led by Sen. Bernie Sanders, recognized that there would still be a great need for community health centers and insisted on authorizing funding for these centers.

But wouldn’t it be even better if everyone had comprehensive first dollar coverage? The clinics would no longer be geared to take care of mostly low-income patients but rather would be transformed into centers that could appeal to all of us, including specialists who would then welcome referrals from these centers.

All we need to do is to enact a well-designed single payer national health program, and the improvements would automatically follow.

Paxil: Same data, opposite conclusion

Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence

By Joanna Le Noury, John M Nardo, David Healy, Jon Jureidini, Melissa Raven, Catalin Tufanaru, Elia Abi-Jaoude
BMJ, September 16, 2015

From the Introduction

In 2013, in the face of the selective reporting of outcomes of randomised controlled trials, an international group of researchers called on funders and investigators of abandoned (unpublished) or misreported trials to publish undisclosed outcomes or correct misleading publications. This initiative was called “restoring invisible and abandoned trials” (RIAT). The researchers identified many trials requiring restoration and emailed the funders, asking them to signal their intention to publish the unpublished trials or publish corrected versions of misreported trials. If funders and investigators failed to undertake to correct a trial that had been identified as unpublished or misreported, independent groups were encouraged to publish an accurate representation of the clinical trial based on the relevant regulatory information.

The current article represents a RIAT publication of Study 329. The original study was funded by SmithKline Beecham (SKB; subsequently GlaxoSmithKline, GSK). We acknowledge the work of the original investigators. This double blinded randomised controlled trial to evaluate the efficacy and safety of paroxetine (Paxil) and imipramine (Toafranil) compared with placebo for adolescents diagnosed with major depression was reported in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001, with Martin Keller as the primary author. The RIAT researchers identified Study 329 as an example of a misreported trial in need of restoration. The article by Keller and colleagues, which was largely ghostwritten, claimed efficacy and safety for paroxetine that was at odds with the data. This is problematic because the article has been influential in the literature supporting the use of antidepressants in adolescents.

On 14 June 2013, the RIAT researchers asked GSK whether it had any intention to restore any of the trials it sponsored, including Study 329. GSK did not signal any intent to publish a corrected version of any of its trials. In later correspondence, GSK stated that the study by Keller and colleagues “accurately reflects the honestly-held views of the clinical investigator authors” and that GSK did “not agree that the article is false, fraudulent or misleading.”

Study 329 was a multicentre eight week double blind randomised controlled trial (acute phase), followed by a six month continuation phase. SKB’s stated primary objective was to examine the efficacy and safety of imipramine and paroxetine compared with placebo in the treatment of adolescents with unipolar major depression. Secondary objectives were to identify predictors of treatment outcomes across clinical subtypes; to provide information on the safety profile of paroxetine and imipramine when these drugs were given for “an extended period of time”; and to estimate the rate of relapse among patients who responded to imipramine, paroxetine, and placebo and were maintained on treatment. Study enrolment took place between April 1994 and March 1997.

Conclusion and implications for research and policy

Contrary to the original report by Keller and colleagues, our reanalysis of Study 329 showed no advantage of paroxetine or imipramine over placebo in adolescents with symptoms of depression on any of the prespecified variables. The extent of the clinically significant increases in adverse events in the paroxetine and imipramine arms, including serious, severe, and suicide related adverse events, became apparent only when the data were made available for reanalysis. Researchers and clinicians should recognise the potential biases in published research, including the potential barriers to accurate reporting of harms that we have identified. Regulatory authorities should mandate accessibility of data and protocols.

As with most scientific papers, Keller and colleagues convey an impression that “the data have spoken.” This authoritative stance is possible only in the absence of access to the data. When the data become accessible to others, it becomes clear that scientific authorship is provisional rather than authoritative.

What is already known on this topic

  • There is a lack of access to data from most clinical randomised controlled trials, making it difficult to detect biased reporting
  • In the absence of access to primary data, misleading conclusions in publications of those trials can seem definitive
  • SmithKline Beecham’s Study 329, an influential trial that reported that paroxetine was safe and effective for adolescents, is one such study

What this study adds

  • On the basis of access to the original data from Study 329, we report a reanalysis that concludes that paroxetine was ineffective and unsafe in this study
  • Access to primary data makes clear the many ways in which data can be analysed and represented, showing the importance of access to data and the value of reanalysis of trials
  • There are important implications for clinical practice, research, regulation of trials, licensing of drugs, and the sociology and philosophy of science
  • Our reanalysis required development of methods that could be adapted for future reanalyses of randomised controlled trials

http://www.bmj.com/content/351/bmj.h4320

***

Comment:

By Don McCanne, MD

Although questions and concerns have already been raised about the SmithKline Beecham study of the use of Paxil in adolescents, this study provides definitive answers in that it is a reanalysis of the full original data set that had not previously been released. Contrary to the original, ghostwritten published report that concluded that Paxil was safe and effective for depression in adolescents, this meticulous reanalysis of the same data led to the conclusion that Paxil is actually ineffective and harmful.

The research and marketing abuses of the pharmaceutical industry abound, now compounded by price gouging behavior. Donald Light and his colleagues have previously discussed the institutional corruption of pharmaceuticals here.

There is a crying need for much greater government oversight, but it likely will not come from an administration that allowed this industry to assist in writing the Affordable Care Act. Citizen involvement in electoral politics does matter, or at least it should. But nothing will happen if we can’t hear the outrage that should be expressed over this.

Health Insurance Coverage Still Low Despite ACA Policies

By Sara Heath
RevCycle Intelligence, Sept. 17, 2015

Health insurance coverage woes continue to affect a great number of individuals, claims the president of Physicians for a National Health Program (PNHP).

According to a recent press release, Robert Zarr, MD, argues that despite the increase in health insurance coverage since the implementation of the Affordable Care Act (ACA), there are still notable and “unacceptable” disparities in coverage amongst underserved individuals.

According to Zarr, the Census Bureau reported that the number of uninsured individuals dropped from 42 million in 2013 to 33 million in 2014. This considerable drop is perhaps a result of the ACA. As reported by RevCycleIntelligence.com, between 2014 and 2015 the uninsurance rate decreased by 8 percent.

Additionally, the number of individuals forgoing a primary care visit decreased by 3.5 percent, and the number of individuals without easy access to medication decreased by 2.4 percent. Overall, the number of individuals reporting fair or poor health decreased by 3.4 percent.

While Zarr notes that these decreases in uninsurance and its effects are certainly a good thing, there are still considerable issues to address.

“[T]he number of people who remain without coverage is still intolerably high,” Zarr said. “And the Census Bureau report leaves entirely unmentioned the millions of people who have health insurance but who can’t afford to use it because of high deductibles and copays.”

In fact, nearly a quarter of all insured non-elderly adults are underinsured, Zarr added. Of these individuals, 44 percent have gone without a physician visit, medical test, or prescription due to an inability to afford the service.

The head of PNHP acknowledged that having expensive coverage is certainly better than having no coverage, and underscored the detrimental effects of having such a large population of uninsured or underinsured individuals.

Citing a study performed by the American Journal of Public Health, Zarr highlighted statistics regarding the potential effects not having health insurance can cause — that for every 1 million people who do not have health insurance, there are 1,000 deaths linked to that very issue.

“[T]he 33 million people the Census Bureau says were uninsured in 2014 means that approximately 33,000 people died needlessly last year because they couldn’t get access to timely and appropriate care,” Zarr said.

This issue of uninsured populations is also expected to continue. According to the Congressional Budget Office, approximately 27 million people are expected to be uninsured over the next 10 years. Even if all states were to adopt the Medicaid expansion policy within the ACA, there would still be a population of approximately 24 million uninsured individuals.

Zarr provided a possible solution to these health insurance woes: a single-payer, Medicare for all, healthcare system. He stated that a single-payer system could be the singular path toward providing universal healthcare, something he believes a nation with such great wealth should be able to provide its citizens.

“A single-payer system would achieve truly universal care, affordability, and effective cost control. It would put the interests of our patients — and our nation’s health — first,” Zarr said. “We need to move beyond the administratively wasteful, complex and inadequate ACA to a more fundamental, comprehensive single-payer national health program for all.”

http://revcycleintelligence.com/news/health-insurance-coverage-still-low-despite-aca-policies

Sen. Sanders: I’ll Create Jobs, Provide Better Care for Less

It is true that I would invest $1 trillion into rebuilding our crumbling infrastructure

By Sen. Bernie Sanders
The Wall Street Journal, Letters, Sept. 17, 2015

Your article “Price Tag of Sanders Proposals: $18 Trillion” (page one, Sept. 15) is misleading.

It is true that I would invest $1 trillion into rebuilding our crumbling infrastructure. Not only would this long-overdue investment make our country more productive and efficient, it would put 13 million Americans to work in good-paying jobs. It is true that I would invest in making all public colleges and universities tuition free and substantially reduce student debt. This higher-education proposal, estimated to cost about $75 billion a year, would be more than paid for by a tax on Wall Street speculation. It is true that I proposed to extend the solvency of Social Security until the year 2065 and to expand benefits. This proposal would be offset by lifting the cap on taxable income above $250,000 a year.

But, here’s where the article is mistaken. While a Medicare-for-all program may cost $15 trillion over 10 years, this proposal would eliminate all payments made by Americans and businesses to health-insurance companies. At a time when the U.S. spends substantially more per capita on health care than does any other country on earth, a single-payer health-care program would substantially lower our total health-care costs and would guarantee health care to all Americans. This approach would end the international embarrassment of the U.S. being the only major country on earth that doesn’t already do this. For The Wall Street Journal to ignore the enormous savings that Medicare-for-all would bring to our wildly inefficient and dysfunctional health-care system is irresponsible.

Sen. Bernie Sanders (I., Vt.) writes from Washington. He is a candidate for the Democratic Party’s presidential nomination.

http://www.wsj.com/articles/ill-create-jobs-provide-better-care-for-less-1442434046

PNHP note: PNHP is a nonpartisan educational and research organization that neither supports nor opposes any candidate for public office.

Census says uninsured rate down ‘sharply’ to 10.4% in 2014

By Bob Herman
Modern Healthcare, Sept. 16, 2015

The first full year of health coverage expansion under the Affordable Care Act significantly drove down the uninsured rate in 2014, according to U.S. Census Bureau data released Wednesday.

The percentage of Americans who had no health insurance in 2014 “decreased sharply,” the Census Bureau said in its annual report on poverty, income and health coverage. The Census data and the Centers for Disease Control and Prevention’s National Health Interview Survey are considered the gold standards of health insurance statistics.

The uninsured rate was 10.4% in 2014 compared with 13.3% in 2013. It’s the largest drop the Census Bureau has recorded in the past seven years, said Victoria Velkoff, a top statistician at the agency. Although 283.2 million Americans had health insurance last year, 33 million people still lacked coverage, compared with 41.8 million in 2013. 

Medicaid and the health insurance exchanges spurred much of the decline. More than 6.7 million people gained Medicaid coverage last year, a direct result of the ACA’s expansion of Medicaid eligibility to people who make up to 138% of the federal poverty level. Thirty-one states and the District of Columbia have expanded Medicaid. Republicans control the governor’s seat or statehouse in the states that have yet to expand Medicaid, which was made optional under a 2012 Supreme Court ruling. 

Approximately 10 million Americans have purchased coverage through the state and federal exchanges created by the ACA, most of whom receive premium tax credits or cost-sharing subsidies to help pay down their insurance costs. Several million more directly purchase healthcare policies from insurers, often called off-exchange plans.

“There is a healthy increase in the nongroup market and in Medicaid, and this is consistent with what other federal surveys have seen,” said Katherine Hempstead, the director of health insurance research at the Robert Wood Johnson Foundation. “It’s indisputable that there’s been a statistically significant decline in the uninsured.” 

Most people still get their health insurance through their jobs, the Census data confirmed. More than 55% of Americans had employer-based coverage. Government-based plans, mostly Medicare and Medicaid, accounted for 36.5% of health insurance.

Medicaid expansion and the exchanges also fueled the drop in the uninsured rate among low-income earners and minorities. The number of uninsured people who made between $25,000 and $49,999 per year fell by 5 percentage points from 2013 to 2014. The uninsured rate among blacks, Hispanics and Asians all declined by more than 4 percentage points in the same period. 

However, 1 in 5 Hispanics, or 11 million people, still lacked health insurance last year, the most of any race or ethnicity studied by the Census Bureau. The uninsured rates for blacks, Asians and non-Hispanic whites in 2014 were 11.8%, 10.1% and 7.6%, respectively. 

But as many health insurance experts have pointed out, higher rates of health insurance don’t equate to comprehensive coverage. For instance, a recent report from the Commonwealth Fund report showed 14 million adults were “underinsured,” meaning their deductibles and out-of-pocket medical expenses absorbed a sizable portion of their household income. That includes people with employer-based health insurance.

The Census data shows that medical expenses are a major factor for those living in poverty. “We’re witnessing a dramatic acceleration of the trend of shifting more and more medical costs onto the shoulders of patients and their families,” Dr. Robert Zarr, president of Physicians for a National Health Program, a left-leaning group that supports a single-payer insurance system, said in a statement. “Such financial barriers are untenable, economically and morally,” he added.

However, the ACA caps how much people have to pay out of their own pockets. The maximum amount any person has to pay for in-network care next year is $6,850 for individuals and $13,700 for families.

“The main advantage of health insurance is protecting against catastrophic expenses,” Hempstead said. While many low-income earners still may struggle with the health law’s out-of-pocket limits, “it’s nothing like the kind of exposure they used to have,” she said.

The Census Bureau changed its health insurance survey methodology last year to get a more accurate read of who has coverage. Conservatives have criticized the switch. Ed Haislmaier, a senior fellow at the right-leaning Heritage Foundation, said in a statement there are discrepancies between the CMS and Census Bureau data and that there was “little net growth in the number of people with private health insurance coverage.”

http://www.modernhealthcare.com/article/20150916/NEWS/150919913

Census Bureau – 33 million uninsured is good news?

Health Insurance Coverage in the United States: 2014

By Jessica C. Smith and Carla Medalia
U.S. Census Bureau, September 2015

• The uninsured rate decreased between 2013 and 2014 by 2.9 percentage points. In 2014, the percentage of people without health insurance coverage for the entire calendar year was 10.4 percent, or 33.0 million, lower than the rate and number of uninsured in 2013 (13.3 percent or 41.8 million).

• The percentage of people with health insurance coverage for all or part of 2014 was 89.6 percent, higher than the rate in 2013 (86.7 percent).

• Between 2013 and 2014, the increase in the percentage of the population covered by health insurance was due to an increase in the rates of both private and government coverage. The rate of private coverage increased by 1.8 percentage points to 66.0 percent in 2014 (up from 64.1 percent in 2013), and the government coverage rate increased by 2.0 percentage points to 36.5 percent (up from 34.6 percent in 2013).

• Between 2013 and 2014, the greatest changes in coverage rates were the increases in direct-purchase health insurance and Medicaid. The largest percentage-point change in coverage was for direct-purchase, which increased by 3.2 percentage points to cover 14.6 percent of people for some or all of 2014 (up from 11.4 percent in 2013). The percentage of people with Medicaid coverage during all or part of the year increased by 2.0 percentage points to 19.5 percent in 2014 (compared with 17.5 percent in 2013).

http://www.census.gov/content/dam/Census/library/publications/2015/demo/p60-253.pdf

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More Americans gain health coverage, but many can’t afford to use it: doctors group

Physicians for a National Health Program, September 16, 2015

“The Census Bureau’s official estimate that 33 million Americans lacked health insurance in 2014 reflects a significant and welcome drop from the 42 million it reported as uninsured in 2013,” said Dr. Robert Zarr, president of Physicians for a National Health Program, today. “But the number of people who remain without coverage is still intolerably high. And the Census Bureau report leaves entirely unmentioned the millions of people who have health insurance but who can’t afford to use it because of high deductibles and copays.”

“How is it possible that in 2015 one of the richest countries in the world still does not guarantee every resident the right to health care?” Zarr continued. “This question would not be necessary if we had a health care system worthy of the name – single-payer national health insurance, or an improved and expanded Medicare for All.”

https://www.pnhp.org/news/2015/september/more-americans-gain-health-coverage-but-many-can’t-afford-to-use-it-doctors-grou

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Comment:

By Don McCanne, MD

The good news in this annual Census Bureau report is that there were significant increases in the numbers insured as a result of implementation of the Affordable Care Act – primarily in direct-purchase due to the mandate and in expansion of the Medicaid program. The bad news is that 33 million remain uninsured and, though not in the Census report, tens of millions are under-insured.

Our current national policies will continue to leave about 30 million people without insurance, and financial hardship due to under-insurance is expected to increase. We can anticipate more unnecessary suffering, hardship, and premature deaths.

PNHP President Robert Zarr said it, “How is it possible that in 2015 one of the richest countries in the world still does not guarantee every resident the right to health care? This question would not be necessary if we had a health care system worthy of the name – single-payer national health insurance, or an improved and expanded Medicare for All.”

8.8 Million More Americans Have Health Insurance in 2014 — But Can They Afford to Use It?

However, just because you’re insured doesn’t mean you can still afford health care, experts say

By Jennifer Gerson Uffalussy
Yahoo Health, September 16, 2015

The latest census data released today (Sept. 16) shows that the percentage of people without health insurance was 10.4 percent lower than the number of uninsured in 2013. 

While 41.8 million, or 13.3 percent of Americans, were without health insurance in 2013, that number dropped to 33 million — 10.4 percent of Americans — in 2014. 

That’s 8.8 million more people who have health insurance coverage year over year. 

Between 2008 and 2013, the uninsured rate was relatively stable — despite the passage of the Affordable Care Act in 2010. In 2014, thought, the uninsured rate sharply decreased, with the percentage of people with health insurance coverage in 2014 spiking to 89.6 percent. 

(Image: U.S. Census Bureau)

The 2014 numbers show that age is strongly associated with the likelihood that a person has health insurance.  In 2014, 98.6 percent of adults aged 65 years or over had some type of health insurance during the year, compared with 93.8 percent of children under age 19 and 85.7 percent of working-age adults aged 19 to 64 years.

(Image: U.S. Census Bureau)

However, the Congressional Budget Office (CBO) predicts that at least 27 million Americans will be uninsured every year for the next 10 years. And the stakes are high: A study in the American Journal of Public Healthshowed in a given year, there are 1,000 deaths for every 1 million people related to the lack of insurance.

What the Census Bureau report neglects to mention is that for some people, just because they have insurance doesn’t mean they can afford to use it due to high deductibles and co-pays, says Robert Zarr, MD, MPH, president of Physicians for a National Health Program. 

That’s a problem called underinsurance — when people have skimpy policies with high deductibles and copays that leaves them with high out-of-pocket expenses when paying for their health care. 

“A recent study by the Commonwealth Fund shows that about 31 million people who have health insurance – nearly a quarter of all insured non-elderly adults – are underinsured, nearly double the rate in 2003,” Zarr says. “Of these, 44 percent went without a doctor’s visit, medical test, or prescription due to cost, while 51 percent had problems paying off medical bills or were paying off medical debt over time.”

Zarr notes that the average deductible for a family with a silver-level plan— the marketplace standard plan that offers, on average, 70 percent cost coverage for retail medical services — bought through the Healthcare.gov marketplace is estimated to be $6,010. And out-of-pocket costs for copayments and deductibles, after premium payments, for a family of four with an income of about $60,000 per year can be as high as $13,200.

https://www.yahoo.com/health/more-americans-insured-in-2014-data-shows-165337271.html