Manufacturer-Funded Research Compromises Patient Care

How interesting to see Forbes run a story on the way Big Pharma is manipulating research to support their drugs, but every effort to expose this dangerous and possibly criminal behavior on the part of these mega-companies is welcome.

How Manufacturer-Funded Research Compromises Patient Care

Robert Pearl, M.D.
7/24/2014
To improve patient care, doctors rely on research and published information.

According to an American Medical News report, professional journals are still the most popular source of up-to-date medical information among doctors.

These medical publications inform physicians on new drugs and treatments, and they contain peer-reviewed studies that both physicians and patients assume are scientifically accurate.

But all too often, research findings aren’t as scientific as they should be. And some are flat-out biased.

Research Studies Confirm Bias In Research

In 2012, the report “Industry sponsorship and research outcome” concluded that studies sponsored by a drug or device company lead to “more favorable results and conclusions” about the products studied than independently sponsored ones.

And a recent study from the Harvard Medical School on plastic surgery outcomes concluded, “Studies authored by groups with conflicts of interest are significantly associated with reporting lower surgical complications and therefore describing positive research findings.”

This was especially true when manufacturer-marketed products were used in the study, according to the study’s abstract.

Perhaps the most damning study comes by way of the National Center for Biotechnology Information.

In it, the authors identified 24 peer-reviewed studies published in highly respected medical journals. Each study compared two different types of suction devices that help wounds heal faster.

One device uses a sponge-type material while the other relies on a gauze-wound interface.

The researchers asked five independent surgeons to read all 24 papers and determine which product was judged as better in each study.

The conclusion: Seven papers seemed to favor the first treatment, 15 favored the second and 2 didn’t reach a definitive judgment.

Now, Here’s The Kicker

Of the 24 studies, 19 were funded by a manufacturer of one of the two devices. Lo and behold, based on determinations made by the independent surgeons, 18 of those 19 papers recommended the product made by the manufacturer who funded the research. Just one manufacturer-funded study was deemed to have a neutral conclusion.

Research advances medicine but conflicts of interest can corrupt outcomes and compromise patient care. (Photo credit: Wikipedia)

From a statistical perspective, this is nearly an impossible outcome.

Flip a coin 19 times and there’s a 1 in 524,288 chance it comes up heads each time.

We might expect that if the two alternative products were relatively equivalent and the research truly unbiased, the product sold by the non-funding company should come out on top about half the time. To have no study go against the funding company yields nearly impossible odds.

And if they are not equivalent, the better product should be identified in nearly all studies, regardless of the source of the researcher’s funding.

There is no way to interpret these results, except to assume the researchers themselves were biased based on who paid for their work.

Biased outcomes like these would raise red flags in any other context. They would have signaled some sort of inappropriate influence. The scientific results would have been rejected by medical journals.

But not under these circumstances.

How Bias Gets By In Medical Research

No manufacturer is foolish enough to demand that investigators reach a specific conclusion in their research. Discovery of such a quid pro quo relationship could result in a major scandal for the company and the termination of the researchers.

The origin of bias in these manufacturer-funded studies may be subconscious, but no less effective.

Researchers and research sponsors interact at events and meetings during the time the work itself is being performance and during subsequent clinical trials.

And social science literature has clearly demonstrated people have a strong desire to reciprocate a gift.

At a minimum, grateful researchers unconsciously want to “return the favor” to their funding organizations.

And given the constant pressure in academia to “publish or perish,” this bias could be more overt as researchers fear losing funding – even if a threat is never explicitly conveyed.

Regardless of the etiology, research bias and skewed results are real when medical companies fund studies on their products. And whether it’s conscious or unconscious, bias is inappropriate in any scientific context.

Curbing Bias In Medical Research
Over the past decades, attempts have been made to limit the inappropriate influence of bias in research.

Today, authors of peer-reviewed articles and presenters at accredited meetings are required to disclose any personal financial benefit from the research. They must also disclose financial dealings with the manufacturer – but not any of the details.

Researchers receiving federally funded grants must register their trials on clinicaltrials.gov and publish their results even when findings don’t favor the funding organization.

The days of sponsors suppressing unfavorable outcomes or helping investigators write their papers before submission are largely behind us.

But as the data demonstrate, today’s system is far from effective at ensuring scientific integrity.

The Negative Consequences of Manufacturer-Funded Research

Physicians rely on published data to determine the best treatment for their patients. When it is contaminated by inappropriate influence, doctors can’t provide the best possible care.

As a result, patients end up with lower quality care, increased complications and higher costs.

Public and private entities could take a number of big steps to curb medical research bias.

For starters, peer-reviewed journals could refuse to publish articles funded by a single company.

If manufacturers wanted to advance medical knowledge, competing drug and device companies could contribute to a common, independent research fund for their particular industry. This would eliminate the manufacturer-researcher relationship from a study’s equation.

Alternatively, a small fee could be added to the sales price of medical devices and drugs to fund independent research. Organizations like the National Institute of Health (NIH) could oversee the distribution of these dollars.

Of course, we should expect manufacturers to resist such changes. After all, drug and device companies aspire to drive product sales, not produce unbiased research.

But the problems created by the current system are far too serious to accept the status quo.

We need to stop hiding our heads in the sand. The data is clear. Change is essential.

~ Dr. Robert Pearl is the CEO of The Permanente Medical Group, a certified plastic and reconstructive surgeon, and Stanford University professor. Follow him on Twitter: @RobertPearlMD.

Hilary Rose - The Problematic Rise of Big Neuro

A little over a week ago, I posted the first section of an article I am writing on the topic of Big Neuro and how it has taken over nearly all of the Federal research dollars in psychology. Based on that, you all know how I feel about the topic.

This brief overview of the topic comes from The Institute of Art and Ideas (IAI).

The Problematic Rise of Big Neuro

Big claims are being made for neuroscience. But what results can we realistically expect?

Hilary Rose | Feminist sociologist and former Gresham Professor of Physics

The first “Big Science” projects came from physics and astronomy – think the atomic bomb, CERN or the Hubble telescope. No longer; now it is the turn of the biomedical sciences. Although the 1990s was supposed to be the decade of the brain and the 2000s that of the mind, brain science has hitherto lacked a big project and certainly a big budget.

Now, suddenly, it has two. Last year the EU announced that one of the winners in its €1billion “Grand Challenges” competition was the Human Brain Project (HBP) – which recently received a funding boost thanks to a 40% increase in the number of partners in the HBP consortium. Also launched last year, with much fanfare, was President Obama’s $3billion “Brain Action Map” (BAM). Obama cited the Battelle Institute’s claim that every dollar spent on the Human Genome Project (HGP) had yielded $140 to the US economy, though as yet only the first $100 million has been committed to the project.

For both the Europeans and the Americans, “solving” the human brain is “the greatest scientific challenge of the 21st century,” making it possible to prevent or cure diseases from autism to Alzheimer’s, enabling new supercomputers to be constructed, and at long last providing a scientific understanding of self and mind. The projects differ in that the Europeans – a collaboration of some 40 labs – argue that the way forward is to create a silicon “virtual brain” through cloud computing. By contrast the BAM, picked up by Obama from a scheme floated by a group of (mainly) Californian neuroscientists, aims to map the trillions of connections between every nerve cell to create a “connectome.”

Apart from the direct beneficiaries of this public largesse, the neuroscience community has largely reacted with scepticism. After all, even for that most studied of organisms, the worm C elegans, with no more than 302 nerve cells all of whose connections are known, it is still not possible to translate wiring diagrams into behaviour. Furthermore, one of the fundamental properties of the human brain is its plasticity – the way that millisecond by millisecond and decade by decade the brain changes; its connections ever being made, broken and remade in different patterns as the brain’s owner responds to the world around them.

Freezing such dynamism, whether in silicon or in a connectome, is to set aside this understanding. The EU’s failure to consult one of the worlds’ richest biomedical research charities and major neuroscience funder, the Wellcome Trust, based in London, whose huge financial contribution to the HGP rescued it at a very difficult stage in its history, looks like something of an own goal. To promise that these mega projects will solve brain and mental diseases, hyperbolic claims we have heard before, it is hard not to respond with a weary sense of déjà vu.

Those who watch biomedical research policy have by now become used to the launching of such gargantuan programmes claiming to deliver near limitless gains for both health and wealth. It started with the HGP in the 1990s, when molecular biologists claimed that genes’R’us and the editor of Science suggested that sequencing the human genome would solve cancer, schizophrenia and depression and thence homelessness. By the millennium, the promise of stem cells was editorialised in The Guardian as “almost biblical in nature.. would make the blind see.. the deaf hear”. Thus far, the health benefits of both genomics and regenerative medicine have been modest, though several fortunes have been made. In these new “Big Neuro” projects, will wealth trump health yet again?


~ Hilary Rose and Steven Rose’s latest book is Genes, Cells and Brains: the Promethean Promises of the New Biology, published by Verso.

Kickstarter - Nevermind: A Biofeedback Horror Adventure Game

My friend Arthur turned me on to this Kickstarter campaign to create a biofeedback-enhanced horror adventure game, Nevermind. It uses your stress levels to make the game harder or easier (the more you get stressed, the harder it is). This seems like an amazingly cool way to teach/learn affect regulation.

One exciting facet of Nevermind is its potential to serve as a full-fledged therapeutic tool for those who suffer from issues - mild or severe - relating to stress, anxiety, PTSD, or other similar conditions. Although informal testing results have been promising thus far, we are excited to be in discussion as we speak with researchers who are eager to explore Nevermind's potential impact via rigorous clinical trials.

As a prime example of our passion to create "games that give back", one of our long-term goals is to craft a health-centric version of Nevermind specifically targeted to help actual patients develop tools to manage and ultimately overcome their conditions.

More from Erin Reynolds, the game's creator:

Nevermind is a biofeedback-enhanced horror adventure game that takes you into the dark and twisted world within the subconscious minds of trauma victims.

As you explore surreal labyrinths and solve the puzzles of the mind, a biofeedback sensor monitors how scared or stressed you become with each passing moment. If you let your fears get the best of you, the game will become harder. If you’re able to calm yourself in the face of terror, the game will be more forgiving.

Nevermind’s goal is to create an unforgettable gameplay experience that also teaches players how to be more aware of their internal responses to stressful situations. If you can learn to control your anxiety within the disturbing realm of Nevermind, just imagine what you can do when it comes to those inevitable stressful moments in the real world . . .

Part of the reason I want to bring this to your attention is that there are only 2 weeks left to get this project funded and they are WAY short of the goal.

If you can help, please do so.

Here is more info on the game:

You'll need an HTML5 capable browser to see this content.

Nevermind is - at its core - an adventure game (in the spirit of classic games like Myst), where you must explore strange worlds and solve puzzles to unlock the terrifying mystery that lurks within each patient’s inner psyche.

In Nevermind, you are a Neuroprober - a unique physician who, through the use of cutting-edge technology, is able to venture into the minds of psychological trauma victims for whom traditional treatment methods have proved ineffective.

As such, each “level” in Nevermind takes place within the surreal subconscious of one of these victims. Your goal is to explore the often dark and twisted world within, solving abstract puzzles as you recover fragments of memories (represented by photographs) surrounding the traumatic event.

Traumatic experiences, especially those left untreated, take their toll in countless ways, often triggering other serious problems as the victim’s subconscious desperately tries to cope. As a result, the patient’s mind doesn’t take kindly to those who attempt to peel back these layers, often prompting it to lash out in terrifying, unexpected ways.

Only the most vigilant of Neuroprobers can withstand the necessary waves of abuse to help their patient find true salvation.

Can you?

*  *  *  *  *

Nevermind started as a 2012 MFA thesis project at USC’s Interactive Media Program, led by industry veteran Erin Reynolds - who returned to academia to pursue new ways to create “positive” games for traditional gaming audiences. After an academic year, Erin and the Nevermind student development team were able to create one fully-functional level - a proof of concept that demonstrated Nevermind’s unique vision and the feasibility of the core technology.

Nevermind has since been featured in numerous festivals and nominated for several awards for innovation and technical achievement, including at IndieCade, Games for Change, SIGGRAPH, Unity Unite Awards, and the Serious Games Showcase and Challenge.

*  *  *  *  *

In light of Nevermind’s critical success, Erin decided to take the plunge - leaving her industry job to commit herself fully to make her dream of a full-featured, commercially viable version of Nevermind a reality. With your support, Nevermind will be the next great horror adventure game - unlike anything you've played before!

BIGGER, BETTER, SCARIER

The final commercial version of Nevermind will contain at least 4 levels (more if we hit our stretch goals!), for 5+ hours of gameplay PLUS the time and resources to feature even higher quality environments to complement a broader variety of new, more terrifying themes and traumas.

From Mother Jones. According to the map near the bottom, Arizona spends $161 or more per capita for mental health (MH), putting us in the top tier of MH spending, yet we have some of the worst issues in the country.

When Governor Jan Brewer (R) cut funding for the Arizona Health Care Cost Containment System (AHCCCS) in 2010, an "estimated 100,000 childless adults" lost their health care coverage (beginning in 2012), a program that also made available free or very low-cost mental health services. These reductions in coverage were part of a $500 million cut in AHCCCS funding orchestrated by Brewer and the GOP-dominated state legislature in order to balance the state budget without raising taxes (and, in fact, cutting taxes for big businesses and the wealthy). This was another pitiful example of how the GOP sacrifices those in need of help and support to increase profits for the 1%.

There is hope, however.

After initially rejecting federal money from the Affordable Care Act, Brewer changed her mind a few months ago and is willing to accept more than a billion dollars in ACA money that requires her to spend another $150 million for state health care.

The Executive estimates that, for Arizona, the expansion of Medicaid eligibility to 133% of the federal poverty level represents a major opportunity: for a state match of a little over $150 million in FY 2015, Arizona can draw $1.6 billion in federal funds into its health care sector – a return on investment more than 10-to-1.

The original cuts placed a huge burden on the few agencies in Tucson that offer free mental health care without requiring AHCCCS or any other insurance, including SACASA (where I work - our waiting list is overwhelming) and the University of Phoenix Counseling Skills Center (which only offers a maximum of 10 sessions).

Anyway, here is the Mother Jones piece on mental health funding in the U.S.

MAP: Which States Have Cut Treatment For the Mentally Ill the Most?

—By Deanna Pan | Mon Apr. 29, 2013

Between 2009 and 2012, states cut a total of $4.35 billion in public mental-health spending from their budgets. According to a report by the National Alliance on Mental Illness, significant cuts to general fund appropriations for state mental health agencies have translated into a severe shortage of services, including housing, community-based treatment and access to psychiatric medications. "Increasingly, emergency rooms, homeless shelters and jails are struggling with the effects of people falling through the cracks," the report says, "due to lack of needed mental health services and supports."

The map below shows how states' spending changed on mental health services between 2009 and 2012.

Click on a state to see the specifics.

These six states and the District of Columbia made the deepest cuts to their mental health budgets.

South Carolina ($187.3 million in 2009 to $113.7 million in 2012, -39.3 percent): The director of the local NAMI chapter says the state’s mental-health department is “approaching crisis mode with funding at 1987 levels.” After closing community mental-health centers and reducing services at its remaining facilities, the department is now serving thousands fewer patients.

Alabama ($100.3 million in 2009 to $64.2 million in 2012, -36 percent): Alabama has one of the lowest numbers of psychiatrists [PDF] per capita in the nation. Despite rising demand for psychiatric hospital beds, Alabama plans to close most of its state mental hospitals this spring, laying off 948 employees.

Alaska ($125.6 million in 2009 to $84.7 million in 2012, -32.6 percent): Alaska has the nation’sNo. 2 suicide rate—and a massive mental-health workforce shortage. Sometimes there is not a single psychiatrist or psychiatric nurse [PDF] available at the mental-health center in Fairbanks, the state’s second-largest city.

Illinois ($590.7 million in 2009 to $403.7 million in 2012, $-31.7 percent): Illinois has more mentally ill people living in nursing homes than any other state. In 2010, the state settled a class-action civil rights lawsuit, agreeing to help 5,000 of them transition into community programs within five years. As of July 2012, only 45 people had moved.

Nevada ($175.5 million in 2009 to $126.2 million in 2012, -28.1 percent): In 2003, Reno police calculated how much it cost the county to repeatedly pick up and hospitalize Murray Barr, a homeless man with an alcohol addiction. Tallying up doctors’ fees and other expenses from his decade on the streets, Barr racked up a $1 million bill.

District of Columbia ($212.4 million in 2009 to $161.6 million in 2012, -23.9 percent): Children on Medicaid wait 10 weeks—or one-third of the school year—for an appointment with a Children’s National Medical Center community clinic psychiatrist.

California ($3,612.8 million in 2009 to $2,848 million in 2012, -21.2 percent): Inmates with severe mental illness often wait three to six months for a state psychiatric hospital bed. In 2007, 19 percent of state prisoners were mentally ill. By 2012, 25 percent were.

CRAZY PRIORITIES

Approximately 10 percent of US homicides are committed by untreated severely mentally ill people.

Chances that a perpetrator of a mass shooting displayed signs of mental illness prior to the crime: 1 in 2

Between 1998 and 2006, the number of mentally ill people incarcerated in federal, state, and local prisons and jails more than quadrupled to 1,264,300.

Since 2006, mental-illness rates in some county jails have increased by another 50 percent.

For every $2,000 to $3,000 per year spent on treating the mentally ill, $50,000 is saved on incarceration costs.

Prisoners with mental illness cost the nation an average of nearly $9 billion a year.

In 1955, there was one psychiatric bed for every 300 Americans. In 2010, there was one psychiatric bed for every 7,100 Americans—the same ratio as in 1850.

Severe mental disorders cost the nation $193.2 billion annually in lost earnings.

Sources for pie charts: National Coalition for the Homeless, NIMH, "Hunger and Homelessness Survey," The US Conference of Mayors,"Inmate Mental Health," National Institute of Mental Health

• Source for "Locked Up. But Where": Bernard Harcourt
• Source for "Docs to Drugs": US Dept. of Health and Human Services
• Source for "States of Denial": NRI

Toward Research on Real-World Effects of Meditation

The Mind and Life Institute has announced its winners for the Mind and Life 1440 Awards supporting research into the "real world" effects of meditation. From my perspective, this looks like a deserving series of proposed studies.

Toward Research on Real-World Effects of Meditation
MARCH 4, 2013

As many of our colleagues are aware, the Mind & Life Institute has been a long-time supporter of research in contemplative science. Since 2004, we have been awarding small grants to advance rigorous research in the field through our Francisco J. Varela Awards program. Over the last decade, we have funded over 120 Varela Awards, and are encouraged to see how much impact these grants have had on both the growth of a new field of scientific study, and also the career development of many young researchers who share an interest and commitment to examining the mind through contemplative practice.

Despite these successes, more can be done to gain a deeper understand of the effects of meditation in our daily lives. To date, research on contemplative practice has focused largely on exploring the effects of meditation on the body and mind in a laboratory setting. Common themes have focused on questions such as: How do contemplative practices affect biological and psychological systems in the practitioner? Are there consistent, measurable changes that lead to positive outcomes (e.g., reduced stress, brain changes, personality changes)? While this stage is a necessary first step to begin to understand the mechanisms underlying meditation, the real work lies in applying this knowledge outside the lab, in everyday life. Thus, the next step is moving toward applied, real-world science: How can contemplative practices be used to increase our awareness of ourselves and others in the midst of our modern world? What practices lead to healthier relationships and more compassionate interactions, and how can we measure this?

Mind and Life recently joined with the 1440 Foundation to design a program in the hopes of advancing contemplative science into this next phase of investigation. Stemming from this collaboration, we were excited to hold the first cycle of the Mind and Life 1440 Awards for Real-world Contemplative Research last fall. These grants of $15,000 – $25,000 are specifically geared towards the investigation of real-world (as opposed to lab-based) outcomes of contemplative practice. Specifically, the 1440 Awards are intended to promote research that evaluates whether and how contemplative practice can promote inner well-being and healthy relationships, as well as the development of new methods to assess these outcomes in everyday life.

After a very competitive funding cycle, we are thrilled to announce the first Mind and Life 1440 Awardees:

• Carrie Adair, West Virginia University: Mindfulness in interpersonal judgments and relationships in daily life
• Julie Brefczynski-Lewis, Northeastern University: Short and long-term behavioral, physiological, and brain changes resulting from compassion meditation training as an intervention for stress due to difficult interpersonal relationships
• Paul Condon, Florida State University: Contemplative practice, emotional well-being, and the transformation of hostility in the lab and real world
• Eric Garland and Amber Kelly, Florida State University: Trauma-informed Mindfulness-Based Stress Reduction to promote intra- and interpersonal flourishing among survivors of traumatic violence

Congratulations to our winners, and we wish you great success in your studies. By enabling high-level research in the area of social and relational outcomes of contemplative practice, it is our hope that the 1440 Awards will expand the applications and impact of contemplative practices in the world.