Life Science Compliance Update

April 21, 2017

Dr. Stossel Corrects a Common Misconception

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Thomas P. Stossel, MD, MD (Hon), is a visiting scholar at the American Enterprise Institute and professor emeritus at Harvard Medical School, who has recently published several articles on how to remove barriers to medical innovation, and how medical innovation actually happens. This article highlights the impressive research by Dr. Stossel, supporting his position that private investment does much more to push the progress of medicine along than people think.

One article, published in the Wall Street Journal on January 5, 2017, addressed the assumption that “the root of all medical innovation is university research, primarily funded by federal grants.” He noted that the assumption is incorrect and that it is the “private economy, not the government,” that “actually discovers and develops most of the insights and products that advance health.”

The article opens with complimenting Congress for passing the 21st Century Cures Act, claiming that it “will promote medical innovation,” while at the same time telling readers to be “wary, however, of the $4 billion budget boost that the law gives to the National Institutes of Health.” In addition to his Wall Street Journal article, Dr. Stossel wrote a more in-depth article in National Affairs, arguing the same points, with more research and information embedded into the article. 

There were few findings in medical science that could significantly improve health until the late 19th and early 20th centuries, with innovation primarily coming from “physicians in universities and research institutes that were supported by philanthropy.” Dr. Stossel notes, however, that things changed after World War II when the National Institutes of Health became the major backer of medical research, changing incentives. Universities that previously lacked research operations started to develop them, and existing programs were largely expanded. As noted in Dr. Stossel’s article in National Affairs, “for decades, Congress allocated generous and growing funds to the NIH that enabled it to provide many research grants to universities. As a result, universities expanded their laboratory facilities and research faculties — and the government-academic biomedical complex, or GABC, was born.”

Since that time, improvements in health have rapidly occurred. Also during that period, funding for the National Institutes of Health has lagged behind the growth of an aging population in need of medical innovation while private investment in medicine has largely kept pace with the aging population and “is the principal engine for advancement.”

In his National Affairs article, Dr. Stossel discussed research papers submitted for publication, noting:

Although revered by academics as a quality filter, “peer review” of research papers submitted for publication (and of grants for research funding) is a flawed enterprise. As scientific journals found success in providing researchers the priority and credit they were looking for, the volume of submissions began to exceed the supply of journals’ publication space. The practice of peer review — having selected experts render opinions regarding the quality of articles submitted to journals — was designed to solve that problem. Today, electronic publication has eliminated the space problem, but a prestige hierarchy of journals has replaced it with a false scarcity. Researchers covet attention in the most prestigious journals, and the high-profile journals sustain their elevated status by arbitrarily rejecting the majority of articles submitted to them. The monopoly power of these journals, fueled by researchers’ vanity, allows indifferent editors to delay decisions about whether to publish research articles until dueling authors and reviewers come to a resolution. The referees of these disputes provide a quality of service that would be expected from the nature of the reviewers: anonymous, unpaid cronies or competitors of a paper’s authors. As a result, research data can languish in obscurity for months or years while authors work their way down the prestige pecking order and finally obtain a place to publish.

According to Dr. Stossel, more than 80% of new drug approvals originate from work solely performed in private companies and such drug approvals come on average 16 years after the beginning of clinical trials, which typically cost $2.5 billion from start to finish. Therefore, it appears even if academics and NIH really wanted to create a new drug, economic reality would get in the way.

The National Affairs article notes that, “achieving innovation requires wanting to innovate more than trying to impress reviewers of research papers or grant applications. It involves trial-and-error efforts that academic-review committees dismiss as “fishing expeditions” and that violate the scholarly premium on ‘hypothesis-driven’ studies. Success in academe also demands sticking to one’s research ‘brand.’ By contrast, innovation usually requires shifting gears to employ different technologies and experimental approaches. Such inconsistency reliably leads grant-application reviewers to discount an applicant’s qualifications.”

Dr. Stossel closes his Wall Street Journal article by stating:

Despite its exaggerated role, basic research in universities does advance human knowledge, train scientists, and contribute to medical advances—albeit uncommonly and inefficiently. But the system is unsustainable. A better approach would be to encourage academics to join with industry, where the financial resources and drive to innovate reside. Unfortunately, the biomedical complex demonizes corporations. If academic institutions stopped demeaning the activities needed to develop medical products, industry might take a greater interest in supporting their research.

Great advances in health care have been made, but there are still important challenges, from obesity to dementia. One step toward addressing them would be for Washington to adopt the right approach to medical innovation—and to stop simply throwing money at the current inefficient system.

April 03, 2017

ACCME President and CEO Calls for Healthcare Leaders to Leverage CME

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Graham McMahon, MD, MMSc, President and CEO of the Accreditation Council for Continuing Medical Education (ACCME), recently published an article in Academic Medicine, “The Leadership Case for Investing in Continuing Professional Development.”

In his article, Dr. McMahon calls upon healthcare leaders to recognize and appreciate the power and capacity of accredited CME to address many of the challenges in the healthcare environment, from clinician well-being to national imperatives for better health, better care, and lower costs. McMahon also offers principles and action steps for aligning leadership and educational strategy, while urging institutional leaders to embrace the continuing professional development of their human capital as an organizational responsibility and opportunity.

McMahon opines that CME is “an underused and low cost solution that can improve clinical performance, nurture effective collaborative teams, create meaning at work, and reduce burnout.” He believes that to optimize CME benefits, clinical leaders need to think of CME as a way to help drive change and achieve institutional goals, in concert with quality improvement efforts, patient safety, and other systems changes.

McMahon notes, “The perception of CME as only lectures in dark rooms or grand rounds with dwindling numbers of participants listening passively to an expert is increasingly anachronistic. Equally outdated is the view that CME is about rubber-stamping applications for credit. The end point of CME is not the credit that’s attained for licensing, certification, or credentials; rather, it is learning.”

A CME program that is properly utilized – with a multi-professional scope and educational expertise – can contribute to initiatives that focus on clinical and nonclinical areas alike. Some such initiatives can include quality and safety, professionalism, team communication, and process improvements. By supporting the achievement of quality and safety goals and engaging in public health priorities, CME programs can help organizations reach various strategic goals and demonstrate leadership.

He further argued that to “reap the greatest return on your institution’s investment in education, you will need to build a collaborative learning culture. We acculturate clinicians to be decisive and confident, but patient safety is compromised when confidence is not matched by ability. Promoting self-awareness as part of your institution’s culture is key to improving patient care and safety because it allows clinicians to stop if they are unsure, seek advice from a colleague or access resources, and ensure they are making the right decision at the right time.”

Additionally, “[b]reaking down silos among professions and throughout the medical education continuum, including the involvement of undergraduate and graduate medical education leadership, improves efficiency and the allocation of resources across an institution’s educational programs. An integrated learning environment that enables health care professionals, residents, and students to share conferencing space, learning management systems, and other resources will help drive team development.”

In conclusion, Dr. McMahon notes, “Healthcare leaders who recognize the strategic value of education can expect a meaningful return on their investment – not only in terms of the quality and safety of their clinicians’ work but also in the spirit and cohesiveness of the clinicians who work at the institution.”

April 03, 2013

Physician Payment Sunshine: ProPublica Database Leads with Disparaging Headlines

Headlines
Doctor collaborates with industry to conduct lifesaving, breakthrough research.”  “Doctor educates colleagues about safety and clinical date to improve patient outcomes.”  “Physician speaks to peers about new trials that improve patient access to needed drugs.”  “Researchers meet to ensure the success of new clinical trial.”   

“Physician invents new medical device that improves cardiovascular health.”  “Industry and physicians collaborate to bring drug to market faster through new approval pathway.”  “Physicians attend education program mandated by FDA under REMS to better understand benefits and risk of drugs.” 

Of all these headlines, few, if any, are ever chosen by mainstream or local media to describe physician-industry relationships and collaboration that produce longer, healthier lives for all Americans.  In fact, the American Association for Cancer Research (AACR) recently released its second Annual Report on Cancer Survivorship, which showed that 18 million cancer survivors are expected by 2022.   

The headlines describing this report, however, failed to recognize that such increased survival rates are influenced significantly by the breakthrough drugs, therapies and treatments pharmaceutical manufacturers have researched, developed and discovered over the past few decades.  As Time Magazine noted, “advances in early detection and treatment are also contributing to helping people are live longer after diagnosis.” 

Consequently, news outlets are continuing their misleading headlines and stories regarding physician-industry collaboration over the last few weeks by relying on the recently updated payment data posted by ProPublica and its Dollars for Docs campaign.  This is particularly troublesome given that such news outlets will be able to significantly enhance the number of improper headlines once all payments are made public in March 2014 under the Physician Payment Sunshine Act.  Arnold & Porter, LLP recently hosted a webinar to discuss the final rule and its implications for all stakeholders. 

Charles Ornstein, who leads the Dollars for Docs campaign, told Medical, Marketing and Media in an interview that “companies’ strategies vary with respect to promotional speaking” in the latest update.  For example, “Forest Labs, which is the 20th-largest pharmaceutical company based on 2011 US sales, spent more money on physician speakers in the first three quarters of 2012 than any of its peers (many of which are much larger).” 

Ornstein recognized that trends are hard to determine given the different stages of brand lifecycles, which play a large role in terms of spending on speakers and marketing/sales.  Ornstein noted that he did not see much change in doctor’s willingness to speak with reporters about such payments.  Given the implementation of the Sunshine Act, Orenstein said that Dollars for Docs will still have a role, and provides unique aspects, such as linking to information about each drug on NIH websites.   

“Beyond that, on every payment page, [Pro Publica] has created a checklist that patient’s can print out and bring with them to their physician visits if they would like to ask questions about the payments or the drugs they are being prescribed.” 

Finally, Orenstein noted that ProPublica will be updating the database “from time to time,” and that it will be updated soon to include three new companies: Boehringer-Ingelheim, Sanofi-Aventis and Amgen.  The site will also offer historical value for payments reported prior to the Sunshine Act collection start date of August 1, 2013.  

Below is a summary of several articles, organized by State, that local and regional news organizations published after using the Dollar for Docs Database.  Most articles include a ProPublica badge and a Dollar for Docs function that lets readers search for doctor payments directly from the article. 

Louisiana 

The shrevporttimes.com reported that Louisiana doctors received $23 million from drug companies between 2009-2012, with more than 36,000 payments.  Doctors in northwest Louisiana raked in at least $4 million in payments from drug and medical device manufacturers since 2009.  While many support the move to make the medical industry more transparent, critics say the data lack context and in its current form do little more than scare patients. 

“Doctors and companies are automatically guilty until proven innocent if you’re looking at this,” said U.S. Rep. John Fleming, R-Minden, which is one of the many reasons he voted against the act.  Fleming, a licensed physician, said doctors may not stop at eliminating speaking engagements as guidelines increase and more documents are disclosed.  The disclosures when taken out of context can make doctors appear unethical, and some doctors may decide to stop participating in trials or anything involving these companies, Fleming said.  “Ultimately, it’s going to hinder innovation and research — research that benefits all of us,” Fleming said. 

Shreveport psychiatrist J. Gary Booker tops the region’s list of doctors receiving the most — $704,642 for research and meals.  Booker emailed the Times saying that the data and figures only told “half the story.”  “The studies pay well, but they are expensive to do,” Booker said.  Booker said he has performed nearly 100 clinical trials over the years, and the work he is doing could translate to long-term benefits for patients.  For example, he cited a recent study in which he worked to remove a plaque associated with Alzheimer’s disease from the brain. 

Robert Marier, executive director of the Louisiana State Board of Medical Examiners, said doctors across the state are participating in cutting-edge research funded by these drugs, and protocols are in place to ensure doctors are behaving ethically.  “When you hear your doctor or any doctor is receiving funds from these companies, it can raise a red flag, but there are so much oversight from institutions, like medical centers, as well as the state and federal regulations,” Marier said.

At LSU Health Sciences Center in Shreveport, Dr. John Vanchiere collected at least $241,000 for research and speaking engagements from Merck and GlaxoSmithKline.  However, Vanchiere, chief of pediatric infectious diseases and vice chair for pediatric research, said the majority of that money went to LSU Health for a clinical trial — not into his pocket.  

“That’s why a lot of people are not happy with these disclosures, and these numbers can quickly be misinterpreted and taken out of context,” Vanchiere said—the final Sunshine rule may resolve this issue.  The trial, funded by Merck, is an effort to limit the number of required childhood immunizations while maintaining effectiveness in preventing disease.  Instead of a series of vaccines, as little as two could be required, he said. “These studies have the ability to impact patients’ lives,” Vanchiere said.  

Maine 

The Portland Press Herald reported that payments to doctors in Maine between 2010 and 2012 dropped by 60%.  Money paid to doctors in Maine for research, usually clinical drug trials, increased by 40 percent from 2011 to 2012 ($450,390 to $788,755).  The database includes 927 total disclosures in Maine from 2009 to 2012.  Merck spent the most on research, followed closely by Pfizer. 

Eli Lilly spent the most money in Maine by far on speaking engagements, paying $571,572 for 37 appearances.  GlaxoSmithKline paid for 50 speaking engagements in Maine during that time and spent $256,262.   

In the top right of the article is a photograph of Dr. Jeffrey Barkin, who received $114,225 from drugmakers between 2009 and 2010.  Dr. Barkin maintained that he never felt his speaking engagements were a quid pro quo arrangement.  “I wasn’t writing more prescriptions for those drugs,” he said.   

Gordon Smith, executive director of the Maine Medical Association, noted that while companies used to reward doctors with perks, “those days are gone … largely because the American Medical Association updated its code of ethics and because of the increasing number of disclosures by the companies.” 

Below that picture, the Herald posts a snap shot of “Maine doctors paid the most by drug companies for speaking engagements from 2009-2012,” with a top 10 list.  Below, is a top 10 list for Maine doctors paid most by companies for research for the same period.  In addition to the top 10 lists, the Herald also provides a look at some of the most commonly known drugs associated with leading pharma companies, such as Eli Lilly, Pfizer, Merck, and GSK. 

Dr. Robert Weiss, an Auburn cardiologist, received $407,498, the highest total amount for research funds between 2009 and 2012.  Weiss, a nationally respected cardiologist, said he was often asked by drug companies to speak about a specific drug or course of treatment.  In most cases, he said, he agreed to the request because he had free rein to talk about both the benefits and drawbacks of the drugs. 

The Herald, however, included a discussion of companies having to review slides or asking doctors to speak from scripts—trying to suggest influence.  However, the Herald failed to recognize that such slides must be reviewed by the company to ensure compliance with FDA regulations and that such procedures are mandated by FDA.   

Already demonstrating the negative impact of increased transparency, Weiss said that some of his colleagues have stopped taking clinical research funds because of the increased scrutiny brought on by disclosure.  Weiss, who has been doing research for 30 years, said that almost all the money he has received from drug companies has gone to pay his 19 employees and cover stipends for patients who participate in the trials. 

There was some debate in the article about whether drug research is conducted properly or clinical trial data is accurate.  Weiss, however, pointed out that he has never been pressured to approve a drug, and most never even reach the market, which is part of the reason drugs cost so much.  

Barkin told the Press Herald that his speaking engagements were never specifically tied to certain drugs.  Rather, his talks were about educating other physicians on appropriate diagnoses for psychiatric disorders and about the overlap of physical disease with psychiatric disease and how that can sometimes lead to fragmented care.  

Scott MacGregor, communications director for Lilly USA, the domestic arm of Eli Lilly, said that employing experts to lead educational forums is a critical part of drug development.  He said payments are largely market-driven, depending on the development stage of a particular drug. 

The Herald claims that the most common payment, for travel and meals, represents about 60 percent of disclosures, “and it is given when a drug company pays physicians to listen to a presentation about a product.”  It is unclear how the Herald made this determination that all such travel/meals are for product education or promotion, rather than for investigator or research meetings. 

Missouri 

Using the biased headline of “Drug Money: How Pharmaceuticals Earn A Doctor’s Endorsement, KMOX news radio in St. Louis noted that hundreds of doctors received payments for speaking fees, travel and meals.  Without providing any context for such payments or the importance of physician-industry collaboration, the article dives into listing several high-paid physicians who work at Washington University in St. Louis.  Later, the article lists payments to several psychiatrists in St. Louis, pointing out that such physicians are paid the most across the country. 

KMOX News reached out to several of these physicians.  Joni Westerhouse, spokersperson for Wash. Univ. School of Medicine, explained that Dr. Jeffrey Gordon, does not see patients or prescribe drugs.  Dr. Brian Dieckgraefe does prescribe drugs, including those made by Pfizer, but, according to Westerhouse, fully discloses to patients his financial ties to the company before doing so. 

Nevertheless, the article fails to elaborate on the nature or context of payments, or even mention that such fees are almost always fair market value and go towards educating other doctors about new safety and clinical data, all of which improve patient outcomes and may even reduce healthcare costs. 

Susan Chimonas, a research scholar at the Columbia University Center on Medicine as a Profession who has been studying these relationships, expressed her concern with some interactions, but recognized that some relationships are “beneficial for physicians, and therefore, for their patients.”  Nevertheless, Chimonas—and the article—dedicate their comments on how such relationships are negative, and paint a picture of the old habits that companies used to engage in.  Those practices are long gone, prohibited under industry codes and strongly prohibited by corporate integrity agreements (CIAs) and other settlement documents between most of the companies and the federal government. 

The article pointed out that the Washington University School of Medicine first revised its conflict-of-interest guidelines in 2007.  The policy prohibits doctors from using promotional items such as pens and magnets in clinical areas and says “meals, sporting event tickets, golf outings, gift baskets, travel, and any other free goods or services” should not be accepted from industry vendors.  The changes also ensure speakers “have final editorial discretion as to lecture content and materials,” however, this must be balanced against FDA’s requirements.  

At the time of the change, four companies – Pfizer, Bristol-Myers Squib, AstraZeneca, and Sanofi-Aventis – refused to comply with Washington University’s new policy.  Dr. James P. Crane, executive vice chancellor for clinical affairs in the School of Medicine, then advised his faculty to cut ties with the companies.  Some of those companies later agreed to comply with the university’s requirements, according to Washington University School of Medicine spokesperson Joni Westerhouse.  

Pennsylvania 

The yorkdispatch.com, in York, Pennsylvania, reported 160 instances in which York-area physicians or medical facilities received payments from pharmaceutical companies.  Of those, 50 of the payments were for more than $1,000—are we really wasting our time being concerned with $1,000?  It probably costs most companies and government agencies over $1,000 to track and report such payments! 

Dr. Wanda Filer, a family medicine physician at Family First Health, was paid by Merck for traveling across the United States giving educational vaccine lectures to medical staff, she said.  “It wasn’t for prescribing anything, …It was for travel costs.”  Filer’s lectures were mostly about Gardisil, an HPV vaccine.  As a result of the lectures, she said, she helped incorporate new public health guidelines in practices nationwide, as “a lot of people were not up-to-date on their guidelines.”  She no longer speaks because she was elected to the board of directors of the American Academy of Family Physicians and didn't want a conflict of interest. 

Dr. Kevin McCullum, a cardiologist at Cardiac Diagnostic Associates, is listed at the top of the database for York doctors with an $84,615 payment from Merck for research.  But he said the money actually went to York Hospital, not his bank account.  Dr. McCullum said the U.S. government funds almost no research, so his clinical research on preventive drugs is paid by pharmaceutical companies because his team looks almost exclusively at new drugs.   

McCullum said he keeps the patient’s needs and the cost of medicine in mind when prescribing to patients, prescribing drugs that correlate to the individual's clinical condition and recommending cost-effective medicine when he can and takes the results of his research into account.  McCullum said he is doubtful about the possibility of these payments being used for unethical purposes -- like doctors partnering with a drug company and getting paid to promote its product.  

“First and foremost, I don't think it happens, … [a]nd I can assure you that here in the WellSpan Health system, that doesn’t go on.”  He said there are layers and layers of safeguards in place when it comes to clinical research, such as performing double-blind trials, where both patient and researcher are unaware if drugs or placebos are being administered.  “All (the safeguards in place) are acting as advocates to the patient,” he said.  “The cost is so high because there is so much work involved.” 

Massachusetts  

The lowellsun.com reported that more than $97 million has been paid to physicians in Massachusetts by pharmaceutical companies between 2009 and 2012, including $1.5 million to Greater Lowell physicians.  Lowell General Hospital spokeswoman Angela Strunk said physicians employed by the hospital must disclose any relationships to pharmaceutical companies, according to their contracts.  Payments to Fitchburg, Leominster, Lancaster and Gardner-based physicians totaled $585,000, according to data released by pharmaceutical companies and collected by ProPublica.  

We recently reported that Massachusetts posted its annual payments for 2011, showing a 3% decrease. 

Partners HealthCare, the parent organization of Massachusetts General and Brigham and Women’s hospitals in Boston, prohibited doctors from participating in promotional drug company speakers bureaus as of January 2010, concerned that physicians could lose their objectivity.  

Dr. Andrew G. Kowal, an anesthesiologist at Lahey Hospital and Medical Center in Burlington, has earned $337,651 from Pfizer and Eli Lilly for speaking, consulting, meals and travel fees from 2009 to 2011.  In an interview with The Boston Globe, Kowal, a critic of the overuse of addictive opiates, said he talks about alternative treatments such as Pfizer’s Lyrica for fibromyalgia.  At the time, he vowed to continue speaking free of charge, but he has not collected any payments since 2011, according to ProPublica’s data.  

Lahey CEO Howard Grant told the newspaper last year Kowal did not violate hospital policy in speaking at Pfizer events because he discussed only fibromyalgia and not a specific drug.  The hospital’s consulting policy states physicians may accept compensation for providing consulting services under certain circumstances.

Lahey’s policy states that a physician is prohibited from participating in talks where the company has a contractual right to control what the doctor says, creates the presentation materials or approves content or controls the publicity related to the event.  

Physicians are also banned from participating in industry-sponsored speakers bureaus for which the doctor receives compensation to act as the company’s spokesperson to disseminate company-generated materials or to promote company products.  Doctors who serve as consultants for industry must submit a conflict-of-interest form that discloses the expected compensation.  

In another article covering the same area, the SentinelandEnterprise.com noted that Dr. Lawrence DuBuske, an allergy and immunology specialist earned more than $688,601 from pharmaceutical companies AstraZeneca, GlaxoSmithKline, Merck and Novartis between 2009-2012.  We noted several years ago that DuBuske had protested new policies banning relationships with industry and resigned from Brigham and Women’s Hospital in Boston.  DuBuske has courtesy privileges at Heywood Hospital in Gardner, which requires physicians to disclose any conflict of interest as it pertains to pharmaceutical companies, medical device companies or other organizations when appropriate. 

HealthAlliance Hospital in Fitchburg, which is partnered with the University of Massachusetts Medical School, has a compliance policy regarding business transactions or arrangements with persons of interest in order to mitigate conflict of interest, according to a hospital spokeswoman Mary Lourdes Burke.  Burke said none of the hospital’s physicians are part of the data collected by ProPublica.

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