Life Science Compliance Update

120 posts categorized "Conflict of Interest"

February 03, 2015

Report Finds "Conflicts of Interest" Have No Effect on FDA Advisory Committee Votes

FDA Advisory

Stringent conflicts-of-interest policies keep many experts off of FDA advisory committees. A new study suggests that the fear of pro-industry bias underlying these policies may be misplaced, and also serves to keep highly qualified candidates off of these committees.

James C. Cooper, director of research and policy at the Law and Economics Center at George Mason Law School and Joseph Golec, professor of Finance of the University of Connecticut, who conducted the study, sought to compare conflicted members' voting patterns with objective criteria. They found that decisions by advisory committees with conflicted members to recommend drugs were more likely to be consistent with both the ultimate FDA decision as well as stock market predictions than non-conflicted advisory committees and members.

View their full report, entitled FDA Advisory Committees: Conflict of Interest and Voting Relative to Benchmarks.   

Background

In the past few years, there has been an increased focus from both the media and responsive legislation on financial ties between advisory committee experts and drug companies.

Cooper and Golec’s study notes that the law casts a wide net on what is a potential conflict of interest, including a situation where an oncology researcher would be "conflicted" if the university where she works received funds from the sponsor drug company, even if none of it funded general oncology research or her specific research. Furthermore, the FDA Amendments Act of 2007 placed additional restrictions on advisory committees, requiring that no more than 13 percent of member participants per year could receive conflict waivers to allow them to participate in a meeting. The study notes that FDA also reduced the maximum size of financial interests eligible for waivers from a combined financial interest of up to $100,000, to a maximum of $50,000.

The reasoning behind these policies is that financial ties between advisory committee experts and drug companies could potentially bias committee members’ recommendations in favor of unsafe or ineffective drugs. However, the authors point out that the “same specialized education and scientific experience that makes these experts attractive candidates to serve on [advisory committees] also puts them in contact with drug companies.”

Pharmaceutical companies often employ or contact these same expert physicians, researchers, and clinicians to help them develop and potentially market products. “For instance, companies seek out these experts to monitor or run their clinical trials, speak at various company-sponsored meetings, consult, write briefs, or serve on review boards,” states the report. “Drug companies, moreover, fund research studies at universities and research institutes that employ these experts.”

Because of the expertise these conflicted experts possess, restricting their participation on advisory committees is not a perfect solution, the authors argue. Limiting the number of conflicted experts who can serve on advisory committees presents its own costs associated with finding qualified, non-conflicted members and appointing less-qualified members.

Study Findings

The authors' main goal in conducting their study was to see if the restrictive policies for FDA advisory committees in fact brought unbiased outcomes. "If such financial ties lead to FDA approval of unsafe or ineffective drugs, then the costs may be justified," they note. If these ties have no impact on approval decisions, however, the authors believe the rules that place excessive barriers to entry can do more harm than good. Indeed, "such policies can impose net costs on society, especially if less expert committee members misinterpret the scientific data and recommend approval of unsafe or ineffective drugs." 

Cooper and Golec conducted a previous study in 2013 which found "no statistically significant difference between conflicted and non-conflicted member voting." To conduct this follow-up 2015 report, the authors examined the extent to which the presence of conflicts impacted advisory committee decisions as compared to two benchmarks--the ultimate FDA decisions and stock market predictions.

As for the first benchmark, the authors found FDA's ultimate decision to be a useful barometer because FDA staff are often hired specifically for their scientific backgrounds and expertise in evaluating the safety and effectiveness of new drugs. Furthermore, FDA experts evaluate hundreds of drugs each year, and are "employed directly by the entity that is politically accountable for poor decision-making." The authors also point out that FDA's noted history of "risk-aversion" suggests a bias away from drug approval. 

The study also benchmarks its committee decisions with decisions from investment companies. These companies hire experts to evaluate the scientific information supporting potential new drugs, and advise their clients about the likelihood of advisory committee and FDA approval, states the report. An advisory committee decision that "surprises the market – as reflected in abnormal returns measured through event studies – can be classified as 'incorrect' in the sense that it is contrary to the best judgment of outside experts."

The results of the benchmarking study were that conflicted advisory committee members, which the authors abbreviate "AC," were potentially more consistent with unbiased benchmarkers than their non-conflicted fellow members:

"The proportion of conflicted members serving on an AC has no statistically measurable impact on the probability that an AC decision is contrary to that of the FDA. The presence of conflicted members, moreover, reduces the probability of disagreement with the FDA for approval decisions. The empirical results thus suggest that if anything, conflicted ACs are more likely than their non-conflicted counterparts to disagree with the FDA’s decision to approve a drug. Results using the stock market as a benchmark are similar: conflicted ACs’ decisions surprise the stock market less frequently and are associated with smaller average abnormal returns than those made by their nonconflicted counterparts. These results suggest that conflicted ACs tend to arrive at decisions that are more consistent with predictions by outside experts than non-conflicted ACs, perhaps reflecting their greater expertise."

 

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While the George Mason University study may not change the mind of the most hardened industry critic, it is not the first study to undermine the conflict-of-interest trend. The FDA commissioned a study in 2009 entitled Financial Conflict-of-Interest Disclosure and Voting Patterns at FDA Advisory Committee Meetings that “found no evidence to suggest that having a financial conflict-of-interest tends to increase votes in favor of that interest.” 

November 12, 2014

Biotronik Settles For $4.9 Million to Resolve Kickback Allegations; Follows Last Year’s Significant Consumer Protection Settlement

Biotronik

Biotronik Inc. has agreed to pay $4.9 million to resolve kickback allegations brought under the False Claims Act, the U.S. Department of Justice announced last week. The settlement resolves allegations that the company induced doctors to continue using or convert to Biotronik devices by paying implanting physician in the form of repeated meals and inflated monthly payments for membership on a physician advisory board.

Biotronik is a multinational, privately owned company based in Germany that focuses on implantable cardiac devices to manage heart rhythms, such as pacemakers and defibrillators. Their U.S. production site is located in Lake Oswego, Oregon.

This case was initiated by a former Biotronik employee, Brian Sant, pursuant to the qui tam provisions of the False Claims Act, which permit private whistleblowers to bring a lawsuit on behalf of the United States and to share in the proceeds of the suit.  The U.S. intervened in the case as to some of Sant’s allegation; he will receive approximately $840,000 of the federal settlement.

Complaint

“In order to increase sales of their [cardiac rhythm management] devices, Biotronik illegally provides monetary and other incentives for physicians who were willing to implant Biotronik devices,” states the complaint. “Biotronik trains and instructs sales representatives, business and marketing managers, and other Biotronik employees and representatives to provide physicians with cash payments, consulting jobs for physician family members, automobiles, expensive trips and meals, expensive gifts, and entertainment in exchange for the physicians’ agreement to implant Biotronik devices.”

Biotronik allegedly established internal guidelines for giving sports tickets and other benefits based on the amount of implants performed by the physicians and the ability of the physician to influence others to begin implanting Biotronik devices.  

The complaint also states that Biotronik would provide incentives to physicians in the form of consultant or “trainer” fees, cash payments for participation in speakers’ bureaus and advisory boards. “Speakers who most zealously advocated Biotronik devices were hired most frequently for speaking events, notwithstanding the fact that many of these events purported to be independent medical education seminars where independent information was supposed to be delivered.”

According to Sant, the relator in the case, some physicians “required kickbacks from Biotronik in the form of research payments in exchange for implanting Biotronik devices. Research studies often consisted of payment for the implant and for several follow-up visits, with much of the money earmarked to compensate for the physician’s administrative costs of conducting the study, despite the fact that Defendants’ employees often did nearly all the clinical study administrative work for the physicians.”

One such example that the complaint references a number of times is an email from one of Biotronik’s sales managers, who wrote that sales reps should nominate physicians to participate and get paid by Biotronik. “If your physician get can get (sic) just a hand full of patients enrolled, he will be receiving monthly (or at least quarterly) checks for the next 3 years – its almost like an annuity.”

Biotronik paid physicians to train sales reps in the operating room, which the complaint also refers to as “kickbacks.” The complaint takes issue with the fact that trainees would sometimes simply “observe” physicians in the operating room. Furthermore, the complaint questioned why new employees were allowed to be trained up to five times. “This is simply a way to funnel cash to physicians in exchange for using Biotronik devices.”

The complaint does not make much of the fact that implanting cardiac devices is a fairly complicated activity and that more hands-on instruction may be beneficial to patient health.

Oregon’s Unlawful Trade Practices Act

Last year, Oregon’s Department of Justice scrutinized Biotronik’s doctor payments as well. Two doctors were part of a Biotronik program to train and certify sales representatives to assist other doctors in programming and calibrating their products. The doctors conducted the training during implant surgery and would be paid $400-1,250 per surgery where such instruction took place. The complaint outlined above alleged that the same practices constituted kickbacks.  

The ODOJ charged the doctors with violating the Oregon Unlawful Trade Practices Act (UTPA) because they had not disclosed the payments in advance of treating patients with devices from the company.

This case has been dubbed a critical “conflict-of-interest case” because it expanded the state trade practices law to physicians, which one of the doctor’s attorneys stated was unprecedented. Furthermore, the attorneys noted that physician input in the complex surgeries at hand is both common and very important. Industry representatives, especially in a medical device setting, understand the complexity of their company’s new products and can provide important information to implanting physicians.

Under the judgments, each physician agreed to pay a $25,000 penalty and to obtain written patient consent before receiving a payment from a drug or device manufacturer associated with that patient’s treatment. The physicians also agreed to include a link on their practices’ websites to the Open Payments database.

We noted last year that “once the Sunshine Act database goes live, plaintiff's lawyers and state attorneys general will both have a buffet of doctors to sue—and not because patients are being harmed.” Indeed this case brought under the UTPA seemed to capitalize on an unclear law as applied to physicians. Physicians should check the Sunshine database and make sure the recorded information lines up with any necessary disclosures they have to make. 

June 10, 2014

Industry Critics Have Diverted Valuable Resources from Innovation with No Evidence of Collaboration’s Harm To Patients

A recent article in the International Journal of Clinical Practice provides a unique and welcomed voice to balance the debate surrounding financial conflicts of interest. The authors provide a well-organized argument against the one-sided conflict of interest discussion, which is spiraling out of control.

"After more than 20 years of impugning the motives of industry and demeaning the professional judgment of physicians," the article states, the conflict of interest "instigators" have failed to substantiate their "central claim that interactions between physicians, researchers and the medical products industry cause physicians to make clinical decisions that are adverse to the best interests of patients."

What the conflict of interest campaign has done, however, is "divert[] resources away from worthwhile pursuits, such as basic and applied medical research, clinical care and medical education towards onerous compliance exercises and obtrusive laws and regulations."

The authors argue that the narrative surrounding the conflicts of interest movement dodges the central issue of patient outcomes in favor of three "proxies."

The first is the high cost of medical products, which the article states is a very unproductive way to pigeonhole the benefits improved therapy offer. Newer drugs, the authors argue, not only may be cost-effective long term, but definitely add value to patient's health and wellbeing.

Absent evidence of negative patient outcomes, industry critics have also questioned the degree of novelty of new drugs and argue that industry, in a sense, creates diseases. The authors rebut these points by stating that innovation, especially in highly scientific fields, is necessarily an incremental process. Critics also often cite the fact that more diagnoses are made for obscure conditions following the availability of treatment for those conditions. "However, this rise in diagnoses is because of doctors having a new way to treat dysfunction and distress, and thus have a reason to diagnose, rather than companies creating illusory conditions."

Third, conflict of interest instigators often criticize the use of new medications because of unknown risks. Of FDA approved drugs, however, only 8.2% acquire black box warnings and 2.9% are withdrawn. The low rate of unforeseen risks "hardly justifies arbitrarily avoiding recently approved therapies."

Industry Critics' Main Points of Contention

The authors methodically go through the industry critics' most common examples of "conflicts of interest," and point out the flaws behind a blind dismissal of each industry-physician interaction.

  1. Detailing: Drug rep visits to physicians in order to provide "details" of their products has been condemned by COI instigators. The authors argue that doctors actually find these visits useful. Detailing provides "patient-care doctors convenient access to FDA regulated information about new products and product-updates through expedient face to face encounters." The authors note that "[t]here is no evidence that these visits harm patients. In the absence of such evidence, the debate boils down to an ideological squabble."
  2. "Gifts": Critics often focus on small "reminder items" used by drug reps used to get doctors' attention during detailing encounters These items formerly included pens, notepads, and free meals. While companies still provide meals, the PhRMA and AdvaMed ethics codes of 2008 banned reminder items. "The bans were intended as a public relations manoeuver to improve industry's image, but were spun by critics into an admission of guilt."
  3. Advertising: The authors aruge that "[w]hile it is true that direct to consumer advertisements increase requests for particular products," this serves the public good by increasing awareness in the public that treatments exist for various health conditions. Advertising aimed at physicians also plays an important role in public health. It too raises physician awareness of the existence of new therapies in a concise format. "The fact that these advertisements are sometimes presented in a lowbrow or even misleading manner or fail to support all claims with high level evidence, while disappointing to purists, is largely besides the points." Ads are "attention-getters and should not be mistaken for scientific evidence."
  4. Peer-to-Peer Speaking: Companies pay physicians to speak to other physicians about new indications and new products. The authors note that "[t]he content of these speeches is regulated by FDA as a form of marketing, meaning that speakers may only discuss products' on label indications, and must spend equal time on positive and negative aspects of the products." Thus, the regulations make physician peer-to-peer speaking "among the most heavily regulated forms of speech in the United States." Doctors want to learn about new products and find it useful to obtain such information from physicians. These events are certainly educational, but should not be confused with continuing medical education. "Physicians should always consult other resources before prescribing a new product," the authors state.
  5. CME Funding: Industry provides 28% of ACCME-accredited CME funding in the US, the authors note. This commercial interest is "only allowed to manifest itself in a limited number of ways." The main route is through the selection of a general area of medicine which the CME event will focus on. Commercial funders are not permitted to select speakers or to fund CME activities that focus on particular products. The authors state that several large surveys of CME participants indicate commercially sponsored CME is not perceived to be biased. "Despite such evidence, the instigators routinely attack commercially sponsored CME on the mistaken ground that such education is biased." Unfortunately, these attacks on industry funding reduce the overall rate of CME activities produced, with "disproportionate impact on providers outside of major cities." Thus, these attacks don't help patients, but "are in fact undermining them by depriving providers of high quality educational content."

The authors conclude their argument by dissecting the focus of conflict of interest research: off-label settlements and publication biases. Neither, the authors note, demonstrate that industry-physician collaboration has detracted from patient care.

Newspaper headlines around huge settlements for off-label promotions often describe the government as catching companies red-handed committing illegal acts. "The real story is more complicated," the authors argue. The cases, brought under the False Claims Act by whistleblowers with a large financial stake in the outcome, are negotiated by the government under very harsh terms. To actually win at trial, the government would have to prove that the pharmaceutical industry caused physicians to prescribe off label, in the scientific 'but-for' causal sense. This would be very difficult. However, when threatened with exclusion from government reimbursement, many companies accept huge settlements to avoid the "death sentence."

The stories surrounding the huge settlements "mislead the public into believing that the medical products industry is exerting a toxic influence on physician prescribing decisions through mechanisms such as detailing and advertisements." Despite the press, "there is little evidence that these lawsuits reveal physicians making decisions that conflict with patients' best interests."

The authors also confront "publication bias," COI instigators have spent a lot of time evaluating whether industry funded randomized clinical trials differ from RCTs funded by not for profits in their rate of positive outcomes, rate of adverse event reporting, or the quality of the trial. However, the article argues that the proper question should be: "Are industry funded studies scientifically unsound?" The authors state that "[i]n the absence of the assumption that industry results are more likely to be positive because of some sort of misconduct, no reason exists to consider this finding relevant to the integrity of industry sponsored medical science." In fact, it "might simply indicate that industry is selecting therapies which are efficacious."

The critics have "neither shown that the scientific evidence presented in industry funded studies is faulty or that it improperly leads physicians to make erroneous prescribing decisions."

A lot is at stake:

"Nearly every major medical advance over the past century has involved industry and most have involved physician-industry collaboration," the authors state. "These collaborations are the lifeblood of medical innovation. We should not restrict or eliminate them based on vague feelings of unease or ideological arguments."

May 30, 2014

ASCO Not Enforcing Pharmaceutical and Device Speaker Ban in 2014

This weekend opens the largest oncology meeting in the world ASCO 2014 in Chicago, IL. Over 20,000 oncologists from around the world come to hear the latest science in cancer treatment including presentations by company scientists on preclinical, phase I and phase II treatments.

Last year the American Society of Clinical Oncology (ASCO), drastically changed their policy on how they deal with perceived conflicts of interest. The policy stated that ASCO would not accept research abstracts or manuscripts by authors who had been an employee, major stockholder, or member of the speakers' bureau of the sponsor of the research during the past two years. We noted that this policy would further shrink US conference attendance.

Just recently, however, ASCO announced that they would delay enforcement of the speaker ban until it could assess the full impact that the restrictions on relationships with companies would have on research publication and presentation with respect to ASCO's educational and scientific offerings as well as the authors. "The author restrictions set out in Section V [the speaker ban] will not be enforced, pending a two-to-three-year period of data-gathering and analysis," ASCO notes.

We believe the speaker ban is an unworkable policy, and this delay shows hopefully that ASCO recognizes it as well. American associations who have adopted similar policies have seen 30 – 40% reductions in attendance for US meetings. European counterparts, on the other hand, have exploded with corresponding increases in attendance. While this would be fine if US patients could benefit from education overseas, the reality is that medical studies presented and published in Europe can take years before US physicians hear about them. In field like oncology, where patients need cutting edge treatment, this is a real problem.

While ASCO delayed the enforcement on the two year outright ban, they adopted new disclosure requirements that are strict. The new policy names eight categories of financial relationships that must be disclosed: (1) compensated employment, (2) leadership positions, (3) consulting activities, (4) speaking engagements, (5) expert testimony, (6) ownership interests, (7) research funding, and (8) patents or other intellectual property interests.

Furthermore, all authors, including the first, last, and corresponding authors, will be required to fully disclose all of their financial relationships with for-profit health care companies, regardless of whether the author believes the relationships to be specifically relevant to their research or ASCO activity. The first, last, and corresponding authors are required to answer additional non-restrictive questions regarding their relationships with the research sponsor for reports on original research.

It will be interesting to see whether ASCO eventually bans speakers or whether the "two-to-three-year period of data-gathering and analysis" changes their minds.

We also wonder what the effect of the original announcement had on the quality and quantity of abstracts submitted to their meeting. I think the "gathering of information" will show them banning company science was a very bad idea to begin with.

April 28, 2014

UC Regents Settles $10 Million Whistleblower Case Stemming From Industry-Physician Relationships

The University of California Board of Regents agreed on a $10 million settlement with a UCLA physician who alleged that the school allowed doctors to take industry payments. The Los Angeles Times reports that Robert Pedowitz, originally recruited to UCLA in 2009 to run the orthopedic surgery department, sued UCLA, the UC Regents, fellow surgeons, and senior university officials because they failed to act on his complaints about conflicts of interest. Pedowitz alleged that they later retaliated against him for speaking out.

According to the LA Times story, Pedowitz stated he became "concerned about colleagues who had financial ties to medical-device makers or other companies that could unduly influence their care of patients or taint important medical research." Pedowitz raised concerns about the financial dealings of several doctors, including an orthopedic surgeon that testified at trial about receiving $250,000 in consulting fees in 2008 from device maker Medtronic. Pedowitz also took issue with physicians who included UCLA logos on personal websites without getting official permission (Patch.com).

After raising his concerns, however, Pedowitz said he was pressured to step down as department chairman in 2010. He accused the university of retaliation, stating he was denied patient referrals and prevented from participating in grants and other activities, LA Times reports. In 2012, Pedowitz sued the regents and several UCLA doctors in Los Angeles Superior Court for whistleblower retaliation as a result of coming forward.

However, UCLA maintains that they followed up on Pedowitz's complaints. Indeed, UCLA conducted "[m]ultiple investigations by university officials and independent investigators [who] concluded that conduct by faculty members was lawful," according to their public statement. "UCLA adheres to stringent ethical and procedural guidelines and will continue efforts to do so," they stated. "Enhancements to UCLA's compliance policies and procedures have been under way for several years and have included the hiring of a nationally recognized chief compliance officer who remains on staff and has expanded the compliance review team."

In settling the case, UCLA settled the case "to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement."

Potential conflicts at a time when there is growing government scrutiny of industry payments to doctors.

Starting this fall, the federal Physician Payments Sunshine Act, part of President Obama's healthcare law, requires public disclosure of financial relationships between healthcare companies and physicians.

Many doctors and universities defend long-standing industry arrangements as essential for carrying out cutting-edge research and top-flight medical education.

"These are serious issues that patients should be worried about," Pedowitz said in an interview with the newspaper. "These problems exist in the broader medical system and they are not restricted to UCLA."

What next?

It's a common tenent of employment law that you can't retaliate against an employee for raising compliance concerns. Thus, while UCLA's $10 million settlement suggests that at least some of Pedowitz' allegations about retaliation are true, the case gets to the tougher subject of what exactly Pedowitz raised his initial concerns about. The answer, it seems, is perhaps perfectly legal industry-physician relationships. Complex compliance programs already provide an enormous firewall for improper industry-physician relationships. Additional—unnecessary—red tape could lead to an unbelievable chill on these important collaborations.

Mark Quigley, Pedowitz's attorney, said the case could have been avoided if California's system enforced the policies it already had in place.

But is that true?

UCLA stated that they conducted "[m]ultiple investigations by university officials and independent investigators [who] concluded that conduct by faculty members was lawful." That is a lot of financial resources to expend attempting to weed out conflicts of interests. And the school still had to pay a multi-million dollar settlement. It's likely this case will result in many expensive wild goose chases for alleged conflicts. Plus, schools will spend more money recording and documenting their investigative efforts going forward. It will be interesting to follow other medical schools around the country to see if similar cases start cropping up.

 

April 10, 2014

JAMA Opinion Article Looks for Bias in Academic Health Systems and Board Membership

The Journal of the American Medical Association (JAMA) recently published an opinion piece entitled "Conflict of Interest Policies for Academic Health Systems Leaders Who Work with Outside Corporations." As we have come to expect from JAMA, the article was packed with generalizations, but low on real facts and relevant data to support their claims.

JAMA has been active in the past few months, recently taking aim at continuing medical education (CME). There, the authors so desperately rummaged for "conflicts of interests" that they failed to differentiate between promotion companies and accredited medical education companies. The article ignored the firewalls, standards, and oversight that have been in place for several years to prevent the alleged bias the authors claimed.

Apparently JAMA has moved on. The new article focuses on academic health system leaders – presidents, vice presidents, deans, CEOs – who work for outside corporate entities. The authors argue that these higher-ups who are involved in financial and business decisions have fiduciary responsibilities that "preclude a paid relationship with an outside entity…unless a case can be made that there is a compelling institutional interest in the leader's service in such a role, or if the role with the outside organization is outside the scope of the leader's role at the academic health system."

JAMA provides an interestingly specific illustration of such a carve-out from their calls for an end of all corporate relationships. The article notes, that an "example of a compelling institutional interest" would be "the leader's role as a founder of an academic health system start-up company based on his or her intellectual property."

The lead author, Etta D. Pisano, Vice President for Medical Affairs Dean, College of Medicine; Professor of Radiology, Medical College of South Carolina, ironically fits neatly into her exception:

"Recently Dr. Pisano co-founded her own company, NextRay, Inc., which will commercialize a device she and the other cofounders invented, a technology which creates medical images using x-rays through diffraction enhanced imaging which provides superior image quality at a dose that is substantially lower than is currently available" (available here).

While her efforts in the medical device arena are laudable, it begs the question: who does Dr. Pisano expect to buy her company, and how is this not a commercial interest? She speaks to the "very difficult" issue of conflict of interest in the article, but enjoys one with her own company.

This is not the first time that JAMA has been engaging in the very behavior it spends an article decrying. In the JAMA CME piece, JAMA criticized medical education companies' policy of sharing data, when JAMA's own policy includes sharing data with undisclosed third parties.

It is tough to take an article too seriously when the authors are actively doing the opposite of what they are writing. In the most innocuous case it suggests that JAMA does not have a full grasp on the material it offers. The fact that the article includes the specific carve-out, however, would tend to imply that the authors knew the deal.

Study

The article looked at the 50 largest pharmaceutical companies and compiled data on the prevalence of AMC leaders on the companies’ boards of directors. The study found that 19 of the 47 companies with public data on governance had at least one board member who concurrently held a leadership position at an AMC, including “16 of 17 (94%) US companies.” In total, “[f]orty-one board members had AMC leadership positions in 2012, receiving a mean financial compensation for board membership of $312,564 (excluding the 6 industry executives).” 

Jama pics

Putting aside the issues of credibility, the main issue with the opinion piece is that it raises questions, but does not attempt to answer them. The article states: "Having a fiduciary responsibility to 2 separate entities is at best a very difficult situation. Will the leader direct business inappropriately to the outside company on whose board he or she sits? Will the leader inappropriately use information about the institution he or she leads to influence decisions by the outside corporation?"

Questions about someone's personal conflict of interest are easy to raise, but the article provides no real-world context. Furthermore, the authors fail to include any evidence of academic institutions ever being harmed by an executive's roles with corporate entities.

We argue that there are actually many benefits to such a relationship with outside entities:

  • The current landscape for academic medical centers is bleak. Many academic centers cannot compete in efficiency with local for-profit medical centers. An academic leader who understands the private sector could provide industry practice to an otherwise inexperienced entity.
  • Relationships could help academic centers recruit and retain faculty members by providing them with the opportunity to engage in outside interests, enabling them to identify new research scholarship topics and apply their theories.
  • Relationships can increase the potential outside financial support for the institution—either directly or indirectly—through joint ventures and the activities and networking of faculty members in the larger community, including the business community.
  • Often companies are crucial to translate academic research into actual medication that can benefit patients.

 

April 08, 2014

ProPublica Misses the Mark in Research Payments Article

The Boston Globe recently published a ProPublica-penned article which attacks doctors who speak about the drugs and antibiotics they have researched and helped develop. Entitled "Double Dip: Doctors Paid to Advise, Promote Drug Companies that Fund their Research," the articles states that "[m]ore than 1,300 practitioners nationwide received both research money and speaking or consulting fees from the same drug maker in 2012." The story provides little context behind these fees, and glosses over the often crucial relationship industry can have with physicians. Worse, Forbes reports that ProPublica completely missed the mark in lambasting infectious disease specialist Dr. Yoav Golan, the article's main target.

ProPublica frames the article around its Dollars for Docs database, which tracks what pharmaceutical companies spend on doctor speaking and consulting fees. ProPublica went through companies' public corporate integrity agreements and created a master database of the spend information. This article targeted research: "Research has been seen as less objectionable than other forms of interactions with drug companies, but 10 percent of researchers have multiple ties among the nine companies ProPublica analyzed," the article states. "That raises questions about doctors' impartiality."

And ProPublica is adept at posing questions. However, they rarely provide information sufficient enough for readers to come to informed conclusions. Forbes notes that the article "typifies a growing gotcha genre of health journalism that portrays doctors as the enemy in a struggle for honesty and openness in medicine." The articles struggle to show conflicts of interests, yet make "unfounded leaps" that will "end up doing patients a disservice."

Forbes contributor Ford Vox took most issue with ProPublica's focus on Dr. Golan, who works at Tufts Medical Center. "Yoav Golan is a remarkably bad choice for anyone who hopes to use him as a poster boy of pharma-physician malfeasance," Vox noted. According to Vox, not only did ProPublica have "little understanding [Golan's] contributions to medicine," but they misstated their facts. ProPublica pointed out that Merck paid Golan $12,050 in research payments. However, the money "went directly to Tufts for administrative expenses on a planned trial. Golan himself actually received no payments for the trial in that year."

Furthermore, ProPublica criticizes Tufts Medical Center:

"If Golan worked at some teaching hospitals, he would be barred or severely restricted from accepting both research funding and personal payments for promotional speaking or consulting from drug makers. These hospitals fear the money could influence clinical findings, or at least create the appearance of a conflict of interest. Yet Tufts and many other academic medical centers allow doctors to accept overlapping payments — and some doctors still take them."

ProPublica's "analysis" hinges on a simple comparison of Tufts with other universities. Vox noted: "That Tufts made a very considered decision to carefully navigate these funding sources means little to ProPublica since other top medical centers have decided differently, barring or heavily restricting the level of industry collaboration Tufts engages in. Yet the NIH encourages private industry collaboration." 

Indeed, the ProPublica article very well may chill the important advances doctors like Golan strive to discover.

Importance of Antibiotic Research

The Washington Post just published an article lamenting the fact that "antibiotics research industry has not kept up with the advancing state of antibiotic drug resistance."

Recognizing the need to stimulate investments in antibacterial drugs, Congress recently enacted the Generating Antibiotic Incentives Now (GAIN) to spur development of new antibiotics to combat the spread of antibiotic resistant bacteria. "Incentives for research and development and fast track FDA review are needed to stop these bacteria and infections from spreading," Senator Richard Blumenthal (D-CT) stated in a press release announcing the legislation. The GAIN Act will provides incentives to increase the commercial value of innovative antibiotic drugs and streamline the regulatory process so that pioneering infectious disease products can reach patients. "Incentives for research and development and fast track FDA review are needed to stop these bacteria and infections from spreading," Blumenthal asserted.

ProPublica takes the opposite approach

Vox notes that "[t]he past is riddled with clear cases of abuse, including companies that paid doctors generously as consultants when the doctors weren't actually contributing anything of value to the enterprise. That type of graft no longer exists in responsible pharmaceutical companies." He adds that he "certainly wouldn't focus a high profile media expose on anyone in particular unless [he] had clear evidence they've been corrupted."

Unfortunately, ProPublica's article focuses on a doctor who works within the rules of his institution, "which contain numerous safeguards and strong similarities to Pew's recommendations, which allow for industry funding of research and scientific consulting relationships, and recommend against 'promotional' speaking."

Hopefully the coming public release of industry transfers of value under the Physician Payments Sunshine Act doesn't trigger similar articles, which brush over the specifics of industry-physician relationship. We recently wrote about how industry can protect their physicians' reputations. In light of ProPublica's story, open communication between companies and their doctor-clients appears to be more important than ever.

April 03, 2014

FDA Finalizes Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers -- Participation Contingent on Public Disclosure

The Food and Drug Administration (FDA) announced a new conflict of interest guidance entitled Public Availability of Advisory Committee Members' Financial Interest Information and Waivers. The guidance focuses on FDA's waiver policy regarding financial conflicts of Special Government Employees (SGEs), the technical name for advisory committee (AC) members who are not members of FDA or other agencies of the government. Because of the complexity inherent in medical innovation, SGEs often include scientists and doctors with highly specialized skills and experience. These well-qualified experts often also have financial ties to industry.

The same day the FDA announced its guidance, March 31st, we covered the 63rd annual meeting of the American College of Cardiology in Washington, DC. The meeting included a conflicts of interest session in which Jill Hartzler Warner, the Associate Commissioner for Special Medical Programs with FDA, spoke to FDA's conflict of interest procedures regarding advisory committees. Hartzler oversees FDA's Advisory Committee Oversight and Management staff, which develops the policies on conflicts of interests for advisory committee members who are external to the agency and thus may have other interests. Interestingly, Hartzler didn't specifically mention the new guidance, but described concepts that appear in it.

According to Hartzler, FDA's challenge and goal is to maintain public confidence in the advisory committee process and to obtain the best expert advice. These goals have resulted in an expansive conflicts of interest policy and an enhanced effort to identify non-conflicted experts. FDA conflict of interests procedures also focus on nonfinancial bias and removing even the "perception" of conflicts of interest.

"FDA implements a rigorous process for soliciting and vetting candidates for advisory committee meetings to minimize any potential for financial conflicts of interest," FDA explains in the guidance. "In preparation for advisory committee meetings involving particular matters, SGEs invited to participate in the meetings are required to report to FDA any financial interests related to the subject matter of the advisory committee meeting."

Unfortunately, rigorous conflict-of-interest rules may keep many of the most knowledgeable academic and industry scientists off advisory committees out of fear that industry ties might bias their judgment.

FDA understands that given advisory positions are temporary, many specialists will have outside jobs which include industry ties. Thus, FDA focuses on managing potential conflicts of interests. "Typically, because the advisory position at FDA is a part time job, they don't want to divest their interests. It comes down to should they be recused from participation or should a waiver be granted," Hartzler stated.

Hartzler notes that FDA advisors are Special Government Employees, and that is the basis of the Federal requirements that pertain to financial conflicts of interests. Federal standards of conduct for government employees apply, with a few regulatory exemptions.

In identifying potential conflicts of interests, SGEs submit a confidential financial disclosure statement to the FDA that identifies potential conflicting financial interests. SGEs submit FDA Form 3410 that identifies current assets, income, outside positions, consulting, grants, contracts, patents, and speaking or writing arrangements that may have an association with the sponsor or topic coming before the committee.

The law prohibits all employees (including SGEs) from participating in any particular government matter that will have a "direct and predictable effect on their financial interests." It also prohibits employees from acting in government matters that will affect the financial interests of others with whom they have certain relationships. These are known as imputed interests.

Whose Interests

Which Interests

Exceptions

Exemptions

  • SGE
  • Spouse
  • Minor child
  • General partner
  • Organization in which SGE serves as officer, director, trustee, or employee- this is very broad in scope.
  • Prospective employer in a case where there is negotiation for employment.
  • Stocks and investments
  • Primary employment
  • Consulting or advising
  • Grants, contracts to study a particular product
  • Patents/Royalties/ trademarks
  • Serving as expert witness
  • Speaking/writing arrangements

SGEs can participate in matters of general applicability where the interest that creates the conflict arises from the SGE's non-federal employment. As long as the matter does not impact the employer or employee other than as a part of a class.

  • Diversified mutual funds
  • Publicly traded securities – matter involving specific parties

    <$15k sponsor, <$25k competitors of sponsor

  • Publicly traded securities – matter of general applicability

    <$25k one company;

    <$50k aggregate

If a conflict is identified, FDA has three decisions regarding its SGE:

  • SGE could sell or divest his or her interest. As we stated above, this would be unlikely given the part-term work
  • Recusal/disqualification
  • Waiver may be granted if the need for their service outweighs the potential for a conflict of interest. FDA publicly discloses all waivers to their website

FDA's new Public Availability of Advisory Committee Members' Financial Interest Information and Waivers focused on this public disclosure.

The guidance document states: "FDA is directed to disclose on its website the type, nature, and magnitude of the financial interests of each advisory committee member who has received a waiver under 18 U.S.C. § 208 and the reasons for granting each waiver prior to the advisory committee meeting, including, as appropriate, the public health interest in having the expertise of the member with respect to the particular matter" (emphasis added).

FDA also said it intends to make advisory committee meeting participation contingent upon a SGE's "acknowledgement of FDA's intention to publicly disclose" information about the type, nature, and magnitude of any waived financial interests. This information will be published using a template provided by the guidance (page 10).

Additionally, FDA plans to post a roster of all advisory committee members expected to attend a specific meeting at the same time briefing materials for that meeting are posted.

April 01, 2014

Relationships Between Doctors and Device Makers Take Center Stage in J&J Lawsuit

A lawsuit involving Johnson & Johnson's pelvic mesh device reveals that relationships between doctors and device makers will be deeply scrutinized in product liability cases. A recent Wall Street Journal article honed in on the actions of Johnson & Johnson's physician-consultant who reportedly influenced language in a research paper that evaluated the Johnson & Johnson's device procedure.

The Wall Street Journal notes that while payments that constitute kickbacks from companies have sparked the most regulatory and legal action, discovery documents in the J&J lawsuit "suggest that potential influence over medical practice also can be more subtle."

Johnson & Johnson's transvaginal mesh device was designed as an alternative to more invasive surgery procedures to treat pelvic organ prolapse. In 2012, the device was removed from the market due to reports of pain associated with the product. During 2007-2012, however, thousands of women used the device

In 2007, the American College of Obstetricians and Gynecologists (ACOG) published an initial report, which said that the mesh procedures "should be considered experimental" and that "patients should consent to surgery with that understanding."

Johnson & Johnson sought input from one of its physician-consultants, Vincent Lucente, a well-known urogynecologist and advocate of the procedure. According to emails uncovered by the Wall Street Journal, Dr. Lucente advised J&J executives that the guidelines' characterization of the product as "experimental" needed to be changed because the devices had been cleared by the FDA and the language would scare off patients, he explained later in an interview. Furthermore, procedures deemed "experimental" have trouble receiving reimbursement from insurance companies.

Shortly after the initial report, members of ACOG began objecting to the use of the word "experimental." Johnson & Johnson denies that it was involved in any of these efforts, but within 7 months, ACOG had changed its guidelines. "Note, no further use of the word experimental!" wrote Dr. Lucente in an email to Ethicon's (a J&J unit) marketing director. "Well, this is one I'm taking credit for. I led the charge on this and never thought we would get a complete replacement of the earlier bulletin."

ACOG stated that it wouldn't have known about Dr. Lucente's relationship with the industry because it requires financial disclosures only when members serve in leadership roles, which Dr. Lucente did not in 2007.

Wall Street Journal notes in the article that, in fact, financial relationships between the medical community and device manufacturers are both legal and commonplace. Johnson & Johnson told the Journal: "Ethicon's relationships with the medical community concerning our pelvic mesh products have been appropriate and responsible." They went on to say that "[a]s part of our efforts to advance the standard of care for women's health, it is customary for us to have discussions with leading physicians and researchers."

Dr. Lucente was paid about $800,000 by Ethicon as a consultant over a 10-year period to educate other doctors. J&J said he was paid to tell doctors about the safety and efficacy of Ethicon medical devices.

The Wall Street Journal stated that the Physician Payments Sunshine Act has been implemented to encourage transparency about such relationships.

"Companies also may exert influence in the medical community through research papers," the article noted. The Wall Street Journal examined this second potential conflict of interest regarding a clinical trial of the mesh procedure conducted by Swedish researcher Daniel Altman, a professor at the Karolinska Institute. J&J gave $750,000 to the university, along with grants from the Swedish government, to support research that Dr. Altman initiated. Dr. Altman reportedly stated that he fought from the beginning to conduct the trial independently from the company. The original contract stipulated that J&J would own the data and could stop the trial whenever they wanted, so Dr. Altman said he refused to sign it. Ultimately, the contract gave Dr. Altman full control over the trial.

"As is customary for independent, investigator-initiated research studies that receive funding from a manufacturer, Ethicon provided commentary on a draft of the Altman study after Dr. Altman asked for our comments," said J&J in a statement. "Ethicon did not inappropriately seek to influence the study results or the author's conclusions. We did not know what, if any, changes Dr. Altman would make until we saw the final paper."

Analysis

Companies and doctors have stated that their relationships are important to improve medical education and inform doctors about the creation of new or improved devices. Complex devices often require thorough training, and who best to talk about an innovative product than leaders in a specific medical field? Device representatives are considered helpful, even at times essential, in training physicians to use important products that can improve patients' quality of life. While many news outlets seem to forget this, teachers, especially highly educated and respected doctors, do not work for free.

This case makes obvious, however, the need to separate a doctors' research and medical beliefs from efforts to improperly promote products. The critical mistake in the fact pattern appears to be that emails appeared to be too friendly between Johnson and Johnson and Dr. Lucente. The WSG points to Dr. Lucente's email to J&J about ACOG removing the "experimental" definition as a "smoking gun" of sorts. As noted above, the email stated: "Well, this is one I'm taking credit for. I led the charge on this and never thought we would get a complete replacement of the earlier bulletin."

Objectively, Dr. Lucente seems to be touting his own business negotiation skills, rather than his medical beliefs about the products efficacy. This is despite the fact that J&J hired Dr. Lucente as a consultant because he genuinely believed in the value of the particular medical device for patient well-being.

It will be interesting to see whether this case marks a change of more litigation in the device field, and if industry reacts by redefining the boundaries with their physician-consultants.

March 20, 2014

GlaxoSmithKline Plans to Bring Physician Reps In-House Instead of Paying External Promotional Speakers

Deirdre Connelly, head of GlaxoSmithKline's (GSK) US pharmaceuticals business, announced that GSK will recruit doctors as in-house representatives to provide education about its medicines instead of paying external speakers (Bloomberg).

Earlier this month, we saw that GSK had been cutting back its promotional speaker payments—including a 60% drop from 2011 to 2012. It looks like they will be whittling that down even further. GSK's decision comes in the wake of a number of changes in their promotional tactics after a $3 billion settlement in 2012.

In December, we reported on GSK's initial plan to curtail speaker pay, and to end their practice of tying sales representative compensation to prescriptions. That announcement came amid a major bribery investigation in China.

According to Connelly, GSK will "continue to disseminate this very important information on drug benefits and risks, but we're just not going to do that by hiring external speakers." She added: "we want to ensure that no one even perceives us to be doing anything wrong" (Bloomberg).

GSK plans to hire a range of people with medical backgrounds, including doctors and scientists with expertise in specific disease areas. These experts will utilize digital tools, including mobile platforms and online streaming of educational content to help market products. Bloomberg reported that the number of new recruits will be fewer than the number of external speakers the company has employed. According to Connelly, the drugmaker has reduced its sales force by more than 30 percent since 2009, while creating new educational roles and jobs targeting pharmacies.

Analyses

Under the Physician Payments Sunshine Act, GSK will not have to report payments to its doctor-employees. Covered recipients, under the Act, include "any physician, except for a physician who is a bona fide employee of the applicable manufacturer that is reporting the payment" so long as the applicable manufacturers do not try to circumvent the reporting requirements by styling a physician as an "employee" and not reporting payments made to such a physician.

The benefit of the physician-employee exemption under the Sunshine Act is offset in part by a potential lack of credibility among the target audience of potential prescribers. GSK employees may not be regarded as having the same clout as well-known external speakers. It will be interesting to see if the employee-physicians also maintain part-time practices as is the case of many physician employees at pharmaceutical companies. That would at least give them practical and up-to-date experience to share with their colleagues.

It is interesting to note that this is a change from the previous announcement that GSK would be utilizing current medical science liasons to provide the lecturers.  This change will probably not begin until 2015 and be fully implemented in 2016 the year that GSK is expected to move completely away from using outside speakers worldwide for their promotional talks.

We will keep watch to see whether the industry shifts as the Sunshine Act discourages external doctors from their previous speaking engagements. Pharmaceutical companies, almost all across the industry, are drastically cutting their speaker payments for physicians. Industry needs a way to promote its products. GSK could be exploring a new model.

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