Life Science Compliance Update

February 06, 2017

Discussion on Open Payments by Philadelphia-Region Doctors

Untitled-1(3)

An article in the Philadelphia Business Journal published in early January 2017 focused on Open Payments and payment information available to the public, and how the public availability of the data is affecting doctors and the way they treat patients.

According to the article, Dr. Stanley Schwartz is on a mission to change how physicians treat diabetic patients. The Ardmore endocrinologist, an advocate for reducing the use of insulin in diabetics in favor of other medicine regimens, placed 15th in a ranking of area physicians who received non-research payments from drug companies and medical-device makers.

"To me the Sunshine Act is, you'll excuse the expression, 'a necessary evil' that is meant to reassure people that I approach the care of my patients ethically as I go out and teach physicians across the region, across the country and across the world how to better take care of diabetes," Schwartz said. "It's a necessary evil because there is a worry money may alter my care. What I submit is maybe there are some doctors where that is true, but in my own mind I feel very comfortable telling you that for me, that's not true."

CMS, in its most recent Open Payments report, noted the total payments nationwide fell into three major categories: $2.6 billion for general non-research-related payments, which include speaking fees and food and travel; $3.89 billion for research payments; and $1.03 billion for royalties, licensing fees or ownership or investment interests held by physicians or their immediate family members.

Payments Made to Specialty Physicians

In the article, it was noted that thirteen of the twenty doctors who received the highest payments in the tri-state area were orthopedic surgeons who specialize in knee, shoulder, and spine specialties. Eight of those thirteen are part of the Philadelphia-based Rothman Institute.

Dr. Alexander Vacarro, president of the Rothman Institute, noted, "Rothman Institute is fully committed to the transparency mandated by the Sunshine Act. As national and international leaders in musculoskeletal science, several of our physicians receive compensation for their tireless dedication to basic science and clinical research in an effort to advance the field of orthopedics. Working in conjunction with industry brings this life-saving technology to not only the patients in the communities we serve, but also to people around the world. The physicians of Rothman Institute remain completely transparent in reporting income from these arrangements and will continue to do so."

According to Patricia Audet, chairwoman of the department of pharmaceutical and health care business at the University of Sciences in Philadelphia, "The issue of physician payments is important because it made people aware of payments made to potentially influence doctors. But it doesn't mean all payments are for influencing doctors."

A Doctor’s Perspective

Dr. Schwartz is a member of the speaker bureaus for several pharmaceutical companies, and he spends roughly one-third of his time teaching other doctors about the "disease state" of diabetes and two-thirds of his time discussing specific medicines that he uses as part of the treatment regimen he has developed to treat diabetics. "If there is a drug I don't believe in, I won't speak for it," he said. "I don't speak for everybody who asks. I speak for ones I believe fit into the construct of what I teach."

Schwartz notes that he "get[s] a rush" out of educating others. "When I see people's eyes light up it gives me a good feeling," he said. "The second pleasure I get is I am changing diabetes not just here, but all over the world. One month ago I spoke in Korea, next month I am speaking in Manila. I've been to China four times. … I think it's a responsibility for somebody like me to educate others, even if our process if being funded by pharmaceutical companies, because I am doing it in an ethical way. I can do it throughout the world and help millions of patients."

He makes no apologies for accepting payment from drug companies to instruct physicians. "Every time I speak to 200 doctors, each of those doctors may have 5,000 diabetic patients," he said. "I am affecting the care of [potentially] a million patients. Shouldn't I get reimbursed if I can do it ethically? I know I can do it ethically."

As an aside, with a quick visit to Dr. Schwartz’ website, one can tell he truly appreciates learning and sharing his knowledge with others. His website includes numerous publications, newsletters, and papers authored by the doctor.

Critics Discuss Flaws and Potential Fixes

One of the most vocal critics of the Sunshine Act and open payment database is the American Medical Association, which after the most recent data was released, issued a statement saying, "While we appreciate the efforts of CMS to verify the data submitted by industry, continued data errors and registration challenges during the previous two years have thwarted many physicians from participating in the review and validation process. The integrity goals of the Open Payments database will not be met as long as physician review is obstructed by a registration procedure that is confusing, time consuming, and overly burdensome."

Dr. Sharad Mansukani had one of the highest totals among physicians in the Philadelphia area, $5 million in payments. The payments were primarily dividends from Par Pharmaceuticals. Dr. Mansukani, however, seems to have appeared in the database in error. "I haven't practiced for well over 10 years," he said. "I work for the private equity firm that owned Par prior to its sale, and I was also on Par's board of directors at the time. My compensation had nothing to do with me being a physician. It was [the result] of my personal investment in the company and my role with the private equity firm and the board of directors."

Former University of Pennsylvania bioethicist Arthur Caplan, now a professor of bioethics at New York University's Langone Medical Center, believes the Sunshine Act has had its desired effect - but he advised regulators to pay even closer attention to another vehicle drug companies are using, sometimes improperly, to promote their brands. He stated that the Sunshine Act has “discouraged some of the shenanigans” we used to see in previous decades, such as “cushy dinners and excursions to balmy locations." He noted that in today’s world, medication choices are dictated less by doctors and more by pharmaceutical benefit management firms with lists of preferred medicines for treating specific medical conditions.

July 26, 2016

FDA: Draft Guidance - Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees

FDA released draft guidance to deal with what it describes as "appearance issues" that make advisory committee members appear to lack impartiality. This applies even to those who do not have financial interests and relationships that are conflicts of interests. If an appearance issue exists, FDA will weigh the member's participation against the concern that a reasonable person may question the integrity of the FDA's decision. This is a troubling development for the constitutional freedom of association, especially if professionals are going to be forced to recuse themselves for merely the appearance of a conflict.

The guidance comes after Public Citizen filed a Freedom of Information Act lawsuit against FDA in a bid to get unredacted copies of advisory committee members' curriculum vitae -- which describe their education, qualifications and previous experience -- posted on the agency's website.

Michael Ortwerth, FDA's director of the Advisory Committee Oversight and Management Staff, said in an FDA Voice blog post that a lack of understanding about the agency's selection and evaluation process has resulted in public confusion and misunderstanding. He explains the guidance contains: "the circumstances that FDA considers when determining whether an appearance issue may exist. We evaluate the circumstances and assess whether the interests, relationships, or circumstances would cause a reasonable person with knowledge of the relevant facts to question the advisory committee member's impartiality in the matter before the committee."

As an example: "if an advisory committee member serves on the board of directors of a nonprofit organization and that organization receives donations from the sponsor that is presenting before the committee, we review the details of the donation to determine whether the member should be cleared for service on the advisory committee."

He notes this is not finalized, however: "The draft guidance is being issued for public comment before we issue a final guidance. Under Federal law, FDA is not permitted to disclose confidential information provided by advisory committee members related to appearance issues. But we are specifically requesting comments on whether the agency should request that advisory committee members voluntarily disclose if they have been granted an appearance authorization."

Background

Members of FDA's advisory committees are subject to Government-wide standards of ethical conduct regulations in addition to Federal conflict of interest laws. Even where a member has no financial interests that would require her to refrain from participating in an advisory committee meeting ("recuse" herself) under Federal conflict of interest laws, the member may be disqualified from participation under the Government-wide Federal regulation at 5 CFR § 2635.502 ("section 502") if she has interests or relationships that may create the appearance that she lacks impartiality on the issue before the advisory committee.

Section 502 gives FDA and other agencies significant flexibility and discretion in deciding whether a member with an appearance issue should participate in a particular matter. Under section 502, when a member has an appearance issue, FDA may authorize the member to participate in the advisory committee meeting based on a determination, made in light of all relevant circumstances, that the interest of the Government in the member's participation outweighs the concern that a reasonable person may question the integrity of the agency's programs and operations. If FDA does not issue an authorization, the individual may not participate in the meeting or the portion of the meeting involving the particular matter relevant to the appearance issue.

In determining whether to grant an authorization under section 502 to a member with an appearance issue, FDA balances the agency's interest in access to the advice of qualified experts to make important public health decisions with the need to avoid serious questions about the member's impartiality. Section 502 places the initial burden of identifying potential appearance issues on the member. It also gives the member the initial responsibility to recuse herself where she determines that the circumstances would cause a reasonable person with knowledge of the relevant facts to question her impartiality in the matter, unless she informs FDA of the issue and receives authorization from FDA to participate. FDA has the discretion to make independent determinations about whether a member has an appearance issue and to decide whether to grant her an authorization to participate once an appearance issue is identified.

Screening to Identify Possible Appearance Issue

In preparation for an advisory committee meeting involving a particular matter, members report to FDA any interests related to the subject matter of the meeting. These interests are reported on the Confidential Financial Disclosure Report. Although the Confidential Financial Disclosure Report Form primarily focuses on current financial interests, it also asks for information about past financial interests that directly relate to the products or issues to be considered at the meeting, and any other interests or relationships that might give rise to an appearance issue.

A member may seek assistance from FDA in completing this form. In completing this form, a member is required to report anything that would create an appearance issue not otherwise disclosed on the Form. The member may make a threshold judgment as to whether the information would cause a reasonable person to question her participation, and so inform the agency. FDA reviews the completed Confidential Financial Disclosure Report for each member in advance of every committee meeting to determine whether an appearance issue exists. As part of this review, FDA may ask for clarification about reported interests or about interests not reported but of which FDA may otherwise be aware.

What Circumstances May Create Appearance Issue?

Section 502 specifically lists certain interests and relationships that could create an appearance issue. It also includes a "catch-all" provision, which covers any other circumstances that may cause a reasonable person to question the member's impartiality. Once these circumstances raise a concern regarding the impartiality of the member, FDA considers the totality of the circumstances when determining to grant an authorization.

  • "Direct and Predictable Effect" on the Current Financial Interest of a Member of the Advisory Committee Member's Household

Under section 502, the following scenario would raise a potential appearance issue: where the particular matter coming before the advisory committee is likely to have a "direct and predictable effect" on the current financial interest of a member of the advisory committee member's household.

  • A Person or Entity with Whom the Member has a "Covered Relationship" is or Represents a "Party to the Matter"

Under section 502, the following scenario would also raise a potential appearance issue: where a person (or entity) with whom the advisory committee member has a "covered relationship" is or represents a "party to the matter" coming before the advisory committee. Both "covered relationship" and "party to the matter" are described in the guidance document.

  • Other Circumstances that May Raise a Question about the Member's Impartiality

Examples include broadly stated, "matters of general applicability". "Particular matters of general applicability" involve potential changes to regulations or agency guidance, or other broad topics such as policy-making and decisions that affect an entire class of products, such as reviewing labeling changes for an entire class of products. Particular matters of general applicability tend to raise fewer appearance issues than particular matters involving specific parties. However, the agency may require members to recuse from particular matters that do not involve specific parties, based on the concern that the member's impartiality reasonably may be questioned under the circumstances.

Other listed examples include relationships that are not technically "covered relationships" such as social relationships. Past financial interests ending more than one year before the meeting that suggest a close relationship with the sponsor or involvement with the product(s) before the committee was also a part of the "catch-all" provision.

Example from FDA Guidance

Scenario: The advisory committee is reviewing the safety and efficacy of a product. The meeting is a particular matter involving specific parties with one party to the matter ("the sponsor").

Example: The member's primary employment is as a dean of the medical school at a large university. The member reported that her employer has a multi-year grant from the product sponsor (i.e., the sponsor of the product that will be reviewed and evaluated at the advisory committee meeting) and the grant is not related to the product before the committee. This is an interest or relationship that could cause a reasonable person to question the member's impartiality.

Factors FDA Would Consider in Determining Whether or Not to Grant a Section 502 Authorization For the Member to Participate in the Meeting:

  • Whether the member receives any personal funding or remuneration from the grant (if not, this would weigh in favor of a section 502 authorization);
  • Size and diversity of the range of products made or under development by the sponsor providing the grant funding to the employer (the larger and more diverse the range of products the more this would weigh in favor of a section 502 authorization);
  • Whether the member's employer relies solely, or principally, on this grant from the sponsor (if not, this would weigh in favor of a section 502 authorization);
  • Whether the matter before the committee is considered sensitive or controversial (matters that are typical and routine without controversy would weigh in favor of a section 502 authorization);
  • Whether the member has expertise that is important to the committee's work and others with comparable expertise have conflicts or appearance issues more extensive than the member's (if so, this would weigh in favor of a section 502 authorization);
  • If there is a need for multiple experts in a field (if so, this would weigh in favor of a section 502 authorization).

Commentary

It comes to a point, that this is becoming ridiculous. The examples FDA uses would disqualify any physician whose institution is working on a research grant for the sponsor for a different product. Good luck in finding medical school faculty. The scenarios of "appearance" could go on forever, if the FDA wants to spend their time on fruitless exercises, then this is the guidance for you. Would not their time be better evaluating products then hunting through CV's for hidden conflicts.

March 22, 2016

ProPublica: Tying Open Payments Physician Data to Medicare Part D Data

ProPublica is once again trying to make a "correlation equals causation" argument between payments made to physicians and their prescribing patterns. ProPublica is arguing that an analysis they performed showed that "doctors who receive payments from the medical industry do indeed tend to prescribe drugs differently than their colleagues who don't."

They are arguing that doctors who received more than $5,000 from companies in 2014 had the highest brand-name prescribing percentages, giving an example that among internists who received no payments, the average brand-name prescribing rate was 20%, compared to about 30% for those who received more than $5,000.

What is interesting in the data is the absolutely high number ranging from 70-90% of generic medications both physicians who don't work with industry and those who do work with industry. In both groups a vast majority of their prescriptions were for generic medications which generally over 20+ years from initial development. A slight increase in the use of branded drugs should be considered a good thing for patients. As it is well known that it takes many years for physician adoption to newer therapies.

However, there is no proof that industry payments sway doctors to prescribe particular drugs, or even a particular company's drugs, just that payments are "associated with an approach to prescribing that, writ large, benefits drug companies' bottom line." There may be much more to the story if ProPublica found a link between payments made to physicians and the brand of drug they prescribed.

It is important to note, as laid out in more detail below, that physicians consider many factors when deciding which medications to prescribe. Some physicians treat patients for whom few, or no, generics are available; for example, doctors who treat patients with HIV/AIDS. Other physicians specialize in patients with complication conditions who have tried generic drugs with no success.

One physician that we discussed this with independently, thought it was appalling that there was no consideration of patient outcomes. If the physicians patients benefiting from the branded drugs then there should be credit given to those physicians working with industry.

According to Holly Campbell, spokeswoman for the Pharmaceutical Research and Manufacturers of America, "many factors" affect doctors' prescribing decisions and according to a 2011 survey of physicians, more than ninety percent of physicians felt that "a great deal of their prescribing was influenced by their clinical knowledge and experience."

Ms. Campbell believes that by working together, "biopharmaceutical companies and physicians can improve patient care, make better use of today's medicines, and foster the development of tomorrow's cures." Physicians provide insights and feedback to inform companies about their medicines to improve patient care and patient health.

By meeting with industry professionals, doctors get a chance to better understand the drugs that exist, the outcomes, and any side effects. Dr. Amer Syed of Jersey City, NJ, said that he does look at the quality of medication and the benefits patients get from taking the medicine before deciding what to prescribe, stating that his "whole vision of practice is to keep the patients out of the hospital."

Methodology

ProPublica examined Medicare Part D prescription data and pharmaceutical and medical device company payment data (found under Open Payments) to measure any relationship between industry payments and brand-name prescribing.

Interestingly, when ProPublica broke down the data by payment type, they found that physicians who received speaking payments had higher rates of brand-name prescribing than those who received other types of payments, and that physicians whose only payments were for meals had lower rates of brand prescribing than those who received other payments. This may speak to the idea that physicians who prescribe the same drug over and over again do so because they are comfortable with it, they know the results and the side effects, and since they know the drug so well, the company asks them to speak for them.

There is a huge "but" with the data cited to by ProPublica. The data does not consider whether branded drugs, for the indications prescribed, are superior to generic medications (or combinations of generic drugs), nor whether patient outcomes were different. Data that confirms safety and efficacy are much more likely to describe branded products than they are generics.

We are big proponents, however, of giving credit where credit is due. In this case, ProPublica did a nice job describing the circular relationship between companies and doctors. They published a quote by Dr. Kim Allan Williams, Sr., the president of the American College of Cardiology, who stated the more physicians learn and understand a new drug's "differentiating characteristics," the more likely they are to prescribe it, and the more they prescribe it, the more likely they are to be selected as speakers and consultants for the company. According to Dr. Williams, "that dovetails with improving your practice, and yes, you are getting paid to do it."

Dr. Williams also explained that new drugs are somewhat responsible for the significant decrease in cardiovascular mortality in the past three decades, and that the relationship between doctors and companies in cardiology may be driving that progress.

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
February 2017
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4
5 6 7 8 9 10 11
12 13 14 15 16 17 18
19 20 21 22 23 24 25
26 27 28