TrialSite News recently wrote about the promise and perils of stem cell practices—with a keen eye on unethical and even unlawful medical practices called out the Food and Drug Administration (FDA). We noted that in one Florida case the state medical license board took too much time to discipline a rogue physician; we gleaned that such a dynamic could represent–potentially—a nationwide issue. Last year Milwaukee Sentinel Journal’s John Fauber and Matt Wynn wrote about a doctor Benedict Liao. Apparently, Liao was prescribing an fictional investigational treatment known as “Allesgen” an “anti-cancer drug” to “cure advanced cancer.” The FDA got wind of this situation and sent Liao a warning letter.
The journalist duo reported that Liao was one of 73 physicians receiving active FDA warning letters over the past handful of years for serious issues. Based on an FDA warning investigation, sponsored by the Milwaukee Journal Sentinel and USA Today and Med Page Today, Fauber and Wynn wrote that out of the 73 only one was disciplined by their specific state medical board. That represents an bad record. The point of the story was the it appeared to be a systemic lack of accountability on the part of state medical boards. Where they somehow protecting those in their profession?
When licensed physicians break rules—and even laws—there has been perhaps, a material lack of oversight by medical boards: despite serious problems they allow physicians to continue practicing medicine without enough controls. All the while, patients—who in the American system must be consumers- have little transparency and are essentially “kept in the dark.” Due to the investigative research, some states have become more proactive in monitoring FDA warning letters. For example at the end of last year, the State of California initiated a program to monitor FDA warning letters. The idea is to consider board and licensure actions should material FDA observations occur. California has nearly 150,000 physicians—by far the largest of any state (New York is second with approximately 94,000). Mr. Fauber writing for the Milwaukee Sentinel Journal reported that “the California board began getting the warning letters” as part of a response to the research revealing the lack of adequate response around the country.
The USA Today, one of the medical license board investigative sponsors, published a follow-up article detailing seven takeaways from the investigation that prompted TrialSite News interest. Does the country’s medical license system face a number of troubling realities? The medical board research team observations included:
- Troubled doctors can run from the past troubles by crossing state lines and setting up a new practice
- Some doctors with severe charges may surrender their license but others can keep practicing
- Doctors that have received disciplinary actions still can make missions taking Medicare checks from taxpayers
- A tool does exist to help track and monitor the problem—The National Practitioner Data Bank—but not enough use it. This database includes malpractice payments, discipline and other actions taken against doctors.
- An individual’s geography impacts what they can discover about their doctor. The USA Today highlights North Carolina and Georgia as examples. Although adjacent, North Carolina maintains a large staff with a detailed medical board website while Georgia maintains a more relaxed reporting culture—asking doctors to self-report.
- Blatant violation of FDA warnings may still not stop doctors from preying on desperate patients. In one case, the USA Today found that despite FDA warnings, at least 30 doctors around the country were selling unproven (investigational) Multiple Sclerosis treatments while “patients remain in the dark.”
- Despite frequent FDA problem flagging, state medical boards don’t necessarily act
Recently in Mississippi, WLBT’s A3 On your Side published “Doctors Deception” revealing an investigation with Mississippi Today highlighting dozens of physicians throughout the state that continue to see patients despite some serious concerns. The Magnolia State investigative team learned that some doctors were in drug recovery and mental health programs themselves. Others had faced professional sexual misconduct allegations crossing several lines–and the Magnolia-health consumer was in the dark. In one case, pending a legal filing, a woman named “Danielle” alleges her Southaven MS gynecologist “assaulted her through wellness exams he insisted she have.” If the allegations are true, this professional culprit was far more interested in carnal knowledge than the Hippocratic oath! The data points back to Danielle’s claim as the investigative news team uncovers several other allegations against the same individual—amended legal affidavit included here. Of course, the other side posits a concerted, organized effort for settlement payouts.
Ironically, as mentioned in the USA Today story open access to the National Practitioner Data Bank (NPDB) could truly empower health consumers.
The National Practitioner Data Bank (NPDB) represents a comprehensive single source of truth for many key data points. It requires states to report the following:
- Medical malpractice payments
- Federal and state licensure and certification actions
- Adverse clinical privileges actions
- Adverse professional society membership actions
- Negative actions or findings by private accreditation organizations and peer review organizations
- Health care-related criminal convictions and civil judgments
- Exclusions from participation in a federal or state health care program (including Medicare and Medicaid exclusions
- Other adjudicated actions or decisions
Undoubtedly, NPDB is a valuable store of knowledge for the health care consumer, researcher and any other interested party. A principal investigator; or for that matter sub investigator—also must possess their physician license from a state medical board. Why not make this public information available for all? A commercial sponsor, or patient (consumer) may want to do physician/investigator due diligence seek to understand a physician track record-whether for a health provider visit; or for that matter—participation in a clinical study. After all, we live and operate in a market-driven health system. As value-based care and individual responsibility becomes a mantra, transparency becomes important.
According to a Consumers Union report consumers do not have access to the NPDB. Reposting an interesting snippet from Daniela Nunez, Consumers Union Safe Patient Project, called for public access to NPDB information. According to a Consumer Reports national poll nearly 88% of Americans believe the public should have access to federally collected information concerning doctors with reported problems. Its paid for with tax payer money. It was set up to improve the health care system. Why shouldn’t the tax payer be allowed to see it in its’ entirety?
Back in 2011 U.S Health and Human Services (HHS) had removed, then restored journalistic and other health professional access to NPDB’s Public Use Data File. But attached additional material conditions. Pia Christiansen writing for Converging Health reported that “the U.S. Health Resources and Services Administration today republished the public version of the National Practitioner Data Bank after intense pressure from journalism groups, researchers and members of Congress.” Material restrictions were included however—constraining what and how journalists—and other professionals– could utilize the data.
The challenges persist. We all seek to improve the nation’s health system—whether it be primary care or clinical research endeavors. Doctor (and by extension possibly investigator) disciplinary records are maintained in a relatively decent single source of truth database: the NPDB. After all, Congress created the NPDB in 1986 “pledging it would improve health care and reduce fraud and abuse.” It represents a treasure trove of data from malpractice payments, disciplinary action, restriction of hospital privileges to other misbehaviors. As Fauber and Wynn from Milwaukee noted as recently as December 2018, thee fundamental constraints are in the consumers’ (note also research participant or subjects) way:
- The system can be (and is) gamed—not all problems surface
- State medical boards often don’t check the NPDB
- The information is off limits to those most at risk—patients!
Carol Cronin, executive director of the Informed Patients Institute, a Maryland-based nonprofit group that produces its own physician “report cards” notes “it is the one source in the country where all the data is available.” Cronin believes the government needs to bring the system in the modern era.
The move toward value-based, market-driven care makes consumer awareness and education an absolute imperative. In the context of TrialSite News subject matter, a patient considering participation in a clinical trial is still a consumer of health services—just investigational health services. Informed consent reveals a lot—but not all pertinent facts. Frankly, today there is no real easy way for consumers to identify any public information about doctors—even though there is a statutory database in existence. Based on our findings, despite the presence of the NPDB, different states interpret and enforce adherence and access differently (remember the North Carolina and Georgia situation). Consumers (and research sponsors) need access to available public information—for example whether there is a history of bad behavior. The NPDB is one place where much of this information is centralized. TrialSite News principals truly believe in and represent “the glass is half full” type of outlook—optimistic and always with a critical slant. We are fundamentally upbeat about humanity; human ingenuity and that health is an individual’s indivisible responsibility. There is a resilience and ultimate adaptability within the American health system to respond to, and address health crisis. And individuals must take responsibility and accountability for their health. Many of the challenges faced reflect an accumulation of self-induced behaviors and patterns—both from a societal and individual perspective. Decades worth of poor consumer (and voter) decisions led to a mounting array of conditions that create an expressway to lifestyle disease crisis; from obesity and NASH to type 2 diabetes—many ailments were, and are, preventable and in some cases even reversable, but in some cases the train has too far left the station and many in population represent an annuity stream for drug producers. We don’t say this to be cynical—that is just the way it is.
Based on our anecdotal estimate (and this is our opinion and our opinion alone)—99% of practicing physicians are upstanding, professional and by-the-book professionals. That is a very large percentage. It certainly represents, possibly, a more positive ratio than other professions. Only 1% represent possible trouble based on our estimate. Of the estimated 1.1 million doctors in the United States we believe only about 11,000 could merit a second look. As health consumers we surely would like to have access to an easy, web-based portal to search for quality indicators. The Congress created the NPDB database in 1986 for that reason. And it was our tax money that funded the system. As investigational health patients (e.g. participants or subjects) which represents a much smaller number, we believe the same is true—that about 99% of the 50,000 or so active investigators (49,500) only have the best intentions in mind; that leaves just about 500 of so meriting a second look; so as investigational health consumers we may seek a little more reassurance. As we have learned in this research journey, there is a federal database that contains valuable information for consumers (and trial participants). But unfortunately the government has decided that for whatever reason, we are not responsible enough to see it. We leave you with the telling HRSA statement under Access Reports: “Federal legislation restricts access to the NPDB to registered entities that meet certain criteria only. The public does not have right to access the NPDB or the reports stored in the systems.”