Another year, another set of scandals making headlines in American medicine.
Adding to the already endless stream of improprieties that rocked U.S. healthcare in 2018 is a pair of tawdry tales involving researchers and clinicians at two of healthcare’s most respected institutions.
Fall was a rough season for the prestigious Memorial Sloan Kettering Cancer Center. In October, its chief executive Dr. Craig B. Thompson was forced to resign from the boards of Merck and Charles River Laboratories after investigations by The New York Times turned up “insider deals among hospital officials and undisclosed industry relationships” with drug companies. A month earlier, the center’s chief medical officer Dr. José Baselga was fired after failing to disclose serious conflicts of interest. Among them, Baselga gave overly favorable reviews of Swiss drug giant Roche but failed to disclose $ 3 million in direct payments from the company since 2014. The embattled doctor told ProPublica the disclosure lapses were “unintentional.”
Meanwhile, Harvard University and Brigham and Women’s Hospital in Boston came forward with information that Piero Anversa, a high-profile physician and cardiac stem-cell researcher, had falsified and/or fabricated data in at least 31 medical journal publications. As director of the Brigham Center of Regenerative Medicine, Anversa manipulated photos and lied about the efficacy of cardiac stem cells used for patients with heart failure. That’s after he and his laboratory received millions of dollars in grants and established their approach as the clinical standard.
These were big stories with no small implications. If these scandals were the work of only a few selfish individuals, most HR departments could resolve them. Unfortunately, the problems are endemic and deeply embedded in medical culture. When it comes to the questionable ethics of accepting money and perks from drug and device companies, doctors and hospital administrators routinely look the other way.
Reading these reports, I was reminded of Richard Adams’ novel Watership Down. Written in 1972, it’s about a group of rabbits who leave their home in search of greener pastures. Early on, they encounter another group of rabbits in a field enjoying an endless supply of carrots and lettuce. These well-fed rabbits warmly welcome the new arrivals while failing to mention that, every couple of days, one of their brethren disappears.
The lesson: In British fiction and U.S. medicine alike, there are no free lunches. And in healthcare, there’s no such thing as a victimless conflict of interest. Every undisclosed payment, free sample or all-expenses-paid trip is an attempt to manipulate. And whenever clinicians or researchers take the bait, its patients who are put at risk.
Nowhere are these ill effects more apparent than in cancer care. A recent report titled “Unintended Consequences of Expensive Cancer Therapeutics” found that the last 71 chemotherapy agents to receive FDA approval extend life by an average of only 2.1 months—time often spent in pain, isolated from friends and family.
Of course, when the TV voice-over reads that a new agent, “significantly increases the chance of living longer,” patients think in terms of years, not weeks or months. What’s worse, the clinical trials that inform these ads are usually made up of younger, healthier subjects who can tolerate the drugs better than most other patients with the same cancer. Add to those facts this one: Medical trials funded by drug companies are 30% more likely to show their drugs are safe and effective compared to independently funded studies, according to the Cochrane Collaboration, a consortium of medical and statistical experts.
Whether this stat reflects the unconscious bias of researchers wanting to please their funding organization or the editing assistance of drug company representatives, the negative impact on patients is nonetheless clear.
To repeat: There’s no such thing as a victimless conflict of interest. Behavioral economics demonstrates that gifts, no matter how small, create an unconscious sense of obligation. Books, dinners and honorariums are tools designed to earn access, spur reciprocity and encourage docs to prescribe expensive brand-name drugs rather than their generic equivalents. If drug companies didn’t expect anything in return for funding research, they’d do what healthcare ethicists have been urging for years: Donate the money to an independent, nonprofit research group and eliminate research bias altogether.
The pay-for-play game in healthcare works the same as it does in Vegas. “High-rollers,” which in medicine are the doctors who generate the most revenue for the drug and device companies, get the biggest perks. They sit on advisory boards and earn sizable speaking fees, sometimes as high as six figures.
Recipients tell themselves they’re being singled out for their clinical expertise. But like the rabbits in Adams’ tale, they’re ignoring reality. The day they stop prescribing a company’s most expensive drugs will be the last time they get invited to a fancy dinner or paid to keynote a conference at a resort destination.
Most of the time, it takes highly complex solutions to fix healthcare’s biggest problems— from its high costs and poor clinical quality to its cumbersome IT and widespread medical error. Not so with conflicts of interest. In fact, the answer is quite simple: Ban outside payments and demand total transparency.
Implementation won’t be easy, of course. Everyone likes free stuff. But over time, doctors and researchers will come to realize their integrity is much more valuable. I know because I saw it happen as the CEO of The Permanente Medical Group.
In 2005, my colleague Dr. Sharon Levine designed and orchestrated the industry’s strictest conflict-of-interest policy, a program that defied the doomsday predictions of many doctors. Only two of the 5,000 physicians working in the medical group at the time left as a result of the new policy.
If these four rules can work for that many doctors, they can work for all healthcare providers:
1. Prohibit doctors from accepting anything at all from drug or device companies.
Note, I did not say “anything of value.” Anything. Period. Doctors and researchers should not accept a pen or coffee cup, and certainly not a free dinner. Ending inappropriate actions requires absolute clarity. Even the tiniest crack can threaten the whole foundation.
What’s great about this policy is that there’s nothing to disclose and nothing to remember. No keeping track of receipts or checks. No lists of “consulting” arrangements to share with medical journals. Just think how much trouble Sloan Kettering would have avoided if its CMO wasn’t allowed to accept direct payments from drug companies.
2. Form an ethics committee to address any concerns doctors may have.
At first, some doctors and staff will decry the new prohibition. They’ll insist it’s not in the best interest of patients to be so restrictive.
One way to resolve this concern is to appoint an ethics committee comprised of at least one outside expert and one patient representative. Together, they can (a) review requests for policy exemptions and (b) grant exceptions when applicable. Of course, given the public nature of this process, I guarantee this committee won’t need to meet often.
3. Direct all research funding, regardless of the source, to the institution and not to individuals.
Although no researcher’s salary should be dependent on, or tied to, drug-company funding, it can appropriate for organizations to accept commercial payments to fund research.
In these situations, organizations should: (a) channel the dollars through the institution and not through individuals, (b) blind the researchers to its source and (c) ensure the organization’s CEO and legal counsel sign off on the agreement and, as with Sarbanes-Oxley, maintain personal accountability should the arrangement prove inappropriate.
Before researchers begin any study, they must commit to publishing outcome data on a searchable website, regardless of the results. This way, patients and clinicians around the world can benefit from the findings.
4. Require all providers to disclose any past payments, prior to the policy’s implementation.
While steps 1, 2 and 3 are being implemented, all physicians, researchers and hospital administrators should immediately enter into an easily searchable database all payments received from drug and device manufacturers (akin to the requirements under the “Sunshine Act”). Further, physicians should be required to disclose to patients any paid relationships they have with makers of the drugs or devices they prescribe.
This approach forces everyone to confront the truth. If there’s no shame in these potential conflicts of interest, medical professionals should feel comfortable disclosing them fully to their superiors, patients and peer-reviewed publications. If there are no ethical issues involved, doctors should be happy to make these relationships public and allow them to be reviewed by independent hospital committees.
In reality, you’ll find that those availing themselves of drug-company dollars know as clearly as the fattened rabbits did that something about the arrangement isn’t right. And most will be glad when their integrity is restored.
If there are medical leaders considering such a policy for their own organization but concerned about its consequences, I’d be happy to talk them through the details. Beforehand, however, I would encourage them to look closely at the list of prominent physicians who got caught in the snares of drug and device companies this year and remember that there are no free gifts in healthcare.