In a bid to ease up on its contentious conflict-of-interest (COI) rules, the Harvard Medical School (HMS) has allowed the school and its teaching hospitals to operate under a relaxed policy. In a letter to HMS, on May 12th, 2016, Dean Jeffrey Flierstated thata researcher can now conduct clinical trials on new treatments whilst enjoying afinancial stake in the company developing them. The researcher will also receive double the amount of funding they were previously receiving from the companies whose products they wereinvestigating.
However, according to Dean Flier,“The new policy will exempt the faculty members from the COI rules only if they can demonstrate a compelling justification that is in line with the rights and welfare of clinical research subjects.” All petitions seeking exemption from these rules will be reviewed by the system’s ethics committee.
Ostensibly, the relaxation has come with a few inescapable conditions.
However, the new rules are definitely not as stringent to not allow immunity.
Under the new regulations,faculty members can now enjoy a handsome sum of up to $25,000 from the company whose product they are investigating,which is more than double the $10,000 they were previously receiving. Simply put, pharmaceutical and biotechnological industries would now have to substantially fund their researches.
These rules further ease the partnership woes of the faculty’s researchers. The researchers, according to the new rules stipulated in the letter by the Dean, can now hold up to $50,000 worth of stock in a publicly-traded company. However, holding stock in privately-held companies still remains a forbidden fruit for faculty members since the new rules continue to thwart the faculty members from holding any stock in private companies.
COI Rules Relaxation – The Background Story
Termed a “small tweak” to its existing policy, the relaxation to the COI rules came amid severe backlash from researchers who thought the sternness of the policy was preventing juvenile laboratory discoveries blooming into medical treatments.
The stifling of human testing of new drugs attracted severe criticism, eventually leading to this change in the rule policy. However, the rule is not permanentand may be revised anytime in the future, should HMS think so.
“The school will monitor the impact of the rule change,” said the thoughtful Fier, “and revisit it if need be.”
COI Rules Relaxation: Harvard’s Conflict of Interest Rules
With the main aim to protect scientific research from corporate influence, the Harvard’s COIpolicy was established in 1990.
COI was designed to prevent its faculty members and researchers from skewing the clinical trial results. The chances of bias and favorable outcomes increase if the researchers have a certain amount of equity in the company whose product they are investigating.
Minimization of COI greatly mitigates the risk of bias on guidelines and recommendations. Unfortunately, the prevalence of financial COI among members of panels producing clinical guidelines is very high whilst the incidence of disclosure is under-reported as well.
A number of studies have investigated the clash such a situation would spark and found that not only do most current panelists have a conflict of interest, but the rules also carrya high risk of considerable industry influence on guidelines and recommendations.
Amidst such risks and threats, Harvard’s COI policy was not only justified, it was exactly the need of the hour.
However, as noble as the aim of the policy might have been, it wasn’t successful in staving off the critique, some of it unquestionably valid. Given its strict rules, the policy has been considered the strictest in the country right from the outset.
Gretchen Brodnicki, Dean for Faculty and Research Integrity at Harvard, believes no other school, save Harvard, had such a “hard-stop” prohibition. Brodnicki’s denigration of the COI policy is based on the premise that many faculty members have been heard deserting specific studies and trials because of the strict rules glued to them.
From Battling Criticism To Sparking More Criticism – Harvard’s COI’s Journey
The new policy is not sitting very well with academic veterans, particularly those that have vociferously censured the detractors of the policy in the past. Three former senior New England Journal of Medicine (NEJM) editors, for instance, believe there is no rationalizing the financial conflict of interest in the medical profession. The attack on COI policy, they believe, is “flawed and inflammatory”.
Robert Steinbrook, Professor Adjunct of Internal Medicine, believes the loosening of Harvard’s COI policy is a “bad decision”. He thinks it will send a wrong message to the academic medicine community, particularly when the reasons and the rationale for change are far from convincing. The professor opines that instead of loosening its COI policies for clinical research, HMS shouldpress other institutions to adopt stronger policies.
“Harvard,” the dismayed professor opines,“has taken a big step backwards.”