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Ethical dilemma for medical practitioners and researchers: A Case study - By Dr. Jyoti Yadav

  • Category
    Ethics
  • Published
    17th Jan, 2019

The Sarah Cannon Research Institute (US) received nearly $8 million in payments from drug companies on behalf of its president for clinical operations, Dr. Howard Burris, largely for research work. Dozens of his articles published in prestigious medical journals did not include the required disclosures of those payments and relationships

Issue

The Sarah Cannon Research Institute (US) received nearly $8 million in payments from drug companies on behalf of its president for clinical operations, Dr. Howard Burris, largely for research work. Dozens of his articles published in prestigious medical journals did not include the required disclosures of those payments and relationships

Issue

Recently, New York Times and a leading non-profit journalism organization, ProPublica reported about disclosure errors and hiding of conflict of interest by the researchers writing for the leading medical journals. The researchers were also found to have corporate interest in the pharmaceutical industry on account of having stakes in the companies. This has brought out a grave ethical issue in the field of medicine and research.

Relevance of the issue:

Medical journals are the chief means of communicating the latest discoveries to the public in the field of medical discoveries. Publishing of the studies, drug or other product discovered, etc. in a leading journal heightens their prospect and acceptance in the field. The journals, on the other hand, enhance their reputation by covering the breakthrough and exclusive studies by renowned and acclaimed researchers. Usually, the researchers have an independent relationship with the journals.  

Transparency is required as researchers’ ties to the pharmaceutical industry may result in favouring of the ones that the researchers have connection with. The conflict of interest is much higher in industry-sponsored research than funded otherwise. Thus, the treatment options available to the patients are the ones that are favoured by the industry and not the ones that are in the interest of the patients in truest sense.

The factors responsible:

Doctors and researchers, primarily, are concerned with patient care and scientific advance, while industry’s prime concern is commercial outcomes. The loyalties and the conflict of interest divide blurs this demarcation jeopardizing the interest of the patients.

The conflict remains due to weak enforcement of laws and fragmented disclosures due to the ambiguous guidelines of the professional societies and the governmental bodies which leaves enough scope for non-disclosure by the researchers.

What needs to be done?

Better disclosure standards and reduction of errors in the reportage in the medical journals is required to be done. International Committee of Medical Journal Editors (ICMJE) is, also, considering a policy to charge the researchers, who commit major disclosure errors to their institutions, of research misconduct thus initiating criminal charges against them.

Another such issue:

Medical profession and pharmaceutical industry relationship has certain desirable aspects (eg, the cooperative efforts of industry and prescribers to achieve quality use of medicines) and many unethical and undesirable ones (eg, kickbacks, gifts, and money for prescription of selected few). The latter one disregards the concerns of the patients and goes against the Hippocratic Oath taken by the doctors.

Despite stringent actions of the professional societies and the criminal justice system, the issue of such corruption keeps coming to surface.

Relevance for India:

Drug promotion and marketing by the industry through medical professionals by the means of biased prescription of drugs is a big area of concern in India where patients’ affordability of the costly treatment is often lacking. Indian government is pushing for generic drugs through network of Jan Aushadi Kendras and amendment of Drugs and Cosmetics Act (DCA).

Another area of concern is the industry-sponsored research and non-publication of select studies and clinical trials by the journals favouring or disfavouring selected ones swaying the industry.

Best practice:

Practice of ‘universal disclosure’ promoted by American Society for Clinical Oncology (ASCO) requires the doctors to disclose all payments. ASCO has a centralized system for reporting conflicts to all of its journals and speaker presentations.

A US Federal law in 2010 requires the pharmaceutical and medical device makers to report the payments made to the physicians to establish transparency in the system.

Way forward:

The overriding principle should be that the values of science and clinical medicine must prevail over commercial imperatives. The relationship between medical practioners, researchers, and the pharmaceutical industry must be open and transparent. The welfare of the community and the patients along with the integrity of the medical profession should be the concern of all the concerned in the field of medicine.

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