Dr. (Prof.) Mahesh Baldwa, M.D, D.C.H, FIAP, MBA, LL.B, LL.M, PhD (law) SENIOR PEDIATRICIAN & MEDICOLEGAL ADVISOR
- Dr Sushila Baldwa, MBBS, MD,DGO, senior gynecologist, Baldwa Hospital, Sumer Nagar, S.V. Road, Borivali (West) Mumbai 400 092
- Dr Namita Padvi, MBBS, MD,DNB, PGDML, Fellowship in pediatric anesthesiology, Assistant Professor of Pediatric medical s at T.N. Pediatric medical College and Nair Hospital, Mumbai-400008
- Dr Varsha Gupta, MBBS, MD, PGDML, Medical officer in department of pathology, Bhagwati hospital, Mumbai
Defining COI
Conflict of interest may be defined as a situation in which politicians, public, servants, consultants, technical/scientific experts, subject matter specialists or even academics have an actual or potential interest (usually financial) that may influence or appear to influence the conduct of their official duties or the quality of advice or recommendations rendered by them. It is rampant in medical profession.
COI without impropriety
The presence of a conflict of interest is independent of the occurrence of impropriety. Therefore, a conflict of interest can be discovered and voluntarily defused before any corruption occurs. A conflict of interest exists if the circumstances are reasonably believed (on the basis of past experience and objective evidence) to create a risk that a decision may be unduly influenced by other, secondary interests, and not on whether a particular individual is actually influenced by a secondary interest.
COI in medicine
“Conflict of Interest” (COI) involves a situation in which faculty, staff, or student employees have financial or other personal considerations that may compromise, or have the appearance of compromising, their professional judgment or integrity in teaching, clinical care of patients, conducting or reporting research, or performing other organizational / corporate/ University obligations or like.
Spectrum of COI related to profession
“A conflict of interest is a set of circumstances that creates a risk that professional judgement or actions regarding a primary interest will be unduly influenced by a secondary interest.”[ Lo and Field (2009). The definition originally appeared in Thompson (1993)] Primary interest refers to the principal goals of the profession or activity, such as the protection of clients, the health of patients, the integrity of research, and the duties of public office. Secondary interest includes personal benefit and is not limited to only financial gain but also such motives as the desire for professional advancement, or the wish to do favours for family and friends. These secondary interests are not treated as wrong in and of themselves, but become objectionable when they are believed to have greater weight than the primary interests. Conflict of interest rules in the public sphere mainly focus on financial relationships since they are relatively more objective, fungible, and quantifiable, and usually involve the medical fields and also common in political and legal profession.
Example:
One way to understand this is to use the term “conflict of roles”. Assuming two different roles is not illegal. A person with two roles—an individual who owns company stocks in stock market and is also a government official, who regulates affairs of the company of which one holds the stock. So holder and second as government regulator of company of which one hold the stock. So has two roles –situations where those two roles may conflict-depends upon governmental decisions taken. An organizational conflict of interest (COI) may exist in the same way as described above, for instance where a corporation provides two types of service to the government and these services conflict (e.g.: manufacturing parts and then participating on a selection committee comparing parts manufacturers).
Areas where COI can happen in medical profession
It is imperative to identify areas where a conflict of interest might occur during the day-to-day practice of medicine, and to assist physicians in resolving such conflicts in the best interests of their patients. A conflict of interest is understood to exist when professional judgement concerning direct patient care might be unduly influenced by a secondary interest.
COI in medical research in pharma
The influence of the pharmaceutical industry on medical research has been a major cause for concern. In 2009 a study found that “a number of academic institutions” do not have clear guidelines for relationships between Institutional Review Boards and industry.[ Policies regarding IRB members’ industry relationships often lacking]. In contrast to this viewpoint, an article and associated editorial in the New England Journal of Medicine in May 2015 [Drazen, Jeffrey M. (2015-05-07). “Revisiting the Commercial–Academic Interface”. New England Journal of Medicine. 372 (19): 1853–1854] emphasized the importance of pharmaceutical industry-physician interactions for the development of novel treatments, and argued that moral outrage over industry malfeasance had unjustifiably led many to overemphasize the problems created by financial conflicts of interest. The article noted that major healthcare organizations such as National Center for Advancing Translational Sciences of the National Institutes of Health, the President’s Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration had encouraged greater interactions between physicians and industry in order to bring greater benefits to patients.[ “Reconnecting the Dots — Reinterpreting Industry–Physician Relations — NEJM”]
Payments or compensation of any sort should not be tied to the outcome of clinical trials. Physician-researchers should not have a financial interest in a company sponsoring a trial or a product being studied in a clinical trial if this financial interest could be affected positively or negatively by the results of the trial; they should have no direct financial stake in the results of the trial. They should not purchase, buy or sell stock (shares) in the company while the trial is ongoing and until the results have been made public. This might not apply for those physicians who have developed a medication but are not part of the enrolment process.
COI leading to Vaccine mafias or vaccine gate
Unfortunately it is very profitable for the drug industry to get the medical profession to promote vaccines to the general population. Drug companies are corporations and they do not have a duty to “do no harm”. Their only duty is to make money and “mitigate” any liability the company might be forced to deal with in a court of law. And since the US Supreme Court decision in 2011, Bruecewitz versus Wyeth, they have been exempted from all liability regarding their vaccine products. It is important the public doesn’t forget this as it is very unlikely your physician or anyone who works for public health will remind you of this reality.
Baby food mafia and COI
Baby feeding companies offer health workers gifts, sponsorship for events and study days organized by the companies themselves. Study days will sometimes have guest speakers on topics of interest, but are usually branded with the formula name and require health workers to provide their personal and workplace contact details to register. Sometimes products are promoted directly.
Cosmetic mafia and COI
First coined by a prominent dermatologist in 1984, “cosmeceutical” is not an officially recognized term by the Food and Drug Administration. These anti-aging creams and serums, or “cosmeceuticals,” actually do what they claim, 15 dollars, or even $100, or $350, would seem like a small price to pay. Most women swear by their favorite products, in spite of or unaware of the often-dubious science used by the companies who peddle them. More likely, though, the secret is in the marketing, not the science — lies told to placate those who have sagging skin and disposable incomes.
Neutraceutical mafia and COI
Awareness of conflicts of interest (COI) in medicine began in the 1980s. More recently, the problem has gained notoriety in nutritional sciences or neutraceuticals used from cold to cancer cure, more particularly chronic and aging problems like joint pains etc. COI with industry could bias study conclusions in the context of research activities and scientific publications on nutritional sciences. The issue of COI in nutritional sciences deserves more attention and requires careful analyses as biased information can negatively impact the development of dietary guidelines and, ultimately, population health. Decision-making is generally based on available, published evidence, but when the results are ambivalent.
Junk food mafia and COI
Fast food and junk food are given through endorsement of big celebrities, non Indian national doctors and company sponsorship is made to look as healthy food. of All of us hope that public health policies and care guidelines, especially those directed at our children, are based on the most careful examinations of the soundest evidence and have been shown to be safe and effective, with benefits that outweigh the potential harms.
Conflict of Interest in Medical Research, Education, and Practice.
Patients and the public benefit when physicians and researchers collaborate with pharmaceutical, medical device, and biotechnology companies to develop products that benefit individual and public health. At the same time, concerns are growing that wide-ranging financial ties to industry may unduly influence professional judgments involving the primary interests and goals of medicine. Such conflicts of interest threaten the integrity of scientific investigations, the objectivity of professional education, the quality of patient care, and the public’s trust in medicine.
COI in clinical medicine
The COI in clinical practice of medicine and direct patient care arises because of physicians assuming several different roles like participation in research, education, and training and also worked in decision making role administrative or managerial positions in organizations creating COI. Each doctor has a moral duty to scrutinize his or her own behaviour for potential conflicts of interest. The term “conflict of interest” refers to a conflict between the private interests and the official responsibilities of an individual in a position of trust. Surely physicians function in positions of trust; in fact, the very foundation of the doctor-patient relationship rests on trust.
COI in Promotion of a drug for off-label use
Imagine the following and, unfortunately, common scenario: At a major clinical or health-related lecture, a physician paid by the pharmaceutical company is “planted” in the audience. The “plant” raises his or her hand and supposedly innocently asks the presenter if he or she has ever used the drug for an illness for which the drug has not been approved by the US Food and Drug Administration (FDA). The presenter then discusses off-label uses of the drug for this or that illness or symptom. Remember that physicians in the United States can write prescriptions for any drug, whether or not it has been approved by the FDA for that illness. So why not add a few more uses, which can translate into multiple sales and millions of dollars in unexpected revenue for pharma companies?
COI in medical publications
Physician-researchers should decline requests to review grant applications or research paper submissions from colleagues or competitors where their relationship would have the potential to influence their judgment on the matter.
Conflict of interest in medical publishing exists when a participant’s private interests compete with his or her responsibilities to the scientific community, readers and society. While conflict of interest is common, it reaches the level of concern when ‘a reasonable observer might wonder if the individual’s behavior or judgment was motivated by his or her competing interests’. Having a competing interest does not, in itself, imply wrongdoing. However, it can undermine the credibility of research results and damage public trust in medical journals.
Disclosure alone is an imperfect remedy; editors still must determine whether a conflict has sufficient potential to impair an individual’s objectivity such that the article should not be published. Even more work may be needed on reviewers’ and editors’ competing interests, given their critical role as gatekeepers for the medical literature.
COI in pharmaceutical companies merged their scientific and marketing divisions
Since the late 1980s the number of articles in the medical and population health literature on conflicts of interest has risen substantially. From 1975 to about 1990, there were no or very few such articles cited in PubMed. But by 2007, the number had risen to 600 and has remained at that level every year since. Not surprisingly, this rise in number corresponds all too neatly to a period when many pharmaceutical companies merged their scientific and marketing divisions.
COI leading to Common mistakes in medical writing
These are some common mistakes that are specific to editors who have health- or
medicine-related conflicts of interest.
| Editors | COI mistakes |
| Owners, employees or contractors of pharmaceutical, dietary supplement, diagnostic, or medical device manufacturers, contract research organizations, and public-relations representatives for such companies | Requesting the addition of un-sourced or poorly sourced content about a product’s safety or efficacy, or the deletion of well-sourced material about adverse effects Requesting the deletion of well-sourced, appropriate material about proprietary technology Requesting the addition of criticism of competitors’ products |
| Healthcare providers (physicians, surgeons, nurses, etc) | Promoting your medical practice, department, or institution Promoting your medical theories, approaches, or inventions |
| Healthcare advocates and activists | Promoting biased or tiny minority viewpoints Changing the page to make sure it has the “right” information. |
| Scientists in academia or companies | Citing your latest paper in the hope that increased visibility will drive up your H-index Attempting to diminish or disparage a competitor’s views or publications |
People with a close tie to the subject may be very knowledgeable about it, and their input on talk pages can be useful when it comes to the who, what, where, when, and how of complex topics. Examples include:
| Editors | Expertise |
| Owners, employees or contractors of pharmaceutical, dietary supplement, or medical device manufacturers, and their PR representatives | Knowledge of sources regarding a product’s regulatory and commercial history |
| Members of healthcare-advocacy groups | Knowledge of sources regarding social movements and their effects |
COI in referral, endorsement and recommendation
Kickbacks (or fee-splitting) occur when a physician receives financial consideration for referring a patient to a specific practitioner or for a specific service for which a fee is charged. Physician should not receive any financial compensation or other consideration either for referring a patient to laboratories, pharmacies and opticians these services. Non-medical products (those having nothing to do with patient health or the practice of medicine) and scientifically non-validated medical products should not be sold by physician.
Types COI
The following are the most common forms of conflicts of interests:
Self-dealing, in which an official who controls an organization causes it to enter into a transaction with the official, or with another organization that benefits the official only. The official is on both sides of the “deal.”
In 2008, the Centers for Medicare and Medicaid Services issued a new rule requiring physicians to disclose to patients the physician’s ownership of or investment in US hospitals
Outside employment, in which the interests of one job conflict with another.
Nepotism, in which a spouse, child, or other close relative is employed (or applies for employment) by an individual, or where goods or services are purchased from a relative or from a firm controlled by a relative. To avoid nepotism in hiring, many employment applications ask if the applicant is related to a current employee of the company. This disallows employed relative to play role in the hiring process. If this is the case, such relative is prevented from any hiring decisions.
Gifts: from friends who also do business with the person receiving the gifts or from individuals or corporations who do business with the organization in which the gift recipient is employed. Such gifts may include non-tangible things of value such as transportation and lodging.
conflicts of interest may arise in several situations, some of which involve pharmaceutical drugs, medical devices, and biotechnology companies by
- accept company gifts of various kinds, including meals and drug samples;
- act as promotional speakers or ghostwriting, and consulting arrangements on behalf of companies
- have a financial interest in a medical product company whose products they prescribe, use, or recommend.
Pump and dump, in which a stock broker who owns a security artificially inflates the price by “upgrading” it or spreading rumors, sells the security and adds short position, then “downgrades” the security or spreads negative rumors to push the price down.
Corruption: accepting bribes can be classified as corruption,
Fraud : use of government or corporate property or assets for personal use is fraud
Security breach: unauthorized distribution of confidential information is a security breach.
Surrogate Self-regulation
Surrogate Self-regulation of any group is also a conflict of interest. If any organization, such as a corporation or government bureaucracy, is asked to eliminate unethical behavior within their own group, it may be in their interest in the short run to eliminate the appearance of unethical behavior, rather than the behavior itself, by keeping any ethical breaches hidden, instead of exposing and correcting them.
In lieu of favour intangible future benefits are granted
Comfort, position, forbearance, opting out of race for position, supporting someone for position of power in lieu of favour intangible future benefits are granted
COI is sometimes termed competition of interest rather than “conflict”, emphasizing a connotation of natural competition between valid interests – rather than the classical definition of conflict, which would include by definition including a victim and unfair aggression. Nevertheless, this denotation of conflict of interest is not generally seen.
In India person can assume multiple, valid, legal roles in hierarchy of medical field along with similar hierarchical roles in politics, administration of organizations or corporation or some such arrangement created consciously or otherwise. Obviously apparently there is a maze of conflict of interest. A conflict of interest could impair an individual’s ability to perform his or her duties and responsibilities objectively.
Offering position of power
Professionals are granted important privileges—including the power to set educational and ethical standards—in return
How to do mitigation COI
COI disclosure
COI guidelines for disclosure or for discontinuing participation in the decision-making process, for those individuals who have COI due to sponsored research, consulting agreements, private holdings or licensing agreements.
Removal of COI
Of obvious COI by resigning from a position or sell a shareholding in a venture, to eliminate the conflict of interest going forward.] For example, Lord Evans of Weardale resigned as a non-executive director of the UK National Crime Agency after a tax-avoidance-related controversy about HSBC, where Lord Evans was also a non-executive director. This resignation was stated to have taken place in order to avoid the appearance of conflict of interest.
“Blind trust” leading to COI
A politician who owns shares in a company that may be affected by government policy may put those shares in a blind trust with themselves or their family as the beneficiary. Blind trusts may in fact obscure conflicts of interest, and for this reason it is illegal to fund political parties in the UK via a blind trust if the identity of the real donor is concealed.
Disclosure of COI
Commonly, politicians and high-ranking government officials are required to disclose financial information—assets such as stock, debts such as loans, and/or corporate positions held, typically annually. Certain professionals are required either by rules related to their professional organization, or by statute, to disclose any actual or potential conflicts of interest. In some instances, the failure to provide full disclosure is a crime. And, an increasing line of research suggests that disclosure can have “perverse effects” or, at least, is not the panacea regulators often take it to be.
Recusal [disallow] needed for COI
Those with a conflict of interest are expected to recluse [self disallow] themselves from (i.e., abstain from) decisions where such a conflict exists. The imperative for recusal varies depending upon the circumstance and profession, either as common sense ethics, codified ethics, or by statute. For example, if the governing board of a government agency is considering hiring a consulting firm for some task, and one firm being considered has, as a partner, a close relative of one of the board’s members, then that board member should not vote on which firm is to be selected. In fact, to minimize any conflict, the board member should not participate in any way in the decision, including discussions.
Third-party evaluations needed for COI
Consider a situation where the owner of a majority of a public companies decides to buy out the minority shareholders and take the corporation private. What is a fair price? Obviously it is improper (and, typically, illegal) for the majority owner to simply state a price and then have the (majority-controlled) board of directors approve that price. What is typically done is to hire an independent firm (a third party), well-qualified to evaluate such matters, to calculate a “fair price”, which is then voted on by the minority shareholders.
NGO’s against COI
The Alliance against Conflict of Interest (AACI) is an alliance of organizations and individuals working in various sectors – doctors, lawyers, women’s and children’s health groups, activists and media. AACI takes up cases with clear conflict of interest and brings them to the notice of the parties involved, the government and media. AACI aims at having a legal protection from conflicts of interests in all sectors in public policy.
Family physicians have no COI in treating patients
Family physicians are widely trusted by their patients and communities. Merely by having chosen specialty of family physicians have demonstrated a commendable commitment to putting the health needs of their patients ahead of personal financial gain.
Legislations for COI
In USA
like Sunshine Act in USA medical ethics 2002 amended in 2012 with respect doctors receiving gifts, payments, sponsorship and benefits derived by doctors
“U.S. to Force Drug Firms to Report Money Paid to Doctors,” by Robert Pear – In an effort to address health care-related conflicts of interest, the Obama administration is moving forward with the Sunshine Act, a new law that will require pharmaceutical companies and device manufacturers to disclose payments made to non-employee physicians.
In India
- India has draft bill for COI,2011, but so far not legislated.
- Even amendment of prevention act has no provisions for COI
In Pakistan
In Pakistan Khyber Pakhtunkhwa Assembly unanimously passed Conflict of Interest 2016. It advocates that any member of the provincial assembly will not use office for personal use or for their family members.
MCI Regulations for COI
MCI medical ethics 2002 amended in 2012also has provision to penalise doctors who do not follow the medical ethics.
a. Accepting gifts worth ` 1,000 to ` 5,000 from a pharmaceutical company can lead to a doctor being issued a censure. This means, that he or she will not be able to travel abroad for work or studies.
b. Accepting gifts valued between ` 5,000 and ` 10,000, could lead to a doctor’s name being struck off the medical register for three months plus censure.
c. For taking gifts between ` 10,000 and ` 50,000, a doctor is issued a censure and suspended from practice for six months.
d. If a doctor accepts gifts worth over ` 50,000 and up to ` one lakh, his or her license can be suspended for one year and if the gifts cost over ` 1 lakh, he can be suspended for more than a year.
Myths of the Small Gifts and Full Disclosures
The first myth is that small gifts do not significantly influence physician behavior. The second myth is that disclosure of financial conflicts is sufficient to satisfy the need to protect patients’ interests. Although these assumptions are widely accepted among physicians but research findings prove it otherwise. Thus sale by promotion of products to physicians and their prescription to their patients rarely is ethical.
Summary and conclusions
A conflict of interest (COI) is a situation in which a person or organization decides [usually with corrupt motivation the decision-making is done]. Such decision is made with an aim to gain. Gain could be direct financial gain or indirect [non financial] gains or favours. The gain doing includes but not restricted to personal favour to someone or overtly dis-favouring some at the instance or direction of person in power hierarchy for personal or organizational future gain, ease, comfort or some such things. All of us should strive for identifying COI with objectivity define scope of COI and Manage COI to eliminate COI.
