ETHICAL ISSUES DURING

INTERACTION WITH THE INDUSTRY!

Dr. Mridul M. Panditrao

CONSULTANT

DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE

PUBLIC HOSPITAL AUTHORITY’S RAND MEMORIAL HOSPITAL

FREEPORT, GRAND BAHAMA

THE BAHAMAS

“Medical Deontology”: a vanishing science

• In Spite of unprecedented advances in the Medical Science

• Fundamental value systems of it’s practitioners have crumbled to a great extent

• The principles and the foundations of the “Noble Profession”, at present are

‘shaky & wobbly!’• The need & greed of lucre is the ‘Principal

principle’ which seems to be ruling this “Materialistic World”

• Original guidelines of ‘Fathers of Medicine’ seem to be slowly fading away

• In these testing times it is imperative, to “introspect” deeply and reinvent this science

“Medical Deontology”: a vanishing science

Defined as “Set of ethical standards and principles

of behavior of Medical Practit ioners while executing their professional duties , professional ethics of medical workers and principles of behavior of Medical personnel , directed towards maximum benefit of treatment of the Patient!”

Panditrao M. M. Medical Deontology: The fading Science and need of the Hour” Editorial: Indian J Pain 2011: 25: 6-8

The Premise of Medical Ethics (Deontology)

include the main duties of Medical Practitioners • Scientific : the section of Medical Science stating

ethical and moral priciples, as a part of Medical worker’s activity.

• Practical : The area of Medical practice, the tasks of which are the formation and application of the interpersonal mutual relations

Described in three basic directions/dimensions: Medical worker - PatientMedical worker - Relative of the patientMedical worker - Medical worker

A Newer dimension may have to be added viz;

The interpersonal relationship between Doctor & Pharmaceutical / Medical

Equipment Manufacturing Industry representative

The person may come under variety of titles as “Sales or Marketing Executive”

‘Product Management Team Manager’ simple, old fashioned title of ‘Medical

Representative’

Thompsons DF: Understanding financial conflicts of interest N Engl J Med 329: 573-76 1993.

This area actually can be considered under the premise of

“conflicts of interest” .

Introspection : CAGE ?!• Have you ever prescribed Celecoxib/Nise, etc…

• Do you get Annoyed by people who complain about drug lunches, sponsorships and free gifts?

• Is there a medication LoGo on the pen you're using right now?

• Do you drink your morning Eye-opener out of a Drug brand coffee mug?

If you answered yes to 2 or more of the above, you may be a ‘drug company dependent’!!!

Levels of Interactions:• Clinicians– “Gifts”– promotional information

• Researchers• Professional societies; medical journals• Continuing Medical Education

(CME)s/Conferences

“Gifts are just a form of promotion or advertising, and advertising is a part of our society, like it or not.”

Gifts:

• Cost money (like other advertising).• Influence behavior (like other advertising).• Create obligation, need to reciprocate (unlike

advertising). Conflict of interest• Create sense of entitlement (unlike

advertising).• Erode professional values; demean profession

(probably unlike advertising).

Case Scenario 1 : Conflict of Interest

It is a busy day in the Out patient clinic, but you have agreed to speak for a minute to a pharmaceutical representative who has stopped by to drop off some samples of a new aminoglycoside antibiotic, called ‘XYZmycin’ Knowing your interest in Tennis, he has brought you Rackets and tennis balls emblazoned with the letter “X,” and also invites you to a Tennis match at his club this weekend.

Would you accept the gift? Would you accept the invitation?

(Adapted From: “Really difficult Problems in Medical Ethics”)

Conflict of Interest

In Medical practice has been defined as “A set of conditions in which professional judgment

concerning primary interest (Such as patient’s welfare or validity of research) tends to be unduly influenced by a secondary interest.

• These interests may be at a personal level in the form of gaining of financial or material interests

• If managed at the personal level professionally and without getting influenced by the gratification based personalized gains, then the ethical issues may not be compromised.

NEJM 1993;329:573-6

Waisel D B, Truog R D: Ethical and legal aspects of Anaesthesia care : in “Millers Anaesthesia eds., Miller RD , Fleisher LA et al, publishers: Elsivier 6th ed, 2005, 3190-91.

Conflict of interest?

“I have never been

bought, I cannot be

bought. I am an icon

and I have a reputation

for honesty and integrity

and

let the chips fall wherever

they may !!!!!!!!!!!!!!!!!!!!!!”

Conflict of interest?

“ It is true that there

are people in my

situation who could

not receive a

million-dollar grant

and stay objective.

But I do.”

“That stuff doesn’t influence me at all. I don’t even know what drug is on my pen. I just go for the food.”

--Fill in your name here????

What is ‘Conflict of Interest’ in the clinical setting?

• When interests of the clinician do not align with the interests of their patients

Or• When interests of the clinician are hijacked by

pharma companies for fulfillment of their interests

Every year in U.S. of A to maintain the high profile of their products to capture their share of market pie In the form of advertisements, promotional campaigns

and in order to make sure that their influence is maintained over the physician community, more that $11 billion are spent by the pharmaceutical industry!

Temple R , O’Brien P: Why would anyone have expected anything else ? Characteristics of material distribution by drug companies. Four points of view J Gen Intern Med 11: 640-641,1996Wazana A: physician and pharmaceutical industry : is a gift ever just a gift ? JAMA 283: 373-380, 2000

In India

• Taking into consideration the Attitudes and Practices of our professional colleagues, especially in the private practice setup, it may turn out that, the figures may be of much larger proportion

• In addition some of the unscrupulous personnel from pharmaceutical industry with their dubious practice of ‘Margin Price system’ in collusion with retail Medical shops owners, approach the physicians with unsavory and under the table propositions

In India• Although the physicians claim most of

the times that they are neither directly involved nor are they indirectly benefited in terms of exchange of cash, but the gifts & other in kind materials may also influence the prescribing practice of the physician

• It is simply the psychological pressure, feeling of obligation or simply familiarity and acknowledgment of frequent association, that tends to have impact upon the physicians.

Angell M, Kassirer JP, Editorials and conflicts of interest N Engl J. Med. 335;1055-1056,1996Shaughnessy AF, Slawson DC, Bennett JH, Teaching information mastery: Evaluating information provided by pharmaceutical representative Fam. Med. 27:581-585, 1995Orlowski JP, Wateska L : The effect of pharmaceutical firm enticement on physicians’ prescribing patterns : Chest 102:270-273,1992

• gimmicks or tactics used by the industry personnel are devised in such a way that the approach appears as if some “Wonderful”, “knowledge–boosting” or “path breaking” information is being imparted to the listener, without any impropriety in it.

• The transmission of information may not be completely falsified or erroneous, but it may have been spiced up, incomplete or partially true. Some of facts may be voluntarily or involuntarily omitted

All of this leads to very high degree of malpractice!Rosner F, Ethical Relationship between drugs companies and the medical profession. Chest 102:266-269,1992

Lexchin J: what information do physicians’ receive from pharmaceutical representative ? Can Fam Physicians 43:941-945:1997Roughhead EE, Harvey KJ, Gilbert AL: Commercial detailing techniques used by pharmaceutical representative to influence prescribing. Aust NZ J med. 28:306-310,1998Rough head EE, havyey KJ, Gilbert AL: Self regulatory codes of conduct : are they effective in controlling pharmaceutical representatives Int. J. Health serv 28:269-279,1998Stryer D, Berol A : characteristics of the material distributed by drug companies .An evaluation of appropriateness J. Gen Int. Med. 11:575-583,1996.Wilkes MS ,Doblin BH, Shapiro MF .Pharmaceutical advertisement in leading medical Journal. Expert’s assessment. Ann Intern Med. 116:912-919,1992.

• Pharmaceutical companies have been implicated in arranging so called “Conferences” or “Workshops” or “CME programs” for specific groups of consultants, which actually may be nothing but all ‘expense paid trips’ to spas, resorts & holiday locations

• Thus instead of patients getting any benefits out of these activities, it is only the pharmaceutical industry mainly and the physicians to certain extent, who are benefitted

• This leads to the paradox, in actuality, causing conflicts in the ethical & moral issues

Orlowski JP, Wateska L : The effect of pharmaceutical firm enticement on physicians’ prescribing patterns : Chest 102:270-273,1992

‘Conflict of Interest’ & Research

• This conflict of interest can also cross the sacred barriers of impartial, unbiased and pure form of ‘Research’

• As a result of “cash or kind” type of approach, these hallowed areas of human conscience may also be breached

Greger JS, Barnes M : Conflict of Interest in human subjects research: Crit care med 31 (suppl.3) 5137-5142,2003

Case Scenario 2“ CLEAR SOLUTION OF PROPOFOL ”

• An industrial company proclaiming various big names being their impartial and unbiased researchers / assessors to influence the young and upcoming Anaesthesiologist community

• Launched a “ CLEAR SOLUTION OF PROPOFOL ” with lot of fanfare

• However within 8-10 days of the launch of this preparation, because of extremely irritating and highly toxic side effect of this preparation, (severe pain on injection, thrombophlebitis, phlebothrombosis, dissolving of plastic syringes and three ways in the preparation itself), it had to be completely withdrawn from the market.

• The researchers and the company in this instance got away absolutely scot free; unrepentant and unscathed.

Case Scenario 3 :Pharmaceutical company sponsored clinical trials.Practicing Academicians cum Clinical Researchers, One such example that can be cited is the • “ Multicenter, Multi country trial” that has been

carried out in our country by Chest / Pulmonology physicians for Anti-Asthma drugs

• Here the drugs were actually first tried in human subjects in third world countries like India, Sri-Lanka, Pakistan etc

• The sponsoring company carried out the lure of cash, material benefits like foreign jaunts, travel grants etc. to entice and enroll the various specialist from many hospitals in these countries as the principal research workers to carry out these trials, using the gullible patients as the readily available guinea pigs

Case Scenario 4 :Pharmaceutical company sponsored clinical trials

Practicing Academicians cum Clinical Researchers

Another example that can be cited is the • In many big hospitals including medical colleges,

the Paediatricians get sponsorship for carrying out trials of various vaccines

• The sponsored free samples of vaccine are sold to the patients under ‘Subsidzed’ price and ‘principal investigators/ team’ get an ‘opportunity’ to present their ‘papers’ at various ‘ international conferences’

• All expenses paid by the company under the garb of ‘Reserach grant’

• “ Stringent, strict, very harsh and penalizing code of conduct and legal implications are necessary to deal with these practices in our country”

Should doctors be held to different (higher) standards?

The physician-patient relationship is a “fiduciary relationship”

http://en.wikipedia.org/wiki/Fiduciary

• A fiduciary duty (from Latin fiduciarius, meaning "(holding) in trust"; from fides, meaning "faith", and fiducia, meaning "trust") is a legal or ethical relationship of confidence or trust between two or more parties

• In a fiduciary relationship, one person (patient), in a position of vulnerability, justifiably vests confidence, good faith, reliance and trust in another (Doctor)whose aid, advice or protection is sought in some matter.

• In such a relation good conscience requires the fiduciary to act at all times for the sole benefit and interest of the one who trusts.

http://www.legalmatch.com/law-library/article/fiduciary-duty-of-doctor-and-patient.html

A fiduciary duty requires the fiduciary to act with all of the following:

• the highest standard of care• the highest order of good faith and fair dealing• show loyalty• serve the patient's best interests• avoid ‘conflicts of interest’

Remedial measures & Professional Guidelines

• The maximum brunt of the commercialization & materialism in this matter to ward off this inappropriate influence and as the minimum standard, ‘American Medical Association’ (AMA) had developed guidelines “Gifts to physicians from Industry”

American Medical Association :Council on Ethical & Judicial Affairs

• “Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value.”

• “Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, or personal expenses of the physicians who are attending the conferences and meetings . . .”

• “No gifts should be accepted if there are strings attached.”

JAMA 1991;261:501

American College of PhysiciansGuidelines on Physician-Industry Relations

• The acceptance of individual gifts, hospitality, trips, and subsidies of all types from industry by an individual physician is strongly discouraged.

• The acceptance of even small gifts can affect clinical judgment and heighten the perception (as well as the reality) of a conflict of interest..

• The dictates of professionalism require the physician to decline any industry gift or service that might be perceived to bias their judgment, regardless of whether a bias actually materializes.

• Ideally, physicians should not accept any promotional gifts or amenities, whatever their value or utility, if they have the ability to cloud professional judgment and compromise patient care.

Annals of Internal Medicine 2002;136:396-402.

American College of PhysiciansGuidelines on Physician-Industry Relations

Acceptable industry gifts:

• Inexpensive gifts for office use (pens and calendars).

• Low cost gifts of an educational or patient-care nature (such as textbooks), So as to benefit the patients are gifts of nominal value,

• Modest refreshment, Frugal meals at the educational events like CME, workshops, Seminars & conferences.

Annals of Internal Medicine 2002;136:396-402.

Important concession awarded by these guidelines

In fact these define educational function as one in which. • The gathering is primarily dedicated in both the time &

effort to promoting objective Scientific and educational activities and discourse.

• With the main incentive for bringing attendees to gather, to further their knowledge on the topics being presented

• Strong rider that “An Appropriate discourse of financial support or conflict of interest should be made

‘Canadian Medical Association’“ Medical Professionalism in the New

Millennium: A Physician Charter.”.

Levine AM; Medical professionalism in the new Millennium: A Physician charter: Ann Intern med 136:243-246,2002

Other Guidelines

• The principle in specific detail is described as “commitment to maintaining trust by managing conflict of Interest

• Physicians have an obligation to recognize, disclose to the general public and deal with conflict of interest that arises in the course of their professional duties and activities.

MEDICAL COUNCIL OF INDIA NOTIFICATIONNew Delhi, the 10th December 2009

• No. MCI-211(1)/2009 (Ethics)/55667.-In exercise of the powers conferred by Section 33 of the Indian Medical Council Act, 1956 (102 of 1956), the Medical Council of India with the previous sanction of the Central Government, hereby makes the following Regulations to amend the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002:-

1. (i) These Regulations may be called the “Indian Medical council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009 Part I”.(ii) They shall come into force from the date of their publication in the Official Gazette.

2. In the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002”, the following additions/medications/decisions/substitutions, shall be, as indicated therein:-

3. The following clause shall be added after clause 6.7:-

• 6.8 Code of conduct for doctor and professional association of doctors in their relationship with pharmaceutical and allied health sector industry.

6.8.1 In dealing with pharmaceutical and allied health sector industry, a medical practitioner shall follow and adhere to the stipulations given below:-

(a) Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied healthcare industry and their sales people or representatives.

(b) Travel facilities: A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations, etc., from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conference, seminars, workshops, CME programme etc. as a delegate.

(c) Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext.

(d) Cash or monetary grants: A medical practitioner shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext. Funding for medical research, study etc., can only be received through approved institutions by modalities laid down by law/rules/guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed.

• (e) Medical Research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfillment of the following items (1) to (vii) will be an imperative for undertaking any research assignment/project funded by industry-for being proper and ethical. Thus, in accepting such a position a medical practitioner shall:-(i) Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities;(ii) Ensure that such a research project(s) has the clearance of national/state/institutional ethics committee/bodies;(iii) Ensure that it fulfills all the legal requirements prescribed for medical research;(iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself;(v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research projects);(vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way;(vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document/agreement for any such assignment.

• (f) Maintaining Professional Autonomy: In dealing with pharmaceutical and allied healthcare industry a medical practitioner shall always ensure that there shall never be any compromise either with his/her own professional autonomy and/or with the autonomy and freedom of the medical institution.

(g) Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities, as consultants, as researchers, as treating doctors or in any other professional capacity. In doing so, a medical practitioner shall always:(i) Ensure that his professional integrity and freedom are maintained:(ii) Ensure that patients interest are not compromised in any way;(iii) Ensure that such affiliation are within the law;(iv) Ensure that such affiliations/employments are fully transparent and disclosed.

(h) Endorsement: A medical practitioner shall not endorse any drug or product of the industry publically. Any study conducted on the efficacy or otherwise of such products shall be presented to and/or through appropriate scientific bodies or published in appropriate scientific journals in a proper way”.Read more: MEDICAL COUNCIL OF INDIA - NOTIFICATION http://www.medindia.net/education/mci-guidelines.asp#ixzz1fNBixZhr

• Although these guidelines may be in force, in actuality it mainly depends upon individual clinician to decide as to, what level of gratification from the industry is impinging upon his or her moral value system and at what level they can draw a line.

Summary• Relationships with industry can create

conscious and unconscious conflicts of interest.

• It is morally and therapeutically vital that we uphold our patients’ trust in our interactions with industry.

Final Thoughts

• “You are in this profession as a calling, not as a business; as a calling which exacts from you at every turn self-sacrifice, devotion, love, and tenderness to your fellow-men. Once you get down to the purely business level, your influence is gone and the true light of your life is dimmed. You must work in the missionary spirit, with abreadth of charity that raises you far above the petty jealousies of life.

-Sir William Osler