BIOETHICS III 3.

02
ETHICS IN THE DRUG INDUSTRY
February 21, 2020 | Dr. Maria Luisa Dela Cruz
Transcribers: 12B, NAS, AFSC
PHYSICIAN-PHARMACEUTICAL INDUSTRY RELATIONSHIP
LEVELS OF INTERACTIONS • In 2012, the Pharmaceutical industry spent more than $27
• Clinicians million on marketing to Physicians and 84% of US Physicians
o Gifts reported receiving drug sample, payments, meals, other gifts
§ May be small or large and/or travel from drug industry
§ Small: ballpens, ballers, t-shirts • Physicians have gradually started to question the ethics and
o Promotional Materials integrities of such interaction and the impact on their
§ It is important for pharmaceutical industry to let doctors prescribing habits and on patient’s
know about their products • In 2010, the Sunshine act was signed into law and requires
§ That’s why Pharmacology is one of the hardest subject in disclosure to the public of all financial relationships between
medicine because in your lifetime as doctors, you’ll be physician and medical device and pharmaceutical manufacturers
prescribing whether you’re in active practice or practice • In 2004, industry spent about $57.5 billion on promotional
in the rural area, you’ll always be prescribing drugs activities (including $20.4 billion for detailing)
• Researchers o Detailing - the act of drug rep going to the doctor’s clinic
• Professional societies, medical journal introducing the drug, explaining what the product is, what’s
• Continuing medical education important about the drug, what are the advantages etc and
o Doctors do not stay put, they have to continually educate they give samples to the doctors
themselves § Sometimes nagkakamali sila because doctors know
o Now, it safeguarded by the Philippine Professional already what they’re talking about, minsan nahuhuli
Regulation Commision that when a doctor need to renew kung nambobola
his/her license, he/she need to have a number of certain • In 2007, industry spent $1.2 billion on support for CME
CPD units which is actually an assurance that doctors are up accounting for more that half the costs of formal programs in
to date in their knowledge of medicine and this will benefit CME
the patients that they’ll take care of o Sometimes, they don’t only cover registration but also
accommodation and transportation and other expenses
FIDUCIARY RESPONSIBILITIES OF THE PHYSICIAN
These are conditions of trust, meaning being trustworthy. RESEARCH
• 60% of biomedical research and developments is privately
1. Physician has specialized knowledge and expertise
funded
• Medicine is a varied specialty that we need to slice them off
• 70% of clinical trials are funded by pharmaceutical companies
to different specialties
• “To maintain integrity and independent-decision making,
• An example is a cardiologist who's been practicing for a
physicians must ensure that they maintain an impartial
decade and he is presented with an infectious disease. He'll
relationship with industry representatives free of any influences.”
have a hard time managing the patient because he already
forgot the antibiotics. He would call a colleague who’s an
FORMS OF DRUG PROMOTIONS
infectious disease expert.
• Drug samples
2. He holds the trust of others
• Small gifts (pens, bags, cotton balls, tissue paper, medical
• You hold the trust of others specially your patients.
instruments, shirts, prescription pad, umbrella, wall clock, etc.)
• Sometimes the mere trust of you make the patient feel
with the name of the drug
better
o Unknowingly, doctors are being used as endorsers or
3. He should have a high standard of conduct
advertisers of the drugs being promoted through the gifts.
• If you are a doctor and you sell drugs like addicting drugs, it’s
• Larger gifts (entertainment, food, sports events, trips - local and
not high standard of conduct
abroad, which may not necessarily be connected to a
• Or if you get involved with business and you get to outsmart
convention)
your competitor but do some dishonesty, that’s not a good
• Publications – Literature: Have to be able to distinguish which
conduct
one is reliable and which one is biased.
4. Ethically and legally accountable
o Pharmaceutical companies are allowed to advertise their
products in reputable journals.
BASIS FOR PHYSICIAN-PHARMACEUTICAL INDUSTRY RELATIONSHIP
1. Cooperation • Advertisements – Multimedia
• Physician provides the health services • Continuing medical education: Sponsoring discussions inviting
medical people.
• Pharmaceutical Company provides the medicines
• Research grants
2. Mutual respect
o From 2020 Trans: Very important because a lot of
• Best patient care
medicines now are products of extensive medical research
• No selfish interests
• Physician endorsements
o From 2020 Trans: Example: Manny & Pie Calayan endorsing
Patient’s well- being should be first and not the profit driving the
Olay. Usually there is conflict of interest. For doctors who
doctor to do his job
endorse a particular product, somehow there is an
authority since they can back up the claims of drug
 companies. However, there is a “silent rule” that as a • Create obligation - need to reciprocate -> conflict of interest
doctor, you must not endorse a specific item because it may o E.g. “I’m giving you a gift so you are expected to accept my
result in conflict of interest. offer of inviting you as a speaker. You must find an
o When the one advertising a drug is a doctor, the available time in your schedule.”
pharmaceutical company has an advantage because of the • Create sense of entitlement
doctor’s credibility. o “I’m using their drug, hence, I must be rewarded.”
• Continuing medical education (CME) • Erode professional values, may demean profession
o There are instances when a certain drug company would o Scenario: Instead of focusing on the lectures/sessions in
offer to sponsor the doctor’s CME fees, which must be the conference, some doctors tend to spend more time
voluntary. It is allowed for as long as it is not an individual checking out the freebies and they sometimes, they even
request, but rather of a group or the entire hospital, to miss the sessions.
avoid the issues on self interest.
Med-reps only highlight the pros/advantages not the cons OBJECTIVE OF DRUG PROMOTION
• Induce prescription, purchase or use of medicinal drug or
devices

FORMS OF DRUG PROMOTION

• Hospitality
• Dinner in Gourmet Restaurants
• Weekends in 5 –star Hotels
• Out of Town Resorts
• Service Cars and Drivers
• Tickets for Shows or Sports Events
• Giveaways (pens, bags, cotton balls, tissue paper, instruments,
shirts, etc.)

In the Philippines, drugs are expensive because of the massive

promotion of pharmaceutical companies.
FIgure 1. Canada’s pharma companies disclose payments to doctors
Payments drug companies give to doctors:
1. Research
• Scenario: Amlodipine besylate (Pfizer) - even if the process
for patency of this drug is not yet finished, a lot of drug
companies have already requested to manufacture the
product because they realized how much it has earned
already in the market, as well as the potential of this drug.
They were also utilizing doctors to give lectures to various
practitioners all over the country regarding the advantages
of this drug. Doctors were also utilized to be advisers of
the board to prevent those who think of producing the
drug while the process for patency is not yet completed.
(Duration of the patent is usually 10 years, which means
that only after 10 years will other drug companies be able Figure 2. Detailing (face-to-face sales and promotional activities),
to legally produce the same drug.) Samples, and direct-to-consumer advertising are the top 3 types of
2. Speaking fees for giving pharma-funded talks expenditure of pharmaceutical marketing. Source: Cegedim Strategic
• Drug companies utilize certain specialists to talk about a Data, 2012 U.S. Pharmaceutical Company Promotion Spending
certain topic (e.g. the treatment of peptic ulcer disease) (2013).
and then the doctor will not talk about any of the drugs
the pharmaceutical company offers. However, after the OVERT INTERACTIONS OF PHYSICIANS WITH MEDICAL
doctor’s talk, there will be a representative from the drug REPRESENTATIVES
company who will be the one in charge of discussing the • Accepting modest gifts
drug that they market. This is allowed since technically, it • Accepting lunches for office staff
is not the doctor who is directly endorsing the drug. • Speaking as part of a “speakers' bureau”
Rather, they are utilized to attract other doctors to attend • Participating in clinical trials
the lectures. • Consulting; or
3. Fees for participating in clinical trials • Other more formal relationships.
4. Travel expenses for attending conferences
5. Pharmaceutical consulting fees When someone gives you a gift, you respond to it politely by
accepting the gift kasi saying naman daw sabi ni doc. Pfizer (on
EFFECTS OF PROMOTIONAL MATERIALS promotion of Norvasc- pioneer of Amlodipine, invited a lot of
• Cost money pharmacologists for promotions done during a lecture about
• Influence behavior hypertension). The invited speakers would promote the drug to other
o Gifts in any form of good will influence behavior. In doctors attending the said event.
general, wouldn’t you be kind to anyone who gives you
gifts?
 SAMPLES LEAD TO INAPPROPRIATE PRESCRIBING • Effect on clinic time (Medical representatives usually take
• Samples are promotional. a significant amount of time from the doctors’ clinic hours.
• Over half of industry’s promotional budget (promotional, not Hence, there are fewer hours left for the patients.)
charity) is spent on samples.
• And for good reason: Nothing is more important for a rep than BRAND LOYALTY - bakit daw laging biogesic gusto ng mga tao, may
to get his or her samples into the “sample closet.” Tylenol, bioflu etc naman daw.
• Once a physician gives out a sample she/he is more likely to use
that medication in the future. 2. Effect on the Character of Physician (may become dependent,
• Problem is: Samples are usually the newest but more expensive self-interested, irresponsible and deceptive).
medication • Bringing the entire family for dinner (dapat doctor lang
• Patients are prescribed more expensive drugs than older, daw) (Even if the pharmaceutical company, for example,
cheaper and just as effective alternative drugs planned to treat you, alone, the company would rather not
tell you that and cater the whole family instead.)
Some patients believe that the samples given to doctors are more • At conventions – get the certificate without attending the
effective than the retail drugs in pharmacies. An example of conflict sessions
of interest happens when the doctor gives free sample of • Visit booths more than the lectures (namamalenke nalang
maintenance drugs of patients. When these samples run out, the daw yung mga doctor instead of attending lecture, tapos
patients are forced to buy the same brand of drug since it was the they still get certificates even though they didn’t attend the
one they initially used. Usually these samples are newer drugs and lectures).
are much expensive than other drugs such as generic drugs. In • Writing prescriptions to get benefits (Writing 5
reality, some newer drugs have the same efficacy as the drugs in the prescriptions would entitle you to an umbrella raw- ganun
market. daw kacheap yung mga residents.)
3. Effect on the Character of Drug Representatives
REVIEW OF RESEARCH EVIDENCE • may become unethical to gain doctor’s favour (gwapo and
Norris et al 2005 [Link] sexy daw usually, lam na)
• Promotion strongly influences prescribing and medicine use • eats, drinks with, entertains and even bribes doctors and
• Health professionals underestimate this influence pharmacists for prescriptions
• The pharmaceutical industry is a frequent information source • uses the doctors as a means – become advertising
on new drugs (siyempre product nila yun so may bias na. pero billboards using umbrellas, bags, prescription pads, pens,
they don’t lie about their drug, they just don’t tell of emphasize etc. bearing the company’s logo or product brand
the cons of the drugs.) 4. Effect on sense of right or wrong (self-respect/respect for
• Funding of key opinion leaders, continuing education and others)
research predicts content favourable to the sponsor’s drugs • Conflicts of interest
• Adair, et al, in a randomized trial, found that residents who • Influence on judgment when providing health care
were randomized to use samples were less likely to prescribe
over the counter medications and more likely to prescribe But the real danger here is that even though there is evidence that
advertised drugs than residents randomized to agree not to use gifts and interactions with pharmaceutical representatives does
samples. influence prescribing habits, most practitioners under-appreciate
• Chew, et al, found that in the treatment of hypertension, over how it affect their prescribing habits.
90% of physicians would dispense a sample that differed from
their preferred drug choice. (minsan may promo pa raw parang CONFLICTS OF INTEREST
buy 5 tapos +5) • “A conflict between a person’s private interests and public
• Boltri, et al, found that following prohibition of sample use in obligations.”
their practice, use of first line anti-hypertensive therapy • A conflict of interest involves the abuse of trust
increased from 38% to 61% (today limited na yung samples • A potential conflict of interest occurs when there is a possibility
because of the prohibition). that an individual’s private interest, or his or her family’s
interests, may influence the individual’s professional actions,
Some doctors had always been prescribing the same branded drug decisions or judgment
because they feel that they can already trust these drugs so when • Physician’s conflict of interest can encompass any situation.
they prescribe they write the branded name instead of the generic May arise when there is a conflict of interest of the physicians
name. and patients. It is being narrowed between the physicians and
OBJECTIVE OF DRUG PROMOTIONS patients. Some evidence in literature shows interactions
• Induce prescription, purchase or use of medicinal drugs or between physicians and industry representatives, the drug reps
devices when not properly manage may compromise the profession
NEGATIVE EFFECTS OF DRUG PROMOTIONS values or negative effects on the physician patient relationship.
1. Less quality of health care services to patients
• Dependence on biased promotional materials for new
products (If you want to receive unbiased information
regarding a certain drug, you must check the books, and
journals which are peer reviewed.)
• Brand loyalty that affect prescribing habits (Issue on the
Generic Law: Doctors were questioning the law, and they
argue about their biases on a certain brand.)
 3. The Physician should behave honorably - with integrity,
transparency and courage
• Should not coerce , exploit, threaten and ask drug reps for
favors (e.g./Chismis: Veteran’s hospital may isang
consultant na natipuhan yung med rep, he would
‘entertain’ the med rep after consultation hours, locking
the door???)
• Should be trustworthy, responsible and have self-respect
• Should refuse expensive gifts not related to patient care or
education (e.g. magsposponsor daw ng mga concerts and
dinner tapos sabay promote ng product)
• Attend conferences or meetings which provide truthful,
balanced information and science more than
entertainment
• Should be willing to pay for registration, transportation
and accommodation and avoid individual sponsorships
Figure 3. Conflict of Interest. Reproduction of Figure 1 from
Washington DC’s Department of Health Access Rx Program (Blue- Marcia Angelli, former editor-in-chief of the New England Journal of
doctors given gifts, Red- doctors with no gifts, x-axis- types of Medicine—argue that the mission of doctors is fundamentally
doctors, y-axis- average cost of claims. Pediatrics lang yung ethical different to the mission of drug companies and that the ties
daw. between them should be completely cut.
MANAGING CONFLICT OF INTEREST
1. Recognition This is not a viable proposition since the medical professionals will be
• Physicians need to recognize that gifts, regardless of the needing drugs when they practice.
value, may influence behavior and a self-serving bias
distorts the way individuals perceive themselves Mission of Drug Companies: Drug companies are investor owned
• It is human nature that you are kind to people kind to you businesses with a responsibility to maximize profits for their
2. Disclosure shareholders.
• Financial relationship with industry
• Research funding and sponsored studies Mission of the Medical Profession: To provide the best care possible
3. Management for patients.
• Eliminate practices that have little or no added clinical • There is a clear conflict of interest when practitioners accept
value (e.g. gifts, free lunches) gifts from pharmaceutical representatives and their
• Manage reported conflicts of interest to minimize or professional judgment is affected, then patient cannot be
eliminate the conflict by assured that the practitioner is doing what is in his or her best
1. Public disclosure interests
2. Independent review (part of this is peer review) • Forty-two percent believed that personal gifts adversely affect
3. Modifying research plan both the cost and the quality of health care. On the basis of
4. Disqualifying participation such data, the American College of Physicians has concluded
that “[a] significant number of patients believe that industry
“But the real danger here is that even though there is evidence that gifts bias their physician’s prescribing practices and ultimately
gifts and interactions with pharmaceutical representatives does drive up medical costs.”
influence prescribing habits, most practitioners under-appreciate • There is a clear connection between gifts from the
how it affects their prescribing habits.” pharmaceutical industry and higher costs for medical care in
two ways:
For example, in a survey of nurse practitioners and physician o First, expenditures for gifts are passed along to consumers
assistants, 86% responded that, “it is appropriate to accept gifts and in the form of higher prices. Patient has to pay more for
these gifts do not influence [my] prescription choices.” Herein lies drugs for the pharmaceutical industry to pay for gifts to
one of the ethical problems with accepting gifts from the give to health practitioners.
pharmaceutical industry—these gifts create potential conflicts of o Second, practitioners will be influenced to prescribe
interest that can affect practitioners’ judgment, without their heavily marketed drugs, which tend to cost more than
knowledge and contrary to their intent, thereby placing professional equally effective alternatives, such as generic drugs.
objectivity at risk and possibly compromising patient care.
What happens is the consumers are the ones who pay for the
GUIDELINES FOR PHYSICIANS IN ACCEPTING DRUG PROMOTIONS marketing and promotion of the drug (ex. Gifts to doctors etc.) since
1. The Physician should be careful, discriminating and prudent in the drug companies expend a lot from this. Moreover, generic drugs
acceptance of individual gifts usually do not market their drugs because of the expenses.
• gifts in all forms affect clinical judgment and heighten the
perception of conflict of interest WHY DO PHYSICIANS ACCEPT GIFTS FROM PHARMACEUTICAL
• It’s ok to accept group sponsorship INDUSTRIES?
2. The Physician should write prescriptions based on principles • Accepting a gift is a natural, socially expected reaction
of rational drug use motivated by a combination of self-interest and politeness. (It is
• based on evidences of efficacy, safety, suitability and cost natural that when someone gives you a gift, you should accept
(eto daw ang tama kapag naging doctor na tayo) it).
• Sa ethics walang correct and incorrect response because it will • Managing Conflict of Interests in the light of day without
depend on your values compromising professional and personal ethics.
• Health care professionals have come to expect gifts as part of a 3. The Third Principle
“culture of entitlement” that has evolved as a result of years of • Avoiding or withdrawing from activities in which the
largesse (money or gifts given generously) on the part of Conflict of Interests cannot be managed.
pharmaceutical companies. (Doctor: Im using the product
because it is a great drug and it works for my patients and in POSITIVE ASPECTS OF THE RELATIONSHIP BETWEEN PHYSICIANS
return due to “culture entitlement” pharmaceutical companies AND PHARMACEUTICAL INDUSTRY
should give me gifts. Peer review process is central to pharmaceutical research since it
• Rob Restuccia, executive director of the Prescription Project in validates the research journals before it is published.
Boston, said the billions spent on drug marketing to doctors 1. Benefits to society
undermine professionalism, increase cost and undermine care. • Clinical research need the guidance of physicians to make
• "From all angles, it's an important issue that is symptomatic of sure they are done right
a lot of problems in the health care system overall," he said. • Physician consultants help shape the type and nature of
"And it's essentially gone unregulated.“ studies that get performed.
• Peer review process is “held as the best available means to
THREE WAYS TO PROMOTE A HEALTHIER RELATIONSHIP BETWEEN help check the quality, relevance and importance of
PHYSICIANS AND THE PHARMACEUTICAL INDUSTRY papers being submitted by medical researchers”
1. Teaching Physicians ‘‘Promotional Literacy’’ • Central to the medical journal publication process
• Medical professionals should be taught to distinguish • Peer reviewed medical journals have historically been
between sound clinical information and promotional considered highly credible sources because they attest to
materials. (You should not rely on promotional materials but the veracity of the results of the research before
on peer reviewed journals and other materials alike). publishing it.
2. Encouraging the Adoption of ‘‘Good Relationship Practice’’ • Helps to ensure that medical treatments are safe and
• Health and pharmaceutical professionals should both follow effective for patients.
a set of rules to guide healthy interactions. • No research = no progress.
3. Ensuring Transparency from Both Parties, While Allowing 2. Indirect benefits to patients from physicians interacting with
Healthy Networking pharmaceutical industry
• Both parties must be transparent about combining research, • For example, physicians may sit on data safety monitoring
clinical, and educational endeavors within a framework of boards, providing unique skill sets that protect patients by
professional networking. focusing on adverse events of drugs in clinical trials, or
• Responsible leadership is no longer about influencing may even close trials completely.
opinion but is instead about aligning aspirations and realizing 3. Patients may directly benefit from the physician–Pharma
ambitions. relationships
• Doctors champion patient needs, and pharma requires a • Regarding research, patients may gain access to
positive presence in health care committed to addressing medications or devices at a much earlier time in their
these needs. illness.
• This may be especially important for those who have failed
[Link] ([Link]) one or more approaches in the past.
An alliance of health care providers who “believe that
pharmaceutical promotion should not guide clinical practice,” and On cancer drugs, clinical trials are being done by recruiting cancer
who hold the mission to “encourage health care providers to patients who have failed in the conventional treatment.
practice medicine on the basis of scientific evidence rather than on
the basis of pharmaceutical promotion.” REFERENCES
• Lecture PPT
CONCLUSION • Recording
• The patient-physician relationship is a fiduciary relationship • Batch 2020 Trans
• Fiduciaries have an obligation to avoid conflicts of interest TRANSCRIBERS
• Gifts from the pharmaceutical industry, whether large or small, 1. TRANS GROUP: #12BestGroupEver (MGA, AKC, AC, LRG, JDG,
create conflicts of interest RAG, AMM, MAR, MR, JS, MGS, JLT)
• Physicians should not accept any gifts from the pharmacutical 2. SUBTRANSHEAD:
industry 3. TRANS HEAD: AFSC

From 2020 Trans:

MECHANISMS TO LIMIT, MITIGATE, OR AVERT CONFLICT OF
INTEREST
1. The first principle
• Making full and formal disclosure of the relationships that
might lead to Conflict of Interest
• Covered in the Physician Payments Sunshine Act which is
designed to make industry interactions more transparent

2. The Second Principle