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While this document is comprehensive in terms of physician relations with industry because of a perceived potential to over-prescribe, it ignores completely the flip side, physicians relationships to governments, agencies and institutions that my serve to limit or ration care to individual patients in the guise of guidelines or best practice.
In these guidelines, the word industry should be replaceable with government committee, LHIN and multiple other potential limiters of health care provision, so that an audience is aware of bias in favour of restriction, rationing or lack of delivery for any reason.
Industry is neither good nor bad and neither is government or its subunits.
All those government, guideline and regulatory relationships by physicians whether paid or unpaid require equal disclosure.
The CPSO cannot ignore this equal or perhaps greater conflict.
very true. But you never hear about this. No body has a greater control over my prescribing habits than ODB. But they are not under a fraction of the scrutiny that “big pharma” is.
Unfortunately this only includes USA physicians. We need a Canadian one!
I don’t agree that physicians and their staff should accept meals, even if of modest value, in the course of receiving information from industry representatives (eg. lines 116-118). In general, the relationship between physicians and industry, particularly the pharmaceutical industry is profoundly unequal and corrupt.
I agree with many of the points made both in the document and by the posts. I do think that any professional should abide by professional and thus ethical standards and as such I see a place for this type of a document published by the CPSO. I just caution that relationship be extended to others who also place specific demands or exert their own influence on providers which is well described by others.
My other point would be that we do not not want limit access to funded education or in any way remove the obligation of pharma and other agencies to be involved in unbiased educational activities, given their resources. I have seen what RX&D has done to attendance at CME functions and I don’t think this has been positive for continuing education at all. A core guidelines for all industries to follow that provide for ethical action with no bias is reasonable but I caution against limiting all access since the overall impact will not be in the benefit of the public.
I would like to start by applauding the CPSO for deciding to issue a policy on interactions with industry. I think the draft policy has several strengths, including calling for registration of clinical trials, and prohibiting physicians from entering into non-disclosure agreements or presenting study results in a misleading fashion. Nevertheless, the draft is weak in many other areas and in its current form is unlikely to have a meaningful influence in addressing the pervasive pharmaceutical industry bias in our field. We have been dealing with an iatrogenic deadly opioid epidemic, overprescription of antipsychotics to our nursing home seniors, and the increasing rate of polypharmacy. I think the “Practice” section, in particular, needs to be strengthened. I think that as the regulatory body of our profession, there is an opportunity for the College to take a leadership role in counteracting commercial bias in our field. Following are some specific comments:
The Introduction does not adequately acknowledge vast body of research showing the industry promotion, including through interactions with sales representatives, results in lower quality prescribing, increased frequency of prescribing, and increased costs.
Again from the introduction: “While industry has a valuable and legitimate role to play in the practice of medicine, its interests and responsibilities may diverge from the professional and legal obligations of physicians.” Industry has a fiduciary responsibility towards its shareholders. Thus, this statement in the introduction is weak and does not accurately represent the extent to which industry and physician interests diverge.
Excessive use of qualifiers such as “potential” and “perceived” weaken the document.
Of industry sales representatives: “these interactions have value”. Again, this discounts the large body of research showing otherwise.
While the policy proscribes acceptance of personal gifts, teaching aids and meals are allowed. In the relationship with industry, these serve the same function as gifts.
Regarding information from industry sales representatives, physicians are encouraged to “not solely rely on this information”. If it is expected that physicians utilize independent sources of information, why should they rely at all on information from pharmaceutical sales representatives? Many physicians, myself included, do not interact with industry sales representatives. Are we missing out on important information for our patients? Should the College not be concerned about this?
The policy fails to recognize the powerful marketing function of drug samples, and the evidence that supports this. They lead to inappropriate prescribing and increased costs.
There is no statement against being part of a company’s speaker’s bureau. This role is essentially that of a paid spokesperson for the compnay’s product marketing plan.
The draft calls for “a mechanism to manage” conflicts of interest, but the only specific thing discussed is disclosure. Disclosure on its own is inadequate, and over-reliance on simple disclosure can in fact make things worse. See the article titled, “The unintended consequences of conflict of interest disclosure” (JAMA 2012 Feb 15; 307(7):669-70).
Industry-sponsored CMEs are still susceptible to bias even when unrestricted grants are used. It would be good if the policy can encourage seeking funds from non-industry sources when possible.
Ghost authorship, and the broader problem of ghost management, is not addressed by simply having a company writer acknowledged or even listed as author.
I wonder how the College will enforce its policy. There are now numerous guidelines on interaction with industry. Unfortunately, many of these amount to little more than a PR exercise. Further, contravening such guidelines has typically been of little consequence. I believe that as our regulatory body, the College has an opportunity to have a meaningful impact on physician behavior to the benefit of the patients whom we serve.
I read this physician’s comments and many that followed and I wonder if any quality evidence will be provided to support the sweeping claims of the ills of modern industry and physician partnership and collaboration. As examples, I bring your attention to the following from this physician’s entry:
“The Introduction does not adequately acknowledge vast body of research showing the industry promotion, including through interactions with sales representatives, results in lower quality prescribing, increased frequency of prescribing, and increased costs.
Of industry sales representatives: “these interactions have value”. Again, this discounts the large body of research showing otherwise.
The policy fails to recognize the powerful marketing function of drug samples, and the evidence that supports this. They lead to inappropriate prescribing and increased costs.
The policy fails to recognize the powerful marketing function of drug samples, and the evidence that supports this. They lead to inappropriate prescribing and increased costs.”
It would be useful if the author of these statements provided a reference list to support these statements. A cursory search of medline revealed very little quality evidence (in the way of randomized trials) that show that samples or sale representative visits affect physicians prescribing practices in a negative way. Opinion papers and editorials are not sufficient evidence to support such claims. Studies of a handful of medical students or residents that are restrospective studies or surveys are hardly good quality evidence. Where is this vast body of quality literature supporting the statements? If they exist, please post a reference list! And if such quality studies do exist, do they prove ‘inappropriate’ prescribing and do they address patient satisfaction and outcomes? Aren’t patients better served by newer medications that have less side effects and are easier to take? Just because a generic treatment exists doesn’t make it the right treatment for the patient in front of you – many marginalized patients cannot access drugs that are the most appropriate treatment for their condition. Samples can help these patients and reduce the disparity in care between the marginalized patient and those who have private drug plans. It seems to be a low moral standard for physicians to deny their patients access to samples when those same physicians can afford whatever drug they need for themselves. And I bet those physicians don’t choose the cheap thrice daily generic medications with 80% bioequivalence to treat their medical problems.
Again from the introduction: “While industry has a valuable and legitimate role to play in the practice of medicine, its interests and responsibilities may diverge from the professional and legal obligations of physicians.” Industry has a fiduciary responsibility towards its shareholders. Thus, this statement in the introduction is weak and does not accurately represent the extent to which industry and physician interests diverge.
I agree that this statement is weak, but it is because there is no clarification how the interests of for-profit companies that develop new medications that improve patient care are divergent from the professional and legal obligations of physicians. In fact, those interests may well be congruent. Again, examples would be useful, with modern quality evidence from literature to support any claims that support or refute the interests of industry negatively affecting physician obligations.
“There is no statement against being part of a company’s speaker’s bureau. This role is essentially that of a paid spokesperson for the company’s product marketing plan.”
If a physician believes in a product and speaks to support that product (namely, educating other physicians), the College should have no role in interfering in this. Physicians who care for patients are in a better position to speak about treatments or medications that would help best serve the patients they care for. It is less meaningful to have a physician speaker who does not have an active practice or is not a physician at all. Speaking for a company that has a great innovation or a new, superior medication does not make a physician unethical or immoral. In fact, their patients may benefit from better treatment.
“Industry-sponsored CMEs are still susceptible to bias even when unrestricted grants are used. It would be good if the policy can encourage seeking funds from non-industry sources when possible.”
It is the reality that a good portion of CME and conferences in every medical field is supported by grants from industry. Why can’t industry be allowed to support education for physicians who prescribe their products and the patients who use their products? Shouldn’t industry be obliged to funnel back money to improving education, thereby raising the caliber of physicians and the care they provide patients? In an era where the Ministry of Health cannot seem to control wasteful spending of tax dollars or manage OHIP funds for modern standards of care, why can’t industry help further improve the quality of Canadian physicians and the care of our patients? Shouldn’t we insist that they do? Industry helps to maintain a highest level of educational activities when few other organization do (including the government and academic institutions).
The days of cruises and expensive presents from pharmaceutical industry are long over – current industry prohibits these practices. It is not sensible to overreact and create overly restrictive policies for unethical events that are extremely rare. The outcome might be a negative impact on research, development, discovery, education, and, in the end, patient care. Innovation is socially desirable – patients with diseases or conditions who have limited therapeutic options would almost certainly agree (and we all may be one of those patients one day!). Physicians want effective medications that benefit their patients and minimize harm, while providing an excellent level of service with clinical scientific integrity. Industry works to develop these products. The goals are not incongruent. Physicians can work with industry to improve patent care are to perceive every industry-physician encounter as sinister is simply wrong.
It is seemingly easier to take the “moral high ground” and avoid all contact with industry rather than the more difficult approach to find the appropriate middle ground that preserves the rights of industry, physicians, patients, and the public to the benefits of medical innovation that comes from collaboration between industry and physicians who actively care for patients. I have no doubt that the vast majority of physicians have a sense of professionalism and can behave ethically in their interactions with industry and filter marketing messages.
If a physician is concerned that they cannot manage ethical behaviour in their interactions with industry then perhaps the College can introduce a course, something like its boundaries course. This could provide objective evidence-based strategies to help those physicians who identify the need for assistance when they feel their professional and legal obligations are being negatively influenced by industry.
The influence of drug promotion on physician prescribing has been extensively studied and demonstrated. This is a good systematic review on the topic:
Essentially, such promotion is associated with “higher prescribing frequency, higher costs, or lower prescribing quality.”
The editor summarizes the value of this systematic review (of mostly observational studies) with the following statements:
“With rare exceptions, these findings suggest that exposure to pharmaceutical company information is associated with either no effect on physicians’ prescribing behavior or with adverse affects (reduced quality, increased frequency, or increased costs). Because most of the studies included in the review were observational studies—the physicians in the studies were not randomly selected to receive or not receive drug company information—it is not possible to conclude that exposure to information actually causes any changes in physician behavior. Furthermore, although these findings provide no evidence for any net improvement in prescribing after exposure to pharmaceutical company information, the researchers note that it would be wrong to conclude that improvements do not sometimes happen. ”
Seems like it is a “good systematic review” of not very conclusive studies.
While there few RCTs of the effects of pharma promotion on physician prescribing behavior, there are numerous other types of studies, and the results are quite consistent. Not everything is easily amenable to an RCT, one needs to consider the range of evidence in every situation. There was never a Randomized Controlled Trial demonstrating that smoking increases the risk of lung cancer. Nevertheless, on the whole, the evidence we have compels us to take action in the public interest. The substantial evidence showing adverse effects of pharmaceutical industry promotion on prescription behavior is getting increasingly recognized around the world. It behooves our College to take a leadership role on this extremely important issue for the purpose of improving prescription practices.
I am afraid your statements are not true. The systematic review quoted in this thread does not support your statement that the results of studies of drug promotion on physician prescribing are quite consistent. They are, in fact, not consistent which was the conclusion of the review. There is no compelling evidence to act on this matter in the interest of the public because there is no good evidence that prescription practices need improving based on available evidence. And of course, prescribing practices and industry interaction are not the same globally.
The comparison of an RCT to investigate an association between smoking and lung cancer is a false analogy and hardly applies in this situation, especially one that involves human behaviour.
1)I fully support the following opnions expressed in this learned discourse&I can`t agree any more.`If a physician believes in a product and speaks to support that product (namely, educating other physicians), the College should have no role in interfering in this. Physicians who care for patients are in a better position to speak about treatments or medications that would help best serve the patients they care for. It is less meaningful to have a physician speaker who does not have an active practice or is not a physician at all. Speaking for a company that has a great innovation or a new, superior medication does not make a physician unethical or immoral. In fact, their patients may benefit from better treatment.`
`It is the reality that a good portion of CME and conferences in every medical field is supported by grants from industry. Why can’t industry be allowed to support education for physicians who prescribe their products and the patients who use their products? Shouldn’t industry be obliged to funnel back money to improving education, thereby raising the caliber of physicians and the care they provide patients? Industry helps to maintain a highest level of educational activities when few other organization do (including the government and academic institutions)`.
`It is not sensible to overreact and create overly restrictive policies for unethical events that are extremely rare. The outcome might be a negative impact on research, development, discovery, education, and, in the end, patient care. Innovation is socially desirable – patients with diseases or conditions who have limited therapeutic options would almost certainly`benefit from the same. `Physicians want effective medications that benefit their patients and minimize harm, while providing an excellent level of service with clinical scientific integrity. Industry works to develop these products. The goals are not incongruent. Physicians can work with industry to improve patent care are to perceive every industry-physician encounter as sinister is simply wrong`.
`It is seemingly easier to take the “moral high ground” and avoid all contact with industry rather than the more difficult approach to find the appropriate middle ground that preserves the rights of industry, physicians, patients, and the public to the benefits of medical innovation that comes from collaboration between industry and physicians who actively care for patients. I have no doubt that the vast majority of physicians have a sense of professionalism and can behave ethically in their interactions with industry and filter marketing messages.`
`If a physician is concerned that they cannot manage ethical behaviour in their interactions with industry then perhaps the College can introduce a course, something like its boundaries course. This could provide objective evidence-based strategies to help those physicians who identify the need for assistance when they feel their professional and legal obligations are being negatively influenced by industry.`
2)Apart from the primary goal of clinical practice,education(partly mandated by MOCOMP etc) &innovation&research is essentially individual pursuit,depending on individual interests&aptitudes&opportunities,in pursuit of not only continuous professional&personal improvement,but legitimate exercise of PROFESSIONAL FREEDOM&FLEXIBILITY.I think,college has to support&commend such activities,as Professional Development,to better the clinical practice&consequently patient care.Apart from prohibiting&disciplining real&proven harm to the patiernts,I believe,College should keep its hands off.Any agregious over-reach with undue restrictions,will become an onerous encroachment on Individual&professional freedom(GUARANTEED BY OUR CONSTITUTION).All the CME programs,I attended,are followed by Peer Assessment forms,for quality,bias,relevance,scientific data,possible risk.College sitting on such Peer assessed activities,looks ludicrous.Declaration of conflict of interest ahould be suffice,in my opnion.Paid cruises or vacations,are long gone.Undue restrictions by the College,at this time,are totally unwarranted&unnecessary.
3)Very small percentage of physicians(a few full time,a few part time,ver few marginal),engage in research activities,again for innovation&exploration,to improve the quality of care,understanding of diseases,provide better treatment options,sharing the unique knowledge&experience of one/group of patients,both positive&negative etc.Overall it is of immense benefit to our patients&as we can see with improved recovery rates&quality of life,in every medical specialty.For publication,all the journals(as much as I know) follow very strict ethical guidelines&specific rules,and they are Peer reviewed,critically analysed&revised, if necessary before acceptance.College sitting on such a onerous exercise,is redundant,and would constitute overjealous encroachment on PROFESSIONAL FREEDOMS&FLEXIBILITY(barring real&proven harm).
4)I`m afraid,if College,gets involved in such exercise,posing restrictions on Professional Development&Freedom,it can easily be dragged into issues like,intra-professionaljealousy,prejudice,dogfights,harrassment,and may end up with dirty laundry.That is not good for the medical profession at all.
I thank the previous colleague (comment by “Physician, March 17, 2:01 p.m.) for her/his excellent and insightful comments, with which I agree, and that will allow me to keep my own contribution shorter than it would otherwise have been.
I would, however, like to highlight a few more points for consideration:
1. On the point of interactions between clinicians and pharmaceutical representatives, there is ample evidence showing that these are not at all beneficial for patients (and physicians) and, instead of being ‘managed’, should be avoided completely. For a short, very well argued discussion of this topic written by a family physician and professor of medical ethics, see: Brody H. The Company We Keep: Why Physicians Should Refuse to See Pharmaceutical Representatives. Ann Fam Med. 2005 January; 3(1): 82–85. (Free full text available at:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1466797/pdf/0030082.pdf, accessed May 14th, 2014).
2. On the topic of ‘managing’ existing relations with industry, the College should advocate for complete transparency, and, like Denmark, require that physicians (and other health professionals such as dentists) seek permission for and fully declare their type of relations with industry (investigator, speaker, advisory board member) and this information should then be made publicly accessible through an online registry, analogous to the Danish one (The Danish National Board of Health, List of permissions for physicians and dentists, available at:
http://ext.laegemiddelstyrelsen.dk/tilladelselaegertandlaeger/tilladelse_laeger_tandlaeger_full_soeg.asp?vis=hele, accessed May 14th, 2014).
In the United States, the 2010 “Physician Payments Sunshine Act” requires that “pharmaceutical, medical device, biological and medical supplies manufacturers report to the Department of Health and Human Services payments that are more than $10 to physicians and teaching hospitals.” (Norris et al. Characteristics of physicians receiving large payments from pharmaceutical companies and the accuracy of their disclosures in publications: an observational study. BMC Medical Ethics 2012 13:24, available online at:
http://www.biomedcentral.com/content/pdf/1472-6939-13-24.pdf and quoted in: Götzsche P. Deadly medicines and organized crime. London, Radcliffe Publishing Ltd., 2013, p. 280). According to the Sunshine Act, reporting of stock options, royalties, consulting fees, honoraria, education, research grants, meals, gifts, entertainment and travel is mandatory and is to be recorded in a publicly accessible database. Additional information to be published in the database include the name of the physician receiving payment, their address, payment dates, and the drug or device that the physician helped promote. Stiff penalties will be levied for both inadvertent omissions (up to $150,000 annually) and intentional failure to disclose (up to $ 1 million annually) (Götzsche, op. cit., p. 280). For patients on Medicare and Medicaid, the data is is expected to be available by late September 2014, after significant delays (See: http://www.pewhealth.org/other-resource/center-for-medicare-medicaid-services-opens-registration-for-open-payments-85899540887, accessed May 14th, 2014).
3. Finally, on the topic of Continuing Medical Education (CME) events supported by industry funding, including ‘unrestricted educational grants’, there is ample evidence (which I will not cite here in the interest of brevity) arguing against any form of industry involvement in physician education, particularly (but not only) in academic settings, because it has been demonstrated that it influences physicians’ prescribing behaviour. Some hospitals and universities have decided to ban such sponsoring (Campbell EG. Doctors and Drug Companies — Scrutinizing Influential Relationships. N Engl J Med 2007; 357:1796-1797; free full text online at: http://www.nejm.org/doi/full/10.1056/NEJMp078141, accessed May 14th, 2014) and for many years, some doctors’ organizations, such as the Danish Medical Association, have refused to offer their members industry-sponsored CME (Götzsche, op. cit., p. 277).
In closing, the CPSO stands at a cross-roads with respect to a crucial issue: will choose the more comfortable path of trying to please all and thereby achieve little in the way of protecting the public – and its physicians – from undue greed and influence in the name of industry’s bottom line? Or will it take the bold step of upholding the values of professionalism, accountability and transparency for the greater good of society, thereby contributing to fullfilling ist mission of „Quality Professionals, Healthy System, Public Trust“. I, as one of its members, sure hope it will choose the latter.
I don’t want my doctor being bribed by food prepared and served by pharmaceutical companies, regardless of how ‘modest’ the meals are. The perception of the physician in the community is too important to be sacrificed by Thai curries and baked goods.
I suppose I should refuse any coffees and food brought in by patients because it would bias me in their favour as well. Honestly, I don’t remember the names of the companies or the products promoted in relationship to any meals received. I attend CME events at local restaurants on occasion because of the speaker and the topic, not for the meal. How else does a rural doctor get to interact with specialists, discuss cases, and learn new stuff?
I commend CPSO for undertaking this contentious issue. I think the 5 principles are excellent but note some deficiencies in the following text.
1)A particular concern is the lack of censure of physicians participating in “speakers bureaus”. These presentations by “experts” are essentially slides prepared by industry (no alterations are usually allowed). The “experts” are basically paid spokespersons for marketing the product. I recently sat through one of these presentations as part of “an academic update program” at an esteemed university and the physician from a speakers bureau presented extremely biased material in an area in which I am very knowledable. When challenged he claimed lack of time to respond. This is not education, it is marketing and should be stopped.
2)Page 1: I question the statement “that industry has a valuable and legitimate role to play in the practice of medicine.” I think the problem rests in the phrase “the practice of medicine” as I believe their role should be limited to the development of products to treat medical conditions and NOT in the provision of marketing(education). Page 3: Product detailing is a major problem as it is unbalanced and should NOT be a source of physician education. Education shoulsd be nonproduct specific and rest in the hands of educational abnd speciality organizations. In fact I think industry reps should not be in physician offices and should only visit hosptals by specific invitation to demonstrate medical devices.
Page6: Disclosure of potential conflicts of interest should be mandatory not only in journal articles but also for ALL presentations to healthcare providers and the public. All presentations (not “if reasonable”) should include fair discussion of other treatment options if available.
The College needs to take a balanced view of this complicated issue. In an ideal world the Policy is fully acceptable. However my issue is with physician education, specifically about new technologies or drugs. Although improvements have been made by the College and the governing professional organizations, the fact is that there is no mechanism to teach doctors what they dont know when they dont know what they dont know.
In my field, the recent introduction of a new class of medications has created turmoil and instances of patient harm. Knowledge of some simple practical caveats in use of the drugs, would have avoided all these issues. Yet the prescribing physicians were not made aware of these in any easily digestable forum. Product inserts, academic rounds and primary papers do not have this kind of practical information. Previously, in my experience, this practical new information would have been obtained at a “drug dinner”.
In 2013, the president of NSERC was quoted as saying “Scientific discovery is not valuable unless it has commercial value.” Medical industries clearly share these values, but do not need to state it, as it is clearly their orientation. Where will unbiased pure science come from in Canada?
I believe the CPSO needs to step back, and challenge the thinking of the public bodies that fund research. If the philosophy stated above is to prevail, there will never be research resulting in concluding that a cheaper product is superior, or abandonment of a profitable, but harmful product, at least in Canada.
For physicians to challenge industry claims, there must be an objective reference point-from where is this to come?
Some would probably believe that there should be no contact, what so ever, between physicians and industry. Where in the document is there some provision for allowing physicians some acknowledgement of what is right and wrong and to make such determinations. Physicians in different specialties may have more or less contact with industry through speaking engagements, conferences, research, etc. One set of rules might not work well for all. Also over the years physicians may form friendships with people in industry, just as co workers in other fields do. How will the college assess a dinner between a physician and a pharma person, can it be 2 friends having dinner or is all contact “bad” To physicians and members of the CPSO council who strongly feel that they have practiced medicine poorly in the past because of their relationship with industry b(their comments speak to one of experience), I say stand up for what you believe, admit to the college that you have practiced poor medicine and accept your punishment before a discipline panel. At that time I will believe you when you say that relationships with industry as outlined are bad. Until then, they are just based on people’s opinions or studies and we all know that study results can be influenced to show the intended result…otherwise we would not be concerned with industry sponsored studies
It is fine for the College to demand the most ethical behaviour of physicians in their relationships with corporations. However, the College is demanding that such behaviour must be perceived as ethical, and not necessarily be real. There is a huge difference.
It is very easy to be completely ethical and yet transgress the proposed guidelines, for example:
1. Using proprietary names for ophthalmic viscosurgical devices instead of generic names in lecturers. Only the most educated with respect to these products are aware that in reality there are no generics. 1% sodium hyaluronate products from different manufacturers are not nearly the same with respect to performance in surgery. The manufacturers of inferior ones truly hope that we use generic names. The manufacturers of the best ones thereby lose out in favour of unethical cheap copy companies when a presenter uses generic names, and the audience is led to believe that a specific procedure can be performed easily with some products that may not only be poor for the procedure, but sometimes dangerous. GENERICS ARE NOT ALWAYS EQUIVALENT TO PROPRIETARY PRODUCTS, AND SUGGESTING THAT THEY ARE MERELY PENALIZES THOSE WHO HAVE SUPPORTED RESEARCH AND DEVELOPMENT IN FAVOUR OF THOSE WHO SIMPLY MAKE POOR COPIES. A speaker should have the option of using either generic or proprietary names, but simply be required to state why that option was chosen.
2. Severe restriction of doctors acting as consultants for companies makes the erroneous assumption that doctors are ill equipped to contribute to product development. Many doctors have backgrounds in engineering and basic sciences, and this knowledge coupled with their unique experience in patient management sometimes makes particular individuals unique resources for companies to request their participation in the development of really new and wonderful devices and technology. There is no more reason to restrict a doctor from using those skills to better humanity than to restrict anybody else from such work. The real evidence of ethics is how the individual uses his ability and skills to educate his or her colleagues about what has been developed or is under development. The College seems to wish to accuse and convict anybody who unfortunately possesses exceptional skills. Chase the guilty but leave the rest alone to advance science and medicine.
3. Ethical doctors generally use samples for patients who cannot afford to buy a given drug that they need. The doctor does not sell them, but performs an ethical and charitable service in giving them away to those who need them but cannot pay for them. Restricting this, because someone somewhere may be unethical is merely an expression of the laziness of the enforcers to find those who transgress, and so choose to simply penalize all doctors and their poor patients in ways that look good when posted.
4. Preventing drug companies from funding “biased” education of doctors, means that you withhold education about new diseases and treatments from the masses of doctors, who have no other source for this education. Our Universities do not have funds to pursue these objectives, and hopefully each doctor is smart enough to be fully aware of the company’s self-interest in holding these meetings. So, unless all doctors are simply stupid, and all companies corrupt, where is the real problem? Closing this avenue of education is simply an error achieved in pursuit of approval of a public that is unaware of the real issues. I have never attended a company sponsored presentation where any bias was not blatantly obvious, and encouraged me to look up independent information on the subject after the meeting. The meeting acted as an impetus to perform specific research, not as a substitute. Sometimes, when chairing meetings, I have actually asked a company to send a researcher to explain the company’s view of a new treatment, because, big surprise, a company that may have invested $100 million dollars to bring a product to market has actually thought about the issues it intends to address. Having their researchers defend their position to a panel of doctors is a good way to gain useful information, not a biased sales job. 5. Excessive regulation has never achieved more than stifling innovation and progress. Doctors are very capable of reading to verify what they have been told. If they do not check, it is their own fault for being lazy, not the educator’s fault. Patients may suffer due to their doctor being lazy, not because a company or lecturer was unethical. Therein lies the real problem. Smart doctors simply disregard bad lectures and unethical sales promotion.
I agree with this physician’s comments. Why is all industry looked in such a bad light? There are many pluses that arise out of a physician’s interactions with industry, and many of those are ultimately for the patient not for the physician. Many aspects of this draft policy (and its predecessor policies) seem to come from a place of mistrust of industry but as well as physicians.
In addition to the comments noted above, I wonder if the College can provide any rationale as to why it is acceptable for industry to provide scholarships for CME/CPD attendance to medical students/residents/fellows but not to full-fledged physicians? What is the ethical and moral rationale behind Lines 192-197 in this draft?
On a more general note, I see that the CPSO has elected to proceed with an increase in annual dues. I find this interesting, as this topic was recently discussed on this website. Indeed, the vast majority of both physicians and public ( i.e. more than 95%, as determined by a simple count of more than 100 posts ) were of the opinion that annual dues should not be raised. In this era of fiscal restraint, I find it ironic that the CPSO has decided to give themselves a raise when their physician colleagues have received anywhere from a 10 % to 30 % pay cut.
I raise the above issue as it appears that neither physician nor public input / feedback appears to play a role in the college decision-making process. I strongly suspect this college endeavour is merely a perfunctory attempt to demonstrate that this institution interacts with ” the people.”
If this is not the case, I would request that the college please provide me with some counter-examples.
College of Physicians and Surgeons of OntarioThank you very much for your feedback. As this comment primarily relates to the recent increase in membership fees, a reply has been posted to that discussion page.
I have reviewed the document related to physician relationship with industry and find it comprehensive and quite complete. I am in agreement with most of it. I do believe that the issue related to medication samples should be reviewed. The pharmaceutical industry has claimed that leaving physicians medication samples for their patients was there to help patients. In fact it is a very powerful marketing exercise aimed at changing physician prescribing habits. There is significant evidence that it does largely influence prescribing habits. Samples are typically the latest or newest medication and the most expensive. I think that accepting samples should be largely discouraged or even banned.
Allowing a patient to try a medication for a few days to ensure the medication is well tolerated before purchasing a prescription is the argument that drug representatives have used to entice physicians to accept samples, but in fact patients would be far better served if this service existed at the pharmacy. I stopped accepting any samples many years ago and I am sure this has not caused my patients any hardships.
Thanks you for accepting feedback and I hope this is a useful opinion
A most comprehensive document. Very well done and I wish to congratulate you .
I am in my 74th year and really wish to note how inclusive and cogent this document is. I especially like your statement…”Physicians who attend CME/CPD events must not accept payment or reimbursement for travel, lodging, or meal expenses from industry.”
Any regulations are essentially meant to prevent unethical practices among medical professionals. Although it may sound logical and necessary I urge CPSO not to fall into trap of a political decision. Why physicians can’t have lunch research or business discussion with industry and a politician may accept such invitation from supporters of his/her campaign? Unethical individuals will find a way bypassing legislative efforts, while ethical person won’t accept equivocal goods regardless of value.
Similar regulations in USA resulted in massive retraction of industry funds from academic centers into private contract research organizations (CRO). Who benefited from this move remained unclear, but definitely not academic physicians. If doctors won’t consult industry, there is no way to figure out which innovation is worth investment and implementation into clinical practice.
Presenting relations physicians with industry as a bribery is harmful not just to these two parties but to society in whole.
Instead of regulations and restrictions CPSO should invest in making a disclosure mandatory and openly accessible, similarly to the Sunshine Act.
Is the Canadian Medical Malpractice Protection an industry?
Are there any polices on the practice of doctors and lawyers “golfing” together?
The standard of care decided on who wins?
What is the college’s view of doctors who sell their patients vitamins which gives them a profit from the sale. To me this is a direct conflict of interest, no different than a physician who profits from owning a drug store. Also patients may feel by not buying these products that they will get worse care from that doctor; and again if a doctor profits from selling these as opposed to perhaps prescribing meds, that patient may suffer.
Response in PDF format.
It would be useful if the author of this entry provided quality evidence to support his or her claims. For example, the references that are used to support the the ills of drug samples are poor quality, either surveys or retrospective studies fraught with confounders that do not address patient satisfaction and outcomes which would be best measured by a randomized trial that focuses on patient reported outcomes. The references about continuing medical education are from 1986 and 1988, almost 30 years ago – things have significantly changed since then. Hopefully some of the discussion forum supporters of prohibiting physicians from interacting with industry can provide some real evidence for the ills of modern industry interactions rather than espouse unsubstantiated opinion.
Overall I think that the draft policy is too non-specific and leaves a lot of room for interpretation for some physicians who feel they are entitled to the benefits from these relationships.
I would suggest review (if not already done so) of the ABPI – Code of Practice for the pharmaceutical industry 2014 (United Kingdom) which provides much more specific details, such as items that are acceptable to receive, as well as number of visits from a drug representative per year, etc, which may be a bit too restrictive but is very clear.
Also, I think that orthopedic surgery needs to be looked at specifically as they appear to have a much closer relationship and more frequent contact with industry reps due to the nature of the surgery/implants that are used.
Also on another note, I am surprised to see that comments made so far are published on the website; I think this is prejudicial to others that have not yet submitted comments. I agree with transparency efforts but all comments can be made available after the closing date.
I applaud you for attempting to deal with misuse of industry dollars. It is unfortunate that the potential good that comes from industry partnership will be affected by this new directive. I have worked closely with industry for many years. Maybe my approach is different, but I have tended to avoid companies that have tried to buy my business with gifts and trips. I am lucky to continue to work with companies that, in my mind, put education high up on their priorities. Many offer valuable educational sessions – both locally and across North America. – with no strings attached. It is true that as a physician, I can afford to pay for these special (often hands on animal labs) myself, but honestly, I probably would not do so.
I have no easy suggestion as to how to police this and to prevent the various misuse that has happened in the past. However, I do know that if blanket statements preventing industry support of bona fide educational events is prevented, this would be a shame.
We all know physicians who are aligned with many companies, travel often paid for by the company and get enormous fees for presenting. How is fair market value determined re presenters? What are the repercussions if presenters violate these policies or is this just a guideline or honour system? How about the CPSO pushing for a Sunshine act as they now have in the USA so people who make huge amounts of money from pharma can be detected?
The companies usually operate in multiple provinces and many are multinational. They will not stop this practice. They will take their research dollars to another jurisdiction where the rules are not as restrictive.
In my opinion, the draft policy is too lenient. Physicians who are practicing and responsible for patients should not be allowed to accept reimbursement/salary from any pharmaceutical or other medical technical industry for any reason. Consulting fees, conference travel, speaker honoraria, none of these should be paid by a drug company to any physician who might use their product on a patient.
For example, some of my medical oncology colleagues never refer to drugs by the generic name, always by trade name (Arimidex for anastrozole, Femara for letrozole, etc). This even when teaching residents or medical students, which perpetuates the habit. Certainly they also use the brand names when speaking to patients. I know that this is probably because they receive consulting fees, honoraria, and free travel from the companies, and that this reflects how they think about the drugs.
Maybe you could provide some insight into why you think physicians who care for patients lack the professional autonomy to do other work for industry for any reason? Physicians who care for patients are probably the BEST physicians to do that kind of work. They can provide the best advice to companies who are developing medications and treatments to improve the lives of our patients.
Maybe your colleagues who refer to drugs by trade name have the insight to know that it is the brand name version of the medication that was studied in trials, not generic company versions. I personally would not accept an 80% bioequivalent generic drug to treat my cancer or any other serious illness for that matter.
Most pharmaceutical companies have very strict rules about physician reimbursement for the work they do, moreover it is unreasonable for physicians not to be paid for their work.
There is ample evidence that industry promotion biases physician behavior towards industry interests. Notably, such bias is largely unintentional. Following is a good article on the topic:
Further, there have been numerous empirical studies on the influence of drug promotion on physician prescribing. This is a good systematic review on the topic:
As the review concludes, such promotion is associated with “higher prescribing frequency, higher costs, or lower prescribing quality.”
I read these two articles with interest. I wondered how they provide ample evidence that industry promotion biases physicians in a way that negatively affects patients.
The main point of the first article is that unintentional bias is something common in everyone, it is natural, and is not a sign of a lack of integrity. This makes sense and it something we can all acknowledge. But the article’s authors identify that “physicians have many relationships that may result in bias other than those involving pharmaceutical companies…”. For example, one can identify that physicians being paid by OHIP is a major conflict of interest. This bias could unintentionally cause doctors to not order necessary tests in order to “save” OHIP money so their income is not adversely affected, as it has been in recent years. What stronger conflict is there than one which impacts your livelihood? To undo this significant conflict of interest would be to move to a private pay system where doctors’ incomes are not dependent on the ability of the government to pay its doctors. Are we ready to undo this significant conflict of interest?
But coming back to the information in this article, it is clear that everyone needs to accept that all of life’s interactions affect one’s behaviour. But it does not logically flow that unintentional bias from industry changes physician behaviours to ones that will harm patients or not be in patients’ best interests. The second article addressed that question using a review of published literature of available evidence
- but it failed to make a conclusion that there is any proven impact.
Most telling about this review are the authors own statements. First, “All of the included studies had design limitations”. Only two the included 58 studies were randomized controlled trials and most of the studies had data collected prior to the year 2000, many with data collected in the 80s and 90s, thereby not providing results that are consistent with contemporaneous interactions between physicians and industry.
Second, the authors themselves state in the first line of their conclusions: “The limitations of the studies reported in the literature mentioned above mean that we are unable to reach any definitive conclusions about the degree to which information from pharmaceutical companies increases, decreases, or has no effect on the frequency, cost, or quality of prescribing”. So there is actually no definitive conclusion of this systematic review and therefore the paper does not support the stance that industry promotion biases physician behavior towards industry interests.
Third, and most importantly, “Any conclusions about harm or benefit for patients are speculative because none of the studies that we found examined clinical outcomes”. None of the studies addressed the prescribing of drugs that provide better health outcomes for our patients (regardless of whether they are more costly or more frequent).
Overall the studies that were identified in this review are poor quality and do not inform us that there is negative impact from physician-industry interaction. The authors make their recommendation that physicians avoid pharmaceutical company information solely as a “precautionary principle” and they acknowledge their recommendation is not based on any good evidence that they found in the literature.
So after reading your two cited articles I am left with the following: physicians, like everyone, are influenced by all of the information that surrounds them whether they realize it or not. Looking specifically at pharmaceutical company promotion, a review of the studies that exist (all of which have design limitations) shows no concrete evidence that there is any proven impact on physician behavior by pharmaceutical promotion. Imposing too many restrictions on a physician’s ethical professional behavior based on a “precautionary principle” seems unnecessary. But of course there are many types of industry interactions and the review article only covers one category.
With regard to the College policy under review, it should not be revised to be more restrictive of useful interaction for which there is no proof of any negative impact on patients. It is possible that more restriction may in fact harm patients by preventing medical innovation and progress (Nakayama, The American Surgeon Sep 2010; 76, 987-994 is an interesting read from another perspective). To promote a valuable discussion on both sides of the issue, the College president in his Volume 10(1) MD Dialogue should not have stated his personal opinion about the matter of industry-physician interactions in his message. Hopefully publishing his opinion will not unintentionally bias physicians against posting their comments in this discussion forum if their opinions are divergent from his.
If the College is concerned about patients’ perceptions of and trust in physicians, the College could embark upon a campaign to educate patients about the real and permitted physician-industry interactions that occur in 2014. Probably most people think the interactions of 1980s still exist, which they most certainly do not. There are real benefits of modern physician-industry interaction. In the end, it is inconceivable that the healing arts and industry are not impossibly intertwined; the challenge is to ensure that a fair, ethical and balanced approach with industry is taken to continue to improve the care of our patients.
While there are few RCTs of the effects of pharma promotion on physician prescribing behavior, there are numerous other types of studies, and the results are quite consistent. Not everything is easily amenable to an RCT, one needs to consider the range of evidence in every situation. There was never a Randomized Controlled Trial demonstrating that smoking increases the risk of lung cancer. Nevertheless, on the whole, the evidence we have compels us to take action in the public interest. The substantial evidence showing adverse effects of pharmaceutical industry promotion on prescription behavior is getting increasingly recognized around the world.
Referring to the 1980s in order minimize current concerns about interactions with the pharmaceutical industry is at best naïve. Drug dinners at high end restaurants occur on a routine basis in our Province. Physicians can make substantial amounts as company spokespersons promoting drugs to their colleagues (“speakers’ bureau”), or acting as consultants or on advisory boards which are often little more than marketing focus groups. There are numerous other examples of problematic interactions. See, for instance, the following advertised event, in which a physician can get paid $200 to ostensibly participate in a “Consultants Meeting” which is little more than a sales pitch for the drug in question:
It would also be naïve to lump pharmaceutical industry bias with the myriad interactions that can influence us in one way or another. Of course, we all have a variety of life experiences that can influence how we approach different issues in different directions; however, pharmaceutical industry promotion stands out in terms of consistency of direction, magnitude, and systemic influence. Further, while the bias by physicians is largely unintentional, pharmaceutical companies seek to influence us in a very deliberate, well-orchestrated, and systematic manner. They may be fully aware of the limitations of their drugs, yet they deliberately exaggerate benefits and downplay risks to suit their commercial interests. Problematic interactions with the pharmaceutical industry have been recognized and can be mitigated. I hope that our College takes a leadership role on this extremely important issue for the purpose of improving prescription practices.
There is nothing naive in asking for quality and contemporaneous evidence to support a position, and since good medicine is evidence-based medicine, shouldn’t we ask for such evidence? Nowhere in this forum has someone referenced a good quality study that supports the notion that physician-industry interaction is harmful for our patients because the interaction negatively impacts prescription practices. I hope our College critically examines the body of available literature and makes a properly-informed, well supported policy based on good quality evidence and not on supposition. Such appraisal is required to produce a policy that does not in the end negatively impact the patients we work so hard to care for.
The following event is an example that entails multiple highly problematic practices:
It does not seem to me that the CPSO draft policy adequately addresses the practices involved in this and similar events.
Considerable information,letters,views etc were published by the free journals,now this is limited by the cessation of publication of these by over 90 percent due to decreased advertising revenues. There is a bias that natural,non patented drugs never get a mention,I wonder why? A typical example is Boron,it may be the answer to many varied conditions especialy athritis, OA & JIA
I believe that the College should be setting a higher bar-being cognisant of best possible evidence and past experience, with the goal of providing best care for patients. The rights and privileges that physicians claim with regard to outsiders providing gifts and compensation would not be accepted by any other public servant-and that is despite the fact that we are compensated higher than the vast majority of society.
Lexchin has looked at these relationships and academic centres.
SSMD has had much more stringent policies for the last four years and tried to prepare educational materials.
And several academic departments and universities across North America have even more stringent policies.
We have to move beyond the lowest common denominator, with loose recommendations asking physicians to use their own judgment, which the College does not take with regard to other issues, if we really wish to move beyond the culture of entitlement.
Consider this. You hire an insurance broker to help you find home insurance, and she recommends company X’s policy. Would you be concerned if you found out that her yearly educational events were subsidized by company X? What if some of the speakers at these events had been paid thousands of dollars by company X for other talks or research activities? And if she assured you she was not influenced by any of this? Would your concerns be allayed?
The study by Sharek presents physicians with a similar scenario- one involving financial planners- with very interesting results. The study shows how is hard to evaluate potential conflicts of interests from the inside. Physicians do not realize they are being affected. The public and the CPSO needs to take a stronger stand.
Sharek, Zachariah, Robert E Schoen, and George Loewenstein. “Bias in the Evaluation of Conflict of Interest Policies.” The Journal of Law, Medicine & Ethics: a Journal of the American Society of Law, Medicine & Ethics 40, no. 2 (2012): 368–382. doi:10.1111/j.1748-720X.2012.00670.x.
OVER THE YEARS I HAVE ATTENDED MANY CHE dinner meetings hosted by pharmaceutical industries.Most of the meetings are very informative.Some of the speakers are biased but most of them are not biased.It is up to the physician to choose what is best in the interest of the patients.
Trials are important because they underpin the advancement of medical science. I recognize that there must be a careful balance between the protection of the public, and the support of the trial industry.
I feel it is important that physician participation in trials be encouraged in Canada. If this participation is discouraged, then a consequence may be to drive the trials to 2nd or 3rd world venues with less strict controls. That may produce less robust evidence about the effectiveness of the agent under study.
I see nothing in this draft policy which encourages Canadian Physician participation in trials.
However, the Draft Policy also fails to control what are obviously blatant contraventions of the spirit of the Policy.
I personally know of a multinational drug trial that probably meets all the requirements of this draft policy, but woefully fails to pass a sniff test. The trial involved multiple countries including several in Europe, Australia, South Africa, North America and Mexico. During the multi-year trial a series of 5 meetings were arranged to update investigators on the ongoing progress of the trial. These meetings were held at a variety of international 5 star locations. I know physician attendees who said they would never be able to afford to stay at these locations. Travel was pure business class, and the Progress Meetings involved short meetings in the mornings over 3 days leaving the attendees with the remainder of the days at their disposal in fantastic locations.
The physicians never received any direct compensation for their efforts, nor did they have any role in the selection of the venues for the meetings, but did receive wonderful short vacations to luxurious locations around the world.
I don’t see how any of this contravenes the Draft Policy, yet it seems egregious.
When ethics boards review trials, are the specifics of the physician-industry interactions also subject to review, or are the ethics reviews solely focused on the prevention of harm to patients from the agent/device under study?
Phrases such as Fair Market Value and Reasonable Rates of Remuneration are subject to vastly different interpretations. For instance, if physicians with different incomes and therefore hourly rates are involved in a trial, should the physicians be compensated at different rates, because their Fair Market Values are different? A reasonable rate of remuneration for one physician may be a pittance to another, and a princely sum to a third. I think if the purpose of the policy is to create a level, transparent playing field, the College should step up and dictate exactly what is a reasonable rate of remuneration. It seems unfair to write policy that carries penalty for transgression, without specifying exactly what the rules are. Its like asking athletes to participate in a new game, but not telling them what the exact infractions are that will draw a penalty. If transparency is the goal, then lets get that completely out in the open with a comprehensive Ontario wide policy that dictates the exact remuneration that physicians can receive, ie. $250/hour for explaining the trial and getting consent from a patient. $500/hr for data interpretation etc.
Lines 231 – 233 are unclear in their intention and/or enforceability. If the idea of preventing “fancy trips / locales” for meetings is the intention, the loopholes in the wording will not achieve this at all. For example, it might be customary for me to attend the European meeting in my discipline. Attending an AdBoard in that location would be congruent with the policy as written.
What about physicians who receive nursing assistance from industry to provide medication to difficult to treat populations (e.g. Hepatitis C populations in prisons)? I think that may be a reasonable form of industry assistance to receive as a physician.
Many physicians double as national/international advisory board members and double as speakers. Lines 227-228 would have implications for many specialist physicians in Ontario.
I think this is a good initiative!
However, the only recommendation is that you modify these two points from 155-156
All funds from a commercial source are in the form of an unrestricted educational grant payable to the institution or organization sponsoring the CME/CPD activity.
and 160 – 161
Payments must be made through the meeting organizers and not the industry sponsor
For larger organized events this is reasonable, but for smaller informal evening CME, this is not as many of these events, including lunch-hour talks, will not have a structured organizer who will be able to manage “educational grants”.
As well, it becomes more difficult when CRA wants HST charged. Smaller events will not be able to deal with HST requests.
In my experience, these steps do not make any difference to the presenter, and are simply an extra bureaucratic step.
HST is never an issue. The pharma company just adds it to the speakers fee. No problem!!!!
Thank you for the opportunity to comment on this draft policy.
On balance the document is typical CPSO policy, long on principle and short on specifics, but quite reasonable. It provides a field day for lawyers because there is so much to argue about when applying specifics of a case to the general language of the Policy. However, this might be the best that is possible under the circumstances.
I have one specific concern, and this relates to the inclusion of patients into trials. If I understand the Policy draft, it will be impossible for a physician to be reimbursed for the inclusion of a patient into a trial, for anything other than his expenses related to his time required for explanations of the risks and benefits of the trial and the obtaining of the appropriate consent from the patient. Please correct me if I am wrong on this point.
The unintended side effect of this policy might be to drive those agencies interested in conducting trials to negotiate directly with patients, rather than having to work through the filter of a physician responsible for the patient. For instance, if there is no benefit for a physician to become involved in a trial beyond an hourly wage, why would they get involved? If there is insufficient buy-in from the medical industry, what would stop an agency from advertising directly to patients, and paying the patients for their cooperation? That would be a potentially much worse scenario, since there would not be the kind of professional responsibility embodied in a physician-patient relationship protecting the patient.
Imagine a certain Pharma company has a new drug for treatment of metastatic prostate cancer. They are unable to get physicians interested in enrolling sufficient numbers of patients. They then place ads in local newspapers and on the radio soliciting patients with metastatic prostate cancer to enrol in a trial for which the patient will be paid. The patients are then randomized to receive the medication and agree to turn over their medical records to the drug company who then publish the data. This is not far-fetched. If patients are willing to receive a payment for blood donation in the USA and Canada, is it unreasonable to assume that they would cooperate with a drug company for a suitably large inducement, say $1000.00 to take a certain medication?
If this scenario plays out as a result of this policy, how has the public safety been enhanced?
The current situation may be far from ideal, but may be significantly safer than alternatives that corporations might dream up to obtain their goals.
I agree completely with this member’s views – consistent with the CPSO’s President’s recent views – medical values (optimal health care ) and industry’s views (optimal profit) are essentially not aligned. I think we should move towards zero tolerance – like slavery, votes for woman and drink drivers. The alternative is a dinner with the Devil – that will require so many rules & regulations that most people will spend their time working around them, or simply dropping the idea!
The world has been moving in this direction for the past several decades anyhow. . . .(unfortunately mostly by repeated corruption revelations).
This statement is simply misleading and false. I have worked for many pharmaceutical companies over the past 20 years and have found the companies to be genuinely interested in high quality CME. They are good people and it is simply unfair to describe them as “The Devil”.
Re: the CPSO quick poll
There is empirical survey data to show that the answer most ordinary patients would give is “no”.
Why would most patients answer “no”? They would answer “no” because they would understand the question to mean “Is it likely that your doctor would deliberately subordinate your health in order to feather her/his own nest?” And most patients confidently answer that their doctor would not act in such a corrupt manner. But then, when asked, they then go on to affirm that other people’s doctors would have their integrity compromised. This result parallels a similar question put to medical residents about whether their own judgement is biased by the acceptance of industry money. The majority of residents answer that their judgement would remain objective and unbiased. But then, when they’re asked about their colleagues, a majority opines that, yes, indeed, their colleagues are likely to have their judgement biased by the acceptance of industry gifts.
So, two important points. First, almost everyone (doctors and patients) has a poor grasp on the mechanisms by which COI biases the judgement of physicians. When asked about COI they interpret this as if they are being asked about whether they (if they’re a doctor) or their doctor (if they’re a patient) think that acceptance by doctors of industry gifts would cause a deliberately corrupt choice. Understandably, doctors see themselves as not easily corruptible. They self-righteously assert: “I can’t be bought for …(fill in the blank with anything you care to name)”. Secondly, physicians recognize (to a much greater extent) that the acceptance of gifts by their physician colleagues will produce bias. Turning to patients: They “get” that doctors in general can be biased by industry gifts but they don’t generally recognize that their own doctor is no exception.
In an important way, the very question posed by the CPSO quick poll – would your trust in your doctor be diminished? – is (unintentionally, I suspect) a tendentious set-up.
I am in agreement with most of the guidelines.some important points have been made by other physicians that should be fully discussed.
I would discourage any direct payment to physician.
Cost incurred in any industry-physician interaction should be refunded.
Any research by physician should be covered by. Pons or of project by payment to hospital/institution where research is done but only to cover actual costs and any justifiable overhead expenses..
I disagree. Speakers take time from their practice to deliver the seminar and usually spend additional time (often many hours) preparing their lecture. The physician deserves and has earned their fee.
Overall, a reasonable and fairly comprehensive document. The physician in thread #4 referred to what I find to be the most disconcerting physician – industry interaction – when a speaker who was not involved in pre-market research uses using the company’s pre-packaged slides to present what is meant to sound like clinical experience with a product before the product has been released for clinical use.
I agree that industry generated slide sets are often flawed, not presenting full data sets, giving incorrect references, etc. Speakers should create their own slides.
Input from stake holders who have vested interest makes value limited. On the other hand every industry has it’s for of bribery and corruption. I would think this is not a college issue unless it affects patient care and outcomes. Usually the scientific Merit is the reason for the consultation from medical advisors.
I agree that guidelines are important to assist physicians in their interaction with industry. Many physicians will not be coerced into inappropriate prescribing based on industry expectations and pressure selling techniques. However, there are those who, due to ignorance or greed, act otherwise. and it negatively affects all physicians in the face of the public and their colleagues. Interaction with industry must solely be for the benefit of the patient yet be respectful of physicians who take time from their personal lives and their offices to provide expert advice, to educate colleagues and the general public on health matters and to participate in legitimate, ethical clinical trials. I have appreciated when industry provided unrestricted educational grants so I could provide valuable patient teaching from allied health professional when the government consistently refused to offer this funding. I have appreciated the ability to take time from my office to attend conferences, to have financial support to offset this loss of office income and to have the ability to return to my community to disseminate what I learned. I have, over time, been able to attend more educational events than I would have been able to do otherwise. I appreciate the ability to provide medication samples to many of my patients who cannot afford any type of drug therapy. I appreciate the ability to provide my patients who volunteer for clinical trials the opportunity to be treated with medications that are not available in Canada. And even if they were available in this country, many patients would not be able to afford them. But guidelines are also in danger of creating an intellectual elitism: those from teaching centres have timely access to relevant and recent medical education, and control the dissemination of this information; therapeutic elitism: the poor and marginalized in our society are restricted from accessing important therapeutic options while the rich and connected have unlimited access; and educational elitism: teaching is from pre-selected individuals from pre-selected educational institutions irrespective of their ability to teach and the value of clinical experience is diminished. This complicated issue should not be simplified. Ethics in medicine is a priority, as is patient care, and this applies to every industry or business that interacts with physicians: pharma, our professional organizations and our government. I think this draft reminds us of the importance of and justification for many changes which are already in place and should not be used to terminate events and interactions which have been historically valuable to the non-elite and marginalized in our society.
This is an excellent entry in to the discussion. Thank you.
although I agree in principle what the CPSO is trying to do it should not lose site of the big picture. lets say for example I can only get to a meeting which is relevant to my practice with support of pharma ( ido not pick the meeting locations). Instead of going to a meeting relevant to my patients needs I will do these little irrelevant CME programs to get my hours even thou they are of little practical use. I will not attend peer reviewed programs that would benefit my patients…is this good medicine…if it is then it certainly makes my life easy (just would hate to be my patient)
The problem is monumental and reminiscent of an iceberg. Much more is beneath the surface than meets the eye! Any proposed solution must have teeth and include disciplinary actions. Just a month ago I attended a conference where 8 speakers were absent from the list of “Faculty Disclosure” at a time when their presentations were clearly promoting a product that they are known to be connected with and which they have been researching! Perhaps too, CMPA protection should be withdrawn where there has ben an undeclared conflict of interest.
Financial remunerations must be disclosed by physician and company to a regulating body (e.g. some ethical body within CPSO etc.).
The CMPA must be made to cooperate in identifying and reporting in the misplacement of trust and the resulting complications.
Study just published on the effect of medical samples on prescription behavior:
One method pharmaceutical companies use to promote new medicines is to give free samples to doctors. A new study confirms that the technique is highly effective.
Researchers compared prescriptions written in 2010 for adult acne drugs at an academic medical center that prohibits distribution of free samples with those in a database of prescriptions by office-based dermatologists nationwide.
At the academic center, 17 percent of prescriptions for adult acne medicine were for brand-name drugs. That was far lower than the 79 percent prescribed in private offices, where drug companies typically distribute free samples.
The study, published online in JAMA Dermatology, found that even when identical generic drugs were available, doctors preferentially prescribed the brand name if they were given samples. The three best-selling acne drugs were all promoted using free samples.
Using the top 20 most prescribed medicines for adult acne, the researchers calculated that the average cost of drugs was $465 in office-based practices and $200 at the medical center where samples were unavailable.
“When we were forced to stop using samples, my practice changed,” said the senior author, a professor of dermatology at Stanford, who advised patients that “you want to know when you receive a sample what other choices you have and how they impact the quality and cost of the medicine you’re receiving.”
In the draft document the following statement is made:(line 386)
“Publishing negative findings
Physicians must seek to publish negative as well as positive results in the spirit of good science, and in the interest of contributing to
the existing body of knowledge….”
I believe that this statement has to be strengthened to say: Before taking on an industry- initiated study, the agreement between the institution the physician practices and Industry, or between the physician and Industry must stipulate that the physician maintains the right to publish any result, regardless of the directionality of the results. Most ethics committee insist to date on this condition, but it must be stated.
We know from psychological research that people feel indebted when given a gift- however small (including a pen, or lunch). There is absolutely the potential for bias when inviting members of industry to present at clinics and leave samples. I commend this document but I think it may need even more teeth.
Without the innovations and research carried out by the pharmaceutical and medical device industries there would have been little or none of the great advances in medicine that we enjoy.
Doctors will be targeted by the promotional efforts of these industries – which spend as much on marketing as they do on R&D.
We doctors press on, vaguely suspicious of the powerful pharmaceutical corporations but knowing that this is the basis of our therapeutic tool kit.
At the very least, though, we expect that the thought leaders, the academic physicians and specialists, will let us know when the slides used in their lectures were prepared by the pharmaceutical manufacturer.
The CPSO has presented this document as a reaction to many years of interference of pharma companies in the prescribing behaviour of the medical profession. It is rather disappointing that it addresses the issue at the lowest level, that of the prescriber and drug representative leaving the pharma elephant trumpeting proudly in the room. Reducing the problem of bias and coercion in medical prescribing to one of mere gifts and samples is like reducing the problem of crime to rap music and tattoos, and is a crying shame that it does not recognise that these are the effect and not the cause of the problem they are seemingly attempting to eradicate. As a result of this patronism, the elephant in the room to which I subtly allude, the pharmaceutical company funded RCT, is left standing proud. How is it that clinicians are called upon not to co-relate with pharma, when the gold standard of evidence, the imminent RCT’s which populate our journals are funded by pharma. In other words, our entire system of medicine, college guidelines and all, are tragically and demonstrably vulnerable to the commercial interests of the pharmaceutical company. “Oh but it works!” I hear them preach, ignoring the withholding of evidence which would prevent many products they have guidelined from ever seeing the light of day. “Oh but we could never fund this ourselves” I hear them cry as they demand clinicians reduce their patients to numerical targets at whom they fire potentially fatal chemicals.
Are you thoroughly lost yet? Let me summarise, our reliance upon an industry which outstrips us in power, technology, and crucial information cannot be denied and will not be ghosted away by this combined document. Until, these very real issues are included in the discussion this exercise will remain a step down, to put it mildly, a futile and rather costly exercise against doctors in Ontario.
On first glance of the draft, I agree with the recommendations. However, with regards to “gifts” to physicians influencing their practice, I am quite skeptical that a free pen or notepad with the company’s logo will change the way an MD will deliver medical care, despite a reference given stating a “gift” will influence the way an MD will practice (within the body of your draft). A free pen has not changed which anesthetic drug I give for a patient. Nor has a free notepad has influenced the way I deliver my anesthetic. As Physicians (and scientists by nature), we should always be wary of new medicines, techniques, treatments and carefully assess them – many times “drug dinners” help me sort through the evidence, and no, a free dinner has not changed the way I practice Anesthesia. My two cents.
As someone who has participated in all facets covered in the draft, I believe it to be well written and comprehensive.
Concerns surrounding the twin evils of overdiagnosis and overprescribing deserve attention. However, pointing the finger at industry as the sole or even most important culprit is misguided.
The CPSO guidelines appropriately address ethical conduct; the wider issues of excessive and unnecessary prescribing have their roots elsewhere. For example, the frequent use of amoxicillin outside of recognized indications cannot be laid at the feet of industry since there are so many generic competitors.
Practicing doctors face many pressures. The current structure of OHIP is the most significant determinant of physician behavior. The system rewards doctors for high volume practices and not for quality of practice. There is great emphasis on making patients happy consumers. In the New Media Age, medicine is becoming doctor-assisted self-prescribing.
Industry is the source of new treatments and diagnostic technology. Industry is willing to support research, development and education which would otherwise unfunded. The lessons learnt from early experience with products translate into quality of care.
If corporations are made uncomfortable in Ontario, there are lots of other places for them to go.
I think the policy is fine. I think there is a gray zone where industry sponsors rounds by providing coffee, sandwiches, etc but not dictate the topic of discussion, nor set up a booth, nor actively participate in the discussion.
Kudos to the CPSO for issuing a policy on interactions with industry !!
By clearly outlining the four Principles and the Key values of Professionalism,the need for this policy,and its guidance in relationships with industry,is understandable.
its requirements is
The draft states “Consultation or Advisory Boards. While in this position, the physician must not provide any promotional or educational activities on behalf of the company” In practice today, physicians on advisory boards regularly provide educational activities on behalf of the company. Therefore this proposal is not sensible or practical.
The draft states: “CME/CPD Events: Physician presenters are paid an amount that is commensurate with the services provided. Payments must be made through the meeting organizers and not the industry sponsor” This proposal is not sensible or practical as many physicians represent themselves and speak at meetings that do not have meeting organizers. Clarity and a draft that reflects reality is required.
I think it should be made very clear that ‘gifts’ include food/free meals, food delivered to clinics etc. and that this should not be allowed – often ‘free lunches’ are the way reps get in the door – and get access to physicians – so this is in direct conflict with the so called education that reps provide (which is biased to their particular product).
So clarify during the policy with respect to industry gifts (including all that swag at meetings) that this includes food, and refreshments.
PS I don’t think this draft goes nearly far enough – and should be much more restrictive, and also include specific information about the risk of ‘seeding trials’.
Office of the Information and Privacy Commissioner of OntarioResponse in PDF format.
To whom it may concern, I have been in a university based practice for 40 years and have seen extensive changes in the way industry and physicians interact. I have read the draft policy and think that most of it makes good sense. I presently sit on a number of Ad boards and have found that these relationships have fostered support for academic activities at our university (through departmental CPD or university office of advancement) as well as national CHE programs through APOG (such as our Introduction to Research course for all first year residents in Ob/Gyn – now in its 21st year). At Queen’s University our Dean of the FHS has gone on record to say that our university must continue to “partner” with industry in these tight economic times…and I agree. My sole comment on your document is : The requirement that the Ad board be in the locale where the physician works does not consider the fact that many (most) international Ad boards have physicians from multiple countries. On a different note …. I sense that there has been increasing criticism of physician involvement with industry sponsored research and Ad boards on one hand…….while on the other hand industry is criticized for not involving medical experts in the design and interpretation of research on new products (most recently a CMAJ editorial several months ago). The long lists of “Conflicts of interest” that accompany the names of authors of most journal articles I read these days have immunized me somewhat and this will continue to be a problem when it is primarily the experts who are consulted by industry. A challenging task to do this right …but I think you are on the right track.
Hi ‘consultation feedback’ – the draft policy does not appear to allow a pharmaceutical company to be an organizer of a CME event if the presenter cannot be paid directly by the pharmaceutical company.
186 • Only accept payments that are commensurate with the services provided and that are made through the meeting organizers and not the industry sponsor. Payments may also include reimbursements for reasonable travel, lodging and meal expenses.
I understand how the draft policy would apply to an organization (e.g. university) who receives financial support from industry. The model most frequently used by industry in our semi-rural community involves the pharmaceutical company as the meeting organizer and sponsor of the CME event. The organizer/pharmaceutical company pays the presenter directly and pays for the meal (alcohol included) for all who attend (occasionally including physicians’ staff and or hospital nursing staff). Some companies also pay a physician who introduces and thanks the presenter and may also have assisted in the recruitment of other physicians to attend the meeting.
I appreciate The College’s endeavour to provide guidance and balance. At the same time, I do not believe the draft is successful in providing quality guidance nor has it achieved balance.
Discrepancies between implied, stated, inferred, and factual comments suggest an underlying bias in the draft document.
For example, the primary citations (1.) are taken to represent fact. Each study cited is methodologically flawed. Footnotes are used to imply authority by citation. Footnote 23. is specious. Notes 20 and 21 are likewise irrelevant. Applicability of judicial proceedings, cf. 22 are questionable.
CME/CPD events: too much emphasis is place on the organizers. The attendees should be intelligent enough to evaluate the quality and nature of the information provided. The implicit and false assumption is that organizers following CPSO guidelines will provide balanced and appropriate events. We know otherwise.
I disagree with the suggestion that industry should not pay for travel or accommodation. Sponsorship of this sort may be the only opportunity for many physicians to attend a high level event. In most instances, the attendee should be responsible for expenses.
Disclosures are not the same as conflicts of interest. There are abundant instances where disclosures occult a conflict of interest. In attempting to protect attendees from obvious miscreants, the guidelines increase the ability of opportunists to promote inferior or misleading communications while being sanctioned by CPSO.
Regarding industry sponsored research, I suggest The College go silent. The draft policy is passingly relevant to clinical research. The College should refrain from entering an arena which has established national and international standards. Alternatively, refer to ICH guidelines, Section 5 and say no more.
Regarding authorship, confine comments to ICMJE requirements.
My recommendation is that the draft be condensed. Footnotes should be confined to relevant citations and all reference to or description of specific behaviour be removed. For example, Authorship could make reference to ICMJE criteria which may be reiterated in the body of the Guideline. Remove extraneous comments: lines 370 – 389.
The document should be no more than 75 lines in length.
Overall it’s a thoughtful and clear document. Mixing in the informed consent piece for the researcher conflict of interest muddies it – I suggest you split this out into your existing research policy and reference it in your main document.
All CME these days is industry funded in some form or another. This is the challenge we face.
The main issues are around educational events. I speak at many – I’m pretty encouraged that I always have control of my subject matter and content, and am usually responding to a request from peers for more information on a certain area. If someone organizes a dinner talk after work that is pharma-funded, does that mean people don’t eat or can’t have travel support if further away? Or is it “ok” as long as it is filtered through a non-pharma organizer?
Also, despite being a provincial organization, you have many internationally renowned physicians in your jurisdiction. It is challenging to ensure that international and national meeting organizers invite you (although they will do it) and fund your travel. Often they offload this to pharma, for example they invite you to speak at the main meeting as an expert or researcher, and also “farm you out” to a satellite symposium where you still have control of your talk and message, so they can decrease their costs/increase pharma contributions. But pharma insists on a contract as they will be giving the organizer money to support your travel costs. This is challenging for many of us who do not accept pharma honoraria for CME, but cannot afford to independently finance our travel to CME events where we are invited to speak.
Pharma often engages physicians and researchers in developing CME kits. How does that fit into the policy? Would this be done now only be through a university or other group? Also, have you talked to pharma about how this fits in with or changes what they do? It would be easier if we weren’t offered forbidden fruit, and I think you will need to educate us all about what is and isn’t acceptable.
I thought the text covering promotional advisory boards was excellent. But there are also “educational” advisory boards (developing toxicity education etc) and research ones. It would be helpful if there were as clearly worded.
Thanks for inviting my opinion!
I have read this document and believe that it is a useful start for maintaining objectivity in patient care. The wording is careful and appropriate.
A few comments:
1. Industry are ahead of the CPSO in regard to influencing prescribing behaviour. The most insidious manner in which behaviour is influenced is in the form of practice guidelines. To whit, the most recent Diabetes Guidelines by the CDA are a well-constructed, highly polished tome that has the appearance of widespread sanctioning of evidence-based medicine yet, in reality, is created by the pharmaceutical industry with substantial conflicts of interest, and the CPSO’s document would have done nothing to prevent it.
2. Industry (and it’s financial influence) creates substantial potential conflict, but there are other forms of conflict as well. For example, a cardiologist deciding to do an angioplasty rather than recommending bypass or medical management. I understand the scope entailed in the document, but we must acknowledge that other forms of conflict pose as much a threat to patient care as industry influence.
3. Over the years, I have seen medical education—from the undergraduate MD level all the way to CME—be dramatically influenced by the availability of new medications. The fact that we are seeing an explosion of education on anticoagulation, hepatitis C, DM type 2, etc., and yet have minimal education on smoking cessation, or osteoarthritis, or colon cancer, or wounds, etc. reflects how our profession has been complicit in advancing the agenda of pharma rather than that of our patients. If this document really wants to improve the care of patients, then it needs to address this in some way.
4. Academia is an industry. It influences how research is conducted. The incentive is promotion, primarily. Shouldn’t that be more carefully reflected here. For example, shouldn’t an academic—in education—state their conflicts in relation to getting promoted? Similarly, how about salaried hospital physicians? Shouldn’t they reflect their conflicts? Such as those who do infection control—they are biased vis a vis hand hygiene, immunization, etc.
I think there should be a paragraph dedicated to the College’s suggestions wrt sale of vaccines in a doctor’s office, or sale of other medically useful items direct to patients.
Attendees to Journal clubs
I think this section is a bit unclear as to whether industry should be able to provide food during the session. …not accept payment or reimbursement….how about food (pay the bill)?
We in orthopedic surgery have I think a different relationship by need with industry since they not only provide a product but also an ongoing service of education of staff IMd, fellows, nurses) on product use. As such a more familiar relationship is developed and admittedly one that is perhaps more open to manipulation.
I was very interested to see the efforts by the College to review our relationships with “Big Pharma”. To be a succinct as possible I will put my concerns in point form.
1. A great deal of education, lectures particularly, and those for CME credits are becoming extremely expensive to mount and therefore only pharmaceutical companies are able to fund these. Over the years there has been a marked improvement in disclosing of funding, etc. but I would estimate in my own field 90% is focused on a system of ideas that lead one to a drug treatment rather than exercise or lifestyle even though hardly or if at all a drug is mentioned by name.
2. There used to be a number of journals where one could get articles and views published on non-patentable products, outside the box. In the last few years about 90% of the “free” journals have ceased publication. These allowed a certain interactive between physicians and experts etc. It is extremely difficult to obtain exposure for non-patented products. I first came across this in the early 1990’s when I came across the European work on Glucosamine. I realize the trials are very varied but believe it is still a useful product especially now that there is considerable evidence that it may improve longevity and inhibit cancerous growth. There are a multitude of agents that the average physician does not get exposed to, so who is going to publish on for example valium pessaries for pelvic pain, Boron for Osteoarthritis and perhaps Osteoporosis and helminthic infections for autoimmune diseases.
3. Over the decades I have been in practice I became very involved in transcutaneous nerve stimulation (TENS), as mentioned above Glucosamine, and now Boron. Trying the various societies for support and research was fruitless and luckily but strangely a generic company supported a small study on Glucosamine at Mt. Sinai Hospital. For many reasons, no patent, no profit, little funding for research or expanding use and discussion.
4. We see many articles, studies on medication, do we ever see any articles on the fact that 10-20% people could discontinue their hypertension medication? On a positive thought, I wondered if by Internet the College might set up a site for a brief discussion on these issues.
I do not think that small gifts to thank physicians for their input and to get them out for educational information nights is not a conflict. Since when does a pen mean a doctor can be bought? Trust the physicians that they will not be bought with mere meals and pens. We are not cheap whores. If the cost of the gift is too high (like those given to pharmacists) we would not accept them. I never changed my prescribing habits because of the dinners and pens I received. The talks at the dinners were by fellow physicians and were on topics of interest we chose. A physician must be trusted not to be swayed by gifts (unlike politicians). As you can tell, I am from the older breed of physicians who trusted themselves to do the right thing. I had a former patient of mine give me a gift (a pen) and he was angry at me because I did not treat him better than others and left my practice.
You can’t legislate “everything” or we will not think for ourselves.
I have already sent some of the following to the College President:
1. studies on breastfeeding and infant feeding in general are often funded by formula companies or makers of feeding bottles.
2. the giving out of formula samples by physicians and pediatricians is common. Mothers often receive samples even if they are breastfeeding, but they should not receive samples even if they are not breastfeeding.
3. education on infant feeding often comes from formula company representatives or in formula company sponsored conferences.
4. just as physicians, usually “experts” in a particular field are paid by manufacturers to speak on their “favourite drug” for treating such and such, the same is true with regard to breastfeeding substitutes, often touted as better than breastmilk in a particular situation (prematures, babies with special needs, etc).
I wanted to expand a little on point 2. Above.
Why is the giving of free samples of formula different say, than a free starter pack of a medication which the patient receives from a doctor? There may be many reasons free samples of medication are given out, including that the patient might try this medication to see if it is effective, especially if it is a new drug and more expensive than older drugs. Perhaps this is legitimate. However, the problem with giving out free formula samples (and the “literature” and brochures that often accompany the formula samples) is that once a mother introduces formula and bottles to her baby, problems with breastfeeding often result, including a reduction in milk supply and even complete rejection of the breast. This is different than providing a sample of a medication. If the medication results in a drug reaction in the patient, or is ineffective, one can always try a different drug or a different approach. But once milk supply starts to decrease or if the baby rejects the breast, it may be difficult, even impossible, to turn things around and get the breastfeeding back on track. In some doctors’ offices, formula samples are given routinely, even prenatally. Sometimes, however, breastfeeding is already not going well and seems to justify the giving of the formula sample, but I disagree. Starting formula and bottles might be the coup de grace which truly finishes off the breastfeeding. Instead of giving the parents the formula samples, the doctor should be helping the mother with the breastfeeding (most do not know how, however) or referring the mother and baby to someone who can help.
I see no justification in giving a mother free samples of formula. Even if the mother never intended to breastfeed or is not breastfeeding, why should a physician with the authority s/he carries in the eyes of most patients, advertise a particular brand of formula, and it is advertising, there can be no doubt about it? Health Canada requires that all formulas comply with certain nutritional guidelines and essentially all formulas are the same from the nutritional point of view, whether they are made from cow’s milk or soy beans.
Many doctors’ offices also have “patient information” pamphlets available for patients to take. Formula company representatives often leave their own pamphlets in the slots sometimes without the doctor being aware that the pamphlets are available to his/her patients. Formula company and bottle manufacturers’ “information” pamphlets are notoriously inaccurate with regards to infant feeding in general and in particular with regard to breastfeeding. Very often the contain visuals and text which undermine breastfeeding and make it seem difficult, painful and exhausting, and formula the answer to every problem. Breastfeeding should not be difficult, painful and exhausting if mothers got off to a good start and received good help and encouragement along the way. Unfortunately few do and those who succeed usually succeed in spite of the “help” they get.
Thank you for this opportunity to comment.
I am a neurologist in solo practice and I have partnered with industry for years in many different roles. I have concerns about the following:
1. CME/CDP is not defined and is much too broad a definition. Much of the CME done in smaller centres involves a specialist (me) going out to educate groups of family physicians, other health care providers and patient groups. I am not a CME organizer ( often pharma arranges the meeting place and attendees), but I am the speaker and provide high quality and balanced/thoughtful education to the audience. Who will pay me – can I accept these honorarium directly from pharma? What is a modest meal? What about patient forums, where a specialist provides unbiased updates on disease states and current treatments to patient groups? I have added tremendous CME value to my community over the years, and the time I have spent has never been adequately reflected in the honorarium. This kind of education will be stifled by these guidelines
2. What about sponsorship to attend international conferences and major congresses – we are routinely sponsored (travel, accommodation, conference registration fees) to attend these ( example: the American Academy of Neurology, ECTRIMS, European Neurologic society meeting, International Movement Disorders Meeting, etc.). All of these congress organization have their own pharma regulations, and being sponsored to attend does not contravene their policies. Also what about sponsorship to take courses ( example I have been supported to attend a number of Mayo Clinic Neurology review courses, or Harvard Review courses. All of these constitute a large portion of our CME as specialists.
3. Detailing from pharma is often done during the day – I am so busy, that I will only meet with pharma over dinner – again what constitutes a modest meal?
4. I participate in many advisory boards both internationally and within Canada – these are invaluable both as a vehicle for participants to give needed feedback to pharma and also for us to interact with each other as specialists with common interests. Under the proposed guidelines, these will likely disappear. That would be a shame as these meetings have a tremendous trickle down effect. We are not invited to these meetings to be “detailed”. Often we are not even paid to attend and certainly the amount paid is not truly reflective of our time out of the office and our personal time we give to attend these meetings.
5. I do clinical research – the only problem I have with the guidelines is the Investigator Meeting section. These meetings are invaluable and cannot be regulated tightly – they are already regulated by ethics boards and by good clinical practice guidelines.
6. I feel as if these guidelines are overall too restrictive and do not allow me to use any of my own ethics and professional common sense when dealing with pharma.
The draft policy states that the interests and responsibilities of industry are not always aligned with the professional and legal obligations of physicians. The corollary is that sometimes the interests of industry do align with professional improve healthcare outcomes. It is in this area that I have always tried to work.
One need look closely at oft mentioned studies showing undue influence by the pharmaceutical industry on physician prescribing. The evidence is weak and very outdated. The RCPSC, CFPC, PAAB , and Rx and D have all created policies that closely regulate relations between Pharma and physicians. I believe the rules and regulations imposed by these organizations allow us to interact with industry in areas of convergence in a professional and responsible manner. The pharmaceutical industry has and I believe should be a partner in educating physicians to use medications appropriately.
The CPSO needs to prove that the system is broken before trying to fix it!
Protecting our public trust, minimizing, removing and declaring bias is crucial. One area the document does not seem to adequaltely address that concerns me is less about direct clinical, but more about balancing professional freedoms to work with any private or public entity or “industry”. As a physician (and citizen) one of our Canmeds roles may involve the independent design and creation of intellectual property, writing of educational materials etc. This includes copyrights, trademarks, licensing, royalties etc. I am concerned that a well intentioned but overzealous prohibitionist mindset to limit interaction with industry may unduly limit the rights of a physican and professional. The policy would benefit from inclusion of a section addressing and specifying limits and permissions for when a physician functions as a creator and owner of intellectual property.
This is a good revision of current policy and appropriate compromise recognizing that there is a wide divergence of opinions.
A couple of comments
1. I get concerned about industry sponsored disease specific health forums – health councils which pretent to be independent but are not – I am not sure how to capture this in the policy but there should be some acknowledgement
2.Re: Industry developed educational materials for patients – there should be a statement that physicians are advised to review the materials and agree with content prior to handing out to patients
3. Inudstry support for education – this particularlyl affects residency education as many residency programs would not be sustainable without industry support. This goes beyond support for travel to meetings which is an accreditatioon requirement and there is no routine funding for residency education activities that comes from medical schools beyond clinical earnings levies. Industry also sponsors other activities – including resident research projects, other learning opportunities national courses/ The descriptors in the policy should extend beyond simple travel to meetings and ensure that iindustry funding is not tied to specific meetings, that the funds do not go directly to students – residents, that there is an equal opportunity for all students-residents.
Its very commendable that the college set a clear and cautious policy such as this one given the indiscretions of the past. The college should disallow meals of any value as food is an efficient and biological way to secure relationships at an emotional/attachment level. Try to be critical of someone who took care of you by giving you a nice meal. Its biologically difficult to do. Physicians need opererate on a rational and critical level when when taking in information. There is no doubt in my mind that indusrty would be well aware of this reality, and would fight to maintain this privilege of feeding physicians.
We appreciate the opportunity to provide feedback on the draft CPSO conflict-of-interest policy in this open forum format. Competing interest and conflict-of-interest relationships between physicians and commercial industry have the potential to undermine not only the trust of the public and patients, but also the ability to prescribe the most appropriate, safe, and cost-effective treatments available.
In 2013, my colleagues and I published our evaluation of the conflict-of-interest policies adopted by each of the 17 medical schools in Canada (http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0068633). We have scored the CPSO policy according to our scoring system (Appendix S1) with some minor amendments because we recognize that 2 of our 12 criteria apply in the context of medical schools, but may not apply to the CPSO policy. These sections are (10) Industry support for scholarships and funds for trainees, and (11) Medical school curriculum (or other documentation of education objectives and course content). Additionally, we recognize that our scoring system does not evaluate 2 sections of the CPSO policy. These 2 sections are (a) industry sponsored research in terms of conducting ethically responsible research, data disclosure, and participant consent parameters, and (b) publishing negative findings.
1. Gifts (including meals): 0
2. Consulting relationships (excluding scientific research and speaking): 1
3. Industry-funded speaking relationships or speakers’ bureaus: 0
4. Honoraria: 1
5. Ghostwriting: 1
6. Disclosure: 2
7. Industry sales representatives: 0
8. On-site education activities: 2
9. Compensation for travel or attendance at off-site lectures & meetings: 0
10: Industry support for scholarships and funds for trainees: 0 (may not apply here)
11. Medical school curriculum: 0 (may not apply here)
12. Samples: 0
Enforcement A: Is it clear that there is a party responsible for general oversight to ensure compliance: NO
Enforcement B: Is it clear there are sanctions for noncompliance: NO
Each category is scored out of 2 (2 = stringent, 1 = moderate, 0 = permissive or no policy), so 12 categories * 2 maximum per section = 24 total maximum possible points + Enforcement A and B measures.
We have excluded the scores for the 2 sections that may not apply in the CPSO policy (10 & 11). We have, therefore, scored the policy out of 20 maximum possible points. Therefore, the CPSO draft policy received a score of: 7 out of 20 (35%) with Enforcement A = No and Enforcement B = No.
I would be happy to provide additional feedback or if you have any questions about the scoring of this policy, please feel free to contact me.
This is a good start. I wish it would go further in addressing this issue, through explicitly articulated penalties or sanctions.
As a psychiatrist, I find the influence of the pharmaceutical industry to be especially problematic. Sponsored “education” typically ignores non-pharmacologically based practices in favour of drugs. Entire areas of study (e.g., an objective approach to disability/impairment evaluations) are also ignored, as any metric that suggests lower prevalence of a drug-ready treatment conflicts with an agenda to promote greater drug sales. I have witnessed seemingly well-intentioned drug industry-sponsored “educational symposia” disingenuously promote entire disease categories (ADHD comes to mind), leading to pseudo-epidemics and over-prescription of the latest but not-so-greatest product.
Sadly, the need to emphasize a more careful, thoughtful and thorough understanding of our complex patients’ experiences seems to have gone out of fashion.
I commend the CPSO For undertaking the challenging task to develop policy with regards to individual physicians interaction with the healthcare/pharmaceutical industry (HPI). In general I support the policy that is being developed and would actually encourage the College to lead physicians in this area so that the culture around interacting with the HPI changes so that drug promotion etc. is clearly distinguished from education and that physicians become highly aware of the conflicts that they may find themselves in when interacting with HPI. I agree with previous posts especially those by physicians on March 17 and 27th. Thus, I will not reiterate them here. I would however like to suggest a couple of areas where the policy may be strengthened.
HPI has very powerful ability to influence the decision-making of physicians with respect to patient care. Thus this is crucial for the CPSO to have clear well-defined policies and practices to appropriately guided working relationship with the HPI. Indeed, I respectfully suggest that the college itself for the same reasons develop its own policy with regards to organizational relationship with HPI.
In this draft of the proposed policy, line 135 states that “Since the interests of industry sponsors of educational activities are not always congruent with the goal of addressing the educational needs of the profession, it is essential that educational activities are developed independent from the influence of industry”. This statement needs to be much stronger. HPI does not have patient care as its main objective as physicians do. The primary interest of HPI is the shareholders of the particular company – make no mistake about it. Hence the statement needs to reflect this reality.
Line 151: “Decisions regarding the content, faculty, educational methods, and materials are made without influence from industry sponsors.” I agree entirely with this but it has to be clearly spelled out how this can be achieved. Would for example a so-called “unrestricted educational grant” be sufficient for a position to conclude that there was no influence from industry? Unrestricted educational grants always have something to do with the product that the company is marketing. Yes, it is left open to the physician organizers to determine the exact topic, but make no mistake the topic has something to do with the product that is being promoted.
The disclosure section needs to be strengthened considerably. Conflicts will always occur and it is our ability to manage and mitigate these conflicts which is key. Disclosure itself is not always sufficient to manage the conflicts. There is considerable literature on the perverse effects of disclosure. One concept ” clarity over purity” suggests that as long as physicians come clean with the number and names of pharmaceutical companies with which they work, then they actually continue to be influenced by industry and this is passed on through their speaking and teaching engagements to their learners. They actually never change their behaviour vis-à-vis their relationship with HPI.
I also think that it is important for CPSO to seek consultation with and perhaps establish congruency with other provincial and national medical organizations so that policies of all organizations are consistent with each other so as not to confuse individual physicians or industry for that matter. For example the College of Family Physicians of Canada has recently completed a report approved by its Board of Directors in November 2013 on its organizational relationship with HPI. Documents such as these can provide the foundation and consistency for policies across all our organizations.
in my opinion any money coming from the industry should be pooled in a hospital fund dedicated only to cme of medical stff (invited speakers,local conferences ect.) or to purchase medical equipment .i do not believe that preventing comletely the industry fromm supporting medical activities is necessary ,but it needs to be regulated.
Dear Sir or Madam,
I am writing to provide feedback on the draft policy that provides guidance for physicians in managing their relationships with industry. I offer the following comments relevant to the numbered text line in the proposed guidelines.
Line 155 and 159. I agree with lines 153 and 154, however sometimes, there is no sponsor other that the pharmaceutical company. This generally occurs when small dinner meetings occur in order to educate other physicians about a new product. Line 155 suggests that these small very interactive meetings would no longer be possible. I think that this would limit the educational opportunities of physicians and might result in inappropriate prescribing due to insufficient training.
Page 5. Footnote 6. It is stated that only the trade name should be given once. When speaking on biologics to treat skin disease, the names are tongue twisters and not recognized by the audience. I have been repeatedly asked to state the trade name as well in order to minimize confusion. What might be a better alternative would be : “When necessary to refer to trade names in educational materials or presentations, the trade name should be stated after the ingredient.” This is also a problem with combination products and biosimilars which contain the same product but are not equivalent. If only the ingredient were to be stated, the audience would have no idea what product was being discussed.
Lines 227, 228. Members who participate in research are often on advisory boards, particularly if they have good powers of observation and analytical skills. At the time of product launch and for the first several months after a product comes to market, they are the only individuals who have any significant experience and clinical knowledge of the product. In addition, in clinical research, patients are followed much more closely (often daily or weekly initially) than in routine clinical practice. This allows for much better observation of drug effects and potential adverse effects. I have attended meetings in which drugs that have recently come to market or are soon to come to market, are presented by physicians who have never worked with the products. These physicians cannot answer questions about study design, efficacy or adverse events other than what the company sent them or what is in the literature. When the products are new, often nothing is published. I believe that the potential bias in these presentations is actually more rather than less than when a researcher/advisory board member presents. By not allowing researchers who are advisory board members to speak on the research that they have been involved with, only people who have never worked with the product would be allowed to speak if these 2 lines are kept. This makes no sense. I believe that it continues to be important at every talk that speakers disclose potential conflicts. The audience will therefore have knowledge of potential conflicts of the speaker. I believe that advisory board members should be allowed to provide educational activities on behalf of the company and that such activities often result in more appropriate use and monitoring of drugs.
Lines 342 to 345 and footnote 23. Many physicians involved in research are salaried by research corporations or other institutions and do not receive additional money to see research patients. There is usually no correlation between revenues received by the institution/corporation for a particular study and the salary received by the physician. Many salaried physicians spend a large percentage of their time on administrative duties for the corporation/institution.
In the event that researchers are not salaried, it is impossible to state at the time of consent what their exact compensation will be. That patient might be a screen failure and in such circumstances, the physician will likely receive no compensation, but in fact incur expenses until it is determined that the patient does not qualify.
Telling patients the amount of the whole study budget is very one sided since this amount is rarely paid for a number of reasons including patients not showing up for visits and not performing all procedures listed in the budget since in many protocols certain procedures are only done on a subset of patients. Some contracts pay per visit, but not for unscheduled visits, collecting data for and filing of adverse and serious adverse events, re-consents, attendance at pre-meetings (usually Friday to Sunday with loss of revenue from not being in the office and for paying staff to attend), training of self and staff including completion of computer training, development of source documents, site inspections, document storage, maintaining facilities, equipment and computers, meeting with monitors throughout the study…the uncompensated expense list goes on. There are a lot of unpaid hours for physicians and unreimbursed hours that are paid to staff. Compensation is very complicated since a fair discussion needs to include all of this. Sometimes after a lot of work is invested in getting a study started, yet before the first patient is screened, enrollment into the study is closed by the sponsor. In such events, there is rarely any compensation, yet a lot of time has been invested and staff paid.
The requirement in bullet 23, to state the amount of any compensation that the physician will receive is very one sided since expenses are not stated and the net income is significantly lower than that received. The true costs are usually not known until the study ends. For the above reasons it is really impossible to give a balanced discussion on reimbursement. In addition, fees that are received also include payments for diagnostic imaging and other physicians which the receiving physician must then pay. The physician never personally sees this money. Payments are often delayed by several months, or in the case of screen failures never received, yet we must pay out salaries to others and for diagnostic tests. A discussion of actual financial remuneration would result in more time spent outside of patient care. It is very rewarding to see patients have their disease come under control with new experimental medications and to see their quality of life improve. This is why we participate in research. OHIP compensation is much more straightforward than research compensation.
Lines 391-394. I agree that physicians should be allowed to report study results, however I am concerned that physicians might report results on their patient subset and that this subset would be underpowered, potentially resulting in publication of misleading results. I don’t feel that they should be able to publish until the entire study subset has been published. With regards to adverse events, patients are often on blinded drug making it difficult to assign causality in the event that an adverse event should occur. In such cases, safety reports could be easily misinterpreted. Once something is in print, retractions even if they occur later, are not linked.
A few comments concerning industry relationships.
The policy fails to mention business arrangements in which there may be a benefit to a physician based on referral patterns. An example would be reduced rent based on number of patient’s referred to clinic or diagnostic facility. This has the effect of increasing inappropriate referrals.
In a similar fashion an IHF may have non cash inducements for referrals. This could include golf tournements or “educational” weekends for physician and family at resort provided enough patients have been referred.
I would assume that rules concerning detailing apply not only to pharmaceutical reps but also to equipment vendors and sales staff from for profit medical and diagnostic facilities.
I think the rules are reasonable and achievable for the most part, though will require changes in culture
Journal Clubs for residents are usually supported by pharmaceutical companies for pizza or a restaurant meal. Will this have to end??
I wonder if a survey has ever been done to find out the percentage of physicians who are influenced by pharmaceutical reps who visit our offices.
I also wonder how many pharmaceutical reps call physicians after their visits to their offices to find out how many of their products they have prescribed in a certain period of time. On a scale of 1 to 100, the influence that pharmaceutical reps have on me is no higher than about a 3. For nearly forty years, I have seen hundreds if not thousandsof reps from various pharmaceutical companies and the number of times that these reps have brought me coffee of other beverages, can be counted on the fingers of one hand.
The CPSO draft policy calls for registration of clinical trials, and prohibition of non-disclosure agreements; the range or limits of enforceability is undefined.
The CPSO draft is, otherwise, weak. I agree with others that the policy as drafted at present lacks the potential for substantive influence in addressing the existing and worsening industry bias in medicine.
The CPSO proscribes acceptance of personal gifts, but “teaching aids” and “meals” are permitted. The pharmaceutical industry is not a charity and would not offer “teaching aids” or “meals” if these did not promote sales. All gifts are gifts. [See: Katz D et al. All gifts large and small. Am J Bioethics 2003: 3 (3) 39-46].
The CPSO urges physicians to “not solely rely on “ ‘information’ from industry sales representatives”. To retain credibility, the CPSO policy would need to acknowledge that the quality of information is overall problematic, including that it is provided primarily to increase sales. [See: Oldani M. Thick Prescriptions: Toward an Interpretation of pharmaceutical sales practices. Medical Anthropology Quarterly 2004; 18: 325-56. ISSN 0745-5194, online ISSN 1548- 1387.]
The CPSO policy appears to fail to recognize the marketing function of representative’s interactions with physicians including the literature which clearly demonstrates the provision of samples leads to inappropriate prescribing, as well as increased costs.
The CPSO fails to address ghost management in any form.
In parallel, the CPSO affirms: “While industry has a valuable and legitimate role to play in the practice of medicine, its interests and responsibilities may diverge from the professional and legal obligations of physicians.” This statement appears to fail to acknowledge the extent to which industry and physician interests diverge.
In fact, it is clear that “[the] purpose of data is to support, directly or indirectly, marketing of our product” [citing a Pfizer sales document, July 27, 2000 [see Moffatt B. Perspect Biol Med. 2007; 50(1):18-31].
To quote a review of a decade ago: “… how tainted by commercial conflicts has medicine become? Heavily, and damagingly so, is the answer.” [Lancet 2002; 359: 1167]. The CPSO needs to acknowledge the problems arising from physician interaction with industry, despite the denial by individual physicians that they are not influenced by these interactions.
The personal ‘integrity’ or lack thereof of individual physicians is not the issue. The issue is that these interactions, and this influence, do not serve our patients well.
Royal College of Physicians and Surgeons of CanadaGeneral comments
1. The document provides a comprehensive review of the key issues surrounding the relationship between physicians and Industry including one of the most comprehensive reviews of relationships between physicians and industry in the domain of research.
2. The document provides some important references as foot notes which enhance the evidence which support the requirement for specific policy statements.
3. The use of the phrase ‘must comply’ on line 70 (rather than ‘should’) suggests there would be regulatory consequences for failing to comply. These consequences for failing to comply should be specified in the document.
4. The document, although written in a clear and comprehensive manner is devoid of any application that illustrates how the principles and policy statements should be understood and applied within specific contexts. There would be great benefit in creating specific scenarios throughout the document to illustrate the application of policy statements in specific contexts to foster understanding and compliance.
5. There appears to be significant overlap between this document and other similar documents leading to a significant concern that if other provincial medical regulatory authorities initiate similar policies this would create unnecessary complexity and confusion as to what professional behaviors in this domain are acceptable across provincial boundaries.
6. In several places throughout the document a number of other policy statements or documents are referenced. Hyper-links to these documents would be helpful and appropriate. For paper copies of the draft policy – a series of appendices that summarize the specific issues relevant to this draft policy would be helpful to include.
Feedback by Section
7. There is no specific reference or comment on the context that stimulated the development of the draft policy statement. Although the purpose of the document is defined on line 47 as setting forth the “the College’s expectations of physicians who interact with industry” the overlap between this document and other similar documents requires clarification as to why this document was deemed to be required or necessary at this time.
8. The definition of what constitutes a Conflict of Interest starting on line 52 appears to be based, at least in part, on specific sections on Ontario Regulation 114/94 without defining or describing what specific situations these describe.
Section 1: Practice
9. The statement on personal gifts ‘of any value’ on line 95 provides a very clear statement.
10. Including a definition of advance disease / treatment education materials would be important since only one example has been provided (patient teaching aids on line 98).
11. On line 117 the policy states that in the context of industry representatives providing to physicians information about products and services that it would be permissible to “accept meals for themselves and appropriate staff where the mean is of modest value.” This statement could be interpreted as in conflict with the statement on not accepting personal gifts of any value. Since a meal has monetary value this could be deemed to be a gift and therefore not appropriate particularly during marketing sessions.
Section 2: Continuing Medical Education / Continuing Professional Development
12. We strongly agree with the statement starting on line 136 that “educational activities be developed “independent from the influence of industry”. It would be helpful to reference other documents that support this statement including the ethical standards of the College of Family Physicians of Canada and the Royal College of Physicians and Surgeons of Canada as well as the draft national standard of commercial support.
13. Line 155 uses the phrase “unrestricted educational grant”. This term should be replaced by the phrase “educational grant”. The term “unrestricted educational grant” has different meanings to various organizations and there are legal obligations of industry to ensure that the funding provided is used for the specific activity it was intended to support. The use of the word ‘unrestricted’ was a barrier to commercial interests providing financial support to accredited learning activities. The key purpose for using ‘unrestricted’ was to state that commercial supports did not receive any benefits (other than recognition) for providing financial support. This principle is strongly supported by other ethical standards.
14. The section on disclosure, starting on line 204, should specify that all presenters and members of scientific planning committees (or similar groups with the responsibility for identifying the needs, content and selecting the speakers) are obligated to disclose their relationships with industry.
Section 3: Consultation or Advisory Boards / Investigator meetings
15. On line 229 a definition of “fair market value” would be a helpful addition to this document
Section 4: Industry Sponsored Research
16. The extensive section dealing with various aspects of consent (starting at line 269 and continuing to line 345) references predominantly sections from the Personal Health Information Protection Act (PHIPA). Given that many of these sections on consent are equally included in the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS-2), references to this policy statement in support of the various questions posed regarding consent would be appropriate.
I have a lot of problems with it, but I mainly want to make one significant suggestion with respect to your draft policy. There should be a requirement of disclosure to patients. That is, every doctor should be required to post, in a prominent location in his/her office where it is readily available for patients to view, a list of all the companies from which he/she has taken money or gifts of any kind, and what those were in what circumstances. The list should also be available online. And it should be updated at regular intervals. You seem to ‘get’ the need for this policy when it comes to research studies — so on what grounds do you then ignore it when it comes to actual prescribing situations which could be equally or even more serious for a patient’s health?
I am a professional journalist. If a drug company rep bought me several nice meals, gave me little gifts, and paid me “honorariums” for “consulting” with him just before I wrote an article for your local newspaper about his company’s new drug, do you believe that should be disclosed to you as a reader of the newspaper? As a matter of fact, any reasonable editor would require me to disclose it to the readers and, in fact, would likely forbid me from even writing the article. So why are we holding our journalists to a higher ethical standard than our doctors?
It seems CPSO is afraid to do its job, which is to get these rampant conflicts of interest that are undermining the credibility and trustworthiness of the medical profession under control.
Canada's Medical Technology Companies (MEDEC)Response in PDF format.
Canadian Medical Protective AssociationResponse in PDF format.
Conflict of Interest Implementation Committee - Schulich School of Medicine & Dentistry - UWOResponse in PDF format.
Medical Reform GroupResponse in PDF format.
Ontario College of Family PhysiciansResponse in PDF format.
Canada's Research-Based Pharmaceutical Companies (Rx&D)Response in PDF format.
St. Joseph's Healthcare LondonResponse in PDF format.
AstraZeneca CanadaPlease note that AstraZeneca Canada endorses the feedback that you will be receiving from Rx&D as it relates to your call for feedback on the draft Physicians’ Relationships with Industry: Practice, Education and Research policy.
JanssenThank you for the opportunity to provide feedback on the College of Physicians and Surgeons of Ontario’s (CSPO) draft policy on “Physicians’ Relationship with Industry: Practice, Education and Research”. Please accept this email as Janssen’s endorsement for the communication sent by Canada’s Research-Based Pharmaceutical Companies (Rx&D) on May 9th, 2014.
As a global healthcare leader, Janssen has no greater responsibility than the health and safety of the Canadians who use our medicines. In every jurisdiction within which we operate – including Canada – we are committed to conducting ourselves in a manner that meets or exceeds regulatory requirements. We believe it is a fundamental responsibility to ensure that health care professionals and patients receive the education and information they need to use our medicines safely and appropriately.
College of Physicians and Surgeons of AlbertaResponse in PDF format.
I would be very careful to restrict CME opportunities that are sponsored by industry. I am a specialist physician in south eastern ontario (1 hour drive from the nearest major centre) and do not have the time in my schedule to attend CME opportunities sponsored by non-industry organizations. These “non – industry” meetings sponsored by non-industry organizations such as universities, happen in big/major cities and are not put on in my town. I have had the opportunity to attend industry-sponsored events in my town (across the street from my work place) with major international speakers that are at the top of their fields. This has had a major positive impact on the treatment of patients in my community. Without these opportunities my patients will be left at a disadvantage when compared to patients treated at major university centres. Industry sponsorship of such meetings does fill a huge gap in knowledge especially in small and distant communities. I am certain that the medical subspecialty societies or universities will NEVER put on a CME in my community.
Thank you for this opportunity to discuss the proposed policy regarding Physicians’ Relationship with Industry: Practice, Education, Research.
I work in a field that is rapidly changing and where patients have very limited life spans and are looking for any opportunity to help improve outcomes. The pharmaceutical industry has been invaluable in helping me provide care to my patients and I worry that any policy that is too restrictive will prevent me in providing my patients with high quality evidence based care. More often than not the drugs that I prescribe are the only ones in their therapeutic class and are not only funded by Cancer Care Ontario but are expected to be administered as standard of care (i.e. based on new Quality Based Procedures rolled out with new HBAM funding model). There is very little conflict of interest in this scenario – if anything my interaction with the pharmaceutical industry – i.e. proposing how to manage observed side effects, nursing education re: medication administration/side effects etc., or hearing from a sponsored world renowned speaker – is actually to the benefit of patients. Again, receiving a “modest meal” or “educational gift” will NOT impact my prescribing habits given that CCO funds and actually mandates the use of these drugs. It is interesting that our centre will be PENALIZED for not using certain drugs.
Also the attendance of advisory boards is an important exercise for physicians in fields such as mine. When treating patients with rare diseases or with new drugs, these are the only forums that allow for discussion between peers regarding any challenges and also allow us to relate back to the pharmaceutical industry any issues that we are having. We are the front line providers and without our insight industry would be missing crucial information that will impact patient care.
I hope that the CPSO understands that a “one size fits all” approach will not work in the rapidly evolving field of medicine and may actually adversely impact the management of patients.
I would like to commend the CPSO for undertaking the important topic of physicians’ relationship with industry. I have already provided detailed comments on the draft policy, which I believe needs to be strengthened.
Reading through the discussion forum, I am struck by how many of our colleagues remain poorly informed on the issue or exhibit classic denial about the potential for negative influence. Nevertheless, such denial is not entirely surprising, and it is in fact a reflection of the extent of the current influence by industry. The problem is that expecting someone in a position of conflict to scrutinize and set limits to the conflict in which they are involved is akin to expecting the fox to guard the hen house. As such, I hope the College takes leadership in developing a strong and effective policy, and take the opportunity to educate the membership about the importance of protecting the quality and integrity of the care we provide to our patients.
Ultimately, I believe this policy will be a test of the practice of self-regulation.
I have reviewed the draft. I would suggest that a fee paid to the presenter from the sponsoring agency/manufacturer is appropriate, provided that i) the presenter acknowledges that such a gift has been received; ii) that it reflects OMA guidelines on remuneration and iii) that the sponsor undertakes to send an appropriate tax slip to the recipient.
I am aware that the deadline for submission is passed, but I would appreciate your consideration of my comments.
The pharmaceutical industry is the producer of all the medications in the service of symptomatic therapy in medicine. Also research is largely financed by the industry. Healing has been largely eliminated from medicine and is disqualified as ‘unscientific’ and’unproven’.
This antagonistic attitude starts already in medical school. The pitfall is the monopoly by the pharmaceutical industry. A mutual dependency between physician and industry is created and the temptation for persuasion and acceptance of gifts is great. It is a form of co-dependency, which can potentially undermine the trust of the patient in the profession, as rightly recognized by our new College president.
In medicine we need substances (medication), for both aspects of therapy: Synthetic medications for symptomatic therapy (symptom suppression and regulation) and medications from nature for healing.
Many patients are yearning for healing especially in the case of chronic diseases and we as physicians have a responsibility to facilitate true healing as much as possible. When we keep this in mind, moral aspects of how to ‘deal with industry’ are more likely to be recognized and felt by the physician as the’ voice of conscience’ in each human being is a reality to which we can awaken more and more.
The College should not be too specific when laying down rules and regulations but leave some freedom in this field.
Ontario Medical AssociationResponse in PDF format.