Science & Medicine

Conflict of Interest

 

 

 

 

 

 

 

— Zhenya Senyak

“We had become aware that academic researchers were receiving large payments from drug companies and that it was distorting their work. For example, I once phoned the senior author of a paper submitted to us to ask why he had neglected to mention the side effects of a potent new drug he was testing. Without any apparent embarrassment, he said that the sponsor wouldn’t let him. We didn’t publish the paper, but another journal did.””

—       Marcia Angell, MD., Harvard Medical School, former editor in chief, New England Journal of Medicine for two decades.

Incyte’s official notes to the clinical trial of Jakafi for PV:

“There is an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI’s rights to discuss or publish trial results after the trial is completed…..Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.”


What follows is an  exploration of Conflict of Interest in the practice of medicine and, how it impacts the MPN world of patients, patient advocates, physicians and drug companies

Medical conflict of interest (COI) is baked right into the pursuit of effective meds. Research and clinical trial requires a mix of profit-oriented drug companies collaborating with academic physicians and scientists…and is fueled by billions of dollars annually.   COI is a complex issue that can impact the health, future and survival of patients.

Out of the shadows

In the United States, drug companies pay physicians and their employers $8.5 billion annually in an effort to develop and market drugs. Most of that is related to research and clinical trial. $3 billion however w unrelated to any research and is shelled out as general payments to physicians.

The Centers for Medicare and Medicaid Services (CMS) manages the Federal Open Payments program that monitors and publishes a record of those payments. It’s called the Sunshine Act. It defines Conflict of Interest as a “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.”

  To help bring COI into the sunlight this overview presents perspectives of observers, physicians and patients in a four part story.”

PART ONE:  A general overview of medical Conflict of Interest, viewed mostly through the lens of publications, observers,  trusted sources with Links to full articles included.

PART TWO:  Results of an on-line survey of MPN patient and caregiver opinions, attitudes and beliefs about conflict of interest/

PART THREERoundtable Discussion by MPN academic physicians, MPN specialists and patient advocates.

 

Part One:  WHAT OBSERVERS THINK

Medical Conflicts of interest affect us directly. They affect our treatment options, the trajectory of drug research, the timing of procedures, the standard of practice… and our trust in our physicians and medical institutions.

Conflicts of interest may be inevitable in many areas of medical practice. The tug of war between self-interest and the practice of good medicine isn’t always financial and isn’t always significant. But the big, the serious medical conflicts of interest may involve a complex set of factors:  prestige, benefits for one’s institution, high value publication, tenure, publicity, etc. generally hinge on money. Lots of money

From the Journal of the American Medical Association:  Dr, William Stead makes an important distinct in one practical outcome of conflict of interest. “Judgment and integrity are two hallmarks of professionalism. Conflict of interest (COI), bias, and dishonesty represent a spectrum of threats to judgment and integrity.”

“COI, a conflict between a professional responsibility and a personal interest, is at one end of this threat spectrum. COI creates a risk of bias. Bias, a prejudice for or against something, is in the middle of this spectrum. If a COI results in bias, the bias may affect a professional judgment. Dishonesty is deceit or fraud. Dishonesty is at the opposite end of this spectrum from COI. Each of these threats exists on a continuum. COI may be present or perceived. Bias may be conscious or unconscious. Dishonesty may be intentional or unintentional.”  (May 2, 2017, JAMA) “The complex and multifaceted aspects of conflicts of interest.”

 

Conflict of interest affects virtually every aspect of medicine, including research, teaching, and clinical care” reads the lead of a Journal of the American Medical Association (JAMA) editorial. “The presence of FCOIs in clinical trials of oncology drugs that receive US Food and Drug Administration (FDA) approval is of particular concern, because these trials may change the trajectory of cancer care. These trials also generate high–impact factor publications, prestige for authors, revenue for the pharmaceutical companies, and newsworthy headlines.”.JAMA Oncology, October 2018 Wayant et alThe recent investigation of a prominent cancer researcher for failure to disclose substantial financial and administrative relationships with drug and health care companies in leading medical journals and his subsequent resignation as chief medical officer of a leading cancer center has once again placed the issue of COI center stage.27

 

Although failure to disclose COIs is not limited to the field of oncology, a recent study found that 32% of 344 oncologist authors did not fully disclose payments from the sponsors of clinical trials of oncology drugs published in major medical journals.The recent investigation of a prominent cancer researcher for failure to disclose substantial financial and administrative relationships with drug and health care companies in leading medical journals and his subsequent resignation as chief medical officer of a leading cancer center has once again placed the issue of COI center stage. .AMA. Published online October 26, 2018. doi:10.1001/jama.2018.17593

 

“It has long been recognized that the dual obligations companies have to both patients and shareholders create real and perceived conflicts of interest (COIs). If not properly managed, COIs can undermine physician and patient trust in industry-supported development of drugs and devices.  Joanne Waldstreicher, MD, Johnson and Johnson”

 

 

Prevalence and compensation of academic leaders, professors, and trustees on publicly traded US healthcare company boards of directors: cross sectional study  

A substantial number and diversity of academic leaders, professors, and trustees hold directorships at US healthcare companies, with compensation often approaching or surpassing common academic clinical salaries. Dual obligations to for profit company shareholders and non-profit clinical and educational institutions pose considerable personal, financial, and institutional conflicts of interest beyond that of simple consulting relationships. BMJ Sept . 2015

https://www.bmj.com/content/351/bmj.h4826

 Top cancer researcher fails to disclose corporate financial ties in major research journals. New York Times. https://www.nytimes.com/2018/09/08/health/jose-baselga-cancer-memorial-sloan-kettering.html. Published September 8, 2018.

 

Investigation Examines Big Pharma Payments to FDA Advisers …

https://www.sciencemag.org/news/2018/07/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical

Dozens of advisory committees vote each year on whether the Food and Drug Administration (FDA) should approve a therapy for the U.S. market

  • Forty of 107 physician advisers on the committees examined “received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms,” the publication said. Of those 40, 26 snagged more than $100,000 and seven of those gained $1 million or more.
  • Science said that 17 top-earning advisers benefitted from more than $26 million in research assistance or personal payments from industry companies. Of those payments, 94 percent “came from the makers of drugs those advisers previously reviewed or from competitors,” Science said..

Big Pharma funnels millions to Patient Advocacy groups, more than double its outlay for Federal lobbying.

https://www.nbcnews.com/health/health-care/patient-advocacy-groups-take-millions-drugmakers-there-payback-n863486

 

Transparency Hasn’t Stopped Drug Companies From Corrupting Medical Research
The outrage over an influential doctor’s hidden millions is misplaced.

By Marcia Angell, Editor of the New England Journal of Medicine for over two decades.Dr. Angell often writes on health policy and medical ethics. https://www.nytimes.com/2018/09/14/opinion/jose-baselga-research-disclosure-bias.html  Sept. 14, 2018

The More Lavish the Gifts to Doctors, the Costlier the Drugs They Prescribe.

The study, in PLOS One, found that 39.1 percent of prescribers received gifts ranging in value from $7 to $200,000, while the rest received none. Health care providers given gifts wrote an average of 892 prescriptions compared with 389 for those who accepted none. The average cost of a prescription was $135 for gift recipients and $85 for the others. Gift recipients chose the brand-name drug a third of the time, compared with a quarter of the time for non- recipients.

https://www.nytimes.com/2017/10/25/well/live/the-more-lavish-the-gifts-to-doctors-the-costlier-the-drugs-they-prescribe.html  Oct 25, 2017

Is the FDA Being Compromised by Pharma Payments:  Forbes

” Since the industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulations, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths.”

https://www.forbes.com/sites/…/is-the-fda-being-compromised-by-pharma-payments/

“The presence of FCOIs in clinical trials of oncology drugs that receive US Food and Drug Administration (FDA) approval is of particular concern, because these trials may change the trajectory of cancer care. These trials also generate high–impact factor publications, prestige for authors, revenue for the pharmaceutical companies, and newsworthy headlines.”’  JAMA Oncology, October 2018 Wayant et al

 

 

 

What do patients think? Here are the full results of an MPNforum Internet survey undertaken in the week preceding Thanksgiving, 2018.  (Respondents were drawn from Facebook MPN sites andMPNforum subscribers. ( N=201)

 

 

1. Do you believe conflicts of interest are common between MPN physicians and the drug industry?

85 % of patients think it is possible or true.

The facts:  Conflicts of interest exist (see text) but physicians believe they manage the risk appropriately.

 

 

 

 

2. Do you believe your physician is unduly influenced by the drug industry’s financial contributions?

67% of patients think it is possible or true.

3. Do you think it appropriate for a physician to accept travel and expense funding from a drug company on whose drug the physician will be reporting?

The great majority of patients think it not appropriate.

Reality: Physicians generally think it  is. (See Roundtable discussion.)

4. Is it ethical for physicians to endorse drugs manufactured by drug companies for which they perform compensated services such as consulting or educational services?

An overwhelming majority of patients think it not ethical.

Reality:  Physicians routinely do it if they believe the drug is effective and appropriate.

5. It is ethical for physicians to recruit patients for clinical trials for which they and/or their institution receive financial support from drug companies.

This one is a bit of a standoff.  41.6% believe such recruitment is unethical.  19.3% think it’s OK and 35.9% are neutral on the matter.

Reality:  Virtually every physician running a clinical trial plays some role in recruiting patients to participate in the trial.    Patient advocate organizations receiving funding from drug companies publish curated lists of available clinical trials

 

6. Do you believe MPN physicians participating in clinical trials as Principal Investigators personally conduct these studies and analyze the clinical trial data prior to publication?

This is a toss-up. Half the patient population think it’s possible, one-quarter think they do and the other quarter thinks they don’t.

In practice: Most don’t.

Conclusions from  the BMJ2018 Collaboration Study: ““In most clinical trials funded solely by industry, the sponsors help design the studies, analyze results, and co-author publications, some of which downplay or omit industry involvement,…Industry employees and academic authors are involved in the design, conduct, and reporting of most industry funded trials in high impact journals. However, data analysis is often conducted without academic involvement.

Who actually does the work?

 

 

MPNforum convened a roundtable of  MPN specialists along with patient advocates to explore the impact of conflict of interest and the steps taken to avoid the reality – or suspicion –of conflict of interest. Participating in the Roundtable are : Ann Brazeau, MPN Advocacy and Education,  Prof. Claire Harrison, Guy’s and St. Thomas, London;  Dr. Jean-Jacques Kiladjian,  Hopital Saint-Louis, Paris. Dr Ruben Mesa, UT Health, San Antonio,  Dr. Richard Silver, Weill-Cornell, Dr. Srdan Verstovsek, MD Anderson ; Michelle Woerhle, MPN Research Foundation.

Several of the eminent physicians participating in this Conflict of Interest Roundtable MPNforum In October-November, 2018 are MPN specialists within a medical teaching facility and have served as Principal Investigator in clinical trial.

Conflict of interest may be inevitable in the necessary mash up of corporate drug executives who are answerable to shareholders and focused on profit with physicians charged with the well being of patients. Theoretically, pharma pursues its objectives scrupulously observing acceptable guidelines, and physicians maintain with laser focus on patient outcomes. Nonprofits accepting grants and support from drug companies face a similar dilemma. The collision of primary interests raises doubts and can strain trust.

There is no presumption of wrong-doing in physicians, medical institutions and non-profit patient advocate organizations accepting funds from drug companies. In fact there is some necessity in that process. But the COI risk is clear. How many of us would bite the hand that feeds us?

In the following Roundtable Discussion you’ll read of the reliance good physicians place on honesty and integrity. With good reason. Ethical behavior and sound character are the bulwarks against bias. The selection of participants in this roundtable was not random. We selected good, honest, capable people, physicians and advocates known to many of us, and recognized to care deeply about MPN patients’ welfare. But the best of intentions and scrupulous attention to rules is no guarantee that COI won’t impact patient care…or the perceptions MPN patients have of conflicts of interest.

THE ROUND TABLE DISCUSSION

SILVER                     HARRISON                      VERSTOVSEK          KILADJIAN                 MESA

 

 

WOERHLE                                                                                                                                                                                                                              BRAZEAU

  •    

What are your guidelines for accepting a paid consulting contract from a drug company ? 

HARRISON: If paid I require this must be done in my own time (ie non overlap with contract). I personally would only accept this if I thought the product interesting and the company sound. If I have accepted this work then I must declare this in any interactions I subsequently have with other companies, in any presentations and publications I make and my institution keeps a register.

KILADJIAN: I don’t do consultancy for drug companies

VERSTOVSEK: Federal, state, and institutional guidelines exist that all academic physicians follow, as is mandated and implemented by their place of work. Same for me; interactions that I have with any drug company are in line with regulations and guidelines that exist, and implemented and monitored by my institution. I would be shocked that any given physician has to develop their own guidelines.

WOERHLE: MPN Research Foundation hasn’t ever had a paid consulting contract with a pharmaceutical company. The closest thing to it is our participation on the MPN Advisory Council they’ve convened, where our travel is paid for to attend the in-person meetings. We also have an ironclad policy of sharing clinical trials information and research news without regards to whether any company has ever been a sponsor or donor of ours. We mention multiple trials at each Monthly Digest and monitor the frequency of each so that we don’t favor one over the other

MESA: In general I only accept honoraria for consulting from companies for which I am not actively an investigator. This is consistent with my institution’s policies.

SILVER: I have reflected at length upon the reality and perception of conflicts of interests arising from grants made by drug companies to physicians, etc., etc.

I am reminded of a page OF Talmud reflecting on Noah’s conversation and covenant with God. The issue of integrity is something each one of us has to establish for ourselves, our set of working rules as taught by our father and mother, teachers, etc. and also developed finally by oneself. It should be strict. I think the West Point credo of duty and honor…should be for all.

  • As a clinical trial investigator for an IND how do you insulate yourself from Pharma/Sponsor influence? 

HARRISON: I only participate in trials which I believe are asking the right question in the right way with an interesting compound. I personally receive no payments for this. I view my duty in this area also relates to patient selection and accurate reporting of adverse events and results.

Many of my own studies e.g., MAJIC and PT-1 are academic studies with free drug/grant from companies. These studies never involve pharma in trial design or data interpretation which is all done within the academic clinical group.

KILADJIAN: Mostly by discussions with peers/colleagues independently of any sponsor organized sessions.

VERSTOVSEK: I assume question is about investigator initiated studies. I am insulated from Sponsor influence by federal, state, and institutional rules and regulations already in place. Following the rules in place is part of my normal everyday work. Sponsors do the same. These rules result in clear separation between Sponsors which provide funding and medication to an institution for a study, and Investigators and their institutions which conduct/analyze/report results of their studies.

MESA: Clinical research is usually nowadays a collaboration between investigators and a pharmaceutical company sponsor. Trials have both oversight by the FDA, the institutional IRBs, and for larger studies a steering committee. If I ever had concerns that a company was unduly influencing the conduct of a study in a negative or biased way there are multiple avenues of recourse including the FDA, the NCI, and even my own institution. I have never found this to be the case. If anything I have found companies are even more conservative than investigators in pausing clinical trials.

SILVER: I have never conducted a trial dictated by a pharmaceutical company. All our interferon trials were conducted with donated or patient-purchase interferon. However, no pharmaceutical company ever tried to influence the results or tried to influence me in any way. Nor have they ever offered any quid-pro-quo.

BRAZEAU: My understanding is the FDA, Office of Inspector General and the Sunshine Act protect and oversee the relationships between physicians/academic institutions and organizations and Pharma.  However, when I personally asked how the FDA manages those issues, I was given a vague response

HARRISON: Stick to published peer reviewed data, give a balanced view and declare fully any COI. In addition I would present any data displaying alternative options for the patients.

VERSTOVSEK: Again, federal, state, and institutional rules and regulations exist to address this matter. Following the rules is mandatory and would free one of possible bias. This is what I do. For example, independent development of slides and content for any presentation is mandatory; plus presentation are typically done at events that have independent review of the content beforehand, etc… My presentations stick to the data as data speaks for itself.

KILADJIAN: Very difficult indeed, I don’t have any tips besides disclosing the links with the sponsor.

WOERHLE: We have an ironclad policy of sharing clinical trial information and research news without regard to whether any company has ever been a sponsor or donor of ours. We mention multiple trials in each Monthly Digest and monitor the frequency of each so that we don’t favor one over the other.

MESA:  Usually through CME certified events which have independent review of content to be sure presentations are free of bias. We usually present the trial data, results, and personal experience for exactly what was found. These events have independent development of slides and content.

SILVER: I have never given a “canned speech” for any pharmaceutical company at any time. Many of our physician friends and colleagues still do.

  • What are your criteria for accepting appointment to corporate scientific boards 

HARRISON: I do not sit on any

VERSTOVSEK: Same as above, sorry to repeat myself, but federal, state, and institutional rules and regulations exist to address this matter. I am not a member of any corporate scientific board but if I am, I would be following mentioned rules already in place, and not try to make one on my own.

KILADJIAN: No particular criteria, since these kinds of boards are usually for companies’ internal purposes. However, they need to comply with general guidelines regarding COI prevention by academic centers.

MESA: I currently do not sit on any corporate boards, only non-profit (Leukemia and Lymphoma Society and CMPN Foundation).

SILVER: I believe academic medical schools should prohibit this. On the other hand, a former Dean is on the Board of Directors of Bristol Myers. The president of MSKCC just retired from Merck’s Board. I don’t think they should be on pharmaceutical boards.

Do you accept drug company financial, creative or administrative support for presentation and production of supporting materials you are presenting relating to that drug company’s product? If you do, how do you preserve an arm’s length relationship in the process? 

HARRISON: Unless presenting the results of large drug company studies I always make my own slides. If I am presenting slides for example those from COMFORT2 or other corporate studies I would never present slides where I personally have not evaluated the data and satisfied myself of its validity nor would I ever present slides without vetting them first. If a medical writer is used that is acknowledged.

VERSTOVSEK: Investigator initiated studies are done by investigators and their institutions which conduct/analyze/report results of their studies without any role for Sponsors; In case of multicenter company sponsored studies, typically Sponsors would engage a third party company that would be helping with administrative support in developing presentations from large amount of data such trials gather. Investigators always have control of the data and content of presentation/publication. Administrative help is always acknowledged in all publications that results from such help. Investigators do not get any funds directly, this is expense that Sponsors have for a conduct of a study. This is unfortunately typically reported under “payment to investigators,” similarly to payment to an institution for a conduct of study itself, which also gets reported as “payment to investigators

MESA: This is support which has always been part of the enormous amount of work preparing and presenting data. The investigators always have control of the content, and this admin help (whose expense is listed as a “general payment” to investigators) is just an expense associated with running and presenting clinical trials. The current process of reporting this as payments to investigators is misleading, as this is simply a corporate expense of the sponsor and does not transfer money to the investigators.

KILADJIAN: Yes, and it’s easier here to reduce the possible pressure by discussion with other academic co-authors. In my experience, discussing with co-authors is always allowed to make the necessary changes or introduce some “missing” information in the version proposed by the medical writer.

MPN PATIENT:

Financial or not, are there safeguards in your practice and your institution to protect against conflict of interest activities? What are they? 

BRAZEAU: As an advocacy organization that provides educational symposia, materials, and direction to resources we accept sponsorship dollars for our educational programs only.  Those funds are never from one source but several.  We are very transparent and have strict contracts with each sponsor. We acknowledge who they are on our website and in some printed materials for each program. They are asked not to engage patients whose first names only are on badges. 

HARRISON: Always asked for in relevant meetings, always declared in appraisal, always declared in considering, for example, academic promotion or clinical/academic excellence awards.

WOERHLE: The MPN Research Foundation has a policy regarding our work with industry called Statement of Independence that is reviewed regularly by our board of directors. The goal is to set forth our guidelines to allow us to interact with industry as well as any other part of the MPN world without having our hands tied, but also stating clearly how we mitigate conflicts of interest that could arise in our grant making process and our general programmatic or business decisions.

All of our board members sign a Conflict of Interest policy in which they must state whether they have any material financial interest in a company working in the MPNs and also lays out that their obligation is to serve MPNRF in their position on the board.

VERSTOVSEK: Of course there are safeguards in place. COI issues are addressed by federal, state, and institutional rules and regulations already in place. For copy of MD Anderson COI policies, I can connect you with our institutions COI office staff, if you wish.\

Beyond formal acknowledgment in published papers and presentations at professional meetings, how do you and/or your institution reveal potential sources of COI

HARRISON: I agree there are wider potential benefits. These matters are held on a register and declared. They are discussed prior to any activity that could be influenced and for me personally are discussed annually at my appraisal. Re Track Tenure boost – corporate funding is declared and not scored as highly as competitive academic grants.

VERSTOVSEK:  I make formal acknowledgements, this is standard practice. For institutional COI policy, we will have to connect you to COI office at MD Anderson

MESA: Yes, a detailed COI policy at my institution, these activities are allowed but are managed, need to be under various ceiling thresholds, and manage these relationships.

KILADJIAN: All financial and non-financial benefits from industry are publicly available on a governmental website for every French doctor.

All industry paid activities need an approval by both the Director of the hospital, and the dean of the University. We must provide the contracts to a board (composed of people from both institutions) that approves or the activity or not.

Whether for research, infrastructure, education, communication etc. do you or your institution have any formal means to report how funds received from drug companies are distributed?

VERSTOVSEK: Yes. For institutional COI policy, we will have to connect you to COI office at MD Anderson

MESA: Yes, although realize research expenses (via itemized and audited budgets, include time certification)and account for 95%. Education usually only through CME events.

HARRISON: Yes

KILADJIAN: No (at least to my knowledge)

Is there a formal institutional policy guideline governing public disclosure of such hard and soft perks as stock options, travel reimbursements, gifts?

VERSTOVSEK: Yes. Again for institutional COI policy, we will have to connect you to our COI off

MESA: Yes, all of the above are considered financial honoraria and reported as such, cost for travel to meetings depends on the nature of the meeting as many such meetings are necessary in the conduct of a trial.

KILADJIAN: Yes, there is a written guideline provided by my institution.

HARRISON: Yes.

SILVER via Barbara Rosenstein for CR&T: In accordance with standard nonprofit practices, [educational grants from] sponsors are acknowledged in the program guide and signage for the Symposium; in the Patient Committee Chair’s remarks at the event; in our newsletter; and on our website (www.crt.org) on the post-event page that features videos of the presentations.

If so, how is that disclosure oversight implemented?

HARRISON: At appraisal on an annual basis and the institution keeps a register.

WOERHLE: All donations are disclosed in our 990, all of which are listed on our website. We follow best practices for a public charity that dictate that an organization should not have more than 33% of contributions coming from any one donor, including industry. We track all corporate donation in our fundraising database as well, for our internal knowledge of the balance of funds raised. This information is available upon request to the MPNRF’s board of directors.

KILADJIAN: Good question, I don’t know….

MESA: Managed by the Office of the Vice President for Research

SILVER: I do think there is required some degree of “verification” as Ronald Reagan said. Trust, but verfy.” I think the issue of conflict of interest in research is not specifically for MPN researchers: Just look at the current issues regarding the drug crisis in the United States. Many doctors have been put in jail; also the pushers, in particular. However, not one pharmaceutical executive has been chastised, fined, let alone imprisoned for supplying huge amounts of opioids for which there was no legitimate medical market. How pure are our congressmen, senators, and president? Thus, the issue is a societal one.

Marcia Angell, MD (long term editor of the New England Journal of Medicine and Harvard Medical School professor, writing in the New York Times last month offered two suggested reforms. (Dr. Angell’s full OpEd in the New York Times is well worth reading.  You can access it here. )

“I would suggest two reforms.

“First, researchers at academic medical centers should not accept any payments other than research support from drug companies, and that support should have no strings attached — no control over the design, interpretation and publication of trial results. We should go back to arm’s length grants.

“Second, doctors should not accept gifts from drug companies, even small ones, and they should pay for their own meetings and continuing education, as is standard in other professions. They can afford it.”

Can they afford it?

The base salary for Physician – Hematology/Oncology ranges from $237,735 to $376,405 with the average base salary of $295,402. The total compensation, which includes bonus, health and retirement, can vary anywhere from $246,851 to $390,554 with the average total compensation of $309,468.

Source: https://www1.salary.com/oncologist-Salaries.html

What do you think?

MESA: I disagree. Consulting, particularly for a drug or trial of which one is not directly involved, is both appropriate for an academic physician to consider and necessary to the process for appropriate drug development. The individuals doing this consulting are paid for their time, and expertise, and do these efforts on their valuable free time. Lack of such guidance, by experts, in the drug development process would lead to bad planning and decision making by companies looking to develop therapies. Note this is distinct from the conduct of a trial itself, where the PI and co-investigators are neither paid nor have value transferred to them for their efforts. The individuals involved with the conduct of the trial control the design, interpretation of trial results – where “consultants” are a sounding board for the company.

VERSTOVSEK: I disagree. There are four constituents to a drug development process: patients, regulatory bodies, pharma companies, and academic physicians. They should not act in isolation from each other. Quite contrary, for drug development to work, we need to work together with good rules and regulations of engagement in place.

BRAZEAU: Our speakers do not get paid an honorarium.  Their travel costs are minimal.  Some physicians are paid by Pharma to speak.  I do not know of any MPN specialist who participates in that way.

SILVER: (via Barbara Rosenstein for CR&T):

CR&T pays only for an additional night’s lodging and ground transportation for each speaker, in addition to a very modest honorarium. The honorarium covers the doctor’s time to prepare the talk, along with the additional administrative expenses for preparation.

It is a fixed amount of $1000.  For all intents and purposes, the speakers’ participation in the program is voluntary. The honorarium is a token sum given in recognition of the time and effort the speakers put into their presentations.

MPN PATIENTS:   79.5%  think a physician should not accept travel and expense funding from a drug company on whose drug the physician will be reporting?

                                                  

CONCLUSION:   what can we make of all this?

We’ve seen there is corruption in the medical-drug-university complex. There are doctors who prescribe drugs based on favors done them by drug companies, There are drug companies that doctor the data and slant their findings. There are doctors who serve as science advisors to the FDA who receive financial reward after they approve a trial drug.  There’s more of course, but the landscape is clear.  And the patient survey confirmed what we all knew.  Patients are cynical.

There are good, caring people in all parts of the medical profession, but simply by virtue of its financial weight and blend of science, medicine and profit,  money and position too often trump scruples and integrity in the healthcare industry.

It’s good for us to be aware of it all, to continually examine our choices and options in light of the powerful forces that shape our medical decisions.

So, can we trust our own physicians? Can we trust their prescriptions, their recommend drugs?

The answer isn’t so simple. Often, since MPNs are so rare a disease, the doctor treating us glances at our CBC and our clinical presentation and reaches for the safe solution: hydroxyurea, the reliable wet blanket cytoreductive drug that usually works.  You’re not likely to get a prescription for interferon, at least not in the United States. Or a non pharmacological solution. So no, the physician who makes a quick judgment and a safe call is not to be trusted. He or she is dangerously biased.

If you show up with MF pr  progressing PV, your doc may now prescribe Jakafi since it’s FDA approved and heavily supported by MPN specialists and prestigious medical institutions.

Is that doctor trustworthy? He or she may be seriously committed to you and following MPN research. Or just relying on peer pressure or responding to a tightly organized marketing program based on questionable research and little long-term data. It’s a judgment call based on your assessment of the physician’s integrity, commitment, and ability.

And maybe that’s our takeaway from this exploration of conflict of interest.

Look back at our Roundtable doctors and patient advocates – all of them have received substantial amounts of money in grants or services to Incyte. Several have even backed drugs that failed. They all have a lot in common. They’re smart, ambitious, and compassionate. They work hard. They’re not angels, I’ve seen petty jealousies and competitive elbows in that crew. They’re human and – and here’s the true bottom line – they care about their patients, about  the MPN community, about people. There’s not a chance any of them would sell us out for money or to advance their careers. So, yes, they’re trustworthy.

And that’s about all we can rely on in this magical corrupt world.

In some things, like everything that draws a breath on this planet, our docs are biased.  (Hell, my parrot is biased.)  They believe in their work, they believe in their opinions, they believe in their capabilities. They’re not always right,  But when it really counts, when you’re sitting in their consulting room and going over your charts and options, these are the people – or someone in a white coat a lot like them — you want to be sitting opposite you.

We’ve got a long, hard MPN path to go down with hope, disaster and mystery around every corner. We need someone we trust to help us along the way. Someone with no conflict of interest when it really counts.

All we can depend on is each other and our own judgment of the capabilities and the essential humanity of our physician and the medical team on which we rely.. And our own intelligent, deep participation in our own therapeutic path. With luck and vigilance, we can reduce the uncertainty we are forced to live with as all around us commercial and medical interests cooperate and collide in pursuit of curative drugs and profit.

 

Take me back to the Contents

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