Over the past several years, academic medical centers, professional medical organizations,industry trade groups, and federal agencies have transformed the way their institutions handle “conflicts of interest.”
Medical schools such as Harvard, Michigan, and Yale, hospitals such as Partners, and the National Institutes of Health (NIH), have all proposed or changed their policies regarding what outside financial activities and interest’s faculty and staff can have. Industry has also taken significant steps to address potential conflicts of interest in medicine and research through the PhRMA and AdvaMed Code of Ethics, and the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support.
In addition to these changes, the news media have fueled controversy and concern about physician-industry relationships and research, mostly stemming from leaked documents from product liability, plaintiff litigation.
This “un-perfect storm” has created an environment in the medical community that stigmatizes working with industry. Instead of being proud of the collaboration and innovation that physician-academia-industry relationships provide, more health care practitioners are seeing their names published in local media. And for what? Educating other doctors and providing services that will progress medicine.
As David William Rattner, MD recently noted, “it’s time to blow the whistle on the individuals who are promulgating overly restrictive policies regarding relationships between physicians and industry.” His commentary was drawn from his keynote Karl Storz lecture at the 2011 SAGES annual meeting.
Dr. Rattner, chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital and professor of surgery at Harvard Medical School, both in Boston, asserted that, “the insistence by academic journals that all such relationships be rigorously restricted is impractical and will compromise patient care.”
Conflicts of Interest
The Institute of Medicine (IOM) defines a professional conflict of interest as “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. Drivers of bias may be financial, academic, professional status, or personal.”
As Dr. Rattner pointed out, many doctors find themselves conflicted professionally when they participate in a promotion process, a search committee, or a program committee in which we are privy to a competitor’s work. He noted how in these situations, physicians are asked to use their judgment and place the interest of what they are trying to do above their own personal interests. “Physicians are never asked to disclose these other kinds of conflicts, and it’s extremely rare that they are asked to excuse themselves from the process.”
He explained that, “one of the greatest conflicts of interest physicians have is the way in which they are reimbursed – whether by capitation or fee for service.” What is in a physician’s personal best interest may not line up with what is best for their patients, but this is not something a physician discloses.
“So why is it that the commercial relationship between physicians and industry or physicians and professional organizations has received such scrutiny? And why have so many authors ignored the benefits that have accrued from physician/industry partnerships, choosing instead to demonize money and commercial interests exclusively?”
The Impact of COI Rules
Dr. Rattner noted that he has been a member of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) for more than 20 years and is also a former president of SAGES. He asserted that if the conflict-of-interest rules currently being forced on physicians had existed in the 1990s or the early part of the past decade, SAGES would not be what it is today.
When he joined SAGES, the organization was a fringe group with about 300 members with no representation on the American Board of Surgery. The leaders had a passion for minimally invasive surgery and made it their mission, often through strategic partnerships with industry, to advocate for new technologies and educate surgeons about how to use them. Without these partnerships, initiatives such as the Fundamentals of Laparoscopic Surgery (FLS) skills enhancement and assessment module would never have come to pass.
He note that, to the best of his knowledge, “no SAGES leader has received a dime from FLS, and the society itself has struggled to recoup the investment made with its own funds. Meanwhile, the FLS has been adopted by the American Board of Surgery, which means that patients will benefit.”
Similarly, Dr. Rattner recognized that the most minimally invasive surgery fellowships wouldn’t happen without industry support. Obviously, the companies do derive benefits, but he asserted that, “the primary beneficiaries are the patients whose procedures are performed by fellowship-trained surgeons rather than by surgeons who are struggling to surmount the learning curve or using outmoded techniques.”
Accordingly, Dr. Rattner noted that, “if future generations of surgeons lack training opportunities because of restrictions, patients will be the big losers.”
With respect to research, Dr. Rattner asserted that, “the implication that industry-funded science is inferior to government- or university-sponsored science is ludicrous.” While companies want to be successful, “doing so at the expense of patient health and safety would simply be bad business.”
He noted that, “the financial impact of a scandal involving the safety of a drug or device so far outweighs the potential profits that no rational CEO would make a decision to risk it.” Additionally, Dr. Rattner explained how drug and device companies anticipate the rigors of the Food and Drug Administration (FDA) review that is required before their products are brought to market and if fraud is discovered or a patient harmed, the consequences can put the company out of business.
Conclusion
The benefits of physician-industry collaboration are remarkable. As Dr. Rattner pointed out, “investment in biomedical research over the past 30 years has led to increased life expectancy in this country, and decreased overall mortality and disability among the elderly.” And what the public must realize is that the research that has helped to deliver these outcomes was conducted not only in universities, but also in the labs of pharmaceutical and device companies, and much occurred through partnerships between physician investigators and corporate sponsors.
Consequently, “before the fruits of this research could save lives, products had to be manufactured, marketed, and distributed, and this was done by industry, not by universities.” The bottom line “is that cooperation among physicians, scientists, and commercial interests has led to dramatic improvements in health care, and no one faction could have done it alone.”
Accordingly, Dr. Rattner asserted that, “the onslaught of overly restrictive conflict-of-interest policies threatens such progress and may have some very damaging consequences on medical technology innovation and graduate medical education, while failing to address the real problems facing the health care system.”
There is no question that “financial conflicts of interest should always be disclosed, and industry-sponsored infomercials masquerading as CME should not be allowed, but physician-industry relationships are generally productive and are essential to the process of discovery, development, and education in medicine.”
If we continue down the path of overly restrictive conflict-of-interest policies, patients will lose access to life saving medicines and treatments and future generations of physicians will not benefit from the innovations and advances physician-industry relationships provide. As a result, institutions, academic medical centers, professional societies, and federal agencies need to take a time out and examine in a scientific, balanced, and evidence-based manner the nature of physician relationships with industry and with government so that we can all work together to deliver drugs and devices that our patients need.
the family struggles to understand what insanity and reason let go of before anything began
the doctor leaves the patient to pay his debt that society can’t grasp
the agency that collects the funding to give care to those rejected from society lies to protect what little remains what emotion can’t sway the people to care anymore than they can
the nurse that replaced the doctors says she is a phycians aid, in front of the matriarch of the the one who had to abandon ever bieng understood to survive emotions that hid her from bieng known and listened to the way everyone wants to be understood
the matriarch trusts the angency from time and again, the only people left to keep what came from her womb from slipping into a world she could only speak of on paper, but even then she could not fight to live is to die and to let go of this world, but the mother knows that no one ever should live as the insane must and do, but there’s never an expert willling to give the proper care, and its not the mothers fault and she can not control where her daughters mind would go if there were no mecidine left to rule, what no one but God can control, and the mother cries and tries not to see that her daughter is afraid of that world her mind can take her to, and truth is the mother can not understand without fear that it isnt her fault when her child isnt here
so the child tries to fight and tries to be heard and tells the nurse all she needs to do the research into the history about the medicine and the facts that were there that remain in a chart so thick only a genious would read it and know what the many doctors that left recorded there
the facts that would tell the one who depends on chemicals and pills that there may be hope, that pershaps there were mistakes that others may have made in that chart no one would read or study at all cause it goes back many doctors and years, and is so thick and has too many variables for anyone to bear except theone who would disapear if the medicine were no longer there, less God in his mercy would make an expert liscensed person care
so the nurse has an ego and is insulted by the adult with emotions like a child who is crying out help me dont take away my hope, dont abuse your aurity to decide how to give me these pills, in a way that would keep me from using them to help me stay and to fight to keep me present and aware she tries to tell everyone she is slipping though on paper she makes sense, she has recorded the facts in her mind but inside her heart she knows that the medicine that keeps her in this world that other people knows will either kill her body or be used in a way that will make the physicains tell those neglectful people at the agency who do not study her chart or trust her experiences to find a way to make the medicine keep working, all these facts in sound become rambling, all that needed to be understood was that no one was listening, to the raw facts that put the agency to blame
and the nurse writes the script as she had before and says i’m not responsible for what remains of your mind after doctors have neglected your care and refused to uncover that another doctor or more simply keep writing scripts without reading and studying the chart so thick and so worn of what was left of the years of this ilness bieng seen instead of her
and she knows that they simply wont be accountable for the job they were given, to read and understand the chart as it was written, not the emotions that blind her and everyone else, but the facts she keeps rambling about how these medicines were prescribed how she always when she takes care of herself is disregarded by professionals who want status and repsect a paycheck to pay off debt the devotion of a expert with knowledge and liscense to care, she knows even as she slips its not her family that doesnt really want to be there
it is the professional hired and paid that doesnt want the responsibility or oppurtunity to make use of thier trade to the one who could benifit most, who could be the best case study if someone with a degree and the job would just do the work
and she as insane as she is in her rambings and her appearance of silence or thought, that races and unlooses all that she feels and makes all that is arround her something no one could ever percieve that she knows
that it isnt the family that is to blame
or the body for how it rejected medicines before
or the mind that gets wild and echoes from somewhere no one can go
but its that damn chart for bieng so thick and the agency that just wants to exist and the doctors that would not digress or discuss the facts dispite the risk involved
who knew she would no stand in court
nor would she be heard
so instead of studying why this mecine or that failed or made such a stir medically to the body
would not judge another of thier peers work
left her to say in total disgust of this world
that its better to die alittle sane
and be prescribed a dangerous dose
than to live never able to have a conversation or see anyone laugh
to live as a body with no judgement or hope
and she cried out in a loud voice that God gave her so no one could forget what the truth is that must be understood
and God gave her words a simple form she never could yeild
and God gave her spirit the oppurtunity to claim the only truth that needed to be seen
beyone the insanity her words bellowed from her soul
“If I die my Body will speak the truth and no one will be able to disprove its character and call it insane, If i die by because of this dosage they will not slander my name”
and so the days of fighting to live and survive reveal that it was useless and the results are the same, and that this is the isanity that she would rather die than to suffer by, so with another liscensed person and another possible arrogant doctor to face in this agency that lies to keep the funding in place, that the child the adult the insane could not make the public care enough to give them the funding that would give her the hope that a doctor would spend more than fifteen minutes on her case, more than write her a script,
but the data was record in the chart for professional eyes, and the patient that did not recieve the proper care was excused as a nuasance and as a failure of her own mind. though the medicine could have been analized and hope revived, though she fought as hard as she could
though the family dug for the answers it wasnt trained or liscensed to know
was left with the horror that all that would one day remain
would be either a body and a report
or a soul suffering with no hope to understand the life that she could have had
and a family that had the heart to inspect and analize but was not the expert or the cause of the wild mind
what i wouldlike is a doctor who would reserch my chart for loop hole, mistakes other docs made and reasons if they can be found as to why i can try an old med i wasnt allowed anymore now in these different life i am living, or to help me know what dosage the meds should go when increased, how high, when lowered how low and when stable when to lower them and when to stay the same. the later part of care they wont try my way, which is just modified to my words the good doctors ways, what i want is hope how to stay alive and as sane as i can i would let the doctor use me as a case study and use my inforamtion to even write a book for his carreer, as i never wished for that exposure, but if i could find a doctor that could help me know how to do more than to live til the day my body rejects another medicne. i would apreiacate that. thank you christine horner, ps the body of work about my horror story is written that way to keep it less painful and easier to express. its a writing techininiquenot a discription of me and how i speak.