Physicians for Clinical Responsibility

From ca. 2009
Staring Down the Beast
To see what is right in front of us requires a continual effort- - George Orwell, in “1984”
There is an 800 pound gorilla sitting right in front of us:
  • There is at least 300 MILLION DOLLARS of incentive money spread out over less than 1000 of the 20,000 ophthalmologists (and additional 45,000 optometrists) in the US, and
  • This 300 million drives the use of well over 2 BILLION dollars of cost for 2 drugs, Lucentis and Eylea, that are no better than about 50 million dollars worth of the alternative, Avastin.

  • Which is swamping the 5 billion dollar medicare budget for all of the rest of eye care (to say nothing of the rest of the health care system).
  • Making ophthalmology, just from this one issue, regarded by the government and the public as the number one predator of the medicare system, when it isn’t really ophthalmology at all but rather the drug industry and its small minority of collaborators, that are ultimately responsible.
  • And finally we have the ASRS, the main professional society for retina care, being compromised by PHARMA’s excessive influence through that same minority. PHARMA uses its KOLs in leadership roles to pervert the cause of evidence based medicine by ignoring selected evidence and fighting for drug company interests instead of the public, the broader ophthalmology community, or the remaining majority of retina doctors.
    All bought and paid for by Big PHARMA
    We spend so much time and energy exploring and debating complex problems, when they are only complex because we ignore the things right in front of us. Things that we think are inevitable or unavoidable. We’ve been conditioned to think so, or we’ve become complacent, or complicit, or some combination of all three. Maybe we have just gotten so used to certain things being there that we ignore them, even when they threaten our very existence.
    The world of ophthalmology is no different. We have grown to accept the myths of our age. Myths like:
  • The myth that it’s okay when 2 drugs cost over 2 billion dollars per year, even when they are only used in a minority of cases, when all the rest of eye care costs Medicare about 6 billion.
  • The myth that it’s okay when if either of these drugs filled a soda can, a single can would
    cost over 14 MILLION dollars
  • The myth that it’s “good business” when the physicians’ cut for this money is about 200
    million per year spread out over only about 800-900 doctors out of the total ophthalmology
pool of 20,000. (That’s over $200,000 PER DOC, not including the millions of frequent flier
miles that are also racked up.)
  • The myth that it’s a “new world of collaboration” when another 150 million or so gets paid in
    kickbacks (so-called rebates) to these same doctors, that’s another $150,000.00 per doc,
    from the same companies that sponsor many Academy and Society activities.
  • The myth that corporate sponsored research isn’t biased by marketing intent; that “evidence-based medicine” isn’t tainted by “marketing-based evidence” and that there is nothing wrong with company-paid “Key Opinion Leaders” and “Thought Leaders” boldly claiming that they are the oracles of the standard of care when all they are doing is shilling
    for their handlers.
  • The myth that taking direction from industry, selling out our patients, and doing as we are
    told in exchange for money is a good thing, a path to security and greater prosperity.
    While accepting such myths, how can we then wonder why the rest of the 20,000 ophthalmologists have been placed under a microscope for everything else that we try to do?
    We have increasing trouble being able to look at legitimate new things that are cost effective, because in society’s view we have become so notorious for pursuing every possible profit. We have shown that we cannot or will not police ourselves. In exchange for sponsorship of meetings, departments, whole professional societies, we have given the keys to the kingdom to increasingly voracious corporations. In the process, we are losing our very profession.
    Martin Luther King once observed that “He who does not resist injustice becomes a party to it.” We have ushered in the era of corporate profiteering, in fact racketeering, at the cost of our patients’ and our society’s welfare, all in the name of “partnership” with industry.
    When we should be fighting for our patients and the good stewardship of our profession, we have instead partnered with a barbarian at the gate, a barbarian that the rest of society has had just about enough of. Money does talk, and we resign ourselves to its power, but it only talks until it provokes a revolt. That is already happening and through partnership with the barbarians, or just looking the other way, we physicians are coming down on the wrong side of history. We have only the narrowest window of opportunity to rectify this.
    Why would we allow a barbarian to enter the castle when it has such a clearly different ethical orientation than ours as physicians? Well, for a variety of reasons.
    He paid his way.

    As government funding for research and education has become tighter, corporate money has filled the gap. The problem is that, just like the mafia, there is always an expected payback. There is always “a thing for a thing”. Loyalty returned. It’s that slippery slope. The one-time check for a meeting becomes a yearly sponsorship that becomes research funding, that becomes “partnership” in designing what is asked and what isn’t and what is published and what isn’t. That then becomes a partnership between R&D and the product roll out, i.e. marketing, which becomes an army of “Key Opinion Leaders” complete with talking points provided by the sponsors’ marketing departments. The KOLs get recognition, earned or not, and recognition becomes self-sustaining, so that company “shills” fill up the speaker lists at meetings, and suddenly the product rollout is defined as “the new treatment standard”.

Somewhere along the way, independent “evidence-based medicine” gets hijacked by the myth that the Randomized Clinical Trial is the oracle of all truth and in fact defines the standard of care. It does not. The “Randomized Clinical Trial”, by its very nature, studies only highly isolated variables, excluding the complexities of real medical life. Interpreting results assumes the valid intent of then thoughtfully applying this isolated finding to the highly variable world of patient care. The thoughtful application by doctors based on broader training and experience is what defines standard of care, not a trial and certainly not a corporate marketing department. Without knowledgable analysis of such results, it requires only a subtle slight of hand to equate highly biased corporate RCTs with unbiased independent RCTs and broad experience, and voila!, the Corporate RCT is anointed as the Oracle of ALL normative standards. And everyone wins. The pharmaceutical industry now owns its own marketing channel and the very doctors who push the product. The doctors now have an opportunity to “partner” with industry on everything from product promotion (“shilling”), to reaping benefits from the oppressive pricing and dosing schedules, and fighting to suppress any resistance to the juggernaut by joining political forces lobbying to protect the channel. Really? Really. A recent example: The only representative related to ophthalmology on the FDA panel determining the fate of using compounded Avastin is an executive from Regeneron, one of the Big Pharma companies trying to kill Avastin. Oh wait, not everyone wins. What about patients and society? Are they disenfranchised, or is that some horrible illusion? Can Pharma can really swing this coup? That depends on us as physicians. Does Big Pharma own medicine or do they just appear to. If they own all of us, why do almost 70% of retina doctors almost exclusively use Avastin? That doesn’t even count the other 17-19,000 ophthalmologists and 45,000 optometrists who aren’t even involved in this. What PHARMA really does appear to own are the medical societies. The same societies that arbitrate what is and isn’t certified standard of care are (in some cases far more than others) simply mouthpieces for their handlers. Many would deny it, and many more didn’t really intend it or think it would go this far, but to gage corporate influence, one need look no further than the editorial programming in EyeNet magazine or look at the prevalence of corporate relationship in the form of personal consulting fees, society sponsorships and the like among society leaders? What is the percentage of academics who DON”T have at least one consulting relationship? How many speakers at society meetings DON’T receive corporate money? Five years ago, I looked at the ASRS annual meeting, and of 173 speakers, only 3 had no financial conflicts of interest. The rest were all promoting something or someone. It’s even worse now, at meetings and in research. At one point, the lists of financial disclosures in The New England Journal of Medicine were so extensive, there was no room to print them in the journal. The reader was instead referred to the website for a full disclosure. Some years ago, Dr. Bill Rich, who has been a bastion of integrity in a challenging world, wrote an opinion piece in Retina Times entitled, “Back to Pizza and Beer”. He was pointing
out that as lavash as our meetings have become (meetings that are far more lavish now), we simply don’t need it. We don’t need opulence to have excellence. We, as physicians, chose a calling, not a killing. We don’t need a windfall from corporate money at all, much less on the backs of the patients we are supposed to serve and protect. What was true then is even more true now. The slide toward profiteering has only gotten worse, now to the point that we are losing our respected place in the rapidly changing world of healthcare and with it our ability to provide that service and protection.

  • Misplaced Libertarianism

    Some object to practice or price controls on the basis of some kind of libertarian claim to freedom. We brandish our special calling as physicians and our sacred right to do what we think is best for our patients. This is a right in the same way that we have a constitutional right to bear arms. For the sake of discussion, let’s look at that. We do have many freedoms in our country, like the right to bear arms, but that right does not extend to giving us the right to use those arms to hold up an octogenarian or the Medicare office that pays for his healthcare. Similarly, we do have a “right” to determine what we think is best for our patients, but this “right” is actually a
    privilege based on our training and our oath to be honest and do no harm. This privilege does not extend to giving us the right to ignore legitimate data, to imply or explicitly state that only corporate data is normative, to treat better insured patients with more expensive treatments and less insured patients with cheaper treatments, based solely on cost while acknowledging the medical equivalence. Our “right” does not give us the right to defraud patients and payers in the same way that our guns do not give us the right to loot those same people.

    Our hypocrisy becomes even more glaring when we look at the enormous profits and frequent flier miles that using Lucentis and Eylea bring, when we acknowledge the “rebates” that are in fact kickbacks solely for using Lucentis instead of Avastin, when we acknowledge Key Opinion Leader and speaking fees. Many publicly say that these rewards are “trivial” and do not influence our decision-making even when making this decision can mean hundreds of thousands of dollars of extra compensation per year. Hundreds of thousands of dollars of bonus money
    per doctor isn’t meaningful? Tell that to a pediatrician, or to the senior who had to sell his car or not see his grandkids at Christmas to pay for his Lucentis.

    For that matter, tell it to the general ophthalmologist who just got audited by CMS or the OIG for $20,000 dollars worth of E&M code disputes. Tell it to the pediatric ophthalmologist who gets paid 20 cents on the dollar to screen premature kids. This is a simple reality that is only denied by the 5% of ophthalmologists who actually benefit from it.

  • The more things change, the more they stay the same.
There is nothing too mysterious about what we are facing. It’s nothing new either, and it’s nothing we have to accept. For now, we have traded our profession as some of us once knew it for a quick profit (for some), for an easy way out of a department or society budget crisis, for an enticement to a more luxurious future, for a handful of magic beans. This is the Faustian deal that we have seen and written about throughout history. Sir William Osler faced it and stood up
to it in the late 1800s. In the 11th century, William the Conquerer won his crown standing up to usury in the Church and then succumbed to the same corruption. Paul and Luke wrote of it in the New Testament as did David and the Prophets in the Hebrew Scriptures. Mohammed, Krishna, Buddha, Lao Tzu. Human beings are almost unique in nature in their capacity to prey upon each other. The other “intelligent” species and even lower species work in community. Human history is defined by the struggle and the decision to either serve each other or prey upon each other. The content of our character is defined by our choice.
It is a choice. Some think it’s a tough choice too, but it is only made difficult by self-interest. Don’t we deserve the best? Isn’t that what capitalism is about? Big Pharma is just doing “good business”, right? No. “Good business” assumes honesty and good stewardship of one’s business, not obfuscating data and racketeering. This transmogrification is a well-documented and often discussed slide in the world of business ethics. It is covered in many books, such as “Higher Aims to Hired Hands” from Harvard Business School, “Trading Patients for Profits”, and more recently, “Deadly Medicine and Organized Crime- How Big Pharma has Corrupted Healthcare”. Even this moral decay within the business world is aside from the fundamentally different ethical context between business, which rightly regards customers as adversaries to negotiate with, and the medical profession, which rightly regards patients as vulnerable charges who need and deserve our advocacy and protection. That is the topic of another essay in this series (Rediscovering Character in Medicine) and numerous other more scholarly works. What we are talking about now is our integrity, the survival of our profession, and the survival of the health care system itself.
4. Facing the beast. Is it really an 800 pound gorilla or just an emperor with no clothes?
Facing this question is simpler than one might think. Winston Churchill said that, “We make a living by what we get, we make a life by what we give.” As physicians and human beings, we should all be preoccupied by the latter, but that doesn’t mean we can’t have the former too. We have a great profession and it is a rare ophthalmologist that can’t have a good living with even a modicum of social conscience and common sense. That does not mean that we have to lie and cheat and steal to get it. It does not mean that we have to fall into the trap of thinking that being able to get more means we deserve more. It does not mean that we fall into another trap of thinking that we need to cash in now because it’s all going to go away. It most certainly does not mean that we appease an alligator in the hope of getting his scraps now and that he will simply eat us last. The only favored place we get teaming up with an alligator is a favored place on his plate, or we actually become an alligator, and neither of those things are the reason we went to medical school.
What we are seeing in the evolution of Big Pharma isn’t capitalism, it is capitalism run amok. It is the proof that power corrupts and absolute power corrupts absolutely. The corporate game plan is based on the need to grow exponentially, which is quite obviously non-sustainable. Growth with honest stewardship is very possible through growing markets into untapped areas. The third world is in dire need and barely served. Right here, we have so much new technology, we not only don’t know how to take full advantage, we actually harm people when we use it wrong. If, for the sake of argument, we were to suddenly have no new advancements for even a decade, we would continue to do more good and save more lives just by learning to take full advantage and maximize availability of what we already have.
Instead, we buy into the Pharma Juggernaut. With literally a world of untapped market and unachieved good from the treatments we already have staring us in the face, the sad, lazy fact is that:
  • It is easier for marketing departments to always hawk “the next big thing”, even when quite often it is simply a reinvention and repackaging of “the last big thing”. The bulk of “new development” is in fact merely the lucrative “me-too” drug market. Lucentis is the ultimate “me-too” drug in that the original was intended to be hidden from view from the beginning because it was priced wrong for ophthalmology.
  • It is easier to invent new diseases and new indications for existing products. Whole books are written about inventing diseases just to market a treatment. ADHD, Erectile Dysfunction (ED), GERD, a thousand new psychiatric ailments most with catchy acronyms, all either invented or mercilessly over-hyped.
    Just as the short-term plan is easier for the marketing departments than actually growing markets of real need, so it is easier for us as physicians to be complacent and accept Big Pharma’s offer:

  • If Big Pharma is offering to fund our academic department, isn’t it wrong to refuse? Isn’t it a disservice to residents? Or.... is a world where their decision-making is dictated by Pharma the disservice?
  • If Pharma paid for developing the new drug and all the studies and our compensation, shouldn’t we be grateful? Shouldn’t we defer to their desire to market things the way they want? After all, it will mean more profits and therefore more for us on the next go-around. Or is it better to ask the hard questions, as some bravely do; to stand up and demand transparency and find what really is the most effective and the most cost-effective?
The underpinning of all of this is the cancerous idea that medicine is “big business”. We live in a world where corporations expect to grow exponentially. The “business people” in medicine find it very convenient to blame greedy doctors and yet, on average, hospital CEO’s and administrators, insurance executives, and above all pharmaceutical executive and even sales people make far more than most doctors. They are literally looting the medical industry and the government. And why not? “It’s big business. We have concentrated this power and wealth, and we are by God going to keep it.” The problem is that the money is finite and the only way to keep it and to
Elisabeth Rosenthal, NY Times May 17, 2014
continue the growth is to do it on the backs of those who have scrapped and saved the longest: real people and especially seniors, either through the entitlement programs they have funded or through personal savings. These “big business” pros are literally confiscating government program dollars and people’s life savings for themselves. If they have to pay off a minority of doctors and help them concentrate influence and wealth for themselves, well that’s just good business, right?
Wrong. Medicine isn’t primarily a business. Over a century ago, medical forefather Sir William Osler reminded us that, “Medicine is primarily a calling, not a business. It is a calling that tests our hearts equally with our heads”.
It was true then, and it is true now. We should take that advice. Maybe we could follow Bill Rich’s idea and return to “pizza and beer”, back to a simpler life with fewer frills, less opulence, as much or more clinical excellence, and far more peace of mind. The classic rock icon, Neil Young, once said that “traveling in the ditch is a rougher ride, but you do meet more interesting people”. I am willing to believe that medicine is the same way. We don’t have to travel in a metaphorical ditch, but we don’t need the opulence either, and only the minority of our numbers really believe otherwise. Real physicians got into medicine to help people. Real leaders, like new AAO CEO Dr. David Parke, do what they do out of love for our profession and its next generation. Real researchers, not the paint-by-number, fill-in-the-blank kind, are far smarter and far more dedicated than the average marketing department wonk, and I’d bet that in a world with real academic freedom, where researchers and clinicians lead the way, we’d get better results for patients even if the spreadsheet guys need to find another way to wow Wall Street.