“Quo vadis, medicina?” Serious doubts about where we’re heading: regulations, influence of “big pharma” and the industry, and the shackles of “level one evidence” studies

The physician–patient relationship is no less important than the treatment of the patient’s disease itself. Sadly, both this relationship and the treatment aspect of practicing medicine have undergone undesirable changes in the recent past – and the future is hardly promising. What follows below is two doctors’ view on this crucial topic, based on a combined experience, from numerous countries, of over 50 years.

In the not-so distant ‘good old days,’ if a patient felt the need to see a doctor, he called for an appointment, and the doctor would see him on a very short notice. Once entering the office and seeing the clerk, he was ushered in to see the doctor without too much wait. The doctor took the history himself, ordered the appropriate tests, based on which the patient received reassuring words (‘it is a benign condition, there is no need for any treatment’), a prescription, or was referred to a facility with specialists.

Sadly, we live in a new reality.

Today, the patient calls the doctor’s office, and the appointment is weeks or months into the future. (If the condition is urgent, the ER offers an impersonal, expensive alternative.) The actual doctor’s visit begins with the patient registering with a clerk who first asks for the insurance card – with luck that particular doctor accepts that particular insurance. The clerk then asks for signatures on multiple incomprehensible consent documents. Next, the patient receives another form to fill out, which largely replaces the taking of the history. Afterward, the patient waits: doctors are always running behind.

Finally the nurse/technician calls. She repeats the questions already asked on the form, performs numerous tests based on certain protocols, and instructs the patient to wait again until at last the doctor arrives. During the encounter, the doctor barely looks at the patient: he must review the paperwork so far gathered, transfer the information into the computer, and tick off a checklist of tasks. The patient–doctor dialog is substituted by a computer–doctor dialog; in fact, much of the nurse–doctor dialog is also done on the computer so that a written record is preserved for the audit.

With minimal time for eye contact and examination, the doctor makes the diagnosis – and now the therapy must be chosen. The selection used to be based on his personal experience, supported by what he ‘objectively’ knew about the disease in question (literature data, various forms of interaction with peers, etc.). But what are the major factors today that determine the choice of a particular therapy?

The input comes from numerous sources; below is an incomplete list.

Regulators (politicians, authorities, bureaucrats)

Laws and rules determine how medicine is practiced, and these vary so greatly by country (or even within a country) that one must wonder about their validity and rationality. In the U.S. alone, the number of federal, state, and local agencies regulating different aspects of health-care delivery is so great that just to list them would fill the pages of this journal [1]. (Without spelling out, here is an incomplete list of selected acronyms for selected federal agencies supervising health care: AHRQ; CCID; CMS; DHQP; DOL; EPA; FDA; HICPAC; HRSA; NIAID; NIOSH; OSH.)

Many of the rules are sensible (e.g. an anesthesiologist should be present if open-globe surgery is performed); others range from the dubious to the insane (e.g. classifying corneal transplantation as if it were identical to a heart or kidney transplant; mandating that the operating-room nurse have special qualifications in cataract surgery while not requiring the same in vitreoretinal surgery; forcing the health-care provider in the outpatient service to wastefully discard every bottle of eye drop after dispensing a single drop, a procedure where the bottle makes no contact with the eye surface). The number of rules continually increases and at an exponential rate; obeying all of them requires an army of accountants, economists, lawyers, compliance officers, etc. to be involved – but ultimately, it is the physician who is held responsible. Doctors and nurses are forced to spend much more time on paperwork than on direct patient care; do we really need five ICD-10 codes for turtle-related eye injuries?

Hospital administration

The head (director) of the institution is almost never a doctor nowadays: In 2009, less than 4% of hospitals were led by physicians in the U.S. [2]. The doctor works as one small part of a giant machinery with the director crunching the numbers and making/enforcing the rules. The director’s primary responsibility is complying with regulations and keeping the entity financially solvent and out of courts. The doctor’s efficiency is ‘objectively’ measured and rated even though the quality of his care is impossible to put on a truly measurable scale. Directors are forced to value high-volume care over high-quality care, and the physician has no choice.

Insurance companies

Health insurance is a (big) business, and despite all the beautiful slogans about ‘the patient coming first,’ Milton Friedmann’s adage holds true: the social responsibility of business is to increase its profits. The internist is warned by the computer that he cannot prescribe medication A in that particular case because the insurance company does not cover it; he is asked to use medication B (even though A would work better for that particular patient). And how about the vitreoretinal surgeon who considers it prudent to remove the lens during vitrectomy but the insurance company does not reimburse the cataract part of the surgery? These decisions are no longer placed in the hands of the treating physician; they are driven by insurance companies. On the financial side: in the second quarter of 2017, the top six health insurers in the U.S. made $6 billion in adjusted profits (https://www.cnbc.com/2017/08/05/top-health-insurers-profit-surge-29-percent-to-6-billion-dollars.html).

Patients

Many of today’s patients are well informed – or think they are – about their conditions. Theoretically, this is worthy of the medical community’s support. However, much of the information patients come equipped with is delivered via a masterfully crafted commercial on television, or by an unknown source online; thus the patient demands a retinal transplant or a new eyeball. At best, such unreasonable requests are a waste of the doctor’s time, but at worst, requests such as anti-VEGF treatment for pucker-related macular edema may eventually make the doctor give up the rationale option (surgery) to become an ‘injectionist’. (On the funny side, one patient recently wanted to reject corneal transplantation for his keratoconus because ‘Dr. Google’ warned that the operation would lead to infertility.)

Drug companies

Just as insurance companies, the pharmaceutical industry wants to make money. This is of course understandable; the cost of bringing a new drug to the market approaches 3 billion dollars (according to a study by the Tuft Center for the Study of Drug Development [3]). But being profit-oriented has side effects: which drug company will rush to support a study that would show drug A to be equally effective as drug B, both made by the same company, if drug B sells for almost a hundred times more than drug A? If you guessed none, you are correct – hence the many years of effort by a courageous group of ophthalmologists to get funding for the CATT study [4], in lieu of industry funding. Along the same lines: In many countries, doctors cannot afford attending international meetings unless supported by pharmaceutical companies. If doctor A prescribes drug X, made by company Y, and doctor B performs surgery for the same condition (and especially if with superior results), which doctor do you think company Y will support to attend a meeting? This corrosive effect is felt throughout our profession and it is not restricted to ‘Big Pharma’. Drug companies are, not by coincidence, highly profitable; the industry’s profit margin in 2013 was almost 20% (ranging from 10% to 42%), the highest of the five main industrial sectors (http://www.bbc.com/news/business-28212223, based on data by Forbes).

Device manufacturers

We used to sterilize all our instruments from the vitrectomy probe to the forceps. Now almost everything is disposable, increasing the cost (including their disposal’s!) – yet the rate of infection remained unchanged. Who benefits from this? Other than the device makers, it is politicians: they can proudly tell their constituents that they are doing everything to keep them safe.

Lawyers

(For background information: there were 48,638 practicing lawyers in Washington, D.C. [population: 592,000] in 2009; in Japan, there were 30,503 in 2011 [population: 127.8 million]). Malpractice insurance and the cost of litigation are relatively easy to calculate; what is impossible to put a monetary value to is defensive medicine: the consequence of doctors practicing in fear, overdoing tests and overdoing medications. A few years ago, one of our friends slipped and hit her head on a stair; the wound was tiny and she did not have any symptoms. She nevertheless went to the ER, where she received a superficial neurological examination (negative), but did get the perfunctory head CT (shockingly: also negative). Medically the CT was of course unnecessary, but the overriding concern of the ER doctor was the fear of a lawsuit. In an example closer to us in ophthalmology: I (FK) have been preaching for decades and in over 30 countries the benefits of using full-thickness corneal sutures for all wound types. In each country, reasonable questions are asked such as ‘would this increase the risk of endophthalmitis?’ In the U.S., however, the standard question is never a scientific argument but: ‘Can I get sued if I use a full-thickness suture in the cornea?’

The Medical Profession

Finally, our own profession’s self-inflicted wounds. Think of the tremendous peer pressure resulting by ‘level-1 evidence-based medicine’ (EBM) being on an unchallengeable pedestal to the point of one publication declaring that ‘…the evidence-based movement…constitutes a good example of microfascism…’) [5]. Naturally, nobody questions the great value of a study performed based on strict scientific guidelines. However, even such a study may be erroneous – a good example being the Endophthalmitis Vitrectomy Study (EVS) [6], which compared the efficacy of surgery versus intraocular antibiotics. But since it did not require complete removal of the vitreous, the study falsely claimed the two treatment to be of equal value in eyes with greater-than-light-perception vision; complete gel removal has vastly superior results [7]. Furthermore, ‘blindly’ (safely?) relying on the EBM removes from the doctor’s armamentarium the very process of thinking, turning him into a robot: once the diagnosis is made, the patient is automatically put on the EBM track so that minimal to no individual decision-making or adjustment is required. Just take the case of diabetic macular edema: how many intraocular injections a patient faces in his lifetime (we recently overheard a colleague describing that next week he'll perform his 85th injection into the eye of one his diabetic patient), what emotional roller-coaster he must undergo as his vision goes up after the injection and then down as the medications wears off. Proper surgery, on the other hand, offers a single-intervention solution with excellent anatomical and functional results: of 44 consecutive eyes 91% had a dry macula and 72% improved at least 3 Snellen lines at 36 months of follow-up (FK, unpublished data).

In summary, the pressure on today’s physicians originates from multiple sources, which includes the need to increase efficiency at work. We doctors therefore readily understand why a patient with a retinal detachment is admitted by physician A on Tuesday; why physician B does the surgery on Wednesday; and why physician C does the follow-up on Thursday. But how does the patient appreciate this, never having his own doctor? (Don’t forget: unless you, the doctor, die young, you will also be a patient one day…)

When we look at the picture painted above, it is obvious that each of the arguments listed here is fairly reasonable in its own right, yet taken together the image is depressing. Our profession is increasingly constricted both from within and without in how it is practiced. If nothing is done to change it, practicing medicine will become a mechanical, satisfaction-lacking, pleasure-deprived, frustrating experience, a routine performed by robot-like people (artificial intelligence?). Can we do something to alter this course? It is harder and harder to remain optimistic.

Declaration of Interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper was not funded