Physicians for Clinical Responsibility

From ca. 2009

Rediscovering Character in Medicine- an Editorial

I recently had the pleasure of seeing a new patient. This gentleman is a truck driver and relies on bilateral vision for his profession. He had seen another retinal specialist four months previously and was correctly diagnosed with an occlusion of a venous branch in one eye and vision loss from related swelling. Although a moderate occlusion like this would have had an excellent chance of responding to available therapies, he was told that there was no treatment, and that he should wait until a study of an obscenely expensive new medicine was available. He was not told of the options nor was he told that the doctor would be paid handsomely for enrolling him in this study. He became disenchanted and came to our office for a second opinion. One month after treating him, his vision is improved enough to renew his CDL and resume driving.

Is that what we’ve come to? Withholding treatment purely to make patients our pawns to make more money? As in all professions, there always have been and always will be doctors who are primarily financially motivated. This used to be the exception. The physician as patient advocate used to be the clear norm. More and more doctors now consider this to be naïve and sentimental.

After all, this is the new millennium. Technology is king, and why shouldn’t doctors share in the windfall? Doctors see surreal incomes among executives in the business world, just as their own compensation is scheduled to decrease dramatically while the cost and risks of practicing soar. This is especially true in the pharmaceutical industry, the darling of Wall Street and the very industry most accessible to physician involvement. It is natural and tempting to ask, ‘Why not me?” After all, if physicians drive health care, why not be paid by the industry that fuels so much of it? If doctors diagnose and treat illness, why not get paid to implement the plans of an industry that works to “define” new illnesses and new “needs” for its products. If doctors do research and if industry is rapidly taking over control of what is studied and how it is studied, why not become a paid mercenary in this process? If industry is so eager and financially capable of funding healthcare, and all physicians have to do is accept the argument that industry’s intentions are good, well, why not just give in? It’s convenient and rewarding and, hey, you can’t fight it anyway, right?

The problem with giving in is that with each step, the patient becomes more of a commodity and a pawn instead of the focus of our service. Giving in betrays that which defines the character of the physician. We simply cannot do that and continue to be a healer, teacher, advocate, and care giver to our patients.

Giving in to profitable complicity with the pharmaceutical industry, or any other industry for that matter, betrays the fundamental ethical difference between the practice of medicine and the practice of business. This is not to suggest that one is right and the other wrong, only that they have different ethical constructs that are fundamentally different. The business ethic accepts that the businessman or woman will act so as to promote his or her business. The business person is expected to be honest but not so altruistic as to prevent making a profit. The relationship with the client is an adversarial negotiation in which a product or service is provided for the highest price that the market will bear, and the consumer’s admonition is to beware lest the price and/or quality of the transaction not be ideal.

The physician’s ethic is entirely different. His or her relationship with the patient is not adversarial, but one of advocacy wherein the physician is expected to serve the patient’s best interests at all times. The defining role of the physician is to be an advocate, to be wary on behalf of the patient and not to be that of which the patient must beware. The physician is to work to make the patient healthy and less reliant on therapy, not more so as is the goal of any pharmaceutical marketing department. There is the expectation that the patient will not be taken advantage of physically or financially or be subjugated to the interests of the physician or any industry agent.

The pharmaceutical industry is a hybrid. It is a business entity and can be expected to behave like one. Unlike other industries though, it trafficks in the health of its consumers, and therefore has a responsibility to the public trust. This industry used to be faithful to that trust, but now increasingly only pays lip service to it. On the whole, the industry has run amok and pragmatically betrays its responsibility to the public when it is financially expedient to do so. Such a charge may seem extreme, but there are countless examples of drug companies justifying outrageous pricing or marketing and research practices as being consistent with their “responsibility to shareholders”.

Although physicians have a right to make a comfortable living, they are obligated to refuse profiteering and even racketeering at the patient’s expense. The medical profession, like all professions, has some members whose primary goal is personal profit. The majority have higher goals, but many have none-the-less followed an insidious slide into the hands of corporate and especially pharmaceutical interests. Like many “slides”, it starts innocently enough. A T-shirt at the Academy booth for listening to the pitch. Later, maybe the company sponsors a dinner for you and your referrals, some nice CME, and of course you pick a topic that flatters the sponsor, or at least doesn’t criticize them. Later they ask you to give a talk with an honorarium and travel expenses, and again the talk appropriately expresses your gratitude. Then maybe a trip to be on the advisory board, and finally the big time: you are asked to be on the “research team”, but of course they own and control the analysis and presentation of the data. You don’t like that, but what the heck. It’s great for the practice, and “everyone is doing it anyway”. It all seems okay, you guess. The only trouble is,

It’s not.

It leads insidiously to full complicity with the marketing efforts of industry at the cost of the patient’s well-being. This complicity comes at many levels. The most self-evident is through the promotion of new, patented (and therefore more expensive) “me-too” drugs of dubious value, through direct-to-consumer marketing and the provision of samples to cajole doctors to use these agents. Another more egregious example of complicity is industry manipulation of the research process wherein they have an inappropriate influence on what to study, how to study it, and how to integrate the research process with the marketing plan.

Stories from the trenches-In the world of retinal medicine, the ultimate me-too drug is Lucentis, an agent so outrageously priced that if it was used just for new cases of Macular Degeneration according to the company’s protocol, it would each year cost more than twice the entire 4.7 billion dollar Medicare budget for all or eye care. I will use the Lucentis debacle as an example of how the ethical practice of medicine has been compromised.

Complicity over what to study-Genentech developed a true wonder drug with Avastin. It was originally approved and marketed to treat colon cancer and has now been expanded to other cancers in doses of 500 to 1500 mg. IV every two weeks. The pricing was set such that a cancer patient could be expected to pay around $50,000.00 per year. The drug is actually a bivalent antibody that blocks abnormal blood vessel growth and would be expected to work very well for abnormal vessel growth in and under the retina. Normally, if a drug might show potential elsewhere it would be tested, but Avastin was not. It had already been priced at about $5.00 per milligram for cancer therapy, and inexplicably it was kept out of sight. Instead of testing it, it was claimed to be too large to penetrate the retina, creating a plausible reason to split a molecule that already worked, rename the active fragment and give it a new name and price of $2000.00 per half milligram! Retina doctors hired to do the company sponsored research were pleased to go along. Even developing Lucentis required an incredible break in logic, which is beyond the scope of this essay, but which is detailed below.

Complicity over how to study new drugs (and what to report or not report)-This example comes from the development of Photodynamic Therapy (PDT) using Visudyne, a drug that ushered in the era of exorbitantly expensive retinal therapies with marginal efficacy. Histologically, PDT does some very bad things to the retina that can explain why vision doesn’t improve more often and in fact why PDT often causes significant visual harm. Although the ability to detect this existed at the time, original studies did not focus on histologic effects. In fact, histologic study with OCT was not only ignored, post-treatment study data was not even collected for three months after the treatments. Subsequent work shows that PDT with Visudyne causes immediate, nonselective devastation to the neovascular membrane and surrounding tissue. The original lesion is actually widened by the treatment, and eventual aggressive neovascular recurrence may occur. The original studies were performed by researchers who, in many cases, were paid with company stock options. Without the suppression of this data, and the redefinition of “visual success” to include 3 lines of vision loss, it might have been more difficult to even get this drug approved and marketed.

Complicity over how to treat patients-Back to Lucentis, the ultimate me-too drug. In spite of all attempts to obscure it, Avastin was independently found to be safe and phenomenally effective. In most surveys, 70 to 80% of retina surgeons in this country and nearly all in other countries use Avastin in preference to Lucentis. Even so, almost a billion dollars is spent annually on Lucentis for what can be accomplished with less than a million dollars worth of Avastin. So what are the incentives to use Lucentis? Fear, misinformation, and money. The company has spared no effort to promote Lucentis over its own parent compound, from inception to the present. They offer free Lucentis to any Avastin study willing to switch, but will offer no free Avastin for any purpose. They have used their paid speakers bureau to spread scare tactics about using Avastin off-label, while they simultaneously support off-label studies and use of Lucentis. (Keep in mind that any use of Lucentis less than every 4 weeks is “off label”.) Beyond that, there is a built-in $100.00 per dose inducement to use Lucentis over Avastin because CMS will pay 106% of wholesale price, which is over 100.00 for Lucentis at $2000.00 per dose and virtually nothing for Avastin at $10-30.00 per dose. This means that for every 40 patients a doctor commits to Lucentis every 4 weeks, he or she makes an extra $50,000.00 per year. Recently, Genentech offered a program that would pay doctors up to $40,000.00 per quarter if they showed an increased use of Lucentis and if they agreed to deny having any knowledge of the program to outsiders! They called this a “rebate” program, although the recipients were doctors who were already profiting from using Lucentis, rather than payers and patients, who continue to get milked.

Redefining Character in Medicine-That is a lot of money. In spite of that, most doctors continue to use Avastin. Why? Because it is the right thing for the patient, and most doctors are still committed to doing the right thing for their patients. The Lucentis story is repeated countless times in this current era of industry controlled medicine. Still the question remains: what defines the physician’s ethical imperative? What defines the physician’s character? Is the doctor’s primary responsibility like the businessman’s, to maximize profits for him or herself, or is it to be an advocate, even an activist, for patients regardless of the prospect of greater personal gain?

Clearly, the ethical practice of medicine demands the latter. This is not to say that medical care must be free, but it does mean that the doctor must:

  • Act on analysis of all available data, not just what companies sponsor and promote

  • Weed out company bias rather than promote or even benefit from it

  • Stand up for the patient in the face of business imperatives that use patients to maximize profits by pushing more expensive me-too drugs, such as Lucentis, with exorbitantly higher prices but no greater benefit

  • Resist the mindset that Big Pharm can define new illnesses for the sole purpose of selling drugs to treat them.

The doctor’s calling has been described as a “higher calling”. It is in the sense that the physician is called to serve needs other than his or her own, even at the expense of personal interest. The physician’s calling is antithetical to the business calling without denying the legitimacy of business practice. Businesses appropriately seek profit, but this is kept in check through competition, government regulation, legislation, public advocacy, and transparency in the media. The concept of caveat emptor is a legitimate warning to the consumer, and businesses can press their advantage to the limit as long as the playing field is leveled by appropriate checks and balances.

Physicians need to return to and maintain a higher ethic. The physician’s imperative is to be the most knowledgeable and therefore most powerful protector of the patient’s interests in the face of business’ quest for profit. It is not to use his or her knowledge and power to subjugate their patients’ interests by becoming an agent of business in the exploitation of their patients. It is just that simple and every priority of the physician must follow from that, whether in patient care, medical education, research, or public advocacy.

There has been a recent wave of sentiment that physicians should be free and independent of “Big Pharm” influence. That is not enough. The pharmaceutical industry provides valuable products (sometimes), but its primary purpose is to generate profits. It is to be the darling of Wall Street. The industry is expected to push the envelope of honesty in marketing, research, and development. It is to be expected to challenge consumers to beware. That is its nature.

It is not enough to be “Pharm Free”. The physician and physician groups are charged to resist those business purposes in the advocacy of their patients. This requires an abstention from corporate complicity for doctors in practice. Practice means patient advocacy. Alternatively, doctors can work for industry, but this needs to be transparently and fully understandable by even the most casual observer.

Doctors in research or education can and should serve the public interest. They must serve the medical and lay public. They should also advise their corporate partners in matters of medical integrity. With full disclosure, doctors can work for industry, but they are still responsible by their medical oath and by their charge as physicians to serve that same public interest. Corporate and independent research can coexist productively if both are presented and understood for what they are. The public’s interests cannot be served if bias is obfuscated or concealed in any way.

A registry of all physician financial involvement in industry can be in no way objectionable, since it would serve only to provide transparency. The data is readily available, from industry who must retain such record to administer their programs, and from physicians who should be eager to demonstrate their independence, if it exists. Only those with something to hide could object. Without their participation, their “secrets” would come to light by virtue of their absent data.

The current system of simply replacing independent research with corporate sponsored research is a broken system. It ignores proven bias in corporate research and naively ignores the effects of corporate interest. This must be replaced. All acknowledge the need for independent research and medical education. Most would agree that industry should help support truly independent research and education given that medical care is the medium in which these corporations profit and find their reason to exist. Corporations could be required to contribute, according to annual revenues, to a pool of funds that would be independently administrated by independent medical professional organizations and patient advocacy groups.

We have had several years in which the system has been gamed and manipulated to serve corporate interests. We could regain integrity by simply dissembling that system and returning to the system where physicians and healthcare workers control medicine and are supported by industry rather than the other way around. We need to do this now, before the healthcare economy has been completely funneled into industry coffers and before we have lost all credibility with the public.

Greg Rosenthal, MD

Toledo Ohio