If you are wondering about the warning silence of the primary care “canary” in our healthcare systems, you need to look no further than this news reported by Reuters.
Lilly, in an effort to catch up with the weight loss juggernaut that is now Nova Nordisk’s Ozempic and Wegovy, has now added Zepbound at a 40% discount from the price they offer for the automatic injector version of the drug through their direct-to-consumer (DTC) website, LillyDirect. Indeed, Lilly is not alone; Pfizer has joined the fray with their medication for migraines. Much of the reporting on the trend emphasizes the dramatic price reductions and the marketing opportunities for Pharma in direct-to-consumer sales of prescription medications.
All hail the impact of market forces on these transactions, bringing about change while politicians continue to consider action.
But in paraphrasing Shakespeare, I come not to hail these transactions but to bury them. In our frenzy for transactions with the lowest cost today, we are sacrificing significant fiscal costs tomorrow, and more importantly, the cost to the core of medical care, relationships.
Let me explain how these transactions interfere with the partnership between physician and patient. I will use Lilly’s direct-to-consumer website to describe those transactions and the person responsible for clinical misadventures as a measure of the physician-patient relationship. [1]
As the manufacturer, Lilly can quickly eliminate all the steps in the retail supply chain, along with the incremental increased costs resulting from selling a product through normal distribution channels – simultaneously increasing their marginal profit and saving the consumer money, undoubtedly a fiscal win-win. Unfortunately, Zepbound and Mounjaro (approved for diabetes) both require prescriptions. If you do not have a prescription that can be uploaded to Lilly, they can and do direct you to telehealth services where a physician will assess your situation and, if warranted, prescribe Zepbound.
The “if warranted” phrase is critical because when describing the series of transactions in this DTC supply chain, like any good three-card monte, those transactions only deflect your attention from the real action – who is liable when things go wrong? Who is medically responsible turns out to be another carnival game – whack-a-mole.
By law, these medications must be prescribed by a physician, and when the prescription is written, responsibility in the form of medical liability is attached to the physician. By following the law and transferring the decision to prescribe to a physician, Lilly no longer carries any clear medical liability should you suffer an ill effect from the medication provided.
To facilitate that prescribing, they offer a link to a specific telehealth provider, Form, “a virtual weight-loss clinic.” Lilly’s lawyers have further insulated themselves from liability by not making a direct referral to Form, where they might in some way be held liable for Form’s actions; they only provide an easy-to-use link. Lilly’s website makes it clear that your prescription can come from any willing provider, your physician, or another telehealth service.
With the click of the mouse, we enter the second transaction in the chain, in this case, with Form. They ask a series of screening questions to identify your motivation for seeking medication and your location so that they can match you to a physician licensed to practice in your state. There are questions to determine:
- your BMI
- whether you have any contra-indications to terzepatide (the active ingredient in Mounjaro and Zepbound)
- Significant medical issues
- Current medications that might impact the use of terzepatide
- Insurance information
And through algorithmic magic, they determine whether or not you are a candidate for care and may now pay a one-time “onboarding” fee for your "weight-loss journey" with Form. [2]
I should state that I have no problem with the care offered as I have no experience with their physicians or care; I only want to follow the physician-patient relationship as defined by liability. To the best of their ability, Form also wishes to insulate themselves from liability. If you take the time to read the telehealth informed consent, you will find
“Form Health, Inc. does not provide the Services; it performs administrative, payment, and other supportive activities for Group and our Providers.”
Yes, Form Health, the “virtual weight-loss clinic,” provides only “back-office” services to what we will find are gig workers, independently contracting physicians aggregated in a second legal entity, Form Health Associates. Form Health has no liability because they provide no medical services. It is not uncommon for health systems to have separate physician groups that hire and credential their physician employees. However, when things go wrong, the liability continues to move from Lilly to Form and now to Form Health Associates and their independent physician contractors.
Because this is an online service, there is the usual boilerplate protection of the providers from false or inaccurate information deep in that informed consent.
“you agree not to provide any User Information that (a) is false, inaccurate …”
At this juncture, responsibility seems to lie with the prescribing physician – just as it would in brick-and-mortar offices. However, that liability appears to have some limits.
- OUR PROVIDERS DO NOT ADDRESS MEDICAL EMERGENCIES. IF YOU BELIEVE YOU ARE EXPERIENCING A MEDICAL EMERGENCY, YOU SHOULD DIAL 9-1-1 AND/OR GO TO THE NEAREST EMERGENCY ROOM. PLEASE DO NOT ATTEMPT TO CONTACT FORM HEALTH, INC., GROUP, OR YOUR PROVIDER. AFTER RECEIVING EMERGENCY HEALTHCARE TREATMENT, YOU SHOULD VISIT YOUR LOCAL PRIMARY CARE PROVIDER.
- Our Providers are an addition to, and not a replacement for, your local primary care provider. Responsibility for your overall medical care should remain with your local primary care provider, if you have one, and we strongly encourage you to locate one if you do not.
The formatting is not for emphasis; it is taken directly from the informed consent to treatment.
So, who is liable? The prescribing physician appears to be an addition, not a replacement for your local primary care doctor. But can your local primary doctor be responsible for care they do not provide? What if you have no primary physician?
Through a series of transactions, from Lilly to Form, to Form Health Associates to their “Provider,” you have obtained medication with significant fiscal savings. However, the same series of transactions sacrificed the hallmark of the physician-patient relationship: responsibility.
The National Academy of Science, writing in a white paper on primary care, indicated among its key components was a
“Sustained partnership between the patient and clinician with the mutual expectation of continuation over time. It is predicated on the development of mutual trust, respect and responsibility.”
Physicians and patients have been less than faithful in maintaining our partnership. That faithlessness has worked to the detriment of clinicians and patients. Direct-to-consumer pharmaceuticals are touted as increasing access, which is a clear benefit for those able to pay the piper. But we should be mindful of what we are giving up.
[1] I have spent more time on Lilly’s website. Still, it is not substantially different than those of other drug manufacturers and entrepreneurial telehealth websites, e.g., Hims and Ro, offering DTC medications. Responsibility for medical misadventures has a long history in medical malpractice law and is critical to the physician-patient relationship.
[2] The onboarding fee is separate from charges from physicians for the initial and subsequent telehealth visits.
Chuck Dinerstein, MD, MBA
Director of Medicine
Dr. Charles Dinerstein, M.D., MBA, FACS is Director of Medicine at the American Council on Science and Health. He has over 25 years of experience as a vascular surgeon.
