We Have to Change Our Healthcare System: Part I (The Problem)

We are in the middle of a medical revolution. It is entirely possible that within four to ten years, a person diagnosed with cancer will be able to spend over a week in the hospital and walk out healthy. The cancer will be gone.

It is also entirely possible that, unless we make some fundamental changes to our healthcare system, cancer cures will simply not be available to any Americans.  This is already happening. Take Guardant 360. It is an a test for a type of lung cancer. It has 92-100% success rate. It is available in more than 30 countries.  But not in the United States.

That’s because Guardant 360 like all such assays is expensive. And there is no incentive in American medicine to invest in patients.  Here, commercial insurers are very concerned about the high up-front cost of therapies or tests because most patients will switch insurers before the payer’s return on investment is realized. In America, we can select our insurance providers annually.  As a result, private payers negotiate with manufacturers the price or cancer cures on a case by case basis.  John and Jane might have the same insurer, the same cancer, receive the same therapy at the same hospital, at the same time, from the same doctors.  But the price their insurer will pay for John’s care will almost certainly be different from the price the exact same insurer will pay for Jane’s care.  These negotiations are time and energy-consuming for everyone. They also risk patient’s lives. Because curing cancer means genetically modifying people, only people who are about to die and for whom no other treatment works can get the cure. These people don’t have the time to wait while the insurer, the hospital and the drug manufacturer come to some agreement.

That, plus the price is why only Medicare beneficiaries can be assured that their cancer cure will be covered.  Medicaid covers cancer cures only in some states and commercial insurers have not made curing cancer a regular part of treatment. Add to this the fact that Medicare and Medicaid do not pay what commercial insurers pay and you end up with cancer cures that are widely available throughout the world but are not available in the United States.  Ironic, considering that the technology for cancer cure was invented here. James Allison just got a Nobel Prize for that invention.

But forget taking new drugs. Our healthcare system is also making it increasingly difficult to develop drugs. Before a company can bring a drug to market, it has to test it in on us. People like you and me have to volunteer to take these drugs. Recruiting enough of us is one of the main problems pharmaceutical companies face when developing the next great thing. If not enough of us sign up (and quickly), investors will lose interest, scientists will leave or get burned out, and the clinical trial that could have resulted in a life-saving drug will be abandoned.

In countries (such as UK) where people don’t have to worry that they will never get insurance because they have pre-existing conditions, pharmaceutical companies partner with whole cities (such as Manchester) to study whether drugs combatting chronic obstructive pulmonary disease and dementia work in a real world setting. That sort of partnership is not possible in the United States even though we have many cities as large as Manchester and our cities are far more diverse. This diversity ought to be a veritable gold mine for pharmaceutical companies.  The whole world lives in the United States. And since pharma’s largest and most rapidly growing market is in the developing world you would think they would want to try their drugs out on Americans–people who are physiologically similar to their main customers. But they can’t.

That’s because Americans are too worried about the cost of healthcare to participate in clinical trials.  Americans worry about safety too but that is a worry European patients seem to share.  But only Americans face economic consequences for participating in clinical trials. Before the Affordable Care Act (ACA), those consequences were especially severe.  People who participated in a clinical trial were denied coverage for routine care was associated with the trial and if people did not have insurance when they tried to sign up, scientists told them not to. That’s because they would later be denied insurance as a result of a documented pre-existing condition. This was especially true of poorer Americans who are also often minorities. They are least able to afford to take the chance of a trial and, even after the passage of the ACA, they are least able to cover the costs (such as travel, missing work) that go with a clinical study.

Thus even though the ACA now offers additional protections to clinical study participants American clinical studies focus still on European-Americans.  And even European Americans are nervous.  Yes, it’s true that as a result of the ACA, if you receive care through a compliant plan, the insurance company can’t deny or limit your regular benefits and you will keep your coverage if you participate in a trial even for serious conditions like cancer. But the ACA is under constant attack. Texas vs. United States could eliminate it entirely and Republicans admit that, if they keep their majorities in Congress, they will repeal the law.  Given those risks, would you participate in a clinical study? Would you let your loved ones do so?

And if the answer is no, what does that mean for healthcare innovation? Isn’t it time we made a change?

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