Opinion | Red tape blocks Michigan cancer patients from cutting-edge therapy

Mark G. Campbell, M.D.

Dr. Mark G. Campbell is president of Cancer & Hematology Centers of Western Michigan

“You have cancer.”

Those three words are among the toughest a patient can ever hear and the most challenging for a physician to ever deliver.  Minds race. Tears flow. Loved ones are embraced. Then the planning begins – planning for the future, for families, for treatment.   Hope rises as every year exciting new cancer treatments are researched, developed and made available to patients, and they’re saving lives.  But hope is dashed when promising breakthroughs are not readily available.

Community Clinical Oncology Programs were conceived in the 1970s when it wasn’t clear if clinical cancer research could be provided by community physicians.  Clinical research was then, and now is widespread, robust, and conveniently common. Phase 2 and 3 studies are predominantly community dependent. All drugs go through an early phase of familiarity with side effects, toxicity adjustments and protocol refinement.  It has been so since the 1960s with every new drug. Often initially in hospital settings but almost always transitioning to more cost-effective and convenient outpatient settings, where patients want to be cared for and where care belongs.

One particular cutting-edge treatment – called CAR-T therapy – is yielding positive results for many cancer patients.  

Unfortunately, unelected policymakers on the Michigan Certificate of Need Commission have approved an unnecessary bureaucratic new standard that would strip access to this new treatment from many Michigan patients and separate them from their local physicians and communities, thus slowing the appropriate integration of newer therapies into clinical care. This will result in more costly care, not better care.

CAR-T (short for Chimeric Antigen Receptor T-cell) therapies are an exciting next frontier of cancer care, but no different than all past advances, or yet exciting future discoveries.

Across the country, there are hundreds of active clinical trials underway that are studying CAR-T therapy in both blood cancers and solid tumors, and while the therapy won’t work for every cancer or cancer patient, for many these therapies are exciting hope.

Now, just as patients begin experiencing the incredible benefits of this newest weapon in the fight against cancer, Michigan’s Certificate of Need commission has approved a proposal to create a new standard for the therapy.  The new standard would require any site of care to receive special CON committee approval and additional third-party accreditation, both far beyond the already comprehensive federal FDA standards and legal requirements.  

The new red tape would be stretched directly in-between many cancer patients and the treatment that would be most effective for them, likely limiting treatment to fewer than a half-dozen locations in the entire state of Michigan.

We need to continue community clinical research as we have since 1970, not restrict it. Health care needs integration and coordination not more regulation, bureaucracy and red tape.   It is suffocating health care and doctors in particular.

Please recall that the majority of cancer patients are treated in the community where they live, which means it couldn’t be more important that we ensure patients have access to transformative therapies all across the state, not just at a few big facilities in a few big cities favored by a few CON commissioners.

“I don’t have any new drug to give you”– those nine words are the toughest a patient can ever hear, and the most challenging for a physician to ever deliver.

For the sake of all Michigan’s cancer patients, I strongly encourage the governor and state Legislature to use their oversight powers to reject the proposal to limit access to this new and evolving technology. Let’s work together to tackle the real obstacles to clinical cancer care integration in Michigan.

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Comments

Steve Williams
Wed, 10/09/2019 - 8:59am

Dr. Campbell is correct about the additional red tape being added and its impact on the availability of this treatment. He is aware of this issue because of his profession, but this is the tip of the iceberg in terms of overreaching regulation. Every person regulated by the state (nearly everyone) can probably point to similar issues. It would be refreshing if the legislature emphasized reducing this needless friction in the system rather than focusing on creating more friction.

Why
Wed, 10/09/2019 - 10:32am

Thank you for the info. It would be nice to hear more details, the reasons why, and the other side's point of view.