Perspectives on Cancer Therapy Development

Get Permission

Long ago, as an ethical alternative to military service, I joined the National Cancer Institute’s Yellow Beret Program, and was assigned to its Division of Cancer Treatment (Dr. Vince DeVita) Cancer Therapy Development Branch (Dr. Steve Carter). This program reviewed and rejected or approved all experimental therapies for cancer centers. Our regular attendance at cooperative group meetings allowed us to get to know all the thought leaders intimately. All U.S. experimental oncology programs were regularly reviewed. Our reports to our bosses affected the goals and direction of those programs.

This intense 3-year experience made me revere the sanctity of our mission, forcing me, always, to keep our oath foremost in my mind and heart. I soon became a tenured research-based clinician scientist and Veterans Affairs (VA) oncologist at one of our highest quality land grant universities.

All my young Vietnam veteran patients with cancer shared deep positive feelings for the Department of Veterans Affairs, which provided them with ethical, solid, and effective care. Each veteran understood the VA was a globally budgeted system. So, if a specific VA hospital’s medication budget was depleted, no more funds would be available until the following year. This gave both patients and providers a shared incentive for responsible drug selection and use.

William J.M. Hrushesky, MD, FACP, ABIM IM & MO

William J.M. Hrushesky, MD, FACP, ABIM IM & MO

‘Not the Only One in This Foxhole’

I vividly recall a young veteran with a highly treatable and potentially curable cancer. We quickly reached what seemed a “fork in the road.” Two effective therapies were available: one inexpensive and generic and a second an equally good patented and expensive medicine. There was no evidence of superiority of either.

I informed him of the vast price difference and asked which he would prefer. This veteran did not hesitate for a second: “I will take the cheap one, doc.... I am not the only one in this foxhole.” This sentence broke my heart, and, to this day, its recall gives me goose flesh and unavoidable flowing tears. This intense and unforgettable experience, although long ago and far away, remains highly relevant to today’s cancer medicine.

Recent decades have diluted our nobility, diminished the essential place of our hearts in cancer medicine. This often causes our patients confusion and additional pain.

Tricks of the Trade

Not so long ago, the Cancer Therapy Evaluation Program (CTEP) and the U.S. Food and Drug Administration (FDA) assured our patients of a real shot at therapies with proven life-quality enhancement or likely improved good quality-life extension. These agencies no longer have the essential leverage to assure commonsense cancer medicine.

The era of “fixed” (purposely unfair study design) is here! The tricks of this unsavory trade are neither subtle nor few. They are employed boldly and universally. The most egregious may be selection of meaningless surrogate endpoints and purposely, by design, choosing control arm designs that obscure any chance of clearly negative results. There are many more.

At one time, the FDA and the CTEP tightly and rightly controlled the objective quality of all cancer clinical trials. Now the makers and sellers of outrageously expensive anticancer therapies make the so-called rules. Concurrently, a thoroughly and professionally corrupted “guidelines industry” covers the tender parts of big pharma effectively.

I conclude: Patients with cancer are being mercilessly used and misused.

Meantime: the TRUTH has emerged: “We are all in the same foxhole.” 

DISCLOSURE: Dr. Hrushesky reported no conflicts of interest.

Dr. Hrushesky is Chief Scientific Officer and Vice President for Innovation & New Product Development, Oncology Analytics, West Orange, New Jersey.

Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO or The ASCO Post.