Lori’s story

My wife of four decades passed away Nov. 22, 2019, after a nearly two-year struggle with cancer. She was younger than her 65 years and very active, slalom skiing behind our family boat and chasing the grandkids down the waterslide. She was happy, serene, and a wise, gracious smiling presence.

Why am I telling you this? After all, we all know people who have been taken by cancer.

Here’s why:

She died because, according to our doctor, the government — the Food and Drug Administration — ordered her treatment to be stopped as prescribed by a clinical drug trial. A drug that was keeping her alive. Let me put it more directly: The FDA hastened the death of my wife, by weeks or months, maybe longer. We’ll never know.

Eventually, she would have succumbed to her disease even with treatment. She had an especially nasty, virulent case of multiple myeloma, probably because of some anomalies in her body’s chromosomal makeup. Multiple myeloma, a blood cancer, is like an evil intelligence that has the capacity to eventually reason out ways around each new defense the doctors throw at it.

It is not curable; it can only be stifled for a time, but it’s always on low boil — remission, they call it — until it discovers a new path around the maze of the latest chemical treatment. Some people can go on for years this way; others months. Doctors are merely buying time for their patients, trying one chemical until it is no longer effective and then moving on to the next until it is no longer effective and on and on it goes. Eventually, they simply run out of treatments and the game is over.

But what if you reached that point and you knew there was a medicine out there somewhere in the world that could save your wife, mother, friend, sister, even if it were only for a few months or even weeks? In our case, there was such a medicine. It was a magic potion that had successfully beaten back the cancer for about five months when nothing else had worked. Then our doctor was ordered by the FDA and the sponsor of the drug trial to cut the dose of the medicine that had been all there was between life and death.

Try explaining this to your three adult children the day you sit them down in the family room and break the news that their beloved mother has very little time to live. Try making sense of that as you look into their stricken faces and hear their cries and their questions and their anguish. What do you mean there’s something that can save her and we can’t do it?!

This is madness.

It all began in a seemingly innocuous way. My wife, Lori, experienced numbness in her face, then double vision. Our family doctor told her it was probably congestion pushing against her sinuses (insert eye roll here). “Could it be a tumor?” she asked. He shrugged. “Maybe.” She left his office and took matters into her own hands. She made an appointment with a specialist and requested a CT scan. It revealed a tumor in the middle of her head, just under the brain, and it was pushing against nerves in her face.

We were told there was a 99% chance it was benign. We arranged to have a highly skilled neurosurgeon remove the tumor. Hours later he emerged from surgery. “Well, that wasn’t what we thought it was,” he said. It was an unusual presentation for multiple myeloma, but there it was.

The chemotherapy began. After a few months of treatments, she underwent a bone-marrow transplant, which can provide remission for several years. The doctor was surprised and thrilled by the results. “Go live your life!” he said. “This is amazing!” And so we did, other than periodic visits to the hospital for tests.

Six months later, in early January of 2019, I made a note in my journal: “The physician assistant called to say Lori’s cancer has returned. She’s out of remission. This news caught us off guard, like a clap of thunder.”

She began another round of chemotherapy. This beat back the cancer again, but it also compromised her immune system, and a simple illness — a respiratory virus — quickly raged out of control. It turned into pneumonia because her body had no defenses to fight it. She was hospitalized for two months, including two weeks on life support. She wasn’t expected to survive. She did.

Miraculously her immune system began to restore itself just as the cancer returned, which enabled her to start chemo again. We tried several treatments but none arrested the cancer, which was escalating rapidly. We ran out of conventional medicines. Out of desperation, we entered the world of clinical drug trials in which patients take experimental drugs to test their efficacy and perhaps prolong lives.

We signed stacks of documents — way too many to actually read. I’m guessing we signed all control over to the sponsor of whatever clinical trial we were in at the time and accepted full liability. We tried a few drugs that were ineffectual. There are three to four phases of clinical drug trials, ranging from a Phase 1 — a drug that is just beginning the test phase on humans — to Phase 4 — a drug that has already gone through several levels of testing on humans and has been licensed. Phase 1 of course is the riskiest and most uncertain. We had run out of options. We agreed to try a Phase 1 drug in June 2019.

The results were dumbfounding. A little background: One of the ways doctors quantify the level of disease is by measuring what they call kappa light chains in the blood. The lower the number, the better. Lori’s light chains not only were climbing, they were climbing at a steep rate, which meant we were running out of time. On June 18, a few days after Lori’s first treatment, we received a text from our P.A.:

“Check this out!! Major improvement in her light chains.” She included a photo of a report. In the first column it showed her light chains three weeks earlier at 384, then two weeks earlier 364, then six days earlier 625, then June 18 — 45.

It was miraculous.

A week later, the P.A. texted us again. “Lori’s light chains are NORMAL!! They dropped again, to 0.80.”

There is no way to overstate how remarkable this was. Of the 40 or so people in the study, we were told, Lori was the only one who got a response from the drug, and the response was spectacular.

Even before we knew the test results, we sensed something had changed. Lori was no longer napping during the day or sleeping in late. She was no longer rocking back and forth in pain as she reclined on the couch because of the lesions and tumors that were growing in her body. After just a day or two of treatment her pain was dramatically reduced.

She continued to take this drug for several months at a particular dose and it continued to arrest the cancer. Life returned to normal. Lori was diminished physically, but she was able to shop with our daughter and her children and play with the grandchildren.

Then this bombshell fell from the sky. In September, our oncologist told us that the FDA had ordered him to reduce the dosage of the drug. The FDA, he explained, informed him that they had detected elevated levels of troponin in post-dosing test results of participants taking a higher dose.

Troponin is a protein that is released when the heart has been in stress or a heart attack has occurred. According to our doctor, Lori did not have elevated levels of troponin at the time and the issue in other patients resolved itself. Not that we cared one way or another about potential side effects considering what we were up against. Nevertheless, the FDA ordered the doctor to cut the dosage from 360 mg/m2 to 240 mg/m2.

We faced a dilemma. Do we continue with the drug at the reduced dose and hope we continue to get a response, or do we fly to Seattle for a immunotherapy treatment that was being offered by a hospital there? We chose the former. As we feared, Lori’s cancer started to rise after a couple of weeks. The doctor decided to continue the dosage for two more weeks, still hoping for a response. We didn’t get it.

The doctor, who had worked so tirelessly on our behalf for months and was clearly caring and fully invested, told me he made several phone calls in the coming weeks pleading with the drug company to allow Lori to continue taking the drug at full dosage; he told them it was a matter of life and death. He was refused.

In early November, we made one last desperate attempt to save her life. We flew to Seattle to see if we could qualify for the clinical trial there, one that manipulates the body’s own immune system to fight cancer. To qualify for the trial, the patient’s cancer had to be within 10% to 30% of her bone marrow cells. By the time we arrived, the cancer had progressed too far. We flew home in silence, beaten, sad, exhausted.

She died in her bed in the middle of the night a couple of weeks later. I was holding her hand.

All of this raises some obvious and important ethical questions.

Shouldn’t patients have the right to continue the use of an experimental drug if it is working and keeping them alive and the alternative is death? Shouldn’t it be their decision? What harm would there be in electing to take your chances with the side effects of the drug when faced with a deadly cancer? What harm would this do to the pharmaceutical company and the clinical trial, especially if we agreed to accept all liability? Once the patient has reached this point, the study terminates, her data has served its purpose and she can be treated outside the study, as most patients are with conventional drugs, thus no longer affecting the integrity of the study.

Taken as a whole, isn’t this a basic human right — that nobody, including the government and the sponsors of these clinical drug trials, can end a life; quite to the contrary, shouldn’t they seek to preserve it when it is threatened?

“These drug companies don’t care,” a P.A. told us at one point. “They don’t even know your name. You’re a number. They are simply trying to develop their drug. It’s not personal to them.”

Apparently, the FDA feels the same way.

At one time, I reached out to our doctor to go on the record for a story about this issue, but he refused. This was disappointing. The only sense I can make of this is that health care facilities and professionals need these clinical trials to advance the development of medicines and because they’re lucrative. They also need patients who are willing to try them, not only for their benefit (potentially), but probably even more for the benefit of future patients.

Meanwhile, nobody at the FDA or, for that matter, the companies that sponsor these clinical drug trials, has to answer for the life-and-death decisions they make. They are big, faceless entities in which decision-makers are hidden in anonymity, cogs in the machine.

Yet somewhere in those organizations, someone — or more likely a committee of people — made this decision, one they knew they wouldn’t have to own. Would they have made the same decision if the patient was their wife? Would they have found a way to continue the drug at the effective dosage then?

These patients are more than numbers. They have names and they want to live as long as they can. This one’s name was Lori Robinson. Her life could’ve been prolonged. Someone made the conscious decision not to grant it.