How We Do Harm (14 page)

Before the FDA advisory committee begins deliberations, members of the public are allowed to testify.
The American Society of Clinical Oncology and a Texas-based company called US Oncology are lobbying against additional restrictions on ESAs.
The patients who come to testify that day feel otherwise.

It’s a pleasure to see Carolina Hinestrosa, a beautiful forty-nine-year-old Latina who had survived two bouts of breast cancer.
Carolina, vice president of the National Breast Cancer Coalition, delivers polished speeches that I agree with in at least nine cases out of ten.
And on the tenth case, our disagreements are respectful.

“We believe that as a community—scientists, clinicians, regulators, manufacturers, patients, and society—we need to learn what really works for women with and at risk for breast cancer to make sure that knowledge is incorporated into clinical practice,” Carolina says that day.
“We must also figure out what it costs us, healthwise and financially, to make fully informed determinations of what is acceptable and appropriate care.
There is an underlying trust patients and consumers have in scientists, doctors, and the FDA regulators to look after their best interests as you evaluate the benefits and harms of the drugs, tests, and all interventions that become available to fight cancer.

“Consumers trust the system to offer interventions that are based on high-quality evidence, and appropriately designed randomized trials are the gold standard to obtain evidence of benefits and harms for all interventions, therapeutic or supportive.”

Yes, yes, yes, and yes,
I scribble in my briefing book.
Carolina understands epidemiology, she understands public health, she understands biostatistics.
Her advocacy is genuine.
There is no posturing, no angling for political advantage or an “unrestricted” grant that drug companies hand out to friendly patient-advocate groups.

Later I would learn that Carolina was battling a sarcoma, a cancer of connective tissue, caused by radiation treatment she received as part of breast-cancer therapy.
She would succumb to that disease at age fifty.

Lilla is next at the microphone:
“Over the course of years of treatment—with only one short ‘chemo vacation’—I have had many doses of Procrit and then Aranesp.
The recent discussion of the risks in using these anemia drugs has caused me considerable worry.
In the case of these drugs, we believe that they stimulate oxygenation, but in stimulating the blood cells have we also stimulated and encouraged the cancer cells?
Have the growth factors that were assumed to help avoid blood transfusions and the effects of anemia led to tumor progression instead?
Does the increased risk of blood clots outweigh the alleged benefits of having greater levels of energy?
How is it possible that what was meant to help me might have actually made things worse?”

These are excellent points, which I agree with wholeheartedly, but I also see that they need amplification.
The advocates in the room are being technical and not speaking in sound bites.
It’s up to me—a technocrat with a pocket protector—to let loose a real zinger that will make the press and the public understand that this is not an obscure scientific controversy.
I have the standing—the gravitas—to commence jumping and shouting, “Shit!
Shit!
Shit!”

As the committee moves to discussion of the data, I summarize the emerging studies that suggest that these drugs stimulate cancer growth.
“I’m concerned that this compound is a stimulant, a ‘tumor fertilizer,’ for epidermal tumors,” I say.
“What data do you have to assure me that this is not Miracle-Gro for cancer?”

Of course, I realize that the question is a variation on “When did you stop beating your wife?”
But why shouldn’t punishment for profiting from tumor growth include a challenge to prove the negative?

Any reporter who ignores this question would probably also be able to block out a jumping, fist-slamming, “Shit!”-screaming Jesuit.
My question ends up on the front page of
The New York Times
as well as in almost every news story covering the meeting.

*

IN
2010—two years after the committee meeting—the FDA placed new, tough restrictions on these drugs.
The restrictions say that ESAs are not to be given in settings where the goal is to cure the patient.
Breast and head-and-neck cancers are now listed as diseases where these drugs are best avoided.
Every time doctors administer these drugs, they are required to explain the risks to patients and document that a discussion of risks has taken place.

Lilla’s disease is kept under control for a decade after it turned metastatic.
Every time her hemoglobin drops too low, she opts for a blood transfusion rather than an ESA.
(Transfusions should be given in place of ESAs whenever feasible, particularly to patients with metastatic disease.
A patient with active disease is more likely to suffer tumor progression: the more tumor you have, the more tumor there is to stimulate.) Lilla learns that she can live comfortably when her hemoglobin drops.

“I have mentioned to my doctor that at 10 g/dl, I do very well.
At nine, I do well.
At eight, I do well.
It’s when it gets below eight is when I need a transfusion,” she said.
“I would have been absolutely fine.
I would not have needed anything.”

In my opinion doctors who prescribed ESAs to patients like Lilla Romeo were not treating actual patients.
They were treating numbers on charts, and such treatment was both costly and harmful.

The exact magnitude of harm is harder to gauge.
In the aggregate, about $37 billion went to pay for these drugs in oncology between 1996 and 2009.
It’s now safe to say that most of that money was spent on drugs that were prescribed for the wrong reasons and under false, manufactured pretenses.
These drugs were not used to cure disease or make patients feel better.
They were used to make money for doctors and pharmaceutical companies at the expense of patients, insurance companies, and taxpayers.

The technical term for this is overtreatment, and overtreatment equals harm.
I can’t stop wondering how many mammograms these resources could have bought for people like Edna Riggs.

*

AS
we were gathering information for this book, Lilla requested copies of her medical records from the doctors who had treated her and learned that she had received a lot more Procrit and Aranesp than she knew.

“I hope you are sitting down,” she said in an e-mail sent before she entered a home hospice.
“I asked for the original flow sheets and got the shock of my life.
My first dose was administered 1/11/01 and almost weekly thereafter.
All and all, I was given 221 ½ doses.”

“Flow sheets” are the spreadsheets that oncologists use to keep track of the dose and date of administered anticancer drugs.
They showed that Lilla received nearly six times the number of doses she thought she received.
Was this medical malpractice?
Not at all.
The oncologists who gave Lilla these drugs were practicing medicine in accordance with widely accepted standards.
The problem was, those standards sucked.

Hemoglobin-building drugs contributed $400,000 to $600,000 to Lilla’s bill alone.
Certainly, if these drugs weren’t available, Lilla would have needed some transfusions, but she would not have needed them until her hemoglobin dropped below 8 g/dl, rather than the arbitrary level decreed by doctors.

The cost of these drugs may have been more profound than money.
They may have shortened Lilla’s life.
This shouldn’t surprise anyone.
When the entire medical—and political—system turns a blind eye to evidence and errs on the side of financial self-interest, people like Lilla pay.

Chapter 8

Defibrillation

AS A MEDICAL STUDENT
at the University of Chicago in the 1980s, I craved the experience of ER duty.
The ER seemed to be the kind of place to flourish as a badass for the forces of good: racing against the clock to stop gushing bleeds, administering shocks to get hearts to beat again, palpating the divide separating life from death.

In the beginning of my residency at the University Hospitals Case Medical Center in Cleveland, I loved the ER—the quick interactions with patients, working six cases at a time, running from room to room.
I got to stitch.
I got to put in central lines and stick needles into body cavities to draw out fluid.

The ER is also the slimy underbelly of the system, the place where its flaws are at their most visible.

*

SAUL
Greenberg’s chart identifies him as a fifty-seven-year-old white male, but that tells only a small part of the story.
Saul is the sort of older Jewish guy you might see wearing white patent-leather loafers with a matching belt, an ensemble known as the Full Cleveland, which is, of course, perfectly appropriate for a guy living in Cleveland.

The Full Cleveland is conjecture on my part.
When I see Saul, he is in a hospital gown.
He is also wearing a massive gold chain and a large, dark brown toupee.
When you work ER, you look at fingernails a lot, they can tell you a lot about a patient.
Saul’s are meticulously manicured, finished in clear lacquer that throws off considerable sheen.

Saul cultivates the appearance of a dangerous man, a Meyer Lansky.
He drinks a lot, smokes, hires hookers.
His chart says he has bipolar disorder.
Saul has also been declared disabled by the federal government and is one of the few people I have ever met who receives Medicare before reaching sixty-five.

Saul’s second major medical problem is heart disease.
He has had several heart attacks, and his heart has rhythm problems.
He will regularly go into ventricular tachycardia, rapid heart rhythm stemming from the ventricles of the heart.
His blood pressure will drop, and he will pass out.
This event is often called sudden death, or SD.
If Saul is not shocked out of it quickly or if he doesn’t get CPR until he gets shocked out of it, he is certain to die.

Since Saul has Medicare, he is able to get an expensive medical device, one of the first mass-produced implantable defibrillators.
Saul has this contraption placed in his abdomen, with wires running up to his heart.
On a chest X-ray, you can see the small paddles near his heart.
If his heart goes into tachycardia, his defribrillator will fire, shocking him out of it.

Today, defribrillators are small—roughly the size of a railroad watch.
They go in the chest, and implanting them takes relatively minor surgery.
In 1987, defibrillators were much larger, and implantation required a significant operation.

Saul comes to my ER because his defibrillator has fired.
He is moved to the head of the triage line and is put on a monitor in a cardiac resuscitation room.
I get called away from other patients to see him.
The defibrillator is a new entity and we already know that we will have to call the cardiologist on call as soon as I finish my initial evaluation.

I give Saul my standard greeting: “I am Otis Brawley.
I am one of the doctors here.
How can I help you?”
(This introduction, which reflects my aversion to titles, is a career-long quirk.
Being a doctor is my function in life.
Yet, I cringe at the
Dr.
before my name.
Friends who noticed this have nicknamed me Dr.
Call-Me-Otis.)
In a jovial tone, Saul tells me that he has a defibrillator and that it has gone off.

“When?”

“Two hours ago.”

“What were you doing?”

“Well, Doc, I was with this pro, and I came to the magic moment, and I was tensing up, and I must have had a rhythm problem.
I must have gone out, ’cause all I remember is waking up hearing her say, ‘Wow!
Are you for real!’
It was great, Doc, and I didn’t even have to pay her.
She didn’t charge me because I charged her, so to speak.”

It takes me a minute to realize—or, perhaps, accept—that Saul is telling me that the prostitute felt the shock of his defibrillator going off.
Did she feel the shock because of the proximity of their bodies?
Did penetration play a role?

I kind of want to know and I kind of don’t.

*

CEDRIC
Jones is a twenty-three-year-old black man.
He is well built, muscular.
He looks like a college athlete, but isn’t.
Cedric is a frequent flier at the University Hospitals ER.
He was born with a malformed heart.
Doctors corrected the condition, called tetralogy of Fallot, with a series of surgeries during his childhood.
He can function normally, except occasionally his heart develops a rhythm problem.

Cedric will go into ventricular tachycardia, a racing heart rate that begins in the heart’s lower chamber.
But unlike most people who have this condition, his body maintains a good blood pressure, and he doesn’t pass out.
When he feels that his heart isn’t beating right, he knows that it is time to get to the hospital.

Cedric has no insurance and has to use the ER for all his health care.
Will any insurer write a policy for a guy with Cedric’s chronic problems?
No way, not in 1987.
He is in a particularly bizarre conundrum: he has no job and lives with his parents.
This makes him too wealthy for Medicaid.
His parents have insurance, but it stopped covering him after he turned eighteen.
Cedric tells me that he has lost every job he ever had because he is constantly in and out of the hospital.

Cedric comes to the ER once every two months, give or take.
In an ER, where foul language is as commonplace as knife wounds, Cedric stands out.
He is a nice young man, drug-free, clean-cut, pleasant, polite.
The permanent nurses greet him and he knows them by name.
Even doctors on ER rotation get to meet him at least once.

I meet Cedric during one of his visits.
He has told the triage nurse that he is in ventricular tachycardia and needs cardioversion—electric shock.
He knows what he needs better than anyone else.

This nurse is relatively new to the ER.
She doesn’t believe him.
It makes no sense for a clean-cut, muscular, young black man to come in and ask for cardioversion.
A junkie might develop all sorts of cardiac problems at an early age, but Cedric is clearly not a junkie.
What is this young man doing asking for cardioversion?
The idea that he can be in V-tach and be walking and talking is even more unbelievable.
And why does he be talk about it with the easy confidence of a physician?