How We Do Harm (13 page)

Another category of horror stories stemmed from my colleagues’ failure to keep up with the literature.
These were shocking accounts of crappy care and deadly ignorance.
Failure to prescribe the drug Herceptin to patients who could clearly benefit from it figured prominently on Lilla’s list.
(Herceptin is used to treat early-stage breast cancers that have receptors for the human epidermal growth factor receptor 2.)

Other callers were women who had exhausted all treatment options.
Everything had been tried and nothing worked.
Now they wanted to go on a clinical trial, but no trial would have them.
They were heavily pretreated, and companies that developed drugs would rather prove efficacy in patients who haven’t had a lot of treatment.

In 2003, to make it possible to vacation in Sicily, Lilla had to have two treatments with Herceptin and another drug, Navelbine, while in Italy.

For this, an Italian clinic billed her as a private patient.
The Herceptin bill was 640 euros, which at the time translated to $717.
In the United States, the hospital billed the insurer between $1,600 and $2,400 for these same drugs.

As an economist, Lilla’s husband, Anthony, is interested in innovation and technological change.
Before leaving academia—he earned a PhD at the University of Pennsylvania and taught at the University of Connecticut—he was particularly interested in medical technology.
Tony is so amazed at the pricing disparity that he uses it as an example in the global-marketing class he teaches at Columbia University.
When neither the government nor private payers in the United States care about drug prices, prices careen out of control.

Tony’s observation is consistent with the findings of a 2007 report by McKinsey Global Institute.
In the United States, the prices of top-selling drugs were 2.3 times higher than in other nations.
Overall, costs of branded drugs in the United States are 70 percent higher than in other industrialized countries.

A trip to Canada can save a patient 60 percent on branded drugs.

This is not about the invisible hand of the market.
It’s the exact opposite.

*

IN
the spring of 2007, Lilla is invited to attend Project LEAD, a four-day residential course taught by the National Breast Cancer Coalition, a Washington umbrella group of which Share is a board member.

LEAD is an acronym for “leadership, education, and advocacy development.”
The course teaches skills needed to interpret medical literature, distinguishing solid science from scientific nonsense.
The course is about scientific rigor, good public policy, and insistence on good quality of care.

Lilla thinks Project LEAD will make her a better peer counselor.
But at the end of the course when she is asked how she would apply her newly earned expertise, Lilla is uncertain.
Everything she learns is intellectually enriching and potentially helpful in counseling.
If a patient has a question about a particular toxicity or about efficacy of screening for relatives, Lilla will be prepared to answer in depth.
Yet, the politics of breast cancer is not among causes to which she is willing to devote the remainder of her life.

In May 2007, Lilla goes to a monthly seminar for graduates of Project LEAD.
The seminar is run by two Share activists, Musa Mayer and Helen Schiff.
Mayer, daughter of the New York School painter Philip Guston, combines a relaxed attitude with nearly encyclopedic knowledge of breast cancer.
Schiff is a classic leftist activist, the sort they don’t make anymore.
She spent years as a factory worker and union organizer, then, after breast-cancer diagnosis, applied the same urgency to her new political struggle.
(Later, Schiff would take a sabbatical from breast-cancer activism to devote more time to advocating for the rights of Israeli Arabs and Palestinians.)

At the seminar, Musa and Helen hand out a stack of back issues of
The Cancer Letter,
a weekly newsletter read by cancer doctors, scientists, and politicized patients.
Starting in January 2007,
The Cancer Letter
published a barrage of stories chronicling the emerging evidence on toxicity and tumor promotion associated with ESAs.
The Cancer Letter
’s biggest scoop was learning that a study in Denmark had confirmed the results the German researcher Henke had reported in 2003.
Now, the FDA was paying ever-more-careful attention, as were the Centers for Medicare & Medicaid Services, as were congressional investigators.
The skeptics were feeling vindicated.

“The FDA will be holding a hearing on these drugs, probably to place them in some kind of a restrictive-access program,” Schiff says.
“Why don’t you testify?”

“Testify?
That’s the last thing I am prepared to do.
I just finished Project LEAD a month ago.”

But Schiff regards Lilla’s case as a perfect illustration of systemic failure in medicine, and she is not about to let go.
The case is all the more astonishing because Lilla is so savvy, so willing to question her doctors.
Moreover, Lilla was not facing these decisions alone.
She consulted her husband, Tony, every step of the way.
(He is so involved and supportive that he later starts a Share group for men whose partners are going through breast and ovarian cancer.)

“Well, why don’t you read some of these studies and see if you still feel the same way about testifying?”
Schiff suggests.

At home, Lilla reads the stack of papers, old issues of
The Cancer Letter
and a package of studies that appeared in
The New England Journal of Medicine.
The materials all tell the same story: these drugs are leading patients to serious complications, worsening of disease, or death.

Lilla read through the stories systematically, issue after issue.
“I was just astounded that I had never heard of any risks or any dangers,” she said.
“I said, ‘Oh my gosh, I had so many of these shots.’”

After reading the papers, Lilla calls Schiff and says, “Yes, I definitely do have to testify.”

Chapter 7

Tumor Promotion

I MEET LILLA
on May 10, 2007, at a session of the FDA Oncologic Drugs Advisory Committee.
She is there to testify at a public-hearing portion of the meeting.
I am there as a member of the committee as it gathers to help the agency decide whether new evidence on Aranesp and Procrit justifies instituting restrictions on the way these drugs are used.

Imagine a large table with doctors and scientists arguing about data.
If you bother to read up on the science, it can be as passionate as a bar brawl.

It seems half of Wall Street slums at cheap hotels in Rockville, Maryland, where meetings like this are held.
This meeting is even farther from D.C.
than usual, in a suburb called Germantown.
The stock analysts are there in order to feel any turning of the tides and be the first to dump, acquire, or short.

Billions of dollars in trades hinge on the words of the doctors and the scientists with pocket protectors full of sharp pencils.
Recommendations from this committee can change a drug’s label, influencing doctors’ beliefs and altering prescribing patterns and, ultimately, sales.

The presentations that day make me feel particularly good about having protected my patients from unnecessary treatment with red-blood-cell-building drugs.
Overtreatment with the drugs under discussion may have been beneficial to doctors, their employers, and the pharmaceutical industry.
But now the data are in, one frightening study after another, showing that millions of patients had been exposed to harm.

I was fortunate to have been immune from concerns about billing and revenues.
Perhaps I was doubly fortunate because accumulation of wealth is not one of my top 10 goals, and a display of wealth doesn’t make it even into the top 250.
My car at the time was a rat-gray 1985 Toyota Camry with peeling trim and a fragile air-conditioning system.
The thing was an insult to doctors’ parking lots, but I felt good about driving it.

*

THE
FDA now stands poised to act.
Would the ESA debacle be handled decorously—in a measured scientific debate?
Would all the greed and misrepresentations be forgot and this shameful chapter portrayed as an orderly evolution of knowledge, as opposed to what it was—a massive systemic failure?

Red-blood-cell-building agents were anything but an exotic little treatment for a rare disease.
These drugs had enormous impact.
The committee was about to discuss a group of products that generated the largest revenues in all of oncology.
Would the press understand the enormity of what was at stake?

Few reporters understand science.
Fewer still have the patience and support of their editors and the space needed to explain complicated issues.
The easiest thing to do is to write a story where “experts disagree.”
This genre of stories persists even in situations where dueling opinions are equally irrelevant.
What matters the most are the data, and now the data are in hand.
Would an important lesson filter out of this room and into the public consciousness?
Would the public and the medical profession hold those at fault accountable?
Or would a teaching moment be lost?

*

AFTER
dispassionate analysis is completed and all the facts are laid bare on the table, emotion can rule.
Forget subtlety, forget decorum, forget dogma, loyalties, niceties, sacred cows.
That’s the lesson I learned from the Reverend George R.
Follen in September 1973, on my first day at the University of Detroit Jesuit High School.

The Reverend George R., as he liked to be called, taught freshman theology.
He sounded like James Cagney even while peppering his speech with biblical Hebrew and ancient Greek.
A crew cut added just the right accent for his bulldog face and his mighty rectangular physique.

His first lecture was entirely barked out: “What to expect, gentlemen … Victor Frankl …
Man’s Search for Meaning
…” The course was a nexus of history, philosophy, and psychology, taught under the broad rubric of theology.

“From the psychological point of view, gentlemen, the greatest word in the English language starts with a soft
s
, builds up onto that
h
, then an
i
, like the squealing of car brakes.
And then if you hit that hard
t
, it’s like slamming your fist into a wall!”
For emphasis, the pugilistic priest slammed his right fist into his left palm, shouting,
“Shit!”

Then, while continuing to slam his fist into his open hand, the Reverend George R.
commenced to jump.
“Shit!
Shit!
Shit!
Isn’t this wonderful, gentlemen?
Shit!
Shit!
Shit!”

I was thirteen years old, and the Reverend George R.
was unlike any priest I had seen.

At home, my parents asked me how school went, and I said it went fine.
I had to be vague.
They would not have understood the enormity of the lesson the Reverend George R.
taught me that day: call things by their proper name, if only to make yourself feel better.

The Reverend George R.
believed that there is right and there is wrong, and that wisdom can be imparted in the form of maxims.
Some of his teachings were narrow, practical, bordering on the trivial: you cannot properly read a textbook without marking up the margins.
The rest of his topics were big, very big, intended to guide us though life’s perils.
Every time he addressed the class, I felt as if he were addressing me, Otis Webb Brawley, directly.
It seemed that he had somehow gained intimate knowledge of all the things that terrified me, and the things that stirred my soul.
Sometimes he would take me aside for a private talk, and surely he realized how grateful I was for this older white man’s counsel of a young black man.

The Reverend George R.
told me what to expect.
Also, he told me how to deal with the unknown.
What is the proper time to stand tall regardless of consequences?
When do you have the obligation to dodge the bullets?

On the way back to the ghetto, on a Detroit bus, I wrote down the maxims that would shape my life:
“You have a fire in the belly, do not let it go out.
You must constantly search for fuel for it.”

“Be a man for others.
Find work where you can make a difference.
Use your God-given gifts to improve the lot of others.
Always focus on improving the lot of others.
Do this for the greater glory of God.”

“Be binary, know right and wrong.
Be truthful.
Have the courage to speak truth to power.”

“Never worry about people thinking you are different.
Realize, people, both black and white, will try to discourage you.
They will try to get at your confidence.
They will try to get at your self-confidence.”

“You will be tested.
Always know your subject matter better than anyone else.
You must be good.
You must stand up to scrutiny.”

“Do not let the naysayers make you feel that you cannot do something.
They will call you arrogant.
They will call you aloof.
They will question your intelligence.
They will call you nigger.
They will try to assassinate your character.
If you are very successful, some will threaten your safety.
Spite them by succeeding.
It is all right to take satisfaction in your success and their disappointment.”

“Do not tolerate fools.
Don’t compromise on excellence.”

“Never let people put you down.”

“Feel sorry for people who see no challenges to overcome.
Feel sorry for the selfish.
Feel sorry for fools.
You should feel sorry for a lot of white people.
Remember you have character they cannot understand.
Relish that you have overcome challenges they could never overcome.”

*

AS
I prepared for the May 2007 meeting of the FDA Oncologic Drugs Advisory Committee, I hatched a plan that I believed would have impressed the Reverend George R.
The day before the FDA meeting, as a courtesy, I informed the Emory public relations department that (1) I intended to set off a pedagogical equivalent of a daisy cutter, and (2) I didn’t give a shit what they thought and would do what I thought was right regardless of consequences.