Knocking on Heaven's Door: The Path to a Better Way of Death (27 page)

throughout their lifetimes. Among those who suffered most,

along with the poor, were the chronically ill and elderly of all

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classes: those with problems that couldn’t be fixed, who most

needed the old, soft technologies of thoughtful, old-fashioned

doctoring, advice on lifestyle and adaptation, and the time-con-

suming hands-on attention of a general practitioner. Despite

the best intentions of its framers, Medicare’s payment structure

punished doctors who practiced the Slow Medicine the elderly

often needed and rewarded those on the hard-tech cutting edge.

Cardiac hypermarketing, meanwhile, grew so outrageous

that it drew attention outside the hermetically sealed worlds of

the operating room and Medical Alley. In what turned out to be

the first of repeating waves of scandals similar to those in the

pharmaceutical industry, witnesses told a Senate subcommittee

in 1981 that some doctors were deliberately performing unnec-

essary pacemaker implantations in return for device industry

kickbacks. Sales reps at one pacemaker company—a company,

as it happened, with a terrible product safety record—gave their

most “productive” doctors free stays at the company hunting

lodge and on the company yacht. Others hired the comedian

George Burns and the cheerleaders for the Dallas Cowboys

to regale doctors at free dinners and parties. “In all my twenty

years experience in the medical sales field, I have never seen a

business so dirty, so immensely profitable, and so absent normal

competitive price controls as this one,” one former salesman

told the Senate subcommittee.

The subcommittee issued a tough report entitled “Fraud,

Waste and Abuse in the Medicare Pacemaker Industry.” The

FBI investigated. Medicare drastically revamped its payment

system in an attempt to get a handle on costs. In 1983, several

executives of Siemens-Pacesetter, Inc. (the pacemaker company

later acquired by St. Jude, which made my father’s pacemaker)

pled guilty and its former CEO pled nolo contendere to fed-

eral charges that they’d paid kickbacks to doctors for implanting

pacemakers. They were given suspended sentences and fined.

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Some troubled cardiologists—often those paid salaries by

universities rather than earning a living in private practice—had

growing doubts about where the whole enterprise was leading.

At a cardiology conference in Manhattan devoted to the elimi-

nation of fatal heart attacks, Henry Greenberg, the director of a

hospital coronary care unit, delivered a contrarian and prescient

paper called “In Praise of Sudden Death.” He’d informally polled

his cardiologist friends and their families, he said, and “not one

wished anything but a sudden, unexpected exit while in the pink

of health. There were not even any votes for a classic death-

bed scene, with the family gathered.” The preferred age for this

death, he said, was around eighty. “We all want to live to the

fullest extent of our capacity as a sapient being capable of joy

and delight, but at the proper time life can be quickly and gently

rounded with a sleep,” he told his cardiology colleagues in 1982:

What if we are fully successful in the purpose of our gather-

ing? Will we devoutly wish for a new risk factor to call into

play as we see memory slipping as our dotage arises? Will we

avoid physicians and hospitals for routine ailments because

we are afraid that unacceptable illnesses will be prolonged

interminably?

In the aftermath of the pacemaker scandal, a committee

appointed by the American College of Cardiology wrote in

1984 a set of clinical guidelines intended to discourage over-

treatment. On a logic that boiled down to “if it ain’t broke, don’t

fix it,” the committee advised against implanting the devices in

patients with no troubling physical symptoms and no sign of

disease beyond slightly irregular cardiograms, slow heartbeats,

or vague diagnoses like sick sinus syndrome. Over the next five

years, pacemaker implantations in Medicare patients dropped

by 25 percent. But the basic pattern—maximum promotion,

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the creeping expansion of diagnoses for which pacemakers and

other cardiac devices were supposedly warranted, disguised gra-

tuities to cardiologists, and a cat-and-mouse game with Medi-

care—did not end. No matter how Medicare tried to change its

rules and tighten the spigot, money continued to flood into the

device companies, and like water seeking its own level, some of

that money trickled down to cardiologists. By 1987, the median

income of cardiovascular surgeons was $271,555, while most

primary care doctors earned considerably less than $100,000.

One former Medtronic sales rep told me that in the 1980s

he was sent to a three-day course in fine wines, all the better to

wine, dine, and knowledgeably converse with the upscale cardi-

ologists who were his sales prospects. One of pacemaking’s pio-

neers, a respected university-based cardiac surgeon, saw how

far things had gone wrong when he flew from the east coast to

Los Angeles to supervise the placement of a pacemaker in his

mother-in-law, who was then in her early nineties. “I went out

there on a Saturday to Cedars Sinai, I guess in February, said

the east coast surgeon, who asked to remain anonymous. It was

a very quiet day, and the surgeon and I were sort of waiting

around. It turned out we were waiting for the sales rep, and

finally he arrived. The doctor put in the pacemaker adequately,

and the sales rep handed the surgeon a package and left. The

surgeon opened it front of me, seemingly not at all embarrassed:

it was a nice gold wristwatch, as a present.”

Time passed. Things changed. Things stayed the same. The

number of transistors in a typical pacemaker grew from only two

to more than four million. U.S. health care costs kept rising, to

nearly double those in some European countries, without a corre-

sponding gain in health. In 2003, the year my father got his device,

when health care was consuming 15.9 percent of GDP and the

average American life span had risen to seventy-seven years, a

Medicare study found that medical device companies were enjoy-

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katy butler

ing average net profit margins of nearly 20 percent. It was,
the

New York Times
pointed out, more than twice the average for all other companies in the S&P 500. Cardiac surgery was so profitable that many hospitals relied on it to subsidize their emergency

rooms and other money-losing departments and ran full-page ads

in major newspapers to attract customers. Cardiologists published

a flurry of journal articles about successful surgeries in patients

over eighty and over ninety. Device-related heart surgeries alone

in 2003 cost Medicare nearly fifteen billion dollars.

By then, there were all kinds of devices: stents, little cage-

like tubes to prop open clogged arteries; drug-coated stents, less

prone to clogging than bare metal ones; external heart pumps

like the one that would later be attached to former Vice Presi-

dent Dick Cheney, each one costing Medicare more than half

a million dollars. There were chemically pickled and sterilized

heart valves taken from human cadavers and from pigs, and del-

icate bionic valves hand-sewn in Southern California factories

by Vietnamese-American and Cambodian-American women

out of the sterilized heart tissue of cows.

Michael N. Weinstein, a senior analyst at J.P. Morgan, called

the cardiac device business “an area of tremendous interest” in

May 2003. Medical devices of all sorts had become a $170 bil-

lion global industry, and cardiac devices alone generated four-

teen billion dollars in worldwide sales. Weinstein’s “top pick,”

he told an interviewer for
the New York Times
’s Market Insight

column, “is St. Jude Medical. They are a play on the cardiac

rhythm market.”

The market was not pleased, however, in the spring of 2006

when Medicare proposed yet another change in the formulas

under which it reimbursed hospitals, in hopes of reducing pay-

ments for implanted devices and paying more for under-com-

pensated services like stroke care. Payments for pacemaker

surgeries were set to drop by about 13 percent, defibrillators

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by 25 percent, and stents by 33 percent. AdvaMed, the device

industry’s primary voice in Washington, pushed back. In April,

AdvaMed hired two former health care staffers from the House

Ways and Means Committee and another who’d once worked

in health policy for Senator Ted Kennedy.

Over the next few months, AdvaMed spent a million dol-

lars on what its chief called “inside the Beltway advertising and

extensive media outreach, ‘grass tops’ advocacy efforts, and

intense lobbying of key House and Senate Members.” It created

a photo exhibit on Capitol Hill featuring enthusiastic patients

like Reagan administration official Michael Deaver, who had an

artificial knee; former Olympic skater Bonnie Blair, who’d ben-

efited from an implanted anti-incontinence surgical device; and

a former NBA basketball player who had a pacemaker. It held

a press conference featuring the heads of two nonprofit, appar-

ently grassroots, groups—the Sudden Cardiac Arrest Asso-

ciation, a defibrillator-promoting group funded mainly by the

cardiac device industry; and the Society for Women’s Health

Research, which got most of its grants from big medical players,

including the Medtronic Foundation and Boston Scientific.

What went unremarked was the eternal background music of

Washington. The makers of pharmaceuticals and medical sup-

plies constitute one of the Capitol’s three biggest lobbies, rival-

ing the defense industry and Wall Street. In 2006, AdvaMed, the

Big Three pacemaker companies, and other medical technology

and supply companies spent at least twenty-seven million dol-

lars on lobbying Medicare, the Food and Drug Administration,

Congress, and other parts of the federal government. They con-

tributed another $1.5 million to federal political campaigns.

The money and attention were well spent. After two hun-

dred members of the House and Senate from both parties wrote

to Medicare questioning the proposed cutbacks, its top admin-

istrator, Mark McClellan, said he had taken the objections “to

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heart” and essentially gutted the plan, making changes that in

the estimation of AdvaMed, recaptured three billion dollars in

at-risk sales revenues. Shares of Medtronic, St. Jude Medical,

and Boston Scientific rose on the news.

Business as usual continued, and money continued to flow and

drip from device companies to cardiologists. In 2007—the year

that my father forgot the purpose of his dinner napkin—a reg-

istered nurse named Charles Donigian resigned from his job

in the regional sales office of St. Jude Medical in St. Louis,

Missouri, where he’d helped administer follow-up surveys of

patients who’d been given pacemakers and defibrillators. Doni-

gian said he’d resigned because he thought he’d soon be fired

for refusing to bend ethical rules. He subsequently filed a law-

suit seeking damages under the federal law that protects whis-

tleblowers.

In his suit, which the Justice Department later joined, Doni-

gian said that St. Jude had essentially paid kickbacks to doctors

who chose its products, in the form of what he called “sham

fees for phony post-market clinical research studies.” The doc-

tors mainly provided the names, Donigian claimed, while he

and others at St. Jude did the paperwork as well as the doc-

tors’ Medicare billings. In one study, St. Jude paid the doctors

$2,000 per enrolled patient.

St. Jude salesmen also gifted doctors with fishing trips to Can-

ada, tickets to St. Louis Cardinals games, airline tickets to Las

Vegas, and dinners at steakhouses, Donigian said. One sales rep-

resentative, he said, had an expense account of $250,000 a year,

mainly to entertain and reward cardiologists. The corruption went

both ways: one hospital cardiac catheterization lab, he claimed,

bluntly told St. Jude sales reps that they expected a catered lunch

for the entire office each time they implanted a device.

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Donigian said that St. Jude employees ghostwrote two

research presentations summarizing the results of one cardiac