Sample text for Generation Rx : how prescription drugs are altering American lives, minds, and bodies / Greg Critser.


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Counter
Unbound
The Strange and Very American Liberation
of Big Pharma

THE MAN IN THE ARENA: WHY PHARMACEUTICAL
COMPANIES
BECAME SO AGGRESSIVE

In the world of bureaucratic Washington,
D.C., few if any possess the
gravitas and smarts to get away with
quoting Teddy Roosevelt. Lewis
Engman, Richard Nixon"s 1973 appointee
as chairman of the powerful
Federal Trade Commission (FTC), was one
of the few. A Midwesterner with
traditional Republican inclinations,
Engman had "the gift," as one friend later
put it -- people simply wanted to be
around him. He was a handsome man,
with a broad brow and piercing dark
eyes, and he was a social creature,
stylishly dressed and coiffed and
noticeable on the D.C. cocktail circuit,
where he could be seen in the company of
many of the president"s closest
advisers. Engman was a personable, if
tightly wound, man as well,
comfortable with business types and
staff typists alike; when a young FTC
appointee named Elizabeth Hanford (later
Dole) had a minor accident and
ended up in the emergency room on the
day she was to be installed,
Engman took his entire staff over to the
hospital and swore her in while she
was still in bed.
More importantly in a town of fiercely
guarded opinions and
fiefdoms, Lew Engman could take the heat
of debate. He seemed to revel in
it. Often he intentionally recruited
lawyers with whom he did not agree. "The
notion," a former staffer recalls, "was
that the tension would produce the best
resolution." That didn"t mean Engman was
thwarted very often; yes, he could
be imperious and even arrogant, but "he
was so personable and passionate
that you wanted to agree with the guy."
Frustrated with the slow pace of
getting anything done in D.C.,
Engman loved to invoke TR"s famous "Man
in the Arena" speech. "It is not the
critic who counts; not the man who
points out how the strong man stumbles
or where the doer of deeds could have
done better," he would quote, his brow
furrowing. "The credit belongs to the
man who is actually in the arena, whose
face is marred by dust and sweat and
blood, who strives valiantly, who errs
and comes up short again and again, but
who knows great enthusiasms . . .
so that his place shall never be with
those cold and timid souls who knew
neither victory nor defeat."
It was an appropriate mission statement
for a young man charged
with running the FTC, which oversaw the
business of the world"s most
powerful, if at the time troubled,
economy. The FTC itself had grown
increasingly controversial. For decades
the commission had operated
somewhat like a European or Japanese
finance ministry, not simply policing
industry"s outright frauds and cons, but
also regulating competition itself. The
agencies under its purview, from the
Civil Aviation Board (CAB) to the
Interstate Commerce Commission (ICC),
were so cozy with their respective
industries that it was all but
impossible for an upstart entrepreneur to
compete. Traditionally the FTC chairman,
in a tacit admission of the powerful
regional political interests that had
created that coziness, remained mute on
the situation. "The policy was never to
criticize another government agency,"
recalls Art Amolsch, who worked for
Engman at the time and went on to
become the foremost observer of the
agency. "That"s why the FTC was
always known as the Old Lady of
Pennsylvania Avenue. It was averse to
almost any change and inclined to say no
to anyone who dared suggest
otherwise."
For a brief period in the late 1960s
and early 1970s, responding to
lawsuits and studies by Ralph Nader over
everything from unsafe cars to
overpriced drugs, the commission had
gone on a proconsumer binge under
Chairman Miles W. Kirkpatrick, and
mainstream business types, the core of
the imperiled president"s political
base, had railed against him during the
1972 election season. To calm them, in
1973 Nixon appointed Engman; he
was supposed to "restore order." In
other words, to put things back where
they were before the Naderites inside
the commission got out of control again.
But Nixon, and whoever had done the
personnel file work,
misjudged Engman"s consumer credentials.
Although he was a classic 100-
percent-free-trade, procompetition
Republican, Engman had developed a
strong proconsumer bent. As Time
magazine would later put it, Engman saw
the world as a "Ralph Nader out of Adam
Smith." You could best serve the
consumer, he deduced, by opening up the
marketplace.
With that in mind and the national
economy in trouble -- inflation
was up and productivity was down --
Engman went looking for ways to use
the FTC"s power to make the country more
competitive and to make
American life more affordable. Quickly
he diagnosed a novel cancer on the
nation"s economic corpus: the regulatory
agencies themselves. By making it
so hard for small businesspeople to
enter their respective industries, the CAB
and ICC were hurting the consumer and
inhibiting innovation, thereby
retarding long-term economic growth and
keeping prices unnaturally high. In
a brilliant, landmark speech at the
normally staid Financial Analysis
Conference in 1974, he laid out his
thesis: "Much of today"s regulatory
machinery does little more than shelter
producers from the normal
competitive consequences of lassitude
and inefficiency . . . [it] has simply
become perverted." As a result, "the
consumer is paying plenty in the form of
government- sanctioned price fixing." It
was time, Engman said, to consider
serious deregulation.
Engman also went after what he called
"professional conspiracy."
He sued the American Medical Association
over its ban on physician
advertising -- something he believed
deprived consumers of the ability to get
the best doctor for the best price. He
went after state medical societies for
their bans on the advertisement of
prescription drug and eyeglass prices. In
fourteen months he filed thirty-four
antitrust actions. "The consumer was
always the bottom line for Lew," recalls
Bob Lewis, who served on Engman"s
staff. ""Is this going to benefit the
consumer?" That was always the question
he asked at the end of the debate about
anything."
By the time he left the FTC in 1977,
when a Democratic
administration was about to take office,
Engman had succeeded in making
deregulation a mainstream Republican
goal. At age forty-two, he was a GOP
legend.
And so it was hardly surprising that,
in the fall of 1980, with a new
president named Ronald Reagan onboard
who was committed to getting
government out of every aspect of
American life, Engman would again be
sought for his leadership skills. This
time the organization in need of help
was the Pharmaceutical Manufacturer
Associations. The PMA represented
the nation"s biggest brand-name drug
makers, who were often referred to
simply as "big pharma" or simply
"pharma." (The organization itself formally
changed its name to the Pharmaceutical
Research and Manufacturers of
America, PhRMA, in 1994.) The PMA
believed that the industry was in a
crisis, suffering from increasing costs,
slipping sales, foreign competition,
and government overregulation. It was a
crisis so severe as to provoke
pharma CEOs to wonder out loud "whether
there will even be a U.S.
pharmaceuticals industry in twenty
years." Then again, just about every
major industry wondered something like
that in the early 1980s, when it was
widely believed that Japan was doing to
U.S. industry what it had failed to do
with bombs thirty-five years earlier.
Some, if not most, of pharma"s
immediate crisis was of its own
making, although this was not something
most drug CEOs would admit. As a
group and individually, they had simply
failed to invest in new drug sciences
and drug development. Instead, they had
relied on (and indeed encouraged)
the FDA"s lack of a generic-drug
approval process, giving pharmaceutical
companies de facto monopolies -- and huge
profit margins -- on many
widely used drugs. This state of affairs
had provoked a legal backlash of its
own; district courts from New York to
California were actively contemplating,
and in some cases ruling, that many
traditional pharmaceutical patents were
invalid. The Supreme Court itself had
grown hostile to the very notion of
patents. In the pharma executive suite
of the time, there was only one word
for that: shock.
Yet some pharma problems were largely
out of the industry"s
direct control. America in the late
1970s and early 1980s was going through
one of its cyclical periods of what
might be dubbed pharmaceutical stoicism.
As a percentage of annual health
expenditures, the Rx share was actually
shrinking. And while cocaine might be
hip, prescription drugs were uncool on
a number of levels. On the cultural
plane, drug makers were the domain of
the blue-chip world, with which the baby
boom had yet to fall in love. The
growing alternative-medicine movement,
with its reliance on herbs and
vitamins, appealed to a generation
concerned with what was natural. The
movie version of One Flew Over the
Cuckoo"s Nest rekindled old suspicions
about psychiatric medications, one of
the industry"s most profitable
monopolies. News stories about abuse of
Valium, one of the most profitable
postwar drugs, led to its
reclassification as a controlled
substance in 1978,
making it harder to prescribe. There
were scares over new heart medications
and horror stories about pharmaceutical
industry negligence, and a new
generation of ambitious politicians had
no qualms about capitalizing on such
fears. When a young congressman named
Albert Gore learned from a staffer
that a Pfizer attorney had made an
off-the-cuff remark about how expensive it
was to monitor the adverse events of one
of his products ("What, are we
supposed to schlep all over the world
just to track down one goddamn side
effect?" the attorney had sputtered),
Gore promptly publicized the incident.
Abroad and in D.C., big pharma was, more
than ever, big fair game.
Worse from the point of view of
pharmaceutical CEOs were
attitudes and trends among young
physicians and medical students. Many of
them were deeply suspicious of the
business end of medicine. Some of their
attitudes grew from social activism by
med students in the early 1970s, who
were concerned with overmedication and
polypharmacy. (Overmedication is
the unnecessary use of medications in
general; polypharmacy is the
simultaneous use of several medications
to treat one or more conditions.)
The concern was deepest among young
psychiatrists. "In our day, it was
almost an aesthetic thing to be against
polypharmacy," recalls one. "It was
more beautiful if you could do it with
just one or two pills." Many believed that
growing rates of polypharmacy were
fueled by pharma promotional activities,
like giving out free samples and
stethoscopes. "At national meetings, the
idea we talked about was to reject the
goodies," recalls Dr. Terry Kupers,
who was head of the Medical Committee
for Human Rights in the
1970s. "[Pharma sales representatives]
would show up at grand rounds, and
we would confront them and turn down the
goodies. We also went to our
intern meetings within our institutions
and told our supervisors that we did not
want [the reps] on grand rounds. It was
happening at enlightened medical
schools around the country. We did it as
a statement."
The statement registered in
establishment realms, a further worry
to pharma, when, in 1978, a number of
influential medical journals began to
consider banning prescription drug ads
in their pages. As Steve Conafay,
then a lobbyist for Pfizer, recalls,
"There was definitely the feeling that the
industry was under attack and that
something big had to be done." Donald
Rumsfeld, then the CEO of G. D. Searle,
Inc., makers of a wide variety of
drugs and chemicals, summed up the
general attitude when, upon greeting
FDA Commissioner Donald Kennedy, he "sat
down across from me," recalls
Kennedy, "slumped a little, and said,
"What are we doing wrong?""
With Reaganism ascendant, the question
quickly turned into:
What is the government doing wrong? For
Engman, now ensconced in
PMA"s head office, the question should
have been: What can I wring out of
the new political reality -- Reagan"s
pronounced antiregulatory bent -- that
will directly benefit my membership, the
nation"s brand-name drug makers?
Certainly many of his members were
clamoring for a preemptive strike, with
several advocating an assault on the FDA
and its much hated efficacy
requirements. (Congress had passed a law
in 1962, known as the Kefauver
Amendments, changing the Food and Drug
Act and mandating that makers
of new drugs prove not just that their
products were safe, but that they
actually worked.) The chief of research
at Pfizer, then as now one of the more
politically active pharmaceutical
companies, had been railing against the
efficacy rules for years, saying they
got in the way of delivering good new
drugs.
But Engman didn"t think that way. He
wasn"t interested in
deregulation for deregulation"s sake.
Perhaps it was that consumer bug, or
perhaps it was his heady experience as
leader of an agency that served "the
public." Whatever the exact source of
Engman"s reservations, his eventual
choice of legislative priorities finally
came down to one issue: patent
restoration. The subject had bubbled
under the surface of FDA-industry
relations for years. Simply put, the
industry believed that the FDA was eating
up the length of its patents, and
profits, because of its slowness in
processing new drug applications.
Companies with a new discovery had to
file for a patent as soon as possible,
to establish ownership of the idea, but
then had to wait years for approval. By
the time the drug was approved, the
company might have as little as half the
original seventeen years of patent life
usually guaranteed to innovators. That
led to higher prices, longer waits for
new drugs, and a general disincentive to
invest in new medications. It was
true that the studies proving the case
for patent restoration -- for laws that
would give pharma additional
compensatory patent time -- were weak and
inconclusive, but the essence of the
industry argument struck a nerve with
Engman: here again was a case of
overregulation hurting the economy of the
nation and depriving the consumer of an
improved product.
What should Engman"s PMA do? Sometime
during the fall of
1980, he got an idea. He would use his
old political contacts to shepherd
legislation to extend pharmaceutical
patents, adding up to seven years of
exclusive marketing time for new drugs
that had taken too long to get through
the FDA approval process.
For a while, all of the old Engman
magic seemed to work. He
circulated studies showing exactly how
industry suffered from FDA
bureaucracy -- and how few new important
drugs made it through the
system. He lined up experts from leading
medical schools to testify on the
subject before Congress. By late 1982,
he had managed to push the political
process as well. A bill extending patent
life was passed by the Senate and
referred to the House for an expedited vote.
Yet the world -- and particularly
Washington, D.C. -- does not lie
under the spell of magic for long, and
Engman"s bill went down to unexpected
defeat. One reason was the weather; a
dense winter storm had settled over
Foggy Bottom on the morning of the vote,
delaying the arrival of several key
supporters. Then there was another, less
natural phenomenon: a man named
Henry Waxman.

Waxman, a short, balding, mustachioed
man who represented the Westside
of Los Angeles, was the quintessential
manifestation of the new post-
Vietnam liberal legislator. In just nine
years he had risen from relative
obscurity to the chairmanship of the
powerful Subcommittee on Health and
Environment of the House Energy and
Commerce Committee. This ascent he
accomplished via the unabashed use of a
political action committee, by
which he funded the campaigns of
like-minded fellow Democrats, who would
then support his nomination to important
committees. Perhaps more
importantly, Waxman was a single- focus
legislator by design, rather than by
circumstance. "I recall him coming up to
me at a fundraiser very early is his
career and telling me he had found the
key to his political life," one longtime
supporter remembered. "He said, "It"s
health. Who can be against health?"" If
Waxman"s concern seemed calculated, it
was also genuine. Some of
Waxman"s earliest supporters were older,
less affluent Westsiders who were
constantly kvetching to him about the
price of prescription drugs.
"There was no way that Henry was going
to give the industry
seven more years of protected profits,"
says Bill Corr, then head of
Waxman"s committee staff. "The more we
looked at Engman"s so-called
studies, the more we saw something else.
For their most profitable drugs,
the brand-name companies had actually
received a substantial -- sometimes
lengthy -- period of monopoly patent
protection."
There was another less tangible but, in
the end, highly potent
factor at play in Waxman"s position as
well: the belief that many of the brand-
name pharma CEOs were anti-Semitic.
Waxman had arrived at that
conclusion after a series of initial
meetings with the CEOs and their
representatives. "Whenever they talked
about the generics guys, the word
they like to use the most was
"parasite,"" Waxman recalls. "Then they
would
talk about how greedy they were, how
they throve off of the back of people
who did the real work. I thought it was
anti-Semitic. You could feel it. They
were so disdainful, these New Jersey
country club types."
Waxman"s anti-brand name inclinations
were further in- flamed by
another political bomb-thrower, a man
named Bill Haddad. Haddad was the
head of the Generic Pharmaceutical
Industry Association (GPIA) and the
owner of a small copycat drug company,
but he was no industry hack. He
had a long, distinguished (if eclectic)
liberal heritage dating back to his days
on the staff of Senator Estes Kefauver,
the author of the important 1962
efficacy amendments. It was through
Kefauver that Haddad picked up the
emotional component of his anti-brand
name jihad, the rhetoric of which often
included such unconventional words as
"liars" and "immoral" to describe his
opponents. As Haddad saw it, it was the
industry"s intransigence on such
issues as generics and open pricing that
had pushed Kefauver over the edge
physically, eventually causing his death
from a heart attack in 1963.
(Kefauver"s legislation had been
rewritten at the last minute behind his
back
by Kennedy administration staffers and
brand-name lobbyists, who deleted
the senator"s beloved generics
provisions.) Haddad loved to tell the
story of
how he had visited Kefauver"s grave in
the rain and swore: "I"ll get those
bastards, senator."
For two decades, he had done just that,
first through a series of
journalistic expose;s (Haddad had
extensive family media connections and
earlier had won a Pulitzer Prize for a
series on price fixing in the antibiotics
industry), then, in the 1970s, through
his work in the New York state
legislature. There, as a staff member
with subpoena power, he had forced the
brand-name firms to disclose which drugs
were off patent. He then put
together a powerful case against then
prevalent anti-generic-substitution
laws, which pharma executives had pushed
through state legislatures across
the country, thus making the prescribing
of generics almost impossible. After
New York repealed its antigeneric laws,
Haddad put together a how-to kit for
repeal and sent it out to "every
ambitious young state legislator across the
country." Within a few years every such
law in the country had been wiped
from the books.
But Haddad"s biggest beef with the
industry -- and the FDA --
had provoked little in the way of
action. By 1982 there was still no workable
economic method for getting a generic
drug approved even after a patent ran
out. That was because the FDA still
required any maker of a generic version
of a brand-name drug to undertake the
same lengthy, costly, and sometimes
dangerous series of clinical trials to
prove its product was safe and
efficacious. Technically, this process
was totally unnecessary. Time-proven
methods of reverse engineering, along
with sophisticated ways of assaying
copycat compounds, could assure that any
generic was biologically
equivalent. "It was totally immoral to
insist that the generic maker do all that
again," Haddad argued. "But they don"t
care . . . they don"t care about the
senior citizens, they don"t care about
the poor single mother, they don"t
care . . ." Many inside the FDA agreed,
but the political power of the PMA,
along with institutional inertia,
cowardice, and plain old bureaucratic ass-
covering had precluded any meaningful
reform.
Then, in mid-1982, just as the PMA and
Engman were using a
new, ostensibly "independent" study to
convince Congress that patent life
had been dramatically shortened by FDA
red tape, Haddad got a letter from a
woman in Florida, a statistician who
claimed she had been an author of the
supposedly independent study. "She said
that not only had the numbers for
the study been prepared for her by the
industry, but that the brand names
had paid for the study and then insisted
that it be presented
as "independent."" Haddad used the
disclosure to stir up discontented seniors
in two Miami Beach districts, who in
turn "drove their congressman crazy"
about why patent restoration was wrong,
not to mention political suicide.
Using Haddad"s activism to mobilize
opposition votes and Al Gore"s
willingness to vilify the industry in
general, Waxman defeated Engman"s
patent-extension legislation.
For a time following his defeat, Engman
worked on a number of
other industry-relief efforts. Certainly
the time was still right for anything that
offered a way to make the nation more
competitive. Congress had passed the
Bayh-Dole Act in 1981, which made it
easier for the industry to use research
discoveries that originated in publicly
funded laboratories. For pharma, that
opened up a wide range of lucrative
partnerships with researchers at the
National Institutes of Health (NIH),
where scientists were making
breakthroughs in developing new
molecules that could treat everything from
heart disease to depression. The law
also made it possible for government
researchers to accept consulting fees
from pharmaceutical companies.
This opening-up process -- in essence
doing away with old
church-state separations that favored
institutional or scientific independence
over commerce of almost any kind -- was
the subject of a lengthy inquiry
from some of the nation"s leading
experts in pharmacology and drug
regulation, who were joined by Engman.
Commenced in the late 1970s under
Tulane University"s Dr. Gilbert McMahon,
the Commission on the Federal
Drug Approval Process was originally
created as an evenhanded, fact-finding
mission to discern whether many of the
industry"s complaints about the FDA
were justified. Under Reagan, it
essentially became an industry organ,
funded
not by the government but -- under the
guise of budgetary efficiency -- by
private interests and philanthropists in
tune with the president"s deregulatory
impulses. As a result, the commission"s
official discussions about opening
up the FDA took place off the record and
out of media view at a Virginia
resort owned by a friend of the president.
By the time the commission presented
its report in late 1982,
almost every discordant (i.e.,
anti-brand name) note had been tuned out.
Instead, what Congress heard was a
venerable choir of scientific voices
demanding that the FDA cut the red tape
and speed up approvals. The
commission then presented Congress with
its list of recommendations, many
of which would eventually make it into
the law books. Instead of requiring
extensive, multiple studies for
approval, the commission asked
that "effectiveness should be found to
have been demonstrated either by
two -- or, when appropriate, one --
adequately designed and well-controlled
studies." Foreign studies should also be
admissible and given equal weight
with domestic studies, even if the
populations were different. The commission
also advised lifting stodgy old
conflict-of-interest restrictions that
barred the
use of industry-paid experts in FDA
advisory committee meetings.
Lastly, "the FDA should provide guidance
to its staff to encourage all review
personnel to conduct timely, forthright,
and evenhanded discussions with
sponsors that arise at any time during
the review process."
"That last one was the one that really
mattered, long-term," says
Jonah Shacknai, then a commission staff
member and now the president of
Millennium Pharmaceuticals. "The real
importance of the recommendations
was a closer relationship between FDA
and manufacturers. It used to be a
solid Chinese wall. Now it had good
windows in it."
But "good windows" into a regulatory
agency were not what Lew
Engman had in mind. He had patent reform
in mind. True, there was now a
little bit of obsession at work -- "he
could get very wound up about it" -- yet
as he listened to Waxman and Haddad
talk, there were also other legitimate
pinpricks on his conscience. What if
Haddad was right? What if the PMA
was on the wrong side of history? After
all, in a recent district court ruling,
Bolar v. Roche, a Brooklyn judge had
ruled that it was not an infringement of
a patent if a generics maker used a
patented drug for experimental purposes
in preparation for a regulatory hearing.
That meant that more generics were
inevitable. It would become known as the
Bolar exemption.
There was also troubling momentum on
the Hill. Waxman had
introduced new legislation that would
make it easier for generics to get
approval -- and with no provision for
patent term restoration for the brand-
name companies at all. Waxman had, in
fact, shifted the entire debate. Now
the "greedy" ones were the brand-name
companies -- something he repeated
with nauseating regularity any time the
media tuned in. And there was the
quintessential Engman worry: Was the
PMA"s opposition to a faster generics
process -- an abbreviated new drug
application (ANDA) -- not all that
different from the FTC countenancing the
Civil Aviation Board"s coziness with
industry? Weren"t all those FDA
regulations requiring duplicate testing
another form of overregulation that hurt
the economy and the consumer?
What if Haddad was morally right?
Slowly, Engman started to talk about
the whole issue differently,
recalls Bob Smith, one of his closer
staff aides at the PMA. "The companies
are basically using human testing to
protect the pill patents," he recalls
Engman saying one day. It wasn"t the
first time anyone had put it quite that
way, but it was the first time the head
of the PMA had, or at least the first
time one had done so out loud. Not long
after, Engman assigned his lead
counsel to begin negotiations with
Haddad andWaxman"s staff to cut a deal:
the PMA would trade its opposition to
generics for a guarantee of patent term
restoration. A deal was struck with
Waxman"s staff. It included the Bolar
exemption, thus putting into the law
books what had only recently been
rendered by a district court. Generic
companies could now use formerly
protected brand-name compounds to
develop their low-price alternatives.
Immediately, a small but loud group of
pharma CEOs called for
Engman to abandon the deal. "I thought
Lew had gone out of his tree," says
Irwin Lerner, then the head of Hoffmann-
LaRoche, which made Valium. "He
was embarrassed by it, I could tell. But
he was also arrogant about it. He
wasn"t going to back off the deal. His
attitude was, "Who the hell are these
guys around the table telling me what to
do?" He thought he was still the
head of the FTC."
"All of the sudden, these guys who had
been for the deal started
freaking out," recalls Bob Smith. "All
of a sudden, everyone had an
exception -- What about my Valium? What
about my Inderal? They were all
afraid that one company would get an
advantage the other would not. Lew
wasn"t totally surprised by it, but he
was determined to live up to his deal
with Waxman."
Joe Williams, then the chairman of the
PMA board and the head
of Parke-Davis, was furious. He asked
for Engman"s resignation. The man in
the arena was fired.
To derail the new bill, Williams and
Lerner turned to an
unexpected source, a man named Gerry
Mossinghoff. Tall, owlish, and
charming in an old-school sort of way,
Mossinghoff was the U.S.
commissioner of patents and trademarks.
As such, he was committed to
traditional patent law, and barely an
official phrase passed his lips without
Mossinghoff uttering something about
"classic, hornbook patent law,"
referring to the nineteenth-century case
books that informed his views. He
was also a textbook Reaganite, inclined
to look unfavorably at regulatory or
legislative limits on patent life. He
had helped the president establish and
populate a new, conservative patent
court. Just who "requested" that he get
involved and testify before Congress on
the pro-brand name side is unclear,
and there were recriminations all
around. It was an unusual position for a
paid
public servant to be in.
But it was too late. Bill Haddad had
made sure that the legislation
would not get sabotaged by going
directly to the congressman most likely to
do so: Senator Orrin Hatch of Utah.
Socially and fiscally conservative, Hatch
was a supporter of pharma, but he had a
pronounced populist streak as well.
He had a yearning to transcend his
narrow reputation as a conservative
firebrand. To exploit that, Haddad hired
Hatch"s longtime chief of staff, who
had just gone into private practice as a
lobbyist, to convince his old boss to
come onboard. Here was a great
opportunity to expand and broaden his
image, and, as Hatch was told, "generics
seemed to be the right thing to do"
to boot. Hatch agreed. The Waxman bill
became Hatch-Waxman -- the order
of the names reflecting not effort but
clout -- and was signed that fall.
The reaction in big pharma"s executive
suites was startlingly clear
and everywhere evident. There was now a
new reality in the business, and
that new reality was fear -- fear of not
exploiting drugs fast enough and hard
enough before generic competition eroded
profits. And there was only one
way to do that: get more new drugs
approved faster and find new ways to
milk them once they were approved.
To help ease the political way, the
brand-name companies hired a
new PMA president. His name was Gerry
Mossinghoff. As Roche"s Irv Lerner
said, "He had all the tickets we could
possibly want."

Copyright © 2005 by Greg Critser.
Reprinted by permission of Houghton
Mifflin Company.


Library of Congress subject headings for this publication:
Drug utilization -- United States.
Pharmaceutical industry -- United States.
Drugs -- Social aspects -- United States.
Drug Industry -- economics -- United States -- Popular Works.
Health Behavior -- United States -- Popular Works.
Health Policy -- United States -- Popular Works.
Population Groups -- psychology -- United States -- Popular Works.