[Paleopsych] NYTBR: Pharm Land: "Generation Rx"

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NYTBR: Pharm Land: "Generation Rx"
http://select.nytimes.com/preview/2005/11/20/books/1124986788383.html
[First chapter appended.]

    GENERATION Rx
    How Prescription Drugs Are Altering American Lives, Minds, and Bodies.
    By Greg Critser.
    308 pp. Houghton Mifflin Company. $24.95.

    By JOE QUEENAN
    Published: November 20, 2005

    APOCALYPTIC literature naturally gravitates toward the maudlin,
    lamenting that the world is going to hell in a handbasket, usually
    courtesy of someone like Eminem or [61]Tom DeLay. This is what makes
    Greg Critser's "Generation Rx" such an unexpected delight. Although
    his message is unrelievedly depressing - drug companies, with the
    nation's physicians and the federal government already on the payroll,
    have transmogrified a self-reliant nation into a herd of functional
    drug addicts - there is something so congenial and non-self-righteous
    about the way he tells his story that few of the scoundrels singled
    out for public obloquy will take personal offense.

    Unlike the malignantly partisan [66]Michael Moore or [67]Ralph Nader,
    arguably the least bubbly reformer since Oliver Cromwell, Critser
    spreads his gospel of rack and ruin in an almost good-natured way,
    explaining who paid off whom and how many Americans died as a result
    of it, but without getting especially nasty. Indeed, what prevents
    "Generation Rx" from reading like a writ of indictment is the author's
    folksy turns of phrase, which sometimes go off in unintentionally
    hilarious directions.

    Thus, describing the evolution of Glaxo from a sleeping giant to a
    juggernaut, Critser says that "in the boggy pharma jungle," the
    company "swung on the vine of prior greatness while withering on
    stultifying British business practices." Marveling at the liver, he
    writes, "It is the only organ that can, with time, regenerate itself,
    a kind of [68]Donald Trump of the human body." And he identifies
    Washington as "an unfathomable brothel to all but the Reverends Rove
    and Cheney."

    Here it is unclear whether he is arguing that the nation's capital is
    an unfathomable brothel open to every client except [69]Karl Rove and
    [70]Dick Cheney, or that everyone, including Rove and Cheney, is
    welcome at the brothel, though they alone can fathom it. Whatever the
    case, it certainly makes a nice break from all the dreary paragraphs
    about prostaglandins, rofecoxib and Heliobacter pylori. These strange
    analogies, bizarre metaphors and weird solecisms provide reassuring
    grace notes in a book whose thrust is otherwise quite sober. They also
    make one wonder if the people involved in the editing process may not
    have experimented with a few [71]pharmaceuticals themselves.

    "Generation Rx" contends that large drug companies have co-opted the
    federal government, seduced the medical establishment and mesmerized a
    temperamentally supine public into taking far more drugs than is
    strictly necessary, much less healthy. Worse, Americans have fallen
    victim to "polypharmacy": using so many drugs for so many ailments
    that they have no idea how the various medications are interacting.

    Nevertheless, this is not the work of a conspiracy theorist. The
    public, particularly "the Tribe of High-Performance Aging," genuinely
    adores Viagra, Zoloft, Paxil and Prozac, believing that they vastly
    improve one's quality of life. As in his previous book, "Fat Land,"
    Critser says the public has been complicitous in its own seduction.
    Gleefully voting with their tongues, Americans use drugs to combat
    [72]depression (Paxil, Prozac), reduce the ruckus from the kids
    (Ritalin), make bedtime more like a night in the seraglio (Viagra) and
    turn the workplace into a hearty party (Vicodin).

    Despite the book's misleading title, the triumph of "big pharma" is
    yet another national tragedy, like Michael Flatley's career, that can
    be laid directly at the feet of baby boomers. As Critser writes, "The
    generation of Americans who rebelliously experimented with drugs is
    now a generation upon whom drugs are experimented, with barely a
    squeak of protest."

    Actually, this argument is a bit hard to follow. Young baby boomers
    never protested against drugs, merely their price, quality,
    availability and the advisability of buying them from furtive men
    named Sweet Memphis or Chucky the Swede. So why on earth should they
    complain about drugs now? (For the answer to this question, go ask
    Alice. When she's 10 feet tall.)

    Because of the dry nature of the subject, "Generation Rx" is unlikely
    to replace Harlan Coben as bedtime reading. Moreover, while some
    details may be new, the overall theme - doctors are on the drug
    industry tab, Republican legislators view regulation as Stalinist,
    consumers have developed an almost Incan belief in the power of
    chemicals, lobbyists run everything - is not. Still, the book is a
    lively, well-told tale, chock-full of fascinating tidbits that will
    bring a smile to the face of even the gloomiest Gus.

    For example, the Learning Annex, in addition to its tutelage in pole
    dancing, offers an online course called "Three Days to a
    Pharmaceutical Sales Job Interview!" And a New York internist's Web
    site offers "pen amnesty" to physicians who wish to quietly turn in
    all the writing materials they have had foisted on them by drug
    companies over the years.

    Some assertions seem debatable. When the author reports that Vioxx,
    "by one count," has caused as many as 100,000 heart attacks, one
    wonders: precisely whose count was that? Similarly, when he reports
    that by the late 1990's, the United States was consuming 90 percent of
    the world's Ritalin, some may be shocked. Judging from the children of
    the corn my son and daughter have been dragging in off the street for
    the past 20 years, I would have sworn that number was far too low.

    Unsurprisingly, one of Critser's major villains in the
    pharmaceuticalization of America is the Reagan administration, which
    helped tear down the Chinese wall that once separated regulators from
    drug makers and created, in Critser's view, an ambience of potentially
    disastrous chumminess. Yet he lauds [73]William Rehnquist, a staunch
    conservative, for issuing a prescient warning about the unforeseen
    perils of direct-to-consumer advertising. "Pain getting you down?" he
    wrote derisively in a dissenting 1976 Supreme Court opinion. "Insist
    that your physician prescribe Demerol. You pay a little more than for
    aspirin, but you get a lot more relief."

    Nothing in the book is more alarming than the disclosure that the drug
    industry spent $50 million on political campaigns between 1999 and
    2003. True, it is comforting to read that "Republican causes and
    candidates" pocketed almost 80 percent of the cash; if only from the
    shareholder's perspective, it is reassuring to know that at least the
    money is being spent wisely. But from a patriot's point of view, the
    paltry size of the bribe is unnerving. Compared with the billions in
    revenue garnered by the sale of hyped, dangerous or ineffective drugs,
    $50 million is mere chicken feed. This suggests not only that our
    politicians can be bought, which is bad, but that they can be bought
    cheap, which is worse.

    Somebody, pass the Demerol.

    Joe Queenan's most recent book is "Queenan Country: A Reluctant
    Anglophile's Pilgrimage to the Mother Country."

First chapter of "Generation Rx"
http://www.nytimes.com/2005/11/20/books/chapters/1120-1st-crits.html

    By GREG CRITSER

    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. . . .