Zzz Dangerous Medicine

Discussion in 'Health and medical' started by Dave, Oct 16, 2003.

  1. Dave

    Dave Guest


    Dangerous Medicine
    So what if the speedup at the FDA is putting poisons on pharmacy shelves?
    Congress doesn't want to know.

    By Daniel W. Sigelman
    Issue Date: 9.23.02
    Print Friendly | Email Article

    Thirteen dangerous prescription drugs have been withdrawn from the market in
    the last decade -- but not before hundreds of patients died and thousands
    were injured. Yet no congressional committee has investigated why the U.S.
    Food and Drug Administration approved these dubious medicines or why they
    were not withdrawn right away.
    In fact, just this past May, Congress opted instead to renew the arrangement
    that's a major source of the problem. For 10 years, drugmakers have provided
    much of the FDA's own funding by paying "user fees." In exchange, the FDA
    speeds up its regulatory reviews. If this Faustian bargain was a factor in
    the recent drug calamities, Congress was not about to find out. Instead, the
    lawmakers allowed the drug companies and the FDA to decide, in closed-door
    negotiations, how much the industry would have to pony up this time around
    and just what concessions it would get from its regulators in return. Then
    Congress tacked the agreement onto an unstoppable bioterrorism bill and --
    without a hearing, debate or vote in any committee -- passed it.

    The legislators' indifference reflects the immense power of the drug
    industry, even though drug regulation can be a life-and-death matter. Among
    drugs recently withdrawn from the market were the infamous diet pills
    Pondimin and Redux, manufactured by Wyeth-Ayerst Laboratories, then a
    division of American Home Products Corporation. When taken in the deadly
    "fen-phen" combination, the drugs regularly caused heart-valve damage, and
    many patients who took them developed a devastating lung disorder that's
    fatal in more than 50 percent of cases. These two drugs generated the most
    massive wrongful-conduct litigation against a pharmaceutical manufacturer in
    American history, as a result of which the corporation expects to pay claims
    and legal costs totaling, thus far, $13.2 billion.

    And that's only one story. Los Angeles Times reporter David Willman won a
    Pulitzer Prize last year for his investigation exposing the costs of FDA
    speedups. Placed under unremitting time pressure, regulators frequently
    approve drugs without regard to their dangers.

    Surely something here needs fixing. But all Congress seems to want from the
    FDA is what former Commissioner Jane E. Henney assured the Senate it was
    getting: an agency that "enhances U.S. competitiveness in global markets ...
    and strengthens the domestic economy as a whole by inviting increased
    foreign investment" in the U.S. drug market.

    Not so long ago, things were drastically different. Public-health disasters
    used to spur lawmakers to action. The slaughterhouse scandals at the turn of
    the last century prompted the FDA's creation. More than 100 deaths from a
    poisonous "elixir" spurred the 1938 passage of legislation requiring that
    drugs be proven safe before they can be marketed. The thalidomide tragedy
    led Congress to pass legislation in 1962 requiring the FDA to ensure that
    drugs are effective as well as safe.

    From the mid-1960s through much of the 1980s, Congress played an integral
    part in drug safety. Lawmakers meticulously probed the regulatory histories
    of dubious drugs, uncovered FDA weaknesses and ordered corrections. It was
    congressional investigators who discovered that the FDA, when it approved
    Eli Lilly's anti-arthritis drug Oraflex in 1982, had missed six reports in
    its own files warning of serious liver and kidney disease. After the drug
    went on the market, congressional investigators alerted the FDA that the
    manufacturer was not reporting deaths and adverse reactions in a timely
    fashion. Both Eli Lilly and Hoechst AG, which was doing the same thing with
    its antidepressant Merital, were criminally prosecuted. In other instances,
    such as the one involving the catastrophically defective Dalkon Shield IUD,
    massive civil litigation was built on the findings of congressional

    Nowadays, however, Reps. W. J. "Billy" Tauzin (R-La.), chairman of the House
    Committee on Energy and Commerce, and James C. Greenwood (R-Pa.), who leads
    the committee's investigative panel, seem to construe oversight not as
    protecting lives but as protecting investments. They are currently
    investigating whether the biotechnology company ImClone Systems Inc. misled
    investors about the FDA approval prospects for its anticancer drug Erbitux.
    They have yet to investigate a drug-safety issue.

    Unfortunately, this shift in priorities has been bipartisan. Drug-safety
    oversight began to decline in the late 1980s when the Democrats controlled
    the House. The real nosedive in 1992 -- when user fees were first
    authorized -- also occurred on the Democrats' watch. With those industry
    fees, the FDA was able to hire nearly 600 people to expedite new drug
    applications, increasing the existing staff by 60 percent. But in exchange,
    the industry insisted that the FDA hasten new drug approvals to meet
    deadlines that would become more stringent each year. Moreover, user-fee
    revenues could only be spent on new drug reviews, and the legislation
    required diversion of public funds to new drug approvals at the expense of
    FDA safety programs.

    After the Republicans took control of Congress in 1994, lawmakers indentured
    to the pharmaceutical industry went even further, targeting the FDA as their
    prime example of regulatory excess. Then-House Speaker Newt Gingrich dubbed
    the agency "the leading job-killer in America" and its activist commissioner
    at the time, Dr. David A. Kessler, a "thug" and a "bully." The right-wing
    Washington Legal Foundation accused the agency of committing homicide by
    denying Americans access to new drugs. The Pharmaceutical Research
    Manufacturers Association flew dying patients to Washington to plead for
    less thorough testing of new medicines.

    Soon only a handful of legislators -- led by Sen. Edward Kennedy
    (D-Mass.) -- opposed proposals to "reform" the FDA. Kennedy called these
    plans a "blueprint for demolition, not modernization." Congress, he said,
    was being "driven by powerful and well-funded interests [to] gut the
    regulatory agency that stands between them and increased profits." He won
    some modifications, but he couldn't stop the train.

    In 1997, Congress reauthorized user fees as part of a "modernization"
    package that reduced the legal standard for new drug reviews: Instead of
    requiring two clinical trials, the FDA could accept just one. The new law
    also allowed manufacturers to promote drugs for "off label" uses the FDA had
    never approved. Other provisions greased the fast track; none enhanced the
    safety of the drug-review process. It was the first time in its 91 years
    that the Food and Drugs Act's public-health protections had been rolled

    The 1997 law codified the FDA's fast-track procedure for reviewing new
    drugs, and it continued to prohibit the spending of user-fee revenues to
    monitor drugs once they were on the market. With government appropriations
    for the FDA essentially flat, the effect was to deny the agency the ability
    to monitor the new drugs it was speeding to market. Nonetheless, Sens.
    Kennedy and Jack Reed (D-R.I.) were the only senators to vote against the

    By 1995, the median time for FDA review of "priority" drugs -- those
    offering significant therapeutic advances over available medicines -- had
    already been reduced to a record low of six months. In 1996, the agency
    approved 53 new drugs, almost twice the largest number approved in any
    previous year.

    By 1997, Congress should have been examining to what extent those numbers
    reflected compromised safety rather than increased efficiency. Was the FDA
    taking big risks only in desperate situations, or in ordinary ones, too?
    Congress, however, was largely responsible for the problem.

    Industry's investments in politicians had by then skyrocketed. Total
    political contributions from pharmaceutical and health-products businesses
    rose 86 percent, from more than $7 million to more than $13 million, just
    from the 1994 to the 1996 election cycle, according to the Center for
    Responsive Politics. From 1997 to the present, pharmaceutical and
    health-products companies have spent $51 million on campaign contributions,
    more or less doubling their spending in each successive election cycle. And
    between 1997 and the last available report (in June 2000),
    pharmaceutical-manufacturing companies spent at least $322 million -- more
    than any other industry -- on lobbying Congress and the president. It's
    surely no coincidence that in five years, congressional "oversight" of FDA
    drug regulation has been confined to four hearings -- three in the House and
    one in the Senate -- each of which was called to ensure that the FDA
    continues to expedite its drug approvals.

    The FDA's pace, as a result, has been frantic. In the words of Dr. Janet
    Woodcock, director of the FDA's Center for Drug Evaluation and Research, the
    push for speed has created a "sweatshop environment that's causing high
    staffing turnover." And, of course, in the parts of the FDA that are not
    user-fee funded, staffing problems have been worse. In the current fiscal
    year, the FDA has only 10 professionals trained as physicians or
    epidemiologists to assess the safety of the thousands of medicines now being
    sold, and to review the hundreds of thousands of "adverse event" reports
    that regulators receive each year. The division responsible for policing
    false and misleading prescription-drug advertising has only 14 people to
    review 32,000 pieces of promotional material annually.

    Ten years ago, Dr. Alan Lisook, then a senior FDA investigator, admitted to
    The New York Times that the agency had no good way to tell when clinical
    study summaries submitted by pharmaceutical manufacturers misrepresented
    underlying patient-safety data. Because regulators base their decisions on
    the summary information, this flaw struck at the very heart of their ability
    to ensure drug safety. Yet the FDA today still does not have a single
    employee responsible for auditing the accuracy and completeness of such

    The user-fee reauthorization that Congress passed in May has been presented
    as a reform. Even Kennedy celebrated it on the Senate floor as meeting "our
    obligation to assure the safety" of drugs brought to market quickly. But the
    accolades are misplaced. True, Congress has finally agreed to increase
    public funding for the FDA's understaffed divisions, and industry
    negotiators for the first time agreed to allow a portion of user-fee
    revenues to be spent on drug-safety monitoring and drug-advertising review.
    But what's still not allowed is crucial.

    The FDA is prohibited from drawing on user-fee funds to monitor the safety
    of any drug submitted for review before October -- so the overwhelming
    majority of drugs on or entering the market cannot be scrutinized using
    these funds. In the few cases where user-fee-supported monitoring is
    allowed, it is limited to only two years (three years if the drug presents
    unusual risk concerns). The FDA is barred from relying on user-fee dollars
    to monitor side effects that were unanticipated at the time of approval. For
    the first time, the agency may spend user-fee money to check a
    manufacturer's compliance with a post-marketing safety plan. But if
    unanticipated safety concerns arise after marketing begins, user-fee
    revenues may not be used to assess them. The safety of drugs already on the
    market is hardly thus ensured by this legislation. And the safety of new
    drugs is not even addressed.

    In the meantime, under congressional and industry pressure, the number of
    new drugs approved by the FDA has soared. In 1988, only 4 percent of all new
    drugs introduced throughout the world were cleared for marketing in the
    United States before they were approved elsewhere. Last year, 80 percent of
    all new drugs were approved here first. But is this a good thing? The FDA's
    Woodcock concedes that "'U.S. first in the world' means our population is
    placed at greater risk because we are [initially] going to discover" adverse
    drug reactions here, rather than learn about them as they crop up elsewhere.

    For drugs that represent no significant therapeutic advance, this hardly
    seems a risk worth taking. Yet among the 13 dangerous drugs withdrawn from
    the U.S. market in the last decade, not one filled an otherwise unmet
    medical need. The diabetes drug Rezulin, produced by Parke-Davis, a unit of
    Warner-Lambert, was approved in 1997 on a fast track despite warnings from
    an FDA medical officer that it could cause liver and heart damage. Moreover,
    it was kept on the market for three years despite mounting evidence of its
    deadly liver toxicity -- and even though at least nine safer diabetes drugs
    of comparable effectiveness were already available. The nonsteroidal
    inflammatory drug Duract, a Wyeth-Ayerst product, which was also known to
    cause liver damage, was approved although 19 similar drugs were already on
    the market. The anesthetic Raplon, produced by Organon, was implicated in
    reports of fatal lung muscle spasms but approved anyway. What's more, its
    risks were understated in the information sent to physicians -- despite the
    fact that equivalent anesthetics were available.

    For pharmaceutical companies whose patents are expiring on blockbuster
    drugs, there is much to gain from rushing even unnecessary new drugs to
    market. But the FDA should not be complicit in this business strategy, nor
    should Congress force it to be.

    Some in the House -- notably Reps. Sherrod Brown (D-Ohio), Bart Stupak
    (D-Mich.) and Henry Waxman (D-Calif.) -- have questioned the wisdom of
    forcing the FDA to financially depend on, and to promote, the U.S.
    pharmaceutical industry. But these minority party members are not empowered
    to run investigations or hearings. The one legislator with the power to
    finally step into the breach is Kennedy, the Senate's liberal stalwart and
    chairman of the Health, Education, Labor, and Pensions Committee. Earlier
    this year, Kennedy considered holding hearings on drug safety. When renewal
    of the user-fee program whisked through Congress, those plans were shelved,
    perhaps indefinitely.

    But the need for congressional attention is, if anything, greater now than
    ever. The FDA lacks authority to levy civil penalties for violations of the
    nation's drug laws, to subpoena industry records when it's necessary to
    investigate industry wrongdoing, or to mandate drug recalls. Under the bill
    just passed, companies that don't perform the mandated follow-up research on
    drugs the FDA approves "pending further study" still won't be fined or
    otherwise penalized. Instead, the FDA will now have the authority to post
    their names on its Web site and try to embarrass them into compliance.

    The pharmaceutical industry and the legislators beholden to it will bitterly
    resist investigations of the FDA's pressure-filled drug-approval
    "sweatshop." And many lawmakers will be loath to examine too closely the
    effects of their own ideological preoccupations. But the drug calamities of
    recent years raise real doubts about the FDA's ability to uphold safety
    standards in an environment where global competitiveness and industry
    profitability are the reigning concerns. Such incidents instill no
    confidence in the agency's willingness to say no to distinctly toxic and
    questionably necessary drugs. It is Congress that put the FDA in this
    position, and it is Congress that must investigate and undo the damage.

    Daniel W. Sigelman

  2. Mark

    Mark Guest

  3. Dave

    Dave Guest

    "Mark" <[email protected]> wrote in message
    news:[email protected]
    > "Dave" <[email protected]> wrote in message

    news:<[email protected]>...
    > > http://www.prospect.org/print/V13/17/sigelman-d.html
    > >
    > > Dangerous Medicine
    > > So what if the speedup at the FDA is putting poisons on pharmacy

    > Meanwhile, there is NO consistent regulation of the contents of
    > "supplements"...fungicide anyone?
    > Mark, MD

    I have never heard of anyone who has been maimed or killed by nutrition.
    Oh, except if you eat Polar Bear liver. LOL
  4. In <[email protected]>, Dave wrote:

    > I have never heard of anyone who has been maimed or killed by nutrition.
    > Oh, except if you eat Polar Bear liver. LOL

    Type II Diabetes
    Food allergies

    | "Really, I'm not out to destroy Microsoft. That will just be a |
    | completely unintentional side effect. " -- Linus Torvalds |
    +--------------- D. C. Sessions <[email protected]> ----------+
  5. Hawki63

    Hawki63 Guest

    >Subject: Re: Zzz Dangerous Medicine
    >From: "D. C. Sessions" [email protected]
    >Date: 10/20/2003 8:20 PM Pacific Daylight Time
    >Message-id: <[email protected]>


    ahhh...PKU should stump davey boy don't ya think??
  6. "Hawki63" <[email protected]> wrote in message
    news:[email protected]
    > >Subject: Re: Zzz Dangerous Medicine
    > >From: "D. C. Sessions" [email protected]
    > >Date: 10/20/2003 8:20 PM Pacific Daylight Time
    > >Message-id: <[email protected]>

    > >Phenylketonuria

    > ahhh...PKU should stump davey boy don't ya think??
    > hawki

    Hmm. I seem to recall that phenylalanine is on both of Dave's lists of
    contents for ginseng and pond scum. Yet he says they are "safe for all
    ages." Talk about maiming children!

    ;o) Rich