$1 Billion Promo Campaign to Launch Rosuvastatin

Discussion in 'Health and medical' started by mfg, Oct 28, 2003.

  1. mfg

    mfg Guest

    $1 Billion promo campaign to launch undertested, unproven drug.

    THE LANCET
    Volume 362, Number 9393

    Tom McKillop is chief executive of AstraZeneca. He is widely respected
    across the drug industry. The UK's
    Academy of Medical Sciences elected him to its Fellowship in 2002, the
    same year that he received a knighthood. Yet this glittering arc of
    success is now
    cast into shadow. For AstraZeneca's tactics in marketing its
    cholesterol-lowering drug, rosuvastatin,raise disturbing questions
    about how drugs enter clinical practice and what measures exist to
    protect
    patients from inadequately investigated medicines.
    The statin market is vast. Pfizer's atorvastatin—the world's
    best-selling drug—had sales in 2002 of US$ 8 billion. AstraZeneca
    predicts that it can take a
    20% share of this global market. It needs to. The company reported a
    17% drop in pre-tax profits in the second quarter of this year. After
    a damaging delay
    over safety concerns, rosuvastatin finally won US FDA approval in
    August and was launched last month, winning a 2% market share after
    only three weeks.
    McKillop has pledged to do whatever it takes to persuade doctors to
    prescrib rosuvastatin, including launching an estimated $1 billion
    first-year promotional
    campaign. "We've got to drive the momentum",
    he said at a recent investors meeting. "You get one shot at launching
    a major new product. This is our shot."
    The sales strategy for rosuvastatin is based around the Galaxy
    programme. Galaxy is the contrived umbrella name for at least 16
    clinical trials of wideranging
    quality designed to investigate the efficacy of rosuvastatin in
    various clinical settings. The trials within Galaxy have names to
    match the company's cosmic intentions—Mercury, Stellar, Orbital,
    Asteroid, Meteor, Jupiter, etc. With no clinical endpoint trial yet
    completed, the company has chosen to market rosuvastatin by applying
    adventurous statistics to an overinterpreted syllogism. The argument
    is
    familiar and seems compelling. First premise:
    atherogenic lipid profiles cause atherosclerosis. Second premise:
    atherosclerosis causes cardiovascular disease.

    Conclusion: reversing atherogenic lipid profiles will reduce the risk
    of heart disease. But AstraZeneca has
    proceeded to push Galaxy into the realms of
    astrological rather than astronomical logic.
    Take one example. Stellar was a six-week, open label dose comparison
    in 2268 patients with primary hypercholesterolaemia. Results were
    recently reported in Current Medical Research and Opinions (2003; 19:
    P1–P10). Rosuvastatin was compared with atorvastatin, simvastatin, and
    pravastatin. AstraZeneca's drug was, dose for dose, more effective at
    achieving national
    guideline targets for lipid concentrations than its competitors. Based
    on these tentative surrogate findings, one Stellar investigator, Peter
    Jones, commented that, "If I have the option of achieving
    goals at a lower comparable dose, I would choose that". This kind of
    gloss does little to foster sensible, let alone critical, appraisal of
    weak data. Similar twists in the statistical wind were reported
    in a promotional supplement to the American Journal of Cardiology in
    March this year by James Blasetto and colleagues. Blasetto, who works
    for AstraZeneca in Wilmington, Delaware, combined soft end-point
    data from five small 12-week trials to conclude with astonishing
    certainty that rosuvastatin "can be of considerable value". It is
    difficult to understand how
    such blatant marketing dressed up as research can appear under the
    name of a respected peer-reviewed
    medical journal.
    Why does the quality of debate about statins matter?

    First, because safety cannot be assured. Bayer withdrew cerivastatin
    in August, 2001, after the occurrence of unexpected cases of fatal
    rhabdomyolysis.
    The 80 mg dose of rosuvastatin was withdrawn
    by AstraZeneca because of safety concerns. Some critics are even
    anxious about the 40 mg dose. The finding of proteinuria and
    microscopic haematuria
    associated with rosuvastatin use are additional worries.
    Second, talking up the efficacy of statins subverts efforts to conduct
    large-scale outcome trials where they matter most—eg, in heart
    failure. And third, given the beneficial results of mortality
    end-point trials for other statins, what possible clinical
    justification can there be for licensing an unproven statin?
    Since there are no reliable data about efficacy and safety—and
    AstraZeneca is facing unusually acute commercial pressure to force
    rosuvastatin into the
    market—doctors should pause before prescribing this drug. Physicians
    must tell their patients the truth about rosuvastatin—that, compared
    with its competitors, rosuvastatin has an inferior evidence
    base supporting its safe use. AstraZeneca has pushed its marketing
    machine too hard and too fast. It is time for McKillop to desist from
    this unprincipled campaign.

    The Lancet
    The statin wars: why AstraZeneca must retreat
    THE LANCET
    Volume 362, Number 9393
     
    Tags:


  2. Crestor is more effective and at lower doses - I switched to 5 mg
    crestor from 10 mg lipitor and improved. It's about choice. FDA
    approved, good enough for me.

    [email protected] (mfg) wrote in message news:<[email protected]>...
    > $1 Billion promo campaign to launch undertested, unproven drug.
    >
    > THE LANCET
    > Volume 362, Number 9393
    >
    > Tom McKillop is chief executive of AstraZeneca. He is widely respected
    > across the drug industry. The UK's
    > Academy of Medical Sciences elected him to its Fellowship in 2002, the
    > same year that he received a knighthood. Yet this glittering arc of
    > success is now
    > cast into shadow. For AstraZeneca's tactics in marketing its
    > cholesterol-lowering drug, rosuvastatin,raise disturbing questions
    > about how drugs enter clinical practice and what measures exist to
    > protect
    > patients from inadequately investigated medicines.
    > The statin market is vast. Pfizer's atorvastatin?the world's
    > best-selling drug?had sales in 2002 of US$ 8 billion. AstraZeneca
    > predicts that it can take a
    > 20% share of this global market. It needs to. The company reported a
    > 17% drop in pre-tax profits in the second quarter of this year. After
    > a damaging delay
    > over safety concerns, rosuvastatin finally won US FDA approval in
    > August and was launched last month, winning a 2% market share after
    > only three weeks.
    > McKillop has pledged to do whatever it takes to persuade doctors to
    > prescrib rosuvastatin, including launching an estimated $1 billion
    > first-year promotional
    > campaign. "We've got to drive the momentum",
    > he said at a recent investors meeting. "You get one shot at launching
    > a major new product. This is our shot."
    > The sales strategy for rosuvastatin is based around the Galaxy
    > programme. Galaxy is the contrived umbrella name for at least 16
    > clinical trials of wideranging
    > quality designed to investigate the efficacy of rosuvastatin in
    > various clinical settings. The trials within Galaxy have names to
    > match the company's cosmic intentions?Mercury, Stellar, Orbital,
    > Asteroid, Meteor, Jupiter, etc. With no clinical endpoint trial yet
    > completed, the company has chosen to market rosuvastatin by applying
    > adventurous statistics to an overinterpreted syllogism. The argument
    > is
    > familiar and seems compelling. First premise:
    > atherogenic lipid profiles cause atherosclerosis. Second premise:
    > atherosclerosis causes cardiovascular disease.
    >
    > Conclusion: reversing atherogenic lipid profiles will reduce the risk
    > of heart disease. But AstraZeneca has
    > proceeded to push Galaxy into the realms of
    > astrological rather than astronomical logic.
    > Take one example. Stellar was a six-week, open label dose comparison
    > in 2268 patients with primary hypercholesterolaemia. Results were
    > recently reported in Current Medical Research and Opinions (2003; 19:
    > P1?P10). Rosuvastatin was compared with atorvastatin, simvastatin, and
    > pravastatin. AstraZeneca's drug was, dose for dose, more effective at
    > achieving national
    > guideline targets for lipid concentrations than its competitors. Based
    > on these tentative surrogate findings, one Stellar investigator, Peter
    > Jones, commented that, "If I have the option of achieving
    > goals at a lower comparable dose, I would choose that". This kind of
    > gloss does little to foster sensible, let alone critical, appraisal of
    > weak data. Similar twists in the statistical wind were reported
    > in a promotional supplement to the American Journal of Cardiology in
    > March this year by James Blasetto and colleagues. Blasetto, who works
    > for AstraZeneca in Wilmington, Delaware, combined soft end-point
    > data from five small 12-week trials to conclude with astonishing
    > certainty that rosuvastatin "can be of considerable value". It is
    > difficult to understand how
    > such blatant marketing dressed up as research can appear under the
    > name of a respected peer-reviewed
    > medical journal.
    > Why does the quality of debate about statins matter?
    >
    > First, because safety cannot be assured. Bayer withdrew cerivastatin
    > in August, 2001, after the occurrence of unexpected cases of fatal
    > rhabdomyolysis.
    > The 80 mg dose of rosuvastatin was withdrawn
    > by AstraZeneca because of safety concerns. Some critics are even
    > anxious about the 40 mg dose. The finding of proteinuria and
    > microscopic haematuria
    > associated with rosuvastatin use are additional worries.
    > Second, talking up the efficacy of statins subverts efforts to conduct
    > large-scale outcome trials where they matter most?eg, in heart
    > failure. And third, given the beneficial results of mortality
    > end-point trials for other statins, what possible clinical
    > justification can there be for licensing an unproven statin?
    > Since there are no reliable data about efficacy and safety?and
    > AstraZeneca is facing unusually acute commercial pressure to force
    > rosuvastatin into the
    > market?doctors should pause before prescribing this drug. Physicians
    > must tell their patients the truth about rosuvastatin?that, compared
    > with its competitors, rosuvastatin has an inferior evidence
    > base supporting its safe use. AstraZeneca has pushed its marketing
    > machine too hard and too fast. It is time for McKillop to desist from
    > this unprincipled campaign.
    >
    > The Lancet
    > The statin wars: why AstraZeneca must retreat
    > THE LANCET
    > Volume 362, Number 9393
     
  3. mfg

    mfg Guest

    [email protected] (mfg) wrote in message:

    "what measures exist to protect patients from inadequately
    investigated medicines." from story...

    You don't really have a choice Brad if they're all going to slam you
    into the boards sooner or later. But of course statins lower your
    cholesterol. They do other things as well and that's where the problem
    lies. More effective in lowering cholesterol? Well expect more
    effective in causing side effects too. And as for the FDA. Hmmm.
    Didn't Baycol get that stamp of approval too?


    [email protected] (Brad Sheppard) wrote in message news:<[email protected]>...
    > Crestor is more effective and at lower doses - I switched to 5 mg
    > crestor from 10 mg lipitor and improved. It's about choice. FDA
    > approved, good enough for me.
    >

    [email protected] (mfg) wrote in message news:<[email protected]>...
    > > $1 Billion promo campaign to launch undertested, unproven drug.
    > >
    > > THE LANCET
    > > Volume 362, Number 9393
    > >
    > > Tom McKillop is chief executive of AstraZeneca. He is widely respected
    > > across the drug industry. The UK's
    > > Academy of Medical Sciences elected him to its Fellowship in 2002, the
    > > same year that he received a knighthood. Yet this glittering arc of
    > > success is now
    > > cast into shadow. For AstraZeneca's tactics in marketing its
    > > cholesterol-lowering drug, rosuvastatin,raise disturbing questions
    > > about how drugs enter clinical practice and what measures exist to
    > > protect
    > > patients from inadequately investigated medicines.
    > > The statin market is vast. Pfizer's atorvastatin?the world's
    > > best-selling drug?had sales in 2002 of US$ 8 billion. AstraZeneca
    > > predicts that it can take a
    > > 20% share of this global market. It needs to. The company reported a
    > > 17% drop in pre-tax profits in the second quarter of this year. After
    > > a damaging delay
    > > over safety concerns, rosuvastatin finally won US FDA approval in
    > > August and was launched last month, winning a 2% market share after
    > > only three weeks.
    > > McKillop has pledged to do whatever it takes to persuade doctors to
    > > prescrib rosuvastatin, including launching an estimated $1 billion
    > > first-year promotional
    > > campaign. "We've got to drive the momentum",
    > > he said at a recent investors meeting. "You get one shot at launching
    > > a major new product. This is our shot."
    > > The sales strategy for rosuvastatin is based around the Galaxy
    > > programme. Galaxy is the contrived umbrella name for at least 16
    > > clinical trials of wideranging
    > > quality designed to investigate the efficacy of rosuvastatin in
    > > various clinical settings. The trials within Galaxy have names to
    > > match the company's cosmic intentions?Mercury, Stellar, Orbital,
    > > Asteroid, Meteor, Jupiter, etc. With no clinical endpoint trial yet
    > > completed, the company has chosen to market rosuvastatin by applying
    > > adventurous statistics to an overinterpreted syllogism. The argument
    > > is
    > > familiar and seems compelling. First premise:
    > > atherogenic lipid profiles cause atherosclerosis. Second premise:
    > > atherosclerosis causes cardiovascular disease.
    > >
    > > Conclusion: reversing atherogenic lipid profiles will reduce the risk
    > > of heart disease. But AstraZeneca has
    > > proceeded to push Galaxy into the realms of
    > > astrological rather than astronomical logic.
    > > Take one example. Stellar was a six-week, open label dose comparison
    > > in 2268 patients with primary hypercholesterolaemia. Results were
    > > recently reported in Current Medical Research and Opinions (2003; 19:
    > > P1?P10). Rosuvastatin was compared with atorvastatin, simvastatin, and
    > > pravastatin. AstraZeneca's drug was, dose for dose, more effective at
    > > achieving national
    > > guideline targets for lipid concentrations than its competitors. Based
    > > on these tentative surrogate findings, one Stellar investigator, Peter
    > > Jones, commented that, "If I have the option of achieving
    > > goals at a lower comparable dose, I would choose that". This kind of
    > > gloss does little to foster sensible, let alone critical, appraisal of
    > > weak data. Similar twists in the statistical wind were reported
    > > in a promotional supplement to the American Journal of Cardiology in
    > > March this year by James Blasetto and colleagues. Blasetto, who works
    > > for AstraZeneca in Wilmington, Delaware, combined soft end-point
    > > data from five small 12-week trials to conclude with astonishing
    > > certainty that rosuvastatin "can be of considerable value". It is
    > > difficult to understand how
    > > such blatant marketing dressed up as research can appear under the
    > > name of a respected peer-reviewed
    > > medical journal.
    > > Why does the quality of debate about statins matter?
    > >
    > > First, because safety cannot be assured. Bayer withdrew cerivastatin
    > > in August, 2001, after the occurrence of unexpected cases of fatal
    > > rhabdomyolysis.
    > > The 80 mg dose of rosuvastatin was withdrawn
    > > by AstraZeneca because of safety concerns. Some critics are even
    > > anxious about the 40 mg dose. The finding of proteinuria and
    > > microscopic haematuria
    > > associated with rosuvastatin use are additional worries.
    > > Second, talking up the efficacy of statins subverts efforts to conduct
    > > large-scale outcome trials where they matter most?eg, in heart
    > > failure. And third, given the beneficial results of mortality
    > > end-point trials for other statins, what possible clinical
    > > justification can there be for licensing an unproven statin?
    > > Since there are no reliable data about efficacy and safety?and
    > > AstraZeneca is facing unusually acute commercial pressure to force
    > > rosuvastatin into the
    > > market?doctors should pause before prescribing this drug. Physicians
    > > must tell their patients the truth about rosuvastatin?that, compared
    > > with its competitors, rosuvastatin has an inferior evidence
    > > base supporting its safe use. AstraZeneca has pushed its marketing
    > > machine too hard and too fast. It is time for McKillop to desist from
    > > this unprincipled campaign.
    > >
    > > The Lancet
    > > The statin wars: why AstraZeneca must retreat
    > > THE LANCET
    > > Volume 362, Number 9393
     
  4. Good point generally about "more effective, more side effects." Also
    good point about being relativily untested. Frankly, if I was taking
    more than 5 mg I'd be concerned. This news group, esp when discussing
    statins, overplays side effects and ignores benefits. It appears not
    only may statins prevent CHD, they may also prevent Alzheimers via
    lowering inflammation.

    [email protected] (mfg) wrote in message news:<[email protected]>...
    > [email protected] (mfg) wrote in message:
    >
    > "what measures exist to protect patients from inadequately
    > investigated medicines." from story...
    >
    > You don't really have a choice Brad if they're all going to slam you
    > into the boards sooner or later. But of course statins lower your
    > cholesterol. They do other things as well and that's where the problem
    > lies. More effective in lowering cholesterol? Well expect more
    > effective in causing side effects too. And as for the FDA. Hmmm.
    > Didn't Baycol get that stamp of approval too?
    >
    >
    > [email protected] (Brad Sheppard) wrote in message news:<[email protected]>...
    > > Crestor is more effective and at lower doses - I switched to 5 mg
    > > crestor from 10 mg lipitor and improved. It's about choice. FDA
    > > approved, good enough for me.
    > >

    > [email protected] (mfg) wrote in message news:<[email protected]>...
    > > > $1 Billion promo campaign to launch undertested, unproven drug.
    > > >
    > > > THE LANCET
    > > > Volume 362, Number 9393
    > > >
    > > > Tom McKillop is chief executive of AstraZeneca. He is widely respected
    > > > across the drug industry. The UK's
    > > > Academy of Medical Sciences elected him to its Fellowship in 2002, the
    > > > same year that he received a knighthood. Yet this glittering arc of
    > > > success is now
    > > > cast into shadow. For AstraZeneca's tactics in marketing its
    > > > cholesterol-lowering drug, rosuvastatin,raise disturbing questions
    > > > about how drugs enter clinical practice and what measures exist to
    > > > protect
    > > > patients from inadequately investigated medicines.
    > > > The statin market is vast. Pfizer's atorvastatin?the world's
    > > > best-selling drug?had sales in 2002 of US$ 8 billion. AstraZeneca
    > > > predicts that it can take a
    > > > 20% share of this global market. It needs to. The company reported a
    > > > 17% drop in pre-tax profits in the second quarter of this year. After
    > > > a damaging delay
    > > > over safety concerns, rosuvastatin finally won US FDA approval in
    > > > August and was launched last month, winning a 2% market share after
    > > > only three weeks.
    > > > McKillop has pledged to do whatever it takes to persuade doctors to
    > > > prescrib rosuvastatin, including launching an estimated $1 billion
    > > > first-year promotional
    > > > campaign. "We've got to drive the momentum",
    > > > he said at a recent investors meeting. "You get one shot at launching
    > > > a major new product. This is our shot."
    > > > The sales strategy for rosuvastatin is based around the Galaxy
    > > > programme. Galaxy is the contrived umbrella name for at least 16
    > > > clinical trials of wideranging
    > > > quality designed to investigate the efficacy of rosuvastatin in
    > > > various clinical settings. The trials within Galaxy have names to
    > > > match the company's cosmic intentions?Mercury, Stellar, Orbital,
    > > > Asteroid, Meteor, Jupiter, etc. With no clinical endpoint trial yet
    > > > completed, the company has chosen to market rosuvastatin by applying
    > > > adventurous statistics to an overinterpreted syllogism. The argument
    > > > is
    > > > familiar and seems compelling. First premise:
    > > > atherogenic lipid profiles cause atherosclerosis. Second premise:
    > > > atherosclerosis causes cardiovascular disease.
    > > >
    > > > Conclusion: reversing atherogenic lipid profiles will reduce the risk
    > > > of heart disease. But AstraZeneca has
    > > > proceeded to push Galaxy into the realms of
    > > > astrological rather than astronomical logic.
    > > > Take one example. Stellar was a six-week, open label dose comparison
    > > > in 2268 patients with primary hypercholesterolaemia. Results were
    > > > recently reported in Current Medical Research and Opinions (2003; 19:
    > > > P1?P10). Rosuvastatin was compared with atorvastatin, simvastatin, and
    > > > pravastatin. AstraZeneca's drug was, dose for dose, more effective at
    > > > achieving national
    > > > guideline targets for lipid concentrations than its competitors. Based
    > > > on these tentative surrogate findings, one Stellar investigator, Peter
    > > > Jones, commented that, "If I have the option of achieving
    > > > goals at a lower comparable dose, I would choose that". This kind of
    > > > gloss does little to foster sensible, let alone critical, appraisal of
    > > > weak data. Similar twists in the statistical wind were reported
    > > > in a promotional supplement to the American Journal of Cardiology in
    > > > March this year by James Blasetto and colleagues. Blasetto, who works
    > > > for AstraZeneca in Wilmington, Delaware, combined soft end-point
    > > > data from five small 12-week trials to conclude with astonishing
    > > > certainty that rosuvastatin "can be of considerable value". It is
    > > > difficult to understand how
    > > > such blatant marketing dressed up as research can appear under the
    > > > name of a respected peer-reviewed
    > > > medical journal.
    > > > Why does the quality of debate about statins matter?
    > > >
    > > > First, because safety cannot be assured. Bayer withdrew cerivastatin
    > > > in August, 2001, after the occurrence of unexpected cases of fatal
    > > > rhabdomyolysis.
    > > > The 80 mg dose of rosuvastatin was withdrawn
    > > > by AstraZeneca because of safety concerns. Some critics are even
    > > > anxious about the 40 mg dose. The finding of proteinuria and
    > > > microscopic haematuria
    > > > associated with rosuvastatin use are additional worries.
    > > > Second, talking up the efficacy of statins subverts efforts to conduct
    > > > large-scale outcome trials where they matter most?eg, in heart
    > > > failure. And third, given the beneficial results of mortality
    > > > end-point trials for other statins, what possible clinical
    > > > justification can there be for licensing an unproven statin?
    > > > Since there are no reliable data about efficacy and safety?and
    > > > AstraZeneca is facing unusually acute commercial pressure to force
    > > > rosuvastatin into the
    > > > market?doctors should pause before prescribing this drug. Physicians
    > > > must tell their patients the truth about rosuvastatin?that, compared
    > > > with its competitors, rosuvastatin has an inferior evidence
    > > > base supporting its safe use. AstraZeneca has pushed its marketing
    > > > machine too hard and too fast. It is time for McKillop to desist from
    > > > this unprincipled campaign.
    > > >
    > > > The Lancet
    > > > The statin wars: why AstraZeneca must retreat
    > > > THE LANCET
    > > > Volume 362, Number 9393
     
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