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Advertising Passed Off As Research: Drug company researchers must be held accountable like stockbrokers and bankers, for their deceit and damage to public health.

This week the front page headlines worldwide announced a simple test called "highly sensitive C-reactive protein" (HS-CRP) and the most powerful cholesterol-lowering statin currently on the market, Crestor (rosuvastatin), used together, could cut the risk of heart attacks, strokes, and death from cardiovascular disease in half.1 For the casual reader, Crestor appears to be a miracle treatment with few risks and reasonable costs.  The publication adds to the belief of a growing number of experts that "statins are so wonderful that they should be added to our drinking water" (like fluoride).

For this study nearly 90,000 people were examined, and most of them were identified as being at increased risk for a heart attack, stroke, and/or premature death. Rather than choosing professionalism and treating the underlying causes of their health problems (their diet and lifestyle) these researchers chose commercialism, creating the most effective pharmaceutical advertising campaign ever devised.  And they have succeeded.

The study was funded by the maker of the drug, AstraZeneca, and the lead author, Paul M Ridker MD, is listed as a co-inventor on patents held by Brigham and Women's Hospital related to the use of HS-CRP for the evaluation of a patient’s risk of heart disease.

Corporate Profits Are Determining Your Medical Care

The cost of Crestor (rosuvastatin) is about $3.45 per day—much higher than that of generic statins. That amounts to $1259 a year just for this drug. Doing the math, this means to prevent one event in one "apparently healthy patient" would cost about $300,000 just for the Crestor. These figures do not include the cost of doctors’ visits, the lab tests and the treatment of side effects from the medications, including the serious adverse events caused by Crestor.(Calculations: Absolute benefit of 1 event for 120 treated patients for 1.9 years at $1259 = 120 x 1.9 x $1259 = $287,052.)

Heart attacks, strokes, and the need for surgery and drugs are caused primarily by eating the Western diet, and secondarily by "bad habits," including cigarette smoking and lack of exercise.  The underlying disease, atherosclerosis, is reversible.  There are no side effects or added costs with diet-therapy—therein lies the problem (no profit).

How Did They Get Those Results?

1) They stacked the deck with sick people, but passed them off as "healthy" to the press and public.

Previous studies of statins have found that people at high risk for a heart attack or stroke will benefit, but healthy people will not.2 The deception in this study began by choosing high-risk test subjects and identifying them as "apparently healthy men and women."

The nearly 18,000 people selected for the study out of the original 89,890 screened had very high HS-CRP levels of over 4.2 mg/L.  Simply based on the HS-CRP these were not "apparently healthy," but rather, people at high risk for cardiovascular disease. The cutoff value for high "bad" LDL-cholesterol level was 130 mg/dL. This allowed the inclusion of many high-risk people—"good health" is associated with a LDL below 100 mg/dL. In addition, the average blood pressure (134/80 mmHg) and total cholesterol (186 mg/dL) numbers were too high for these people to be considered "apparently healthy."

The baseline median body mass index (BMI) was 28.3 (normal 18.5-24.9), indicating most of these people were overweight or obese. At the beginning of the study 41% were reported to have "metabolic syndrome." (Metabolic syndrome is a combination of medical disorders, such as abdominal obesity, elevated blood sugar, triglycerides, and blood pressure, which considered together indicate an increased risk of cardiovascular disease.)

2) They Emphasized Relative, Not Absolute Benefits

Reporting the "relative benefit" of a drug is the most common method used by drug companies to deceive patients and their doctors. In this case relative risk reduction was determined by dividing the number of designated events (heart attacks, stroke, and deaths from cardiovascular disease) for the treated (Crestor) group by the events for the placebo group: 83 vs. 157. This mean the treated group had half (53%) the chance of an event compared to placebo.  This figure is impressive.

However, the "absolute benefit"—the real life benefit a person can expect from treatment—is a very different story. Consider the numbers: nearly 18,000 people were treated for almost 2 years.  In absolute numbers this means 83/8901 or 0.9% of those people taking Crestor had a serious event, as opposed to 157/8901 or 1.8% of those in the placebo group. This is an absolute event reduction of less than 1%.  In other words, 120 patients had to be treated with Crestor for 1.9 years to prevent one designated event: heart attacks, strokes, and death from cardiovascular disease.

3) Early Termination of the Study Is Impressive but Suggests Dishonesty.

The study was supposed to go on for 4 years, but was stopped at 1.9 years for "ethical reasons." It was considered unethical to continue the study because continuation would mean depriving the people in the placebo group of the advantage of the treatment—Crestor in this case. "Early termination" of research is a powerful technique used by pharmaceutical companies to enhance the perceived value of the treatment in the minds of the medical profession, the press, and the public. But it has been shown that studies that are stopped early are biased and prone to exaggeration.3 According to a recent review in the Journal of the American Medical Association, "RCTs (Randomized Controlled Trials) stopped early for benefit are becoming more common, often fail to adequately report relevant information about the decision to stop early, and show implausibly large treatment effects, particularly when the number of events is small. These findings suggest clinicians should view the results of such trials with skepticism."4

No mention was made in this report about two other recent studies (CORONA and GISSI-HF) where Crestor did not result in any improvement in survival.5,6

4) Researchers Underemphasized Serious Adverse Events from Crestor

One of the most important findings from this study (found in table 4) is the similar number of serious adverse events in both the Crestor-treated and placebo groups—1352 (15.2%) vs. 1377 (15.5%).  How can that be? Wasn’t the number of events about half (83 vs. 157) for those taking Crestor? The study focused on events (heart attacks, strokes, and deaths from cardiovascular disease) that are expected to respond favorably to treatment.  The study, and the media that followed, did not give appropriate attention to all adverse events that occurred. Clearly, there was an increase in non-cardiac serious adverse events in the Crestor group.  Obviously, it is not in the best interest of the sponsor of the study to give attention to this finding.

The article did mention an increase in risk of diabetes in those treated with Crestor (270 reports of diabetes, vs. 216 in the placebo group). But there must be more. Amazingly, this study reported only one case of serious muscle damage (rhabdomyolysis).  The expected rate is 3.16 fatal cases per million prescriptions written for Crestor.7  This is 16 to 80 times higher than that reported for other statins. Almost four years ago Dr. David Graham, FDA's associate director for science and medicine, named Crestor as one of five drugs that pose serious safety concerns and the FDA told AstraZeneca to pull its ads for Crestor because they do not mention its risks of causing acute kidney failure or rhabdomyolysis.

There is no long-term information on the safety of using these high doses of Crestor to lower "bad" LDL-cholesterol to 55 mg/dL (as they did in this study).  This study was stopped after less than 2 years, but patients prescribed statins can expect to take them for 20 years and longer.

One More Deregulated System That Must Be Fixed

Neither the patient nor our over-burdened health care system can thrive with this kind of deception from the pharmaceutical companies and the medical journals.  Fortunately, health care professionals are beginning to recognize that what is happening in medical care is just like the tragedies we have recently witnessed in the stock market and the housing industries.  Unregulated business practices lead to a few very rich people becoming even richer, and severe suffering for the rest of us.  The time has come for change.  Researchers and publishers must be held accountable like stockbrokers and bankers.  Regulation enacted to protect the public is long overdue.

What is HS-CRP?

C-reactive protein (CRP) is a molecule produced in response to inflammation. It is non-specific, in other words, it does not identify the source of the inflammation, which could be due to an infection of a toe, arthritis, or a bad cold.  The connection to cardiovascular disease (heart attacks and strokes) is that the sores (like pustules) on the artery walls cause the CRP to rise.  This festering artery disease (atherosclerosis) is the underlying cause of heart attacks and strokes.  The elevated CRP is simply one sign of the trouble—other signs are elevated blood pressure, blood sugar, cholesterol and triglycerides.

Highly sensitive (HS) refers to laboratory methodology used to increase accuracy. A level of less than 1mg/L indicates low risk, a level between 1 and 3mg/L indicates moderate risk, and a level greater than 3mg/L indicates high risk of active artery disease. The people in this study were on average in the high-risk group, in need of immediate and intensive dietary intervention.

Statins, like Crestor, are believed to be anti-inflammatory, reducing HS-CRP levels.  Even without the postulated benefit of reduced inflammation, the cholesterol lowering effects of statins have been shown to reduce the risk of serious cardiovascular events in people at high risk.2 A low-fat diet also cuts CRP in half in 4 weeks.8  This reflects less inflammation, which means healing the arteries as a result of following a healthier diet.

References:

  1. Ridker,P Danielson, E Fonseca F, Genest J, Gotto A, Kastelein J, Koenig W, Libby P, Lorenzatti A, MacFadyen J, Nordestgaard B, Shepherd J, Willerson J, Glynn R, the JUPITER Study Group. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. N Engl J Med. 2008; 359:2195-2207
  1. Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet. 2007 Jan 20;369(9557):168-9.
  1. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, et al. PLoS Medicine Vol. 5, No. 1, e20 doi:10.1371/journal.pmed.0050020
  1. Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, Lacchetti C, Leung TW, Darling E, Bryant DM, Bucher HC, Schünemann HJ, Meade MO, Cook DJ, Erwin PJ, Sood A, Sood R, Lo B, Thompson CA, Zhou Q, Mills E, Guyatt GH. Randomized trials stopped early for benefit: a systematic review. JAMA. 2005 Nov 2;294(17):2203-9.
  1. Kjekshus J, Apetrei E, Barrios V, Böhm M, Cleland JG, Cornel JH, Dunselman P, Fonseca C, Goudev A, Grande P, Gullestad L, Hjalmarson A, Hradec J, Jánosi A, Kamensk? G, Komajda M, Korewicki J, Kuusi T, Mach F, Mareev V, McMurray JJ, Ranjith N, Schaufelberger M, Vanhaecke J, van Veldhuisen DJ, Waagstein F, Wedel H, Wikstrand J; CORONA Group. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007 Nov 29;357(22):2248-61.
  1. Gissi-Hf Investigators.  Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Aug 29.
  1. Bruce J, Rabkin E., Martin V.  Rhabdomyolysis associated with current us of simvastatin and Nefazodone: Case report and current review of the literature.  Advanced Studies in Medicine 2003; 3: 168-172.
  1. Rankin JW, Turpyn AD. Low carbohydrate, high fat diet increases C-reactive protein during weight loss. J Am Coll Nutr. 2007 Apr;26(2):163-9.

Article by John McDougall MD

Originally posted to Yo yo yo on Fri Nov 14, 2008 at 06:57 AM PST.

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Comment Preferences

  •  After the Vytorin fiasco (12+ / 0-)

    (I took it for a few months)I'm sceptical of miracle drugs like this. Exercising is way cheaper.

    Let tyrants fear.-Queen Elizabeth I

    by Virginia mom on Fri Nov 14, 2008 at 06:59:32 AM PST

  •  Tips for exposing Big Pharma for what it is... (10+ / 0-)

    One big Corporate money grubbing DRUG DEALER, who could care less about actually helping people...Look up, they're posioning you everyday.

    "The entire American standard of living is artificially high right now, resting on the ability of Americans to borrow money from foreigners."

    by ChemicalsInTheSky on Fri Nov 14, 2008 at 07:02:52 AM PST

  •  everytime i go see my doctor, which isn't (8+ / 0-)

    often... she looks at my chart and says "what meds can i put you on" and i'm like, none thank you... she is a pill pusher i think. it is a big practice with lots of docs and it's funny every time i've been there, just as many pharma reps as patients! i know that's how business is done for them, but geez.

    Barack Obama... More Cowbell

    by titotitotito on Fri Nov 14, 2008 at 07:07:36 AM PST

    •  Get a new doctor!!!!! (10+ / 0-)

      Seriously - get a new doctor, there's no reason for that crap.

      I went from a doctor who couldn't give a *%!^ about my health to a doctor who actively engages me and challenges me about my health - and he does not push anything that isn't needed.  You can find one, too!

      "You only live once. Let's keep trucking. If we don't do that, who's going to do it for us? We have to be happy. Why hate?" - Anthony Acevedo, WWII veteran

      by Black Leather Rain on Fri Nov 14, 2008 at 07:12:02 AM PST

      [ Parent ]

    •  Exactly why (11+ / 0-)

      I stopped seeing doctors 10 years ago.  Even when I went to the dentist last, he asked me what meds I was on (seems reasonable and responsible) but he all but called me a liar when I told him none.  In his opinion, no one of my mid to late 60's could not possibly be free of chemical pharmaceuticals.   Apparently people of my age group average 7 to 10 different meds.  Geeze!  We are killing of our elders by poisoning them with chemicals, many of which should not be taken together and most of them with no actual reliable testing as to their safety.

      As long as Big Pharma rakes in the BIG BUCKS. . .that seems to be the criteria.

      I couldn't afford it even if their crap actually worked.

      *the blogger formerly known as shirlstars

      by Shirl In Idaho on Fri Nov 14, 2008 at 07:17:00 AM PST

      [ Parent ]

      •  Lazy and/or overtaxed and/or underinformed (3+ / 0-)

        doctors plague our medical care system. There's various factors why they resort to writing rx's and getting you out of their office ASAP instead of providing actual care. This is why we need patients to advocate for themselves, and why we need heath care reform and universal health insurance, so ppeople aren't stuck with ineffective doctors simply because they can't afford to seek out a better one.

        I've been down the "here's a pill for your woes" road. Five years ago, I developed arrhythmia, angina, tachycardia and borderline hypertension. I don't have health insurance, so I could only afford the walk-in clinic. They did what they could, within  my budget, include rx'd me a beta blocker. Seeing it was just a walk-in clinic, the doctor could not properly diagnosis my condition (but she was condescending enough to suggest it was just "in my head").

        I was on my own to educate myself about what I could do to prevent my symptoms progressing, Thankfully, I have succeeded to reverse all the symptoms via diet, exercise and other lifestyle changes (although I do have occasional edema in my ankles which I didn't have prior to the onset of those other symptoms). But the doctor I saw offered no advice in this regards whatsoever. It does make one fee like it's pointless to see a doctor, especially when you have to pay out of pocket.

        "Your world's no wider than your hatred of his" - Elliott Smith

        by croyal on Fri Nov 14, 2008 at 07:52:00 AM PST

        [ Parent ]

        •  Thank goodness for the Internet. . . (2+ / 0-)
          Recommended by:
          blueocean, Yo yo yo

          I have done and do plenty of research on my own of things that are or could potentially be of concern to me.  I happen to be interested in the "natural" ways and means of taking care of health issues.  I find lots of information and make my own decisions about diet, and supplements I might choose to include in my health regime.

          Ten years ago I was taking heart meds, blood pressure meds, arthritis meds. . .etc. etc.  First because I could no longer afford these things, I began my research, second, I just one day threw them all out and was amazed that within days I felt better than I had in years.  My health has improved markedly.  I never felt healthier and happier than I do right now.

          Informed common sense has done more for me than anything I can think of.  I have no desire for extending my life indefinitely if I must give up my quality of life and focus on being ill and in declining health.

          I have chosen to really live each day and enjoy it for what it brings me rather than live in worry and fear about "what if?" and "When that day comes."  As far as I know, we are all going to leave this planet one day.  Meantime I intend to LIVE my life joyfully and appreciate whatever time I may have.  Be it long or short, I'm here to do the best I can and enjoy it.

          *the blogger formerly known as shirlstars

          by Shirl In Idaho on Fri Nov 14, 2008 at 08:55:17 AM PST

          [ Parent ]

      •  Doctor-free for 25 years . . . (1+ / 0-)
        Recommended by:
        Yo yo yo

        . . . since escaping my parents' custody.  As a kid, I was seriously overmedicated for allergies.  I have a dim view of the medical profession and a dimmer view of the pharmaceutical companies they pimp for.  

        We (meaning multicellular lifeforms in general) have spent almost a billion years evolving and fine-tuning our chemical defenses.  Why screw them up by adding something that doesn't belong?  Eat right and exercise.  It's a lot more sensible (and a lot cheaper) than trusting your health to big pharma.  

    •  Adderall and xanax make my day niiiiiiiice n/t (1+ / 0-)
      Recommended by:
      Katie71

      "...the fundamentals of our economy are strong"- John Sidney McCain 09/15/08

      by Shhs on Fri Nov 14, 2008 at 07:24:26 AM PST

      [ Parent ]

  •  High levels of CRP mean you have inflammation in (10+ / 0-)

    ... the body somewhere, it can be caused by many things.

    Such as gum disease from not getting one's teeth cleaned regularly and not flossing.

    Remember how many people cannot afford dental care now.

    Scam is perhaps too mild a term.

    "Toads of Glory, slugs of joy... as he trotted down the path before a dragon ate him"-Alex Hall/ Stop McClintock

    by AmericanRiverCanyon on Fri Nov 14, 2008 at 07:10:12 AM PST

    •  Dental health and cardiovascular health (5+ / 0-)

      are closely linked. Bacteria present in the mouth (and the human mouth has some nasty ones, like staph bacteria) can migrate into the blood stream via ulcerations and bleeding gums. The staph then can inflect blood vessel walls, causing inflammation there, which is a critical factor in heart disease

      There's a lot of stats that show a strong correlation between poor dental health and heart disease.

      But yes, the current CRP test is indiscriminate and DOES NOT indicate the inflammation is due specifically to heart disease, only inflammation somewhere. People recently inflected with the flu, or having an allergic reaction, for example, would likely test high for CRP even if they had no heart disease.

      "Your world's no wider than your hatred of his" - Elliott Smith

      by croyal on Fri Nov 14, 2008 at 07:38:23 AM PST

      [ Parent ]

    •  Exactly, (5+ / 0-)

      ...and inflammation can be treated in different ways. First, find the cause of the inflammation and see if it can be cured. If not, there are alternatives. I'll give you my story. I see things differently now.

      I have hay fever. I has gotten worse every year since I've moved south. One particularly bad hay fever spring I also caught a cold from my son. I went to my doctor so stuffed up and inflamed from my neck up, he just shook his head and said rarely has he seen someone this bad. I told him I was the poster child for side effects with the hay fever nasal sprays. He urged me to take one that was noted for no side effects. I agreed. A few days after I started taking it (I know it takes a week or two to start to work well) my ears were so plugged from the cold and hay fever that I started to loose the hearing in both my ears. (I did not have an ear infection, but every tissue was red and raw).

      My husband came home to find me crying about how I might loose my hearing before this whole thing blew over. He is a big natural health guy and immediately started looking up natural anti-inflammatories, went out and bought 4 different things and told me to take each one 3 times a day. I was sceptical. He bought Grape seed extract, Quercetin (king of the bioflavonoids), Turmeric, and fish oil. All four are really powerful ant-inflammatories (and yet natural, any health food store sells them).
      In two days my ears were normal. I was shocked. I went from this thing spinning out of control, getting worse by the day, to total arrested symptoms two days later. All my swollen tissues were practically normal.

      Ever since that horrible episode, every time I get a cold I feel my inner ears throb. Only one other time did it start to affect them to the point that I pulled out these anti-inflammatories. Again, total reversal of any ear problems.

      So... to put the entire population on a prescription drug to treat inflammation is bizarre, and dangerous. Crestor was one of the drugs cited as unsafe due to its high incidence of muscle problems (as you cite above).

      Truth is harmonious, lies are discordant.

      by Babsnc on Fri Nov 14, 2008 at 08:11:44 AM PST

      [ Parent ]

  •  My husband is taking an (2+ / 0-)
    Recommended by:
    MsWings, Pris from LA

    immunosuppresant that cost almost $900 before insurance paid their share.  We still ended up paying $350 for one month.

    Knowledge is a deadly friend, if no one sets the rules, The fate of all mankind, I see, is in the hands of fools....

    by minerva1157 on Fri Nov 14, 2008 at 07:13:18 AM PST

  •  Drug Companies (7+ / 0-)

    Are in my revenge trifecta fantasy.  (with oil companies and banks)

  •  Can't rec this diary (7+ / 0-)

    Although it's nice to see JUPITER make DKos.

    The data presented here is very antagonistic to the trial. I've got the paper here on my desk, and I was at AHA and was in the audience when Dr Ridker gave the plenary presentation on the trial.

    The applicants were fairly screened, there was sufficient placebo run-through, AZ had no access to the trial or data until completion. This was an ethical study. The patients selected were chosen on the basis of having elevated C-reactive protein, because patients at zero risk would have been unlikely to show any benefits.

    The hypothesis here was not to encourage more people to take Crestor, rather, it was to see if people at risk for developing atherothrombosis would positively respond to lowered LDL-C and CRP. They did.

    The number needed to treat across 5 years was determined to be 25. This is, from an epidemiological standpoint, pretty damned good. Ridker estimates that if all persons at risk for CVD adopted the study strategy, some 250,000 deaths could be prevented.

    The cost of Crestor is a red herring here. It was chosen because the active ingredient, rosuvastatin, is the most powerful statin available in monotherapy. Ridker was asked in the Q&A followup to his presentation if other statins would be equally effective and he said that they very likely would be. As for implications, Ridker said that the conclusion of the research team was that anti-inflammatory drugs should be the target of new research.

    There is no promotion of statins in the conclusion section of the paper. Only anti-inflammatory agents are identified as next-steps for study. Until the mechanism of action is understood, and it currently isn't, Ridker suggests that patients and physicians take no action and make no decisions based on the JUPITER results. This is encouraging news and we learned something.

    Turning this into pharma-bashing is not helpful. Government and academic grants are drying up. Pharmaceutical companies are often the only source of funding for basic research and unrestricted grants like the one that funded JUPITER are tremendously important for the pursuit of novel research and therapies. When they mess up, call them on it. Here, you could argue, we see pretty much a model of what should happen in this field.

    Every day's another chance to stick it to The Man. - dls.

    by The Raven on Fri Nov 14, 2008 at 07:18:32 AM PST

    •  Thanks for clarifying information. n/t (3+ / 0-)

      "When fascism comes to America it will be wrapped in a flag and carrying a cross." Sinclair Lewis

      by MsWings on Fri Nov 14, 2008 at 07:32:03 AM PST

      [ Parent ]

    •  baloney (3+ / 0-)

      Thanks for promoting Dr. Ridker's position (and yes, as the guy doing the study and personally benefiting financially from it's findings, that's a HUGE conflict of interest...)

      As you may know, this study is being touted in the press by Crestor as:

      "Crestory cuts heart attacks, strokes in HEALTHY people"

      And here you are admitting that they selected sick people, not healthy people. They are targeting healthy people with a study that only looked at sick people. And you consider this sound, reliable science??

      I wonder why you aren't disgusted by Crestor's false advertising here, but seem okay and want to defend it...

      •  Let's not get into this (1+ / 0-)
        Recommended by:
        dbradhud

        I'm disinclined to fight with a Kossack over industry news. But I'll respond to your comment.

        First, Ridker and his team cannot control what the press reports. The patients selected for JUPITER were healthy, but predisposed to develop CVD, if you buy into the CRP hypothesis. They were screened to rule out any common cause of elevated CRP not related to arterial inflammation.

        When "apparently healthy" was used in the paper, what was meant is that this population would not normally be prescribed a statin because the average LDL-C was under 130 mg/dL. It was the CRP-reducing property of statins that was under investigation.

        The paper discusses the percentage with metabolic syndrome, the BMI index and so forth. This was part of the study methodology. These are the exact people you would expect to develop CVD. It is why they were selected. I don't understand why you think you've latched onto some kind of conspiracy here. Ridker has given full disclosure in the study itself of his affiliations.

        There is no smoking gun here and you are promoting a hysterical reaction to a very well conducted study. This is not helpful to medical science.

        Every day's another chance to stick it to The Man. - dls.

        by The Raven on Fri Nov 14, 2008 at 07:45:27 AM PST

        [ Parent ]

        •  I agree with most of your comments... (3+ / 0-)
          Recommended by:
          The Raven, Old Gardener, dbradhud

             There is however a balance that I think both of you are missing in the study.
             First the study is examining the CRP levels and moving these downward with treatment. It just so happens that the LDL is reduced also. Many believe that high LDL has been the primary cause of heart disease. At least with this study, we recognize that CRP levels are at least as important as LDL's.
             I do have some serious questions on why the trial was stopped early. I note that it has been reported a median time of 1.9 years. Thus some of the trial was considerably less. With the increase in diabetes in the Crestor group of 25% and knowing that diabetes develops slowly, I would like to see the figures on the time in the trial for those that developed diabetes from both groups. If the majority of those that developed it with the Crestor group had 1.9+ years, we may begin to see a trend that needs explaining.
             Also from reading the actual study we see that fatal adverse attacks with the Crestor group was 9 persons. In the placebo group, it was 6. Again, did these deaths occur with trial members who had been on Crestor a longer time period. I have a real concern about lowering a persons LDL to 55. We don't know how our system would react to long-term LDL reduction to that level.

          The human race is truly the highest species on earth. No other species can procreate with the female on top.

          by NC Dem on Fri Nov 14, 2008 at 08:04:13 AM PST

          [ Parent ]

          •  Regarding termination (1+ / 0-)
            Recommended by:
            dbradhud

            I do have some serious questions on why the trial was stopped early. I note that it has been reported a median time of 1.9 years.

            Initially, they wanted to proceed until the primary endpoint was reached in 520 confirmed events. Based on previous studies with similar goals, they were expecting to see an approximate 25% reduction in risk.

            When, after 2 years, they were seeing a 50% reduction [p<.00001], there was no further point to continuing this particular study. Ridker notes that study of very low LDL-C is needed and agrees with you that this is something to be considered.</p>

            I can't find the "fatal adverse attack" figure you cite. In the paper, table 3, it shows that the treatment group experienced fewer deaths than the control group in every single catagory. Here's Ridker on the question of diabetes:

            Although the increase in the rate of physician-reported diabetes in rosuvastatin group could reflect the play of chance, further study is needed before any causative effect can be established or refuted.

            That seems fair because there has never been shown any relationship between statins and diabetes, and statins are the most-studied class of drugs ever developed.

            Every day's another chance to stick it to The Man. - dls.

            by The Raven on Fri Nov 14, 2008 at 08:18:29 AM PST

            [ Parent ]

        •  okay but (2+ / 0-)
          Recommended by:
          Old Gardener, blueocean

          I don't we disagree -- these were not "apparently healthy" people, as the study claimed, unless the definition for that is intended to mean "people with elevated risks of developing heart disease."

          At a minimum, it's highly misleading. But more likely, it's entirely deliberate, since the target for drug sales from this study is "7 million healthy individuals."

          Ridker et al. absolutely CAN impact how the study info is disseminated by how they report their findings which -- let's face it -- are dictated by the study's funder, Crestor. Crestor even reserved the right to bury the study findings if they didn't like them, as is common these days.

          There is a lot of equivalence between Wall Street cozying up with Standard and Poors and Aurthur Anderson to create junk CDOs to rip off people, and the way Big Pharma works to create scenery to sell pills.

          But you seem to be an MD and perhaps you have a busy prescription pad. I just lament that the medical establishment in this country is focused on $$ and not on caring for health. Reading the rest of the posts on this string show the system for what it really is -- nothing to do with prevention. Our "prevention" is $300,000 worth of Crestor and dangerous side effects. That is truly sad.

          •  I'm flattered (1+ / 0-)
            Recommended by:
            dbradhud

            But you seem to be an MD

            I'm not but I appreciate the compliment. Let me leave you with a parting thought, OK?

            In this study, it was found that the group being treated halved its morbidity and mortality. The study speculates that this was due to anti-inflammatory properties of statins, and that we should investigate this further.

            That is it. Anything beyond that is something you are reading into these results. It is good to be critical of the intersection where industry meets medicine. I am on your side in that endeavor. It just happens to be the case, purely by coincidence, that I am familiar with this specific study and the people involved in it. Try as I might, I can't see anything wrong with it at all.

            You know, I was sitting next to a physician researcher as these results were being announced and he mentioned to me that the data involving female mortality "is a missing piece of the puzzle." This was great science because there are so few studies that allow for these kinds of endpoints. It's a landmark trial because it will be the foundation for a large number of subsequent studies.

            Every day's another chance to stick it to The Man. - dls.

            by The Raven on Fri Nov 14, 2008 at 08:27:30 AM PST

            [ Parent ]

            •  my final word then (1+ / 0-)
              Recommended by:
              AmericanRiverCanyon

              I would argue to see Point #2 above. They "havled the morbidity and mortality" in the study, you say -- but that's actually an absolute event reduction of less than 1%.

              I'm reminded of how the food industry tells people how much fat is in their products -- "only 1% fat!" -- labels often read. Then when you look at the fine print, you see that the food is is actually 70% fat by calories. How do they get away with saying it's 99% fat free? Because they measure the fat BY WEIGHT.

              Now never mind that there is no health or nutrition standards anywhere in the world that are based on evaluating foods using percentage of fat by weight. The government doesn't talk about fat by weight, nutritionists don't -- but the food industry does. And by using fat by weight, they can make high fat foods appear to be "99% fat free!" But it's a lie.

              If you want to know what I mean on this, watch this short video from a former Kraft brand manager...

              Saying that they "halved the morbidity and mortality" of study participants isn't really that impressive when you realize they had less than a 1% rate of reduction.

              So I'm not that impressed, as you seem to be, that by spending over $300,000 you might prevent one heart attack. And you seem to overlook the fact that these statins (and Crestor in particular) induce nasty side effects in a lof of people, in a number of studies.

              But here's the money quote from one of the recent articles:

              Some analysts say they believe the findings open Crestor to a large group of new patients, and are predicting a significant sales jump. UBS pharmaceutical analyst Gbola Amusa said in a note Monday that Crestor sales could grow to more than $7 billion in 2012, from $2.7 billion last year.

              And there you go! Shareholders in AstraZeneca are jumping for joy!

              By the way, you can get your LDL down below 80 by diet, if you want to basically eliminate heart disease. It's a lot safer than drugs, it's based on science, but AstraZeneca and doctors don't earn much by telling people about that...

              Regards.

      •  The diarist has his own self interests too. (2+ / 0-)
        Recommended by:
        BlackSheep1, The Raven

        He sells DVD's and books on his website that promotes nutrition over statins but yet does prescribe statins.  In addition, you can attend live in retreats that I'm sure cost a pretty penny.  I look at company backed studies with the same jaundice eye that I look at people like Dr. McDougall.  

        I belong to no organized party. I am a Democrat. Will Rogers

        by thestructureguy on Fri Nov 14, 2008 at 07:51:29 AM PST

        [ Parent ]

        •  Link to his website? (0+ / 0-)

          The human race is truly the highest species on earth. No other species can procreate with the female on top.

          by NC Dem on Fri Nov 14, 2008 at 08:10:38 AM PST

          [ Parent ]

        •  correction (2+ / 0-)
          Recommended by:
          jabney, AmericanRiverCanyon

          I am the diarist but I am not Dr. McDougall.

          •  Thanks for pointing that out (2+ / 0-)
            Recommended by:
            The Raven, Yo yo yo

            I saw the doctors name at the bottom and thought it was a signed diary.  

            I belong to no organized party. I am a Democrat. Will Rogers

            by thestructureguy on Fri Nov 14, 2008 at 08:20:36 AM PST

            [ Parent ]

            •  maybe I should clarify (2+ / 0-)
              Recommended by:
              The Raven, AmericanRiverCanyon

              Dr. McDougall sent this out on an email I got his permission to post it here.

              I agree that Dr. McDougall has self interests, as we all do, but I would argue from personal experience that what he is selling (information) actually makes a lot of people well, rather than the interests of big pharma, which is to push a lot of drugs that may provide some relief but don't actually cure anyone.

              My wife was quite seriously ill and the MDs could only help her manage her disease with powerful drugs like prednisone. We discovered Dr. McDougall 12 years ago and we changed our diet dramatically to see what would happen. Her disease went into remission within a month, where it's remained. That's just one story, I know, but it opened our eyes to the power of environmental factors and disease. And there is no more intimate way you interact with the environment than by taking it into your body through your mouth!

              •  I have serious medical issues also (0+ / 0-)

                and believe diet and exercise is the most important part of my treatment. But I also believe prescription drugs as well as vitamins play a critical role.  However, assuming the pharm companies are only made up of people interested in making money and the safety be damn is nothing more then tin foil hat thinking.  And those that reject alternative medicine or treatments as something like vodoo are equally wacko. Both treatment opitions play a role and in some cases one or the other may play a more important role.  Lots of kool-aid drinkers on both side of the issue.  Very emotional issue I know.  

                I belong to no organized party. I am a Democrat. Will Rogers

                by thestructureguy on Fri Nov 14, 2008 at 10:39:25 AM PST

                [ Parent ]

                •  I agree (0+ / 0-)

                  And I don't know that Dr. McDougall or anyone else here is saying that all drugs or supplements are scams. But our medical system is really "disease care," and it's phenomenally expensive. I personally think health care should be teaching people how to take control of their own lives to protect themselves against diseases, and not try to offer them a pill mentality to solve a problem.

                  I think our health care system has failed us, it's built on money making and the rewards are for sickness. It doesn't reward spreading health or making sure people can have good info to keep healthy.

                  And this Crestor study and its aggressive marketing is the ideal example of what is worst about our system, what is most bankrupt about it.

                  Women don't eat vegetables when they're pregnant, so the medical establishment tells them to take a folate pill.  They don't eat vegetables, the baby comes out, we give it a shot of Vitamin K into the baby's thigh.

                  In the US we make everything into a medical solution, instead of getting back to the basics of what constitutes a healthy life.

                  And it seems from reading a lot of the posts on this string, some folks have already woken up to that. What would be nice, would be to have the government wake up, but the pressures of the medical-pharmaceutical-industrial complex are very hard to take on. And if you don't think that's about money, then what are you doing on Kos??  :-)

                  An article like the above from McDougall, followed by people seeking out nutritional and lifestyle alternatives to maintaining or restoring their health, is one powerful way people can discover new potentially life-saving information.

                  Peace.

    •  "Prevention" sometimes oversold (2+ / 0-)
      Recommended by:
      The Raven, Yo yo yo

      Its not a perfect world, and not every patient can prevent cardiac disease. There are inherited risks and, obviously, other unknown factors. People who don't respond to weight loss, dietary changes and exercise deserve to have other intereventions to prevent cardiac disease.

      Stopping studies early isn't always a good idea, particularly if benefit is measured in "relative" vs "absolute" risk reduction.  Longer term studies often reveal more information about long-term side effects, an important consideration when  medication may be used in patients who have other health problems.  We saw something similar in early stopping of trials for aromatase inhibitors for breast cancer patients, where longer term studies would have shown increased risk of bone necrosis.

      The major concern here is physicians who prescribe these medications, with their high cost and risky side effects, to people who have the ability to reduce risk in other ways. Sometimes older medications that may be as effective, cheaper and carry fewer side effects.

      As for government funding of research grants, there haven't been many cuts in overall funding.  Researchers can become their own advocates by taking a look at the internal politics that drive funding and budgets. There's a growing amount of "junk" and "safe" research going on, as well as poorly designed and expensive research programs at institutions like NIH.  Find some allies outside the research community who can help you make change.

  •  I can't tell you how happy I am... (4+ / 0-)

    that you took the time to write this diary. Big Pharma is going to kill us but, first, they are going to bankrupt us.

    I have let doctors put me on "great new" drugs one time too many, to my enormous detriment, so I'm not falling for the breathless hype anymore. But the public at large needs to be better educated on how the pharmaceutical companies manipulate the system and feed off of them.

    So thank you very much!

    Now, what I'd really like to see is Medicare Part D revisited.

  •  asdf (2+ / 0-)
    Recommended by:
    Pris from LA, Yo yo yo

    If people weren't brainwashed into thinking they need a pill for everything then maybe health care would't be so expensive.  Running to the doctor for every sniffle or perceived flaw (menopause, acid reflux, erectile disfunction!) is one of the main reasons that the health care system is so crazy.  The waiting rooms are full of people who aren't even sick.  Nine times out of ten, the only thing wrong is that a person needs to stop supersizing their meals and get some exercise.  Leave the doctors to work on the people that have a real disease.

  •  Lifestyle modifications? (3+ / 0-)
    Recommended by:
    vacantlook, Pris from LA, Yo yo yo

    Pffft. Too hard and too much work. Give me a pill.

  •  Crestor side effects include muscle damage (5+ / 0-)

    The drug did in my dad with MS - one of the potential side effects is damage to muscles. He could barely use his legs as it was. Once his MD prescribed Crestor he completely lost the use of his left leg.

    This can be life threatening and the FDA forced AstraZeneca to revise the label regarding this in '05.

    May we never forget the fallen. Help us remember them in the IGTNT tributes.

    by greenies on Fri Nov 14, 2008 at 07:28:56 AM PST

  •  My non-profit (6+ / 0-)

    Was on the receiving end of some pharma retribution.  I won't go into details, but these are not nice people when you interfere with their profit streams.

  •  Statins probably have a place in our (1+ / 0-)
    Recommended by:
    Yo yo yo

    pharmacopia. There are many drugs invented to treat lifestyle diseases, such as the results of careless eating and inactivity. But that's not to say that physicians should only prescribe exercise and a redesigned diet plan. Sure, those things are good. But, first, if the risk of serious side-effects is low, it makes sense to use it as an acute-care tool to take care of immediate needs while the patient trains himself to get around more, to eat better, etc. - because those things have a significant lag time. Second, there are always going to be people who, no matter how healthy their diet or activity level, will have high cholesterol problems, or high blood pressure, or whatever. It's one of those curses of genes. So you could use statins long-term to help with refractory high cholesterol.

    Do we need new, patent-protected statins? Ah, that's a good question! Reminds me of the studies that compared the new anti-psychotic neuroleptic drugs with the old ones, and found that the new ones were comparable to the old ones in effectiveness, had side effects of equivalent severity (and many side effects identical to the old ones), and were lots more expensive than the old ones. To quote one such study,

    Olanzapine does not demonstrate advantages compared with haloperidol (in combination with prophylactic benztropine [to reduce motor-control side effects]) in compliance, symptoms, extrapyramidal symptoms, or overall quality of life, and its benefits in reducing akathisia and [slightly] improving cognition must be balanced with the problems of weight gain and higher cost.

    The annual cost of maintenance treatment with olanzapine, a later-model drug, is over $5,000. The annual cost of maintenance treatment with halperidol is $300. Hmm...

    My nametag says, "Yes, I can help you." Don't believe everything you read.

    by Shaviv on Fri Nov 14, 2008 at 08:58:54 AM PST

  •  Great, great diary (n/t) (0+ / 0-)

    "The only sin is stupidity" -Oscar Wilde

    by Raskalnikov on Fri Nov 14, 2008 at 09:03:14 AM PST

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