Study review: yet another Lipitor study

3. December 2007 William Davis (6)
This continues a series I've begun recently that discusses studies that have emerged over the past 10 years relevant to heart scan scoring and reversal of coronary atherosclerotic plaque.

The St. Francis Heart Study from St. Francis Hospital, Roslyn, New York, was released in 2005. This was yet another study that set out to determine whether Lipitor exerted a slowing effect on coronary calcium scores. This time, Lipitor (atorvastatin), 20 mg per day, was combined with vitamin C 1 g daily, and vitamin E (alpha-tocopherol) 1,000 U daily, vs. placebo. A total of 1,005 asymptomatic men and women, age 50 to 70 years, with coronary calcium scores 80th percentile or higher for age and gender
participated in the study.

After four years, heart scan scores in the placebo group increased 73%, compared to 81% in the treatment group. Statistically, the cocktail of drug, vitamins C and E had no effect on heart scan scores.

Other findings included:

--Participants experiencing heart attack and other events during the study showed greater progression of scores than those not experiencing heart attack: score increase of 256 vs. increase of 120.

--While treatment did not reduce the number of heart attacks and events overall, participants with starting heart scan scores >400 did show a benefit: 8.7% with events on treatment (20 of 229) vs. 15.0% with placebo (36 of 240).

(Note what is missing from the treatment regimen: efforts to raise HDL (starting average HDL 51 mg/dl); reduce triglycerides (starting average 140 mg/dl); identify those whose LDL was false elevated by lipoprotein(a); omega-3 fatty acids from fish oil; correction of other factors like vitamin D deficiency.)


Are we pretty in agreement that just taking Lipitor and following an American Heart Association low-fat diet is an unsatisfactory answer to gain control over coronary plaque growth? No slowing of heart scan score growth seen in the St. Francis Heart Study and similar studies is consistent with the 25-30% reductions in heart attack witnessed in large clinical trials. Yes, heart attack and related events are reduced, but not eliminated--not even close.

And when you think about it, it should come as no surprise that the simple strategy studied in the St. Francis Heart Study failed to completely control plaque growth. Lipitor and statin drugs exert no effect on small LDL particles, barely raise HDL cholesterol at all, and have no effect on Lp(a), factors that increase heart scan scores substantially.

Though these discussions have frightened some people because of the suggestion that increasing heart scan scores are inevitable and unavoidable, they shouldn't. It really should not be at all shocking to learn that taking one drug all by itself should cure coronary heart disease.

Instead, findings like those of the St. Francis study should cause us to ask: What could be done better? How can we better impact on heart scan scores and how can we further reduce heart attack, particularly in people with higher heart scan scores?

My answer has been the Track Your Plaque program, a comprehensive effort to 1) address all causes of coronary plaque, and then 2) correct all the causes.
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Comments (6) -

  • Anonymous

    12/3/2007 10:59:00 PM |

    Dr Davis, What would be your reaction to another Dr's blog site quoting the latest NCEP report of 9/07 that lowering LP(a) is not necessary unless it is in the 80-90th percentile? He also states that the report says raising HDL is only an "option" but not a proven deterrent. I don't have the credentials to argue this point but.... I certainly want to disagree with him.   Over&Out

  • Dr. Davis

    12/4/2007 2:53:00 AM |

    If the question is whether this physician is properly reiterating NCEP guidelines, he is right.

    I regard NCEP as being as least 10 years behind the times and a consensus opinion driven as much by big science as big pharma.

    It is also based on outcome studies, what I would call "body count" studies, rather than studies based on surrogate measures like heart scans. If we wish to wait for people to die in order to understand whether a treatment works or not, then his comments hold water. If our desire is to not gamble our lives away waiting for consensus opinions, then taking reasonable action based on available data is, in my view, a more rationale approach.

  • Anonymous

    12/4/2007 3:12:00 AM |

    The problem with following surrogate markers is they are just that.  The danger is illustrated well with the Torcetrapib story:  the drug did raise HDL the surrogate marker but the trial had to be halted because adverse events were so high.  It made "sense" to raise HDL and it is not clear what the exact mechanism of the excess deaths are (elevation in BP which the drug caused or ?).  Random controlled trials are still the best way to move forward no matter how long or messy they may be.

    On the subject of people having to decide in real time what treatment strategy they want to follow I believe one can make informed guesses but ultimately people should realize they are only guesses and may or may not prove to be correct.

  • Dr. Davis

    12/4/2007 3:29:00 AM |

    Yes, I agree with your second statement.

    However, I think we're talking apples and oranges here.

    With torcetrapib, we're not talking surrogate markers, but introducing a foreign substance with generally unknown extent of effects. With heart scanning, we're talking about a surrogate measure of the disease, and one certainly far closer to the disease than the rather "distant" HDL-to-event relationship.

  • Lipitor Prescription Information

    11/10/2008 8:45:00 PM |

    My name is Giulia White and i would like to show you my personal experience with Lipitor.

    I have taken for 9 years. I am 60 years old. I took 20 mg for 9 years and I told numerous physicians about my pain and stiffness and was told that I had arthritis and to keep taking it. I left it at home by accident when we went on vacation and within 3 days, the pain in my legs began to go away. After 2 weeks I knew it was a very dangerous medication. I went to my new physician and he wanted me to try Pravachol. Afer 4 days on it, I was in a fog and thought I had the flu. I have been off it for just 36 hours and feel better. I am an RN and should have known that I was experiencing side effects with Lipitor, but you listen to your Doctor because you trust him. I now tell my patients to trust what their bodies are telling them. Statins can't be good for anyone but the drug companies!!!!!!!!!! They keep lowering the recommended levels so that almost everyone is considered to have "high" cholesterol. If someone is 30 and on this for 30 or 40 years there is not telling what the long term effects will be.

    I have experienced some of these side effects-
    Joint and Muscle Pain / Stiffness.

    I hope this information will be useful to others,
    Giulia White

  • buy jeans

    11/3/2010 8:47:11 PM |

    (Note what is missing from the treatment regimen: efforts to raise HDL (starting average HDL 51 mg/dl); reduce triglycerides (starting average 140 mg/dl); identify those whose LDL was false elevated by lipoprotein(a); omega-3 fatty acids from fish oil; correction of other factors like vitamin D deficiency.)

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Disease Engineering

Disease Engineering

20. October 2008 William Davis (0)
Imagine you contract pneumonia.

You have a fever of 103, you’re coughing up thick, yellow sputum, breathing is getting difficult. You hobble to the doctor, who then fails to prescribe you antibiotics. You get some kind of explanation about unnecessary exposure to antibiotics to avoid creating resistant organisms, yadda yadda. So you make do with some Tylenol®, cough syrup, and resign yourself to a few lousy days of suffering.

Five days into your illness, you’ve not shown up for work, you’re having trouble breathing, and you’re getting delirious. An emergency trip to the hospital follows, where a bronchoscopy is performed (an imaging scope threaded down your airway) and organisms recovered for diagnosis. You’re put on a ventilator through a tube in your throat to support your breathing and treated with intravenous antibiotics. Delayed treatment permits infection to escape into the fluid around your lungs, creating an “empyema,” an extension of the infection that requires insertion of a tube into your chest through an incision to drain the infection. You require feeding through a tube in your nose, since the ventilator prevents you from eating through your mouth. After 10 days, several healing incisions, and a hospital bill totaling $75,000, you’re discharged only to be face eights weeks of rehabilitation because of the extreme toll your illness extracted. Your doctor also advises you that, given the damage incurred to your lungs and airways, you will be prone to more lung infections in the future, and similar situations could recur whenever a cold or virus comes long.

A disease treatable by taking a two week, $20 course of oral antibiotics at home has been converted into a lengthy hospital stay that generated extravagant professional fees, testing, and costly supportive care. You’ve lost several weeks of income. You’re weak and demoralized, frightened that the next flu or virus could mean another trip to the hospital.

Such a scenario would be unimaginable with a common infection like pneumonia, or it would be grounds for filing a malpractice lawsuit. But, as horrific as it sounds in another sphere of healthcare, it is, in effect, analogous to how heart disease is managed in current medical practice.

First, you’re permitted to develop the condition. It may require years of ignoring the telltale signs, it may require your unwitting participation in unhealthy lifestyle choices. Palliative treatments that slow, but don't stop, the progression of disease are prescribed like cholesterol drugs. The process then eventuates in some catastrophe like heart attack or similar unstable heart situation, at which point you no longer have a choice but to submit to major heart procedures. That’s when you receive your heart catheterization, coronary stents, bypass, defibrillators, etc. and you're proudly declared a "success" of medical technology.

Of course, none of these procedural treatments cures the disease, no more than a Band Aid® heals the gash in your leg. The conditions that were present that created your heart disease continue, allowing a progressive disease to worsen. At some point, you will need to return to the hospital for yet more procedures when trouble recurs, which it inevitably does.

A coronary bypass operation costs, on average $85, 653 (AHA 2008 Update; based on 2004 data). That doesn't include the $25,433 cost for the heart catheterization performed by a cardiologist to provide the surgical roadmap of your coronary arteries. If there are any complications of your procedure, then your hospital bill may total a substantially higher figure.

$85, 653 is just the upfront financial pay-off. Over the long run, your life is actually worth far more to the cardiovascular healthcare system because no heart procedure yields a permanent fix. In fact, repeated reliance on the system is the rule.

In fact, over 90% of people who enter the American cardiovascular healthcare system do so through a revolving door of multiple procedures over several years. It is truly a rare person, for instance, who undergoes a coronary bypass operation, never to be seen again the wards of the hospital because he remains healthy and free of catastrophe. A much more familiar scenario is the man or woman who undergoes two or three heart catheterizations, receives 3,4, or 6 stents, followed a few years later by a heart bypass, pacemaker, defibrillator, as well as the tests performed for catastrophe management, such as nuclear stress test, echocardiogram, laboratory blood analysis, and consultation with several specialists. Re-do bypass surgeries--a 2nd, 3rd, or 4th bypass--now comprise 25% of all bypass procedures.

The total revenue opportunity is many-fold higher than the initial 80-some thousand dollars, but instead totals hundreds of thousands of dollars per person.

What motivation can there possibly be to 1) identify coronary disease early, when in its asymptomatic stage, then 2) identify its causes, then 3) correct the causes, and finally 4) shut off the disease? You and I can accomplish this with a few hundred dollars of cost, perhaps a few thousand over many years (to cover costs of fish oil, vitamin D, niacin, and whatever else it takes to stop the expression of the disease). Nobody therefore profits substantially from your prevention effort--except you.

Then what if nobody told you that heart disease could be managed this way? That's what I mean by "disease engineering."
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