Is Life a Statin Deficiency State?

By Larry Dossey, MD.

On three sparkling, crisp days in late February, I attended a meeting in the nation’s capitol at the Institute of Medicine (IOM). The IOM is part of America’s great temple of science, the National Academies. The meeting, Summit on Integrative Medicine and the Health of the Public, drew approximately 600 persons and was reported to be the largest group ever assembled at the IOM.1The assembly was cosponsored by the Bravewell Collaborative, a forward thinking, bighearted philanthropic foundation whose goal is to “bring about optimal health and healing for individuals and society.”2

A Landmark Gathering 

The purpose of the IOM meeting was to explore the science and practice of integrative medicine; how this field addresses together the mental, emotional, and physical aspects of the healing process; and how the breadth and depth of patient-centered care and the nation’s health might be improved and promoted. (The spiritual component of health and healing was almost completely omitted at the meeting, but that’s a story for another time.) The gathering was a who’s who of those who have labored for decades in the field of integrative medicine, even before it had a name. Also present were prominent representatives from government, industry, and academia.

A word about the National Academies. These bodies are considered crown jewels by America’s scientific elite, and they offer invaluable services to the nation. They are comprised of four organizations: The National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, and the National Research Council. All these divisions bring together committees of experts in every area of scientific and technological activity. These experts serve pro bono in addressing critical national issues and giving advice to the federal government and the public.3The IOM has been a section of the National Academy of Sciences since 1970. Its mission is to serve as an advisor to the nation to improve health. It provides evidence-based, authoritative information and advice concerning health and science policy to lawmakers, leaders in every sector of society, and the public at large.4

From the moment the attendees met in the magnificent rotunda of the National Academies building, the atmosphere was heady and surreal. I could hardly believe the meeting was taking place. For decades, practitioners, researchers, and proponents of integrative medicine and whole-person healing have been marginalized and grudgingly tolerated as some ill-mannered stepchild who threatens to embarrass the rest of the family. In many ways the ostracism was advantageous, because it forced the field to get its house in order and produce evidence backing its claims. Now we were actually being invitedinto the hallowed halls of perhaps the most prestigious scientific body in the world. This volte-face occurred because of a single, overwhelming reason—the increasing scientific evidence supporting integrative medicine. The National Academies were not making nice. This was, after all, an academy of science, where the lingua franca is proof.

Each day featured a splendid array of talent, eloquence, and wisdom—not only from leaders within integrative medicine, but also from leaders in business, technology, and government. A common acknowledgment permeated the meeting: America’s healthcare system is seriously broken, and everyone’s best efforts are needed to fix it.5I was struck by the humility of the leaders of integrative medicine. There was no triumphal boasting or grandstanding, no sky-blue prophecies that integrative medicine will solve everything, if only it is properly funded with federal dollars. Every speaker demonstrated a grounding and maturity that has been hard won in the long struggle for respectability and a seat at the table of healthcare. It hasn’t always been this way. Over the past decades there have periodic irruptions of fervor in which practitioners’ enthusiasm for this or that therapy has outrun their good judgment. It has been occasionally hinted that nutrition, exercise, herbs, acupuncture, homeopathy, biofeedback, and yoga can lead us out of the darkness into the light of health, and that prevention and behavioral changes could render most drugs and surgical procedures unnecessary. At the IOM meeting, this sort of talk was nowhere present. It had simply been outgrown.

The Cancer Report

Nearby on Capitol Hill, Senator Edward Kennedy’s Senate working group on healthcare reform held hearings on integrative medicine, again featuring leaders from the field, shepherded by Senator Barbara Mikulski.

The third event in this trifecta was a report that was issued on the second day of the IOM summit and that resoundingly sanctioned the IOM and Senate proceedings. The document, Policy and Action for Cancer Prevention, was prepared by the World Cancer Research Fund and the American Institute for Cancer Research, and was presented to US lawmakers on Capitol Hill with considerable media attention.6

The report states that better eating habits and physical activity could prevent a third of all cancers in the United States, and that smoking cessation could prevent another third. This means that a behavioral, nondrug approach to cancer prevention could eradicate two thirds of the cancers in America. Ponder the implications. If a drug were suddenly available to accomplish this, the entire nation would perk up overnight. Cost-benefit analyses would sprout like weeds. The drug’s manufacturer would saturate television with ads urging consumers to badger their physicians to prescribe the new product. Pressure groups would attempt to make the wonder drug available to everyone in the belief that no one should be denied its sweet benefits. This anticancer drug would probably be recommended for use from the cradle to the crematorium. And it would probably be so costly, like statins currently, that it would be out of reach for millions of Americans.

This scenario is not entirely hypothetical. These therapeutic benefits are available now—not in the form of a drug, but as the preventive approaches embodied in integrative, whole-person medicine.

There is an additional benefit to the recommendations of the Policy and Action for Cancer Prevention report. In addition to preventing two thirds of cancers by proper diet, exercise, and smoking cessation, these same measures also prevent heart disease—up to 80% of cases, according to most experts.7

So the integrative, preventive approach is a twofer, because it is predicted to eliminate most cancers and heart disease, the top two killers that stalk Americans. But in fact, this approach is a “threefer” and a “fourfer,” for not only will these approaches eliminate the majority of cancers and heart disease, but they are also an antidote for the twin epidemics of obesity and type 2 diabetes now raging in America.

I suggest that these implications should elicit jaw-dropping responses in anyone who retains the ability for wonder.

Is Life a Statin Deficiency State? 

What prevents us from embracing an integrative approach that emphasizes prevention and behavioral changes? We have become so enchanted with technological and pharmaceutical fixes that we are selectively blind toward an integrative, whole-person perspective. Do not misunderstand me. I have spent most of my adult years practicing internal medicine, and I periodically thank the Universe that modern surgical and pharmaceutical options are there when we need them. Only an idiot would wish them away. But why would any informed individual wish to rely on them exclusively?

The problem is that we have lost our balance in thinking about what works. As a single example, consider the pharmaceutical approach to preventing heart disease through the widespread use of statin drugs.

In November 2008, the JUPITER study made headlines. JUPITER is an acronym for the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating rosuvastatin. It found that in healthy men and women over 60, who have elevated blood levels of C-reactive protein (CRP), a nonspecific marker for low-grade inflammation, rosuvastatin (Crestor) significantly reduced the incidence of major cardiovascular events by 44%. These findings were widely hailed as justification for starting apparently healthy people on intensive therapy with Crestor to prevent first-time heart attacks, strokes, and other vascular problems, even though these individuals have no evidence of cardiovascular disease and may not even have other risk factors for stroke or heart attack.

Although some experts enthused about these findings, cardiologist Bernadine Healy, former director of the National Institutes of Health and the American Red Cross, put the issue in a sobering perspective. Writing in U.S. News & World Report, she said, “If you’re healthy, the question to ask your doctor before starting on intensive therapy for prevention is just what your personal risk of a heart attack or stroke might be. If you are truly healthy, and it boils down to a 1.5% chance of having a heart attack in the next 10 years, cutting the risk in half means 0.75%. In neither case are you likely to be in significant danger. Before swallowing the first pill, remember that that computes to improving the odds of not having a heart attack or stroke from 98.5% to 99.3%. The choice is yours.”8

People were dazzled, however, by the 44% reduction in cardiovascular events in JUPITER. “This sounds very dramatic, and it is,” says Nathan Wong, director of the UC Irvine Heart Disease Prevention Program. “But the risk of heart attack in those patients was pretty tiny to begin with—2.8%. The 44% drop took it down to 1.6%.”9

Many experts voiced concerns about the cost of widely prescribing what Healy calls “perhaps [the] most expensive statin on the planet.”8 If physicians routinely begin to test patients for CRP levels and prescribe statins to the estimated seven million patients who would demonstrate elevated levels, the total cost would be around $10 billion annually. According to an analysis by James Stein of the University of Wisconsin School of Medicine and Public Health, this practice would indeed prevent about 28,000 heart attacks, strokes, and deaths annually, but the cost of saving one life would total about $557,000.10

Some cardiologists have expressed concern that whatever the benefits of Crestor might be, they may only come after years and years of intensive therapy. Drugs usually don’t get safer with extended use; the longer any drug is used, the greater the likelihood that side effects will occur. In the JUPITER study, physicians reported a statistically significant increase in diabetes in those being treated with Crestor. The median duration of therapy was only 1.9 years, with a maximum of five years. What side effects will be seen if patients take Crestor for decades? The answer is that no one knows.

Healy and other experts have criticized JUPITER because the trial “was riddled with obesity, high blood pressure, prediabetes, and genes predisposing to heart disease. Almost 3,000 enrollees were smokers, a big-time CRP elevator.”8 David Jones, a Texas dentist, pointed out that gingivitis causes elevated CRP, and he wondered whether JUPITER patients had been screened for this common gum disease.11 Moreover, the placebo group did not experience significantly more deaths overall than the statin-treated group, and the difference between the two groups was narrowing when the study was suddenly stopped.12

Others were troubled that JUPITER was funded by AstraZeneca, who makes Crestor. Six months prior to publication, AstraZeneca released the results of the study. Within two days, shares in AstraZeneca jumped more than 8%. David Brennan, AstraZeneca’s CEO, saw gold. He predicted that some 25 million people in the United States alone are estimated to have elevated CRP levels, making them potential candidates for Crestor. Financial analysts noted that Crestor was a crucial product for the company, since sales of Nexium, its top seller, are slowing, and its second biggest seller, Seroquel, is facing generic competition.13

Should everyone take statins to prevent heart disease, just in case? “I think this is the biggest myth in medicine right now,” says cardiologist Stephen Sinatra, of the New England Heart & Longevity Center in Manchester, Connecticut. “Would I prescribe statins to a 60-year-old man who has high CRP levels and hardened arteries? Absolutely, but I’m not convinced statins are worth it as a preventive measure.”12

A New God?

I may be suffering from an overheated imagination, but I am struck by the acronym JUPITER that was chosen for the Crestor study. In Roman mythology, Jupiter is the chief deity, originally a sky god associated with thunder and lightning. No god in the Roman pantheon is more powerful. “When Julius Caesar celebrated his military triumphs in Rome,” writes historian Christian Meier, “he rode in a chariot drawn by three white horses and attired in a purple toga, a laurel wreath on his head, an eagle scepter in his hand, and his face coloured with red lead to represent the god Jupiter, whose power had made possible the victories of Rome’s armies. A slave held over him the golden wreath from the temple of the supreme god and constantly repeated in his ear, ‘Remember you are human.’”14 It’s a lesson rooted in antiquity: those whom the gods would destroy, they first make proud.

Is it just me, or do you also detect a whiff of hubris in the acronymic choice of JUPITER? Like the great god-king Jupiter of old, who made possible Rome’s victories, has JUPITER created a new sovereign, Crestor, which will enable victory over disease? AstraZeneca has in mind other kinds of victories as well. The goal of the company is to position Crestor as the king of all the statins, the pharmaceutical Jupiter who will reign over statin competitors such as Lipitor, Zocor, Mevacor, Pravachol, and Lescol. AstraZeneca is eying other conquests. Like an all-powerful potentate, the new drug king is extending its therapeutic territory far beyond its original border as a preventer of cardiovascular disease. Preliminary studies suggest that statins in general may also be useful in preventing and treating an array of additional conditions such as autoimmune diseases, multiple sclerosis, psoriasis, advanced prostate cancer, and Alzheimer’s disease.9 No one can say what the eventual boundaries of the therapeutic kingdom will be.

The “astra” in AstraZeneca points to the stars and suggests that the corporation has its sights trained on the astronomical. It gets grander. JUPITER is a part of AstraZeneca’s extensive GALAXY clinical trials program, designed to address important unanswered questions in statin research.15 GALAXY contains several other component studies, whose acronyms suggest a cosmic, universal, infinite reach. For instance, there is a study called COMETS (COMparative study of rosuvastatin in subjects with METabolic Syndrome), as well as studies with the acronyms MERCURY, URANUS, DISCOVERY, and RADAR.16 Don’t ask.

Costs and Benefits

While experts debate whether we should all be on statins just in case, let’s go back to the above statistics: two thirds of cancers and four fifths of heart disease can be eliminated by integrative health measures that involve making decisions about how we live our lives. No drug or drugs can do such a thing. Dietary discretion, weight control, physical exercise, and stress management are not as sexy as statins, but they are exponentially more effective, less toxic, and cheaper.

How much cheaper? One of the luminaries at the IOM summit was Dr Kenneth Pelletier of the University of Arizona School of Medicine, also director of the Corporate Health Improvement Program, a collaborative research program with 15 of the Fortune 500 corporations. Pelletier is the author of The Best Alternative Medicine: What Works? What Does Not?17 He has helped many major American corporations craft disease prevention and health promotion programs for their employees. He noted that 62 of 63 studies of cost effectiveness, cost benefit, and return on investment have shown positive results.18 His research suggests that a return on investment for disease prevention and health promotion programs usually takes only 3.25 years. Further, return on investment ranges from $3.50 to $4.90 for every $1.00 invested. Pelletier noted that we may not necessarily need new monies in healthcare, but just better allocation of present resources. Because so many high-tech methods presently used have not yet been proven efficacious, there are significant savings to be made by no longer reimbursing expensive and questionably effective health interventions.5

Just how many therapies in common use are ineffective or harmful comes as a shock to most people, even physicians. Recently, the British Medical Journal published an assessment of the state of current knowledge in conventional healthcare, “How Much Do We Know?”19 What proportion of commonly used treatments is supported by good evidence? Which therapies should not be used or used only with caution? How big are the gaps in our knowledge? The report states, “Of the 2,404 treatments covered in this update, 360 (15%) are rated as beneficial, 538 (22%) likely to be beneficial, 180 (7%) as trade-off between benefits and harms, 115 (5%) unlikely to be beneficial, 89 (4%) likely to be ineffective or harmful, and 1,122 (47%), the largest proportion, as unknown effectiveness.” In other words, only about a third of the therapies in vogue in conventional medicine are of clear benefit or even likely to be beneficial, whereas two thirds are either actually harmful, possibly harmful, or of unknown effectiveness.

Why Not Wider Use? 

Why, then, are Americans not using integrative medicine more widely? Many are using it, of course. They are not waiting for a physician to endorse the virtues of personal choice making in matters of nutrition, exercise, or stress management, but are making informed decisions and charting their own course. Whether these interventions are reimbursed by private insurance is often of secondary importance to them, because many of the treatments cost little or nothing to implement. A prescription is not required to lose weight, change one’s diet, and begin exercising. The most important requirement is a change in perspective, a new point of view.

Why haven’t the great majority of Americans come on board? If we were solely creatures of reason, people everywhere would be lined up to learn about integrative approaches purely on the basis of the evidence. What holds us back? I have often thought there may be some hard-wired biological reason why we ignore the virtues of prevention, behavioral changes, and a whole-person, body-mind-spirit approach to health and healing. As someone once said, “Man is chiefly distinguished from the lower animals by his desire to take a pill.” Where does that desire originate? Is it genetic? If the preference for pills is biologically innate, then those who have opted for the integrative approach may be mutants of sorts, evolutionary progressives who are out front in a never-ending game of survival.

The Way Ahead

The IOM summit injected key questions into the growing national debate about healthcare reform. Should integrative measures receive federal endorsement and reimbursement? Should insurance plans reimburse preventive measures as eagerly as they reimburse for a heart catheterization or coronary bypass surgery? What demonstration projects show how people can be encouraged to adopt these measures and integrate them into their lives? Who are the best “encouragers”—physicians, nurses, social workers, health coaches? How can long-term adherence and compliance with integrative measures best be achieved?

The IOM summit was an indicator that the nation’s healthcare system is no longer business as usual. Change is in the air because we can no longer deny that America’s health record is both a tragedy and an embarrassment. We rank miserably in longevity and infant mortality, in spite of spending ourselves silly.20,21 Forty-six million citizens, including nine million children, are uninsured.22 The leading cause of personal bankruptcy is a health crisis, even among individuals who have some health insurance and some college education.23 Throughout the country, one of every eight elderly Americans must choose between food and the medicine their doctors prescribe.24 As many individuals pointed out at the IOM meeting, we don’t have a healthcare system, we have a disease-care system, and even disease is not being cared for as it should be.

It’s been four months since the IOM summit. Whether or not it will be judged to have made a difference will depend largely on whether ordinary citizens act on its premises, catch fire, and demand meaningful change.

It has happened before. Remember the discarded phrase “alternative medicine”? When those who jogged and paid attention to what they put in their bodies were called health nuts? When meditation and yoga caught on? When people began boycotting the offices of conventional physicians by the millions? Individual citizens made these choices one by one, and they shook American medicine to its foundation and ushered in perhaps the most titanic social transformation in the late 20th century.

As I write, I hear grumblings from congressional leaders that we must temper our reform of the current system. We cannot get carried away, they say. We must come up with a uniquely “American system,” meaning, reading between the lines, that we have to keep the insurance-based, for-profit, disease-care system largely intact, with only minor tinkering. The fear mongering is ratcheting up, scaring people with terms like “European socialism” and that old standby “socialized medicine.” Congressional spendthrifts have been suddenly transfigured into fiscal misers who warn of bankrupting the nation “if we don’t do healthcare reform right,” which seems to mean making just enough cosmetic changes to the current system to tamp down the public’s indignation for another generation.

As the IOM gathering adjourned, a question lingered. How can our nation, in the name of sanity and science, continue to ignore integrative, whole-person healthcare?

We will be living with the consequences of the answer we give for a very long time.

References:

1. Summit on Integrative Medicine and the Health of the Public. Institute of Medicine of the National Academies Web site http://www.iom.edu/?ID=52555Accessed March 24, 2009.

2. The Bravewell Collaborative. Web site. http://www.bravewell.org/Accessed March 24, 2009.

3. The National Academies Web site. http://www.nationalacademies.org/about/Accessed March 23, 2009.

4. Institute of Medicine of the National Academies resources and links page. Institute of Medicine of the National Academies Web site http://www.iom.edu/CMS/AboutIOM.aspx Accessed March 23, 2009.

5. Ullman D. Institute of Medicine’s historic summit on integrative medicine. Integrative Practitioner.comhttp://www.integrativepractitioner.com/article_ektid13662.aspxAccessed March 20, 2009.

6. World Cancer Research Fund and the American Institute for Cancer Research. Policy and Action for Cancer Prevention. dietandcancerreport.org

http://www.dietandcancerreport.org/Accessed February 28, 2009.

7. McKinnon JM. For women, it’s heart-unfriendly Toledo; risk factors sink the area in a health ranking. toledoBlade.com. May 20, 2008 http://www.toledoblade.com/apps/pbcs.dll/article?AID=/20080520/NEWS32/805200352Accessed March 23, 2009.

8. Healy B. Interpreting JUPITER: statins for everyone?. U.S. News & World ReportWeb site. November 10, 2008 http://health.usnews.com/blogs/heart-to-heart/2008/11/10/interpreting-jupiter-statins-for-everyone.htmlAccessed March 23, 2009.

9. Davis EC. Should statins be available for everyone?. Los Angeles TimesWeb site. December 22, 2008 http://articles.latimes.com/2008/dec/22/health/he-statin22Accessed March 23, 2009.

10. Study might prompt expanded use of Crestor, increase U.S. health care costs by $10B annually, analysis finds. Medical News TodayWeb site. November 12, 2008 http://www.medicalnewstoday.com/articles/129026.phpAccessed March 23, 2009.

11. Healy B. CRP test may lead to overuse of statins like Crestor. U.S. News & World ReportWeb site. November 11, 2009 http://health.usnews.com/blogs/heart-to-heart/2008/11/11/crp-heart-test-may-lead-to-overuse-of-statins-like-crestor.htmlAccessed March 24, 2009.

12. Quinn E. The scary truth about statins: what you need to know before you fill that prescription. Natural Solutions. 2009;49–52February.

13. Hirschler B. AstraZeneca sees study fuelling Crestor sales. ReutersWeb site. April 1, 2008 http://www.reuters.com/article/businessNews/idUSL0174532120080401Accessed March 23, 2009.

14. Meier C. Caesar. In: New York, NY: Basic Books; 1982;p. 443.

15. Crestor cuts risk of stroke by nearly half in JUPITER study. [press release]. finance.yahoo.com. February 19, 2009 http://finance.yahoo.com/news/CRESTOR-Cuts-Risk-of-Stroke-prnews-14414948.htmlAccessed March 24, 2009.

16. New data demonstrates the efficacy of Crestor® in treating a broad range of patient populations for elevated cholesterol. [press release]. October 25, 2004. BioSpace.comhttp://www.biospace.com/news_story.aspx?NewsEntityId=17826820Accessed March 24, 2009.

17. Pelletier KK. The Best Alternative Medicine What Works? (What Does Not?). New York, NY: Fireside; 2002;.

18. Pelletier KR. A review and analysis of the health and cost-effective outcome studies of comprehensive health promotion and disease prevention programs at the worksite: 1995-1998 update (IV). Am J Health Promot. 1999;13:333–345. MEDLINE

19. Clinical evidence: how much do we know?. BMJWeb site http://www.clinicalevidence.com/ceweb/about/knowledge.jspAccessed March 24, 2009.

20. U.S. slipping in life expectancy rankings. Health & Longevity News Web site. August 12, 2007 http://healthlongevity.blogspot.com/2007/08/us-slipping-in-life-expectancy-rankings.htmlAccessed March 24, 2009.

21. Country comparisons–infant mortality rate. Central Intelligence Agency Web site http://www.cia.gov/library/publications/the-world-factbook/rankorder/2091rank.htmlAccessed March 24, 2009.

22. CoverTheUninsured.comhttp://covertheuninsured.orgAccessed March 24, 2009.

23. Himmelstein DU, Warren E, Thorne D, Woolhandler Steffie. Marketwatch: illness and injury as contributors to bankruptcy. Health Aff (Millwood)[serial online]. Jan-Jun 2005;(suppl Web exclusives):W5-63-W5-73 http://content.healthaffairs.org/cgi/content/full/hlthaff.w5.63/DC1Accessed March 24, 2009.

24. Cummings EE. No American should be forced to choose between food and medicine. House.govhttp://www.house.gov/cummings/articles/archived/art99_20.htmAccessed March 24, 2009.

© 2009 Larry Dossey, M.D. This article is also published in the July 2009 issue of Explore: The Journal of Science and Healing, available at www.explorejournal.com; HMDI has reprinted it with permission from Larry Dossey, M.D.

 

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