Dad suffered a coronary at 57 and died three years later. Afterwards, two of my five brothers had fatal heart attacks, Leon at 39 years of age and Larry at 46. In 1987, the year Larry died, our childhood family physician urged the remaining four of us--Tom (53), myself (48), Jerry (44), and James (42)--to have tests run and to follow doctors' orders. Those tests showed that we all had "high" cholesterol. As advised, we checked our cholesterol levels periodically, took prescription cholesterol medicines at times, and occasionally made recommended lifestyle changes, some of us more consistently than others. Jerry said, "We just assumed that we had inherited a tendency to have high cholesterol and that it would kill us one day." Twenty years later we began questioning that assumption and my own research now concludes cholesterol is not the killer pharmaceutical companies suggested then (and still do).
Like most Americans, my brothers and I had confidence in the Food and Drug Administration and the medical profession, especially our personal physicians, trust we soon learned was dangerously naive. As we awakened to this realization two decades after Larry's death, I sent my brothers this passage from Matthew Arnold:

Ah, love, let us be true/ To one another, for the world, which seems/ To lie before us like a land of dreams,/ So various, so beautiful, so new,/ Hath really neither joy, nor love, nor light,/ Nor certitude, nor peace, nor help for pain;/ And we are here as on a darkling plain/ Swept with confused alarms of struggle and flight,/ Where ignorant armies clash by night.

I explained in my forwarding e-mail:

It was a land of dreams, for all Americans, with faithful doctors, researchers, and drug makers under the watchful eye of the FDA, all striving selflessly to keep us healthy. But it is better that we have awakened to the sadder truth, one which makes it all the more important that we remain, as Arnold said, 'true to one another.'

Indeed, always close, we brothers grew even more so as our investigation went along. Yet we grieve for the many good doctors caught in the uglier threads of medicines' web, their trusting patients, and for ourselves, whose comfortable illusions have been diminished. Saddened and discouraged, I might have let the matter end with us. But my brother Jerry reminded me of John Donne's famous unction:

Any man's death diminishes me, because I am involved in mankind; and therefore never send to know for whom the bell tolls; it tolls for thee.

Recognizing my lack of expertise for this I agreed to do some research. Now, Jerry insists that I do more.

American medicine in general involves third-party payers, a recipe for limitless demand and inevitable rationing. Further compounding the problem, health insurers along with drug and medical device companies have found ways to avoid the spirit, if not the letter, of anti-trust regulations, weakening that necessary restraint. So with insurers and government paying and suppliers unrestrained by competitive forces, customers are patsies for drugs and treatments promising small, or even hypothetical, benefits. Besides, most patients simply trust their doctors, not suspecting physicians are pre-empted in many respects-- and often conflicted in others.

By 2009, I became convinced that cholesterol medications were essentially a $28 billion a year boondoggle, eclipsing the Madoff Ponzi scheme. And Madoff's shenanigans were almost inadvertent compared to those of my offenders. Madoff apparently had co-conspirators, tacit and overt, but not throughout his industry. And he operated with lax government oversight but, insofar as is known, he did not exercise much control over his regulatory structure.

Like President Obama, I also came to believe that the standards of care concerning stents and bypasses, at least, were unsupported by respectable research. These "reperfusion" procedures neither prevented heart attacks nor extended life for patients with stable angina, the majority of relevant instances--and perhaps in no significant category of cases at all. Yet more than million a year were administered in the U.S. alone.

How can this be? I fear a large slice of the medical community is "On the Take," as long-time NEJM editor Jerome Kassirer puts it, to such a degree that virtually no high-dollar therapy or drug is free of financial influence.

The SEC was a central player in securities trading, Madoff's playground. Likewise the FDA for healthcare. Accusations of conflict of interests there are continuous. For example, in August of this year the Department of Health and Human Services inspector general was investigating such claims against the FDA drug chief. And the head medical device regulator had already resigned under pressure. Obama's new FDA Director is a Harvard-educated physician whose mother had been the first black woman to attend Vassar College and whose resume included service as health commissioner of New York. Though touting reform, she faced an entrenched bureaucracy funded by user fees from the very corporations the FDA supposedly regulated, corporations which were often referred to as "customers" of the agency.

Against this background, we four brothers are striving to develop strategies to manage our own medical care and to exert whatever influence we might as citizens and, in the biblical sense, neighbors. What, for example, should I have said when my neighbor, an RN, told me her husband was taking Lipitor and was suffering what seemed to be neurological disorders? When my sister-in-law described how doctors had saved my niece's life by stenting her heart three days after a painless fainting spell, a spell which initially led to four defribrillations by EMTs, with the patient screaming during each and her mother-in-law listening helplessly from the front seat of the ambulance. Or when a friend smiled contentedly as he showed me the scars where "heroic" surgeons "fixed" his heart with a triple bypass after a brief episode of angina, which he called a "heart attack"?

My investigation had begun in earnest in 2007. In June of that year, Tom's son Doug, then 44, experienced difficulty breathing while climbing several flights of stairs in a hot area of the plant where he worked. He reported having experienced "indigestion" and generalized malaise over the preceding six months or so. Blood analysis and an EKG appeared normal but the results of the attendant nuclear tests were declared "questionable" by the cardiologist. "I wanted to go home and get my clothes and stuff," said Doug, "But she ordered me not to leave the hospital."

The cardiologist referred to the problem as a "kink." The "kink" was bypassed by grafting the left internal mammary artery (normally providing blood to the left breast, which quickly reperfuses naturally in most instances) to the left coronary artery. To facilitate this work, another artery (the circumflex) was shunted using a vein taken from Doug's leg. Such operations involved stopping the heart for several hours and the use of a heart-lung machine.

Learning of Doug's situation, I wondered if the "kink" might be an inherited defect, which could explain the early deaths and allow preventative measures for other family members. Asked about this, the surgeon equivocated about the use of the term "kink" and suggested that a better analogy would be a bent pipe which had wrinkled toward the inside, limiting flow. Looking back on this two years later, Jerry remarked, "I don't think there was a damn thing wrong with Doug. It may be that the cardiology group just hadn't met its quota that month."

Citing the nuclear images, our "family history," and Doug's own reports of "exertional angina and a positive stress test," the cardiologist performed an angiogram the next day, reporting that the left coronary artery, often called the "Widow-maker," showed 65 percent stenosis (narrowing of the artery's diameter) near its exit from the aorta. Doug's heart was found otherwise healthy and free of disease.

Although an experienced researcher, I had limited knowledge of medicine. So I sought advice from several physicians during the following months. And Jerry interviewed many present and former heart patients, sometimes recording the discussions. "Most were anxious to show me their scars or to tell me how the cardiologists had saved their lives or 'fixed' their hearts," he said. Tom talked with our family physician mentioned above, then in his eighties. According to Tom, the doctor recanted his earlier warning and said that he then considered "the whole cholesterol thing a bunch of hogwash."

Early on, my investigation confronted a premise often cited, but overstated, in medicine's favor. James put it this way, "People used to die in their forties and fifties and now they usually live into their seventies. Who do you think deserves credit for that? Doctors and medical researchers, that's who!" Examining James' premise, I learned that the 28-year increase in U.S. lifespan during the 20th century was mainly due to infant survival, not to people dying in their middle years. For example, a new baby boy born in 1900 could expect an average life of 48 years; but if he lived past age 20, he would average living to about 65. Life expectancy of a 65- year-old male increased only about 5.3 years during the 20th century; for an 85-year-old, the improvement was about 2 years.

Paul Offit, of the Children's hospital of Philadelphia, told me "almost all" of the increase in life span during the twentieth century was due to vaccines, not to better medicine in general. Yet, practically everyone with whom I broached the subject, farmer or physician, degreed or uneducated, believed that our "world's best" medical care system had given Americans added decades of life. A few years, perhaps, but not decades.

Physicians have consistently placed my brothers and me in an "at risk" category. As advised, we had checked our cholesterol levels periodically, took prescription cholesterol medicines at times, and occasionally made recommended lifestyle changes, some of us more consistently than others. Jerry said, "We just assumed that we had inherited a tendency to have high cholesterol and that it would kill us one day." Our father as well as Leon and Larry had been heavy smokers and overweight when they died. I had never smoked. And James and Jerry smoked little or none after the mid-1980s. But Tom, formerly a heavy smoker, was known to sneak several cigarettes a day in 2009. He also had a pacemaker. None of us was overweight. So, with some reservation about Tom, we came to realize that we might not be as much at risk as we had thought.

Family data Jerry collected in 2008 further lessened our concerns. To begin with, we had all lived beyond the life expectancy for American males at our births around 1940 (61.6 years) and, ignoring our immediate family history, could look forward to an average of about 11 years more. Our paternal grandmother and grandfather died at 101 and 83, respectively. Our maternal grandmother had lived into her 80s, although mother died during an epileptic seizure at 60. Dad's five siblings died at 83, 81, 79, 74, and 59, the latter two of cancer. Insofar as could be determined in 2008, there had been no history of heart disease on either side of the family, except for the three heart attacks mentioned above and Doug's putative problem. In 2009, all four of us remained active and fit, hardly obese or slovenly.

Cholesterol Drugs

A spate of media reports in late 2007 and early 2008 indicated that cholesterol-lowering drugs, which we four brothers had all taken from time to time, neither decreased heart attack or stroke. As was the case for stents and bypasses, the lack of convincing proof that taking cholesterol drugs extended life or decreased heart attack risk was more or less passé within broad segments of the medical community by 2006. In 2002, researchers from the University of California at San Diego School of Medicine wrote,

[I]n relatively young, healthy men from higher socioeconomic strata, a (naturally) low total cholesterol (TC) is associated with increased longevity...Can we extrapolate the favorable observations concerning low TC in younger persons to older persons? The best evidence is--not really...Some evidence suggests that elevated TC in old age is protective.

James M. Wright, director of the Canadian Therapeutics Initiative, said that upon surveying the available literature he found

no benefit [from taking cholesterol medications] in people over 65, no matter how much their cholesterol declines, and no benefit in women of any age.

Although he noted a "small reduction in the number of heart attacks for middle-aged men taking statins in clinical trials," even for these men he saw "no reduction in total deaths or illnesses requiring hospitalization--despite big reductions in 'bad' cholesterol."

As my investigation proceeded, I was surprised to learn how science was being subverted, not only by the major pharmaceutical companies and medical device makers, but by doctors themselves, who often applied standards of care for fear of being sued, or out of simple laziness or naivete. Bryan A. Liang, director of the Institute of Health Law Studies at the California Western School of Law said,

What the shrewd marketing people at Pfizer and the other companies did was to spin it to make everyone with high cholesterol think they really need to reduce it. It was pseudoscience, never telling you the bottom-line truth, that the drugs don't help unless you have pre-existing cardiovascular disease.

Bruce Psaty, professor of medicine and epidemiology at the University of Washington, was quoted in the New York Times:

When there have been adverse effects, when the benefits don't look impressive, those are the trials that historically don't make it to press.

Later, in a USA Today article, he said:

The drug industry appears to treat scientific data as if they were a marketing tool.

A 2008 study found that "publication bias" inflated the reported effectiveness of drugs in this $21 billion a year category--for example, by 69% for Serzone, 64% for Zoloft, 61% for Remeron, and 40% for Paxil. Here's a WSJ story on it. My brother Tom was taking Paxil in 2008 but soon stopped.

In 2006, statin-type cholesterol drugs produced about $28 billion in revenue, almost half of that from Lipitor alone. Zetia (a non-statin) and Vytorin (Zetia combined with generic Zocor)generated $5 billion in 2007. Drug companies had increased the pace of clinical trials by half, from 40,000 in 2000 to 59,000 in 2006.

In any event, industry marketing expenditures, not to mention "charitable" giving by these companies, nearly quadrupled between 1996 and 2004. An estimated $25 billion was spent in 2006 on free samples and other strategies to woo doctors. Jerome P. Kassirer, former editor of the NEJM, said,

I go to medical conferences and ask, 'Why do you think the pharmaceutical companies are spending all that money and giving you all that free stuff?' I get blank stares. Doctors continue to insist that they can't be bought.

Evidence of conflict and industry influence continue to mount and top medical journals began to take note last year. For example, the Journal of the American Medical Association (JAMA) editorialized,

The profession of medicine, in every aspect--clinical, evaluation, education, and research--has been inundated with profound influence from the pharmaceutical and medical device industries. This has occurred because physicians have allowed it to happen, and it is time to stop.

Similarly, the NEJM noted,

Recent years have seen the creation of nonprofit foundations housed at academic institutions but organized for the benefit of individual investigators and funded by industry sponsors...We expect that authors will be particularly attentive to transparency in reporting if a funding entity has a vested interest in the outcome. The public's trust in biomedical research depends on it.

Just after these editorials appeared, the FDA began informing drug companies that cholesterol drugs would no longer be approved on the basis that lowered TC, lowered LDL, and/or increased HDL constituted "efficacy," but that clinical benefit would have to be proven. A growing body of research suggests that reducing cholesterol, "good" or "bad," with medications apparently did not do any appreciable good at any age, especially for women, maybe a lot of harm.

Yet the marketing efforts continued, even escalated, in 2009, then aimed more at patients than their doctors and built around such themes as "What was I thinking...Now, I trust my heart to Lipitor." Again, these slick ads actually don't claim clinical benefit from taking Lipitor.

To make matters worse, "Pay for Performance" was being increasingly promoted in large hospital systems. The young physician mentioned above wrote, "One ethical dilemma I have been pondering recently is that of my future responsibility with treatments for high cholesterol and the emerging "pay-for-performance" environment of health care. Pay-for-performance, which is being implemented on various levels at different clinics/hospitals/programs, rewards & penalizes physicians on the basis of their adherence to guidelines and standards of care.

For example, a certain percentage of my earnings may be either withheld or added to my salary upon completion of an audit of medical records. If I fail to check my diabetic patients' blood sugar, or fail to adequately prescribe (or document the refusal of) hypertension medications, or fail to check cholesterol and prescribe statins accordingly, I may be penalized. On the other hand, if I do perform these things a high percentage of the time that they "should" be done, then I may be rewarded.

With the advent of physician "scores" and quality evaluations being made available to the general public, lack of adherence to current guidelines (which are relatively slow to change) could harm me significantly. I could make excuses all day long that the evidence doesn't support giving statins to elderly women or young healthy people, but this shows little promise for validating my medical decisions in the public eye, much less a courtroom. Not to mention the fact that I could be sued out of house and home (and out of my posterity's houses and homes) and perhaps even have my license revoked if I fail to follow guidelines and an adverse event (such as an MI in an untreated hypercholesterolemic patient) occurs.

After all this research I am suggesting that my brothers, who have dropped their cholesterol medication, never again allow their cholesterol levels to be checked. Moreover, I hope that each of us will minimize medical treatment of any kind and avoid it unless we understand the purpose and likely effect in some detail. No attending physician, nurse, or, more certainly, no EMT should be allowed to make our important medical decisions. We all should change our Living Wills to prohibit angioplasty even in event of a heart attack and to dictate that statins not be administered.

As for me, I will depend on my body re-routing blood around any clogged arteries, knowing now that the promised effects of cholesterol lowering drugs are nil, stents are dangerous, and open-heart surgery is deadly. In the larger picture, I fear any diagnosis for other disease might be prejudiced by the same games of misinformation. If the bones are not sticking thru the skin, a wrap will do nicely.

As I always tell people, "Check with your doctor" about important medical questions and "request appropriate tests." But I now add, "Investigate what the doctor tells you and make your own decisions."