With statin medications, used to prevent heart attacks, among the most widely prescribed drugs in the U.S., most people make certain assumptions:
There is solid science for their use.
There is no doubt that their targeted mechanism of action prevents a heart attack.
No less costly approaches exist.
None of these is entirely true.
When it comes to any widespread medical treatment, most people want to trust that the health recommendations they receive are for their benefit. People don’t want to have to evaluate the credibility of their doctor’s medical advice, no less the premises of the healthcare system. While many treatments are effective, it’s not wise to overlook that the economic motive sometimes intrudes in the health equation. This occurs because the interlocking sectors of the current healthcare system blur important ethical boundaries, and in some cases erase them.
The intrusion of economics into health science is most noticeable in the gaps between health claims and actual outcomes. When seemingly “evidence-based” research is shaped by market considerations, healthcare treatments may fall short in delivering favorable aggregate health results. In this article, I’ll explore the gap through the disputed science, and protectionism accorded one of the most widely prescribed medications in the conventional medical arsenal: Statin drugs.
Conspiracy of False Hope
Currently, 24 million Americans take statin medications that lower cholesterol as so-called “secondary prevention,” which research has demonstrated to be effective. Secondary prevention means deterring subsequent heart attacks and strokes in those who have already experienced a heart attack.
In contrast, “primary prevention” is the prevention of cardiac incidents in people who have yet to experience any cardiac problems. Though initially approved by the FDA only for the purpose of secondary prevention, statins are now in even wider use for primary prevention, despite the fact that the medical evidence of their efficacy for this specific use is sketchy. Encouraged by pharmaceutical companies, doctors often prescribe drugs beyond their proven scope of efficacy, with the result that millions can be on drugs that may or may not work, and may have harmful side effects (which can include muscle weakness, kidney damage, blood sugar levels, memory loss, and cataracts).
Statins are one of the most well-known examples of this standard practice of extended use of a drug beyond its area of solid efficacy. How does this happen?
“There’s a conspiracy of false hope,” explained Harvard Medical School’s John Abramson, a critic of widening statin use. “The public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.”
Phrases like “simple, fast, and easy,” are droned repetitively in all forms of health advice from the self-help to the medical realms. They speak to a population too pressured, preoccupied or concerned with economic goals to spend much time taking care of themselves (or each other for that matter). People are entrained by all forms of medical advertising to go for the quick fix.
The Science for Statin Use
Prescribing statins to prevent heart disease seems like a bona fide quick fix. Except that there is a debate as to whether science has demonstrated their efficacy for “primary prevention.”
That claim rests upon the findings in a sole study.
Today, the results of the so-called JUPITER study (“Justification for the Use of Statins in Primary Prevention,” published in 2008) serve as the principle basis for the statin prescriptions doctors write for millions of people who have never had heart attacks and who take them as per their doctor’s advice to prevent heart attacks.
A trio of articles published in the June 2010 Archives of Internal Medicine (AIM) revisited the JUPITER study to probe whether the efficacy claim for primary prevention is borne out by the data. The scientists found that, “contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack.”
Further, a critical analysis in this same issue of AIM probed how the JUPITER trial was conducted. This probe revealed, “Potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study.” The authors concluded that the widely hailed trial was “flawed” and raises “troubling questions concerning the role of commercial sponsors.”
What was at stake in the study outcome was “tens of billions of dollars of revenue for the sponsor over the patent life of the drug … as well as potentially millions of dollars in royalties for the principal investigator,” wrote Lee Green of the University of Michigan Medical School.
As Green admitted, “Doubtless, both sponsor and investigative team believe they made their design decisions for the right reasons… But social psychology research provides abundant evidence that we human beings both respond strongly to self-interest incentives and firmly believe that we do not. ”
You don’t need a PhD degree in psychology or sociology to understand the economic inducements that might motivate doctors evaluating drugs they have developed, weighing in on studies they have conducted, or made by companies they work for. Even though countless doctors and scientists operate with impeccable integrity, they do so within a system that permits and rewards a lack of integrity. Condoned practices (and regulatory policies) permit the potential for cross-contamination of interests, rather than offering frameworks that prevent or limit them.
Melissa Healy writing in the L.A. Times noted that:
In an ideal world, debate over the clinical virtues or vices of a drug would be long settled by the time the medication saw a meteoric rise in use. But in a healthcare system that relies on commercial incentives to spur drug development, prescription medications are a product like any other.
Government regulatory agencies, in this case the Food and Drug Administration, are supposed to act as public watchdogs. But those familiar with the workings of the FDA question the agency’s ability to manage the activities of the pharmaceutical industry. Healy adds:
The FDA assesses drugs’ safety and effectiveness for specific use; but its judgments are based on preliminary data, most of it generated by a drug company seeking approval for its product. Once the agency approves a drug for marketing, the company that makes it will move quickly and aggressively to expand the universe of patients taking its product.”
What about down-line physicians urged to fall in with these recommendations? Were all the cardiologists in the U.S. prepared to take out their prescription pads based on the questionable JUPITER study results? Yes, they were, because these results were soon thereafter instated as “standard practice.”
As noted in an article in the English medical journal, The Lancet, when the U.S. revised its guidelines for primary prevention of cardiac disease, it did so by moving the previously established benchmark for statin use: It lowered what doctors characterized as optimal cholesterol levels. That meant that millions of people who previously had cholesterol safely within the designated “optimal” range, now learned that overnight their numbers had become too high. There was no change in their actual cholesterol level. What changed was the benchmark.
An additional 23 million people thereby became candidates for statin use, which as the study authors note, “offers huge economic implications for the manufacturers of statins.”
Who changed the guidelines?
Writes Mark Hyman, MD, “Eight of the nine panel members who established these new guidelines had industry ties. An independent group of over 30 scientists in a letter to the National Institutes of Health publicly opposed these recommendations.” While it’s laudable that honest physicians stood up and attempted to clean house, it’s unfortunate that this is not an isolated instance of corruption.
Similar to the panel that established the new cholesterol guidelines, expert medical panels are routinely convened to create medical practice guidelines, Hyman points out. Physicians rely on these guidelines to “determine what medications to use and how to keep up with best practices. Yet scientists and physicians with financial ties to the industry or to the drugs being evaluated are allowed to participate in the panels and shape their decisions.
For example, Hyman says, “in a survey of 200 expert panels, one-third of the panelists had a financial interest in the drugs they evaluated.”
So while most members of the general public are wowed by the promise of objective science, the rules accepted in actual practice stray from the objective ideal.
The Right Mechanism of Action?
By designating a lower cholesterol level as optimal, the vested panelists instantly broadened their market. But since extending treatment to non-cardiac patients failed to reduce death rates, the rationale for treatment must be examined. Were lowered cholesterol levels a sound determinant for decreasing cardiac risk? Would a drug that lowered cholesterol levels wind up lessening the incidence of cardiac disease and death?
According to a National Public Radio piece, “Doctors call the practice of using a drug to move a biochemical marker, ‘treating the numbers’ — trying to get a patient’s test results to a certain target, which they assume will treat — or prevent — disease.”
But a study released in 2010 questions that widespread practice. The study found that people taking a drug that lowers cholesterol saw no corresponding change in major arterial plaque, believed to be a precursor to cardiac disease.
“It reminds us of something that we often forget: the number isn’t the outcome. And this raises concerns that just lowering the number doesn’t get you where you want to be,” Steve Atlas of Massachusetts General Hospital told the NPR reporter.
For nearly 50 years, medical treatments have targeted high levels of “bad” cholesterol as the prime contributor to plaque formation and cardiovascular illness. But over time, an increasingly vocal group of scientists have questioned the sequence of cholesterol, then plaque, then cardiovascular illness as the prime mechanisms for heart disease.
For example, aspirin, a widely used over-the-counter approach to lowering heart attack risk, and one recommended by many cardiologists, targets inflammation, not cholesterol levels. A more recent and growing body of medical thought targets inflammation as the precursor to cardiovascular illness.
The Most Effective and Low-Cost Treatment?
Statins are not the only treatment option. A natural food called red yeast rice has similar properties. When used in combination with lifestyle changes for patients who could not tolerate statins due to side effects, the supplement was found to be effective in lowering cholesterol just as effectively as statins. According to the University of Maryland Medical Center website, the red yeast rice component monocalin K, has the same chemical composition as certain statins and produces a similar effect.
Some researchers think that’s why red yeast rice lowers cholesterol. But others point out that the amount of monacolin in red yeast rice is less than you would find in the prescription drug. They think there may be other substances in red yeast rice that help lower cholesterol. More research is needed.
Statins cost approximately $100 per month in the US (400 percent the cost in the UK, a study comparing the two countries found). One month’s supply of red yeast rice costs from $13 to $20, a fraction of the cost. But there is one problem. In deference to the pharmaceutical producers of statins, in 1998, the FDA declared that the presence of monocalin K transformed the supplement into an “unapproved drug.” The FDA requires supplement manufacturers to excise the active component from their products, even though it is naturally found in the food. It’s unclear whether some trace amounts of the active components may remain in certain products.
James S. Turner, chairman of Citizens for Health, a grassroots health advocacy group, questions the rationale by which a government agency favors the business interests of the manufacturers of a synthesized product, while demanding that supplement manufacturers remove naturally occurring components in food products. This policy is part of the legal continuum that permits companies to patent genes and seeds.
On what basis does an agency charged with serving the public compel citizens to pay higher prices for a drug when a food is available at lower cost? Until a better-informed public makes the FDA accountable for such policy decisions, the favored status accorded pharmaceuticals will likely continue.