Globalist Perspective

Limbaugh, Lipitor and the Incivility of American Political Life (Part I)

Is the widespread use of statins such as Lipitor responsible for America’s politics of anger?

Credit: jordache/Shutterstock.com

Takeaways


  • Expenditures on marketing statins has assured that most of the medically insured, over-50 population of the United States has been prescribed statins.
  • How likely are the scientific establishment and the agencies that regulate prescription drugs to detect more subtle changes if no one is looking for them?
  • One study found that violent criminals had significantly lower cholesterol than others identical in age, sex, alcohol indices and education.
  • Vytorin was shown to be no more effective than the oldest and cheapest statin, but racked up $5 billion of sales in its first year on the market.

The last decade or so has seen a distinct lack of civility and successful collaboration in our national civic life. Politicians of all stripes seem unable to bridge their ideological differences to collaborate on the process of government. Personal animosities and ambitions at times seem to influence the political dialogue more than any constructive agenda.

Perhaps not coincidentally, these developments (like the phenomenon of road rage) parallel the unprecedented widespread use of potent new drugs by millions of men and women over the age of 40. These drugs are called statins, and include the commercial blockbusters Lipitor, Zocor and Crestor, which now account for over $30 billion a year in global pharmaceutical sales. On February 28, the U.S. Food and Drug Administration (FDA) announced it would now require labels for statin drugs to carry new warnings about side effects, including memory loss, confusion and increased risk of Type 2 diabetes.

It is undisputed that statins can reduce fatal heart attacks in patients with increased risk factors — such as diabetes, very high cholesterol, or prior heart attack — and that these drugs can be life-saving for some patients. However, for the general population (more precisely, the male population), statin treatment offers about a 30% reduction in the risk of heart attack. While that sounds impressive, what it means is that a healthy 60 year-old who has a 10% risk of having a heart attack over the next decade can reduce that risk to 7% with statins.

This risk-reduction data has been the basis of broad recommendations for the treatment of much of our “midlife” population with statins, assisted by over $2 billion a year of aggressive marketing efforts by major pharmaceutical companies. Remarkably, the benefit in women has actually never been documented, nor the benefit in men over 70 years of age.

According to Dr. John Abramson, a professor at the Harvard Medical School and author of Overdosed America: The Broken Promise of American Medicine, “These drugs have been on the market for 21 years… and yet there is still not a single study that documents a health benefit to women of any age, or men over 65 who don’t already have heart disease or diabetes.”

A large study by Bristol-Myers Squibb, known as PROSPER, showed that patients over age 70 who were at high risk but didn’t yet have heart disease saw no cardiovascular benefit from taking statins, and had no decrease in mortality. Yet the immense yearly expenditures on marketing statins has assured that over the past decade most of the medically insured, over-50 population of the United States has been prescribed statins.

Statins and aggression

Overlooked in the developed world’s rush to medicate cholesterol to lower and lower levels have been profound questions about the relationship between cholesterol and cognitive function, mood and behavior. The pre-statin scientific literature provided numerous hints of a link between low (or lowered) cholesterol and violent death, as well as aggression. Reducing cholesterol reduces levels of serotonin, a critical brain neurotransmitter, and low brain serotonin is well known to be linked to violence, impaired impulse control and aggression in both humans and animals.

Additionally, over at least the past ten years, a number of small studies and case reports have reported a compelling relationship between statin use and cognitive symptoms such as memory loss and loss of concentration, especially in women, which could also be an effect of altered neurotransmitter levels.

Dr. Beatrice Golomb, lead researcher on the single U.S. study currently investigating the side effects of statins (including effects on cognition and behavior), published an alarming medical paper in 2004. This “case report” study documented personality changes involving extreme aggression and irritability (including road rage incidents and homicidal impulses), which occurred in six patients (four male and two female) on cholesterol-lowering drugs. The personality changes resolved when the patients stopped the drug. In four patients, they recurred when doctors assured the patients that the changes could not be statin side effects and restarted the drugs.

A study published in 2000 looked at the cholesterol measurements of 79,777 individuals and subsequent police records for violent crimes. The study found that violent criminals had significantly lower cholesterol than others identical in age, sex, alcohol indices and education.

These dramatic behavioral responses to statins may represent the tip of a much larger iceberg. While only a small percentage of patients may be unusually susceptible to the behavioral effects of lowered cholesterol, how likely are scientists and physicians (not to mention patients) to associate less pronounced increases in aggression and irritability with a medication their doctor prescribes for their heart?

How likely are the scientific establishment and the agencies that regulate prescription drugs to detect more subtle changes if no one is looking for them — and the drug industry has a huge financial incentive to discourage their study?

In 2007 a New Zealand study published in the journal Drug Safety looked at the reported side effects from statins in that country. “The reactions mentioned in these reports include depression, memory loss, confusion and aggressive reactions,” the authors concluded. “Convincing reports of recurrence of these reactions upon re-challenge add weight to recent studies reporting serious psychiatric disturbances in association with statin treatment.

The study’s authors noted that while aggressive behavior associated with statins is still poorly documented, “these observations emphasize the need to be vigilant in looking for these reactions as they can have a significant personal impact on a patient.”

Large population studies in Scandinavia have also shown a significant statistical association between low cholesterol levels and motor vehicle accidents, violent death, and incarceration for violent crime.

Risk of depression was recently added by the FDA to the label of Vytorin, the most recently approved and expensive cholesterol-lowering drug, after numerous reports of the side effect to the FDA. This new warning, along with other significant cognitive side effects for this and other statin drugs, raises the deeper issue of whether more subtle behavioral side effects may be changing the civility of our political discourse.

Meanwhile, Vytorin — which, in Merck’s own (reluctantly released) large study, was shown to be no more effective than the oldest and cheapest statin in preventing plaque build-up in arteries — racked up $5 billion of sales in its first year on the market.

Continue to Part II of this article.

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About Edward Bernton

Edward Bernton has worked for more than 15 years in the field of clinical pharmacology and early-phase drug development. He is currently a consultant to small biotech companies.

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