Terry A. Rondberg, DC | Wellness for Mind and Body

While pharmaceutical companies have boasted for decades that their pills and potions are “approved by the FDA,” does that really mean anything? Apparently, very little, if the story of how one drug — Multaq (dronedarone) — “earned” its approval is any indication.

Drug maker Sanofi-Aventis touts Multaq on its website as “a prescription medicine used to lower the chance you would need to go into the hospital for heart problems.” The FDA’s decision to approve the drug was based primarily on a study conducted last year by Richard Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health. The paper was published in The New England Journal of Medicine.

However, it turns out that Page was pretty much “bought and paid for” by Sanofi-Aventis. The drug company PAID for the research, collected data, and performed the analysis without an external audit. Page put his name on the paper, never having seen the raw data. He simply trusted the company to be honest and ignored the fact that the major financial experts, including Morgan Stanley, estimated the drug could reach nearly $3 billion in revenues.

In addition, Page and four co-authors were Sanofi-Aventis paid consultants and/or speakers, and two co-authors worked directly for Sanofi-Aventis, and owned stock in the company.

Despite all that, Page shrugged it off with a glib, “There is a sense of trust that they won’t falsify data.” Either he’s incredibly naïve, or he thinks the rest of us are.

To add injury to insult, the Multaq branded pill was selling for 47 times as much as its generic equivalent — in Britain Sanofi was selling the drug for £2.25 pounds per day, compared to 5 pence a day for a generic competitor, amiodarone. That equates to $3.30 compared to 7¢!

But wait … it gets better. Another research study (this one, by researchers at the Cedars-Sinai Heart Institute — Journal of the American College of Cardiology, 2010; 55: 1569-76) has concluded that the branded drug is far less effective than the current standard drug, Cordarone (amiodarone) for atrial fibrillation, and has no safety benefits.

That’s pretty much what was known back in 2003, when a drug trial was actually stopped because patients receiving Multaq were dying in greater numbers than those getting a placebo.

Still, the drug was “approved” by the FDA. You have to ask yourself — what would it take for a drug to be rejected?

It’s true. According to a study conducted by researchers from University College London and published in the European Heart Journal, people with more stressful jobs have a higher risk of developing heart disease.

For 12 years, researchers monitored a group of British civil servants by gathering data related to their heart rates, blood pressure, and cortisol (stress hormone) blood levels.  Participants were asked about their jobs, diet, exercise, smoking and drinking habits.

Researchers found that participants who reported a high degree of stress, were 70 percent more likely to develop coronary heart disease than those who reported no stress. The effect held for men and women and was strongest for people under age 50.

Among people of retirement age, those with less exposure to work stress, the effect on coronary heart disease was less severe.

Researchers also noted that people with more stress reported having less time to eat healthy or exercise properly, which would increase their risk of heart disease. But the stress itself was also associated with biological factors that increased risk.

People who reported more stress also had higher levels of cortisol in their blood, even after awakening. This suggests that stress interferes with the body’s ability to properly regulate the neuroendocrine system, which releases hormones.

Long-term exposure to stress hormones will damage the body. Those reporting more stress also demonstrated poor functioning of the part of the nervous system which regulates the heart beat.

The British Heart Foundation welcomed the study results, and said it is vital for people to make the time to exercise. Being physically fit helps relieve stress and is one of the most important factors for reducing the risk of heart disease.

About the Author – Terry A. Rondberg, DC
Dr. Terry Rondberg is a chiropractic visionary who writes and speaks worldwide on the subject of wellness. He resides in Rancho Santa Fe, Calif., where he enjoys running several businesses, pursuing yoga and martial arts, and spending time with his family.