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?
The media constantly communicates to its vast audience the recent medical breakthroughs. Traditional medicine dominates our society. The recent medical mishaps such as dangerous prescription painkillers, are associated with the failures of regulators who ignore the apparent loopholes of allopathic medicine.
However, alternative health care is gaining attention. It is commonly utilized by the general population. A recent study by Hong at Ohio State University found that nearly three out of four adults over age 50 use some type of alternative medicine. Hong noted, “The most commonly used…was chiropractic, which about 43% of respondents had used.” [1]
Unfortunately, the general public is unaware of chiropractic’s potential contribution to overall wellness.
According to the results of the World Federation of Chiropractic (WFC) survey titled, “Identity of the Chiropractic Profession,” only five percent of participating DCs believed the public considers that chiropractors are doctors who correct subluxations, while 81% believe the public defines chiropractic as doctors who help treat back and neck pain.” [2]
Eighty‑five percent of the chiropractors said the nervous system is essential to the practice of chiropractic, and 65% indicated the public should define chiropractic as stress and subluxation correction.
In 2003, the Institute for Social Research at Ohio Northern University conducted a survey of North American chiropractors. The results showed that 89.8% of respondents felt adjustments should not be limited to musculoskeletal conditions and 88.1% felt that the term vertebral subluxation complex should be withheld. [3]
Some chiropractors have expressed that the public perception should identity the profession. Others wish to limit our role to musculoskeletal pain practitioners, justifying their position by claiming that only low back pain has sufficient research evidence and backing. Both sides are incorrect for reasons I have discussed elsewhere. [4,5]
A successful public relations approach should match the public’s interest with our vision of chiropractic. It is necessary for the public to be properly educated on how chiropractic meets their needs.
The success of this strategy came to light when Dr. Madeline Beherendt’s study on infertility was published in the Journal of Vertebral Subluxation Research, (JVSR) which resulted in positive and credible media coverage for chiropractic.
Among the television programs reporting the study’s results were: KBCI Boise, WCBS New York, KING Seattle, KYW Philadelphia, WTNH New Haven, KUTV Salt Lake City, WCPO Cincinnati, WOAI San Antonio, KOLD Tucson, and KPTM Omaha. On one of the specialized health news wire services, the press release was accessed by journalists more than 700 times by the end of March. [6]
Furthermore, Dr. Erin Elster, an upper cervical chiropractor in Boulder, Colo., gathered data from 44 MS patients and 37 PD patients treated during the span of five years. After treating upper neck injuries in 81 patients, 91% of MS patients and 92% of PD patients improved, suggesting that correction of neck injuries may reverse MS and PD.
The Chiropractic Journal reported, “The World Chiropractic Alliance (WCA), publisher of JVSR, distributed a press release on the research results, which was quickly picked up by major news media, including Reuter’s wire service. The news was relayed to newspapers and television stations around the world, and the story showed up in a wide array of media.
“Viewers watching CNN coverage of the Florida hurricanes saw the headline scroll by on the late breaking news crawl … readers saw all the details in The Washington Post … Internet browsers found the story on sites as varied as the National Institutes of Health’s MEDLINE and the Armenian Medical Network. Yahoo News featured the story and it even appeared on the Merck pharmaceutical company’s website.
“Within days, millions of people were exposed to information about chiropractic and how correction of subluxations might result in an improvement or reversal MS and PD. Although the research examined the two specific diseases, the press release emphasized that the role of chiropractic was not to diagnose or treat those diseases directly, but to correct subluxations and, in doing so, affect the progress of the diseases.” [7]
More recently, a collaborative study of chiropractic care, oxidative stress, and DNA repair has peeked the interests of medical news services and alternative health websites. [8, 9]
The public and journalists are not interested in “manipulation” for the treatment of low back pain. However, they are interested in learning about chiropractic as a focal point on wellness and quality‑of‑life issues often neglected by traditional medicine.
The answer is university-based research and not just a few studies focusing on small case histories. Although encouraging, a long‑term solution must be implemented. The university based research, should involve thousands of patients, and published in prestigious, medical journals. The group QOLR has embodied this challenge but your assistance is paramount.
About the Author – Dr. Terry Rondberg
Terry A. Rondberg, DC, is a tireless advocate for drug-free chiropractic, chiropractic patients, wellness, and the mind-body connection for physical, mental, emotional and spiritual well-being. As CEO of the World Chiropractic Alliance, he is a global activist for the interests of doctors of chiropractic and their patients.
Neurofeedback has evolved from a fascination during the ‘60s and ‘70s to the current mainstream methodology for improving certain health conditions and human performance. Neurofeedback, like chiropractic, was considered a radical type of health care approach, but as the years have passed, it has become more mainstream. Now it is accepted as another form of health care.
This evolution has been driven by years of scientific research demonstrating that the mind and body are connected, and that people can be taught to harness the power of this connection to improve physical activity and health. Interest in neurofeedback is growing, and the need for an answer to: “what is neurofeedback and why is it a perfect fit for chiropractic?” The leading professional organizations representing the field have provided the following definition:
“Neurofeedback is a process that enables an individual to learn how to change physiological activity for the purposes of improving health and performance. Precise instruments measure physiological activity such as brainwaves, heart function, breathing, muscle activity, and skin temperature. These instruments rapidly and accurately “feed back” information to the user. The presentation of this information — often in conjunction with changes in thinking, emotions, and behavior — supports desired physiological changes. Over time, these changes can endure without continued use of an instrument.”
The patient is strapped to sensors that provide real-time readings of internal bodily processes, such as muscle tension, blood pressure, heart rate, skin temperature and brain-wave activity. Then, they are taught strategies to gain better control over those processes, which can help achieve certain health goals.
Neurofeedback is like using computers to listen to your body and displaying that information so you can see it and decide how to change it. We think of this as an emotional exercise. You use your head instead of your muscles.
It is directly training the brain to function more efficiently. We observe the brain in action from moment to moment and share that information with the patient. Then we reward the brain for changing its activity to more appropriate patterns. This is a gradual learning process. It applies to any aspect of measurable brain function. Neurofeedback is based on electrical brain activity, the electroencephalogram or EEG.
Practitioners apply electrodes to the scalp to listen to brainwave activity. The signals are processed by computer, and we extract information about certain key brainwave frequencies. (All brainwave frequencies are equal, but some frequencies respond differently). We show the ebb and flow of this activity to the patient, who then attempts to change the activity level. We promote some frequencies but other frequencies, we hope to diminish. We present this information to the person in the form of a video game. The person is effectively playing the video game with his or her brain. Eventually, the brainwave activity is “shaped” toward more desirable, more regulated performance. The frequencies we target, and the specific locations on the scalp where we listen to the brain, are specific to the conditions we try to address, and to the individual.
About the Author – Terry A. Rondberg, DC
Terry Rondberg, known worldwide as an expert on chiropractic and wellness, is publisher of The Chiropractic Journal and the author of several books on the medical field, including Chiropractic First and Under the Influence of Modern Medicine.
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.
According to a recent national survey by the U.S. Centers for Disease Control and Prevention, more than one in nine children and teens use herbal supplements or some type of alternative medicine.
This is the first time children’s use of such remedies, including meditation and chiropractic care, has been measured. Adult use of alternative care remains about the same as it was in 2002 — more than one in three.
Given that children are generally healthy, the finding that one in nine uses alternative medicine is astounding.
The study is based on a 2007 survey of more than 23,000 adults who discussed themselves and more than 9,000 adults who spoke on behalf of a child in their home.
The adults most likely to report using alternative care were women, college graduates and those who live on the West Coast. Among most adults, alternative care was used equally by those with private health insurance and those without.
Children were five times more likely to use alternative care if a parent did. Those covered by private health insurance were more likely to use alternative care than children who were uninsured or covered by public programs.
In 2002, adult use was 36 percent, compared to 38 percent in 2009.
In this decade, many academic medical centers and other mainstream health care providers have integrated alternative care into their research and patient services. Chiropractors can be found in general hospitals. Insurance coverage and licensing of alternative care is on the rise.
There were differences in how the 2002 and 2007 surveys were conducted. Regarding herbal remedies, the 2007 study asked participants whether they had used such a product in the previous 30 days, while the 2002 study asked if they had taken it in the past year.
In both studies, herbal remedies were the most popular form of alternative care for adults. In the latest survey, nearly one in five adults reported taking a supplement in the previous month.
For adults, pain was the primary reason for seeking chiropractic care.
About the Author – Dr. Terry Rondberg Terry A. Rondberg, DC, is a nationally recognized author, speaker and publisher on chiropractic care and wellness. He’s an outspoken proponent of chiropractic and drug-free healthcare.
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.
