How to get FDA approval for anything!

Buying the FDA - By Terry A. RondbergWhile 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?

Neurological impact of acupuncture studied

Acupunture benefits - Terry A. Rondberg, DCIn recent years, chiropractors have once more turned their attention to the neurological component of the subluxation. After decades of concentrating on musculoskeletal aspects, it’s a move that is as timely as it is important. In the years to come, our understanding of how we impact the brain will be the key to becoming the leader in the wellness revolution.

It’s a trend we’re seeing in other non-medical fields as well. In fact, a British research study published earlier this year in the journal Brain Research revealed that acupuncture has a significant effect on specific neural structures.

The researchers explained that when a patient receives acupuncture, it triggers a sensation called deqi (literally, the arrival of chi, pronounced duh-chi). Scientific analysis shows that this energy impulse deactivates areas within the brain that are associated with the processing of pain.

Dr. Hugh MacPherson, of the Complementary Medicine Research Group in the University of York’s Department of Health Sciences, noted: “These results provide objective scientific evidence that acupuncture has specific effects within the brain which hopefully will lead to a better understanding of how acupuncture works.”

Neuroscientist Dr. Aziz Asghar, of the York Neuroimaging Centre and the Hull York Medical School, added: “The results are fascinating. Whether such brain deactivations constitute a mechanism which underlies or contributes to the therapeutic effect of acupuncture is an intriguing possibility which requires further research.”

Last summer, following research conducted in York, acupuncture was recommended for the first time by the National Institute for Health and Clinical Excellence (NICE) as a treatment option for NHS patients with lower back pain. NICE guidelines now state that GPs should “consider offering a course of acupuncture comprising a maximum of 10 sessions over a period of up to 12 weeks” for patients with this common condition.

Current clinical trials at the University of York are investigating the effectiveness and cost-effectiveness of acupuncture for Irritable Bowel Syndrome (IBS) and for depression. Recent studies in the US have also shown that acupuncture can be an effective treatment for migraines and osteoarthritis of the knee.

The York team believes that the new research could help to clear the way for acupuncture to be more broadly accepted as a treatment option on the NHS for a number of medical conditions. “Our results show the importance of collecting and accounting for needle sensation data in neuroimaging studies of acupuncture,” researchers concluded.

There’s an equally important need to collect information on the neurological impact of chiropractic adjustments, such as that being collected by doctors who use the NeuroInfiniti equipment.

ABSTRACT:  “Acupuncture needling sensation: The neural correlates of deqi using fMRI.” Brain Research, Vol. 1315, 22 February 2010, Pages 111-118.

AUDIO: Dr. Hugh Macpherson, from the University of York, discusses new research into the effects of acupuncture on the brain published in Brain Research.

Researchers discover additional benefit of Vitamin A

By Terry A. Rondberg, DC

For years, chiropractors and other non-medical wellness professionals have advocated taking nutritional supplements to make up for the deficiencies in our modern diets. Vitamin A has always been among the most recommended, since it’s critical to maternal health and child survival.

Terry A. Rondberg, DC - Vitamin A BenefitsRecently, researchers at The Johns Hopkins Bloomberg School of Public Health have found a link between a newborn’s lung function and the vitamin A supplementation the mother has taken. The results were published in the May 13, 2010, issue of the New England Journal of Medicine.

“Children of mothers who received vitamin A supplementation before, during and after pregnancy had significantly improved lung function when compared to those whose mothers received beta-carotene supplementation or placebo,” said lead author of the study, William Checkley, MD, PhD, assistant professor in the Division of Pulmonary and Critical Care of the Johns Hopkins School of Medicine with a joint appointment in the Bloomberg School’s Department of International Health. “Lung function of offspring in mothers who received maternal vitamin A supplementation improved by about 40 ml versus those whose mothers received a placebo. This represents an approximately 3 percent increase in lung function. Furthermore, the magnitude of effect observed in this study is slightly greater than that associated with preventing exposure to parental smoking in school-age children.”

Vitamin A deficiency isn’t as widespread in the US as it is in some developing countries, where nearly 190 million pre-school age children worldwide don’t get enough vitamin A — the underlying cause of night blindness among children, as well as 650,000 early childhood deaths annually. But since the main sources of natural vitamin A are raw vegetables like carrots, sweet potatoes, winter squash, spinach, and cantaloupe, many people in America and Europe are not getting enough A either.

The new study emphasizes the need to eat nutritional, wholesome meals including plenty of vegetables, or to take supplementation as a safeguard. Since medical doctors receive little or no training in nutrition, this is where chiropractors and other wellness professionals can really make a difference. By educating patients and even providing access to nutritional supplements, we can make profound differences in the lives of all the people we serve.

Chiropractic Neurology – Q & A

by Terry A. Rondberg, DC

Chiropractic Neurology - by Terry A. RondbergBased on my previous articles on the subject, it’s clear there is a lot of interest about chiropractic neurology. What’s it all about? I’m posting this blog in frequently asked question (FAQ) format to ensure you can quickly find the answers you need.

Q. What’s chiropractic neurology?

A. According to the American Chiropractic Neurology Board (ACNB), chiropractic neurology is defined as “the field of functional neurology that engages the internal and external environment of the individual in a structured and targeted approach to affect positive changes in the neuraxis and consequent physiology and behavior.”

Q. So what does that mean in plain English?

A. It means that a chiropractic neurologist examines how the nervous system is functioning (or malfunctioning). If the system is out of balance, chiropractic treatment focuses on repairing the imbalance, such as vertigo, Autism, attention deficit disorder (ADD), to restore the patient to health.

Q. What others types of disorders can chiropractic neurology address?

A. Chiropractic neurologists may treat the above conditions, as well as dizziness, disequilibrium and imbalance, dystonia, tremors, chronic pain syndromes, back pain and movement disorders. They may also treat behavioral disorders such as Tourette’s Syndrome, as well as changes in personality or motor, sensory or cognitive impairments resulting from head traumas, accident injuries, traumatic brain injury (TBI) and mild TBI.

Q. So what’s the difference between a chiropractic neurologist and a medical neurologist?

A. According to the ACNB, the chiropractic neurologist provides the same manner of consultation as a medical neurologist, with the major difference being that the therapies and applications are performed without the use of drugs or surgery. So, a medical neurologist or neurosurgeon will prescribe medications, injections or brain surgery to correct a disorder or condition. On the other hand, the chiropractic approach is to therapeutically change brain and nervous-system function.

Q. How is a chiropractic neurologist different than a “traditional” chiropractor?

A. Most chiropractors are trained in the detection and correction of spinal dysfunction. But spinal function is just one of many influences on the nervous system. A neurologist not only has completed the doctor of chiropractic program, but must receive three years of additional training and testing to become a board-certified neurologist in the chiropractic profession. The extra training is specific to the field of neurology and includes the study of neurophysiology and clinical and diagnostic techniques.

Q. What are the benefits of chiropractic neurology?

A. Simply put, many conditions of the brain and nervous system do not respond well to aggressive interventions such as drug therapy or surgery. Both drugs and surgery are often associated with increased risks for serious complications or dangerous side effects. Thus, the approach taken by chiropractic neurologists can be highly beneficial in treating brain and nervous system disorders using safe and effective methods with lasting health benefits.

Neurofeedback Defined – By Dr. Terry Rondberg

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.