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?

The Amazing Human Brain, Part Two – Dr. Terry A. Rondberg

Part Two of a Two-Part Series.

The dominant anatomical feature of our brain is the undulating surface of the cerebrum – the deep clefts are known as sulci and its folds are gyri. The cerebrum is the largest part of the brain and is largely composed of the two cerebral hemispheres. In terms of evolution, it is the most recently developed brain structure, dealing with more complex cognitive brain activities.

It is often said the right hemisphere is more creative and emotional while the left deals with logic, but the reality is more complex. Nonetheless, the two sides have some specializations, with the left focusing on speech and language and the right focusing on spatial and body awareness.

Further anatomical divisions of the cerebral hemispheres are the occipital lobe at the back of the brain and the parietal lobe positioned above the occipital lobe. The former lobe is devoted to vision, while the latter controls movement, position, orientation and calculation.

Behind the ears and temples lie the temporal lobes, dealing with sound, speech comprehension and some aspects of memory. To the fore are the frontal and prefrontal lobes, often considered the most highly developed and most “human” of regions, controlling thought, decision making, planning, conceptualizing, attention control and working memory. They also deal with various social emotions such as regret, morality and empathy.

Another classification is the sensory cortex and motor cortex, controlling incoming information and outgoing behavior, respectively.

Below the cerebral hemispheres, but still referred to as part of the forebrain, is the cingulate cortex, which directs behavior and pain. Beneath it lies the corpus callosum, connecting the two sides of the brain. Another significant area of the forebrain is the basal ganglia, responsible for movement, motivation and reward.

Beneath the forebrain lie more primitive brain regions. The limbic system, common to mammals, deals with urges and appetites. Meanwhile, the brain structures of the amygdala, caudate nucleus and putamen are most closely linked with emotions. The limbic brain also houses: the hippocampus – vital for memory formation; the thalamus – a sort of sensory relay station; and the hypothalamus, which is reponsible for regulating bodily functions.

The back of the brain has a highly convoluted and folded swelling called the cerebellum, which stores movement patterns, habits and repeated tasks – actions we perform without much thought.

The most primitive parts, the midbrain and brain stem, control the bodily functions we conduct subconsciously, such as breathing, heart rate, blood pressure, and sleep patterns. These parts of the brain also control signals that pass through the spinal cord between the brain and the rest of the body.

Though we have discovered an enormous amount of information about the brain, crucial mysteries remain. For instance, how does the brain produces our conscious experiences?

The majority of the brain’s activity is subconscious. But our conscious thoughts, sensations and perceptions, which define us as humans, have yet to be explained by brain activity.

About the Author – Terry A. Rondberg, DC.

Dr. Terry Rondberg received his Doctor of Chiropractic (DC) at Logan College, and has gone on to found the World Chiropractic Alliance, The Chiropractic Journal, and author several books on chiropractic and wellness.

The Amazing Human Brain, Part One – Dr. Terry A. Rondberg

Part One of a Two-Part Series.

The brain, it is said, is the most complex organ in the human body. It produces our thoughts, actions, memories, feelings and experiences. This jelly-like mass of tissue, weighing about 1.4 kilograms, contains one hundred billion nerve cells, or neurons.

The complexity of the connectivity among these cells is mind-boggling. Each neuron can make contact with tens of thousands of other neurons, via tiny structures called synapses. In fact, our brains form a million new connections for each and every second of our lives. The pattern and strength of the connections is continuously changing and no two brains are identical.

In these changing connections, memories are stored, habits are learned and personalities are shaped, from reinforcement of certain brain activity patterns and losing others.

While most people know about “gray matter,” the brain also contains white matter. The gray matter is the cell bodies of the neurons, while the white matter is the branching network of thread-like tendrils, called dendrites and axons. They spread out from the cell bodies to connect to other neurons.

Another cell is the glial cells. These outnumber neurons ten times over. Once thought to be support cells, they are now known to amplify neural signals and to be as important as neurons in mental calculations. There are many different types of neurons, only one of which is unique to humans while the other is unique to great apes, the so-called spindle cells.

Brain structure is shaped in part by genes, but mostly by our experiences. In fact, via a process called neurogenesis, new brain cells are being created throughout our lives. The brain experiences bursts of growth and also periods of consolidation, when excess connections are pared. The most notable bursts are in the first two or three years of life, during puberty, and also a final burst during young adulthood.

Brain maturity also depends on genes and lifestyle. Exercising the brain and proper nutrition are just as important as it is for the rest of the body.

Our neurons communicate in various ways. Signals pass among them by the release and capture of neurotransmitter and neuromodulator chemicals, such as glutamate, dopamine, acetylcholine, noradrenalin, serotonin and endorphins.

Some neurochemicals work in the synapse, passing specific messages from release sites to collection sites, called receptors. Others also spread their influence more widely, like a radio signal, making whole brain regions more or less sensitive.

Deficiencies in certain neurochemicals are linked to disease. For example, a lack of dopamine in the basal ganglia (the part of the brain that controls movement) leads to Parkinson’s disease. It can also increase susceptibility to addiction because dopamine affects our sensations of reward and pleasure.

Similarly, a deficiency in serotonin, used by regions controlling the emotion, can be linked to depression or mood disorders, and the loss of acetylcholine in the cerebral cortex is characteristic of Alzheimer’s disease.

Within individual neurons, signals are formed by electrochemical pulses. This electrical activity can be detected by an electroencephalogram (EEG), placed outside the scalp . These signals have wave-like patterns, which scientists classify from alpha (common while we are relaxing or sleeping), to gamma (active thought). When this activity goes awry, it is called a seizure. Some researchers think that synchronizing the activity in different brain regions is important for perception.

There are other, indirect ways of imaging brain activity. Functional magnetic resonance imaging or positron emission tomography monitor blood flow. MRI scans, computed tomography scans and diffusion tensor images (DTI) use the magnetic signatures of different tissues, X-ray absorption, or the movement of water molecules in those tissues, to image the brain.

These and other scanning techniques have helped determine which parts of the brain are associated with which functions. For example, different parts of the brain govern activity related to sensations, movement, libido, choices, regrets and motivations. However, some experts argue that we put too much trust in these results, which also raise privacy issues.

Before scanning techniques, researchers relied on patients with brain damage caused by strokes, head injuries or illnesses, to determine which brain areas perform certain functions. This approach exposed the regions connected to emotions, dreams, memory, language, perception and to more enigmatic events, such as religious or “paranormal” experiences.

One famous example was the case of Phineas Gage, a 19th century railroad worker who lost part of the front of his brain when a 1-metre-long iron pole blasted through his head during an explosion. He recovered physically, but experienced permanent personality change, showing for the first time that specific brain regions are linked to different processes.

About the Author – Terry A. Rondberg, DC

Dr. Terry Rondberg is has been a champion of the chiropractic profession for decades. After receiving his Doctor of Chiropractic (DC), Dr. Rondberg founded The Chiropractic Journal, the industry’s first professionally edited source for chiropractic news and features.

Chiropractic Instrumentation – Terry A. Rondberg, DC

Dr. Terry Rondberg
Terry Rondberg

Chiropractic Instrumentation

Not long ago, the only “instrumentation” chiropractors needed was their own hands. We palpated for subluxations, conducted relatively simple range-of-motion or leg length exams, and detected subluxations and corrected them.  Later, we obtained X-Ray machines that helped verify our visual and manual findings, although we never relied solely on this machine and still remained confident in our sense of touch and sight. That, however, was before outcome measurements, evidence-based practices, reliance on third-party payers, and an appreciation for the science as well as the art and philosophy of chiropractic.

Over the years there have been several developments in instrumentation for chiropractic use: weight scales, postural measuring, galvanic skin response measurements, para-spinal thermal devises etc. Although much of the instrumentation has provided valuable information for Chiropractic, it has been rated as scientifically unacceptable and has given non-reproducible results.

Earlier chiropractic instrumentation was bulky, awkward, and hard to use. I often wonder how many doctors and staff members gave up trying to learn about their new equipment and how much of that equipment is now sitting in a corner. I have seen some classified ads on popular Internet websites.  Here are some of the actual descriptions for sEMG machines on sale:

  • “Brand-new condition; rarely used.”
  • “Unit is like brand new, Less than 2 years old and used only about a dozen times.”
  • “All in great condition, dynamic SEMG never used.”
  • “Great condition — rarely used.”


“Today, in order to deliver the safest and most effective chiropractic care to our patients, and satisfy the more stringent requirements of the insurance industry, the government, and the courts, we must go beyond just feeling for subluxations.” – Terry A. Rondberg, DC

Thanks to computerized techniques, we now gather a wide range of data for neurological activity, leading to a better understanding of normal/ideal functional levels.  Surface electromyography (sEMG) and para-spinal thermal scans made a huge contribution about 12 to 15 years ago. While these seemed to support the chiropractic position of spinal care and joint mechanics, one must question if this deals with cause?  Furthermore, X-Rays, sEMG and thermal scans offer a static view of a dynamic being.  To base any care on a single static view is questionable. These instruments have served their purpose, which demonstrates the value of objective measurements in replacing the anecdotal foundations of chiropractic. It is better to move towards objective evidence than just sharing our philosophy and telling the chiropractic story.

In addition to sEMG, inclinometry and infrared temperature evaluations, instrumentation provides the ability to perform stress assessments and neurofeedback.  Much of this was developed by doctors of chiropractic Richard Barwell and Ken Vinton; it translates all data into detailed neurological reports that validate and document all clinical findings and guide health care decisions. This equates to the survival of modern chiropractic practice and plays an important role in case of a lawsuit or board complaint. Another reason to choose the NeuroInfiniti Instrumentation is that it is currently the only reliable system that allows field doctors to participate in a global research project that will prove the effects of how correcting vertebral subluxation impacts the autonomic nervous system while proving the real value of chiropractic care. The ultimate goal is to accumulate and analyze objective data from all the doctors who use the NeuroInfiniti to demonstrate the efficacy of chiropractic, to elevate our professions acceptance insure our rightful place in the health care professions.

We need powerful instrumentation that not only aids us in detecting subluxations, but provides an accurate outcome assessment system which correlates the value of what we do. Since chiropractic is the largest natural health care system in the world, we need the highest quality instrumentation. Let’s not settle for less.

We are working with state-of-the-art instrumentation developed for chiropractic that will transform chiropractic offices into the most effective, health care resources ever offered to the public.  A scientific evidence based practice will act as a patient magnet, drawing families into your office so you can provide the finest chiropractic care.

We do not often have the opportunity to revolutionize our offices, dramatically increase our patient volume and revenue, help more people lead healthier lives, and contribute to research validating what DD and BJ represented.  Chiropractic is a fast-moving profession.  Physicians can either join the frontrunners or be left in the dust.  They can either create the practice and the profession of their dreams today or they can continue to do nothing.

About the Author – Terry A. Rondberg, DC.
As CEO of the World Chiropractic Alliance, Dr. Terry Rondberg is the author of myriad, thought-provoking articles in the wellness field. He is the author of several best-selling books on the subject of chiropractic, and is a sought-after speaker at medical events worldwide.

Neurological Activity (Part Three) – By Terry A. Rondberg, DC

Part Three of three articles.

In a previous Journal article, although medical authorities acknowledge neurological complications may occur as a result of subluxation, classical chiropractic definitions mandate the presence of a neurological component.  Researcher, Charles Lantz, PhD, DC, writes, “Common to all concepts of subluxation are some form of kinesiological dysfunction and some form of neurological involvement.”

Nevertheless, we’re often ignoring that neurological involvement.  As a result, we are known as back-pain doctors and used the same way as aspirin or exercise equipment: to relieve musculoskeletal stiffness and pain.  One reason is we were sold a bill of goods to find a “niche” market. Back pain, we were told, was a lucrative market, with nearly eight of every ten adults suffering from it at one time or another. We thought the medical profession would allow us to treat back pain as long as we did not invade their territory.

It was also less complicated to describe how chiropractic could ease back pain than it was to explain the entire vitalistic philosophy.  It was also easier to advertise.  All we had to do was show a person with red lightning bolts radiating from his or her back or neck and we were in business!

The final reason we ignored the neurological component was that we didn’t have the scientific research to prove what we knew from clinical experience.  As Dr. Davila says, “We need to show a neurological connection to the subluxation so we have the proof we have talked about over the years and then tie that connection to functional improvement.”
Why then is so much of our current research focused on back pain and similar musculoskeletal conditions?  Here, for instance, is the complete list of all the projects funded by FCER last year:

  • “Chiropractic Dosage for Lumbar Stenosis”
  • “Chiropractic and Acute Neck Pain: A Practice-Based Study”
  • “Preventive Care of Chronic Cervical Pain and Disabilities: Comparison of Spinal Manipulative Therapy and Individualized Home Exercise Programs”
  • “Does Chiropractic Care Decrease Fall Risk in Older Adults?”  (The grant description notes that: “It is proposed that balance, the risk factor for falls, is adversely affected by both musculoskeletal function and low back and lower extremity pain — which have been found to be responsive in previous studies to chiropractic intervention.”)


Do you see the pattern here?  Instead of locking our profession in the miniscule musculoskeletal box, we need to reclaim the missing component of subluxation: neurological involvement. The World Chiropractic Alliance is dedicated to this mission.  We must discuss with our patients and members of the community, integrating it in our patient education programs. It is also necessary to redesign our advertising so we are not reinforcing the old, erroneous idea of back pain doctors. Furthermore, we should demand that our colleges and research institutions stop plucking the low-hanging fruit by examining the connection between chiropractic and back pain! Field doctors need to start using the NeuroInfiniti instrumentation to accurately measure a patient’s neurological response before and after subluxation correction, and learn to document vital information for use not only in research but for the government and all insurance companies.

In the hundred-plus years since DD Palmer discovered chiropractic, we’ve lost much of the spirit and substance of chiropractic. If we lose the neurological component of the subluxation, we will lose our original identity and possibly, our future.

I don’t want to wait until someday for chiropractic validation. Certainly, you do not wish to wait to transform your office into a smooth-running and modern, scientific evidence-based practice, with easy-to-use technology that maximizes your patient outcomes AND your bottom line! However, we do not need to wait until that elusive someday.  We can have it all NOW.

About the Author – Terry A. Rondberg, DC.
As CEO of the World Chiropractic Alliance, Dr. Terry Rondberg is known worldwide as one of the chiropractic profession’s leading proponents. After receiving his Doctor of Chiropractic (DC) Dr. Rondberg began publishing The Chiropractic Journal, a leading publication in the field. In addition to publishing the Journal—which continues to be an authoritative reference for chiropractic practitioners and professionals —Dr. Terry Rondberg has written a number of best-selling books on the subject of chiropractic.