The fear of losing cognitive ability tends to overshadow the fear of physical disability; 60 percent of American adults say they are “very worried” or “somewhat worried” about memory loss.1
Chances are, you’re among this majority. The good news is that your brain is a dynamic organ, constantly adapting and changing, for better or for worse.
While some activities, such as lack of sleep, can have a detrimental effect on your memory and brain function, a healthy lifestyle will support your brain health over the long haul, and can even encourage your brain to grow new neurons—a process known as neurogenesis or neuroplasticity.
This phenomenon was not known when I was in medical school. Back then, we were taught that the loss of brain cells was an irreversible condition and there was nothing you could do to change it.
It’s Never Too Late for Your Brain to Regenerate Brain Cells
Your brain’s hippocampus, i.e. your memory center, is particularly adaptable and capable of growing new cells throughout your entire lifetime, even into your 90s, provided you give it the tools to do so!
For example, one year-long study found that adults who exercised were actually enlarging their brain’s memory center by one to two percent per year, where typically that center declines in size with age.
According to John J. Ratey, a psychiatrist who wrote the book Spark: The Revolutionary New Science of Exercise and the Brain, there’s overwhelming evidence that exercise produces large cognitive gains and helps fight dementia. Indeed, research has shown that exercise helps protect your brain by:
•Improving and increasing blood flow to your brain
•Increasing production of nerve-protecting compounds
•Improving development and survival of neurons
•Altering the way damaging proteins reside inside your brain, which appears to slow the development of Alzheimer’s disease.
In animal studies, significantly fewer damaging plaques and fewer beta-amyloid peptides, associated with Alzheimer’s, were found in mice that exercised. Diet, sleep, and exercise are three lifestyle factors that can significantly influence your brain health and memory. Here, we’ll discuss the influence of exercise, as recent research has again confirmed its ability to improve memory.
One way by which exercise benefits your memory is by prompting nerve cells to release proteins known as neurotrophic factors. These growth factors signal brain stem cells and muscle satellite cells to convert into new neurons and new muscle cells respectively.
This in part explains how exercise benefits both your muscles and your brain at the same time. One growth factor in particular, called brain-derived neurotrophic factor (BDNF), triggers numerous other chemicals that promote neural health, and directly benefits cognitive functions, including learning. Fasting also triggers BDNF, and in combination (i.e. exercising while fasting) can go a long way toward keeping your brain, neuromotors, and muscle fibers biologically young.
Lifting Weights Improves Memory, Study Shows
A 2010 study2 on primates revealed that regular exercise helped the monkeys learn new tasks twice as quickly as non-exercising monkeys. This is a benefit the researchers believed would hold true for people as well. More recently, researchers at Georgia Institute of Technology in Atlanta found that a mere 20 minute weight training session could improve long-term memory in the participants. You can see that in the above video.
According to lead researcher Lisa Weinberg: “Our study indicates that people don’t have to dedicate large amounts of time to give their brain a boost.” In this experiment, 46 volunteers were randomly assigned to one of two groups—one active, and one passive. Initially, all of the participants viewed a series of 90 images, classified as either positive, neutral, or negative. Afterward, they were asked to recall as many images as they could.
Next, the active group was told to do 50 leg extensions at personal maximum effort using a resistance exercise machine. The passive participants were asked to simply sit and let the machine move their leg for them. Two days later, the participants were again shown a series of images, including ones they’d not seen previously. Interestingly, even though it was two days since they performed the leg extensions, those in the active group had markedly improved image recall. As reported by Medical News Today:3
“The researchers found about 50 percent of the original photos were recalled by the passive group, while the active group remembered about 60 percent of the images. All of the participants were better at recalling the positive and negative images than the neutral images, but this was even more true for the active participants. The researchers suggest that this is because people are more likely to remember emotional experiences following short-term stress.
The team believes their results are consistent with previous research in a rodent model that found stress responses result in releases of norepinephrine – a hormone that may improve memory… The Georgia Tech study looked at weight exercises, but… other forms of resistance exercise – such as squats or knee bends – would most likely produce similar results.”
Exercise Builds New Brain Cells and Boosts Brain Performance
The hippocampus belongs to the more ancient part of your brain known as the limbic system, and plays an important role in the consolidation of information from your short-term memory to your long-term memory, as well as spatial navigation. Previous animal research4 has found that not only does exercise activate hippocampal neurons, it actually promotes their growth. In one study,5 exercising mice grew an average of 6,000 new brain cells in every cubic millimeter of tissue sampled. The growth occurred in the hippocampus, the memory center of the brain, and the mice showed significant improvements in the ability to recall memories without any confusion. A number of other studies have investigated the impact of exercise on brain performance and IQ. Some of the research highlights6 include:
•Among elementary school students, 40 minutes of daily exercise increased IQ by an average of nearly four points
•Among 6th graders, the fittest students scored 30 percent higher than average students, and the less fit students scored 20 percent lower
•Among older students, those who play vigorous sports have a 20 percent improvement in Math, Science, English, and Social Studies
•Students who exercised before class improved test scores 17 percent, and those who worked out for 40 minutes improved an entire letter grade
•Employees who exercise regularly are 15 percent more efficient than those who do not, which means a fit employee only needs to work 42.5 hours in a week to do the same work as an average employee does in 50
Exercising After Studying Boosts Retention
In a Danish study,7 published in 2012, men were asked to learn a tracking skill on a computer, which required them to use a joystick to trace a red line as it squiggled across the screen. Some of the men exercised before learning the new task, some did no physical exercise at all, and some exercised just after learning the new skill. At follow-up testing an hour later, the men’s performance remained about the same, but as the experiment went on, those who exercised gained a clear advantage. Those who fared the best belonged to the group who exercised just after learning the task.
At testing sessions one day, and then one week, later, they traced the line more accurately and with greater agility. The group that exercised prior to learning the new skill also performed better than those who didn’t exercise (though not as well as the group that exercised after). It appears, then, that if you want to help strengthen your memory, the new information you’re receiving can be more successfully imprinted into your brain for later recall if you work out immediately following your study session.
How to Get the Most Out of Your Strength Training Routine
The type of exercise program that will benefit your brain is identical to the one that will benefit the rest of your body. Ideally, you’d want to strive for a comprehensive routine that includes high-intensity interval exercise (HIIT), strength training, core work, and regular intermittent movement to avoid the hazards associated with prolonged sitting. If you’ve been sitting for an hour, you’ve sat too long. Stretching is also important, especially if you’re doing sprints.
High intensity exercises form the core of my Peak Fitness program and can be done using a number of different machines, such as a recumbent bike or an elliptical, or you can do sprints. HIIT maximizes your secretion of human growth hormone (HGH), optimizes your metabolism, and helps regulate your insulin and blood sugar. And nothing beats it in terms of efficiency. You can complete an entire Peak Fitness workout in 20 minutes or less. For detailed instructions and a demonstration, please see my previous article, “High Intensity Interval Training 101.”
You can also turn your strength training routine into a high intensity exercise by slowing it down. This technique offers the same benefits as other high intensity exercises, and may actually be even more beneficial in some ways. It’s a particularly well-suited form of high intensity exercise for older individuals. Super-slow weight training is safer than conventional weight lifting as it actively prevents you from accidentally harming your joints or suffering repetitive use injury.
In the video below, I discuss and demonstrate the proper execution of a number of different super-slow weight training exercises. They can all be done using either free weights or machines. The benefit of using a quality machine is that it will allow you to focus your mind on the effort, as opposed on the movement. The typical super-slow resistance workout can be completed in about 15 minutes. Just one or two of these workouts are needed each week, as you need to make sure you’re sufficiently recovered.
Download Interview Transcript
Your Brain Craves Regular Activity
If you work out religiously for three months, then suddenly stop for an extended period, your muscle tone isn’t the only thing that will suffer. Your brain will too. Two studies presented at the 2012 annual meeting of the Society for Neuroscience revealed just how quickly the brain benefits of exercise fade if your exercise program stops.8
In the first study, active rats that had a week of inactivity were pitted against completely inactive rats while performing memory tests. The previously active rats completed the tests much faster and had at least twice as many new neurons in the hippocampus region of their brains. But remember, this was after just one week of inactivity. At three weeks of inactivity, their new neurons began to decrease, as did their performance on the memory test. After six weeks of inactivity, the neurons declined even more, as did their memory test scores, leading the study authors to suggest the “exercise-induced benefits may be transient.”
In the second study, rats that were active for 10 weeks, followed by three weeks of inactivity, had brains that were nearly identical to those of rats that had been completely inactive. The bottom line is that your brain needs regular, ongoing physical activity, not just a brief stint here and there. The same can be said for your body, as mounting research now shows that bouts of exercise, even when done regularly, cannot counteract the ill effects of many hours’ worth of sitting. So another key for overall health is to avoid sitting as much as possible. At minimum, strive to move about or stand up for 5-10 minutes for every hour of sitting.
Vitamin D has been shown to improve a number of brain disorders, including dementia and its most severe form, Alzheimer’s disease,1 the latter of which now affects an estimated 5.2 million Americans.2
The latest mortality statistics places Alzheimer’s in the top three killer diseases in the US, right behind heart disease and cancer.3 Vitamin D deficiency is also rampant. Researchers estimate that half of the general population is at risk of vitamin D deficiency or insufficiency.
Among seniors, that estimate reaches as high as 95 percent. While certainly not the sole cause of dementia, evidence suggests vitamin D may be a very important factor for successful prevention.
A wide variety of brain tissue contains vitamin D receptors, and when they’re activated by vitamin D, it facilitates nerve growth in your brain. Researchers also believe that optimal vitamin D levels boosts levels of important brain chemicals, and protect brain cells by increasing the effectiveness of glial cells in nursing damaged neurons back to health.
Vitamin D may also exert some of its beneficial effects on your brain through its anti-inflammatory and immune-boosting properties, which are well established.
‘Most Robust Study of Its Kind’ Confirms Link Between Low Vitamin D and Dementia
The link between low vitamin D and dementia has again been confirmed with the publication of a robust six-year long study4 conducted by an international team of researchers. As reported by Science Daily:5
“[S]tudy participants who were severely vitamin D deficient were more than twice as likely to develop dementia and Alzheimer’s disease…
[A]dults in the study who were moderately deficient in vitamin D had a 53 percent increased risk of developing dementia of any kind, and the risk increased to 125 percent in those who were severely deficient.
Similar results were recorded for Alzheimer’s disease, with the moderately deficient group 69 percent more likely to develop this type of dementia, jumping to a 122 percent increased risk for those severely deficient.”
The authors concluded that: “Our results confirm that vitamin D deficiency is associated with a substantially increased risk of all-cause dementia and Alzheimer disease. This adds to the ongoing debate about the role of vitamin D in nonskeletal conditions.”
The findings also suggest there’s a threshold level of circulating vitamin D, below which your risk for dementia increases. This threshold was found to be right around 50 nmol/L, or 20 ng/ml. Higher levels were associated with good brain health.
Based on previous research, I believe 20 ng/ml is still too low, and potentially dangerously so… When it comes to vitamin D, you really want to be in the optimal or clinically relevant range, and as the years have gone by, researchers have progressively moved that target range upward.
At present, based on the evaluation of healthy populations that get plenty of natural sun exposure, the optimal range for general health appears to be somewhere between 50 and 70 ng/ml, or 125-175 nmol/L—a far cry from the threshold suggested in this study.
vitamin d levels
References for target ranges
Sun Exposure Is the Ideal Way to Optimize Your Vitamin D Level
I believe sensible sun exposure is the ideal way to optimize your vitamin D levels. As a general rule, you’ll want to expose large amounts of bare skin to the sun until it turns the lightest shade of pink, if you’re light-skinned.
This typically occurs in about half the time it would normally take you to burn. So if you know you tend to get sunburned after 30 minutes, you’d want to stay in the sun for about 15 minutes.
Those with darker skin may need to pay closer attention to notice when this slight reddening occurs. It’s really impossible to give any firm recommendations for how long you need to stay in the sun to optimize vitamin D production, as it varies greatly depending on a number of factors, such as:
Antioxidant levels and diet in general Age
Skin color and/or current tan level Use of sunscreen
Latitude and altitude (elevation) Cloud cover and pollution
Ozone layer Surface reflection
Season Time of day
Other Alternatives: UVB emitting lights or Supplements
Your second-best option would be to use lights that emit UVB.
If your circumstances prevent either of these strategies, then you’re left with taking a vitamin D supplement. GrassrootsHealth has a helpful chart showing the average adult dose required to reach healthy vitamin D levels based upon your measured starting point. Many experts agree that 35 IUs of vitamin D per pound of body weight could be used as an estimate for your ideal dose.
Be sure to take vitamin D3—not synthetic D2—and take vitamin K2 in conjunction with it. The biological role of vitamin K2 is to help move calcium into the proper areas in your body, and without sufficient amounts, calcium may build up in areas such as your arteries and soft tissues.
This can cause calcification that can lead to hardening of your arteries—a side effect previously thought to be caused by vitamin D toxicity. We now know that inappropriate calcification is actually due more to lack of K2 than simply too much vitamin D.
Magnesium Is Also Important for Vitamin D Activity
Magnesium is another important player—both for the proper function of calcium, and for the activity of vitamin D, as it converts vitamin D into its active form. Magnesium also activates enzyme activity that helps your body use the vitamin D. In fact, all enzymes that metabolize vitamin D require magnesium to work. Magnesium also appears to play a role in vitamin D’s immune-boosting effects. As noted by magnesium expert Dr. Carolyn Dean, MD, ND:6
“The effectiveness and benefits of vitamin D are greatly undermined in the absence of adequate levels of magnesium in the body. Magnesium acts with and is essential to the activity of vitamin D, and yet most Americans do not get their recommended daily allowance (RDA) of this important mineral.”
As with vitamin D and K2, magnesium deficiency is also common, and if you’re lacking in magnesium and take supplemental calcium, you may exacerbate the situation. Vitamin K2, magnesium, calcium, and vitamin D all work in tandem with each other, which is why it’s important to pay attention to their ratios. Vitamin A, zinc, and boron are other important cofactors that interact with vitamin D, and indeed, zinc deficiency has also been identified as a contributing factor to Alzheimer’s disease.
When taking supplements, it can be easy to create lopsided ratios, so getting these nutrients from an organic whole food diet and sensible sun exposure is generally your best bet. Dietary sources of magnesium include sea vegetables, such as kelp, dulse, and nori. Vegetables can also be a good source. As for supplements, magnesium citrate and magnesium threonate are among the best.
My Alzheimer’s Prevention Strategies
Because there are so few treatments for Alzheimer’s, and no available cure, you’re really left with just one solid solution, and that is to prevent it from happening to you in the first place. Diet is part and parcel of a successful prevention plan, and my optimized nutrition plan can set you on the right path in this regard. As explained by neurologist Dr. David Perlmutter, author of the book, Grain Brain, Alzheimer’s is a disease predicated primarily on lifestyle choices; the two main culprits being excessive sugar and gluten consumption.
Another major factor is the development and increased consumption of genetically engineered (GE) grains, which are heavily contaminated with glyphosate—a herbicide thought to be worse than DDT, and DDT has already been linked to the development of Alzheimer’s… GE sugar and grains are now pervasive in most processed foods sold in the US, so swapping out processed fare for whole foods is an important part of the equation. In terms of your diet and other lifestyle factors, the following suggestions may be among the most important for Alzheimer’s prevention:
•Avoid sugar and refined fructose. Ideally, you’ll want to keep your sugar levels to a minimum and your total fructose below 25 grams per day, or as low as 15 grams per day if you have insulin/leptin resistance or any related disorders
•Avoid gluten and casein (primarily wheat and pasteurized dairy, but not dairy fat, such as butter). Research shows that your blood-brain barrier is negatively affected by gluten. Gluten also makes your gut more permeable, which allows proteins to get into your bloodstream, where they don’t belong. That then sensitizes your immune system and promotes inflammation and autoimmunity, both of which play a role in the development of Alzheimer’s
•Optimize your gut flora by regularly eating fermented foods or taking a high-potency and high-quality probiotic supplement.
•Increase consumption of all healthy fats, including animal-based omega-3. Healthy fats that your brain needs for optimal function include organically-raised grass-fed meats, coconut oil, olives and olive oil, avocado, nuts, organic pastured egg yolks, and butter made from raw grass-fed milk. High intake of the omega-3 fats EPA and DHA are also helpful for preventing cell damage caused by Alzheimer’s disease, thereby slowing down its progression, and lowering your risk of developing the disorder.
•Reduce your overall calorie consumption, and/or intermittently fast. Ketones are mobilized when you replace carbs with coconut oil and other sources of healthy fats. As mentioned above intermittent fasting is a powerful tool to jumpstart your body into remembering how to burn fat and repair the inulin/leptin resistance that is also a primary contributing factor for Alzheimer’s. To learn more, please see this previous article.
•Improve your magnesium levels. Preliminary research strongly suggests a decrease in Alzheimer symptoms with increased levels of magnesium in the brain. Unfortunately, most magnesium supplements do not pass the blood brain levels, but a new one, magnesium threonate, appears to and holds some promise for the future for treating this condition and may be superior to other forms.
•Eat a nutritious diet, rich in folate. Vegetables, without question, are your best form of folate, and we should all eat plenty of fresh raw veggies every day. Avoid supplements like folic acid, which is the inferior synthetic version of folate.
•Exercise regularly. It’s been suggested that exercise can trigger a change in the way the amyloid precursor protein is metabolized,7 thus, slowing down the onset and progression of Alzheimer’s. Exercise also increases levels of the BDNF, (brain derived neurotropic factor) and PGC-1alpha. Research has shown that people with Alzheimer’s have less PGC-1alpha in their brains and cells that contain more of the protein produce less of the toxic amyloid protein associated with Alzheimer’s. I would strongly recommend reviewing the Peak Fitness Technique for my specific recommendations.
•Optimize your vitamin D levels with safe sun exposure. Sufficient vitamin D is imperative for proper functioning of your immune system to combat inflammation that is also associated with Alzheimer’s.
•Avoid and eliminate mercury from your body. Dental amalgam fillings, which are 50 percent mercury by weight, are one of the major sources of heavy metal toxicity. However, you should be healthy prior to having them removed. Once you have adjusted to following the diet described in my optimized nutrition plan, you can follow the mercury detox protocol and then find a biological dentist to have your amalgams removed.
•Avoid and eliminate aluminum from your body: Sources of aluminum include antiperspirants, non-stick cookware, vaccine adjuvants, etc. For tips on how to detox aluminum, please see my article, “First Case Study to Show Direct Link between Alzheimer’s and Aluminum Toxicity.”
•Avoid flu vaccinations as most contain both mercury and aluminum, well-known neurotoxic and immunotoxic agents.
•Avoid anticholinergics and statin drugs. Drugs that block acetylcholine, a nervous system neurotransmitter, have been shown to increase your risk of dementia. These drugs include certain nighttime pain relievers, antihistamines, sleep aids, certain antidepressants, medications to control incontinence, and certain narcotic pain relievers. Statin drugs are particularly problematic because they suppress the synthesis of cholesterol, deplete your brain of coenzyme Q10 and neurotransmitter precursors, and prevent adequate delivery of essential fatty acids and fat-soluble antioxidants to your brain by inhibiting the production of the indispensable carrier biomolecule known as low-density lipoprotein.
•Challenge your mind daily. Mental stimulation, especially learning something new, such as learning to play an instrument or a new language, is associated with a decreased risk of Alzheimer’s. Researchers suspect that mental challenge helps to build up your brain, making it less susceptible to the lesions associated with Alzheimer’s disease.
•Avoid electromagnetic fields (EMF) created by wireless devices. The BioInitiative Report,8 initially published in 2007, and again in 2012 by an international working group of scientists, researchers, and public health policy professionals, concluded that the existing standards for public safety are completely inadequate to protect your health. The report includes evidence that electromagnetic fields and exposure to radiofrequencies can have a detrimental impact on Alzheimer’s disease, along with a whole host of other chronic health problems.
How Vitamin D Performance Testing Can Help Optimize Your Health
A robust and growing body of research clearly shows that vitamin D is absolutely critical for good health and disease prevention. Vitamin D affects your DNA through vitamin D receptors (VDRs), which bind to specific locations of the human genome. Scientists have identified nearly 3,000 genes that are influenced by vitamin D levels, and vitamin D receptors have been found throughout the human body.
Is it any wonder then that no matter what disease or condition is investigated, vitamin D appears to play a crucial role? This is why I am so excited about the D*Action Project by GrassrootsHealth. It is showing how you can take action today on known science with a consensus of experts without waiting for institutional lethargy. It has shown how by combining the science of measurement (of vitamin D levels) with the personal choice of taking action and, the value of education about individual measures that one can truly be in charge of their own health.
In order to spread this health movement to more communities, the project needs your involvement. This was an ongoing campaign during the month of February, and will become an annual event.
To participate, simply purchase the D*Action Measurement Kit and follow the registration instructions included. (Please note that 100 percent of the proceeds from the kits go to fund the research project. I do not charge a single dime as a distributor of the test kits.)
As a participant, you agree to test your vitamin D levels twice a year during a five-year study, and share your health status to demonstrate the public health impact of this nutrient. There is a $65 fee every six months for your sponsorship of this research project, which includes a test kit to be used at home, and electronic reports on your ongoing progress. You will get a follow up email every six months reminding you “it’s time for your next test and health survey.”
In the wake of shocking reports on how the FDA, terrified of being outed for its questionable practices, spied on its own employees in the hopes of rooting them out before they could become whistleblowers, a new story has emerged on how deep the deceit goes. From marginalizing safety reports to not reading them at all?and then going ahead and approving the drugs in question?the FDA once more stands accused of being little more than a rubber-stamping agency for Big Pharma.
Explosive revelations of an intensive spy operation by the FDA on its own scientists emerged last month. Using sophisticated spy software, the agency tracked and logged every move made by the targeted individuals. The program even intercepted personal emails and copied documents on their personal thumb drives.
The targeted scientists had expressed concern over the agency’s approval of dangerous medical imaging devices for mammograms and colonoscopies, which they believe expose patients to dangerous levels of radiation. Now, another whistleblower has stepped forward, and what he has to say about the agency’s drug safety reviews is shocking even to the jaded…
Former FDA Reviewer Speaks Out About Systemic Suppression of Safety
Ronald Kavanagh was a drug reviewer for the FDA in the Center for Drug Evaluation and Research from 1998 to 2008. In a recent interview he reveals how the FDA bypassed or ignored safety issues on major drugs approved during his employment. In an interview for the online news magazine Truth-Out he tells Martha Rosenberg1:
“In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee.
There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees.
In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug’s approval – which of course was our job as drug reviewers – management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.”
According to Kavanagh, people would be shocked if they knew just how malleable safety data is. As examples, he points out that human studies are typically too short and contain too few subjects to get a clear picture of potential risks. In such a scenario, even a single case of a serious adverse event must be taken very seriously, and data from other longer term safety studies also need to be carefully analyzed. Kavanagh claims he has seen drug reviews where the medical safety reviewer completely failed to make such evaluations prior to the drug’s approval.
FDA Actively Thwarts Serious Safety Investigations
There’s no telling how many ineffective and/or dangerous drugs and medical devices have been approved and ushered into market through sheer intimidation and bullying, either by pharmaceutical companies or FDA management. Perhaps even more shocking are the revelations that some of the internal rules and regulations of the FDA are clearly designed to thwart serious safety reviews from the get-go.
According to Kavanagh:
“[H]uman clinical pharmacology trials are typically done in Europe, yet clinical pharmacology reviewers at FDA have been barred from analyzing this information prior to studies being conducted in the US. Without being able to do this, we are unable to detect evidence of risks early and cannot provide guidance that would help with the development of the drug in terms not only of safety and proving efficacy, but also with the efficiency and cost effectiveness of the drug’s development.”
Another loophole that can put your health in serious jeopardy is that drug companies are not required to include adverse events on the drug’s label if the adverse reaction is:
- Below a certain percentage, and/or
- Below double the rate of the adverse event found in a placebo
According to Kavanagh:
“By this rule, certain serious and potentially lethal adverse events that eventually resulted in a drug being withdrawn from the market would not have had any mention of the adverse events made in the labeling at all.”
Kavanagh also claims to have discovered another common loophole used by pharmaceutical companies to circumvent safety issues. They’d simply submit bits and pieces of data to different places, effectively preventing the reviewer to pull it all together. Then, because the safety issues falsely appeared to be negligible, it would be decided that no further evaluation would be necessary…
“On one occasion, the company even told me they were going to call upper management to get a clear requirement for approval that they did not want to fulfill eliminated, which I then saw happen. On another occasion a company clearly stated in a meeting that they had “paid for an approval,” Kavanagh says.
“Sometimes we were literally instructed to only read a 100-150 page summary and to accept drug company claims without examining the actual data, which on multiple occasions I found directly contradicted the summary document. Other times I was ordered not to review certain sections of the submission, but invariably that’s where the safety issues would be. This could only occur if FDA management was told about issues in the submission before it had even been reviewed.
In addition, management would overload us with huge amounts of material that could not possibly be read by a given deadline and would withhold assistance. When you are able to dig in, if you found issues that would make you turn down a drug, you could be pressured to reverse your decision or the review would then be handed off to someone who would simply copy and paste whatever claims the company made in the summary document.”
Examples of Dangerous Drug Approvals
In his interview, Kavanagh discusses some of the dangerous drugs that were approved in the face of unequivocal safety concerns. One is the nerve gas drug pyridostigmine—a prophylactic drug against the nerve agent Soman. The drug was approved under the “Animal Rule,” which allows drugs to be approved based on animal data alone. There were multiple problems with this approval. First, the animal studies did not reflect how the drug would be used in humans. Second, the drug actually increases lethality if nerve agents other than Soman are used.
According to Kavanagh:
“This information was not secret – both FDA and DoD public documents acknowledge increased lethality with other nerve agents such as Sarin, and DoD and other government documents that are public also document that Saddam Hussein was not using Soman and was instead using these other nerve agents exclusively.
Yet because I raised this as an objection, I was immediately replaced as the primary reviewer so that I could not document my concerns and so that pyridostigmine could be approved. It’s since been proposed that if we ever face the prospect of nerve agents in the future, that this approval will be used as a justification to convince the President at that time to waive informed consent without presenting a full picture.”
Pediatric drugs also end up posing unnecessary risks due to the FDA’s failure to adequately review safety risks, and the many scientific loopholes employed by pharmaceutical companies. For example, the following flawed parameters are typically used in pediatric drug studies:
- Dosages are based on approved adult dosages, without regard for metabolic differences between a developing child’s body and an adult
- Exposure studies oftentimes use overweight children, and include too few children to adequately evaluate risks
- No allowances are made for race, age, puberty, or actual weight
Dangers to pregnant women and their developing fetuses are also frequently ignored. All in all, the FDA appears to be engaged in a systematic hush-operation designed to give just about anything Big Pharma develops the green light. Essentially, dangerous drugs are given a rubber stamp of approval—the necessary go-ahead to make obscene profits while killing and injuring hundreds of thousands of people every year. It is, quite simply, inexcusable. The mainstream media has a lot to answer for as well, as their lack of reporting on these issues contributes to the problem by keeping a lid on reality.
According to Kavanagh:
“FDA’s response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then simply add a watered down warning in the labeling. In fact, when patients exhibit drug toxicity, it is usually attributed to an underlying condition which we know is likely to make the drug toxicity worse. This also allows the toxicity to be dismissed as being unrelated to the drug in any way.
Consequently, toxicities are only attributed to the drug when the evidence is irrefutable. Thus the majority of cases where there is a contributing factor are simply dismissed. When you do raise potential safety issues, the refrain that I heard repeatedly from upper management was‚”where are the dead bodies in the street?” Which I took to mean that we only do something if the press is making an issue of it.”
FDA Safety Reviewers Made to Fear for Their Lives?
Kavanagh was not surprised to learn about the agency’s retaliation against the five whistleblowers, giving several examples of how he was personally intimidated, to the point of fearing for his life, and the safety of his children!
“After FDA management learned I had gone to Congress about certain issues, I found my office had been entered and my computer physically tampered with,” Kavanagh tells Rosenberg.
“… After I gave Representative Waxman’s (D-CA) office a USB drive with evidence, FDA staff was admonished that it was prohibited to download information to USB drives. Then, after I openly reported irregularities in an antipsychotic drug review and FDA financial collusion with outsiders to Senator Grassley’s office and the House Committee on Oversight and Government Reform, I was threatened with prison if I should release trade secret information to Congress… [T]he Food Drug and Cosmetics Act explicitly allows communication of trade secrets by FDA employees to Congress, but since most people are unaware of this, FDA management can use the threat of jail for violation of the Trade Secrets Act, not only to discourage reviewers, but in my case they got Senator Grassley’s staff to destroy the evidence I provided them.
The threats, however, can be much worse than prison. One manager threatened my children – who had just turned 4 and 7 years old – and in one large staff meeting, I was referred to as a “saboteur.” Based on other things that happened and were said, I was afraid that I could be killed for talking to Congress and criminal investigators.”
We Now Know What Domestic Surveillance of Whistleblowers Looks Like
The following video features attorney, Stephen Kohn, executive director of the National Whistleblowers Center and attorney for the FDA whistleblowers in the recently revealed FDA spy operation against them2.
“For the first time, we now have a glimpse into what domestic surveillance of whistleblowers looks like in this country with the modern technological developments,” Kohn says. “The agency [sought] to destroy the reputation of these whistleblowers forever.”
FDA Failures Place Health of Americans and Nation at Grave Risk
The FDA’s mission statement reads as follows:
“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
- Its scientific base has eroded and its scientific organizational structure is weak
- Its scientific workforce does not have sufficient capacity and capability, and
- Its information technology (IT) infrastructure is inadequate
Furthermore, the report found that “the development of medical products based on “new science” cannot be adequately regulated by the FDA, and that the agency does not have the capacity to carry out risk assessment and analysis. Additionally, the agency’s science agenda “lacks coherent structure and vision, as well as effective coordination and prioritization.”
The fact that the FDA does not have its ducks in a row; has sorely misplaced its priorities; and is not working to fulfill its mission is clearly evidenced in the numerous cases where hundreds and sometimes thousands of complaints about dangerous drugs (like Vioxx and Avandia), vaccines (like Gardasil), and additives (like aspartame) are stubbornly ignored, while SWAT-style teams armed to the teeth are sent to raid supplement makers, whole food businesses, organic farmers, and raw dairies when oftentimes not a single incidence of harm can be attributed to their products.
According to the Science and Technology Subcommittee’s report, the failures of the FDA is placing the health of Americans, and indeed the economic health of the entire nation, at grave risk:
“The FDA constitutes a critical component of our nation’s healthcare delivery and public health system. The FDA, as much as any public or private sector institution in this country, touches the lives, health and wellbeing of all Americans and is integral to the nation’s economy and its security.
The FDA’s responsibilities for protecting the health of Americans are far-reaching. The FDA protects our nation’s food supply through regulatory activities designed to cover 80 percent of the food consumed in this country. The FDA also regulates all drugs, human vaccines, and medical devices, and hence plays a critical role in ensuring the appropriate safety and efficacy of rapidly emerging medical products.
… The FDA is also central to the economic health of the nation, regulating approximately $1 trillion in consumer products or 25 cents of every consumer dollar expended in this country annually.. Thus, the nation is at risk if FDA science is at risk. The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.”
One of the root causes for their utter abandonment of public safety is that the majority of the FDA’s funding comes from the very companies that it is seeking to monitor and evaluate. The FDA has progressively morphed into a mere pawn and instrument of the drug industry, which has little to do with drug safety, and everything to do with maximizing profits.
As Dr. David Graham—another prominent FDA whistleblower who blew the lid on the Vioxx scandal—stated in a 2005 interview:
“As currently configured, the FDA is not able to adequately protect the American public. It’s more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent. Unfortunately, that is the way the FDA is currently structured.
Within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared towards the approval of new drugs and 20 percent is for everything else. Drug safety is about 5 percent. The “gorilla in the living room” is new drugs and approval. Congress has not only created that structure, they have also worsened that structure through the PDUFA, the Prescription Drug User Fee Act, by which drug companies pay money to the FDA so they will review and approve its drug.”
The only real solution isn’t minor changes to the existing structure, but a complete reform of the FDA. But until then, please, don’t risk your money or your life on a paradigm designed to profit from your ill health. Instead, switch to natural methods that will allow your body to heal itself without the need for the deadly drugs being pushed on you by the drug companies and the FDA.