Archive for Acupuncture
Acupuncture Blocks Sympathetic Nerve Activity to Heart
It is becoming more and more difficult to say that acupuncture has no effects on the human body… It is just so hard to accept the concept of a series of meridian, energy fields, etc… that can and do affect human health. I would go on to say that acupuncture is just one tool to be used in human disease management, but anyone who has studied traditional Chinese medicine already knows that they know this! TCM also includes herbal remedies and manipulation as well as acupuncture.
American Heart Association’s 2001 Scientific Sessions Dr. Holly R. Middlekauff of the Medical School of the University of California at Los Angeles pointed out that sympathetic nerve activity is two to three times higher in patients with heart failure. The higher the activity, the worse the prognosis. On the basis of animal studies that have shown acupuncture to be sympathoinhibitory, Dr. Middlekauff and colleagues selected 14 patients with advanced heart failure and randomized them to one of three treatment arms: traditional acupuncture with needles; acupuncture with needles but delivered to non-acupoints; and needleless acupuncture, in which patients were touched on the backs of their necks and believed they were receiving acupuncture. Investigators subjected the patients to 4 minutes of mental stress, having them perform math problems, “chastising them when they got the answers wrong,” and performing a color/word mismatch test, where they had to identify the correct color, while a written cue gave them the wrong answer (e.g., presenting the word “blue” in red letters). Stress testing was conducted prior to acupuncture and then again after a 20-minute session. During mental stress testing, sympathetic activity increased 25%, with increases in heart rate and blood pressure. However, a single 20-minute acupuncture session completely blocked these increases in the active treatment group. Patients in the non-acupoint and needleless acupuncture groups showed increased sympathetic activity as usual. “We would like to see what a full course of acupuncture would do,” Dr. Middlekauff commented. “Acupuncture could be adjunctive or complementary to beta-blocker therapy for heart failure patients.” She added that it could also be advantageous in patients intolerant of beta-blockade.
Acupuncture for chronic headache in primary care
This was a relatively large study of patients with headaches being treated with acupuncture 12 times over the course of 3 months. Results were strong in favor of acupuncture. Just add this to the list of effective, non-drug, safe approaches to headache. Manipulation, soft tissue approaches, fever few are just a few others shown to be effective.
bmj.com Abstracts: Vickers et al. 328 (7442): 744
Electroacupuncture for Tension-type Headache on Distal Acupoints Only
Let the sticklers in acadamia figure this one out. Acupuncture is definitely gaining ground on the research front.
Electroacupuncture for Tension-type Headache on Distal Acupoints Only: A Randomized, Controlled, Crossover Trial – Headache, ..
DOES ARTHRITIS MEAN I HAVE TO HAVE PAIN FOREVER? In our office, the answer is almost always a strong “NO,” but it is a perception that many patients have, possibly because their PCPs don’t have many answers. Keep in mind that the joint is surrounded by the soft tissues (fascia, ligaments, tendons, muscles) and, in most cases, these tissues actually create much more pain than the joint does. Address the problems in the tissues surrounding the joint and the pain can go away.
In this particular study, the authors looked at what patients did after being given a diagnosis of knee arthritis. 75% percent of them took matters into their own hands by increasing activity levels, 33% turned to acupuncture, orthotics, braces and 36% started supplements. The results were very encouraging–after 6 months, the majority of patients in the study had found some relief from this approach. I know that in our office, we strongly urge patients to increase their activity levels with very good results.
Hypofibrinolysis in insulin resistance: implication in cardiovascular diseases.
The research linking poor insulin sensitivity is now so strong as to be unquestionable. One of the problems, however, is a good, solid lab test that can be used to diagnosis and monitor insulin resistance. Plasminogen activator inhibitor-1 (PAI-1) may turn out to be the marker we are looking for. Stay tuned…
Hypofibrinolysis in the insulin resistance syndrome: implication in cardiovascular diseases – J Intern Med, Vol 255, Issue 4,..Click here for more information.
Incidence and Severity of Potential Drug–Dietary Supplement Interactions in Primary Care Patients.
This article pretty much says it all. In this study of 458 veterens, 43% were using at least one supplement. Of these, the “potential” for interaction was present in 45%. Of these, most were determined not serious. And the authors admit that, in the medical literature, actual evidence of interaction was “sparse.” I have brought up this seeming disparity between actual, documented interactions and the actual press that drug-nutrient interactions get. Try finding actual cases of birth defects from Vitamin A taken in pregnancy. Try finding actual cases of death from St. John’s Wort and heart meds. I’m not saying that they don’t exists and that patients should not be aware and conscious of potential interactions, but there have been several times I have had patients told they should not take a supplement that would clearly benefit their health because of the over-percieved danger of interaction. In reality, drug-drug interactions are much more common, well founded in the medical literature, and result in a large number of deaths per year. Arch Intern Med — Abstracts: Peng et al. 164 (6): 630 - Click here for more information.
Acupuncture for chronic headache in primary care.
This was a relatively large study of patients with headaches being treated with acupuncture 12 times over the course of 3 months. Results were strong in favor of acupuncture. Just add this to the list of effective, non-drug, safe approaches to headache. Manipulation, soft tissue approaches, feverfew are just a few others shown to be effective. bmj.com Abstracts: Vickers et al. 328 (7442): 744 - Click here for more information.
Modulation of Resistin Expression by Retinoic Acid and Vitamin A Status.
Speaking of Vit A’s bad rap…Resistin is a hormone secreted by the fat cells that has been shown to worsen insulin resistance and overall make the obesity problem worse. In this interesting article we see that retinoic acid (the acid form of Vit A) and Vitamin A given to mice actually lowers the genetic expression of resistin, thus improving insulin resistance and resulting in weight loss. What I would consider interesting here is that, given that Vitamin A is a fat soluble vitamin, it’s absorption would be impaired with gastric bypass surgery as well as patients will non-surgical digestion problems. Might poor digestion contribute to weight gain at least in part by reducing Vit A absoprtion? Just some food for thought…Diabetes — Abstracts: Felipe et al. 53 (4): 882 - Click here for more information.
Activation of methionine synthase by insulin-like growth factor-1 and dopamine: a target for neurodevelopmental toxins and thimerosal.
For those of us that are not biochemists and our eyes glazed over at the title to this one–basically, environmental toxins can have their negative effects by inhibiting the methylation of DNA. Remember that methylation reactions are incredibly important and effect such a basic role in human physiology. Thus, problems with methylation can lead to problems in many organ systems. In this study, the authors found that environmental toxins such as mercury-containing thimerosal inhibit DNA methylation. For the life of me, I cannot see how anyone in the pharmaceutical industry could have even considered the use of mercury as a preservative. I can see it now…”I need something to extend the shelf live of this vaccine so we can make a larger profit on vaccines given to infants. Hey–how about that potent neurotoxin mercury?”
Activation of methionine synthase by insulin-like growth factor-1 and dopamine: a target for neurodevelopmental toxins and thimerosal. Click here for more information.
Extra Virgin Olive Oil Biophenols Inhibit Cell-Mediated Oxidation of LDL.
Two comments here. First, I frequently remind patients that LDL cholesterol by itself does not cause damage. It only causes damage to our blood vessels after IT gets damaged. So, protecting that LDL is very important. Lifestyles that include high levels of antioxidants, and now, with this study, high levels of olive oil, can help protect the LDL and prevent it from leading to atherosclerosis. Second comment, the closer the olive oil is to fresh off the tree, the more antioxidants the olive oil contains. So always go for the extra extra cold pressed virgin, unless you plan on cooking with it in which case it doesn’t matter because the heat will destroy the antioxidants. Nutrition.org — Abstracts: Masella et al. 134 (4): 785 - Click here for more information.
CRP, Homocysteine Related to Frequent Fruit and Vegetable Intake.
All this fuss trying to find a drug to lower CRP levels. It’s almost laughable. And you know when they find that some drug (most likely front runner is the statins) lowers CRP it’ll be all over the news with recommendations to have CRP levels checked and drugs used to manage levels. Nutrition.org — Abstracts: Gao et al. 134 (4): 913 - Click here for more information.
Consumption of high-fructose corn syrup in beverages may play a role in the epidemic of obesity.
The first line in this abstract says “Obesity is a major epidemic, but its causes are still unclear.” Huh?? Unclear? How about an increase in processed, high refined carb, high trans/sat fat foods? Sometimes researchers can be so disconnected from reality as to make the results of their studies pointless. Do you think any high school student out there doesn’t think increased consumption of soda pop can make you overweight? AJCN — Abstracts: Bray et al. 79 (4): 537 - Click here for more information.
Increase in intranuclear nuclear factor kappa B and decrease in inhibitor kappa B in mononuclear cells after a mixed meal: evidence for a proinflammatory effect.
Sorry for the long title–I left it that way for effect. This is something that we need to come to grips with and understand. The food we put in our bodies is not just carbs, protein and fat–it is composed of hundreds of messages that tell our genes how to react. Next time you’re about to shove that double quarter pound burger with all the fixins into your mouth, think the message all these molecules will send to your genes. This article focuses on another fact of meals–they tend to be proinflammatory in nature. Eating actually raises your level of inflammation. The question here, however, is do different foods have differing effects on level of inflammaiton produced? I would postulate that it does. AJCN — Abstracts: Aljada et al. 79 (4): 682 - Click here for more information.
Modulation of neonatal immunological tolerance to ovalbumin by maternal essential fatty acid intake.
The basic question is, does the diet of a pregnant and nursing mother have long term consequences on the health of the infant? Of course the answer is yes. This study was done in rats but should transfer to humans as well; it confirms that poorer quality fats lead to a increase in allergy to ovalbumin (egg whites). Once again, however, we venture into the tricky world of liablity. As much as we try to avoid it, the big pink elephant in the room is the fact that parents are almost wholly to blame for the health of their children. Sure, there are genetic conditions that are not due to environment, but these are rare. As soon as we break down and start blaming the parents, then we can move on to educating them and hopefully changing behaviors.
Modulation of neonatal immunological tolerance to ovalbumin by maternal essential fatty acid intake – Pediatric Allergy Immunol..Click here for more information.
Impact of a low glycaemic index diet on hospital stay following coronary artery bypass grafting.
I have always considered hospitals as a dangerous place to be, and a large part of that is because the food served is incredibly bad from a quality standpoint. We know that refined carbs and hydrogenated oils suppress the immune system and this can surely contribute to the large number of nosocomial (hospital acquired) infections that end up putting these same patients BACK in the hospital!! This study finds that a healthy, less refined diet leads to a quicker release from the hospital after heart surgery by about 2.5 days. Multiply 2.5 days by the cost of a typical hospital stay and the numbers are astounding. So, the question is–would hospitals want to feed better food to have patients in less time and generate less income?
Retrospective analysis of the impact of a low glycaemic index diet on hospital stay following coronary artery bypass grafting. Click here for more information.
Cardiovascular Risk Assessment and Triptans.
I was not aware that there was concern with triptan use (in this case when used for the treatment of headaches–in my opinion, not a very good use) in patients with cardiovascular disease. Live and learn. However, what makes this VERY interesting is the following article….
Cardiovascular Risk Assessment and Triptans – Headache, Vol 44, Issue s1, pp. S31-S39 (Abstract) - Click here for more information.
Closure of patent foramen ovale reduces the frequency of migraine attacks.
I’m finding this article very interesting. Fixing a patent foramen ovale (this is an opening from right to left ventricle that bypasses the lungs in the fetus who does not use the lungs, this should shut at birth) cuts migraine frequency in these patients by HALF. This really opens up a can of worms here. I’ve always had a problem with mainstream medicine’s approach to headaches in general. There is almost always an underlying physiological or anatomical imbalance that creates headaches. This needs to be found and fixed NOT COVERED UP WITH PAIN MEDS!!!! I cannot tell you how many times patients come into my office after years of unsuccessful treatment of headaches from the medical community and they are gone in 2-3 weeks. This article would suggest that some degree of oxygen deprivation (patent foramen ovale leads to some blood skipping the lungs) was a major contributor to these patient’s migraines. Might some degree of this be present in patients without PDA? Maybe approaches designed to improve oxygenation, oxygen delivery and facilitate efficient use of the oxygen that is there might show strong benefits in migraine patients. Neurology — Abstracts: Schwerzmann et al. 62 (8): 1399 - Click here for more information.
Parental perceptions of the therapeutic effect from osteopathic manipulation or acupuncture in children with spastic cerebral palsy.
There is a clinic in Oklahoma City (www.chiropractic4kids.com) that has stories of treating patients that would bring tears to your eyes. There is no doubt that manipulative therapy (96% of which, I might add, is performed by chiropractors) has positive effects on the nervous system that lead to improvements in a wide variety of conditions such as autism, asthma, heart rate variations and in this study, cerebral palsy. Entrez PubMed - Click here for more information.
Lactic acid bacteria secrete metabolites retaining anti-inflammatory properties after intestinal transport.
Why is it, with all the research supporting the benefits of normal, healthy (probiotic) flora, that many still consider the main concern with antibiotic overuse the spread of resistant germs? It would take me days to explain all the benefits of good healthy flora on our health and how they can be virtually wiped out by one course of antibiotics. This study finds that lactic acid bacteria (such as lactobacillus) have the ability to suppress TNF-alpha production systemically from their home in the GI tract. Remember that one of the hot new drugs out for psoriasis, rheumatoid arthritis and Crohn’s disease (Umbro) blocks TNF-alpha action as well. Gut — Abstracts: Ménard et al. 53 (6): 821 - Click here for more information.
Homocysteine Levels and the Risk of Osteoporotic Fracture.
Now that homocysteine is a well established risk factor for heart disease, the research community is moving on to other things homocysteine may contribute to. Remember the homocysteine may just be a marker for altered methylation ability, which is a process aided by Vit B12, B6, riboflavin, SAM-e, betaine and folic acid that is integral to the proper cell division of every single cell and well as the protection of DNA and the production of some neurotransmitters. So, defects in the homocysteine pathway (which are very suseptable to genetic uniquenesses) can lead to a wide variety of downstream conditions. The bottom line–interventions designed to lower homocysteine levels would probably benefit most patients and be cheaper than checking blood levels. NEJM — Homocysteine Levels and the Risk of Osteoporotic Fracture. Click here for more information.
Homocysteine as a Predictive Factor for Hip Fracture in Older Persons.
Just in case you don’t believe ONE study. NEJM — Homocysteine as a Predictive Factor for Hip Fracture in Older Persons. Click here for more information.
Low-grade systemic inflammation impairs arterial stiffness in newly diagnosed hypercholesterolaemia.
Sorry for the long title, but basically, CRP as a marker of inflammation and waist to hip ratio were a better marker for less elasticity in the aorta (not a good thing…) than “traditional” risk factors such as LDL and total cholesterol and blood pressure. It is still rare for me to see a CRP level come back from any labwork ordered from another physician. This is just another example of clinical practice running decades behind what is in the medical literature.
Low-grade systemic inflammation impairs arterial stiffness in newly diagnosed hypercholesterolaemia – Eur J Clin Invest, Vol . Click here for more information.
Association between diet and esophageal cancer in Taiwan.
Preserved foods and overheated drinks were found to increase risk of esophageal cancer 3.4 fold. Increased fruits and veggies were protective. Wow. Such surprising findings… Sarcasm over the waste of money on an obvious outcome, this study find increased risk at intakes of preserved foods at least once per week. How bout 3 times a DAY here in the US.
Association between diet and esophageal cancer in Taiwan – J Gastroenterol Hepatol, Vol 19, Issue 6, pp. 632-637 (Abstract) - Click here for more information.
Insulin resistance and CRP as independent risk factors for non-alcoholic fatty liver disease.
I just thought I would use this article to tie in with the new documentary “Supersize Me.” This is exactly what happened to the star of this film. He ended up with elevated liver enzymes just 3 weeks into his program. The fast food had induced insulin resistance and elevated inflammation in this short a period of time.
Insulin resistance and C-reactive protein as independent risk factors for non-alcoholic fatty liver disease in non-obese Asia. Click here for more information.
Pfizer pleads guilty, but drug sales continue to soar.
Never forget that the pharmaceuticals are big business, and just like GM or Honeywell, they are out there to turn a profit for the shareholders. The fact that the illegal pushing of off label use of a drug that earns a guilty verdict of $240 million is effective at getting doctors to use Neurontin for conditions it DOESN’T EVEN HELP is just wrong. bmj.com Lenzer 328 (7450): 1217 - Click here for more information.
The defence of dirt.
This is a neat commentary about the theory that our sterilized society is responsible for the increased rates of atopic disorders. I strongly agree with this theory. The increased rates of immunizations coupled with the rampant use of antibiotics (without replacing with probiotics) leads to a Th2 dominant state. This does not happen in a vacuum–it is the end outcome of a serious of events that leads to the imbalance of the immune system. bmj.com Watts 328 (7450): 1226 - Click here for more information.
Dietary fiber fraction of germinated barley foodstuff and the GI tract
This study evaulates a fiber source (GBF) on the health and healing of colonocytes. The results were promising, identifying the fiber component of GBF as the protective factor (not the protein) and also confirming its ability to aid the healing of the cells of the colon. Butyrate is the substance produced when healthy GI flora digest fiber; it has shown the ability to protect colonocytes, help them heal and also help them differentiate properly (possibly avoiding cancerous changes). Remember, to be effective, the fiber AND the healthy flora have to be present… Synergy Abstract http://onlinelibrary.wiley.com/doi/10.1046/j.1440-1746.2001.02427.x/full
Impact of the 1999 AAP/USPHS Statement on Thimerosal in Vaccines
This review looks at the effects of the recommendations to delay the first after Hep B vaccine in newborns due to the presence of thimerosal, a mercury containing preservative. This review finds that the rates of vaccination dropped with the recommendation and have not return. A few things to consider. Hep B is a blood borne illness; transmitted via blood contact, unprotected sexual relations and IV drug use. How many infants are unknowingly exposed to these risks factors? Not many, I would guess. Infants borne of Hep B+ mothers know this. I would support vaccination in these infants. But a blanket recommendation to all infants? I have a problem with that. Not all infants are at risk. An additional note on the “safe” thimerosal. The mercury present in these vaccines given to infants can potentiall cause problems. The mercury is directly injected, thereby bypassing the GI’s ability to reduce absorption. The infant has no effective route of elimination of mercury via the bile. And the infant has not yet developed a strong blood-brain barrier to keep mercury away from nervous tissue. Does thimerosal still sound safe? Impact of the 1999 AAP/USPHS Joint Statement on Thimerosal in Vaccines on Infant Hepatitis B Vaccination Practices
additional reading: Entrez-PubMed http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5006a3.htm
Relation between sugar-sweetened drinks and childhood obesity
Are these results such a big surprise? Not only to soft drinks add additional, empty calories, but they also replace needed drinks and calories such as water, fruits and vegetables. Couple this with a lack of physical activity and our “mysterious” obesity epidemic is not so hard to believe. It still get my blood pressure up to see toddlers with soda in their sippie cups. I firmly believe that no child should even be exposed to these types of drinks until at least 8 years of age (if ever). That includes such sugar laden drinks such as Sunny Delight and Hi-C.
Lancet 2001; 357: 505-08 The prevalence of obesity among children in USA increased by 100% between 1980 and 1994. Recent national estimates indicate that 24% and 11% of children are above the 85th and 95th reference percentiles of body mass index (BMI), for age and sex, respectively. Various environmental and social factors relating to diet and physical activity have been identified that could contribute to obesity. One such factor, which has received little attention, is the consumption of sugar-sweetened drinks. According to data from the US Department of Agriculture (USDA), per capita soft-drink consumption has increased by almost 500% over the past 50 years. From 1989-91 to 1994-95, soft-drink intake rose from 195 to 275 mL in the general population, and from 345 to 570 mL among adolescent boys. Half of all Americans and most adolescents (65% girls and 74% boys) consume soft drinks daily, most of which are sugar-sweetened, rather than artificially sweetened. Currently, soft drinks constitute the leading source of added sugars in the diet, amounting to 36·2 g daily for adolescent girls and 57·7 g for boys. These figures approach or exceed the daily limits for total added sugar consumption recommended by the USDA. Although this increase in soft-drink consumption coincides with secular increases in obesity prevalence in children, the long-term effects of sugar-sweetened drink consumption on measures of body weight need to be prospectively examined. We aimed to determine the association between change in sugar-sweetened drink consumption and change in BMI, and incidence of obesity among school-age children, over 2 academic years. Interpretation: Consumption of sugar-sweetened drinks is associated with obesity in children.
Proximity to Pesticide Use and Risk of Birth Defects, Fetal Death
Not only do we have to pay attention to the things we knowingly put into our bodies in order to stay healthy, but we also have to be aware of other sources of toxins from the environment: polluted city water, air pollution, pesticides from home use as well as from nearby agricultural use. The scary thing about this study is that the most dangerous time for exposure to the developing fetus is 3 to 8 weeks–many times this is before a woman even knows she is pregnant.
Epidemiology. 2001:12(2):148 The study, which involved almost 700 women in 10 California counties, showed an increased risk of death among developing fetuses, ranging from 40% to 120% among those whose mothers lived near crops where certain pesticides were sprayed. A report on the study will appear in the March issue of Epidemiology. “Our study showed a consistent pattern with respect to timing of exposure,” said Dr. Erin M. Bell, who earned her doctorate with the research at the UNC School of Public Health, and is now an epidemiologist with the National Cancer Institute. “The largest risks for fetal death due to birth defects were from pesticide exposure during the third week to the eighth week of pregnancy.”That span — much of the first trimester — appears to be a special window of vulnerability for birth defects, Bell said, as earlier research has suggested.”The risks appeared to be strongest among pregnant women who lived in the same square mile where pesticides were used,” she said.
Lumbar Belts Fail to Prevent Back Pain or Back Pain Disability
Despite their widespread use and general acceptance, several large studies have not demonstrated any benefits from the use of back belts. One of the reasons for this is that many may use the belt and consider themselves safe from poor lilfting habits. This is NOT true. A back belt is supposed to be used as a reminder when you exceed or perform certain undesireable movements. I believe many may cause their own injuries thinking that back belts make them “super” lifters, immune from injury.
Back Letter 16(1):1, 6, 7, 8, 2001 According to a large new prospective cohort study conducted by researchers at the National Institute of Occupational Safety and Health (NIOSH) back belts do not prevent back pain or back pain disability, according to James T. Wassell, PhD, and colleagues. (See Wassell et al., 2000.)”In the largest prospective cohort study of back belt use, adjusted for multiple individual risk factors, neither frequent belt use nor a store policy that required belt use was associated with reduced incidence of back injury claims or low back pain,” Wassell et al. conclude. (See description of Wassell study on page 6.)The study found no beneficial effect of belt use in any group: among employees with and without a history of back injury, employees with consistent belt-wearing habits, or employees with the most strenuous jobs. The study had some obvious strengths. In addition to its large size, it included subjects from a wide geographic area. The investigation had concurrent comparison groups and detailed exposure information, and was able to control for a wide variety of potentially confounding factors.”Results based on these multiple analyses of data all converge to a common conclusion: back belt use is not associated with reduced incidence of back injury claims or low back pain in material handlers,” according to Wassell et al.
Acupuncture Can Reduce Arthritis Pain
I think positive results in trials of acupuncture are probably the hardest for mainstream medicine to follow. There is very little correlation between our Western beliefs and Eastern medicine. It requires an entirely different view. Just because we do not understand something, however, does not mean it is ineffective. Acupuncture has literally thousands of years of anecdotal evidence relating to its effectiveness and safety. Mainstream medicine barely has decades.
(article) Acupuncture offers a significant adjunct to conventional therapy in the management of osteoarthritis, according to the results of an NIH-supported study of complementary medicine in osteoarthritis pain management presented here at the 17th Annual Meeting of the American Academy of Pain Medicine. Although more patients are turning to complementary medicine and more physicians want to integrate complementary medicine into their practices, evidence for the efficacy of these methods is lacking, according to Dr. Brian M. Berman, professor of family medicine and director of the complementary medicine program at the University of Maryland School of Medicine in Baltimore. Dr. Berman and colleagues at the University of Maryland conducted a study to investigate the impact of acupuncture on pain levels in osteoarthritis of the knees in the elderly. In the first phase, the researchers evaluated 73 patients, all with moderate to severe osteoarthritis of the knees, who were not relieved by anti-inflammatory medications. The subjects were randomized to continue on anti-inflammatory drugs alone or anti-inflammatory drugs plus 8 weeks of acupuncture treatment. “We found on the 3-month follow-up that there were significant changes,” Dr. Berman told Reuters Health. “Acupuncture did reduce their pain, they had less stiffness and they were able to function better.”
US Supreme Court Says Law Bars Suits on Medical Devices
Let me get this straight. The FDA has the final say in whether a medical related device is safe enough to be released to the public. This information is almost always provided by the manufacturer wishing to market the item. Bias in the info provided and financial ties with the FDA are well known and even documented in some cases. Now, the Supreme Court basically says it’s okay for the manufacturer to provide fraudulant info to the FDA to get their item approved???? And yet the safety of supplements is frequently called into question?? People in glass houses…
(article) The US Supreme Court on Wednesday ruled that individuals cannot sue manufacturers of medical devices for allegedly defrauding the US Food and Drug Administration (FDA) in order to win marketing approval. The case involved a lawsuit in which more than 5,000 individuals accused a company of fraudulently winning federal approval for marketing bone screws used in spinal surgery. The lawsuit alleged that the Buckman Co., a consulting firm for medical device manufacturers, used misrepresentations to get FDA approval in 1986 for marketing a device known as the Variable Screw Placement Spinal Plate Fixation System. The ruling also was a victory for the company. Chief Justice William Rehnquist said for the court that a US appeals court had been wrong in reinstating the claims against the company and allowing the lawsuit to go forward. Allowing such lawsuits might expose manufacturers of medical devices to “unpredictable civil liability,” he said. Rehnquist said the federal regulatory scheme amply empowered the FDA to punish and deter fraud against the agency, and that the FDA used its authority to achieve a delicate balance of objectives that can be skewed by allowing such lawsuits. “The FDA…has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the agency,” Rehnquist said in the opinion. He said this flexibility was a critical component of the framework under which the FDA pursues its objective of regulating marketing and distribution of medical devices. Rehnquist said state law fraud claims inevitably conflict with the FDA’s responsibility to police fraud. He said companies complying with the FDA’s detailed regulatory regime, but then facing possible lawsuits under the laws of 50 states, might be deterred from seeking approval of devices with potentially beneficial uses. In the case at issue, the FDA had rejected Buckman’s two previous applications, made on behalf of AcroMed Corp., for marketing the device. But a third application, which separated the device into its component parts and which said the screws were intended to be used in the arm and leg bones, won FDA approval. The plaintiffs claimed they were injured when their doctors implanted the device into their spines and alleged that Buckman had perpetrated a fraud on the FDA. The individual claims seeking monetary damages were consolidated into one lawsuit. The lawsuit said that Buckman won FDA approval under a pretext because the intention all along had been to market the bone screws for use in spinal surgery. The FDA did not approve the marketing of bone screws for spinal surgery until 1995.
Hip Pain Not Related to Structural Damage
Any good chiropractor could come to this conclusion without all the money spent on a study. So many times I hear patients coming in saying “My doctor told me I have arthritis.” Guess what?? If you’re over the age of 25, you’ve got arthritis. We can not always rely on X-rays for a diagnosis.