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Bad Choices, Pharma

A second portion of this article is "Bad Choices" with concise recommendations on Aspirin, natural estrogen (estradiol), Q10, testosterone, and the niacin and other cholesterol lowering agents.  http://healthfully.org/rc/id14.html



Two Changes in content coming up


  1. The cholesterol myth.  Numerous critics have pointed out that cardiovascular disease is not caused by higher levels of blood cholesterol or fats.  Pharma promotes the cholesterol myth and ignores the major causes.

  2. Major cause of cardiovascular disease is pathogens living within the middle layer of artery walls.  It initiates the immune response which involves LDL, HDL, and white blood cells.  Reactive chemicals such as simple sugars and carbon monoxide can potentiate the process resulting in the formation of plaque within the artery walls.

     


For confirmation from journal articles on primary role of infective agent enter into http://scholar.google.com/ terms such as bacteria + atherosclerosis or go to http://healthfully.org/rl/id8.html and id9  for collection of articles

For confirmation of cholesterol myth enter into http://scholar.google.com/ or http://www.amazon.com/ cholesterol myth, or go to http://healthfully.org/rl/id5.html for collection of journal articles

 




Pharma treatments summarized with healthful alternatives

Subsection coronary vascular issues

Heart issues:  The biological process leading to cardiovascular disease explains (1) why pharma’s drugs are not effective (once their side effects and costs are included in the calculations); and (2) why the prevention of hardening of the arties is the best approach.  Hardening of the arteries is caused by an inflammatory by lymphocytes which causes a scavenger response by macrophages to engulf the oxidative damaged LDL (low density lipoproteins, bad cholesterol).  The macrophages die and form foam cells which constitute most of the plaque in hardening of the arteries.  As the load of plaque accumulates and ages it causes cardiovascular disease (CVD), which makes the arteries stiff and occluded and this causes high blood pressure.  When the plaque breaks off, a thrombosis can result, and when it occurs in the coronary artery it can cause a heart attack, and in the brain a strokes (acute events),   Acute events are only moderately associated with high levels of LDL.  LDL causes CVD only when it undergoes oxidative damage.  The principle cause for oxidative damage of LDL is carbon monoxide (found in smoke) and other blood-borne reactive chemicals.  The more LDL, the more targets for reactive chemicals and thus a faster the rate of formation of plaque.  However, over 85% of acute events are caused by young, unstable plaque (not old hard) that leaks, when the plaque occlusion is from 20% to 50%—young plaque is not encapsulated.  Thus about 20% of heart attacks occur in those without the signs of CVD:  high blood pressure, angina, or high levels of cholesterol.   Another factor is chronic inflammation (such as by gingivitis of the gums and pylori bacteria in the stomach).  It is estimated that about 1/6th of all heart attacks and strokes are caused by chronic inflammation.  The common type of heart attack results when plaque breaks loose in the coronary artery and form a partial plugs down-stream, and then a clot forms to totally occlude the coronary artery.  Blood turbulence increases with the occlusion caused by the plaque plug which can result in a clot forming.  High blood pressure increases the turbulence and thus the likeliness that a clot will form.  That is why high blood pressure is a causal factor for a heart attack.   A like process can happen in the brain, a stroke.    The best treatments is to prevent hardening of the arteries starting early in life, and thus less plaque and normal blood pressure. This is best accomplished by 1) healthful lifestyle including avoiding carbon monoxide, 2) inhibiting oxidative damage to LDL and 3) inhibiting the inflammation response of white blood cells to damaged LDL.  Lowering LDL when it is high is far less effective way to prevent hardening of the arteries—for which doctors prescribe statins.  For one thing, high LDL might not occur until after there is a large amount of plaque in the arteries.   Clearly the best drugs are 325 mg aspirin, 300 mg Q10, and natural estrogen post-menopause, or testosterone past the age of 70 .  These choices are much better than statins and blood pressure drugs (see below).  If these were taken by teenagers and continued throughout life, pharma’s income would eventually be cut in half.  Pharma thus teaches that aspirin, estrogen, and testosterone pose major health risks that outweigh their coronary benefits, and they ignore their other benefit of them and Q10.  And all this is supported by their tobacco science, which is taught to doctors in their continuing education classes and pushed through treatment guidelines.  Pharma also teaches doctors that high blood pressure and high levels of LDL cause CVD in order to promote their sales of drugs that treat these health issues, for which they make billions.  Their mantra is “safe and effective.”

  

Anticoagulants (blood thinners):  They are widely prescribed to prevent or treat thrombosis (blood clots), which can damage the brain (stroke), heart (myocardial infarction), lung (pulmonary embolism), and other organs.  They are commonly given to those who undergo major surgery, are hospitalized for 3 days and longer, or have arrhythmia (irregular heart beat) because of their higher risk of thrombosis.  With a few exceptions, they aren’t worth the side effects.  Pharma exaggerates the risks and benefits; their sales mantra is “safe and effective”.  Once out of the hospital this treatment is normally continued.  They aren’t worth the side effects.  A much, much better choice is to take a 325 mg of aspirin in the morning and another in the evening, and it has many other health benefits (see aspirin above).  At this higher dose it is a better long-term anticoagulant for preventing heart attacks and strokes (by about 50%), and it lowers the risk of most cancer overs 40%.  Cardio-exercise and weight control offer significant benefits because a poor flow of blood is the major causal factor, and it lowers blood pressure another causal factor for blood clots.

 

Arrhythmia (irregular heartbeat):  is any of a large and heterogeneous group of conditions in which there is abnormal electrical [nerve] activity in the heart. Although many arrhythmias are not life-threatening, some can cause sudden death.  Most such sudden deaths occur during a major heart attack due to the destruction of heart muscle.  A basic problem with treating an irregular heart beat with drugs is that they are not magic bullets that just work upon the cardiac nerves.  They inhibit neurotransmitters; thus upset cognitive and bodily functions.  Arrhythmia is a disease of mostly seniors, and most drugs are on the American Geriatric Society’s avoid list.   Moreover, they don’t stop arrhythmia (just modestly reduce them short term) and can cause pro-arrhythmia (drug induced arrhythmia), and they have at best minimal effect upon death.  Other treatments include physical maneuvers, electricity conversion, and electro or cryocautery.  Just like drugs, the merits of these physical interventions are oversold.  

  

Hardening of the arteries (atherosclerosis, cardiovascular disease):  Aspirin and Q10 are the best first line of defense and should be taken daily starting in the teen years (see Q10 and aspirin).  In addition women starting with menopause and continuing thereafter should take the natural estrogen (estradiol), and men starting between 60 and 75 should take testosterone.  There is major cardiovascular protection with estradiol; it is why cardiovascular disease and heart attacks occur following menopause. Men on testosterone are less likely to develop metabolic syndrome (diabetes, hypertension, and atherosclerosis) and are more likely to survive a heart attack.  Cardiovascular disease results from oxidative damage to LDL and VDL (the bad cholesterols) that stimulates an inflammatory response in macrophages.  They also ingest the damaged LDL and become foam cells that become part of the plaque, and this sequence of events causes plaque formation.  Macrophages are a type of white blood cell that scavenges damage cells, and also oxidative damaged LDL.  Estrogen and Q10 protect LDL and VDL from oxidative damage, and aspirin and estrogen inhibit the inflammatory process.  As for statins:  pharma hypes its benefit and hides their side effects.  (See section below as to their failure to reduce mortality though they lower LDL.)  Once hardening of the arteries occurs, since the plaque is encapsulated, it is beyond the reach of drugs.  Aspirin, estradiol, and Q10 along with healthful lifestyle can stop the formation of new plaque, and in most cases over the years there will be a gradual improvement through revascularization. 

 

Heart Attacks (MI) and treatments:  “Each year [2005] 1.5 million Americans experience a heart attack and nearly 460,000 are fatal.  Of those who die, almost half die suddenly, before they can get to a hospital” AHA.   As with most acute conditions the list of standard treatments, most are not worth the side effects.   Following the list below when the patient is depending upon the help requires making the doctor aware of who is the ultimate decider.  With MI, there are two phases acute and recovery.  For recovery the typical well insured patient is treated long-term for a variety of issues that cost on an average over $70,000 per year.  Nearly all of them have better alternatives.  CRITICAL CARE AVOID:  (in order of importance):  downers (psychotropic drug), Protein Pump Inhibitor (PPI), heparin & other blood thinners, high blood pressure medication except if extreme 180 over 110, antiarrhythmics except for lidocaine, and oxygen.   Downers (psychotropic drugs) have many indications such as anti-nauseas, muscle relaxant, sedative. If drowsiness or mental confusion is a side effect, it is probably a downer (or an opiate).  Drugged, the patient is less likely to inform the nurse of a negative turn in their condition, or resist their doctor’s advice.  PPIs for acid indigestion are addicting.  Instead of heparin or similar anticoagulant promptly take 975 mgs aspirin, followed by one every 4 hours.  Drugs for hypertension other than nitroglycerin do not lower morality Cochrane Library  and many of them are downers.  RECOVERY AVOID:  PPI is given with the anticoagulant, but PPIs are addicting because of the rebound effect, and long-term usage causes serious life-shortening, side effects such as osteoporosis & colitis.  Tums, when needed, is a better choice.  Statins are totally over sold, and are justified only by marketing science.  Counter to their marketing science, they are not cardiovascular protective through they improved the lipid profile and thus are not worth the side effects.   PPI, statin, blood pressure drugs, blood thinner, antiarrhythmics drug therapy, and downer lack quality evidence that proves their net worth and superiority to other choices; yet they are routinely administered in the hospital and nursing home, when the patient is most vulnerable.  Avoid polypharmacy because it multiplies the risk of major side effects.  All too often their side effects are treated with additional drugs.  All side effects are grossly under-reported.  Most drugs started in the hospital and nursing home will be continued long-term. While recovering, avoid both stent and bypass operation, they do not prolong significantly life, though they reduce angina pain.  The vast majority of MIs do not originate with obstructions that narrow arteries" Wiki.  An exception would for acute STEMI with unstable refractory angina with objective evidence of ischemia, UK study. The best choice is to follow the recommendations in the section on Niacin below.

 

Hypertension:  First choice is Q10 (300 mgs), exercise, sodium restriction, and weight control.  Over half of those who follow this program will have normal blood by 1 year.  Moreover, the prestigious Cochrane review concluded that:  “Drugs for mild hypertension have not been proven to benefit patients.” Mild hypertension is a systolic 140-159 and diastolic 90-99.  If after 2 year there isn’t sufficient progress at lowering blood pressure below 160 over 100, then the second choice is thiazide and thiazide-like diuretics [lowers the amount of water in the body].  [They] have good evidence of beneficial effects on important endpoints of hypertension … [and they] also increase calcium re-absorption at the distal tubule” Wiki, and they are among the cheapest drugs.  They are widely recommended as first line in treatment guidelines.  Treating hypertension with pharma’s drug arsenal (over 100 drugs of which 3 are typically prescribed at one time) has serious side effects including drowsiness, cognitive impairment, ED, and low libido.  Moreover, pharma’s régime of drugs when taken long-term doesn’t extend life.  For example the very popular group of calcium channel blockers cause a “higher mortality rate over extended periods of use” Wiki.  The first approach (Q10, diet, etc) is the only reasonable choice.  Long term prevention of further development of hardening of the arteries through aspirin 325 mgs, Q10, and estrogen will in most cases result in a gradual lowering of blood pressure, and a significant long-term reduction in mortality. 

 

Statins and cholesterol:  Cardiovascular disease (CVD) results from oxidative damage to LDL and VDL (the bad cholesterols) that stimulates an inflammatory in T-lymphocytes which then causes macrophages to engulf the oxidized LDL.  This result in the formation of foam cells (dead macrophages), which constitute most of plaque.  Macrophages are a type of white blood cell that scavenges damage cells and oxidative damaged LDL.   A lower level of cholesterol entail that there is less LDL to be damage by reactive chemicals, the most significant being carbon monoxide--a product of incomplete combustion.  Thus some of the carbon monoxide will react with other molecules.  Thus lower level of cholesterol only has a modest effect upon plaque formation.  For a complex set of reasons, statins positive effect of lowering cholesterol is undone by its promotion of oxidative damage through inhibition of COX enzymes and its slowing the process of converting unstable to stable plaque.  Statins don’t protect against coronary artery disease and its deadly consequences.  Several large proper scientific studies have failed to find significant health benefits—though of course there are marketing studies that produce positive results.  Statins side effects (especially its negative effects upon cognitive function, sexual activity, and physical energy) make it not worth taking.  Pharma, as is their norm, has done marketing studies to show that statins are safe and effective.  That 90% of doctors believe that statins are safe and effective is testimony to the effectiveness of pharma’s use of continuing education to promote sales.  Moreover, those above 70 years and those with congestive heart failure definitely should not take statins, a fact that most doctors are not aware of.  The critics lack an effective forum to affect medical practice.  Only those with a familial genetic defect that causes cholesterol levels that are twice the norm should be on statins, which is what the first statin was approved for.    For high cholesterol the best choices are Q10 300 mg, which prevents oxidative damage to LDL, aspirin 325 twice daily, which lowers the inflammatory response of macrophages, and estradiol 4 mg (the best of the 4 natural estrogens) and testosterone 100 mg.  These hormones lower the risk for CVD, metabolic syndrome, and the resultant much higher rates for heart attacks and strokes.  Estrogen is significantly more effective than testosterone.  Best source for hormones is a compounding pharmacy.        




AVOID LIST  --6/23/14


With position papers: acetaminophen, chemotherapy for cancer (with a few exceptions). 


Other Drugs:  bisphosphonates for osteoporosis, psychotropic drugs (downers), Alzheimer’s disease, protein pump inhibitors for heart burn.


A separate paper here sets out the cholesterol myth and the ineffective treatments for high blood pressure, high cholesterol, irregular heartbeat, and blood clots, with a list of much better alternatives.  The article on the role of diet in chronic conditions contains a list of foods to avoid.  There are links to the longer articles.  For Cardiovascular Disease and drugs.


 


Drugs with position papers:


 Acetaminophen (Paracetamol, APAP):  It is the most widely sold over-the-counter drug for the relief of pain[1], fever, and headaches.  It is found in over a 100 over-the-counter and prescription preparation (mostly opiates).  As a mild analgesic APAP’s inclusion with an opiate cannot be justified given its severe side effect of causing live damage.  The annual percentage of potentially fatal acute liver failure (ALF) hospitalizations caused by acetaminophen rose from 28 percent in 1998 to 51 percent in 2003.  A major cause is that acetaminophen is indicated as APAP on most opiate prescriptions and the common use of the over-the-counter Tylenol as a second drug for relieve of pain.  In a well-designed study it was found that 39% of those taking the recommended dosage of APAP had 3 to 8 times the upper limit for ALT a marker for liver toxicity.  APAP in 2010 caused 56,000 emergency-room visits, 26,000 hospitalizations and 1,600 liver failures, and this is based on a system designed to grossly underestimate the severity of the problem.  New FDA limits and warning goes into effect in 2014.  A study of 205,487 children age 6-7 found that the use of APAP is associated with a 323% increase in the risk of asthma.  Four weeks of prenatal use of APAP is associated with lower motor, cognitive development and more behavioral problems when compared to a sibling by over 70% for each.  Other study found that APAP during pregnancy was associated with hyperactivity (ADHD, another with failure to develop testes (cryptorchidism), and a third with lower masculinization development.  The medical literature on liver toxicity goes back to the 1960s.  Pharma is very good at controlinge information given to doctors and the public. 


Chemotherapy & Cancer:  For simplicity the discussion is limited to the most common types of cancers. Within them are two groups, one with an overall survival of above 50%, colon, prostate and breast; while for small cell lung and pancreatic cancers the 5-year survival is less than 5%.  If fatal, it is metastatic--spreads to distant tissues, and chemotherapy is not curative.  The basic question, once diagnosed, is the prognosis?  Several factors are relevant to estimating how invasive the cancer is.  A biopsy examined under the microscope that reveals many highly abnormally shaped cells has a high statistically association with aggressive (fast growing) cancer, but about 40% are still indolent.  Found in 3 local lymph nodes is associated with metastatic (about 60%), and aggressive (about 80%) of cancers.  Distant metastatic cancer has about a 10% chance of being indolent with about half (5%) living past 5 years.  However, there is no way to know at stages I through III, if that cancer has become metastatic.  If small colonies have already spread to distant tissues, removal of the primary tumor does not change the prognosis.  The clock however is running as to when a cancer will change from indolent or local aggressive to a metastatic cancer.  This change is through the involvement of stem cells.  The prompt removal of the cancer is the prudently choice to prevent stem cell involvement.  If some indolent cancer remains, once discovered it can be removed; chemotherapy does not affect the course of the disease, it just extends life 3 months.  Those few with metastatic cancer who live several years, do so not because of an atypical response, but because the cancer is indolent.  Without strong proof that the chemotherapy is curative, it is not worth taking.  Remember as stated in “Marketing Science”:   the assorted conflicts of interest created by the role of pharm in research, education, treatment guidelines entail that the oncologist is a misinformed patient guide.  Also major Positive bias is the norm:  pharma funds clinical trials, owns the results, write it up, and publish in pharma “friendly” journals. 


Cancer basics:  cancer is distinguished from a benign tumor by its ability to invade neighboring tissue and sometimes spread to distant tissues (metastasize).  Also benign tumors generally have a slower growth rate and are more differentiated (look like normal cell ).  This is the first area where business has blurred the distinction between benign and malignant by often calling benign “carcinoma”; it isn’t unless there is evidence of invasion to adjacent tissue.  Critics have pointed out the negative consequences of treating benign tumors of the breast prostate, thyroid cancers, and other tissues chemotherapy following excision or radiotherapy.   Such aggressive treatment in long-term trials show no benefit or worse.  Benign breast tumors, called “cancer”, when treated with chemotherapy shorten life over 4.5 years (mostly through the use of an estrogen blocking drugs and the exclusion of those patents from HRT).  In general treating stage I, II, & III cancers aggressively with chemotherapy doesn’t change the course of the disease, but shorten the life of all for who are cancer survivors.  The chemotherapy is pointless because all of it has been removed by excision.  With the exceptions of a few tissue types, chemotherapy doesn’t cure cancer, but rather shuts down an essential biological process that affects the rate of cell reproduction, including in the cancer.  This toxicity limits the chemotherapy.  The average remission (slowing of growth) is 3 months.  About half of the patients will have long-term side effects.  Patients and physicians believe that the chemo destroys cancer missed by excision, it doesn’t, and they also believe that those with metastatic cancer who live pass the average do so because of a typical response to the chemotherapy, but rather it is because that patient had an indolent (slow growing) cancer.   Pharma’s two deception are to deny indolent metastatic cancer, and to claim that chemotherapy can destroy for a few patients the cancer missed by excision.   The oncologists’ greatest source of income is the spread between the discount price they get the chemo and what they bill.  Chemotherapy is thus oversold.


 


Other Dangerous Drugs--without position papers:


A number of different families of drugs are clearly not worth the side effects for which we have not written a position paper, yet we are aware of the tenuous evidence and warning issued by others.  We turn to site such as Worstpill.org, and Cocharanereview.org act as watchdogs.  But they are limited by their sources:  they rely upon the FDA and meta-analysis (combining results of several clinical trials) of the treatments.  They choose their battle and thus repeat the pharma generated errors on aspirin and hormones.  But clinical trials are funded by pharma and positive bias averages 32%, thus meta-analysis reflect this distortion.   Our other sources are critics of treatments that are published in medical journal, older medical textbooks.  Sometimes we find a conflict between the scientific analysis of the condition and the modus operandi (method of action) of the drugs.  Also many on the face of it are suspect:  giving downers to depressed patients, treating osteoporosis with unnatural chemicals that go to the bones rather than calcium compounds, attempting to treat a condition with a drug that doesn’t act upon the underlying cause.  A junk drug does more harm than good, and often there are clearly better alternatives.    Below is the current list of other junk drugs.


Junk list:   Bisphosphonate for osteoporosis.  They increase the bone density by putting a compound containing two phosphate groups (P03) in the bones,  It isn’t the same as bone building the natural way with hydroxyapatite (Ca10(PO4)6(OH)2) and collagen.   Bisphosphonates don’t prevent fractures long-term and there are side effects. NSAIDs but for aspirin.  They have minimal pain reduction effect, work well as an anti-inflammatory drug by reducing inflammation, thus their affect upon pain is minor, as demonstrate by clinical trials.  Unfortunately they increase with long-term usage the incidents of heart attacks and strokes—from 50% to 400%.  This includes the block buster Celebrex which increases with long-term usage risk 200%.   Psychotropic drugs used for psychiatric conditions are much worse than behavioral therapy and worse than no treatment.  When both published and unpublished trials are looked at, paroxetine [Paxil] does not appear to be any better than placebo in adults with moderate or severe depression” Wiki. With only a couple of exceptions all psychiatric drugs are tranquilizers (downers):  hinder cognitive function and cause drowsiness.  Since “downer” and “tranquillizer” have negative connotations, they all wear different labels for marketing, such as mood elevator, muscle relaxant, ACE inhibitor, SSRI, etc.  Besides used for behavior issues, tranquilizers are widely prescribed for physical conditions such as for back pain, angina, brain trauma, epilepsy, menopausal hot flashes, hypertension, and so on; even though they don’t affect the core problem and benefits in pharma’s clinical trials are only slightly better than a placebo.  Tranquilizers are spotted by the side effect of drowsiness and their indication for psychiatric conditions.  FDA approval is based on 6-week clinical trial of an ideal population for the goals of the trial—not a real-world clinical population.   By impairing cognitive function, these drugs do not promote long term behavior improvements in the general population (no more than alcoholism or marijuana does).  They do not help people deal the underlying psychiatric behavior problem,  In a 2014 population study, “After excluding deaths in the first year, there were approximately four excess deaths linked to drug use per 100 people followed for an average of 7.6 years after their first prescription” BMJ.  These downers by reducing cognitive function make the patient more dependent upon expert opinion, their doctor and thereby are associated with polypharmacy; and they shorten life.  They negatively affect quality of life, which is why there is low compliance.  Treatment of children psychiatric disorders--before the 70’s quite rare--is unwarranted (with rare exceptions).  Most conditions requiring hospitalization will include a tranquilizer, protein pump inhibitors (PPI) and acetaminophen (APAP).  Sleep and cognitive confusion reduces discussion with staff and thus lightens the work of the care givers, plus they increases profits.  Alzheimer’s disease (AD), drugs do not affect the course of the disease.  Factoring in the side effects, they are worse than a placebo.  Downers are often included in treatment of AD, as if the patient needs more cognitive impairment.   Avoid for AD Aricept (donepezil), tranquilizers, & Cognex (tacrine) and all other drugs given to purportedly slow the progress of AD (they don’t) or make the patient more manageable.  Downers that shorten life and increase signs of dementia.  Acid reflux condition (heart burn) should be treated with over-the-counter antacids; avoid the prescription alternatives, especially protein pump inhibitors which have rebound effect if stopped which increases heart burn.  There is a lack of effective drugs for COPD, restless-leg syndrome and many of the minor complaints that are listed in the Merck Manual, such as fungal infection of the nails.  Tamiflu and other flu medications such as are junk (see Bad Pharma supra 81-91).  Pharma is very good at making a drug not worth taking appear as safe and effective. 


Pharma is also very good at cooking up new indications for drugs and having them used off label.  Over half the prescriptions given are for uses that have not meet the very low FDA hurdle.  Most off-label uses have shoddy marketing research (phase IV clinical trials), which are used to “educate” doctors.  In general, off-label uses are not in the patient’s best interest.  Doctors have been cast in the role of drug pushers through clinical guidelines, clinical administrators, peer pressure, financial rewards from pharma, a lack of reliable information on treatment alternatives, and continuing educations class given by pharma to name the main ones.  The $600 industry is very good at marketing. 




[1] The mechanism for pain reduction is through the reduction of inflammation by blocking only 50% of COX2 & COX1 enzymes and inhibiting the production of prostaglandins (Goodman & Gilman’s pharmacology textbook 2007 edition, p. 693).  This is why they are classified as “mild analgesics” (G & G at 681).  Other claims as to medicinal use is at best only weekly supported. 





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Disclaimer:  The information, facts, and opinions provided here is not a substitute for professional advice.  It only indicates what JK believes, does, or would do.  Always consult your primary care physician for medical advice, diagnosis, and treatment.