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Marketing Science and Misinformation

raw data is clinical trial
cymbalta-missing-trials-side-effects.jpg
journal articles hide side effect 65% of times

 

The topic is central to the making of wise medical choices.  It is central to your accepting the well supported conclusions that are in the following articles on this site which run counter to corporate medicine..  An understanding of how bad things have gotten is worth another essay.  If you need convincing please read the next article at http://healthfully.org/rc/id9.html

Highly recommended is Junk treatments, which explains the methods pharma used to turn physicians into pill pushers.   

 

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 As Dr. Philippe Even, the author of "The Guide to the 4,000 Useful, Useless or Dangerous Medicines"[1] told The Guardian: “The pharmaceutical industry is the most lucrative, the most cynical and the least ethical of all the industries. It is like an octopus with tentacles that has infiltrated all the decision-making bodies:  world health organizations, government agencies, parliaments, high administrations in health and hospitals and the medical profession." My 10 years of developing the website http://healthfully.org has confirmed that summation. You should take better care of your health than your car.    

at link are a collection of documentaries confirm the claims made below about pharma and the state of medicine. 

A few additions will be added, because of additional methods of pharma that I have uncovered relying upon those professor who stood up (see http://healthfully.org/critics/ ) and others. 
  

[1]   The book was published in French in September of 2012, and as of April of 2013 it hasn’t been translated. 

 

     Marketing Science and Misinformation—2pg—jk, 11/23/15 http://healthfully.org/rc/id1.html

All the issue raised below can be also found in “The Truth About the Drug Companies, by Marcia Angell, MD, Harvard Professor, by David Healy article, and book Pharmagaddon, and those listed on my critics page.  This work conforms to academic standards of supporting references.  Two-noted French doctors in their recent 900 page book "The Guide to 4,000 Useful, Useless or Dangerous Medicines proves that “half of France’s drugs are useless.”  This is what we get corporate tobacco ethic  and regulatory capture in our corporatist state.  The subsequent article gives examples of the process.  As Prof. Angell puts it: “What can the 800 pound gorilla do; just about anything it pleases,” referring to the $800 billion dollar industry. Hundreds of articles at www.healthfully.org confirm Angell’s assessment.        

TERMS:  Marketing science, research done with the objective of promoting their drug; distinguished from medical science.  Raw data is the data collected along with the conditions of a clinical trial.  Science journals—except medical)  require inclusion of the raw data so the review committee can evaluate the article submitted; without it review is a facade.  Key opinion leaders (KOL) are renowned specialists.  Their rise to prominence is based on consistently promoting pharma’s goals and, for which most receive 6-digit income for services.  KOLs are the lecturers at continuing educational classes, appear in the media, write textbooks, sign off on ghost written journal articles, and are on guideline committees.  Treatment guidelines are pharma friendly standards of treatment issued by the FDA & other organizations.   



Key points (the business norms):    1) The FDA has always been headed by those with proven track records, often executives from big pharma.[1]  2) The FDA creates the façade of supervision through their approval of drugs and subsequent regulatory actions such as black-box warnings for serious side effects. This deception of protecting the public is promoted by the corporate media.  3) The marketing departments of pharma control the production of medical opinions:  a) by funding 95% of large clinical trial pharma decides what to study, trial procedures, and they own the results.  b) They always manipulate published results.  c) Pharma’s influences FDA-funded trials.  d) Pharma creates the  KOLs.  e) Pharma funds the mandated continuing-education courses for doctors--$50 billion spent annually for sham education—twice what they spend on research.  f) Pharma provides half the funding of all health organization including the AMA, the APA, & the American Heart Association. e) These organizations set up treatment guidelines that expand usages for drugs through relying on shoddy phase-4 clinical trials.  g) Litigious patients can use these guidelines in courts to claim malpractice.  f) Sales reps (one for every 4 doctors) establish a relationship with doctors to educate doctors.  h) Doctors who push a company’s drug are given perks worth up to 6 figures annually. i) Direct-to-consumer ads create product recognition and patient requests for them.  j) Low quality phase-IV clinical trials find new indications for their drugs or to “prove” their drug is superior to off-patent drugs.  k) KOLs write pharma friendly textbooks.  4) Administrators of hospital, HMOs, and nursing homes receive through sales reps kickbacks for setting up treatment protocols using patented drugs[2].  5) Large perks are the norm for those doctors who favor one big pharma company.  Over 25% of pharma budget goes to influencing doctors, 14% to research.  Large cash reward for teaching and research is a powerful incentive.  6)  Given that bias is norm journals and that 90% of articles on line require a payment of $35, doctors rely upon guidelines & KOLs for guidance.  We have pharma’s “expert” based medicine.  7) For patent approval by FDA, the drug must be slightly better than nothing at all (placebo), and side effect are rarely a reason for rejection.  Half the drugs aren’t worth their side effects.  8) Since side effects reduce sales, they are always grossly under reported.  8)  Research is market driven thus treatment for chronic conditions are given priority over cures.  9) Instead of competing to make the best drugs, all of big pharma use junk science and marketing techniques to hawk their me-to-drugs (knockoffs).  Less than 10% of new drugs are innovative. This is what corporate tobacco ethics gives us, and we pay for their marketing!  10) As Harvard Prof. Marcia Angell MD wrote: “If we set out to design the worst system that we could imagine, we could not imagine one as bad as we have”--her excellent President’s Lecture.


Supporting examples. 8) Most drugs are tested on am ideal population and in real-world uses do more harm than good.   E.g., most cancer drugs delay death in stage 4 (terminal) cancers by less than 3 months.  These drugs are then used for all stages of cancer.  The net outcome is to shorten lives of those cured by excision (without metastatic terminal cancer) because of their side effects[3]. Blood pressure drugs suffer from similar negative usage. 3) Bias in journal articles is the norm.  In a study of 37 drugs for which the raw data given the FDA became available through Freedom of Information Act to a group of researcher, they found all the journal articles based on this research exhibited a bias--between 11% and 69%, with an average of 32% (NEJM).  This entails that all published clinical trials are biased.  Thus doctors have can’t know what is best.  Also about ½ of clinical trials are not published  This is equivalent to flipping a coin ten times and only reporting that there are just 5 flips, all of which are positive. 2 & 3) The FDA has done flawed studies with the intent of promoting the sales of patented drugs.  A prime example of this is the Women’s Health Imitative (2002) which the FDA knowingly used the worst formulation of HRT, Prempro.  Then the FDA extended Prempro results to all HRT formulas and warns that HRT has one valid medical use, for hot-flashes, and it should be used at the lowest dose for the shortest time.  Natural HRT prevents osteoporosis, Alzheimer’s, atherosclerosis, heart attacks, and colon cancer. Older journal articles prove this.[4]  Pharma profits from drugs for those conditions.  2 & 3) FDA does not require head-to-head studies of drugs.  When pharma funds a comparative clinical trial of their drug (most often for off-patent drug), it has been manipulated to “prove” theirs is superior—e.g. aspirin cause more stomach bleeds, they use a 2-pint transfusion for Plavix.  2) The combination of marketing and other methods listed above entail that a number of older, more effective off-patent drugs have lost their market position.  A prime example is that of diuretics for high blood pressure (ALLHAT study).  Their use has been replaced by the newer less-effective patented drugs such as ACE inhibitors.  2)  Basic medical science has been tweaked to support sales.  Heart attacks are not caused by high level of cholesterol and hypertension, rather by hardening of the arteries caused by inflammation.  Giving a drug to lower blood pressure or cholesterol does not prevent hardening of the arteries and subsequent pathology—numerous articles and books prove the cholesterol myth.  Pharma used the worst cases to show only very modest benefit from Statins based on flawed clinical trials.  2) FDA’s drug safety review is a façade.  They don’t enforce either the requirements to report side effects or to do a post-marketing studies on side effects when requested.  The FDA licenses worse-than-placebo medication including bisphosphonates (footnote),SSRIs, most cancer drugs, ACE inhibitors, and Prempro. The most outrageous example that I have uncovered are the selective COX-2 inhibitors. Vioxx caused 125,000 heart attacks resulting in 55,000 deaths between 1999 to 2005; before it was voluntarily removed.  They more than double the risk of heart attacks, a fact exposed in 2001 in the VIGOR, & the APROVE Studies.   Civil actions over the big 3 of COX2 inhibitors, Celebrex, Vioxx, and Bextra, resulted in over $3-billions civil settlement. The gross disregard for public safety is why a number of organizations critical of the industry (Worst Pill) recommend that patients use older medications unless there is clear and convincing evidence that the newer one is better.  The FDA allows the blockbuster Celebrex; though other nations don’t.   6) Pharma’s reduced usage of aspirin by exaggerating risks, ignoring benefits[5] and promoting an ineffective low 82 mg dose, for which tolerance develops within a year.  Aspirin prevents cancer through apoptosis (death) of abnormal cells, effective treatment for arthritis, prevent heart attacks, etc. thus the assault upon aspirin.  2)  Surrogate endpoints are used instead of cures and life extension too often when the drug is useless, such as statins and blood pressure drugs.  They are taken to prevent illness which they do not.  8) Side effects are dirty words, and there are numerous ways to under-report side effects, including using healthy, young subjects, not including certain side effects in study (e.g. reduction in libido from SSRIs is the norm), don’t quantify them but include them in a list of over 20 side effects, trial period is too short for certain side effects, such as cancer, no long-term follow up, to name some.  3)  Ghost writing by pharma for TV broadcasts & new articles for to promote drug sales.  Journal articles, medical textbooks, etc. are all pharma friendly. 

Healthfully.org mission is to publish sound evidence-based advice on drugs and treatments.  This is an arduous process.  In 1980 I relied upon my current edition of the pharmacology text book by Goodman and Gilman.  Now in the main, textbooks repeat pharma’s bias, some are even ghost written by pharma.  Critics are still published in journals, I look for them.  Much of my research time is spent looking for articles whose results are contrary to what pharma spouts.  Animal and in vitro studies fill the gap left by pharma not wanting to expose a problem, such as Statins reduce CoQ10 by 40%.  They are not pharma funded. I look for bias in abstract that are not supported in the article. Often I find glaring gaps in information, which supports my suspicions.  Older articles, when there was still medical science, are of value, such as on aspirin and HRT.  A knowledge of the biology behind a condition will often exposes marketing science. To sort out bad science, hundreds or hours are spent on each topic published here.  Often the evidence for the bad drugs is stronger than the positive alternatives.  The harm done by marketing entails that pharma should be limited to just manufacturing.    



[1] Read the Consumer Report article on the failure of the FDA. “Pharma” means drug manufacturers; “PhARMA” stands for their trade organization. 

[2] Bloomberg’s article on major settlements over kickbacks; it lists J&J, Pfizer, Lily, AstraZeneca, and Omnicare.  It is the norm for the industry. 

[3] Lengthening life a few months is not the same as saving lives from cancer; it fails to measure total deaths or quality of life.  If the drug can’t cure a type of terminal cancer, then it can’t prevent a stage 1-3 cancer from becoming metastatic, though pharma claims it.     

[4] The prevalence of osteoporosis is because women aren’t taking HRT which prevents bone remodeling (loss).  Now women receive the class of drugs called bisphosphonates.  They increase bone density settling in the bones, but that doesn’t reduce bone fractures.  Calcium loss can only be prevented by taking natural estrogen replacement, estradiol,—plant products don’t work as well.   

[5] The risk of many other cancer have since then been shown to be reduced, and as a treatment for breast cancer and most other adenocarcinomas  it increase survival of sage 1, 2 and 3 by over 40%, and also reduced Alzheimer’s disease risk.




As of 1/27/14 on our don’t-take-list are acetaminophen, anticoagulants, arrhythmia, bisphosphonates, hypertension drugs other than diuretics, PPI inhibitors, NSAIDs other than aspirin, statins, Alzheimer medication, and downers (psychiatric drugs that cause drowsiness).[1]  On the take list is niacin, aspirin, natural HRT, testosterone, and CoQ10--for the evidence, 2-page updates.  All chemotherapies should not be taken but for only  about 4 cancers that are  curative or capable of producing a remission on average of over 2 years. For those without metastatic cancer they significantly shorten life, and they won’t prevent part of a cancer missed from following its natural course.  If that pieces missed is metastatic, then the patient’s fate has already been sealed.  If it isn’t metastatic, then when it is later visible, it can be removed.  Chemo does more harm than good.  The side effects are serious. Alzheimer’s meds aren’t worth their side effects.  For most psychiatric conditions behavioral therapy at 1 year out is significantly superior to drug therapy.  More drugs are added every month.  For nearly every condition for which there is an effective treatment, the treatment is expanded to include those who statistically don’t benefit.  Pharma’s performance is measured by profits, and profits have no conscience. Pharma has co-opted the entire healthcare, regulatory, and information systems.



[1] Pharma has found many indications for downers beside psychiatric conditions.  Among them our nausness, muscle relaxant, post partum syndrome, pre-menstrual  dysphoric syndrome


A gem:  covers every major point in one page.

http://www.bmj.com/content/346/bmj.f2695?ijkey=E4DHSRQzgZwTWOT&keytype=ref

Bad medicine: the way we manage diabetes

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2695 (Published 29 April 2013)

Cite this as: BMJ 2013;346:f2695

Type 2 diabetes is a modern plague largely brought on by lifestyle and is considered a progressive, non-reversible condition. The polypharmacy of chronic disease is the drug industry’s lottery win, and no more so than in diabetes, with new drugs and the increasing use of analogue insulin in type 2 diabetes worth tens of billions of pounds worldwide.1 

The drug industry’s business plan for diabetes follows a familiar pattern:

·         (1) Conduct questionable research and control the original data.

·         (2) Schmooze the politicians, health regulators, and patient groups to suggest under-treatment and need for “urgent action.”

·         (3) Recruit tame diabetologists, massage them with cash, and get them to present at marketing events that masquerade as postgraduate education.

·         (4) Pay doctors to switch to newer drugs in dubious international post-marketing “trials.”2

·         (5) Seek endorsement from the National Institute for Health and Care Excellence to bully doctors to treat diabetes aggressively with drugs.3

And so the complexities of diabetes are reduced to simply lowering blood sugar.

What is the annual cost of pursuing this reductionist, drug based approach? In the past decade, spending on insulin in the UK has risen 300%, to £311m4 (€356m; $463m), and on oral diabetic drugs 400%, to £277m. And have you ever wondered why companies generously give away glucose meters? Test strips are a £166m market, the value of which has risen 300% in 15 years.4 Factor in staff time (when not attending more educational updates sponsored by the drug industry) and the patient and family’s time, and you have a great but expensive business.  But do analogue insulins, new diabetic drugs, and self monitoring of blood glucose improve outcomes? Does even tight glycaemic control make a difference? No data on mortality or morbidity exist for the new therapeutics.5 6 7 8 9 10 11 Likewise intensive glycaemic control is not superior with respect to mortality and cardiovascular disease.12 So billions of pounds are being spent chasing a ghostly surrogate endpoint: low blood sugar. Worse, there is evidence that these new drugs cause harm. Rosiglitazone has already been withdrawn; pioglitazone has been linked to bladder cancer; and exenatide and sitagliptin double the risk of acute pancreatitis.13 14 All this is an example of the scientific illusion that is so called evidence based medicine, where research is just mechanically reclaimed statistics pulped into junk educational nuggets—mere marketing by another name.  There remains another fundamental question. Can diabetes be reversed or cured by weight loss? A small, well designed study of 11 patients irrefutably showed that it can.15 And clinical effect is more important than any statistically significant yet clinically undetectable effect that a huge study funded by the drug industry might find. The therapeutic approach in diabetes is upside down. Incredibly, spending on diabetes drugs could employ 40 000 personal trainers. The complicity of doctors and lack of dissent against the drug model of diabetes care is bad medicine.

Notes

Cite this as: BMJ 2013;346:f2695

Footnotes

·         Provenance and peer review: Commissioned; externally peer reviewed.

·         Follow Des Spence on Twitter @des_spence1

References

1.    

Cohen D, Carter P. How small changes led to big profits for insulin manufacturers. BMJ2010;341:c7139.

FREE Full Text

2.    

Gale EA. Post-marketing studies of new insulins: sales or science? BMJ2012;344:e3974. 

FREE Full Text

3.    

National Institute for Health and Care Excellence (NICE). Blood-glucose-lowering therapy for type 2 diabetes. April 2013. http://pathways.nice.org.uk/pathways/diabetes#path=view%3A/pathways/diabetes/blood-glucose-lowering-therapy-for-type-2-diabetes.xml&content=view-node%3Anodes-considering-triple-therapy.

4.    

Health and Social Care Information Centre. Prescription Cost Analysis—England, 2012. April 2013. www.hscic.gov.uk/catalogue/PUB10610.

5.    

Davidson MB. Counterpoint: self-monitoring of blood glucose in type 2 diabetic patients not receiving insulin: a waste of money. Diabetes Care2005;28:1531-3.

FREE Full Text

6.    

Horvath K, Jeitler K, Berghold A, Ebrahim SH, Gratzer TW, Plank J, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev2007;2:CD005613.

Medline

7.    

Van de Laar FA, Lucassen PL, Akkermans RP, Van de Lisdonk EH, Rutten GE, Van Weel C. Alpha-glucosidase inhibitors for type 2 diabetes mellitus. Cochrane Database Syst Rev2005;2:CD003639.

Medline

8.    

Shyangdan DS, Royle P, Clar C, Sharma P, Waugh N, Snaith A. Glucagon-like peptide analogues for type 2 diabetes mellitus. Cochrane Database Syst Rev2011;10:CD006423.

Medline

9.    

Black C, Donnelly P, McIntyre L, Royle PL, Shepherd JP, Thomas S. Meglitinide analogues for type 2 diabetes mellitus. Cochrane Database Syst Rev2007;2:CD004654.

Medline

10.  

Richter B, Bandeira-Echtler E, Bergerhoff K, Clar C, Ebrahim SH. Rosiglitazone for type 2 diabetes mellitus. Cochrane Database Syst Rev2007;3:CD006063.

Medline

11.  

Ooi CP, Loke SC. Colesevelam for type 2 diabetes mellitus. Cochrane Database Syst Rev2012;12:CD009361.

Medline

12.  

Hemmingsen B, Lund SS, Gluud C, Vaag A, Almdal T, Hemmingsen C, et al. Targeting intensive glycaemic control versus targeting conventional glycaemic control for type 2 diabetes mellitus. Cochrane Database Syst Rev2011;6:CD008143. 

Medline

13.  

British National Formulary (BNF). www.bnf.org/bnf/index.htm.

14.  

Singh S, Chang HY, Richards TM, Weiner JP, Clark JM, Segal JB. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med2013;173:534-9.

Medline

15.  

Lim EL, Hollingsworth KG, Aribisala BS, Chen MJ, Mathers JC, Taylor R. Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetologia2011;54:2506-14.

CrossRefMedlineWeb of Science

 

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From Worstpill.org:   A recent article in the British Medical Journal by a Scottish general practitioner reminded me of a book about diabetes pills that we published 35 years ago telling much the same story…. When our book Off Diabetes Pills was published in 1978, none of the diabetes pills available in the U.S. had evidence, beyond lowering blood sugar, of a positive effect on mortality or a reduction in cardiovascular disease… A major reason for our writing this book was that back in the 1970s, there was already some evidence of harm from oral diabetes drugs. Since then, the number of harmful diabetes pills has greatly increased, with several so dangerous they had to be banned. These included phenformin, which caused often-fatal lactic acidosis, and troglitazone, which caused frequently fatal liver failure. Most recently, the widely used rosiglitazone (AVANDIA) was banned in Europe in 2010 due to increased cardiovascular risk, including heart attacks and heart failure. Worst Pill

The point of taking a drug is improvement of life quality.  To change a surrogate end-point, blood glucose without improving health or extending life is a hollow victory.  To do so with risk of serious side effects, expense, and inconvenience is a bad choice.  For how had PhARMA is, please read http://healthfully.org/rc/id1.html and http://healthfully.org/rc/id9.html --jk

                                                                                                                                                                                                                           

 

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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.