RECOMMENDED CONCISE

Marketing Science and Misinformation

raw data is clinical trial

journal articles hide side effect 65% of times

     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.