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more financial shenanigans in the medical research industry



“AstraZeneca today confirmed that the American College of Cardiology (ACC) and American Heart Association (AHA) have released a treatment guideline on the duration of dual antiplatelet therapy. Brilinta (ticagrelor) is now preferred over clopidogrel (Plavix) for the management of patients with acute coronary syndrome….

This update is the first time the ACC/AHA has recommended Brilinta over clopidogrel…..” From the May 31, 2016 issue of Business Wire.  Be aware that a renowned cardiologist by the name of Jonathan Halperin not only chairs ACC/AHA Task Force on Clinical Practice Guidelines, he’s been involved with writing at least 24 different cardiac guidelines.  Read my recent articles on the corruption in the ACC HERE.

“There’s Plavix, a tried-and-tested blood thinner, that prevents clot formation; the generic version of the drug costs as little as 25 cents a pill. And there’s Brilinta, a newer medicine that is also effective in clot prevention; it costs about $6.50 a pill — 25 times as much. Brilinta is admittedly more effective than Plavix — by all of 2 percentage points. In a yearlong trial of 18,600 patients, 10 percent died from vascular causes, heart attack or stroke on Brilinta, while about 12 percent on Plavix. 

How much should clinicians be the gatekeepers for cost, such as when weighing the small absolute advantage of ticagrelor (Brilinta) over clopidogrel (Plavix)?”   Siddhartha Mukherjee from the April 3 2018 issue of the New York Times (Can Doctors Choose Between Saving Lives and Saving a Fortune?)

“Common side effects of Brilinta include: bruising, bleeding more easily, nosebleeds, headache, dizziness, cough, nausea, diarrhea, irregular heartbeat, high blood pressure, back pain, low blood pressure, fatigue, and chest pain.

Tell your doctor if you experience serious side effects of Brilinta including severe bleeding or uncontrollable bleeding, shortness of breath, colored urine (pink, red, or brown), red or black stools (looks like tar), coughing or vomiting that produces blood or blood clots, or vomit that looks like coffee grounds.”  From the Brilinta warning label — Common Adverse Events (RxLists)

Remember how BIG PHARMA continues to say that financial conflict-of-interest (COI) in creating MEDICAL GUIDELINES doesn’t matter?  And remember how I showed you the studies that prove the FDA and big pharma have become one and the same entity (HERE)?  And remember how bad things have gotten in the field of EVIDENCE-BASED MEDICINE on almost every conceivable level; from the researchers themselves (HERE) to the people in the peer review process (HERE)?  Thus, we can’t be shocked by Charles Piller’s brand new article in Science (Hidden Conflicts?).  As I provide a short synopsis of his article, be sure to have a trashcan or plastic bag handy just in case you toss your cookies.

It seems that since the physicians creating medical guidelines must declare any conflicts of interest, pharma has created a unique little work-around by taking a “pay later” approach, sometimes shelling out millions (that would be 1,000,000 plural) of dollars after the research has been validated and the drug has been approved.  What are these individuals “officially” paid for after the fact?  Almost always they make their money by “advising” or “consulting” industry or in similar fashion to certain politicians, by giving short speeches to select groups for exorbitant fees.

“For example, those companies paid or reimbursed cardiologist Jonathan Halperin of the Icahn School of Medicine at Mount Sinai in New York City more than $200,000 for accommodations, honoraria, and consulting from 2013 to 2016. During that period, Halperin got $7500 from AstraZeneca to study Brilinta, and the company separately declared nearly $2 million in “associated research” payments tied to him. 

Brilinta fits a pattern of what might be called pay-later conflicts of interest, which have gone largely unnoticed—and entirely unpoliced. In examining compensation records from drug companies to physicians who advised FDA on whether to approve 28 psychopharmacologic, arthritis, and cardiac or renal drugs between 2008 and 2014, Science found widespread after-the-fact payments or research support to panel members.

The agency’s safeguards against potential conflicts of interest are not designed to prevent such future financial ties.  Other financial support from the drugmaker or key competitors included consulting, travel, lectures, or research. FDA did not publicly note those financial ties.”

How crazy were the financial ties?   Get this, Science investigated 107 doctors who were on specific committees charged with creating guidelines (remember that these guidelines frequently and specifically promote certain drugs or devices as the “standard of care“).  Although a substantial number received ten grand or so, a quarter got over 100 grand, with seven raking in more than a million bucks apiece.  Here is what is even crazier.  The process has essentially become a bidding war. 

The top 17 “earners” took in over $300,000, with the money not only paid by the drug makers, but by competitors.  In other words, they are being paid by both sides; the manufacturer to OK their drug, and their competitor not to.  And none of the monies are being paid up front where the FDA might notice (not that they would care), but after the fact, usually in the same or following year.

Here’s what’s funny about this whole sordid affair.  The doctors who are engaging in this — typically the medical community’s mouthpieces — have said repeatedly that the money does not affect their decisions.  Not surprisingly, studies have shown the opposite (HERE is one example).  Honestly, it’s why an increasing number of elite and renowned scientists, physicians, and researchers are saying that it’s becoming impossible to trust anything coming out of the field of peer-reviewed medical studies (see EBM link in first paragraph).

If you are truly interested in getting healthy and staying that way, your doctor can’t help you.  Why not?  Doctors are not in the business of helping you get healthy, they are in the business of disease management (HERE).  Got DIABETES?  They are not sharing THIS INFORMATION with you.  Got CANCER?  Why in the world would they not tell you about THIS simple fact that has been common knowledge for over 85 years?  The harsh reality is that there is one and only one person who can help you get healthy, and you already know that person extremely well (hint; look in the mirror). 

What I would like to do now is follow the money trail and history of Brilinta.  Manufactured by pharmaceutical giant AstraZeneca, Brilinta was approved by the FDA in 2011 after being “fast-tracked,” but not before hitting a roadblock and first being rejected in 2010.  What was it about that one year that made so much difference in the approval process?  The July 27, 2010 issue of Motley Fool (an online journal for investors) let readers know in Brilinta? I Think Not: AstraZeneca’s New Blood Thinner is Far From Brilliant, which stated…

The FDA’s documents on AstraZeneca’s Brilinta were far from brilliant for the drugmaker…   The data from clinical trial patients in the U.S. were troublesome, with U.S. patients experiencing a worse outcome than those seen abroad…  Tomorrow, the FDA will ask the panel of outside experts if they think the disparity was due to chance or some other factor that’s unique to the U.S….  AstraZeneca needs a blockbuster to deal with looming patent expirations, but I don’t think Brilinta is the gleaming light that’s going to save the British drugmaker.”  

In a similarly-timed article from The Guardian (AstraZeneca Blockbuster Brilinta Fails to Win FDA Approval), we learned that “the FDA requested more analysis of existing clinical trials data.”  In other words, there were some ‘questions’ about the veracity of the study.  Stick around and you’ll wonder why there weren’t more.

“AstraZeneca last fall acknowledged the U.S. Justice Department was probing its controversial late-stage study of the blood thinner Brilinta, but was circumspect about what might have set off the investigation. But according to The Wall Street Journal, it might stem from a complaint filed by Victor Serebruany accusing AstraZeneca of rigging the Brilinta study so that it appeared to outperform the competition. 

The court records in Dr. Serebruany’s complaint are sealed, but The Journal has reviewed documents from the case and spoken with sources familiar with it. Some of his allegations are similar to others that have been made against the study, including those published by two scientists from Charles University in Prague. They pointed out that almost half of the favorable results for Brilinta were drawn from just two countries, Hungary and Poland. They also said that reporting on cardiovascular events appeared to favor Brilinta, to the point that some possible cardiovascular events or deaths were deleted or softened. 

The trial has also drawn criticism because in the U.S. portion of the study, Brilinta did not perform as well as Plavix, the drug to which it was compared. AzstraZeneca’s drug was linked to a 27% greater incidence of vascular deaths, heart attacks and stroke in that portion of the study.”  From Eric Palmer’s Feb 3, 2014 article in Fierce Pharma (Wall Street Journal: Scientist’s Lawsuit Accuses AstraZeneca of Fudging Brilinta Study)

Although Brilinta was eventually approved by the FDA, Dr. Victor Serebruany, a cardiologist at Johns Hopkins University, began making accusations of his own.  Along with a pharmacist, Dr. James J. DiNicolantonio, they responded to a series of public communications with a letter to the editor in the July 2013 issue of the journal Stroke

By June of 2017, Serebruany had, along with five other researchers, published a study in the American Journal of Medicine titled Excess Ticagrelor Mortality in the Food and Drug Administration Adverse Event Reporting System: Time to Recount PLATO Trial Deaths.  He explained the team’s findings several weeks earlier in the March 30 issue of the Atlas of Science (Higher Ticagrelor Mortality in the FDA Adverse Event Repository: Time to Stop TV Ads?). 

For the record, FAERS is the Federal Adverse Event Reporting System.   Also, although this piece was comparing apples to apples (the AE’s for all drugs are underreported), you should be aware of the magnitude of this problem —- studies have repeatedly shown that just over 1% of all pharmaceutical AE’s are ever reported to FAERS (HERE), and are likely even worse for VAERS.

“The numbers matter. In the PLATO trial, ticagrelor was associated with 89 less vascular deaths and 107 less all-cause deaths than clopidogrel, allegedly representing an 18% mortality reduction. In FAERS, however, the latest evidence for 2015 alone indicates that the rate of ticagrelor deaths was about 40% higher when compared to clopidogrel, and almost tripled when compared with prasugrel (Effient)….

This is especially concerning, because the latest evidence failed to confirm PLATO ‘mortality benefit,’ since even a favorable trend was lacking in all post-PLATO outcome-driven trials (PEGASUS, PHILO, SOCRATES, and EUCLID).  Finally, there are no reason(s) to believe that FAERS reporting has been biased towards ticagrelor, hiding unreported death cases for prasugrel or clopidogrel. Indeed, some cases are missing from FAERS, but the reporting here trends of death distribution will remain the same. Regardless, the consistency and magnitude of excess deaths after ticagrelor suggests that the excess mortality signal is real.”

Dr. Serebruany’s critiques are certainly brutal, but are they legit?  Probably.  Maybe.  Who really knows?  I say this because Serebruany also happens to be the lead author of study published in the November 2016 issue of the Journal of Thoracic Disease (Ticagrelor and Heart Surgery Controversy: We May Have Better Antiplatelet Options).  The point of this (ahem) “study” was not only to disparage Ticagrelor (Brilinta), but to pump his own drug, Vorapaxar (Zontivity), which had gained FDA approval two years prior. 

In the section labeled Conflicts of Interest, we learn that Dr. S holds the patent on Vorapaxar. “Dr. Serebruany is listed as an inventor for the issued US patent (7,842,716) assigned to HeartDrug™ Research.”  Furthermore, we see that he had also “received compensation for the issued U.S. Patent 11/996,380 on prasugrel assigned to Lilly.”  So; who can you really trust when it comes to your healthcare?  How about YOUR GRANDMOTHER!

What else can I tell you about Brilinta?  For one, the SOCRATES study mentioned above showed just how poor the drug really is.  Ben Adams, writing for the March 23, 2016 issue of Fierce Biotech (AstraZeneca Suffers a Setback as Trial Shows Brilinta ‘No Better than Aspirin’ for Stroke), summarized it by saying (CHERRY-PICKED),

AstraZeneca took a major hit today after it released data showing the pill did not help stroke patients any better than a drug first discovered in the 19th century.  Brilinta did not fare well and missed its primary endpoint of time to first occurrence of any event from the composite of stroke (ischemic or hemorrhagic), heart attack and death.  This means that a 40-cent tablet–first sold by Bayer in 1899–was just as good at helping patients as AZ’s new drug that costs around $7 (before discounts) per daily treatment.” 

What’s just as interesting for people who believe regular use of aspirin is safe is that in this study aspirin actually had a worse side effect profile than the prescription drug.

For those of you who have never heard the term, “Data Mining,” is the name given to the common practice of using statistical analysis by high-powered computers to to churn into a data set and almost magically prove almost anything imaginable.  For instance, just yesterday I learned that the moon really is made of green cheese. 

An interestingly titled article by John Carroll from last August’s issue of Endpoints News (AstraZeneca Researchers Plumb Positive Data to Back Extended Use of Brilinta) said it best.  “After suffering back-to-back clinical failures last year that forced AstraZeneca to finally back off its projection of a brilliant megablockbuster future for Brilinta, the struggling pharma giant has come up with a positive batch of data that could persuade physicians to extend its use among high-risk heart patients.”  I really hope you like green cheese.

I suppose, however, that the real test of a drug like Brilinta is what real-life patients think of it.  I took a quick peek at the website, Ask A Patient (Drug Ratings for Brilinta) and saw that on a scale of 1 to 5, 52 people had rated Brilinta an average of (gulp) 1.6.  The one and only perfect score (five) came from a 38 year old who had just suffered a heart attack and been on the drug for — I’m not making this up folks — one day.  Lots of nasty side effects listed and no one had been on the drug long term; most under a year.

If you are truly interested in getting off the medical merry-go-round, taking your life back, and beginning the process of restoring your your health (cardiac health included), there are some steps you might consider taking (HERE).  Start by creating a WRITTEN PLAN using material I give out to all my patients completely free of charge (HERE are my online patient handouts).  And if you feel that this information should be seen by the rest of the world, do your part by spreading the word on FACEBOOK.  Liking, sharing, or following is a great way to reach those you love and care about most.

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