Below features excerpts from the recent article by Forbes followed by a personal response from Dr. Dale.
This post was written by Steven E. Nissen MD, the Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. This commentary expresses his personal opinions and not necessarily the views of the Cleveland Clinic.
On June 5th and 6th, the FDA will convene an advisory committee meeting on the diabetes drug Avandia, which was removed from the market in 2010 in most countries and placed under severe restrictions in the United States. Currently, only 3000 patients take what was once the best-selling oral diabetes treatment in the world. Its maker, GlaxoSmithKline (GSK), did not seek this public meeting and has publicly stated that it did not request a modification to the drug’s extremely restrictive label. In 2012, GSK pled guilty to criminal misconduct related in part to concealing the hazards of Avandia and paid a $3 billion fine, one of the largest in U.S. history. In this context, why is the FDA seeking a new review of Avandia?
The most likely explanation: the leadership of the division of the FDA responsible for drug regulation, the Center for Drug Evaluation and Research (CDER), is seeking to avoid accountability for its role in the Avandia tragedy. In 2005 and 2006, GSK secretly conducted an analysis of the cardiovascular safety of Avandia and concluded that the drug increased the risk of heart attacks and related events by about 30%. This observation had grave implications: two-thirds of diabetics, the intended recipients of the drug, eventually die of cardiovascular complications. Initially, GSK withheld the internal analysis from the FDA, but in 2006, the company informed CDER of the findings. FDA statisticians confirmed the risks, but, incredibly, CDER and GSK agreed privately to conceal this hazard from patients and practitioners.
Dr. Dale: Maybe GSK bought more prostitutes for the FDA/CDER? Yes, this is a method that drug companies use to sell their drugs. You can find more information and references on this subject here: Vaccine Maker that Bought Prostitutes for Doctors Found Deleting SIDS Cases
So, we can all pretty much understand why GSK wanted to hide the truth, it was after all the top-selling diabetes drug in the world at the time and the truth would have meant massive losses in profit. Beyond that, like always if a drug company can keep their deadly drugs and ineffective drugs on the market for even a year longer, sometimes only a few months longer, that will make up for the small fines they will pay in the end when they are found guilty. $3 Billion may sound like a lot to us, but when we take into account that this $3 Billion was not for Avandia alone, but rather multiple drugs including Paxil and Welbutrin. The company lied about the risk of suicide in children when given Paxil and that drug alone was profiting billions each year. Avandia brought in $3 Billion in profits in one year alone. So, we can see that their crime has gone without real punishment as these “fines” are nothing more than a business expense for the drug companies and what I would consider, “profit sharing” with our government.
Now, no matter the reason, we can only expect it was money or other forms of bribes. The fact is the FDA colluded with GSK to continue to kill people for profits. This fact should bring criminal conviction of all individuals who took part knowingly in this matter. Yet our “justice” system, legislators and anyone who should be serving justice or representing the people harmed and protecting patients have ultimately allowed criminals to continue on with “business” as usual.
In May 2007, my colleague Kathy Wolski and I published an independent analysis of Avandia in the New England Journal of Medicine (NEJM), showing a statistically significant 43% increase in a heart attack. In Congressional testimony, CDER officials acknowledged that FDA statisticians had confirmed our findings, reporting a 40% increase in the risk of a heart attack.
The leadership of CDER was intensely embarrassed by these revelations and furious with us for publicly challenging the safety of Avandia (and indirectly the competence and integrity of CDER). The FDA appeared incredibly insensitive to the welfare of patients. GSK knew, FDA knew, but patients and physician were not warned.
Dr. Dale: For the FDA/CDER to have only been “embarrassed” and then ultimately “furious” that someone in the ethical scientific/medical community (an extremely small community in the Pharma/Medical/Gov. community these days) would point out their criminal negligence, should say something to us all. These people are not afraid of being punished, rather simply afraid that the public might find out that they are willfully taking part in genocide for profit. If there was true justice in this field and matters such as this then these people should be in jail and tried for murder and punished according to their action or “inactions.”
But it is the world we live in, that few truly realize, and like the 2016 Lancet article: “Politics: for sickness or for health?” states very well how Human Rights lawyer Reed Brody, Counsel and Spokesperson for Human Rights Watch and long-time “dictator hunter”, has mordantly argued: “If you kill one person, you go to jail; if you kill 20, you are committed to an institution for the criminally insane; if you kill 20,000, you go into comfortable exile with political asylum.” But what if your country’s (or a corporation’s) policies and practices are responsible for the chronic illness and premature deaths of millions? Following Brody’s logic, as a politician you will earn fame and a handsome living; as a corporate CEO you will enjoy a life of luxury and impunity as a 0.01 percenter.” Much of this statement makes me think of Julie Gerberding, the former CDC director at the time when Dr. William Thompson and other CDC “scientist” fraudulently covered up solid, undeniable, “huge” if you want to use the Whistleblowers words specifically, evidence that the MMR vaccine causes autism. After allowing and most likely ordering her inferiors to publish the fraudulent data, which protected Merck’s profits and the imaginary image of “vaccine safety” for the MMR vaccine, she immediately went to “work” for Merck, maker of the MMR vaccine. She was handed a multi-million dollar salary and thousands of dollars in stock as she “coincidentally” took over the position of head of Merck’s vaccine division. Read more here:
In regards to the fact that physicians not being notified by the FDA. I wish to say that I understand that there are medical doctors who may desire to help their patients. So when I show anger toward the actions of evil, I do it out of love for all the children of God who have been harmed and with a desire to see no more lives sacrificed or harmed for the love of money that is so obviously in the hearts of so many working in the Pharmaceutical, medi-sin, and government these days. I understand that this level of corruption inhibits good doctors from doing good for their patient’s. The evil is so deep within even the “medical/Pharmaceutical regulatory bodies,” like the CDC and FDA that I feel all good doctors should and must stand and fight, demanding real justice to be served in matters such as this. The act of harming and taking advantage of people and children especially who are sick and suffering should be given zero tolerance. Yet so many doctors have sat idly by over many years as the Pharmaceutical industry and all the rest involved have lied to them over and over again. I cannot comprehend how any doctor can trust any drug they sell for these drug companies. How many times will you let them lie to you doctors before you do something to stop these crimes and you truly protect the lives of your patients? I ask.
Since 2006, CDER has expended considerable taxpayer dollars trying to absolve itself of responsibility for this inexplicable error in judgment that cost many lives.
Dr. Dale: So they are basically stealing money as they cover their crimes against those they are stealing from and whom ultimately they state to be protecting. How are our nation’s laws and legislature allowing this to happen? Why has this committee not been abolished and those involved in this crime that killed people, not in jail?
In 2010, CDER and GSK saw an opportunity clear Avandia of any cardiovascular hazard and scheduled an FDA Advisory Committee meeting to exonerate the drug. CDER had received the study report for a clinical trial known as RECORD, conducted by GSK in Europe to examine the long-term safety of Avandia. Because RECORD did not confirm a cardiovascular hazard, key senior CDER leaders saw this as an ideal opportunity to absolve themselves of culpability in the Avandia scandal. However, the CDER plan backfired during the public hearings for four reasons:
- Independent FDA statisticians confirmed the hazards of Avandia, this time reporting an 80% increase in the risk of a heart attack.
- FDA Deputy Commissioner Joshua Sharfstein took a personal interest in the issue and insisted that the Advisory Committee include independent scientists who would fairly judge the evidence.
Dr. Dale: Why is this not the law? Instead, we have a never-ending revolving door between regulatory agencies like the CDC and the FDA. Wanna read more on this? Click here:
- Dr. Sharfstein supported me in my request to present my independent analysis of the Avandia safety data to the committee.
- The RECORD trial was analyzed by legendary FDA reviewer, Dr. Tom Marciniak, a physician of the highest integrity and independence, and his review was devastating.
Dr. Dale: I would love to read this analysis!
Marciniak’s 2010 review of RECORD showed extraordinary bias in the conduct of the trial. For example, the trial was unblinded; meaning that physicians and patients were aware which drug each patient was taking. Even GSK was unblinded. Incredibly, whenever a study site reported a clinical event, GSK and its contract research organization (CRO), knew immediately which drug the patient was receiving. Marciniak’s review showed that events occurring in Avandia patients were changed or deleted, sometimes months after they should have been reported and counted. These and many other flaws make the RECORD trial totally unreliable.
Dr. Dale: Yet despite these scientific crimes that are killing people you will see no warning of this fraud on the Lancet’s website where you can access the RECORD trial for yourself! If anyone finds a warning by this journal, please let me know!
With a balanced committee membership and a fair hearing for both sides, the advisory committee voted overwhelmingly in favor of either removing Avandia from the market or severely restricting its usage (of 33 members, 12 voted for withdrawal and 10 for severe restrictions). European regulators banned Avandia entirely and US regulators relegated the drug to usage only in patients who had failed all other diabetes drugs.
However, the CDER leadership refused to accept the conclusion of regulators around the world and its own advisory committee that Avandia is hazardous. Instead, CDER arranged for the RECORD trial to be “re-adjudicated” (re-analyzed) by an outside group, the clinical trial center at Duke University.
Dr. Dale: How ironic that I read this current article at such a time as this. My laughter comes from the fact that Duke Univ. was just found guilty of multiple counts of research fraud and stealing roughly $200 million from taxpayers just a couple weeks ago. How “coincidental” that the CDER would ask Duke to do their “re-analysis.” Criminals helping criminals all while the patient and citizens of the U.S. pay for crimes to be committed against them.
These Agency officials hope to show that the RECORD trial really did “prove” that Avandia is safe. If the RECORD trial was reliable, the logic goes, then the 2006 decision by CDER to conceal the risks of Avandia did not represent a dereliction of its public duty.
But GSK was allowed to prepare the materials for the Duke reanalysis,
Dr. Dale: This is so common in “science”we should only suspect that anything promoting a drug is fraudulent. The medical community and even the FDA allows for drug companies to hand over their own statements and “materials” that say their drugs or vaccines are safe. It’s truly insane! This is nothing short of allowing a criminal the opportunity to decide and hand the jury the “evidence” that they will be allowed to use in determining guilt. Worst of all our gov. is complicit in all of it.
undermining the independence of the process. Beyond that, the entire idea of reanalyzing a trial that began in 2003 is simply ludicrous. Such a long interval seriously compromises the ability of adjudicators to retrieve original hospital records, laboratory findings, and other relevant patient data. Marciniak’s 2010 review revealed such extraordinary irregularities in the trial conduct that no subsequent effort could possibly correct the flaws.
The ostensible purpose of the June 5-6 Advisory Committee meeting is to consider the “re-adjudicated” RECORD trial. However, this time the meeting seems systematically designed to absolve the drug of harm and the CDER leadership of any responsibility for ignoring the public health hazard of Avandia. The current effort is intended to “whitewash” the Avandia scandal and re-write history.
Dr. Dale: That’s a little George Orwells “1984” right there!
Certain respected and independent members of 2010 Advisory Committee have been recused from the 2013 meeting. I requested the opportunity to present an independent analysis to the Committee, but was denied and offered a 5-minute statement in the “open public hearing.”
Keen observers should compare the roster of this new committee to the 2010 hearings to determine which participants have been re-invited and which have not. Similarly, assess whether prominent drug safety experts within FDA, such as Dr. David Graham, are listed as speakers or excluded. Finally, will any GSK consultants address the panel?
Why are these hearings important? The FDA has been rocked by a series of scandals over the last decade. One FDA commissioner resigned under a cloud and later pled guilty to charges he had not reported owning stock in companies the agency regulated. Another commissioner resigned during the investigation of the use of political influence to gain approval of a medical device that was subsequently withdrawn. We have endured a series of drug and device safety disasters (Vioxx, Avandia, Ketek, defective defibrillator leads, and recently, compounding pharmacy oversight, and the list goes on) that have harmed many of our fellow citizens.
Dr. Dale: I’d just like to add a few more and mention that these are the times these criminals were caught in their crimes and lies, and undoubtedly a mere fraction of the real evil they have committed.
- Opioid epidemic where the FDA has worked hard with politicians like Marsha Blackburn to keep this dangerous, extremely addictive, and deadly gateway drug on the market.
- How about when the FDA helped Bayer sell their drug that was contaminated with HIV to children all over the world? I suggest watching this video “Rat of the week” and read about it here also.(Note that even then, something so evil and cruel was not met with a public or even physician outcry but rather a Gov. and so-called “justice” system that worked to cover up a crime of devilish proportions!)
- Then just one more for time sake. FDA “advisors” work “around” the system with Pharmakeia to get big bucks to approve drugs that later are found to be deadly. It’s truly sickening to realize how much greed there is in medi-sin. I promise you though, no matter how sick I get over it, I will never take an FDA approved drug for it 😉 lol.
In each case, the permanent FDA bureaucracy has sought to deny responsibility and often failed to learn the appropriate lessons necessary to prevent future catastrophes.
Dr. Dale: Let’s get real, they aren’t taking notes on how to “prevent future catastrophes” these criminals are using the lessons learned to figure out better ways to not get caught.
In the middle of the sequester, CDER is willing to spend a large sum of taxpayer dollars to conduct a 2-day advisory meeting on a drug nobody uses, for the sole purpose of absolving its own bureaucracy of responsibility for a terrible drug safety tragedy. The current Director of CDER, Janet Woodcock, has directed this division for nearly 20 years, increasingly insulated from the Agency’s true constituency, the American public. If CDER is allowed to re-write the history of Avandia, this vital FDA Center will continue to function as an unsupervised, self-regulating bureaucracy, accountable to no one. That’s just unacceptable when the public health is at stake.
Dr. Dale: At this time, I will let you know if I figure out what came of this meeting and if any real justice was ever served, but for now I won’t have the time to look into this matter more. I can only guess but with the evidence of history, I doubt these drug salesmen and their FDA partners will ever repent of their sinful ways, nor truly be held accountable.
Dr. Nissen consults for many pharmaceutical companies, including companies making or developing diabetes drug. However, he requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction.
Update: The FDA says that Nissen was invited to the previous meeting because his analysis was relevant, but that the topics he is covering would be covered by other speakers. “The FDA encourages participation from all public stakeholders in the open public hearing portions of advisory committee meetings,” the agency said. For the FDA’s full comment, click here.
Resources / References:
Vaccines for measles, mumps, and rubella in children
The FDA Responds To Steve Nissen’s Criticism Of Upcoming Avandia Meeting
Politics: for sickness or for health?
Posey Calling for an Investigation of the CDC’s MMR reasearch fraud
Former CDC Head Makes Millions On Merck Stock
Centers for Disease Control and Prevention: protecting the private good?
Research misconduct identified by the US Food and Drug Administration: out of sight, out of mind, out of the peer-reviewed literature.
Is FDA’s revolving door open too wide?
George Orwells “1984”
Did the FDA ignite the opioid epidemic?
Bayer Aspirin, Rat of the week
Bayer Admits It Paid “Millions” in HIV Infection Cases — Just Not in English
GlaxoSmithKline’s $3 Billion Hit: Deterrent or Business Expense?
Duke backs safety findings from controversial Avandia trial
Meet Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research