The Secret Glaxo Tape Recording By Steve Nissen
37 CommentsBy Ed Silverman // February 23rd, 2010 // 8:05 am
Nearly four years ago, just before his controversial metaanalysis of Avandia was published in The New England Journal of Medicine, Cleveland Clinic’s Steve Nissen met with Glaxo execs and - fearing he would be pressured over his efforts, especially since Glaxo hadn’t cooperated with his requests for trial data - he secretly recorded the meeting, The New York Times reports. This was legal in Ohio, by the way.
During the meeting, the four Glaxo execs spoke as if they did not know the results of Nissen’s about-to-be-published study. And Nissen didn’t mention he already sent it to the journal. But a week before the meeting, according to Senate investigators, Glaxo had been secretly and inappropriately faxed a copy of Nissen’s manuscript by a journal reviewer who also worked as a Glaxo consultant, the Times reminds us (here’s that story).
Meanwhile, the Glaxo execs repeatedly promised to begin a crucial analysis of Avandia safety “within days.” Nearly three years later, the study has not been published in a medical journal, although the company has posted results on its web site. Also during the meeting, Ron Krall, Glaxo’s chief medical officer, predicted almost exactly the results of another crucial study of Avandia that was two months from publication and whose results, according to scientific protocols and the company itself, should have been kept secret from the company, the Times continues.
Nissen tells the Times the recording showed that Glaxo hoped to persuade him not to publish his study by suggesting they had contradictory info they would share with him in a joint study. “In retrospect, it seems clear that neither statement was true,” Nissen says. “They did not have contradictory data, and they never intended to cooperate in any analyses.”
Glaxo tells the Times its execs saw Nissen to discuss a possible research collaboration and to review Avandia safety info. “GSK was not aware that Dr. Nissen secretly recorded the May 10 meeting and is disturbed to learn that he did so without advising GSK,” the company wrote in an email. In his own email, Krall wrote he didn’t recall discussing potential results of the Avandia study in the meeting, but added he did not learn the results “until many days after the meeting with Dr. Nissen.”
Glaxo then went about trying to figure out how to minimize the fallout from Nissen’s study and quickly published its RECORD trial, although the design made it difficult to know what caused the higher rate of heart problems experienced by Avandia patients. Meanwhile, internal documents released by Senate investigators last weekend show Glaxo scientists realized Nissen’s analysis was valid (here is the report).
In internal email, a company statistician wrote “there is no statistical reason for disregarding the findings” of Nissen’s study. In another, Moncef Slaoui, Glaxo’s research head, wrote to the FDA that Nissen and Glaxo researchers seemed to agree that studies showed Avandia substantially increased the risks of death and heart attacks. “FDA, Nissen and GSK all come to comparable conclusions regarding increased risk for ischemic events, ranging from 30 percent to 43 percent!” Slaoui wrote.
SFM
Good call on the part of Nissen.
Glad it was legal in Ohio too.
masonwatcher
posted this in another thread:
just read new NYT story regarding Dr. Nissen. Man he taped a convo. taped all over the place, video maybe?
drifter
taped all over the place, video maybe?
Superman
How did Krall know about the RECORD results before the study was unblinded? He must see through walls.
Terry
I looked on youtube. Couldn’t find any video.
riv
I advise this for anyone seeing a medical professional about the negative effects of a drug said professional gave them.
P.S. This method works well with Toyota too. However in that case, I suggest the customer just cut to the chase and put the tape recorder on the desk between them and the dealership owner. Then proceed to ask about your warranty.
That'sEntertainment!
The tape will be track 2 on “Glaxo’s Greatest Hits (and Some that Weren’t).”
It will be one great RECORD!
BTW, the video can be found at Blockbuster, next to “Adventures on Vio…”.
johninma
who has the tape or video?
pharmavet
I worked for Dr. Krall at a previous company for nearly five years. Not only is he the smartest scientisit I’ve worked for in 28 years, but one of the most honest and ethical ones too. If Ron was able to “predict” the results of a not-yet-unblinded study, it was because he was probably able to figure out the likely results from the blinded data. This is no different from ENHANCE. The clinical scientists at the company had pretty much figured out the results before the study was unblinded. If you’ve worked with data for a long enough time, as I’ve had, you get a “feel” for how the results will eventually turn out, and for a smart guy like Ron, you wind up being right more often than you are are wrong. If you’re looking for bad actors in this drama, don’t look Ron’s way.
Lisa Van Syckel
Pharmavet,
What a pile of Donkey Dust,.. Why bother with blinded studies, when you can have Dr. Krall, the great Predictor of Science!!
Superman
But is Krall able to leap tall buildings in a single bound?
pharmavet
Lisa, the is an old saying that we oldtimers in clinical research know very well, which is that sometimes the results of a study appear so obvious that you don’t need statistics to prove them. There are also alternative ways to interpret the same dataset, which is obviously happened with Nissen and GSK in this case.
It is also standard practice to set up “firewalls” between the blinded clinical scientists and the biostatisticians analyzing the data. I’ve read all of the documents in this case, and I can tell you that all of the appropriate firewalls were set up by GSK. Breakdown of these firewalls could theoretically jeopardize the integrity of the results and potentially the jobs of those involved. Knowing Ron as I do, he would be a stickler for keeping ultrasolid firewalls in place.
From my perspective all of the SOP’S were followed, there was no “criminality” or coverup, only legitimate differences with Nissen, a series of hypotheticals posed by GSK to Nissen, and an honest, if sometimes clumsy attempt By GSK to manage those differences.
Justice in MI
Strangely enough, Ron K. and I went to the same high school and knew each other slightly. When I sent a note about my interest in pharma to the “alum notes” notes one year, he responded openly and graciously.
I cannot pretend to see through walls either. But it would not be surprising if this were one of a zillion examples–in all occupations–of good people conforming to the MO of their particular workplace.
Or it may not be.
patrons99
Naive (non-attorney) question: At some point, was there probable cause for the U.S. Attorney to intervene?
Generally speaking, the U.S. DOJ has all of the tools it needs for criminal convictions. All that is really lacking is the political will to enforce the law. See the Federal Wiretap Act, Federal Fraud and Abuse Statute, Fraud Enforcement and Recovery Act of 2009, and False Claims Act Correction Act of 2009.
http://www.monnat.com/Publications/Wiretap.pdf
http://www.justice.gov/jmd/2010factsheets/pdf/cff-fisc.pdf
If they “do the crime”, shouldn’t they “do the time”? Or does DOJ consider pharma to be off limits and above the law?
pharmavet
Thanks, Justice. I glean from your comment that both of us would find it hard to see Ron getting caught up in this. I’m sure that it was not easy to put his name to the Letter to the Editor in Lancet defending Avandia. BTW, Ron is no longer with GSK but is doing very well.
Lisa Van Syckel
Two Words,… “Damage Control”,.. Yes?
riv
Man is this ever pathetic. Name-dropping when the name is compromised and “doing very well”.
Justice in MI
I’m not sure you can “name drop” from a moniker.
Anyway, my point was not about a particular person about the ease with which almost (but not quite) anyone can get caught up in “what’s happening” around them. Whether that applies here, I have no idea. It makes the question more “real”–whatever happened–when you happen to have slight acquaintance.
More generally, I find the intimidation and data suppression dimensions of the Avandia story more chilling.
Superman
DR. RONALD L KRALL MD
Allopathic & Osteopathic Physicians Psychiatry & Neurology Neurology
Provider NPI: 1053644278
Provider Information:
DR. RONALD L KRALL MD
Gender: M
Sole Proprietor
Practice Location:
31645 TIMBERS RIDGE WAY STEAMBOAT SPRINGS, CO 80487 US
Tel: 970-879-6671 Fax: 866-735-3417
Business Mailing Address:
PO BOX 775727 STEAMBOAT SPRINGS, CO 80477-5727 US
Tel: 970-879-6671 Fax: 866-735-3417
Doc
This entire situation with Avandia just reinforces to the public that big pharma only cares about profits. Patients are only a vehicle to making money. In light of multiple cases over the last few years, and many more to come on off label promotion, etc - I have to say, I agree with the general public.
This industry looks bad and has only itself to blame.
J.O.
Doc, how does this reinforce anything to the public? Will this be on the 6:00 news? What about victims of this drug who can’t hold GSK accountable because their state law protects the drug maker? That’s not going to be on the news either.
patrons99
One more naive question: Why not a class action for product liability against GSK in federal court under the Class Action Fairness Act?
http://www.abnormaluse.com/2010/02/when-is-class-action-not-class-action.html
Walter
GSK is a fraud and should be taking to task on all counts of the law!!!!!! Dr.Krall is the problem and so many other GSK Sr management..
harry
the fda are holding the avandia advisory meeting this july. how arrogant are these people? what if this drug truly causes harm, how can they wait so long to pull it? it will be interesting to see who prevails at the FDA. Hamburg and company have the backing of powerful senators, dem and rep, so there is no excuse this time.
Gherkin
It’s the “disease” stupid!
2+ years from now, Actos & Avandia will be available generically. All this legal and safety furor will be forgotten (no big, bad brand companies to sue or hate!).
Doctors will then have the most effective,inexpensive therapeutic class to treat the Type 2 diabetes epidemic in decades! You watch.
mark phd
All these places pride themselves on controlling the message. Well this is a massive mess up and GSK can’t do anything about it.
Respect was low for these companies and they just keep going lower.
Sean
If Nissen was so confident in himself, then why tape a conversation? If you want to play hardball, then expect to get brushed back. The fact Nissen is never held to the same level for working, speaking and taking fees from Takeda is almost laughable. Additionally,I know he donates his fees to charity, but the question is what charity! His own…if a meta-analysis is the gold standard for evidenced based medicine…then good luck!
Johnny
Can anyone explain the fact that there were additional studies that Nissen did not include in his analysis? Why not include all available data? Also adjudicated vs non adjudicated events need to be explained.
I believe the 43% was a 43% RELATIVE RISK INCREASE not 43% of the people taking the drug.
I would love to hear a 30 minute scientific and statistical explanation for both sides.
Johnny
I am confused when Nissen says that Avandia increases cholesterol and Actos lowers it. I just read both package inserts and they both say they increase it.
pharmavet
Dear Riv, my self and most of the other pharmaceutical company executives that I have worked for and with during a nearly 30 years are doing “well” because we have dedicated our careers to doing “good” for patients and healthcare professionals. This has not been an easy task, as my colleagues on this board will agree. And I am not referring to the unsubstantiated accusations that we endure daily basis in our efforts to bring objectivity to the proceedings. That’s a trifling as far as I’m concerned when stacked up against the important work we do. Given the typical industry batting average, most of us in clinical research have worked on way more failed drugs than successful drugs. So why do we do it? Contrary to popular opinion, most of us could make a heck of a lot more money doing other things. No, we do it because we believe that somewhere along the line, either by effort, serendipity, or both we might stumble across a drug that may improve human health. I have had the good fortune to have stumbled on a few in my career. That’s why I and the other career scientists will always be doing “well” because we have done “good”.
Justice in MI
“That’s why I and the other career scientists will always be doing “well” because we have done “good”.
There is no shortage of people who “do good” in this world. Some are scientists; some are parents; some are teachers; some are everything else. Just as those who work in pharma should not be demonized as a collective, they should not be romanticized either.
If “doing well” means living comfortably with one’s choices and one’s fate, that is terrific. If it means to there is a correlation between worldly goods and good done in the world, I would say…not on this planet.
vince
“…..most of the other pharmaceutical company executives that I have worked for and with during a nearly 30 years are doing “well” because we have dedicated our careers to doing “good” for patients ….
Most pharma CEOs apparently have the same high regard for ethics as the leaders on Wall Street. How many needless deaths from drugs after the dangers where apparent but before the patents ran out.
BATMAN
Nissen is a very “tell it like it is” specialist. Respect him. He is brilliant.
Doc
J.O. I am in line with your thoughts, however, this info is getting out here and other places on the web, it will diffuse out to some in the general public.
Also, the more egregious these things become, even some of the die hard big pharma defenders are having second thoughts, at least to admit that big pharma has serious issues.
BP Watch
It’s not the physicians or the scientists who work in R & D who are the bad guys here. It’s the unethical commercial jerks and their medical pawns who work in sales and marketing and the greedy top executives who encourage the immoral behavior.
Pharma Giles
Pharmavet: “doing well by doing good”? Why, that’s a line from the famous song about this character…
I too have had a long career in the industry, and have also had the privilege of developing two or three life saving drugs, before headaches and hard-ons became the Holy Grail of the modern pharma marketplace. I left the industry in disgust and of my own volition, when I became sick and tired of the arrogance, mendacity and overweening ambition of those working in it.
The Avandia debacle stems from such behaviour.
And I just love your comment “sometimes the results of a study appear so obvious that you don’t need statistics to prove them.” Says it all, really…
I don’t miss the industry. Not one bit.
pharmavet
Thanks, Giles. Sorry to hear you’re out of the game. You probably didn’t get to take the seminar on “How to Prepare for a Legal Deposition”. Pretty much required stuff these days.