Whistleblower Lawsuit Filed Over Baycol Fraud
30 CommentsBy Ed Silverman // April 25th, 2008 // 3:20 pm
The suit was brought by Laurie Simpson, a former Bayer strategic research analyst who joined the drugmaker just after the controversial cholesterol pill was launched in 1998, and she accuses Bayer of violating the federal and state False Claims Act. The suit was initially filed in 2006 in US District Court in Newark, New Jersey, and was just unsealed. [WHOOPS: We initially wrote the feds joined the suit, but in fact, the US Attorney has declined to do so.]
The lawsuit alleges that over a three-year period, prior to its withdrawal from the market, Bayer engaged in illegal and deceptive marketing practices in selling the Baycol cholesterol pill, which was later withdrawn due to side effects, predominantly rhabdomyolysis, a severe weakening of the muscles. Numerous death and 1,600 injuries were linked to the drug.
The lawsuit alleges Bayer exaggerated Baycol’s efficacy and safety, downplayed its risks, and concealed info about the drug’s dangers from doctors, the federal government and consumers. The lawsuit claims that Bayer paid kickbacks to doctors and other providers to influence them to prescribe the pill, and alleges that these scrips would never have been written and or paid for by the government had everyone been properly informed. Here is the lawsuit.
Among the evidence cited: A 1997 report by a consulting firm noted that one drug interaction “only kills the drug: ‘Asking for Liabilities,’ ” and that multiple drug interactions would be a ” ‘Competitive Vulnerability (Suicide if it happens).’ ” Then there was a September 1998 meeting in which Simpson noted that Bayer Healthcare ceo David Ebsworth suggested push Baycol more aggressively ‘the legal area is grayer than we treat it,” he allegedly said. And he also said Baycol should be promoted as comparable to Lipitor, which clinical data didn’t support. Don’t stop, there’s more…
There were also key graphs with responder data, some of which was omitted because some patients didn’t respond well to the drug. These were given to sales reps to distribute as non-approved sales material, or ‘homebread bread,’ the very same practice that company policy - written by Ebsworth - prohibited, according to the suit. And sales aids containing risk info was minimized in hard-to-read small type. Bayer execs discussed the possibility the material violated FDA regs, but proceeded anyway because it would take awhile for the agency to find out and new aids could then be in place. An FDA warning letter was issued later.
As part of her job, Simpson gathered adverse events reports for Baycol and other statins and, in her report, noted that Baycol garnered much larger numbers, but she was ordered to remove that info before the report was distributed internally “in case of litigation.” Simpson also alleges Bayer orchestrated a ghostwritten article in the American Journal of Cardiology to allay fears over rhabdomyolysis and that Bayer reorganized its safety team to better control the flow of information about Baycol side effects. There was also a misleading press release and a Dear Doctor letter that downplayed the side effect.
Let’s not overlook an alleged ’switching seed trial,’ in which Bayer budgeted millions of dollars to pay some 3,900 docs to attend seminars in hopes they would boost their Baycol scrip writing. The suit labels these as kickbacks. One of the links below, by the way, has a list of all the docs who attended.
The list of alleged fraudulent moves is lengthy. Feel free to read the lawsuit to soak in the details. Again, here it is, and here’s some more. But don’t stop - there are the exhibits here and here.
Jack2
Off topic, but…
QUOTE:And he also said Baycol should be promoted as comparable to Lipitor, which clinical data didn’t support.
Exactly. Lipitor’s the best
-not a, and never was, a Pfizer employee
Angry
Just one more Big Pharma company with many skeletons in its’ closets. They can join the large list of those being accused of such actions - Merck, Schering-Plough, Pfizer, Novartis, Lilly, JNJ, GSK, BMS, SA, etc., etc., etc. Pharmaceuticals is a regulated industry, but acts like it’s selling consumer products. What is with these guys? When will the federal government do what it needs to do to get them to clean up their act? Until the commercial executives are held responsible for their actions, prosecuted appropraitely, pay huge fines themselves, and spend time in jail, these misdeeds against the public will continue!
Doc
I agree with Angry’s post. Until an exec goes to jail or pays a personal fine, there is little incentive to stop disingenous promotion. “Fines are just the cost of doing business today”. This is a regular mantra with pharma execs today. The industry has such large profit margins, a few hundred million dollar fine is nothing on a multi-billion dollar drug.
Justice in Michigan
I am not someone easily made squeamish about corporate revelations, and I am aware that any lawsuit tells its own side of the story. Still, based on having read the first few sections, I find this one about as chilling as it gets.
As contributors to Pharmalot, I think that leaves us with an important choice. The “critics” can use this material to hit the industry as a whole over the head. The “insiders” can either opt out (through silence and avoiding the thread) or just push back. That is what we often do.
I want to suggest a more sober approach on both sides. First, take the time to read what is here. There seems to be a good deal of solid documentation. And then what I would most like us to try, as we’ve done before, is to respond not as members of this or that “constituencey” but as human beings _all_ of whom care about public health and integrity.
How do people - especially from within the industry - respond when a case like this comes to the surface? I genuinely want to know what _you_ make of this and - to the degree you view it as a likely accurate depiction - how do you understand the process by which this occurs.
It is easy to throw bricks (on all sides). And what you end up with, on both sides, are piles of bricks.
Unlike in my own profession, we are undeniably talking about issues of life and death here. I appreciate the fact that “sobriety” is not the first virtue that comes to mind. Still, I think we need to try that if we are to make any meaningful and serious gains.
Thanks for reading.
a PFE rep
Jack2,
10 mg every day. Don’t know what people with high LDLs and myalgia with every statin are going to do if Zetia is really ineffective. My mom’s cholesterol is way over 300, but every single statin has given her myalgia.
Doc
Justice,
I am in the industry and for many decades. What I read in the Baycol complaint is standard operating procedure among a number of marketing, sales management and exec types too often unfortunately. Public safety too frequently takes a back seat to dollars and personal career goals. Remember, for a marketing, sales exec to be linked to a blockbuster product, opens many more doors for them professionaly, so if it moves business, it is good for them.
Bless The Truth
Does anyone really care?? A lot of crimes go under the carpet because Pharmalot is not doing enough to expose them.
Hey Ed, You are doing a fantastic job. I read this daily. But the question is how can we inject ethics and conscience to the big pharms? They are killing people for money. Is FDA of any value?
Justice in Michigan
Many people care, inside industry and outside (don’t forget this report is about a whistleblower).
In my view, Pharmalot is a superlative forum, exactly because we can have discussion between people who may differ on policy but rarely on essential goals. Trashing either the whole FDA (where David Graham still works) or an entire industry (where a lot of good people here work or have worked) don’t move that discussion forward, in my view.
We do need to face the ugliness that exists. And move together in response. But just facing it together - rather than as polarized camps - is a good start.
Anonymous
From a rep prospective, I can provide insight as to representations/assertions of company and efforts to read through the lines. As with Baycol, the company maintained its’ position with regard to the safety and efficacy of the medication right up till the end. They promoted as such to physicians until the point it was pulled. The media was ruthless, and only partially accurate. If you know about these medications, the metabolism of Baycol is primarily through the liver, utilizing the cyto P450 2c8 pathway to a significant extent. An unfortunate coincidence is that Gemfibrozol also utilizes that very same pathway to a significant extent. (When 2 drugs go through the same pathway invariable it increases the bioavailability of one of the medications, this increases exposure to the side effect profile of the medication.)
Gemfib is a fibrate much like Tricor, also used to impact lipid levels. The majority of instances pertaining to Rhabdo occurred through this combo of therapy. However, The PI indicated issues with using in Baycol combo with Gimfib a 7 fold increase if memory serves me correctly. I am not aware of the efforts of the reps in relating this information to physicians in the early goings. It is my understanding an effort was made to relate this issue to physicians as events mounted up. Also Baycol is the most potent statin ever marketed with a very narrow therapeutic index. .4-.8 MG were common doses. However it was not the most efficacious. A common misconception, potency does not always translate to efficacy. As a general rule it does, but not always. Bayer wanted to push the envelope and doubled the highest dose available to the market to increase efficacy. Very bad idea. This also upped the ante on issues with Rhabdo independent of Baycol’s use in combination with Gimfib.
Now lets look at cost benefit of prescribing this drug. Cholesterol was becoming the largest potential market for medications, Statins have the most profound effect and would gain the lions share. I am by no means an insider, but would speculate as to what was going on at Bayer. If they could limit their exposure to the rhabdo through educating physician practices, They stood to be a player in the largest (potential utilization) class of medicines available to address cholesterol.
To this day I call on physicians that think Baycol was a good medicine that was prescribed improperly; to this day Gemfib has limited utilization due to potential interactions with statins. But I do have physicians that very prudently utilize the Gimfib/Statin combo to impact HDL as no other combination of medicines achieves quite the same results, up to a 50% increase, I have been told.
You might also consider Rhabdo is not the first sign of an adverse event with any of these medications. Essentially, Rhabdo is a wasting of the muscle tissue, this waste product (protein) is excreted through the urine. The protein is too large to filter through the kidneys and as a result damage the kidneys to the point of kidney failure. Much like taking a piece of cheesecloth and pouring water through. then throwing rocks through the cheesecloth. It would no longer be able to filter the water. (Very simplistic, but you get the idea.)
Prior to this occurance, Myalgia should be present. Muscle pain, not specific to any one location but all over, remember these drugs work systemically. This should be evidenced by elevations in CK or Creatine Kinase, a simple lab test. Elevations 10X the upper limits of normal suggest the next stage Myopathy. Again muscle pain but with associated CK levels 10x the normal levels. The individual’s urine would be brown as protein spills into urine. Then Rhabdomyalisis occurs which generally results in death, as the kidneys are no longer able to function. A lot of physicians reference Rhabdo at the point that is actually Myopathy. A conservative approach to addressing a very serious issue. This process would likely be accelerated by increasing the bioavailability through the combination therapy.
This is a lengthy response, but when you evaluate a drug company’s response to a medication that has the potential to be pulled from the market, I think it is appropriate to understand the complexity of the decision.
Yes, people did die on Baycol, 67 deaths in all I believe. I haven’t looked the figure up in some time. The rates of Myopathy are listed in the PI for all statins currently in use (.02%) roughly. Most instances at the higher doses. 2/10th of 1%, pretty low when you consider 25% of all deaths in the US according to 2004 data could be attributed to the effects of atherosclerosis, and 50% of all cardiovascular events occur in people where that event (Stroke, MI, Angina, etc.) is the first indication of Atherosclerotic disease.
This is not an effort to absolve Bayer of any wrong doing. I would have no insight as to their decisions. But I hope it points out that the vilification of Drug Company’s can have a tendency to go a bit overboard. And as much as is made about what is a stake, Profits vs Patient safety, there is much more to consider than typically is reviewed by the media.
Justice in Michigan
Appreciate the points, anonymous. Assuming the case is accurate, no need to speculate on some of what you write, particularly re: the baycol/gem issue and how it was addressed (or not).
M Helm, MD
I’m not anonymous, but I have a little history with cerivastatin and Bayer. There were concerns among the Medical folks about the potential for adverse effects given the potency of the compound. The marketing folks were initially enthusiastic about the potency as a point of differentiation.
Bayer’s history with ciprofloxacin and psuedomonas resistance is also somewhat ignoble. The IV formulations of ciprofloxacin were approved based on kinetics/plasma concentrations matching the oral doses. There were three strengths of ciprofloxacin initially with the 750mg strength as the “severe infection” strength. Prior to the IV formulations pseudomonas infections were reasonably well treated with ciprofloxacin, but at the highest dose twice daily. When the IV formula came out, hospitalized patients were given the 400mg IV twice daily (equivalent to the 500mg twice daily oral dose). The correct dose should have been 400mg every 8 hours to be equal to the 750mg oral dose twice daily. Bayer was aware that this use (inappropriate underdosing) was common, but elected to do nothing to correct the prescribing practices or warn hospital pharmacies.
Pseudomonas resistance to ciprofloxacin (and other quinolones) rapidly became more common after the IV was widely used. I doubt it could be proved, but I suspect Bayer’s failure to warn about the inappropriate use contributed to the eventual loss of utility for this entire class of medications against pseudomonal infections.
Anonymous
Dr Helm,
Are you at risk of losing your source of income by commenting on a public forum of this nature. I am, and as such will remain anonymous!!! But thank you for your contribution to the forum.
Justice in Michigan
I appreciate the potential risks of not being anonymous on a thread like this. I’m not sure it would be that different in my own, academic context.
Still, I can’t help but think of the irony juxtaposing this with the political thread on the board (about donations to Obama, etc.). People talk about the virtues of small government, economic liberty, etc. And yet some of us appear to be living in the equivalent of police states within our own places of employment.
a PFE rep
Dr. Sal and Chris,
Excellent points. Thank you.
a PFE rep
oops,
retract above, my computer burped and I got posted to the wrong blog!
Justice in Michigan
So there are no ambiguities about what we are discussing, here are a few excerpts from the first few pages of the filed lawsuit. Again, I understand that any lawsuit will argue its particular side. At the the same time, evidence represented should be weighed against its consistency with official records and with the credibility of the person who supplied it.
So here are just a few items:
- “Although Bayer knew that people were dying as a result of taking Baycol in combination with gemfibrozil, Bayer included the message of low risk of drug-to-drug interactions … in marketing material and messages almost to up to the time of Baycol’s withdrawal.” (18)
- Official meeting minutes reflected Dr. David Ebworth’s [then CEO] sentiments: “Other companies have developed an attitude of pushing marketing materials aggressively, following the philosophy,: “we do no[t] know where the legal boundary is until we hit it.’ One may not value this – but since it is the rule of the market, we as a company have to follow it. The area is grayer than we treat it, e.g., we can pick the better study for detail aid.’” (18)
- “Documents that Relator believed to be misleading were circulated at the meeting, including documents showing deceptive responder rates. In fact, a few key graphs did not provide complete data for all patients. A decision had been made not to include those patients who did not respond well to the drug….
Immediately after this meeting, Dr. Ebsworth authorized and spearheaded the distribution of the deceptive responder rate graphs to Baycol sales representatives for use in dettailing, thus authorizing the use of ‘homemade bread’ or non-approved sales material.” (19)
- “Senior Management discussed the risks associated with using material that likely violated FDA regulations and concluded that it would be acceptable to use because by the time the FDA reviewed the questionable material, another Baycol sales aid would be out, and therefore the impact of any FDA warning letter would be negligible.” (21)
- Re: a 1999 Adverse Event summary. “The summary included a paragraph stating that there was very likely a material difference in adverse adverse event rates between Baycol and other statins, and that further investigation should be pursued. When Bayer management reviewed the report, Relator was directed to remove this conclusion from the report ‘in case of litigation.’” (22) [The conclusion was, in fact, removed.]
****************************************************
Perhaps further information will modify the impression. But, as it stands, we have the picture of a company which deliberately lied about both the benefits and risks of its product, which found ways to be both technically in compaiance with FDA but able to subvert FDA in pratice, which suppressed safety information for fear of its use in anticipated litigation, and was thus directly complicit in deaths and injuries caused by Baycol.
It would be nice to be able to slice it another way. But, if this material is accurate, no other slicing appears to be possible.
Justice in Michigan
This is perhaps a relevant COI dislosure. For the past thrity years, I have been writing and teaching about the history of the Nazi genoicide. As is well known, Bayer was a part of the I.G. Farben conglomerate which used slave labor in order to futher its “medical experments.” That is to say, the company has a significant history of using human beings as disposable material if not outright garbge) in the interest of corporate advancement.
Bayer made ups a significant part of Auschwitz III/Monowitz(along with BASF and Hoescht, now Aventis), which used slave labor as human fodder to advance the company’s objectives). Thus, whether relevant or not, the company has a significant history of using human beings as disposable “material” to advance its coprorate objects.
Here is the standard summary mos often used to depticttrole of Bayer A.G. during the Holocaust:
*******************************************************
“In the Auschwitz files, correspondence between the camp commander and Bayer Leverkusen was discovered. It dealt with the sale of 150 female prisoners for experimental purposes:
“With a view to the planned experiments with a new sleep-inducing drug we would appreciate it if you could place a number of prisoners at our disposal (…)” - “We confirm your response, but consider the price of 200 RM per woman to be too high. We propose to pay no more than 170 RM per woman. If this is acceptable to you, the women will be placed in our possession. We need some 150 women (…)” - “We confirm your approval of the agreement.
Pease prepare for us 150 women in the best health possible (…)” - “Received the order for 150 women. Despite their macerated condition they were considered satisfactory. We will keep you informed of the developments regarding the experiments (…)” - “The experiments were performed. All test persons died. We will contact you shortly about a new shipment (…)”
Former pharma Marketing Exec
This is an excellent thread.
Thanks Justice for your disclosure it is something that people need to know - whether or not it is relevant to this particular case.
The point is that unless we all find a way to come forward and disclose the problems we face on the inside of this industry, these things will continue to happen.
It is too easy for those whose incomes are supported by the industry to accuse those of us who tirelessly offer our opinions and ideas here as being anti industry. This is not the case at all. I think that those of us who are willing to disclose the deceptions in this industry are the people who still believe that the industry can be saved and that integrity and good business ethics can be given prominent emphasis in the rebuilding of the industry.
We cannot be silent witnesses to these things anymore.
We need to all think and act like human beings who are equally affected by this. We need to stop behaving with a us/them attitude.
At some time or another we are or will be patients. If we continue to allow these deceptions to continue then we are no better off than our fellow human brothers and sisters living in third world countries with no access to health care. Is this what we really want for ourselves?
The money you make personally off of this will not be worth one dime, it won’t help you at all in a system that is over run with corruption and dishonesty.
Christy
There is no excuse for this type of behavior!!!!! Profits should never be placed before patients, but over and over and over again, we see this happening with Big Pharma. The companies involved are numerous and the ramifications are pitiful. If Bayer knew about these problems and continued to market and push Baycol without appropriate warnings to doctors and patients, then in my mind it is criminal. If they hid safety data from the FDA and/or others, then I believe that this is criminal as well. Will they ever be called to task for it? Hell no! Why? Because the US government will not go after them! This is a private suit for a very public problem. The government needs to protect patients instead of the Big Pharma companies. Sady, it looks like it never will. particularly with W in Washington.
Jack2
I don’t have a lot of time, but you asked for someone who works in industry to comment…
1. I don’t know anything beyond what’s on this page, but, keep in mind… This page comes from a theoretically unbiased pharma blog, that more often than not comes down anti-pharma, with comments from JIM that include only the prosecution’s comments.
2. If the company hid safety data they need to be prosecuted. The penalty needs to be severe enough so that this sort of thing isn’t just viewed as a cost of doing business, but instead the cost becomes so high it makes business sense not to do it.
3. I see people here calling for criminal prosecution. I don’t know if that’s feasible, because so many people get involved in this process, it’s hard to single one person out. Plus, Bayer correctly stated they operate in a grey legal area. It’s grayer than most people think. I don’t think anyone likes the grayness, but it is what it is.
4. You want to know how common this is? I can only speak from my own experiences, but I’ve never felt pressured to do anything I would consider unethical.
SP 1
I’m and MD and I’ve been pressured on a regular basis! I’m frankly tired of marketing people jumping up and down and screaming for their way! They’re like a bunch of spoiled kids. Positive data - shout it from the mountaintop and put it in very large bold print. Negative data - bury it, hide it, ignore it, or put it in miniscule print that nobody can read.
Justice in Michigan
To Jack 2 - The information I cited was from the case that Ed linked. I reitered several times in this thread that one must expect a brief on one side to make the strongest possible case. If I had I any access to Bayer’s reponse (if there has been any), I would certainly have included excerpts from that too. I also initially raised the question as a hypothetical - wondering especially how people in the industry would view this _if_ it were mostly confirmed.
Re: Jack2, if you do read the case as provided by Ed, you will find your sense about prosecutions to be confirmed. While there appear to have been a few “point people” whatever culpability there was was widely spread throughout management and beyond. So, indeed, it does not appear that singling out individuals would mean much, just as you write.
It is possible to levy criminal (as well as civil) fines against companies, not only individuals Some of the famous $430 million fine levied against Pfizer/Warner-Lambert for the Neurontin fraud was based on criminal charges. Just as Jack 2 describes, the DOJ’s justification was how widespread and systematic the fraud scheme was in that case.
I do regret bringing in Auschwitz, although people should certainly know that history (the medical profession as a whole was deeply implicated in the Holocaust). Still, it was a little “over the top” in this context. I was, indeed, furious having found the excerpts that I included, and that outrage led to what followed. I have not forgotten, however, that my outrage may turn out to be less justified when more is known.
Also agree that gray is generally where things are, and gray is what makes things interesting. When things go on in this industry, it very often has to do with the strange career of what began as good intentions.
Justice in Michigan
A last word as this thread fades into history. In one of the best known studies of Holocaust perpetrators, a book called _Ordinary Men_ by Christopher Browning, the commander of a troop (not SS types) that became famous for exterminating a village of 1500 people, was a guy named Trapp. Trapp was no hard-core Nazi. He is reported to have been upset during the massacre, pacing around and saying things like, “Man such jobs don’t suit me. But orders are orders.” He was genuinely upset and tearful.
I was immediately reminded of Trapp when I read the bit about CEO Ebworth saying, “One may not value this – but since it is the rule of the market, we as a company have to follow it.”
The point is not to compare Baycol (or any other pharma event) with genocide nor is it a slam about Germans. The reality is that this kind of moral near-sightedness - if that is what it is - is an illness that most of us share. I count myself among them.
Most of us do what is in front of us to do. And, in the process, it _feels_ like we have no real choice. “Orders are orders.” “The rule of the market is the rule of the market.”
None of this is real. In actuality, no perpetrator was even lightly punished for choosing not to carry out orders during the Holocaust. And I doubt that Ebworth - or Baycol, for that matter - would have faced significant consequences if he had opted out of “home-made bread.”
But we convince ourselves that the systems we are in are they only possible realities. And we act accordingly.
It is that unreflective habit which may be part of the key to the way out.
riv
Quite trying to cover with gemfibrozol.
“An unfortunate coincidence is that Gemfibrozol also utilizes that very same pathway to a significant extent.”
Well so does caffeine.
I damn near died on Baycol, and I wasn’t using gemfibrozol or any other drug concurrently or drinking grapefruit juice or eating grapefruit or grapefruit hybrids. I was put on Baycol for prevention. One day when I was leaving my clinic, the Baycol rep told me, after asking who gave me the drug boxes I was carrying, that he would have to thank my doctor for putting me on Baycol. Thank my doctor. Why? How?
“An unfortunate coincidence…” my ass.
Chris
This comparison with Bayer’s leaders, including Ebsworth, and Nazis is really a stretch - caveats notwithstanding - and should stop.
Decisions made in modern day pharma and those made by German companies under whatever duress was imposed in WW2 are in no way comparable, nor are the consequences.
Enough. Let’s look forward.
Former pharma Marketing Exec
Actually, I think that what Justice wrote here was appropriate. If you look back in history you can understand how it was that with time Hitler and his buddies were able to convince the mass population about the rightness of their dogma’s.
Justice isn’t saying that Bayer or pharma industry as a whole is still behaving like they did during WWII but I think it was a good reminder of how we need to all be careful with pushing our boundaries too far.
So, I do think this was in the appropriate context here.
The point being is that we all need to be more mindful of our own moral compasses and not just follow what the market is doing. If we have learned anything at all, it must be that we need to stop and ask questions and understand why we do some of the things we do. To me that was the point of Justice’s comments.
riv
Baycol Argentina
http:// http://www.cbgnetwork.org/4.html
Jack2
JIM, I wasn’t implying I disagreed with anything that you (or Ed, or others) stated, and I understand that you only have half of the story.
I was just giving my opinion, which you asked for in your first post. I didn’t want to be seen as “opting out.”
And Angry mentioned prosecution.
I don’t like the grayness. I’m a math/science guy and while often they’re impossible to find, I like clear rules and answers.
Justice in Michigan
Right. The caveats are there and clear, I think. As Former put it, I think we learn by extreme circumstances to less extreme ones. So it is about defining moral options and how easily we can lose touch. Milgram showed us all that a long time ago.
For the record though: For the most part, companies (way beyond pharma) were _not_ under significant duress during WW2. The most recent and best research shows that senior management were more likely to be true believers and/or seized the advantage of playing ball. So the Trapp example was, in that context, a less typical one, which is what makes it interesting to me. You didn’t _have_ to be hard-core or purely mercenary to go with the flow.
Jack2 - I appreciate your coming in on this. I wish more people from industry also had, but there are other threads in which they have.
Solution
I say lock the executives away! It’s high time they are held responsible for hiding safety data and putting corporate profits above public health. Why does it continue? because the companies and the executives weasel their way out by cutting a deal and admiting no wrongdoing. This is bullcrap!! make them pay with time in a cell!