Roche Rep Fired For Refusing To Promote Off-Label
30 CommentsBy Ed Silverman // December 9th, 2008 // 9:22 am
That’s the claim made in a lawsuit filed by Carolyn Gleason, a former rep who visited hospitals and other big medical institutions in northern Florida to sell Mycamine, an anti-fungal med that Roche co-promotes with Astellas Pharma. The trouble began, according to the lawsuit, when a regional manager wanted to boost declining sales by relying, in part, on off-label promotions.
In her lawsuit, Gleason charges she was sexually harassed and, eventually, fired because she refused to follow orders to market the drug for “all purposes,” such as telling docs the drug could be used in lower-cost, 100mg doses to treat candidemia. The FDA, though, had not approved Mycamine for that use or dosage. As an example, she cites a June 2007 club luncheon at which a presentation was being made and she refused her supervisor’s instructions to discuss an unapproved clinical study article.
However, her supervisor, Tom Long, allegedly proceeded to discuss the article. “In violation of FDA rules, Mr. Long represented to the physicians who were present at the luncheon that Mycamine 100mg is being used at Tampa General Hospital and Jackson Memorial, two large hospitals in Tampa Regional’s sales territory,” according to the lawsuit. “Mr. Long falsely told the physicians present at the luncheon that, with regard to Mycamine, ‘no one questions the 100 mg anymore, it’s a given.’ ”
Later, Gleason claims Long began to sexually harass her by kissing and hugging her inappropriately. About the same time, Long had begun questioning her expense reports and job performance. Until she began reporting to Long in 2006, Gleason claims she never received a negative job critique or was disciplined, but in fact, had received a special recogition award six times during her 10-year tenure.
However, Gleason was fired in September 2007, three months after she claims to have refused to promote Mycamine off-label and 17 days after she reported the allegedly harassment to the human resources manager in Roche’s Tampa, Florida, regional office, according to her lawsuit. We have contacted a Roche spokesman for comment and will update you with any reply. UPDATE: A spokesman declined to comment, citing pending litigation.
Dan A.
Carolyn, I feel your pain, but you did what others choose not to do, which is doing the right thing,
Dan
Luis
I congratulate Ms. Gleason for her courage and believing in her principles. Having been a sales manager in the industry for many years I can relate to her situation as I spent many a moment with representatives who believed in the doing the right thing. What appalls me the most is Mr. Long’s conduct as a sales manager and the HR individual which allowed this to continue and eventually fired Ms. Gleason. This is the exact reason why these individuals i.e. Mr. Long gives the entire industry a black eye and physicians continue to shut doors to access to those “Professionals” like Ms. Gleason whom everyday go out and work hard and professionally to not only represent their products but their companies. Looking forward to the update!
BPW
It’s the Big Pharma way! Push employees to do the wrong thing just to drive sales and profits. This has been going on for years because there is virtually no risk to Big Pharma.
If any employee refuses to go along with the company line, then fire them. They’ll be left to fend for themselves because they weren’t good soldiers. They’ll neevr have any success coming after you becias you’re too big and have too many lawyers.
If you get caught for promoting off-label, then admit no wrongdoing and pay a fine. The fine is paid by the shareholders anyway. The execs walk away with their big bonuses and laugh all the way to the bank.
Bottom line - patient suffers, employee suffers, company gets away with it, execs get rich. Disgusting! I’ve seen it several times!
Salmon
Luis,
What the manager did is common. In fact the manager might have even been put up to it. If someone has good evaluations etc. then they try to harass the person into leaving typically first through overwork. If that doesn’t work then harassment of a different sort (e.g. sexual harassment) along with the impossible assignments. If the person gets irritable etc. it can be claimed that they were rude, etc..
If the the person makes an EEO claim then the amount of effort it takes to fight the EEO claim as well as the excess work and ongoing sexual harassment makes doing your job even worse, helps destroy your personal life, and gives them more excuses to say things like she was discourteous to bosses. As for the discrimination case the company simply argues that the person was already being admonished for poor work and the rep simply filed an EEO complaint after the fact to protect themselves. These situations take years and a lot of money and a toll on your life and if you miss any kind of deadline your EEO case is thrown out, and they can go ahead and fire you for the other stuff. If you win in the end pain and suffering is maybe $10,000. But then you’re back at work and open to retaliation by a new boss and upper management is laughing about it the whole time.
Salmon
pharmavet
I agree with Salmon. One time I overheard a marketing manager say that unless the company received at least one warning letter per year from DDMAC they weren’t pushing the envelope hard enough.
Christopher
This article is about a lawsuit in which allegations have been made. The allegations are yet to be proven - if at all - but every single comment so far presumes guilt. Mr Long is about to be hung, drawn and quartered and they haven’t reached court yet. Who would wish to be tried in the court of public opinion?
Jim
Fuggedaboudit, Christopher. Everyone else on this site agrees that what the rep did was heroic (more should do the same) and the harrassment and firing are common.
I won’t do justice to the man by stating his name. I wonder what the name of the rep was who pushed the Medicaid doctor into using Zyprexa, on a pack of lies, which ultimately took the life of my son. I’ve never known the name of the rep, and it is just as well.
Christopher
There are thousands of people who view this site Jim but only a few (relatively) who comment. My point was that, as usual, there is an anti-pharma prejudice.
Shultz
I currently work for Big Pharma. Having been employed in the industry for over 20 years I have witnessed a new trend in the way we are instructed to do business. It’s called “off-label selling”. While looking you straight in the eye, its “on label” only. However, out of the side of their mouths, they “suggest”, or should I say, encourage the opposite. Off-label selling is not only acceptable but the manner in which they expect you to do business. Just don’t caught or it is your head on the chopping block. Fortunately, I work for a Manager who finds this unacceptable and will discipline those who do. He should be the CEO of the company I work for.
Salmon
Christopher,
I have to agree that some posts and even the first sentence of my own indicate a presumption of guilt. I should have been more careful. Personally I was not trying in my post to point to Pharma but how retaliation is done in general in all industries even down to the Mom and Pop business level (when it occurs).
In spite of the EEO laws they have not really been enforced and this is true for psychiatric illnesses in particular.
Almost immediately after the passage of the ADA as amended in 1990 the courts began to cut back on rights that were explicitly spelled out in the act.
For example although the law says a person is covered if they have a disability or a history or a disability or is presumed to have a disability the courts have interpreted this for psychiatric illnesses that if you use drugs to mitigate your disability then you don’t have one and aren’t covered.
Plus even if the courts did uphold the law it’s really only for the most severe psychiatric illness and so not all psychiatric illnesses are covered.
It’s been especially bad under the Bush administration. In 2002 the VA which is the largest employer of the disabled in the federal government outsourced a lot of lower level functions (were the disabled tend to be congregated) and there was a huge drop in the number of disabled employed. Although the VA played it up that 700 disabled had been hired the net effect was hugely negative. Then the EEOC delayed the release of the 2003 figures that usually come out in late Spring until after the Fall elections. If you obtain the employment figures by disability for FDA over the past several years as well as the FDA No Fear data I believe you’ll find evidence of systematic discrimination and forcing the disabled to leave FDA.
Now I don’t know for sure but if you are trying to hide the fact that dangerous drugs are being approved it would also seem to me that you certainly don’t want people around who have a vested interest in the proper approval of those drugs.
Plus you’ll find that FDA has not followed the law in terms of EEO requirements. Since the Center Directors and the Commissioner had to sign off on the forms MD-715 for submission to Congress. I would think that their signatures might constitute evidence of lying to Congress and falsifying Federal documents.
For anyone who has a psychiatric illness or has a child with ADHD and thinks that the ADA will protect them (it’s only when in school and someone is making money off of programs) after that having let people know your child has ADHD may come back and hurt them.
Salmon
Opinions are my own and do not represent the opinions of the FDA.
Jim
Salmon
Not all courts view the fact that an individual may take medication to mitigate their conditions as an appropriate defense by the defendant. The regulations are silent on this fact, however the use of any mitigating devices or drugs should be considered when the employer becomes involved in the interactive process, which is still required by law (US Airways v Barnett).
The Supreme Court most closely associated with the topic of corrective measures made by the applicant in an ADA case is Sutton v UAL. However, the decision in Sutton v UAL did not deal with issue of whether an individual should not be considered disabled if they can use corrective measures for their condition. The Sutton decision only ruled that Sutton was not disabled under ADA becasue her condition only disqualified her from the position at UAL and not from a broad variety of jobs.
That being said, if the employees in question are taking medication and the medication is working I would tend to agree with the decision that although their underlying condition may be covered, the fact is their medication makes an accommodation unnecessary, unless I am missing something here.
On the other hand if their medication is not working or working in a limited capacity then it is up to the agency to determine if the accommodation is reasonable and the employee with an accommodation can perform the core duties of their position.
Finally, you mentioned that various functions were outsourced; if this is the case then the positions that were outsourced should have an equal impact on all employees; you do not gain additional rights if you are covered under the ADA. The only time disabled individuals may file a claim is if the outsourcing program has a disparate impact on that particular segment of the workforce. However, I am a little rusty in this area and I believe Disparate Impact Claims are now harder to prove, at least they were under the ADEA.
Salmon
I am not a lawyer. I am simply relating my understanding of what I have read. As to drugs being mitigating measures I was talking in particular regarding psychiatric illnesses. I know that in severe cases they do not completely mitigate the effects of the illness. There are various degrees of response and for some there may be some mild symptoms that pop up from time to time which interfer with social skills and this can easily prevent advancement due to job criteria such as ‘exceptional interpersonal skills’. Thus we have issues with hidden barriers which by regulation have to be identified and addressed. In addition the same regulations require government agencies to do certain required trend analyses each year to see if they can detect patterns of discrimination and they are required to report on them to Congress.
As to the VA this was very obvious as people with disabilities are disproportionately congregated in the lowest ranks (GS grade levels) in government. These were exactly the ranks that were thinned by outsourcing. In fact there are large numbers of deaf in the cleaning staff at FDA. These used to be government employees now it’s outsourced and these individuals wear the company’s logo. Yet it’s definite that they no longer have the job security they did with the government and I wouldn’t be surprised if they have less health and retirement benefits.
It’s also blatently clear if you look at the employement statistics for the Federal Government to see that trend analysis is not being done. For example the government is supposed to be a model employer and representation at ALL levels is supposed to reflect the participation rate in the civilian labor force. Yet for severe unipolar depression alone the participation rate in the CLF is around 5% yet the all participation rate for ALL disabilities in the Federal Government is now under 1% (it’s been declining for like 15 years straight). Last time I checked as of a year or 2 ago there were only 3 individuals in the entire Senior Excecutive Service (SES) with Mental Illness out of a labor force of over 2 million and around 15,000 - 20,000 people in the SES. This surely doesn’t represent the population.
It isn’t that there aren’t qualified people available. If you look at the feeder grades for SES the 14’s and 15’s it’s well under the CLF but it drops off like a cliff going to the SES level. No other disability has this pattern, although deafness which also results in difficulties communication skills also has a decrease with each level you go up , but not the cliff seen with MI and the SES. To give perspective there are around 15 people with blindness in the SES compared to 3 people with a history of mental illness. True blindness is so rare that the NIH has no prevalence rates for less than 40 years of age and then from 40 - 65 yo it’s only 1 in 400,000. In contrast the participation rate in the CLF is for Severe Mental Illness is around 5% - 6% of the population.
Why doesn’t HHS including FDA have people at these SES levels? Isn’t part of the rationale for the ADA is so that people with diverse experiences can bring unique perspectives especially to areas that they can effect? Don’t the mentally ill deserve members of their own group in HHS (including FDA) to give voice to their concerns? What about even equal opportunity. If you grow up with severe mental illness the chance of being able to even gain higher education and skills drops off like crazy. Should we shunt aside US citizens in high tech fields who bring those unique perspectives so that we can hire foreign nationals?
If you’ve worked so hard to overcome and gain the skills and knowledge and even had to do twice as much as others to even get in the door in the first place. It isn’t special treatment to simply want a fair chance to even work without harassment and retaliation much less have a chance for advancement.
Shultz
Excuse me; however, what do some of these posts have to do with the question at hand? I believe you have lost me when you removed yourselves from the original topic. I believe it was “off-label” selling. Could I be wrong?
Salmon
There are many examples of articles of off-label selling. This one is more unusual as there is the element of potential intentional sexual harassment as a form of retaliation.
More typically illegal retaliation with EEO cases don’t take the form of sexual harassment but rather of harassment resulting in exascerbation of mental illness that people otherwise try to avoid revealing to bosses and coworkers. Workers almost never win those cases because employers have leeway to set behavioral standards and by intentially harassing someone and getting them to react you can fire the employee for violating standard employment workplace standards due to the symptoms of their illness without the worry of the legal repurcussions for violating someone’s civil rights.
Salmon
Benji
As a former sales DM and recent Medical Liaison Manager I find the allegations very interesting and just cannot outrightly condemn the manager. The most common situation when a manager brings up a counselling session or performance review which is unacceptable to a subordinate of the other sex or gay/lesbian is to plan and mount an attack against the manager and company. So many mediocre reps squeek by for years because no manager wants to cofront them and most managers change after 2 or 3 yars anyway so there are lots of lousy reps that have been milking the system for years. It’s about time pharma takes a hard look at what reps do and starts to get rid of some of the non-performers. A rep is not worth $50-80 plus bonus for dropping samples and booking lunches and breakfasts. They dont communicate hardly any data anymore and as soon as a doc asks an off-label question they are so paranoid they just look stupid. Cut the pharma sales forces in half, stop having multiple reps cover the same zips, increase the bonus to the high achievers and let the loafers find another sales job in some other industry where they have to work for a living. The days of part time pharma rep work for FT pay is coming to an end. The common way of retaliating against a poor performance review or counselling is sexual harassment and now claiming forcing a rep to do “off-label” promotion. I agree, Off Label is still very common and if you want to play by the rules you simply have a clinical educator or MSL visit and answer the docs questions on off-label use and cite the studies. I’d like to know the age of the rep and the age of the manager cause that often tells alot about philosophy of selling. If the manager is an old time hard ass marine type put him out to pasture. If the rep is a pharma-Barbie with little substance dump her.
Pharma Dude
Roche takes a very hard line on sexual harassment and this rep probably just used the harassment charge and allegation of off-label as retaliation for a mediocre or poor performance appraisal or field trip review. I cant believe this manager would be stupid enough to kiss and hug a subordinate with all the HR training managers go thru on sexual harassment and maintaining and unhostile workplace. If he has a history of harassment he should be nailed. Ten years of employment and 6 sales awards by the rep does not impress me cause many times the awards are team related and an individuals performance is not the primary indicator. The company has the right to fire a rep if they are not meeting sales quota and maybe that was part of her problem or just bad attitude. If she doesnt want to talk off label get an MSL -Roche has a good medical affairs dept. She should write it off and move on to another position but maybe she is blackballed for her bad attitude or sales numbers.
David
Pharma Dude -
“If she doesn’t want to talk off label get an MSL” is an inappropriate recommendation. Unless these discussions are FULLY UNSOLICITED and INITIATED by the individual prescriber, then a MSL talking does not help make it any more acceptable.
> The company has the right to fire a rep if they are not meeting sales quota.
PD - If the sales number require off-label promotion in order to be realistic, then that is also unacceptable.
Salmon
Pharma Dude,
The fact that Roche talks the talk is not evidence that they walk the walk. If the rep’s story is true then it’s likely that Roche will have not looked into allegations seriously and instead you will see a pattern of the company doing these things chronologically that suggests they’re just doing CYA and backing the manager because the manager was doing what was expected. (Nudge, Nudge, Wink, Wink). We cannot determine what the true story is from the information available.
Salmon
The Sarge
With the way this stuff is peddle, get rid of the reps and bring back the medicine show. At least we will be entertained instead of the scare tatic that if we don’t consume the stuff, we will drop dead marketing.
Christopher
Salmon, David:
We’re off down the same path. “If” and “Likely” and “We cannot determine what the true story is from the information available” capture it really don’t they? Seems as if PD knows of what it speaks and the truth is probably somewhere in the middle, as always. Speculating about CYA and other naughty behaviour is fun but not always accurate. Let’s wait and see how this plays out.
Doc
After reading all posts, the one grain of truth is that big pharma is very difficult and very expensive to fight. Even if the rep is found to be telling the complete truth, few people have the money and grit to fight these companies to the end.
Kalahari
This is one just reason I take no drugs, Rx or OTC, and never will except in dire, emergency situations. I strongly suspect Big Pharma’s petrochemical-based “drugs” are behind the huge surge in cancers and other deadly health disasters. Yet we see in the news almost daily that they skew and fund tests and reports on vitamins, minerals, etc. to make a trusting public believe they are worthless or even harmful. They are what nature put in our foods to nourish and keep us healthy, not man-made poisons. No one ever suffers due to a drug-deficiency and not one drug has ever cured anything - EVER! But they kill well over 106,000 Americans every year. How many die from clean foods and their nutrients? NONE!…unless it is way overdone.
The Cleaner
What?! Are you kidding me? Try getting over an invasive fungal or bacterial infection on yogurt and broccoli!! You can get those infections by digging in the dirt or swimming in a lake or river. Sorry to get off topic, but Kalahari needs to move to a third world country with no health-care to appreciate the pharma R&D. Artificial sweeteners are the real killers!
Ivy
I’m sorry, but if The Cleaner agrees that artificial stuff is bad for consumption then he, she, they, or whatever should not be criticizing Kalahari’s assertions.
Clifford Rowell
Hooray for te salselady who refused to sell off label. I sold and travelled for over 45 years and no one in management would ever push me to do illegal or imoral things. I would have blown the roof off the whole thing wether I got fired or not. Right is right and wrong is wrong. She did the right thing and should have been promoted for her ethical stand.
Liz
Ivy - I’m afraid you’ve gotten a hold of some misinfo.
Aspartame breaks down into residual chemicals like aspartic acid, phenylalanine, and methanol, among others. Aspartic acid ALONE is known to cause brain lesions and tumors.
Splenda was my favorite until recently.. when I found out that the chemical it breaks down into w/in the body actually has the capability of altering DNA. This one was discovered when they were attempting to create new insecticides. No joke.
Read what chemists themselves have to say after evaluating these tasty bits.
Our country is chemically dependent, whether it be artificial sweeteners or RX. Around 300,000 ppl on average die per year due to “safe”, “approved”, “regulated” prescription drugs - the human race made it quite far without their aid.
Andrew Nabors
Hey Mrs. Gleason,
I am glad you are choosing the higher moral ground. It was nice seeing you at Jonathan’s wedding. Litigation is not a fun practice, but it sounds like you have a strong case.
Andrew
Dennis K.
Just a small realization, upon reading this article. The multi-conglomerate pharmaceutical companies. With the approval of the grease palmed, bureaucratic policymakers. Continue to push unsafe substances on the populous. Much like the street level “Drug Dealers”. Many times with expotentially worse effect. Than the supposed “Hard Drugs”- such as cannabis.
Point in fact, is the over prescription of speed for an invented condition….A.D.D. Realistically, Ritalin is speed, or more chemically known as methaphetimane.
So, Madame Gleason chose to get out of the “gang mentality” of big pharma. And, got harrassed, shunned, and jumped on in a corporate fashion.
Thank you for your time fellow free thinking people.
puzzled
Hmm…
He tells her to perform an illegal act.
She, upright and virtuous refuses.
He aroused by this erotic response then attempts to jump her bones.
In front of witnesses?????
Lilly Becks
I wonder if anyone asked the attendees at the presentation to confirm or deny the allegations that the manager presented or pushed off-label information after the rep refused to do so. And if anyone witnessed his harassment or “attack” on her.