Novartis Whistleblower Speaks: ‘We Wasted Money’
69 CommentsBy Ed Silverman // October 1st, 2010 // 9:50 am
For six years, Jeremy Garrity worked for Novartis promoting various cardiovascular medicines, such as Diovan and Tekturna. But he was fired in 2008 and later filed a whistleblower lawsuit, one of four that prompted the federal government to launch an investigation into off-label marketing. Yesterday, the drugmaker agreed to pay $422.5 million to settle civil and criminal charges. Garrity, who no longer works in the pharmaceutical industry, revealed in his lawsuit several interesting practices: some doctors who served as speakers read from prepared scripts; some doctors were recruited as speakers even if their English was poor; both doctor and event attendees were paid honoraria, and doctors who did not prescribe did not get paid. We spoke with the 35-year-old Garrity, who lives in the Midwest and was represented by Nolan and Auerbach, an established healthcare fraud whistleblower law firm, and asked him to reflect on his stint…
Pharmalot: At what point did you feel uncomfortable with the way Novartis conducted business?
Garrity: We had a meeting in Las Vegas in 2006 and the president of sales stood on the stage and said one of our biggest goals was to have the most programs of anyone in the industry. Dinner programs, medical education programs. We’d gotten beaten out earlier by Benicar, it’s a (Daiichi) Sankyo drug. They had more events than we had. And they had a higher market share than Diovan, so it was presumed that if we had more events, we would have more market share. That was a turning point for me…The only true programs were few and far between. By that I mean where you would have a respected physician who knew the disease state very well and a lot about the drugs and the class of drugs, not a physician who would spew out a commercial. The reps saw this decision as the company cramming programs down our throats. You had to have a certain number each month. I was putting in extra hours. I was sick of it. The work was exhausting and I was burning out.
Pharmalot: And this was a change from what you experienced previously?
Garrity: When I started at Novartis, there wasn’t the push for programs. So you’d get a legitimate turn out. But that changed over time. You would have your bogus programs where no one would show up and you would still have to pay the honorarium. You would have two programs in the same small town in the same week. They pressured reps to get speakers and turn out these new drugs. It snowballed and continued to go in the wrong direction. One of the other irritating things was you had to buy a lunch for an entire office in order to see anyone. These are all the complaints of a drug rep. But things had started to get worse, probably in 2004.
One of the issues that really bothered me was the waste of money. That was a gradual thing. You just don’t notice it right away. Like how much honorariums were paid out for physicians. I knew how much the dinners cost and for what? So you could outdo other companies with dinners? At the time, there was no data at all to support switching a patient over to Tekturna. And you want to convince doctors to write prescriptions for Tekturna over a generic ace inhibitor that you can get for 10 bucks at Walmart? We wasted hundreds and hundreds of thousands of dollars that could have been spent on something better. It could have been spent on a program to give less fortunate patients access to medicine.
Pharmalot: What happened after the Vegas meeting?
Garrity: Around the same time of that meeting, I had interviewed for a spot that I was told would be more in medical science. Those folks would talk to key opinion leaders, but I ended up as an area scientific sales consultants, or ASSC. They work congruently with medical science liaisons. I had wanted to get away from the marketing stuff. My forte was the science. I started at Bristol-Myers Squibb in 1999 and by ‘06, I was tired of the marketing aspect. But this didn’t turn out to be the kind of job I had hoped. I ended up being a liaison for the speakers in my area. So I was in limbo. I wasn’t a rep but I wasn’t on the medical science team.
When I was a rep. I was isolated to a fairly small geographic area. When I took this job it was almost the third of a state, so I saw a lot more of what was going on. And I had to make sure these guys (the speakers) were trained, that they had their slide decks, and we were the ones who looked after the money, the budgets. How much guys got paid. That’s all I was doing. I thought it was a waste. I thought maybe it could change from the inside. It was not the job that I signed up for.
Pharmalot: What led you to become a whistleblower?
Garrity: I had an excel spreadshseet that had everybody’s payments – all these physicians across the US. It was a lot of money and I knew the quality of what had gone on at these medical education events. There would be a doctor who could barely speak English, but wrote a lot of Tekturna (prescriptions). He had a pretty high market share relative to another physician in the same practice who didn’t speak for Tekturna. So he would be a speaker and get paid. It’s not very hard to put together the numbers, especially when you launch a drug and track it…But management would say you couldn’t use someone (as a speaker) if they didn’t write a lot of Tekturna, even if the person was an authority.
Pharmalot: Did you approach anyone inside Novartis and talk about what you saw and whether it may have been illegal?
Garrity: That stuff came up in a discussion at a manager’s meeting at the regional office…I had the info. I just thought, ‘Hey, it’s worth a shot if they’ll stop this nonsense.’ These things we were doing were a colossal waste of time…No, I didn’t have discussions where there was mention about the law. I did have discussions saying that it wasn’t what I signed up to do. And what are we doing here? It wasn’t right. He said we work within the constraints we’re given. Maybe things will change in the future but this is the job we’re doing now.
Pharmalot: Some people say whistleblowers are only in it for the money. What’s your reaction to that?
Garrity: Not at all. I remember talking to (my lawyer) for the first time and she said a lot of times, this (type of lawsuit) goes nowhere. And I said that’s allright. I’m willing to do that because I honestly believe what they were doing was wrong. It’s wrong to pay doctors to write prescriptions for drugs that were proven no better than the generic. I mentioned I was selling Tekturna and there was no data to support switching a patient. But that’s the problem with industry…But I feel like justice has been served. I think Novartis should be punished for what they did because it was wrong…I’ll pay bills, give to charity. And save some for my family.
Pharmalot: What would you say to someone who wants to be a rep?
Garrity: I’d say don’t do it. This isn’t a sales job. I mean it’s changed a bit since I left the industry. There are supposed to be new rules in place. But it wasn’t a real sales job. You may be disappointed if what you’re looking for is a pure sales job. I call it marketeering.
pic thx to katerha on flickr
shytown
Bravo Jeremy!
TarHeel Rep
This is an example of whistleblowing done right. We could save millions in Drug Co. expense by cutting dinner program budgets in half.
Jack Friday
Great job!
Well done Jeremy and Ed.
Doc
The industry has changed little, the outright payola is gone, but still exists in “promotional program speakers”.
Good for Mr. Garrity, doing the right thing is important - money or no money.
Now if the DOJ would just lock up a few execs that push this stuff, it would have more impact.
Pharma looks at DOJ civil fines as the “cost of doing business” - I’ve heard it more than once since my company paid a large fine for off-label marketing.
shytown
Doc,
Haven’t we heard for months now how the FDA is going to get tough on these companies and start sending these crooks to prison.
Park Docterine.
This was NVS’ 3RD Strike!
I guess it is just another case of not putting your money where your mouth is!
NVS gets BILLIONS in extra revenue, and pays a fine that is equivalent to what the company makes in 4 DAYS OF SALES.
Don’t believe me, here is the math:
44 Billion divided by 52 weeks = 785K/WEEK.
Novartis is laughing all the way to the bank!
shytown
Sorry, the above 785K/WEEK, Should be 846M/WEEK.
I was never good at math.
Angie Maher
Congratulations to Jeremy and ALL of the brave individuals that stand up to the pharmaceutical giants. Enough is enough! The shady practices of pharmaceutical companies needs to end. Today. Period.
Angie Maher
JNJ/Ortho - McNeil Whistleblower
Settled Case April 2010
Dan Abshear
http://www.henrymakow.com/i_was_a_corporate_whistle_blow.html
Not M. Black
Kudos Jeremy! The industry needs more people that will draw the line and say “enough is enough” like you, and acts with mind and gut!
~ Not M. Black
industry insider
Ed, do you have any thoughts as to why this and other whistleblowers have been willing to talk to you on the record? Most whistleblowers wind up blacklisted from the industry, collect little if any sustainable income and wind up in careers outside of Corporate America that pay them far less than they received in industry. To wit, Dr. Jeffrey Wigand.
Teflon no more
Novartis has lost it teflon finally. I predicted this few years ago for I have watched what has gone in USA. Other companies paid over 20B in fines but Novartis stayed “clean” this long even though it was one of the worse offenders as far as illegal behavior is concerned. I always claimed that all companies are just a form organized crime and I named it OCC (Organized Corporate Crime. They do it with planning and approval by the very top. Dr. Vassela knows this is going on. Personally sent him evidence few years ago and it was covered up and I was out. Jeremy did the right thing. He did not whistleblow internally as Novartis codes of conduct ask, but went outside and was successful. Had he gone to ther security aparatus called BPO, they would heve taken the evidence, cover the thing up and he would have been out with nothing.The company would have gone on with same but different and improved illegal stuff.
This latest fine will not stop them as it did not stop others. They consider the fines as cost of doing biz evethough they are so big.The returns are so huge when they use illegal promotional practices that they simply can’t give them up. Only when some of the key crooks start doing some jail time this may change. In the meantime I invite all who have evidence to blow the whistle on their employers. You owe then nothing and it is the right thing to do. I wish we had the same laws as you do so my evidence on this Co would not go to waste as it did. If you don’t have the evidence look for it, file it and then do the right thing. It is the only thing to do and it works.
Batman
In the end this guy stands for something. His colleagues stand for greed. They stayed and took bonuses and think they will retire Rich from engaging in fraud. To all those folks, I scoff at your ignorance and lack of social conscience. You have nothing but shame. This guy deserves credit. Heros come in many ways. He is one.
Agree, but....
I’m all for punishing companies who break the rules. The only exception I take with Jeremy’s comments deals with a speaker’s prescribing history relative to a drug. I hate the phrase, “They have to write a lot,”, but they do need significant experience with the product to speak about it intelligently.
BOB
BY THEM PAYING A FINE, THEY SOLD ENABLEX FOR 500 MILLION TO PAY THE FINE. BUT NOW MANY PEOPLE ARE GOING TO BE DOWNSIZED OUT BECAUSE OF THIS FINE
Rep
I forget what these whistleblowers make (10% of the settlement?)…that’s about $4 million dollars. Jeremy does not need to be commended for his actions…his hands are dirty and he took the money.
You want respect…turn all the money over to charity!
Batman
Dear Rep,
Go back to your sorority or frat house where your rotten tail came from. You represent what ruined this industry. Your ignorance of the FCA which is supposed to be required education in the pharma world tells the whole tale. It is minimum 15 percent and that is before taxes and attorneys take their rightful share of the long fought recovery. So after Jeremy is blackballed for doing the right thing what then? Your lazy stupid and complicit butt gets to keep doing the wrong thing and taking checks from dirtbags like Novartis or is it Nofartus. You are exactly what ruined the industry. You are the classic moron. You are pathetic. The law is the law and guess what unless Jeremy invented the fraud at his employer he is legally entitled to his share. You can kiss this Batman’s butt. I think you are part of the problem. He is part of the solution. As one says to another with zero respect….drop off loser.
Scully
Here we go again…
Doc
Rep,
Virtually all whistleblowers undergo stress, many divorce, economic loss, etc. Most never went into it for the “money”, but out of a sense of trying to stop corrupt practices that endanger lives.
Going up against a multi-billion dollar corporation is no easy task, even with the Government.
If more people would report this type of harmful activity and execs were locked up, then patient safety would be forced into a higher priority at pharma comapnies.
sick of the garbage
I commmend this guy for what he did. He is right, we all know we have seen crooked practices no matter how long you have been in pharma.
Good luck to him and his family.
Rep
Batman-
You’re angry…I get it. It must difficult to go through life with your level of reasoning and communication skills.
I am very familiar with the FCA and get trained on it twice a year. That said, following your logic, I cannot be part if the problem since I did not “invent” fraud. The reality is that Jeremy was involved in fraud but chose to get an even larger payday through the qui tam vehicle.
Rep
Doc-
I appreciate your position. If you would like to travel down the corporate corruption road of greed, let’s take it to another level.
It’s no secret that government pays a substantial portion of drug costs (I forget the exact number but it’s around 30-60% of sales for many companies). Do you see where I’m going?
Many, if not most, Qui Tam lawsuits have lilttle to do with “endangering lives” so much as costing he government large sums of money for off label uses that have yet to be approved BUT may be nonetheless EFFECTIVE. In my opinion, government’s role should be to determine safety (continually monitored) and initial efficacy, then, let the medical provider determine how a drug should be used thus taking some level of responsibility if they choose.
And while I realize that taking on big pharma in court is difficult, the risk entails the potential for a giant payoff. According to the 15% cited above, Jeremy walked with about $2 million. Not bad. It’s harder to win the lottery.
I think many get off base by focussing on the bad apples and assume the entire bushel is rotten. Again, poor logic. The vast majority of pharma employees try to do the right thing and the vast majority of execs try to have their company run in an ethical manner. Yes, some should be locked up…and some doctors should have their licenses yanked, and there are corrupt politicians, judges, policeman, etc. I have yet to see utopia.
Batman
Rep,
I am not angry, but rather totally disgusted with mental midgets like you. You claim to know everything yet you did not even know the basic percentages involved in the FCA. Don’t be an angry little witch because I called you out on your own ignorance in Your post. There is absolutely nothing in your post resembling apologetic feelings toward breaking the law. It is my word that you define the problem. Just because everyone does it does not make it ok. Those with death from excessive doses of Vioxx that Merck reps said was great efficacy and that the drug was safe despite obvious data showing it was just the opposite is classic pharma. People die as a result of off-label. They either get poisoned or are kept off of medicines that are PROVEN to work. Go to your dictionary and look up that word. Also, see if you can find what a double blind crossover trial means too. I know you know what a dummy is as you define it. That is placebo and that is the empty set between your ears. Sit and spin.
Rep
Batman-
It appears as though your emotion overwhelms rational thought. Nowhere in my posts did I claim to know everything as you suggested. Besides, whistleblower fees are not part published in the FCA and I claimed I “forgot”. If you want to score a win for that, so be it.
I did not apologize for breaking the law because I have not given one suggestion that I have broken the law. Jeremy did break the law and cashed in, similar to a crack dealer cutting a deal with the authorities. It appears that you are making an assumption based on guilt by association - another logical fallacy.
I am acutely aware of the Vioxx controversy and your issues are confused. The people who died taking Vioxx did not result from off label promotion so much as the safety e.g. Elevated BP. And by the way, people die from ” labeled” drug use, and people die from cancer, heart attacks, infections, suicide etc. Your point is what?
“Proven”, if I’m not mistaken any drug approved by the FDA has “proven” information. Or do you have a different perspective?
Rep
Batman
As an afterthought, I also wanted to address your comment on “placebo”, again, a topic with with which you know little about. In drug research, the placebo effect accounts for 10-70% of a given drugs efficacy. In order to spell it out for you, “placebo” can be a very effective treatment. Next time genius, try a different metaphor…rookie!
I dunno
This column belongs to Batman and Rep. All other inputs should be disregarded. (Joking but feel that way)
Justice in MI
OK. I’ll try. This assertion needs documentation: “Many, if not most, Qui Tam lawsuits have lilttle to do with “endangering lives” so much as costing he government large sums of money.”
While the suits are about bilking and fraud, the DOJ virtually always accuses the offending company with endangering pts. The Kaiser/Pfizer lawsuit (not qui tam, but same essential logic) was able to demonstrate that docs made rx’ing decisions based on company misinformation. While they did not pull up the corpses–they weren’t asked to–it would be extraordinary, indeed, if people were not injured or killed either as a result of not receiving genuinely effective treatment (as opposed to a “witches’ brew” of BS).
Batman
Rep,
You really should not speak as you just show more ignorance. Vioxx at 25 mg per day dose which Merckettes promoted as “safe” and “super effective” and “cardio protective” actually did the opposite. In fact, moron, Merck was tagged for misasigning deaths in one trial to cause of death unknown and unrelated to keep the “p value” from going over naproxen. Check your own journals…sweetie. You really are just a talking soupcan. Do they pull a string on you and all you can say is what you were told ata rah rah sales meeting? Ever actually read anything? Go look at the Cleveland Clinic and how Merck tried to intimidate and silence (they called it “neutralize” influential cardiologists who wanted to spread the word that Vioxx was unsafe for those with any cariovascular issue beyond 12.5 mg a day. You really are silly now.
Back to sorority row with you.
Go now….
I am way more intelligent drunk than you are totally sober. That is so very sad.
Rep
MI Justice-
Magnesium sulfate and betamethasone are commonly used off label for premature delivery, Tegretol for mood stabilization, SSRI’s for premature ejaculation, etc…up to 20% of all drugs are used off label and that rises to almost a third in psychiatry. If you get cancer, there’s a good chance (50%) that you will be given at least one drug off label.
The point is, just because the DOJ sues the manufacturer does not mean the drugs are not effective…it just means there is a perceived violation of marketing according to the FDAC.
You could likely assume there may have been injury in the Neurontin case but as i have said before, there may have been injury taking other treatments or not taking any treatment. The bottom line is that taking drugs involve some level of
risk just as not taking drugs involve risk. If patients have concerns, they should take it up with their medical providers.
Rep
Sorry Batman -
You can’t bully me. While your 4:33 post is mostly accurate, Merck’s claim was within labeling at the time (e.g. 25mg dose safe/effective) and was my point. Vioxx was not a labeling issue…Vioxx was a safety issue (incidentally, Bextra was both a safety and labeling issue).
In my opinion, Merck is completely guilty for everything else you claim. I read the clinical research and I heard the reps, so you can kiss my ass with your attempts at belittlement.
doc
Rep,
If you read the settlement, Mr. Garrity received significantly less than $2 million, plus attorneys usually take ~ 40% and the net is fully taxable in a settlement of this type.
Patient well being may be a secondary issue to the Government, but there are probably more government employees in the FDA and DOJ that care about patients than pharma execs and sales people.
You are correct that the average pharma company sells about 40-60% of it’s product to the government in one venue or another. Therefore, as a taxpayer, I am not happy with pharma’s off-label promotion that is taking tax money out of my pocket.
Pharma has some noble employees, no question, but those that make many decisions at higher levels put profit above everything else.
Rep
Wow doc, did you see the numbers for the other guys? I stand corrected…Mr Garrity didn’t make squat ($750k) compared to the other three…two guys made $2.2-2.5 million and one made $20 million.
We can agree to disagree on government drug expenditures. I pay taxes as well and see it differently.
Pharma Guy
OK, I’ve read all the posts. Rep has the more persuasive argument and communicates better than Batman!
Rep
One last loose end to tie up then I am done. For those of you who believe there is altruism with people like Jeremy Garrity, that they care about patients, their families, etc. and then bring about qui tam lawsuits out of some sort of benevolence…please rethink your position.
Research reported in Business Ethics magazine and published in the Journal of Finance looked at what incentives might influence fraud revelations. The study indicated that whistleblowers in fraud cases, often involving healthcare, on average collected almost $47 million.
Follow the money. Yes, corporate pharma greed exists, however, it is becoming marginalized as pharma has come to terms with the fact that is cheaper to report themselves than pay out qui tam lawsuits. Government greed also exists.
And in my opinion, personal greed exists and many pharma whistleblowers are good examples. Not everyone makes great money but the odds are in your favor compared to playing the lottery.
Doc
Rep,
You might want to read the paper on pharma whistleblowers that was published in the NEJM, May 13, 2010 issue by Kesselheim et al at Harvard Medical School.
pharmavet
I am tired of posting as Batman.
Listen up punk. I called them Merckettes. I called them sorority chicks, I called them gel heads. Regardless, they didn’t pay me any attention. Not when I did field rides with them, not when I sat in my cube.
Fire all the donut eating reps! ARRRRRRRRGGGGGGGGHHHHHH!
Joseph
Alot of credit and praise is being heaped ona guy who brought the suit only after being fired and his hand was no longer in the til. While I agree he did the right thing I would have more respect if he had done it earlier and when he had something on the line.
harpy
Oh Rep - you sound so smooth and rational. I bet you’re really good at your job. but if the the drugs are effective, as you say, then why don’t the companies run clinical trials and apply to FDA for new indications? it would really bolster your argument that pharmaceutical companies care for the patients. (oh, wait, you never said that, did you?) or simply submit to certain drugs being used off-label by medical professionals (which, as we know, is perfectly fine) without marketing them for off-label purposes? why is it so hard to stay within the confines of the law when these companies are making money hand over fist? surely your average $400-800 million fine for off-label sales violations could cover the cost of a legitimate clinical trial if the drug could truly be proven to be effective, right? they can prove the drugs work, can’t they?
Rep
Harpy-
I’m kind of with you on that and agree there should be more robust research. But then again, there is a finite amount of money to be spent on research and a limited time to do it before a patent expires. It’s not a perfect world. Then again, clinical trials are not perfect either…sometimes the wrong measurement tool is used or there is an abnormal placebo effect and a trial fails, when the drug is known to be effective. And I’m sure you have familiarity with the FDA…usually a 12-18 month delay from the sNDA filing.
Justice in MI
I am not against docs rx’ing off-label. I’m against fraud.
Rep
MI justice
Hypothetically, if I were to sell a drug off label to a doctor, I potentially have committed fraud. If that same doctor took my information, wrote off label, and the patient went south, that doctor may be potentially negligent. The only thing separating the two legally is “intent”. I would rather do my homework.
Batman
YOUR LAST COMMENT SAYS IT ALL. AS YO YOUR COMMENT THAT 25 MG WAS WITHIN LABEL FOR VIOXX…IT WAS STUDIED IN PATIENTS WITHOUT CV ISSUES AND MERCKS OWN MEDICAL PEOPLE ADVISED OF THE ISSUE OF USING OVER 12.5 MG VIOXX IN A REGULAR CV POPULATION BEFORE LAUNCH BUT MARKETING TOOK OVER AND MEDICAL IN MERCK LOST. PEOPLE DIED AS A RESULT. TO REPS LIKE YOU THAT SEEMS TO NOT MATTER. ONE OF THEM WAS MY FRIEND AND HE DIED. MI AND YES I BLAME PEOPLE LIKE YOU. I ALSO THINK THE STUDIES NEED TO REPRESENT THE POPULATION YOU PROMOTE YOUR DRUG FOR DAILY USE IN AS WELL!
MARKETING TAKES IT TO THE TOP AT THE EXPENSE OF PATIENTS AND REPS COLLECT BIG CHECKS AND FAT PAYCHECKS. I AM OVER THE ATTITUDE YOU PRESENT. YOU MAKE ESCUSES FOR ILLEGAL CONDUCT AND THEN PROFESS ITS THE DOCTORS FAULT WHEN YOU LEAVE HIM OR HER OFF-LABEL RX INFO ON A DRUG. YOU ARE SO WRONG. THE CHAIN STARTS WITH YOU REP. IT STARTS AND ENDS WITH YOU.
MAYBE YOU SHOULD GO BACK AND LOOK AT HOW MERCK CONCEALED INFO ON VIOXX BEFORE YOU SPEAK AGAIN. YOUR IGNORANCE IS SHOWING YET AGAIN. TRY READING A TRIAL TRANSCRIPT. I WONDER WHY THEY SETTLED IF THEY DID NOTHING WRONG TO THESE PATIENTS WHO DIED ON VIOXX. HMMMM.
BATMAN
industry insider
Batman, did your capslock key get stuck?
Rep
Batman-
Sorry to learn about the death of your friend. There is no need for me to read trial transcripts as it would only confirm what I already believed. As I said before, I AGREE WITH MOST OF WHAT YOU DESCRIBED ABOUT MERCK’S HANDLING OF VIOXX!!!
Whatever you believe to be true, the facts on Vioxx’s labeling: OA, RA, Pain, and Dysmenorrhea. It’s been some time since I read the clinical research and I don’t recall CV disease specifically excluded from the early OA and RA Vioxx trials, though I think I remember low dose aspirin being excluded which could have skewed the population. Come to think of it, there wasn’t any discrimation with race, age, gender, etc. Even still, the CV issues really didn’t get going until the Kaiser study in 2003-2004.
Point the finger where you want on whose to blame, I disagree with you.
Batman
Re caps lock. I was yelling. Whatever.
Former Pharma Marketing Director
Interesting posts…..
Doctors prescribing off label is fine, doctors talking to the medical department of a pharma to acquire information in order to make an informed decision to prescribe off label is also fine.
Creating marketing programs were people are rewarded with incentives to promote off label prescribing without the clinical data to support it is not fine.
Rep, you have done a good job of TRYING to blur the story and mislead everyone - so I conclude that you THINK you are a good rep…
This story was about incentives being paid to coerce doctors into prescribing drugs, that may not have been necessary for the patients.
Garrity isn’t a hero. The sad truth is that many people have to pay mortgages, send their children to school and put food on the table, so, like you, they do these stupid things and keep their mouths shut…But that doesn’t make it right. Not only did these programs cost lots of money, but now the fine is costing more..it is all a sad waste in the system, which we the consumer (we all eventually become consumers, even you REP) pay for ….
Everyone wants incentives, either for selling or for whistle-blowing…
The consumer who was ripped off, doesn’t get back any money. They took it out of the consumers pocket, gave it to NVS, who saved it for the inevitable fine, then paid the whistle-blowers (double dipping anyone, he got incentives for selling the program in the first place), and the government got the fine - but nobody makes restitution to the consumer, or the insurance provider who were ripped off. Not to mention if anyone of those patients were harmed. But, truth be told, not many of those patients who realize that they were on a drug that they shouldn’t have been on…
Crazy system….
Former BP MD
MDs are free to prescribe off-label as long as they are willing to accept the risk of doing so. Big Pharma companies cannot promote off-label as it is against the law. However, they frequently do so until they’re caught. Then they get to pay a measly fine, accept no responsibility and laugh all the way to the bank. Such is the state of modern reinforcement.
Reality
Most individuals who raise any questions regarding the ethics of promotion are ostracized and have their careers destroyed by the execs in pharma. They are crucified for trying to do the right thing. I’ve seen it happen so many times it makes me sick. Particularly when the top execs escape with millions and millions of dollars without being held accountable for their actions. Think Pharmacia. Think Schering-Plough. Let’s see, who was involved in both of these situations. You got it! Please prosecute these crooks!!!!
Rep
Tough group…I’ve been named a moron, pathetic,”talking soupcan” and now been accused of blurring a story and misleading everyone by a “pharma marketing guy”.
Still off topic a bit but I’ll respond…
Consumer restitution? A salesman convinces you to lease a BMW but unknown to you it’s really a Mercedes. You drive it for 18 months without any problems and you like the car. Authorities later tell you it was a Mercedes not a BMW…do you get 18 months of lease payments back? No, there was no harm and you had no issues. If by “consumer” you mean those (like myself) who inevitably pay higher costs because of the lawsuits…that’s a different matter that goes back to my earlier posts.
Former Pharma Marketing Director
Rep,
Go back to school, or go somewhere else and get a moral conscience - you clearly do not have one.
We are not talking about cars…
These drugs are not entirely inert….If you take something you are not supposed to take, you can cause harm…
Sorry to have to have to spell it out to you….
Rep
A rep convinces a physician to prescribe an antibiotic off label for an infection. Patient gets better. DOJ investigates, rep is thrown in jail, huge fines paid. Should the patient be paid restitution? No, there wasn’t any harm and there weren’t any other issues.
If you are saying that all drugs “harm”…there is a remedy for that…civil litigation. Go back and read my posts about the risks of taking drugs and STFU.
Holy Smokes…Now I see why Batman and others get frustrated.
Rep
Also, you know nothing of my moral conscience and I’m guessing there’s a good reason why you’re a “former” Pharma Marketing Director.
Batman
The former marketing director sounds entirely morally grounded unlike you. I feel sorry for you. The sad part is when someone is so unaware of how they sound or come across. Go to a priest and confeS your sins and seek redemption. You clearly live a shallow existence. When you make guinea pigs out of patients outside of label you are laughing at the authority of the FDA to regulate and PROTECT patients from predators like you. When an “antibiotic” is used off indication at the urging of a rep it can kill them. For instance, there was a quinolone launched and removed from the market because it was aggressively used in a child at the urging of a rep and it shut down the teens kidney. Guess that was justafiable in your world because you know more than the FDA. Without evidence based medicine and a real trial that is blinded and properly constructed you are playing God. You are vastly underqualified mental midget. You have no soul.
I normally reserve myself but to me you are exactly what I detest.
Hope you find help.
Rep
You read much more than I stated. I’m done.
whatever
Whistle blowing! It is a joke.. a sham. We can argue until cows and other animals come home. Dollars and cents are the force behind blowing the whistle, not right or wrong. Right and wrong are not that clear cut or defined; otherwise we would not keep commenting on this like this.
Former Pharma Marketing Director
Rep,
Doctors ultimately have to face the music. If you do not have appropriate evidence and the Doctor does what you suggest anyway, trust me the Doctor feels the heat also. I am amazed that you paint a picture of the Rep being the only one to face the music…
Former - because I chose to be. I am doing other things with my life that hopefully help others do the right thing. I think it is working so far…
@Whatever - Sure some people do it for the money. Most of the problems we have faced in the past few years have been greed related. But some do it for the right reasons…The challenge is to get more people to do it for the right reasons. People do need lots of money to come forward, they will never work again in their lives in the area of business were they have built their skills. Other companies may not hire them either, as far as other employers are concerned sometimes it is a matter of not wanting people to “think about what they are doing - just do what I say and we will be successful”….
That is what I was very happy to walk away from…
Rep
Marketing director
Again, please read my previous posts before you comment (oct 4, 12:34). Reps are not the only ones that face the music…docs are on the hook also (negligence). It just so happens that drug companies have deep pockets and make an easy target.
Btw…while you may think whistleblowers are blackballed, there are at least a few cases where they returned to industry (and one blew the whistle again in a different company and cashed in twice).
Batman
My advice to “Rep” is this. Please get help. You have no conscience indeed and totally justify your behavior.
Antibiotics were promoted to a physician in my area in a chikd in an unappproved treatment and guess what? The child (teen) died. Really great idea. Hope the rep got her commission on this effort. Maybe she should get a sales award for it too.
It would really look nice on the wall. Make guinea pigs out of patients for profit is just insane and obviates the FDA which is there to PROTECT patients from vultures like you.
Regulation is not all bad. It serves a purpose, unlike you.
BATMAN WINS
Rep
Batman
It’s a tragedy that a child died but I do not know the details of your example. However, you chose a keyword “aggressively” and that implies an extraordinary circumstance, especially since quinolones are generally avoided in children due to tendon rupture risk. I could only assume that drug was chosen because nothing else worked. Many infections are serious and kill. Unfortunately, the child died as a result of apparent treatment. I know this sounds cold, but would the patient have died without treatment?
From what I have seen, off label choices are made when all other conventional (approved) treatments have failed, not always the case…but usually the case.
Regardless of label or off label, it sounds like this drug had a safety issue and should have been removed.
Rep
Incidentally Batman, if the patient was treated for a superficial infection, I hope they sued the crap out of the doctor, rep, and drug company. (evidence of conscience).
REP WINS!
harpy
no, Rep, you don’t win. you make it sound like every case of off-label prescribing turns out super with roses and lollipops, but that isn’t the case. a half-assed, cursory look around the web (or even this website) would show you that many, many people have been hurt or killed by pahrmaceutical companies pushing their drugs off-label - even when they knew they were hurting people. I won’t comment on your morality, but I will tell you to be very careful what you’re selling and how you’re doing it. it seems to me you’re one who could end up on the wrong end of a DoJ investigation. keep a clear conscience.
Rep
You’re right, there’s no winning this debate. I’ll sumarize my positions on this topic, then I’m off this topic.
1. I’m skeptical of whisteblower motives. I believe they have more to do with money than altruism.
2. I’m skeptical of DOJ investigations and believe they too are money motivated. Of the billions of dollars collected thus far, in my opinion, little or none of the money has bolstered NIH funding for independent research compared to the DOJ hiring more lawyers and investigators.
3. If a pharma company withholds safety information from the public, they should be punished.
4. Taking drugs involves a RISK. Patients and doctors should be informed of the risk and make educated decisions based on research and the doctor’s clinical judgement of the risk/benefit. If a patient is uncomfortable, they should discus it with their doctor and/or walk.
5. Pharma companies marketing off label use is WRONG (and illegal). Notwithstanding, there is practical side to the issue other than greed (many times off label use is beneficial to the patient). I do not condone the practice, just pointing out the other side.
6. Unlike some of you, I tend to not communicate in absolutes by using words like “every”, “always”, and “never”. There is usually an exception and exceptions are just that…not the rule.
Former Pharma Marketing Director
Rep:
To you point 1.) I too do not believe that all Whistleblowers are being altruistic….Money and the hope and chance of rewards seems to help certain people develop a conscience - who cares? The point is that the harm is being exposed and hopefully fixed.
Your point 3.) - we agree
Your point 4.) There is a problem, unfortunately the marketing efforts have severely interfered with many doctors, not “all” doctors, from providing their patents with all the known risks. This, as was pointed out in the other article, the interview, has eroded the all important “trust” element. Once trust is gone, what makes a physician and indeed the entire industry any different from snake sellers from days of yore? Not much…Yes, everyone who takes drugs better do their homework and figure out what they are taking and why, and they better be prepared to negotiate and walk away. The problem is that very often the patient is not well enough to do this and is supposed to rely on the health care professionals to do the “right thing”. That is what has been undermined….
Your Point 5.) correct, pharma should not market off label. We all agree on the practical side. It is up to the doctor to pursue and investigate from their own initiative. If a doctor hears of a novel off-label use of a drug in a particular case, with obvious good outcomes, from a well respected colleague then of course they should pursue it. We’ve done a great disservice by taking this and trying to make it occur on a regular basis. Marketing programs have grossly interfered with the natural development of knowledge that is meaningful and important.
There has been in many cases, not all cases, were there has been more of an emphasis placed on short returns without much thought to long term effects.
Invariably, the industry is hurting themselves….The rise of folk medicine is not just a coincidence. People are starting to think they could probably do a better job then their doctors can….
Do not make fun of people by saying it is the patients own folly; we have undermined their trust and we are responsible for that. We are responsible and accountable for our own actions.
Wherever you go, there you are! It is not someone else’s job, it is all our jobs…
Batman
The law is the law. There is no “exception” to engaging in unlawful promotion of a drug outside of the FDA approved labeling or things in the Compendia.
Nice spin effort, REP.
Back to the sorority house you go.
Kim Il Sung
As we have learned here in the Blessed Land, incorrect beliefs and dissent are always a symptom of flawed character and underlying criminal intent.
It is inspiring to see that even in America, there are some who understand this.
Observer
Interesting discussion? Can’t help but notice time stamps. Do any of you have jobs?
industry insider
Observer, haven’t you heard about the job title of Professional Bloviator? Stick around these boards and you will learn.
Observer
Sorry, I’m new.
Ethical Monitor
Dear Rep:
I applaud you for finding a way to bring into the light an unethical situation.
I wish there was a way that clinical research monitors (CRAs) could whistleblow. As a person with over 22-years of monitoring clinical research trials, I have not yet found the way to bring how badly clinical research trials are conducted and how little oversight there is for human subject protection. I have even had a large pharmaceutical company try to raid my house for my monitoring files in 2004. It frightened my neighbors and it frightened my family because they were afraid I would be harmed by big pharma other than just getting fired. This was wrong and nobody would help - not even an attorney or the FDA.
Yes, I was recently fired AGAIN for trying to do my job as a Senior Regional CRA according to the intent of the regulations. I have sought help from the FDA, my state senator, and attorneys. Nobody will help. I have seen subjects hurt, data misrepresented, and a lack of adequate oversight of active clinical research trials. Nobody cares. The only time people care is when a drug gets to market based on poorly run clinical trials and people start dying or are permanently impaired. Then the class-action suits start. Much of this could have been avoided if the truth about a products benefit to risk was provided from adequately and ethically conducted clinical research trials. Allowing study monitors to do their jobs according to the “intent” of the regulations would be great way to help ensure adequate oversight of clinical research and the integrity of the data and safety of study subjects.
CRAs should not be Public Relations experts, system trainers, or involved with marketing, as expected by our Pharmaceutical employers. We travel 75% overnight work 70 hour work weeks. Study Monitors or CRAs are expected to meet efficiency rating metrics that are nearly impossible. Why - because unlike Sales Representatives, Study Monitors are not wanted by our employers we are just an expense required by the federal government in the process to get a drug to market. Approximately ten years ago the clinical research industry decided to make study monitors responsible for everything and started labeling us as “Total Site Managers”. We are strapped with tasks that could be and should be done by the in-house staff. We spend more time on PR and training that ensuring the welfare of study subjects and the integrity of data and has gone by the wayside. The purpose of a study monitors job according to federal regulations is to “evaluate” whether quality clinical research is being done not to “ensure” or help “clean-up” misconduct or to make each site conducting a study “audit ready”. We should be able to report misconduct to both the FDA and our employers without being ignored or fired. Ethical Monitors or CRAs like myself are never promoted and are punished for doing our jobs according to CFR Title 21; Part 312 and 314.
The bottom-line, the current CFR regarding the oversight of active clinical research trials gives the Fox the full right to quard the Hen House. It needs to change. Routine oversight/monitoring of active clinical studies at research sites needs to be done through independent agencies that do not get paid directly by the pharmaceutical companies. Study Monitors need to be given more power to have our observations made during monitoring visits addressed. I am not politically sauve and but those with the ability to make regulatory changes just ignore me.
I wish I could find a way to make a difference in an issue that is wrong and continues to worsen by the day. I hope you are successful.
I also understand your dilemma about being stuck with finding employment or a role that fits with your ethics, your talents, and your experience. I am too looking for my niche or place in the world and I am quite confused even though I am very close to retirement. I do not expect an employer to be 100% perfect (unlike what my last employer expected of me) but it would be great to find one that really walks the walk of their altruistic talk.
Batman, even though I am the one that is again unemployed, I feel really sorry for you. You are an example of what is wrong with the work ethic in the pharmaceutical industry. They tout missions statements about helping cure disease to present an image of being saviours and heros to the world. It is telling that you gave yourself the moniker of someone who is thought of as an imaginary hero. All I can say is that your admonishment of people who want to improve the world by speaking the truth to resolve problems and living a moral life is incongruent with how you have labeled yourself.
sparrowbell
Came late to this interesting discussion. Former NVS employee, not sales rep. If the drug was approved, the safety info is well-scrutinized within the clinical data collected. If you talk about a side effect that happens one in million while the clinical trial consists typically a couple to tens of thousand, you can’t really blame that on pharma. Drug is approved based on probability. Response rate is never 100% and AE is never 0%. It would be hard to believe they would push very hard into the off-label use if none of the KOLs buy into the ideas.
How the marketing style is carried out at the regional area, is a bit off global team (the team that manages the product at NVS)’s control. I think pharma just have to adopt more *quantitative* approach when advocating for off-label use. A lot of info probably could be teased out from the clinical data even though it is not primarily studied for that.
Btw, I’m skeptical of the whistle-blower, why was fired in the first place? Can’t imagine too many truly altruistic people would be a sales rep for any kind …