The FDA Criteria For Going After Pharma Executives
21 CommentsBy Ed Silverman // February 8th, 2011 // 8:08 am
Nearly a year ago, the FDA wrote US Senator Chuck Grassley that criteria had been developed to determine which cases should be selected for prosecuting individual executives (read the letter). The move came after growing criticism that drugmakers paid huge fines to settle allegations of fraud, but higher ups were never held responsible and the payouts were seen as a cost of doing business.
Since then, FDA deputy chief for litigation Eric Blumberg gave a speech reiterating agency interest in targeting pharma execs (back story). These moves also come as the Health and Human Services Office of Inspector General pushes for measures to make it possible to ban pharma execs from doing business with federal health programs, if their companies have been convicted of fraud.
The FDA plan, though, has been to use the Park doctrine, which says a corporate official can be convicted of a misdemeanor based solely on his or her position of responsibility and ability to prevent underlying violations of the Food, Drug & Cosmetic Act. The doctrine also stipulates there is no requirement that an exec acted personally in any wrongdoing, or had knowledge of the wrongdoing.
But the FDA never released the criteria - until late last month. So what are the factors to consider? Whether the violation involves actual or potential harm to the public; whether the violation is obvious; whether the violation reflects a pattern of illegal behavior and/or failure to heed prior warnings; whether the violation is widespread and/or serious; the quality of legal and factual support for the proposed prosecution; and whether the proposed prosecution is a prudent use of FDA resources.
To what extent these will be deemed helpful to those trying to avoid trouble is unclear. As the FDA explains, the criteria “do not create or confer any rights or benefits for or on any person, and do not operate to bind FDA. Further, the absence of some factors does not mean that a referral is inappropriate where other factors are evidence” (here is the Regulatory Procedures Manual).
In other words, there is wiggle room, especially since these are not binding. Or as the FDA Law blog carps, the criteria are not really criteria at all. In fact, these are not so different from the sort of litmus test used to assess most any violation. As a result, pharma execs and their lawyers may be gnashing their teeth. Perhaps the agency will one day fine tune its criteria, or not. Meanwhile, of course, it is up to prosecutors to prosecute. But maybe the open-ended nature of this list is deliberate - leave them guessing, as they say.
Justice in MI
I’m guessing that Ed’s last speculation makes sense. The criteria pretty much have to be vague, keeping in mind the various factors Ed lists as well as the extent to which any prosecution is likely to have a deterrent impact more broadly. We are certainly not going to see much of it, so the choice of any particular case will be “surgical.”
Elmore
So Pfizer pays a couple billion in fines for illegal marketing–after the guys at the top collected their bonuses for the increased sales generated–and then, when it came time to please Wall Street, a couple billion dollars worth of scientists, researchers, and R&D facilities got the heave ho.
There is nothing that will stop this kind of practice from continuing except marching off execs in hand cuffs–and making them return a portion of their bonuses as part of the fine.
Civil Justice Law Blog
Thanks for the update. While civil liability is the main tool available for holding pharma companies accountable for product safety issues and fraud, it’s unfortunately not always enough. On this (criminal) front however, we see advantages and disadvantages to vagueness of the “criteria”: on the one hand, allowing the feds to use their discretion in deciding whom to prosecute affords them flexibility to exercise their best judgment. On the other, any time you have too much discretion in law enforcement, questions will arise about the fairness and predictability of punishment…
Pharma Critic
Unfortunately, there are so many of these greed-driven executive snakes that have slithered under their rocks over the past 10 years that bringing them all to justice would decimate the ranks of pharmaceutical executives. There is so much dirt, the industry is impossible to clean. Many of them have done the same unethical things at multiple companies. I will applaud the day when they are held accountable, tried and convicted, suffering personal fines and jail. Sadly, it will likely be way too late for the thousands that have been wrongfully terminated, fired, ostracized and humiliated because they dared to stand up for the right thing and question fraudulent immoral behavior.
harpy
There is nothing that will stop this kind of practice from continuing except marching off execs in hand cuffs–and making them return a portion of their bonuses as part of the fine
that and not having any patented products…
Insider
Mentioning unethical things at multiple companies. I know regional directors that went through training by the compliance department, signed documents that they would not do this any longer, and then on the next drug launch went ahead and trained the reps to do the same illegal activity that the RD signed he would no longer allow. Of course the compliance officers have no power as the executive directors can over rule the compliance officers even when they recommend termination. WHen a company is right in the middle of these illegal activities, harassing all their reps for doing what they were trained to do would be the time for the government to act, not five or more years later after the company had dismissed most of the employees and moved their managers. Reps repeatedly see wrong doing and are powerless. Kind of like what Kindler with Pfizer did with Bextra and Lyrica.
Ethical Monitor
“Walking the talk” of the ethics demonstrated in corporate SOPs - developed to be in compliance with regulatory and ethical standards is the key. Those SOPs are just there for demonstrative purposes to show the FDA corporate ethics and regulatory compliance. At the work level the SOPs are not followed. Executives need to follow the morality they give in their sermons. Most of the executives don’t have a clue what the reality with both the research and the marketing of drugs. Basically, they are absent and therefore removed from the corrupt and unethical situations that occur daily. It is the people that report to them that are also not telling the truth.
The right thinking is that people need treatments for their afflictions and the pharmaceutical industry spends billions on promoting the benefits of their products and under promoting the risks associated with the product. So the idea is not to keep drugs from getting to market but to have an honest understanding of the harm that can be caused by using a drug. Consumers and healthcare professionals should have a right to honest information so they can make “uninfluenced” choices for themselves about the merits of a product. As it is all the risks and costs of taking a prescription drug have been displaced onto the patients and the Pharma Executives just reap all of the rewards. I remember learning about that many years ago in a dilemma called the “Tragedy of the Commons”. It is about the displacement of unwanted consequences onto other people.
It does not appear that financial penalties have any effect on changing the pharmaceutical industry. PhRMA will make sure of that with all the lobbyists and threats of job losses. Perhaps, the humiliation associated with doing jail time will be more effective when executives cannot just use their “I didn’t know” mantra anymore. It is their responsibility to get involved and know what is going on at the bottom level of the people who actually do the work not just make decisions. They need to roll-up their sleeves and help get the work done to ensure oversight of ethical corporate conduct. Not having done that, perhaps exchanging locked cufflinks for the gold shirt cufflinks will get the message to them. Better yet perhaps those executives need to take their bad drugs that get to market and experience the serious adversities like cardiac arrhythmia or muscle wasting. Pharmaceutical company executives need to stop displacing the harm they cause by their lack of involvement or unwillingness to do what is right unto patients and hardworking employees.
I was working up to 14 hour days at GSK before getting fired. Andrew Witty would not be able to do my job as a low level peon Study Monitor/ CRA. He didn’t care about the fraud that I was being told to ignore or the mistreatment the Director of the Clinical Research Division gave to me because she did not like me. He did not care that my Managers were encouraging people at the clinics to scream at me. He did not care that I took weekly 3 hour lectures from my Manager about what a worthless and valueless employee I was at GSK. I would have liked Andrew Witty or even the Director of Research to follow me around for just 1 week – I bet both would have been exhausted and would have given up. No rides in first class cabins or private jets – just cheap back-row middle seats next to the bathrooms on a plane is quite a different style of travel than what Andrew Witty is used to. Times that by 5 flights, 3 budget hotel rooms, and 3 budget rental cars a week. From my view, I should be the one traveling in high class and Andrew Witty should be stuck in a middle back-row seat next to the smelly overflowing bathroom. I bet I worked much harder than he does for GSK.
This may seem naive to you but how do people make it to the top anyway - by ignoring unethical stuff? Do their sumptuously furnished bedrooms allow them to sleep at night? Is it simply that they are more concerned about self-promotion than really helping other people? Are they really smart? I am serious, I don’t understand? I am old, alone, and I am really tired of being poor and having no control over how I do my job. So I am currently unemployed and I cannot get myself to look for work because the same old stuff has been around for 2 decades and the issues are getting worse. This includes the lack of adequate monitoring of investigational sites by corporate sponsors. I am angry, hurt, and very disappointed in both the world and myself. More mad at myself because I don’t know how to effectively initiate changes. There seems to be no justice for some of us who have tried to make it in the Pharma industry. But seeing a picture of someone like Andrew Witty or the Director of Clinical Research at GSK, in handcuffs and in jail would help. Unfortunately, I doubt if it would make any changes because PhRMA would bail them out.
Insider
I think the people reporting to the executives do tell the truth. It is the executives that decide to cover it up rather than do the right thing for the American people. Some of these organizations are like being in the military. Direction comes from the top down that is why the reps feel so safe in going off-label and the managers so safe because they are doing what they are told. No ethics or morality, I would agree but the executives know what is going on. THe compliance officers are talking directly to them and being snubbed if they try to do the right thing.
industry insider
EM is correct. I had a boss early on who said “I wrote the SOP’s, but if I had to follow every one to the letter, I’d never get any work done”.
Case closed.
Kim
The fundamental problem with biopharmaceutical marketing is that it doesn’t work particularly well anymore. That’s largely because so much of the power over a prescribing decision has moved out of the control of the physician and now rests in the hands of third-party payers. Since the sales and marketing executives in question are generally only responsible for promotion to providers, they continue to “up the ante” when traditional tools don’t work, and this results in is some of the excesses we see reported in the press. This problem won’t really be solved until the industry recognizes that its world has changed irrevocably and begins to adjust its sales and marketing strategy to reflect the new reality.
Insider
Kim, you are absolutely correct. If it is not approved by the HMO or PBM then you are not going to see much even if it is a greeat drug. So much of the business is out of the control of the representative because the physcian can’t prescribe it anyway. If the product is on the formulary, it needs to be on most of the formularies or you will still run into problems. Anyway, Kim, you are correct, the process does not work very well and there is tremendous pressure on reps to get it to work anyway they can. This usually involves using money to make your numbers. You need big changes fast generally.
Former SP
All they need to do is go into every major company in America and start investigating, Thye have to have tips on all of them. At my former company, top execs were well aware of what was going on. They gave orders behind closed doors in meetings without minutes, threatened to destroy anyone who ever pointed the finger at them, and terminated anyone who dared to ask questions or mention compliance and regulations. They tried to preserve denaibility, but ask a few questions of their reports under oath and the truth will come out.
BMS Veteran
I had the same experience at my former company. Threats by top executives behind closed doors were commonplace. I want you to do this regardless of what your ethics tell you. And if you get caught, it’s your fault. I’ll deny, deny, deny and ruin your career if you ever cross me. You’ll have no proof because nothing is written and you’ll never work in pharma again. I’ll black-ball you. Many of the top execs are nothing but schoolyard bullies in suits who rule by intimidation. So many careers ruined. Good people who stood up for the right thing. The state of the pharmaceutical industry is disgraceful!
Beth
All of your comments are very cerebral and well said. Some of it I get. However, as a grandmother who just lost her son-in-law due to Cymbalta and Abilify I have done some research. Perhaps not exactly on track with the article but it provoked me to write and say I cannot understand why there isn’t a public outcry about all the over-prescribing and lack of real healing. Most med school trained doctors (back by pharma) want to prescribe pills and not get to the real cause of the complaint. I digress, my son-in-law went to his family med dr. because of a back ache four years ago. He is now dead and I can’t go into details because of litigation but read between the lines and get educated on the dangers of anti-depressants. What I am told is the pharmaceutical companies aren’t liable for these poisons and what they are doing to our country. Most school shooters were on anti-depressants. Most mass shooting were done by people on psychotic drugs. Congress’ biggest lobbyist is not oil but pharma. FDA is a joke. Many on the board of FDA came from pharma. Go to YouTube and see doctors, ex-pharma reps, patients, etc and see what is happening. There all corrupt and I believe the FDA is ineffective. How can a “black box warning” absolve Eli Lilly and other corrupt companies from the mayhem and murders conducted while people are high on these “legal” psychotropics? When will people wake up. Many doctors are not doing you a favor. It is all about the money. I resent all the marketing on TV, internet and magazines. Take a pill for this, take a pill for that, for life. Stay away from these poisons. The best way to stay alive is to not take most prescriptions. Anything that has two or more side effects many times worse than the ailment I am out.
Ethical Monitor
Hello Beth
I am writing to you as someone who has been hurt by Cymbalta and as someone who has been hurt by the pharmaceutical industry as an employee. I apologize for your Son-In-Law. I have been a peon in the drug industry for 25-years. I can say that during that time I have gotten fired from many of those jobs because I could not ignore the dishonesty and fraud. So I am again poor and about to lose my house even though I have worked very hard over the years to try and help get products to market that really help people. Your points are right-on and even though some try to sound so profound and “cerebral” I believe the issues are not as confusing as some who are into “marketing” would have us believe.
Physicians have become people who “practice medicine”. Remember Granny on the Beverley Hillbillies? She practiced medicine - her drug of choice was her rheumatize medicine. We all knew what it actually was- homebrewed hooch. She said it would cure anything. At least Granny’s potion would not kill you and would make you feel just fine for a while. Yet it just became another form of substance abuse. The sad part is the entire health care industry has created this mentality of acceptable substance abuse. It keeps people using and buying the product.
My point is that many therapies were based on alcohol. Some were based on manmade concoctions that would kill and the claims about cures were false. Look at Listerine. It was mostly alcohol and even sold for a while as both a cure for gonorrhea and a floor cleaner. Its advertisements were false. So, the agency that we know today as the FDA was put in place to prevent the “false advertisement” associated with ineffective and lethal concoctions promoted by Snake Oil peddlers that we know today as pharmaceutical companies. Unfortunately, the mentality of the Pharmaceutical Industry has not changed from that of the Snake Oil peddler except they have become very rich and very powerful. The FDA has been very ineffective at standing up to the money and power and has not protected patients or ethical research workers in the pharmaceutical industry. I have tried to report documented fraud and research misconduct to the FDA only to have them dismiss the claim. Reporting anything to the FDA has the same effect as spitting into the wind. Along with the acceptable abuse of substances, we have become accustomed to expecting “miracle cures” or instantaneous relief.
And what about those so called “happy drugs” like Cymbalta and Abilify. First, those drugs are only researched for short-term use. Not for a lifetime for people who get labeled as chronically depressed. (And just for the record, antidepressants cause chronic depression). Secondly, those drugs were developed with the assumption that everyone has a healthy neurotransmitter system. I myself cannot take any antidepressant because they cause more physical problems than being depressed including severe joint and muscle spasms. After 30 years of trying every antidepressant it was discovered that I do not have a normal neurotransmitter system and I don’t make Serotonin or GABA, etc. I had to make the doctors look into this problem myself and testing verified that I was right. So I have what doctor’s call treatment failure depression because they don’t want to spend the time exploring other therapeutic options besides drugs. Lastly, there is another huge issue with drugs like Cymbalta (especially Cymbalta) called serotonin depletion or another one called serotonin syndrome. This problem is well documented yet researchers and the drug manufacturers and doctors dismiss the complaints of their patients with symptoms of serotonin depletion caused by antidepressants. When a patient finally has had enough of the physical pain caused by taking Cymbalta and titrates properly off the medication then the real fun starts. The depression rebounds triple fold from the pre-treatment depression level. The depression is then so intolerable that most people go back on a drug, or multidrug therapies, or commits suicide. Then the patient is stuck on a lifetime of antidepressant use and physical pain. This has now added to their problems with the new label of chronic depression and the person in essence has also become a substance abuser. If patients can stick out the havoc caused by the severe depression rebound and social isolation and stigma, it takes years for the person to get back to their original baseline level of depression. But the social isolation and stigma will stay forever. It takes support that society is not willing to give - they simply want the person to go back on the antidepressant. Meanwhile the person’s life is ruined and they get labeled as a mentally unstable person.
So with just antidepressants or the entire class of mood-altering CNS medications, the FDA needs to be looking into and demanding that pharmaceutical companies research the effects of the long-term use of their products and the associated problems like serotonin depletion or serotonin syndrome. The blogs written by patients on these medications are full of complaints about the adverse effects of antidepressants. Yet these complaints are dismissed because the people are labeled as mentally unstable and unreliable. Do you think the FDA gives these blogs any merit – of course not. Also, pharmaceutical companies that produce these drugs should develop and foot the costs of long-term inpatient and outpatient treatment programs for people going off antidepressants and suffering through severe depression rebound. But it is easier for the world to ignore all of these problems caused by just one class of drugs. In my opinion as someone who has been involved with the research of drugs and taken them - these products are creating more illnesses than they are treating. This is especially true for mood altering products.
The best cure would be for society to accept people for what they are not what society wants as 100% perky, positive attitude, rose- colored eyeglass wearing individuals. Some of us just are not but that should not make us less valuable or stigmatized as mentally inferior- but it has. To get the acceptance from others and stability in life that everyone deserves, we try to make instantaneous changes through just taking another pill. You are absolutely right -stay off those pills. For me diet and exercise work just as well along with allowing myself to have a full range of emotions including sadness. Pharmaceutical companies and especially physicians should be genuinely caring for their patients rather than quickly and thoughtlessly prescribing another pill. Prescribing another pill to counter the adverse effects of another is ridiculous. Substance abuse is so rampant because of this mentality. In reality the big cure would be a care pill called altruism and the ability to put people before profit.
Don’t let the level of “cerebral” or profoundness of some of these comments seem beyond your comprehension. Some of the responses are written to be either brief or creative more than informative. Some think they are being funny. But the big benefit is that people like you are able to tell the truth learned from the awful reality. From what I read in your comments you very clearly have a great understanding of the problems. I know this will not bring back your son-in-law, but I am really truly sorry. I hope you will find a small measure of justice in the outcome of the legal proceedings – which I am sure are also delightful.
Jeremy
This sounds a lot like China’s doctrine.
AnnePME
So, I was just reading about health insurance high risk pools.
Couldn’t FDA/DOJ nudge a few insurers to start a type of ‘high risk’ D&O insurance pool for pharma (and a few other) corporate wrongdoers?
I can give them the name and contact information for the senior execs at my health insurer…they should be able to offer some tips on strategies used to get a high risk pool going and/or tips about how to get seemingly excessive and endless premium increases to pass actuarial muster and high enough so that certain senior executives and board members are uninsurable…this would be cheaper for the taxpayer and likely stockholders than jail time, especially if the exec or boardmember is forced to pick up some (or all) of the tab.
I would think that certain homeowner insurers might also be able to offer helpful hints on how to drop policyholders from a D & O insurance plan.
Also, maybe a few associations in Texas or FLA (or other states where the tax laws are favorable for these types of people) could change their bylaws so that execs and board members who are convicted of misdemeanor or a felony can be banned from certain clubs and or associations….but only after they pay their dues or give a hefty donation…I think that this worked pretty well for a few gated communities in FLA during the Tyco scandal.
Beth
Hello Ethical Monitor,
Thank you for confirming what I knew to be true but further substantiated by an “insider”. A couple of questions. With regard to your personal financial challenges, isn’t there a whistleblower law? I have read of some big settlements although I suspect proving such a crime is very difficult. Second question I suppose I already know the answer to. Why isn’t there a huge public upheaval? My guess is 1. apathy by those that know 2. corruption by those that know 3. lack of knowledge (such as myself) until one is snagged in this horrific web.
I keep thinking fighting the pharmaceutical companies is similar to fighting big tobacco. However, like big tobacco I believe someday there will be a turn around by the people when enough innocents are damaged.
Thank you again for your comments.
Weary skeptic
Interesting to read that the FDA “might” go after pharma execs and see that one or more is sent to jail. Why do they even have a litigation department if it is not to do just this? And why, then , has it done been done before now?
The FDA litigating is to me like the fox guarding the henhouse. The agency has looked the other way so many times that it has whiplash. When the public speaks out against the dangers of the drugs in FDA advisory committee hearings, they are limited to three minutes each with no cross-questioning. CDER officials roll their eyes or close them when members of the public, often speaking of family members killed by the drug in question, have their say. Too late do they learn that this agency, which once did something post thalidomide, has done little since.
Perhaps these “new criteria” for prosecuting executives are a public relations maneuver, done to quell complaints that nothing at all has been done. Another example of saber-rattling by a powerless agency.
Ethical Monitor
Hello Beth,
Maybe I can address some of your questions about why there is not a huge upheaval.
First it is not only apathy by those of us in the clinical research industry but fear of job loss. You report fraud and non-compliance to the FDA and you lose your job. I am again out of work (and unable to pay bills) because for me I take the tough road and report the fraud. The company I worked for GSK retaliated by firing me for reporting fraud to them about a high-prescribing, high-subject enrolling site (physician). It took them 10 months to find reasons and 4 warning letters for stuff, I did not do. I followed the correct chain of reporting within the company. The fraud was cleaned-up. Even reporting fraud and research misconduct to the FDA anonymously will get you fired. Also, reporting to the FDA is like spitting into the wind - they do nothing. To make matters worse, people in research who report fraud to the FDA will not be told the outcome. The FDA by their laws will not reveal this to the person reporting research fraud. I am in the process of reporting the fraud that got me fired to the FDA. It is taking all of my spirit to finish because I know the likely outcome will be the Investigator(s), the Big Pharma (GSK) and another research network called US Oncology will get away with whatever they want. Ultimately, it is a big waste of my time.
Also, you are correct there are some in the Pharmaceutical industry that get compensation through the ability to file Qui Tam lawsuits. According to an attorney I spoke with who has settled very large Qui Tam lawsuits, these can only be initiated when there has been fraud committed and an exchange of money (Like the State Medicare, Medicaid agencies or public money). The people that start these lawsuits are generally manufacturing inspectors and salespeople and they get a portion of the suit award for being the whistleblower. However, for folks like me in clinical research it is unclear how much public funding is used by the FDA to approve a drug for marketing. That is because the pharmaceutical companies pay the FDA what is called a Prescription Drug Users Fee (PDUFA) for getting their drug reviewed by the FDA in exchange for a speedy review and approval. The ultimate result is that as a study monitor, I do not have the same ability to start a Qui Tam suit like a manufacturing inspector or a salesperson because it would be difficult to determine how much public funding was used to get a drug approved through the FDA.
The other result is that drugs are getting to market that are really poorly researched and in great haste (despite what the data from PhRMA shows). Big Pharma has claimed the FDA has slowed down innovation and caused delays in getting needed drugs to the market place. In reality more and more bad drugs are getting to the market place because of speedy reviews. Courageous reviewers at the FDA who question a drug and slow down the market approval stand a really big chance of losing their jobs too. So, more and more FDA Reviewers are in bed with Big Pharma rather than doing their job of protecting patients from bad drugs or incorrectly labeled products.
Bottom line is the federal laws need to change especially when it comes to Study Monitors or what the industry calls CRAs. My job as a study monitor is to ensure that no patient involved in a clinical trial is harmed and that reported data is not fraudulent, inaccurate, or not precise. We work 70-hour work weeks and travel at least 75% overnight. The employers of Study Monitors are the Pharmaceutical Companies or an outsourced agency hired by the pharmaceutical company called a CRO. It is ludicrous that Pharmaceutical Companies have been given full power by the federal government (FDA) to be self-monitoring of their own clinical research trials. It is rather like the fox guarding the hen house. The FDA will not inspect or get involved with an on-going clinical study. They are supposed to get involved when a Study Monitor, like me, reports fraud and misconduct - but they very rarely do. When they do most likely the fraud and misconduct has been covered up and nothing happens. When Study Monitors try to report unwanted data trends that we see in clinical trials that cause safety concerns to the statisticians or Project Managers – we get ignored as being stupid and not medically competent to have a valid observation, or, we get fired. Then the safety data gets hidden or goes unreported to the FDA with the study results submitted for market approval.
The diabetes drug Avandia made by GSK is a good example. GSK had concerns about the cardiovascular risks of this drug from their early clinical trials. How did they get around this issue – easy they designed study protocols or clinical studies that would not collect any data potentially showing cardiovascular safety issues in their research trials? Now that Avandia is going through class-action suits and has harmed or killed many people due to cardiovascular risks, GSK, simply claims they were not aware of cardiovascular problems because it was not revealed in their clinical trials used for market approval. They are claiming ignorance and innocence.
So here are some suggestions from me. Do not take a drug that has only been on the market for 2 years (unless it will save your life). The risks to benefits are still being determined because clinical research trials only study a select group of patients that will yield them good results and a higher potential for market approval.
When you start on a new medication ask your doctor to provide you with any recent information about the risks that have not yet been added to the product label.
If you are harmed by a drug or a device or have any unwanted side effects ask your doctor to submit a MedWatch Report. If he/ or she will not then you submit the MedWatch Report. This report form can be found on the FDA website. http://www.fda.gov/Safety/MedWatch/default.htm This website will also provide you with more information about a product than known on the current product label. This is how more information is gathered about the harmful effects of a product after market approvals that were not revealed in the low quality hastily conducted clinical trials. Doctors and patients do not take the time to complete these forms so it takes 10+ years to get a bad drug off the market and usually only after many people have been seriously harmed.
I hope this helps. I am still looking for work but it is tough because I have been black-listed in the industry for a long time. It is also cheaper for pharmaceutical companies to hire entry level study monitors and they don’t see the fraud or misconduct. This is coupled with my wholehearted disappointment in the industry. I am an excellent monitor with a great eye for fraud because I have been doing the job for 22 years and fired many times for trying to report misconduct. It is really ironic to be fired and out of work for doing your job well. I enjoy helping people like you to better understand the drug approval process. So, I hope I have contributed a little. Here is another resource for you to better understand the drug and device development process http://www.centerwatch.com/health-resources/general/ I am not a big fan of CenterWatch but they can provide you with some educational resources as a patient or consumer.
I know you are living through the result of a bad drug(s) and I wish you all the best.
Rich
Do people lie to their managers - sure! Why do they do it, because that is what their managers want them to do.
If you are a manager and want your employees to lie to you, just announce in advance that whoever saves the most money or contributes to company revenue the most will get the biggest bonuses. Then, when you’re meeting with your employees spend 50 minutes talking to them about how they’re tracking towards those big bonuses for making money, and then in the last two minutes of your meeting before you’re done, ask them “oh, you’re not doing anything illegal or which could cause safety problems, right?” They’ll understand what the right answer is loud and clear.
When the guy who slows down a project and costs the company millions of dollars because they spotted that something was done wrong gets a bigger bonus than the guy who completed his project on-time and on-budget you’ll start to see people coming forward about problems.
No executive tells their employee “lie to me” - at least not if they’re any good at being a sociopath. They just make sure that the best liars are well-rewarded for telling them what they want to hear.
Besides, if they get caught the company just pays a few hundred million in fines or whatever. That doesn’t come out of the execs salary - assuming the exec is even still employed there. If the company has to really look determined they might end up leaving for “career development reasons” or whatever, and they’ll have to try to live on the millions in bonuses they’ve collected over the past few years.
This is really nothing unique to pharmaceuticals - the same thing happens in many industries. Rarely to executives in any company have any incentive to do anything that ensures the well-being of the company beyond their next bonus payout.