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A Note on Pharmaporn
Every few days, it seems we get a new one-liner from the annals of trial materials. “We may need to seek them out and destroy them where they live,” said a Merck insider about Vioxx critics. “"Thus far, we have buried Trials 15, 31, 56…”, writes John at AstraZeneca. Trial 15, as it turns out, showed the diabetic risks of Seroquel. This is the same study about which we also read company players congratulating each other for their “smoke and mirrors” success in downplaying its significance.
The examples go on. Endlessly. But what I am always left with is the question of what we do with such “material.” All the defense arguments have a degree of truth. It would be a rare company (or individual) who didn’t write a bad-looking email at some point. Materials of this sort sometimes reveal what is a widely shared marketing plan. At other times, they may represent the views of a lone sociopath.
Perhaps the most recurring theme—when the issue of fraud or cover-up is broached in these communications—is that other companies are doing it “so why shouldn’t we.” All of us learned from our mothers about what “just because others are doing it” means. The relevance here is the question of whether these assertions are rationalizations (and, inevitably, self-fulfilling) and/or whether they represent an accurate snapshot of standard industry practice, at least in the marketing-of-blockbusters arena.
Understandably, people from within industry almost never comment on this question. That was true on Pharmalot when there was plenty of opportunity. Again, this makes sense for all the relevant reasons—the great majority of people in a company have no involvement with such goings-on; there is the anticipation of vicious push-back by critics; there is probably also the anticipation of sanctions from within the company if one’s identity is uncovered.
The rest of us are left with the question of what to make of these bits and pieces. Like porn of other kinds, there is undeniably a certain titillation in the face other people’s corruption. Many of us carry an “inner church lady.”
But lives are, indeed, on the line. My guess is that nothing good will happen to change these aspects of industry short of revulsion within companies robust enough to clean up their scuz. Strongly as I oppose preemption, I think that it will take whistleblowers, not private plaintiffs, to do the job. Only insiders can distinguish, and document, what represents the views of lone cowpokes versus the orchestrated strategy of a significant coterie of senior management.
Unfortunately, the latter appears to be the most common.
Sunday, April 5, 2009
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Dear Justice,
ReplyDeleteMy apologies, this is not really a "comment" so much as a general inquiry. I am an editor and reporter for FDA News, a trade publication, and I have just discovered this blog. I was an avid Pharmalot reader and remember your many comment posts. One of my daily newsletters comments on a blog of the day. However, if I am going to be able to posts links to this blog, I will need adequate attribution. I know you may be weary of posting your real name, and possibly the other bloggers here feel the same way. If it is not possible for you tell me your name, perhaps you might have suggestions for attributing the authors of these blogs to their individual entries? Please email me when you get the chance, I would really appreciate it. Thank you for your time.
Kind Regards,
Nick
nwills@fdanews.com
Nick - The majority of bloggers here, as on Pharmalot, do not go by their "real names."
ReplyDelete" If it is not possible for you tell me your name, perhaps you might have suggestions for attributing the authors of these blogs to their individual entries?"
I don't follow this question. The authors, real name or screen name, are provided for individual entries.
Justice, great summary of the current pharma environment. The idea that you bring forward (among others) is -
ReplyDelete"other companies are doing it 'so why shouldn’t we."
And that attitude is understandable if there is no eye opening punishment for seemingly ever worsening "good" management practices. You can profit handsomely for fraudulent behavior in any environment soaked with money. There are those out there that don’t have a problem with pushing the corruption envelope so we should see an ever escalating trend of fraud.
A very important letter was written to President Obama last week which should be mentioned as it supports the view that we have a serious problem. I think at this point only a statement by our President can turn the tide.
http://www.pharmawatchdog.com/wp-content/uploads/2009/04/fda-letter-to-the-president1.pdf
Thanks, Jaynesday.
ReplyDeleteThe phrase, "other companies are doing it" etc. is a direct quotation from a number of the internal documents that have surfaced over the past year or so. Obviously, it both rationalizes and stimulates the race to the ethical bottom.
Quoting from the letter to the President from the FDA Scientists -
ReplyDelete"The clearance/approval of medical devices that were not made in accordance with the laws, rules and
regulations, need to be re-visited. Furthermore, those FDA employees who have engaged in
wrongdoing, who have violated laws, rules, and regulations, who have abused their power and
authority, and/or who have engaged in retaliation, should be dealt with swiftly. Immediate and
decisive disciplinary action will send a strong message FDA-wide that wrongdoing will no longer be
tolerated and those who engage in wrongdoing will be held accountable. Some wrongdoing may be
beyond the scope of FDA’s jurisdiction and may need referral to the U.S. Attorney General."
Justice, I agree regarding insiders. Recent happenings suggest much of the documentation has been compiled, and history tells us evil regimes eventually come to an end.
ReplyDeleteThanks for this excellent summary Justice!
ReplyDeleteAs we all know it will be hard for anyone active in Pharma to respond to any of these questions. But, I am not sure that a response is really needed. The bottom line is that this industry is being profit/bonus driven. This is the very same thing that has completely undermined the financial world lately.
None of us are opposed to making money and profits and providing shareholders with value. The problem is that when doing so is mostly done through corruption, deception and mis-truths. When the situation has to be "contrived" then this should be a "flag" for everyone.
Go to Merck's website and read through their mission and core values statements. They were updated recently (2005). In fact, just follow this link to the PDF file:
http://www.merck.com/about/conduct.html
Clearly what these companies lack is guidance from an ethicist committee. From my perspective any pharma or medical device company who intends to conduct clinical trials on drugs needs to have this guidance within their organization so that individual employees can be vetted out before harm is done to patients primarily, physicians secondly and the companies own reputation. Physicians and health care institutions are required to conduct themselves under a code of ethics which is completely undermined the moment they interact with industry. Enough is enough...
PhrMa produced a new code of ethics last summer: http://www5.aaos.org/industryrelationships/pdfs/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.pdf
There were countless infractions on all previous codes so it will be interesting to see how many infractions will occur while the "updated" code of ethics is enforce. It seems highly unlikely that we, the public, can feel secure in pharma's ability to govern themselves.
Someone in government needs to be in touch with all the various IRB's in the hospitals and teaching institutions and conduct an audit on what trials are currently underway and what are the rationales. It would be a real eye-opener. I would suspect that in many instances theses trials are merely "make work" situations with the aim of increasing bottom line profits and not really reflective of patients needs.
Since the citizens and governments support the cost of the drugs and innovations through insurance payroll deductions, government reimbursements schemes and support of publicly funded clinical trials, there should be some form of auditing conducted that brings to light the gap in research and resources.
The current system not only undermines the patients ability to access informed consent through concealing information (hiding the results of trial 15 for example), but it undermines the ability of the physician to treat their patient. In the end it undermines the entire health care system.
Fixing the problems in the FDA is part of the solution. Clearly individuals inside these companies who have perpetrated these acts of fraud and subterfuge need to be brought to justice. This might just help in some way for the industry's severely damaged reputation to be restored - but there are no guarantees.
Going forward, I think there should be some requirement for industry employees to show proof that they have taken basic bio medical ethics courses and understand reasonably well the ethical issues physicians and health care institutions are required to adhere to. This may be much easier to do now then ever, after all, with the recent mergers and economic downturns, the sales forces and marketing teams in pharma are much leaner these days.
This is as good a time as any to repair the damage and move forward.
Here are a few necessary steps, in my view.
ReplyDelete1. Strenghten and incentivize whistleblower actions.
2. Jail sentences for senior management, including CEO, of felonious companies. There is precedent, even if the CEO can claim (rightfully) not having knowledge of wrongdoing. "Deniability" is no longer a viable defense.
3. Make it a crime _not_ to report known and serious regulatory violations. There is also legal/historical precedent for that.
4. I am less sanguine that ethical codes or courses make any difference. Most of the evidence suggests they don't. It's the ethical culture "on the ground" and as exemplified and sanctioned every day by managers that make a difference.
5. Make sure Compliance dept. is serious business, has a high place in company hierarchy, and is staffed by people with track record of doing their job (that job) rather than bootlickers.
Thanks for these thoughts Justice.
ReplyDeleteWe are in agreement on your points 1 - 3. Point 5 is contingent on point 4. The Compliance/ethics department needs to ensure that employee training programs adhere to basics with regards to biomedical ethics. This is critical in that it makes sure we are all on the same page.
Marketing has too strong an input on how and where the company chooses to spend their money. They also too strongly influence the medical departments. This is partly because it is "profits before patients" and this is not such a bad thing. As long as it is done within reason. Companies need to be profitable, otherwise why would they be in the "business". Before anyone jumps out of their skin, read the rest of my remarks...
The point being that people in marketing very rarely have any background in ethics, including business ethics. They need to be brought up to speed.
Most Pharma companies have pretty much picked the markets they are invested in by disease category. Their employees should be given training on a regular basis about more than just the economics of these disease categories, but sensitizing them to the actual plight of the patients. In other words, going through a phenomenological understanding of what it is like to be a patient, to be the physician.
This is about compassion. If you have picked a disease category where you want to take leadership, you must instigate compassion in every step and process of the way, from bench to physician to patient. The current approach to health care is mostly economic-utilitarian, and lacks the compassion that should guide the overall vision of what the patients really need. The provision of Health care, including drugs and devices, cannot be drawn up in some ivory tower somewhere without windows on the world where economists design it "solely by ink and paper" delivering their edicts to the workers in the trenches, the physicians and patients themselves, with what they can and cannot have.
If everyone in the chain is truly driven by compassion first, economics second, we will all find that there are ways of arranging the world so as to bring these treatments, cures and improvements within people's grasp. And this, is something that can only come from basic virtue ethics training. Additionally, ethics training provides a universal platform for all of us, regardless of our religious beliefs. We act in a compassionate ethical manner simply because it is the right thing to do. Ethics is not supervenient on someones concept of god. Ethics becomes the universal language with which we can interact with the world.
Hmm, I am almost tempted to sign my real name to this....
Do we really need an ethics course to know that burying studies and "seeking out and destroying" people are the sort of things folks oughtn't do?
ReplyDeletePharmascolds versus ?
ReplyDeleteWeigh in on the Hooked: Ethics, Medicine, and Pharma blog.
To Kantalope,
ReplyDeleteApparently we do need to be reminded. It seems that when we act as employees of a large corporation we take on a persona of some one who all of a sudden has forgotten what it is like to be a REAL human being.
Immanuel Kant was quite good at thinking and teaching us much in this direction. But he popularized the idea of "ought". The problem with that word is that it appears to give us a choice. What I am saying is there is no choice. It is not what we "ought" to do, but what we "must" do.
Or perhaps it is something more like this: You can still think in terms of "ought" and then choose not to do the right thing. However, be warned that when you choose not to do the right thing, you are basically saying to the world, that although you have the gift of reason, you have chosen to act in a most akratic way.
This is an important conversation. I hope it continues.
ReplyDeleteFormer Marketing, you mentioned earlier in the thread that ethics training may help company employees, who are not directly involved in patient care, make better consumer-oriented decisions (as opposed to profit-motivated decisions).
I agree that something needs to be done, however I wonder first, can compassion in decision-making be taught; and second, how successful have ethics training programs been in achieving this goal?
Good Questions Anonymous..
ReplyDeleteGlad we can keep this thread alive a little while longer.
I do believe compassion in decision making can be taught. It isn't completely non-existent actually, it is just that all the bad in the world overshadows it sometimes. First of all, if you act from compassion, that means you stop and put yourself in the other persons shoes, or at least in the shoes of the people/patients who will be affected by what you do. I guess this is where Immanuel Kant's categorical imperative comes into play or at least his first formulation of universal law. It really requires for you to decide if what you are doing is something that you honestly wouldn't mind for yourself. Then imagine a possible world were everyone would do "this thing". If you see any irregularities, or contradictions, then this wouldn't be allowed in a real world. Importantly, acting with compassion does not preclude any business from making profits. I think most of us, if not all of us certainly agree that people need to be paid for their work. Drug companies are not charities, and they should not be required to conduct themselves in that way (this is an entire different subject matter, and I have thoughts on that too).
As for how successful have ethics training been in achieving this goal, I think the fact that doctors for one are, are held responsible by their oath indicates that this type of training is quite successful. I am not saying that there are not many doctors who haven't been caught in crossing a line or two. But when you look at the entire picture, Doctors, Nurses, and members of the IRB's are about the only people in healthcare who are constantly reminded of the ethics. Yet, industry plays an important role, and as such they should be required to undergo ethics training, and be reviewed regularly by an ethics committee.
Hopefully you would have a situation were before someone buries a cardio toxicity study, they would remind themselves what it would be like to be a patient who HAS to take that drug and winds up with a quadruple by pass? Obviously you would want the benefit of being given the important information as part of the informed consent process. Can you imagine a world were hiding all this information is the norm? You would have to imagine that doctors would not even have this information and therefore would not be able to discuss it with their patients. That means informed consent, and your right to it, are abolished. How would you handle all the influx of reportable AE's, what about deaths? Eventually there would have to be an investigation into what could be causing this problem. Is that a world you can live in? I don't think it is. Then, it is easy to see that the answer would be to make the cardio toxicity profile information available, so that doctors can weigh which of their patients can take which of the drugs and then monitor the patients closely. This would reduce reportable AE's, which invariably improves the overall safety profile. Had Merck done this with Vioxx, it would still be on the market making 2.5 billion a year.
How successful is ethics training? Can you imagine a world were Doctors and Nurses were not held to a strict code of ethics? I can't.
Thank you for this, Former Marketing.
ReplyDeleteYou point out that acting with compassion does not preclude any business from making profits. I agree. In my view compassion (empathy, understanding, connecting) for the consumer is a necessary condition for the creation of a successful business. Your example of this, Merck and Vioxx, is a good one.
I am interested in your views on the related subject you mentioned as well, on industry profits.
Actually, there is a fair amount of empirical study on this question, especially in the "business ethics" literature.
ReplyDeleteI think a fair summary is to say that ethics courses--like mission statements, etc.--have minimal impact unless the relevant folks walk the talk--from the CEO on down. Even then, corporate culture can carry on pretty much independently of management.
Here's a bit from something I once wrote:
"Thus Gellerman (1986) writes in the Harvard Business Review that “the practice of declaring codes of ethics and teaching them to managers is not enough to deter unethical conduct” (65). Andrews (2004), also in HBR, announces that “a highly moral and humane chief executive can preside over an amoral organization” (73) and reiterates that “codes of ethics are now commonplace. But in and of themselves they are not effective.” Paine (1994), yet again in HBR, reminds us that “ethics is as much an organizational as a personal issue” and that ethical practice always “involves the tacit, if not explicit, cooperation of others and reflects the values, attitudes, beliefs, language, and behavioral patterns that define an organization’s operating culture” (86). Coming from the perspective of nonprofit management, Jeavons (1994) writes that “most people with any significant experience in organizational life know that there is often a marked disparity between rhetoric and practice in organizational behavior. They also know that that rules…can be, and frequently are, followed ‘in the letter’ while being totally ignored or even violated ‘in the spirit’” (183).
Very good points Justice. This is exactly why I am saying that Pharma industry professionals need to go through ethics training, maintain their certification, and possibly report their status as a company.
ReplyDeleteJust as you point out in the work you did in this area; saying you have adopted a code of ethics, versus implementing and/or enforcing adherence to ethics as a requirement in the manner of other health care professionals, is a different thing entirely.
As for the comment that "ethics is as much an organizational as a personal issue" may be so, but it doesn't make it right. This is particularly more relevant when we are talking about business professionals who can have a significant impact in a vulnerable patient population. We should absolutely mandate that they are on the same page. If people who choose to work in health care do not reflect the same values, beliefs, language and behavioral patterns as one would expect in a world where patients lives and outcomes are affected, then they shouldn't choose to be in the industry.
Business ethics is an o.k. place to start, but it is not entirely what I have in mind.
Hi Former--I'm not talking about what should be, but what I think is. There are a few companies (not pharma) who have developed an ethical culture from the ground up. It directly informs who they hire and whom they do not. And it's not about what people say they believe, or what courses they've taken, but having a demonstrable record of integrity in prior positions. Without that record, no job.
ReplyDeleteI continue to believe that meaningful change needs to be radical and structural--a commitment a company makes, in essence, all at once and collectively. Every significant aspect of the incentive structure, from hiring, to firing, to promotion, to where regulatory affairs fits in the hierarchy, and on and on has to be part of it.
Short of that, I don't think we'll see change from the inside. And external sanctions, while they help reign in shortrun, will not be more than a temporary fix.
So I'm still not convinced courses make much difference. The people who choose not to kill at My Lai showed no difference in level of education or courses they took from the most gung-ho sadists. Those who did not obey in the Milgram experiment also showed no such difference from those who did (including ethics profs and clergypeople).
Justice, I think we are both saying the same thing. I am hoping that courses and review boards are tools that companies use to bring their current employees into a program. Virtue ethics training offers everyone a chance to learn about the lifestyle changes, and thinking processes that can be re-habituated toward the change needed.
ReplyDeleteOnce you go through a virtue ethics course, you access ways to implement the fundamental change needed. Virtue Ethics should show people "how" to be ethical.
The other thing is, Pharma industry does a great deal to offer many opportunities to their employees for continuing education and constant updating of skills. I really appreciated that kind of access while I was in the industry. Most companies sponsored all higher education classes. Additionally, most companies I worked for had programs to help employees improve their own quality of life. Virtue ethics certainly fits in to these areas....
So, I agree with you, there does need to be a cultural change within Pharma. But I do believe virtue ethics training will certainly help with the shift that is needed.
Psychiatrists get mad, and they're not going to take it anymore. Look here:
ReplyDeletehttp://pn.psychiatryonline.org/cgi/content/full/44/9/3