Merck’s Dick Clark Has An Epiphany
49 CommentsBy Ed Silverman // May 2nd, 2008 // 8:00 am
The plain-spoken ceo is on something of a confessional tour. His new mantra is to sound contrite. Rather than blame the media or some other group for Merck’s problems, Dick has recently taken to public hand-wringing when asked about not only the Vytorin scandal, but Merck’s credibility, in general. His new favorite phrase: ‘trust deficit.’ He uttered that last month in an interview and does so again this week.
“We need to do a better job as a company and as an industry. Having been at Merck for 35 years, we take way too much for granted. And I don’t think we’re aggressive enough in getting our stories out there,” Dow Jones reports him saying at a conference. “There’s a trust deficit around us as an industry, and somewhat as a company…I’ve become much more sensitive to issues around trust and what we can do to improve trust globally…I can’t blame the media. I have to blame us. We have to do a better job of it.”
Back in January, though, he was blaming the media for the Vytorin controversy. “With media hype, there is a great deal of confusion,” he told Wall Street analysts on a conference call (look here).
Actually, Merck is plenty aggressive. The issue, Dick, is which stories do you want told? The ones about playing Dodgeball with Vioxx data and how Vytorin endpoints are changed without the primary investigator being informed? If not, then ensure different practices are in place. Emphasizing other points or issues is no substitute and won’t deflect attention. But this is an industrywide problem, and it’s not new. Your challenge, Dick, is to do more than sound contrite. What’s your next move?
Hat tip to PharmaGossip and the WSJ Health blog
Doc
Sounds good on the surface, but as a pharma insider, profit continues to be the bottom line, data and facts that negativley impact patient well being (and hence profits) will continue to be minimized as much as possible. Remember, these guys were caught red handed - hence we see the new strategy of public contrition. Not very impressive.
Nathan
Ed,
I think people expect too much out of these executives. A corporation is not a person. A corporation cannot appologize or be “contrite”. Only individual people can do that. The corporation is essentially a robot that is designed to maximize profit. It’s not good, it’s not evil. It’s essentially an “autopilot” pointed towards maximizing profit. There are only two ways to get a corporation to “behave” the way you think it should:
1) Create a profit incentive
2) Create a legal incentive
I’m tired of the insinuation that somehow companies should have morals and ethics. People have morals and ethics. Companies don’t. Companies work within whatever legal framework they are given in order to maximize profits. Doing so is not bad and it’s not good. It’s just the way it is in a free-market economy. Let’s all get used to it because that isn’t going to change anytime soon.
Ed Silverman
Hi Nathan,
I understand your points. That said, there are still laws and business practices that society formulates to address acceptable conduct. Whether Clark, in fact, is trying to address that, in his own limited way, or is simply concerned with nothing more than image is unclear.
But I disagree with the notion that corporations are robots - they are collections of people who, like any group, will have bad days, make mistakes or do things they shouldn’t. Yes, a large corporation is an unwieldy group and dealing with its transgressions is different than with individuals. But should transgressions not be addressed?
As I see it, the issue is how to pursue corrections, not whether corrections are desirable - unless the goal of achieving profits is a license to do just about anything. And I don’t think you’re saying that.
Cheers
ed
Jaynesday
What is interesting to me is the issue of public trust which is highly, highly important because it is the basis of profit. If a company loses the trust of its customers it is very hard to get it back. I don’t think at this point that the public as a whole has any idea that Merk as a company has a problem. Some may have hear about Vytorin, but knowing that Merc is the company that produces that product is probably a little to far from the public’s level of sensitivity.
Mr. Clark however rightly realizes that if you even get on the radar screen of public awareness about being untrustworthy you will pay a monumental price.
In short, it takes big issues and big money to turn the lumbering attention of the public but once it has moved you had better be ready for the fallout…. good or bad.
Mr. Clark and company could be standing on the precipice of a very deep fall. Who is really at fault is not as important as how can we keep our image in tact.
Doc
Nathan,
Doc
Nathan,
I disagree with your thought that corps cannot have ethics or morals. They put forth to the general public that they indeed do through their DTC PR campaigns and especially through their Mission Statements, Core Behaviors or whatever term each might use. There has been a disconnect between these corp mission statements and many uncovered practices these last few years in pharma. Profit is good, if ethically achieved.
Laurie
From http://www.merck.com, it’s “value #2″ in their mission statement. Bolding is mine.
“We are committed to the highest standards of ethics and integrity. We are responsible to our customers, to Merck employees and their families, to the environments we inhabit, and to the societies we serve worldwide. In discharging our responsibilities, [B]we do not take professional or ethical shortcuts. Our interactions with all segments of society must reflect the high standards we profess.”[/B]
A corporation without ethics is a danger to society. I don’t buy the “it’s the people who have to be ethical”…that’s an excuse for bad behavior by a company. Can you imagine if a hospital took this approach? Sorry, that is no defense when a product can cause harm.As Doc said, this is why there are Mission Statements in business. If a corporation can’t live up to their mission statement, they shouldn’t be in business.
Nathan
You guys make some good points. Maybe it’s just semantics, but I’ll stand by my assertion that companies are not ethical and not unethical. They are “aethical” (if that’s a word). The people within them choose ethical or unethical behaviour. The profit motive that we have in our free-market economy creates constant pressure for unethical behaviour by the employees. Over time, the behaviour of those employees is going to migrate towards PROFIT, not ethics. Those people that are ethical likely end up making choices that aren’t as profitable. Therefore, they get pushed aside over time by greedy shareholders (Wall Street) and greedy executives.
In order to create a LASTING ethical environment, you have to create a profit motive or a legal motive that encourages ethical behaviour. In the absence of that framework, all companies (of any kind) will migrate towards unethical behaviours that enhance profit.
How does that look? Well, you could create a financial incentive that encourages transparency. You can set up laws that REQUIRE transparency. But don’t expect transparency just because it’s the “ethical” thing to do.
Lisa Van S
Nathan,
Dont we all have a responsibility to be ethical?
Jack2
I think what Nathan’s trying to say is we can’t force or control individual people’s behavior.
So we should try to focus on designing a system, using reward and punishment, that encourages ethical behavior and makes ethical behavior for companies the best choice. Then the companies themselves will reward individuals within the company who behave ethically.
Nathan
Thank you Jack2 — you said in two sentences exactly what I’m getting at.
Laurie
A corporation is the sum of it’s parts, and as a corporation has to accept responsibility for all of those parts. So while it takes individuals to be ethical, the corporation is ultimatly responsibile for those individuals functioning within their corporate structure.
As a nurse I am bound by my hospitals mission statement and core values. If I choose to violate those core values, then it’s on me…if my hospital chooses to ignore my violation and allow the violations to continue, the it’s on them AND me. As a corporation they have a responsibility to enforce their values.
Merck, in their lack of oversight and the subsequent blame game, ignored/spun the evidence in front of them….therefore violating their own Core Values.
Mercks statement about Corporate Responsibility:
“At Merck, our business is discovering, developing and delivering novel medicines and vaccines that can make a difference in people’s lives. But our mission also entails something more. As a Company, we seek to maintain high ethical standards and a culture that values honesty, integrity and transparency in all that we do. Company decisions are driven by what is right for patients. And we are committed to our employees, to the environment in which we live and to the communities we serve worldwide.”
Honesty and transparency……something they have to work on.
harpy
corporation
n. an organization formed with state governmental approval to act as an artificial person to carry on business (or other activities), which can sue or be sued, and (unless it is non-profit) can issue shares of stock to raise funds with which to start a business or increase its capital. One benefit is that a corporation’s liability for damages or debts is limited to its assets, so the shareholders and officers are protected from personal claims, unless they commit fraud. Etc.
Nathan, I don’t think one can say one is “ethical” if it is compelled by punishment or reward. To be ethical one must do something because it is the right thing to do not because someone will pat your head or smack your fanny for it. Why on Earth would there be classes devoted to “business ethics” if not for the fact that businesses are expected to be ethical? Do you think it was ok for the contractors on Boston’s Big Dig to use sub-par materials that caused the death of a woman because it was more profitable to them? Are they justified because no one told them to be ethical? Good grief, boy, business has more obligation than just making money.
Justice in Michigan
One of my favorite topis, after preemption.
There are companies (albeit relatively small ones) whose leadership has made it their business to incentivize ethical behavior all the way up the chain. That is what it takes. Not punishmennts for violatons or external accountability alone.
The successful companies in this regard make a track record in ethical behavior a pre-condition for employment. There is one campany that has been reviewed in the Harvard BR (I forgot which one) which describes would-be sales people being asked if they ever lied as part of their sales jobs. The typical response was; “I’m in sales; what else could I do?” It was simply incomprehensible to these folks that mispresentation, even if in a small and selective degree, was not part of sale was all about. We would call it “selectively putting your best foot foward.”
Even this degree of inaccuracy was verboten at this company. And, yes, they thrived; not only survived.
In my view, it takes that kind of radical reframing of culture and expectations for that to happen. Without that, a little CEO shmooze, CRP window dressing, and minor incentives mean squat.
As far as Dick Clark, I wish he’d to back to American Bandstand.
Justice in Michigan
One further way to look at this.
Pharma’s decline in public trust is generally not “nuanced.” Unfair at it often is, a whole range of people are tarred with the brush of corruption when only a few decision-makers may have been involved with illegal or unethical acts. Sometimes it is more systematic and widespread. But, even then, it certainly does not involve everyone in a company.
Nonetheless, the very fact that the public responds globally makes it an incentive for pharma employees to do what they can to defend the reputation of their companies as wholes - and to take clear stands (within the limits of self-preservation, however defined) when they do not.
At Pfizer, there was a program in “pharmaco-diplomacy” to help employees “speak for” the company and the industry when attacked. That’s fine. But it came off as one more essentially defensive response.
I believe the changes that are needed, tough as they are, need to be more radical. Employees need to understand that turning the other way, allowing diffusion of responsibility and deniability by senior managers, agreeing that “business is business” and the law is where it hits you back, are - sadly - all ways of contributing to the bad fortune of their own companies and the industry as a whole.
Self-interest lies in _not_ keeping your head down and looking the other way.
Jack2
Harpy I think it’s very easy to talk about how it “should be” and cry when things are not as they “should be.” Nathan is talking about how to go from “should be” to “be.”
CMC guy
Jack2 states it well on encouraging ethical behavior and feel corporations can instill attitude and conduct of high ethics. Most people with children probably can attest to the greater power of positive rewards over negative punishments (although still need latter in certain cases). JIM provides a good example of potential model that I wish was the norm not the exception (applies not only to sales as a valid question to any scientist in regards to handling data). Each individual does have responsibility with the CEO probably having the most influence in establishing and maintaining such a culture.
I view this as not only a pharma problem in deterioration of business/personal ethics but a larger US cultural issue, perhaps even global, where bad behavior appears to be constantly “winning”. I am proud of what I do/have done and likewise see what pharma is capable of so do get aggravated when the majority gets tarred for the bad acts of a few. Because of nature our business pharma should indeed strive to be leaders in reversing attitudes and practices ethics while at the same time getting back to focus on science/drug development/patients rather profits/stock prices.
Nathan
Interesting discussion - you guys make some good points. But here’s another way to look at it: Who is ultimately responsible for the direction of the company? The employees? The CEO? No. No. THE SHAREHOLDERS.
When is the last time you heard SHAREHOLDERS cry out over the lack of ethics of their company? Have any of you ever looked into the ethical practices of the businesses that you invest in? I’d venture to say no. We invest our money where we can get the most return. We DEMAND that our investments receive as big of a return as possible.
As long as this remains true, ethics will continue to be pushed aside whenever ethics competes with profit (as is often the case). Again, I’ll come back to my assertion: There needs to be a profit motive and a legal motive (a carrot and a stick) in order to compel businesses to behave ethically.
HorusCat
Hi Nathan! As usual, I agree with you except for this point: corporations ARE ethically bound. They have a fiduciary duty to provide return on investment for their shareholders–corporations have been sued for NOT doing things to maximize shareholder value. But the end result is the same: Carrots and sticks.
Justice,
I have never lied to a doctor. Well, maybe my own personal doctor about how much catnip I’m using…
Paul
Give the CEO a break. At least he’s trying. Merck has been beaten up a great deal - some deservedly, some not.
Let’s accept a few things:
- Corporations have their first allegiance to shareholders and therefore are profit oriented
- It is not companies that make decisions, it is people who make decisions and should therefore be accountable
- These companies have done some stupid things
- But they have also done many good things. We do have to accept, like it or not, that they have done a lot for health advances and we’re all enjoying many of the benefits
- There are other bad players: insurance companies, managed care companies, many doctors, bad governments, greedy lawyers and their clients, etc.
- The system is broken and the solution goes far beyond the realm of these companies
Anon
Nathan I may be attempting to overly assign or define things here but trust it is the employees, especially CEO that are taking the lead responsibility for direction of a company. Exceptions might be small VC funded/controlled enterprises and also acknowledge many companies act based solely upon effects to shareholder value but that impact is on survival which is less direct determinate (but possibly huge) of how a company operates.
At the same time I agree that situation works against higher standards and suggest it is part of the cultural manifestation mentioned where the demand for biggest and quickest ROI frequently overcomes other considerations. I do look at reputation/business practices in investing and in employment. Problem comes in finding the data as Mission/Policy Statements that look good on paper don’t always reflect what real situation is.
truthman30
A company is not a machine Nathan.
It is very much guided by people.
Be they shareholders or corporate executives.
When ethics are abandoned it is the people from within the company who decide on the decisions.
And there should be full accountability by the “corporate people”when mistakes are made or unethical decisions are decided.
For far too long the pharmaceutical industry has hid behind its corporate facade.
Laurie
“Corporations have their first allegiance to shareholders and therefore are profit oriented”
Sorry, this doesn’t fly when you are selling drugs. Yes, they have to make a profit, but just like any other corporation you don’t knowingly put out a bad product and then blame the shareholders for making you do it.
“There are other bad players: insurance companies, managed care companies, many doctors, bad governments, greedy lawyers and their clients, etc.”
The this case it’s Merck and their alteration of scientific data that has brought this on their head. NOT doctors, lawyers and the government. No one told them to mislead patients and doctors to see more drugs…they did that themselves.
Nathan
“Corporations have their first allegiance to shareholders and therefore are profit oriented”
Laurie responds: “Sorry, this doesn’t fly when you are selling drugs.”
It may “not fly” in your mind, but until drug development becomes a government responsibility, it’s reality. Corporations (whether they sell tennis balls or vaccines) are responsible to thier owners. If those owners demand high ethical standards, then the company will reflect that. The problem in our society is that the owners are SHAREHOLDERS. Those shareholds (99% of them) really don’t care about ethics enough for it to shift thier investment patterns. Therefore, the driving motive is PROFIT. I’m not saying that’s the way that it SHOULD be — I’m saying that’s the way it IS.
If we want corporations to be more “ethical”, then shareholders will have to demand it or our government will have to legislate it. I have more faith in the latter than the former.
Justice in Michigan
As already relayed, I am a shareholder in a pharm company about whose practices I have serious questions. I will not hesitate to make these known, even though my small number of shares is, in itself, nowhere near large enough to make a difference by itself
Still, the the scheme of things, cutting corners is bad pratice _and _bad business. There is good empirical evidence that consumers are willing to pay more for companies that take social responsibilty seriously. (I’ll cite it in a later post).
Once again, we are in the grip of short-term thinking and a number of assumptions about what shareholders do and do not want. I believe such assumptions are more in the interest of bolstering a particular argument than making a convincing point, empirically.
Justice in Michigan
Sorry, but again a further point. As one reads through this thread, there is a constant shifting of responsiility.
It’s the CEO’s responsibility. It’s the sharebholders’ responsibility. It’s pharma employees’ responsibility.
In reality, every one of these groups, and more, are responsible. As things now stand, both jobs and share prices are on the line. The pass the buck approach will not right the ship.
I am not calling for heroics. But I am calling for looking the situation as it is, as Nathan put it. The situation as it is is not tenable for the future of the industry. That means that jobs, share prices, and public health are on the line.
If folks don’t feel how critical is the crossroads, they are taking more diazepam than is probably good for them.
Nathan
I’m not putting the “blame” on shareholders. I’m just saying that to get a system working the way you want it, there has to be pressure coming from SOMEWHERE. It seems to me that the pressure has to come from either shareholders or the government. I just don’t think a free-market economy naturally lends itself to ethical behavior. There needs to be an “external push” of some sort. That push needs to be either legal or financial.
Some pharma CEOs and employees are unethical. We can complain. But some CEOs and employees will ALWAYS be unethical. There’s no way around it. Let’s set up a legal or financial system that encourages ethical behavior. We are already moving that way, of course. It’s nice to see regulations that require clinical data to be deposited publicly. It’s nice to see requirements for full disclosure of conflicts of interest. We need more such regulations. We can’t expect companies to do it on their own. We need to be TOLD exactly what kind of ethical behavior is expected of us. It sounds juvenile — but if children aren’t TOLD what the boundaries are, then they can’t be held accountable to stay within those boundaries.
truthman30
Nathan “We need to be TOLD exactly what kind of ethical behavior is expected of us. It sounds juvenile — but if children aren’t TOLD what the boundaries are, then they can’t be held accountable to stay within those boundaries”
So you’re saying that the pharmaceautical industry needs to be told that “killing patients for profit” is morally and ethically wrong”? ..
Laurie
“We need to be TOLD exactly what kind of ethical behavior is expected of us.”
Wow…..so sad, yet so true! When the line between ethics and profit is so thin that a map needs to be created…the problem is worse that anyone realizes. When it is “percieved” by management that they have to do unethical things for profit to shareholders, we have a basic breakdown of distinguishing between good and evil. A VERY scary thought.
If corners are allowed to be cut for profit…it is a short lived gain. An company functioning in an unethical manner will not survive…..and there go the profits.
So it’s in everyone best interest that a company not cross the line that will put then out of business.
How sad that business has to be told how to be ethical in their practices.
Anon
Re the profit incentive: Somehow we need to create a system which rewards companies for what we value about their work, but doesn’t reward their unethical activities. There is no argument that R&D (when done with integrity) is valued by society, as is the manufacturing aspect of the industry. As it is, we reward this work by paying for it through sales, but the consequence for deceptive marketing, bribing doctors etc is currently … also more sales!
There are those who are calling for R&D to be rewarded separately - from government coffers through competitive tender, or from a prize pool. Serious international attention to these sorts of alternatives seems to me to be the only way we will fix the system.
Jaynesday
How about this for a suggestion on how to force pharma companies to behave. The FDA(?)… or some other organization could be responsible for grading, or somehow determining, which companies are “ethical”. Those that were would be granted an extended amount of time for exclusive rights or extensions to their patent.
Sorry if this isn’t even in the realm of possibility.
Justice in Michigan
I have only a few moments, so I hope to return to the following points in a later posts:
1. The assumption that the free market, in itself, works against ethics is largely untrue.
2. The assumption that shareholders are only a force toward discentivizing ethical behavior is also not true.
3. Some of the reforms noted by Nathan and others are useful ones.
4. There are more radical ways that companies can remain fully competitive and capitalistic while valuing ethings as an integral part of business pratice - not an “add-on” or “externality” the way regulations or threat of lawsuits os often viewed. As essential as good science.
More to follow.
laura
Nathan,
I think you’re a closet anti-premptionist! You’ve said several times in this thread that there needs to be a legal motive to encourage companies to behave ethically. What better legal motive than requiring companies to have direct accountability to the consumers of their products? Medical device companies no longer feel the pressure of this requirement. Drug companies may not, as well, in the very near future. It seems to me that we are moving away from providing legal incentives for ethical behavior and instead relying totally upon financial incentives…and that can’t be good.
CMC guy
Anon I am not certain R&D and Manufacturing is obviously valued by society, largely because they are not understand plus these are subject to problems too that get high profile coverage (lack of innovation, recalls/adulterations). Although I cringe at most marketing and the too frequent abuse angers me the plans I have seen for alternate funding for drug discovery & development look like they could be counterproductive. Getting better government involvement is needed but control by committees would probably mean less and slower progress. Likewise who will determine who gets the prize much less provide the funding to advance something to a stage where it is more than an academic exercise?
HorusCat
Laurie,
I think Nathan’s point is there should be preemption, but fraud would be exempt from preemption. I think fraud such as occurred with the Paxil case should be punished criminally as well as financially. If side effects develop over long-term use of the drug and therefore weren’t evident in trials, and the FDA approved the drug and indication, the company should be immune.
Jaynesday
HorusCat
Side effects that develop over the long term use of the drug that weren’t evident in the trials - seems to be part of the problem, in that it is apparently too easy to make sure that the long term effects don’t show up in the trials.
Maybe this the basis of the phara industry’s problem. If product design is based on statistical analysis the temptation is just too great to make the numbers say what you want them to say or not say. If you have statistical “proof” you can feel pretty good about introducing a drug or device that may or may not cause adverse events.
Then what about a drug or device that had no indication but the manufacturer realizes it clearly indicates a problem after its on the market. Will the manufacturer act to have the drug/device removed from the market, will the FDA even know there’s a problem, how many people will be hurt or killed before the situation is corrected? Again ethical behavior is the question without an answer.
Justice in Michigan
As I’ve repeated, the questions are a company are:
1. What did they know?
2. When did they know it?
3. What did they do (or not do) in response?
They apply whether pre- or post-approval. Indeed, the most egregious cases of companies remaining minimally in compliance but still disguising, withholding, and otherwise misrepresentating information (which they later called actions that were “unintended) happen post-approval. Preemption would make all such actions accountability except for the extremely rare instances in which the DOJ acts.
I won’t run through the whole argument again, but the pro-industry, pro pharma jobs position is to be anti-preemption. With it, the current “black eye” will look like a very small booboo indeed. There are other good reasons to reject preemption, but industry self-interest (and especially of its employees) ranks high.
Meanwhile, I posted this elsewhere, but I just learned of it today, so I include it here as well. It raises the question - does the current incentive scheme make such actions less likely, re more?
http://www.youtube.com/watch?v=XS3mhjt7TrY
Justice in Michigan
For HC and others.
Who determines when there was “fraud.”? The resources that it would take to fund relevant Justice Dept. investigations would be astronomic. That is why such cases are virtually always settled without prosecution or punishment of any kind. At “worst,” come kind of “remedial plan” is put into effect.
The cose of carrying through prosecution would be many, many times anything that has been proposed to add to CDER’s budget. Are you ready to support that?
What if you knew fraud occurred, but company has already pulled drug, knowing DOJ “had the goods”? Still ready to pursue prosecution?
The reality is that the FDA/DOJ has _relied upon_ civil liability to provide the kind of accountability that they can neither afford to pursue nor have needed to.
Although it sounds “reasonable” in principle to suggest a “fraud exception” to preemption (which is what we’ve had on paper in Michigan), it is entirely meaningless in practice.
So choose your case - any of the SSRIS, fen-phen, Baycol, Rezulin, etc. etc. - Michigan citizens have been locked out of court. Do you believe that there was no fraud in any of those cases?
Further, as already noted on this board, the DOJ is already on the record as saying they do not want their determinations and prosecutions _ever_ to serve as the gateway to civil liability.
So injured people or their survivors, post-fraud, remain fully without any way to seek compensation.
Sound fair to you?
Justice in Michigan
Let me also respond in a gentler way, and as a clinical psychologist (which I am).
FDA preemption is so grotesquely unfair, “perverse” as the New York Times described it, that it is hard for people to believe it is what it is.
We have seen this in Michigan over all the past thirteen years. People insist it _can’t_ be true; there _must_ be a “fraud” exception; there _has_ to be some recourse (e.g., federal court, filing in another state, etc. etc. etc.). It seems simply beyond belief that we could have a law this bad.
Thus, people understandably try to find ways to make it make sense, because it so profoundly does not. It is that hard to believe that it can mean precisely what it does.
That is part of the argument’s power. By the time folks realize it really _does_ mean what it does, it is generally too late to stop it.
Yes, this is a very old trick in the archives of Power Grabbing.
Nathan
Sorry — not much time to respond tonight — but my thought over the last couple of days about this topic are definately making me reconsider my opinions about preemption. I haven’t switched sides yet, but I’m definately on the fence….
Nathan
jaynesday says:
“Side effects that develop over the long term use of the drug that weren’t evident in the trials - seems to be part of the problem, in that it is apparently too easy to make sure that the long term effects don’t show up in the trials.”
As I’ve pointed out, there is no financial incentive to do long term studies. I really think this is part of a fundamental problem in our industry. We need longer patent life that will allow companies to do the long term studies they need and still have enough patent life remaining in order for a profit motive to be in place.
(this is exactly one of those situations where free-market works AGAINST ethics! Free market demands short trials while ethics demands longer trials)
Jaynesday
Whenever a person or a company comes up against the crisis of decision about their ethical behavior they are in the midst of a battle between what is best for themselves or what will benefit someone else. Part of the equation for those that are generally dishonest or unethical(maybe a good number of we sinners at times), is what do I feel like I can get away with? Another avenue of what’s best for me.
Preemption puts the opportunity to get away with it on a whole new level. What do you think, maybe 20%, maybe 50% more articles about disturbing breaches of ethics in the future?
Of course we can only go on the past experiences that we are aware of to estimate the probability of future behavior.
I would think that maybe the probability of future unethical behavior would directly correlate with suffering, death and profit.
Justice in Michigan
For Nathan - The fence is a reasonable place to be. I know that companies have, and no doubt will, send out their own info on preemption. I would be happy to try to respond to any aspect. Yes, I am obviously not neutral. But I will try to present the facts as I understand them.
In the meantime, with regard to Jaynesday’s comment, I always emphasize that there are very self-interested reasons for industry people to be against preemption. While it may provide “cover” in the short-term, in the long terms I believe (as I’ve reiterated) it will inevitably lead to a disaster for the industry as much as the rest of us (which disasters obviously are part of the same thing)).
Likewise, I do not deny that the trial lawyers (on all sides) have their share of sleaze. But that can be reformed short of the nuclear option. (E.g., clear and reasonable limits on class actions, punitive damages, share of any awards that gos to lawyers, etc.)
Agree with Nathan re: patent life and long-term studies.
laura
Nathan,
OK, maybe you’re not a closet anti-preemptionist. Maybe, instead, you’re a pro-preemptionist with a conscience (and, as you may be demonstrating, they usually eventually become anti-preemptionists;))
Justices comment, “FDA preemption is so grotesquely unfair, “perverse” as the New York Times described it, that it is hard for people to believe it is what it is.”, is absolutely correct. I can’t believe it is what it is, and I’m living it.
When I tell people about my families situation, (and I don’t tell many because of the “stigma” attached to filing a lawsuit), they truly cannot believe that our basic right of seeking relief through the justice system, our sole means of holding the medical device company accountable for what they sell, has been taken away from us. This entire process has shaken my confidence in the way our government works. I used to be a Republican, although I am certainly not a “George Bush Republican”. I guess I’m a Republican with a conscience, and I think they eventually become Democrats;)
Jaynesday
Politically speaking – the weakness of politics anymore is that if one side takes a stand on an issue the other side seems to have to take the polar opposite view and justify it somehow. More than that they use the issues as a weapon to beat the other side into oblivion. The result is that practically nothing gets done. The more we politicize issues the less will actually change things because some people would rather defend their political party than support the real solution. Putting any problem into a political blame game causes the “contestant’s” rational thinking to go into an “I must win this battle for my team” mentality. Not good.
Justice in Michigan
Good point, Jaynesday. Whatever may be the real problems with the civil justice system, “tort reform” and lurid portrayals of “greedy trial lawyers” became pure political fodder some years ago.
“Big bad pharma” serves the same purpose for some number - a completely one-dimensional condemnation, used to make political hay, which blinds everyone to the realities.
So we end up with the politicized counter-demonizing you describe. Thinking through good policy is already hard enough.
Turning it all into a circus, or political theatre, doesn’t help.
Jim
This is a very important thread and my compliments to the many thoughtful contributors. Nathan’s point about the perverse incentives created by the current patent structure is critical - and not discussed often enough by industry. Accompanied by an adequately funded FDA, NIH-funded academically-managed comparative trials, a revision of the patent system would go a long way towards getting the industry where everyone wants it — providing innovative medicines, data to support their appropriate use, and the ROI the capital markets require.
But then Mssrs Waxman, Stupak, and Dingell wouldn’t get any good Capitol Hill theater out of such a system, so I won’t hold my breath waiting for it.
HorusCat
“NIH-funded academically-managed comparative trials” is where you lost me, Jim. It is not the federal government’s constitutional mandate to fund medical research. Not only would it be yet more thievery of private property, it would mean the government would be deciding which disease states merit resources and which don’t. We would, perhaps, end up much like England, where “life-style” altering medications such as the interferons for MS are severely limited in their use–not being cost-effective, you know.
Jim
HorusCat I take your point — I wouldn’t want to unleash a bureaucracy like the UK’s NICE on our market. The challenge is that the market does not really provide any incentive for corporations to conduct comparative studies, more often than not they backfire, PROVE-IT being a classic example. But there clearly is a need for data like this.
And while there may be no constitutional mandate for the government to conduct trials, an example of the type of NIH-supported trials I am talking about would be ALLHAT. The study itself was far from perfect, but that’s the model I was referring to.
Again, I would agree with you that the expectation that we could get unbiased data from government supported trials (when the governments economic incentive to restrict the utilization of innovative therapies is so powerful) is optimistic to say the least.