Schering-Plough Exec To Merck Exec: ‘F… Off’
149 CommentsBy Ed Silverman // April 11th, 2008 // 6:12 pm
Here’s another nugget from the leaked Vytorin documents released today by the House Energy and Commerce Committee. Last September 14, John Kastelein, the primary investigator for the infamous Enhance trial, writes an e-mail to Soren Christiansen, the general manager for the endocrine franchise at Merck, which jointly markets Vytorin with Schering-Plough. Kastelein is upset that he had heard nothing about an upcoming ‘consultant meeting’ to review the trial and plans to write Christiansen’s counterparts at Schering-Plough.
So Christiansen writes an e-mail of his own to several others involved in the Vytorin venture to say that he’s “concerned with how Schering-Plough Research Institute is interacting with one of the most important customers…” And he then notes that there has been no communication with Kastelein. His note his forwarded by Sean McNicholas, a Schering-Plough employee, to a pair of Schering-Plough execs, including Enrico Veltri, a group vp of global clinical development and a leader of the joint venture with Merck, and he urges them to “stay calm.”
So what does Veltri write back? “Soren is a prick. How’s that for staying calm. Tell him to f… off. Rick.”
Given that the House committee released these documents today, we wonder if Veltri is any calmer now.
Chris
Well I don’t think this looks good for either company. The Schering response is terrible but not surprising given the company’s track record. However, the request from Soren Christiansen is no better. Christiansen is a senior business leader and he is referring to this lead investigator as an “important customer.” It is of course true that since clinical investigators are healthcare practitioners in their respective fields, they are thus also in a sense customers who might use relevant products in their clinical practice. However, they should not be retained as investigators because they are “important customers.” That calls the science and the fees into question.
I think this highlights a key problem in PhRMA. PhRMA business leaders only see the science as a means to an end, they have no respect for the scientists or the scientific process unless it advances their own business goals. Soren Christiansen deserved to be concerned and certainly should have written to Schering. But he should have been concerned about the integrity of the science, not just the company’s relationship with an “important customer.”
Kastelein is a scientist and was serving in the critical capacity as lead investigator. It is concerning to even ponder the apparent wheeling and dealing that was going on behind his back. But it is also very telling to see what concerned Merck — not the integrity of the scientific process but its relationship with a key customer.
It is perhaps unfair to hold different companies to different standards. But I have been in PhRMA for 20 years and the conduct of Schering never surprises me. But Merck was a scientific vanguard. It’s so disappointing to see how far Merck has fallen. Shameful.
Justice in Michigan
Chris says it well.
This moves us off the immediate topic (which should certainly continue), but I wonder if people who have been in pharma for some years think that companies’ standards more generally have fallen - in the ethics/marketing area - over, say, the past ten years (or whenever you would date it)?
Dan
It’s an illustration of the flawed concept of co-promotion.
Bob Freeman
Justice, I started in the industry in 1985 after being in academia for a decade. I had complete “academic’ freedom up until the very end–I frequently had to apologize but remained unscathed (and unrepentant). Has industry fallen? Absolutely, and it’s falling like a rock.
I blame it on the following factors: 1) operating models developed by consulting companies that rely on matrices, the nature of which leaves very little accountability for bad behavior; 2) the growing influence of PR agencies that “spin” and practice revisionist history; 3)the proliferation of incremental therapies (”me too’s” if you prefer) that require bloated sales and marketing organizations and questionable DTC advertising; 4) senior leaders who do not want feedback and rely on consultants for strategy; and 5)a growing reluctance to tackle innovative research internally. Finally, the industry was more socially responsible and ethical when founding families controlled a majority of the company’s stock. Now, there is no loyality to employees or the public in spite of corporate PR spin.
A bit harsh, I admit, but accurate.
Justice in Michigan
Bob - Much thanks. I am very interested how others view this as well. Also - if you believe there has been a downward trend - I would be very interested to hear about any _substantial_ efforts to turn the tide. I don’t mean cosmetics, of course, but initiatives that impact the core of a company’s everyday practice and culture. Thank you.
Dan
Mr Freeman,
Your comment appears rather familiar to my situation and views, so thanks for writing it with such honesty and conviction,
Dan
Bob Freeman
Dan, thanks for your comments. Admittedly, I engaged in a diatribe but I am increasingly appalled at the industry’s behavior and its stubborn reluctance to discuss issues in a straightforward manner. If I read anther PR from PhRMA or any company that “xyz will have a chilling effect on innovation” I’m likely to choke on my own vomit.
Justice, I will get back with you tomorrow on specific changes that might change the tide. Unfortunately, I don’t see dramatic changes in the near- to intermediate terms.
M Helm, MD
J.I.M. and B. Freeman
First, the email string is both appallingly crass and immature. The “important customer” reference is a bizarre characterization. Who was really buying and what was really sold in that relationship?
That Veltri, or any executive worth their pay, would write and send an email response like that is amazing. Isn’t this is what we used to call a CLM? Who promoted this guy, and why did no one make sure that he knew what was apropriate to launch into the ether?
I started in PhRMA only a couple of years later than Bob, though I took a break for medical school and residency. Over the past 20 years I’ve been all of the stakeholders described in J&Js Credo. Bob has hit many of the issues I’ve seen. (Whenever I had to interact with the account team from Burson-Marsteller, I always felt like I needed a shower.)
A couple of suggested additions to the contributors to the decline and fall of PhRMA:
- increasing emphasis on quarterly earnings and profits (not limited to PhRMA),
- consolidation in the industry and the locker room (my sales force is bigger) mentality along with the pressure to generate blockbusters (real or imagined) that came with it,
- increased realization that consumer marketing can cover a multitude of deficiencies in clinical performance,
I think there has been an erosion of the value PhRMA corporate cultures have placed on science/health/
innovation, and increased appreciation for surface appearances and holding to the corporate line - in short valuing looking good rather than being good or doing good. Bob may be right that the removal/dilution of the founding families may have contributed, but it may also be that PhRMA boards just work like most other corporate boards these days.
Justice in Michigan
Again, much thanks for these responses which are extremely informative. Before we move to “what _would_ change it,” I am personally interested in any programs underway, in any company, that are already seriously addressing these issues. I know there are lots of people in the industry who care about this enormously. I also get the “feeling,” that it has been hard to translate those convictions into significant changes of practice and culture. I hope I’m wrong, so want to find out if there are any vanguards in that direction!
Doc
This entire Enhance situation has been a Godsend to the general public. Big pharma tries so hard to enhance (no pun intended) their public image as the benevolent life givers of humanity. It is about time that the public saw “the man behind the curtain”. My long time experience with marketing and sales admin/management is that most have no scientific background (much less a medical background), are convinced their product is better than any other theraputic choice and hold doctors in distain as unknowing idiots if they are not using the company’s meds in as many patients as possible. Profits - yes, greed - no. If the public could hear the typical discussion about how the marketing department develops ‘campaigns’ to sell their wares, they would riot in the streets.
Nathan
I’ve considerably less experience than Bob or M. Helm, but it sure seems from my vantage point that M. Helm hit the nail on the head with “increasing emphasis on quarterly earnings and profits”. However, that has been a shift that has occurred THROUGHOUT CORPORATE AMERICA. We really can’t blame just Pharma for this — our executives are jumping on the same bandwagon that every other company has jumped onto. If we can turn around our earnings for a couple of quarters, then our stock price will jump and everyone will be happy. No one seems to think very hard about how their actions today will impact earnings 5-10 years from now….
Frankly, we could put the blame for that “short-sighted” attitude right on ourselves: We (as Americans) want short-term fixes. We are unwilling to fix our social welfare system or to address our oil dependency. Meanwhile our economy goes into a tailspin when housing prices stagnate for a few quarters. How can corporate executives be held to standards that we can’t hold ourselves to?
ol cranky
Justice:
I’ve been in the industry since mid-90’s and I agree that bio/pharma companies have, regardless of size or status as public vs private, have gotten exponentially worse over the years. The lack of ethics/integrity that were at a dull roar when I started in the industry has gotten exponentially worse with an overt disdain for compliance that is creeping into clinical development by way of medical affairs. The “very important customer” comment is not unique with regard to PIs on clinical trials and is not limited to national or international level KOLs. Usually, the term is changed to very important OL, physician or something else to indicate you must use the doc, give them whatever they want (financially) regardless of ability to conduct the trial and never shut his or her site down for lack of oversight/protocol violations or any other legitimate reason for concern. The message is clear: the guy writes script for our products, so you make him happy (if he really is a KOL you need to make him even happier so he will tell everyone else to write for a company’s products).
Execs and Sr Management will publicly say compliance is key while not only breaking every rule there is, they will root out anyone who complains out the do as I do not as I say attitude. At smaller companies these people have the ability to root out those involved in clinical research who are naive enough to think they are immune to the screw compliance attitude. This becomes a bit of a vicious cycle because those who play ball are the ones who are rewarded financially and promoted so they can be the enforcers of the “maintain a facade of compliance but do whatever makes it easiest for you to make Sr Management/the board happy” attitude.
Pharma suffers from the Hollywood complex. Like the movie and recording industry, this blockbuster attitude is destroying the industry itself. Unfortunately, with pharma it’s also hurting healthcare and patients (as well as the economy).
You want it to change?
Compliance needs to be enforced and lack of it needs actual punishment with teeth. If there’s actual fear of audit and companies, key personnel, study staff (at sponsors, CROs and/or sites) really facing tangible consequences of their actions, things may improve.
Increase development activities and competition by preventing any more mega-mergers (big pharma mergers and/or acquisitions of mid-sized companies by big pharma). A me too isn’t necessarily a bad thing since some people respond appropriately to everything in a class (we don’t know enough about pharmacogenetics just yet) and the competition could help drive down prices.
I hate to say (and never thought I would) but maybe all clinical trial agreements and vendor work orders (CROs) to conduct trials should be public. These costs are tax deductible so let’s have a glimpse to see if there are hidden kick-backs or other financial irresponsibility
Go European when it comes to independent research. The work is more credible if a pharma company isn’t pulling the strings (either to make their product look good or to hurt the opponent’s product), so let’s make sure they aren’t. If pharma is to continue to provide grants and product to conduct these studies, require they be conducted under an IND (seriously, you have no idea how many poorly designed protocols that don’t even detail study procedures I’ve seen some companies push to fund).
ban DTC
I’d love to see an increase of non-profit bio/pharma development companies. It would be interesting to see if those companies end up with a better track record for development of non-blockbusters since they won’t have the bloat of traditional companies and more of an impetus for good quality research
Big Pharma Employee
To ol cranky,
Big Pharma Employee
ol cranky is on target. As a health care provider in the industry for over 20 years, all cited is on target. The movement for quarter on quarter earnings increases with little value on 5 to 10 years goals and management of the scientific research by marketing contributes to the demise of the focus on the patient. Sales meetings with “stand and demand” and “return of investment” tag lines have come to surface since the late 1990’s. Research is in bed and intertwined with marketing so completely that it will be difficult if not impossible to untangle them. In addition, the money and power to silence those who make a whimper is beyond one’s imagination and collectively makes the FDA and inspector general’s budget pale by comparision. The problem is obvious, yet the solution remains elusive.
Big Pharma Employee
Ah no, the solution is not elusive and is simple in nature. Let the lovers disentangle themselves… not through legislation or senate hearings. Guilty parties have been levied with fines in the 10’s to 100’s of thousands while corporate laughs all the way to the bank…it’s the cost of doing business. If fines levied for guilty parties were 10% ro 15% of the parent company assets…there would be no laughing. If fact, the fines could help fund the FDA and inspector general’s office to better uphold the current legislation without tax dollars.
Laurie
I never thought I’d see the day when I agreed with all the pharma folks on here, but today is that day.
Pharma Researcher
I joined pharma a decade ago on the research side of the business. Our industry is a disgraceful business nowadays.
Put the perps in jail along with the CEO. Fine the company min 5x last years sales up to the total sales of the drug since it was released. Fine the BOD members min $1 mil each and prevent insurance or the company from paying it for them. People respond to incentives. Right now, the fines are tiny and no one goes to jail. They have every incentive to cheat, lie, and thus kill patients because they make big $$ when they do it.
Bob Freeman
M Helm, Justice, Ol Cranky et al.
Thanks to everyone for their comments and I find agreement with the statements and eloquence with which they were delivered. Certainly, the pressure to deliver numbers on a quarterly basis has contributed to the bad behavior of all corporations. Add to that a business or operating model that relied on a portfolio of blockbuster drugs (annual global sales of $1 billion plus) and you’ve got a receipt for failure in terms of sustainable double digit growth that Wall Street demands. Acquiring other companies to get synergies from headcount reductions and “improved” R & D productivity (a myth) contributed to the mess we’re in as others have accurately noted. Finally (for this reply) many companies are now, because of past legal problems, run by the general counsel’s office–this, in and of itself, has a “chilling” (I threw up in my mouth a little because I hate that pharma-speak word) effect on open and honest debate.
Dan
Bob,
If you feel like producing more emesis, think of those times you have been at pharma meetings and execs express thier elation to reps about the projected increase of various diseases states for which thier products treat.
Bob Freeman
Dan, it just progressed to projectile.
This too shall pass.
Bob
B. Martin, MD
I don’t know Christiansen or Veltri, either one, but c’mon…who hasn’t felt Veltri’s succinct frustration at some finger-wagging colleague/partner (a pharma marketing type, no less) who makes it his job to tell everyone else that you’re not doing yours. We can all feign shock at Veltri’s colorful response, but the e-mail (which really is kind of admirably funny) was obviously meant to be private and stay private.
And just because Veltri works for the much-malgined SP, doesn’t mean Merck’s Christiansen’s NOT a prick.
Justice in Michigan
Once again, I really appreciate the thoughtfulness of these remarks.
To Laurie - We should not be surprised to agree. No one (almost) wants to work in an industry or institution that is getting blasted from all sides, not always fairly, but which makes it that much harder to look honestly at what _are_ issues and problems. While there will be disagreements on this board, we are generally all on the same side of how how things _ought_ to be; and feel the same shame (even projectile shame!) when we are part of what is not.
While I don’t have the overview to really know, I would tend to agree with Nathan that lots of these patterns are more general than pharma. Just in the past few weeks, I’ve seen the senior people of my own university bare-assed lie for a week (this concerned denying programs designed to help star athletes get around NCAA minimal academic requirements). As we all know, even the church is not “above” heavy-duty “promotional” (and CYA) operations at various times.
That said, others also note more particular “temptations” to trespass in pharma - esp. the blockbuster model and the ways marketing has intertwined itself with (if not fully trumped) science.
In any event, this board is at its best, in my view, when we can have candid such candid exchanges rather than dueling talking points (which we all know so well and have heard so often). This is a shared problem and a shared concern. It has aspects tht are both particular and general. And it appears that its mediation will require changes that are both inside and outside what has become everyday normative practice.
As always, and even though I often emphasize external organs of accountability, I am especially interested in what can be done from within. Despite the pressures and patterns many are describing, there does not seem to be a shortage of people who also would welcome the chance to make substantial changes if they found the means, the support, and the leadership to do so.
Dr. Sal Giorgianni
At the suggestion of Justice In MI, I read the entries in this blog regarding changes in PhARMA culture. If you would like to see a bit of my perspective on all of this please check out my post today on the Pfizer Cafeteria-Gate story.
If others would like to discuss the issue of the change in PhARMA culture I too would be interested in this topic. I am afraid though, regardless of how highly I think of Pharmalot, I would be circumspect in using this as the best forum to do so.
One of my pet-perspectives is that one of the important inflection points in how PhARMA began to change its views and its approaches to the marketplace happened with the advent of the broad influx of generics and the rough and tumble commodities market approach that the proliferation of generic companies brought to the market place. To this day I remember lamenting with to one of my colleagues in regulatory affairs and medical that the pressure to meet the market dynamic changes in the mid-80’s was changing the “worthy competitor ” approach (sort of in the style you would see in the NFL – hard hitting but with sportsmanship valued) that I believed was used to the “street fighter” approach (sort of what you would see in the NHL [sorry hockey fans] – hard hitting both while they were looking and when they were not ) seen in other price-sensitive commodity markets.
I continue to believe that many of even the contemporary problems that afflict this industry can often be traced back to the commoditization of pharmaceuticals.
Paul
I don’t see anything inappropriate in the Merck guy’s e-mail. Seems like he was concerned and asked a valid question. The fact that he called him a customer is not a big deal to me.
What I find totally inappropriate is Schering’s and Vetri’s response. That is totally wrong in any context even if it was true. I am not surprised that a middle of the road mediocre company would act that way, and it seems to be consistent with their whole mishandling of Enhance.
Phrma Researcher
I disagree with Paul and agree with many of the other commenters. I would not say that merely calling Kastelein an “important customer” is a BIG DEAL but it certainly doesn’t cast a great light on Merck given this person’s position and the issues at stake. Under the Anti-kickback statute it is illegal to make payments to physicians in order to induce prescribing. There have been many cases where physicians were paid to conduct research where the researchers were selected merely because of their business and where the studies lacked any real scientific merit. The payments were in essence kickbacks. Physicians should be selected and paid to perform clinical research projects based on their skills in clinical research, not because they are important customers. If they are selected because of the business they bring to the table, then it does in fact call the financial relationship and more importantly the integrity of the science into question. Here it seems very clear that Kastelein was performing real and credible services. However, senior executives in this industry should be more careful. The words that Soren Christiansen used tend to suggest that Dr. Kastelein was retained as an investigator because he is an important customer, not because of his scientific credibility. We certainly must accept that researchers can be prescribers, but as we deal with them in their research role and make important decisions about research that may impact public safety, their prescribing should be irrelevant.
Yes, Soren Christiansen’s words are certainly no “big deal” given the sad place of the industry today. But if you understand the scientific process, then you would understand that Mr. Christiansen probably does not.
Soren should have been asking questions. He should have been asking why the lead investigator of a large and important clinical trial would be cut out of meetings involving the results? That would have been a good question. It is not just a question of how Soren Christiansen referred to Kastelein. The question asked simply reflects a perspective that Merck was far more concerned with its relationship with a customer than the sciencific process. Perhaps it is true that in today’s industry that is no “big deal.” But it should be.
Yes, we are in an industry that can and should make money. Our american history demonstrates that reward fosters innovation. But somewhere along the line we tricked ourselves in PhRMA to believing that we just deserve the rewards period. And that is not the case. The innovation has to come first. And that means that the science has to come first. We are not going to be rewarded for high-priced products with unsubstantiated benefits simply because we are great at spinning the results. Unfortunately, we have gotten so good at spinning that some folks have started to believe it. But over time, it catches up. In my opinion, Merck and Schering tried very hard to spin their way through the science and right to the reward. And for a short period of time it worked. And I think that Merck tried something similar with Vioxx, hoping to bypass the science and again move ritht to the reward. And that too worked for a while.
We are in grave trouble because our business leaders seem to beleive their own spin. They might even think it’s science. But it’s not. Competition and the free market combined with patents foster innovation because the reward is there for the truly novel new therapy. But we need to wake up and remember that the science has to come first.
New ideas, scientific rigor and innovative medicines deserve reward. Data manipulation and marketing spin deserve exactly what they ultimately bring.
Dr. Sal Giorgianni
Re Pharma Researcher
Data manipulation is a bad phrase and an unaccptable practice.
Marketing is not a bad word but improper marketing is an unaccptable practice.
Spin - well not I’m not sure. After all your spin on the process and the situation being discussed is - I presume at least you would agree - a good one.
Doc
To Dr. Sal,
While I appreciate your thoughts, I believe that the industry on the promotion/marketing side changed in the early 80s. This is when I saw pharma cos leave hiring people with some kind of scientific background/education en masse to non-science folks who essentially believe whatever their company tells them. When many reps etc were Rphs or nurses, they seemed to have a better understanding of patient care and some degree of ethical promotion. Today’s environment of sell or get cut by your company has led to many aggressive tactics all the way to the top. I wasn’t a big Vagelos fan when he was CEO of Merck, but he seemed to have a sense of patients first. Thats gone.
Dr. Sal Giorgianni
Re Pharma Researcher
Data manipulation is a bad phrase and an unaccptable practice.
Marketing is not a bad word but improper marketing is an unaccptable practice.
Spin - well, not I’m not sure. After all your spin on the process and the situation being discussed is - I presume at least you would agree - a good one.
Dr. Sal Giorgianni
To All
Sorry for the double post Re Pharma Researcher
Re Doc
Obviously, this is one of those days when I have lots of time on my hands. But this is one of those topics I have given a lot of thought to.
I don’t disagree with anything you have said, so no need to beg exception to mine. The timing of the shifts in culture and approach in PhARMA were, of course, not happen in quantum bursts but slowly. The shifts did not even happen homogeneously in any one company, let alone in the entire industry. So sure I can see differences in perspctive on when things happened.
Your comment about who does the hiring is a good one. Yet, HR is only a functionary of the hiring mentality of the VP in an area. One interesting side note about your statement on timing, the early to mid-80s was the beginning of the rise of high-powered MBA schools. May be only a coincidence, maybe not. I can only observe that many of the recruiting efforts of PhARMA prior to the mid-80’s were somewhat limited by the size and stature of the industry compared to The Big Boys of the Dow Industrials. Later on when PhARMAs grew into that rarefied club I noted that we began to slowly bring in and then almost exclusively bring in new managers from high-powered MBA schools. Very few were promoted from within. Very few came into positions of authority having been indoctrinated into the culture and ethos of health care marketing. They came w/o a sense of this industry (as no one in MBA schools could really teach about pharmaceutical industry or health care delivery) but they did come with notions of organizational management, marketing and finance form the culture of such successful organizations as GM, American Airlines, US Steel and Exxon. These are the standards of style and culture that this new breed of power brokers brought to PhARMA in its business adolescence.
Phrma Researcher
Well I wish I could understand what the so-called Dr Sal writes but I must admit I don’t have a clue.
He says “Data manipulation is a bad phrase and an unaccptable practice” as if to suggest that I wrote something different. The entire point of my post is that data manipulation is hurting the industry. But ok apparently it’s not really a point until the Dr writes it. Excellent work. It’s all very clear now.
He writes: “Marketing is not a bad word but improper marketing is an unaccptable practice.” I said nothing about appropriate marketing. I made it very clear that our PhRMA companies deserve the rewards that truly innovative medicines offer. That of course includes appropriate marketing and selling.
He writes “Spin - well, not I’m not sure. After all your spin on the process and the situation being discussed is - I presume at least you would agree - a good one.” I have no idea what this means. But on the third reading (I am apparently slow as compared to the good Dr. Sal) I concluded that he thinks spin is acceptable since in my own and many of the posts here on Pharmalot we are “spinning” the Merck-Schering situation. That certainly may be so. But I don’t think so and in the end who cares what I spin.
In my opinion, real “spin” happens when someone in a position of some authority with access to correct information offers it to the public in a manner that is less than transparent or manipulated in some way to create an impression that does not directly correspond to the data. When PhRMA executives have non-public scientific data about their medicines that they reveal or don’t reveal in a manner that misleads the public then at a minimum that is spin. What people post on Pharmalot and other sites is subjective editorial opinion from people with no inside knowledge. And people reading it know that, so they can give it whatever little weight it deserves. It is calculated to create discussion rather than provide in-depth bakground or information. But when a PhRMA executive provides scientific data, the perception (and hope) is that the information is truthful and complete. But when that information is spun to create a different impressions the chance for harm is real.
So certainly you can call everything on here spin because it is all just personal opinions, mine are no more relevant than yours. And everyone has the ability to take them for what they are worth. No one listens to me at my own company so I sure don’t expect anyone to listen to me hear. That is fine. But if you honestly believe that a company spinning its own efficacy or safety data is the same thing as people spouting off on pharmalot then you my good Dr are very much part of the problem.
Justice in Michigan
Dr. Sal wrote: “If others would like to discuss the issue of the change in PhARMA culture I too would be interested in this topic. I am afraid though, regardless of how highly I think of Pharmalot, I would be circumspect in using this as the best forum to do so.”
I’m guessing the concern is that people’s comments could be somehow taken out of context and misused, is that correct?
I respect that possibility, and yet there is certainly nothing that has been said that has not been said by many others in one forum or other, or that is specific to a particular company or situation.
On the plus side, I believe reflections like this provide an opportunities to get beyond the tedious polarizations and learn genuinely important things.
Former pharma Marketing Exec
I have been quite busy lately, but wanted to chime in. I started in pharma business in the early 90’s - has it deteriorated? Yes.
I think all of you who have taken the time to post here are hitting the nail on the head with regards to the problem(s).
Definitely, the comodification of the health care industry in general is the underlying problem. The over use, in my opinion, of PR firms wanting to “manipulate” the data and spin tales of blockbuster miracles are very definitely factors,but the ability of the marketing department to override their own medical/regulatory affairs department has contributed much to the equation.
How can we fix it? There have been very good suggestions here. Compliance to pharmaceutical marketing rules and guidelines is key. I have said before, and I will say it again - transparency. Full disclosures. The return to completely unrestricted educational grants. Marketing departments should submit all material to their internal medical affairs and regulatory departments and live by what they are told. Likewise, pharma needs to empower their own regulatory/medical affairs department and I would include incentives on adherence programs. All raw data needs to be fully disclosed to the PI’s.
Perhaps there should be a special board established, not sure what to call it, where physicians can, free from any consequences, address with their peers, any situations of interference from pharma on clinical studies data and information.
We as citizens, regardless of status in the industry, should never lose our ability to question results and outcomes and demand and receive prompt clarification.
DTC should be stopped immediately. Patients should be able to receive pertinent information from un affiliated, un-biased, un-branded publicly available information.
We must understand the consequence of drug information and the impact on the patient’s access to unencumbered informed consent. Not only does misinformation harm the patients physically, but we must understand the obstruction of decision making and the impact on trust in the system.
Thanks so much Justice, for prompting this discussion.
The memo by the way was appalling, but I am so glad it is now in the public domain. Perhaps the general public will understand the situation and use their voice more.
ol cranky
unfortunately, way too many physicians are [a willing] part of the problem
Dr. Sal Giorgianni
Re Justice In MI
Yes, comments could be taken out of context. Also, inappropriate comment, unhelpful sniping and personal attacks can sometimes pervade serious and well intended conversation conducted in the wide open blogosphere. A moderated forum is one way to help facilitate good quality discussion and possibly consensus. This takes a lot of effort to do but this is an important topic.
I agree to with many of the comments here, but regrettably they are comments. Only if PhARMA Executive Committee members sit down, as they did a few times before (such as on user fees, and the PhARMA Code of the 1990’s) and seriously agree to hold the line will any meaningful change occur. But history suggests that such meeting of the minds has only occurred to avert some imminent disaster.
Yet, I am afraid some of the other cultural shifts in the industry have made cultural change if not impossible most unlikely. A kinder gentler PhARMA would be welcome.
Lisa Van S
Former Pharma Marketing Exec,
How did you get to be so wise? Ever Consider becoming a speech writer, the Democratic Party could sure use one.
Lisa Van S
Dr. Sal,
A moderated Forum! hmmm, Are you offering?.. Will that bring about change, transparency and full disclosure?… or is it just another means of muzzlig the disgruntled consumer,.. who I believe has the same rights as Pharma folks. Where would we be if parents didnt push for, and demand hearings on the suicidal/homicidal effects of antidepressants in children? Those who deliberately withhold vital information from parents are no better than a pedophile.
Paul
This is to Pharma Researcher and others who are referring to the US anti-kickback statutes in relation to Christiansen calling Katelein a “customer”.
1) It is important to realize that US law does not have jurisdiction over the whole world. Kastelein is not a US prescriber and the anti-kickback statute is specific to activities in the US - it can only be so.
2) The anti-kickback statute is with respect to prescriptions written by the “receiver” physician which are paid by the US government. Kastelein does not practice in the US and therefore cannot be implicated in a such a scheme.
3) Simply calling someone a “customer” is not an offending act. It might add to an offense if in combination with lots of other corroborating activities, but just calling someone a “customer” as a means of insisting that they deserve an appropriate communication is not bad.
The problem with all these accusations is that they start from the premise that someone is guilty right off the bat. We would have a much greater impact in this blog if we were more pragmatic and balanced.
Bob Freeman
I’m a bit off tonight–our academic department lost a great friend and colleague today from a systemic strep infection that resulted in multiple organ failure. He was only 32 and had already received a NIH young investigator award. I am saddened by the personal loss and am musing about the loss of potential discoveries that may have come from his lab.
I also wonder where the new antibiotics are to treat resistant bacterial strains. Seems like we have enough drugs for ED, dry eye and insomnia. (Yes, I do understand the difficulties of infectious disease research and the market economics thereof. I am lamenting the loss of a friend and the failure of drug therapy to reverse his illness)
To Justice in Michigan, meaningful change will only come with a new crop of bold, risk-taking CEOs. The current crop is mediocre at best. Without complete and total buy-in at the top, change will be PR-driven and a process, the steps of which will be checked off without regard for impact. Those who are within companies who advocate change are marginalized at best and cashiered out worse. All of us in industry can list programs that appear to address corporate responsibility but I doubt many will be either impactful on corporate behavior in the long-run or sustainable in a challenging environment.
i will add more when I can focus better.
Justice in Michigan
Bob - Very sorry to hear about your loss. And, from what you say, the loss to all of us.
Yes, my sense has been that ethics officers and CSR programs are too often yet another marketing device. But I am heartened to hear from many of the good people here.
Bob Freeman
Thanks for the kind words, Justice. We are really going to miss him.
One of the other problems with trying to change pharma companies is that corporate structures have become very lean and have, oddly enough, not as much control as one would think over brand teams. This means corporate initiatives can be largely ignored if not subverted by brand teams’ sales and marketing decisions. I’ll try to elaborate a bit more on this tomorrow and would welcome others’ though. Decentralization and autonomy of brand teams is, in my opinion, one of the major factors contributing to unethical behavior.
ol cranky
Paul:
It is very naive of you to think that an exec who refers to (and, therefore thinks of) an ex-US KOL as a very important customer does not have the same attitude and thought pattern in countries in which special treatment in the forms of kick-backs are not compliant.
Grift is grift regardless of whether it is legal in the places it is occurring or not. In my experience in this industry, when Medical Affairs/Sales/Marketing/Sr. Management refer to any HCP or institution as an important or very important customer, they are reminding you of that customer’s current or future impact on sales and that you must make that customer happy to ensure not only prescriptions written by that customer and/or that the customer will be able to help you sway others to prescribe. I hate to break it to you, but way too many of those important customers are not necessarily prescribing or speaking in favor of a compound based on the data and science, they will use their important customer status to get their way and threaten to discontinue prescribing a company’s products (or even help promote a competitor’s product) because, in denying them, you are not showing them the respect they feel they are due. Even when this is legal and acceptable in other countries, it is still unethical.
As for it being OK to think of Kaseltein as a VIC because he works in Amsterdam, you seem to be forgetting that ENHANCE is a big deal trial that was to be used to support promotion here in the US. If it was conducted under an IND, IND regulations apply to the study sponsors. Even if not, the important customers are being used to sway prescribing in the US, so this is a legitimate matter of concern.
Rep
That is SP for you, speaks volumes about the company.
BP MD
I know both of these indiviuals in the MSP joint venture. In my opinion, Veltri is accurate in his assessment of Christiansen, simply another marketeer trying to stir up the pot. Unfortunately, the colorful language is now in the public domain. It’s funny, but a little crass. It pales in comparison to some of the stuff I’ve heard in the boardrooms in the past. Veltri is really a very bright guy who has gotten caught in this huge mess of ENHANCE. The study is negative, but he didn’t make it that way. He’s also done some very good work in research in the past that is admirable. The real villians here are the top executives, not the researchers.
Former pharma Marketing Exec
Lisa,
To your question; “How did you get to be so wise?”
Like I’ve said, I have worked in the industry for a very long time. I am very fortunate that the teams I worked with followed the rules, worked with our regulatory/medical affairs department and worked very closely with the government to ensure that we were doing the right thing. There were some very ethical people during the peak of my career and I was then, as I am now very aware of how lucky I was.
So, why the Former in my moniker? Not too long ago, I was diagnosed with an incurable disease. I am right in the middle of all the things I have worked so hard to eradicate in this industry.
It was a very strange thing to have to tell my Doctor that I wouldn’t be his average naive patient. As you can imagine we have had many interesting conversations when deciding on my treatment. So, I understand your own battle.
However, I have made many differences in how industry and doctors interact in my disease area (which I cannot share at this time). Patients who were/are from the industry have the knowledge and know how to make things happen.
I firmly believe that we are making a difference and we are affecting changes and I think this blog forum on Pharmalot is key to making those changes happen.
So, what I post here are not just comments.
So, let me throw this out to you Lisa, and to Justice and to Bob. If you want to form a panel of sorts and put together an ethical committee that is comprised of industry and patients please let me know - but make sure you are serious - because I am.
Speech writer for the democrats? I am flattered, but they haven’t asked me ;-)
Be the change!
Lisa Van S
Former Pharma Marketing Exec,
Several members of my family have been effected by diseases like Myotonic Dystrophy and Multiple Sclerosis,.. My niece Melissa died from Spina bifida and a cousin to Down Syndrome. My question for years have been where is the cure?
Maybe,.. if industry placed their energy in finding cures, rather than pushing me too drugs to Infants, Toddlers, children, and Adolescents,.. Maybe, just maybe they would than begin to reverse the discust that the consumer has for them.
I would love to participate in a roundtable discussion, Im game,..Lets do it.
Lisa Van S
Bob Freeman,
My deepest sympathy to you, and your collegues.
Dr. Sal Giorgianni
Re: Lisa Van S
I am sorry that I was not clear about my notion of a moderated forum - an inherit limiation of blogs (compounded by a lack of entheusiasm for typing).
I would not at all suggest that such a forum be a stacked deck. There are ways to craft such forums to have representation from different segments of society and through the spectrum of positions. The key is good moderation, think Tim Russet. What a good moderator does is keep constructive tension and build an inclusive balanced dialog that works towards a particular programmatic goal. That goal could be a range of things such as defining the topic, or key-levers or driving to consensus or action items. This, of course takes a lot of work.
I am sure that all of this dialog is making our host, Mr. Silverman, either grimace or grin.
Re: Former PhARMA Mkt. Exec.
I too am serious about a panel to address these issues. Only a serious and thoughtful dialog will move those in PhARMA, government and media who can make a difference.
Re: All Who Are Suffering or Frustrated (Posted and Annonmous)
My sympathies and prayers to all of you and those you care about.
Your personal perspectives and experiences are why the stakes are so high here. All, researchers, government, industry, payers and media can all do a lot better.
Justice in Michigan
FME - I would also be deeply interested in serious and respectful work with you on these issues. There is little I think is more important. You can reach me at justiceinmich@gmail.com (not surprisingly).
ol cranky
I have to point out that one of the problems in American culture is an unrealistic expectation of the magic bullet/cure for everything. This is what often lands people in realm of “must take X” and/or “must do Y” that leads to inappropriate use of medications.
In many cases, finding an adequate treatment for disorders should be sufficient in the near-term with, where appropriate and applicable, a cure for a long term. In some cases you would not like the answer to your where is the cure question. The only cure for down’s syndrome and the co-morbidities that come with it is not to be born with it; the preventative measures for that is something I’m quite sure you would not condone.
Drugs, biologics and devices are not the only the only potential route of treatment for what ails us. Pharma companies are not, and should not be, the sole source or support for advancing scientific/clinical research.
Semi - OT (and please note that I do not want to get into some skewed hystrionics on the psychotropic drug use topice) but I was wondering if the details on the use of neuroleptics and other psychotroics in very young children indicates whether these kids are in-patient (including “sub-acute care”/medical rehab or out-patient facilities). There seems to be an awful lot of neuroleptics being used to manage patients that spend more than a couple of weeks in ICUs. While I do understand some of this use, I am very concerned that a vast majority of it to make patients more manageable (pliant) for staff as opposed to providing any actual clinical benefit to the patient him/herself.
laura
I’m not a industry insider, or a doctor, or a lawyer. What I am is a victim. My mother was killed by a medical device over two years ago and I, along with my family, have been unable to let her rest since the day we let her go. We know that her death was the result of the device, we know that the device company is not doing anything to prevent this from happening again, and we know that it is still happening, and yet we feel helpless in stopping it. Thank you to all who are spending your time and efforts to make the public aware of the injustice that is being forced upon them in order to protect big business. I truly hope that Justice in Michigan, and Former pharma Marketing Exec, and Lisa, and Bob Freeman, and Dr Sal and anyone else who can contribute with compassion and knowledge to a forum or committee that will bring this issue to the forefront are successful in their goal. Knowledge will provide change.
Justice in Michigan
Laura - Without minimizing real differences in experience, perspectives, and convictions, I think there are serious grounds to work together on these issues.
As said elsewhere here, even though I usually write about accoutability in the form of civil liability, I think the real hope for change resides _inside_ the industry.
As we have heard from many in this thread, things were not always the way they are now. That means they do not need to remain as they are now.
Bob Freeman
Laura, Justice, Sal, Lisa et al., until we are able to see consisent changes in industry’s behavior on issues related to responsibility and accountability, pressure will have to come from outside the industry as it is now. I noted earlier that I do not see meaningful change from within until the current cohort of senior executives is replaced by visionary change agents who hold the industry to higher standards. Until then pressure through litigation, Congressional pressure, state legislatures, concerned individuals like yourself and the from the press is our most viable option. Of course, CEOs are appointed by Boards of Directors, so they too should be a target for change.
Lisa Van S
Bob,
Hopefully,.. we will see the resignations of key FDA officials in 2009. You have to start somewhere.
Bob Freeman
Lisa, I couldn’t agree more. In fact, although I (and we) could elaborate, your statement says it all.
Lisa Van S
Bob
Id start with Dr. Tom Laughren,… A classmate of his daughter,. who was 12, was given Zoloft to treat test anxiety, she hung her self from her canopy bed. My opinion,.. the man has ice in his veins!!!
Justice in Michigan
I won’t elaborate … other than to say that the part of external accountability that relies on civil liability will almost certainly soon be history.
Some will welcome that, I understand. If it were balanced by some of the other changes discussed here, it would certainly be less ominous.
Bob Freeman
Justice et al, As we’ve discussed the current operating model of big pharma has relied on the development and launch of products with $1 billion plus on global sales. (or, the launch of oncololytics or other specialty products that have lower marketing/sales organizations). Conventional wisdom states that the model is not sustainable. Looking at the trends in outsourcing R & D and the formation of alliances with biotechs and niche pharma companies (along with downsizing), it appears that the new model is more of a virtual company with a sales and marketing focus and culture. Taking R & D off the books and letting smaller firms take the risk of innovative drug discovery certainly seems in evidence.
Given this trend, if it is indeed the “real” evolutionary one, I wonder if meaningful reform is possible. Marketing has already trumped medical, so this may not as big a deal as I pose it.
Laurie
“Some will welcome that, I understand. If it were balanced by some of the other changes discussed here, it would certainly be less ominous.”
I think this is key. If we had a fully disclosed system of drug approval, long term surveillance of side effects, open reporting of potential risks and side effects, and rapid removal of dangerous drugs from the market, then the attempt to limit lawsuits becomes a bir more palatable.
But until that day it is only through litigation that the truth comes out. Taking away that option with no change in the system as it stands puts patients in danger that they won’t even know to look for.
Nathan
This started out as a decent conversation — we all (even the insiders) recognize that there are problems in the pharmaceutical industry. But the conversation seems to have descended into a “let’s fix the evil pharma corporations” dialog. As I’ve pointed out many times, the pharmaceutical industry is made up of lots of individuals who make individual decisions. The vast majority of what we do in the pharma industry is perfectly ethical, perfectly legal, and very benificial to society. Don’t forget that. In your haste to fix this “evil corporation” you may well throw a wrench in all the good stuff that we do.
Dr. Sal Giorgianni
Re Nathan
This drifting is what usually happens in the blogosphere. Hence, my view that meaningul dialog is best obtained with expert moderation.
Laurie
I don’t believe that Pharma is evil. There are alot of good lifesaving drugs out there. But you have to admit that some of the latest revelations do highlight some of the inadequacies of the current system of regulation.
I advocate for full disclosure to those who are swallowing the pill. I don’t think that’s asking much. If a drug has such a good profile, then this shouldn’t be a problem.
Bob Freeman
Nathan, no one discounts your point that there are many honorable, ethical people in the industry. In my experience that is indeed the case.
With the relative power that product teams now have, you have behaviors that occur without the checks and balances you once had when there was stronger oversight. This, I would argue, is a major problem. Again, from my own experience I have seen the actions of one person bring great harm to both a brand team and the corporation. The self-correcting, ethical behaviors don’t get attention because problems are prevented.
And yes, I agree that skilled facilitators can keep a thread on topic.
Justice in Michigan
Hi Nathan - We are a diverse group. Inevitably, there are going to be differences in emphasis in tone.
Here, the overall question did have to do with changes in ethical practice and culture over the past 10-20 years. And, yes, most people who contributed did feel that those changes have not been for the better.
But that has nothing to do with condemning the majority of people in industry, or their own practice on the scale of their everyday working lives. As I’ve understood it, at least, we’ve been talking on a far more general level.
What is subtle about that level, I think, is that it can “have a life of its own” more or less independently of people’s everyday working lives (except for the most senior decision-makers).
Bobby C
Look, the pharmaceutical industry suffers from the same problem as the oil industry or the hamburger industry:greed. The oil companies will drill and sell as much oil as humanly possible, regardless of the major societal consequences. McDonalds will sell as many greasy cheeseburgers to as many fat, stupid people as possible.
Big pharma will scare-monger and fear-monger in hopes of selling as many drugs as possible. The problem is systemic and large.
Ed Silverman
Hi Folks,
To the point about moderation raised earlier by Dr. Sal, let me share my evolving notion of moderation, such as it is.
Those of who you are regular readers and participants probably realize that I almost always let a conversation take whatever direction those involved want it to take. I view my role as host, but not necessarily someone who must set the tone by directing discussions.
Of course, I could attempt to direct people to stay focused on a topic - I sometimes do, actually. But I view a conversation as if it’s taking place among a circle of people at a large gathering. Perhaps, someone walks by, stops and makes a comment. Perhaps the comment is worthy of a reply, or perhaps it’s ignored. Take your pick.
So what should ‘expert moderation’ entail? Should I zap and remove a comment that is veering off the topic? Should I jump in when that happens and request everyone go back to the original subject? Real conversations - by those, I mean conversations among people who are talking in person or by phone - will drift and circle as much as any thread. And more so, perhaps, in a group setting.
As to the comparison to Tim Russert, keep in mind that he’s on the air for a fixed and limited period of time. Threads go on and on at all hours. As much as I’m on the job, it’s unlikely that I will have the opportunity to redirect every discussion in real time. I do read, and learn, from the comments. Sometimes, I chime in. But I can’t play Tim Russert and get everything else done. Is that a failing? I prefer to see it as a limitation, at least for now.
I’ll try to chime in more, if I think it’s warranted. But if there is a comment that seems to shift the discussion onto a different track, you’re free to ignore it and address what you believe to be are the real issues in the next comment you make. You may not realize it, but you’re becoming part of a community as you engage others here. And communities involve people who are interacting in myriad ways. That’s a lot more dynamic and fluid than a bit of time spent with the host of a panel discussion.
Hope this helps,
ed
Laurie
I don’t understand the call for moderating. This is a discussion that has many facets, and all of them are being discussed. Moderation doesn’t mean removing posts that don’t follow the commenting trend. I don’t believe that any of the posts here have gone off topic. They are comments as they apply to personal situations regarding the original posted article.
There are many moderated sites that would give Dr. Sal the specific responses that he wants to hear.
This isn’t one of them…..and that’s a good thing.
Nathan
After thinking about it a little more, I’m coming around to the idea that you really can’t legislate or enforce ethical behavior. That will have to come from the inside. There will always be unethical people in this industry (and every industry) so we will always have our debacles from time to time.
So what could raise the bar to encourage more ethical behavior and help bring to light problems before they turn into heath disasters? Here’s a couple thoughts that other here have also raised — I think some of these are already implemented. Because drug discovery is such a long process, we will have to recognize that it will take a long period of time (3-7 years?) for any changes in policy to significantly influence outcome:
1) Publicly deposit ALL clinical trial data and protocols (domestic and foreign) in a publicly accessible repository.
2) Stop DTC for specific drugs — however, I support continuation of “educational” type ads. It’s important that people know if and when a new treatment for a disease area has come out.
3) Give all FDA approved drugs a minimum period of exclusivity (8 years?) — regardless of the remaining patent life. This would discourage “rushing” through clinical trials and approval in order to beat the ticking clock.
4) Full disclosure of risks AND benefits expected to the patient. A doctor (or other health professional, maybe a nurse even) should spend 5 minutes going over possible side effects and potential benefits with each patient. The patient should be required to SIGN the statement stating that they have received and reviewed the information and voluntarily choose to accept the risk of treatment. (Obviously there would be exceptions for emergencies, minors, etc) These side effects should be REAL side effects that have been seen in the clinic, not laundry lists – the list should be approved by the FDA. The only reason for lawsuit should be if the company failed to disclose some side effect. (this would be pretty hard to do if all clinical trial data were publicly available)
Any thoughts?
Dr. Sal Giorgianni
Thanks for your insight on the issue of moderation, Mr. Silverman.
I too agree that a blog-site is, for the most part, a virtual conversation without Mom or Dad keeping the kids in line. I would not at all think of proposing moderation for Pharmalot as a general M.O.; heck that would take a lot of the fun out of this and we all need a bit of fun.
I believe that the sense of it is from some of the folks on here is that this corporate culture and approach issue is a very crucial topic and that we might be able to contribute some important perspectives and possibly even suggestions for those who can make things change; i.e. the power brokers in PhARMA. My experience is that these folks will listen to comments but they have to be of the nature that befits the time, temperament and approach that senior executives are used to. Like every compelling article or presentation it has to have a beginning, middle and end – to be meaningful it cannot be a thread it has to be a story.
What I would suggest is considering a Special Event. A time limited virtual forum in three or four parts. With an objective of focusing the comments on one area of the issue: for example, what is the problem, who can address it and how can it be addressed, or some such arrangement.
laura
Nathan,
Your suggestions seem to be based on the premise that all side effects, or adverse events, are obvious through clinical trials. In reality, many, if not most, become apparent after the drug or device is on the market being used on the public. If a device company fails to report or chooses to ignore these adverse events, with the preemption that they have recently been awarded, they have no fear of retribution. This preemption must be reversed in order to send a message to the Supreme Court that drug companies aren’t next in line for “get out of jail free cards”.
U.S. Representatives Waxman and Pallone will introduce the Medical Device Safety Act of 2008 to Congress this month. This act will state that existing federal law governing medical device approvals does not “modify or otherwise affect” lawsuits brought in state courts. I see this act as just as important as addressing the mortgage crisis, illegal immigration, the war in Iraq…and yet the public seems blissfully unaware of the ramifications that medical device and drug preemption will bring. If this issue isn’t brought into the forefront, I’m certain that drug preemption will slip through. What can be done to make this an issue that is in the public eye?
Former pharma Marketing Exec
Justice, Dr. Sal, Lisa,
Certainly lets dialog on the ethical panel of sorts. My email is formermarketing@hotmail.com
I think Ed does an excellent job here of moderating and I think he would probably be an excellent choice to maybe do a spin off blog on ethical considerations for the pharma industry. I think we would have it closed and have membership with registration and use it as a think tank to come up with ways to suggest and push forward meaningful solutions.
What do you all think?
Nathan,
Those were some good ideas you posted up there. I think you are beginning to see that we want to fix the troubled parts of pharma. You must realize that in order for us to be this passionate about it we must want to see the change that needs to happen so that we can all of us get the best out of the potential that it has.
Looking forward to hashing this out more.
Nathan
Laura — you are preaching to the wrong person. I’m generally in favor of preemption. It’s the only mechanism I see to reduce all these frivolous lawsuits. People HAVE to realize that taking drugs entails a real risk. I’m sick of people suing health care providers and drug manufactures for side effects that were previously reported or were not known at the time of approval. Unless there is evidence genuine fraud, there shouldn’t be a court case. I only see two ways to get rid of all these lawsuits:
1) Full disclosure of risks before a prescription is written. The patient must sign the statement of risk and absolve the doctor and manufacturer of responsibility for the highlighted risks.
Or
2) Preemption. The FDA is the expert. Why should pools of poorly educated juries second-guess decisions made by a panel of experts?
I don’t see any sort of movement towards full-disclosure, so preemption seems to be the only way to lower the judicial burden.
laura
Nathan,
I know you’re pro-preemption, and I won’t hold that against you ;) I just wanted to point out that one of the arguments that you and others that are pro-preemption use is that clinical trials reveal all possible adverse events. In reality many side effects are revealed after the drug or device is on the market affecting the people it is used on. Then it is up to the company to let the FDA know. I know from my own experience that this is not always done. Companies are not always willing to risk losing sales in order to make people aware of possible reactions to their drug or device. One of the ways to ensure that they do is by holding them accountable through our legal system. This accountability has been taken away from device companies and possibly drug companies in the near future. That is frightening to me.
Lisa Van S
Nathan,
Frivilous Lawsuits!.. Hmmm. Maybe you should walk a mile in the shoes of a Parent who has lost a child, due to an antidepressant induced suicide. Industry withheld vital, life saving information from the public,.. and FDA stood by and did nothing!.. How would you like, having your child’s dignity stripped from them. Im saddened that you believe, a child’s life isnt worth a damn,.. and when a Parent fights back,.. you call it frivilous. Pretty sick perspective if you ask me.
Nathan
Lisa,
Re-read my statemend and I’ll think you’ll find that you are the one with a “pretty sick perspective”. Lawsuits that alledge fraud (and have credible evidence to support that allegation) are not “frivolous”. I don’t know anyone (inside or outside of industry) who supports lying and covering up lifesaving data. I know full-well it has occured, and those lawsuits should certainly continue and should be weighed based on the evidence of wrongdoing in-hand.
My point, once again, is that companies should not be held liable for products causing harm unless there is some sort of coverup that took place. Human biology is (and always will be) far too complex to predict every type of adverse event in advance.
Laura, I see your point. Aren’t companies required to report adverse events to the FDA? Also, isn’t there a government agency in charge of collecting this data as well?
Oldskool
I began my pharmaceutical marketing career in 1973 without scientific credentials (the horror!) but with a great deal of respect for the scientific method and the people who employ it. I ran away from corporate life eight years ago and now consult mostly on biomedical startups.
IMO, the industry is heading for a “blowoff”, literally the end of the thesis of its traditional business model. Many of the conditions of its formation post-World War II no longer hold, and - like a body approaching the speed of light - the physics are getting weird.
Marketing practices and materials always will be somewhat in tension with the legal/regulatory side of the business, and as long as the tension results in an appropriate balance there won’t be a problem. But when much of the industry has to rely on sleaze to meet its objectives, that’s a flashing red light that there are deep, systemic issues.
Of course, one might also argue that if the science were all that great, there’d be one clearly superior blockbuster after another rolling off the assembly line and speeding through FDA review, such quantum leaps in medicine that my dog could sell them just by dropping off a copy of the Phase III studies in my MDs’ respective offices. Um, anybody seen any of those lately?
Jack2
Yes, companies must file adverse event reports within 3 days of receipt, and get them to the FDA. People can also call the FDA to report AEs directly to them. The system really leaves the FDA with the most complete information.
Disclaimer: I didn’t read the whole string to get here, just Nathan’s post.
Justice in Michigan
Just a few bits - I agree with Ed. In general, I think we do a pretty good job self-moderating, like a good graduate seminar. Of course, every now and then someone veers. But we will just send them to the principal’s office (to change grade levels).
I like most of Nathan’s suggestions. I won’t reiterate all the reasons I think preemption will end in nightmare - including for the industry, which means a nightmare for all of us - but will suggest that there are all kinds of ways to deal with “lawsuit abuse” (which I agree exists) that are short of nuking all of them.
Overall, I have really appreciated people’s contributions. We certainly don’t all agree on specific policies. But I think there is basic consensus on what the end should look like, even as we debate the means, the assessment of the current situation, and how we got to where we are.
Onward and best to all.
Lisa Van S
Nathan
You defend Preemption, May I remind you, that the Industry doesnt have to disclose clinical trial data to the FDA, unless of course they are trying to get drug approval. So if the studies are bad, and the drug is widely prescribed, and tragedy occurs, lawsuits are the way to go to get to the truth.
Jack2
That is not true anymore Lisa. The existence of any phase 2* or later clinical trial** must be publicly disclosed at this time. There are also rules about how long, from last patient out, a company has to disclose results. I just can’t quote those rules off the top of my head.
*The first phase where a trial looks at efficacy at all
*Unless the trial is not for “a serious or life-threatening disease” - the requirement will not affect these trials until the end of this year/beginning of next.
Bob Freeman
Oldskool, thanks for weighing in.
Yes, you’re correct about innovation: a good point is how many first-in-class drugs remain best-in-class after other entrants come on board? Of course, the first-in-class is often rushed through just to get on the market first, but I’m stating the obvious.
We’ve sort of ignored in this discussion, the interaction between the insurance industry/PBMs and pharma companies. The aggressive rebating that goes on to win preferred formulary status and its implications for the public is little understood. While ostensibly, clinical superiority is supposed to drive formulary decision-making, it’s clearly price concessions in many therapeutic markets.
laura
Nathan and Jack 2,
I think that you both (like the Bush administration) live in an ideal world…one where drug and device companies actually follow the rules, and look out for the customer (and I don’t mean doctors, I mean patients), and put safe drugs and medical devices on the market without concern for the all mighty dollar. If clinical trials were the end-all as far as adverse events go, and if drug and device companies actually reported truthfully to the FDA, and if, after a drug or device is approved, no other adverse events occurred, and if the FDA were properly funded and able to effectively monitor all drugs and devices that are placed on the market, then everything would be perfect and no one would be harmed or die from a poorly monitored, fraudulently approved medical device or drug. However, you may have heard the saying, “If ifs and buts were candy and nuts, then we’d all have a very Merry Christmas.”, all of those “ifs” just don’t exist… and what truly disheartens me as an American citizen is that both the executive branch and the judicial branch of my government apparently live in the
la-la-land world where all of these “ifs” are true. And, as a result, we, the public, are left holding the bag with no recourse.
Lisa Van S
Jack2,
With all due respect,..you are wrong. I was one of many parents walking the halls of Congress to push for legislation of Clinical Trials Registry. Releasing of Raw Data was not included in this bill. Patient summaries never paint the full picture.
HorusCat
Hi all!
I just read through all the posts…what a great discussion!
I had a couple of thoughts…this is not just pharma. I think all companies do this weighing of gain/loss when they know of a problem. My husband’s boss drives a Mercedes of some kind. He went out to the garage Sunday morning, and the car was kind of sitting completely down on the front left tire. Something had broken and the whole side of the car just collapsed. He called the dealer and it turns out Mercedes knows about the problem; they are having a “silent” recall. That means if a consumer has the problem, they will fix it, but they aren’t proactively telling anyone about it. What if this collapse happens while someone is driving? Clearly, they figure they will lose less money by dealing with a wrongful death suit than by paying to have all their cars reworked.
I recently sent the CEO of the company for which I work an email, suggesting that we need completely to rethink the pharma model. Mostly gone are the days of the low-hanging fruit–block-buster drugs for hypertension, cholesterol, etc. We are entering the age of boutigue biotech and niche market drugs. This means a couple of things, I think:
a. Pharma needs to re-educate Wall Street on how business is going to be done. No more “next quarter” projections; we are looking years out.
b. Longer, more complex clinical trials with more meaningful endpoints.
c. Some sort of guaranteed life on the market, much as Nathan suggests. This would help with lower prices, too.
d. Re-education of the public that medication, like cars and lawn mowers and any other product, is not without risk.
I haven’t heard back from him, BTW.
I also have to say that I don’t think it is just a case of pharma “pushing” drugs on an unsuspecting society. I think it is just as often a case of pharma stepping into to make the most of an opportunity where society’s desire for a quick fix creates an opening. I mean, think of it–didn’t men used to think of ED as just a part of aging? (My husband seems to be slowing down a bit; it makes for some occasional laughter in the bedroom.) But given the opportunity to take a pill and fix it!!! Well, there you go. Explains why men taking nitrates will lie in order to still get an Rx for Viagra!
HorusCat
I suspect there would be HIPAA issues involved with releasing raw patient data. Significant details about individual patients could result in identification.
M Helm, MD
HC,
Do you remember the tagline that said “super sugary cereals ara a part of this healthy breakfast?” I really like your list, but I would suggest an ‘E.’
e. educate prescribers and patients alike that a medication alone is not the answer to maintaining health and preventing illness/disability.
Your last paragraph at 7:25 indicates you know and accept this - even if there may be HIPAA issues in the telling…
I’m sure that everyone here would like to know if and when you hear back from the CEO on the suggestion. It is truly a good one, so sadly I’m not that hopeful for you or the rest of us.
HorusCat
M Helm,
LOL at your post (nice laughs). My husband STILL believes that those sugary cereals are part of a good breakfast. Actually, all General Mills cereals are made with whole grains now–so there is at least that.
I am with you all the way that we ALL need to educated that pills and medical procedures do not provide HEALTH. The problem is that the energy needed to maintain good health far exceeds the energy needed to drive to the doctor and then to the drugstore. I firmly believe that people need to be charged a significant out-of-pocket fee for going to the doctor and the pharmacy. Maybe if it cost much more to get the pills, people would be more inclined to exercise, eat right, etc. Unfortunately, we have the mindset that no one should be denied “free” Cadillac health care despite their failure to take care of themselves.
M Helm, MD
HC, You can also tell your husband that bacon has zero grams of trans fat. Honestly, I saw that in a big yellow sunburst in the corner of the last package I bought.
To take the analogy a little farther, we treat our own healthcare as if we are the chickens at breakfast - we are involved, In truth were are the pigs - committed whether we know it or not. (With apologies to my friends of all faiths who keep Kosher, or who do not consume their fellow animals.)
To be more realistic, how about this as a suggestion for future change - health maintenance visits should be very cheap and expected to maintain future coverage, sick visits incrementally more expensive.
This would mean that MDs would have to actually do high quality, personallized maintenance visits that actually yeild some result (hopefully an improvement in health).
Jaynesday
HorusCat
I agree with you, this blog is great, even as it does its wandering. I am very impressed with the honesty, experience and intelligence apparent here on all sides of these difficult issues. It is evident that there are a number of people truly concerned about the condition of the pharmaceutical industry and/or American society as a whole?
I appreciate your unfortunate but appropriate automobile metaphor. It’s clear evidence that the issues we discuss go beyond one industry. The real root cause I think is still yet to be clearly defined.
Another parallel in your example may be obvious. Forgive me; I know that some might consider this spin but spin is fun too.
What would you husband’s boss say if he went back to Mercedes and they told him, hey we’re sorry but this design was approved by the Federal Automotive Administration and even if you bring a law suit against us we don’t have to fix your car. After all we designed this car under the strict specifications and testing of our governing body, how can we be expected to change our design because a small percentage of our customers have a problem?
HorusCat
J,
That is an interesting parallel. What would it do to Mercedes if they were allowed to continue making the car as is, but they had to put a big black box warning on it: THIS CAR MAY COLLAPSE SUDDENLY AND WITHOUT WARNING, LEADING TO YOUR DEATH OR POSSIBLY JUST YOUR INCONVENIENCE.
Of course, it only goes so far, because cars don’t have to pass inspections and changes are fairly easily made. If a pharma company were to take steps to change a med, they would have to go through the entire approval process all over again.
I think, though, that we do say what you express in your last paragraph all the time with most products. We know that there is risk inherent in everything we do and everything we use, to more or less extent. We accept a certain level of risk with an activity or product because we value the benefit. Thus, I drive my car all over the place even though I know I could get run over by a semi. Similarly, I eat processed foods even though I know they might cause cancer, because I like the taste. Medications are no different. They come on the market because they have benefits. They are regulated because they have risks. The tension lies in what we find acceptable. There are some, like Lisa, who would argue the SSRIs shouldn’t be on the market, that the risk is unacceptable. There are others, like me, who say they have literally and figuratively saved too many lives to be taken from the market. What is the common ground between these two viewpoints?
The problem with meds versus something like cars is that the human body is so complex that it can be difficult to sort out what is purely one medication’s effects. So with the SSRIs. Do they CAUSE suicide? People who take them are likely to commit suicide. People who take them commit suicide, but so do people who don’t take them. Sometimes, the side effects of a med are apparent (baby takes adult dose of heparin and dies); sometimes they aren’t. If that thingamajig on the car breaks, it’s pretty obvious that’s why the car is sitting on the ground. No one is going to say it’s because the glove compartment is faulty.
I’m sort of rambling around, but I think my point is that the issue is far more complicated that just “let’s punish evil pharma.” Nathan is right: pharma is full of individuals, most well-intentioned and ethical. At the same time, big pharma is corporate, and corporations have different assessment of acceptable risk (i.e., it’s ok if one or two people die from this thingamajig, because we are responsible for the bottom line and the bottom line is better served by that than by fixing the thingamajig). The only way past that is by ridding ourselves of the free market, capitalism and the risk/reward drive that most of us have. Then you have socialism, and we’ve seen where that leads. Then ALL the cars have faulty thingamajigs.
Justice in Michigan
HC - Please let us know if/when you hear back from ceo! Dare I ask (of course, I always ask): How do people think pharma ceo’s would respond to this thread in general?
Lisa Van S
HC
its called redaction.
Bob Freeman
Justice, for the most part I think they would say their companies are doing many of the things we are talking about. The problem is down the food chain, at the product team level. They are held accountable for P & L, which is rolled back up the financial reporting chain. They have numbers to deliver and ignore any initiatives that would distract from that. So, what we’re talking about is not in the operating model.
Jaynesday
HorusCat
I understand your point also and we just seem to be chasing our tails again. Where is the common ground? How do we get there? I think many have pondered this over and over again. Either end of the pole is no good. Just punishing evil pharma or giving pharma a free pass aren’t good answers.
Former pharma Marketing Exec
To Dr. Helm,
Your suggestion about health maintenance visits being more affordable - brilliant.
To all: Think about this, and this comes to me regarding the banter about sugary breakfast cereals and bacon. How come we fall to see that the food we eat is just another drug? Do we fully understand this?
The food we eat is taken into our bodies and eventually winds up in our cells and is converted to energy. Additives and chemicals that we use in the processing of food then gets into our bodies the same way as drugs do.
So, we really need to start looking at the quality of our foods and the mfg process behind them as well.
The best way to poison a nation is through its food source.
If the middle class cannot take care of themselves and access good health care services, and the middle class has historically been the first ones to join the military and defend the nation, then what happens?
Many of today’s costly illnesses can be delayed, if not completely eradicated by changes in lifestyles.
All this to say - Dr. Helm, wouldn’t it be quite an advantage to us all if the doctors here in the US were paid incentives (like the doctors in the UK) to improve the health of their patients by proving that they have helped to guide their patients to better health style choices. I.e. lower their cholesterol through diet before drugs, etc.
Many things to think about…
Justice in Michigan
Partly I have a real quesion for Bob. Partly I want to see if we can break 100.
Bob, you suggest that the problems are “down the chain.” But isn’t that the classic way in organizations - CEOS say, in whatever form, “get it done,” and it is up to the teams to do so. That provides both deniability for CEO and wild west for teams.
There is the famous case of Sears encouraging their service managers to “get it done” - until they got busted for what was getting done. The CEOS were not allowed to claim ignorance. By their actions, and inactions (leaving guidelines deliberately vague), they encouraged it.
Is that a different situation than the sort about which you were thinking?
Justice in Michigan
To FME - I’m with you in spirit, but I think it is actually the working class who mostly fight our wars, certainly in the U.S. and certainly without a draft. In any event, the middle class, like our waist lines, is harder and harder to locate.
Of course, there is a long tradition of thinking of food as medicine. Herbs, naturapathy, etc. Here, down the road from Kellogg’s, it is not hard to remember that.
But, if anyone saw the PBS series “Unnatural Causes,” there is a far more direct way to impact public health, and profoundly. Disparities in social status- as defined by social class, ethnicity, and related - are _far_ more powerful predictors of health status, throughout life, than _anything_. And this remains true when one controls for diet, exercise, access to professional care (including drugs), and _all_ the variables that we tend to think are the important ones.
See the program if you haven’t. It is about as radicalizing - in thinking if not in politics - as anything I know.
Nathan
I think HC’s letter to the CEO demonstrates the problem with all our brainstorming. Let’s say we collectively come up with a great list of 4 or 5 things that could significantly impact the ethics, sustainability, and public image of the pharmaceutical industry. Now what? Some of us who are employed in the industry might be able to influence small and incremental changes within our departments or teams, but that would have an infinitesimally small impact on the industry overall. Who could implement some of these changes proposed? CEO’s are not dictators. There are powerful and influential (and egotistical) people who are well below the CEO level. Even if you got the CEO to buy into such a 4 or 5 point plan, he or she would likely encounter serious opposition from within the organization. There is some VERY SERIOUS inertia to maintain the “status quo” at a company that employs tens of thousands of people. People are happy with their jobs the way they are. A lot of people (even managers) perform very well at their particular roles within the company, but really don’t think much about the bigger picture and about the future of the industry and of healthcare. It’s not that these people are “bad people”, it’s just that a large corporation becomes a sort of “self-maintaining-entity”. There are very, very significant barriers to even modest change….
Bob Freeman
Justice, I think your comparison is valid. I would also add that Nathan nailed it–there is tremendous institutional resistence to change. Only with consistent directives from the CEO and his/her direct reports will signal to the organization that the directive is “real” and must be implemented and that negative consequences will follow if the directives are not operationalized. I have had direct access to CEOs and it always amazed me that their directives would be largely ignored, and that the CEO assumed his instructions were being implemented when in fact they were not. There is an attitude in all corporations that “we don’t do it that way.”
Bob Freeman
Justice, Nathan & HorusCat: Here’s how good ideas go to die. Suppose HC’s e-mail to her CEO catches the CEO’s eye. A committee would be formed to discuss the idea, its implications for the firm and strategic fit. Given that HC’s idea may be perceived (or actually be) a new way of doing business, certain members of the committee or task force would quietly try to kill it without drawing the ire of the CEO, since ownership of the idea is now his/hers.
A good way of doing that is adding process after process (along with bringing in outside consultants by the ones who want to kill the concept or render it impotent). By the time the process is done one or two things have happened: 1) the CEO has forgotten about the concept or 2) believes it is being implemented cautiously by the committee. Of course, a good old crisis in the market can result in the concept being placed on the back-burner and forgotten about.
Jack2
The existence of any phase 2* or later clinical trial** must be publicly disclosed at this time. There are also rules about how long, from last patient out, a company has to disclose results.
No, this is true and new. Lisa, you seem dissatisfied with it from your post, but it is real and new. Basically every company already did it, because failing to do it prevented you from publishing in most top journals, but now it’s required.
Justice in Michigan
Totally agree with Nathan - the “trickle down” approach to institutional change almost never works in corporations, certainly not ones of any size. Actually doing some research on this. Interesting stuff.
Also agree with Bob - there are _some_ instances in which CEOs have impacted culture and practice, but the efforts have to be sustained, serious, consistent, and modelled, day in and day out. That’s a rare event, to say the least.
I think that this partly goes back to Bob’s early reference to companies that were still relatively small and still essentially family businesses. Obviously, there was room to found a culture from “the ground up,” and to maintain connection between the center (or the top) and the periphery.
There are a few companies that have reinvented themselves along such a model. But they are relatively small (not tiny, just compared with, say, Pfizer!).
What Nathan says is precisely what I meant in an earlier post about the issue not being about the ethics of individual people but about systems that have a “life of their own.” They still _can_ be changed. But, as above, there needs to be a commitment (and time, long-range thinking, etc.) that is, to say the least, hard to find.
But here is a radical idea (and one that risks my being hung as commie rat…): What if the employees who really believed in such change organized? FDA reviewers did a few years ago - not about wages/benefits, but about ways to insure scientific integrity in the review process.
OK, time to slip out the door and meet Norma Rae for coffee…
BP
I’ve been in the industry fro over 15 years. The FDA is very clear on its’ expectations for the reporting of studies. Many years ago, companies either never reported any trial that had any potential negative impact on their marketing efforts or delayed their work and took many years to “wrap it up.” The FDA was not happy with this approach. As of about a decade ago, the results of all trials registered and conducted by pharmaceutical companies are to be reported to the FDA within one year of study completion. Howevr, there are still many cases in which the companies don’t comply with this expectation.
Former pharma Marketing Exec
Justice et al,
This is the dilemma isn’t it? What if we come up with the solution, yet it gets blocked higher up on the basis of it not being implementable? This is a new version of the “prisoners dilemma”: To re-cap for those who haven’t heard of this before: The angry authorities just want to arrest someone, anyone because th masses are getting hungry for blood. You are arrested along with another person and you are given these choices:
1.)If you confess, and testify against prisoner B - you go free - prisoner B gets ten years
2.) If you do not confess, and prisoner b confesses against you, you get 10 years
3.) if you both confess you both get 5 years
4.) If neither of you confess there isn’t enough evidence to hold either of you - you can be held for only one year
Problem is you can’t communicate with Prisoner B.
The only answer is, you must confess - even if you didn’t do it, even if you think it is not in your best interest, because this is the only way you can try to get the least amount of jail time.
This is the same problem here with some of the problems, not all of the problems in pharma. When “cheating” happens, results are covered up, drugs are overcharged and scams are perpetrated, it affects all of us.
To JIM- I guess it is just the way you define middle class..
The poor and minorities usually have more health issues, because they do not have access to food and reliable sources. Go to really poor neighborhoods and count how many grocery stores there are? They become the bigger burden to society because of this, therefore there is more of them not to treat - think about it…
Nathan
FPME,
Maybe I’m dense, but I really didn’t follow any of what you wrote. What are you suggesting that we (reasonably ethical) people within the industry do? Should we leave it because of a few corrupt people up top? Or should we just continue to plug along and do the best we can within our assigned role in industry?
HorusCat
Hi All!
Wow, this thread is just chugging along. I know you all are right–the CEO really can’t do all that much. He can come in and do the usual things–lay-offs, cost-cutting, switching things around, but basically it’s all status quo. The kind of transformation I’m talking about would take phenomenal energy throughout a company.
But that has me wondering: how do drugs like Pristiq get to market? It had to be started a decade or more ago. Somebody’s directive is to come up with products that will sell $500 million or so, be easy to market, hit a known target, etc. So who would be responsible for going to research and saying, here is the direction we are going: boutique diseases, oncology, totally new mechanisms of action… Is it endemic to the nature of large corporations that the more successful they are the less likely they are to take risks? If a company like Pfizer decided to transform its R&D direction, would Wall Street turn around and punish it?
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Nathan
HC,
In my (limited) experience, big pharma isn’t afraid to take big risks early on. We have exploratory biology teams working on all sorts of unusual targets and previously unreported mechanisms of action. We explore all sorts of novel mechanisms, unusual chemical entities, etc. However, as the project gets pushed to a more and more advanced stage (ie, more $$ involved), the criticism goes up and up. People are ready and willing to take risks early on. But when it comes to pushing things into the clinic, the tolerance for risk plummets. Management wants our clinical pipeline full of things with a high probability of success. In theory, they try to maintain a balanced portfolio containing both “high risk” and “low risk” projects. In reality, it seems they are ready and willing to pull the plug on the high-risk projects at the first sign of problems while the “low risk” projects keep chugging through the pipeline in spite of their shortcomings…
Justice in Michigan
FME and others - Catch “Unnatural Causes,” if you can. It has become conventional wisdom to associate poverty and health issues with access and diet. While those factors obviously play a role, they play (statistically) a relatively _small_ role compared with the fact of low social status itself. The mediating terms are lack of feeling of control over one’s life, chronic stress, the impacts of cortisol (especially) and adrenalin on organ systems, etc.. The research here seems very solid - not cooked for the sake of this or that political point. Of course, we should be concerned with all relevant variables. But, in my view, the bigger picture is the one we are least likely to see (and be least willing to address and/or feel helpless ourselves in the face of it).
Re: rest of the discussion here, it would be nice to have examples (if there are any) of companies that have turned around in some of the ways we have been discussing. My guess is that there are some. Again, though, almost certainly that means facing some radical music. While there is talk about moving away from the “blockbuster” model, my sense is that, so far, it is, “After you, Alphonse.”
Justice in Michigan
re: Nathan’s good comments, I am wondering if there aren’t alternatives between “plugging along” and some sort of open (and futile/suicidal) protest.
I don’t know what they are - you and others in industry would have a far better sense. But presumably it starts in conversation - what already is getting said at the bar off-site, around (or behind) relevant water coolers, etc..
Conversations potentially lead to more organized conversations. More organized conversations lead to meetings. At some point (often later than one imagines) there may be push-back. That also leads to conversations.
I am trying to be realistic and careful. I am no whistleblower within my own work context, even though there have been issues about which I might have been. But there is more I could be doing, and have sometimes done, working from within. Much of it is strategic timing and clarity of goals. A quiet, modest, steady approach - not storming the Bastille.
Former pharma Marketing Exec
Nathan,
For the record, my point was we - as in you me and CEO’s have to drop the us versus them attitude. This is very much like the prisoners dilemma. Sometimes doing something for pure altruistic reasons cannot be rationalize, but that doesn’t meant it doesn’t get done. This is exactly the case with health care.
The reason I went down the food path, is clearly t show, that according to Dr. Helm’s view we could have a program where preventative medicine would be made available at a fair and equitable cost to everyone. Good preventative medicine would have to in some way include helping people understand that what they put into their bodies as in regards to food, plays an important role.
Justice, I hear what you are saying, the stress (cortisol) issue is a big one. Just google epigenetics and go to the Nova clip on it. You will understand what I am talking about. Food, by the way, is the only reason homo sapien sapiens evolved to where we are today. We were never programmed to eat meat, but somewhere we ate the leftovers, which led to amino acids being formed which led to our species developing a brain and the probable split in the evolution trail - with all due respect to creationists.
Going to the CEO, just one CEO isn’t going to help. A panel needs to be formed. Real suggestions with real reasons as to what their overall beneficence leads to is key. We as a society have to buy into the fact of interconnectivity - if we do not we are doomed.
This is even more critical today as we stand on the verge of some breakthrough technology. Think about this! The trend is towards exposing what needs to be exposed in order to benefit us. Whether that exposure is the result of another persons greed i.e. collecting WB awards, or just for the pure sake of humanity is not up for debate. The fact of the matter is the public is waking up, they are asking questions. They want and deserve answers. The internet is moving this issue faster than we could have ever imagined. We are becoming “one world”.
Gone are the days when patients didn’t know about the existence of each other. Look at how many patient chat groups are on the net. They are talking, they are comparing notes - they are getting really, really smart.
A well formed panel, is the icing on the cake…
Nathan
FPME,
That makes a little more sense — but I’m not so sure a panel can do much either. Panels are generally “advisory” bodies with little or no actual power. I suppose that a congressional panel of some sort could recommend new legislation to be enacted. Otherwise, change really has to take place internally. Unfortunately (or fortunately), the current system is driven by the free-market and therefore any change that takes place has to fit within the context of (at minimum) having a neutral effect on the bottom line. You may disagree with me, but I doubt that public discontent will change much. Regardless of how much “discontent” the public has, they are still likely to continue to buy our drugs for the foreseeable future.
Former pharma Marketing Exec
Nathan,
Think more along a panel that is able to address these issues and bring them to the public. Once the public is aware of the issues - well I think the more traction/momentum is gained.
The panel needs to be comprised of people that “people” can trust, i.e. real people…
Then the panel watches looks at reports, takes the pulse and reports back to the public.
The public would really like this, they would have a sense of someone is looking out for them. Some people would actually start to sleep better at nights, like some patients…
As to the bottom line. I only have to point back to Vioxx. If that drug was better managed, if the cardio toxicity issues were dealt with up front, the product would still be on the market making about 2 billion a year.
And think of the savings in fines, reputation, ability to continue to be a big player. There’s your bottom line…
Justice in Michigan
Good point re: Vioxx, FME.
Re: the public, I am seeing friends around the country react to the NYT editorial on pre-empiton yesterday (”a perverse legal doctrine” as NYT put it). Most have the same reaction that we in Michigan did re: our own law. They simply don’t believe it could be real.
The wider point is that most of us assume that we are, indeed, better protected (from all kinds of things) than we are. I’m not talking about feeling entitled or not knowing there are risks in life. But the “won’t/can’t happen to me” factor is very strong. Maybe that’s how we get to sleep at night.
Re: public buying drugs, I don’t have numbers. No doubt things haven’t changed much, probably increased. But the suspicions and doubts are certainly out there.
This (yet again) is my greatest fear re: preemption. If a “triple Vioxx” does happen while the lights are off, it would bring more down than people. Sure, people won’t abandon their meds in droves. But we are likely to see a “restructuring” then that would make current regulation seem like very small potatoes. And it is not likely to particularly rational, deliberative, or calm.
Lisa Van S
Jack2,
I am quite aware of the “NEW” legislation! But,.. like I have said before,.. this legislation does not address the issue of raw data,.. which is quite different then Industry’s published summaries.
Jaynesday
Nathan,
you seem to be expressing the nature of business very well. Not just pharma but any business. I’ve seen it in my company (non pharma). Real change doesn’t happen until it absolutely has to and usually after it should have. You can come up with any number of internal initiatives that will be implemented to the tee but it only amounts to a graph on a chart and then on to the next initiative. And here we’re talking about not just one company but a whole industry.
It’s unfortunate but real catastrophe is the usually the starting point of real change. It’s scary to think about the kind of catastrophe we might be on the verge of with the food and drugs we consume.
I think that the change we are talking about will require some very, very strong external forces hopefully applied before not after they are needed.
Carol
FPME and Jaynesday,
I think you both are right. This will not be solved internally. The public MUST be made aware of what is going on with the drug and medical device companies. Until that happens and the public bombards the Congress with their concerns nothing will change.
Justice in Michigan
I don’t disagree with Carol, FME, and Jaynesday. But the reality is that Vioxx took out an estimated 30-50,000+ people, twice that many serious injuries. And we ended up with the FDAAA, as diluted a “reform” as one could imagine, and signed on by all the Congressional usual suspects - Kennedy, Dodd, Waxman, Grassley, Dingell, , et. al.
In any case, all the history suggests that, yes, some disasters do create real change - thalidomide, elixir of sulfanilamide, etc. Some would add Vioxx; as above, I would not. Many companies welcomed the changes that followed thalidomide because they were already working at those standards. (Don’t forget that two companies - SKW and Lederle - turned down thalidomide because they knew it had untested dangers.)
In any event, it is not either/or. As has been shown on this thread many times, the overall vision of the end is not very different among us. External accountability must be framed to support the people in companies who, in the end, we will necessarily rely on. No threat of lawsuit or FDA regulation will cover all the “cowboys.” Luckily, many people are not into being cowboys.
A _true_ industry-consumer coalition group (not a front organizaton) would be unprecedented.
And I am also ready to march on Washington if that is what it takes to make our voices hard.
laura
Justice,
I live 45 minutes outside of DC. We can all meet at my house!
Carol
Justic,
“And I am also ready to march on Washington if that is what it takes to make our voices hard.”
I, and I am sure my whole family, would be there with you hand in hand.
Carol
Laura, Name the time and place.
Lisa Van S
Laura and Carol
Contact me
lvansyckel61@yahoo.com
Jaynesday
Let’s March!
Former pharma Marketing Exec
Justice,
I am worried about Preemption.
I have said it before, and I say it again - I am ready to RUMBLE!!
I just know that we will have many many voices join ours, it can’t be any other way.
Name it!
Justice in Michigan
Holy cow! Well, we know how to reach each other, which is how to discuss whatever.
I am very serious when I say that any such thing would not be “anti-industry.” On the contrary, it would be in support of industry at its best, and of the people who carry the ball.
The folks on Drug and Device Law (Preemption Central) like to talk about the “good guys” (their clients). If others will forgive the sexism for a moment (this is meant in a gender-neutral way), I would love contribute to a _real_ celebration of the “good guys,” of whom there are no small number.
Former pharma Marketing Exec
Me too Justice. This isn’t going to be about bashing Pharma, it is going to be about helping us to maximize the best there is.
I would hope that we come up with ideas that really can be implemented and stop the corruption. We must do this is such a way as to garner full collaboration. Maybe some sort of amnesty rule applies once we start out. After the ground work has been laid then we get buy in from the major pharma’s to live up to their part of the bargain.
Just thinking off the top of my head, there is much to explore on this topic.
Hope you are not kidding…
Jaynesday
Coincidently today’s quote on my MSN home page is:
What concerns everyone can only be resolved by everyone.
Friedrich Durrenmatt (1921 - 1990)
Swiss writer
I think that says it all. The consumers and the producers need to come together to resolve the issues in an agreeable manner.
Jaynesday
Question - Would it be a good idea to establish a separate blog or web site devoted to this idea?
Positives would be:
1. It could be used to establish a point of gathering for all who are interested and would be supportive;
2. a way to gage interest.
3. A means to publicize the movement
4. A way to firm up the focus, direction or purpose of the group.
5. Other?
Some Difficulties might be:
1. How to determine the focus, direction, purpose that is agreeable to the group.
a. Maybe someone would like to begin with a basic list of issues, direction, or other defining statements.
2. How to manage site publication that agrees with all. This would need to be an on line collaboration system.
3. Other?
There are probably some out there that have some experience with this, they might have a better idea on how to start up and sustain such an effort. I personally have never done anything like this before.
Former pharma Marketing Exec
All good ideas Jaynesday.
Certainly all worth thinking about…
Justice in Michigan
First response - I like the concept, but I am not sure about a fully open forum, at least initially. I think it is very important early on for folks involved to establish trust, and maybe some genuine acquaintance with each other - probably through real conversation as well as emails.
As Dr. Sal notes somewhere up the thread, security and the prevention of abuse of information is important. So the initial setting-up process will be important to think through.
Some of us have provided contact info, and, it’s fair to say, a few bits are underway. Others are certainly welcome to follow on.
laura
Horus Cat,
I realize that this thread is almost at its end, but I hope that it isn’t to the point where no one sees it… What bothers me about your post is that you seem to view reactions to drugs or devices as an all or nothing sort of thing. If someone reacts, then we all want it taken off the market and let’s all make a whole bunch of money suing whatever “evil pharma” company manufactured it. You say that we say “evil pharma”, I say that you say “evil consumer”. You say that we’re all out to make a buck off of the company that is only trying to help us get our “quick fix”.
In reality, although I can’t speak for everyone, I think I speak for most people who have had a loved one die or be harmed from a reaction to a drug or device, I don’t want to make money off of this, I just want to be assured that no one else will have to go through the heartache that I am going through. I am not looking for the company that manufactured the device that killed my mother to stop making the device. I understand that it helps many people. What I want is for them to figure out who should not receive this device and fairly warn them that that is the case. You say that big corporations look at the “acceptable risk” and say that it’s OK if one or two people die because they’re responsible for the bottom line. Well, my mother didn’t get to volunteer to be one of the “acceptable risks”. And, guess what, my father’s insurance company payed for the medical device that killed her. So I guess she helped the company reach its bottom line.
I know I sound bitter, and I guess I am. But, what I want you to know is that despite what you think about all victims of fraudulently approved drugs and medical devices, we are not out to make money and we are not necessarily out to have the drug or device removed from the market. What we want is for the company to legitimately figure out who should and should not receive that drug or device and fairly warn those who shouldn’t…even if it means that they will lose sales.
HorusCat
laura,
Thanks for the post. I appreciate your points. The problem with sites like this is people tend to get polemical and use extremes. I seldom read posts like yours–well-reasoned, fair, acknowledging the good and bad about pharma. You are absolutely correct that as companies discover information about who is and who is not suited for their products they should reveal that in a timely and very public manner. I was pointing out that to a certain extent, to all companies that make potentially dangerous products (cars, meds, construction machinery, etc.), we are not individuals. We are statistics, and we figure into risk-benefit ratios. I am not saying this is right–but in a free market, I suspect it is unavoidable. There are evils in over-regulation and other efforts to eradicate all risk.
What I say that few on here say is that we need to work together to create an environment where a company can AFFORD to publish their failures, and therefore, lose money. What we have is an environment where everyone (who has a 401k or an IRA!) wants performance NOW. Look at the lead blog Ed has up. Pfizer may have to cut its dividend for the first time EVER, I think. You can bet PFE stock is not going to up on this news. The Street is punishing the company for going through a dry spell. Pfizer is losing Lipitor–a $13 billion drug. Of course they are going to have trouble showing revenue gains. DUH. The way I see it, Wall Street should expect this kind of cycle from pharma and not expect, literally and figuratively, miracle drugs to show up. The industry is changing. Blockbusters may be few and far between now. If we want a vibrant, creative, HONEST pharma industry in the coming century, we need to give pharma room to fail, not in the sense of having drugs like Vioxx, but in the sense of having a rhythm of ups and downs. Instead, we create price pressure (you cost too much!!!), want to shorten patent life (less time to make money!!!), hype all the bad and ignore the good, want more trials before coming to market to insure more safety (again, not making money while the drug is in trials)….What I react to on this site is the adversarial relationship that is established–people seem to relish describing evil pharma (I’ve had posters call me a murderer, in so many words).
That sort of polemic does make me sarcastic and it makes me laugh–because it will kill the goose that lays the golden eggs. These same people who tell me I shouldn’t be able to sleep at night (didn’t know I was the next worse thing to Joseph Mengele) also want my company to find cures for cancer, heart disease, Alzheimer’s, Parkinson’s, Crohn’s disease, etc., etc. People like you need to speak up, yes, about what happened to your mother. For you, that is a tragedy, probably one of the worst things that has ever happened to you. But you also need to speak up about creating a positive environment for pharma to change–we need some frank acknowledgement that pharma needs to make a profit, just like every other industry in this country. We need to figure out how to make that happen in such a way that tragedies like what happened to you become virtually non-existent.
Justice in Michigan
HC - If you read back through this thread, you will see very, very little of the kind of attitude you describe. Most of the participants, I think, took real pride in the kind of discussion we were able to have here - the candor and the degree of nuance - even while when there were differences in views (fewer than one might imagine).
I actually think this kind of thread is _more_ typical of Pharmalot than what you describe. But maybe I don’t read those other threads.
What this thread reflects is what all of know - that we are all in this togehter. Everyone in industry is also a patient, consumer, etc.. Virtually no patients, consumers, etc. want anything but success for the industry.
One story of many possible ones:
One week after the Vioxx withdrawal, Ray Gilmartin gave a talk at our Business School on “business ethics.” This had been scheduled months before. The coincidence with Vioxx was only that.
He invited “all questions.” I was the only one who asked anything even remotely challenging, and it was really a softball. I asked: when all the litigation is over, and all the liability or lack thereof is resolved, wouldn’t Merck be doing a tremendous service to all of us to take a hard and open look at how this could have happened? If the numbers are even remotely like what has been reported, wouldn’t that be an enormous service for everyone?
On one level, I can imagine why Gilmartin didn’t want to go anywhere near it at that moment. On another, it would have been easy for him to say, “Sure. If there are things we can and should learn from this, Merck will do that, as we always have.” That would have been easy and cost-free.
Instead, he went into full denial mode. He interrupted me several times even as I was asking the question. He insisted that he already knew there was “nothing to learn” from Vioxx because it was a “stochastic event” - a statistical anomaly which, by definition, had no relevance to any other circumstances that could come up, then or ever.
There are complexities in the Vioxx case, and there are certainly instances of more egregious behavior. But that immediate wall of denial showed me something I hadn’t seen before, and which this long, good thread addresses.
It will take a very different kind of attentiveness, effort, and leadership if we are to get out of the present crisis.
Jaynesday
Justice
I may be too cynical having worked in business/manufacturing for over 30 years so take this with a grain of salt. (Can I get a patent on that?) :)
Your experience with Mr. Gilmartin underlines my feelings about how change has to be generated in certain environments; especially in environments where there are huge amounts of money and many different people with differing motivations.
Human nature being what it is, we unfortunately tend to promote people in business, that more often than not are somewhat ruthless (for lack of a better word). They do the job that WE want because they find ways to cause our companies to make a profit. If they fail they don’t move on. So it’s no wonder that we tend to see people in the top levels of management that sometimes surprise and sadden us by what they have done or at least allowed to happen.
But they do what they do for the sake of our company. However misguided that might or might not be.
If, however, the bottom falls out and the company as a whole (all employees) realize that something must be done, then real change will happen. Usually a new CEO is hired. All of the employees wake up and push in the right direction if they have enough time before complete collapse, to bring the company back to a strong footing. By the way I think the new CEO doesn’t have as much to do with the turn around as they are often given credit for. It’s the waking up to “I might lose my employer” part that does the trick.
So it’s with this unfortunate basis that I feel that change in this environment will take intense outside pressure. That pressure comes in different forms including loss of customers and financial collapse or other means. I hope we can find other means because at the point of loss of profits, in this industry we usually also see a loss of lives. And forgive my cynicism (please take another grain of salt) but I feel that true change in this environment will have to be accomplished with the industry kicking and screaming. I have to be honest; I don’t see the light bulb going on within the industry. It has to be a spotlight on the industry.
Justice in Michigan
Jaynesday - Really appreciate your comments, as usual. Just as you describe, my sense - as an outsider with friends in industry - is cycles as you describe. Some kind of disaster, shake-up at the top, a few course changes, but nothing substantial until the next iceberg. And, if the Titanic still seaworthy, on it goes. Until the next iceberg.
As you know, one of my arguments re: preemption is that its advocates _think_ they are taking icebergs out of the way.
In reality, however, they are seeding the place with them.
laura
…and with preemption, for the manufacturers, the Titanic truly is an unsinkable ship.
Justice in Michigan
Here’s why I don’t think so, Laura.
Eventually, the problems will come out, but it will take much longer for “blockbusters” (upon which major proportions of annual income depend). I have some friends who were involved, in one way or other, with the Vioxx litigation (not as lawyers or plantiffs, btw).
Just their opinions, of course, but their estimate was that Vioxx would have stayed on the market at least another 3-4 years if not for civil liability. They didn’t mean in some “titrated” form so that people with CV risks would be less likely to be rx’d it. They meant in full blockbuster mode.
Were that true, than we can extrapolate another, roughly, 40-50,000 deaths and twice that many serious injuries. Those numbers are about the same as the genocides in Bosnia or Kurdistan.
What would the reaction be if - four years later - the public/Congress discovers that FDA had been futzing with the issue for ten years, company had continued to camouflage/delay/deny, and with have 100,000 dead - thirty 9/11s?
What would the public trust in pharma look like at _that_ point? What would faith in FDA look like? What sort of truly strangulating regulation would be proposed in response?
How many people would stop taking, and trusting, the drugs they really needed? That, indeed, kept them alive? How large would the body count then become?
Given the FDA as we know it (even with a few proposed tweaks), and what has become standard practice for _some_ companies with _some_ drugs, it is a certainyy that, under preemption, such a disaster would eventually happen.
And that is why it is in everyone’s greatest interest - industry as much as all of us - to try to head it off.
We will probably fail.
Justice in Michigan
BTW, the disaster scenario above was suggested (though far less explicitly) on Drug and Device Law, and cited by Ed when the post came out.
Shortly after the Riegel decision - which affirmed preemption for medical devices - the blog, which spearheads preemption, noted that if a preemption regime “can’t deliver the goods, then its failure will discredit the medical device industry, discredit the FDA, and discredit us lawyers who represent the industry. If that happens, we’ll be worse off than we were before Riegel.
And that would be a very bad thing.”
My argument is that - given human and institutional realities and frailties - that “very bad thing” is inevitable.
laura
Justice,
I don’t understand why you say that attempts to overturn preemption will probably fail. This may be extremely naive on my part, but I think that, if the public were aware of what preemption will mean for them, there would be an outcry against it, an outcry that our lawmakers and the president and the Supreme Court can’t ignore. The public is not aware that preemption even exists let alone how it will affect them. I don’t know how to make them aware, but I feel that it needs to be done. It is the American public that will provide the momentum for change.
Justice in Michigan
Laura - Obviously, I’m glad that you are more hopeful than I am. I’ve been in this fight for five years, working very hard. In Michigan, we have had a preemption law since 1995 - thirteen years. There have been many attempts to call attention to it, etc.. 70% of Michigan citzens polled are against it. But they are not the ones voting in the half of our State Assembly (the Michigan Senate) which will kill the bill to repeal (which passed 70-39 in the Michigan House).
In the case of the national scene, it will take only the Supreme Court to make it the law of the land. That means five people out of 9. Those 5 people are almost certainly there. Preemption was upheld in Riegel (medical devices) 8-1. The key priciples are not _essentially_ different. And this despite the fact that NEJM has called it a disastrous policy. And the New York Times, one week ago, called the doctrine “perverse.”
I have spoken with aides of my own Congressman, who happens to be John Dingell. AS you know, no one publicly “champions” FDA and related issues more than Rep. Dingell. I was told by people who would know that “preemption is not a priority for the Democratic leadership.” Why not? Use your imagination.
I am not saying to give up. I am anything but giving up. And even if we lose I will not give up. But this is what we are up against. A mostly indifferent Congress (who are certainly well versed in the issue) and a Supreme Ct. that thinks differently than you and I do.
Here is how it could happen differently. There are plenty of people in industry who know what FDA compliance really means, and what it does not mean. They also know the role of potential liability in drug safety. I would not ask anyone to do something I would not do. But those are the people who have to speak out. Anonymously or whatever it takes. They are probably the last hope we have. And the reality is that, if my analysis is correct, there jobs are much more on the line with preemption than without it. But this has to come from their own knowledge and their own conviction. I have included my own contact info in this thread, justiceinmich@gmail.com, but there are lots of ways to speak out. I will confer with anyone.
The other point is that this is an election year. Every member of the U.S. House is running, including Rep. Dingell. Whether or not the Dem leadership believes preemption is a priority, there are ways to suggest to them that is is _our_ priority. And they work for us.
As someone wrote in a poem once, “through every middlesex, village, and town.”
You don’t see me stopping. And you won’t.
Justice in Michigan
Also this, for Laura and anyone else who reads this. Obviously, it is possible to find out (I mean, really find out) where your Congressperson stands on preemption. This should be important to you whether you are against preemption or in favor or it.
If you are not satisifed by the answer, or you don’t get one, then you can ask again. And ask again. And go to meetings. And rallies. And ask again. And ask again. And make sure the answer is clear. And that everyone hears it. And that everyone understands it. And ask again.
Jaynesday
Might be a long shot but what isn’t - Consumers Union is looking for health care issues to support – see:
https://secure.consumersunion.org/site/SPageServer?pagename=CAT_ShareYourStory&JServSessionIdr005=47ezk5s932.app45a
Has anyone heard anything about New Jersey Rep. Pallone’s proposed ammendment to § 521 of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) called “Medical Device Safety Act of 2008,” ? Is it dead, moving forward or other?
Justice in Michigan
Jaynesday - As you probably know, Public Citizen is active on this and involved in all the Supreme Court cases. So those-type folks are certainly involved.
Which amendement is this? - he has introduced a number, including one which would have explicitly rejected preemption as upheld in Riegel. Is that the one?
In any event, there are a lot of Congressfolk. Every one of them has to hear from “their” voters.
Justice in Michigan
Indeed, that is the one. I can’t find any update since late March. Is he your Congressperson? If so, contacting is relevant. Waxman was going to be a co-sponsor, as you know.
My guess is the the “leadership” decided not to go there. But I don’t know.
Jaynesday
Justice,
No he isn’t my Congressperson. I’m from Illinois. I did email Obama and others about a month ago but no answers. I’ll try again.
I also contacted the House Subcommittee on Commerce and Energy but also no response. I don’t have a lot of confidence that email contact ever gets to the target especially since this issue isn’t to the level that it will garner votes for a polititician.
Justice in Michigan
Understand. Unless you are a constituent (voter!), it is hard to reach these folks. But we are all a voter for someone, including, obviously the “higher offices.”
As relayed, some issues have to be made. In Michigan, we have battled for 13 years. Now, people know about it. The House voted to repeal 70-39 - yes, majority were Dems, but one-third of the Reps also voted to repeal. As quoted, they said that it was “tort reform” gone crazy, “clearly unjust,” “dangerous,” “anti-libertarian,” “anti separation-of-powers,” “abrogation of power by federal gov.,” etc.
So this really does not need to be a partisan (in the sense of traditional parties) issue. The conservatives are the anti-preemptors - wanting to conserve the system we have. The radical “I know better than you do” folks, the “don’t worry your little heads about it” people, are those pushing for preemption.
Justice in Michigan
Come to think of it, Obama is still your Senator, yes? True, he’s a little preoccupied. But if he didn’t take a formal “leave,” he remains responsible as your representative.
Lisa Van S
Jaynesday,
Best not to e-mail,.. call Obama’s district office and ask to speak to the chief of staff, be assertive, but not rude.
Then contact his aide in Washington who oversees legislative health issues. Its important to remember that you have two Senators. Vitally important to contact both
Rep. Frank Pallone is an advocate for the consumer, and is highly respected here in NJ.
Jaynesday
Lisa,Justice -
Thanks for the advice. I will make some phone calls and see what happens.
dheis@msn.com
Justice in Michigan
Please let us know how it goes.