Worried About Preemption? There’s A Petition
140 CommentsBy Ed Silverman // August 26th, 2008 // 8:30 am
Preemption may still not be the sort of discussion you hear by the pool, at the golf course or while walking the supermarket aisles, but the issue is, nonetheless, gaining traction as a Nov. 3 review by the US Supreme Court grows ever closer. (Back story with loads of links for summer reading).
What is preemption? The legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
And so, now, an ad-hoc group of individuals -who, we are told, coalesced while discussing the topic here at Pharmalot - have posted an Internet petition in hopes of generating enough public awareness to stir a societal debate and, possibly, influence the decision-making this fall. The effort, by the way, was organized by Hank Greenspan, who helped lead a group called Justice In Michigan, which has fought against a state law that bars citizens from filing product-liability lawsuits against drugmakers.
For the curious, here is the petition…
UPDATE: And now, a loyal reader who supports preemption - and is upset that we have given publicity to a petition that is against preemption - has created his own petition. For the record, we reported on this first petition because we believe its existence is newsworthy in that it attempts to engage the public on an important topic. So here is the other petition. Sign whichever one strikes your fancy.
Alan
Ed, why are you giving a conduit to Justice in Michigan? In my opinion, you are putting yourself to the left of neutral. I don’t think you can say you are neutral if you devote a whole post and then link to a website for a petition. I understand he is a loyal reader, like many of us are. I respect your site because I think you try and walk the line responsibly, down the middle. I don’t really care to see what I perceive as a front for a cause, no matter how noble one may feel that cause is. Please come back to the middle.
Ed Silverman
Hi Alan,
With all due respect, the fact that I cover the existence of a new petition shouldn’t suggest that I support or oppose the topic at hand. To my mind, the existence of the petition is newsworthy, because it represents an effort to engage the public at large in the topic. Please notice that I didn’t encourage or discourage anyone from signing.
I did the same thing last year when an online petition was created to ask Amgen’s board to force ceo Kevin Sharer to resign (I never wrote that he should resign or stay although, in the interest of full disclosure, I did write several posts poking fun at his insistence that the biotech wasn’t facing a crisis).
http://www.pharmalot.com/2007/08/should-amgens-sharer-walk-the-plank/
If there were a petition to support preemption, I would also find that newsworthy and post a similar item for the same reason - an effort to engage and energize the public in a matter of importance to those with an interest in pharma. I’m not aware of such a petition. If you start one, let me know.
Regards
ed
Melody
It’s always interesting to see who will be first to try to “kill the messenger.” Ed, thanks for your reporting. While the comments are certainly biased (as should be expected), I find the reporting quite neutral. I sometimes find myself wishing that since you have a ‘pulpit’ you would advocate for those issues dear to me . . . but that ISN’T what good journalism is about. Again, thanks.
Alan
Ed,
Don’t shoot the messenger. I was providing you my point of view, my opinion, which I clearly stated at the begining of my post.
I don’t want to see your site turned into “cause of the day” where anyones cause can be given credence, credibility, and access.
My opinion is that you are completely within bounds to cover the fact that there is a petition out there. But where I felt it went to far is when you link directly to the petition. You just served up free press and advertisement to Justice in Michigan, which I am sure he is grateful for, because it certainly helps his cause.
Again, this is one persons opinion, mine. I only wanted to provide my feedback on how I percieved the post. No need to respond, you are a busy guy who does a great job on this site, I just wanted to let you know my opinion of the post.
Alan
Melody, my point is similar to the one you make. I don’t want Ed to take up causes, and felt that this particular post was to close to doing just that.
Ed Silverman
Hi Alan,
I understand, but as I indicated earlier, I’ve linked previously to a petition. And sites such as mine are all about linking, whether to medical studies, market research reports, SEC documents, litigation, surveys, analyst reports, press releases or government reports, among other things (I know I forgot something).
By linking, I am providing readers/viewers an opportunity to see for themselves whatever it is I may be writing about or referring to in the way of context. That is one function I fulfill here as part of the news gathering and disseminating process. The linking is not meant as an endorsement or a swipe. I’ve seen readers pick apart surveys, medical studies and analyst reports for all sorts of reasons, but by bringing such things to attention, I hopefully provide an opportunity to discuss the pros and cons. In my view, that should go for petitions, too.
Anyway, I didn’t take your note the wrong way. But since you’ve asked the question, I feel obligated to give my best answer for those who wonder about all this and want to know how I make such decisions.
Regards
ed
Justice in Michigan
A bit of a correctrion: The petition was organized by several people’s hard work. I just happened to be a “contact.” In fact, what is unique about it is the range of people involved - healthcare workers, patient advocates, policy analystis, and so on (but no lawyers, if anyone cares!). Politically, we are equally divided - from conservative Republicans to liberal Democrats. It is geuinely multi-party. And no one, by the way, is “anti-industry.”
So it is about an issue, not about an individual or even individuals. What may be “newsworthy” is that, as far as I know, this is the first such petition on preemption that arose in an entirely grass roots, spontaneous way. The effort has no ties with any other group - be that Public Cititien, AAJ, AARP, etc. It is just citizens who are deeply concerned, acting on it.
If there a pro-preemption group similarly organized (not the kind of “astroturf” group one sees so often) that, I’d think, be equally of potential interest.
Justice in Michigan
For what it’s also worth, I don’t see Ed “taking up the cause” whatsoever (much as we’d love to have him, as an individual.)
Again, the “news” is that such a group exists - what is unique, I think, is its form, diversity of membership, and political diversity. There is a bit of “local” news in that most of us met through Pharmalot which probably says some interesting things about the role of such blogs in general. I assume Pharmalot has “sprung” a range of such groups. I’m recalling HorusCat saying she was doing so when she departed.
On this issue, where there has been so much discussion here, linking a new petition is, I think, similar to linking a brief (but obviously less ’scholarly’), as Ed did to all those in the Levine case. It is one set of perspectives as they get “out there.” No doubt there will be many more.
BPW
The big problem here is that the FDA makes its decisions on the data that they receive and we have become increasingly aware of Big Pharma companies not presenting all of the data they hold in order to avoid marketing and sales difficulty due to perceived safety concerns. When the Big pharma companies start delivering everything they have and the FDA can then make a fully-informed decision, then is the time to consider pre-emtion. My guess is that this will never happen - at least not before hell freezes over!
I hope the Supreme Court sees fit to proect US citizens rather than huge corporations. Now that would be justice!
laura
Justice,
I agree with you. I don’t believe Ed linked the petition in order to encourage others to sign. He linked it because, as he said, “For the curious, here is the petition…”
Ed has done an excellent job of providing a place where people with many different viewpoints can gather and discuss. He is fair and balanced in his reporting. He provided the link because he had mentioned the petition and, therefore, it would only make sense that he would link to it…nothing more, nothing less.
laura
I am one of the petition organizers and, as Justice said, we are truly a diverse group with various backgrounds. What we share is a deep concern that the issue of preemption has largely escaped the publics’ consciousness. Our hope, in initiating this petition, is that we will raise awareness of the reality (in the case of medical devices) and the possibility (in the case of drugs) of complete, unquestionable FDA preemption. Despite the fact that medical devices and drugs do a tremendous amount of good, they also have the potential to do a tremendous amount of harm. If all accountability is removed from their manufacturers, the potential for harm is greatly increased. Imagine what would happen in any industry if there were no concern for accountability. What would happen in the auto industry if the manufacturers no longer had to be concerned with creating safe cars? What would happen in the travel industry if airlines no longer had to be concerned with maintaining safe airplanes? What would happen in the food service industry if restaurants no longer had to be concerned with providing safe meals?…and the list goes on and on. Amazingly, this has happened in the medical device industry and will potentially happen in the drug industry. And yet, amazingly, there appears to be no public concern. This can only be because the public isn’t fully aware of what is going on. Therefore, we hope to help raise an awareness through this petition. I encourage everyone to sign it and pass it on to their friends, family, acquaintances, business associates,…whomever. People can’t form an opinion if they aren’t aware of the issue. We all deserve a right to make our voices heard.
ernest
Alan and all,
The American people will decide on which side of preemption they stand only if and when they know that it exists. The drug industry, the FDA, and the media at large have done little or nothing to inform the public of this policy.
As a victim of FDA approved medications and as a petitioner for ADDA, I applaud Pharmalot and people like Ed Silverman for reporting the news.
Nathan
Ed,
I fully agree with Alan. You try to walk the center — but you have clearly stepped away from center on this issue.
In your story about the Amgen petition (your link in the above comment), the primary story was about Amgen — not about the petition.
You write: “If there were a petition to support preemption, I would also find that newsworthy and post a similar item for the same reason.”
Well, I just made one. I’ll email you the link. I hope you run a story on it. It’s equally newsworthy.
Justice in Michigan
Hi Nathan,
I hope those involved in your petition will also provide full COI disclosure, as I would like to do here.
As mentioned in other contexts - I have significant investments in both device and drug companies, at least as measured by Justice Roberts standards.
So there is a definite COI in that it is in my financial interest that industry succeeds as fully as possible. As I have stated many times, I believe that being opposed to preemption does, indeed, help protect my investments while protecting legal rights and public health at the same time.
You will choose to believe it or not, but I say this - and have said it - with full sincerety. I believve are few worse things that can happen to industry (and my own investments) than preemption, for reasons that I have listed many times.
I hope you will be forthcoming about your own interests in whatever positions you espouse.
But let there be no mistake. I am a “shill” for industry. 100%.
truthman30
Nathan..
All I can say to you is, god forbid that you or your family are ever damaged by a defective medication…
If you are in favor of Preemption , then you are obviously anti-consumer, anti-patient rights and anti-democracy..
I think it is to everyones detriment that this law is being pushed through, whether you work for pharma or whether you are a concerned consumer, this law will not discriminate , it will affect all Americans..
I think you should have a good think about the implications this law could have on your own family, friends and children Nathan before you jump on the side of your employers, because in the end you are just another number to them, and if they could screw you over for a quick buck, I’m pretty damn sure there would be no hesitation from them to do so..
Food for thought maybe?..
Ed Silverman
Hi Nathan,
Please go back and read carefully the Amgen post from a year ago. There were five graphs, one of which was from the petition language itself. The rest were background explaining why some investors and employees were upset with the Amgen ceo.
Now, go back to this post about preemption. There are just three graphs, but I include a link to a previous post of mine with numerous links to the various briefs pertaining to the preemption case to be reviewed by the Supreme Court. In other words, it’s also background as to why there is debate over preemption and, hence, a petition.
If PhRMA had circulated a petition and I posted about it, would you then have gotten upset and accused me of being one-sided? That may be an unfair question, but you apparently assume that I’m biased because I posted about a petition that espouses a point of view with which you seemingly disagree.
Again, please go back and read my first remark near the top of this thread and then re-read the Amgen post from a year ago. I may not be perfect, but I tried to be consistent. And if you really do create a petition, I will add it to this post. We can then have dueling petitions.
ed
Justice in Michigan
As obviously follows, I also believe PhRMA’s (the organization) position on preemption is an anti-industry one.
It will serve folks who get helicopters to and from their desks, and who can always bail out and land elsewhere, with extraordinary parchutes.
But, as far as the industry itself and the vast number of people who do terrific work in it, preemption is poison policy.
Nathan
Justice,
First about COIs: Did you provide a COI on your petition? And how can you talk about COI when you believe that preemption will HURT the industry? In that sense, the signatories on YOUR petition should provide COIs - right? Signatories of my petition are likely to be hurt financially.
Second: I’m still rather ambivalent about preemption. I think the pendulum has swung too far in favor of protection of the individual at the expense of protection of society. Preemption will push the pendulum back the other way. But I agree that it has the potential to push the pendulum too far.
Third: my real point in creating this petition was to scoff at the “newsworthiness” of the story that Ed ran — not of the petition itself.
Fourth, and finally: I think these kind of petitions are actually rather silly. We (the people) do not create laws. We elect people (and employ people via our tax $) who’s full-time job is to study and examine laws and provide a balanced viewpoint. Public petitions such as this shouldn’t be considered by lawmakers and judges when deciding on cases. This case should stand or fall based on its merits alone — not on the court of public opinion.
Nathan
Justice — I actually didn’t realize that PhMRA had issued an opinion on preemption. As of a few months ago, they had remained silent. Here is their current statement about preemption:
———————————–
Washington, D.C. (June 11, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding federal preemption:
“Federal preemption is not about providing blanket immunity for America’s pharmaceutical research companies. It is about allowing the Food and Drug Administration (FDA) to do its job to protect patients by overseeing drug warnings.
“Federal preemption can play a constructive role in achieving national goals. “For 70 years, Congress has charged the FDA with ensuring that medicines are adequately labeled to warn about potential side effects. Patients and healthcare providers should be concerned that, without adequate preemption, lawyers and states could require information that conflicts with FDA’s expert judgment. These inconsistencies may be, at best, confusing, or at worst, life-threatening, because patients and providers could be scared away from needed medicines.
“Indeed, patients are best protected by a single, strong, uniform regulatory authority that is the sole arbiter of the benefits and risks of medicines. That is why Congress empowered the FDA to approve how that information is conveyed on the medicine’s label.
“The U.S. regulatory system for prescription drugs already is one of the world’s most rigorous. Regrettably, while Congress has increased the FDA’s regulatory responsibilities dramatically, it has not sufficiently increased the agency’s appropriated funds. This disparity has been highlighted by the FDA’s own Science Board.
“The health and safety of the American public rests on a strong, well-funded FDA. We applaud the efforts of U.S. Senators Herb Kohl and Robert C. Byrd to bolster Congressional appropriations to the agency and ask their Congressional colleagues to significantly increase appropriated resources to help the FDA realistically fulfill its regulatory obligations.
“PhRMA wholeheartedly supports the Administration’s attempt to boost FDA funding by $275 million – over and above the $2.4 billion previously included in the President’s budget. Some $100 million of those extra dollars will be devoted to strengthening FDA’s ability to help assure the safety and effectiveness of medical products from their development to post-approval. The agency also stands to receive additional appropriated dollars to track side effects linked to medical products more aggressively.
“However, such efforts to strengthen the FDA should not be diluted by substituting the opinions of lawyers and juries for the expert judgment of FDA’s scientists and doctors. Allowing prescription medicine labels to become clogged with inconsistent warnings would confuse physicians and frighten away patients from taking life-saving and life-enhancing medicines. That would harm, not help, public health.
“Contrary to critics’ allegations, federal preemption will not deny patients their day in court. State judges and juries may still levy damages against manufacturers that fail to comply with FDA standards. But those state judges and juries should not be permitted to interfere with an important public health goal: Uniform, science-based risk communication.
“America’s patients benefit from a regulatory system that is one of the world’s best at balancing safety and access. Permitting state law actions to undermine this inherently federal function could serve to impede access to patients, while adding no real benefit.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.
Doug Bremner
Wake up people. The head of the FDA is a political appointment. Dan Troy, the ex chief counsel, came there from a job with pharma. The foot soldiers at the FDA themselves probably don’t want preemption. What I don’t understand is why the ‘drive-by media’ as the right wing talk show hosts call them haven’t shined a light on this issue.
Dianne
I believe we missed the point in Michigan. Our beautiful state is the birthplace of FDA preemption. We were made to be the “model” for the rest of the country. After 13 years, most folks have no idea the law exists. Sad stories are told here and there, and people will think, “Oh, “Isn’t that a shame?” “I’m glad it’s not me or my family.” Never realizing that it is already them and their family, because all of us, drug victim or not, lost the civil right of “due process of law.”
Letting Americans know there is a “quiet” agenda at work to rob us of our civil rights, along with our health and safety, is about as un-American as it gets. Telling us about it was the job of the media. Apparently, they wimped out.
I am proud to say I helped in the creation of a petition that will inform and empower the American public.
Steve
Nathan
Your input and insertion of PhRMA’s statement is excellent and I have espoused this before.
To argue with those that really have no understanding of Preemption and the right of the patient to sue, falls on deaf ears. All they want to do is see themselves in print with or without substantive facts.
Justice in Michigan
Lots of good stuff here.
I agree with Nathan that petitions of this kind are a “long shot” at best. But there comes a time when “we, the people” have to take as clear and vocal a stand as we can. You have heard from three of those who initiated the petition. There are more. And, behind them, there are _many_ more.
Nathan, my COI is that I want industry to succeed. That is what informs my being against preemption (among other things). My financial interest in the industry is a potential bias in supporting my view that preemption is a terrible thing. Because I really do _not_ want the industry to fail. And lose even more public trust than it has. And preemption will lead to that. It will provide cover in the short run. It will provide disaster in the long run.
Re: the PhRMA statement, there is no polite way to say it, so I’ll just tell the truth: It is false and misleading in a hundred ways. Here is one. The claim is: “State judges and juries may still levy damages against manufacturers that fail to comply with FDA standards.”
If preemption is upheld in the drug arena, that is horse manure. As has been explicated on Drug and Device Law - the premier site for lawyers defending preemption - plaintiff and juries that seek to make some case that manufacturers failed “to comply with FDA standards” will be preempted by Buckman, the case which declares, in essence, that only FDA - not private legal actions - can make any claim based on whether a manufacturer was in compliance.
There is some debate about what are called “parallel claims.” But FDA’s own position, and preemption’s supporters, is that the shield will and should be total in such instances.
PhRMA is, well, lying.
Justice in Michigan
Who are you, Steve, and on what do you ground your understanding of preemption?
Justice in Michigan
If anyone still has doubts about what preemption actually means, read some of the briefs that are linked in the post lined in Ed’s first paragraph. I would especially recommend the NEJM brief (9 current and former editors), the law profs, and two former FDA commissioners (Kessler and Kennedy).
Then compare what they say to the statement by PhRMA. And decide which seems most trustworthy, who gets it and who doesn’t, who is trying to inform and who is trying to mislead.
Doug Bremner
I’ve had people from the FDA tell me that they don’t have the power to do anything about drug safety after the approval process is over. They said they would have to go to court, and they don’t have the budget to do that. I signed the petition. I wasn’t aware that Michigan already had a pre-emption law. Pretty scary stuff.
atlex
JiM,
Having your opinion is fine. As you know, I disagree with it, although we are not 180 degrees apart. However, I do think you are completely wrong when you insist that you know what’s best for the industry as opposed to those who work in it and are charged with making decisions as to what policy positions to take.
Also, you are wrong when you say PhRMA is lying. I don’t think we completely know what the result will be. Undoubtedly, there will be additional protections for companies that follow FDA regulations. However, it is far from clear as to how complete the shield will be.
Atlex
atlex
Doug,
I presume you know that the head of the FDA is always a political appointment.
Atlex
Doug Bremner
Atlex, yes I do know that, and that is my point. When you have an administration (like the current one) that is heavily supported by pharma, they will do things that are favorable for industry. That is why you get the schizophrenic atmosphere where the head is going one way and the body the other. Look at the studies done of morale amongst FDA employees. Very low, for this reason.
Justice in Michigan
Let’s take it apart:
PhRMA writes:
Washington, D.C. (June 11, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding federal preemption:
“Federal preemption is not about providing blanket immunity for America’s pharmaceutical research companies. It is about allowing the Food and Drug Administration (FDA) to do its job to protect patients by overseeing drug warnings.
–in the white papers distributed within drug and device defense firms, “blanket immunity” is precisely what is emphasized about preemption. That is why the full shield in Michigan has been the model.
“Federal preemption can play a constructive role in achieving national goals. “For 70 years, Congress has charged the FDA with ensuring that medicines are adequately labeled to warn about potential side effects. Patients and healthcare providers should be concerned that, without adequate preemption, lawyers and states could require information that conflicts with FDA’s expert judgment.
– In product liability cases, no “lawyer or state” has ever required “information” (I assume the mean, labeling) that conflicts with FDA. FDA has full institutional authority over what is and is not on the label. It has had that during the 100 years that FDA and civil liability have co-existed. That is why no previous FDA sought blanket preemption.
These inconsistencies may be, at best, confusing, or at worst, life-threatening, because patients and providers could be scared away from needed medicines.
– More on those “scared” pts below
“Indeed, patients are best protected by a single, strong, uniform regulatory authority that is the sole arbiter of the benefits and risks of medicines. That is why Congress empowered the FDA to approve how that information is conveyed on the medicine’s label.
–FDA remains “single, strong, and uniform.” The chaos argument has no empirical foundation.
“The U.S. regulatory system for prescription drugs already is one of the world’s most rigorous. Regrettably, while Congress has increased the FDA’s regulatory responsibilities dramatically, it has not sufficiently increased the agency’s appropriated funds. This disparity has been highlighted by the FDA’s own Science Board.
–Regrettably, the industry and those who support preemption now were in the forefront of efforts to destry FDA in the mid-90s. Read what the Washington Legal Foundation and Competitive Enterprise Institute had to say about the agency, and increasing its funding, in _those_ years.
“The health and safety of the American public rests on a strong, well-funded FDA. We applaud the efforts of U.S. Senators Herb Kohl and Robert C. Byrd to bolster Congressional appropriations to the agency and ask their Congressional colleagues to significantly increase appropriated resources to help the FDA realistically fulfill its regulatory obligations.
– Would have been nice to hear this a few decades ago. But since everyone agrees, it costs PhRMA nothing to say it now.
“PhRMA wholeheartedly supports the Administration’s attempt to boost FDA funding by $275 million – over and above the $2.4 billion previously included in the President’s budget. Some $100 million of those extra dollars will be devoted to strengthening FDA’s ability to help assure the safety and effectiveness of medical products from their development to post-approval. The agency also stands to receive additional appropriated dollars to track side effects linked to medical products more aggressively.
– It took persistent effort to get PhRMA to agree that _any_ PDUFA money should go to post-marketing surveillance. Initially, none did. Now a trickle does.
“However, such efforts to strengthen the FDA should not be diluted by substituting the opinions of lawyers and juries for the expert judgment of FDA’s scientists and doctors. Allowing prescription medicine labels to become clogged with inconsistent warnings would confuse physicians and frighten away patients from taking life-saving and life-enhancing medicines. That would harm, not help, public health.
— The usual bs. I’m still waiting to meet those confused physicians and frightened patients. As I’ve noted, Washington, Oregon, and a few other states have a Medicaid formulary that is _not_ based on cost but on safety/efficacy. Some drugs are on; some off. I am waiting to hear about the guy in Idaho who freaked out or stopped his “life-saving” medication after hearing about what was happening over the border.
“Contrary to critics’ allegations, federal preemption will not deny patients their day in court. State judges and juries may still levy damages against manufacturers that fail to comply with FDA standards. But those state judges and juries should not be permitted to interfere with an important public health goal: Uniform, science-based risk communication.
—As already stated in prior post, this is an outright misrepresentation of the truth. We, in Michigan, know this. Our FDA preemption law - which is the model for the national version - has denied Michiganders days in court for twelve years - whether related to Baycol, Vioxx, fen-phen or any of the other drugs that have been withdrawn during those years. (A few Rezulin plaintiffs got lucky out of state because of a fluke ruling in Kent.) This is clap-trap.
“America’s patients benefit from a regulatory system that is one of the world’s best at balancing safety and access. Permitting state law actions to undermine this inherently federal function could serve to impede access to patients, while adding no real benefit.”
— This is another way of saying that the prior paragraph should not, in fact, be read to mean what it says. Unless PhRMA, unlike preemptors in general, support parallel claim civil actions. Let’s hear if they are willing to say that publicly. Their lawyers do not.
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $44.5 billion in 2007 in discovering and developing new medicines. Industry-wide research and investment reached a record $58.8 billion in 2007.
—Indeed. It would be great to see a lot more of that money devoted to accountability, public health, patient rights, and the truth.
Doug Bremner
August 26th, 2008
2:30 pm
Link to this comment
Justice in Michigan
Doug - Yes, Michigan has had a full shield since 1996. It is actually even more draconian than some versions of preemption.
Atlex - Part of my views about what will happen as a result of preemption comes from people within industry. No doubt there are multiple opinions. I try to weigh what I see, what I hear, and what I know from the past, and make my best possible prediction. That is how all policy judgements are made.
Of course, I could be wrong. Believe it or not, I passionately hope I am. But I fear I am not. Either way, you should know that my views are very much informed by many who are inside as well as many who are not.
PhRMA is lying based on what the lawyers associated with them say they hope for - in the Levine decision, for example. You are right that it could come out differently. But PhRMA ought to be honest about the situation it (again, the organization) _wishes_ will result. If they get that wish, it will not resemble what they say in their statement.
Jack2
I’m late to the party here but I agree with Nathan. If someone creating an online petition becomes newsworthy, it must be a really damn slow news day.
For the curious, here’s some info on the overall effectiveness of online petitions: http://www.snopes.com/inboxer/petition/internet.asp
Of course, I include this link only for the *curious*, and not because I in anyway endorse the idea that internet petitions don’t do very much.
(With all due respect JIM)
Ed Silverman
Hi Jack2,
Actually, no, this hasn’t been as slow a news day as I expected. In fact, I have 2 items queued up that will have to wait for tomorrow, because I didn’t have enough time to get through them today. I wish I had.
That said, I used the same rationale I did a year ago after spotting the Amgen/Kevin Sharer petition - there’s a contentious issue out there and some folks are stirred up enough to circulate a petition. Is it earth shattering? No. But I thought it was worth noting. And so I did. And that’s all I did.
Here’s an open question to anyone who isn’t finished lambasting me: If a petition isn’t a big deal, why is that a few people are bothering to jump all over me and decry the use of the space? And if the petition came from a crowd in favor of preemption, would the same few still criticize me for being biased and wasting space?
This site covers a lot of different subjects and, once in a while, also runs a video, a guest editorial, a question and answer interview. And let’s not forget the silly tchotchkes given doctors. But none of these drew the same derision.
Finally, I’d like to reiterate that I didn’t endorse or decry preemption. Only recently has the topic gained sufficient attention in the mainstream media. Even Nathan, who is the quickest to accuse me of bias, recently acknowledged that this site was one of the few places that consistently followed the issue, including links to pertinent documents whenever possible. And it was in keeping with that interest and commitment that I posted news of a petition.
Cheers
ed
Justice in Michigan
Jack 2 - As I’ve conveyed, the internet petition was not mainly my initiative. Whether it has any impact I’m willing to stay agnostic about. Sometimes surprising things happen.
Back to Atlex’s point above: “I do think you are completely wrong when you insist that you know what’s best for the industry as opposed to those who work in it and are charged with making decisions as to what policy positions to take.”
I realized that I didn’t say the obvious:
1. I don’t think I “insisted” that I knew what was best, but I did say (and have explained) why I belive preemption is bad policy.
2. As a shareholder, I feel I have an obligation (as well as right) to say what I think is good and bad policy - fiscally, ethically, and otherwise. Does that mean I know more than those “charged with making decisions”? No, not on a lot of particulars. Does that mean shareholders are not part of the decision-making process of a publically-owned firm - absolutely, they are.
3. The core of my concern is not about industry in a vacuum, but about the nexus between FDA and industry, and so has as much to do with FDA policy as with industry’s. Here, my rights and obligations are most obvious. The FDA functions under laws that are _our_ laws; its top officials are appointed by _our_ government; it is working for _us_.
The very (bizarre) fact that this needs to be said is the preemption issue in microcosm. One side is saying, in effect: “Don’t worry your little heads about it. We are the experts. We know what’s ‘optimal’.”
And the other side is saying, “History and reality suggest otherwise.”
Steve
Justice
I can’t recall when so much uncondensed discourse has been perpetrated by one person. Justice, you remind me of the AT&T ad about the free talk time. The person says,”Now I can talk to my mother all day, about nothing”. How many more ways are you going to say the same thing? Readers like it short and sweet, aka, to the point, not when asked what time it is, tell them how to build a clock.
Jack2
Ed,
Whichever side the petition supported I don’t think it would be newsworthy. As evidence, I don’t jump on you when you cover other news about preemption. I personally think part of the reason you covered it was because of the role Pharmalot/Pharmalot readers played in it’s creation. To me that’s actually the bigger story, and a better reason to cover the petition.
Jaynesday
I am also one of the petition organizers. David Heisner
We are a diverse group. I call myself a Republican so my reason for supporting this petition is obviously not political. My family has been mortally wounded by a defective device that the manufacturer refuses to investigate and furthermore has successfully claimed to be preempted from accountability.
My only desire is to see this manufacturer and or the FDA make this product safe for future patients. Since the manufacturer, through the FDA, refuses to take the responsibility for this assault, my family and I must try to force the issue.
This is what preemption seeks to take away.
Despite all of this, I like many others here wish the best for Pharmaceutical companies. We are not so blinded by our loss that we think people can do without drugs and devices. This is not our aim.
Before you too come to a grave site as my family and I kneel at, make sure you understand how you would feel about preemption if it was one of yours that rested there. I would hope that you would not be so blinded by hatred for the offender that you would forget about those who might also some day be in your shoes. So that is my reason for being a part of presenting this petition.
As an American I am afforded certain rights. The right to be heard in a court of law is not limited by who I am or what I want to say. Preemption begs to differ. Preemption cancels that right.
Until now when we have a social problem in America, it has never been the practice to take away our fundamental rights to solve that problem. We are smarter than that; we don’t need or want that crutch. This activity is more typical of China or Russia, not America. I have faith that we can find a better way. It might not be as easy but it will be just.
Lastly concerning Ed bringing this topic up on Pharmalot; I admit that I hope that this article brings this issue to the forefront. Its place is at the forefront not obscurely hidden in the recesses of political and commercial debate. The American public is the entity that stands in the way of these ill winds. How can we allow it to be so unknown?
I hope that those that think this is objectionable will bear with us. Discourse for and against this issue is what we seek; the louder and longer the better. In fact I would love to examine how those on both sides of this issue would feel if the Preemption Debate was on the front page of every newspaper in America. I know my fellow petitioners would like nothing better. What about preemption supporters? Would they appreciate full disclosure to the American public? Somehow I think not.
Thank-you Ed, I think you have achieved your objective of stimulating an informative discussion about one of the most under-rated and misunderstood topics of our time.
Lisa Van S
WOW!!! This Petition appears to be a threat to Industry. So I guess that explains the attacks against Ed.
Ed Silverman
Hi Jack2,
Well, honestly, it’s nice that they coalesced on this site and I see your point, but that’s irrelevant to me. My only litmus test is that preemption is a contentious issue and, as we saw last year with Amgen’s ceo, some folks reacted this way. It’s a hot topic and I was continuing to pay attention.
And yes, yr correct. You don’t jump on me with other preemption posts. I didn’t mean to imply that you had done so. I confess to a little frustration today after being accused of bias. I’ve deliberately left the pros and cons of the preemption debate to others. I understand full well the implications for all involved and if I want to express my opinion, well, it’s easy enough to do so. I’m not going to take a back-door approach, which is somehow lost on a few others.
Thanks for writing in. I appreciate the note and sorry if I seemed a bit sharp in my last comment.
ed
laurie
I’m another participant in the creation of this petition. This comment from Pharma is exactly why preemption is such a problem:
” Allowing prescription medicine labels to become clogged with inconsistent warnings would confuse physicians and frighten away patients from taking life-saving and life-enhancing medicines. That would harm, not help, public health. ”
The “frighten patients away” argument is insulting to all patients. It is the patients free will to take a drug or not, and it is NEVER ethical to withhold medical information for the sake of compliance. Last time I checked patients still have the right to say no to a drug.
If a physician is “confused” about a drugs warnings, then he/she should not be prescribing it. If a patient is “scared off”, it’s for a reason that is compelling for them and they have the right to not take it.
To use this argument only bolsters the argument against preemption. The “I’m not going to tell you about the adverse effects of this drug because you may not take it” and then removing the legal recourse of not being fully informed…this is a lose/lose for the patient.
Justice in Michigan
It’s been a long day. For anyone who actually went to the petition, you will see that it does not stand alone. It is one project of a group called ADDA (Americans for Drug and Device Accountability) and, frankly, it is not our main project.
The goal, as Jaynesday beautifully stated, is to have this dicussion as well and deeply as we are able. We view preemption as important as policy issues get. So does NEJM.
For a variety of reasons - mainly because the petition got out ahead of other organizational things - what is most “newsworthy” about who we are, what we are doing, and why, was inevitably lost in favor of the fact of one petition. And so its importance grew out of proportion relative to the rest. Our fault.
The core of it, though, is what Ed, Jaynesday, and others have said. Frustrated by the relative silence in the media (with some exceptions), we have taken it upon ourselves to stir whatever discussion and awareness we can. Pharmalot has been the great exception media-wise. And I believe it is that, and not that we met via Pharmalot (which is more effect than cause) which makes our organization of particular relevance on a site has been uniquely committed to covering this issue - for which, I believe, we should all be grateful.
Dianne
Look out America! I live in the great state of Michigan, and we lost our right, in 1995, to hold a drug manufacturer liable for harm. What a deal. An entire industry was given complete and total immunity from product liability when they knowingly injured or killed.
Oh, I know. There is an exception to our law. Ask any greedy tort reform or pharma lawyer. We can sue if fraud on the FDA can be proven. But then, there is that pesky little federal regulation that says “fraud on the FDA is pre-empted by federal law, because [it] interfere[s] with the federal government’s regulation of pharmaceuticals.” See: Law.com - Justices Wrestle With Michigan Lawsuits Against Pfizer; Federal Jurisdiction at Issue
Darn it. Oh, well. I guess it’s a “Catch 22,” huh?
BTW, has anyone heard about our law? Was it anywhere in the media where an American citizen could understand what happened to the good people of Michigan? Ya know, a little “heads up?” Probably not. Most of the people in Michigan are not aware of our un-American, unjust Drug Immunity Law.
Nathan, please don’t tell me 12 people don’t have the smarts to decide a case. We’ve been doing it that way for a long time, and it has worked out just fine. Why would anyone agree to a system where the accused holds all the cards?
Also, Nathan, may I ask, if FDA Preemption is such a good policy, one that will make us all happy and safe, and will set a legal precedent affecting every American, then why isn’t Pharma bragging about it? Why all the hush-hush?
I am not an attorney. But I have to tell you, I wish I was. I am a wife and mom whose husband was seriously affected by a FDA-approved drug. All I can say is, Pharma picked on the wrong person.
This is not a political issue. It is a civil rights issue. An attempt has been made to take away “due process of law” from the American people. This is a violation of civil rights. Shame on the media for not doing their job.
Justice in Michigan
And shame on the major candidates for not doing theirs.
Justice in Michigan
Ted writes: “Justice, you remind me of the AT&T ad about the free talk time. The person says,”Now I can talk to my mother all day, about nothing”.
I’ll try to learn from this. Sorry to hear about you and your mom.
Nathan
Lisa writes: “WOW!!! This Petition appears to be a threat to Industry. So I guess that explains the attacks against Ed.”
You’re kidding, right? Do you know anything about the subject matter about which we are speaking? A preemption victory may HELP the industry, but a ruling AGAINST preemption would just maintain status-quo. It certainly is not a threat in itself.
All of the OTHER factors we face are much more ominous: loss of patent protection, off-shoring research, increasing incompetence at the FDA, etc.
Nathan
Ed writes: “And if the petition came from a crowd in favor of preemption, would the same few still criticize me for being biased and wasting space?”
Probably not — but certainly the other side of the crowd would! That’s the nice thing about this site as compared to other web sites out there. And that’s probably why we keep coming back… We get to hear both sides of the issues with neither side getting “drowned out”. In spite of my critisism, I do appreciate it.
Lisa Van S
Nathan,.. My dear, you are clearly a newcomer to this issue!! In 2004 I was the author of a petition for the removal of Dan Troy from the FDA,.. He Resigned shortly thereafter! My advice to you,.. NEVER,..EVER,… underestimate the voice or determination of the American consumer!!!!!
Nathan
Justice — it looks like I’m getting my butt kicked: 52 to 1!
;->
Lisa Van S
Nathan,.. I am so glad to hear that you are admitting to getting your but kicked!!!
Lisa Van S
Hey Ed,… Industry Apologist admits to getting his “BUTT KICKED”,..HOW SWEET IS THAT!!!
Lisa Van S
Hey Nathan,.. Cat Got Your Tongue!!!
Jack2
No problem Ed. I like the site and that’s why I read it whenever I get the chance.
Lisa so you think that you directly contributed to the resignation of Dan Troy?
Perhaps you should consider taking some of those medications you crusade against.
Lisa Van S
Jack2,… Energy and Commerce! WJLA!.. Are you insignificant?…. I believe so…
Justice in Michigan
OK, first of all I do “go on” too long in some posts. Apologies when I have. I’ll call Dr. Tobinick.
Nathan - What really pissed me off about Hoozits was when he said, “To argue with those that really have no understanding of Preemption and the right of the patient to sue, falls on deaf ears.”
“Deaf ears” is not what this site is about. Too bad it is where he lives. We do learn from each other.
Secondly, preemption is not capitalized. Doofus is capitalized. Especially at the start of a sentence.
Third, if we could decide policy by petition, we’d be in deep doodoo, indeed.
Come to think of it…Maybe Doodoo is capitalized?
Whatever
Lisa Van S
Jack2,
“Perhaps you should consider taking some of those medications you crusade against”
I have been vetted by the Secret Service,…HMM, how about you?
Lisa Van S
Jack2,.. Like Nathan,.. can one assume that cat has your tongue?
Lisa Van S
JACK2, When it comes to politics!… Its not what you know,..but who you know!!! Bipatisanship,.. You never get better than that.
Lisa Van S
Jack2,Nathan,Atlex,..No Comment!!!.. I Rest My Case1
Nathan
Dianne writes: “Also, Nathan, may I ask, if FDA Preemption is such a good policy, one that will make us all happy and safe, and will set a legal precedent affecting every American, then why isn’t Pharma bragging about it? Why all the hush-hush?”
I can think of several reasons:
1) Limiting consumer rights is generally not looked upon favorably by the public.
2) The general public probably does not have a good sense of how to balance the right of the individual with the rights of society. (that is ultimately what this debate is about in my mind)
3) Maybe the “upside” of preemption really isn’t as big as people on this site are making it out to be. Let’s say Wyeth wins the Levine case. What would happen to the valuation of Wyeth and other big-cap pharma? Probably not much. I would bet that pharma stock prices go up at MAX about 5%.
4) This issue is largely a lose-lose situation for pharma. If we lose Levine, then we maintain status-quo (which isn’t exactly a great thing). If we win, it’s likely our image will be even further tarnished than it presently is. We’ll just save some $$ on legal fees in the process.
5) Parties to court cases typically remain silent on the issue other than the standard court filings. Doing otherwise can risk a mistrial.
In other words, I wouldn’t read much into the silence you hear from big-pharma. What is odd to me is the silence from financial analysts. THAT speaks volumes to me. Either the analysts expect us to loose or they think that the impact of preemption is negligible.
Lisa Van S
Nathan,.. No Challenge to my comments!!..CHICKEN!!!
Steve
Lisa
You talk way too much and say even less. But, keep patting yourself on the back. By the way, the majority of the posters are the “petitioners”. Loaded deck? You still have to deal with the Supreme Court. Don’t buy the champagne just yet!
Have you considered hiring a lobbyist who may know the ropes better than you? Maybe even a congressman or senator would help.
Nathan
Ed,
Can something be done about Lisa’s comments? Frankly she’s hijacking this thread. 9 out of the last 13 comments were by her. Only about 2 of them had anything of substance to say. I understand you don’t like to censor…but this?
Lisa Van S
Steve;
“Lisa you talk way too much and say even less. But, keep patting yourself on the back.”
Learning the ropes!!… ARE YOU THE ULTIMATE IDIOT!! Clearly you are a laughing stock,..JERK!! Could have said asshole!!!
Lisa Van S
Hey Nathan,.. Are you a Coward?.. Does truth disturb you?.. clearly it does!!
Lisa Van S
Nathan,.. You, Atlex, and Allen have attacked others, You have provideed no substance to the conversation.
“Censor”,.. My Nephew is a US Marine ready to serve his second tour in Iraq, May I suggest,.. that you speak to him directly, and let him know, what you think about me,.. my position on drug safety, and that it is your belief, that the Marines can go to HELL, and they dont deserve to be told the truth.
laura
Justice,
Don’t worry about “going on too long”. What you say on your posts are relevant and your points are made in the time it takes to do so. If some people don’t have the attention span to read them, that’s their problem not yours.
Steve,
you say…”To argue with those that really have no understanding of Preemption and the right of the patient to sue, falls on deaf ears. All they want to do is see themselves in print with or without substantive facts.”
All I can say is, until you’ve walked a mile in my shoes and everyone else’s shoes who put together the petition we have been discussing today, please refrain from making such flippant comments. I can tell you, I understand preemption and the right of the patient to sue. And I can tell you everyone else who put together that petition understands preemption and the right of the patient to sue. I can also tell you, we understand the heartache that under researched, over marketed, illicitly approved drugs and medical devices can bring. We also understand the feelings of injustice, disbelief, anger, sorrow, resentment, discouragement, abandonment, that preemption’s victims are left with. So, for you to say that we have no understanding of preemption is truly an insult. We understand preemption in a way that, thank goodness, must people will never know. So when you discuss preemption, please try to look at through the eyes of someone who has truly experienced it. I think it might help you to understand.
Lisa Van S
Nathan is a Cry Baby!! He attacks Ed!!.. Unfortunately.. Then he wants ED to protect him against little old me.
Lisa Van S
Dear Pharmaceutical Industry,
Many statements have been made on your behalf on this website. I feel your pain, many individuals have spoken on your behalf,.. One can only assume that you cringe every time they open their mouths. Do you want to restore your integrity? Place a Muzzle on your employees. At this point,.. you clearly have no damage control!!
Justice in Michigan
Thanks, Laura. I’m not worried, that’s for sure.
Part of why we take the time we do is to _really_ address the points that others make, rather than push them away with arrogance and denial.
People like Jack2 have my greatest respect - they really do take the time to think things through. And so do a number of others with whom I may not agree. They are honest, and don’t try to weasel out of actual discussion
Others reveal their cowardice, ignorance, or childishness. Either way, not much to respect there.
Lisa Van S
Hey Steve, Im quite baffled in regards to your earlier comments,and it appears to me,… that you made no effort to invesrtigate me. If you were a part of Pharma you would have refrained from embarrassing the Company who employs you.
Ed Silverman
Hi Folks,
I actually walked away from the computer for awhile tonight and returned to see a little too many, well, stray comments. So I’m going to respectfully ask everyone - no favorites, no one singled out - to please return to the topic at hand and refrain from ‘getting personal’ with others.
The issue in play is preemption.
ed
Lisa Van S
Ed,.. Preemption is personal,.and I, in no disrespect to you, disagree with comments made here on this site. Nathan and others have opened the scope and there is numerious room for debate. Its just that simple!!!!!!!
Nathan
Ed,
Why do you single no one out? It’s obvious who the problem is here. Have a look at the conglomerated quotes in a single post:
“Hey Nathan,.. Are you a Coward?”
“Nathan,.. No Challenge to my comments!!..CHICKEN!!!”
“Jack2,.. Like Nathan,.. can one assume that cat has your tongue?”
“Nathan is a Cry Baby!! He attacks Ed!!.. Unfortunately.. Then he wants ED to protect him against little old me.”
“ARE YOU THE ULTIMATE IDIOT!! Clearly you are a laughing stock,..JERK!! Could have said asshole!!!”
Censorship is the ban of someone’s speach due to their beliefs. I think it’s time to ban Lisa Van S. not because of her beliefs, but because of her consistent rude behaviour. That isn’t censorship - it’s discipline. If there are no rules and no consequences, then there is no incentive for her to behave and speak in a civil way about her experiences and beliefs.
Ed, seriously. I would challenge you to find a single post of substance that she has made within the last few months. (A year or so ago I remember having conversations with her about real issues — she has ceased to do that) IT’S TIME YOU ENFORCED SOME RULES ON THIS SITE.
Reguardless of which side of preemption you are on, will anyone else agree with me on this?
Ed Silverman
Hi Nathan,
Have you ever moderated a forum? As I’ve explained in the past, I view the site, in part, as a great big lawn party, where people with presumably similar interests can flit among different groups and, at will, linger as long as they wish in order to listen and chat, or simply move about. So as long as no one throws the wine glasses, I prefer not to get involved in the conversations, unless I also would like to participate.
My one note was designed to be a gentle reminder to address the tone and direction of the discussion which, in fact, was threatening to go off track a couple of times during the day.
By late last night, when I returned to the site, I agreed that the conversation would benefit from a polite request for everyone to step back for a moment. There is nothing served, however, by publicly alienating anyone. That said, I always reserve the right to take more stringent steps, but I feel that would have to be a last resort and I prefer, for the moment, to rely on everyone’s ability to heed the kind of note I posted.
Please bear in mind that much of what you’re complaining about, in this instance, took place during a stretch of time that I was away from the computer last night. Unfortunately, I run the site myself - but for tech issues - and so I can’t be in a position to respond to such requests at every moment. By the same token, I did respond when I logged on and hope that my ‘reminder’ note will be taken seriously, by everyone.
To assert that I don’t enforce any rules or fail to be responsive, in this situation, is premature, I believe. Moreover, I want the conversations to be constructive and for everyone, including you, to feel comfortable enough so that the discussions are enjoyable and, hopefully, informative. And so, as I noted already, I continue to reserve the right to take additional steps. As of now, though, I’m relying on everyone’s willingness to heed the call. I’d like to think this will achieve the desired goal.
Regards
ed
atlex
Nathan,
Although I side with you that the petition is not very newsworthy, it is Ed’s site and he gets to determine what is and is not newsworthy. Also, I like his analogy to a lawn party. In this instance, most of us adults are having intelligent discourse despite significant differences of opinion. However, on occasion a bratty child (perhaps with ADHD)comes along to annoy us all. My experience is that ignoring the child is usually the best option. Maybe, he or she will get tired and leave the lawn party.
Atlex
Jack2
I wouldn’t worry about your long posts JIM. This is a complex issue and it won’t suddenly offer a simple solution.
joe
Alan and all,
The American people will decide on which side of preemption they stand only if and when they know that it exists. The drug industry, the FDA, and the media at large have done little or nothing to inform the public of this policy.
As a victim of FDA approved medications and as a petitioner for ADDA, I applaud Pharmalot and people like Ed Silverman for reporting the news.
Former pharma Marketing Exec
JIM,
I think your long posts have done an excellent job of explaining the situation in a very clear and concise manner.
Jack2 is right, this is a complex issue.
However, I cannot imagine why the creation of a petition wouldn’t be “newsworthy”?
I think the fact that a diverse group of individuals coming together to raise awareness of an issue, that seems to me at least, to be an integral component of what is meant by “Civil Rights and Freedoms”.
It would be a very sad day here and for humanity if there wasn’t this “passion” left in the world where people stand up for and demand to be heard on issues as critical as this one.
The very least we can expect is that this petition will stir up a dialog and all concerned parties will have their say into the matter.
So, frankly, the petition is just as newsworthy as the editorial piece by the NEJM was on the issue and just as newsworthy as any other piece on Preemption that was given “air” time.
Every voice deserves to be heard…
harpy
In the interest of drawing big, invisible lines in the air, I think this preemption issue is a microcosm of many of the issues the country is dealing with. Those who believe our civil rights have eroded too damn far already are digging in their heels and crying “enough!” Thanks to Homeland Security our Bill of Rights is in tatters, and preemption is an extension of this in a small way. I find it interesting that the people who seem to be the first to holler about a law turning government into a “nanny” state are also the first to jump up and support the “daddy” state regulations. I think the distinction between the two is that “nanny” makes you do something because it’s proven to be good for you while “daddy” makes you do something because it will be good for the “country” and, hopefully, ultimately you, but don’t-question-it-because-I-said-so. Or something like that. I haven’t worked out the specifics yet, but I’m getting awfully tired of being told I’ll “be taken care of” and “trust me.” Trust is earned and from what I’ve seen so far, pharma is one of the last industries I trust to have my best interest at heart. Am i really supposed to believe that’s my fault?
Really, Nathan, sometimes I can’t decide if you’re simple or naive, but stomping your foot and demanding that Ed punish Lisa for making you feel bad does nothing to assuage the petulant tone of many of your posts. Grow up.
Steve
Lisa,
How do I investigate a person who uses only the first letter of their last name? I have better things to uncover such as how your mind develops “preemption” conclusions.
Re my company embarrassment, you have just drawn a false conclusion.
If you wish for me, and the others, to be impressed with your CV, then give us your full name and attendant credentials.
Steve
Jack2
Let’s put it this way, Justice would have a cushy job at LAX as a wind bag. Of course, this is just my opinion.
Justice in Michigan
Steve/Ted - You seem capable of offering personal attacks, but no substance. Squat.
As above, I am not sure if this is a cover for ignorance, arrogance, or immaturity. It has no place on this site, whatever it is.
I did note that you supported the inclusion of two pages of horse hockey from PhRMA as all to the good. But an extra page of picking it apart was too much for you.
Have you actually nothing useful to say about preemption? Would love to hear it if there is anything there.
Justice in Michigan
Harpy - I think your take is right on. That’s why, when PhRMA decides FDA is worth defending (when they own it), they get all goofy about it’s “optimal” determinations. And how the rest of us will dissolve into chaos and confusion if we don’t leave them alone, unquestioned by anyone.
Shhhh…..Daddy’s working…..
Justice in Michigan
One of the pro-preemption arguments that was not engaged fully yesterday was the “big picture” issue that Nathan (like others) raised. Courts just see the victim in front of them. FDA seens the “big picture” of risks/benefits, as they show up in populations.
This argument would hold water if one could show instnaces in which, _as a result_ of product liability suits, a drug was withdrawn that actually should not have been because of what it was doing for the popoulation at large.
There is essentially only one case that fits those criteria - that of Bendectin. That is why, when preemptors make the argument, we hear “Benedectin” again and again and again.
(For those who don’t know, Benedectin was approved for morning sickness.)
So are there any other such cases? If not, this argument also goes down as more fear-mongering.
Jack2
JIM, do you just want drugs approved, removed, and then reauthorized for marketing? Or do you have added caveats before you will accept them as evidence?
Justice in Michigan
Jack2 - I was waiting for someone to go to Vioxx, which is a complicated discussion. Bring it in, if you want.
Otherwise, it sounds like your criteria would work - again, the “removal” happening as a result of litigation.
Jack2
Lotrenox (alosetron)
That’s all I have time to get in 10 minutes. I might be able to get more tomorrow, if there are anymore.
I wasn’t going to go to Vioxx because it isn’t back (yet, although I know some people would take the risk and swear it’s the only drug that works for them).
Plus Merck didn’t technically withdraw Vioxx because of litigation. Merck withdrew it voluntarily (although you could reasonably argue that the impending threat of litigation contributed to the withdrawal).
Finally, the reason I sit on the fence is due to economics. The best argument for preemption (for me) would be proof that drug companies spend enormous amounts of money defending themselves from exploitative lawsuits (which definitely occur, and I would guess pharma probably suffer them more than most/any industry). These lawsuits act like a tax on the industry draining recourses that could otherwise be more productively applied to R&D, reduced drug costs, or increased shareholder value. I’m not so naive as to believe it would necessarily go in that order, but I believe some would go into all of those buckets and all three of those buckets represent a better use of money.
That needs to be weighed against an unknown increase in safety risk.
Since both of those numbers are unknown, I find it really tough to decide what’s better.
Nathan
Justice,
I think you are missing the point. The drug does not have to be removed in order to a wrong to be done. The FDA approves the drug based on the “big picture” benefit to society (not the individuals — some of which who will surely be hurt by the drug). The FDA approves not just the medication but the LABELING AS WELL in order to benefit society (not the individual). Why should juries and justices be able to decide that the FDA made the wrong decision in either approval or labeling of a drug?
It’s not a matter of drugs being withdrawn from the market — it’s a matter of who is the expert: judges&juries or the FDA.
Even though you may not see the consequences in terms of withdrawn drugs, we in the industry surely feel it when a compound is withdrawn from clinical trials due to seemingly insignificant side effects that are deemed too risky to proceed into a phase III trial. My belief is that lawsuits are at least partially responsible for the major drop in drug approvals over the last several years. Pharma is unwilling to open itself up to liabilities and therefore has become extremely risk-averse.
Steve
Nathan,
Very well thought out comments. I subscribe to your thinking.
As I tried pointing out (substance) in two earlier posts, all I got was a fan blowing right back at me. Whatever you or I say, there will always be a remark to dispute the observation.
For those who are following this Supreme Court matter, the case number is 06-1249. A reply to extension was filed yesterday to
9-15-08. The matter is set for argument on November 3, 2008.
Also, I see quite a few Amicus filings which appears to be representing both sides of the argument. They are very powerful entities.
Just A Thought
This is an emotional thread but don’t doubt for a second that folks want to be able to trust medications and their manufacturers again. Seems to me that pharma would want our trust. Preemption works directly against it. Why this industry is dirtying itself by causing more animosity is puzzling. That they think we can approve of them after they have worked to take away our rights is nuts.
You cannot assault or insult your customers and expect their loyalty. It’s a shame when people begin to fear the very thing that is supposed to make them well. No one wants to have to investigate everything they swallow but pharma and the FDA have created that situation, not the consumers. Don’t tell me that folks need less information or that too much information is too confusing and overwhelming. It only looks like you have something to hide.
As for reporting AEs to the FDA- I remember reading someone’s explanation about what is reported and how. Buddy, when your medication is changed to have a new DNC#, a new manufacturing process, and a new list of ingredients- it is a new drug. You cannot base the name of a drug on the fact that it has one active ingredient that is the same as the innovator drug, giving way too little consideration to the dissolution which is determined by the drug’s excipients. To do so would make R&D redundant. So when a drug is changed to that extent, the list of possible reactions may well work for new consumers. But when long time users start having reactions that they didn’t have before then someone needs to take steps to correct the problem. When you change a drug to the extent that the active ingredient is nearly all that remains, you need to warn your consumers and their providers in advance. No denial, no ‘yeah buts’, no ignoring. Because maybe that new formula would not have been approved with these additional AEs and severity of those instances when the innovator drug was found to be safe under much more scrutiny than a one dose study.
Let’s not forget that money is not the main objective for the consumer. It sure as hell should not be the only objective for the industry. If it is then you have much bigger problems than unhappy shareholders. People will have to weigh whether they should take your products. Is the condition bad enough to consider swallowing anything that comes from you? You should also keep in mind that for a consumer to bring a suit is to put himself on trial, bearing the burden of proof, it is terrifying.
You don’t have to agree with me, but I am Joe Public and you should at least be aware of what people are feeling. I sincerely hope that pharma can regain our trust. It is vital to everyone.
Justice in Michigan
Still waiting for substance from Steve/Ted. The amici have been well covered here. Can you site your prior posts?
At the risk of repetion…
1. Juries do not “second-guess” FDA’s labeling.
2. FDA approval and labeling already figures as a compelling defense in virtually every failure-to-warn case.
3. Juries rule on whether FDA _had_ the data they ought to have had to create, and update, labeling
4. Once again, the relevant questions are:
- What did company know?
- When did they know it?
- What did they do?
5. Those Qs can be complicated to answer, but they are the relevant ones. All of them concern info that FDA _did not have_. Not real subtle in Baycol and fen-phen cases discussed further up stream.
Meanwhile:
1. Fraud and lesser versions of the same do not require FDA-type expertise to understand.
2. Even defense attorneys (I know industry folks who’ve worked with them) say that most of the time juries get it right.
3. The impact of potential lawsuits on approvals is an empirical question, although complex. As you know, most explanations point elsewhere. So we need evidence, not ideologically-driven policy.
Back to Jack 2 later.
Nathan
Justice, you write: “Juries do not “second-guess” FDA’s labeling.”
Can you please expound on that? My understanding is that is exactly what is happening. As I’ve said before, I’m all for prosecution of fraud. But I’m tired of individuals who can sue for getting breast cancer from HRT when the label clearly spells out that clinical trials show that HRT does increase the risk of breast cancer. Clearly a warning was given. The FDA clearly believes that the benefit is worth the risk. Yet individuals still sue (and win) when they get breast cancer. This is a system out of control.
I believe that the pendulum needs to swing the other way. As I’ve said, preemption may swing the pendulum too far — but I don’t see any other viable tort reform on the way that will get rid of today’s problems. The current system is broken. Preemption may fix it or it may make things worse. But I say let’s try something…
Nathan
Just as a follow up: Clearly the HRT patients that are suing believe that the warning label was not adequate. Isn’t this second guessing the experts at the FDA? As long as the FDA had all available data in hand, they are the experts that should make the judgment call about the type (and wording) of a warning. If it’s too harsh a warning, no one will take the drug and no one will benefit. If it’s too lenient, then people will believe there is no risk. IT IS A JUDGEMENT CALL THAT *SOMEONE* HAS TO MAKE. In the US, we have decided that it is the FDA that makes that judgment call. Yet state courts still decide that the warning was not adequate and plaintiffs win big bucks.
As I’ve said before, I think we are quickly going down the road of the “cover my butt” warnings by listing every conceivable side effect. (See the FDA docs for Naproxen that I’ve referenced in the past if you don’t believe me) The level of warnings that individuals (via the state courts) are demanding is pushing us in a direction such that the warnings aren’t headed or understood.
In my opinion, preemption is really just a reaction to the US attitude of “if I get hurt, it must be someone’s fault, and I must get my compensation”. If US consumers wouldn’t be so “sue-happy”, then all this wouldn’t even be an issue. Ok, I’ll step off my soapbox…
One other point: You and others repeatedly point out that the process of “discovery” wouldn’t take place in the absence of these lawsuits. While I understand your point, I think you should cease using this argument. This is really just a type of “the ends justify the means” argument. It really has no place in the whether or not preemption doctrine is correct. It’s really a simple question in my mind: Either the FDA has the authority the government has granted, or it doesn’t. If it does have the authority, then reforms to drug safety need to take place WITHIN THE FDA – not within the courtroom.
Nathan
One last thing — I promise! ;->
The FDA currently is the sole regulatory body that approves drugs and drug labeling. We all agree on that. If the consumer is not happy with the FDA decision (ie, they get hurt), they can sue the pharma company. What recourse does Pharma have when IT disagrees with an FDA decision? ZERO. ZILCH. NADA. NOTHING.
We (in pharma) are absolutely 100% bound by the decision of the FDA. The consumer is not. Now who has the upper hand?
Justice in Michigan
I actually need to be short. N writes: “As long as the FDA had all available data in hand, they are the experts that should make the judgment call about the type (and wording) of a warning.”
That’s the ballgame, from my perspective. And I agree. So the question is: How do we know?
I genuinely don’t understand why you then object to discovery, or some similar review (Sharkey model), to find out. Explain, if you would. Keep in mind that judges don’t allow discovery to proceed if they don’t think there is good enough reason to do so.
BTW, personally, my ideal policy would be a package of three reforms: (1) Tort - ending or making rational punitive damages. Generally happens in practice (2) FDA - FDAAA doesn’t go nearly far enough. Both post-marketing surveillance and criminal investigation remain severely hamstrung. I also favor an independent ODS because of intevitable COIs within FDA (3) If the first two were in place, a narrower preemption when FDA definitively (a) has reviewed relevant risk and (b) has done so on the basis of all relevant data. A version of the Sharkey model.
Re: how “bound” industry is by FDA, there’s a lot of history to suggest how fluid the “bounding” can be in actual practice.
Justice in Michigan
Chris2 - I am not familiar with the particulars of the Lotronex saga, but found FDA’s summary when first withdrawn below:
http://www.fda.gov/bbs/topics/ANSWERS/ANS01058.html
Based on my googling - admittedly incomplete - I could not find even Glaxo saying that this initial withdrawal had to do with lawsuits. In any case, FDA report suggests both FDA and company believed there were safety issues that deserved scrutiny, and that that was main reason for withdrawal at that time.
There is probably an example from device arena - silicon implants.
Jaynesday
Nathan, you make some good points. As I’ve stated before I am no expert so my comments are mostly judgment calls. I go on what sounds logical and what sounds fair and right. Common sense I guess. So for what its worth here are a few comments. I hope you don’t mind my parsing your argument.
You say -
1. “Isn’t this second guessing the experts at the FDA? As long as the FDA had all available data in hand, they are the experts that should make the judgment call about the type (and wording) of a warning.”
My concern about this is the part about “the experts at the FDA”. From what I’ve read this statement is in doubt. Not that the staff are not the cream of the crop but that some management decisions and outside support have been suspect.
Also the part about “as long as the FDA had all the available data in hand” – It appears that sometimes that’s not the case.
2. “In the US, we have decided that it is the FDA that makes that judgment call.”
I think that’s a presumptuous statement. The jury literally is still out on that one.
3. “As I’ve said before, I think we are quickly going down the road of the “cover my butt” warnings by listing every conceivable side effect.”
I also think we