Henry Waxman Gives Pharma & The FDA A Gift
86 CommentsBy Ed Silverman // November 24th, 2008 // 8:23 am
The consensus last week was that the upcoming change at House Energy & Commerce Committee, where California Democrat Henry Waxman will replace Michigan Democrat John Dingell, is something of a wash for pharma and the FDA. That’s because both men were known to be tough on drugmakers and regulators alike, and have launched numerous investigations into pricing, marketing and safety issues.
But it may not be that simple, at least in the short run. The changeover, which made for compelling intrigue on Capitol Hill, may actually cause efforts already under way by the House Committee on Oversight and Government Reform to languish. Among the topics it explored: Glaxo’s Avandia diabetes pill, FDA enforcement, preemption and Medicare Part D pricing. In fact, whether the committee continues to be just as tough will depend upon who succeeds Waxman.
And what of the fate of the investigations under way by Dingell and his ally, Bart Stupak? Speculation on the Hill is that committee staff will largely be replaced once Waxman arrives, making it difficult for those same investigations to continue apace, especially if the departed include David Nelson, a long-time Dingell aide and point person for pharma and FDA probes. Even if Waxman tries to keep those probes on track, months may well be lost. Dingell, for instance, focused extensively on the Vytorin controversy and FDA oversight (look here).
There will be more clarity, of course, in coming weeks. Meanwhile, though, drugmakers and regulators may have been given, if nothing else, a welcome respite.
Justice in MI
A “wash” is probably the right conclusion at this point. Waxman has been much more a bulldog on preemption than Dingell has been. Dingell also tended to focus more on FDA in isolation, which - in my view - could sometimes be a diversion from the “big picture” (including Congress’s own responsibilities).
Ed Silverman
Hi Justice,
I suppose this may depend on the topic one examines. Dingell et al moved on Vytorin, for instance, and the issue of clinical trial disclosure. My point in raising this question is that, for now, whatever probes begun by Dingell may get delayed, or perhaps derailed. Again, we don’t know what will happen to Waxman’s probes. Will they all get shifted to his new committee assigment or might one or more somehow get left behind? And will Waxman’s staff continue the Dingell probes? What if the staff doesn’t pursue the Vytorin controversy? If you worked at Merck or Schering-Plough, what would your reaction be?
Cheers
ed
Lisa Van S
David Nelson has done an excellent job over the years, his departing would be a tragic loss to the American Consumer.
David Ross
I truly hope that Rep. Waxman understands how much good work the current Oversight & Investigations staff have done, and how important it is to retain their hard-won experience.
An FDA Reviewer
Good to hear from you David. We’ve met.
For anyone who doesn’t know Oversight and Investigations is the subcommittee in the Energy and Commerce Committee headed up by Rep Stupak and where Dave Nelson and others work.
An FDA Reviewer
Steve
FDA Reviewer,
It seems you have a lot of time on your hands. Is this where our tax dollar should be going, to your (many) blog responses?
Do you have authority from the FDA to act as their spokesperson? I see no disclaimer.
I wonder how many others are taking valuable time away from the business of (government) reviewing.
Dianne
I believe Rep.Waxman will be very good in his new role. Last June, I wrote him with my concerns about FDA preemption. I live in Michigan and am not his constituent; however, he took the time to respond with the following letter which shows he is very aware and concerned with the issues of preemption.
June 2, 2008
Thank you for writing to express your concern about the
Wyeth v. Levine court case, which will be heard before the U.S.
Supreme Court this fall. I appreciate your taking the time to be in
touch. You can be certain I will be carefully monitoring the
developments in this case, especially in light of the recent Supreme
Court decision in Riegel v. Medtronic Inc. relating to similar
questions regarding medical devices.
As you know, a February 2008 Supreme Court decision has, for the first time, immunized medical device companies from
state lawsuits brought by patients who are injured by certain
medical devices. This decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval devices or inadequate safety warnings. It also removes one of the industry’s most important incentives to
maintain product safety after approval and disclosure newly-discovered risks to patients and physicians.
The Court premised its decision on the theory that approval by the Food and Drug Administration (FDA) adequately protects
patients from unsafe medical devices. That theory has proven false time and again. There have been numerous recent stories of patients
who have suffered serious injuries from defective FDA-approved devices, like implantable cardiac defibrillators and pacemakers. Until the Bush Administration, FDA had always viewed state product liability cases as an important supplement to the Agency’s regulation of medical devices and as an added layer of protection for consumers.
Should the Supreme Court make a similar decision in the upcoming case regarding FDA-approved pharmaceuticals, you can be sure I am prepared to take corrective action
To learn more about my work in Congress or sign up for periodic e-mail updates, please visit http://www.waxman.house.gov and
http://oversight.house.gov.
Again, thank you for contacting me and I hope you will continue to keep in touch on issues of concern.
With kind regards, I am
Sincerely,
Henry A. Waxman
Member of Congress.
As stated here before, Engler asserted Michigan’s law is intended to be the “law of the land.” Today, with Wyeth v Levine, that prophecy is at hand. The only way to stop the mass production of “Michigan’s model” is with strong, responsive leaders and public awareness.
Is this America’s future?
To see an October 22, 2006, WXYZ TV news story about Michigan’s law, into Search type:
YouTube - DeRoche cornered on drug immunity.
Since then, zipppity to dah.
Justice in MI
Ed, I agree, we will see what gives. My impression that is based on a small bit of hard information is that a number of staffers were responsible for what Rep. D. chose to champion. So, as suggested by some above, a lot will depend on how many of those people remain involved.
An FDA Reviewer
Steve,
All comments are written on my own time and are my personal opinion. I have stated this before and will continue to state it intermittently. Thank you for the reminder. FDA can easily verify if it’s on my own time because the only government computer I have is in my office at the FDA. If I were doing it on government time they would see it from my computer usage.
An FDA Reviewer
An FDA Reviewer
PS Steve.
As for the (many) posts (your words) the last ones I see are on November 19th and 18th before and after normal work hours. I don’t see any before that going back to Nov 14th. I admit there were some days earlier where there were many, however I was not working those days. As many of those posts were highly critical of FDA and FDA positions I would think that it would be fairly obvious to anyone that these were personal opinions and not official FDA positions.
Actually I thought that I was doing the taxpayers a favor by revealing how FDA actually works.
Isn’t that how our democracy is supposed to work?
That is free speech so that the citizens can actually see how their government functions and if we are actually working on behalf of the citizens. And with the FDA isn’t that supposed to be protecting the public health?
Lisa Van S
Steve,
If I were you, I would be more concerned with the time, FDA’s Dr. Tom Laughren spends with pharma and ghostwriting to promote unsafe drugs on the taxpayers dime
Steve
Reviewer and Lisa,
I am very involved in the bio industry but don’t have the interest in educating everyone with extended theses for those who read these blog responses.
I have always lived by the words, “don’t bite the hand that feeds you”. I am referring to your employer (Reviewer). No matter how an employee feels, public space should not be used to set forth their OWN feelings and conclusions.
To me this is a “conflict of interest”. By identifying yourself as “An FDA Reviewer” you are acting under color of authority and a presumed agent.
If an employee doesn’t like what a company is doing, then that individual should find other avenues for recompense.
Lisa Van S
Steve,
Bit curious, why include me in your post to FDA Reviewer? As a consumer, I find the FDA’s reviewer’s comments educational, while on the other hand I find your comments irrelevent! Why you may ask?,.. they have no substance or value to the consumer.
Justice in MI
FDA reviewer writes:
“Actually I thought that I was doing the taxpayers a favor by revealing how FDA actually works.
Isn’t that how our democracy is supposed to work?
That is free speech so that the citizens can actually see how their government functions and if we are actually working on behalf of the citizens. And with the FDA isn’t that supposed to be protecting the public health?”
I could not agree more. WE (the American people) are your clients. WE pay your salary. It is to US that you are responsible.
I am grateful for your participation. Folks like “Steve” try to intimidate others into silence. Their tactics will not succeed in the United States.
An FDA Reviewer
Steve,
There’s a big difference between a company and the government.
I disagree with you about acting under color of authority and a presumed agent. Who would you say authorized me? If I were authorized and an agent wouldn’t it make more sense that my name, title and position would be included? Also why would I post to comments on a blog? Wouldn’t it make more sense that if I were an agent that the FDA could arrange for me to write op-ed pieces in the Washington Post of NY Times, or have an FDA sponsored press conference.
I state that I am an FDA Reviewer only to show that my opinion is informed by actual knowledge and experience and is not based on conjecture about what goes on inside FDA.
I personally believe that the people who criticize me as a person here only do it because they have something to hide, otherwise they would simply rebutt my arguments. As Justice Brandeis said, “Sunlight is the best disinfectant.”
You state: “I have always lived by the words, “don’t bite the hand that feeds you”. I am referring to your employer (Reviewer). No matter how an employee feels, public space should not be used to set forth their OWN feelings and conclusions.”
This seems to imply that it’s not that I didn’t include a disclaimer that you didn’t like but that I’m speaking out at all.
Well if you look at FDA funding essentially 100% of all actual review work and reviewers is funded by the pharmaceutical industy. Does that mean I’m not allowed to turn down a drug because I would be biting the hand that feeds me?
This is not something I did lightly. I only did this as a last resort after years and years of going to Congress because there is a massive imminent as well as long term danger to the public health. In my opinion nothing less justified going public with my concerns. This danger is ongoing and at this point I can’t prevent it. I can only mitigate the degree of harm. Based on the number of people from FDA who have also blogged here as well as elsewhere it appears I am not alone.
In fact it also appears that I and others may have the support of the majority of Congress based on the text of the Whistleblower Act of 2007, which is currently being held up being passed into law by a single senator. Is this true representation where a single senator for who knows what motives can stymie the will of the rest of Congress and can prevent the actual implementation of the first amendment. As far as I know this may be Senator Kyle and I would urge every reader here to write him and to urge him to remove the hold from this bill and to let the house and the senate to actually vote on it. Then we can see if my opinion is justified or not.
Jaynesday
Steve,
I also thank FDA Reviewer for the input. I suppose when you work for a corrupt organization trying to correct from within would be somewhat foolish.
Lisa Van S
FDA Reviewer,
I can assure you this, Senator Kyle will here from this registered republican. I will also see to it that the republican parents in his ditrict contact him also.
Steve
Lisa,
I was referring to your 8:17 pm message addressed to me. Just being courteous.
Your 8:55 pm message reflects naivete. Try and follow the bouncing ball.
Your 9:27 pm really sounds tough. Maybe you will be the deciding factor.
Lisa Van S
My Dear Steve,.. The one thing I am not, is naive, nor am I gullable. GSK taught me well!!
Steve
Justice,
Your 9:09 pm message indicates that your plebebian response is somewhat innocent.
If Reviewer wants the world to know the truth, as she sees it, then why not be a “whistle blower”? Or, take the matter to an attorney who might be able to change the FDA?
Complaining here will not open doors.
Steve
Lisa,
Your 10:05 pm indicates that you are hiding behind letters. Come out and tell us who the party is. These initials could mean anything and lead us in the wrong direction.
Are you beginning to see what I mean?
Lisa Van S
Steve,
Sure I do,.. your’e playing cutsie, and it does you no justice!!
Steve
Reviewer,
Your 9:15 pm message shows your confusion of what these descriptions mean.
I will not go into a long boring speech, explaining the essence of my comments. I would suggest you check out what I described earlier.
Steve
Lisa,
Your 10:15 pm still doesn’t cut it with me. So, tell us whose initials they are. Pretty please!
Salmon
Steve,
I find your comments to Lisa simply rude and insolent.
First you addressed Lisa and Reviewer yet you do not write anything relevant to Lisa’s 8:17 post and so how is this courteous?
As for the second comment I think it clearly speaks for itself.
Your last comment seems to be mocking Lisa.
Please keep this to the issues and do not make it into personal attacks.
Salmon
Lisa Van S
Steve,
Funny,.. do really think I care what cuts it with you!!
Lisa Van S
Steve,
Funny,… do “you” really think I care what cuts it with you!!
Lisa Van S
Salmon,
Its ok, When Industry little ones speak, like steve, it only makes Pharma Execs cringe, I actually enjoy it.
Jaynesday
Steve, what is your purpose here, near as I can tell it’s just to tell everyone to shut up. Why?
Salmon
Lisa,
I see your point. Yes it simply doesn’t look very good for Pharma industy employees to publicly mock patients and especially not mothers of children who have been severely harmed.
Steve,
As for your 10:15 remarks, reviewer never claimed she was a lawyer. It appears she simply tried to use common sense, but then by your use of the term “whistleblower” it appears you’re not a lawyer either. So I guess no one here can rely on your interpretation of what terms mean.
Salmon
Christopher
Who says Steve is a pharma industry employee and Salmon, where did that come from? Nothing wrong with FDA reviewer using common sense - mercifully - but let’s not ignore what Steve suggested, as unlikely as it may sound. Of course in today’s economic maelstrom few will sacrifice a paid position on principle, but let’s keep alive the hope that if a position becomes untenable that the option remains for the truly committed (and presumably independently wealthy).
An FDA Reviewer
Thank you everyone.
When I joined the government the first thing they had me do was take an oath of office.
I believe it is the same as the President takes:
“I will support and defend the Constitution of the United States against all enemies, foreign and domestic; that I will bear true faith and allegiance to the same; that I take this obligation freely, without any mental reservation or purpose of evasionl and that I will well and faithfully discharge the duties of the office on which I am about to enter.”
Government ethics regulations require that I put allegiance to country and to defend the constitution above all other duties I have; and above loyalty to any particular person, group, or even government agency. It’s really disappointing to me when I hear so many politicians at the highest levels say that they value loyalty above all else. To me that says they believe that loyalty to them takes precedence over loyalty to country and the constitution.
I take this oath and my duties very seriously.
In my view the only possible way that I can fulfill my duties to protect the public health, and to protect the constitution, and in particular the First Amendment, is by actually exercising my First Amendment right to freedom of speech and to disseminate information through publication. For if we don’t use our rights, then in truth we really don’t have them.
Steve seems to believe that my obligation is to my superiors at the FDA and that it takes precedence over my oath of office. I had hoped that the whistleblower act would have passed and I would have more protection. Unfortunately that was not to be.
I believe that I will not come out of this unharmed. It has however given me new appreciation of many things. For example the correctness of Alexander Hamilton’s fear that the Bill of Rights would be slowly whittled away by the executive, legislature, and especially the courts. I also believe I understand now Patrick Henry’s sentiment “I regret that I have but one life to give to my country”. I am no longer as fearful for my life as I was but I now think I understand the meaning and in spite of any damage I’ve done to my life and livelihood, if I had the choice to make again about standing up and speaking out. I would do it again.
I’ve put my trust in certain members of Congress and I hope that the little bit I reveal here will help them in what I think they want to accomplish.
Lastly I want to say I trust in God. It seems as though all the past things that I went through in my life put me in a unique spot, with unique skills, at the right time. I know not everyone agrees with my sentiments about God and do not expect them to. I am simply grateful that I live in a country that respects my rights to my beliefs.
Lisa Van S
Christopher,
Would you please explain, further, simple language would be much appreciated for us local NJ Moms, and of course New Grandma’s!!
Lisa Van S
FDA reviewer
Im “very” good at keeping secrets!! Confidentiality,.. my middle name, Id like to speak to you privately lvansyckel61@yahoo.com
Steve
Lisa,
“good at keeping secrets”! Then it wouldn’t be a secret anymore. I wonder what all the “secrets” are for. Doing a little snooping?
Lisa Van S
Steve,
When all else fails,.. have another drink!!
Lisa Van S
Steve,
Since you frown upon secrets, how about providing the pharmalot readers with a resume. Normally I would ask for a CV, but it is quite clear that you are not a physician, or an individual who can provide a medical opinion!!
Steve
Okay, all I am trying to do is involve the bloggers by more than just being aggravated about a situation. There are all sorts of avenues to approach the problems at hand. I am very much bothered by what I see in the industry and I have been involved in many media interviews.
I am trying to bring about all of you to think and act out of the box.
I am well acquainted with the FDA and how it works. They have problems but all businesses do. Whether it is government or private industry, they are businesses.
Probably the biggest problem with the FDA is their funding. They are overwhelmed and it shows. Recently, the FDA asked if the various pharmas would finance the reviewing of submissions, as they don’t have enough money to accommodate the huge load of business.
I am also aware of all the politics that go into the operation. I can’t recall how many FDA Commissioners we have had in the last 6 or 7 years. Some are hired on as permanent and others as interim.
As far as “whistle blowing” is concerned, it is used both private and government. In fact, the government has set up a whistle blower unit and it has proved fruitful.
Regarding my comment about a “lawyer”, many have gone after private and agency operations.
Lisa Van S
Steve,
Provide pharmalot readers w/your identity!! Provide the pharmalot readers with a CV. When an individual, who is a bio investor, who takes it upon themselves to attack NJ mother’s, be prepared. We will aniliate you!!. Our children, are,.. our number one priority!!! I hope I have made myself perfectly clear. Either you put up, and if you cant!… Just shut up..
An FDA Reviewer
Steve,
So you know how the FDA works.
I hate to tell you but lack of money is not the problem for reviewing new drugs at the FDA.
Most of the review work is loaded onto a few reviewers in order to overwhelm them and the tracking and bureacracy is also made to be overbearing.
Most of the review staff in certain divisions are actually being diverted to work on projects to help the industry develop drugs quicker. (He who pays the piper pays the tune.) Post marketings surveillence may be a different matter but lack of resources holding up reviews of new drugs NO WAY.
So “the government has set up a whistle blower unit and it has proved fruitful”. Do you mean the Office of Special Counsel under Scott Bloch whose own staff whistleblew on him to Congress and who called in Geeks on Call to wipe his hard drive in his office to destroy evidence and who the FBI raided his office and home I believe, and who the White House finally fired just a couple of weeks ago. If so then I have trouble seeing how you could come to the conclusion it was fruitful, unless you mean fruitful for groups like the pharmaceutical industry.
Lawyers? Interesting idea since it’s illegal for any reviewer to tell a lawyer about the drugs they’re working on or provide any documents to them without formally requesting them through FDA and having the FDA redact them. In fact according to my contacts in Congress the FDA has even sent threatening letters to Congressional offices telling them that they were in violation of criminal acts for simply receiving certain information from reviewers and the documents had to be destroyed immediately. In spite of the fact that the FD&CA explicitly allows it.
You want us to think outside the box? Believe me I’m pretty good at thinking outside the box. In fact my bosses at FDA have repeatedly complemented me on my ability to do so. They just let me know that they’re not so thrilled with what I apply it to.
An FDA Reviewer
Just a clarification. Whistleblowing for government employees is a whole different ball of wax than for businesses. The whistleblowing offices are different for government employees than for private business employees who can go to the Justice Department. Plus Lawyers can help employees of private businesses especially with Qui Tam cases, however that also isn’t available to government employees as it’s supposed to be part of our job duties anyway.
An FDA Reviewer
For those who want to see a summary of the actual status of whistleblower protections. See the following link to a transition paper to President Elect Obama from the Government Accountability Project that was sent just a few days ago.
http://www.whistleblower.org/doc/2008/TransitionMemo.pdf
Lisa Van S
FDA Reviewer,
It is truly a shame that you choose!!.. to ignore those who can help. It truly is a shame that you choose to stay silent. How many children have to die before you do something. “NO” job is worth jeoparding the life of a child. Do you have concience? I dont believe you do. If you believe that the life of a child is precious,then do something about it
Lisa Van S
FDa Reviewer,
GET OFF YOUR SOAP BOX, PROTECT ANERICA’S CHILDREN FROM UNSAFE DRUGS.!!!
Justice in MI
Just seeing Act II.
It’s the first time I’ve been called “plebebian” [sic] before, but even the real Roman nobles sucked at spelling.
As for the core issues, FDA Reviwer is a point of many spears. We have recently heard how many more people at the agency are beginning to tell the truth in all sorts of contexts, not all of them private, and certainly not all on blogs. The same is true for people in industry who know the truth. indeed, the truth is seeping out pretty fast these days, despite terrible whistleblower protections.
They are all doing great service.
If I were Steve, I’b buy a swamp boat.
Former Marketing Exec
What I find amazing is how someone like Steve has gone through an undergraduate program in a University without encountering one ethics class? Otherwise, this does not say much about ones character if they actually did take a course in ethics and still behave the way they do. This would mean that the person has deliberately chosen this behavior and intentionally wants to mislead, obscure, and potentially harm fellow human beings.
How is it that nearly everyone who works in Pharma and tries to claim they are doing so in order to help humanity, conduct themselves in a very rogue fashion?
Additionally, I would like to know how is it that these very same people who have no trouble corrupting government systems designed to protect and serve it’s citizens, can do so with such conviction and belief that they themselves will never be part of the population that must rely on the very healthcare services they corrupt? What magical elixir are they privy to that provides them some immunity to illness and disease?
If we want to know which drug company Steve works for, just look in the top ten, those with the most to lose fall the hardest.
I am beginning to think that there are some people in pharma who could be classified in another form of terrorism that intends to corrupt and destroy the government of the United States and cause serious harm to the citizens of the United States of America.
Citizens trust in government, their doctors and the medicines they are being prescribed has been severely eroded - this is the perfect storm and it was created by the Pharma industry.
I certainly hope our President Elect does something about this, otherwise there will soon be no country left to govern.
An FDA Reviewer
Lisa,
I understand your sentiments. However If I did it, in truth it would allow many more children to die. I don’t like it. I can’t stand that I have to let ANY child to get hurt in the interim. But if I did what you suggest it only make a small difference and not the bigger systemic changes that are really needed to stop harm to many more people.
If I do my review work honestly I have to balance things. This drug will kill or hurt X number but if it isn’t approved Y will die. Is there someway that I can label it or adjust the dose or tell people how to take it so X becomes 0.75X and thus 0.75X is < Y. That may cut sales but it will also allow the company to have 90% instead of 0% so maybe they can come up with something better in the future. I have struggled with things for years and thought through many options and the likely outcomes, it comes down to how to do the most good. I’m not going to explain the ins and outs and why’s in public. It just gives others more understanding of how they might be able to manipulate their message.
You think Rep. Stupak doesn’t care and doesn’t want to do anything? He’s a congressman and chairman of the investigations subcommittee with responsibility for the FDA. He could go public with documents if he wanted to and it would make a much bigger difference, but instead he works quietly. Do you want to win the battle and lose the war? There are people in congress who are listening and they are working on it. I’m pretty cynical at this point but I’ve put my trust in them.
You claim you are “very” good at keeping secrets. Well your latest post (if it is you) doesn’t engender me with confidence. I believe that people down on capital hill know a lot more about how to do this than you or I. I hope I haven’t caused too many problems for them in fixing things, but I’m certainly not going to do anything that I’m fairly certain will make their task even more difficult. It’s hard for me too to not simply get up walk into newsroom and start talking. Maybe that feeling has already caused me to say too much and have hurt the effort.
Nathan
I never thought the day would come… FPME labels me a “terrorist” for working in the pharma industry while I completely agree with something that FDA Reviewer has to say! (The “X and Y” business)
I don’t think Steve is being quite as radical as you guys think he is. He’s essentially saying “put up or shut up”. If there is something clearly illegal or immoral going on in the FDA, then it’s time to publicly take a stand — not just in the “shadows” of a blog — but in the real public sphere.
FPME, the same is true for those of us in pharma. I’m in early research. If I saw something clearly immoral going on, I would (try my best) to make a stand and say so. But I just don’t see it here. From my perspective, we are a business of honest and hardworking scientists doing something we love while trying to better mankind.
Nathan
(By the way, Justice, I posted a comment for you over in the “toll-free-#” thread — but I think it got lost in the shuffle because of the meyhem of this thread)
Former Marketing Exec
Dear FDA Reviewer,
Many of us believe that you are doing the right thing. I am one who also understands the thought and care you must weigh all of your decisions with.
When I worked in the Pharma industry I was amazed at some of the dealings that went on, but they were never as many as we have seen in the last decade.
It was very difficult for me to work in Marketing and rein in the middle managers and product managers who were just to aggressive at times and overstepped the process. I can tell interesting stories of the messes I have cleaned up that were created by over aggressive marketing people. The marketing departments of big pharma need to be reined in and their influence and control needs to be closely monitored. Their direct access to doctors needs to be closely supervised.
Additionally, any money earned through illegal marketing and business practices should be re-paid just as illegal drug traffickers possessions are seized.
Being a doctor is a hard earned privilege. We must create programs that protect the doctors from being harmed by illegal and immoral business practices. Once a good system of protection is in place then, any Doctors who allow themselves to be corrupted must lose their licenses, because they will have already lost the trust of the patients that they are there to serve.
Much work needs to be done.
Jane
FDA Reviewer,
You have obviously struck a nerve with industry people. Good Job! I justed wanted you to know I have referred others to this site to look for your comments. Your terrorist comment is spot one. Keep up the good work. (BTW, I don’t think Lisa wrote those last comments!)
Former Marketing Exec
Nathan,
Why would you take a statement like this ” I am beginning to think that there are some people in pharma who could be classified in another form of terrorism that intends to corrupt and destroy the government of the United States and cause serious harm to the citizens of the United States of America.” And think that I am speaking directly to you and about you or researchers for that matter?
Now, if I would have said I think Nathan is a terrorist, well that would be different.
Additionally, you know why FDA reviewer cannot just go to the news room and start talking, and if you don’t then you shouldn’t be in your job…
And by the way, I have done a stint in research in Pharma and on more than one occasion I was told that when I put on the lab coat, I hang up my soul on the coat hook. Stealing other researchers work, taking credit for others work, sabotaging someone’s work because they might get ahead faster. Ego’s are involved in research Nathan, and therein lies the problem.
Your tenacity in spewing forth misperceptions and untruth’s is becoming annoying. Think, do a reality check with your intentions, then and only after careful consideration, speak. Otherwise, you make people in the industry look more ridiculous then they are.
Nathan
FPME asks: “Why would you take a statement like this …And think that I am speaking directly to you ”
Read your quote in context and you’ll see why. Here’s a few more of the niceties that you’ve spoken about me and my collegues in pharma in this thread:
“nearly everyone who works in Pharma and tries to claim they are doing so in order to help humanity, conduct themselves in a very rogue fashion”
“that these very same people who have no trouble corrupting government systems designed to protect and serve it’s citizens”
“What magical elixir are they privy to that provides them some immunity to illness and disease?”
You then say:
“I am beginning to think that there are some people in pharma who could be classified in another form of terrorism”
Nathan
FPME writes: “Your tenacity in spewing forth misperceptions and untruth’s is becoming annoying”
I am equally frustrated and confounded by the constant tirade of vitriol and so-called “righteous anger” that you feign against those of us who work very hard in this industry in order to find cures and treatments for ailments that our families and our societies face. I speak the truth as I see it - plain and simple. I abhor the suggestion that I am deliberately “spreading untruths” as you put it. You and I may disagree, but you have no right to call me a liar and no right to call myself or my colleagues “terrorists”.
Nathan
FPME, one more thing. Rather than accuse me of “spreading mistruths”, please specificly give me the statement of which you are accusing me of lying about. (please, quote me directly — use your copy and paste feature)
Former Marketing Exec
Nathan,
You are labelling what we and I myself say as “righteous anger”? I refer to the articles and information that is posted on this site. My comments are for those individuals who have behaved unprofessionally and have been caught and whose activities are being brought to light to us through this blog.
If you Nathan, put yourself in the group of people I am thinking about when I make my commentaries, then that is your prerogative.
Speaking strictly in terms of some of the news items reported in this blog, if you can say to me that these things are just happening by some sick weird coincidence and nothing that has happened illegally was premeditated by anyone who could have chosen otherwise, then please tell me what color is your Kool-AID in the cup you are drinking from?
The fact of the matter remains that on this blog there have been reports of some serious wrong doing’s by people who work in the pharmaceutical industry. If you think people should be ashamed of being outraged by the breech of trust, then you need to examine your personal values.
Nathan, you are not Mr. Pharmaceutical Industry and you have got to stop thinking that everyone’s comments on this board are directed personally to you.
Did I specifically call you a liar? No, I didn’t. You are an interesting person who plays a good game of smoke and mirrors, but I and many of us see through it. But nice try….
Nathan
FPME, you need to write more carefully:
You ask: “Did I specifically call you a liar? No, I didn’t”
Yes you did. Here’s your quote: “Your tenacity in spewing forth misperceptions and untruth’s is becoming annoying”
Again, I’M WAITING FOR THE QUOTE OF MY UNTRUTH. (I notice you didn’t respond)
You write: “If you Nathan, put yourself in the group of people I am thinking about when I make my commentaries, then that is your prerogative”
Again, re-read what you wrote: “nearly everyone who works in Pharma…conduct themselves in a very rogue fashion”
You write: “The fact of the matter remains that on this blog there have been reports of some serious wrong doing’s by people who work in the pharmaceutical industry.”
I agree and I’ve spoken out against those things when it’s clear that they have been done. (some of the coverup of SSRI studies on children, for example) But many times the accusations are just hear-say and propaganda - not proven events.
You write: “Think, do a reality check with your intentions, then and only after careful consideration, speak.”
I suggest you do the same. You paint the industry with very broad strokes — by the very quotes I just gave you (YOUR OWN WRITING) you’ve insinuated that nearly everyone in pharma is corrupt. Please think before you write. Maybe I’ve just got thin skin today… It’s a slow day at work the day before Thanksgiving….
Compliance Analyst
FME, I guess it is all where you come from. I was in the research arena as well, and never got that thought or feeling from the people that I worked with. It was with a smaller company with different objectives, but I understand Nathan’s feelings.
There have been a few comments of late vilifying the entire industry (some definitely deserved) and I am sure when the term “terrorist” comes out, people not in the upper echelons of the company (that are making these bad decisions) are seeing their name next to it since they work for that company or are a part of the industry.
People are just interpreting what is being said in different ways.
Steve
Well, I didn’t think I would get such a positive reception. Now, we are beginning to be aware of “out of the box” thinking. Let’s take our gripes and anger to the right people who can/may change things.
Lisa, you seem to me to be looking more closely at some of the comments made on this blog.
Nathan, from your up to date messages, you definitely know what I am talking about. One light comment, arguing with a person, on and on, is okay but not productive.
The general thread of this group takes no action but for loud complaining. Do something. That’s all I am saying. Take your anger and go public. Some of you know who I am. I put my money where my mouth is, and I got the attention I was seeking. Going public does not guarantee success but, it does guarantee dissemination.
Anon
Going public also guarantees jail time for those in the FDA.
Nathan
I guess what really pi**es me off about FPME’s remarks is that he/she is supposedly a former “insider” in the pharma industry. When Lisa or Truthman proclaims that all pharma employees are corrupt, I take it with a grain of salt. They really don’t have a clue what they are talking about.
But FPME claims to have been a part of this industry and surely knows that most people employed within this industry are no more (and no less) corrupt than those employees within any other industry. He claims to be speaking from a position of authority and experience, yet paints the industry with such broad “evil” strokes that he is either lying or is delusional. The true picture isn’t so nearly black-and-white as he likes to portray.
Justice in MI
Entirely agree with the concept of choosing battles instead of losing wars. The successes, on all sides, have come from discretion, stategic planning, organizing, and, yes, guts, integrity, and risk-taking at the right moments.
I respect that skill, even when deployed toward policy goals that are not mine.
Former Marketing Exec
I actually agree with Steve’s idea of going public - I have done it many times.
Nathan, I have not said that everyone in the industry is bad and evil. I have said that the people who have allowed or committed these harmful illegal activities (they must be illegal if they are getting fined or jail terms..) should be held accountable.
I am a former insider, and I have a clue about what I am talking about.
If you conduct yourself in an ethical responsible manner, as I did while I worked in pharma, then you should be just as upset as I am with some of these harmful activities come to light.
I am very disturbed about the corruption of the research data, doctors and our educational institutions that have been reported here and are seemingly done all for greed, or political motivations.
As for my use of the word terrorism, here are some definitions of terrorism:
1. League of Nations Convention (1937): “All criminal acts directed against a State and intended or calculated to create a state of terror in the minds of particular persons or a group of persons or the general public”.
2. UN Resolution language (1999):”1. Strongly condemns all acts, methods and practices of terrorism as criminal and unjustifiable, wherever and by whomsoever committed; 2. Reiterates that criminal acts intended or calculated to provoke a state of terror in the general public, a group of persons or particular persons for political purposes are in any circumstance unjustifiable, whatever the considerations of a political, philosophical, ideological, racial, ethnic, religious or other nature that may be invoked to justify them”. (GA Res. 51/210 Measures to eliminate international terrorism)
3. Short legal definition proposed by Alex P. Schmid to United Nations Crime Branch (1992): Act of Terrorism = Peacetime Equivalent of War Crime
4. Academic Consensus Definition: “Terrorism is an anxiety-inspiring method of repeated violent action, employed by (semi-) clandestine individual, group or state actors, for idiosyncratic, criminal or political reasons, whereby - in contrast to assassination - the direct targets of violence are not the main targets. The immediate human victims of violence are generally chosen randomly (targets of opportunity) or selectively (representative or symbolic targets) from a target population, and serve as message generators. Threat- and violence-based communication processes between terrorist (organization), (imperilled) victims, and main targets are used to manipulate the main target (audience(s)), turning it into a target of terror, a target of demands, or a target of attention, depending on whether intimidation, coercion, or propaganda is primarily sought” (Schmid, 1988).[13]
Former Marketing Exec
Nathan - you said ” I agree and I’ve spoken out against those things when it’s clear that they have been done. (some of the coverup of SSRI studies on children, for example) But many times the accusations are just hear-say and propaganda - not proven events.” Are you saying Ed posts propaganda here?
Perhaps you are thin skinned today. We all can get a little thin skinned.
Remember any comments I make here are directed toward people who are unprofessional, and are supported by first hand knowledge of similar situations.
Now enjoy the holiday!
PhD, FDA Reviewer
This is from the commenter formally known as An FDA Reviewer
I am not a lawyer and do not know if I can be considered acting under the color of authority or not. However since Steve has raised the point I checked and found the following ethics information and so will follow it as I understand it.
“An employee may include or permit the inclusion of his title or position as one of several biographical details when such information is given to identify him in connection with his teaching, speaking, or writing provided that his title or position is not given more prominence than other significant biographical details.”
Due to space and other reasons I will provide 2 biographical details. That is not to say that there aren’t others such as MD, PhD or JD or working in industry. I just don’t believe I need to give any more.
Nathan,
I have been somewhat puzzled by the contradictory nature of some your posts, but when you say you work in early research it makes more sense that you wouldn’t necessarily see things. Things really get more and more unethical in drug development the closer you get to the approval and the marketing. There are many good people in the industry but as a friend of mine who is a clinical research VP at one of the biggest companies tells me “you don’t call the baby ugly”.
I think a lot of people in the industry think along the lines of the X and Y analogy. However having literally worked on hundreds of NDAs at FDA and numerous labeling negotiations I’ve come to realize that this is not how things actually work and it’s maximize sales regardless.
I don’t want to kill the goose that lays the golden egg but it is getting more and difficult not only to find drugs that are safe but also to come up with enough to maintain sales and growth and as things become more desparate the corruption only increases.
So I don’t believe we have any legal or ethical choice but to recommend turning down drugs when the industry (and our supervisors) won’t let us do the X and Y analysis.
You don’t think there are the kind of problems in industry that others see, well taking you at your word I would have to say that’s based on your experiences and others have different experiences.
As for Steve I definitely don’t trust him. He intimates he’s a whistleblower and has gone public yet he refuses to identify himself here. He appears to be ignorant of how government and things work and his back and forth positions are most readily explainable by ulterior motives to try to get me to provide clear evidence of my identity. This of course could be used to squash me and prevent the ultimate revelation of what FDA and Industry know that I know from coming out or to impugn my credibility. I believe they strongly suspect who I am but just can’t do anything about me (yet).
One of the things that began to really open my eyes that it was more systemic than a few rogue individuals is a few years ago I was walking through the lobby and overheard a medical division director tell a senior manager that he was going to get the head of an advisory committee to direct the discussion and swing the vote over a serious safety issue and get the drug approved and by extension dismiss the safety issue. I could tell you who and what but I have no proof other than what I personally heard and saw. (Although the video of the AC meeting sure does tend to support me.) Besides it got stopped although it was extensively used as one of those examples in the press of the FDA being overly cautious. Since then I’ve seen things simply getting worse and worse.
I’m going to become lower profile for a while.
Happy Thanksgiving Everyone.
The opinions expressed are my own and do not reflect the opinions of the FDA.
PhD, FDA Reviewer
Doug Bremner
Well you only have to read the newspaper to see that the American medical complex has become corrupted and for those who have been reading this blog for a while the anonymous comments made by ‘insiders’ regarding the cynical way that information is distorted, it is worse than we previously thought. I am not sure why some try and argue for it but perhaps sometimes it is easier to move through the blood than to say you’re sorry.
FDA Reviewer: You are doing your job, protecting the health of Americans. Your job is not to move drugs through the pipeline, although we all know that your politically appointed superiors don’t think so. We can see many examples of the corporatization of our institutions, including those of higher learning, where professors are pushed toward becoming ‘entrepreneurs working with industry’ instead of critics of ideas and research studies, or preemption of state law by federal law (get out of jail free cards for corporation) in drugs and in all product areas.
That said I will say, Happy Turkey Day everybody.
Jaynesday
All,
Backtracking 4 years we can see that not much has changed at the FDA. Many of the comments by Dr. David Graham are very similar to what we hear now in many different venues. People say they’re going to change things. Politicians stomp their feet and make grand expositions, even threaten to “pass a law”, but end up doing little or nothing to move things forward.
See the CBS story from 2004
http://www.cbsnews.com/stories/2004/12/07/health/main659529.shtml
Seems we can talk ’till we’re blue in the face.
Hey - Would I get any royalties for inventing the new disease - “Blue in the Face Syndrome” along with a cure - duct tape. I’m sure that some in the industry and a number at the FDA would fast track this one.
Off label use would be for weight loss, smoking cessation, bad breath and snoring. AE’s would be painful withdrawal and redness around the mouth if a measured dosage reduction is not followed.
Happy Thanksgiving All!
Steve
PhD,FDA Reviewer,
Number one: I do not care who you are or what your name is. How you draw the conclusion I am interested in your personal background is inaccurate and of no interest to me.
I have no interest to “squash” you.
Two: Whistleblower? I never said that I am a whistleblower; I am not, nor have been. I do consider myself well knowledged and only pointed this avenue out.
As you say and I disagree, I have “no back and forth positions”. I do not have one sided blindness.
My conclusion: You seem to me to be quite anxious and very protective by becoming a “lower profile for a while”.
I may be confused over your blog name. You refer to “formally”. Do you mean formerly? Please clarify if you are the “An FDA Reviewer” and also “PhD,FDA Reviewer”. If so, you tacitly agree that something was amiss as if not, the name would not be changed. I like your disclaimer at the end.
Justice in MI
Ph.D./FDA Reviewer - If it means anything, I have drawn on some insights in courses at the University of Michigan. I do not present them as representing more than one person (and I don’t cite Pharmalot or your moniker specifically). As you well know, there are no shortage of other voices from within FDA. And so the issue is one of seeing how perspectives line up, confirming or disconfirming, on all sides. Likewise, when one knows where to look, there is much one can discover on one’s own. Sometimes, all one needs is help re; where to look.
So you have contributed well beyond this blog, and I hope you will continue to do so. I believe you _have_ kept a low profile, and a very selective, limited, and strategic one. Smart play, in all respects.
Jane
Steve,
Briederman etal have a few treatments you may be interested in to help tame your hostilities. Really, they’re safe!
Justice in MI
Let me put it a different way, which should be reassuring except for those who aspire to secrecy and silence.
There is _nothing_ that FDA Rev. has said here that hasn’t been elucidated by many others, and in many other contexts, including from within industry itself. The truth does not rise or fall on any single voice, and there is a lot more “transparency” than many seem to imagine. Peek-a-boo!
Doug Bremner MD
JiM: Ha ha ha!
The message for FDA Reviewer is we thought we owned the town so stop being a renegade! Fall in line with the corrupt process! Don’t rock the boat!
harry
To all the FDA reviewer (s). You work at the FDA and are a part of the system. I think it’s self righteous to speak from a platform that the for the most part is not held in high esteem.
The FDA is an extension of corporate policies. In other words you are are subject to the same pressures as someone working in the pharmaceutical company who knows what is going on, but stays on anyhow, for job, money personal reasons. you have made your decision. either do something or stop preaching. We are not stupid, we know what goes on in the FDA.
Lisa Van S
Nathan,
A correction,… I have “never” said “all” Pharma employees are corrupt!!
Steve
Jane,
Have you tried them? Will it hurt? Is the treatment non invasive unlike some of those on this blog with those lobotomies, aka zombies?
Hostilities are good for the development of acute senses. You should give it a try!
Steve
Justice,
Well said !
Steve
Harry,
What’s going on, someone who has something to say that makes practical sense!
I agree, if you don’t like the heat, get out of the kitchen. The FDA complainers have no time to do a day’s work but plenty of room to bite the hand that feeds them.
Their moaning and groaning spreads to other employees and causes further disintegration. I wonder if this qualifies for “insubordination”!
Salmon
Steve wrote:
Nov 26 5:43 PM
“I have “no back and forth positions”. I do not have one sided blindness.”
Let’s review what else Steve wrote that sheds light on one sided blindness:
Nov 25 8:39 pm
“I have always lived by the words, “don’t bite the hand that feeds you”. I am referring to your employer (Reviewer). No matter how an employee feels, public space should not be used to set forth their OWN feelings and conclusions.”
Nov 26 12:23 PM
“Do something. That’s all I am saying. Take your anger and go public.”
Nov 26 8:42 PM
“if you don’t like the heat, get out of the kitchen. The FDA complainers have no time to do a day’s work but plenty of room to bite the hand that feeds them.”
I rest my case.
Justice in MI
Yikes. I think I’ve been misunderstood. I see what FDA Rev. has done has courageous and critically important. “Moaning and groaning” is the last way I would characterize it. The fact that other voices help confirm it does not take away from the service provided. “Insubordination” may be a meaningful term to Captain Blye. But it, too, would the last word I would use here.
The notion that FDA Rev., or the many others like him/her, don’t do a “day’s work,” is pure defamation. They are the ones on whose integrity all of us depend.
Steve
Salmon,
Yes, sanity has returned.
Thank you for your support.
Jaynesday
Steve, you’re getting silly. Go back to whence you came son.
Steve
Justice?
I like your approach. It cements the fact that you don’t understand the meaning of “integrity”. Integrity is support, not subversion. (Check the dictionary for definitions, I did.)
I have other things to attend, so for now, it’s good evening.
Henry
Jaynesday et al.
I think we should all simply ignore steve from now on he acts as though he may be a kid who’s just trying to get a response from people.
Salmon
Back to the original topic.
Well the WSJ ran an op-ed piece today from someone from the Hoover Institute vilifying Rep. Dingell and claiming that he broke the law by asking FDA officials to provide ‘confidential’ information in the 80’s and interferred with FDA. I thought that the FD&CA actually specifically allows committee chairmen to see this stuff.
No it looks to me like Rah, Rah we got rid of intense oversight of FDA.
I am more comfortable that Dingell would have done something during the next Congress. I still don’t know what to think of Waxman. I read many things from him that sound good, including things in places like NEJM going back 10 years and more specific, but I simply don’t see him going after specific things the way Dingell was. Plus Grassley is definitely on the reviewer’s side and he publicly stood with Dingell.
I don’t want to knock fighting preemption but if you don’t support the front line people who have to take stands day in and day out then the word gets out and you won’t have anyone left who will do it.
Justice in MI
From the most immediately convenient dictionary:
in⋅teg⋅ri⋅ty /ɪnˈtɛgrɪti/ Show Spelled Pronunciation [in-teg-ri-tee] Show IPA Pronunciation
–noun 1. adherence to moral and ethical principles; soundness of moral character; honesty.
To suggest a version that means subsversion strikes me as, well, perversion.
Justice in MI
Totally agree with Salmon’s last point. Time will tell, but, from what I understand, front-line people (reviewers, et. al.) have very much seen Waxman as someone they could rely upon (and have).