Civil Servant Disobedience: A Critical FDA Site
13 CommentsBy Ed Silverman // July 18th, 2008 // 12:55 pm
A new web site called Thoreau-FDA.com has emerged that is highly critical of the agency and, in particular, FDA commish Andy von Eschenbach, who is accused of oppressing FDA employees and preventing them from doing their jobs. The site, which is anonmyously crafted, is allegedly the brainchild of an unknown number of current and former agency employees.
Their goal: “to intensify public scrutiny of FDA upper management’s efforts at ensuring public health protection in an increasingly complex global marketplace…and engage (Andy), his successors and FDA upper managers in a public question and answer dialog … to end the entrenched process flaws in FDA’s pre-approval drug review and post-approval regulatory enforcement systems.
“Among the flaws that need to cease,” it continues, “is the abuse of FDA staff, who do their jobs by making publicly known, the existence of harmful and deadly products already approved for, and in, the market.”
Why Thoreau? Thoreau-FDA stands for Thorough – High – Objectivity – Review – Ends – Are – Us – FDA. And the site goes on to say that “wrongful directives/requests” from FDA upper management “cause drug review outcomes to be misrepresented as carefully considered objective ’science based’ assessments, when they are, in fact, pre-determined.”
And there’s an open letter to Andy saying that “evidence has been presented to the US Congress that shows some instances of Undocumented Top Down ‘Approve’ Directives or Requests, by FDA upper managers that interfere with the independent decisions of lower level drug reviewers.”
You can sign the letter, watch a video and read some background info on the site.
UPDATE: An astute reader points out that the site name appears to be registered to Jim Dickinson, who runs a site called FDAWebview and assorted publications that track the agency. Look here. We have reached out to Jim and will let you know if we hear anything.
UPDATE NO. 2: Jim Dickinson just returned our call to say that he agreed to let his name be used to register the site. “I have no involvement, though. A few of them asked me if I would let them use my name, because apparently they were having some trouble registering without disclosing a name. And they’re terrified of recriminations. But I have nothing do with running it or the content.”
Dan
The FDA and Its Progressive Lack of Citizen Protection
The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States. Who became the catalyst for the formation of the Food and Drug Administration was a socialist named Upton Sinclair, who was a writer. One particular book, while fictional, addressed the working conditions in a meat packaging company that were quite shockingly described by Upton in this book. While the author intended with composing, “The Jungle”, to address and focus for the benefit of the readers the effects of capitalism, the issue regarding food safety is what ultimately captured the attention of everyone, including the president, so the FDA began during this time.
However, their purpose and function seems to have changed the past few decades, as the FDA appears to have formed a pathological alliance with the pharmaceutical industry in particular, to name one of the industries that the FDA is obligated to oversight.
An example is the large amounts of money the industry gives the FDA for various reasons created recently- amounts so large that this accounts, according to some, for about half of the FDA’s total income, although it is a governmental administration, and this is upon information and belief. An example of funds received is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and is now required to pay the FDA for faster approval of their pending medications, called New Drug Applications.
Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs as demonstrated by their removal or given a black box warning of such drugs. The lack of regulation and monitoring required by the FDA of such industries as the pharmaceutical one may be why there is this progressive safety concern of medications prescribed to many in the United States. In addition, perhaps, the FDA continues to validate what has been posited through their known financial support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public as best as they should. However the growth of generics is about twice of branded meds annually, though, I believe. This may be a relief to some if not many.
Yet, the presumed intimacy between these two organizations speculated upone, which are the FDA and the pharmaceutical industry, does in fact seem to continue to worsen that do not have generics available as of yet- possibly due to the growth of generics being a concern for the branded companies. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval and presumed elation to possibly create harm to patients with this proposal due to the obvious uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional if not absurd, to say the least. Especially when one considers the high number of drugs that historicallyhave been removed from the market or have been given black box warnings that have been mentioned already.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically and legally, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity that deviates from the product insert that illustrates the medication’s indications. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more pharmaceutical companies are and have been penalized in the form of large settlements for this behavior in the past as determined to some degree by the department of justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, rarely admit guilt as part of such settlement agreements, which include agreements where the corporation is not prosecuted. Off-Label activities are only some of the federal laws that have been frequently fractured in a progressive manner as well.
This FDA protocol for drug reps that has been described and proposed by our FDA is called, “Good Reprint Practices.” This would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials, aseptic and sterile without bias, when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol suggested by the FDA, yet possibly influenced by others. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration when they did suggest this ridiculous and frightening authorization.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug reps have no medical or clinical training in any objective way, and, in my experience, have no interest in such training. So this seems to further complicate the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to embellish statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.
However, there is freedom of speech, but in the amendment should certainly be restrictions in regards to public health, as speech should be accurate and objective when conducting dialogues with prescribers. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves, which could be the case now with the FDA. And the health of the public is that interest what I believe we as citizens demand, and should be enforced than it appears to be presently.
“Unlimited power is apt to corrupt the minds of those who possess it.” — William Pitt
Dan Abshear (author’s note: what has been written was based on information and belief)
Gretchen
I’m not so sure that this site is actually “the brainchild of an unknown number of current and former agency employees.”
According to the WHOIS record for the url, the site is owned by James Dickinson — who has been a longtime FDA critic (never an FDA employee) and runs Dickinson’s FDA Review (http://fdaweb.com/default.php?ea=aboutus).
WHOIS: http://who.godaddy.com/WhoIs.aspx?domain=thoreau-fda.com&prog_id=godaddy
It may all be irrelevant, but I’m not seeing what the agenda is here.
Ron Kavanagh
Gretchen,
Prior to seeing this post on Pharmalot I had no knowledge of Thoreau-FDA. Yet regardless of whether the site is hosted by Jim Dickinson I do believe the site is “the brainchild of an unknown number of current and former agency employees.” The reason I believe this is because I am the reviewer who stood up at the February 6, 2008 All Hands meeting and asked Dr. Von Eschenbach about policies regarding op-ed pieces. In addition I also see other information on the site that I am personally aware of that could only have come from FDA employees.
I invite Mr. Silverman as someone who is independent of Mr. Dickinson to contact me via the appropriate FDA channels and I will verify this.
I do have a concern with the idea that the site engages in civil disobedience. Instead I believe that it is in fact an act of civil obedience. The Declaration of Independence indicates that the purpose of government is first and foremost to protect the lives of its citizens, followed by freedoms (which are needed to most importantly protect life), and finally the freedom to pursue financial independence.
As FDA employees our obligation must be first and foremost to protect life. In some cases this means getting drugs out quickly with less safety information, but in most cases it means first making certain that the drugs won’t kill or unacceptably injure more people than it might potentially help. We are also required by law to report waste, fraud and abuse, and as governments employees we are also sworn to protect and defend the Constitution.
When FDA management breaks the laws and endanger the lives of citizens I believe we have an obligation to speak up. This can be done within the law. In fact I believe that speaking out publicly and exercising First Amendment Rights may be the only possible way for us as government employees to fulfil our obligations to protect both human life and the Constitution.
Surely if drug companies have a first amendment right to provide information on off-label use that will increase sales, then we have an even greater justification in exerting our first amendment right in order to protect lives of the American Public for whom we work, not to mention in order to protect our own lives and the lives of our children and families.
Ron Kavanagh, B.S.Pharm., Pharm.D., Ph.D.
Senior Reviewer
Office of Clinical Pharmacology / Office of Translational Sciences
Assigned to the Division of Psychiatric Drug Products
FDA
The opinions expressed are my own and do not reflect the position(s) of the FDA
adam feuerstein
nice catch, gretchen. if you’re right, the agenda is clear: to waste everyone’s time with a bunch of B.S.
politics at the FDA? i don’t need a poorly designed, say nothing, anonymous web site to tell me that.
Thoreau is spinning in his grave…
Jaynesday
Dr. Kavanagh,
I hope you can hear the faint but growing applause of the American public. Thank-you
Justice in MI
Ron - I don’t know anything about the website or you personally. But if the line reviewers at FDA are willing to speak publicly about their experiences at the agency - whatever they may be - there could be no greater service. Even moreso, at this critical time.
As preemption and similar initiatives become part of the landscape, there is a great deal of mythology disguised as fact about how things work at the agency. If we are to have anything approaching rational policy, we need to hear from those who are there.
I personally thank anyone who is able and willing to do come forward, and whether their view supports my own perspective or not.
Jim Dickinson
Gretchen:
OUCH! “A long time FDA critic”?? Actually, I have been a long time defender (since 1974) of my favorite agency. Only since the abusive politicization of FDA took real flight with the advent of the Bush Administration (for which I voted in 1980 but not again) have I become a critic.
If that’s a long-time posture in your eyes, I envy you your wonderful youth!
On a more positive note, I see several signs of the agency getting its moxie back as the Bush Administration visibly wanes, and as the consequences of Bushism leave FDA with no other sane alternative.
Ron Kavanagh
To me the posts critical of Thoreau-FDA provide nothing more than ad hominum (i.e. personal) attacks based on inneuendo.
FDA reviewers have every possible financial, career, and personal reason NOT to post comments on this site, and the very fact that people are willing to speak out publicly, even if anonymously, speaks volumes and follows in a great American tradition.
This is in contrast to the some in the financial, public relations, and media, as well as many people in academia.
As a new site I will support it and intend to send in pieces for publication. Thank you Gretchen for identifying how to do it for me.
Let’s remember what Silence Dogood said on September 18, 1787 to Mrs. Powel’s question, “Well Doctor, what have got a republic or a monarchy?” “A republic, if you can keep it.”
For further comments please watch Thoreau-FDA.com.
Ron Kavanagh, B.S.Pharm., Pharm.D., Ph.D.
Gretchen
A few thoughts after reading some of the comments here:
Ed: Thanks for the updates and the additional work in clearing this up. Much appreciated.
Dr. Kavanagh: Thank you for your intelligent post and your willingness to discuss the agency you work for. I commend your public service and admire your dedication.
Jaynesday: Well said; I agree wholeheartedly.
Justice in MI: Again, well said.
Mr. Dickinson: Thanks for replying to Ed. Perhaps “critic” was the wrong choice of words. Please feel free to substitute “watchdog” or “follower” if those are more accurate. I also agree with your more positive assessment of the agency as the current administration loses its power. We can all hope for the best – and sites such as yours (and maybe Thoreau-FDA) – will contribute to a much-needed public dialogue about the agency’s issues. I will stand behind the use of the phrase “long-time,” however, as 28 years is, well, a long time. (Indeed, I was in grade school.)
Dr. Kavanagh: I’m pleased to hear that Thoreau-FDA will provide a forum for your ideas and thoughts, and please do use it to publish writings from your unique and informed perspective. I’ll be reading.
Thanks to all.
Kerry
On of those predetermined fda decisions appears to have ocurred in the case of Dendreon’s Provenge.
Dr. Pazdur, who recruited Dr. Scher, were poised to see Provenge approval denied before the AC. They conspired and successfully sabotaged Provenge making a non science based decision (it was denied approval despite a 17-0 and 14-3 vote even after Pazdur tried to modify the question to obtain “no” votes.
Any insiders at the FDA please provide us with any knowlede you have about the power play of CDER vs. CBER that went on regarding Provenge.
This information could help 83 men a day who are dying. About once a weeek or so CTL is contact by the family member (usually a wife) who wants to know about gaining acess to Provenge which she had been unable to obtain through any so called passssionate use program.
Provenge should have recived conditional approval and it could be helping these men now. These people are dying, desperate and need hope!
We believe responses to the CareToLive Freedom of Information Request to be prepared and sitting in a room not being delivered since the Court gave them until December 9th. If the Court knew that the docuemnts had already been compiled and reviewed by the FDA and available to be sent the Court would be very angry and order them produceds. They would then shed light on Dr. Padur and his conspiracy to see Provenge denied.
Any information regarding responsive documents to our FOIA request or or about Pazdurs threast to hold a demonstration if CBER did not do as he wanted please sent to me at my private e-mail DonahueDublin@aol.com.
Any info on why the language of the question got changed and why they made a non science based decision that is costing lives. Dendreon is not big pharma they are a small biotech..which maybe the biggest hurdle at the fda.
Please help the patients!
Kerry
On of those predetermined fda decisions appears to have ocurred in the case of Dendreon’s Provenge.
Dr. Pazdur, who recruited Dr. Scher, were poised to see Provenge approval denied before the AC. They conspired and successfully sabotaged Provenge making a non science based decision (it was denied approval despite a 17-0 and 14-3 vote even after Pazdur tried to modify the question to obtain “no” votes.
Any insiders at the FDA please provide us with any knowlede you have about the power play of CDER vs. CBER that went on regarding Provenge.
This information could help 83 men a day who are dying. About once a weeek or so CTL is contact by the family member (usually a wife) who wants to know about gaining acess to Provenge which she had been unable to obtain through any so called passssionate use program.
Provenge should have recived conditional approval and it could be helping these men now. These people are dying, desperate and need hope!
We believe responses to the CareToLive Freedom of Information Request to be prepared and sitting in a room not being delivered since the Court gave them until December 9th. If the Court knew that the docuemnts had already been compiled and reviewed by the FDA and available to be sent the Court would be very angry and order them produceds. They would then shed light on Dr. Padur and his conspiracy to see Provenge denied.
Any information regarding responsive documents to our FOIA request or or about Pazdurs threat to hold a demonstration if CBER did not do as he wanted please sent to me at my private e-mail DonahueDublin@aol.com.
Any info on why the language of the question got changed and why they made a non science based decision that is costing lives. Dendreon is not big pharma they are a small biotech..which maybe the biggest hurdle at the fda.
Please help the patients!
Teddyboy
A website that turns the light on the FDA, thank God.
I am an advanced prostate cancer patient who has been seeking a vaccine that just may extend my life and the thousands of patients like me. We are now looking at a terrible end to our lives just weeks and months away.
APPROVE PROVENGE NOW…YOUR OWN FDA ADVISORY BOARD ALREADY HAS…170-0 IT’S SAFE AND 13-4 IT SHOWS SUSTANTIAL EFFICACY.
Allow us to have little dignity back. Cancer has taken much of it from us, don’t let the FDA take away the rest!!!
May God Bless all who fight for justice,
Ted Girgus
kyoto27
Bravo Ed for getting this much needed dialogue started! I would also like to salute the efforts of Kerry Donahue on reminding us all of the ‘due process’ that was denied dying cancer patients.
The more you dig into the FDA’s handling of Provenge, the more you realize that “good science” had little to do with the FDA’s final decision to issue a Complete Response Letter. Politics and the ability to act with impunity allowed a corrupted FDA process to conduct “real meetings” in secret and AC panel meetings in public.
Kerry M Donahue, the attorney who filed the CareToLive lawsuit clearly saw this impunity when he wisely noted that the FDA took the ‘due’ out of ‘due process’ in the Provenge hearings. The following excerpt from the lawsuit speaks for itself:
“Its not meaningful if the public AC hearing is merely a sham and the “real meeting” occurs behind closed doors in ignorance that this is The United States of America where operating in secrecy in a non- democratic manner is frowned upon. The decision to take the “due” out of due process was a deliberate wrongdoing and more than just run of the mill negligent conduct…”
In the case of Provenge, the FDA’s move to overrule its panel was, as you know, unprecedented because the agency had never before ruled against a positive panel finding in a terminal illness. Why did they do it with Provenge? And that question begs a larger question:
Who stands to benefit in this country or within the FDA by giving the FDA absolute sovereignty over matters of Life & Death without due process? And what of the potential absolute corruption that that power can engender? And is this really the way Congress wants the FDA to conduct its business?
When ruling against a panel in a terminal illness finding, shouldn’t the FDA—especially being a “science-based agency,” be mandated to give us at the minimum what the Supreme Court provides –a list of who voted; how they voted and a summary of their arguments? As Kerry wisely noted, considering this is the United States of America, do Americans—especially the Fourth Estate and Congress, really have to beg our FDA to tell us that life and death decisions are not being made with “winks & nods” but with serious discussion and debate? And here’s a frightening thought for RPM readers and all Americans:
Since no one outside of the FDA is privy to the internal discussions that took place in the Provenge decision (or any other) what if we discovered that, in fact, no internal discussions take place? What then?
Does our FDA really make decisions based on ‘good science’ but is afraid to publish their arguments? Or do they make decisions based on emotions?
Does Andy vE or Dr Richard Pazdur just pick up a phone and tell someone to kill the application?
Given what is being discussed here I think it is clear the time has come for Americans and particularly the Fourth Estate to ask for complete access to FDA records for these meetings or non-meetings –specifically (i) who calls for the “real meetings” (ii) who attends the “real” meetings and (iii) transcripts of all arguments, notes and votes of those who attended.
Taking the “due” out of “due process” is not just a ‘deliberate wrongdoing’ by the FDA –it shreds the entire fabric of this Republic.