FDA Touts Recruiting Drive, But Will It Work?
55 CommentsBy Ed Silverman // September 12th, 2008 // 7:42 am
The agency recently hired more than 1,300 professional staffers in a move that officials hope will help it better protect the public health amid rapid technological and scientific change. But skeptics say the effort simply replenishes diminished ranks and the ability to retain the new hires is uncertain.
“Every pay period, we have had more than 100 people walking through our doors,” Kimberly Holden, the senior manager directing the recruitment initiative, tells the Associated Press. “We have had some people who left to go into industry and ended up wanting to come back. The revolving door swings this way every once in a while.”
The staffing drive will result in an estimated 10 percent increase in the FDA’s work force, and Holden maintains the new hires will provide critical expertise after years of losing valuable medical and scientific people who took industry jobs, the AP writes. But independent observers say the staffing increase is only a first step, albeit a much needed one.
“This is really just bringing them back to where they were in earlier years,” William Hubbard, a former FDA associate commissioner now leading a lobbying effort for sustained increases in the agency’s budget, tells the AP. “It restores losses that they have incurred, but they still have along way to go to where they can make improvements.”
FDA officials say about 1,000 of the new hires have already started, with another 158 due to report later this month. An additional 160 have accepted offers, and are going through background checks. Of those on the job already, more than 850 are professionals, including chemists, biologists, pharmacologists, statisticians, medical officers, microbiologists and field inspectors, the AP writes.
Of the total 1,317 positions, 770 are new jobs and 547 are posts that were left vacant by people leaving the agency for other jobs or due to retirement, according to the AP.
Within the FDA, the biggest number of jobs will go to the Center for Drug Evaluation and Research, with 663 new staffers. The smaller food safety program will get just 104, although that amounts to a 10 percent increase. The FDA’s enforcement branch, which has lost many field inspectors in recent years, will get 245 new staffers, the AP reports.
The FDA’s budget is about $2.2 billion a year, with some $1.7 billion coming from taxpayers and the rest from industry user fees, the AP notes. About 40 percent of the total number of positions are being paid for with industry user fees, meaning that the new hires will mainly be evaluating new drugs or medical devices and, in some cases, monitoring safety issues.
Certain positions, such as cancer specialists, were hard to fill. The FDA hired nine, but another 20 rejected offers. “They could not make the money they would be making on the outside if they came into public service,” Holden acknowledges to the AP. The agency could offer as much as $275,000 a year, she says, but oncologists can make $400,000 annually elsewhere.
Congress approved the hiring drive and the Bush administration gave the FDA special authority to make on-the-spot offers. The drive was launched in the spring, with a goal of hiring 1,300 staffers by Sept. 30.
The campaign’s apparent success shows that public service is still attractive for highly specialized professionals, Arthur Levin, director of the Center for Medical Consumers in New York, tells the AP. But he cautioned that the FDA has a history of letting such gains slip away.
After the attacks of September 11, 2001, the agency hired food inspectors to guard against the threat of bioterrorism, but gradually cut the program back. As a result, the FDA was caught flat-footed by outbreaks of foodborne illness.
“Historically, one of the millstones regarding the FDA has been resources,” Levin tells the AP. “Cost-of-living increases don’t ever seem to be part of the funding from Congress. It may be that they hire all these people now, but they can’t afford them down the line.”
Source: The Associated Press
Matthew Holford
This is quite funny, because it’s one of the factors that the Health Select Committee picked up on, when it investigated the influence of the pharmaceutical industry, about four years ago. It noticed that there was a flow of personnel, in between the industry proper, and the regulator, the MHRA. Presumably it was concerned that it would be difficult to tell one from the other, eventually!
How does one hire the requisite expertise, and be sure that its mindset is not influenced by established relationships with the industry? How the fuck would I know?!
Matt
An FDA Reviewer
Many of the hires for front line reviewers are either coming from Big Pharma where there are layoffs occuring or from academic programs with exceptionally close ties to big pharma.
In both cases the new hires tend to be those individuals who are supportive of big pharma and the change in FDA’s mission to ‘promote the public health by making new drugs available’.
Many of the new hires are foreign nationals on H1-B visa’s who come from countries where corruption in government is rampant and who culturally are more compliant. This is not to say that all individuals from these countries are so and in fact a number of the best reviewers both scientifically and ethically are from these countries and came to the US in part to get away from that.
A number of the positions that the new reviewers are filling are due to experienced reviewers (primarily native born US citizens) having been forced out due to harassment or even from reviewers being fired for raising safety issues.
Other industry people have been hired over the last few years as reviewers and have been rapidly promoted to that they dominate the lower management ranks and there won’t be anyone or anyway to change FDA back under a new administration.
In any event ex-industry VPs have come to FDA and implemented new processes over the past several years that will prevent the detection of serious adverse events including death, and detection is instead moving to post marketing rather than pre-marketing evaluation. When detected under the new sentinel program it’s likely that genetic tests will be co-marketed or other drugs will be promoted as treatments. This appears to be the rationale behind much of the Food Drug and Amendments Act of 2007, (FDAAA). In fact there were industry VPs walking freely around the restricted areas of FDA who had come to work on this act even though it nominally came from the offices of Senators Kennedy and Enzi.
FDA has also been sending it’s managers to China and India to train scientists in those countries to help get products through the FDA. Yet these scientists are performing the same types of clinical and preclinical research that was being performed in the US until the recent layoffs in Big Pharma.
As for numbers of primary reviewers over the past couple of years only a little over 1/3 of the review staff in some areas have been actually doing reviews. The remainder are managers (in some cases 16 managers having oversight of one reviewer) or are working on projects for Big Pharma developing drug-disease models or promoting biomarkers.
Dr. Von Eschenbach had said 90% of these 2000 new hires will only be for 2 years and are primarily for training purposes and will then have to find jobs elsewhere. Since many are on H1-B visas they will likely go back to their home countries and work there or will be used to replace the US citizens who have been laid off.
If you look at the data FDA has on its website, over the past couple of years the number of INDs per year had doubled to nearly 400/yr whereas it had stable at 200 / year for decades. This suggests that there will soon be a rash of NDA submissions that these new reviewers will be working on. However without the experience and with the new review system being implemented (with the help of a rigged evaluation system using outside consultants including Booz Allen Hamilton and the Carlyle Group) many safety issues will likely be missed.
Although FDA and Big Pharma like to show graphs at show that the number of NDAs approved since 1994 has been decreasing, if you look at the data from the past 3 - 4 decades (which is available on the FDA Website) the numbers are actually stable. The drop is due to a high number of approvals in 1994 / 95 due to a backlog that was removed under PDUFA 1 and due to companies hurrying up submissions so they would be reviewed by inexperienced reviewers. This resulted in about 10% of these drugs being withdrawn from the market due to safety reasons within a couple of years. Thus I believe we are looking at similar situation that will occur over the next couple of years. As for approval rates and FDA being tougher, actually if you look over the past 3 - 4 decades the % of drugs approved has been steadily increasing from around 60% to 80%. In part this could meand that companies are getting better are submitting and going through the process however in my experience over the past few years the drugs being submitted are more and more dangerous and we are simply lowering our standards.
The entire FDA has been rigged so that no matter what a new administration tries to do to undo the damage many dangerous drugs will likely soon come onto the market and with preemption and new FDA policies to try to find a way to keep dangerous drugs on the market no matter what there will be no recourse.
An FDA Reviewer
Lisa Van S
An FDA Reviewer
Two words,… Absolutely Frightning!!
Anne
I always knew that the good people at the FDA were either fired or muzzled. Now I find out that those still there or being hired on are patsies or such neophytes that the critical information will pass them by.
I used to think that speaking before the FDA as the parent of a son dead from Zyprexa might make a difference. I more fully understand after those early innocent years that the public hearings are just a dog and pony show. Now I “get it” why Dr. Laughren looks like he is sleeping during these hearings, because, in fact, he is.
I have heard several stories similar to “An FDA Reviewer’s” on the phone; no names given. One honest scientist told me he would be long gone “but for the golden handcuffs”. The man had to stick it out for one more year.
An FDA Reviewer
Lisa,
If I could present the actual scientific information and specifics you wouldn’t only be frightened you would be absolutely terrified.
I believe that what we’re looking at will make Vioxx look safe in comparison.
If you note Ed’s link to an AP article today that reports carbamazepine found in the drinking water. Carbamazepine stimulates the activity of enzymes that are probably responsible for creating toxic metabolites from other drugs that will probably severely injure millions of people.
As for the hiring replacing diminished ranks well that 10% who will be retained are probably for the 10% who refused to go along and have been forced out.
I also indicated there were industry VPs running things. If you note the problems with miscoding of adverse events with paxil (glaxo) that has been in the news over the past several months. Well last November Rep. De Rosa sent a letter to Dr. Von Eschenbach talking about the control Pharma will have over the Reagan-Udall Institute at FDA and the former industry VPs in the Office of Translational Sciences. I believe she was referring to Bob Powell. Bob Powell was VP at Glaxo in the 1990’s, then worked at Pharmacia UpJohn, and then at Pharsight doing strategic placement of their data analysis software, before coming to FDA. At FDA Bob Powell has been responsible for drug-disease modeling, and setting up using Pharsight’s programs and the standardized coding for data files that Pharma will use. This is all public information if you just google his name (Robert J. Powell) or Pharsight otherwise I wouldn’t be able to say anything about this.
Right now the whistleblower protection act (WPA) is held up in committee and the difference in the Senate and House’s versions are primarily in the protections for scientists (i.e. FDA reviewers) revealing scientific misconduct (i.e. safety issues). Even though the house version includes it, I believe that this is really a case of I voted for/ sponsored it (but I’ll help kill it in committee later).
If there is any hope for protecting the American people it has to come from revealing what is actually going on, and the only chance that this can occur is if the WPA passes soon with protections for scientist. It must also include the ability of whistleblowers to go to court immediately to stop harassment and retaliation. This is because the harassment is so intense in some cases that it would be like not allowing a person to get a restraining order against someone who has been convicted for assault and has threatened to kill the other person. Yes things are literally that intense for some FDA reviewers. I hope this helps you and others understand why reviewers have left and what we are having to deal with every day just in order to do our jobs ethically.
An FDA Reviewer
Lisa Van S
An FDA Reviewer,
Which Committee is it in?
contact me lvansyckel61@yahoo.com
An FDA Reviewer
I don’t know. I’ve been trying to find the information myself but can’t.
Perhaps if you contacted the Government Accountability Project (GAP) or the Project on Government Oversight (POGO) they might know.
An FDA Reviewer
Lisa Van S
An FDA Reviewer,
Tht’s ok. I’ll ask a few contacts in Washington.
An FDA Reviewer
Anne,
Not everyone remaining are patsies or are muzzled. There is a fraction (20-30%?)don’t have the degree of scientific expertise to pick things up, or are quietly feeding Congress information and praying that Grassley, Dingell, and Stupak are successful.
I believe you’re right about most hearings simply being a dog and pony show.
An FDA Reviewer
Lisa Van S
An FDA Reviewer,
Have any thoughts on the discrepencies in the Abilify, Seroquel Medication Guides. Im curious as to how the FDA was able to pull the wool over the eyes of consumers.
Justice in Michigan
FDA Reviewer - If you have been at this site for a while, you will know that the topic of FDA preemption has often been discussed. I have a very specific question for you.
There is movement toward a Congessional hearing that will include people both from indusry and FDA who will provide testimony about what FDA approval and compliance actually mean - as they have participated in it directly. In most instances, the descriptions these people will provide will “deconstruct” in fine detail the image of regulatory oversight that pro-preemption advocates assert.
Even if covered by subpeona, these people know that they are putting their jobs and perhaps more on the line by “coming out.” What can be done to help them?
Lisa Van S
I will place bets on Grassly and Stupak!! Pallone is another good bet, if you’re a betting person.
Chris
FDA Reviewer -
You are referring to HR 985 [Whistleblower Protection Enhancement Act of 2007] (sponsored by Waxman) and S.274 [Federal Employee Protection of Disclosures Act]?
Full text of bills and their status can be found on http://www.opencongress.org
(HR1165 also looks like an interesting bill)
An FDA Reviewer
Lisa,
I have not looked at the medication guides for abilify or seroquel. I will though.
Justice,
I believe that actually testifying and being in the public spotlight would help them. Once individuals are known publically it becomes much harder to retaliate against them without repercussions. That’s not to say that they would probably never be promoted but it’s better than the alternative. If FDA management knows of whistleblowing without it being public knowledge, it simply invites retailiation. Even just ‘not being on board’ without whistleblowing results in severe harassment. One more thing is to increase the amount of damages available., emotional distress might get you $10,000 and you have to put up with things for years. It’s not that any whistleblower does it for the money, the amounts are too low and the chances of winning are too small. The problem is you need a lawyer to help you fight and until you’re actually on the verge of being fired (which is probably too late) no lawyer is even interested in talking to you as scientific whistleblowing are incredibly complex cases. Managers also need to be sued for big amounts as individuals and not be protected by their position and the presumption that they’re acting appropriately and that the agency will foot the bill eventually. The WPA bills address this to a degree by tripling the lawyers fees but even that may not be enough. You can easily spend $5000 a month fighting for several years just to keep a $90 -100,000/yr job and you only get reimbursed after the end of everything and if you win. If you look at Peter Rost’s website a large fraction of whistleblowers go bankrupt, commit suicide, or their marriages end, and this is in addition to losing their careers. The problem with whistleblowing on scientific misconduct is the other side can rig the scientific literature it with all the ‘expert’s’ opinion and can introduce doubt into the science. They did it with tobacco and they’re doing right now with a number of drugs and serious adverse effects that have been in the news in the past few weeks.
Chris,
Yes, those are the bills I’m referring to. As I mentioned earlier there are individuals who are sponsor’s on both the house and senate bills who actually have quite close connections with Big Pharma and from what I’ve seen with what they’ve actually done I don’t trust their activities regarding these bills in committee. As to HR 1165 I was not aware of it. There are both good and bad points both. It’s sponsored by a single rep. and will die at the end of the current congress so it’s probably just a means to say something to the voters at home.
An FDA Reviewer
Dan A.
While i failed to read all of the very informative posts above, what is occuring is called, ‘the revolving door’, syndrome. Govt. goes to Corp. Corp. goes to govt. Corporations do this with the DOJ and congress, to name a few more.
No one stops this. And clearly indicates collusion, of not an outright love affair between the entities.
An FDA Reviewer
Dan,
I disagree. The revolving door syndrome geneally refers to senior level political appointees.
What is occuring is the wholesale removal of highly trained (sometimes 2 or more doctorates), highly skilled (sometimes there may not even be anyone else in the world with the same skill sets) native born career civil servant employees who are not going to industry (more likely to no job at all) and instead are being replaced by foreign nationals without the proper training but who will simply rubber stamp things and are looking for a permanent career so they don’t have to go back to their own countries.
This is a remolding of the entire FDA workforce, the mission of the FDA, and how things are done. Part of the reason for the budget deficit is so that there will not be money to change things back. You can already see executive orders preventing Congress from specifying how money can be spent to fix things by labeling them porkbarrel earmarks. While the present administration is largely responsible there are those on both sides of the aisle in congress who are helping big pharma as there are people on both sides of the aisle who have realized this is too much and are fighting against it.
What we are seeing is much different than what we are accustomed to with the revolving door and changes in administration.
An FDA Reviewer
An FDA Reviewer
P.S. there are also many people who also came in under the present administration as appointees who are also became disgusted with the current administratin as they realized what was really going on.
An FDA Reviewer
Jaynesday
Welcome, An FDA Reviewer.
First, thank-you so much for sharing! Your descriptions are absolutely chilling. Many of us have been arguing back and forth for months, some for years, about information that we see in the news about pharmaceuticals, FDA and government issues. In my mind there has always been the concern that we go overboard at times and assume too much. Hearing you now I fear we haven’t gone far enough.
The level of criticality, especially for the issue of preemption has been heightened considerably.
As some already know there is a petition against preemption available at http://www.ipetitions.com/petition/fdapreemptionbadmedicine/ . I realize that a petition may have little affect in the large scheme of things but at last check there were over 600 signatures, some with very interesting comments. The comments are probably the most interesting thing. The names of a few of the signers are also impressive.
The bottom line is that we must inform the public of the “Ike” that is forming on the shores of our public health system.
Thanks again FDA Reviewer for putting some flesh to this issue.
Justice in Michigan
Thanks for your response, FDA R. Yes, the fate of whistleblowers often goes far beyond job loss/harassment. Years ago, a political scientist named C. Fred Alford wrote a rather chilling book about this, _The Whistleblower_.
You noted: “There are also many people who also came in under the present administration as appointees who are also became disgusted with the current administratin as they realized what was really going on.”
When the time comes, I hope at least some of these folks will be willing to tell their tales.
The time will come.
Justice in Michigan
Your thoughts on what sort of hearing would be needed to go beyond “dogs and ponies” would also be much appreciated!
There is also mobilizing toward a hearing independent of Congress. The Winter Soldier investigations during Vietnam provide a model (independent of particular political positions).
Congress is not the only context in which public testimony can be given and publicized, particularly by “veterans” who have been there.
Jim
To FDA Reviewer
Thanks for your insights into the FDA. It is truly a shame that an Agency initially created to protect the Public Interest has been subverted into a Corporate Shield.
To Jaynesday
Thanks for the link to the petition, I signed the petition and added my comments. It’s a shame that the number of petitioners is not greater. However, I am sure that there are other Consumer Protection Groups involved in this issue.
PS: I am not in the Pharmaceutical Field and am assuming that the Preemption Doctrine that is being referred to here involves the upcoming Wyeth v Levine case.
Justice in Michigan
Jim - Given how little publicity that petition had (beyond this site and a couple of others), it’s amazing there were over 600 in a few days. That includes people like FDA’s David Graham, as well as many other “worthies,” and concerned citizens.
FDA preemption is the core of Levine, but the doctrine has been in the making for a much longer time, and turned into what it has become during the current administration.
In my personal view, if the Court upholds a broad interpretation of preemption in Levine - as most believe is likely - it will be the most disastrous domestic legacy of the past eight years.
From that perspective, it would certainly be extraordinary to see 100+ FDA reviewers on the Capitol steps, committed to telling the truth.
Jaynesday
Jim
You are correct that preemption talked about here involves Wyeth v Levine. This would be the case to be heard in the Supreme Court late this year for drug companies.
Also earlier this year medical device manufacturers were actually granted preemption from liability for their products failures in Riegle v Medtronic. So preemption isn’t a possibility it is already a reality and possibly a growing reality. Don’t give up on medical devices because Congress may step in to reverse the Supreme Court’s decision with pending bills in both houses. Call your Congress person now. Find out where they stand on the issue and why, they may be our last chance.
It’s quite a battle being waged in our country right now. And it’s a strangely quite battle given the enormity of its meaning for the health of the people of our country.
If the American public was aware of what is going on and could determine if preemption should live or die, it would be boxed up and buried in short order.
Drug and Device Manufacturers, some politicians, and the FDA would just as soon we didn’t know what preemption was until the time comes that we have been harmed by a product and we seek to make the manufacturer accountable for their failure. At that point we will know what preemption is all too clearly and our jaws will drop in disbelief and we will say, “How can this be? Why didn’t someone do something about this when they could have?”
An FDA Reviewer
Lisa,
The medication guides that you mention deal with suicidality of antidepressants especially in children and are class labeling.
I’ve found that class labeling is used to actually hide that whatever effect is being discussed is typically much more severe with 1 or 2 particular drugs.
The timing of this as well as much of the other labeling and safety information I’ve seen recently appear designed with preemption in mind and protecting the industry presuming the Supreme Court rules in Wyeths favor and interprets preemption expansively.
If you look at the rates of suicality in teens in the body of the professional labeling it’s for an average over 9 antidepressants (not antipsychotics which might be worse) and it’s listed as 14 more cases per 1000 than with placebo, but we aren’t given a rate for placebo. Look at it this way, FDA’s new standard is 5% and double placebo. That means if it’s 50/1000 with drug (5%) it’s 3.6% or (36/1000) on placebo. or approximately a 40% increase. Now if it were close to this in absolute numbers (and remember this is an average across all drugs) I would expect that some of them would have been taken off the market already or an even bigger fuss would have been raised, because it would be too obvious to have 1 in 10 kids having suicidality and maybe 1 in 20 kids dying on a particular drug. So it’s more likely toward the other extreme where it wouldn’t be picked up so easily. The other extreme would be ~1/1000 on placebo (0.1%) and 15/1000 or 1.5% on drug. That means a 15 fold increase on drug over placebo which is huge. For actual completed suicides the rates are approximately half of the rates for suicidality. Notice that the dosage range is the same for adolescents as for adults. This is to account for the larger 16 and 17 year olds who are as large as adults however, it doesn’t preclude use in younger children at these doses. If the effect is even in part dose related then younger/smaller children may be at much greater risk and this may partially explain differences in suicidality between adults and children. There is much, much more information in these labels if you know how to read between the lines and what is not being said that these companies would not want me to discuss with regard to these particular drugs.
Justice,
I’m not a ‘veteran’ yet. I am thinking about it though, as I need to consider how I can do the most good. With what I know about drugs I don’t need to use any protected information but I believe that what I could say even without the protected information I know would cause major financial damage to many big pharma companies (i.e. in the $10’s of Billions per company). If I do become a ‘vet’ it would be before the preemption case and it may be as soon as this week. If I left FDA it might be one of the worst things that could happen for Pharma because I know too much and it would free me up to say things that as an employee I’m still prohibited from mentioning. I have no desire to hurt companies financially as it would have repurcussions for availability of new treatments. I do however want to help strike an appropriate balance and I still have some hope by working internally.
Jim,
Hate to burst your bubble but I was just at the National Archives two weeks ago and they had an exhibit on the hearings that resulted in the 1906 Pure Foods Act that established the FDA in the wake of publication of Upton Sinclair’s ‘The Jungle’. The real reason for the formation FDA was to mitigate the financial damage that the meat industry was taking due to the drop in sales by reassuring the the public.
An FDA Reviewer
Justice in Michigan
AFR - I appreciate your position. As I’ve mentioned here, I have known industry people who were inclined to “go public,” but refrained because of the consequences it would have for their companies - a punishment that did not “fit the crime” and would, overall, do more harm than good.
In any event, from a policy perspective, the issue is not a particular drug or company but how things work in general. Personally, I have learned much from people who never mentioned the drug or company that figured into their accounts.
Lisa Van S
FDA Reviewer,
“1906 pure foods act that established FDA”
Ahhh… Camden, NJ!!
Thank You for your response to the Med Guides,.. FDA has failed to respond to a Congressional request to clarify. I am great at keeping secrets, and I will be more than happy to fill you in. If you you’re a little leary, just google Lisa Van Syckel 2003-2005 News articles.
An FDA Reviewer
Lisa,
I read your testimony before the Energy and Commerce Committee and I’m very sorry.
I believe your daughter’s case is classic and there are many things I could tell you that are not based on any inside information. I do however have to consider what will have the greatest impact and don’t believe this forum is the best place.
Could you provide the citation for the congressional request. I assume it’s on the web.
An FDA Reviewer
Lisa Van S
FDA Reviewer,
“Could you provide the citation for the congressional request. I assume its on the web.”
Its not,.. What is important, is, what is being discussed behind closed doors and not what’s necessarily being discussed in the public domaine.
Can one truly know for sure, who you really say you are, or are you just another Industry insider looking to gain trust and info.
Supremacy Claus
Lisa: How would you treat children who believe their parents are the devil, and attack the police? Tell us your treatment protocol so other children may benefit.
Lisa Van S
S.C.
You taper the child off their medication very slowly, and seek the support of friends and loved ones.
Salmon
Supremacy Clause again misleads.
Lisa asked about class labeling regarding suicidality with antidepressants. The symptoms that supremacy clause describes are delusions that are associated with extreme cases of psychosis.
Lisa is also talking about symptoms that occur after drug is started which supremacy clause doesn’t bother to address either way. The appropriate action would be different in the different situations.
With regards to treatment of delusions associated with psychosis in children this may occur in extremely severe cases of schizophrenia or extremely severe cases in bipolar disorder and would involve use of an antipsychotic not an antidepressant.
Biederman (who is under Senate Investigation) last October published a Lilly sponsored study of Zyprexa in teenagers with acute manic episodes. From the stats it’s clear that the kids virtually all had Young’s Mania Rating Scores of > 30, the type of symptoms you describe are really more in line with scores of 40 - 60. Since full blown mania includes scores > 20 you’ve got to wonder why Lilly limited the study to kids (adolescents) with scores of greater than ~30. In contrast NIMH is pushing use in kids with ADHD with irritability so in essence use in kids with scores in the single digits and who are much younger i.e. 6 years old and soon 3 years old.
If you look at the numbers from Beiderman’s study 50% of the kids got no benefit, 30% got a placebo response and only 20% got an effect of the drug. So even treating appropriately you only get a drug response in 20 of 100 kids. Whereas the suicidality (e.g. self mutilation) that emerges after treatment begins is 1.5 / 100, with maybe 1 death per 100. So for every 20 kids who get a benefit ~1 dies and ~1 has other severe psychiatric side effects. Plus these have got to occur in the 50% of kids who don’t even get a placebo response.
Now if you include the kids with Bipolar spectrum disorder and ADHD with irritability that NIMH is recommending use in you have 10 times as many kids being treated. So you expect ~1 death for every 2 kids who you expect would get a benefit, and since these kids are younger and thus receiving a higher dose for their body weight, there may be an even higher rate of these toxic effects.
Recent press releases from companies whose antipsychotic drugs have been turned down indicate that they haven’t been as effective. Since this is based on changes in average scores and since the difference from placebo for drugs that are effective is so small this means that if these new drugs are working at all (which since the companies are doing more studies we can assume) it means that a sizable fraction of people (20%? 40%? of the 50% of nonresponders) are actually getting worse.
The FDA and companies have a responsibility to label the drugs so that use is appropriate. Even off-label use needs to be appropriate and justifiable otherwise it’s malpractice. For 6 year olds the scenario you’re talking about where it’s truly due to a disease is quite rare likely < 1 in 200,000 to 1 in 1,000,000. However the likelihood of drug use and the symptoms you describe being due to the drug is quite high.
So what you do with in a case with the symptoms supremacy clause describes depends on whether they occurred before any drugs were given or if they started after drugs were begun. Most of the cases are going to occur after drug is started and are due to the drug itself and not an illness. Drug labeling doesn’t point these things out and drug company sponsored medical education keeps pushing use of these drugs. So it’s likely that if the symptoms occur on drug the physician will actually increase the dose and make things worse. Even if they switch to another drug eventually any improvement would likely not due to a beneficial effect of the new drug on the illness but rather due to removal of the first drug.
In medicine there’s a saying when you hear hoofbeats don’t think zebras think horses. Supremacy Claus keeps focusing on zebras and ignores the horses.
Salmon
Lisa Van S
Salmon,
S.C.’s comment was a personal jab at me, and is more or less poking fun at the hoorific side effects my child endured while on Paxil.
Salmon
Yes I realize that.
I’ve been following the posts and looked up the testimony that FDA Reviewer indicated. It’s horrible what happened to your daughter, the self mutilation etc. and it fits the scenario that you would expect for drug induced toxicity with simply using more drugs to treat the toxicity. It’s common for the pharmaceutical industry to try to label anyone who disagrees with them over psych drugs as crazy and to try to say but if we don’t use with drugs even more children will be hurt. When if you look at the data it’s the opposite with more children being hurt by the drugs than by the illnesses. Plus as I indicated you can differentiate the kids who it may be appropriate to use them in and those who it isn’t and you need to look for emergent psych symptoms after starting, and even that may not be enough. The psych drugs account for more than 1 in 5 dollars spent on prescription drugs in this country and according to Glaxo will account for 16 of the top 30 diseases worldwide by 2030. Plus according to sales figures use in children is the fastest growing segment and much of this is paid for by tax dollars.
Supremacy Claus definitely has characteristics of having a psychopathic personality disorder, who else would sadistically intentionally try to antagonize a mother whose child went through what yours did, and he/she is likely a paid pharmaceutical industry stooge.
Salmon
Lisa Van S
Salmon,
The “Industry Motto”:
If we can’t defend our drug, attack the child!
Matthew Holford
Supremacy Claus wrote:
“…Tell us your treatment protocol so other children may benefit.”
Put the real life scenario in front of me, and I’ll model it for you. I can’t say fairer than that, can I?
Matt
Another Reviewer
Getting back to the original article and thread.
Articles on the 2000 total new hires indicate that this is 15% of the FDA workforce. That’s true but there are only 2000 people in the Center for Drugs and of these maybe a third are reviewers.
In fact they’ve been intentionally starving the psych review teams for certain disciplines so that there will not be any comments made to the companies during development (INDs) when problems could be averted or FDA input could result in study designs that adequately characterize safety issues. Instead new hires are going towards drug disease state modeling of biomarkers and helping pharma develop drugs.
Even the new hires going into postmarketing surveillence aren’t going to help stop dangerous drugs before they reach the market. In fact the new risk management plans are being reviewed by the postmarketing division before the new drug reviewers have had a chance to do their reviews and find the side effects. It’s all about closing the gate after the horses have gotten out and even then closing the gate veeeerrrry slllooooolllllly.
FDA management compartmentalizes reviewers and have put people who are supposed to be doing collaborative reviews into 3 different buildings with 20 minute walks between them. There are now urveillence cameras everywhere including monitoring of computers and phone calls. Some division directors as a pilot program have even been ordering their staff to stay in their rooms and communicate entirely electronically. They can’t even go and talk in person to the reviewer in the room next to them.
There are posters up on the walls telling new reviewers that anyone who isn’t happy and cheerful and going along is a problem. In meetings the new reviewers are told that anyone who is against the new way of doing things is a sabatour, and there are parties and baseball caps and special emphasis to indoctrinate these junior reviewers on the new way of doing things while at the same time senior reviewers are scheduled so they can’t attend and are excluded. This also goes for meetings regarding the science of safety issues on drugs reviewers are reviewing.
FDA management also keeps reviewers in the dark. Reviewers don’t even know what other reviewers in the next room are working on, and they don’t tell reviewers about adverse effects that might be class effects. Labeling changes and public safety announcements are also hush hush inside FDA. Unless you actively look yourself.
As for the lack of keeping up with the latest science that Pharma’s complaining about. That’s only because FDA management has prevented reviewers from keeping up with things so they won’t know about class toxicities or have qualifications to obtain a new job when they’re forced out for raising safety concerns.
Another Reviewer
Lisa Van S
Maybe the FDA should be Unionized, The Teamsters come to mind.
Justice in Michigan
As I understand it, there was a union established among reviewers specifically in the interest of pushing back against muzzled science. Does that still exist?
I believe everyone on this site should be terrified if the following is true:
“There are posters up on the walls telling new reviewers that anyone who isn’t happy and cheerful and going along is a problem. In meetings the new reviewers are told that anyone who is against the new way of doing things is a sabatour, and there are parties and baseball caps and special emphasis to indoctrinate these junior reviewers on the new way of doing things while at the same time senior reviewers are scheduled so they can’t attend and are excluded. This also goes for meetings regarding the science of safety issues on drugs reviewers are reviewing.”
Welcome to Animal Farm. If anyone can take the risk of doing so, I can be reached at justiceinmich@gmail.com. My record here pretty much speaks for itself.
An FDA Reviewer
Yes I saw one in the hallway in the office of scientific investigations (where the new inspectors will be located).
It shows 2 triangles one pointing up and green and one underneath it pointing down and red. The up one shows positive attitudes and the down one shows ‘negative’ attitudes and warns new people away from anyone having ‘negative’ attitudes. Of course who would have negative attitudes but people who have been harassed and retaliated against. It’s also noteworthy that the OSI is where reviewers who are ‘troublemakers’ i.e. those who raise safety issues tend to go if they are forced out of their division but not entirely forced out of FDA.
The poster is from the Center for Professional Development. This is the firm that Dr. Von Eschenbach hired to assist with the Culture change he promised at FDA after Vioxx and his baseball speech (the one where he told reviewers ‘first we talk to you, then we bench you, and then we trade you’.)
The center for professional development’s website is http://www.cpdinfo.com/ and they do a lot of work with big pharma companies. In fact they have a publication on their cite about what Big Pharma execs from 17 companies say about them. The following is a quote from this article.
As one of the leaders in the study succinctly put it: “Every business can be sustained in challenging times if it truly focuses on precisely what it’s good at, eliminates all unnecessary costs, and has a workforce that is in complete harmony and understands exactly the position the company is in, the context they’re working in, and have the belief that they can make a difference.”
Eliminating unnecessary costs at FDA means eliminating those reviewers Pharma doesn’t want. They pay the bills don’t they? But more troubling is that the remaining workers have to be in ‘complete harmony’. The article goes on to say that workers must be aligned. At FDA reviewers are also told they must be aligned with the ’strategic plan’ and those who are will be rewarded and those who aren’t will be punished.
If you think this is scary, you ain’t heard nothin yet.
An FDA Reviewer
Jaynesday
FDA Reviewers,
I do hope that there is a way for you to alert others about these things; people who can do something to help, because it does sound pretty scary.
Being in manufacturing management myself, I know that management doesn’t do anything without a justification and a reasoning that would be “politically correct”. I would be interested to know how FDA management can justify such actions to the world. Certainly they don’t think they can keep these things under wraps forever? What would be their “spin” on this?
Lisa Van S
FDA Employees could always call a “Strike”,.. Power is in the numbers.
Justice in Michigan
Re: Jaynesday’s Q, my guess what FDA management would say:
1. We are trying to create a positive work environment.
2. We don’t want reviewers distracted from doing their critically important work (thus no communication with each other).
3. Every organization has its troublemakers. We are doing our best to keep them from disrupting the work of the serious members of our staff and our overall public health mission in service to the AMERICAN PEOPLE.
4. We have always been open to hearing any concern from our superlative team of reviewers. We have nothing to hide. We are the gold standard, the optimal agency, the Land of Oz.
5. Now go F yourself.
Jim
To FDA Reviewer
Thanks for “Bursting my Bubble.” While you are probably correct and I do believe you are in that the Pure Food and Drug Act was passed to protect the financial interests of the Meat Packing Industry it still had the effect of protecting the public from abuses in that industry at that time.
If “The Jungle” was written today it would be easily dismissed by the corporate PR machinery with complicit government assistance.
The problem is corporate abuse and malfeasance surface all the time today and no one pays attention until it’s too late.
We have a largely uninformed electorate that is too easily swayed by platitudes; anyone with a legitimate grievance against the Medical Profession or the Pharmaceutical industry is quickly labelled as a money grabbing opportunist looking for a quick buck.
To Jaynesday:
I will take your advice and see where my Congressman stands on the issue of preemption. Is there any specific legislature I could cite?
Thanks for the Feedback.
Jim
Justice in Michigan
Once again impersonating Jaynesday (when I’m not impersonating Steve Galson and assoc.), both Rep. Frank Pallone and Senator Ted Kennedy have introduced legislation that would reverse the Supreme Court decision in Riegel, which upheld broad preemption in the device arena.
Thirtenn Reps and Senators signed an amicus against preemption in the Levine case. So it is perfectly possible simply to ask a Rep. where he/she stands on the issue of FDA preemption, and Frank Pallone’s bill in particular.
There is a reasonable chance you will get non-committal gobbledeguck. Try to wade through that and push for a real answer. If you don’t get one, write a letter to the editor about not getting one.
Chris
JiM -
Do you have a number for the preemption bill sponsored by Rep Pallone?
Justice in Michigan
Chris - The info is below. There is also a Senate bill which has the same name - Medical Device Safety Act - of which Kennedy is the major sponsor.
H.R. 6381 is available at http://www.house.gov/waxman/pdfs/bill_MDSA_2008.pdf. Waxman’s letter can be accessed at oversight.house.gov/documents/20080626115635.pdf.
Matthew Holford
Another Reviewer wrote:
“…It’s all about closing the gate after the horses have gotten out and even then closing the gate veeeerrrry slllooooolllllly…”
In essence, then, a reviewer’s job is about giving the illusion of having rigourously assessed a given drug, presumably via a highly selective box-ticking exercize to avoid finding anything, when no such rigourous assessment has actually taken place? This only stands up to the most cursory of inspections, though, because as soon as a drug hits the market, the stuff that should have been flagged before becomes painfully evident, I should have thought.
Is it just me, or is this whole thing just a really elaborate scame?
Matt
Chris
FDA Reviewer(s) -
Do you have any idea if it is standard practice for the FDA to implement a gag order for members of an FDA Advisory Committee meeting after the meeting?
An FDA Reviewer
Lisa,
Without going into details, the Union in the last 2 years has really stepped up to the plate. However, there is only so much they can do and management ties the union up too. For example if management wants to overload a particular reviewer or give them a herculean task so they can fail and then have a basis for retalation that prima fascia is reasonable they can. Also once you get involved in any complaint with management (if an innocent comment can be taken as a complaint) it invites harassment that takes up your entire life and this can go on for years. As for striking we would have to get the entire national union (IRS employees etc. to go along with us) it’s only a couple of hundred of preapproval reviewers at FDA and not that many are even union members. Plus government employees are not allowed to strike.
Jaynesday,
I think Justice provided a reasonable answer.
Matt,
‘as soon as a drug hits the market, the stuff that should have been flagged before becomes painfully evident, I should have thought.’
No. Look what happened with Vioxx it takes over a year in most people and then it’s ascribed to age. Same with the cardiac effects with antipsychotics. Even when things are reported to companies they don’t have sufficient detail. Sometimes companies don’t report things as they should. When they are they’re explained away and then if they aren’t they have to have hearings and advisory committees that drag on for years and then after years a generic class effect is put in place so that you can’t tell which is the really bad actors. Look at the recent black box warning with antipsychotics. Plus this is all now spelled out that we have to do this in the Kennedy-Enzi bill that passed last year.
Even to pick things up is difficult. Look as I said before assuming the risk of suicide in kids on antidepressants according to the labeling may be around half of the suicidality rate so 0.75% or less. Psychiatrists see patients for 1 hour at a time (maybe 0.5 hour for a medication visit) so working 2000 hours a year (50 weeks x 40 hours) and a visit every 3 months on average you have about 500 patients. Now not all are going to be on antidepressants most will be patients with ADHD. So even if 1/3 are on antidepressants not all are going to be on a particular one, then even if one death occurs a year it maight be one drug this year and a different drug the following year and will be chalked up to the illness and not a particular drug.
Chris,
I don’t know anything about gag orders however they are bound by confidentiality agreements and they don’t necessarily get the full story. Plus do you really think they actually read through even the background material they get. It’s more likely they take a quick look through it on the plane flight in. Plus I can tell you the way it’s set up with new drugs we’re not even finished looking at the material ourselves when we’re supposed to provide it. Then the companies get to look the presentation over before hand so they can design a rebuttal. As for post marketing safety ACs these are because things are already getting press and there needs to be damage control. One of Bob Temple’s favorite sayings to reviewers whenever reviewers under him would raise a safety issue (before it was reported in the comments of the UCS survey) was “Where are the bodies in the street?” So if the major press outlets aren’t reporting on it why worry? The new presumption at the FDA is it’s not the drug it’s the patient. (i.e. they must be a genetic outlier) and new genetic testing will take care of that (plus we can sell a genetic test in addition to the drug). That’s part of the reason for the all new monitoring initiative. Well that’s only part of the story. Plus why implement it and decrease sales until you absolutely need to so as to prevent further loss in sales.
From the description and having similar effects on multiple drugs I wouldn’t be surprised if your daughter was one a genetic outlier and those studies she was enrolled (without your approval) actually took some blood to look for genetic mutations in case she did have the type of reaction she did. The drug companies started doing this in the mid-late 1990’s but under the Voluntary Genomic Submission Guidance MOU this sort of safety information doesn’t have to be submitted and even if it is won’t be given to reviewers. Which is a violation of the Food Drug and Cosmetics Act which requires submission of all data (even preclinical) related to safety.
This is a huge ship and only constant repeated messages will help. Billy Tauzin said Pharma is now dying the death of the thousand cuts. The day of reckoning is coming. But I don’t know when it will be. Remember it will take a complete housecleaning to even begin to get things back on track and that can’t occur until the USDOJ is willing to prosecute and that won’t occur until there’s a new administration. If you follow shearlings got ploughed and cafepharma they’ve been waiting for months and months for criminal indictments.
I think these are reasons we’re seeing the increase in activity by Congress lately. Look at Grassley and Dingell recently. But things like the Wall Street bailouts that just occured can’t be allowed to side track things and remember Grassly and Baucaus are the finance committee they can only handle so much at one time and need to clean that mess up first. Timing is everything. I don’t know when it’s coming whether before the election or after (remember the timing for Vioxx) but it’s coming.
Keep writing and blogging and saying things. There are people who pay attention. Plus momentum is now building and eventually there will be a tipping point when the politicians will be jumping on the bandwagon to save their own necks. Look what’s happening in a general way with the election. Don’t be fooled however. Follow the Pharma money!
Lisa Van S
FDA Reviewer
Check out our website
http://www.ssristories.com
Lisa Van S
FDA Reviewer,
Here’s another
http://www.paxilharmschildren.com
Matthew Holford
FDA Reviewer wrote:
“No. Look what happened with Vioxx it takes over a year in most people and then it’s ascribed to age…”
Hmmm. It’s difficult to come to any kind of conclusion, on that, because patients (and, indeed, just about everybody else), are denied access to all the data, quite deliberately so, most of the time, as far as I can tell.
Let’s suppose that a company did know that its product was shite - it’s certainly very easy to fudge the numbers and blame the patient, as we’ve seen. But these things do get noticed. His view wasn’t very fashionable, at the time, but David Healy started saying that SSRIs have issues attached almost as soon as they appeared on the market. And it turns out that he was right.
My take on the medicalization of human behaviour is somewhat different: even if we assume that a given behaviour may be described as (mental) illness, can a drug fix that? The answer is, of course, a resounding “no”. So, not only are they dangerous, but they don’t help anybody. And it’s that, I think, more than anything else, which ought to be acknowledged, when the drug hits the market, irrespective of which KOLs said what, and what marketing spin says. In fact, it’s so painfully obvious to me that these drugs don’t work in any real sense, that I’m still staggered that there’s still a discussion surrounding the side effects.
You’re right, though: if the regulator passes a drug as safe and efficacious, then it’s predictable that people are going to run with that, particularly those who are prescribing drugs (let’s assume that there are no ulterior motives for the prescription of drugs, such as personal profit). Does one have to scrutinize every piece of information that one receives, on the ground that it might be flawed? Well, the Worshipful Company has done itself no favours, here, because the answer to that question, given the industry’s track record, is probably “yes.” Unfortunately, once a drug is licensed, the motivation for a company to do anything other than wait for the SAE reports to come in is practically nil - why would one wish to undermine one’s revenue flows - it’s easier to turn a blind eye to potential issues, particularly where one has a successful (in terms of sales), drug.
Matt
Concerned Parent
Just curious, FDA Reviewer, to what extent do the issues described above apply to licensure and post-marketing surveillance of vaccines? Or, is this only an issue within the traditional drug areas? I ask this, in part, because of concerns about Gardasil, the HPV vaccine. In particular, the large number of reports in previously healthy teenage girls of fainting and syncope that are very unusual in that the episodes happen well after the shot is given (20 minutes and more) and can recur for days/weeks as in the case of my neighbor’s daughter who also has numbness and tingling in her hands and feet. Plus, the number of sudden cardiac arrest reports with this vaccine seem high but the FDA and CDC say these health problems and receipt of Gardasil are just coincidences. Does the public have a reason to be concerned about FDA’s ability to monitor the safety of vaccines?
An FDA Reviewer
Concerned Parent Biologics which reviews vaccines is being incorporated under the drug division. I am not familiar with the particulars at this point.
From news reports it’s clear that the problems are systemic (devices, food, blood banking), and as more companies shift to biologics from small molecules there will be more and more problems.
As for monitoring of post marketing safety just look at what happened to David Graham, Andy Mosholder, Rosemary Liang, Rep. Stupak.
No when signals are seen they are minimized and dragged out for years and years.
I was not aware of the types of side effects you describe however, remember viral infections cause a revving up of the body e.g. increased temp, energy metabolism, protein production, etc.. Plus many serious drug toxicities also involve revveing up of metabolism or effects on mitochondria which are responsible for energy production, e.g. psychosis, neuroleptic malignant syndrome, diabetes and lipid dysorders, hepatic fibrosis, pulmonary arterial hypertension, cancers, etc.. Plus many lethal drug reactions occur in people who have chronic viral infections or get viral infections while on drugs, e.g. mutiple organ failure, Reye’s syndrome, cardiomyopathy, choreoathetosis, hepatic failure, as well as linkage (with various degrees of strength) with certain diseases, e.g. hepatitis, autism, schizophrenia, PANDAs (pediatric autoimmune neuropsychiatric disorders and SSRI’s). This also extends to bacterial infections but not as commonly, e.g. rheumatic fever, Syndeham’s chorea etc..
I do not know specific mechanisms and at this point these are simply observations on my part, however the commonality makes me suspect that there’s more there and some interrelationship. I have only noticed these associations in the last 18 months or so, yet toing back through old public documents from the FDA suggests to me that others including FDA management have noticed these associations starting over a decade ago. It’s likely that companies noticed them even earlier. These things seems to coincide with the FDA industry PDUFA agreements and the beginning of broader industry infiltration into FDA and placement of ex-industry people in positions evaluating FDA science policy.
An FDA Reviewer
PS
Various articles in the medical literature and elsewhere suggest that these problems may be more common in children with certain diseases, e.g. autism, OCD. Thus there may be a genetic factor making some kids more susceptable which industry will then sell a genetic chip to use for screening for use in everyone, but only after enough cases and the market has already taken up the drug/biologic.