FDA Warns Five Drugmakers Over ADHD Ads
18 CommentsBy Ed Silverman // September 26th, 2008 // 9:28 pm
Five, count ‘em, five warning letters were sent yesterday by the agency to different drugmakers for incomplete, false or misleading promotional materials for ADHD meds. Among the ads cited - a YouTube video for Shire Pharmaceutical’s Adderall XR with Ty Pennington that was featured on the “Extreme Makeover: Home Edition” television show.
The charges would appear serious - the FDA says the drugmakers variously omitted material facts; miminized important risks; overstated efficacy or made unsubstantiated claims.
This is the warning letter sent to Shire and some other promotional materials cited; the letter sent to Johnson & Johnson for its Concerta pill and the ad; the letter sent Novartis over its Focalin XR Med slides; the letter sent Mallinckrodt for its Methylin drug ad; and the letter sent to Lilly for its Strattera pill and the offending promotional material.
The drugmakers were contacted by Bloomberg News, which gathered the following comments:
A Shire spokesman wrote the news service that the web posting cited by the FDA “was made in error” and the drugmaker is “committed to complying with both the letter and the spirit” of the agency’s regulations. The video posting was removed last year, and wasn’t intended to appear on its own without additional information on dosing and use, he added.
Lilly is reviewing the letter and “will work with the FDA to address their concerns,” a spokesman says.
A J&J spokeswoman wrote the news service that the drugmaker “will work closely with the FDA to address the issues raised in its letter.” A Mallinckrodt spokeswoman tells the news service the drugmaker is “preparing a response to address the FDA’s concerns.” And a Novartis spokeswoman says the drugmaker will respond to the FDA after reviewing the letter.
“Manufacturers will always try to go right to the limit in making their promotional claims to doctors, and doctors tend to follow their claims,” Larry Diller, a behavioral pediatrician who wrote Running on Ritalin: Should I Medicate My Child? and says ADHD meds are overprescribed, tells Bloomberg. “When claims are overstated, there is both over-prescribing and mis-prescribing and in the end children get hurt.”
Justice in MI
Question for all - Assuming the facts are as described, does anyone think that they are serious enough to open the door to potential lawsuits? What if it were proven that one or more of the companies involved was aware that their promotional materials pushed the envelope of compliance. They reasoned that non-compliance means when the FDA calls you on it. Would that change your views?
If not, where would you place the bar - if anywhere - in which violation of FDA regulations would rightfully constitute grounds for civil liability?
Your thoughts genuinely appreciated.
Matthew Holford
Justice in MI wrote:
“…Your thoughts genuinely appreciated.”
I think that this represents a pattern, and I can’t believe that nobody within the relevant companies noticed.
I think that the companies are run, not by scientists, or compliance experts (nor do these demographics even have significant input), instead they are run by marketing men, or liars, as their known in colloquial terms. I think that the *appearance* of science and compliance is of greater significance to these psychopaths, than the pursuit of anything approaching the real McCoy.
I think that knowingly breaching basic principles of science, and Law (or accidentally breaching those principles, and then not correcting the mistakes, when they’re discovered), is the mark of amateurs, not professionals. And it certainly isn’t the mark of scientists.
Matt
Justice in MI
Thanks, Matt. Part of the reason I’m asking my question is that there have been proposals that, if there were preemption, companies might not be immune if there was “a finding of fraud” by FDA.
But what does a “finding of fraud” mean? In most instances, it would mean a successful and finished prosecution by the agency. As we’ve often discussed, that essentially never happens (unless they accept a whisleblower suit and are forced into it). Instead, there are warnings, remedial plans, settlements, etc. none of which qualify as a “finding of fraud” in that strict sense.
So, in essence, the “find of fraud” proviso may be meaningless in practice.
Meg
I attended the first hearing on ADHD drugs. Steven Nissen led a charge in the drug safety advisory committee to vote 8-7 to urge the FDA to put black box warnings on all these drugs. This was a no no. His committee was not supposed to do this. The next day, the chicken-headed pediatric advisory committee voted against this recommendation. Of course, we know what the FDA did.
I am hoping school staff are beginning to get it that these drugs are bad and life threatening, and try social-behavioral techniques.
laurie
Ed, the Lilly link to the letter regarding Strattera goes to the Methylin drug ad PDF.
laurie
” “committed to complying with both the letter and the spirit” of the agency’s regulations.”
But chose to publish the inadequate information anyway. This is blatant and inexcusable.
Justice in MI
While I don’t know the particulars in these cases, it has been practice in some instances to use promotional materials known to be non-compliant. And then see if/when FDA responds. By then, promos have usually moved on, so the deed is done with no consequence to the company beyond the time it takes to shmooze up DDMAC (and bs the rest of us).
Fred Baughman MD
Fred Baughman, MD, Neurologist, Child Neurologist
Author: The ADHD Fraud—How Psychiatry Makes “Patients” of Normal Children
http://www.Trafford.com
Comments on (439 words): FDA Warns Five Drugmakers Over ADHD Ads
Pharmalot, Ed Silverman
September 26th, 2008
Ed Silverman (Pharmalot, September 26th, 2008) writes. “…five warning letters were sent yesterday by the agency (FDA) to different drugmakers for incomplete, false or misleading promotional materials for ADHD meds.” “… the FDA says the drugmakers variously omitted material facts; minimized important risks; overstated efficacy or made unsubstantiated claims.” “Manufacturers will always try to go right to the limit in making their promotional claims to doctors, and doctors tend to follow their claims,” said Larry Diller, a behavioral pediatrician in Walnut Creek, California, who says the hyperactivity medications are overused though he prescribes them for some patients. “When claims are overstated, there is both over-prescribing and mis-prescribing and in the end children get hurt,” Diller said in a telephone interview with Bloomberg News, September 26, 2008.
The glaring omission here is that ADHD has never been proved to be a disease (throughout medicine, disease = physical abnormality—gross, microscopic, or chemical). Shown no proof of an abnormality, the Panel of the 1998 Consensus Conference on ADHD could only conclude “ …we do not have an independent, valid test for ADHD, and there are no data to indicate that ADHD is due to a brain malfunction.” Carey reporting on “Is ADHD a Valid Disorder?” concluded: “What is…described as ADHD in the United States appears to be a set of normal behavioral variations…” Nor has ADHD or any other psychiatric diagnosis/ “disorder” been proved since to be a bona fide disease, having, as it must, a confirmatory physical abnormality. This being the case, all research and all treatment predicated upon the presumption that ADHD is an abnormality/disease is false. For this reason what we have today is not “mis-diagnosis” and “over-prescribing” but a total, one hundred percent fraud. No child diagnosed with “ADHD” is demonstrably abnormal/diseased. Their first and only abnormality is the intoxication with amphetamines and other psychotropic drugs that invariably follow the “diagnosis” of ADHD.
Lawrence Diller, quoted above, is widely viewed as a voice of moderation when it comes to the diagnosis and treatment of this “disorder” that does not exist. On page 7 of his book Running on Ritalin: Should I Medicate My Child? Diller writes: “Before 1990 I needed perhaps one pad of a hundred forms every nine months; by 1997 I realized it was one every three months,” or approximately 400 Ritalin prescriptions a year, hardly “moderate” given that no such disease exists—that the children are normal to begin with.
Kat
What I find hilarious is that as soon as Shire’s new ADHD drug (Vyvanse) was released, Ty Pennington suddenly stopped being the spokesperson for Adderall XR and became the Vyvanse spokesperson. You can no longer find “Ty’s Story” anywhere on Shire’s Adderall XR site; however. And if you go to http://www.adderallxr.com (the official Adderall XR website), you’re instead taken to a page promoting Vyvanse. Interestingly, you can’t even find the news announcement of Ty Pennington becoming spokesperson for Adderall XR on the Shire website by searching the archives; you can only find the announcement of him becoming spokesperson for Vyvanse. The only photographic evidence I could find of this was on a blog: <>.
I would like an explanation from Shire as to why Ty Pennington switched from Adderall XR to Vyvanse in the first place. Did Adderall XR not really work? Did Adderall XR stop working after initially treating his symptoms? Did he switch in some sort of cosmetic psychopharmacology experiment, just to see whether Vyvanse might work “better” than his current medication? What is Shire telling us here? That we shouldn’t believe their claims and their spokesperson’s claims about the efficacy of the medication they market and manufacture? Or that you should try a newer medication just to see if it’s better than the one that’s currently working? In other words: is Shire promoting bad medications or are they promoting bad medical practice?
Kat
What I find hilarious is that as soon as Shire’s new ADHD drug (Vyvanse) was released, Ty Pennington suddenly stopped being the spokesperson for Adderall XR and became the Vyvanse spokesperson. You can no longer find “Ty’s Story” anywhere on Shire’s Adderall XR site; however. And if you go to http://www.adderallxr.com (the official Adderall XR website), you’re instead taken to a page promoting Vyvanse. Interestingly, you can’t even find the news announcement of Ty Pennington becoming spokesperson for Adderall XR on the Shire website by searching the archives; you can only find the announcement of him becoming spokesperson for Vyvanse. The only photographic evidence I could find of this was on a blog: http://radiodiatribe.com/2007/02/25/ty-pennington-your-friendly-neighbourhood-drug-pusher/.
I would like an explanation from Shire as to why Ty Pennington switched from Adderall XR to Vyvanse in the first place. Did Adderall XR not really work? Did Adderall XR stop working after initially treating his symptoms? Did he switch in some sort of cosmetic psychopharmacology experiment, just to see whether Vyvanse might work “better” than his current medication? What is Shire telling us here? That we shouldn’t believe their claims and their spokesperson’s claims about the efficacy of the medication they market and manufacture? Or that you should try a newer medication just to see if it’s better than the one that’s currently working? In other words: is Shire promoting bad medications or are they promoting bad medical practice?
An FDA Reviewer
Coming on the heals of the Senate’s DTC advertising investigation and other investigations on the use of psychiatric medications in children. I believe this be an attempt by FDA management to mitigate damages to themselves on why they didn’t pursue this earlier. Especially when it was repeatedly reported to them by their own review s€taff.
Matthew Holford
Justice in MI wrote:
“…So, in essence, the “find of fraud” proviso may be meaningless in practice.”
Proving fraud is a tremendously complex business, in a criminal court - it requires proof of an intention to deceive, as you probably know. Civil actions, such as the one successfully pursued by Eliot Spitzer, against GSK, do not even allow one to say that GSK is a bunch of fraudsters - only a criminal court may do that. A regulatory finding? That’s got to be the next rung down on the ladder, hasn’t it? In any case, the FDA only has regulatory sanctions, as far as I’m aware, such as those you mention.
The facts of the matter are, to an extent, irrelevant, anyway. Human nature is at play, here: the FDA finds that a company has stepped across the line in a big way, let’s say. Perhaps in a way that, if the FDA had had its eye on the ball, it would have noticed. Let’s say that the company concerned advised the FDA of what it was doing, but nobody did anything, or worse, that this was a known problem, but the FDA had taken no action to ensure that a regulatory loophole was not exploited.
Suddenly, it’s the FDA’s fault, at which point the FDA is investigating itself. What kind of decision do you think it might make? The company isn’t stupid, after all - if the FDA tries to scapegoat the company, the company is going to let everybody know how crap the FDA is…
And so, it’s in everybody’s interests “to work together to resolve the matter, improving systems to ensure that the best interests of patients are served.”
Gosh, that does look cynical, doesn’t it? Experience can be a terrible thing.
Matt
Justice in MI
Indeed.
Re: FDA’s powers, its Office of Criminal Investigation, in conjunction with the DOJ, can bring criminal charges. Along with civil penalties, that happened, for example, in the Neurontin case.
On the other hand…
Vic Mencarelli
Morning everyone. I have been a frequent reader of the site and have chosen (for specific reasons) not to become involved in most of the discussion. However, this one I think requires it.
In general, I think that the pharma business has done more good than harm especially in the past. However, now, with the looming issue of preemption, I find it interesting that the FDA has chosen to send Warning Letters on this topic. Essentially, from my understanding of preemption (as it works in the device world), as long as the agency has taken an action, ANY charge or court filing is preempted by that action. This would include fraud on the FDA because there is currently no right of private action specifically mentioned in the law. In fact, the law specificaly states that the ONLY person capable of bringing any level of action against the industry in the FDA.
As a parent who refuses to medicate my child with this garbage which has (as far as I am concerned as a scientist, regulatory specialist and parent) NEVER been shown to do anything other than make it easier for the teacher in the classroom to handle a difficult student (oh, and by the way, in my own experience the most LIKELY person to suggest medicating a child is the TEACHER NOT THE DOCTOR) and to have a child become a zombie (and they DO NOT learn that way at all!). Sorry, these drugs should NEVER have been allowed on the market in the first place as far as I am concerned.
Overall, the problem with preemption is simple: if the FDA does ANYTHING then the right to bring civil actions would be completely and totally preempted (see FDA’s amicus brief in Levine and Riegel) by the fact that the FDA has ruled on whatever the issue might have been and the FDA is the sole decision maker in these actions. I find it funny sometimes that the FDA is so much the “expert” but that the FDA’s own people told the GAO a year or two ago that they were forced to or bullied into recommending approval of dubious drugs with incomplete or questionable safety or efficacy concerns.
Justice in MI
As far as I know, VM is correct. I raised the question initially because some people who otherwise support preemption argue that it should not hold if the FDA had been defrauded in approving the device or drug.
But this would require FDA to take action showing fraud against itself. And, assuming that means proving fraud in court - whidh FDA essentially never does - such a “fraud exception” to preemption would be, de facto, meaningless.
And then there is this: Even if the FDA _did_ prove fraud, FDA and DOJ argued in the Kent case that that its approved products (yes, even if approved through fraud) should _still_ be protected from lawsuits.
Barn door closed.
Jaynesday
Just a thought -
What other American social entities are above being examined through litigation by the judicial branch of the government?
The ones I can think of are:
The Supreme Court itself including all Judges and Juries
Congress
The President (other than for impeachment by other branches of the government)
Regulatory agencies including the FDA
State and local governments
Publicly held utilites
I’m sure there are others.
The leaders of these exempt entities are either appointed by elected officials or are directly elected by the citizens themselves.
We are about to elevate a number of publicly held companies to this new level of social standing. I think that this should call for a drastic restructuring of their top level management to come into alignment with what is customary for this new exempted status. Also maybe we should consider how to better control other aspects of their business practices including limits on profits, controls on spending, advertising, pricing etc. more in alignment with a utility company for example. ;-)
What About the Docs?
Interesting string and one comment I want to add–what about the responsibility of the physician(s) to truly investigate and understand the medications they prescribe? Physicians are supposed to be highly trained specialists and while they have a busy schedule and insurance challenges to face daily, this should not alleviate their comittment to care. If we want to look at accountability, we cannot forget the person that signs the prescription and recommends the drug, as well as the pharmacist who is to call out any warnings, or potential side effects. Let’s not forget that pharma does not market directly to patients, it requires a doctor’s recommendation for a patient to begin medications. Ownership needs to fall across the boards at every level and not just with the pharmaceutical companies.
Wendy B
Great discussion.
Another interesting point to note is that the YouTube video represents the first time a warning letter has been issued for something posted on that site. And only the second one I know of issued for something exclusively online.
That said, it’s also important to note it’s not the site or the digital channel that was at fault — it was some basic rules the companies broke that would’ve been a problem no matter what the channel.
More discussion on my blog at http://intouchsolutionsdigital.blogspot.com/