The FDA can allow free speech on off-label uses, but restrict MD prescribing power to only on-label indications, or they can keep the status quo which is prohibiting off-label marketing by drug reps but allowing off-label prescribing.

Maybe the FDA can’t regulate drug rep speech, but the FDA can regulate MD prescribing authority.

But you still haven’t addressed how to do this. How can you regulate that? Make a law that says on pediatricians can prescribe drugs to children? Or limit it to classes of drugs in certain cases? How do you define that? And especially only for off-label use? It quickly becomes a quagmire to implement and navigate. Also, your experience aside, many family practice physicians actually take the time to gain further knowledge and relevant specialization. How do you regulate that? Is their knowledge suddenly worthless? Do they have to get official licensure? Who would devise it? On what evidence would it be based? Would the patients of this doctor suddenly need to go to a child psychiatrist? What if there wasn’t one available nearby? Or in the network of the patient? Or didn’t have an appointment for a very long time?

It is vastly more complicated than just saying we should regulate an off-label use. Because yes, while it isn’t illegal, it is still off-label. So how do you then define the regulation you wish to impose? Because saying “Any use not on the label” is too broad – it (potentially) affects to many populations with too diverse a range of conditions. So then you have to be specific, and that becomes the quagmire.

Your further assume that the family physician doesn’t have the necessary or relevant expertise. This is certainly not true. Family/general practice physicians are specifically trained to be within their limitations. They will hedge and say a referall is needed to prescribe medications they are not comfortable with (and since your evidence is experience, I will counter with mine – in my GP rotations, I had many instances with new patients and child patients asking for psychotropic medications and the attending GP refused to prescribe more than a handful to get them by until proper follow up was met with the referall we gave). And it is also false to think that a GP can’t then follow the case – part of the training is to recognize when things go wrong and a referall back to specialist is needed. Insisting that all cases must be initiated and followed by a specialist (in this case sub-specialist) is onerous, expensive, and certainly not necessary. Certain more difficult and complicated cases do, and those are, usually at the bhest of the GP.

The issues raised here are more about bad doctoring rather than bad regulation and a need for a plethora of laws to describe every scenario for every off label use of every drug. And it is sadly tough to regulate bad doctoring. I would also argue that it is the minority – though still a significant problem – that would fall under this category.

There are few regulations regarding off label use… for exactly the reasons I have been discussing. As I said before, creating a system to make an evidence base to help guide off label use is, IMO, a decent idea. But I still fail to see how to regulate things the way you seem to think they can/should. Perhaps I am misreading you, but at least a good chunk of what you have written is based on incorrect assumptions and experience rather than actual data – which contradicts what I know about how physicians are trained and how we are already supposed to act.

Furthermore, in regards to your link about the child psychiatrist, there are studies which claim there is no efficacy beyond placebo for any anti-depressants in any population… which have been thoroughly debunked by the likes of Jim Coyne and others. The point is that accurate measurements and quality studies are hard to do, and much more so in special populations like children. It is absolutely unfair and untrue to say that they do not help any children at all and that most prescribers don’t know what they are doing. They do help, and in many cases it is a limit of knowledge on the topic rather than a limit of practitioner knowledge that is the issue. So you are left either throwing the baby out with the bathwater or merely saying “Exercise more caution when prescribing to children” which is something already drilled into our heads and not something one can codify into a regulation.

I am certain more clever people can come up with a few god regulations to improve the situation, but it is not as simple as “regulate it more and make it so that only pediatric psychiatrists can prescribe…”

In my opinion, I am not fear mongering. I believe that medicine should be prescribed if there is evidence that it is helpful (i.e. stimulants for AD/HD in children), as long as the proper follow up medical care is provided to ensure that the side effects aren’t more harmful than the problem they are trying to resolve (i.e. liver damage, weight gain, no effect on behaviours, etc.).

There is no research to suggest that Paxil is helpful for children. There has been research on the subject, by GSK. It is not an “argument from authority” because the guy I quoted above has actually done research on Paxil for children and found that there is no evidence to support its use. There has also been a successful lawsuit against GSK by the US Dept. of Justice for falsely promoting Paxil use in children. The company was fined $3 billion for, in part, promoting Paxil use in children/teens. (http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?_r=0)

Search for Study 329 for more information about the misinformation provided by GSK.

Paxil is not safe for children, in my opinion, because it does not provide benefits (this has been researched) and there is evidence to suggest that it increases the risk of suicide in depressed teens and children (this has not been thoroughly researched, but antidepressants now carry warnings about this).

The FDA has not approved Paxil for use with children/adolescents, neither has Health Canada or the UK equivalent. I don’t know about the equivalent agency in the Australian government (I’m not Australian).

To admit I have the same reservations, but I would like to point out you have to answer several other questions before you can make that blanket statement. reckless and no efficacy.

1. Does what he says about the research match with the research on paxil? otherwise it is just an argument from authority.
2. Is there good research in other drugs of that class in children?
3. What does that research say about safety and efficacy?
4. How long has the class of drug been used in children and what is FDA( or aussie eqiv.) feedback?

If all those pieces line up with an equal fail I think your point is valid. If it just opinion and scare mongering with children as a emotional component then no.

When he is a drug rep, he is paid to tell doctors the approved uses of the drugs he is selling, not his opinion or what the company would like him to be able to say.

If the drug companies are prepared to accept liability for off-label uses promoted by their representatives, rather than doctors, I’m sure we can come to a compromise, until then I suspect a mistake was made here and it will likely be successfully appealed.

I agree it may be a difficult position for a drug rep, but it is probably more helpful if the law is clear (no promotion of off-label uses) than some more nuanced position.

Vioxx was promoted off-label with Merck both ignoring FDA warnings, and withholding safety data. The story of Vioxx is shady from beginning to end, and highlights why such restrictions are a necessary safeguard and thus justify a restriction on the free speech of drug salesmen.

I have to disagree with you. It would be quite easy to regulate the off-label drug use – it is ‘off label”, not black market, illegal or clandestine. Regulation is a very complicated matter and there are many ways that the use of these drugs with children/teens can be controlled or even restricted. In my experience, general family physicians, who have no specialization in psychiatry or paediatrics, should not be prescribing psychotropic medication for children without knowing the efficacy of the drugs or the risks (which they often do). At the very least, these drugs should be prescribed only by a paediatrician or a child psychiatrist, someone with some specialized knowledge in the field. There should also be proper follow up with those specialists – what often happens is that a child will see a psychiatrist, who will write a script, but then ask the family physician to follow up with the patient. Again, that family physician does not have the expertise to understand how the drug may impact the child. Furthermore, it is common that group homes, youth jails and other facilities use these drugs in an effort to control children’s behaviours, when there are other means of controlling their behaviours that are more effective and less risky. Currently, there are few, if any, guidelines regarding off label use of these medicines for children. In my opinion, medical colleges and other regulatory bodies need to come up with standards of practice when prescribing medicines for children.

“The question is how much are the harms and do they outweigh the benefits? ”

If there is evidence to suggest that the medication is effective and has few risks, fine, prescribe the medication. The reality is, we either don’t know or we know they aren’t effective, but they are used anyway by people who don’t know what they’re doing. These drugs often aren’t tested on children or adolescents and, therefore, practitioners just assume that the drugs will do the same thing for kids/teens that they do for adults. Alternatively, they are tested but the results are buried by pharmaceutical companies (look up Study 329 for an example). Steve advocates for science based medicine. Off label use of a drug in this situation is not science based. There is some evidence to suggest that it can be harmful and, in some cases, contribute to the death of a kid/teen. We don’t know what impact these drugs may have on a child’s brain development, even though they are routinely used. We know more about the effect illegal drugs (i.e. marijuana) and alcohol have on child cognitive development, than we do about these commonly prescribed drugs.

This is an excerpt from the article I linked to above:

‘Australian child psychiatrist Jon Jureidini, who has extensively researched Paxil’s safety and effectiveness in youth, said, “none of the antidepressant trials in children show any clinical advantage of the drug over a placebo. The ones that claim to have (shown such an advantage) have all got flaws in them, either scientific or in the way that they’re presented. That means we have no evidence at all to support the use of antidepressants in children.”’

“Because a lot of off-label use is beneficial and I posit that completely removing it without any other fundamental changes in how we do things would be a net detriment to peoples’ health and well being. ”

I never advocated for removing off-label drug use. Steve was talking about areas in which it can be helpful – where there is evidence that it is helpful. My wife was prescribed domperidone (a drug banned in the US by the FDA) – it is a stomach medication that prevents nausea – but they accidentally found out that it increases breast milk production (an off-label use), which is why my wife took it. I just think that off label use is reckless in the case of children receiving psychotropic medication, especially when we know that certain drugs have no efficacy with young people.

“Pharmaceutical companies spend nearly twice as much on marketing in the U.S. as they do on research and development (R&D)”
Gagnon, M. A. and Lexchin, J. (2008, Jan) The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PloS Medicine. http://medicine.plosjournals.org/perlserv/?request=get-
document&doi=10.1371%2Fjournal.pmed.0050001

Is this a judicious use of resources?

Problem 2: Some would argue that you spend as much time arguing over the facts as beginning the conversation. Destroying any benefit of them being exposed to the new treatment.

Problem 3: It is marketing not education. The greatest resources are behind new drugs. Biggest unknowns, risks, and expense. Good upside for company not patients. There is no drive to market proven treatments with a less favorable bottom line. Everyone knows what the “purple pill” is due to great marketing but how many people still are on it now?

Problem 4: You and I spend a lot of time money and education to stay current in medicine. Is it realistic that a consumer can learn anything useful in a 60 second TV spot other than the tag line.

I do not think that you can justify the money the US has spent on pharm in the last decade without considering the cost of marketing. I can think of several ways to better educate my patients about new treatment options other than antonio banderas voiced bee marketing. Or the 2007 zoloft commercial that asked the question have you ever had a bad day, or felt down.

You can easily argue that it begins the discussion with you doctor or starts the patient looking for treatment. I give you that, but is it cost effective?
In my opinion no.

Nobody here is arguing for a broad or blanket acceptance of just any off-label usage. We are arguing that evidence based off-label usage is an important facet of quality patient care.

Of course that requires some extra work and intellectual honesty on the part of the prescriber, as well as some sort of evidence base to work with (which, as we have seen thanks to Ben Goldacre is tougher than we had hoped). So of course there is opportunity for abuse as well as mistakes.

But citing evidence of abuse of off-label use does not negate the fundamental principle and rationale for it. And citing evidence of mistakes being made doesn’t either. We fully recognize it is an imperfect system and no physician around these parts would like anything more than a robust set of data for all drugs for all indications in all populations. But that is simply impossible to do.

Perhaps off-label use in children, particularly with psychotropic agents, is something over-abused and much more likely to mistakes in usage. In fact, I think that is an entirely reasonable argument. The question is how much are the harms and do they outweigh the benefits? One needn’t elucidate the precise outcomes of specific drugs in pediatric populations to do a good study demonstrating that we should exercise more caution and decrease off-label usage in [children in general, psychotropics in children, etc] and thus change the culture of usage to reflect this until we have better data to fill in.

But merely saying there should “be more regulation” of something that by definition can’t really be regulated (that’s why it is called “off-label” after all) without offering some ideas for an alternative is a non-starter.

Perhaps something like what Dr. Novella proposed where the FDA (or pharma co’s) can aggregate lesser evidence to provide a framework to better rationally direct off-label use. Couple that with a general admonition that children are a special population for whom these ideas apply less and that may be a reasonable solution. But until we are much better at what we do, have much more resources to devote to it, and a population with priorities and desires in line with it, I don’t see a fundamental shift in how it is done to be reasonable. Because a lot of off-label use is beneficial and I posit that completely removing it without any other fundamental changes in how we do things would be a net detriment to peoples’ health and well being. I could be wrong, of course.

“It’s always ridiculous to see someone make some rant against the value of free speech while they are running their mouth on the Internet. Apparently, by your own brief description of “lack of action”, your opinion conflicts with what the government has decided. And yet nobody is silencing you over it! You must be one of that tiny minority.”

I wasn’t talking specifically about speech and never said that I was being silenced in any way. It’s always helpful to read what people have written, then say rude things about them running their mouth.

My point was that bad public policy that benefits very few people has been put in place in the name off freedom, but it’s all bullshit. E.g., let’s look at your completely incorrect reading of what I said about climate change. Climate change is not being dealt with, in large part, because the necessary policies would infringe on our freedom, which is absurd.

The Wall St collapse was in large part caused by a lack of regulations, of course in the name of freedom. Capital requirements or reinstating Glass would be tyranny! Instead, we’ll just crash the global economy – but we’re free to do so!

But none of these things are really about freedom for 99% of people – they’re druthers that are completely non-applicable to the average person. Yet the exercising of these freedoms for the few by the few costs us all dearly.