Bush sop to Big Pharma: Reps sell docs on unapproved applications

More eleventh-hour bullshit: The FDA says that pharmaceutical companies can promote their products to doctors for unapproved uses. 

Why spend all that money on research to prove that drug X works on disease Y when you can just sell it as if it did? So much for pharmaceutical companies advancing medical science. We're regressing to the snake oil era, here. 

I mean, companies still have to show that the drug is good for some condition or other. But once you get it approved for depression, you can start marketing it for Parkinson's or psoriasis or some other niche the marketing department identifies. 

Comments

[Joe Wurzelbacher]

I think researchers should be abolished from, uh, you know, researching.

[Mandos]

While I wouldn't trust or allow pharmaceutical companies to do this in marketing, I'm wondering what your position is on "off-label" prescriptions of medication by doctors. Should prescription simply be targeted to precisely what the FDA suggests?

[Lindsay Beyerstein]

Individual doctors should use their judgment based on standards of care, the costs and benefits of the particular disease/drug in question, and above all, controlled clinical trials.

Pharmaceutical companies are advertising and marketing. Commercial claims should be regulated stringently for accuracy, especially on potentially life and death matters like these.

[Mandos]

So, in these discussions it often seems like either one is in favour of current institutional practices, or one is a total altmed freak. I realize fears about the exploitation of patients, but I'm a little dubious about such firm faith being placed on the controlled clinical trials system, etc. For many diseases, particularly rare or incurable ones, especially those where the origin and progression of the disease is very different for each patient (many cancers, for instance), it seems a little glib to say so firmly and confidently that one should play by the standard rulebook.

[Jen]

Argh, typed in a gorgeous long explanation of the system last night and for some reason it got eaten. Will try to repost later today.

[Lindsay Beyerstein]

You don't have to take a position on alternative medicine to say that if you're going to advertise and take people's money for product X, you'd better have some proof that X does what you say it does, and safely. That's true for vitamin C or Prozac or melatonin, or whatever.

[parse]

If the drug is approved by the FDA, are advertising claims still subject to scrutiny by the FTC? Does this policy change mean that drug companies are now held to the same truth-in-advertising standard as other companies or to no such standard whatsoever?

[parse]

The linked story implies that that promotion newly allowed is that drug companies "may distribute copies of medical journal articles that describe unapproved uses." Are the publication practices of medical journals loose enough that if a drug company's marketing department identifies a niche to which they would like to design promotions, they are assured of finding a medical journal that will publish an appropriate article they can use to pitch the new use for their product to doctors?

[Mandos]

You don't have to take a position on alternative medicine to say that if you're going to advertise and take people's money for product X, you'd better have some proof that X does what you say it does, and safely. That's true for vitamin C or Prozac or melatonin, or whatever.

If we're talking about advertising as such, I agree. I was more thinking about this statement, which seemed to be an admonishment to doctors:

Individual doctors should use their judgment based on standards of care, the costs and benefits of the particular disease/drug in question, and above all, controlled clinical trials.

But perhaps I was misinterpreting it as a general statement. The reason why is that we're running into situations (such as in cancer) where the sort of incremental approach of clinical trials as constituted today may be too limited to exploit combinations of drugs that may offer some faint hope to the terminally afflicted. Instinctively I agree that pharmaceutical companies shouldn't be able to market untested claims, but I'm not sure we've perfected the standard of evidence yet.

parse's objections apply here. I realize that you have experience with the industry, but off-label unapproved/non-phase-III-tested uses of drugs seem to be more and more common and possibly beneficial for some patients if the doctors are made aware of the limited research behind them. Such as, eg, animal model studies, genes related across diseases, etc.

[ol cranky]

Individual doctors should use their judgment based on standards of care, the costs and benefits of the particular disease/drug in question, and above all, controlled clinical trials.

Pharmaceutical companies are advertising and marketing. Commercial claims should be regulated stringently for accuracy, especially on potentially life and death matters like these

As someone with > 15 years in clinical drug development, I can say Lindsay is 100% on target here. You have no idea how sleazy the industry has become in pushing off-label uses and the horrific excesses they go to paying docs to provide them with good news publications from poorly designed "trials" and skewed human(and extremely noncompliant) experimental use. This is very different from the adequate and well controlled trials that are performed to be able to get approval for an indication. [fyi - the worst transgressions are actually from small bio/pharma companies, not big pharma)

[Mandos]

Alright, but I've read of drugs and treatments being rejected after Phase III trials for not meeting a 5% confidence value, which seems a little perverse at times for some conditions. Maybe I'm just reading cranks or whatever, but while I recognize the potential for pharma abuse, I'm a little skeptical that trials needed for an indication aren't perhaps too arbitary or stringent.

While it's good to put a lid on vested interests, I'm just worried about throwing the baby out with the bathwater, so to speak.

[Lindsay Beyerstein]

Doctors can use their own judgment, or make the case to other doctors. I just don't think that drugs should be marketed for a specific indication without FDA approval. An indication is worth big bucks, not least because of all the expensive testing required to establish that it is warranted. If you let drug companies shirk the research and do the promotion anyway, the public is doubly short-changed.

The flip side of the confidence interval argument is that when there's no relationship between the treatment and the measure of efficacy, you will still reject the null hypothesis five percent of the time if p

Evan a statistically significant study in isolation is meaningless, especially when the sponsor is a
pharmaceutical company that could afford to fund 20 trials for every publishable paper. The drug company has a vested interest in declaring a paper to be good or good enough evidence to justify prescribing it. Theoretically, the FDA can be more dispassionate and evaluate a broader range of evidence.

Marketing a drug for an indication means sinking a huge amount of resources into changing the medical practice of physicians in general, or at least a big segment of the market. That's a much more serious proposition than a single doctor deciding on her own to prescribe a treatment for an non-approved indication. I'm not saying that every medical decision should be made by the same criteria that the FDA uses. Frequently, practicing evidence-based medicine at the level of the individual clinician means going with evidence that falls short what the FDA would require for an indication.

[Mandos]

The flip side of the confidence interval argument is that when there's no relationship between the treatment and the measure of efficacy, you will still reject the null hypothesis five percent of the time if p

OK, but if I'm understanding you correctly, then in some cases this is probably a worthy risk.

Frequently, practicing evidence-based medicine at the level of the individual clinician means going with evidence that falls short what the FDA would require for an indication.

Fair enough. But the flip side of this is that the FDA and its standards becomes the gatekeeper of what lines of research are pursued in the first place. This is a double-edged sword, and it means that extra care has to be taken in the design of the standards, and not everyone is convinced that it isn't possible to be too careful.

[cfrost]

Thalidomide.