To Promote Off-Label Or Not Promote Off-Label
40 CommentsBy Ed Silverman // December 18th, 2007 // 9:42 am
Scott Gottlieb likes to kick up dust. A former FDA deputy commish, who is a trained physician, resident fellow at the American Enterprise Institute and consultant to Novartis, wrote an Op-Ed in The Wall Street Journal yesterday in which he skewered the federal government for branding off-label promotion a speech “crime.” In his view, such activities may really be a public service.
In presenting his argument, he cites a case two years ago in which Lilly pled guilty to a criminal indictment and paid $36 million in fines for promoting studies that its Evista cancer drug could prevent breast cancer in post-menopausal women. Back then, Evista was approved only for treating osteoporosis, not preventing cancer, he noted. But three months ago, the FDA approved the drug for use against breast cancer (FDA statement here).
Such episodes rile him to no end. In his view, doctors are being told they can’t be trusted when given off-label info without FDA supervision. And patients, ultimately, suffer the most because their docs are denied access to info that can be significant for treating people with, say, cancer. “Efforts to confine patients and doctors to FDA-approved uses have their own health consequences,” he writes, “raising the question: Just who is in the best position to make these hard choices?”
Of course, Gottlieb is correct that big money is involved. The federal government has collected nearly $12 billion in fines by prosecuting health care fraud over the past decade. And drugmakers have impetus to settle - lose in court and you may lose the right to sell to Medicare.
Still, off-label promotion can be troubling. Some studies, at first blush, can appear revelatory but fail to hold up over time. And of course, a drugmaker may tout studies selectively. There may be commercial free speech rights, but what happens when promotion goes too far? Gottlieb suggests that society would benefit if this practice was unchecked. But what do you think?
Has the federal government gone too far?
- Yes (55%, 58 Votes)
- No (45%, 47 Votes)
Total Voters: 105
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Lisa Van S
Dr. Scott must have forgotten his oath,. The one that states, “First Do No Harm”. He must enjoy the comforts of the AEI….Maybe he should consider opening up his own Practice. Maybe, Then, Hopefully,..reality will sink in..
Atlex
Ed,
What is interesting to note is that only Pharma is restricted from off-label “promotion.” Health plans and state Medicaid programs have no problem promoting off-label uses of some meds when it suits them (ie, when it saves money). In fact there are cases where a pharma company has been successfully sued regarding off label use in government programs, only to have state or health plans “prefer” off label use once the product is available as a generic.
Atlex
Lisa Van S
Atlex,
Is it true that some States prohibit off-label prescribing?
James
Yet another case of well-intentioned government regulation to limit evil corporations that ends up hurting consumers.
If you have a doctor that you trust, you want him/her to have access to as much information on treatments for your condition as possible.
Do you then expect your doctor to independently find and read every journal and every study as soon as it comes out? Pretty unrealistic expectation if you also expect you doctor to see you and other patients, and then deal with the pain of getting reimbursement from Medicare and private insurers.
So why not have drug reps bring in study results and journal reprints? If you have a doctor worthy of your trust, then he/she will be able to see through any promotional b.s. and evaluate the content of the study for what it is. And, based upon many of the comments I see here from self-proclaimed M.D.’s, I think that is likely true–it seems many doctors have a, erm, healthy skepticism towards what drug reps have to say.
Of course, if you don’t simply trust your doctor to give you what is best, as an informed patient, you probably seek out information on your condition anyway, and bring it to the doctor. Interestingly, because of the current limitation on off-label use communication, it is these knowledgeable, resource-seeking patients who are more likely to gain access to novel and cutting-edge treatments, as they know the products and are asking their doctors for said treatment.
As a result, those who are not as aware of treatments are receiving less advanced care. Once again, the disadvantaged suffer thanks to government regulation.
Chris
What makes you think you can tell which studies are independent versus which are not? Some are obviously biased but others are much more subtle. Publication planning gets a great deal of attention already - what studies shall we conduct to improve our ability to market this drug? I still see journal articles without appropriate disclosures. Also, what makes you think that sales reps will provide fair balance or distribute the pieces that may not be favorable for a given use? So a sales rep provides 10 journal reprints, all favorable. Is a doctor then going to go on his own and see if there are other studies which don’t come to the same conclusion?
Also, where does that leave a pharma company with any incentive to conduct the relevant clinical trials?
Lisa Van S
Check out these Sales Rep. MEMOS
http://www.paxilharmschildren.com/13.html
http://www.paxilharmschildren.com/15.html
Should the consumer feel confident?…..
Atlex
Lisa,
States cannot prohibit off-label prescribing. Essentially, physicians can prescribe any approved drug for any indication. Reimbursement, though is another issue. By law, the definition of a coverable drug for Medicare and Medicaid include FDA approved indications, listing on any of a number of compendia, or 2+ clinical studies in profressional journals (though the latter only works in Medicaid and Medicare Part B, but not for Medicare Part D). States can limit reimbursement by having preferred drug lists, but cannot limit prescribing. Commercial plans have more discretion regarding reimbursement.
Atlex
Lisa Van S
Atlex,
Thank You for clearing that up for me, I appreciate it.
ol cranky
It’s easier to get a prescription that a patient takes on their own at home and is on formulary reimbursed; though some times the physician does have to call to justify the prescription. The bigger fights (and bigger violations by companies) come with expensive meds and injectables.
Companies get insurance companies to reimburse for off-label use by providing data, case reports and published studies that appear to show efficacy and safety. Up until recently, I believed that all of these were legit. Unfortunately, it appears as though many of those case-studies were situations in which the manufacturer provides free samples and sometimes pay a physician to treat off-label and publish data from a non-compliant “clinical study” as a case study/case series and/or go to the insurance company to provide data and justification for insurer to reimburse for the indication. They also present all of the positive data from “investigator sponsored” clinical studies most of which are paid for completely by the manufacturer (the amount of money paid is frequently above UCR for a study and, when the budget for the study indicates payment for physician/staff time instead of for study procedures, patients or the insurers may actually have been billed for study visits.
Dan
Off label use of some meds clearly have benefits. The risks, however, is when there are meds out there that are possibly approved for certain disease states that have a clear benefit based on studies performed to receive such an indication for this. Off label use of meds, arguably, do not have the clinical data to back up such use, in many cases.
BP Watch
This is an absolute joke!! Dr. Gottlieb should completely rethink this position, but perhaps he has been paid a huge amount of money by Big Pharma to be their puppet. Perhaps he can still look at himself in the mirror, but he must have little conscience. The problem is not with physicians knowing the most up-to-date data and deciding to try an available drug for another condition. That is their professional judgement. THE PROBLEM IS WITH SALES REPS FROM BIG PHARMA RUNNING AROUND AND UNABASHEDLY PROMOTING A DRUG FOR AN OFF-LABEL INDICATION AND POTENTIALLY RISKING PATIENT SAFETY. Drugs are not without side effects, and some are very dangerous. To listen to a sales rep and promote off-label because they say so is almost equivalent to malpractice. Physicians are ethically bound to know the data themselves and “first do no harm.” When I first read this, I asked “What is the matter with this guy?” Now I realize that he’s sold out and is in Big Pharma’s backpocket! Absolutely disgusting! He’s abandoned his profession for the almighty dollar!
Nathan
If the FDA would loosen up thier criteria for getting drugs approved, maybe this would become a non-issue.
James
BP Watch, I’m confused–maybe you can clear something up for me. In your words:
“The problem is not with physicians knowing the most up-to-date data and deciding to try an available drug for another condition. That is their professional judgement.”
Also in your words:
“THE PROBLEM IS WITH SALES REPS FROM BIG PHARMA RUNNING AROUND AND UNABASHEDLY PROMOTING A DRUG FOR AN OFF-LABEL INDICATION AND POTENTIALLY RISKING PATIENT SAFETY.”
Wow, that was loud.
Anyway, if doctors have no problem knowing the up to date data, and if they use their professional judgment, what does it matter what sales reps say? They can’t go direct to the consumer and write them a prescription–the doctor has to do it.
Seems like you acknowledge that doctors are an effective firewall between drug company and patient. So where’s the problem in off-label promotion?
TOdd
you guys realize half of rx’s written are technically off-label, right? I will post the link when I find it online but read it in the APhA journal this year.
so the answer is to not treat and let pts. suffer?
Cheryl-Anne
I guess the big issue here is where does one draw the line? If Off-label promotion is a good thing then how do we entrust safeguards to stop the abuse of off-label use? Doctors need to know, preferably from their peers, potential off label use that may help patients. How far do we let this go? What sort of clinical data will back any of this up? Now, if off label use is allowed, what protection do patients have?
So, I can clearly see where off label promoting could be beneficial at times for patients. I just do not understand how we would manage this and still keep the integrity of clinical trials, and FDA and regulatory processess.
Interesting,
Cheryl-Anne
TOdd
It really doesn’t matter if reps are promoting - keep things the way they are. No doc listens to reps, and if they tried to do any off-label selling they would have absolutely no credibility. Now the industry can’t take that position because that is admitting the army of reps is/was a mistake. But with all the new faces, no relationships, no trust there aren’t many docs that will listen.
It would actually influence much more if the doc found the info on their own in a journal — now that’s what drives scrips. The doc can always request off-label information from the medical affairs dept. They are allowed to provide requested off-label info, and that looks much more credible as well versus an off-label pitch by a rep.
BTW — off label use of any med is allowed and rampant. I would bet each one of us has been treated off label at some point this year.
Lisa Van S
TOdd
I would bet each one of us has been treated off label at some point this year.
I haven’t….
TOdd
When you were cured of Lyme’s disease ….. you WERE.
AV Block
Government regulation obviously affects the adoption of new technologies. It is important to recognize that these invigorated efforts to curb off-label usage have potential adverse consequences on the speed of innovation, particularly in areas of unmet medical need. Before proceeding to attack drugmakers and the autonomy of physicians, the government needs to measure any “side effects” of these efforts. I doubt that the government has properly assessed the potential adverse consequences. As such, it is more likely than not that its actions are motivated primarily by short-term political interests.
Lisa Van S
TOdd,
No I wasn’t…. and actually,..have had nothing prescribed to me this year. I know its rare, but some of us dont have a medical need to take Meds on a regular basis.
If you know of a cure for Chronic Lyme Disease, please share, their are a lot of Patients out there who would love to be cured..
Jack
The only way to “do no harm” is to do nothing. Some things first thought of 2,000 years ago may require some reconsideration.
Second, off-label use will not go away. For example, some cancers are so rare that no company will invest in FDA approval. Do you tell those patients to go home and die, or do you take the best available information and formulate treatment from there? As stated, docs can proactively ask the rep to have a companies medical group send them any info - in writing.
ol cranky
Docs can also obtain lit on their own. They’re more likely to find a mix of data if they do their own search whereas I highly doubt any manufacturer will provide a publication containing negative data when asked to provide literature regarding a non-approved indication.
Outside the Box
What a conundrum. The people who don’t trust the industry say “no” to off-label, but the industry knows that no off-label severely limits opportunities for innovation. Reimbursement usually restricts off-label, but codes are gamed in any event so who knows what is really going on, and FDA can’t agree to off-label promotion - or what are they for?
What about a system that allows pharma to inform physicians about off-label data without using reps and other poorly controlled mechanisms? Just a thought, but couldn’t we allow pharma to send info to physicians (by well marked mail maybe - not sure about the medium)with additional information about drugs that already have an approved indication? The information could be screened by a new division of the FDA (called the OLDUA - Off label Drug Use Administration) which would be funded by fees paid by pharma for the service. The OLDUA would not be able to prevent any information passing to physicians but would have the authority to validate the source of the information. So the message to physicians would be “this is info on using Lipitor in early onset dementia patients; the big study was funded by Pfizer, but the two smaller studies were independent” (maybe even a comment on statistical reliability but certainly no interpretation. The pharma company gets to send the info they want to send, physicians keep up to speed with the latest developments on existing drugs, FDA has a role in validating the data - and no nasty reps or adverts are involved.
I am sure there are some other ways of doing this, but as an industry we have to get past all this name-calling and bad-mouthing and start to come up with workable solutions - before the really nasty Government does it for us.
TOdd
Lisa, I guess everyone with lyme’s will have to suffer — no labeled treatment for it, no market for pharma to research. now lot’s of evidence with some success on different regimens, but since not FDA approved I won’t waste the space
TOdd
ol cranky — you have not worked in a med affairs dept. you would be surprised what gets sent out. doesn’t always make reps happy
ol cranky
Outside:
Pharma uses regional medical directors and MSLs to discuss off label use. How well those avoid promotional activity depends on the pressure exerted by the company and the scruples of the RMD/MSL.
I don’t think anybody has a problem with a physician objectively evaluating use to treat off-label, the problem lies in how pharma companies manipulate the interest and what data is presented/is available. If a physician is truly interested in reviewing literature of a drug’s use in a non-approved indication, I don’t see why it is considered such a hardship for the physician to conduct a lit search on pubmed and obtain the literature him/herself. This way, we know the interest hasn’t necessarily been prompted by the manufacturer’s promotion or manipulated by the choice of what literature is provided. My concern is that the manufacturer supplies the lit they want to provide and then a company employee essentially feeds the interpretation to the physician. I’m also concerned that publications do not accurately reflect support received by manufacturer’s of the product (or, in some cases, support from the manufacturer of a competitive product). In many other countries, independent research must be completely independent of any support from a manufacturer; due to the insufficient independent grant funding, the same is not the case in the US.
TOdd
ol — when is the last time you worked in a medical affairs dept.? Otherwise your views don’t really hold any weight to a guy who has written those responses and managed MSL’s.
What makes you think that all docs have access (or time) to every journal that might have published an article on a drug?
So give me your credentials, and we can compare notes on how ethical companies do things.
In other countries they do a lot of things. Including raising taxes so an inefficient gov’t can do research. I feel as if companies do a better job than the gov’t — but if you would rather save the insurance company $10/rx due to lower prices and pay significantly more in taxes for an independent research arm, fine by me.
Lisa Van S
TOdd,
Nice job,.. You have done your homework.. Have a Solution?..
BP Watch
James,
You must be a Big Pharma rep. As such, you can’t be trusted to do the right thing. If they could be trusted to accurately represent results, then there wouldn’t be any problem. Unfortunately, they’ll promote data from pre-clinical and undersized studies from obscure journals as truth! Perhaps not all, but most, will sell their own mother for an extra product sale. They will say ANYTHING to get the docs to write the scripts. There are rules, regulations, and policies that need to be followed. Some are called LAWS. Of course, Big Pharma rarely follows the law.
Again, the problem is not the docs writing off-label, the problem is with corrupt Big Pharma reps telling them to do so!
BP Watch
MDMD
Todd,
Docs may not listen to the reps, but they accept their lunches, dinners, and consultant fees that are designed to get close to the docs and influence their prescribing habits.
MDMD
TOdd
MDMD,
I have NO control over that. That isn’t my area. This is, I had a strong opinion on it and expressed it. What sales does is way out of my control. I am responsible for providing credible information to the request of practicing physicians. BTW - there is strong FDA oversight of everything we do, period. There are even random audits by the agency without notice. You can say what you want about the FDA, again not my responsibility.
This is just like at home, I can only control what I am directly responsible to do. My company follows the rules laid out and as a HC pro, I ethically do the right thing all the time - PERIOD.
Lisa,
I am sorry I don’t have a sol’n. I actually trust the majority of docs to do the right thing. Do their homework, find the right information and appropriately treat. You do have to remember that medicine is truly an art - there are very few black/white issues and no one comes into the office with a sign above their head telling you what is wrong with them. Are there bad docs out there? Yes, just like everywhere else in the world. Would they practice poorly even if they didn’t accept lunches, etc from pharma? My guess is Yes as well. A bad doc or ethically challenged doc isn’t going to change to a model citizen just because a guy making $200,000/year didn’t get a $5 sandwich.
CVMD
All,
Are there truly ethical drug companies? I doubt it! I’ve worked in Medical Affairs and the pressure to approve commercially-oriented information is incredibly intense. If you don’t, you’re labelled as an obstuctionist and a bad fit. Next thing you know, the pink slip arrives because you won’t rubber-stamp the tactics of commercial.
Unfortunately for MRDs/MSLs, they are frequently pushed and pushed by the company to be “super reps” and only say what commercial wants them to say. They’re expected to ride with reps and parrot the company message. if they don’t, then they’re labelled as ‘no good” and ineffective because they don’t drive sales in their region. In fact, many companies evaluate their performance by drug sales.
Big pharma needs to be set straight by the government. Whether it’s Congress, the FDA or the OAG doesn’t matter. They are corrupt money-hungry corporations who care little about patients, and are driven solely by their earnings and their stock price.
There’s liars, d%$&mn liars and Big Pharma liars. The latter are the absolute worst, because patient safety is at risk! See SP, MSD, GSK, AZ, Lilly, JNJ and many others recent news articles - most of them report wrongdoing in some way or the other!
CVMD
MDMD
Todd,
If you’re able to maintain your morals and ethics within a Big Pharma company, then you are truly in a unique company. I’d advise you to never leave, because you are not likely to find another company where you can do the right thing. I’ve worked at two of the Big Ones and they were both as crooked as a ram’s horn. My personal ethics were compromised almost every day. Off-label was viewed as “free speech” and “encouraged” by commercial management. Just don’t get caught! Then they’d fire the rep “to make him/her an example of how they deal with non-compliance” and go on to commit it again.
MDMD
Lisa Van S
TOdd,
This may suprise you,..I agree with what you say. Fortunately,. I have the financial resources to provide the best medical care for my family, unlike the majority of others.
ol cranky
Todd:
Up until recently I was a hard core clinical development person, who summarily rejected many of the accusations against the industry. Over the past few years, however, I worked in Medical Affairs which has exposed me to amazingly egregious compliance violations related to off-label promotional activity, off-label sampling and not so independent research. I would love to think that the reason my company is so very sleazy is because we have unethical senior leadership and it’s a small biotech, but the physicians with whom I’ve spoken have indicated that our competitors are equally sleazy with regard to pushing off-label uses.
I also have to note that, having worked across multiple therapeutic areas, CNS seems to be the area in which medical affairs & sales take the most liberties.
TOdd
ol cranky,
it is too bad you have worked for the wrong people.
If you want to stay in the industry, are a doctorate level practitioner let me know. I can personally vouch for 3 companies that are incredible. In each, I at the very least know the med director if not higher up and all are great people at great companies that would never ask you to compromise your ethics/values. If you are nonHC - which I suspect, I can’t help you. I think that sales/marketing people should be very well separated to prevent any influence from those without clinical backgrounds.
So let me know if you are a doc, your specialty and area of the country and I will provide you some contacts.
MDMD
Hi Todd,
I’m an experienced physician who would love to hear about companies where ethics and integrity are valued. Lots of places say that’s what they want, but there just as bad as everyone else.
Thanks in advance.
MDMD
Ex SP
All,
I saw my previous company blatantly promote off-label and claim that it was their right to free-speech to do so. They put it in their business plans and carried it out without warning - with drugs that have serious side-effects. The goal was money, more money and still more money. They didn’t care one bit about patients and what they might suffer. It was absolutely disgusting and personally made many of the people with integrity very sick. They got rid of any objectors and laughed all the way to the bank.
Typical Big Pharma - rotten to the core!
TOdd
MDMD,
Let me know your specialty and location. If interested I will give you my generic e-mail address and I can put you into contact with the correct people.
TOdd
What was the drug and claim? Very interested