ATTENTION PHYSICIANS!
This is a call for an immediate Rozerem prescription boycott!
This is a call for an immediate Rozerem prescription boycott!
Dear Doctor:You undoubtedly are aware of the sleep aid drug Rozerem marketed by Takeda. The company's sales representatives surely have paid you many visits extolling the so-called virtues of Rozerem. You may also have seen the big "Zero" logo at meetings and in print ads (if not, see "Rozerem Sleeper Cell at Pri-Med Conference").
But you may not have seen recent Rozerem DTC reminder TV ads that Takeda has run in violation of its pledge to abide by PhRMA's Guiding Principles for DTC Advertising, which specifically bans reminder ads on TV (see "Rozerem Reverts to Reminder TV Ads"). As you may know, reminder ads mention the drug name but do not mention the indication or side effects.
In addition to that questionable behavior, Takeda also received a Notice of Violation letter from the FDA that said some of these ads were aimed at children and were not reminder ads at all and should include side effect information (see "Back to School for Takeda, Rozerem, and Abe Lincoln!").
The worst offense, however, is Takeda's claim that no one in the company was involved in the "approval, release or broadcast of the advertisement in question" (see "Takeda Borrows Cephalon's Excuse for FDA Warning Letter").
I am sure that like most people, you find that excuse hard to believe and, if true, it must give you pause. That is, either Takeda is not trustworthy -- it lied -- or it is incompetent.
I am asking you, therefore, to refrain from writing prescriptions for Rozerem in protest. There are several other alternative drugs available for the treatment of your patients with insomnia.
The next time you see a Takeda sales representative, tell him or her that you are boycotting the product until you are assured that Takeda takes the necessary steps to (1) determine who in their company and/or ad agnecy was responsible for the violative DTC ads, and (2) terminates the employment of the responsible employee or cancels the contract of the responsible ad agency.
Only you have the power to make Takeda comply with FDA regulations, PhRMA DTC Guidelines, and minimal industry ethical standards. FDA and PhRMA appear to be ineffectual in this regard.
Sincerely,
John Mack
--------------------------
This grassroots boycott needs your help:
- Join the call for a Rozerem Rx boycott by posting the "Dear Doctor" letter on your blog or web site. You can also use the logo if you want.
- Ask your doctor if a Rozerem prescription boycott is right for him or her.
- Take the following poll:
I don't know, this seems a bit overboard to me. If there were some hidden danger, false claim, or other drug-related issue that was being suppressed, I'd say yes. But in this case, the ad is relatively harmless and already falls under the FDA's/DDMAC's/et al's purview.
ReplyDeleteI'm not saying there was no wrongdoing here, as there certainly was, but not something that rises to such an extreme level. Even taking the most cynical view of it, it's sneaky, but not dastardly. But that's just my humble, naive opinion.
I appreciate your point of view.
ReplyDeleteThe industry, however, is the first to defend "market forces" as the corrective measure for companies that are unethical or that make blunders. I am simply calling upon those market forces -- ie physicians prescribing preferences -- to come to bear upon Takeda to teach it a lesson.
The FDA's hands are tied here. They can write a letter, but can do virtually nothing else.
PhRMA has no mechanism for enforcing its DTC guidelines other than issuing a yearly report that doesn't even name names!
Takeda's disregard for both voluntary guidelines and FDA regulations hurts the whole industry.
Moreover, Takeda's competitors will feel the urge to play on the same field. We should not allow Takeda to define where the out-of-bounds lines are.
Ah, I thought DDMAC had the power to levy fines.
ReplyDeleteIn that case, I'm still not sure boycotting the drug is the right avenue, since you could theoretically be denying the drug to a patient who needs it out of spite for the ad campaign, which doesn't sit well with me. (Obviously there are alternatives, but I think you understand what I'm saying.)
Instead, I'd say they should bar reps from offices and hospitals, and contact the FTC, which if I understand correctly, can impose fines.
You're being specious here. Market forces are defined as those acting in a natural manner -- e.g., the market defines whether a product will live or die. Calling for a boycott is the exact opposite of market forces at work. That's an unnatural, third-party influence trying to upset the natural balance of market forces. Not that there's anything wrong with it, just that this is not an example of "market forces" at play.
ReplyDeleteSecond, if doctors' first interests are for their patients health and well-being, they would not accept a boycott as being ethical. One does not deny a specific treatment for a patient that is medically appropriate for political reasons. Well, you can, but whether that's very ethical is an interesting question (e.g., doctors who refuse to prescribe birth control). Doctors shouldn't make prescription decisions based upon political, religious or moral grounds, but rather only on medically-relevant grounds.
Yes, companies should do what they say and say what they do. However, I'm far more concerned about companies who do something that actually could harm an individual than a stupid reminder ad that has little influence one way or another.
Speaking of "unnatural, third-party influence trying to upset the natural balance of market forces", take a look at another Rozerem ad trying to disguise itself as a news story:
ReplyDeleteRead the USA Today "story" here.
: )
ReplyDeleteIf DDMAC is not in a position to levy any fines, why are we even bothering to submit to the FDA to begin with? Isn't it OIG that should come knocking since this is such a "violation" of off-label promotion? If not, I am not going to pull my sales reps off the street nor my ads off billboards promoting Zyprexa or Seroquel to peds.
ReplyDeleteDDMAC can seize the inventory of a product, ban its continued sale, and demand corrective advertising. OIG will only get involved if there is a direct violation of Federal Law.
ReplyDeleteWhen was the last time that happened?
ReplyDeleteI am learning DTC rules and am still navigating my way through FDA regulations so please pardon my ignorence.
ReplyDeleteFirst off, pharma companies must adhere to the policies set forth, it hurts the credibilty of DTC advertising when they bend the rules
Rozerem violated responsible DTC advertising, can they be fined? I think I'm confused on the actions that are allowed to be taken.
Speaking of FDA/DDMAC... (well, not DDMAC really)
ReplyDeleteJohn Mack may have gotten his wish. Today, the FDA slapped the whole class of drugs with harsher warning labels.
See FDA press release: "FDA Requests Label Change for All Sleep Disorder Drug Products" at:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html
While this has been in the works for a while, it was fast-tracked after the Takeda snafu.
I just read this again. To my knowledge, the last time DDMAC demanded corrective advertising was Amgen's Enbrel.
ReplyDeleteReply to Pharm aid:
ReplyDeleteYou are mistaken. This was NOT my WISH -- it was my prediction!
This is precisely why the industry has to nip the bad apples in the bud more pro-actively to show the regulatory agencies that it can police itself.
I haven't read about the FDA action yet -- I'ma ctuall on vacation for a few days. but when I return, I will no doubt have more to say!
Reply to anonymous on fines:
ReplyDeleteThe FDA cannot levy fines. They can take the extreme action of pulling the approval for marketing which takes the drug out of circulation.
PhRMA -- the industry trade group -- has guidelines with no teeth - they don't levy fines. However, the drug industry trade group in the UK can and does levy fines against its members for violations.
So when people talk about companies being fined for materials or congress booths for being in violation of a particular rule, which agency is doing the fining?
ReplyDeleteI don't know what people you are talking about, but they are likely to be mistaken. FDA doesn't fine -- it sends warning letters to cease and desist.
ReplyDeleteI think you have way too much time on your hands. The very fact that you know nothing of this drug and decide to BOYCOTT it just shows your ignorance for a safe product that could potentially save your life. The elderly, someone such as yourself, that doesn't sleep needs a safe sleep medication which does not impair your stability or balance throughout the night when you have to get up for a drink of water or use the restroom.
ReplyDeleteYou are either misinformed or uneducated as to the processes of the FDA and the benefits that this product has for milliions of people. Next time you decide to start a campaign against something, make sure that your are informed and not just a person out to cause problems.
Thanks for your comment, NOT!
ReplyDeleteI don't know whether to laugh or cry at your joke regarding sleep aids saving lives! I'd hate to kill myself jumping out of bed for a drink of water! Or sleep driving while on Ambien, for example. Maybe if Rozerem had ads that assured us that those kinds of things would not happen while taking their product, then I might be impressed.
Instead, the marketers violate not the FDA regulations, but their own pledge to do responsible DTC advertising. On top of that they claim no responsibility for ads cited by FDA as violative!
Takeda is just not a trustworthy company, which cannot be trusted to keep its word or own up to mistakes regarding advertising. If it can't be trusted with that, I cannot trust its products either!
Once again you are speaking to something you are not educated about. Falls and fractures are the #1 cause of death in the United States for the elderly. Not to mention 100,000 automobile accidents are caused each year by sleepy drivers, most of them insomniacs.
ReplyDeleteOn top of that, if you had educated yourself on Rozerem, you would understand that it does not work in the part of the brain that causes sedation and amnesia. Instead, it works on your SCN where the sleep/wake cycle is located, thus not causing side affects such as SLEEP DRIVING! Rozerem is a completely different type of medication than Ambien.
Finally, WHO really cares if YOU can't trust a company due to advertising. That is your opinion and you are entitled to it. However, next time you might try educating yourself before writing something that you have no experience nor education about.
I sure hope you never have sleep problems! You will just have to deal with them and hopefully you will not become a statistic.
Thanks for making these Rozerem benefit statements. You should hire yourself out to the Rozerem ad people who also seem to be "speaking to something they are not educated about" because if they were, the Rozerem ads would tell us everything you mention.
ReplyDeleteInstead, they show beavers and blue jackasses. BTW, there are NO elderly people in their ads at all. Did you notice that?