tag:blogger.com,1999:blog-8550428.post2769188260681871603..comments2024-03-28T13:38:36.788-04:00Comments on Pharma Marketing Blog: Call for a Rozerem Prescription Boycott!Vladhttp://www.blogger.com/profile/04114063498108633047noreply@blogger.comBlogger20125tag:blogger.com,1999:blog-8550428.post-70884275413976564952007-06-28T07:11:00.000-04:002007-06-28T07:11:00.000-04:00Thanks for making these Rozerem benefit statements...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.<BR/><BR/>Instead, they show beavers and blue jackasses. BTW, there are NO elderly people in their ads at all. Did you notice that?PharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-37901130128414779862007-06-27T22:15:00.000-04:002007-06-27T22:15:00.000-04:00Once again you are speaking to something you are n...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. <BR/><BR/>On 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. <BR/><BR/>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.<BR/><BR/>I sure hope you never have sleep problems! You will just have to deal with them and hopefully you will not become a statistic.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-15273492725373329802007-06-27T07:00:00.000-04:002007-06-27T07:00:00.000-04:00Thanks for your comment, NOT!I don't know whether ...Thanks for your comment, NOT!<BR/><BR/>I 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.<BR/><BR/>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! <BR/><BR/>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!PharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-30806175550306745842007-06-27T00:16:00.000-04:002007-06-27T00:16:00.000-04:00I think you have way too much time on your hands. ...I 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. <BR/>You 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.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-36804814381940907072007-03-15T18:23:00.000-04:002007-03-15T18:23:00.000-04:00I don't know what people you are talking about, bu...I 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.PharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-92119707633107538932007-03-15T09:38:00.000-04:002007-03-15T09:38:00.000-04:00So when people talk about companies being fined fo...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?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-82869219715995240692007-03-14T17:23:00.000-04:002007-03-14T17:23:00.000-04:00Reply to anonymous on fines:The FDA cannot levy fi...Reply to anonymous on fines:<BR/><BR/>The FDA cannot levy fines. They can take the extreme action of pulling the approval for marketing which takes the drug out of circulation.<BR/><BR/>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.PharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-25471342581909857372007-03-14T17:19:00.000-04:002007-03-14T17:19:00.000-04:00Reply to Pharm aid:You are mistaken. This was NOT ...Reply to Pharm aid:<BR/><BR/>You are mistaken. This was NOT my WISH -- it was my prediction!<BR/><BR/>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. <BR/><BR/>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!PharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-51748829589613730092007-03-14T12:32:00.000-04:002007-03-14T12:32:00.000-04:00I just read this again. To my knowledge, the last...I just read this again. To my knowledge, the last time DDMAC demanded corrective advertising was Amgen's Enbrel.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-3146171057548745022007-03-14T10:46:00.000-04:002007-03-14T10:46:00.000-04:00Speaking of FDA/DDMAC... (well, not DDMAC really)...Speaking of FDA/DDMAC... (well, not DDMAC really)<BR/><BR/>John Mack may have gotten his wish. Today, the FDA slapped the whole class of drugs with harsher warning labels.<BR/><BR/>See FDA press release: "FDA Requests Label Change for All Sleep Disorder Drug Products" at:<BR/>http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html<BR/><BR/>While this has been in the works for a while, it was fast-tracked after the Takeda snafu.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-21207079345061522122007-03-14T10:21:00.000-04:002007-03-14T10:21:00.000-04:00I am learning DTC rules and am still navigating my...I am learning DTC rules and am still navigating my way through FDA regulations so please pardon my ignorence. <BR/><BR/>First off, pharma companies must adhere to the policies set forth, it hurts the credibilty of DTC advertising when they bend the rules<BR/><BR/>Rozerem violated responsible DTC advertising, can they be fined? I think I'm confused on the actions that are allowed to be taken.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-52119796618672077472007-03-14T09:28:00.000-04:002007-03-14T09:28:00.000-04:00When was the last time that happened?When was the last time that happened?PharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-66155273723976586012007-03-14T08:05:00.000-04:002007-03-14T08:05:00.000-04:00DDMAC can seize the inventory of a product, ban it...DDMAC 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.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-57475170827394011532007-03-12T20:10:00.000-04:002007-03-12T20:10:00.000-04:00If DDMAC is not in a position to levy any fines, w...If 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.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-69648209589649772007-03-12T15:15:00.000-04:002007-03-12T15:15:00.000-04:00: ): )High Power Rocketryhttps://www.blogger.com/profile/11537203640644706903noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-87330625601844997422007-03-12T14:54:00.000-04:002007-03-12T14:54:00.000-04:00Speaking of "unnatural, third-party influence tryi...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:<BR/><BR/>Read the USA Today "story" <A HREF="http://www.forums.pharma-mkting.com/showthread.php?t=217" REL="nofollow">here</A>.PharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-35924143383226483282007-03-12T14:43:00.000-04:002007-03-12T14:43:00.000-04:00You're being specious here. Market forces are defi...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.<BR/><BR/>Second, 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.<BR/><BR/>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.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-32679120781065815392007-03-12T12:44:00.000-04:002007-03-12T12:44:00.000-04:00Ah, I thought DDMAC had the power to levy fines.In...Ah, I thought DDMAC had the power to levy fines.<BR/><BR/>In 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.) <BR/><BR/>Instead, I'd say they should bar reps from offices and hospitals, and contact the FTC, which if I understand correctly, <I>can</I> impose fines.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-8550428.post-40793299174317698652007-03-12T12:03:00.000-04:002007-03-12T12:03:00.000-04:00I appreciate your point of view. The industry, how...I appreciate your point of view. <BR/><BR/>The 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.<BR/><BR/>The FDA's hands are tied here. They can write a letter, but can do virtually nothing else. <BR/><BR/>PhRMA has no mechanism for enforcing its DTC guidelines other than issuing a yearly report that doesn't even name names!<BR/><BR/>Takeda's disregard for both voluntary guidelines and FDA regulations hurts the whole industry. <BR/><BR/>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.PharmaGuyhttps://www.blogger.com/profile/10211557578124130640noreply@blogger.comtag:blogger.com,1999:blog-8550428.post-8055188431755390222007-03-12T11:51:00.000-04:002007-03-12T11:51:00.000-04:00I don't know, this seems a bit overboard to me. If...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 <I>relatively</I> harmless and already falls under the FDA's/DDMAC's/et al's purview. <BR/><BR/>I'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.Anonymousnoreply@blogger.com