The Best Drug You Ever Detailed?

Discussion in 'Ask Dr. Dave' started by DrDave, Apr 9, 2011 at 6:38 AM.

  1. Anonymous

    Anonymous Guest

    In the world of compounding (combination pain creams), it is hard to define what is done as "detailing". We are certainly not scripted, we can have rich clinical conversations yet have to be very careful about safety and efficacy discussion because 1)Compounders are not regulated by the FDA, but by each individual state board of pharmacy, however some aspects of their marketing are, and 2)Although we can only use generic medications we are not required to do studies. I think if you find one or two pharmacies it is good to stick with it for consistency, although the recent/ongoing Makena case showed that if anything, the Compounded product from several pharmacies was at least as consistent from batch to batch as the FDA approved product (exact same drug entities) was from batch to batch, probably moreso. For Pain patients, I think finding a Pain Specialty Pharmacy that does all the billing for your patients/staff offers the most benefit to the Provider, and has the most expertise in what combination of products to use for what condition (COX inhibition, NMDA receptor antagonist, Ca2+ or NA2+ channel blocker(s), etc, say for X condition).


    The science has emerged a great deal over the past 5+ years about peripheral mechanisms sustaining chronic pain mechanisms-recent pain conferences are focusing much more on the Skin as an organ, for instance. I can walk into a Physicians practice and confidently know that I can offer something new, something that works in a way that a physician cannot otherwise provide, is on the cutting edge of medical science yet has been around for centuries, something that is not systemic therapy which as you stated Dr. Dave, physicians find very appealing for obvious reasons, and much more. Other countries use Topicals much moreso than the U.S., and I believe a recent Cochrane's analysis (past 2-5 years) actually stated something to the effect of, and I am paraphrasing,"....not sure why Topicals have not caught on in the U.S., or why they are not prescribed more despite the Clinical Data supporting its use....". There are numerous ways the conversations can be productive for the physican, but if there is even a moderate effect on pain there is the potential for patients to become less reliant on pills. Specialists certainly are more likely to prescribe these, but I think this type of therapy is something that Primary Care physicians would like to be more educated on. However, small Compounding Pharmacies don't have the funds to pay for large educational programs on a consistent basis which is a shame.

    If nothing else, these are great drugs to sell to Providers because it really opens up another world for many physicians I am working with. I have been able to see physicians repeatedly that I could only see for new products over my 20+ year career. The Triad of "Physician, Pharmacist and Patient" needs to be protected because the one size fits all concept of commercially approved therapeutics (medications, surgeries, procedures) leaves many patients w/o adequate relief.

    Perhaps, Dr. Dave, you have stated all that you would like on this subject of "Best Drug You Ever Detailed", but I can say there is a great deal of interest AND skepticism from many of my colleagues who are still in Biopharma about these evolving sales positions. Can you state what niche you feel Topical RX Pain Compounds may have, why you suspect you will gain more experience over the next several months, and if you view a sales rep coming in representing a Compounding Pharmacy different from a BioPharma rep?

    Your feedback on this site is very much appreciated.
     

  2. Anonymous

    Anonymous Guest

    Are you people serious? Going to bat for compounding pharmacies? After one of my cousins almost died from an injection that was not made properly by a supposed 'reputable' compounding pharmacy, think I'll wait until the FDA has oversight before I get anything from these risky businesses.
     
  3. Anonymous

    Anonymous Guest

    What happened in the world of compounding pharmacy was a tragedy. There is nothing much to add to that. Horrible.

    Compounding Pharmacy can be divided into 2 categories: Sterile and Non-Sterile. Sterile is high risk formulations, such as injections into the spinal column.....Non-Sterile typically focus on simpler medications, such as Creams or Gels. Topical Pain Creams are minimally absorbed into systemic circulation, usually anywhere from 0-10% of the oral dose equivalent. Increased regulations are coming, and you can argue the pros and cons of that, but the fact remains that the increased regulations are focusing almost solely on the high risk formulations, or Sterile compounding. Topical combination pain medications will increasingly be seen as a nice alternative/add on to opioids, or perhaps even injections in some cases, to NSAIDS, and so on...one of the goals of topicals is to reduce opioid intake, or oral medication intake. This route is used all over the world, but in the US where we consume 90% of the opiates or some crazy number, the world of pain management is increasingly moving towards the topical route of administration...
     
  4. DrDave

    DrDave Member

    Joined:
    May 6, 2006
    Messages:
    557
    Likes Received:
    0
    Thanks for pointing out the difference in the compounding issues. Not knowing much about the compounding pharmacy business, my follow up question for clarification is-

    Generally speaking, given the difference in regulation, do different compounding pharmacies tend to focus on topical vs. injectable compounding, or are they doing both on the same corporate roof most of the time?
     
  5. Anonymous

    Anonymous Guest

    I want to buy in but.....
    -you say you're not scripted but this sure sounds scripted
    -once you say "efficacious" you don't sound "real"
     
  6. Anonymous

    Anonymous Guest

    So does Bystolic-& it has the BB benefits. Doc- your thoughts?
     
  7. DrDave

    DrDave Member

    Joined:
    May 6, 2006
    Messages:
    557
    Likes Received:
    0
    For those of you just picking up this most recent post, in context, Wonka was referring to Norvasc (amlodipine). I'm not sure if the question refers to Bystolic vs. Norvasc, Bystolic vs. generic beta blockers or Bystolic vs. the entire anti-hypertensive field. I'll throw out a few thoughts, and if you want me to elaborate, just let me know.

    Norvasc -has outcomes data in htn based on the ASCOT data plus a generic copay. The downside: edema, especially at higher doses. Bystolic has maybe a slight tolerability advantage, European outcomes in CHF (not sure about essential htn? not aware of any at least) but a branded copay. Advantage to amlodipine.

    Beta blockers - Bystolic definitely has a tolerability advantage, CHF data noted above (included data in more elderly patients than carvedilol has), but branded co-pay/higher cash price. If cost not an insurmountable obstacle, prefer Bystolic over other BBs.

    The Field - In the field, Bystolic is, for me an overall third line-ish choice for hypertension with a small cadre of patients in whom it's first to second line - co-morbid CHF, post MI with BB tolerability issues, migraines, etc.

    Of course, my knowledge of the data might not be nearly as expansive as others' here, so please correct me if there are inaccuracies above.

    Thanks for your question!
     
  8. Anonymous

    Anonymous Guest

    Bystolic has endothelial dependent vasodilation, no alpha block, no difference in young vs old? I don't rep BYS, I used to-no longer there. However, believed in it & still do. Do you buy in to not just a number (regarding hyp) theory?
     
  9. DrDave

    DrDave Member

    Joined:
    May 6, 2006
    Messages:
    557
    Likes Received:
    0
    I definitely buy in to "just not a number" based on outcomes evidence. If it were just a number, we wouldn't see outcomes differences between various agents/classes with similar blood pressure reduction.

    I just try to be very cautious at looking at a single physiologic effect/mechanism (e.g., vasodilation) and drawing conclusions about outcomes from it. We've been burned by that many times in the last 50 or 60 years. In this disease state, Valturna is probably the most recent example. Based on intermediate evidence like proteinuria reduction, you would have thought that it would be great for diabetics with kidney trouble. Not so, it turns out.

    That said, Bystolic has European data that is much more compelling to me. Unfortunately, Forest reps can't really cite that data when they market it.

    Bottom line: IMO, Bystolic is a good drug in a niche population, usually not first line. Nothing wrong with believing in it, as you put it, and there is more to it than just a number.
     
  10. Anonymous

    Anonymous Guest

    Hello Dr. Dave--I have posted (somewhat lengthy) posts on the topic of Compound Pharmacy and Topical combinations for various pain syndromes above....I am probably more excited now then ever about this field (been in compounding 18 months, Biopharma over 20 years). I wanted to answer the question below. Overwhelmingly, compound pharmacies do BOTH sterile and non-sterile compounding. Topical preparations are a type of non-sterile compounding. In the future, it looks like the question will be how much more will pharmacies who formulate sterile compounds be regulated. There is a small minority of pharmacies who only formulate Topical formulations, and a smaller amount still that only focus on Topical Pain Formulations. However, the market/clinical need for a safe alternative in pain therapeutics is enormous, and I would also say the same thing as to the need for additional choices that are efficacious (to answer another post on this thread). In talking with an extremely busy RHEUMATOLOGIST spell check) last week, he said that for the first time ever NSAIDS were not in his top 10 most prescribed drug list that he receives monthly from his largest insurers. COX2's were largely responsible for that, but this MD went on to say that there are alot of issues with COX2's, and he is beginning to have very good luck with topical combinations and thinks this will have a major role in his practice moving forward (they are working, although he was initially drawn to them due to safety)...In pain management, most specialists agree that if you can achieve a 30% or greater reduction in pain with a specific intervention (such as a Topical Pain combination cream), you have achieved a very successful outcome. Based on this fact, I feel there is a need for more agents that are also efficacious. We also (NOW) know that a persons genetic makeup will help to determine ones response to medications, and also the level of pain certain patients are prone to experience The era of personalized medicine is right around the corner, the "one size fits all" approach of big pharma/blockbuster drugs is over, and niche therapeutics tailored to a specific patient is where I believe medicine is going. In pain management this is certainly true, and there are so many patients where nothing has worked for them points to the fact we need more choices that are also efficacious....one may disagree, it is just an opinion. But I think alot of variables are pointing to topical therapy being much more relevant in the U.S. in the future.


     
  11. Anonymous

    Anonymous Guest

  12. DrDave

    DrDave Member

    Joined:
    May 6, 2006
    Messages:
    557
    Likes Received:
    0
    This is a very interesting issue. While intuitively one wonders if wider variation in active ingredient could affect safety/efficacy, the party that stands to gain the most from definitively proving the inferiority of generics - Pharma - generally doesn't do it. Most of the drug classes named in the segment would require very short, low cost studies to prove the point. I'm pulling this number out of the air, but if it cost $100 million to bring a drug to market, why not spend $1 million to show that we should continue prescribing it even after it goes off patent?

    I also specifically thought naming the "antidepressant" class was a bit disingenuous. Depression is a serious illness, don't get me wrong. That said, with SSRIs, good branded data generally has 40-45ish per cent response rates compared to a 25ish per cent placebo response. IE, 25% (or so) of the time, patients respond to NO active drug, and 1/2 the time the branded active ingredient doesn't work. Not exactly my definition of a "narrow therapeutic window."

    I realize this is a charged topic. I'm curious to hear the thoughts of others. Thanks for your question!
     
  13. Anonymous

    Anonymous Guest

    Dr. Dave, thanks sor your thoughtful responses. Regarding the generic issue-i saw yesterday that Teva's generic buproprion (wellbutrin) was pulled due to its delivery compared to the branded. I understand what you said about the antidepressants vs other noted classes where it may be risky or unwise to switch to a generic. However, like you alluded to, since placebo response and clinical trials are generally less conclusive for mental health drugs, might it be that N=1 is perhaps the MOST relevant for patients who are responding to any formulation of any drug by any manufacturer-whether it be branded or generic? It seems to me that if something is working, it shouldn't be changed in any way. I represent and have represented medications for many different disease states. Thinking about this makes me feel more comfortable discussing and even recommending that physicians put some subjective medications to the test, especially if there is a generic option. However, I'm feeling i should fight more for patients doing well on psychotropic meds to remain on EXACTLY what they're taking that's working. What do you think?
     
  14. DrDave

    DrDave Member

    Joined:
    May 6, 2006
    Messages:
    557
    Likes Received:
    0
    You do make an interesting point with mental health drugs. In disease states where successful treatment is more challenging to objectively describe and quantify, should a stability that satisfies patient and provider be potentially compromised by shifting the meds month to month? After all, if placebo effect is at work, even the appearance of the pill can matter (and I don't mean that facetiously). Many insurance carriers do have a provision for covering continuation of branded meds if there is a threat to medical stability, so that at least helps some of the coverage issues. I also think the most valuable bit of practical information in the videos is that you can shop around for the specific generic version you want if that matters to you.

    As with many things in health care, perhaps the answer ultimately lies in allowing the patient to do their own cost/benefit analysis. While I think the Oz segment is a bit sensationalized and oversimplified, it does make the absolutely factual point that generic drugs are not as strictly regulated for content as their branded competitors and counterparts. (Aside: I was a bit surprised that Dr. Oz didn't seem to know this - I kind of thought of that as general knowledge among physicians.) Though it's challenging, I think the job of the prescriber is to try to lay out the risks and benefits of the $4 Wal-Mart generic vs. the third tier branded option. Unfortunately, as much as the branded pharmaceutical industry warns about generic "danger," it doesn't really have randomized, controlled outcome studies that quantify the danger, so we're left guesstimating. In simple terms, if the choice is $4 vs. $40, how do we assure patients that the branded option is 10X more safe, tolerable and/or more cost effective? It's very difficult to know unless the same patient tries them both - back to your N=1 point.

    Your point about Teva's extended release bupropion is interesting. The Oz segment does specifically warn about extended release drugs, and, intuitively, it makes sense that a combined wider variation in amount as well as delivery system could make more difference.

    Thanks again for your comments and questions! Other thoughts?

    I am also going to start this discussion as a new thread - great topic.
     
  15. Anonymous

    Anonymous Guest

    Hands down, Capoten. The drug revolutionized the treatment of CHF patients. People who could not walk across the room, could resume close to normal lives. It was great for HTN too, and developed from snake venom! Doesn't get better than that.
     
  16. Anonymous

    Anonymous Guest

    25 years with Merck. Cut teeth selling first statin, Mevacor, then enjoyed detailing outcomes with Zocor. Truly felt like we were making positive impact on patient health. Not to discount the value I felt that I brought with Cozaar/Hyzaar, Prilosec, Fosamax, Proscar, Maxalt, and Januvia. I've been fortunate to develop many long-term relationships with thoughtful Drs like you, Dave, thanks to tremendous products that I promoted. I've always struggled with Big Pharma micro-management, but overall enjoyed my career. I am disappointed that it may come to an end soon due to the lack of productivity from our research labs, so I may look into topical pain creams!

    Thanks for the opportunity to post.
     
  17. DrDave

    DrDave Member

    Joined:
    May 6, 2006
    Messages:
    557
    Likes Received:
    0
    I have a bias here, but in that earlier era (late 90s, early 00s) I was always a bit disappointed with my colleagues that Lipitor gained so much traction even though Zocor had amassed an impressive body of outcomes data, specifically with 4S and Heart Protection Study. What was your experience trying to sell on Zocor's outcomes in terms of prescribers' responding [or not] to what I thought was compelling evidence?

    Thanks for posting!
     
  18. Walking Eagle

    Walking Eagle Active Member

    Joined:
    Jul 24, 2006
    Messages:
    3,952
    Likes Received:
    11
    We have the culmination of generic substitution laws in the mid eighties followed by the proliferation of HMO/PPO vultures. They have always tended to approve for preferred positioning the products with the best discount/rebate programs over the most efficacious, the one with the best outcome/longevity results, the most cost effective, etc. I always thought that the HMO/PPOs should take bids and announce: ACE inhibitors---> $35/100 best bid with $7/100 rebated quarterly($$ amounts for example only). All who accept these terms and prices will be on preferred formulary.

    Too much under the table dealing. Supposedly this is all monitored and controlled by the Feds, but they are just as corrupt as well as vindictive toward whose who do not comply with the "unwritten" rules and/or who complain and make public the drity doings. Do I have proof? No. Just my opinion based on experience, observation and listening to key people who DO know but are afraid to go public.
     
  19. Vagitarian

    Vagitarian Well-Known Member

    Joined:
    Jul 22, 2006
    Messages:
    23,737
    Likes Received:
    247
    Years ago selling Children's Advil vs the J & J version and Children's Tylenol was fun and may have saved a liver or two. Also sold Suprax for 2nd line AOM and rocked it. Those were good years when we could use reprints and we just rocked. I took a few high writing peds from single digit percentiles up to the 60s, 70s and 80s.
     
  20. Anonymous

    Anonymous Guest

    It was a "device", the Dalkon Shield.