Generic Vs. Branded

[DrDave]

This discussion started on the "Best Drug You Ever Detailed" thread; thought I'd restart it here.

Dr. Dave-did you happen to see Dr. Oz's show on generic vs branded drugs? Two short videos. This link is to first and second has link below first. Would love to hear your thoughts. Thank you.

Re: The Best Drug You Ever Detailed?
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!
__________________
Respectfully,

Dave

Re: The Best Drug You Ever Detailed?
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?

Thoughts? You can also check out the tail end of the discussion here.

 

[Walking Eagle]

First off, due to escalating co-payments, more and more generics are being requested by patients, especially those on multiple chronic meds.

Second, the biggest problem with generic meds is the ones that are in time release/delayed release form. The generic companies just have problems replicating the release systems (the problem with generic Wellbutrin).

Third, a personal experience with generics. One would expect the least problems to occur with theh simplest meds, right? Had surgery a few years ago and had my kid run into the pharmacy on the way home from the hospital to pick up pain meds--hydrocodone with APAP. While in the hospital, pain relief lasted about 5 hours with 2xLortab 7.5(branded generic for Vicodin) with no significant side effects. True generic lasted a bit over 3 hours but did not totally control the pain, caused stomach distress, dizziness, and just an overall weird feeling. Had a few 5mg Vicodin left over and took 2 of them (10mg of hydrocodone vs 15 with generic) and got complete pain relief lasting over 5 hours, and NO side effects. If the generic companies can't get APAP and HC right, why should we expect them to be any better with more critical meds???????

 

[DrDave]

Thanks, WE - did you happen to view the Dr. Oz video that the anonymous poster linked? Thoughts?

If not, here it is again for reference:

Dr. Oz - Generics

 

[Anonymous]

It seems that most docs don't consider that the generic might not be the same or equivalent. I understand drs don't want to imply that a pill might not work or won't have the same response or efficacy as the branded they've been taking (or just a different manufacturer). Docs are already under-compensated in most cases and it seems like if we, as reps, bring this up they'll see it as one more time consuming hassle unless perfectly positioned.
Are their certain classes or disease states where you think this would be more appropriate ?

What do you think of Dr. Oz segment?

 

[DrDave]

In a nutshell-

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.

The Oz segment also specifically warns 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 for the question - other thoughts?

 

[Anonymous]

The lack of responses and posts on your thread is pathetic to me. I think it's an indication of the quality of many of the reps that post on here and an indication that even good ones aren't using these boards as a resource.
It's too bad. You've given us an amazing opportunity to gain insight, ask questions anonymously, and and learn about the way docs think. Thanks Dr. Dave!

 

[Anonymous]

In a nutshell-

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.

The Oz segment also specifically warns 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 for the question - other thoughts?

Dr. Dave, after 30 years in Pharma, the entire generic has less quality than name brand is bogus. Earlier posts point out to variation in release, etc and note generics being pulled from the market. Countless name brand drugs have been pulled from shelves over the years for potentcy, mold, metal inclusions from manufacturing, etc. Of course we also have the one poster's anecdotal "study" with a N=1, themselves, dissing generic pain meds. Worthless data.

The FDA forbids Pharma companies from making superiority claims of name brand vs generic when they have an A/B rating in the Orange book.

Quality control is an issue in both parts of the industry. The billions of dollars saved by quality generics helps all patients. The patient has the right to ask for name brand if they want to pay the difference. Since we the taxpayers pay for over 50% of all meds in one form or another, generics should be mandated unless the patient and their doctor feel strongly enough to do the prior auth work to get the brand.

 

[DrDave]

Dr. Dave, after 30 years in Pharma, the entire generic has less quality than name brand is bogus. Earlier posts point out to variation in release, etc and note generics being pulled from the market. Countless name brand drugs have been pulled from shelves over the years for potentcy, mold, metal inclusions from manufacturing, etc...
Quality control is an issue in both parts of the industry.

Thanks for your post. To clarify up front, I think we agree on this issue for the most part. If generics are truly inferior, no one would have more motivation to prove the point with RCTs than branded drug producers; yet, they haven't. However, internal quality control failure is a separate issue from setting up different parameters for acceptable active ingredient variation. I agree that having different parameters is not proof of superiority or inferiority in clinical effect, but it is an objective, measurable difference.

The FDA forbids Pharma companies from making superiority claims of name brand vs generic when they have an A/B rating in the Orange book.

Once again, just to clarify - the FDA requires that superiority claims always have to be supported by a head to head trial under any circumstance, correct? IE, this is not specific to claims against generics?

Thanks for chiming in - I'm guessing here, but are you the rep who referenced on another thread having Capoten years ago?

 

[Walking Eagle]

Dr. Dave, after 30 years in Pharma, the entire generic has less quality than name brand is bogus. Earlier posts point out to variation in release, etc and note generics being pulled from the market. Countless name brand drugs have been pulled from shelves over the years for potentcy, mold, metal inclusions from manufacturing, etc. Of course we also have the one poster's anecdotal "study" with a N=1, themselves, dissing generic pain meds. Worthless data.

The FDA forbids Pharma companies from making superiority claims of name brand vs generic when they have an A/B rating in the Orange book.

Quality control is an issue in both parts of the industry. The billions of dollars saved by quality generics helps all patients. The patient has the right to ask for name brand if they want to pay the difference. Since we the taxpayers pay for over 50% of all meds in one form or another, generics should be mandated unless the patient and their doctor feel strongly enough to do the prior auth work to get the brand.

One person studies mean one hell of a lot to the person taking the meds. Not so worthless when YOU are the test rat. What if the drug had been for a life threatening condition instead of intense pain??

 

[Walking Eagle]

Thanks, WE - did you happen to view the Dr. Oz video that the anonymous poster linked? Thoughts?

If not, here it is again for reference:

Dr. Oz - Generics

The data presented is basically what the Brand companies have said since the Mid 80s when prescribing laws changed to favor generics. It has plagued grand promoters for years. Doc Rxs brand drug for 10+ years with great results and suddenly starts getting side effects reports and/or lack of efficacy reports from his patients. In the beginning or the generic age, docs usually did not even know a generic had been substituted until the patient fessed up that he saved a few bucks or brought the meds in with them.

In the days before the law changed, I witnessed on many occasions a pharmacist change to a generic to help a patient save a few bucks by throwing the Rx away and logging it as a call in for the generic. It got even worse when the laws changed. Now, many pharmacies have placards stating the decision for brand vs generic is between the patient and the pharmacist--the doctor on longer has a say!!

The quality and absorption data is still about the same. This is complicated by greedy pharmacists who but the absolute cheapest generics in order to improve profit ratios; by pharmacists who try to keep absolute minimum shelf stock and buy from several wholesalers and get a different brand generic all the time; from wholesalers and chains doing the same thing to control inventory stocking the brand and ONE generic (usually the cheapest). The three people who should care most about quality (the patient, the doctor, and the dispensing pharmacist) now only care about prices.

Prices: the biggest culprit in the whole mix is the insurance company. HMO/PPO formularies are predatory. They design formularies to force most patients to accept cheap generics. The tier system for generics rewards the cheapest drug in a class with top position and lowest co-payment with RARE regard for efficacy and side effects. People on low fixed incomes and Medicare have little choice when faced with 5 key meds and picking a $7 co-pay each or a $55-65 co-pay each. PLUS, Medicare prohibits the use of the co-pay discount cards that bring brand name drug prices down to generic prices or even below generics.

 

[DrDave]

WE, what is your take on why there hasn't been a collaborative, prospective RCT (this would benefit all branded pharmaceutical manufacturers) designed to refute definitively the equivalence of generics in some way, at least with one drug or one class? You may remember the details better than I, but the only trial of that type I can recall was when Abbott (or Knoll? It was a while ago) attempted this with Synthroid and (as I remember it) didn't get the robust results they expected. Or have there been others since of which I'm not aware?

Thanks for your posts. Your views reminded me of a provocative interaction I had with a rep several years ago. I'm sure others have used this illustration, but I had never seen it at the time: The rep said, "Patients don't want generic products. They want generic PRICES." Then he pointed to a lone sealed bottle of generic cola among several half empty Coke products on our lunch counter. "You see that? This is the fourth lunch for that generic bottle, and nobody has touched it." A bit apples to oranges, but not completely.

Thanks again!

 

[Walking Eagle]

The FDA used to exist to APPROVE new drugs: verify the studies, verify ingredient quantities were consistent, verify adverse effects and their severity and frequency, and to verify interactions with existing products. They now exist primarily to keep new, expensive products off the market. Only significant discoveries allowed--no more multi drugs in the same class(ARBs, ACEs, PPIs, NSAIDS, etc).
Point in case--most see PPIs as pretty much interchangeable in efficacy and side effects. When I promoted Prilosec a relative was taking the enemy Prevacid. I told her she should ask her doctor for Prilosec as I could have him sign for extra samples and she could get her meds for free. She told me she couldn't take Prilosec due to a reaction I had basically never heard of and questioned the accuracy of her problem(Dr Drug Rep, right??). Got out the magnifying glass and scoured the prescribing info and sure enough, in the area of rarely reported reactions that may or may not be due to the drug was her problem and sure enough, it was NOT in the Prevacid info.
Back to the FDA problem: When a new drug in approved, any new drug for the same indication has to be proven SIGNIFICANTLY better in a crucial aspect of treatment or no go. NSAID under that system would be Motrin, Naprosyn(BID vs QID/TID), and whichever QD nsaid hit the market first.
Brand vs Generic: head to head studies have gotten VERY expensive and the feds have already ruled and re-approved the allowances for generic active ingredient levels to vary significantly. The AMA that I knew when I got into Pharma was one of the strongest lobbies in DC. It has lost its balls and not only will not fight for doctor rights, it sides with the liberals totally. The Pharma lobby was pretty much chopped off and the knees and has lost its power and presence. So even if the studies were done and were indeed conclusive in favor of brands, the feds will simply say that the generics meet the ordered standards and thus the problem with generic potency and absorption standards remain biased toward schlock generics with amazing variability from lot to lot with the blessings of the FDA and for you and your paitents to deal with suffer from. Answer?? Don't have one that is viable with our current administration and FDA rulers.

 

[Anonymous]

Dr. Dave,

I found the comment on Anti-D's interesting. (I'm a Diabetes Rep, btw.) I take an anti-depressant and when I started it was still on patent. About a year into treatment, it went generic. Most of the time I don't notice much difference but occasionally when I refill I notice feeling completely different (sexual side effects and GI upset.) The pharmacist tells me that they use different generic manufacturers and cannot control which one I might get.

So, in my experience (N=1) there is a difference even between the generics and it's not so much in efficacy but in the tolerability. Makes sense I guess with a class of drugs that is adjusting hormone levels.

 

[Walking Eagle]

Many years ago, early in the generic change, the schizophrenic son of couple in our neighborhood had a problem and ended up back in the state hospital. They put him on generic Mellaril, got him under control and he was released. Did okay for several weeks, then started going downhill. Ended up killing several dogs in the neighborhood. Because it was the state, they did assays on his meds. The stuff the state was buying for the hospital was +22% and the stuff filled at local pharmacy that was labeled as the same dose was -17%. That was more than enough variance to send him over the edge and back to the hospital. Sadly, a very polite, but quiet to the point of often being withdrawn, young man. Docs finally put him on one of the newer meds with NO generic. He did okay for over a year--lost track when dad was transferred.