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Interesting analysis of responders and clinical trials

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Anonymous

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there are two issues while comparing clinical trials to real world – Drop rate, and Responders rate.

1. The drop rate in the placebo group was similar to the “real drug” group in all phase III clinical trials, which means no drop because of severe adverse effects!

2. In real world (unlike in clinical trial) the placebo effect counts!

3. In real world (unlike in clinical trial) you don’t subtract the placebo group weight loss.
In this case it is very significant since the placebo groups went on diet and exercise (so they lost weight much more than just the placebo effect)!

4. In real world (unlike in clinical trial) the placebo effect is much stronger since everybody knows he is taking the real drug!
In clinical trial the patient can’t be sure that he is on the real drug group.

5. In real world the motivation to succeed is much higher.
You know already that you take the real drug that is potent and safe, and very often you are paying for the drug (it’s not free like in clinical trial).
In this case the motivation is very significant since you’ll not be entitled for the drug if you’ll not lose 5% in WK 12.

6. Some patients will start BELVIQ from the very beginning together with other drug (such as Phen) or dietary supplements that will help them with diet and weight loss.

7. Many T2DM will get HbA1c improvement (before WK12) that will make them highly motivated.
HbA1c improvement is very significant EVEN FOR NON-RESPONDERS!

8. All people will see many other improvements in many parameters and endpoints (LDL, Liver enzymes, etc.).
Many patients will be able to take fewer drugs and smaller dosages.
Many patients will need to pay less for food.
Many patients will be able to quit smoking, nail biting, etc.

And still, 40% Responders will be more than enough to become a blockbuster!
40% of the Americans that are entitled for BELVIQ give us about 35M Responders (in US only)!
10M of them are covered (and will get reimbursement) already!
 




Ya, we ca tweak the numbers to tell the Drs what we want, bottom line, we are much less effective, less safe, more potential to interact with other meds, 5h2a,b risk minimal or not, a risk, bid,ore expensive, serotonin synd., half as effective. Oh ya, the othe drug is now retail, what do we say now? It was a good sale for 2 weeks. Now, our, we are easier to get is gone, any ideas marketing? Oh, ok dr, they are 2x more effective, safer, cost less, 1x a day, no drug interactions, can get at pharmacies but uh?????
 








You're a liar, and not an Eisai salesman - here to corrupt the minds of REAL salesmen. EXPOSED.

"bottom line, we are much less effective, less safe, more potential to interact with other meds, 5h2a,b risk minimal or not, a risk, bid,ore expensive, serotonin synd., half as effective."

WE? You sound like one of the nervous short sellers especially when you say things like "less safe". Have you had any training on Belviq's safety? It's awesome. Beats Qsymia hands down.

Not sure if I'll buy the "WE".

Maybe a matter of perspective but perhaps more a matter of having the right information.

1) Belviq's efficacy is comparable to Qsymia's recommended dose.
2) Doctors understand responder data is what counts.
Completers lost an average of 8.2% of body weight (average 26 pounds). Responders (those who lost 5% in 3 months) lost between 11% and 12% of body weight in a year. 47.5% of patients who took BELVIQ lost at least 5% of their weight versus 20.3% for placebo patients. Of those completing the studies, 63.9% lost greater than 5% of their weight, 34.7% lost greater than 10% of their weight, and the top 25% lost over 16.7% (or 35 pounds). It has been scientifically proven that even a 5% drop in weight can result in meaningful improvements in overall health.

"Oh, ok dr, they are 2x more effective, safer"

Moto of short sellers. Doctors write scripts not hedge funds. Safer? Did you say SAFER? Dead giveaway. You're a liar, and not an Eisai salesman - here to corrupt the minds of REAL salesmen. EXPOSED.

2 times more effective? BS. According to what study comparing the two? Did you know the trial designs were different? And B's 8.2% and 11-12% completer / responder efficacy is VERY comparable to Q.
 




Anonymous said:
In the Real World we have a thing called a Package Insert and Compliance.
Click to expand...

Sure, understood. But you can also tell the docs clinical data right out of the trials.

Tested on over 8000 patients. Completers lost an average of 8.2% of body weight (average 26 pounds). Responders (those who lost 5% in 3 months) lost between 11% and 12% of body weight in a year. 47.5% of patients who took BELVIQ lost at least 5% of their weight versus 20.3% for placebo patients. Of those completing the studies, 63.9% lost greater than 5% of their weight, 34.7% lost greater than 10% of their weight, and the top 25% lost over 16.7% (or 35 pounds). It has been scientifically proven that even a 5% drop in weight can result in meaningful improvements in overall health.
 




Yes and I have had DRS ask if I can say for sure B does not have any affect on 5th2b receptor. I cannot lie and say it des not. DRS also ask about depressed patients, once again, I cannot lie or I lose all credibility. We can talk about responders, but, the majority of the patients did not respond. This is fishing for only the certain patients. I sold BP meds for over 2 decades. Not once did I ever have to say, but dr, forget the patients who only got a 10 point drop, the other 24% of the responders got an average of 19% so, my medication give a 19 point drop. Keep drinking the kool aid. We have been told to turn this average efficacy into something the drug isn't. The other company will explain this and make us look really dumb when they are showing the results of all the patients in their studies, not just the responders. Also, AACE does not support us for the more complicated patients, how do we try to spin that. Even the governing body feels we are inferior when it comes to efficacy. We barely got FDA approval after being rejected in 2010 for lack of efficacy. Don't you, some young punk try to educate me, I have over 30 years and too many awards, the only reason I am here is because I was making too much at my last company. Don't lose credibility or you hurt yourself and the brand forever.
 




DRS love our data for 2 years. The graph is so embarrassing. I try to hide that. I had a dr show me the other ones 2 year data and it is dumbfounding. Maybe I can say, but dr, we had 2 responders who didn't gain most of the weight back while still spending ungodly amounts of money for this crafter the 1st year thru the end of the 2nd year.
 




"if I can say for sure B does not have any affect on 5th2b receptor. I cannot lie and say it des not."

But you can say there was no clinical signal. Nothing is "for sure" in this field but the level of confidence is very very high and that's why FDA approved it and did NOT require REMS or pre marketing CVOT.

"DRS also ask about depressed patients, once again, I cannot lie or I lose all credibility."

You should not lie. You can say depressed patients will be much less depressed when they lose weight -- I've heard of docs taking patients off SSRI and only on Belviq. Some docs prescribe both a the same time and just monitor it for syndrome. If none patient good to go -- if in rare cases there, they can take them off B.

"We can talk about responders, but, the majority of the patients did not respond."

A large % were responders -- 44% is pretty good. You have the numbers - diabetic and none.

"This is fishing for only the certain patients."

In real world the responder rate will be even better. And the patient knows EVEN IN THE FIRST 2 WEEKS ON FREE MEDICINE if they're a responder. They'll just know it. Check out www.belsuccess.com. And many will lose much more than the 5% in 3 months.

"We have been told to turn this average efficacy into something the drug isn't."

Oh poor thing. I'm sure that's not true. You just have to be able to state the FACTS. The 8% -- the 11-12% number -- and the 5% requirement in 3 months which many will lose in a matter of days or weeks.

"The other company will explain this and make us look really dumb when they are showing the results of all the patients in their studies, not just the responders."

Why worry about Vivus. Many doctors have said in the last 12 months they don't like Qsymia. They know the ingredients and don't need Q.

Bel is a diff ball game. You have a tremendous opp to present the competitive advantages including excellent safety profile.

"Also, AACE does not support us for the more complicated patients, how do we try to spin that."

Drop idea of spinning. Truth of B will sell itself. You just go along with truth but say the important things.

"Even the governing body feels we are inferior when it comes to efficacy. We barely got FDA approval after being rejected in 2010 for lack of efficacy."

You are MISINFORMED. 2010 issue was safety and it turned out was a non issue.

Many have been brainwashed by wall street to believe the efficacy of Belviq is not good. FACT is it is. Obesity trials typically have a high drop out rate. And the placebo adjusted rate in real world is meaningless. 8% is GREAT. 11-12% IS GREAT. Even 5% is good.
 




Still didn't address how I should address 1-2 yr wt gain when Q shows no wt gain and wt loss in study dr showed me. If real world, won't their efficacy be better also, have had severSl Drs tell me patients have list 70-80 lbs since on Q
 




There isn't 1 competent dr who would risk taking a controlled depressed patient off their ssri, snri to put on B. what is the clinical purpose. We don't affect the 5HT reuptake pump, no efficacy to report for depression. Drs would be sued so quickly if that patient harmed themself or anyone else. Ce up with a better answer. That is a patient we should not go after. There are too many others to even suggest that. Are you Fn stupid?
 








Depends on what they take ssri for. A lot of people are not really depressed or are marginal or just unhappy -- far too many people on ssri's than should be anyway.

Doc has to decide case by case. And also it depends on the SSRI. Maybe ramp it down.
 








Anonymous said:
But would never make that suggestion. Liability suggesting to come off a med that might keep them from killing them or others. Gutsy suggesstion
Click to expand...

It's a case by case situation and it's up to the doc to decide. Anyway there are tons of obese and overweight patients who are not about to kill themselves :)
 




Vivus here, If you are having to "spin" your data by taking out all those who didn't respond you've already lost this battle. You have to remember, we could take out our non-responders and data would be even more impressive too. Drs. are smart enough to realize if you do that for B you can do it for Q too.

The poster above is correct, I in my territory alone have many doctors who have patients who have already lost 50, 60, 70+ pounds on Q. I even had a doctor tell me about a patient he had who was going to have bariatric surgery. He convinced her to try Q 1st and she has lost over 70 lbs. He husband has been so motivated by her success and change in health status, he has lost 20+ lbs without Q. Both their children have also lost weight (without meds of course). The fact is that Q is life changing for many patients.

Drs. really don't like B's safety profile. No doctor in their right mind is going to take a patient off an SSRi just so they can put them on B. Why would they when they can put them on Q and keep them on their SSRi? Also, Seratonin Syndrome is nothing to mess around with. Yes it is rare but a doctor would be crazy to keep a patient on an SSRi, add B and "monitor" them for S. Syndrome.

Don't worry too much though, even Q has non-responders (albeit very few). You and Contrave can fight for those patients when Contrave gets approved. Untill then, they're all yours.
 




B has side effects that are not well known (out of body experiences, hallucinations.; check the FDA documents). Medical affairs MSLs and their former boss who was demoted for compliance and other reasons don't like to talk talk about it. SSRI issues will become more apparent with time....
 




These have to be vivus contract reps or short sellers. Every doctor out there has a clear understanding that Qsymia is a combo pill. And, FPs and IMs won't touch it because it contains phentermine. It's irrelevant why they won't use it, the fact is they won't prescribe it. Belviq is getting scripts in weeks where vivus has failed for 9 months.

The Belviq primary and secondary endpoints are significant and relevant. Ask the endos what a .9 a1c drop means to them and their patients. Just ask, don't offer the benefit, ask them for their thoughts. For the naysayers, if it's just because of the weight loss and, as you say, the weight loss isn't much compared to placebo then why was the separation in A1c so dramatic?
 




Belviq's -.9 effect on a1c was due to the fact that patients were not well controlled at the time they started on Belviq. Qsymia trials in diabetics had a drop in a1c of -.4 but the patients a1c was already pretty well controlled at a baseline of 6.8. Belviq's baseline was 8.1 if memory serves me correctly. MUCH easier to show big drops in a1c the higher the baseline is. If you don't believe me just ask you endos!

Qsymia is a more effective drug than Belviq. Phentermine is only a hold up for some docs. There are millions of scripts each year for Adipex so don't think docs wont write Qsymia because of its phentermine component. Topirimate is also not a real issue. Ask all those neurologist how many of the have their patients of childbearing potential on 2 forms of birth control and monthly pregnancy tests. Most of them will tell you zip, zero, nada.

Where Belviq might have an advantage is in marketing. Apparently Vivus senior mgmt had no clue how to market in this huge arena so First Manhattan has now overthrown mgmt and will implement its own strategy. Only time will tell what effect it will have.

But, make no mistake, Qsymia Is by far the more effective drug. I happen to sell Qsymia and hope we are all successful (maybe us a little more than you). Their ate "tons" of patients that desperately need help with obesity.
 




So true. I just explained the A1C point to a Dr who, after listening, felt upset the B rep 'misled' him by telling him B was more effective at lowering A1C. Thank you. You make my job so easy making you look like an incompetent liar.
 








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