Just got offered https://corcym.com/devices/aortic/US/perceval tissue valve

[pellicle]

Morning

One would like to think that agencies like the FDA would somehow control this sort of thing but

...but they are not typically experts in the specific field , and show similar issues to the peer review system.

But, we need to try to use our critical thinking caps and identify marketing hype when we see it.

As the old saying goes "caveat emptor"

 

[Survived03]

The free dinners, regular visits from 'detail' people (drug reps), gifts, office lunches, and other methods to buy a doctor's time (and mind) are an all too common marketing tool -- and they work.

I have some experience with this and would like to add to your post. The days of free dinners, gifts and expensive junkets are long gone in the US due to the Sunshine Act of financial transparency. There is a lot more documentation required for activities outside of normal interactions with medical care employees (not just physicians). In addition, you are not allowed to provide a medical care employee with peer reviewed studies, unless directly asked. However, there are educational paths forward for providing information “favorable” to your product but it’s a tight rope journey. But all of this assumes a company does not want to risk millions of dollars in fines if they break the law. We can assume some take that risk.

Yes, the cost of research is a positive AND a negative -- the drug companies argue that their prices MUST be high because of the expense of developing new drugs. But is it fair to gouge patients for these newly developed medications?

It is true that a public medical company has a fiduciary responsibility to share holders and they are in the business of making profit. Are all drugs or otherwise priced with the patient in mind? Doubtful in my opinion. But true gouging is probably rare and risks a tarnished reputation.

Is the cost of advertising - not insignificant - a big part of the cost of the actual drug? Are patients suggesting to their doctors that they should take a heavily advertised product vs. a similar product that isn't being pushed as hard? And, FWIW, why should patients be requesting certain medications just because they saw it advertised 300 times in the last week?

This, I agree, is way way out of control. I predict this will be pulled back in the future. I heard somewhere that >80% of US television advertisement is paid for by pharmaceutical companies. Not sure if true but that’s crazy.

Where's the trade off? Should the government kick in more funds for R&D so that the cost of newly developed medications can be reduced when the product is developed? Would the manufacturers actually agree to reduce the price of the medication if the Feds funded the development?

Strange thought here - what if the Feds would reimburse the pharmaceutical companies for their R&D costs in exchange for making the medications affordable? Perhaps the companies can get a fair profit, but

I have had multiple conversations about similar ideas, but with medical industry participants. The replies that keep coming up over and over over are “ you will destroy the need to be more competitive than the other guy”, “innovation will take a hit”, “let capitalism do its thing“, “it will upset a major market sector”, “bringing in the feds would be a mistake” I remind you that I’m just sharing comments.

Also, even as you mentioned earlier, the manufacturing is typically not the major costs associated with drugs and other devices. The costs are tied
up in R&D, clinical trials, FDA approval, and intellectual property in some cases. Some big medical companies spend ~20% on R&D. Huge amounts of money.

Its very complicated but perhaps some day there will be a positive solution leading to global reform.

 

[pellicle]

I'm getting the Prevagen Extra Strength!

After the first bottle starts going down, advise your wife to buy some of this and refill the bottle when you're not looking.

This can also work in a homeopathic manner because there will be traces of prevagen on the inside of the bottle and so you will still be getting some molecules of Prevagen for quite some time (in case you're a wise-up to the placebo nature of the above)

 

[V__]

Interesting thoughts, but I'm of the persuasion that "one cannot legislate economics". Or there would be severe side effects.

Should the government kick in more funds for R&D so that the cost of newly developed medications can be reduced when the product is developed?

Hm. NIH is huge already, as the government sponsorship goes.

Would the manufacturers actually agree to reduce the price of the medication if the Feds funded the development?

IMHO they will agree with the research sponsorship part. And will do more research on paper, and maybe in real life as well. The part about the price reduction for a new object/drug gets into the subjects of "what do you compare it with?" and "who checks the reduction?" I would not be optimistic about it.

I think the core issue is that in the system with protected IP one gets a legal monopoly with a new invention, for a set period of time. One can argue that it benefits the inventions and inventors. But monopolies are bad in many ways.

 

[pellicle]

I think the core issue is that in the system with protected IP one gets a legal monopoly with a new invention, for a set period of time. One can argue that it benefits the inventions and inventors. But monopolies are bad in many ways.

(*looks over the partition at the direct Xa makers) ... and maybe may bring pressure against existing well proven products which just don't happen to be "one size fits all" and only got through their testing by not being inferior to badly managed warfarin therapy.

 

[QuincyRunner]

I work as a volunteer in a hospital’s Heart & Vascular Center and every week or two cartloads of catered food are brought in from various restaurants and are whisked through locked doors into the Cath Lab next to my work station. I always just assumed that the interventional cardiologists were just treating their staffs but now I’m beginning to have second thoughts……

 

[3mm]

I heard somewhere that >80% of US television advertisement is paid for by pharmaceutical companies

Currently I think 80% of the advertisements are from candidates for political office!

 

[Protimenow]

Currently I think 80% of the advertisements are from candidates for political office!

Wait till January.

 

[Chuck C]

https://www.dicardiology.com/content/livanova-sells-heart-valve-business-gyrus-capital

Thanks for the link @ATHENS1964.

Always interesting when a company sells off a valve and I decided to look a little deeper. I have a few red flags about this new valve and will give my thoughts below.

A little digging finds additional details about the motivation for the sale:

“A steady decline in heart valve sales and pressure from investors have ultimately resulted in a new home for LivaNova’s product line.”

https://www.medtechdive.com/news/livanova-offloads-heart-valve-tech-to-gyrus-capital/591540/
Also, please see the publication below, published in 2020, which discusses concerns about the structural integrity of this sutureless valve, particularly in young patients:

"The use of newer generation bioprostheses, although attractive for their ease of implantation, can potentially carry higher long-term risk due to their shorter durability leading to reintervention to address valve deterioration. This is especially true in low-risk patients who are young and active. These patients are likely better served with the time-tested prostheses with long-established durability and freedom from structural deterioration. A mechanical valve in a young, otherwise healthy and compliant patient has an excellent long-term prognosis despite the risks of lifelong anticoagulation and bleeding or thrombosis"

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7092772/
Here is a randomized trial for this valve on elderly patients with average age of 75 and severe symptoms. I can't help but get a little laugh when I look at how they worded their Objective: "We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis."
Did someone slip the writer of the abstract truth serum? Yes, we know that in industry funded research that the goal is to demonstrate noninferiority or superiority, but in theory those conducting randomized trials are supposed to be seeking accurate data, not to have the goal to demonstrate noninferiority of the product sponsoring the research. Technically, in science when you have a hypothesis, you are supposed to try to disprove your hypothesis, not prove it. But, in reality, I just point this out for the humor of it and not counting the way they worded their study objective against this valve. I actually appreciate the honesty in the wording.

Also, this is only one year data on what appear to be high risk patients.

They looked at MACCE (major adverse cerebral and cardiovascular events) outcomes after one year, which were very similar, but they did find significantly more need for pacemakers in the Perceval group, at the rate of 308% higher rate. I would not gloss over this.

" ...but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). "

https://www.jtcvs.org/article/S0022-5223(20)33339-0/fulltext
Here are some comments and questions I have about this valve:

1) There was a lot of marketing generated excitement about this valve around 2016. Why have sales not matched the expectations? If this valve is truly so revolutionary, why did they feel the need to sell off this division to stop the bleeding? If you truly have a superior product, why not continue to invest in more studies in the hope of demonstrating the superiority of your product in the long run?

2) The well respected Eric Roselli of the Cleveland Clinic was one of the lead authors of the Perceval study. We have had dozens of members get their procedures done at Cleveland Clinic over the past few years and I don't recall anyone sharing that they have been offered the Perceval valve as an option. CC prides itself at consistently being ranked #1 in the nation in valve surgery and they go to great lengths to maintain this reputation. So, why is this exciting new valve not being offered to their patients? Hopefully, if someone has been offered such a valve at CC or any other clinic, they can share that with us, especially if they opted for this valve choice. Do let us know how it is going please.

3) While the one-year data is comparable in terms of MACCE outcomes, there are concerns about this valve's structural integrity beyond this, particularly with younger patients. I would define young as under 70.

4) There appears to be over a 3x greater risk of the need for pacemaker implantation during the first year with this valve.

5) Picking up from my commentary from #1 above, is the new owner of this valve targeting 3rd world clinics with aggressive marketing, despite the fact that there are serious durability issues with this valve and questions about its use for low risk patients under 70?

6) Perhaps this valve is a good option for high risk patients who do not qualify for TAVI. In fact, it is similar to TAVI in some ways. If a patient is 85 years old with comorbidities and high risk, yet is not eligible for TAVI, perhaps the lower cross clamp time would justify use of a sutureless valve for this patient. However, it does not appear that they have even made the case for these patients- the data seems to show "noninferiority" and not superiority. And then there is the 300%+ risk of the need for pacemaker. I don't see any data for lower risk patients under 70, so this would appear to be a significant roll of the dice.

Overall, before this valve is recommended for patients, given the concerns about long term structural integrity, perhaps more data needs to be seen. There appears to be a complete lack of data for younger low risk patients for this valve.

 

[pellicle]

Chuck, a great post and an excellent summary, well done on due diligence there, hats off to you .

However, it does not appear that they have even made the case for these patients- the data seems to show "noninferiority" and not superiority.

I personally "love" how often this is used for accepting something which is actually just a little bit inferior...