The ANTHEM HFrEF trial of vagal nerve stimulation was proceeding well when the sponsor stopped the trial. The story...and some thoughts about the research enterprise
The Mandrola Disease typically presents with the enhancement of thought toward critical appraisal and the reduction in bandwidth spent in blind compliance. Victims of the disease suffer from humility, deliberateness, and dangerously high skepticism without its complement cynicism.
It is a chronic ailment—not quite yet pandemic—and I hope there is no cure.
Appeal to ethics clearly didn’t suffice for this company. To speak in a language companies like this understand, there would need to be a contractual obligation with (stiff) financial penalties for early termination without scientific justification.
John- active and smart docs and patients (on social media) ; limiting reps access to physicians have increased the risk that approved FDA devices or meds will be bashed in the world of instant information.
I would not demand the company make a product.
I would however- make them specify a positive result that in their estimation would also result in positive cash flow based on the cost of production. Super cheap medicines or tech to produce need less utilization . I think the FDA could then decide if government support of the product might be warranted- but that review should be done pre study
Another aspect of a decision like this is that it distorts the scientific record by omitting potential negative results. Researchers in general are more likely to publish positive than negative results - for reasons including but not limited to financial incentives. The result is that future meta-analysis or other statistical evaluations are skewed towards effectiveness.
Thus even if "no rule was broken" here arguably the early termination was still unethical.
Thank-you. I am only a "lay-person" but am familiar with VNS because one of my adult children has severe autism and epilepsy. They wanted to use VNS for his seizures (now grand mal but not too often) but he is so ocd about bandages, he would have ripped it off. I do not know whether it would have helped him. Of course, another subject. I agree with Larry below, we need to find the source of diseases and sometimes they vary... I have pneumonia and NOBODY caught it because I have several other dx's... I'm fine and THANK-YOU MY DEAR FOR YOUR POSTS... you help even those of us who know very little!
My Goodness. The primary efficacy endpoint occurred in 34.6% in the treatment group and 40.2% in the control group. And adverse events were 3%. The company was prudent not to continue. We don't need more marginal devices or meds. We should concentrate on the root causes of these diseases.
The 5-6% ARR is on par with the absolute effect sizes of Dapa HF, Emperor Reduced, and Paradigm HF, all using roughly the same primary endpoint (Dapa did include the cheesy “urgent visit for IV lasix” bit).
This therapy (had the effect been shown to be real) would be on par with “new” HFrEF therapies of the past 10-15 years. I don’t think that’s nothing.
The Mandrola Disease typically presents with the enhancement of thought toward critical appraisal and the reduction in bandwidth spent in blind compliance. Victims of the disease suffer from humility, deliberateness, and dangerously high skepticism without its complement cynicism.
It is a chronic ailment—not quite yet pandemic—and I hope there is no cure.
Appeal to ethics clearly didn’t suffice for this company. To speak in a language companies like this understand, there would need to be a contractual obligation with (stiff) financial penalties for early termination without scientific justification.
Until the public invests the same amount of money as in industry to advance scientific discovery, things like this will continue to happen.
John- active and smart docs and patients (on social media) ; limiting reps access to physicians have increased the risk that approved FDA devices or meds will be bashed in the world of instant information.
I would not demand the company make a product.
I would however- make them specify a positive result that in their estimation would also result in positive cash flow based on the cost of production. Super cheap medicines or tech to produce need less utilization . I think the FDA could then decide if government support of the product might be warranted- but that review should be done pre study
Another aspect of a decision like this is that it distorts the scientific record by omitting potential negative results. Researchers in general are more likely to publish positive than negative results - for reasons including but not limited to financial incentives. The result is that future meta-analysis or other statistical evaluations are skewed towards effectiveness.
Thus even if "no rule was broken" here arguably the early termination was still unethical.
Thank-you. I am only a "lay-person" but am familiar with VNS because one of my adult children has severe autism and epilepsy. They wanted to use VNS for his seizures (now grand mal but not too often) but he is so ocd about bandages, he would have ripped it off. I do not know whether it would have helped him. Of course, another subject. I agree with Larry below, we need to find the source of diseases and sometimes they vary... I have pneumonia and NOBODY caught it because I have several other dx's... I'm fine and THANK-YOU MY DEAR FOR YOUR POSTS... you help even those of us who know very little!
My Goodness. The primary efficacy endpoint occurred in 34.6% in the treatment group and 40.2% in the control group. And adverse events were 3%. The company was prudent not to continue. We don't need more marginal devices or meds. We should concentrate on the root causes of these diseases.
The 5-6% ARR is on par with the absolute effect sizes of Dapa HF, Emperor Reduced, and Paradigm HF, all using roughly the same primary endpoint (Dapa did include the cheesy “urgent visit for IV lasix” bit).
This therapy (had the effect been shown to be real) would be on par with “new” HFrEF therapies of the past 10-15 years. I don’t think that’s nothing.