k********n
发帖数: 756 | 1 今天和一个ATTENDING谈论起BOTOX injection for migraine, 说到简直不敢相信FDA竟
然APPROVE了这个治疗， ATTENDING说还是有些EVIDENCE的, 我说EVIDENCE是EVIDENCE,
但是是MONEY-BASED EVIDENCE。ATTENDING听了说，若干年前当他听说 17 个PHASE II
的临床试验证明BOTOX无效，没有MEET primary end point, 但某公司仍然要进行
PHASE III的临床试验的时候，他的反应就是“见证奇迹的时刻就要到了”。 然后讲了
一通故事，听得心里一颤一颤，医药这个水真是太深了... |
A*******s
发帖数: 9638 | 2 From mechanism, Botox helps dystonia and muscle spasm. It makes sense to
treat chronic daily headche or transformed migraine. But how to promote the
use of botox is another story.
Off-label use of Botox for migraine is difficult due to the price. FDA
approval makes it affordable to those ordinary patients. |
k********n
发帖数: 756 | 3 1. Somebody (taxpayer) other than the patient still needs to pay 1200 per
visit. It is lucrative for physicians and the company but the price is not
decreased.
2. There is no scientific evidences and logic supporting its actions on
nociceptor and cortical spreading depression.
3. Why a company wanted to conduct the most risky and expensive phase III
trial after seeing 17 trial failed?
4. Why other countries rejected it based on the same data?
the
【在 A*******s 的大作中提到】
: From mechanism, Botox helps dystonia and muscle spasm. It makes sense to
: treat chronic daily headche or transformed migraine. But how to promote the
: use of botox is another story.
: Off-label use of Botox for migraine is difficult due to the price. FDA
: approval makes it affordable to those ordinary patients.
|
A*******s
发帖数: 9638 | 4 Man, the word lucrative is really abused here.
Why 17 trials？ Does it only mean all those trials are not reliable?
【在 k********n 的大作中提到】
: 1. Somebody (taxpayer) other than the patient still needs to pay 1200 per
: visit. It is lucrative for physicians and the company but the price is not
: decreased.
: 2. There is no scientific evidences and logic supporting its actions on
: nociceptor and cortical spreading depression.
: 3. Why a company wanted to conduct the most risky and expensive phase III
: trial after seeing 17 trial failed?
: 4. Why other countries rejected it based on the same data?
:
: the
|
d**o
发帖数: 618 | 5 Just a technical question - do you really believe CSD is the sole mechanism
of migraine? What do you think about the possibility of arising from TMJ? |
s********e
发帖数: 1596 | 6 I have seen patients who benefit from Botox injections, and of course, also
some who don't. The latter group wouldn't continue Botox injections anyway.
Really not much harm there:)
EVIDENCE,
II
【在 k********n 的大作中提到】
: 今天和一个ATTENDING谈论起BOTOX injection for migraine, 说到简直不敢相信FDA竟
: 然APPROVE了这个治疗， ATTENDING说还是有些EVIDENCE的, 我说EVIDENCE是EVIDENCE,
: 但是是MONEY-BASED EVIDENCE。ATTENDING听了说，若干年前当他听说 17 个PHASE II
: 的临床试验证明BOTOX无效，没有MEET primary end point, 但某公司仍然要进行
: PHASE III的临床试验的时候，他的反应就是“见证奇迹的时刻就要到了”。 然后讲了
: 一通故事，听得心里一颤一颤，医药这个水真是太深了...
|
k********n
发帖数: 756 | 7 TMJ can be a trigger but not the primary cause. Correct me if I am wrong
mechanism
【在 d**o 的大作中提到】
: Just a technical question - do you really believe CSD is the sole mechanism
: of migraine? What do you think about the possibility of arising from TMJ?
|
k********n
发帖数: 756 | 8 I agree but sometime doing good things does not mean doing the right thing.
also
.
【在 s********e 的大作中提到】
: I have seen patients who benefit from Botox injections, and of course, also
: some who don't. The latter group wouldn't continue Botox injections anyway.
: Really not much harm there:)
:
: EVIDENCE,
: II
|
