OUTRAGEOUS FDA DELAY ENDANGERS MELANOMA VICTIMS

FYI:

The FDA vote was 8 to 7, to approve use of melafind with 1 vote of abstention. It should however never take the place of a biopsy.

FYI:

The FDA vote was 8 to 7, to approve use of melafind with 1 vote of abstention. It should however never take the place of a biopsy.

FYI:

The FDA vote was 8 to 7, to approve use of melafind with 1 vote of abstention. It should however never take the place of a biopsy.

the cancer business machine is so powerful.. .why would they want to save lives and not make the $30,000 a treatment?? i find this so disgusting.. it makes me want to vomit…

i have read and watched too many articles and movies to not know the underlying sinister squashing of new and safer methods of treating cancer… its all about $$$$$… and it needs to change…

xx

the cancer business machine is so powerful.. .why would they want to save lives and not make the $30,000 a treatment?? i find this so disgusting.. it makes me want to vomit…

i have read and watched too many articles and movies to not know the underlying sinister squashing of new and safer methods of treating cancer… its all about $$$$$… and it needs to change…

xx

the cancer business machine is so powerful.. .why would they want to save lives and not make the $30,000 a treatment?? i find this so disgusting.. it makes me want to vomit…

i have read and watched too many articles and movies to not know the underlying sinister squashing of new and safer methods of treating cancer… its all about $$$$$… and it needs to change…

xx

I have followed MelaFind for a few  years with interest since finding it in an obscure Google Scholar article from an even more obscure link contained in the LA Times.

Though not a fan of the FDA nor Corporate Cancer, what has stood out in following MelaFind is that, although an important discovery;  from the outset the problem has been how to  fit it into the model of clinical trials which is :"measure tolerance,measure  to specific disease and contrast it with known discoveries and evaluate the difference in benefit, cost and longevity" in a fashion that would garner regulatory approval through clinical trials.

First,trial  they tried "is it more accurate than a biopsy?"…………….the answer was no. The patient still needs a biopsy for the patient to be Staged. And because it was only an additional cost without benefit, the cost to benefit ratio was not met.

Second, they tried "is it more accurate than visual analysis?"  The answer again was no, because visual analyisis alone always had to be confirmed through a biopsy .

Three they tried visual analyisis versus MelaFind.  That required doctors to submit samples they deemed suspicious for pathology AFTER being scoped out by MelaFind.  If considered suspect by the doctor, it was sent to pathology, but NOT if it was considered suspect by MelaFind alone. That didn't work either as a peer reviewed trial construct.

Four……and this was the most dificult.   How do you get doctors to say a lesion does not require biopsy, but based upon MelaFind alone, we will? Why?  So the doctors can be proved wrong?  That did not work either.

Five.  Enter the Dermacope, A most used tool, the Dermascope was the perfect product for comparison.  Problem is Dermascope was brought to market by the Endoscope folks,,,,,,,,,,,,,,,,not unlike Shering-Plough……………..the one time owners of Coppertone…………remember them?……….."tan don't burn get a coppertone tan", who later held the original patent for Interferon.

I will stop there, but will end that your view of the FDA as a bad Santa is really only half the story.

Reminds me of when I witnessed the progressive FDA approval process from CT Scans to MRI Scans to PET Scans to CT/Pet Overlay scans.

Almost identical.

Maybe esoteric, but in close to 25 years, I find it interesting.

INot their defender, but t ain't the FDA alone.

Charlie S

I have followed MelaFind for a few  years with interest since finding it in an obscure Google Scholar article from an even more obscure link contained in the LA Times.

Though not a fan of the FDA nor Corporate Cancer, what has stood out in following MelaFind is that, although an important discovery;  from the outset the problem has been how to  fit it into the model of clinical trials which is :"measure tolerance,measure  to specific disease and contrast it with known discoveries and evaluate the difference in benefit, cost and longevity" in a fashion that would garner regulatory approval through clinical trials.

First,trial  they tried "is it more accurate than a biopsy?"…………….the answer was no. The patient still needs a biopsy for the patient to be Staged. And because it was only an additional cost without benefit, the cost to benefit ratio was not met.

Second, they tried "is it more accurate than visual analysis?"  The answer again was no, because visual analyisis alone always had to be confirmed through a biopsy .

Three they tried visual analyisis versus MelaFind.  That required doctors to submit samples they deemed suspicious for pathology AFTER being scoped out by MelaFind.  If considered suspect by the doctor, it was sent to pathology, but NOT if it was considered suspect by MelaFind alone. That didn't work either as a peer reviewed trial construct.

Four……and this was the most dificult.   How do you get doctors to say a lesion does not require biopsy, but based upon MelaFind alone, we will? Why?  So the doctors can be proved wrong?  That did not work either.

Five.  Enter the Dermacope, A most used tool, the Dermascope was the perfect product for comparison.  Problem is Dermascope was brought to market by the Endoscope folks,,,,,,,,,,,,,,,,not unlike Shering-Plough……………..the one time owners of Coppertone…………remember them?……….."tan don't burn get a coppertone tan", who later held the original patent for Interferon.

I will stop there, but will end that your view of the FDA as a bad Santa is really only half the story.

Reminds me of when I witnessed the progressive FDA approval process from CT Scans to MRI Scans to PET Scans to CT/Pet Overlay scans.

Almost identical.

Maybe esoteric, but in close to 25 years, I find it interesting.

INot their defender, but t ain't the FDA alone.

Charlie S

I have followed MelaFind for a few  years with interest since finding it in an obscure Google Scholar article from an even more obscure link contained in the LA Times.

Though not a fan of the FDA nor Corporate Cancer, what has stood out in following MelaFind is that, although an important discovery;  from the outset the problem has been how to  fit it into the model of clinical trials which is :"measure tolerance,measure  to specific disease and contrast it with known discoveries and evaluate the difference in benefit, cost and longevity" in a fashion that would garner regulatory approval through clinical trials.

First,trial  they tried "is it more accurate than a biopsy?"…………….the answer was no. The patient still needs a biopsy for the patient to be Staged. And because it was only an additional cost without benefit, the cost to benefit ratio was not met.

Second, they tried "is it more accurate than visual analysis?"  The answer again was no, because visual analyisis alone always had to be confirmed through a biopsy .

Three they tried visual analyisis versus MelaFind.  That required doctors to submit samples they deemed suspicious for pathology AFTER being scoped out by MelaFind.  If considered suspect by the doctor, it was sent to pathology, but NOT if it was considered suspect by MelaFind alone. That didn't work either as a peer reviewed trial construct.

Four……and this was the most dificult.   How do you get doctors to say a lesion does not require biopsy, but based upon MelaFind alone, we will? Why?  So the doctors can be proved wrong?  That did not work either.

Five.  Enter the Dermacope, A most used tool, the Dermascope was the perfect product for comparison.  Problem is Dermascope was brought to market by the Endoscope folks,,,,,,,,,,,,,,,,not unlike Shering-Plough……………..the one time owners of Coppertone…………remember them?……….."tan don't burn get a coppertone tan", who later held the original patent for Interferon.

I will stop there, but will end that your view of the FDA as a bad Santa is really only half the story.

Reminds me of when I witnessed the progressive FDA approval process from CT Scans to MRI Scans to PET Scans to CT/Pet Overlay scans.

Almost identical.

Maybe esoteric, but in close to 25 years, I find it interesting.

INot their defender, but t ain't the FDA alone.

Charlie S

I have followed MelaFind for a few  years with interest since finding it in an obscure Google Scholar article from an even more obscure link contained in the LA Times.

Though not a fan of the FDA nor Corporate Cancer, what has stood out in following MelaFind is that, although an important discovery;  from the outset the problem has been how to  fit it into the model of clinical trials which is :"measure tolerance,measure  to specific disease and contrast it with known discoveries and evaluate the difference in benefit, cost and longevity" in a fashion that would garner regulatory approval through clinical trials.

First,trial  they tried "is it more accurate than a biopsy?"…………….the answer was no. The patient still needs a biopsy for the patient to be Staged. And because it was only an additional cost without benefit, the cost to benefit ratio was not met.

Second, they tried "is it more accurate than visual analysis?"  The answer again was no, because visual analyisis alone always had to be confirmed through a biopsy .

Three they tried visual analyisis versus MelaFind.  That required doctors to submit samples they deemed suspicious for pathology AFTER being scoped out by MelaFind.  If considered suspect by the doctor, it was sent to pathology, but NOT if it was considered suspect by MelaFind alone. That didn't work either as a peer reviewed trial construct.

Four……and this was the most dificult.   How do you get doctors to say a lesion does not require biopsy, but based upon MelaFind alone, we will? Why?  So the doctors can be proved wrong?  That did not work either.

Five.  Enter the Dermacope, A most used tool, the Dermascope was the perfect product for comparison.  Problem is Dermascope was brought to market by the Endoscope folks,,,,,,,,,,,,,,,,not unlike Shering-Plough……………..the one time owners of Coppertone…………remember them?……….."tan don't burn get a coppertone tan", who later held the original patent for Interferon.

I will stop there, but will end that your view of the FDA as a bad Santa is really only half the story.

Reminds me of when I witnessed the progressive FDA approval process from CT Scans to MRI Scans to PET Scans to CT/Pet Overlay scans.

Almost identical.

Maybe esoteric, but in close to 25 years, I find it interesting.

INot their defender, but t ain't the FDA alone.

Charlie S

I have followed MelaFind for a few  years with interest since finding it in an obscure Google Scholar article from an even more obscure link contained in the LA Times.

Though not a fan of the FDA nor Corporate Cancer, what has stood out in following MelaFind is that, although an important discovery;  from the outset the problem has been how to  fit it into the model of clinical trials which is :"measure tolerance,measure  to specific disease and contrast it with known discoveries and evaluate the difference in benefit, cost and longevity" in a fashion that would garner regulatory approval through clinical trials.

First,trial  they tried "is it more accurate than a biopsy?"…………….the answer was no. The patient still needs a biopsy for the patient to be Staged. And because it was only an additional cost without benefit, the cost to benefit ratio was not met.

Second, they tried "is it more accurate than visual analysis?"  The answer again was no, because visual analyisis alone always had to be confirmed through a biopsy .

Three they tried visual analyisis versus MelaFind.  That required doctors to submit samples they deemed suspicious for pathology AFTER being scoped out by MelaFind.  If considered suspect by the doctor, it was sent to pathology, but NOT if it was considered suspect by MelaFind alone. That didn't work either as a peer reviewed trial construct.

Four……and this was the most dificult.   How do you get doctors to say a lesion does not require biopsy, but based upon MelaFind alone, we will? Why?  So the doctors can be proved wrong?  That did not work either.

Five.  Enter the Dermacope, A most used tool, the Dermascope was the perfect product for comparison.  Problem is Dermascope was brought to market by the Endoscope folks,,,,,,,,,,,,,,,,not unlike Shering-Plough……………..the one time owners of Coppertone…………remember them?……….."tan don't burn get a coppertone tan", who later held the original patent for Interferon.

I will stop there, but will end that your view of the FDA as a bad Santa is really only half the story.

Reminds me of when I witnessed the progressive FDA approval process from CT Scans to MRI Scans to PET Scans to CT/Pet Overlay scans.

Almost identical.

Maybe esoteric, but in close to 25 years, I find it interesting.

INot their defender, but t ain't the FDA alone.

Charlie S

I have followed MelaFind for a few  years with interest since finding it in an obscure Google Scholar article from an even more obscure link contained in the LA Times.

Though not a fan of the FDA nor Corporate Cancer, what has stood out in following MelaFind is that, although an important discovery;  from the outset the problem has been how to  fit it into the model of clinical trials which is :"measure tolerance,measure  to specific disease and contrast it with known discoveries and evaluate the difference in benefit, cost and longevity" in a fashion that would garner regulatory approval through clinical trials.

First,trial  they tried "is it more accurate than a biopsy?"…………….the answer was no. The patient still needs a biopsy for the patient to be Staged. And because it was only an additional cost without benefit, the cost to benefit ratio was not met.

Second, they tried "is it more accurate than visual analysis?"  The answer again was no, because visual analyisis alone always had to be confirmed through a biopsy .

Three they tried visual analyisis versus MelaFind.  That required doctors to submit samples they deemed suspicious for pathology AFTER being scoped out by MelaFind.  If considered suspect by the doctor, it was sent to pathology, but NOT if it was considered suspect by MelaFind alone. That didn't work either as a peer reviewed trial construct.

Four……and this was the most dificult.   How do you get doctors to say a lesion does not require biopsy, but based upon MelaFind alone, we will? Why?  So the doctors can be proved wrong?  That did not work either.

Five.  Enter the Dermacope, A most used tool, the Dermascope was the perfect product for comparison.  Problem is Dermascope was brought to market by the Endoscope folks,,,,,,,,,,,,,,,,not unlike Shering-Plough……………..the one time owners of Coppertone…………remember them?……….."tan don't burn get a coppertone tan", who later held the original patent for Interferon.

I will stop there, but will end that your view of the FDA as a bad Santa is really only half the story.

Reminds me of when I witnessed the progressive FDA approval process from CT Scans to MRI Scans to PET Scans to CT/Pet Overlay scans.

Almost identical.

Maybe esoteric, but in close to 25 years, I find it interesting.

INot their defender, but t ain't the FDA alone.

Charlie S