Samuel Clemens (Mark Twain) famously said "There a
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Posted On: 04/18/2019 8:39:32 AM
Samuel Clemens (Mark Twain) famously said "There are 3 types of lies -- lies, damn lies, and statistics."
This is a long post, so here's an executive summary for the impatient: the statistical claims are bogus. Skip to the last 2 paragraphs for actual analysis.
People can find a way to manipulate statistics to try to make it look like their premise is true. If someone wants to cast doubt on the prospects of a drug's approval, they can compare it to things with which it should not be compared, and then say "oh dear, look at these terrible statistics -- just trying to help" -- instead of looking at an appropriate comparison group. Better yet, looking at the specific drug's prospects, instead of a broad group of unlike drugs, is actually meaningful data.
To look at statistics that include a broad spectrum of drugs, many of which are for notoriously difficult-to-treat complex diseases like Alzheimer's, Parkinson's, and cancer, to make a claim about the probability of one particular drug, is a completely specious "analysis" of the situation.
Difficult-to-treat diseases are usually long-term diseases with complex outcomes. What is "success" in an Alzheimer's treatment? Stopping the loss of brain function? Slowing it? What if you can slow the rate of cognitive decline but the treatment causes death in a relatively short period of time (a couple of years instead of the usual 5-10 years after diagnosis)?
Then there are diseases or conditions that are short-term, with easily measurable outcomes. For instance, a relatively minor skin infection, or Oral Mucositis. Drugs for these conditions are administered short-term, and their results can be measured on a much more objective scale.
Using Oral Mucositis as an example, and the Brilacidin-OM formulation clinical trial as an example, here is what would be asked:
Did the patient get oral mucositis? If they did, how long did it last? How severe was it? Did it result in hospitalization? And how does that compare to a control group or to the very well- known statistics for the untreated population -- which is to say, everyone who has had chemo and/or radiation for head and neck cancers, before this drug was developed?
Oral Mucositis is a short-term condition. A clinical trial is fast. Results are much less ambiguous than they are in complex diseases.
This is why it is utterly absurd to try to claim that a rate of approval for ALL drugs with complex, long-term analyses can possibly apply to a much simpler, easily measurable disease.
Would you compare strep throat drugs (antibiotics) to esophageal cancer chemotherapy drugs?
If someone wants to assemble statistics on how many drugs for non-chronic conditions (like oral mucositis and strep throat) are approved after they have had successful Phase 2 clinical trials, AND FOR WHICH THERE IS NO CURRENTLY APPROVED TREATMENT, then I'll take a look at those with interest.
But in the meantime, I prefer to look at actual relevant facts, not bogus comparisons.
• Brilacidin-OM was a huge success in the Phase 2 clinical trial.
• There is no currently approved treatment for Oral Mucositis.
• Brilacidin-OM is easy to administer.
• Brilacidin-OM has NO systemic absorption and no side effects that could interfere with the patient's ability to continue cancer treatment.
• Because there is no systemic absorption there are no concerns that it could interact with chemo drugs and make them less effective.
So THOSE are the only facts that matter -- bogus statistics about other clinical trials are utterly, completely meaningless.
This is a long post, so here's an executive summary for the impatient: the statistical claims are bogus. Skip to the last 2 paragraphs for actual analysis.
People can find a way to manipulate statistics to try to make it look like their premise is true. If someone wants to cast doubt on the prospects of a drug's approval, they can compare it to things with which it should not be compared, and then say "oh dear, look at these terrible statistics -- just trying to help" -- instead of looking at an appropriate comparison group. Better yet, looking at the specific drug's prospects, instead of a broad group of unlike drugs, is actually meaningful data.
To look at statistics that include a broad spectrum of drugs, many of which are for notoriously difficult-to-treat complex diseases like Alzheimer's, Parkinson's, and cancer, to make a claim about the probability of one particular drug, is a completely specious "analysis" of the situation.
Difficult-to-treat diseases are usually long-term diseases with complex outcomes. What is "success" in an Alzheimer's treatment? Stopping the loss of brain function? Slowing it? What if you can slow the rate of cognitive decline but the treatment causes death in a relatively short period of time (a couple of years instead of the usual 5-10 years after diagnosis)?
Then there are diseases or conditions that are short-term, with easily measurable outcomes. For instance, a relatively minor skin infection, or Oral Mucositis. Drugs for these conditions are administered short-term, and their results can be measured on a much more objective scale.
Using Oral Mucositis as an example, and the Brilacidin-OM formulation clinical trial as an example, here is what would be asked:
Did the patient get oral mucositis? If they did, how long did it last? How severe was it? Did it result in hospitalization? And how does that compare to a control group or to the very well- known statistics for the untreated population -- which is to say, everyone who has had chemo and/or radiation for head and neck cancers, before this drug was developed?
Oral Mucositis is a short-term condition. A clinical trial is fast. Results are much less ambiguous than they are in complex diseases.
This is why it is utterly absurd to try to claim that a rate of approval for ALL drugs with complex, long-term analyses can possibly apply to a much simpler, easily measurable disease.
Would you compare strep throat drugs (antibiotics) to esophageal cancer chemotherapy drugs?
If someone wants to assemble statistics on how many drugs for non-chronic conditions (like oral mucositis and strep throat) are approved after they have had successful Phase 2 clinical trials, AND FOR WHICH THERE IS NO CURRENTLY APPROVED TREATMENT, then I'll take a look at those with interest.
But in the meantime, I prefer to look at actual relevant facts, not bogus comparisons.
• Brilacidin-OM was a huge success in the Phase 2 clinical trial.
• There is no currently approved treatment for Oral Mucositis.
• Brilacidin-OM is easy to administer.
• Brilacidin-OM has NO systemic absorption and no side effects that could interfere with the patient's ability to continue cancer treatment.
• Because there is no systemic absorption there are no concerns that it could interact with chemo drugs and make them less effective.
So THOSE are the only facts that matter -- bogus statistics about other clinical trials are utterly, completely meaningless.
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