Mike Murray said:
gwhite said:Again, this is a technical statement of efficacy that is completely blind
to economic
Quoted message said:considerations. I assert then, that it is incorrect or at the very least
unproven and in serious
Quoted message said:doubt. "Availability" sounds nice. Rolls Royces and $10k racing bikes
are "available."....
I would basically agree with the above statement and the portions of the
posting that followed them with the exception that I think it would make a
lot more sense for the newer, safer agents to be made available OTC. If it
is reasonable that there is an OTC agent for treatment of asthma shouldn't
it be the safest one? If albuterol were available OTC then the economic
argument for continued availability of ephedrine would go away since we
would then be looking at just the costs of the drugs themselves which are
not substantially different.
I'm all for that. If albuterol can supplant ephedrine via market force alone, then the correct
result is acquired.
Quoted message said:I also have to point out that there is a counter argument to be made. In
the last several years in the US there has been an increase in the rate of
asthma related deaths. There has been an increase in the number of
asthmatics but even given this the rate of death per asthmatic patient has
been increasing. People have suggested that one of the reasons that this is
happening is because of the availability of effective and relatively side
effect free beta agonist bronchodilators. The claim is that with the newer
drugs patients will continue to treat themselves at home longer and not
present to medical care as early as they might have with the older, more
toxic drugs. Whether this is true or not is debatable and difficult to
study. If it is true than it might be expected that an unintended
consequence of making newer asthma drugs more available would be an even
greater increase in the number of asthma deaths.
If the conclusions are that debatable, we can adjourn the case and allow the drugs, the burden being
on prohibition rather than foundational liberty of transactions. If anything it suggests ephedrine
is *better* in a totally unanticipated way -- its side effects steer folks into the care you believe
is to their benefit.
Quoted message said:It is important to understand the process of how a drug is made OTC in the
US. Someone needs to apply to the FDA for OTC approval. The applicant
needs to show evidence that the drug can be sold directly to the consumer
without input from medical care providers without exposing the consumer to
undue risk. The applicant is generally the company that makes the drug.
The process of applying for this approval costs time and money so it is only
likely to happen if there is an economic incentive. Usually this is if the
drug company feels that there will be more sales of their drug if it gets an
OTC approval. This has recently happened for several drugs; NSAIDs
(ibuprofen and naproxen), H2 antihistaminics (Tagamet, Zantac), proton pump
inhibitors (Prilosec). In part this is because there has been pressure to
make more drugs OTC due to the rising costs associated with seeing a doctor
but, especially in the cases of the drugs I listed, it has also been
motivated by the drug coming off patent and/or the availability of competing
drugs in the same category and a wish on the part of the drug companies to
widen the market for their drug by removing the restriction of requiring a
doctor visit and prescription. In the case of already off patent drugs like
albuterol there is less likelihood that the drug companies will see
increased sales or profits after getting OTC approval so it is less likely
that there will be an application made.
The high cost of albuterol is then maintained -- that suggests the rightful sustenance of ephedrine
on the marketplace.
Quoted message said:It is important to understand that
this process does not include automatic removal of OTC approval for older,
less efficacious or more risky drugs when better drugs become available.
Older drugs are only removed from the market if there is some evidence that
they are dangerous, as was the case for ephedrine. Even then, the removal
can appear capricious since if the drug truly was dangerous it probably
would not have made it to the market in the first place.
This is largely what I suspect.
Quoted message said:There is no
provision for providing a replacement for drugs removed form OTC approval.
There are not provisions for taking into account what might be the "best"
drug to make available or deciding which illnesses can safely be self
diagnosed and treated except on a drug by drug basis.
Technical arguments for "best" when the government is involved simply smells like fruit ripe for
special interest exploitation.
Quoted message said:Basically even
though this is a governmental regulatory process it is for the most part, in
keeping with the general principles in the US, an economically and market
driven process.
I have not seen one decent economic argument against banning ephedrine. I have seen reports of death
attributed to it.
I have seen reports of death attributed to bike riding. The removal of ephedrine is distinctly a
non-market act, pretty much by definition.
Quoted message said:Some people see collusion between the regulatory agencies,
the drug companies and medical care providers in this process but, at least
from my vantage point, the process is more often adversarial rather than
cooperative.
Even altruistic motivations can produce unintended and unfavorable results. As you may gather, I
have a liberal leaning in this matter and believe the government has a bigger burden of proof than
it currently exercises in interfering with private exchanges. Thank you for your thoughtful
response.
