Comment by Don McCanne
Since it is impossible to read all of the research studies on new drugs, we can be
thankful that we have the Food and Drug Administration (FDA) to collate
and evaluate all of that information so that we know that new drug
products released on the market have been demonstrated to be both
effective and safe. Or can we? This new study adds to our concerns.
thankful that we have the Food and Drug Administration (FDA) to collate
and evaluate all of that information so that we know that new drug
products released on the market have been demonstrated to be both
effective and safe. Or can we? This new study adds to our concerns.
With the politics in our nation being under the control of the pro-market
neoliberals and conservatives, the pharmaceutical industry and insurance
companies have been given a most favored status under the belief that
markets will serve the public better if not constrained by supposedly
excessive government oversight.
neoliberals and conservatives, the pharmaceutical industry and insurance
companies have been given a most favored status under the belief that
markets will serve the public better if not constrained by supposedly
excessive government oversight.
In the case of pharmaceuticals, the public can experience the benefits earlier of the
new blockbuster miracle drugs if the government (FDA) will just get out
of the way, or so they say. More recent laws and regulations have
allowed pharmaceutical firms to pay fees to enter an accelerated process
for new drug approval (like buying their way to the front of the
queue). This accelerated process has been expanded to include most new
drugs, ignoring the fact that there may be a conflict of interest when
firms can buy off government regulators to expedite approval of their
products.
new blockbuster miracle drugs if the government (FDA) will just get out
of the way, or so they say. More recent laws and regulations have
allowed pharmaceutical firms to pay fees to enter an accelerated process
for new drug approval (like buying their way to the front of the
queue). This accelerated process has been expanded to include most new
drugs, ignoring the fact that there may be a conflict of interest when
firms can buy off government regulators to expedite approval of their
products.
To be sure that the information evaluated truly represents the value of the new drugs,
pharmaceutical firms have agreed to register all studies in advance and not just the
studies with favorable results. But research studies with adverse
results are still being filed away without public oversight, explaining
some of the reason that drugs on the market do not have the same
benefits and safety margin as the pre-marketing studies submitted to the
FDA show. Also the firms have promised close post-marketing
surveillance, but that seems to disappear once the drug is approved.
Also the firms are not required to compare new drugs with existing drugs
even though many turn out to be inferior. Yet with our lax rules on
direct-to-consumer advertising, a demand can be created for these new
drugs in spite of their typically outrageous prices. Now Congress is
advancing the CURES Act to further benefit the biomedical firms,
potentially at a cost to the public’s health that may offset the
benefits.
pharmaceutical firms have agreed to register all studies in advance and not just the
studies with favorable results. But research studies with adverse
results are still being filed away without public oversight, explaining
some of the reason that drugs on the market do not have the same
benefits and safety margin as the pre-marketing studies submitted to the
FDA show. Also the firms have promised close post-marketing
surveillance, but that seems to disappear once the drug is approved.
Also the firms are not required to compare new drugs with existing drugs
even though many turn out to be inferior. Yet with our lax rules on
direct-to-consumer advertising, a demand can be created for these new
drugs in spite of their typically outrageous prices. Now Congress is
advancing the CURES Act to further benefit the biomedical firms,
potentially at a cost to the public’s health that may offset the
benefits.
This problem is serious. The study by Saluia et al. shows that over 100 million
prescriptions were issued for drugs that had to be withdrawn from the market
because they proved to be unsafe. About 100,000 people die each year from
drug reactions, and this is particularly tragic when it is from a drug that never should
have been on the market in the first place.
prescriptions were issued for drugs that had to be withdrawn from the market
because they proved to be unsafe. About 100,000 people die each year from
drug reactions, and this is particularly tragic when it is from a drug that never should
have been on the market in the first place.
The stewards of a well designed single payer system would demand much
better performance from the pharmaceutical industry - drugs and other
biomedical products that are effective, that are an improvement over
existing treatments, that are reasonably safe, and that are priced
appropriately based on legitimate costs and a fair profit margin.
Regardless, the government has to step up if we want better quality and
value in our nation’s drug supply.
better performance from the pharmaceutical industry - drugs and other
biomedical products that are effective, that are an improvement over
existing treatments, that are reasonably safe, and that are priced
appropriately based on legitimate costs and a fair profit margin.
Regardless, the government has to step up if we want better quality and
value in our nation’s drug supply.
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