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03/29/2017

21st Century Cures Act – Promises or Problematic?

Late last year a new healthcare act was passed.  The 21st Century Cures Act has been lauded by many on both sides as a compromise that would help many sick individuals. The 21st Century Cures Act promised to bolster new cures and create faster regulatory processes that would help the nation get promising innovative cures to those who need them.   The basis of these claims is that the nation’s current set-up slows down innovation by asking for randomized control trials (RCTs) and spending too little on finding new cures. While these claims seem true on the surface, many criticize the new healthcare act for its incentives for pharmaceutical companies.  Personally, I have a saying that goes “A good compromise will probably leave both sides unhappy.”  So when an act passes with as much praise and speed as the new act did, I cannot help but wonder if the disadvantages would outweigh the advantages.  For this reason,  I will analyze the act’s contents to determine strengths and weaknesses of the act, then make an informed conclusion as to whether it is a net positive or negative.

The positives of the 21st Century Cures Act are numerous.  The biggest benefit for society  would have to be funding for the National Institute of Health (NIH).  The NIH is an invaluable part  of research funding in the nation.   Since the NIH does a large portion of its research through grants, organizations can more efficiently allocate money given to them in ways that benefit their research.  That established,  the new act has secured over 4 billion dollars for the NIH over the next 10 years.  The NIH is probably the single greatest driver of innovation owing to the intrinsic costs of pathophysiologic research.  The fact is that pharmaceutical companies can make no guarantee that the research to discover the pathophysiology of a disease will yield them any wealth.  It is actually a well-known fact that as much as $3 billion can be invested in new drug discovery research and no new drug may be approved by the Federal Drug Administration (FDA).  This is because the complexities of biology prevent researchers from always knowing the effect of changes they make.  In essence, intended benefits and side-effects generally do not yield actual benefits and side-effects.  So, funding the NIH to do the burden of such research frees pharmaceutical companies to aim more money on specific treatments. This will make it cheaper to find cures for disease with few or no treatments and expand the treatments already in existence.

One of the major concessions of the act, from a safety stand point, is that the 21st Century Cures Act has eroded the FDA’s strength to determine the value of new cures.  The problem with the act comes in the degradation of the data that is being given to the FDA.  It is no secret that RCTs are regarded as incredibly valuable data.  This owes to the fact that personal experience is subject to many external factors including one’s own biology.  The bigger issue with the new law and the FDA is “real-world experience.”  From a scientific standpoint, RCTs are “ideal-world experience”.  RCT’s do not give perfect data of all the flaws of a drug, they set a relatively high bar that allows the FDA to make reasonable assumptions about the safety of a drug.  By moving over to “real world experiences”, more side-effects could be missed.  This is important because many drugs carry risks that are not discovered until years after they have been in the market.  Considering that it takes 12 years to get a black box warning on a medication and 5 to get it removed, the negative implications of rapid approval start to become more worrying.   Without expediting the process of getting black box warnings added or getting drugs removed from the market, it becomes worrying that many new drugs are being added to the market. 

The 21st Century Cures Act’s most worrying aspect is that it could lead to many dangerous drugs coming to market, without novel drugs that may help ever seeing the light of day.  The FDA was created at a time when dangerous substances with little or no medical value were being peddled as cures.  The act could end up creating more overall problems caused by an expansion of medications known as me-too drugs.  To be fair, me-too drugs do come with benefits.  In the statin class, many me-too drugs currently exist for the sole purpose of competing with other drugs in that class.  Because the market, dyslipidemia, is so large even a small percentage can be worth billions over a decade.  If one can make an improvement in this class then the benefits are net positive.  Me-too drugs can also increase economic output via creating a need for advertising, production and other media.  Another noteworthy advantage is that it could lead to drugs that are not as potent as a competitor getting priced more cheaply to undercut the competition.  The problem is that, it could also jeopardize patient safety by adding many new drugs with too little information on them.  The lack of information could lead to inappropriate use creating harm or death.  For example, 81 mg aspirin is no longer sold under the therapeutic label of “baby aspirin”.  This is because it was noted that 81 mg aspirin could cause Reye’s syndrome in children with viral infections.   Adults are not subject to this same deadly adverse effect, and with the existence of other drugs such as ibuprofen or acetaminophen, it was decided that aspirin would no longer be used in children.  Since even well-known drugs can have interactions that are not well known for years, adding more medications with less data could have effects that will not bode well in time for society.  While adding new classes of drugs can hold many of the same negatives, it also gives a unique form of treatment.  In the long run, new drug classes could potentially be used in conjunction with existing therapy.  In this way, the funding for new drugs comes off as dubious.

In summation, while the 21st Century Cures Act was a well-intentioned idea, its overall likelihood for net negative healthcare is high.  The positives are noteworthy.  We will see more drugs enter the market.  This will almost assuredly increase the number of jobs and boost the economy in general.  New cures will help patients and lead to instances of better outcomes.  At the same time a rational person can look at the situation and say that the possibility for negatives does exist.  Adding 1 or two more high intensity statins could help the healthcare industry, but if a patient is statin intolerant then 20 new cure does not help.  Also, those who are already doing well on a statin but might need an additional medication will not benefit from this new act.  Adding more problems is the lack of data that is compounding this problem.  In the healthcare industry, mistakes can be life altering or threatening.  Adding more potential cures without sufficient data to assess them is not a good idea.  In this respect, the 21st Century Cures Act is problematic legislation that will not help patient healthcare as much as it was promised to do.

Adekunle O. Adejare, PharmD Candidate – ‘19

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