The drug regulation and approval process is nuanced and complicated. A story has recently emerged that begs questions about the efficacy, judgment, and communication of both drug regulators and pharmaceutical companies.
This controversy spans international lines, with American researchers weighing in and British scientists speaking up to share their opinions. Let’s dive in and find out what exactly is going on with Spravato.
What is Spravato?
Spravato is an esketamine treatment primarily recommended for those struggling with severe depression. It is an intranasal spray that can be taken weekly. One unique aspect of this medication is that it can produce results within hours, compared to other antidepressant treatments that can take weeks to show slight effects.
One of the reasons for the high interest in this treatment is its possibility of decreasing treatment-resistant depression (TRD). Those with TRD are often turned away by mental health providers who have done everything they can in the way of SSRIs and psychotherapy. For those that are discouraged by their lack of effective options, Spravato provides a unique opportunity for hope.
The FDA approved Spravato for use in the US on March 5, 2019.
In the years since 2019, Spravato has been used by many different patients and widely prescribed by medical professionals for those that have TRD. American research has shown that it’s safe. If that is true, then why was Spravato blocked from entering the British market?
This controversy began when the UK’s National Institute for Health and Care Excellence (NICE) did not approve Spravato. Their main concern was the demand on hospital resources, as the treatment needed to be administered in that medical setting. NICE also didn’t believe in the efficacy of the drug, implying that the current research was not substantial enough to be utilized by the NHS.
The drug firm responsible for Spravato responded to the allegations from NICE. They believe that the drug’s rejection brings up serious concerns about the reliability and integrity of NICE decisions. The original rejection by NICE occurred in May. By June, the drug firm responsible for Spravato had appealed the NICE decision. This appeal was met with support from the Royal College of Psychiatrists.
The Royal College noted serious concerns about the guidelines that NICE is upholding. They believe that NICE is not allowing for fair representation of the needs of those with various mental health diagnoses, making it impossible for them to access the treatment needed for symptom reduction. While it is possible that NICE made an error in judgment, the rejection is bringing up some serious questions.
It is rare that the Royal College would side with a pharmaceutical company. However, their support does raise some causes for concern. Janssen, the producer of Spravato, has made several large donations to various psychiatry departments in the UK. This has made some question the credibility and motivation of the Royal College’s stance.
The concerns that NICE noted are bringing up important questions for those in the US. Is Spravato really worth the high price tag? Is the research as sound as we’ve been made to believe?
The recent developments in the UK have led some in the US to revisit the approval process that Spravato originally went through. This audit has raised some red flags that must be acknowledged.
Spravato was only approved by the FDA because the administration agreed to relax their guidelines in order for the drug to pass through requirements, accepting trial criteria that would previously have been rejected. This revision of requirements brings into question the role of the FDA in the growth of Spravato. If Spravato wouldn’t have passed the original requirements, should the revised guidelines be taken seriously?
When taking a more critical look at the Spravato trials submitted for FDA approval, there are some serious gaps. Galdston and other researchers noted that only one of three trials truly showed esketamine’s benefits rising over placebo reactions. The use of placebos is standard for drug research. If the drug is truly as effective as Janssen believes, then why didn’t it have higher clinical significance?
Suicide is another factor that was overlooked by the FDA. Janssen submitted that the three suicides noted (all within less than a week after treatment) could not be proven to be drug-induced. The FDA accepted this and overlooked the three deaths, but more attempts would follow.
Examining the correlation between a drug and suicide rates should be a fundamental part of the approval process, especially when the drug is recommended for a disorder with high amounts of suicide.
Is Spravato Safe?
While Spravato is still approved for use within the US, its future is somewhat unknown. Questions are continually being raised about the integrity of the FDA’s conclusions when approving the drug. If more concerns are brought forth and questionable decisions are uncovered, the FDA’s original approval may be revoked.
While it’s important to think critically about the drug approval and implementation process, Spravato may still be effective. Its use should not be immediately discontinued, but rather, researched further.
Relying on the judgment of the FDA is a cornerstone in American pharmacology. In order for the general population to feel safe about the medications they’re taking, they must be able to trust the decisions put forth by the FDA. The FDA’s willingness to relax its standards for specific drug approvals brings into question its integrity and clinical judgment.
Holding the FDA accountable is extremely necessary for ensuring that new drugs submitted for approval are truly safe for the public. Asking important questions is an excellent way to make sure that the FDA is establishing safe boundaries with pharmaceutical companies, as well as open communication with the public.
The discussion of Spravato has also raised important questions about the price tag associated with treatment. In order to reduce depression symptoms on a wide scale within our society, medications must be accessible. In many cases, this means lowering the out-of-pocket cost for consumers.
Psychedelic treatments have the potential to revolutionize the mental health field. In order for their true potential to be reached, more research has to be done and prices need to be lowered. Examining the correlation between Spravato and suicide, as well as the original clinical trials that were submitted, are good places to start when evaluating this drug from a critical standpoint.