Regulatory generated market needs and supply crises

Pain medications, baby formula, Adderall - I keep hearing about more and more prescriptions drugs that appear to be in short supply or unreliable availability.  Hard to get a good read on just how bad the situation is for a variety of reasons.  The baby formula issue which I thought was resolved months or a year ago actually appears to be ongoing though to a smaller degree than it was.

Pain medication shortages appear to be a mixture of the government simply wanting to reduce people's access to pain reduction medication and also, depending on the medication, also an issue of availability.  Adderall sounds like it has been a pure shortage issue that has been continuing for the better part of a year.

I am only familiar with the pain medication issue owing to rheumatoid arthritis.  Baby formula and Adderall I hear about in the news or from acquaintances.

Just how many drugs are in short supply, affecting how many people?  I have a worrying sense that hydrocodone, Adderall and baby formula might be the tip of an iceberg that the mainstream media is not discussing.

The Free Press is a new news organization focused on providing better and more accurate information than the mainstream media.  They have an article out, America’s Love Affair with Adderall by Maya Sulkin.  The subheading is And what happened when we were forced to live without it.

The shortage is a mere catalyst for the larger issue that the US introduced Adderall in the 1990s and the medical and education establishments swooned over it as a silver bullet for improving behaviors and educational outcomes without understanding the full implications of large numbers of people routinely taking a sustaining prescription without understanding the long term physical or mental implications.

Because Adderall is apparently now in short supply, the dependency and behavioral issues are apparently coming in to sharp relief.

The Adderall shortage has highlighted the central role the stimulant plays in many American lives—more than 19 million children and adults are estimated to have Adderall prescriptions. Some, like James, are desperately searching for the pill they credit with turning them into productive people. Others, mostly in their twenties and thirties, who have been taking Adderall since they were kids, are questioning if they were just normal, restless teens who were given a quick fix—and wound up tethered to the pharmaceutical industry. They now wonder who they would be without it, and are also afraid to find out. 

Then there are those who are misusing the drug—they either had a prescription that ran out long ago, or never had one and are obtaining it from friends or the black market. According to a 2020 national survey, more than 5 million people are estimated to misuse prescription stimulants. In the face of the shortage, they are occasionally trying alternatives such as psychedelic mushrooms. But many are also buying counterfeit versions of Adderall that the DEA warned might contain “potentially life-threatening hidden ingredients, such as fentanyl or methamphetamine.” The threat is real. Last year, two students at Ohio State died after taking fake Adderall laced with fentanyl. 

Adderall itself does not have as deadly a profile as opioid drugs—although it can be fatal if misused—so it has attracted less interest from officials. But the shortage, and the reasons for it, has focused the attention of the federal government on the online world where ADHD is easily diagnosed, and prescriptions of stimulants to treat it are given almost instantly. Recently there has been a law enforcement crackdown on these portals, plus enhanced warnings from the U.S. Food and Drug Administration about the dangers of the abuse of Adderall and other ADHD drugs. 

A new FDA advisory states that most people who “misuse and abuse” these drugs usually get them from friends and family members who have prescriptions. The agency also warns that people who don’t have ADHD, but take Adderall to enhance studying or partying, run the risk of addiction. 

Why is there a shortage?

There are a host of causes of the Adderall shortage. One is manufacturing delays from Teva, a major producer of the amphetamine mixed salts that comprise the drug’s main ingredients. Another is that Adderall is a controlled substance, and its production is regulated by the U.S. Drug Enforcement Administration. Having too much of any controlled substance floating around makes the DEA nervous, so it caps the amount of amphetamine made available to pharmaceutical manufacturers each year. During the shortage, both manufacturers and the government have pointed fingers at each other.

Another reason for the shortage is a dramatic rise in Adderall prescriptions in recent years, thanks to online medical providers willing to prescribe the drug quickly, especially during the Covid-19 lockdowns. From 2020 to 2021, there was over a 10 percent increase in prescriptions among males aged 25 to 44 and females aged 15 to 44, as people found working from home can pose more distractions than a gray cubicle. For American women between the ages of 20 and 24, Adderall prescriptions spiked a remarkable 20 percent between 2020 and 2021.

Adderall was approved by the FDA in 1996 to treat restless kids, and millions of dollars were spent to market it to physicians. It worked, with ADHD diagnoses and Adderall prescriptions increasing in tandem. (A non-amphetamine stimulant, Ritalin, has been approved to treat children with behavioral problems since 1961.) According to the CDC, 3 to 5 percent of American children were believed to have ADHD in the 1990s. Today that figure is almost 11 percent. 

Adderall is no longer thought of as just a pediatric drug, something for restless children—mostly boys—to take until they outgrow their ADHD. There is increasing recognition that for many, ADHD is a lifetime diagnosis. 

From a public health perspective, it sounds like the regulating agencies in combination with the pharmaceutical industry, both created the market for Adderall medicine and have also created the shortage of it.

And it sounds like their solution to the overdependency and the shortage is to increase their regulatory control over who gets how much of the medication.  

It also sounds like, despite being on the market for thirty some years, there is relatively little informative research as to the mental and physical health consequences of sustained dependency of this relatively new drug.

In fact, it sounds like a massive regulatory and governmental failure.  

Our kids were just coming into school in the late 1990s when Adderall was approved.  Schools, teachers, and parents were treating it as a wonder drug which would moderate behavior (especially of boys) and improve education scoring results.  Since it was the least accomplished teachers who seemed to be the most enthusiastic apostles for the miracle drug, I was strongly disposed to skepticism.  And remain so.

I suspect it is a useful drug for some people at some times under some conditions.  I also suspect that the FDA and CDC have no clue as for whom it is useful at what times and under what conditions.  

Between all these drug shortages (known and unknown) and the wretched response to Covid-19 and the dismal review process for the Covid-19 vaccines, you've got to wonder just how deep is the commercial, professional and ethical rot might be at the FDA, CDC, and their sister agencies.  They clearly are not good at their jobs.