Showing posts with label DTC advertising. Show all posts
Showing posts with label DTC advertising. Show all posts

Friday, April 11, 2025

The Tech Bros Want to Replace Your Teachers and Doctors

 The Matrix


 

Just last week I was contacted by an acquaintance about Viagra.  He was not a physician and got the prescription through an online business that specializes in dispensing hair loss, erectile dysfunction, anxiety, and depression medications. When I see these businesses advertising that combination of medications it always piques my interest. Why these medications? Comparing them with the most prescribed drugs in the US – 3 antidepressants are in the top 20 - sertraline, trazodone, and escitalopram.  They can double for anxiety medications.  Viagra (sildenafil) is 157 and Cialis (tadalafil) is 172.  Finasteride can be used for both hair loss and prostatic hypertrophy and it is number 72.  Topical minoxidil is not on the list. It is not like there is a shortage of prescriptions for any reason.

My contact person had talked with one of the online prescribers and was not sure about how he was supposed to take the medication. Should he take it every day or just on the days he was going to have intercourse?  Reading the prescription label and the information he was sent was not helpful.

More of these online prescribing services seem to be advertising every day.  They promise cost effectiveness, the same medications that your physician would prescribe, ease or use, and no embarrassment.  How many times have you been in line at your clinic or pharmacy and had a staff person belt out some information about you that you preferred stay private?  That line on the floor separating you from the other patients is not enough distance to muffle a receptionist shouting through plexiglass.  The online service promises to send you the medication in a plain brown wrapper. 

The real downsides to this new relationship are never mentioned. No access to your records to check for contraindications, drug-drug interactions, pre-existing medical conditions, the status of your liver and kidney function, or allergies. No access to your physician who may know you so well that they can say if taking a new medication would be advisable or not. No detailed discussions of risks, potential benefits, and unknowns. For me that discussion has taken longer than most of the telemedicine visits I have heard about.  And most importantly – no access to somebody who knows your situation if something goes wrong.

There is a real issue about how much information these rapid online prescribers keep on file and what it is used for.  Do they list your major medical conditions?  Does that lead to marketing? Does that lead to data mining to develop sufficiently large programs to make more money off you?  Recall that wherever your data is on the Internet, somebody is trying to profit from it.

That brings me to a stark conclusion about capitalism that I discovered too late in life. Growing up in the US, you are sold on the idea that capitalism and democracy are the mainstays of the country.  We are special because of both and we do both better than anyone else in the world.  The wealthy are idealized and everyone aspires to be wealthy.  If you can't get wealthy maximizing your material possessions seems to be a substitute.

American products are good because our environment producers entrepreneurs and competition among entrepreneurs produces superior products.  Think about that for a second.  The entrepreneur gets all the credit.  Forget about all of the science and engineering behind any product.  The faceless people laboring behind the scenes are hardly ever mentioned. If you are industrious enough, you might be able to find out who holds the patents but in the end they are all property of a large company.  And that company is there for one reason – to make as much money as possible.

In a service industry like medicine corporate profits were initially hard to come by because it was a cottage industry of private physicians.  Even as the corporate takeover began in the 1980s, physicians resisted to some extent as a powerful mediating class between corporate interests and the interests of physicians and patients. The end run around that physician mediation was hiring them as employees.  Initially corporations proposed that they were going to make primary care more accessible and minimize specialists.  In the end that was merely a tactic and they acquired specialty care as well as primary care.  Today most physicians are employees and have minimal input to their practice environment.  They are essentially told by middle managers how to practice medicine.  They work by default for companies like managed care companies and pharmacy benefit managers that waste physician time to rubber stamp their rationing procedures. 

The profits from the corporate takeover of medicine are high.  It is after all a recipe for making money.  There is a stable subscriber base fearful of medical bankruptcy and the corporation can decide how much of those funds it wants to spend. In thinking of new ways to make more money, telemedicine is the latest innovation. Convenience is a selling point. It has been used for decades to reach people in rural areas who would have a hard time travelling long distances to clinics.  But the current model is more like Amazon online shopping.  If you have condition x, y, or z – contact us and we will get you a prescription. Better yet, let’s take the pharmacy middle man out of the picture and prescribe and sell you the medication at the same time.    

A recent commentary in the NEJM pointed out the potential problems of the new relationship between pharmaceutical companies and telehealth firms (1). It is as easy to imagine as the following thought experiment.  Suppose you are watching a direct-to-consumer ad about a weight loss drug.  You go to the suggested web site where it tells you to make a telehealth appointment the same day for a nominal fee. One study showed that 90% of patients referred through this sequence got a prescription for the advertised drug.  The pharmacoepidemiology, quality of care, and legal ramifications of these arrangements are unknown.  The scrutiny is nonexistent compared with the claims that physicians were being influenced for decades by free lunches.  That matches my suspicion that the physician conflict of interest hype was more a political tactic than reality to suppress any objections to the political and corporate takeover of medicine.  

That brings me to the Bill Gates (2) comment.  Expectedly he is an unabashed promoter of computer technology and the latest version – artificial intelligence or AI.  His thesis is that AI will commoditize intelligence to the point that humans will not be necessary for most things including teaching and medicine. No mention of the conflict of interest.  The company he founded – Microsoft is currently heavily marketing computers with an early version of AI. A couple of years ago they also changed to a license for life model.  In other words when you buy a Microsoft computer or software package – you no longer own it outright.  You must pay a monthly licensing fee if you use it or if they decide not to support your computer any more – you must upgrade it to continue paying monthly fees for a long as you use your new computer.  Or until they tell you again that you have to buy a new one.  Even though intelligence is “free” Microsoft and all of the other major tech companies are not really giving it away – they have a recipe for making money off of you for the rest of your life.   

There is a reason that doctors don’t know much about business or politics. Both are highly corrupting influences. Medicine is a serious profession that is squarely focused on mastering a large volume of information and technical skill and keeping that current. Businesses on the other hand are focused on every possible way they can get your money and they are very good at it. If it comes down to an AI program providing medical care that is all you really need to know.

 

George Dawson, MD, DFAPA

 

References:

1: Fuse Brown EC, Wouters OJ, Mehrotra A. Partnerships between Pharmaceutical and Telehealth Companies - Increasing Access or Driving Inappropriate Prescribing? N Engl J Med. 2025 Mar 27;392(12):1148-1151. doi: 10.1056/NEJMp2500379. Epub 2025 Mar 22. PMID: 40126465.

2:  Richards B.  Bill Gates Says AI Will Replace Doctors, Teachers and More in Next 10 Years, Making Humans Unnecessary 'for Most Things'.  People Magazine March 29, 2025.  https://people.com/bill-gates-ai-will-replace-doctors-teachers-in-next-10-years-11705615

 

Graphic Credit:

Click on the graphic directly for full information on the Wikimedia Commons web site including CC license.  It is used unaltered here. 

 

 


Tuesday, February 3, 2015

Did The FDA Forget About America's First Amphetamine Epidemic?




That was the first thought I had when I read through the FDA release on the approval of Vyvanse for "binge-eating disorder".  I thought of the rotation I did on the Eating Disorder service at the University of Minnesota with some of the top experts in anorexia nervosa and bulimia.  In those days the residents admitted the patients and also rotated through the outpatient clinic where they saw new cases of eating disorders and developed treatment plans with the supervision of the attendings.  We talked about a lot of binge eating, since binge eating was a critical aspect of bulimic behavior.  ""Do you ever consume an amount of food large enough that it might be embarrassing if someone else found out?" and getting the details of that specific behavior was one of my standard interview questions.  It was clear that the binge eating of bulimia was a volume and rate task.  I would hear about large amounts of diet soda and popcorn being consumed in order to complete the cycle.

In the intervening 2 decades the only real changes was the addition of bulimia nervosa a composite of bulimic and anorexic behaviors.  That is until the advent of Binge-Eating Disorder in DSM-5.  In addition to a binge definition not much different from the one I used in 1984 eating an amount of food that is "definitely larger than what most people would ingest in the same period and similar circumstances" there is loss of control, and behavioral specifiers for rapidity, physical sensations, appetite, and psychological reactions to the binge eating.  Marked distress needs to occur and it cannot be part of another eating disorder.  The time specifier is that it needs to occur at least once a week for 3 months.  A summary of the FDA release about the indication states:

 “Binge eating can cause serious health problems and difficulties with work, home, and social life,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating."   

The DSM-5 has a point prevalence estimate of 1-1.5% in women with a peak in late adolescence and early adulthood.  That same section in the DSM-5 suggests that the course is variable:

"However, over longer-term follow-up, the symptoms of many individuals appear to diminish with or without treatment, although treatment clearly impacts outcome. Periods of remission longer than 1 year are associated with better long-term outcome." (DSM-5 p 351-352)

As far as I can tell, the evidence supporting the fast tracked application for Vyvanse is a typical 8 week clinical trial that looked at remission and reduction in binge eating rates in a multicenter study of 255 individuals (1).  Both the 50 and 70 mg doses were effective.  The publication of the research coincides fairly closely with the FDA release.  Searching through the FDA web site reveals no information about the opinion of a Scientific Committee and whether there was any consensus on the decision or concerns about the addictive potential of the drug.  

The pharmacology of the Vyvanse is interesting.  It is a prodrug - lisdexamfetamine that is a conjugate of lysine and amphetamine.  After it is absorbed into the circulation it is hydrolyzed to lysine and amphetamine.  There has always been some debate about whether this prodrug approach confers a decreased likelihood that the compound can be abused or used in an addictive manner.  Most addiction psychiatrists will tell you that it can and  the FDA approved package insert confirms the fact that it has significant abuse potential.   It is a Schedule II drug according to the DEA.

The lesson of the first amphetamine epidemic is that these drugs will be prescribed, to the point that there is very high demand and production of the drug.  Widespread health consequences were noted from overprescribing stimulants for questionable indications (weight loss, nasal congestion, depression, anxiety, psychosomatic complaints).  During the peak of this epidemic (1969) the total number of 10 mg amphetamine doses was about 25 million.  This was not exceeded until about 2005 and then only as a combination of amphetamine and methylphenidate.  As a psychiatry resident in the 1980s, I was still seeing obese people who had not lost a pound using very high doses of amphetamines.  The weight loss indication was subsequently banned in order to establish some limits on the overprescription of these compounds.  In other words, they were taking the drug because of an addiction rather than using it for any therapeutic effect.  It is clear that the prescription of controlled substances for diagnoses that are based on subjective findings is a recipe for epidemics of addictive drugs both in terms of total prescriptions, escalating use, and diversion.  Stimulant medications have the additional allure as possible performance enhancing drugs and are widely diverted for that purpose.

In that context, it would seem that the FDA would need to come up with a clear rationale for using a Schedule II drug to treat what may be a time limited disorder or a disorder that responds to non-medical therapies.  The complex nature of medications that have addictive potential needs to be recognized.  The prescription of these compounds takes more than rote knowledge. At the minimum there needs to be strict pharmacosurveillance on how this drug is prescribed and flags need to be in place for trends indicating that the prescriptions are starting to exceed the known prevalence of the disorder or the dose ranges are higher than recommended and/or combined with short acting stimulants.  These are all common problems seen in the overprescription of controlled substances.

Passive post marketing surveillance can no longer be considered a viable option for stopping the overprescription of controlled substances.   Waiting for intervention by law enforcement when problems have already begun is an approach from the 1960s.  In an era when data mining is commonplace, the FDA can do a lot more than get drugs out into the marketplace and wait to see what happens.         



George Dawson, MD, DFAPA


1: McElroy SL, Hudson JI, Mitchell JE, Wilfley D, Ferreira-Cornwell MC, Gao J, Wang J, Whitaker T, Jonas J, Gasior M. Efficacy and Safety of Lisdexamfetamine for Treatment of Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Jan 14. doi: 10.1001/jamapsychiatry.2014.2162. [Epub ahead of print] PubMed PMID: 25587645.

2: Nutt, David, Leslie A King, William Saulsbury, Colin Blakemore. Development of a rational scale to assess the harm of drugs of potential misuse. The Lancet 2007; 369:1047-1053. PMID 17382831;doi:10.1016/S0140-6736(07)60464-4








Supplementary 1:  The following graph is from Wikimedia Commons and it is public domain.  It is a derivative work of reference 2 above and a complete description is available at this link.  I could find no author to cite.




Supplementary 2:  Almost on cue I noticed the first banner ads for Binge-Eating Disorder today (2/12/2015).  It is advertised as a "real medical disorder" and is a brief informational film.  It has a spokesperson who talks about her experience with the disorder and refers the interested viewer to the company web site at BingeEatingDisorder.com.  It carefully coaches people in how to talk with their doctor.  The pharmaceutical company and manufacturer is listed at the bottom on the page.  The graphic of a pizza slice over a drawing of a brain varies in different views.  I don't know exactly what that means.  It suggests psychological therapies for B.E.D. and does not mention Vyvanse.  But let's face it - when people read there is a pill for their eating problem and it is an amphetamine - how many people will be asking for the psychological therapies?