The Federal Report on Financial Relationships Between Pharma Industry and Prescribing Physicians

But Shadows Remain on the Controversial ADHD Drug Market

The new Social Security Act, an Obamacare-inspired, Open Payments report came out September 30^th. As part of the new healthcare reform policy, this federal report requires pharmaceutical and medical device companies to annually share documentation of direct payments they provided to entities such as medical practices and teaching hospitals. The goal of Open Payments is to monitor how much doctors are receiving in the form of cash payments or incentives (e.g., free meals, travel junkets, and entertainment) related to the promotion of specific drugs and medical devices marketed in the USA. Details from 2013 reveal that hundreds of pharmaceutical companies (as well as medical device companies) gave a combined $3.5 billion to doctors nationwide.

The more than 2.6 million individual payments or gifts given directly to more than 825,000 health providers and teaching hospitals ranged from a penny for things like “education,” food, and entertainment to more than $9 million for royalties and “research” grants. If you follow just how many hundreds of billions the pharmaceutical industry actually pulls in on an annual basis, the $3.5 billion itemized within the report might seem like a drop in the bucket. In fact, to some who support the pharmaceutical industry’s role in modern medicine, this small amount of money spent might serve as evidence debunking the belief that doctors are being heavily “bribed” or “incentivized” to push more drugs on Americans. But before anyone gets excited and thinks there is finally a reliable and valid monitoring method to document that such payments are minimal as well as on the up and up, please note that 40% of the payment records (considered for inclusion in the 2013 Open Payments report) were not included in the $3.5 billion due to “unresolved questions” being cited.

This initial partial Open Payments report, however, does serve as a much-needed source for shedding a bit more light on a debate fraught with controversy. For decades many have suspected there was a pay-for-favors practice taking place in the health services industry. The belief held that such unethical practices were based on a quid pro quo relationship; we do this for you and you write more prescriptions for us and also – oh, by the way – teach your colleagues and medical students how to write more prescriptions for us. Regardless of which side of this possible conflict of interest debate one might sit, however, for those who take the time to look more closely at the specifics provided in the report, there are many questions left unresolved – even when one considers what actually was reported.

The Devil is in the Details… Consider ADHD Drugs

Before we get much further; if you haven’t read my book or blogs before, I should admit that I have a bias as to which side of the debate I fall when it comes to the Open Payments report. As a psychologist who researches kids and schools nationwide (and has serious concerns about the over-diagnosis, misdiagnosis and far-too-often misguided early diagnosis of children, not to mention the growing trend of drugging kids for acting like kids), I am focused these days on the supposed ADHD epidemic. With a 41% increase in ADHD diagnoses within the last decade, an 89% increase in ADHD drug sales during the past few years, and more than 4.5 million kids waking up every morning to the pharmaceutical-inspired, stimulant-enriched breakfast of champions, to me and millions of others this runaway ADHD pharmaceutical freight train is on a crash course for destruction.

Therefore, when I began exploring the Open Payments report, I will admit I approached it with a great amount of excitement complemented by ample skepticism. What I found however, suggests there is good reason to approach such investigations using the scientific method of inquiry and questioning what the results share. There is a strong possibility we might not be looking at an open, honest account of the amounts and specific intentions behind the payments being reportedly given to doctors.

For example, with ADHD drugs being one of the most popular prescriptions written for the blossoming juvenile drug market, and dozens of pharmaceuticals relying on ADHD meds to be the company cash cow, one might expect to see the Open Payments report reflecting an adolescent breakout when it comes to reported payments supporting ADHD drugs. But as the Open Payments’ dataset documents, 60% of the leading ADHD drug companies I examined claim that 0% of their payments were given to doctors to reward, educate or incentivize the prescribing of ADHD drugs. For some strange reason, these companies supposedly did not put any assets toward incentivizing or educating doctors when it come to the ADHD drugs that lavishly reward the owners and stockholders of billion dollar corporations.

Doing the Math

When word reached me that the report‘s data files were available I immediately went online to download the details. The files were very large, however. In one file there were as many as 2.6 million lines of data detailing payments to practitioners. As a result, the Excel software that came with my Star-Trek inspired Acer laptop choked and sputtered as it tried to open the file. A 2001, A Space Odyssey-like error message at warp speed, saying; “I’m sorry Michael, I can only provide you with a limited portion of this file’s data.” I decided to import the 2.6 million plus lines of data into my more powerful and robust SPSS statistical software. After analyzing the dataset and then using the results to explore some of the specifics related to what was paid to doctors by just 10 companies in the report – companies which provide the controversial ADHD drugs to millions of kids in America – I came to an alarming, yet predictable, discovery.

I came to the conclusion that we shouldn’t assume the “Open” Payments report is actually forthcoming when it comes to how much money and courtship was put toward incentivizing doctors to prescribe ADHD drugs for kids.

In total, the 10 pharmaceutical companies I considered (see Table 1), who manufacture and/or market the most popular brand names in the ADHD drug market, as well as their generic counterparts, were reported to have paid approximately $34.6 million in 2013 to prescribing physicians. This number seemed rather small to me given that some of these companies report profits in the billions annually. But also, given that the ADHD drugs they produce are rumored to be the golden goose for many of their bottom lines, I expected I would find that the majority of these 10 companies’ payments reflected efforts to incentivize the popular ADHD drugs prescribed. But this was not the case.

The detailed Open Payments dataset allows one to actually break down the payments not only by how much each pharmaceutical company paid to each provider, but also by what drugs they discussed during the complimentary lunch, or junket to Spain. When I did an analysis exploring the payments received for discussions specifically on ADHD drugs, the total paid by the 10 pharmaceutical companies specifically for the ADHD drugs they sell was only $634,106.91. Yes, according to the Open Payments report we are expected to believe that these 10 ADHD drug companies spent less than 2% of the mere $34.6 million they contributed to dowry gifts pertaining to ADHD drug promotion.

 

RrrWhat?

This conundrum left me scratching my head, and speaking like Scooby-Doo. The numbers reeked of a mysterious caper. So I decided to go “old school,” tie on my pastel-colored ascot, and start exploring the dataset line-by-line, company-by-company.

One of the companies I investigated was Shionogi Inc. They are a Japanese company that in 2013 made 16,036 payments totaling $1.87 million to wine and dine doctors. If you visit their website you will find they have 13 products advertised. One of those products is called Methylin, an ADHD medication. They also at one time had another ADHD drug called Kapvay. “Be Kaptivated with Kapvay”® is their slogan; sure to excite even the mellowest of medicated children. But Kapvay was no longer listed on their website. More details to follow on this related clue shortly.

As I explored what drugs were listed for the payments made by Shionogi for said lunches and “Entertainment,” I basically only found a few of their 13 drugs connected to the payments they provided for the Open Payments report. The drugs most often reported were Osphena (a drug to treat vaginal pain associated with intercourse) and Naprelan (an anti-inflammatory). My first thought was, “Where are the payments for lunches on the ADHD meds?” But then I started to see a similar pattern across many companies covered in the report. Upon closer examination, many companies were only reporting a few of their drugs related to all of the gifts given.

As I continued to dig further into Shionogi’s expenses, however, I stumbled onto one payment that made everything crystal clear. On line 2,221,306 of the dataset, I found a payment for marketing efforts related to a podiatrist (foot doctor), and the drug listed as the topic of discussion was Osphena; yes, the vaginal pain drug. I couldn’t help but laugh thinking about how my past foot doctors, nice folks but not necessarily the most interpersonal competent medical experts I have met, might work this into their repertoire. Perhaps it would go something like this:

Patient: “Doc, my feet hurt!”

Foot doctor: “”OK, and are you experiencing vaginal pain with intercourse?”

This example goes to show you that the pharmaceutical folks are possibly just willy-nilly putting a few select drugs into the expense account. They also are leaving many of the payments uncategorized (e.g., Eli Lilly had $2.6 million in payments not connected to a specific drug). It almost makes one think they don’t want the ADHD meds to be in the report if possible. Due to the growing controversy surrounding the practice of drugging kids for ADHD, might they not want the public to know? They possibly don’t want us to find out how much they are giving to doctors, or how many favors they are doing for doctors, in an effort to increase the sales of ADHD drugs that coincidentally are contributing greatly to their companies’ annual 100% plus growth in net sales.

But Wait… There’s More!

Are we supposed to believe the pharmaceutical drug reps visiting these doctors, carrying a briefcase full of logo-imprinted company pens, happy-face stress-reducing sponge balls, samples of medications, and an assortment of accompanying drug brochures, only discuss one drug when treating to lunch, dinner, the Bahamas or a sporting event? That’s similar to a produce supplier going to a grocery store with a full truck of fruit and vegetables but only selling lemons. Now for Shionogi, it should be disclosed they signed over their juvenile drug rights in the summer of 2013 to Concordia Healthcare, a Bahamas based company. We should also note that many of the payments in the Open Payments report took place in the last 5 months of 2013.

Therefore, I guess we should assume that even though Shionogi is still selling Methylin on their website and only profiting indirectly from what Concordia sold of Kapvay the last half of the year, they did not discuss ADHD meds at any point of the 16,000 visits. But given they are pushing Osphena on a foot doctor; I hesitate to accept such assumptions so readily. (Now, of course I could be wrong; it is possible I do not know the correct lyrics to the song that explains what the foot bone is actually connected to.)

Regardless, this selling of exclusive marketing and distribution rights seems to be a popular thing in the pharmaceutical industry. For awhile Shire had GlaxoSmithKline selling Vyvanse; Shire’s latest drug to follow up on their blockbuster success with Adderall. But according to Wall Street insiders and an on slot of websites, this partnership didn’t work out so well; both lost money in the deal plagued by legal disputes. But currently Janssen is marketing Johnson & Johnson’s big ADHD med, called Concerta.

Note: I didn’t find any snappy slogans for Concerta. Their marketing approach is more directed at helping parents to think that putting a child on highly addictive Schedule II controlled substances is a good idea. They seem to be of the opinion that putting a child on drugs that share similar qualities to Cocaine and Opium is the best way to get children on the “path to success.” I digress.

But riddle me this, Batman; should we really assume that the sales reps or corporate execs at Janssen made 139,974 payments totaling $15 million (& change) to doctors in the form of cash or other benefits, and not once during the visits or educational trainings did they discuss Concerta? Such efforts seem highly unlikely and quite honestly shortsighted from a business perspective. But as Table 1 highlights, this assumption is what Janssen, Shionogi, Johnson & Johnson, Sandoz, UCB and basically Novartis want us to believe. Yes, according to the “Open” Payments report we are to believe that 60% of the larger companies, supplying pharmacies with the ADHD drugs being doled out to more than 4.5 million kids every morning, did not spend even 1% of their millions or billions on incentivizing the ADHD prescription writing practices.

Business as Usual

I know I have shared my bias when it comes to the pharmaceutical industry drugging kids for – what I would label – quite often normal behavior due to normal developmental delays and childhood challenges. I realize that such business lunches, schwag bags and travel treats are common practice in the business world. And I am sure there are a few folks that would even argue or ask whether exchanging favors in the form of cash payoffs for future services rendered ever leads to unethical business practices. But despite the assortment of unfortunate outcomes from such practices discussed in Business Ethic courses every semester, we are not talking about your average exchange for services, wink of the eye, insert envelope of cash here business pact.

We are not talking about whether a business person buying lunch for a client or potential client as a means of getting them to use one graphic design service or fastener over another’s will harm the end user. We are talking about a different product, business, and end user. We all know how many medical misfortunes are taking place annually due to wrongly prescribed medications. We are talking about doctors prescribing drugs that might not be needed or might not be in the best interest of the patient; the patient being a person who quite often is not in a medical or mental condition, or of the age or expertise, to determine if the advice is healthy, open and safe.

I know, I know; I probably worry too much about drugging kids with medications that even the pharmaceutical companies acknowledge not knowing what the drugs actually do to a child’s brain. As Novartis shares, “The mode of action in man is not completely understood, but Ritalin [Methylphenidate] presumably activates the brain-stem arousal system and cortex to produce its stimulant effect.” Given they presumably know how it might work …What could possibly go wrong with having doctors base their prescribing practices on marketing highlights and in-house research claims provided by the pharmaceutical companies?

I guess we should assume that given the long periods we spend in their waiting rooms, doctors don’t have time to read non-biased peer-reviewed research completed by those not paid by the pharmaceutical companies. Given anything’s supposedly possible, the possibility exists that information about prescribing drugs is much more efficiently and effectively delivered over a highball and baked brie (mmmm, with a peppered Scottish marmalade … that would be nice). Luckily, if we are to believe the Open Payments report is actually open, we do not need to worry about such practices even taking place when it comes to ADHD drugs.

Of course I joke.

I am NOT Knowing

To be candid, the Open Payments report left me with more questions than it did answers. After completing the analysis, I found myself momentarily at a loss for words or reasons behind the surging ADHD drug movement. I thought for sure the report would finally illuminate the true secret behind the ADHD pharmaceutical companies’ massive success in marketing drugs to kids, whom we also try to teach in our schools to “say no to drugs.” I thought the report would show once again that money makes the world go around. But instead I continued to scratch my head in disbelief and bewilderment.

If no one is supposedly paying or incentivizing doctors to put kids on ADHD stimulant drugs, why are they so readily prescribing these drugs to kids that have been on this planet for as few as 36 months? As the New York Times reported, more than 10,000 toddlers are being prescribed ADHD drugs. Why do we even think that it is possible that every young child could be behaving perfectly, performing somewhere above normal (whatever that is), and paying close attention to subjects in school that they often find “boring”? Did these highly-educated doctors attend schools where everyone was an “A” student and normal kids did not attend? Why are they putting millions of our kids on drugs that the FDA warns are highly addictive and hold risk of sudden death? Have they not read the latest pharmaceutical funded multimodal researchers’ study documenting that the drugs provide no benefit from long term use? Have they not read that research does not conclusively document the drugs even provide any benefit for short-term academic outcomes?

Doctors used to take the Hippocratic Oath – “First, do no harm.” Today, however, many in the profession seem to suffer from hypergraphia, and can’t stop themselves from writing more prescriptions for children who can’t help but fidget and daydream in their ergonomic-void, cushion-less seats for seven long Common-Core-designed class periods a day. With recess, physical education, art and music (everything kids actually like about school) being reduced or eliminated across the country, is there not a better explanation (beyond labeling them with a disorder or learning disability) for why they are not paying attention in school or behaving like angels? Is there not a better treatment or avenue educators and parents can provide to help such kids that holds more promise than accepting yet another prescription from a doctor?

I could be watching the wrong TV shows, but between the barrage of erectile dysfunction, depression, and restless leg syndrome television commercials promising blue skies, useless outdoor bathtubs and happiness for all, I rarely see commercials on ADHD drugs. If they are not being educated by the drug companies via commercials or fancy educational dining excursions, or reading the biased brochures so many leave in their waiting rooms explaining just how real ADHD is, where or how are doctors being brainwashed to continue this shortsighted practice, surely to be viewed in the distant future – alongside treating women for Hysteria – as one of the most pathetic moments in medical history?

My Take Away

I end many of my talks with the statement, I could be wrong. And I guess I could be wrong again when it comes to the legitimacy of the Open Payments report. For instance, I have always been astonished by how little cash it takes for a politician to be persuaded by a lobbyist to vote for their cause. Hypothetically, I would think if I was ever to pursue a career in unethical politics, surely I would demand more in order for my vote to be bought. Instead of a small campaign cash contribution or a trip to the Bahamas, I think my own island in the Bahamas would be a much better price tag in exchange for giving up my last cell of dignity.

But as we all know, thanks to federal policy and the internet, most politicians accept small amounts from many lobbyists in exchange for endless political favors and supporting votes. Therefore, to some degree, the Open Payments report could be reflective of a similar low ball approach to buying one’s business in the medical world. I guess it is quite possible the minimal payments received are making an impact in persuading doctors to drug kids for acting like kids, and the Open Payments report is accurate. Maybe doctors truly are a cheap date. Or maybe it is, as the upscale dating service promises, “Just Lunch.”

Regardless, I think it is safe to say that similar to many courses of treatment recommended in the medical profession, the Open Payments report falls short of identifying or solving the problem when it comes to the financial relationships between the pharmaceutical industry and those who prescribe their pills. Though the Open Payments report is enlightening, essential and a much-needed effort, when it comes to exploring the ADHD drugs’ side of the payments, the report highlights that we still have several much bigger problems.

First, the Open Payments report is not accurate. We still have 40% of the payments unaccounted for due to “unresolved questions.” The $3.5 billion reportedly spent for 2013 still could easily double. But also, I do not believe the pharmaceutical companies selling ADHD drugs are being open when it comes to what has been reported. And if the ADHD subsample of the pharmaceutical population is not being forthcoming, the possibility exists the practices are being repeated throughout the industry.

Imagine Apple only advertising their less popular or affordable desktop computers, and never advertised (or offered incentives to their distributors) on the iPhone, their biggest seller. Given many of these ADHD-based pharmaceutical companies profit billions every year, I do not believe they are that dumb. They must be doing something to convince so many doctors to continue this trend of medicating children. Thus, a few of the bigger problems with the Open Payments report most likely subsist of a lack of accuracy, as well as transparency and quite potentially a high level of dishonesty on the part of the pharmaceutical industry.

But the biggest problem is that for some strange reason we have thousands of doctors who would rather prescribe ADHD drugs than share with parents that the 18 simplistic symptoms used to diagnose kids with ADHD are reflective of 18 normal behaviors we see nearly all children exhibit regularly. Instead of being honest with parents and not making a rush to judgment (instead allowing natural child development to occur), far too many mental and medical health providers are providing a drug that supposedly guarantees a quick fix to kids for this apparently All Do Have Disorder. Coincidentally, such practices lead to the child coming back for frequent office visits because the endless list of serious side effects requires close monitoring of their heart, possible stunted weight and height growth, and the need to have prescriptions adjusted regularly (as they lose potency over time and, like any addictive substances, must require more to continue having an effect).

I understand the allure of a quick pharmaceutical fix. I’m a parent and professor. I’ve taught in the juvenile detention system. Yes, kids can drive us crazy. But they call it parenthood, not parentpalooza. This ain’t no party. This ain’t no disco. This ain’t no fooling around. With the same vigor our medical providers are giving honest and healthy advice to patients fighting obesity or heart problems, and explaining that exercise, diet and changing daily routines and habits is the most critical factor for treating such critical conditions, we need practitioners to step up and give the same honest advice and suggested methods for more holistic or family systems-oriented treatments pertaining to ADHD. Let’s increase assets such as parent involvement, structure and sincere empathy for our kids before increasing stimulant medication use.

Thanks a lot, Obama 

President Obama (and the doctors and pharmaceutical companies as well as parents and educators who refuse to play a part in drugging kids for acting like kids), on behalf of your future non-medicated generation of youth; I thank you for the Open Payments report and your efforts. Yes, I really mean it! Thanks Obama! They only get one childhood. Every child going through their critical neurological development stages deserves to spend their days daydreaming and practicing creative expression drug-free. Especially when there are so many other common sense and more healthy treatments available to help parents and educators help kids who are still trying to use a not-quite-developed brain to learn how to be better students and better behaved young adults; or toddlers.

ADHD is not the problem and ADHD drugs are not the answer. Apparently, payments by the ADHD companies to doctors are not the problem or answer. The real answers to getting beyond even caring about such federal watchdog reports lie in putting forth the effort to be better, smarter and more patient parents as well as more inspiring, caring and honest educators. We need more adults to put forth the due diligence to help kids become the future citizens our communities need; not the highly-medicated young adults our businesses try not to hire and our armed forces refuse to enlist. We need to stop believing advertisements and pharmaceutical company claims that drugs are the best approach to capturing our children’s attention. And we need to question such future Open Payments reports for years to come.