Episode 1 of Season 2 of Last Week Tonight with John Oliver took on the important relationship between doctors and the pharmaceutical industry, encouraging his viewers to look up their doctors’ relationships with the industries (meals, speaking events, “thought leader” status) through the website http://openpaymentsdata.cms.gov. And as an avid fan of John Oliver (I do indeed profess my belief to Our Lady of Perpetual Exemption) and as a citizen interested both personally and professionally in interest group influence in our legal and medical systems, I spent a lot of time on there. This is an issue of immense magnitude: Americans spent $329.2 billion on prescription drugs in 2013, and few of us understand the science underlying them or the rationale behind the prescription unless particularly inquisitive. I looked up all of my doctors over the years (sadly, there have been many) and took satisfaction out of knowing that my favorite ones had little to no connection to pharmaceutical companies (and confirmed that it was not merely due to the policies of the hospitals with which they were affiliated). One of my doctors, for whom I have utmost regard, took a speaking fee but he is heavily engaged in research as well as clinical work, and thus it seemed well within reason, and the others’ contributions were meals totaling less than $200 (sometimes less than $50) in a given year. Not exactly big-time influence, but I was primed to keep on the lookout.
As an insomniac, I am often after the miracle drug that will help me to get through more than 4 hours without waking up, and I have tried a number of natural and medication remedies. Yoga. Meditation. Deep breathing. Running in the morning. Running at night. Melatonin. Ambien. Trazodone. Klonopin. Some worked for a little and then stopped working, others didn’t work at all. And then a doctor brought up a new medication to my attention, one that I had not heard of before: Belsomra, which is manufactured by Merck. It cost at least $300 out of pocket but a coupon that he issued to me, the cost was knocked down to $30. (For perspective, Ambien is about $10 with insurance but without such special discounting).
I subsequently began to see ads for this new drug on TV, but more importantly saw the next week in this doctor’s waiting office a pharmaceutical representative talking with another patient about, you guessed it, Belsomra. (This particular doctor was not that high ranking when it comes to funds and gifts, but at over $500 and with this particular presence, I was given reason to at least ask for a second opinion from another doctor who expressed suspicion about going on medications that were newly marketed and not tried and true over the years with respect to impact, side effects, etc.). I still gave it a shot (after all, a lot of my favorite products have been sold to me by buying ad time or influence – I posit a direct causal relationship between DSW commercials and my bank balance), but it wasn’t for me. I’m still on my quest for the magic pill. But many others gave this new medication a shot too. Just one month after its February 2015 introduction to the market (admittedly after failing FDA approval at higher doses), physicians were writing approximately 4,000 prescriptions for it a week and huge financial gains as a consequence, in an insomnia market that has been otherwise, ironically, sleepy. Unlike much of the antidepressant market, this drug is in fact novel. In my case, I didn’t like the price tag personally or on principle, and some medical professionals have questioned whether it is indeed more effective than more cost-effective alternative medications (or perhaps better yet, cognitive behavioral therapy).
The point here is not that pharmaceutical companies are marketing their products, or that doctors are willing to try new medications when others have failed. The problem is the motivation underlying these influences, with consumer confidence not likely aided by the fact that pharmaceutical companies spend more money on marketing than they do on the medical research itself.
The fact of the matter is that there are a lot of medications on the market that chemically are very similar to one another, but that for idiosyncratic reasons may be more effective or problematic for one person than for another. For example, Zoloft, Prozac, Lexapro, Luvox, Celexa, and Paxil are all anti-depressants falling under the category of Selective Serotonin Reuptake Inhibitors, or SSRIs (and not too surprisingly, are manufactured by competing companies, with Prozac manufactured by Eli Lilly & Company, Zoloft manufactured by Pfizer, Lexapro manufactured by Forest Pharmaceuticals, etc). Thus, they all function in a similar way, which is to block receptors in brain cells that reabsorb serotonin so that more serotonin will be made available, potentially reducing the extent of the depression. The major variants are things such as their half-life and the particulars of their binding properties (so in some cases, there can be variation in potency).
They also tend to come with similar clusters of side effects, such as gastrointestinal problems, drowsiness, sexual side effects, and weight gain (the last of which is a claim more challenging to make in some cases given the relationship between depression and appetite). For reasons that are not easily explained or well understood, a person may respond better to one than the other despite these functional and chemical similarities.
But it is worth thinking critically about what those close similarities mean in real terms from the standpoint of financial gains. Because obviously given the complexity of the mind, it would stand to reason that more diverse options is better than the alternative, right? Maybe in theory, but it doesn’t look like that’s really what we’re getting all the time, which looks more like tweaks than innovations.
Because of the way that American patent law is structured, a modest chemical change can justify a new patent (and in turn protect against others producing the same product), and with it a new brand name, new marketing to doctors, and more money for the hot new item on the market. When a patent expires, a tweak can lead to a new set of free samples and ads advising you to ask your doctor of that medication might be right for you. It’s new. We like new. We line up outside for hours for new Apple technologies that we know will become obsolete and incompatible with everything else in two years, but we do it anyway. We try the new restaurant in the neighborhood rather than the tried and true. And some of us like to give a new drug a shot and see if we’ll be among the first to get relief. But on balance, rather than choosing between medications 1 and 2 we’re more often choosing between medications 1.1 and 1.2.
For example, in 2002, Forest Pharmaceuticals cut Celexa in half and marketed escitolopram, or Lexapro, as the new antidepressant to try. Was this innovation? Not really. But it was new, and that meant new marketing and money, and as the document “Lexapro Fiscal 2004 Marketing Plan” summoned by the Senate Special Committee on Aging demonstrated, given these chemical similarities to the inexpensive and already available Celexa, Forest Pharmaceuticals’ plan to persuade psychiatrists to prescribe the new drug was through giving them money and food, with even a civil suit about kickbacks to doctors in exchange for prescribing it (which rightly is illegal, or else we would go to MBAs rather than MDs for medical care). And while they did tinker with the molecule and thus legally allow the company to patent the new medication and sell it as a new product, the Food and Drug Administration had not required thorough investigation into its being an advancement on existing treatments. While Celexa and other SSRIs are notably inexpensive, Lexapro garnered $2.3 billion in sales in 2008, at that point selling at about five times the price for a month supply of Prozac (it has since been lowered).
That Lexapro and other medications have some dubious histories attached to their development does not take away from the fact that they may indeed be medically effective and advantageous for a given patient in the eyes of the prescribing physician. But the pharmaceutical industry is an important and complex interaction of economics and public health, and the two can often find themselves at odds with one another, with money holding much of the power and the human side sadly neglected.
It is not hard to see why pharmaceutical companies would have a big stake in who holds the political reins in the United States. In the aftermath of Citizens United v. FEC, the Supreme Court controversially held that campaign contributions constitute speech protected by the First Amendment and should be unregulated provided that it is independent of the party or candidate, a holding that has led to increased concern as to the influence of super PACs and other such organizations. As one can find through Open Secrets, pharmaceutical companies have poured millions into campaign contributions, largely though certainly not exclusively to conservatives and Republicans. Moreover, there is a well-known “revolving door” between federal agencies (e.g., the FDA), Congress, and the pharmaceutical industry, thus reinforcing these potentially problematic monetary incentives governing the provision of modern health care in this country.
Given this marked influence in drug manufacturing and marketing to doctors and their influence in the government itself, it is important as we evaluate the current presidential candidates the types of pharmaceutical-public health-government relationships that they would reinforce as the next president. Ironically, Donald Trump has referred to pharmaceutical companies as villains and takes a more leftward stance on the drug industry, allowing for the re-importation of cheaper drugs from overseas, though he does support removing barriers to entry into free markets for drug providers offering cheaper products, and it is not altogether clear what that will mean with respect to the multitude of similar drugs with similar effects from competing manufacturers as we see in the case of SSRIs. Cruz’s RESULT Act works to break down barriers to medical innovation by way of allowing Congress to intervene if he FDA is slow to act in adopting certain new medications, but which could mean that in the name of promoting the innovation in which we are lacking, people could be consuming medical products approved with lower standards in other countries or with inadequate evidence of their efficacy. Both Clinton and Sanders have spoken on the importance of reducing the prices of prescription drugs, though Sanders has accused Clinton of being too close for comfort to the pharmaceutical industry.
Fixing the system itself is something of high aspirations – worthy aspirations, to be sure, but lofty goals unlikely to be addressed adequately in a conflictual partisan environment. And the manufacturers of medications that can be potentially very beneficial may have valuable information to provide to the physicians confronted with treating those conditions. Thus, there is an important informational value in giving physicians timely access to information about medicines and new treatment options becoming available. The question is whether that informational value is indeed the main mechanism by which they are operating, as opposed to the more nefarious deal-making. Further, we owe it to ourselves as consumers to do the research on what we are being prescribed and why, and to work to promote a culture in which doctors can be freer to practice medicine than business.
As an insomniac, I am often after the miracle drug that will help me to get through more than 4 hours without waking up, and I have tried a number of natural and medication remedies. Yoga. Meditation. Deep breathing. Running in the morning. Running at night. Melatonin. Ambien. Trazodone. Klonopin. Some worked for a little and then stopped working, others didn’t work at all. And then a doctor brought up a new medication to my attention, one that I had not heard of before: Belsomra, which is manufactured by Merck. It cost at least $300 out of pocket but a coupon that he issued to me, the cost was knocked down to $30. (For perspective, Ambien is about $10 with insurance but without such special discounting).
I subsequently began to see ads for this new drug on TV, but more importantly saw the next week in this doctor’s waiting office a pharmaceutical representative talking with another patient about, you guessed it, Belsomra. (This particular doctor was not that high ranking when it comes to funds and gifts, but at over $500 and with this particular presence, I was given reason to at least ask for a second opinion from another doctor who expressed suspicion about going on medications that were newly marketed and not tried and true over the years with respect to impact, side effects, etc.). I still gave it a shot (after all, a lot of my favorite products have been sold to me by buying ad time or influence – I posit a direct causal relationship between DSW commercials and my bank balance), but it wasn’t for me. I’m still on my quest for the magic pill. But many others gave this new medication a shot too. Just one month after its February 2015 introduction to the market (admittedly after failing FDA approval at higher doses), physicians were writing approximately 4,000 prescriptions for it a week and huge financial gains as a consequence, in an insomnia market that has been otherwise, ironically, sleepy. Unlike much of the antidepressant market, this drug is in fact novel. In my case, I didn’t like the price tag personally or on principle, and some medical professionals have questioned whether it is indeed more effective than more cost-effective alternative medications (or perhaps better yet, cognitive behavioral therapy).
The point here is not that pharmaceutical companies are marketing their products, or that doctors are willing to try new medications when others have failed. The problem is the motivation underlying these influences, with consumer confidence not likely aided by the fact that pharmaceutical companies spend more money on marketing than they do on the medical research itself.
The fact of the matter is that there are a lot of medications on the market that chemically are very similar to one another, but that for idiosyncratic reasons may be more effective or problematic for one person than for another. For example, Zoloft, Prozac, Lexapro, Luvox, Celexa, and Paxil are all anti-depressants falling under the category of Selective Serotonin Reuptake Inhibitors, or SSRIs (and not too surprisingly, are manufactured by competing companies, with Prozac manufactured by Eli Lilly & Company, Zoloft manufactured by Pfizer, Lexapro manufactured by Forest Pharmaceuticals, etc). Thus, they all function in a similar way, which is to block receptors in brain cells that reabsorb serotonin so that more serotonin will be made available, potentially reducing the extent of the depression. The major variants are things such as their half-life and the particulars of their binding properties (so in some cases, there can be variation in potency).
They also tend to come with similar clusters of side effects, such as gastrointestinal problems, drowsiness, sexual side effects, and weight gain (the last of which is a claim more challenging to make in some cases given the relationship between depression and appetite). For reasons that are not easily explained or well understood, a person may respond better to one than the other despite these functional and chemical similarities.
But it is worth thinking critically about what those close similarities mean in real terms from the standpoint of financial gains. Because obviously given the complexity of the mind, it would stand to reason that more diverse options is better than the alternative, right? Maybe in theory, but it doesn’t look like that’s really what we’re getting all the time, which looks more like tweaks than innovations.
Because of the way that American patent law is structured, a modest chemical change can justify a new patent (and in turn protect against others producing the same product), and with it a new brand name, new marketing to doctors, and more money for the hot new item on the market. When a patent expires, a tweak can lead to a new set of free samples and ads advising you to ask your doctor of that medication might be right for you. It’s new. We like new. We line up outside for hours for new Apple technologies that we know will become obsolete and incompatible with everything else in two years, but we do it anyway. We try the new restaurant in the neighborhood rather than the tried and true. And some of us like to give a new drug a shot and see if we’ll be among the first to get relief. But on balance, rather than choosing between medications 1 and 2 we’re more often choosing between medications 1.1 and 1.2.
For example, in 2002, Forest Pharmaceuticals cut Celexa in half and marketed escitolopram, or Lexapro, as the new antidepressant to try. Was this innovation? Not really. But it was new, and that meant new marketing and money, and as the document “Lexapro Fiscal 2004 Marketing Plan” summoned by the Senate Special Committee on Aging demonstrated, given these chemical similarities to the inexpensive and already available Celexa, Forest Pharmaceuticals’ plan to persuade psychiatrists to prescribe the new drug was through giving them money and food, with even a civil suit about kickbacks to doctors in exchange for prescribing it (which rightly is illegal, or else we would go to MBAs rather than MDs for medical care). And while they did tinker with the molecule and thus legally allow the company to patent the new medication and sell it as a new product, the Food and Drug Administration had not required thorough investigation into its being an advancement on existing treatments. While Celexa and other SSRIs are notably inexpensive, Lexapro garnered $2.3 billion in sales in 2008, at that point selling at about five times the price for a month supply of Prozac (it has since been lowered).
That Lexapro and other medications have some dubious histories attached to their development does not take away from the fact that they may indeed be medically effective and advantageous for a given patient in the eyes of the prescribing physician. But the pharmaceutical industry is an important and complex interaction of economics and public health, and the two can often find themselves at odds with one another, with money holding much of the power and the human side sadly neglected.
It is not hard to see why pharmaceutical companies would have a big stake in who holds the political reins in the United States. In the aftermath of Citizens United v. FEC, the Supreme Court controversially held that campaign contributions constitute speech protected by the First Amendment and should be unregulated provided that it is independent of the party or candidate, a holding that has led to increased concern as to the influence of super PACs and other such organizations. As one can find through Open Secrets, pharmaceutical companies have poured millions into campaign contributions, largely though certainly not exclusively to conservatives and Republicans. Moreover, there is a well-known “revolving door” between federal agencies (e.g., the FDA), Congress, and the pharmaceutical industry, thus reinforcing these potentially problematic monetary incentives governing the provision of modern health care in this country.
Given this marked influence in drug manufacturing and marketing to doctors and their influence in the government itself, it is important as we evaluate the current presidential candidates the types of pharmaceutical-public health-government relationships that they would reinforce as the next president. Ironically, Donald Trump has referred to pharmaceutical companies as villains and takes a more leftward stance on the drug industry, allowing for the re-importation of cheaper drugs from overseas, though he does support removing barriers to entry into free markets for drug providers offering cheaper products, and it is not altogether clear what that will mean with respect to the multitude of similar drugs with similar effects from competing manufacturers as we see in the case of SSRIs. Cruz’s RESULT Act works to break down barriers to medical innovation by way of allowing Congress to intervene if he FDA is slow to act in adopting certain new medications, but which could mean that in the name of promoting the innovation in which we are lacking, people could be consuming medical products approved with lower standards in other countries or with inadequate evidence of their efficacy. Both Clinton and Sanders have spoken on the importance of reducing the prices of prescription drugs, though Sanders has accused Clinton of being too close for comfort to the pharmaceutical industry.
Fixing the system itself is something of high aspirations – worthy aspirations, to be sure, but lofty goals unlikely to be addressed adequately in a conflictual partisan environment. And the manufacturers of medications that can be potentially very beneficial may have valuable information to provide to the physicians confronted with treating those conditions. Thus, there is an important informational value in giving physicians timely access to information about medicines and new treatment options becoming available. The question is whether that informational value is indeed the main mechanism by which they are operating, as opposed to the more nefarious deal-making. Further, we owe it to ourselves as consumers to do the research on what we are being prescribed and why, and to work to promote a culture in which doctors can be freer to practice medicine than business.
RSS Feed