Showing posts with label opioids. Show all posts
Showing posts with label opioids. Show all posts

Tuesday, December 7, 2021

"Dopesick": The story of the marketing of killer opioids will really make you sick. Don't trust any of them!

I have recently been watching “Dopesick”, the Hulu/Disney+ quasi-documentary drama about how the Sackler family-owned Purdue Pharma developed and marketed Oxy-Contin®, and about the efforts of some brave federal prosecutors and DEA and DOJ agents brought them (somewhat) down. Based on the book by Beth Macy, it is a good series, with terrific performances and many sympathetic characters (not the Sacklers, though, none of them) and although I am sure that there fictional elements involving the personalities portrayed, it is essentially factual. It is also infuriating, and nauseating.

If you haven’t watched it, you probably should, but you probably already know the main theme, so what I write won’t be spoilers. It is still worth watching, to understand the extent of the evil, and the way in which the medical profession and federal agencies were “played” successfully as thousands of Americans became addicted and died. A few of the outrages include that when Purdue developed Oxy-Contin, using a delivery scheme developed for MS-Contin®, which was going off patent, they claimed its slow-release delivery mechanism made it essentially non-addictive (less than 1%), and got a first-ever special label for a Class II narcotic from the FDA saying it was less addictive (it was not). They did a very effective job not only marketing (detailing) to physicians with this lie, but created new diseases (conditions) that justified its use. This was also taken from a previous drug and scam, when Arthur Sackler invented the condition “psychic tension” to market Valium®. When, predictably, people first got pain relief, then developed tolerance they invented the condition of “breakthrough pain” which required a higher dose. Then folks got tolerant of that. And when they stopped, they went through awful withdrawal. This is what happens with opiates and opioids. And yet Purdue was able to convince doctors to continue to prescribe it – and prescribe it in increasing amounts.

This was part of a movement going on in the 1990s to address the issue of people not always receiving adequate pain relief. The pain of diseases, such as cancer, that occurs as people approach death, got conflated with the moderate chronic pain that millions have from work related injuries (the focus of the drama is on a mining area of Virginia) and from conditions such as osteoarthritis. These are real problems, but the answer was presented as opioids, and ever increasing doses of them. What was not well-known at the time is that, to a large degree, this “movement” was in fact a campaign funded by Purdue. They funded – and thus heavily influenced -- most of the medical Pain Management groups, as well as the campaign to label pain the “fifth vital sign” (after temperature, pulse, respiration, and blood pressure), an idea they invented. It was a drumbeat that was ubiquitous. The pain movement was essentially, a marketing campaign for a lethal drug. It was successful, in both ways. It made the company, and the family, a lot of money, and it addicted and killed a lot of people.

The Sacklers didn’t seem like the meanest of billionaire families (of course, this is a low bar). They were philanthropists, who gave a lot of money to the arts, and to Israel and Jewish organizations, and health care, and even funded a medical school, the Sackler School of Medicine, part of Tel Aviv University and located in Israel but chartered in NY state. It still exists. They were, however, and remain, avaricious and essentially amoral, continuing to refuse to recognize their evil-doing, while remaining #30 on the Forbes wealthiest list, and managing to retain and hide nearly $11B in their own private money despite the $8.3B settlement. And thousands of people are dead and addicted. The people most affected were poor and working class people, those who work with their bodies and most often experience chronic pain, such as those the series focuses on, miners.

But the story cannot end with the Sacklers, Purdue, and Oxy-Contin. While some of their tactics were particularly creative and perfidious, the effort to market drugs with high profit margins (even when they are often less effective and more dangerous than other existing drugs) is the Holy Grail of the pharmaceutical industry. What Purdue did was possibly more insidious – and effective -- but it was typical in being multi-pronged, targeting consumers, physicians and the federal government.

The government was targeted by lying to them, and knowing they were unlikely to be caught as the FDA’s staff (as the staffs of almost all regulatory agencies) had been decimated by cuts beginning with the Reagan administration, aimed at allowing corporations to have freer rein – to lie, cheat, and profit at the public’s expense in $$ and, in this as in many cases, their health. It was a flagrant example of the corruption of the ubiquitous “revolving door”, where those who are tasked with regulating industries then leave government service and get high-paying jobs in those same industries. Indeed, this is what happened with the FDA official who approved the novel labeling of Oxy-Contin -- he went to work for a big salary at Purdue -- and it happens every day in every field, not just pharmaceuticals. It is, pure and simple, graft.

Doctors were targeted through pharmaceutical sales representatives (“detail” people) who provide them with incomplete and often inaccurate information (e.g., that Oxy-Contin was only 1% addictive), and take them to expensive dinners and even vacation retreats under the guise of medical lectures. And the company, of course, encouraged their own reps to lie with enticements such as vacations. And the public? They present tantalizing, incomplete, and dangerous information through ads, especially on TV.

I have written about TV direct-to-consumer advertising, (e.g, DTC Advertising on TV illustrates the corruption and inequity of the US medical care system, Mar 6, 2021) and think it is pretty much all bad. I think that the marketing of drugs to doctors, to get them to prescribe expensive drugs, is mostly all bad. I have thought that, by the way, pretty much since at least medical school. I didn’t meet with drug reps, was very skeptical of information they provided (which I saw in journal ads and heard from colleagues) and assumed any positive claim was very likely incomplete or untrue. During my career, any number of highly-touted drugs were pulled from the market after causing major morbidity and mortality that was either not predicted in the pre-approval studies or suppressed by the companies. As a teacher of medicine, I sponsored “counter-detailing” to point out the flaws of the pharmaceutical company claims. I was aghast when residents would come back from conferences supposedly sponsored by professional associations but funded by drug companies that recommended the substitution of new expensive drugs for old standards that worked at least as well. This has been recently documented for diabetes (another field in which much of the funding has come from the drug makers) in an article from Reuters, ‘Drugmakers Pushed Aggressive Diabetes Therapy. Patients Paid the Price’, featured by Medscape Nov 5, 2021.

And yet, even so, I was not immune to the campaigns that Purdue funded, especially the idea that pain was being undertreated, although I remained unconvinced that it was the “fifth vital sign”. To be sure, I was much more skeptical than many of my colleagues, and was careful to distinguish between relieving the pain of a terminal cancer patient and addicting a person with chronic moderate pain. But it was a very well-done campaign, and I knew that at least sometimes we were undertreating pain. At Cook County Hospital, where I worked, we saw many patients with sickle-cell pain crises, treated with opiates and opioids, and frequently becoming addicted (interestingly, the chief of pediatric hematology only used aspirin and hydration, but as soon as those children became adults they began to receive narcotics).

We must remember that it was and is not just Purdue. Don’t trust what any drug company (or maybe any company) says in TV ads. Don’t trust what the pharma reps say. And sadly we cannot always trust recommendations of professional organizations when they are getting money from drug companies. This is real conflict of interest, and makes our professional organizations suspect.

It is all about making the most possible money by any means necessary, no matter who gets hurt, what Noam Chomsky calls “gangster capitalism”. You’re better off trusting real gangsters who literally put a gun to your head. At least you know where you stand.

Friday, November 29, 2019

Decreasing life expectancy in the US: A result of policies fostering increasing inequity


Four years ago, in 2015, economists Anne Case and Angus Deaton published a landmark article in which they documented decreasing life expectancy for white Americans, specifically those aged 45-54, which I discussed on November 14, 2015 in  Rising white midlife mortality: what are the real causes and solutions? This was somewhat shocking data, for it was the first time in decades that a decrease in life expectancy for a group in the US was seen. For a century, life expectancy had been rising.

Although the decrease in life expectancy was in whites of middle age (and lower income), and especially for low-income women (amazingly, low income women born in 1950 had, at the age of 50, a lower life expectancy than their mothers born in 1920!), it was important to remember that life expectancy for African-Americans and some other  minority groups still fell far short of that for whites. This decrease in life expectancy was not the case for other developed countries; it is a uniquely American characteristic – and obviously not a desirable one.

It is, thus, all the more depressing to have a comprehensive new study that finds that not only white people, but all Americans in the 25-64 year old age range have increasing mortality. “Life Expectancy and Mortality Rates in the United States, 1959-2017”,[1] by Steven H. Woolf and  Heidi Schoomaker, just published in JAMA, found that

Between 1959 and 2016, US life expectancy increased from 69.9 years to 78.9 years but declined for 3 consecutive years after 2014. The recent decrease in US life expectancy culminated a period of increasing cause-specific mortality among adults aged 25 to 64 years that began in the 1990s, ultimately producing an increase in all-cause mortality that began in 2010. During 2010-2017, midlife all-cause mortality rates increased from 328.5 deaths/100 000 to 348.2 deaths/100 000. By 2014, midlife mortality was increasing across all racial groups.

This new study confirms that a large part of the increase in middle-age mortality comes from what Case and Deaton called “deaths of despair”: suicide, drug overdoses, and alcoholism. But there was also a large contribution from “traditional” diseases such as heart disease, chronic lung disease, and stroke. People suffering from these conditions may increasingly be unable to receive adequate medical care for them, because they are uninsured or underinsured or because their out of pocket costs in co-payments and deductibles are unaffordable for them, and even because they live in the wrong places, rural areas far from hospitals. This is very different situation from that in other developed countries which, essentially universally, have universal health care. The New York Times article by Gina Kolata and Sabrina Tavernise quotes Dr. Woolf as saying “The whole country is at a health disadvantage compared to other wealthy nations…We are losing people in the most productive period of their lives. Children are losing parents. Employers have a sicker work force.”

Dr. Woolf also notes that “death rates are actually improving among children and older Americans,” unsurprisingly, “because they may have more reliable health care — Medicaid for many children and Medicare for older people.” Yes. Having health coverage and being able to access health care may actually make a difference, especially with treatment of chronic disease. And if there were adequate treatment for mental health and substance abuse, it could be even better.

Of course, increasing mortality is not just about access to health care. It is mainly about the overall lives many people in the US live. Working-class and formerly-working class people who often no longer have jobs, or at least good jobs, and have given up hope of getting them and re-creating their vision of the American dream, have joined the long-term disenfranchised, underserved, and underemployed. This is a common narrative provided for white working-class people who have turned to Donald Trump because of his (empty) promises to bring back manufacturing and mining jobs to the US. And it is the lack of any reasonable set of social services to prevent large swaths of the American population, of all races and colors and ethnicities, from going hungry, or being homeless or inadequately sheltered, or having heat in the winter and education (and thus hope) for their children.

This is another major issue; the US spends a much lower percent of its GDP on social services of all kinds than do other Western nations. If we add in the money spent on “health care” the gap narrows, but most of that money is being spent on medical care, and medical care often for those with far advanced conditions and a lot of money and/or good insurance, and much of that expense going into health system, insurance company, and pharmaceutical company profit. This was documented by Elizabeth Bradley and Lauren Taylor in 2011 (see To fix health care, help the poor, NY Times and my blog post To improve health the US must spend more on social services, December 18, 2011).

Dr. Woolf says “We need to look at root causes. Something changed in the 1980s, which is when the growth in our life expectancy began to slow down compared to other wealthy nations.” He, of course, knows what changed, and so do we. It was the election of Ronald Reagan and the rapid elimination of the social safety net that had developed in the New Deal, and a move toward greater economic aggrandizement of the already richest and most powerful at the expense of the poorest and least empowered, a trend that accelerated under both the Bush administrations, was only slightly slowed by the Clinton and Obama administrations, and has taken off full steam under our current President.

Yes, there is also an opioid crisis, brought on by not just despair but aggressive marketing by pharmaceutical companies such as the Sacklers’ Purdue. Yes, there is, as the Times article notes, a dramatically higher mortality with powerful synthetic opiates like fentanyl. But this is not a root cause. When you died from an episode of pneumonia complicating your lung cancer, it is misleading to say your death was from pneumonia; the real cause was your lung cancer. Ultimately all deaths are caused by cardiopulmonary arrest (your heart and lungs stopping working), but this is a mechanism, not a cause. Similarly, opioid deaths are the mechanism of death, but the cause is a very inequitable and unjust society. And this is the biggest difference between the US and other wealthy nations.

Ironically, some would say, the parts of the US that are most affected by the increasing death rates are those that not only supported, and are likely to again support, President Trump, but those that provided – and may again provide – the electoral vote margin for him. In addition to northern New England (Vermont, New Hampshire and Maine), the hardest hit states are Ohio, West Virginia, Indiana, and Kentucky. A third of all the excess deaths in the US are concentrated in four Ohio Valley states: Ohio, Pennsylvania, Kentucky, and Indiana. One commentator notes that there are “bright spots”: ‘Life expectancy in the coastal metro areas — both east and west — has improved at roughly the same rate as in Canada.’ But I don’t see this as a bright spot, I see the desperation and death and increasing mortality in the rest of the US as the sore spot. We could do better, but we haven’t; as I noted above even the 16 years of Democratic presidency (admittedly, often with a GOP-controlled Congress) have been more focused on meeting the desires of the wealthiest than the needs of most Americans.

We need to do better, and despite the fact that the Trump administration is the least likely to do so in recent history, it may well be re-elected because of the failure of “mainstream” opposition to come up with effective solutions.


[1] Woolf SH and Schoomaker H, Life Expectancy and Mortality Rates in the United States, 1959-2017. JAMA. 2019;322(20):1996-2016. doi:10.1001/jama.2019.16932

Thursday, July 25, 2019

Opioids, deaths, and capitalism: It's the capitalism, people!


The opioid epidemic is real. Far more opioids (the term that includes opiates, naturally-derived from opium, and synthetic drugs) are consumed than could conceivably be used for medical reasons, whether for short-term use post-surgery or injury, or chronic use for terminal diseases like cancer. The explanation, at one level, is the excessive use of opioids for pain relief for chronic conditions (like back pain, for which other drugs are often more effective) or excessive duration for what should be short-term (acute) reasons, and the fact that they are very addictive. This last has led to the creation of new addicts, who have been placed on prescription opioids for pain, and means that they can be used to substitute for opiates (such as heroin) for those who became addicted to street drugs. This is especially true with the increased availability of extremely potent synthetic opioids, such as fentanyl (50-80 times more potent than morphine), but can go both ways; when those who have become addicted to prescription opioids find the supply drying up, they often move to heroin.

But, like most things, it is complicated. The biggest complication is that many of those who have become “hooked” on opioids are suffering in pain, and opioid withdrawal is, to put it mildly, not fun. The pain relief is greater than that of other pain relievers, for many (but not all) problems, but opioids increase tolerance, so the doses people need to take to relieve their pain, or get their high, continually increases. The “consensus” pendulum has swung, from the message that people are not getting sufficient pain relief (“pain is the fifth vital sign”) to “doctors are creating addicts by overprescribing opioids”. Patients – people -- are caught in the middle.

Another complication is, as is usual in any big issue in the US, race. Opiate addiction and problems were a focus more of criminalization than treatment when it was perceived as mainly a problem for minority populations. The increasing revelation of white, albeit often poorer, less educated, and more rural, white people suffering from the prevalence of opioid abuse, has changed the discussion. Not that this is unimportant – the message that for the first time in a century a portion of the population – middle aged white people – have an increasing death rate (discussed in Rising white midlife mortality: what are the real causes and solutions?, November 14, 2015, and based on the work of Case and Deaton, “Rising morbidity and mortality in midlife among white non-Hispanic Americans in the 21st century”) is shocking. So is the finding that poor white women born in 1950 will live shorter lives than their mothers born in 1920 (“Life expectancy, socialism, and the determinants of health”, February 14, 2016). None of this to deny or ignore the fact that death rates for minorities, although dropping are still higher than those of whites.

The New York Times has had a series of exposé articles on the opioid crisis, and a recent installment completely pulls back the curtain on the marketing and sales practices of opioid manufacturers. “3,271 Pill Bottles, a Town of 2,831: Court Filings Say Corporations Fed Opioid Epidemic” reveals that many manufacturers, not simply Purdue, the maker of Oxy-Contin®, and many pharmacies including all the big chains, have been complicit in the spread of this epidemic. Its content is damning, and the evil acts of these companies are made public, and the information needed to ascertain the reason for the problem is clear.

But the Times does not explicitly call it out. That is because the problem is capitalism, specifically “unfettered” capitalism, essentially unregulated capitalism that not only permits, but encourages, anything that will make more money, regardless of the cost, including (and perhaps especially) the human cost. These corporations are responding to the pressure of Wall St. and their stockholders not only to make more money, but to “exceed expectations”. The value of a stock is not based on whether the company is actually earning a profit, but whether it is earning enough of a profit to please the casino players. This is augmented by the incentives for often huge bonuses for the top management based upon – how much profit the company makes. There are no bonuses for actually helping more people, or even not killing them, or not destroying the world. Sorry, you who die from opioids or suicide, you are collateral damage. Oh, yes, you also, future generations.

To be clear, this is not a result of Republican or Trumpian policies, although they have been both more open about it and have further pushed the envelope with their gargantuan tax cuts for corporations and the 0.1%. It has been the policy of every government at least since Reagan in the 1980s, Clinton and Obama certainly included. Of course, every US government has been pro-capitalist, but for much of the 20th century, starting with (Republican) Teddy Roosevelt, there were both implicit and explicit limits set. Even conservative economic guru Milton (“the only goal of a business is to maximize shareholder profit”) Friedman believed that monopolies were ultimately not a problem because technology and the market would take them down. He was wrong; there are no limits to what they will do for more money.

So we have Americans dying by the tens of thousands from opiate and opioid overdose, and from the “suicides of despair”. We have children being separated from their parents and migrants being housed in prisons because it makes money for the private prison industry, a major donor to politicians. (Kudos to Illinois for being the first state to ban private prisons.) We have the environment being irreparably destroyed for the profit of some companies, with government complicity. We have wars being fought across the globe, killing hundreds of thousands, and each being the potential spark that could destroy the world more quickly through nuclear war. We continue to increase the defense budget although we already spend several-fold more than all our potential adversaries put together, because it is the way that the federal government subsidizes US industries.

Why do we do these things? Our oligarchs (a term the media seems to reserve only for foreigners, especially Russians, even though the US has so many more of them) demand it, and pay for it, essentially through kickbacks. They care not for the future, even for their grandchildren, or for whether there is a world.

They must be stopped. Our health, and our lives, depend upon it.

Tuesday, January 23, 2018

Tom Petty, the opioid epidemic and changing structural inequities in the US

In October 2017, the rock musician Tom Petty died at the age of 66. Given Mr. Petty’s history of heroin addiction back to at least the 1990s and the frequency with which overdoses seem to cause the death of celebrities, there was some early assumption that it may have caused his. This was confirmed by the coroner, (NY Times, January 19 2018); however, the cause was not heroin but rather prescription opioids (oxycodone plus 3 types of fentanyl), combined with two also-addictive anti-anxiety medicines known as benzodiazepines: “The coroner, Jonathan Lucas, said that Mr. Petty’s system showed traces of the drugs fentanyl, oxycodone, temazepam, alprazolam, citalopram, acetyl fentanyl and despropionyl fentanyl.” (The citalopram is an SSRI anti-depressant). According to a statement from his wife and daughter, he had many ailments including a fractured hip that caused him great pain.

Thus, Mr. Petty becomes another victim of the epidemic of prescription opioid-related deaths. His previous heroin addiction (chronic use of opiates or opioids leads to tolerance, requiring higher and higher doses for relief) and his stature as a rich and famous person (which seems to make it even easier to find doctors who will prescribe such drugs) may have increased his risk, but his death is one instance of a widespread American problem that has been the subject of academic articles, government reports, and opinion pieces from medical providers, patients, and the general range of pundits.

David Blumenthal and Shanoor Servai of the Commonwealth Foundation write in their report “To Combat the Opioid Epidemic, We Must Be Honest About All Its Causes” that “History offers only one other recent example of a large industrialized country where mortality rates rose over an extended period among working-age white adults: Russia in the decades before and after the Soviet Union’s collapse. The economic and social contexts have been eerily similar, and substance abuse has been a dominant factor in both countries: alcohol in Russia, opiates in the United States.” A major study by Princeton economists Anne Case and Angus Deaton in 2015, “Rising morbidity and mortality in midlife among white non-Hispanic Americans in the 21st century” (which I have previously cited, Rising white midlife mortality: what are the real causes and solutions?, November 14, 2015) posits opioid-related deaths as a major cause of the surprising  increase in mortality rate among white Americans. Blumenthal and Servai note that “Based on weighted estimates, 92 million, or 37.8%, of American adults used prescription opioids the prior year (2014); 11.5 million, or 4.7%, misused them; and 1.9 million, or 0.8%, had a use disorder. The epidemic is spreading so rapidly that it’s likely the numbers are higher now.”

So it’s a very big problem, with many causes, and the solutions are not simple. Doctors play a big role, since they must prescribe the opioids (whether these are taken by the designated patient or illicitly redistributed). While well-known surgeon and author Atul Gawande, in an interview with Sarah Kliff on Vox.com, says “We started it”, I don’t think that is completely true. Certainly doctors have been vehicles for its perpetration but there are other forces at work. One is the movement that began in the 1990s to adequately address patients’ pain, which was seen as insufficient by many critics. In many institutions pain was labeled the “fifth vital sign”, and staff were instructed to ask about pain relief in every interaction. While this is important, especially for acute short-lived pain (such as post-operative or post-traumatic), the use of opiates for chronic pain skyrocketed. The obvious problem is, as cited above, the more you have taken them the more you need; tolerance to opiate and opioid effects often requires increasing doses. The “high” resulting from these drugs (whether intended or not) increases their potential for abuse.

Long-acting opiates and opioids (such as extended release morphine or oxycodone, methadone, and fentanyl patches) are preferred as they can control pain with less of a “high”, but they still lead to tolerance. While addiction is not an issue for people who are dying of their cancer, it is for people with chronic diseases such as sickle-cell and chronic pain syndromes, most commonly in the US back pain. Opiates and opioids have been shown to be poor choices for long-term treatment of chronic back pain, but taking them is often easier and cheaper for patients than complicated (and often expensive) modalities such as physical therapy, and it relieves the pain more quickly and completely until higher and higher doses are needed. So patients, as well as physicians, are part of the problem, and physicians are working to try to help people, while complicating the problem.

Real villains include those who have originated and perpetuated this crisis only to make money. This includes insurance companies, who often deny more expensive treatments such as extended physical therapy or drugs such as buprenorphine, essentially pushing doctors and patients into the use of opioids. They certainly include the pharmaceutical companies who have developed and heavily marketed these drugs, notably the Sackler family who owned Purdue and made and pushed Oxy-Contin®, as documented in the New Yorker article “The family that built an empire of pain” (October 30, 2017). In brief, they acquired the rights to long-acting morphine, but because this was losing its patent protection (and thus its profitability), they developed a long-acting form of oxycodone, which was patented and thus more profitable. Counting on the negative associations that the public and even physicians associated with morphine, they pushed Oxy-Contin, which was at least as addictive and dangerous, for an ever-expanding list of chronic conditions. Back pain, of course, was the target market, and it soon seemed as almost everyone had an indication for opioids. And we have since been paying the price with their deaths.

The flaws of capitalism that directly drove and continue to drive this epidemic through the pursuit of profit should be clear enough. The structural flaws that have and continue to ruin the lives of so many Americans (not to mention people in the rest of the world) may be less obvious but are no less real. The dramatic redistribution of wealth from the vast majority of us to the already-wealthiest, with the concomitant decrease in the quality of life for so many, proceeds apace. The 1%, maybe even the 5%, are doing great, although the biggest benefit (including from the new GOP tax “reform”) law goes to the 0.1% or less. The richest 1% now owns half the world’s wealth and the 8 richest men have as much as half the world’s population!  Worldwide, it is those in the poorest countries that suffer most. In the US, it remains minorities. While the shocker in the Case and Deaton study was the fact that white mortality is increasing, the fact remains that minorities, especially African-Americans, still have far higher mortality rates.

If we wish to decrease this excess mortality, it certainly will be important to address the opioid crisis, by physicians becoming more reticent to prescribe long-term opioids for chronic conditions, patients to accept alternative treatments, and insurers being willing to pay for those treatments. It will also be important to address other chronic addictions, like alcohol (Blumenthal and Seervai observe that while “11.5 million, or 4.7%, misused them [opioids and opiates]; and 1.9 million, or 0.8%, had a use disorder…By comparison, there are 17.1 million heavy alcohol users among adults over 18.” Legal does not mean safer, whether we are talking alcohol abuse or “legitimized” (by prescription) opioid abuse. It most often reflects the relative power of the industries that financially benefit.

The core problem is in the unfair, unjustifiable, and oppressive structural inequities in our society. These are so deeply seated that we often assume they are inevitable, and that there is no other way. There is. We may not be able to eliminate inequality, but if we are to seriously address the epidemic of unnecessary deaths, we need to do more than treat the symptoms; we must grapple head-on with and change our society’s structure. 

Tuesday, December 20, 2016

Opioids and other pharmaceuticals are the tip of the iceberg: It's the profit, stupid!

The NPR program “Fresh Air”, with Terry Gross, had Anna Lembke, MD as a guest on December 15, 2016. Dr. Lembke is the author of the recent book “Drug Dealer, MD”, in which she apparently (per the discussion on air; I have not read it) implicates physicians and pharmaceutical companies in the widely discussed “opioid epidemic”. Dr. Lembke is a Stanford psychiatrist and director of the addiction medicine fellowship there, and she is able to articulately describe what is known and what is not about the neurological impact of opiates and opioids on the brain. One important point she makes is that continued use of opioids causes tolerance and a need for higher doses; in addition she describes how chronic use of opioids causes a pain syndrome of its own (decreased tolerance to pain) in some people, and how weaning them off opioids can actually decrease or eliminate their pain.

Her key issue, however, is that the epidemic of opioid use was orchestrated by the pharmaceutical manufacturers of opioid analgesics, who heavily promoted them, created the perception among doctors and the public that physicians were heartlessly undertreating the pain that their patients were in, and hooked in (mostly) well-meaning doctors to become, in essence, their pushers (“Drug Dealer, MD”) while they made huge profits. And continue to do so. And, as the reaction to this epidemic begins to form, continues to promote new syndromes that require treatment with their drugs.

An example of this is “OIC”, opioid-induced constipation, which made its first big appearance during the Super Bowl of 2016. The commercial left it a vaguely mysterious ailment, but it is a real one. Of course, the commercial was a prelude to an advertising campaign, in this case for Movantik ®, a partial opioid antagonist manufactured by a collaboration between AstraZeneca and Daiichi Sankyo designed to treat this condition. Constipation, in fact, is the only side effect of opioids that does not decrease with continued use, so as a person uses higher and higher doses of the opioids to try to control their pain, their constipation gets worse and worse, sometimes requiring surgery and occasionally death from a ruptured colon. My reaction, while understanding we would soon see a drug for this condition promoted, was that it was a cynical and disturbing attempt to “normalize” opioid addiction. “Oh, you have this problem? Well, it’s not just you! LOTS of people have OIC!” It turns out that I was not the only one with this reaction; Ahiza Garcia on in a piece on CNN Money called “Super Bowl drug ad sparks big backlash”, quotes Dr. Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing: "It's very disturbing to see an ad like that. It's normalizing the chronic use of opioids, which aren't demonstrated to be safe over the long term.”

Of course the greed and anti-social behavior of pharmaceutical manufacturers is neither new nor is it going away. Their efforts to use doctors and exploit the public as much as they can possibly get away with in pursuit of exorbitant profits continues to generate news, and occasionally, reaction by states. We have all heard about the huge price increase in Daraprim ® by Martin Shkreli and Turing (Drug prices and corporate greed: there may be limits to our gullibility, September 27, 2015) and Epi-Pen® by Heather Bresch and Mylan (Epi-Pen® and Predatory Pricing: You thought our health system was designed for people’s health?, September 3, 2016) and maybe thought that this publicity would rein in further abuses. But not so. Reuters just reported in “US states sue Mylan, Teva, others for fixing drug prices” that “Twenty states filed a lawsuit Thursday against Mylan NV (MYL.O), Teva Pharmaceuticals (TEVA.TA) and four other generic drug makers, saying they conspired…on pricing of two common generic drugs, according to a copy of the complaint.” Lest you think that this conspiracy is just preventing these companies from being undercut by each other, we are talking fantastic price increases for common and necessary drugs. “The drugs involved in Thursday's lawsuit include the delayed-release version of a common antibiotic, doxycycline hyclate; and glyburide, an older drug used to treat diabetes. Doxycycline, for example, rose from $20 for 500 tablets to $1,849 between October 2013 and May 2014, according to Senator Amy Klobuchar, a Minnesota Democrat who had been pressing for action on high drug prices.” In case you missed it, this is a 9245% increase in the price of doxycycline! And it may well be up to the states to bring such legal action, since there is little reason to think that the federal government, led by President-elect Trump and his corporate cabinet, along with the Republican-dominated Congress, will be doing anything about it.

Which, of course, is the core problem, and has been for a long time. Corporate profit has become the be all and end all of US policy. Anything that increases corporate profit is seen as good. This certainly includes subterfuge, cheating, exploitation, and corruption. While this has long been the case, it is likely to increase under the Trump administration, with its depressing panoply of corporate exploiters and climate change deniers. We are likely to see not only tolerance of encouragement and celebration of such outrageous excesses. Of course, it is fine to make a profit, but that profit should be reasonable and honest; it should not be highway robbery, generated by dishonesty, exploitation, and trampling others.

The pharmaceutical company activities cited about are the result of an attitude that “if we can make some money honestly, look how much more we can make if we are corrupt!” that pervades virtually every industry, from fossil fuels (see Rex Tillerson, the Exxon CEO who is Trump’s nominee for Secretary of State) to financial services. After campaigning against Goldman Sachs, the largest investment bank, and its ties to Hillary Clinton (“I know the guys at Goldman Sachs. They have total, total control over [Cruz]," Trump said. "Just like they have total control over Hillary Clinton"), Trump has named at least four current and past Goldman execs to cabinet-level positions, including its #2, Gary Cohn, as director of the National Economic Council. And, should anyone harbor any illusion that the survival of Goldman in the face of the collapse of rivals Bear Stearns, Merrill Lynch, and Lehman Brothers has anything to do with their being more honest or less evil, less likely to have indulged in “the Big Short” and transferred all their toxic investments to their own clients, read the recent piece by Matt Taibbi in Rolling Stone, The Vampire Squid occupies Trump’s White House”.

Speaking of Rex Tillerson, his close ties to Russia and Vladimir Putin are seen (by the President-elect) as major qualifications for Secretary of State. In this context, the New York Times Op-Ed by Andrew Rosenthal from December 15, 2016, “To understand Trump, learn Russian”. Rosenthal notes that Russian has two words for “truth”:
The word for truth in Russian that most Americans know is “pravda” — the truth that seems evident on the surface. It’s subjective and infinitely malleable....But the real truth, the underlying, cosmic, unshakable truth of things is called “istina” in Russian. You can fiddle with the pravda all you want, but you can’t change the istina.

The pravda will change a lot with the new administration. Fossil fuel extraction is all good, climate change is a hoax, public education is bad, getting rid of the ACA will improve access to healthcare, immigrants are the problem, Putin is good, and gays and transgender people have no rights. That putting foxes in charge of the henhouse makes sense, and that having corporate titans in direct rather than indirect control of government will benefit us all. But the growth in the gap between the wealthiest and the rest of the people has grown under both Republican and Democratic administrations and anger at it was actually one of the drivers of the vote for Trump.


The istina, though, is that making the wealthiest wealthier and destroying the earth in the process is not the answer. Attention to the common good, for all of us, is the only thing that will move us forward, as a society and as a world.

Saturday, September 24, 2016

“It’s always worse than you think … even if what you were thinking is pretty bad”

On the heels of the Epi-Pen® scandal (well, at least I think it is scandalous, Epi-Pen® and Predatory Pricing: You thought our health system was designed for people’s health?, September 3, 2016) in which Mylan Pharmaceuticals and its CEO Heather Bresch raised the price of this life-saving medication 500% (and her salary by about the same degree), that itself followed last year’s Daraprim® scandal where Turing Pharmaceuticals and its CEO Martin Shkreli raised the price of this anti-parasitic drug over 5000% (Drug prices and corporate greed: there may be limits to our gullibility, September 27, 2015), we have some good news. Sort of. Brent Saunders, CEO of Valeant Pharmaceuticals, also identified last year for hefty price increases in two life-saving heart drugs,has now announced it will keep its price increases under 10%. Of course, it will raise the price 9.9%, which is certainly less than 10%, and even less than 9.99%, which they could have done and still been below 10%. There is speculation that this may have been in response to proposed federal legislation that would have increased the scrutiny on drug price increases of 10% or more, but of course we cannot know for sure.

The predatory greed of drug companies is becoming legendary, threatening to eclipse that of insurance companies as the leading bad guys in keeping Americans from being able to afford the medical care that they need. After all, insurance companies have increased every form of payment (premiums, co-insurance, co-payments and deductibles) that people, the insured, need to pay out of their own pockets in an effort to decrease the probability that they will be bankrupted when they need medical care. This is sometimes justified by the risks that they take; particularly by the “adverse selection” that occurs because it is the sick, rather than healthy, people who were most likely to sign up for insurance under the ACA’s insurance exchanges. The “individual mandate” of ACA was supposed to prevent this, but the penalties people have to pay are far less than the cost of buying insurance for many (if they are unsubsidized), and maybe they won’t even be caught. Or get sick.

Of course, the degree to which insurance companies are actually losing money rather than simply making less profit than they would like is uncertain, but it is clear that, at least in some markets, it is close. The transfer of many patient-borne costs from premiums to co-insurance, co-payments, and deductibles is designed to keep premiums from going even higher, but of course impacts the sick more. In (at least slight) contrast, the price increases of pharmaceuticals can only be justified by an ethos of “charge what the market will bear”, and make as much as possible before regulators come down on them. In a really ‘cool’ effort reported by the New York Times on September 16, 2016, Mylan is trying to get the federal government to add Epi-Pen to its list of life-saving preventive medications. This would mean direct users would not have to pay so much, but Mylan would continue receive its outrageous price – supported by all of us, as federal taxpayers. Now, there’s a really terrible solution! (Good solution: lower the price. A lot.)

And they have been doing it for a long time. Pharmaceutical companies bought dinners, bought presents, and bought trips for doctors who prescribed their drugs. There has been some clamping down on the most egregious excesses in recent years, but they have not been eliminated. Especially concerning are the revelations (no news to physicians) of the aggressive promotion of opiod pain relievers to doctors, and their contribution to the incredible epidemic of prescription opioid addiction in the US today (48,000 women died of prescription drug overdose between 1999 and 2010, a period during which prescription drug addiction increased over 400% among women and 237% among men, according to the American Society for Addiction Medicine. The Centers for Disease Control and Prevention (CDC) reported:
We now know that overdoses from prescription opioid pain relievers are a driving factor in the 15-year increase in opioid overdose deaths. Since 1999, the amount of prescription opioids sold in the U.S. nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report. Deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have also quadrupled since 1999.

The entire campaign to “eliminate pain” was largely supported by opioid manufacturers, such as Purdue and Abbott through their creative marketing to physicians. The most “funny”, reported by STAT, was the use by a drug rep of creatively-arranged donuts to catch the attention of an orthopedist who would not otherwise meet with him, by appealing to his sweet tooth. It is not, of course, really funny, and it is almost worse that physicians could (and maybe still can) be bought not by trips to the Bahamas but by a box of donuts!

Speaking of donuts, we have the even more incredible exposé in the Times that for decades, beginning in the 1950s, the sugar industry worked assiduously to fund and support researchers whose work blamed dietary fat, rather than refined carbohydrates (sugar) for the prevalence of heart disease, (“How the sugar industry shifted blame to fat”, September 12, 2016). This was not a one or two time payoff to a couple of researchers, but a continued campaign over more than a generation to have the scientific community, and thus the rest of us, minimize the impact of sugar on heart disease. This work forestalled the more recent campaigns to limit sugar-containing foods, especially soft drinks, and was a major contributor to an epidemic even greater than opioid addiction, obesity and its related health effects. Sugar is not a prescription drug, but it probably has had more negative health consequences than all prescription drugs together.

So who can we trust? I have often argued for the scientific community, but such reports of corruption of scientific research are sobering; at least, we can say that today there are increased safeguards in place. Clearly we cannot trust politicians; while they will respond to the crises in the news (like drug price increases and such) they are dependent on contributions from large corporations, and those large corporations are pursuing their financial interests. Whether directly involved in our medical care, like insurance companies and drug companies and hospital chains, or dramatically affecting our health like the high-calories food industry (including sugar), or polluting and destroying our environment like many energy companies, our interests (at least as far as our health is concerned) are not their interests, and there is often (or usually) little overlap between the two. As a physician colleague put it, “It’s always worse than you think … even if what you were thinking is pretty bad.”

Pursuit of financial gain by such companies is not in the interest of our public, or private individual, health. The most vulnerable of us – the poorest, sickest, youngest and oldest and least empowered – suffer first and most, but all of us suffer. Drug prices should be regulated tightly, and competition (including pricing as in other countries or import of drugs) should be encouraged; insurance should be single-payer, and the impact on the public’s health the main criterion in deciding on environmental pollution.

Profit should have no place in determining our health or health care.


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