Showing posts with label Sackler. Show all posts
Showing posts with label Sackler. 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.

Sunday, April 22, 2018

The Political is Personal: Corporate power, social isolation, and the health of the nation -- Part 2


This talk was presented at the 29th Conference on Primary Care Access, Monterey, CA April 16, 2018

Many officials and policymakers pay lip service to the importance of health, but most of the actual support (spelled M-O-N-E-Y) is for treatments for individuals, often with uncommon diseases. Being on the “frontiers of knowledge” is much sexier than rather than the old, pedestrian “taking care of people”. And such policies ensure enormous profit for drug manufacturers, who, like military contractors, are guaranteed huge returns while most Americans are not even guaranteed subsistence.

We abhor the individual excesses of Martin Shkreli and Turing jacking up the price of pyrimethamine (Daraprim ®) from $13.50 to $750 a pill (he has been sent to prison but not for this action against the health of the people; rather he committed the much worse sin of defrauding investors), or Heather Bresch and Mylan raising the price of Epi-Pen ® from $100 to $600, or the manufacturers of colchicine (URL Pharma), with the complicity of the FDA, being allowed to patent a drug that was identified as effective for gout in Egyptian papyri in 1500 BC and raise the price from a few cents to $5 a pill. And what is there to say about the scammer Elizabeth Holmes and Theranos and its A-List Board of Directors?

The Atlantic recently told us the history of the creation and marketing of Oxy-Contin ® by the Sackler brothers. When they bought Purdue, they inherited an expiring patent for extended-release morphine. So they not only developed extended-release oxycodone and marketed it, taking advantage of the public (and physicians’) caution about morphine, they greatly broadened the indications for this drug, which is just as addictive, from cancer and sickle-cell and the like to any chronic pain, especially back pain. Thus, we almost all are eligible users, and we see the results with our nation’s opioid crisis.

If we are still practicing, we see the results of the “breakthroughs” in recombinant DNA “-ab” drugs (actually, anyone who watches TV will see the ads for them), promising (occasionally with some validity) new hope for sufferers from cancer, auto-immune disease, and a variety of neurologic conditions. The TV ads do not contain, and I hope that we as physicians are aware of, the prices, often $30,000 to $100,000 a year or more, far more than the average family income in the US. The frequency of serious side effects, including death, from these drugs is very real – many are immune system stimulants that frequently, not rarely, cause autoimmune hepatitis, pancreatitis and the like – and these are not clearly portrayed on TV, or in marketing to physicians.

Even when the individual is partially shielded from the cost by insurance, the out-of-pocket costs to patients can still be enormous. In any case, no matter who is paying, the pharmaceutical companies are making out like the bandits they are, and less and less money within the whole system is actually available for population health, for prevention, for public health, for treatment of common diseases like hypertension and diabetes. And even for those conditions, we keep seeing newer – and always more expensive – drugs. While all the new diabetes drugs have some use for some individuals, many people with diabetes are still getting inadequate basic treatment with metformin, insulin, and good counseling and support for diet and exercise.

And what can be said about “precision medicine” (sometimes called “personalized medicine”)? Tens, or hundreds, of millions of dollars spent or promised by the federal government, promoted by former President Obama as part of the “moonshot on cancer”, the idea that every individual will have a relatively unique treatment based upon learning and understanding her genetic makeup. The promise is that we will be able to prescribe treatments for cancer and other horrible diseases as precisely as we target antibiotics to the culture results (and, I imagine, overprescribe them as we do with antibiotics). Pursuit of the money being allocated for these “cures”, as well as the cachet of being “scientific industry leaders”, has become a major motivator of medical school deans and chancellors, with every academic medical center developing Institutes for precision or personalized medicine.

What, by the way, has been the outcome? Not much, so far. Two genes have been shown to, themselves alone, cause cancers, and they have been well-known for a long time, BRCA-1 and BRCA-2. And the amazing precision/personalized medicine treatments? Well, get mammography earlier and more often and maybe consider prophylactic bilateral mastectomy. Where are the precision cocktails that cure each person? Do not fret; billions more will be spent on looking for them for years to come.

Is there a problem with this? Taken in isolation, pursuing effective treatments for terrible diseases that affect a significant (if relatively small) proportion of our population is not intrinsically a bad thing. But nothing is done in isolation. Those dollars that NIH spends on looking for these treatments, those insurance company dollars spent paying for outrageously overpriced drugs, the infrastructure development in our academic medical center that continues to support high-tech, high-specialization research and care, are dollars not being used for population health, public health, prevention and primary care, not being used to actually, effectively and broadly implement the treatment strategies that we know work so that they are not only available to but used for the benefit of everyone.

This is what we, as family doctors and primary care providers, and public health workers, can do. It is important, cost effective, and will make a real difference in the health of the population. But because it is cost-effective, it is not profitable for those corporations that have great influence in public policy, and so it continues to be recognized mostly with words and not resources.

Some years ago the VCU Center for Human Needs developed the County Health Calculator. You can click on any state, or any county, and find out the number of deaths per year, number of people with diabetes, cost of diabetes, percent of people with greater than a high school education, and percent of people with an income of at least twice the poverty level. You can compare to the best and worst county or state, and a neat slider lets you see how many lives and dollars would be saved if you had higher or lower percents. Here is Monterey County, CA, where we are. Despite the impression that might be generated by Reese Witherspoon’s HBO show “Big Little Lies”, it is not the richest or best-educated county in the state, but closer to the middle.  Allocating more of our money to addressing core societal functions, like education and poverty, will make a big difference in health, much more than any individually-directed medical care.

It should be obvious that the emphasis in medicine and health care to focus on individual treatments, despite (and maybe because of) huge costs (and remember, costs are someone’s profits!), rather than on interventions to improve the health of our overall population, is totally related to the political and social conditions and circumstances I spoke about at the beginning. We not only feel we are alone, we are actively being encouraged and directed to feel alone, and that we just need to look out for ourselves, and the treatments for our diseases, and our housing and food and children’s education and tax burden, and not for anyone else.

This serves the dual purpose of 1) pursuing, as I hope I have demonstrated for medical care (and others have also demonstrated for military contracting and other areas), strategies that maximize corporate profits, as well as 2) limiting the probability that people will organize together to attack the core structure of cynicism, exploitation, and greed that has become so ubiquitous that we can often not imagine any other way of society being organized.

I have talked about a number of issues, which I think are all related to our health, as individuals and as a nation. I have talked about social isolation, consumerism, a health system that is organized mainly for profit, the excesses of pharmaceutical manufacturers, “precision” or “personalized” medicine, and community health. Changing all of this is about changing society, but I think we, as health professionals, definitely have something to contribute. Whenever we think about these issues, whenever we are confronted by the false idea that we are each alone, that we cannot band together, that we should not care for the others in our society, that there is not value in social cohesion, we need to resist it and increase our efforts to work with others. As physicians and health workers, especially in public health and primary care, we need to continue to demand that most health dollars are spent on the strategies that benefit the health of most of the people.

       While policymakers and subspecialists and deans talk about “personalized medicine”, we as family doctors and other primary care providers, talk about personal medicine.  We are talking about the interactions between people – the medical term for whom is “patients” -- who need to be heard, and validated, and supported, with doctors and other providers who have enough time to do so. This is where the magic of personal medicine happens, not mainly in the provision of ever-more-expensive dangerous drugs and procedures. It is what we know how to do, and need to continue to teach others to do, and it is where we need to direct our efforts. It will not be easy, given the poor pay and resultant shortages of primary care doctors, and the mega-mergers that employ strategies such as retail clinics, currently being adopted. These strategies combine two major themes I have mentioned –  it is “corporate profit meets social isolation and instant gratification”, where people are encouraged to no longer value the relationships that come from continuity and community-based practices. 

We may well be on the road to 1984, even though it’s 34 years late. But I think we can still band together and resist going all the way there.

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. 

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