What is a standard therapy and why do we care?^[1] Used interchangeably with phrases like best practice, standard medical care, standard therapy, and standard of care, this term refers to “the degree of care a prudent and reasonable person would exercise under the circumstances.”^[2] In medicine, it is what medical experts and healthcare professionals generally consider acceptable treatment for a particular disease.

Standard care is not, however, the same thing as optimal care. Used as a benchmark to determine whether a medical provider is liable for the outcomes of their care, standards of care are primarily relevant to medical malpractice lawsuits. These interchangeable terms are frequently misunderstood, and they not static: they evolve alongside legal precedence and the medical community’s understanding of disease and treatment.^[3]

It’s important to remember not only that there can be substantial differences between standard care and optimal care but also that standard therapies can turn out to be very harmful. The history of standard treatments harming patients goes back many centuries. But what might we learn from more recent examples?

The Opioid Epidemic: How Overprescription and Big Pharma Have Killed Hundreds of Thousands of People

According to the latest Centers for Disease Control brief on the opioid epidemic, nearly 645,000 people died from overdose between 1999 and 2021, including both prescription and illicit opioid overdoses.^[4] Additionally, the estimated economic cost surpassed $1 trillion several years ago.^[5] Several contributing factors to this epidemic have been identified: epidemic loneliness, lacking health services in rural communities, job loss due to international trade, and the increased prevalence of fentanyl.^[6][7][8][9] The two factors that are the most impossible to overlook, however, are the overprescription of opioids and the reprehensible actions taken by pharmaceutical corporations seeking record profits from pain and death.

No name is more commonly associated with the opioid epidemic than the name of the Sackler family, owners of Purdue Pharma.^[10] Known most of all for their aggressive, deceptive marketing of OxyContin, the company has been at the center of numerous lawsuits from both state attorneys general and private parties. Though they have now opted for a settlement and declared bankruptcy, they withdrew more than ten billion dollars from 2008 to 2018, as the epidemic was worsening, and deposited the money into offshore accounts. (In a separate lawsuit, settled in 2007, they pleaded guilty to misbranding the dangers of their product while fully aware of its addictiveness.^[11]) The legal status of the company’s bankruptcy plan is still pending due to disputes over a provision in the plan that shields the family from civil liability.^[12] As Arthur Gale writes in the journal Missouri Medicine:^[10]

At the peak of their sales and marketing, Purdue hired 3,000 doctors to serve on their speakers bureau—a fact which certainly does not reflect well on the medical profession. Richard Sackler, the current chairman of the board of Purdue and who closely directed the firm in recent years, went to Harvard Business School—a fact which also does not reflect well on America’s premier business school. At Purdue, profits trumped ethics.

The Sacklers were generous donors to universities, academic medical centers, museums, and other charitable institutions in the U.S. and all over the world. Their names adorned these venerable institutions.

This final detail, the philanthropic facade put on by the company, has been aptly described as reputation laundering and a disgrace to museums worldwide.^[13] Many institutions have since distanced themselves from the Sackler name.
By focusing only on the headline figures, however, we risk missing the more important takeaway: Purdue Pharma is by no means uniquely driven by the profit motive. Pharmaceutical corporations everywhere seek profit above all else, including, most importantly, the health outcomes of their product users. (Even just this phrase, product users, betrays the sort of cold, dehumanized outlook at the heart of their enterprises.) An article published in 2023 showed how competitors in the pharmaceutical industry reacted to the threat of punishment hanging over Purdue Pharma.^[14] They demonstrate that, “rather than [attempting] to distance themselves from association with Purdue, other prescription opioid firms significantly increased their spending to promote competing opioids to physicians previously targeted by Purdue, including in counties where the opioid epidemic was known to be severe [emphasis added].” Given a vacuum and a vulnerable population already struggling with addiction, these companies saw only the opportunity to sell more of their drugs.

This increased spending on promotion is not harmless: the pharmaceutical industry’s investments directly influence doctors’ prescribing patterns. The industry spends billions every year to target physicians with gifts, samples, trips, and more, which researchers have empirically shown influence the drugs doctors hand out.^[15] Likewise, Big Pharma’s lobbying efforts target elected officials to ensure policies do not substantially regulate the industry’s power.^[16]

All of these factors contribute to the overprescription of opioids and the resulting deaths. In the decade leading up to 2008, prescription opioid sales increased fourfold alongside a fourfold increase in deaths attributable to those very drugs.^[7] In addition to pharmaceutical companies’ aggressive marketing tactics, other changes within hospitals contributed to overprescription: patients’ self-reported pain levels were adopted as a vital sign, and the increased use of patient surveys allowed for increased comparisons between hospitals, which could influence hospital funding. Seeking higher patient satisfaction, hospitals tended toward more liberal prescriptions, particularly in rural areas where patients would otherwise have had to make multiple long-distance trips to refill their prescriptions.

Although more widely publicized because of the indisputable dangers, the overprescription of opioids is not out of keeping with broader prescription patterns in the US. We spend far more for our prescription drugs than the rest of the world, and while it’s difficult to measure precisely what proportion of the drugs we purchase go unused, we are surely among the highest per capita users in the world. A selective review analyzing four common medication categories found prescription increases in recent years; “most concerning,” writes the author, “is that they have been frequently prescribed for extended periods, usually with inadequate evidence of benefit.”^[17]

Even if prescriptions for opioids have decreased in more recent years, we still account for the vast majority of global opioid prescriptions.^[18] As of 2018, there were more than 50 times as many opioid prescriptions in the US as the rest of the world combined.^[19] And even after overprescription is brought under some control, much of the damage remains unresolved, as addicted individuals often turn to drugs like heroin or illicit fentanyl.

Just as it’s simplistic to blame only Purdue Pharma when the entire industry is geared toward the same degenerate end, it’s also simplistic and unfair to blame individual hospitals or doctors. It is precisely the systemic nature of the opioid epidemic that makes it so difficult to contain; even if its results have been disproportionately devastating, we should not mistake the phenomenon for an anomaly within the larger healthcare system. It’s business as usual.

Hormone Replacement Therapy: How Inadequately Tested Drugs and Big Pharma . . .

The prescribing of estrogens and progestins for postmenopausal women has had a frightening history, with several similarities to the more recent opioid epidemic. “The history of these drugs serves as an excellent example of how different constituencies with competing objectives often collide to produce health practices and policies with questionable benefits and potential harm,” write Naughton and others.^[20]

They write that these hormones have been available in the US for nearly a century, with Premarin being the most notable oral hormone used by postmenopausal women. “Aggressive marketing of Premarin [. . .] was documented by 1945;” however, animal experiments more than a decade earlier had shown that conjugated estrogens induced cancer. Despite these valid concerns of carcinogenesis, the FDA approved their use in 1941; “evidence suggests approval resulted largely from concerted lobbying by drug companies aided by the cooperation from physicians [. . .] However, little was known regarding appropriate dosages, and potential short-and long-term risks and benefits.”

It wasn’t until stronger evidence of harm emerged from the Women’s Health Initiative (WHI), many decades later, that the practice met more significant pushback. As one commentator wrote in 2002:^[21]

The most important part of this story has received little attention: why did the medical and research community ever believe that [HRT] prevented or treated disease? [. . .] For decades, physicians have acted as an unwitting volunteer sales force for pharmaceutical companies that have promoted HRT for disease prevention in the complete absence of controlled trials supporting this claim.

Advertising and detailing have been only a small part of this campaign; far more effective is the hidden influence that pharmaceutical companies have on the information that physicians receive [emphasis added].

This quote gets at an essential detail: that menopause has become not only a stage of life but also “a multibillion dollar industry for the pharmaceutical manufacturers that produce HRT” tells only one part of the story.^[22] It’s not only the amount of money the industry is willing to spend on advertising that we need to be concerned about; it’s also their malignant underhandedness.

For instance, “dozens of ghostwritten reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms of [HRT].”^[23] Wyeth, the manufacturer of Premarin plus common over-the-counter drugs like Advil and Robitussin (acquired by Pfizer for $68 billion in 2009^[24]), used this tactic not only to downplay the risks of their drugs but also “to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles.”

Such concerted misinformation campaigns, which are not limited to hormone therapy drug producers, have severe consequences: even decades after the beginning of the Women’s Health Initiative that began to raise alarms about the potential side effects of these drugs, many patients and providers remain misinformed about the risks and benefits of hormone therapy. In a 2020 article on older women’s perceptions of the benefits and risks of long-term hormone therapy, researchers found that many women continue to use hormone therapy because of unfounded hopes of preserving youthful physical and mental function.^[25] The findings strongly suggest widespread “distorted views of HT efficacy and risk,” with all of the women interviewed expressing little concern for the risks of prolonged use.

Also, recall how opioid producers not named Purdue Pharma responded to the void in the marketplace. Big Pharma (and other industries too) does not and never will respond to evidence of harm the way you or I would. Rather than wait for more in-depth studies, they seek to secure and then multiply their grossly obtained wealth.

In the case of opioids, that means increasing spending and targeting the most vulnerable regions. In the case of cigarette smoking, it means systematically nurturing confusion, fearmongering about governmental overreach, and propping up phony “expert” opinions.^[26] In the case of hormone replacement therapy, facing the alarming evidence from the WHI and a subsequent decline in consumer demand, it was inevitable that prescriptions would decrease and promotional spending would shift.^[27] Though promotional spending on the standard-dose Prempro decreased following the WHI evidence, the company quickly turned its focus toward a lower-dose formulation of the same product. Increased prescriptions for the new agent followed, but at what cost? At the time, “it [was] still unknown whether simple dose reductions [would be] sufficient to alter the imbalance of harms and benefits.”

None of this is to say that all hormone replacement therapies are categorically dangerous or that they absolutely cannot provide any relief for certain symptoms of menopause. But why must we wait decades before these potential harms and benefits are properly assessed? Why should standard treatments race recklessly ahead of the evidence? And whose agendas are we serving?

Have We Learned Our Lesson?

The two case studies introduced here, neither of which are resolved, illustrate that just because something is standard practice does not mean it is beyond questioning. The conflation of authority with truth is a lapse in logic far too common in matters of life and death. My doctor told me X is not sufficient proof that X is true.

So, where does that leave us? Should we automatically disbelieve what our physicians tell us and disregard advice for which there is a legitimate consensus? Obviously not. All things being equal, would any sane person reject treatment for a broken arm? I hope not. Iatrophobia (fear of doctors) and paranoia are foolish substitutes for blind faith in the medical profession’s ever-evolving standards. Somewhere between the two extremes is a probably smarter and more empowering alternative that involves trying to stay informed, advocating for yourself as much as possible, learning about preventive medicine, and keeping an open, critical mind.

References

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