Medicare was poised to save money with rule changes for some drugs. Then industry and interest groups arrived with torches and pitchforks.
Great news, seniors: Armies of patient groups just protected your right to be put into a chemical straitjacket during your golden years.
Sorry if that sounds alarmist. It’s hard to get people’s attention about a health policy abstraction like the defeat last month of a fix in the way Medicare does business.
You could say the illness-awareness industry ensured Medicare beneficiaries unlimited access to questionable drugs. You could say the day we develop a smarter national conversation on health care — not to mention a rational single-payer system — just moved farther out of reach. But the alarming opener really does get to the point: Why did so many advocacy groups fight a move to curtail schizophrenia drugs in nursing homes?
The answer lies in decades of seductive narratives about the promise of prescription drugs, and in the power of their primary messengers — advocates who confuse fighting for pills with fighting for patients.
The rule change in question dropped early last January, and arrived for battle with the most artless of titles: “Policy and Technical Changes to Medicare Advantage and Medicare Prescription Drug Benefit Program, Contract Year 2015.” Exactly … how could such a compelling call to action fail to galvanize support? A scheduled review of the way the government oversees the purchase of drugs for seniors and the disabled, the plan went public for a standard period of comment, and the launch was met with mass protest.
Talking points were mass-inboxed to the effect that Medicare had a 90 percent user satisfaction rating, so why fix something that is already working, mister man? That sad little riposte found an airing in places like Forbes and the Heritage Foundation, and on the floors of Congress. (Though if “user satisfaction” gets to determine which drugs are authorized to cover what illnesses, we can soon expect opioids for colds.) GOP lawmakers wrote an opposition bill they called the Keep the Promise to Seniors Act, a line they so enjoyed repeating they threatened to vote on it even after Medicare had gone home. A bipartisan group of senators signed a letter of protest. A combative hearing was held.
But the loudest protest came from the Healthcare Leadership Council, a Mount Olympus coalition of CEOs from all the big drugmakers, insurance companies, device firms and hospital systems, including those of Medtronic and my hometown champion of efficiency and health outcomes, the Mayo Clinic. (Wal-Mart sits in on HLC conference calls, too.)
Industry amassed the troops
The HLC corralled signatures from more than 350 businesses, clinical-practice associations and illness-awareness groups, but mostly the latter, including advocates for people with AIDS, ALS, Alzheimer’s, arthritis, diabetes, epilepsy, hepatitis, kidney cancer, lupus, pain, Parkinson’s and prostate cancer. Collectively, the patient groups sounded the alarm that patient choice, free markets and Medicare costs would all be at risk if the reform passed. Co-signers ranged from the Chamber of Commerce to LGBT-ers to drug-lobby Pharma and an all-hands-on-deck team effort from the National Alliance on Mental Illness (NAMI) — a group that put out alerts in Washington that reverberated through my local chapter in southeastern Minnesota.
Facing such a sympathetic, well-organized and powerful show of opposition, Medicare folded under pressure. “Given the complexities of these issues and stakeholder input,” said Centers for Medicare & Medicaid Services (CMS) head Marilyn Tavenner, “we do not plan to finalize these proposals at this time.”
The measures would have saved more than $1.3 billion in the next five years, streamlined the insurance marketplace for seniors and opened the playing field for rural pharmacies. But as the Wall Street Journal reported, the real reason the reform died was because it would have corrected an extravagant federal policy now in place for three classes of pills. “[Medicare] had proposed ending protected status for antidepressants [and] transplant drugs starting in 2015,” reported the Journal, “and antipsychotics as early as 2016.”
The underlying philosophy
A Medicare-using senior cannot demand any drug he likes, for the simple reason that many of them are no better than their competitors but are much more expensive. Six classes of pills are protected from scrutiny, however: drugs for cancer, AIDS, epilepsy, organ transplant, depression and schizophrenia. This protection was meant to ensure access to pills needed quickly for survival and which could not be swapped out for cheaper substitutes.
But it’s expensive to guarantee access to an entire class of drug — you leave insurers with little leverage on payments and manufacturers with little incentive to bring down price. That’s why the protected six classes drove nearly a third of medication spending in a recent year surveyed, costing taxpayers and beneficiaries an added 10 percent, or $500 million a year.
Yeah, yeah, money gets wasted every day in the federal government. What seemed notable about the failure of this stab at reform, however, went unmentioned in the rounds of congratulatory cheer that followed the defeat. In sifting facts from faith surrounding some of our nation’s priciest and most-consumed pills, Medicare identified liabilities in popular drugs ignored by the very clinical societies and patient-advocacy groups who have long been our only authorities on their use.
In the case of antidepressants, for instance, Medicare concluded that to delay your start on any given brand had little effect on a your chances of being harmed, and that the drugs were largely interchangeable in the eyes of their prescribers. The American Psychiatric Association doesn’t argue that one brand of antidepressant should be used over another; rather, its 2010 guidelines seem to suggest it’s all a big toss-up. “The effectiveness of antidepressant medications” says the reference, “is generally comparable between classes and within classes of medications.” The much-noted role of side effects in separating one drug from another seems like a poor excuse for their protection from market forces. Side effects are so underreported — their industry-controlled trials are too small, incurious and brief to learn much about the harm they may or may not do to our health — that the little doctors do know about side effects likely tells us more about a competitor drug’s marketing study than the protection of you and I from harm.
Nor did Medicare find that transplant drugs deserve their hallowed status. But the nation’s largest health system saved its darkest worries for the protected status of so-called “atypical antipsychotic” sedatives — drugs like Seroquel, Abilify, Risperdal, Geodon and Zyprexa. CMS supported the urgency of quick access to every one of these drugs among people with serious mental illness — in itself a questionable presumption, given its conclusion the drugs were indistinct in terms of effectiveness.
Sedatives were the real battle line
But the rulemakers were clearly distressed about patients whose lives faced harm thanks to their protectionist policy with sedatives — specifically, the maltreatment of seniors and young children subjected to schizophrenia drugs for unapproved conditions thanks to a rapacious drug-marketing pipeline.
“We believe the profitability of products not subject to normal price negotiations,” as Medicare blandly put its astute finding, “is a strong incentive for the promotion of overutilization, particularly off-label overutilization, of some of these drugs.”
More than half of Americans on antipsychotics in a year surveyed “had no psychiatric diagnosis,” according to Medicare. There is clearly something anything-goes about the antipsychotic sales juggernaut, in its view. Something that has roped in “individuals with dementia … persons for whom antipsychotics are being used as sleeping aids … and children who have not been diagnosed with a disorder for which an antipsychotic medication has been FDA-approved.”
Medicare was not getting cautious about antipsychotics because of the bottom line — it was feeling guilty. It had helped make these agents of questionable medical utility and certain potential for harm ridiculously profitable. It had done this by putting them in a hallowed reimbursement category shared by cancer drugs, and that enshrinement had encouraged drugmakers to broaden their market far beyond the treatment of rare illnesses like schizophrenia.
The administrators’ attack of conscience was wasted on patient advocates, however, who quickly lined up to demand tax-funded psychotropic medications at any price. Take the AIDS Institute, for example, which effectively waved off concerns over seniors with dementia being given the added insult of antipsychotics, by arguing that “ensuring that those living with HIV are adherent to both mental health drugs and HIV drugs is especially important,” and, “part of encouraging adherence to mental health drugs (both antidepressants and antipsychotics) is ensuring that patients have access to the drugs that work best for them and have the least challenging side effects.”
Children being given sedatives for unapproved uses were clearly not their problem, either.
Pills have consequences
Patient groups would do well to pick up a new critical history of the drugs they just rallied so loudly to protect, “The Bitterest Pills, The Troubling Story of Antipsychotic Drugs” by British psychiatrist Joanna Moncrieff. Moncrieff describes how “companies promoted antipsychotics for use in elderly people with dementia, targeting the staff of nursing homes and pharmacies despite the fact that they were not [approved] for the treatment of dementia, and regardless of accumulating evidence that the use of antipsychotics in nursing homes shortens people’s lives.”
Moncrieff might help them better appreciate how “a motley collection of unpleasant and toxic substances could rise to modern day blockbusters” … “prescribed to millions of people worldwide, including children, many of whom have never even seen a psychiatrist.”
Patient advocates might learn that not every pill is worth going to the wall for — that studies show brain shrinkage associated with long-term use of antipsychotics, heightened risk of diabetes, heart failure and metabolic disorders. They might take pause in their troubling commonplaceness in the wake of the bipolar boom, and how, as a result, “antipsychotics have become everybody’s problem.”
Medicare’s aborted attempt to fix a prescribing system that won’t police itself placed so many health care ironies on display: That a reform meant to increase competition could be depicted as harming competition. That a reform meant to trim waste could be depicted as wasteful. That a reform meant to protect seniors was depicted as harming seniors.
It’s no fun to raise awareness about the groups raising awareness. I can say from experience that you invite the scorn of the lawmakers, professional societies, social-services providers and state-agency heads taking direction from these defensive and outfoxed organizations. But if the alternative means ever more sickness and ignoring the lessons of our errors, it sure seems worth trying.
Paul John Scott is a health-sciences writer living in Rochester. On Twitter: @pauljohnscott.
The Opinion section is produced by the Editorial Department to foster discussion about key issues. The Editorial Board represents the institutional voice of the Star Tribune and operates independently of the newsroom.