Dr Martin Luther King

I’ve posted this one before on a previous MLK Day, but I think it bears repeating.

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Here’s to the new year and century

I’ve definitely been slacking on this blog for the past few years with just occasional posts.  I definitely want to change that this coming year, but I’m not going to guarantee that or make it a resolution.  But, hopefully there will be so more posts.

In the past, I’ve always posted a New Year’s Eve post – I’ve always enjoyed the holiday and the closure one gets at the end of the year, the new chapter that awaits us in the new year.  It’s a chance for us to reflect on the year that has come and gone.  A chance to maybe change some of the things in our control in the new year.  An opportunity to start again.

I will fully admit that 2019 was full of changes and was fairly good to me.  I FINALLY finished my medical training with the completion of hand fellowship in July.  After graduating from medical school over 10 years ago, I settled into a job on Cape Cod.  This summer, my boyfriend proposed and I accepted – naturally we’re now in the throws of wedding planning.  So seriously, I can’t complain.

But 2019 definitely wasn’t good to everyone.  There are A LOT of people struggling out there.  A lot of people who couldn’t wait for 2019 to be over and start over again.  So here’s the message for the new year and the new century.  For those of us who are fortunate enough to have things going our way – we need to look out for those who are down and out.  Let’s do a better job of looking out for one another, for helping one another.  Pay it forward a little bit.  Because honestly, you never know when you’re going to be the one who needs to be taken care of.

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Overtreated

I’ve started reading Shannon Brownlee’s book Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer.  Bear in mind that the book is from 2007, prior to the ACA enactment and the current debates about the next direction for health insurance coverage in this country, but I found this passage – which is actually in the introduction – to be interesting with regard to the insurance industry.  It’s not a direct connect, but I think it applies.

[…] talking about costs means talking about overtreatment, and bringing up overtreatment means facing the fact that reducing unnecessary, wasteful care would lead inevitably to a small health care industry.  The seven hundred billion dollars we currently spend on unnecessary care doesn’t just go down the drain – it goes to paying for drugs and medical devices, which are manufactured by American workers.  It helps pay the salaries of doctors, hospital administrators, nurses, orderlies, and pharmacists.  It covers part of the cost of hospital beds and the constructions of new hospital wings, which are built by American construction workers.  It helps support the insurance industry and the salaries of all the clerks who shuffle those mountains of paperwork.  Think for a moment what it would mean to eliminate this wasteful, unnecessary care.  Getting rid of seven hundred billion dollars’ worth of useless medical care is roughly the equivalent of wiping out the entire US high tech industry, including all the jobs it provided and the money it makes for shareholders.

Aside from the fact that I’m almost certain my salary will go down – a salary I have yet to start earning after four years of medical school, five years of general surgery residency, two years obtaining a MPH, three years of plastic surgery residency, and one year of hand fellowship – this is actually my next biggest concern about the Medicare for All plans that entirely eliminate private insurance.  Look, I hate insurance companies just as much as every other physician and American, but what happens if we just wipe them out?

In 2017, health care spending accounted for 17.9% of the US Gross Domestic Product.  Obviously, the private medical insurance industry does not account for anywhere close to that entire amount, but some of that 17.9% is certainly fueled by the insurance industry itself.  There are a significant number of jobs tied to the insurance industry – as Brownlee points out, the “clerks who shuffle those mountains of paperwork” are actual people.  Sure, some of them would undoubtedly be hired by the government to run a significantly expanded Medicare program, but not all of them.  Overhead costs are currently significantly lower for Medicare than for private insurance companies, predicting that a Medicare that covers every American won’t need to hire all of those people.  What happens to those folks after those jobs are gone?  And what’s the ultimate ripple effect – because altering any part of the health care industry, nearly 1/5 of the economy, is bound to have a big effect.

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overread

No matter what measures are taken, doctors will sometimes falter, and it isn’t reasonable to ask that we achieve perfection.  What is reasonable is to ask that we never cease to aim for it.

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Complications

I know I’m late to the game, but I’m finally reading Atul Gawande’s 2002 book Complications: A Surgeon’s Notes on an Imperfect Science.  I’m about a quarter of the way through the book, and it’s obvious where much of the inspiration and the groundwork for his later book Checklist Manifesto came.  Gawande dedicates a section to errors in medicine and – much like many who have come before and after him – points to other “high reliability industries” to show that errors occur but can be minimized.  In 2019, we are still debating that central tenet in medicine, albeit there are few who disagree now than there were when Gawande wrote this book.  Yet there are still people, physicians in particular, who point out that checklists, protocols, formulas, and equations cannot account for every possibility given how complex medicine and patients are.  These same individuals will point to “intuition” and “the art of medicine” as the bedrocks of diagnosis and treatment.  To those individuals, I steal a quote from Gawande,

Of course, patients are far more complicated and idiosyncratic than airplanes, and medicine isn’t a matter of delivering a fixed product or even a catalogue of products; it may well be more complex than just about any other field of human endeavor.  Yet everything we’ve learned in the past two decades – from cognitive psychology, from ‘human factors’ engineering, from studies of disasters like Three Mile Island and Bhopal – has yielded the same insights: not only do human beings err, but they err frequently and in predictable, patterned ways.  And systems that do not adjust for these realities can end up exacerbating rather than eliminating errors.

Adverse medical events are believed to kill between 250,000 to 400,000 people each year, making it the 3rd leading cause of death in the United States.  The real question then is, when can we finally put this debate to rest?  When can we finally wrap our heads around the idea that there are far better and safer ways to deliver care than “intuition”?

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Drug makers and generics

Drugmakers Master Rolling Out Their Own Generics To Stifle Competition

When PDL BioPharma’s $40 million blood-pressure medicine faced the threat of a generic rival this year, the company pulled out a little-known strategy that critics say helps keep drugs expensive and competition weak.

It launched its own generic version of Tekturna, a pill taken daily by thousands. PDL’s “authorized” copycat hit the market in March, stealing momentum from the new rival and protecting sales even though Tekturna’s patent ran out last year.

PDL’s version sold for $187 a month versus $166 for the competing generic, made by Anchen Pharmaceuticals, according to Connecture, an information technology firm. PDL’s brand-name Tekturna runs about $208 a month.

The plan is “to maximize profit at this point,” Dominique Monnet, PDL’s CEO, told stock analysts in March. With the boost of PDL’s house generic, “the economics would still be very favorable to us” even against the generic rival and even if prescriptions plunged for the brand, he said.

Lawmakers who created the modern generic-drug industry in the 1980s never imagined anything like this — brand-pharma companies maximizing profits by appearing to compete with themselves.

But it goes on all the time. In fact, there are now nearly 1,200 authorized generics approved in the U.S., according to the Food and Drug Administration. While these might look like products that would push prices down, authorized generics can be as profitable as, if not more profitable than, brand-name drugs.

“Authorized generics are not generic drugs,” Dr. Sumit Dutta, chief medical officer for drug-benefit manager OptumRx, told Congress in April. “The marketing and production of authorized generics is exclusively controlled and directed by brand-drug manufacturers. They do nothing to promote competition.”

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Last year, authorized generics appeared at the rate of about once a week. High-profile examples in recent years included Mylan’s generic version of the EpiPen anti-allergy injector, introduced to soothe public outrage after the company raised the brand price 400%. In March, Eli Lilly said it would launch a less expensive generic of its Humalog insulin, whose branded list price has also soared.

Of all the ways drug companies try to protect sales as patents expire — changing doses, adding ingredients, seeking approval to treat new diseases — authorized generics are by far the most profitable, returning $50 for every dollar invested, research firm Cutting Edge Information calculated in 2015.

Brand-drug companies say authorized generics increase competition even if they’re not an independent product.

This “reduces prices and results in significant cost savings,” said Holly Campbell, spokeswoman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, the brand-drug lobby. “Congress should reject attempts to delay, restrict or prohibit authorized generics.”

But critics say authorized generics hurt long-term competition and often perversely increase costs, even in the short term.

Authorized generics don’t just steal sales from existing generic rivals. Critics say they erode incentives to make generic drugs, partly by thwarting the intent of Congress to let one company temporarily have generic business to itself after a brand patent expires.

Tactics like this can “stave off generic competition and make sure that generics can’t get much of a foothold when they do get to market,” said Robin Feldman, a professor at the University of California Hastings College of the Law, who studies pharma policy. “That’s the game. And drug companies have become masters at this.”

Authorized copycats may help explain why relatively few true generics are reaching the market despite a surge in approvals, analysts say.

The 1984 Hatch-Waxman Act founded the modern generic business by establishing rules for safety and competition, including granting six months of market exclusivity to the first generic rival to each brand. The idea was to give the first mover a profitable head start to attack the established pill.

Few realized the law left room for brand companies to launch their own generics at the same time as or even earlier than rivals, often slightly lower in cost and nearly indistinguishable to patients and doctors from the brand as well as any independent generics.

PDL acquired Tekturna from Novartis via an affiliate in 2016 and soon learned that Anchen was planning a generic. It moved quickly to fight back.

PDL’s authorized generic version of Tekturna “was timed to secure us the benefit of being first to market,” before Anchen’s version was even on the shelves, PDL’s CEO, Monnet, told analysts. “We believe this provides [PDL] with a distinctive competitive advantage.”

PDL was so confident the authorized generic, called aliskiren, would produce substantial revenue without much effort that it got rid of its Tekturna salesforce of 60 people.

“There’s a lot of parts of the system that just automatically switch” to generics, whatever the source, said Maxim Jacobs, who follows PDL’s stock for Edison Investment Research. So even if the authorized generic isn’t much cheaper than the brand, “it’s almost like a no-brainer” to roll one out, he said.

Monnet was unavailable for an interview, a spokesperson said. Anchen did not respond to requests for comment.

Oddly enough, authorized generics can be more profitable than the brand-name drug even if their list prices are much lower, OptumRX’s Dutta told Congress. That’s because they usually aren’t subject to rebates that flow from the drugmaker to middlemen such as OptumRX and effectively lower a brand’s revenue.

“These authorized generics often result in net prices higher than the brand drugs they replace,” he told Congress. “Authorized generics are just another tactic for drug manufacturers to improve profitability.”

The list price for the authorized generic of Humalog insulin is half the brand’s — $137 versus $275. That apparent discount offered limited relief to uninsured patients paying cash and generated spirited headlines saying Lilly had lowered the price significantly.

But the move won’t cost Lilly any money, said another senior pharmacy benefits executive who asked for anonymity to speak candidly about a vendor. After rebates, $137 is about what the drug giant nets for Humalog now, the executive said. And it’s still far higher than what insulin costs in other countries.

“It’s a parlor trick,” the executive said. “They’re bending to political pressure, but are they taking any money out of the system? They’re not.”

Lilly’s Humalog generic, called insulin lispro, and Mylan’s EpiPen copycat departed from the traditional playbook by launching well before patents for those brands expired. The companies were trying to calm outrage over rising prices rather than fend off generic rivals, analysts said.

Generic Humalog “was made available to help people paying full retail price for their insulin” because of coverage gaps or lack of insurance, said Lilly spokesman Greg Kueterman.

The mere threat of an authorized generic can also smother competition.

A 2013 Supreme Court ruling challenged deals in which brands blatantly paid rivals to keep generics off the market. So pharma firms came up with an alternative: They could would hold fire on an authorized clone if generic firms agreed to delay launching their products or gave some other concession, according to the Federal Trade Commission.

Both sides win. The brand stretches its monopoly beyond the life of the patent, while the generic firm avoids facing an authorized rival later on.

Authorized generics can generate outsize profits in yet another way: as a method to game Medicaid contracts that costs taxpayers hundreds of millions of dollars a year, according to investigators for the Health and Human Services Department.

Brand-pharma companies routinely “sell” authorized generics to a corporate affiliate at a sharp discount, establishing an artificial wholesale price, said Edwin Park, a research professor who studies Medicaid at the Georgetown University Center for Children and Families.

Because of complex discounting formulas, this strategy minimizes rebates the drugmakers owe to Medicaid, found HHS’s Office of Inspector General.

Congress is eyeing bipartisan legislation to close that loophole, which the Congressional Budget Office estimates would save the federal government $3.15 billion over 10 years.

The next frontier in authorized generics involves harder-to-make biologic drugs, such as generic Humalog, which are made from components of living organisms, analysts say.

Such products tend to be expensive and highly profitable, producing especially strong incentives for brand companies to preserve their franchises.

Makers of valuable biologics such as arthritis drug Humira have avoided the kind of competition from generic-like “biosimilars” that exists in Europe, partly due to patent extensions and litigation settlements.

But once patents do expire, authorized biosimilars are likely to be an integral part of their profit-preservation tactics, analysts say. In February, Lilly asked regulators to clarify their stance on “branded biosimilars” — a clear indication of its interest.

The query is “part of a number of questions Lilly and others have posed” about shifting FDA treatment of biologics, said Lilly spokesman Kueterman.

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Medicaid expansion in Virginia

Yesterday, Virginia became the latest state to expand Medicaid under the Affordable Care Act.

What changed? The 2017 statewide elections which broke GOP control of the Virginia legislature and governorship.

Votes matter – and in some cases your well-being depends on it.

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