What to Know

Don’t move

At least don’t exercise too much. It can lead to serious cardiovascular problems. Really.

White men who exercise at high levels are 86 percent more likely than people who exercise at low levels to experience a buildup of plaque in the heart arteries by middle age, a new study suggests.

On the other hand, another study finds a little light walking can make a huge difference.

The fingers are a-pointin’

The Senate is having hearings about drug prices and why they’re so high. Who’s at fault? “In Congressional spotlight, drug industry groups blame each other.”

Veterans sue pharma, claiming bribes

A group of more than 100 veterans or their families are suing four pharma companies (and General Electric), saying those companies paid bribes to Iraqi officials and “transacted business with a post-Saddam health ministry that was controlled by Shiite terrorists.”

The bigger they drop

Eye drops are way too big — by design. And that’s not a good thing. In fact, almost half of a given bottle goes to waste.

Eyedrops overflow our eyes because drug companies make the typical drop — from pricey glaucoma drugs to a cheap bottle of Visine — larger than a human eye can hold. Some are so large that if they were pills, every time you swallowed one, you’d toss another in the garbage. The waste frustrates glaucoma experts like Dr. Alan Robin, whose patients struggle to make pricey bottles of drops last. He has urged drug companies to move to smaller drops — to no avail.

Maybe not a problem in this case

Late edit: Apparently there’s a lawsuit about this very issue.

There’s a lesson here

Moms in Disney films have as much chance of surviving as the cop who’s “just three days from retirement.”* But you know what? It’s a great opportunity to talk to your kids about death.

* Or anyone in a red shirt on Star Trek. Or Sean Bean in anything.

Second major gene therapy for non-Hodgkin’s lymphoma approved

The FDA has approved Kite Pharma’s Yescarta, only the second gene-altering immunotherapy for cancer patients.

The treatment, considered a form of gene therapy, transforms the patient’s cells into what researchers call a “living drug” that attacks cancer cells. It is part of the rapidly growing field of immunotherapy, which uses drugs or genetic tinkering to turbocharge the immune system to fight disease. In some cases the treatments have led to long remissions.

Skin in the game

You know all that talk about your gut microbiome? Next up: Your skin’s microbiome. As in, a couple of researchers have used probiotics for the skin to treat eczema.

Did French scientists find the cause of dyslexia?

Maybe. They believe the problem is the color-receiving cone cells in the eye and is easily detectable.

In people with the reading disability, the cells were arranged in matching patterns in both eyes, which may be to blame for confusing the brain by producing “mirror” images, the co-authors wrote in the journal Proceedings of the Royal Society B.

Medicaid spending in 30 seconds

From a survey of state Medicaid officials:

States’ Medicaid spending has been slowing since 2015, when Obamacare first took effect in a big way. Enrollment is expected to go down as more people get private or employer insurance.

What’s causing the biggest increases now? Rising prescription-drug spending tops the list.

What’s going to cost more in the future?

  • When the federal government cuts funds for “disproportionate share hospital payments” this month
  • Paying for children, “if Congress fails to reauthorize the Children’s Health Insurance Program (CHIP)”
  • If Medicaid financing is restructured as part of “legislative proposals under consideration”

About one in five Americans is covered by Medicaid — 74 million or so.

Children of the corn

MIT and Harvard have reached an agreement for using CRISPR/Cas-9 gene editing for agriculture. In unrelated news, “Day of the Triffids” is playing next Thursday….

—Andrew Kantor • Oct. 19, 2017

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Anthem launches new PBM

Anthem is launching it’s own, new PBM: IngenioRx, which will debut in 2020. It’s going to be working with CVS Health to run the new company, although it’s not clear what (if any) connection there will be between IngenioRx and CVS’s Caremark.

(Unfortunately, Anthem came up with the name before checking to see if a company with that name already exists. It does. Oops. You can find more info about Anthem’s company at ingenio-rx.com — don’t forget the hyphen.)

Police: Think before you shoot

Georgia police are working to keep people from shooting dementia patients.

A plan emerges

Two senators have devised what looks like a bipartisan deal to provide health insurers the subsidies they were promised under the Affordable Care Act to help pay for low-income patients. President Trump has refused to pay that money in an effort to undermine the ACA, but Congress can override that by funding the subsidies.

Trump both said he supported the plan and that he will continue to work to destroy the ACA.

The plan would also allow states to get more types of ACA waivers and would also offer protections for low-income people and those with serious illnesses. It would also restore money cut by the White House for publicizing the options available under the ACA.

All that said, the bill still has to get through Congress. Fun! Although at least some members from both houses and both sides of the aisle said they support it.

GPhA represents at UGA

GPhA member extraordinaire* Michael Crooks spoke yesterday at the UGA College of Public Health’s annual “State of the Public’s Health” conference. The topic (not surprisingly) was opioids. Check it out in Online Athens.

* You’re all extraordinary, actually

Simon says

The paper’s title is “N-back Versus Complex Span Working Memory Training.” Part of the abstract reads, “Participants completed adaptive training on either a dual n-back task, a symmetry span task, or on a non-WM active control task.”

What does it all mean? If you want to improve your memory, head back to the 1980s and get your Simon.

J&J talcum verdict tossed

An Alabama woman who claimed Johnson & Johnson’s talcum powder caused her cancer had won $72 million, but now that verdict’s been vacated by a Missouri appeals court because neither the woman nor J&J are based in that state.

The woman’s lawyers said that the company did some packaging and labeling in Missouri, so that was enough. The court disagreed.

—Andrew Kantor • Oct. 19, 2017

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They can’t wait to be Georgians

Georgia’s preterm birth rate is higher than the national average — and rising. It was 11.2 percent in 2016 — that’s up from 10.8 percent in 2015 according to the Department of Public Health. The national preterm birth average was 9.8 percent in 2016.

Patent fight pending

That whole brouhaha* over Allergan selling its Restasis patents to the Mohawk Indians may be moot: A federal judge has invalidated four of those patents. Allergan pledged to appeal, natch.

*Aka, slightly larger than a kerfuffle

Trump to declare national emergency over opioids

The Trump administration will soon declare the opioid crisis as a national emergency. In August the president said he would make the declaration (“we are drawing documents now”), but it hasn’t actually been done yet. Expect the paperwork to be filed in the next week — maybe sooner.

Wait, what?

Emory University Hospital won’t give a two year old a kidney transplant until his father — who’s donating the kidney — can prove he hasn’t violated his parole. The hospital said that it’s committed to the highest quality of care for its patients.

Make them pay

Thinking about waiving a co-pay as a favor to a patient? Think twice. Those co-pays are there to keep patients from getting unnecessary healthcare. So what you call “being nice” the Office of Inspector General calls “a kickback.”

Marino out, opioid law under fire

A 2016 law, championed by Rep. Tom Marino and others, made it much harder for the DEA to stop suspicious sales of hundreds of millions of opioid pills. (You may have caught the “60 Minutes” piece.)

Now Sen. Claire McCaskill is introducing legislation to repeal that law: “Media reports indicate that this law has significantly affected the government’s ability to crack down on opioid distributors that are failing to meet their obligations and [are] endangering our communities.”

Ironically, Marino was expected to be tapped at the national “drug tzar,” but today withdrew his nomination.

Will life be worth living?

The good folks at the Goldenson Center for Actuarial Research created a calculator to figure out not just how long you’re likely to live, but how many of those years will be healthy ones. Give it a shot.

—Andrew Kantor • Oct. 18, 2017

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Good news for Georgia (sort of)

The White House’s latest attempt to collapse the ACA was foreseen, so most insurers had already requested higher rates — a jump of more than 50 percent. Kaiser Permanente is the only one not to have requested a big rate hike, but now that’s expected as well.

Federal tax breaks will compensate for the price hikes for most people, but about 15 percent — those earning more than $48,240 (or $98,400 for a family of four) — will have to pay the higher premiums.

And related…

Eighteen states (and Washington, DC) have sued to stop the White House from halting those payments. Donald Trump said the ACA is “imploding” as he works to dismantle it “step by step.” About 10 million Americans get their health insurance through Obamacare exchanges.

Maybe Pinky is The Brain

So, you’re a smart person? There’s good news and bad news….

Before you ‘cuse us, take a look at yo’self

The Mohawk Tribe, responding to criticism of its purchase of Allergan’s patents, sent a letter to the Senate Judiciary Committee. Four senators had requested that the committee look into the deal the tribe made with Allergan. (The Indians bought the patent for Restasis, and are licensing it back to Allergan to avoid facing patent challenges under U.S. law.)

The letter points out that the tribe possesses “the same sovereign authority exercised by state governments and public universities” when it comes to patents, and, in fact, “[I]n 2012 the four states represented by the Senators who objected to the deal owned over 7,000 patents combined.”

Me too!

Atlanta has made possession of small amounts of marijuana akin to a traffic ticket. (“Decriminalized” is the common term.) Could Savannah be next?

Whoops

Acerta Pharma made acalabrutinib, and anti-leukemia drug. It published an article in the journal Cancer Research showing the drug had a significant effect on tumors in mice.

AstraZeneca liked what it saw and in 2015 bought a majority share in Acerta for about $4 billion.

But now Acerta has retracted that paper saying the results were fabricated. AstraZeneca — which got FDA “breakthrough designation” for the drug — says that other studies show that yes, it really is effective, and one falsified study won’t change anything.

Mama always told me not to look into the sights of the sun*

And yet, bright midday light might help treat bipolar depression.

* Manfred Mann, Schmanfred Mann. The Springsteen version is better.

Oh, baby

Good news: The teen birth rate in the U.S. continues to drop — 9 percent from 2015 to 2016. In fact, the overall U.S. fertility rate is at its lowest level ever. That said, while the birth rate for women from 15 to 29 years old is down, the rates for women 30 to 49 was slightly up in 2016.

—Andrew Kantor • Oct. 16, 2017

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Not serious enough

Drug ads list so many potential side effects — the mild (“nausea”) and the serious (“children born with the head of a golden retriever*”), that consumers just tune them out — the “argument dilution effect.”

So finds a study published in Nature Human Behaviour.

* https://youtu.be/4MtmIaNc2FI

And Leon’s getting laaaaaaaaarger

More than 10 times as many kids are obese today as in 1975.

In unrelated news, which smartphone is better for your middle schooler? Time compares them.

Congress’s pharmacist clarifies remarks

I am not aware of any member that actually has Alzheimer’s and would certainly not disclose any such information if I did know,” said Mike Kim, owner of Grubb’s Pharmacy, which serves the U.S. Congress.

“I was speaking very broadly about disease states that the general American population have and that it also applies to everyone including members of the US House and Senate since they are also people just like you and I.”

E99. Z22.

Bingo!

Anthem planning Atlanta IT hub

352,000 square feet of health technology goodness, opening in 2020.

“I’m not dead yet”

If, like most people, you live in fear of being prematurely buried, don’t worry. You have options.

Trump signs order to halt insurance subsidies

President Trump issued another executive order to undermine the Affordable Care Act, this one saying that he won’t allow the government to pay cost-sharing subsides to health insurers. (The subsidies were promised in the ACA, but not officially authorized by Congress, leaving them in a sort of legal limbo.)

Expect court challenges and Congressional action, but until then, what does it mean if insurers aren’t getting the funding they were promised?

You can click here to read the 14-page summary from the Congressional Budget Office (enjoy!), or just check out our brief summary:

Obviously, without subsidies, insurers will raise premiums for silver plans. (The CBO estimates a 20 to 25 percent rise.) And some will pull out of marketplaces, at least at first, meaning some people won’t be able to buy health coverage, although the CBO figures the number of uninsured won’t change dramatically.

Then there are the tax implications. The move is likely to increase the federal deficit. Huh? you say. That’s because, as insurers exit the marketplace and raise premiums, the government will pay more tax credits to individuals — and those credits are linked to premiums. Higher premiums, bigger tax credits.

(One exception: Single adults making more than about $48,240 or families of four earning more than $98,400 — 400 percent of the Federal Poverty Level. They don’t qualify for subsidies, so they’ll pay the higher premiums if they don’t get employer coverage.)

The end result will be that the deficit will increase by $194 billion from 2017 through 2026, according to figures from the CBO and the government’s Joint Committee on Taxation.

Hence, likely Congressional action: The Left wants to be sure people can afford healthcare, and the Right wants to keep the deficit under control without raising taxes … and doesn’t want to be blamed when people can’t afford medical treatment.

But what if nothing happens? The good news is that the bottom-line cost for many people who purchase individual policies is likely to be about the same … or even lower. Sure, initial premiums will be higher, but the tax credits they get from the government will offset them.

But this is all speculation at this point. Congress can act and authorize the subsidies, and lawsuits are already in process from insurers. Once again, the mantra: Wait and see.

—Andrew Kantor • Oct. 13, 2017

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How do members of Congress get their meds?

From Mike Kim at Grubb’s Pharmacy, the official pharmacy of Congress’s Office of the Attending Physician. Read all about it.

“At first it’s cool, and then you realize, I’m filling some drugs that are for some pretty serious health problems as well. And these are the people that are running the country,” Kim said, listing treatments for conditions like diabetes and Alzheimer’s. “It makes you kind of sit back and say, ‘Wow, they’re making the highest laws of the land and they might not even remember what happened yesterday.’”

And don’t miss this:

In a STAT survey of some two dozen House and Senate members from both parties, only one knew about the single pharmacy that delivers all their drugs: Congress’s only pharmacist, Rep. Buddy Carter (R-Ga.).

So far, so good

An experimental Ebola vaccine works for at least a year.

Association health plans: Good and bad

Donald Trump is expected to sign an executive order that would loosen rules on association health plans.

An AHP means that associations could offer health insurance plans for members that did not meet the requirements of the Affordable Care Act, i.e., they could offer fewer benefits and charge sicker people more.

Good: Healthy people could buy bare-bones plans with significantly lower premiums, e.g., ones that don’t offer prescription coverage or maternity care, if they don’t need those services.

Bad: People who buy that limited coverage might not realize the limits, and would be hit by huge bills if they need extra services — for example, if they’re diagnosed with an serious illness or get pregnant.

Also bad: If healthy people leave employer plans and the individual marketplace, premiums for those plans will go up. That could be bad for … well, everyone else. As the American Academy of Actuaries put it, “Such adverse selection would result in higher premiums in the non-AHP [association health plan] plans. Ultimately, higher-cost individuals and small groups would find it more difficult to obtain coverage.”

Gottlieb wants to stay at FDA

He had been rumored to be on the short list to replace Tom Price as HHS secretary. But he thinks he can be most effective where he is.

Why Adam Fein is wrong

Adam Fein of Drug Channels argues that California’s new pharma law — which requires drug makers to notify the state 60 days before a price hike of more than 16 percent over three years — will cause pharmacies to stock up at the lower price and will result in “windfall profits” for those pharmacies. (Oh no!)

But these notifications are only required for major price increases over three years. Fein’s argument assumes a single big increase (e.g., 16.5% all at once) that pharmacies will rush to take advantage of. In reality, we’re more likely to see a series of smaller increases (5%, 8%, 7%) that eventually add up to 16 percent — at which time the company will notify the state.

It also assumes that pharmacies will be able to buy at the lower price and then (somehow) be reimbursed for the higher price by insurers.

So … yeah.

Bury that deal at Wounded Knee

The entire world wants Congress to put a stop to Allergan’s deal to sell its Restasis patents to the Mohawk Tribe. And by “entire world” we mean PBMs, insurance companies, the generic drug industry, and others.

Jury misconduct in talcum powder trial?

So a jury handed a $417 million verdict to a woman who claimed that the Johnson & Johnson’s talcum powder gave her ovarian cancer.

But it turns out that, when the jury deliberated on the amount of the verdict, it wouldn’t let three members participate in that discussion because they didn’t think J&J* was liable in the first place.

So the company wants that judgement reviewed, if not thrown out entirely.

It’s worth noting that, as J&J pointed out, “no peer-reviewed study, regulatory body or public health organization has found that talc use causes ovarian cancer.”

* Yes, our subject yesterday said “K&K.” Sorry about the typo.

—Andrew Kantor • Oct. 12, 2017

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Think of them as ‘better customers’

Today’s middle-aged Americans are in worse health than previous generations.

Today’s “Universal flu vaccine coming any day now” story

Rather than targeting the proteins that change from year to year, a new type of flu vaccine will target the ones that remain the same. The result could be a more-universal vaccine.

She’s on the roof….

If you’re giving bad news, don’t embellish — cut to the chase. “Explanatory information prior to bad news was never preferred over bad-news-first.” Besides, crying is good for them.

Oops!

The bad news: More than one in five people report being on the wrong end of a medical error.

The good news: More than half the time, someone takes responsibility for it.

Food labels delayed

The FDA will be delaying new food-labeling requirements for 18 months; they would require more and better nutritional information, but manufacturers argued that they needed more time to relabel their products and the administration agreed that two years wasn’t enough.

In unrelated news, Campbell’s Soup is introducing a new series of Star Wars themed soup labels, just in time for the release of “Star Wars: The Last Jedi. ”

The big O

And you thought they just wanted cuddles.

—Andrew Kantor • Oct. 09, 2017

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Cue the lawsuits

The Las Vegas gunman was taking diazepam (10 mg). Make of that what you will — others will certainly have something to say.

The word of the day is phylloquinone

It’s vitamin K-1, it’s found in leafy vegetables (kale, cabbage, broccoli, and even (shudder!) Brussels sprouts), and it may promote healthy hearts in kids.

Xarelto trial halted

Bayer: Meh, aspirin’s as good as Xarelto for preventing clots.

Stopping the revolving door

What if — now hang on, hear this out — what if instead of simply punishing opioid addicts for drug possession, we actually tried to help them? Crazy, right? But maybe crazy enough to make a difference.

The public defender’s office here is an enthusiastic backer of the opioid court. Flynn, the Erie County DA, says local law enforcement are supportive as well. It’s dumb, Flynn says, to keep arresting, jailing and prosecuting repeat offenders who are, first and foremost, opioid addicts in need of help.

No rest for the wicked

Insys has settled with Massachusetts for illegally marketing Subsys [fentanyl] and for paying kickbacks to physicians for prescribing it. The cost: $500,000.

But before the company could celebrate, guess what? New Jersey filed suit for just about the same reasons. Bonus: The state AG used the word “evil” to describe the company.

The lawsuit, filed in Middlesex County Superior Court, alleged Insys also paid kickbacks, including sham speaker fees to medical practitioners to prescribe Subsys and defrauded insurers into paying for it.

Have you detoxed your armpits lately?

What are you waiting for?

Vitamins during pregnancy may prevent autism

At least that’s the result of one study. It concluded: “Maternal multivitamin supplementation during pregnancy may be inversely associated with [autism spectrum disorder] with intellectual disability in offspring.”

Now simple remove the word “may” and ignore the authors’ comment that “These results on their own should not change current practice” and — presto! — you have a nightly news headline.

—Andrew Kantor • Oct. 06, 2017

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Atlanta votes to decriminalize marijuana

No, that doesn’t mean it’s legal. It means the cost for possession of less than an ounce will be $75 and no jail time. (The penalty had been up to six months in jail and a fine of up to $1,000.)

Come for the windmills, stay for the tulips

The EU’s version of the FDA, the EMA, has to move from Britain — you know, Brexit and all. The staff voted on where to move. The winner: Amsterdam.

Who’s gonna buy your next drink?

Let us recommend any of these folks:

  • Shilpa Durbal (Lawrenceville)
  • Brianna Aycock (Baxley)
  • Kayla Shuman (Claxton)
  • James Farr (Woodstock)
  • Janet Foley (Powder Springs)

They’re the five lucky winners of $100 Visa* gift cards just for answering our 2017 Member Satisfaction Survey. W000000t!

*Maybe American Express. It depends what Mary picked up.

These people need a better headline writer

Their hed: “Utilization, Cost, and Outcome of Branded vs Compounded 17-Alpha Hydroxyprogesterone Caproate in Prevention of Preterm Birth.”

The real story: The branded drug Makena costs 100 times more than the compounded version. Ingredients: same. Results: same.

The $10.7 billion we’ll all pay Allergan

So you know that deal Allergan has with the Mohawk tribe? The one that protects its Restasis patent? Some folks crunched the numbers: Without a generic, Americans will spend at least $10.7 billion-with-a-B more because of it. That’s the price difference over five years, coming out of taxes (Medicare, Medicaid) and insurance premiums and going into Allergan’s pockets.

UGA Pharmacy gets a cool $1 million

The UGA College of Pharmacy will receive $1 million from the Arthur M. Blank Family Foundation “to support pharmacy students facing financial hardships.”

The foundation is also giving UGA another $500K (matched by the Georgia Commitment Scholarship Program) for “need-based scholarships benefiting UGA students from Atlanta’s historic Westside neighborhoods.”

The mamas and the papas

The teen motherhood rate in the U.S. is about the same. But the teen fatherhood rate? Up, up, up.

Why? There are only hypotheses right now: Better paternity testing, the “cougar effect,” the changing tastes of teenage girls. Good news: Teen parents are staying in school longer.

You know what you need to do

Regular sauna bathing is associated with reduced risk of hypertension

SCOTUS rules against GSK

Six women sued GlaxoSmithKline in Illinois over birth defects they claim were caused by Paxil.

GSK said that Illinois doesn’t have jurisdiction because the women didn’t live there.

An Illinois court ruled that yes, yes it does.

GSK appealed to the Supreme Court, but yesterday SCOTUS declined to review that ruling. Illinois it is.

US stockpiles a million doses of Ebola vaccine

Nothing to see here, citizen.

—Andrew Kantor • Oct. 03, 2017

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It’s American Pharmacists Month

You got that right. The APhA even has a planning guide to help you celebrate it: events, tours, counseling, you name it. So spread the word, join the party, get schwifty … and celebrate being a pharmacist! (Technicians can celebrate October 17 — that’s Pharmacy Technician Day.)

Share the love: Show off your pics, stories, and whatever else you got with aphm@aphanet.org or hashtag it #APhM2017 on Twitter or Facebook. Or Instagram. Or Snapchat. Or whatever the kids are using these days.

Join GPhA in Cherokee County

If you’re near Woodstock (the one in Georgia) tonight, stop by the Cherokee County Opioid & Heroin Community Awareness Forum. GPhA’s gonna be there with a table, helping to spread the word that pharmacists are fighting the epidemic, too. The more white coats, the better!

STD rates are going up

According to the CDC, there are about 110 million cases of chlamydia, gonorrhea and syphilis in the U.S. right now, walking among us. (Note: That doesn’t (yet) mean that almost one in three Americans has an STD. Some people have more than one.)

Have some fun facts:

  • Chlamydia is the most common STD, and it’s up 4.7 percent just from 2015 to 2016.
  • Almost one in 10 girls aged 15 to 19 have it, and 8.0 percent of women aged 20 to 24. Rates are highest in the South.
  • Rates of chlamydia are down among African-Americans and American Indians.
  • Gonorrhea infections went up more than 22 percent among men and almost 14 percent among women — again, just from 2015 to 2016. “Almost 92 percent of cases are in people 15 to 44 years old.”

9 million kids about to lose health insurance

Congress has allowed the Children’s Health Insurance Program to expire. Without funding, about nine million will lose access to medical care ranging from routine checkups and immunizations to dental care and hospitalization.

Researchers uncover the source of diabetic nerve pain

Painful diabetic neuropathy appears to be caused by a single molecule: HCN2. The investigation is ongoing; police say HCN2 has been cooperating with their inquiries.

Compounders take note

USP intends to postpone the official date of General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings.  You know what this means.

Tick tock, Clarice

The Nobel Prize in Physiology or Medicine 2017 was awarded to three Americans “for their discoveries of molecular mechanisms controlling the circadian rhythm.”

Bonus: Unlike the prizes for physics or chemistry, this one is actually understandable by lay people.

The buyer bites back

A judge has ruled that yes, a new Maryland law that lets the state say ‘No’ to price gouging on drugs can go into effect.

The state’s Medicaid program pays for a lot of drugs, obviously, and the new law allows it to flex some of that buyer’s muscle. If an “essential” generic drug’s price rises 50 percent or more over a two-year period, the state’s attorney general can take the drug maker to court.

Pharmaceutical companies had argued that the state should have to pay whatever they wanted to charge for medications. Seriously.

Bandwagon Watch

Washington state joined the growing list of states, cities, and towns suing opioid manufacturers for their role in the opioid epidemic.

Separately, the city of Seattle joined the growing list of states, cities, and towns suing opioid manufacturers for their role in the opioid epidemic.

Tom Price is out

The Health and Human Services secretary was asked to resign after investigations into his use of taxpayer money for private flights embarrassed the administration. (Yes, you know this already; we just couldn’t ignore it.)

—Andrew Kantor • Oct. 02, 2017

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