What to Know

Get yer annual OSHA training

If you give immunizations, you’ll probably want to get your annual OSHA update. (Can you say “bloodborne pathogens training”?)

Take it online from the comfort of your living room, with GPhA’s webinar, “The Dreaded OSHA Update.”

The deets: 60-minutes. September 7 at 7:30 PM. A mere $20.

Click here to sign up today!

Was it you?

One in 10 Georgians was affected by a healthcare data breach in the past year.

Immunize Georgia is coming

The headline says it all: The annual conference is being held Friday, September 15 at the Columbus Convention and Trade Center. Register to “learn the latest recommendations and best practices in immunization services.”

Check out the agenda here, or click here for all the info.

FDA approves country’s first gene therapy

The U.S. has just approved the first genetic treatment — specifically for childhood leukemia. Novartis’s use of CAR-T cells will cost $475,000, but it said there would be no charge for patients who didn’t show a response within a month.

CAR-T treatment uses gene therapy techniques not to fix disease-causing genes but to turbocharge T cells, immune system soldiers that cancer too often can evade. Researchers filter those cells from a patient’s blood, reprogram them to harbor a “chimeric antigen receptor” or CAR that zeroes in on cancer, and grow hundreds of millions of copies. Returned to the patient, the revved-up cells can continue multiplying to fight disease for months or years.

Opioid-maker lawsuit watch

Bensalem, Pa., sues opioid makers.

Missouri widens its lawsuit with “investigative demands.”

Beauty watch

Beyond the pale

Yet another reason — besides, you know, skin cancer — not to use a tanning bed.

Stories you wouldn’t think needed to be told

Instagram isn’t the place to find a plastic surgeo

—Andrew Kantor • Aug. 31, 2017

Comment!

Try to keep up, folks

Fats are good for you (says a new, large, long-term study), carbs are bad. And remember, if a food is labeled “low-fat” there’s a good chance there are lots of added sugar.

Contrary to popular thinking over the last few decades, the researchers found no significant association between eating more than the recommended amount of fat and developing heart disease or having a stroke. In addition, a fat intake of about 35 per cent of total calories was associated with a lower overall risk of dying compared to a lower percentage of fat in the diet.

In contrast, people who ate a lot of carbohydrates (more than 60 per cent of their total calorie intake) were at higher risk of death overall, as well as death not related to cardiovascular disease. 

Serendipity and drugs

You probably know the story of penicillin (open window, bread left out, mold kills bacteria, etc.), but how about the equally interesting story of warfarin? (Bonus: It has cows!)

Sci-fi writers, take note

These scientists are reprogramming cells using nanoparticles. (“[W]e develop targeted mRNA nanocarriers that are simply mixed with cells to reprogram them via transient expression.”)

The goal is to get those cells to produce disease-fighting proteins, not to start a new breed of superhumans.

Yet another coffee study

This one shows that having at least four cups* of coffee a day cuts your risk of death. Caveat: The people studied were those who ate a traditional Mediterranean diet, but still. (The study was presented at the European Society of Cardiology’s 2017 Congress.)

Among 200,414 person-years of follow-up, a total of 335 participants died. Participants who consumed at least four cups of coffee per day, showed a 65% lower risk of all-cause mortality than those who never or almost never consumed coffee.

  • A “cup” of coffee is about 6 oz., so one typical mug = two cups

CVS lawsuit sorta dropped

Remember that suit accusing CVS of overcharging for generics (via clawbacks)? It’s been dropped … sort of. The woman who filed has dropped it, but the law firm she hired is planning to refile.

—Andrew Kantor • Aug. 30, 2017

Comment!

Nothing is simple

The Trump administration hasn’t yet officially made the opioid crisis a national emergency. (The president said it was, but when there’s government involved it’s a bit more complicated. Paperwork has to be filed, choices have to be made, and so on.)

According to a White House spokesman, any such emergency actions are going through “an expedited legal review,” but it is unclear how long this review will take.

The eyes have it

There are two constants in the universe, Einstein supposedly said: hydrogen and stupidity. This is not a story about hydrogen.

Aetna opens a window to lawsuits

Pro tip: If you’re mailing sensitive information to people, make sure it’s not visible through the envelope’s window.

Who isn’t taking their diabetes meds?

Surprise: It’s millennials. Fewer than half adhere to their oral medication schedule.

What’s that you say?

Older folks may have trouble hearing you. Yeah, yeah, that’s not a surprise — but a new study looked a little deeper. It’s not just hearing loss, it’s hearing loss in a clinical setting.

It’s not just that they can’t hear you well, it’s that they mishear you, especially if you use any type of jargon.

[E]mergent themes consisted of (in descending order of citation frequency): general mishearing, consultation content, physician-patient or nurse-patient communication breakdown, hospital setting, and use of language. (Emphasis ours.)

Please, sir, can I have some more?

Georgia Medicaid is looking for “millions more,” reports Georgia Health News. (Remain calm: It amounts to of two-tenths of one percent of the agency’s budget.)

Most of it is going to “disproportionate share’’ payments to hospitals that serve a high number of indigent patients.

Antibiotic use down … mostly

Antibiotic use is going down overall, according to a report from Blue Cross Blue Shield, especially in infants and children. But “Portions of Appalachia and the South have the highest prescription fill rates,” and “Prescription fill rates in rural areas are 16 percent higher than in urban areas.”

City mouse, country mouse

There’s a rural-urban divide in teen vaccination rates — but only for some vaccinations. The CDC would really like to know why.

—Andrew Kantor • Aug. 28, 2017

Comment!

Eight Georgians OD

The culprit appears to be fake Percocet.

Well that seems like a good idea

The FDA is having a meeting and accepting public comments. The topic: giving kids opioids in their prescription cough meds.

My heart is in my hand….

Literally.

Senate ready to try the unthinkable

On September 6 and 7, the Senate will begin — wait for it — bipartisan efforts to ‘fix’ the nation’s healthcare system. I know, right?

The goals: Keep premiums down in the individual marketplace (where 18 million Americans get coverage), make sure plans offer comprehensive coverage, insure choice of providers … you get the picture.

—Andrew Kantor • Aug. 24, 2017

Comment!

Express Scripts to limit opioids

The PBM will limit first-time users to seven-day prescriptions, will not authorize long-acting drugs, and will limit dosages. Not surprisingly, physicians don’t like the idea of the PBM making medical decisions.

For it’s part, Express Scripts’ spokesperson said, “A lot of times physicians are prescribing these drugs blindly. They don’t know that a patient may be going to see multiple prescribers.”

Docs to state: Kids need meningitis B shot

Four Georgia physicians’ groups are asking the state to urge students: Get a meningitis B vaccine.

Georgia law requires public and private university students living in on-campus housing to be vaccinated against meningococcal disease, but it is likely that students are protected against just four of the five strains of meningitis.

Meningitis B protection requires a separate, relatively new vaccine.

Gottlieb promises to increase generic competition

Drug makers are trying to stifle generic competition says Scott Gottlieb, and the FDA chief is Not Happy At All.

Done right, yes, probiotics work

The problem is the “done right” part. Adding any ol’ bacteria to a food product won’t do the trick.

Because most of the probiotic products you can buy at the grocery store have easy-to-grow bacteria (as opposed to bacteria that can actually work), they typically don’t do much. But …

[E]ven though probiotic products might be underwhelming, the probiotic concept is sound. Bacteria can beneficially tune our immune systems and protect us from disease. It’s just a matter of finding the right strains, and helping them to establish themselves.

Now researchers have shown in the first large-scale study that yes, the right mix of bacteria can make a big difference — in the case of this study, to prevent sepsis in babies.

Lack of sleep can lead to diabetes

So shows a new study in children: Missing sleep increases their risk of developing diabetes. How?

That’s because each additional hour of sleep children get at night is associated with a lower body weight, more lean muscle mass and less accumulation of sugars in the blood, researchers report in Pediatrics.

Earlier studies had found a similar link in adults.

Tired of hearing about the opioid epidemic?

OK then — how about the constipation epidemic?

Insurers will get their subsidy payments for at least another month

The Trump administration said it will make at least one more month of ACA-mandated subsidy payments to insurance companies.

Uncertainty over whether the so-called cost-sharing reimbursements will continue has already led some insurers to exist Obamacare markets next year, or to ask for significantly higher premiums for 2018.

After the announcement Wednesday, Sen. Lamar Alexander, R-Tenn., said Congress should act soon to guarantee that the CSRs will be paid to insurers through 2018.

Since 1973, the sperm count in Western men has dropped more than 50 percent

Is it obesity? Smoking? Chemicals? A combination? A meta-analysis of research done over the past 40+ years found that male fertility has been dropping — and continues to drop.

This rigorous and comprehensive analysis finds that [sperm count] declined 52.4% between 1973 and 2011 among unselected men from Western countries, with no evidence of a ‘leveling off’ in recent years.

Or, if you prefer a picture:

—Andrew Kantor • Aug. 18, 2017

Comment!

Linda Wiant and deputy quietly leave Georgia Medicaid

We don’t know the details, but Director of Georgia Medicaid Linda Wiant has left that position, as has Deputy Medicaid Director Marcey Alter. Neither Wiant nor the Department of Community Health has released a statement, and no replacements have been named.

Wiant took the post in early 2015, and we enjoyed working with her (even before then, when she was the pharmacy director for Georgia Medicaid). We wish both Wiant and Alter the best of luck, and we’ll keep you updated if we learn more.

CBO report: Ending subsidies would hurt

Ending insurance subsidies would cause insurance premiums to skyrocket (20 percent in 2018) and increase the national deficit by $194 billion over the next decade.

Here’s the news story, and here’s the report itself.

Adding to the bandwagon

Cincinnati and South Carolina have joined the — gosh, we’ve lost count — the lots of other states and cities that are suing pharmaceutical companies over the cost of the opioid epidemic.

Mandating e-scripts for controls

New legislation introduced in Congress would require all prescriptions for controlled substances for Medicare Part D patients be handled electronically.

Post-truth society, Canadian pharma edition

Here’s a fun (sort of) story about how one pharmaceutical company made up a fake Canadian law, sued the government for violating that law, lost the suit, then spread “news” about patients supposedly (but not really) affected by the court’s ruling.

It created the fictional legal rule that, after several failed formulations, came to be known as the promise utility doctrine or just the promise doctrine. It was loosely based on the requirement in both U.S. and Canadian law that an invention be “useful” in order to gain a patent.

[…]

While artfully articulated, the promise doctrine never existed.

Chasing the red bull

Pot, schmot — energy drinks are apparently the gateway to drug use.

The researchers found that participants with a persistent trajectory of energy drink consumption were at a much higher risk of using [non-medical prescription stimulants] and stimulant drugs, and being diagnosed with an alcohol use disorder at age 25.

—Andrew Kantor • Aug. 16, 2017

Comment!

Clawback lawsuit against CVS

A lawsuit against CVS says the company charges people more if they use insurance than if they pay cash — a practice we know as a clawback.

The suit claims that the pharmacy agrees with pharmacy benefit managers […] to sell certain drugs at a higher price if a customer is paying with insurance.

The lead plaintiff in the case is a woman named Megan Schultz, and she claims that she bought a generic medication at CVS that cost $165.68 under her insurance but would’ve cost only $92 had she paid in cash without using her insurance.

Study says using marijuana once raises risk of hypertension death

A new study from Georgia State University found that “Compared to non-users, marijuana users had a 3.42-times higher risk of death from hypertension and a 1.04 greater risk for each year of use.”

The study considered someone a “marijuana user” if he ever used marijuana — even once, decades ago.

No emergency, and that’s fine

Trump won’t declare a national emergency over the opioid epidemic — and this Washington Post columnist explains why that’s A-OK.

Declaring a problem a “national emergency” frees up some additional federal funding and provides a few more routes to address the issue via programs like Medicaid. But not by much, experts say.

Abuse-deterrent? Maybe

Abuse-deterrent opioids sound great, but the evidence that they actually work is still limited (“promising, but inconclusive”). The big concern: They’ll just push users to other drugs instead.

Drug-overdose deaths continue to climb

The latest government statistics show overdose deaths jumped almost 20 percent from the third quarter of 2015 to the same period in 2016. About 60 percent of those deaths are from opioids.

The National Center for Health Statistics reported that overdose deaths reached a record 19.9 per 100,000 population in the third quarter, a big increase over the 16.7 recorded for the same three months in 2015.

At this pace, more than 60,000 Americans will have died of drug overdoses in a single year.

FDA expected to approve more generics than ever

The FDA continues its record-setting pace for generic drug approvals — it’s on pace to surpass its 2016 numbers, which were already high (and significantly higher than its European counterpart).

Generics get cheaper, but consumers don’t see it

Generic drug prices have been going down for at least the last seven years. That’s saved insurance companies a lot of money, but patients? Not so much.

Dulling the pain

Why yes, drinking alcohol does reduce the pain you feel. Or as one news story put it, “Beer is a Better Pain Reliever Than Tylenol.”

A mean blood alcohol content (BAC) of approximately .08% (3–4 standard drinks) produced a small elevation of pain threshold and a moderate to large reduction in pain intensity ratings, or equivalently, a mean reduction of 1.25 points on a 0- to 10-point pain rating scale.

Elsewhere

A new Maryland law targets pharmaceutical price-gouging, but as one columnist points out, it doesn’t actually affect the drugs with “excessive” prices: branded medication.

Despite the rhetoric, “[T]he bill leaves untouched the segment of the pharmaceutical industry that is responsible for the ‘unconscionable’ increases in drug prices in recent years.”

New Hampshire* *is the latest rider on the sue-the-opioid-makers bandwagon.

—Andrew Kantor • Aug. 09, 2017

Comment!

Every Georgia county will have a health insurance provider in 2018

Blue Cross Blue Shield has agreed to stay in any county — there are 85 — where there’s no other health insurer. However, it will not be available in the 74 counties that have other insurers.

Health insurers in Georgia and across the country have left counties where they were losing money when Congress refused to make subsidy payments promised* under the Affordable Care Act. But both Republican and Democratic lawmakers are pushing for those subsidies to be paid, so the insurance picture is likely to change.

About 300,000 Georgians buy individual policies from BCBS.

*Sort of. It’s a legal mess because, while the ACA requires the subsidies, Congress never made an appropriation for them.

DEA wants to cut controls for 2018

DEA wants to cut the number of controlled substances manufactured in the U.S. by 20 percent next year.

To be clear: It’s proposing cutting the amount it will legally allow — the “Aggregate Production Quotas.” Rationale: Demand for opioids has dropped so fewer doses need to be created.

Better med school = fewer opioid prescriptions

A study out of Princeton found that physicians who graduated from higher-ranked medical schools (e.g., Princeton’s) write fewer scripts for opioids.

[P]hysicians trained at the lowest ranked US medical schools prescribe nearly three times as many opioids per year as physicians trained at the top medical school.

—Andrew Kantor • Aug. 08, 2017

Comment!

Justice sends out opioid task force

The Justice Department is dispatching 12 federal prosecutors charged specifically with fighting the opioid epidemic by investigating healthcare fraud related to opioids.

[Attorney General Jeff] Sessions said the group of prosecutors he has dubbed the “opioid fraud and abuse detection unit” will rely on data in their efforts to root out pill mills and track down doctors and other health care providers who illegally prescribe or distribute narcotics such as fentanyl and other powerful painkillers.

Artist’s interpretation

Pharma companies hide their involvement in fight

Which pharmaceutical companies are donating money to fight an Ohio bill that’s trying to keep drug prices lower? (The law would set the price the state pays for medication (e.g., via Medicaid) to the same cost paid by the U.S. Department of Veterans Affairs.)

PhRMA, the industry trade group, isn’t saying — and it took advantage of a loophole in Ohio law to hide the information.

It created an LLC, then funneled pharma companies’ money into that LLC. Then the LLC made the contribution to the lobbying group — not the individual companies.

[T]he LLC reported making $15.8 million in contributions to the campaign, disclosing the only donor as the Pharmaceutical Research and Manufacturers of America (PhRMA), the international trade association representing drug makers.

“I have no idea if the money came from all of those [PhRMA member] companies or just some of them … and, if it was the latter, which ones,” said a spokesman.

Not just for children, but let’s start with them

About 50 feet from where my mother is buried is a section of the cemetery with much smaller graves. These are children who died in the 1918 flu epidemic. There was no such thing as a flu shot back then, of course.

What the heck? I hear you say. Why would I possibly share this? Because August is National Vaccine Awareness Month, that’s why.

Most post-surgery opioids get tossed

Turns out that something like two-thirds of the painkillers prescribed for surgery patients aren’t used … at least not by the patients.

At the low end of the spectrum, 67% of patients who went under the knife to treat kidney stones, prostate cancer or other urologic conditions had unfilled prescriptions or leftover pills from prescriptions that were filled. On the high end, 92% of general-surgery patients had excess pain medication, the researchers found.

So what happened to all those pills? “In 70% of cases, patients said they hadn’t given the situation any thought at all.”

Gene-editing was a success in experiment

Those U.S. scientists who edited the genes of a human embryo? Turns out it worked — they were able to remove a mutation without causing other effects in the cell. And while they could have allowed the embryos to grow and then implant them to create a pregnancy, they didn’t do that. Not this time.

Health policy watch

It looks like members of both parties want to continue to pay health insurers the subsidies they were promised under the Affordable Care Act. But actually doing that might be tough, because politics. (Notably: Democrats want to keep the ACA’s minimum standards for health insurance; Republicans want to allow states to set those regulations.) Politico has more.

—Andrew Kantor • Aug. 04, 2017

Comment!

GPhA’s Advani waxes technological

Check it out: GPhA board member and pharmacist Ashish Advani has an article in Forbes, “How Prepared Are We For The Predicted Burst Of Technological Progress in 2021?”

Today, most commercial flying is already done by auto-pilot, most stock market trading is done by algorithms, and real estate agents, drivers, travel agents and waiters also currently find themselves on the tipping point of a similar revolution. Technology has impacted, and will continue to impact, every industry without bias; but perhaps none more than healthcare, which I’ve seen firsthand from my pharmaceutical company.

Georgia looks at Medicaid’s future

Post-ACA-repeal-effort, Georgia’s leaders are looking at Medicaid waivers and other ways to keep the state’s rural hospitals open and get healthcare for the state’s poor… without costing more or relying too much on Federal dollars.

Opioids at home

Whitfield County is on track to see double the number of opioid overdoses this year as in the last two.

[W]hile prescription painkillers account for some of those overdoses […] they aren’t the biggest culprit.

“The big things are a drug we haven’t seen for a long time, heroin. That’s making a comeback. And the other thing is fentanyl.”

Urgent, urgent, [public health] emergency

The White House’s commission on the epidemic recommended that Trump declare a national emergency. It also wants Medicaid to allow more lower-income people to receive addiction treatment. Alaska, Arizona, Florida, Maryland, and Virginia have all declared states of emergency regarding the opioid addiction. (Technically Alaska calls it a disaster declaration.)

What would declaring an emergency mean? Waivers of certain Medicare and Medicaid limits, for example. Check out the gov’ment’s “Public Health Emergency” website.

Express Scripts, CVS release 2018 formularies

Express Scripts has released its 2018 formulary, and at least 64 brand-name drugs are off the list. Out: Neupogen (filgrastim). In: biosimilar Zarxio (filgrastim-sndz). Out: Forteo (teriparatide) as well as two of Valeant Pharmaceuticals’s big sellers.

CVS is removing 17 drugs from its formulary and making some other changes (e.g., Xtandi and Levitra are back; Elelyso and Horizant are gone. (Note: The company’s list is hard to understand. Drugs with a “P” or “NP” are being added, while those without the letters are being removed.)

Do you really need to finish your antibiotics?

You absolutely must take your full course of antibiotics, right? That’s been the conventional wisdom to prevent antibiotic-resistant drugs. But that might not be right.

A July 27 paper in the British Medical Journal, “The antibiotic course has had its day,” points out that “With little evidence that failing to complete a prescribed antibiotic course contributes to antibiotic resistance, it’s time for policy makers, educators, and doctors to drop this message.”

One physician wholeheartedly agrees, writing:

[I]n the last two decades, we actually have had dozens of clinical trials published demonstrating that shorter courses of antibiotics are just as effective as longer courses. Furthermore, the shorter-course regimens led to lower rates of antibiotic resistance.

An idea so crazy it just … might … work

A group of 21 Republicans (soon to be 22) and 22 Democrats in the House are — wait for it — working together to craft a reasonable series of fixes for the Affordable Care Act.

They call themselves the Problem Solvers Caucus. And get this: They’ve already agreed on the major fixes for Obamacare.

Their ideas:

  • Continue the cost-reduction payments for insurance companies (see below).
  • Relax the ACA’s employer mandate so it only applies to companies with 500 or more employees, not 50 or more.
  • Define “full time” as 40 or more hours per week, not 30.
  • Give money to states “for reinsurance and other strategies to reduce premiums.”

Georgia members include Reps. John Barrow, Sanford Bishop, and Jack Kingston.

Meanwhile, the weather forecast for Hell apparently calls for a chance of flurries.

ACA update

The issue emerging: payments to insurance companies. The ACA requires the federal government to pay insurance companies so lower-income people can afford insurance. But the Trump administration has threatened to stop those payments “in an effort to trigger the collapse of Obamacare,” as Bloomberg put it.

Insurance companies and now at least 17 states are taking the government to court. Insurers want their promised payments, and states don’t want to see insurers pull out of exchanges if they don’t get them.

—Andrew Kantor • Aug. 02, 2017

Comment!