Category Archives: Pharma

How formidable would Amazon be in pharmacy?

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Oops

I’m a big fan and customer of Amazon, having placed thousands of orders since 1998. I understand why retailers (and other businesses) quake in their boots at the thought of Amazon disrupting them. As a healthcare insider, I also understand why healthcare companies are especially nervous. Deep down, we understand that US healthcare is tremendously wasteful and inefficient and that Amazon could make the industry look bad and eat its lunch.

Still, I’m not convinced that Amazon is going to take over the pharmacy business, the latest topic of discussion. The Wall Street Journal (Amazon’s push into pharmacy is full of promise and pitfalls) has a piece and we’re also told that CVS’s play for Aetna is a direct result of the Amazon threat.

My own recent experience with Amazon left a bitter taste in my mouth and provided a glimpse of just how hard pharmacy could be. I don’t usually take painkillers, but the past three weeks have been an exception. Since getting hit by a car while crossing the street, I have been a pretty good customer for OTC pain meds. On a recent Sunday I noticed I was running out of ibuprofen, and rather than asking family members to do one more errand, I used Amazon to place a same-day order.

I pressed the button around 9 am, and was promised that my order would be at my doorstep by 9 pm. By around noon the item was “out for delivery” but it hadn’t arrived by 8:30 pm and I was starting to get a little worried. Nine o’clock came and went, and Amazon switched my status to “delayed.” Finally I had to ask my wife to go out to the pharmacy, which luckily for us is close by and open late. I would have had a difficult night without my refill.

Eventually Amazon canceled the order and said my address was undeliverable –a weird claim for a home that receives Amazon shipments nearly every day.

Most of the skepticism about Amazon’s entry into pharmacy focuses on new complexities like third-party payment, which are admittedly pretty serious. But my own experience shows that Amazon’s current infrastructure isn’t robust enough for the basics, so I definitely won’t be among the first to sign up for AmazonRx.

Of course Amazon isn’t the only one with shipment woes, and this experience was an exception to my usual good ones. Still, it gives me pause.


By healthcare business consultant David E. Williams, president of Health Business Group.

Hospice: Another sad sector of the opioid crisis

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Help yourself?

A person addicted to drugs might do anything to get their hands on the next dose. Whether that means ‘borrowing’ painkillers from a relative who had their wisdom teeth extracted, breaking into cars to grab small bills and coins, or stealing their mother’s jewelry –all things I’ve seen myself– there are no real limits. So I was saddened but not surprised to read Dying At Home In An Opioid Crisis: Hospices Grapple With Stolen Meds, which highlights the trouble dying patients face in keeping hold of their painkillers.

The Kaiser Health News examples are only anecdotal, but the combination of high quantities of opioids and homebound patients unable to fend for themselves is an ideal setting for diversion. The problem is two-fold: theft of drugs while the patient is alive, and diversion once the patient passes away. Since many patients die within days or weeks of beginning hospice, the second problem is a major one.

The examples offered in the article are heartbreaking:

  • In Mobile, Ala., a hospice nurse found a man at home in tears, holding his abdomen, complaining of pain at the top of a 10-point scale. The patient was dying of cancer, and his neighbors were stealing his opioid painkillers, day after day.

  • In Monroe, Mich., parents kept “losing” medications for a child dying at home of brain cancer, including a bottle of the painkiller methadone.

  • In Clinton, Mo., a woman at home on hospice began vomiting from anxiety from a tense family conflict: Her son had to physically fight off her daughter, who was stealing her medications. Her son implored the hospice to move his mom to a nursing home to escape the situation.

Some hospices are trying to do something about the problem, but it’s not easy. After all, their primary goal is to ease the pain of dying patients. It’s not really their job to keep track of and control everyone else. Some of the ideas being tried include:

  • Screening families for a history of drug addiction
  • Limiting the amount of meds delivered at any one time
  • Drafting agreements with families about consequences for drugs that disappear
  • Encouraging the destruction and disposal of drugs after the patient dies

None of these approaches is likely to succeed on its own. The country will have to address the broader opioid crisis in order to bring this part of it under control. However, there are a couple additional steps that could be taken now:

  • A few states let hospice employees destroy drugs once a patient dies. That should be expanded nationwide and made mandatory. There is no conflict here with the patient’s needs
  • Some patients, who would otherwise be eligible for home hospice, should be moved to facilities such as nursing homes, where controls can be tighter. (Much as I hate to argue against home care this needs to be part of the discussion)

By healthcare business consultant David E. Williams, president of Health Business Group.

Drug treatment for opioid addiction: Podcast interview with CleanSlate CEO Greg Marotta

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The opioid epidemic gives addiction treatment providers an opportunity to demonstrate what they can do to stem the tide. CleanSlate operates treatment centers in multiple states, employing a medication assisted approach. In this podcast interview, CEO Greg Marotta describes what he’s seeing and how the company is responding.

We discussed:

  • (0:10) How serious is the opioid epidemic?
  • (1:09) What kind of approaches are traditionally to treat addiction? What works well and where are there shortcomings?
  • (2:22) Are people coming to treatment through primary care? Or the behavioral health system?
  • (4:06) How does medical/behavioral integration work? What does it really mean?
  • (6:56) CleanSlate is well know for medication based treatments. What kind of medications are available? Who is the approach best suited for?
  • (8:09) What is the typical course of treatment?
  • (9:49) As addiction has become more visible, it’s now front and center for others in health care. Do you collaborate with other organizations and if so, how has it gone?
  • (12:52) You operate in a variety of states, with different cultures. Do you see key differences between Massachusetts, and other states like Texas, Indiana and Wisconsin?
  • (14:53) Will we still be talking about an opioid epidemic in five years? What will it take to get out of it?

By healthcare business consultant David E. Williams, president of Health Business Group.

eCOA in action: Podcast interview with iCardiac CEO, Alex Zapesochny

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Alex Zapesochny, CEO, iCardiac Technologies

Electronic clinical outcome assessment (eCOA) platforms collect data from patients, clinicians and caregivers to make clinical trials more efficient and accurate. iCardiac Technologies, an innovative core lab where I am a board member, just introduced its QPoint eCOA platform to complement its existing cardiac safety and respiratory function product lines.

In this podcast interview, iCardiac CEO Alex Zapesochny shares more about the launch.

  • (0:11) What are some of the key trends you are following in clinical drug development?
  • (1:04) You started with cardiac safety testing and then added pulmonary function testing. How do those fit together?
  • (3:00) Now you have a new platform, QPoint. What is it, and why is it the next logical service?
  • (4:44) For those who are less familiar with eCOA, what is it? And what are some of the challenges that are typically encountered?
  • (7:09) Compliance is often an issue with patient reported outcomes. Do you address compliance with QPoint?
  • (10:30) How important is eCOA for drug development? Is it a major change or incremental?
  • (12:20) You have explained the move from cardiac safety to respiratory to eCOA. What can we expect next from iCardiac?

By healthcare business consultant David E. Williams, president of Health Business Group.

What if the FDA is eliminated?

President Trump’s first couple of weeks have people taking him literally, not just seriously. What does that mean when it comes to the regulation of drugs?

As I wrote in early December (Would an FDA radical make any real difference), I’m not convinced that even a major shift away from regulation will dramatically change the market. Even if the bar for approvals is lowered, third-party payers will still want to see compelling safety and efficacy data before they provide reimbursement. Medicare and Medicaid may also up their game by directly or indirectly discouraging prescribing of medications that are unproven.

The pendulum tends to swing back and forth between the demand for speedy approval and concern about harms to patients from inadequately tested drugs. Recently the pendulum has been swinging toward fast approval, and the newly enacted 21st Century Cures Act continues that trend.

But what will happen when a drug that’s rushed to market causes patient injury and death?

“We’re going to be cutting regulations at a level that nobody’s ever seen before. … And we’re going to have tremendous protection for the people — maybe more protection for the people,” Trump said Tuesday.

Trump is promising the impossible, and it may come back to bite him. Then again, maybe it won’t.

Just a granule of sugar makes the medicine go down (and out)

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What Would Mary Do?

Many drugs fail in development due to safety problems. A study indicates that impurities in the non-active ingredients may sometimes be to blame. According to lead researcher Daniel Weinbuch from Leiden University:

“We found that sugar excipients themselves contain nanometer-sized particles, which can damage proteins and make drugs unsafe. These nanoparticle impurities in sugar could even trigger the immune system itself.”

Obviously, drug companies need to learn about this problem and find sugar manufacturers who can make pure products.

It’s unfortunate that this problem exists, but it also holds out the possibility that some drugs that were previously thought to be unsafe could actually be safe. If so, it would be time to restart the development process.

The academic paper (Nanoparticle Impurities in Pharmaceutical-Grade Sugars and their Interference with Light Scattering-Based Analysis of Protein Formulations) was published in Pharmaceutical Research.

By healthcare business consultant David E. Williams, president of Health Business Group.

 

Would an FDA radical make any real difference?

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Totally radical, dude!

Trump considers naming FDA chief who would radically overhaul the agency, blares the headline from STAT. The candidate, Jim O’Neill is indeed a radical: he wants to eliminate the requirement for drugs to demonstrate efficacy in order to gain approval, favors payments for organ donors, and is part of a group that wants to create sea-based libertarian communities.  He also doesn’t seem to know much about the FDA and its people –he said “one thing that surprised me is that the actual human beings at the Food and Drug Administration like science; they like curing disease and they actually like approving drugs and devices and biologics.”

As scary as the guy sounds, in practice he probably would not have much of an impact. Here’s why:

  • Just because a drug or device is FDA approved does not mean payers will pay for it. Pharma and device companies have to demonstrate that their products work and that they are cost effective before they will be reimbursed
  • Since the biggest payers are Medicare and Medicaid, even if you take FDA out of the business of judging efficacy the government is still heavily involved. (However, some Republicans including the likely HHS Secretary look favorably on eliminating Medicare and Medicaid, which I guess would negate my point)
  • O’Neill still thinks products should be shown to be safe before they gain approval, and that’s arguably more important than efficacy in terms of saving lives. But safety can’t be fully evaluated without considering efficacy. A really effective drug that’s active against a serious illness can be considered “safe” even if there are occasionally serious side effects and even deaths. But we wouldn’t accept the same safety profile as “safe” for more benign conditions
  • O’Neill says FDA is under too much pressure from Congress in its current structure. Whenever there is an unpopular decision the commissioner has to testify before Congress, where he’s raked over the coals. I think the same thing will still happen –the public will rise up, perhaps even more, if FDA backs off its traditional role

Ted Cruz actually had an even more radical approach.

So, rest easy for now.

By healthcare business consultant David E. Williams, president of Health Business Group.