Category: Pharma

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

published date
March 20th, 2017 by

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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

published date
March 6th, 2017 by
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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?

published date
February 1st, 2017 by

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)

published date
December 15th, 2016 by
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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?

published date
December 9th, 2016 by
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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.