Category Archives: Pharma

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

freedom-1886402_1280

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

from-rbj-article-headshot-21

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)

disneyland-1786152_640

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?

skateboard-423801_640

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.

Recreational marijuana is becoming legal. How will the laws be implemented?

id-10020100

I opposed the ballot question legalizing recreational marijuana in Massachusetts. Nonetheless, the measure passed and it looks like legalization is going to happen. I asked marijuana entrepreneur Rob Hunt, President of Teewinot Life Sciences, to provide the industry perspective on some of the key issues.

Here’s what he had to say:

How does recreational marijuana interact with the market for alcohol? Do you expect alcohol sales to rise or fall? Why?

The adult use cannabis market should have almost no impact on the alcohol market at all. What this market represents is simply an orderly conversion from a long-standing illicit market to a now regulated legal market. It is not as if this new adult use market is emerging from nowhere, it already exists and has existed for years. Now adult cannabis users simply have a safe way to purchase cannabis from licensed retailers who have laboratory tested state-approved products rather than from a criminal enterprise with no safety considerations or government oversight.  

What is the evidence of the impact of marijuana legalization on the black market?

Adult-use legalization will have a very large impact on the illicit market. Using Colorado and Washington as comp sets, the legalization of adult-use almost eliminated the illicit market overnight for adult cannabis users within the state. There is simply no reason for one to put themselves in a potentially dangerous situation when they can go to a local shop down the street that has a larger selection of tested products at a comparable price. Best of all, in a legal market, the money stays in the local community and generates tax revenues for the state and the Federal Government.

Some (including me) are concerned that the availability of edible marijuana products will pose a danger for children but also for adults and pets, especially when they are packaged as candies or treats. Are these concerns warranted?

The cannabis industry is very aware that edibles must be very closely monitored. The trend is to make edibles less potent for this reason and to make sure that labeling and packaging are obvious and accurate and that the exit packaging is childproof. As for making products that are packaged as candies or treats, it is no different than making an alcohol product as a blend with fruit juices or iced tea. Flavor should not be the consideration, education and making sure products are kept in safe places should be a much larger consideration for adults using any cannabis product.

According to published research, about 30 percent of marijuana users have some degree of marijuana use disorder, including dependence and addiction. What is the argument for introducing a product that causes harm in a significant percentage of users?

I think the most simple answer is that the state is not “introducing” a product at all. This product was, is and would continue to be available to anyone that wishes to consume it on the illicit market. The question that should be asked is “If this product is already available to anyone that wants it, would it not be smarter to regulate it, keep it out of the hands of children, make sure it is labeled and packaged properly, has potency information available and is grown using specific standards?” If the answer to that question is yes, which is what the voters recently decided it was, then the next question, to address the concerns of many should be, “With the revenue and taxes that are being produced from this now regulated program, would it not be prudent to reallocate some of those dollars back to education and treatment for those who need it? Furthermore, perhaps should we not allocate some of the money that was previously earmarked for incarceration to rehabilitation?” 

The medical marijuana ballot initiative was passed in Massachusetts just a few years back. Was that initiative mainly a tactical stepping stone by the marijuana industry on the way to recreational legalization, as appears to have been the case in Colorado? 

The two issues are not at all related. Those who need cannabinoid based medications to treat a host of indications had no other options to procure it outside of these compassionate state programs. This was a health question. It is very likely that cannabinoid based medicine continues to move away from the plant and further into the lab. Patients that require cannabinoid based therapies are not concerned with cannabis, they are focused on the complex chemical compounds that the plant produces called cannabinoids. There are to date one-hundred and eleven of these cannabinoids identified. Many of them have been proven to have efficacious qualities, most notably to treat spasticity and for palliative care. As science progresses, new ratios and formulations of cannabinoids will be developed to advance where these medicines will be used to treat the infirm. 

Legalizing cannabis for use by responsible adults is a social justice question. These laws were passed simply to allow adults to use a product that has been statistically shown to be less harmful than alcohol without fear of arrest or incarceration. 

There is a very clear bright line distinction between these two laws and the reasons for their respective introduction. The one thing they both have in common, as evidenced by the percentage of voters supporting each, is that they are sensible policy by comparison to cannabis prohibition.

What did the Massachusetts ballot measure get right, and what are you concerned about?  

It is too early to tell either way. The law just passed and has not made it through rulemaking yet. We will see how it is implemented before we will be able to opine on what is right and wrong with it. 

What do you project as the net economic benefit or harm to Massachusetts? What are the key factors to consider?

As James Carville once famously said “It’s the economy, stupid” This law will create many new local jobs both directly tied to cannabis and on the ancillary as well. More importantly, it will take jobs away from criminal enterprises. Previously revenue derived from the sales of cannabis flowed directly back to Mexican cartels, Canada, or local criminal organizations. Now it will all stay in the Commonwealth. Then there are the taxes. Not just the excise taxes, but the Federal and State business taxes, payroll taxes and others. Lastly, the state will not need nearly as much capital for prisons, policing or other programs reliant on cannabis prohibition. You will also see much of this windfall redirected to support social welfare programs. That is good for all citizens in the Commonwealth.

As for harms, there will be a greater need for proper cannabis education and that will cost money. New state agencies or internal departments will be created to oversee the program and that will have related costs as well. Finally, there will no doubt be capital required to treat some users as there is with alcohol and tobacco.

There is tension between US and state law in places like Massachusetts that have voted for legalization. What are the key issues and what is your expectation for how they will be addressed by the incoming Administration and Congress?

I do not think there is enough room to discuss all the related issues in a short article. Things to consider are: the 10th Amendment to the Constitution, The Supremacy clause, the Rohrabacher-Farr amendment, the power of the incoming Attorney General – Jeff Sessions, How Trump or Pence decide to direct AG Sessions, how people close to the administration who are strongly supportive of cannabis progression, such as Peter Thiel or Congressman Dana Rohrabacher, influence the administration policy. 

But the most important issue to consider when addressing any political question is – What is the will of the people? What do they want? Because ultimately, politics is about winning elections and if a politician believes that an issue is important enough to the voters in their district, then they will not likely take a stand against it if they wish to remain in office. At this point in time, there is no doubt how the voters feel about advancing cannabis policy. Almost 60% of the electorate supports adult use cannabis and that is taken from polling across both sides of the aisle in liberal and conservative states alike.

Anything else you would like to add? 

Please take a look at what is being done on the true pharmaceutical side of cannabinoid-based therapy. I am certain that it will alleviate many of your articulated concerns. When you realize that these pharmaceutical and biotechnology companies are conducting clinical trials and are undertaking all the same steps with the FDA as for any other forward thinking drug development, I am certain that it will illuminate that this issue is about helping patients and not about finding a way to back-door legalization. I am happy to point you in the right direction.   


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

PCSK9 experience shows drug market isn’t completely broken

 

id-100263084

Why isn’t this thing growing?

Everyone knows that the market mechanisms that make most of the US economy efficient are lacking in healthcare. That’s especially true for pharmaceuticals, where drug companies can raise prices at will, and only the government can step in with price controls to put things right. At least that’s what we’ve been hearing in the press and on the campaign trail for the last year or more.

So I read with interest a recent STAT article These pricey cholesterol drugs aren’t selling. And that has the biotech industry sweating, about how the market is blocking high-priced drugs –and preventing pharma companies from doing all the things we’ve been told they can do at will.

No one disputes that the new drugs, Repatha and Praluent, are excellent at lowering bad cholesterol, or LDL. They often succeed where the traditional treatment — an inexpensive class of drugs called statins — fails. The problem boils down to doctors who are reluctant to write prescriptions, insurers who are unwilling to pay for them, and drug companies that have failed to understand a fast-changing marketplace.

The failures could send a chill through the still-booming biotech business, which relies on the idea that the risky, expensive process of developing new drugs can one day pay off big.

Contrary to the views expressed in the STAT article, I think the market is actually doing an ok job here. There are two main reasons why the drugs haven’t sold well:

  • First and foremost, while they are proven to lower cholesterol they are not proven to reduce heart attacks or strokes or to lower death rates
  • Second, most patients do just fine with generic statins, which are inexpensive and have a long track record, compared with the new drugs that have list prices of about $14,000 per year

The result is that doctors who want to prescribe the drugs have to jump through a lot of hoops to get insurance company approval. That’s a hassle and it’s expensive and time consuming, so I sympathize. But by the way, before we get mad at the PBMs and insurers, consider that the experience for prescribers might not be that different under a fully capitated payment model since health system administrators would still be worried about their budgets.

The companies that make these drugs are conducting studies of the impact on outcomes that people really care about: heart attack, stroke, death. If they demonstrate that the drugs are effective on these measures, they will have no problem generating prescriptions or charging premium prices –at least in the United States.

Image courtesy of iosphere at FreeDigitalPhotos.net

——-

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