Epilepsy Talk

What’s Really In Your Meds? | March 10, 2020

From MedPage Today

“As Americans become more concerned about quality issues with prescription medications made abroad, one company is trying to offer an additional layer of reassurance — by doing chemical analysis before dispensing drugs to patients.

Valisure launched just over a year ago, positioning itself as a pharmacy, a lab, and a wholesaler. Now licensed in 38 states and with a staff of 25 in Yale University’s Science Park in New Haven, Connecticut, Valisure analyzes some 2,000 drug products — mostly generics, but also some brands — to introduce an additional level of quality control into the system.

‘We thought, wouldn’t it be great to have chemical analysis at the end of the supply chain, here in the U.S. where it matters the most, when patients are going to get the drug,’ Valisure Founder and CEO David Light told MedPage Today in an interview.

Valisure has already made an impact on the pharmaceutical supply chain. The company identified a fourth carcinogen in valsartan, proffered evidence that ranitidine degraded into NDMA, and now is raising alarms about contaminated metformin. In each case, the company got media attention for its findings and also filed citizen petitions with the FDA requesting recalls.

‘The fact that we found so many big problems within about a year of launching our pharmacy underscores that it’s really needed,’ Light said. ‘Nobody has been doing this third-party check.’

Getting Started

Back in 2015, Light’s friend and company co-founder Adam Clark-Joseph, PhD, told him about problems with his anti-convulsant medications. Every now and then, Clark-Joseph wouldn’t feel good on the meds, or he’d have side effects or relapses. His doctors told him that was typical, since most drugs were made in India or China and there wasn’t much that could be done about the variability.

Light was familiar with some of the challenges in the global drug supply chain given his molecular biology degree from Yale and having worked at startups including Synthetic Genomics and Ion Torrent. He knew that companies self-reported the quality of their drugs to FDA, and agency inspections typically involved checking the facility itself, but not the chemistry of the medications beyond the tests required for approval.

So Light and his co-founder put up their own money and spent a few years developing a new system for chemical analysis of medications, ending up with a Raman spectroscopy method that they say is both fast and accurate. The company filed patents on its technology and secured ISO accreditation for their laboratory.

The FDA told Valisure the company is the only pharmacy that’s attached to an analytical laboratory, Light said.

How It Works

Like any U.S. pharmacy, Valisure buys drugs from approved U.S. distributors; the difference is that these distributors allow the company to sample any batch before they purchase it.

Light says the strategy is based on evidence that quality is consistent within batches, but can vary from batch to batch: ‘We’ve seen with same manufacturer completely clean lots, then another lot comes along and who knows what happened, but the quality is very different.’

Valisure checks not only for contaminants, but also for correct dosage, issues with inactive ingredients, and dissolution problems. While the company borrows largely from industry standards, Valisure charts its own course if the metrics don’t ‘make scientific or physiological sense.’

For example, the industry standard for dissolution uses a very potent solvent, Light said. ‘This solution does dissolve the pill really well. I mean, it would dissolve your hand well,’ he quipped. ‘But it’s obviously not indicative of what’s happening in the body. The product may pass in this absurd scientific scenario, but we don’t test it that way.’ (Valisure and the FDA had a public spat last fall over assay methods involving nitrosamines and ranitidine.)

If Valisure is satisfied that the drug is high-quality and uncontaminated, it’ll go ahead and buy it in large quantities, such as a 6-month supply. That’s distinct from standard pharmacies, which typically buy daily or weekly in order to save money, Light said.

Light says the company has rejected over 10% of the batches it’s sampled, and the FDA has asked Valisure to share information on rejected batches with drugmakers.

Business Model

Valisure’s marketing is targeted to individual patients and doctors, but the company is also working higher up the healthcare chain, looking to act as a wholesale partner to hospitals and health systems. Light says the idea is to focus on key drugs that are often a pain point for hospitals.

The company has also launched a partnership with a pharmacy benefits manager called CapitalRx, and recently signed on to a collaboration with GovZilla, a company focused on artificial intelligence in the regulatory sphere.

With GovZilla, Valisure will work to create quality scores, ranking manufacturers according to their chemistry quality data. The idea is for health systems to have additional information, beyond just price and availability, when buying medications.

Valisure is privately owned, so data on revenue and customers aren’t available. But Light says the time is right for his company to shake up the market.

‘Consumers are increasingly engaged, vigilant and careful about everything they put into their body. Whether the consumer is an individual or a hospital with a billion-dollar pharmacy, no one has any information about the quality of what they’re getting,’ Light said. ‘We’re paying more for healthcare than ever before, so we’re also paying attention to our dollars. What are we actually paying for? The health system is feeling that pressure even more. What are they reimbursing? Is it effective?’

That pressure will only intensify as the coronavirus outbreak further disrupts pharmaceutical supply chains, Light said, leading to more questions about the purity of medications in a system that’s already struggling with consumer trust.

Mahmud Hassan, PhD, MBA, a healthcare economist at Rutgers University in New Jersey, acknowledged the growing fears in the U.S. about the quality of prescription drugs and said Valisure’s approach could be a timely strategy to allay those concerns.

‘People are scared, nowadays, of drugs coming from China, India. There’s a bad record there,’ Hassan told MedPage Today. ‘This country needs a much safer method of getting drug supplies. I think safety is a good strategy, and [hospital systems] may give this a shot, if this will increase trust in the market.'”

Resource: Medpage Today https://www.medpagetoday.com/special-reports/exclusives/85333?xid=nl_medpageexclusive_2020-03-10&eun=g1202771d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=MPTExclusives_031020&utm_term=NL_Gen_Int_Medpage_Exclusives_Active

 


22 Comments »

  1. Wow Phylis this is Laura Hood—with so many of us being rx intolerant this is wonderful. Pls keep us updated on how we can use a this co. My whole many of our whole lives could change if we had the real refills of the meds. I guess I should forward this to my neurologists and pharmacists. ? Mar 10 2007 was when my huge storm seizure was and was caused by a med. This is a real wowowowow. Thank you so much for all your help and support. Sincerely, laura

    Sent from Mail for Windows 10

    Liked by 1 person

    Comment by Michael Hood — March 11, 2020 @ 5:23 AM

    • Yes, please do pass it on to anybody and everybody.

      It’s from a very reputable source and I think it’s going to rock the world of pharmaceuticals as we know it.

      Like

      Comment by Phylis Feiner Johnson — March 11, 2020 @ 9:38 AM

  2. Cheers to Valisure! 👍
    Keep shaking the corrupt empire!
    Gerrie

    Liked by 1 person

    Comment by BahreNegash Eritrea — March 11, 2020 @ 7:33 AM

  3. Also see druginfo.nlm.nih.gov, which lists all the manufacturers of any given drug, together with other information. With a little mousing around, you can find out who owns the U.S. company and whether your supply line might be in danger.

    Liked by 2 people

    Comment by HoDo — March 11, 2020 @ 10:26 AM

    • Thank you HoDo and please be well and take care 😊💕

      Liked by 1 person

      Comment by Kathy S.B — March 11, 2020 @ 9:36 PM

  4. Great information, as always, HoDo!

    Thanks — again…

    Like

    Comment by Phylis Feiner Johnson — March 11, 2020 @ 11:04 AM

  5. So now, most to all the AED’s & ADD’s alike are being made in China, which is why now doctors say we all get the side effects. I have been on these drugs since 7 months old & side effects with me started in the 1960’s & 70’s for me & they were made in the USA then. More than I had side effects in the 1960’s taking the same drugs I was on, when China never knew what making drugs was about. They had their own ways of acupuncture to actually heal people, and NOW they are to be trusted drug makers for the USA & world ? It seems strange now how we now can have the same side effects, because drugs are from China. What was the reasoning for side effects from the 1960’s through the 80’s when most drugs made were here in the USA ? Many of the AED’s & ADD’s, among other neurological drugs have the METALS, COLORINGS, MSG’s & ASPARTAME type additives in the drugs, and many get seizure activity from them like ZONEGRAN, ONFI, & KEPPRA among the many where the generic names will have MORE of them than a brand name drug has. When I was on ZONEGRAN just 25 mgs a day I had seizure activity, 50mgs a day I had MORE & MORE AGGRESSIVE seizure activity, so I said NO in trying to take 100mgs a day & I did not get to 75mgs a day yet. Knowing the HYDROGENATED OILS are MSG chemicals, I took 1 tsp full of pure 100% coconut oil with the Zonegran 50mgs a day when I took my dose, & I had NO seizure activity at all, but I wasn’t going to try 75mgs or 100mgs a day & the coconut oil had no effect against the MSG toxins BUILD UP in my brain that was in Zonegran. So you all know 100mg tablet of the VIMPAT is the safest of any of the tablets you can take. Look it up on http://www.dailymed.nlm.nih.gov. Have fun, I enjoyed ”’learning & protecting my brain” from these brain abusers of this world.

    Liked by 1 person

    Comment by James D — March 11, 2020 @ 7:31 PM

  6. Out of curiosity does that apply to Canadians as well? Thank you

    Liked by 1 person

    Comment by Kathy S.B — March 11, 2020 @ 9:27 PM

  7. Thank you Phylis

    Liked by 1 person

    Comment by Kathy S.B — March 11, 2020 @ 10:44 PM

  8. This is a very timely report. In New Zealand there has been a brand switch in lamotrigine/lamictal to the generic medicine, Logem. There have been six fatalities possibly linked to that switch and many more people have experienced break-through seizures and side effects. This problem is currently being investigated.

    For more information please follow this link:

    Click to access 3.-Letter-to-Pharmac-_EWCT_18-December-2019.pdf

    Liked by 1 person

    Comment by Maria Lowe — March 16, 2020 @ 1:53 PM

    • OMG. And we thought we had it bad!

      I’m so very sorry to hear that.

      Please take care and stay well.

      Like

      Comment by Phylis Feiner Johnson — March 16, 2020 @ 5:38 PM

    • Great to note that the New Zealanders are fighting back, tracking down & investigating the costly drama, setting important example to the rest of the world.
      Let’s hope some strict international regulations, requiring patients informed consent comes out of these miscalculated tragedy.
      Gerrie

      Liked by 1 person

      Comment by BahreNegash Eritrea — March 16, 2020 @ 10:42 PM

  9. This is Adam Clark-Joseph (the guy in the article) writing. For the sake of full transparency, I want to be clear that although I do need to take an anticonvulsant, I do *not* have epilepsy. We all have our own challenges, and I would never want to misappropriate the things facing those who suffer from epilepsy. I am delighted that my company’s work is helping those with epilepsy, but those people possess a fortitude of character to which I can only aspire so someday emulate. Be well, and please take at least a modicum of comfort that some very driven people are implementing solutions that will make your lives easier.

    Liked by 1 person

    Comment by Adam D. Clark-Joseph — March 25, 2020 @ 10:26 PM

    • OMG. Thanks for writing. I admire your work, perseverance and fortitude so very much.

      I know you don’t need to have epilepsy to “appreciate” what it entails. Especially when someone of your talent seeks to understand and conquer it.

      I really don’t know what else to say except “Thank You”.

      Like

      Comment by Phylis Feiner Johnson — March 25, 2020 @ 11:34 PM

      • Your thanks warm my heart, but the lives my work can save and improve provides a bottomless wellspring of hope and motivation 🙂
        I also sent you a longer email with some general thoughts on how we may achieve some synergy on joint efforts. I’m sure you’re busy, but I’d love to chat when schedules permit!

        Liked by 1 person

        Comment by Adam D. Clark-Joseph — March 25, 2020 @ 11:53 PM

      • I’ll read your email and see what we can do.

        Thanks again!

        Like

        Comment by Phylis Feiner Johnson — March 26, 2020 @ 10:13 AM

    • Adam,,, This world needs heroes like you, rooting for those who’re stuck between a rock & hard place fighting to survive medical adversity & corrupt corporate empires exploiting the misfortunes of human race, everyday.
      Thank you for your brave commitment, you’re doing a lot of good in the service of human kind, more than you will ever come to know.
      Keep up the great work.
      Cheers!
      Gerrie

      Liked by 2 people

      Comment by BahreNegash Eritrea — March 26, 2020 @ 3:17 PM

  10. Gerrie, I just spoke to Adam and read him your comments. I think it made his day.

    Like

    Comment by Phylis Feiner Johnson — March 26, 2020 @ 3:40 PM

    • Phylis, Thank you for letting Adam know that his dedicated commitment & brave hardwork for the wellbeing of human kind is deeply respected, appreciated & admired by the voiceless victims of medical hardships & wanton negligence of the hospital & pharmaceutical industry.
      It’s pleasing to know that Adam recognizes the credit he earned & deserve for his heroic services, advocating for common good of all those who need it the most.
      I’m delighted to find out there are heroes amongst us.
      Best wishes to all.
      Gerrie

      Liked by 1 person

      Comment by BahreNegash Eritrea — March 26, 2020 @ 6:47 PM

      • He’s very modest. 🙂

        Like

        Comment by Phylis Feiner Johnson — March 26, 2020 @ 6:50 PM

      • Obviously, modesty is true character of the real heroes who don’t need public circus nor extravagant celebration to prove their place in the world.
        And so goes for Adam.
        Gerrie

        Liked by 1 person

        Comment by BahreNegash Eritrea — March 26, 2020 @ 7:06 PM


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    About the author

    Phylis Feiner Johnson

    Phylis Feiner Johnson

    I've been a professional copywriter for over 35 years. I also had epilepsy for decades. My mission is advocacy; to increase education, awareness and funding for epilepsy research. Together, we can make a huge difference. If not changing the world, at least helping each other, with wisdom, compassion and sharing.

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