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Why Former FDA Commissioner, Scott Gottlieb, Joined the Aetion Board | Carolyn Magil, CEO Aetion

By JESSICA DAMASSA, WTF HEALTH

Big news from Aetion CEO, Carolyn Magil, as she talks about the addition of former FDA Commissioner, Scott Gottlieb, to her Board. WHOA. What a HUGE endorsement of support for what Aetion is building…which is what, exactly? Carolyn explains how the company is using real world data (any data outside of clinical trial data) to figure out how different people will react to the same drug. That means they’re using data from health insurance claims, EMRs, wearables, pharma registries, etc. to ultimately save the time, money, and headache of finding out which medicines will work best for which patients. What’s more? A priority for Aetion is helping bring to light how populations usually under-represented in clinical trials (women, seniors, kids) will react to certain treatments. Backed by $77M in funding, and now the former FDA head, tune in to find out what’s next for Aetion.

Filmed at the HIMSS Health 2.0 Conference in Santa Clara, CA in September 2019.

Can we move on?

By CHADI NABHAN MD, MBA, FACP

Every so often, my cynical self emerges from the dead. Maybe it’s a byproduct of social media, or from following Saurabh Jha, who pontificates about everything from Indian elections to the Brexit fiasco. Regardless, there are times when my attempts at refraining from being opinionated are successful, but there are rare occasions when they are not. Have I earned the right to opine freely about moving on from financial toxicity, anti-vaxers, who has ‘skin in the game’ when it comes to the health care system, the patient & their data, and if we should call patients “consumers”? You’ll have to decide.

I endorse academic publications; they can be stimulating and may delve into more research and are essential if you crave academic recognition. I also enjoy listening to live debates and podcasts, as well as reading, social media rants, but some of the debates and publications are annoying me. I have tried to address some of them in my own podcast series “Outspoken Oncology” as a remedy, but my remedy was no cure. Instead, I find myself typing away these words as a last therapeutic intervention.

Here are my random thoughts on the topics that have been rehashed & restated all over social media outlets (think: Twitter feeds, LinkedIn posts, Pubmed articles, the list goes on), that you will simply find no way out. Disclaimer, these are NOT organized by level of importance but simply based on what struck me over the past week as grossly overstated issues in health care.  Forgive my blunt honesty.

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Investment State-of-Play in Big Pharma: Bayer’s Eugene Borukhovich Weighs In

By JESSICA DaMASSA, WTF HEALTH

Bayer’s G4A team launched their 2019 program today, so here’s a little help for anyone curious about the state of pharma startup investment and what it takes to land a deal there these days.

I had the chance to pick the brain of Bayer’s Global Head of Digital Health, Eugene Borukhovich, during JP Morgan Healthcare Week and pulled out these three gloriously thought-provoking soundbites from our conversation to give you some insight as to the mindset over at big Bayer.

  • “Digital therapeutics are shining light on the convoluted, complex mess of digital health”

If you’ve wondered what lies ‘beyond the pill’ for Big Pharma, wonder no more. It seems the answer is digital therapeutics. Eugene predicts that “within the next couple of years, ‘digital health’ as a term will disappear,” and calls out organizations like the Digital Therapeutics Alliance for their efforts to set standards around evidence-base and behavior modification so regulators and strategic investors alike can properly evaluate claims made by health tech startups. As time goes on, it looks like efforts to ‘pharma-lize’ the ways startups take their solutions to market will increase, pushing them into more traditional go-to-market pathways that have familiar and comforting guidelines in place. As Eugene says, “Ultimately, what we say in my team, is that it’s about health in a digital world today.” Sounds like that’s true for both the products he’s seeking AND the way pharma is looking to bring them to market… 

  • “These multi-hundred million [dollar] press releases are great to a certain extent, but what happened to the start-up style mentality?”

When asked about Big Tech getting into Big Health, in the end, it seems, Eugene shakes out to be in favor of the ‘Little Guy’ – or, at least, in their approach. Don’t miss his comments about “cockiness in our healthcare industry” and how Big Tech is working around that by partnering up, but the salient point for startups is that big companies still seem very much interested in buddying with smaller businesses. It’s for all the same reasons as before: agility, the ability to iterate quickly, and the opportunity to do so within reasonable budgets. Eugene offered this telling rhetorical musing: “Just because it’s a combination of two big giants…do you need to do $500 million? Or, do you give some…traction, milestone, [etc.]…to prove it, just like a start-up would?”

  • “In large organizations, transformation equals time, and…we don’t have time.”

“To me,” says Eugene, “the biggest challenge is actually landing these inside the organization.” He’s talking about novel health solutions – digital therapeutics or otherwise – after learning from previous G4A cycles. Culture, precedent, and years of market success loom large in big healthcare companies across the ecosystem, which is one reason why innovation inside them is so challenging. Eugene says he’s “a big believer in a small team – even in large organizations – to take something by the cojones, and get shit done, and move it forward, and push the envelope from the bureaucracy and the process.” There’s a sense of urgency to ‘innovate or die’ in the face of the growing competition in the healthcare industry. “Back to this earlier conversation around whether it’s tech giants or other companies,” he adds, “it is a race to the speed of the organization. How quickly we learn and how quickly we make the decisions. Bottom line, that’s it.”

There’s plenty more great insights and trend predictions where these came from, plus the juicy details behind how G4A itself has pivoted this year. Check out the full interview now.

Saying No to the Drug Crisis

By BRIAN KLEPPER

In a recent essay, VIVIO Health’s CEO Pramod John guides us through four sensible drug policy changes and supporting rationales that could make drug pricing much fairer. Reading through it, one is struck by the magnitude of the drug manufacturing industry’s influence over policy, profoundly benefiting that sector at the deep expense of American purchasers. As Mr. John points out, the U.S. has the world’s only unregulated market for drug pricing. We have created a safe harbor provision that allows and protects unnecessary intermediaries like pharmacy benefit managers. We have created mechanisms that use taxpayer dollars to fund drug discovery, but then funnel the financial benefit exclusively to commercial interests. And we have tolerated distorted definitions of value – defined in terms that most benefit the drug manufacturers – that now dominate our pricing discussions.

The power of this maneuvering is clear in statistics on health industry revenues and earnings. An Axios analysis of financial documents from 112 publicly traded health care companies during the 3rd quarter of 2018 showed global profits of $50 billion on revenues of $636 billion. Half of that profit was controlled by 10 companies, 9 of which were pharmaceutical firms. Drug companies collected 23% of the total revenues during that quarter, but retained an astounding 63% of the profits, meaning that the drug sector accounts for nearly two-thirds of the entire health care industry’s profitability. Said another way, the drug industry reaps twice the profits of the rest of the industry combined.

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An Op-Ed Ghostwriter Speaks

Is it “a breach of trust” for a publication to publish an opinion piece that was written with the participation of public relations professionals?  That was the conclusion of a recent article in Health News Review, a publication that bills itself as “Your Health News Watchdog.”(“Another ‘breach of trust’ at STAT: patient who praised TV drug ads says pharma PR company asked her to write op-ed”).

The article traces the origins of an op-ed that appeared in STAT, the respected medical blog published by the Boston Globe,  headlined  “You can complain about TV drug ads. They may have saved my life.” Health News Review managing editor Kevin Lomangino found that a public relations firm working for Gilead, a pharmaceutical company that makes the hepatitis C drug Harvoni, had reached out to a patient named Deborah Clark Duschane and asked her to write about her experience with drug ads.

Lomangino quotes Charles Seife, a professor of journalism at New York University, who called the situation a “breach of trust.”

“The whole point of ghostwriting is to hide the hand of an actor — to make an industry position seem like it’s coming from an unaffiliated individual,” Seife said. “That’s deception. It’s meant to disarm the natural skepticism that we have when an industry makes self-serving statements. And when someone tries to disarm our skepticism, well, it ain’t good.”

As a professional ghostwriter, who has been hired by public relations professionals to work with authors on op-eds that have run in respected publications, I disagree.

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BTG buys Oncoverse–Amanda Goltz explains all

Amanda Goltz is a massive ball of energy in the world of digital health. For the past 2 years she’s been working for English pharma company BTG. But how does a pharma company get involved in health tech without wasting everyone’s time, and what exactly are they trying to do? Amanda certainly has both opinions and a plan. Today part of that plan became official with the purchase of Oncoverse, a cancer management program BTG has been working on with Wanda and Dignity Health. I spoke to her Monday morning my time to find out more (and yes, if you wait to the end, there is both a job “offer” and I have my own BBC Live home office moment!)

What Experts in Law and Medicine Have to Say About the Cost of Drugs

Pharmaceutical drug costs impinge heavily on consumers’ consciousness, often on a monthly basis, and have become such a stress on the public that they came up repeatedly among both major parties during the U.S. presidential campaign–and remain a bipartisan rallying cry. A good deal of the recent conference named Health Law Year in P/Review, at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, covered issues with a bearing on drug costs. It’s interesting to take the academic expertise from that conference–and combine it with a bit of common sense–to see which narratives about drug costs hold up.

The Industry Narrative

In defending the ever-growing cost of drugs, the pharmaceutical industry can’t roll out a single, intuitive explanation. Rather, their justification breaks down into many independent but interacting parts. We have to tease these apart before examining their validity.

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Rallying Cry: Cloud and Data First For Pharma

DAN HOUSMANMaybe it is just the shock of being post Labor Day and realizing that summer is fading into the rear view mirror or maybe it was something I ate for breakfast that spurred new hope. But I think that this is the year that the patient centric approach to data in life sciences finally takes off. And along with that launch will come the massive rapid migration to cloud and data lake architectures for pharma data.

Really? Why now you may ask?

Yeah – that’s right. Every group I have been talking to is worried that they are sitting atop a jigsaw puzzle of siloed data resources that can’t be assembled fast enough to meet the needs of business and scientific users. Organizations are thinking that they can’t answer their questions about why drugs work in some patients and not others if they can’t link phenotype and genotype data. Groups can’t look across clinical trials. They can’t look beyond and between clinical trials and EMR data. Progressive safety groups are considering using automation and cognitive computing to lower costs in processing events so they can then look in parallel to expanding sensing new signals into 10X current volumes of data within large real world data sets.Continue reading…

Congress Has a Little Drug Problem

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The Congressional committee that recently demanded Martin Shkreli’s appearance must have hoped to spotlight a smug jerk responsible for the outrageous prescription drug pricing that we’re all up against. Of course there are lots of Shkrelis running drug companies, but most are shrewder and less brash, and might not make for such good theater.

Rep. Elijah Cummings (D-MD), one of the Committee’s questioners, seemed to think that his witness could move healthcare forward by disclosing the machinery of the drug sector’s excesses. “The way I see it, you could go down in history as the poster boy for greedy drug company executives or you could change the system. Yeah, you.”

Excessive treatment and cost are at the core of the entire U.S. healthcare crisis. The fact that other societies and a few innovative firms here consistently deliver equal or better quality care at dramatically lower cost betrays the idea that conventional U.S. healthcare is necessarily superior or even appropriate.

Every part of healthcare is guilty, but the pharmaceutical sector is a case in point. An open record of lobbying spending and what pharma has obtained from Congress makes clear that its contributions have worked to that sector’s economic advantage and against the interests of American patients and purchasers.

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A Parasite meets Wall Street

Screen Shot 2015-09-24 at 9.23.55 AMToxoplasma gondii is a parasite that causes opportunistic infection in helpless people. It may have met its match. The cost of treating Toxoplasmosis, a rare but extant infection, just shot up exponentially. Drug-resistant strain, you ask? Have physicians in Infectious Disease gone mercenary, you wonder? No. A change in ownership.

Daraprim (pyrimethamine) is a nifty drug which kills parasites. It’s been around for eons. I still recall its name from my medical school pharmacology exam. The price of Daraprim, whose production barely costs a dollar, may rise from $13.50 a pill to $750 a pill, after the rights to distribute the drug were acquired by Turing Pharmaceuticals.

Why? The answer is best told by Michael Shkreli, the CEO of Turing, and former hedge fund manager. The reason why Shkreli has acquired a generic drug lying in a forgotten backwater, and raised the price of a magnitude more suited to the hyperinflation of the Weimar Republic, is to make profits. Lots of profit. If this answer seems inane, ask yourself why a former hedge fund manager would be interested in a rare disease of devastating consequences. Penitence is the wrong answer.

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