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Tag: Pharma

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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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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Pharma and Volume-to-Value: The Big Throwdown

Joe FlowerThe collision between the “volume-to-value” movement and the pharmaceutical and biotech industries over the next few years will have a powerful impact on them and on the healthcare industry and on us as customers, patients, and payers. 

On the one hand, pharma is perhaps the part of the healthcare industry least exposed to direct price regulation under the Obama reforms. The actual costs of pharmaceuticals have been rising as a percentage of what people spend on healthcare, and are seen as the part they have the least influence on. At the same time, many new drugs for cancer and other life-threatening diseases have come with astonishingly high price tags, often not fully covered by insurance (due to the high deductibles and co-pays of the new plans), and with few ways for regulators or the market to push back on them. The public perceives these huge price tags as threatening people with a Hobson’s choice of bankruptcy or death. In the volatile political atmosphere of the 2016 elections, this leaves the pharmaceutical industry highly exposed to political attack and actual new price regulation.

On the other hand, the pharmaceutical and biotech industries also potentially offer some of the best answers to bringing the cost of healthcare down through the use of personalized medicines, smart medicines, new methods of administration such as implants, as well as the possibilities glimmering at us from recent research of real breakthroughs in such important chronic disease areas as Alzheimers, diabetes, addiction, behavioral medicine, and functional medicine. For the most part, though, these answers remain potential. We will not see them adding to the “value” side of the equation until they become fully integrated into a system that is at risk for the health of its customers and using every trick in the handbook to bring those costs in line.

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Pseudo Innovation

Screen Shot 2014-08-01 at 2.06.25 PMFew people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options and need to. Faster reviews advocated by the industry-funded public regulators increase the risk of serious harm to 1 in 3. Yet most drugs they approve are found to have few offsetting clinical advantages over existing ones.

Systematic reviews of hospital charts by expert teams have found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients given drugs have serious adverse reactions for a total of 2.74 million. Further, the expert teams attributed as many deaths to the drugs as people who die from stroke. A policy review done at the Edmond J. Safra Center for Ethics at Harvard University concluded that prescription drugs are tied with stroke as the 4th leading cause of death in the United States. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the US and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.

Perhaps this is “the price of progress”? For example, about 170 million Americans take prescription drugs, and many benefit from them. For some, drugs keep them alive. If we suppose they all benefit, then 2.7 million people have a severe reactions, it’s only about 1.5 percent – the price of progress?

However, independent reviews over the past 35 years have found that only 11-15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs. While these contribute to the large medicine chest of effective drugs developed over the decades, the 85-89 percent with little or no clinical advantage flood the market. Of the additional $70 billion spent on drugs since 2000 in the U.S. (and another $70 billion abroad), about four-fifths has been spent on purchasing these minor new variations rather than on the really innovative drugs.

In a recent decade, independent reviewers concluded that only 8 percent of 946 new products were clinically superior, down from 11-15 percent in previous decades. (See Figure) Only 2 were breakthroughs and another 13 represented a real therapeutic advance.

Spokesmen for the pharmaceutical industry point out that therapeutically similar drugs have advantages. First, physicians need some choice within a therapeutic class because some patients do not respond well to a given drug. This is true, but after about three choices, there is little evidence to justify a 4th , 5th, or 6th in a class.

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Breaking: Health 2.0 Fall Conference Lineup Is Out!

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Tech giants storming the digital health landscape will be center stage at Health 2.0’s 8th Annual Fall Conference in Santa Clara, CA. An impressive line-up of health and tech executives headline three full days of live demos and innovative sessions. Highlights include keynotes from visionary physicians Eric Topol and Patrick Soon-Shiong as well as Samsung Electronics President, Young Sohn in conversation with Health 2.0 CEO, Indu Subaiya. Leaders from Intel, Humana, IBM Watson, Qualcomm Life, Merck, athenahealth, eClinicalWorks and the Office of the National Coordinator for Health Information Technology (ONC) will showcase and discuss their latest technologies and initiatives on the main conference stage this fall. As always, Health 2.0 features over 150 live demos of new technology, 250+ speakers, 50+ sessions, more networking, and deals-done than anywhere else in health technology.

The main stage will feature the following panels:

Smarter Care Delivery: Amplifying the Patient Voice: Matthew Holt, Co-Chairman of Health 2.0, sparks the discussion on how new technology platforms, payors, and providers are working together for enhanced patient care delivery and engagement.

Consumer Tech and Wearables: Powering Healthy Lifestyles: Bringing together the most innovative wearables that are pushing individualized medicine into the future, Indu Subaiya, CEO of Health 2.0, leads this session focused on how consumers are experiencing new lifestyles centered around technology. Don’t miss the live fashion show featuring all the latest trends in digital health wearables!

Buy, Sell, Exchange: New Markets for Consumers, Employers, and Providers: Nearly a year after ACA implementation, this session will dive into the new ways benefits are being offered to consumers, how employers are buying care directly, and what new technologies are enabling change in direct care provision.

Data Analytics: From Discovery to Personalized Care: This panel focuses on how data analytics and powerful visualizations are pushing forward clinical research. Highlights will include genomics, non-invasive diagnosis tools, and integrated data collection are uncovering new discoveries, promoting personalized medicine and new care protocols.

Returning crowd favorites include 3 CEOs … (and a President!), The Unmentionables hosted by Alexandra Drane, The Frontier of Health 2.0 hosted by David Ewing Duncan, and Launch! with ten brand new companies unveiling their products for the very first time! Many more sessions and panels can be found on the Health 2.0 online agenda.Continue reading…