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Tag: Big pharma

We Can Stop America’s Surge in Opioid-Dependent Babies

By STUART H. SMITH

Imagine a massive public health crisis in the United States that affects tens of thousands of people. Now imagine that the government had a simple tool at its disposal that could prevent this kind of physical and psychological trauma. You might think that I’m writing about America’s deadly outbreak of gun violence, which has made headlines this summer from Dayton to El Paso.

But actually I’m talking about a different crisis that affects even more people – all of them children — and which could be sharply reduced with one simple step that lacks the bitter political animus of the gun debate. The issue at hand involves babies born to mothers who used opioids during pregnancy – babies who tend to develop a condition called Neonatal Abstinence Syndrome, or NAS.

Experts say that state and federal governments have grossly underestimated the number of NAS babies currently born in the United States, as the addiction crisis triggered by Big Pharma’s greed in pushing painkillers refuses to fade. They say an accurate accounting would find a minimum of 250,000 children — and possibly two or three times that every year born with NAS. These kids will face chronic symptoms such as trembling and seizures, gastrointestinal problems, and an inability to sleep. Their numbers are more than eight times higher than the last official estimate from the government.

For more than a year now, I’ve been working with a team of attorneyscalled the Opioid Justice Team who are fighting for any settlement of the massive court fight pitting more than 2,000 localities against Big Pharma to include a medical monitoring fund for the estimated hundreds of thousands of kids born with NAS syndrome. But our team has also been pushing for radical measures that would prevent many of these unfortunate cases.

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If Marketing Is so Dangerous, Should Medical Schools Be Doing so Much of It?

flying cadeuciiBeginning about 5 years ago, many US medical schools introduced severe restrictions on marketing activities by pharmaceutical companies and medical device manufacturers.

These measures often prohibited representatives of such firms from entering patient care areas and even medical school facilities, with the exception of tightly controlled training activities, and then by appointment only.  In some cases, medical schools have issued outright bans against industry support of educational activities.

What is the rationale behind such actions?  It boils down to a concern that industry funding may inappropriately influence both medical education and patient care.  For example, a physician visited by an industry representative might be more likely to prescribe one of the firm’s drugs.  In announcing a ban on such activities, one school likened the industry to Don Juan, worrying that physicians might prescribe drugs because they were “seduced by industry,” and not because “it’s best for the patient.”

There is evidence that even physicians who believe their decision making is not biased by marketing are in fact affected by it.  Moreover, a good deal of such marketing is not exactly purely scientific.  A perusal of medical journals reveals a plethora of full-page ads featuring slogans such as:

“Simplicity is clear information at your fingertips,” and highlighting images such as a physician walking down a hallway with a tiger, describing the featured drug as a “powerful partner.”

Such marketing is not inexpensive.  Placing a full-page ad in a medical journal typically costs around $4,000.  On the other hand, as an air traveler I have come across a number of slick full-page airline magazines ads touting medical schools and their affiliated hospitals.

These cost on average $24,000.

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A New Era in Value-Driven Pharmaceuticals

flying cadeuciiAt the end of March the Amercian College of Cardiology (ACC) and the American Heart Association (AHA) issued a joint statement saying they “will begin to include value assessments when developing guidelines and performance measures (for pharmaceuticals), in recognition of accelerating health care costs and the need for care to be of value to patients.”

You may have heard of value-based medicine, but are we entering a new era of value-based medications or value-driven pharma?

Price transparency is great, but it has be combined with efficacy to get to value (price for the amount of benefit). Medical groups are catching on to how important value assessments are, because if patients can’t afford their medication, they won’t take their medication, and that obviously can turn into poor outcomes.

Twenty-seven percent of American patients didn’t fill a prescription last year according to a Kaiser Family Foundation Survey. This trend seems likely to continue as we move toward higher-deductible plans, where those with insurance can have great difficulty affording medications.

Included in the ACC/AMA statement was a quote from Paul Heidenreich, MD, FACC, writing committee co-chair and vice-chair for Quality, Clinical Affairs and Analytics in the Department of Medicine at Stanford University School of Medicine.

“There is growing recognition that a more explicit, transparent, and consistent evaluation of health care value is needed…These value assessments will provide a more complete examination of cardiovascular care, helping to generate the best possible outcomes within the context of finite resources.”

Spreading risk and payment to different members of the health care value chain is beginning to make it apparent to more people and organizations that resources are finite. Patients and their physicians are starting to ask which treatments are worth the cost and have best likelihood of adherence.

An outgrowth of the move toward digital health and accountable care is that we’re entering every patient into a potential personal clinical trial with their data followed as a longitudinal study, and we can look much more closely at efficacy and adherence and reasons why it happens and why it doesn’t.

It won’t be long before we start to see comparative effectiveness across a variety of treatments and across a variety of populations. When we can connect outcomes data, interventions and costs all in the same picture we begin to see where the value (price against results) is and where it isn’t.

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The Cholesterol Gulag

Last week, we were amongst the very first opinion leaders to speak out against the new cholesterol guidelines from the American Heart Association (AHA) and the American College of Cardiology (ACC).

Our error was not going far enough.

Monday’s New York Times carried a devastating portrait of the development of the guidelines, leaving readers with the unmistakable impression that this absurd attempt to make people into patients was not just poor policy it was a hubristic, avoidable policy folly, sort of like the bridge to nowhere and federal housing policy pre-2008.

Trust is an interesting thing; once broken it almost resists reconstruction.  Public trust in the AHA and ACC is crumbling as we write and deservedly so, as what should have been clear becomes more confusing and conflicted by the minute.

Instead of giving generally healthy middle aged American adults (like the three of us) the safe haven of a cardiovascular disease (CVD) prevention framework that is understandable, sensible and actionable, we got a cholesterol gulag.  Only here in the land of the free, it’s not a government gulag imprisoning the political opposition.

No, in a phenomenon unique to the US, it’s a health gulag intended to take people who need advice, support, and guidance and give them a pill, which is the first step in an intentional ensnarement in the medical care system.  It’s the Hospital California…on steroids, and you can’t even checkout because that would be against this addled medical advice.

To clarify: we have zero objection to providing statins, especially low-cost generic ones, to people under age 75 with current CVD, diabetes, or extremely high cholesterol levels.  The drugs may very well save their lives.

Our beef is with the cockamamie reduction in the ‘risk-to-treat’ threshold from 10% risk of heart attack or stroke in the next 10 years to 7.5% for people with none of the above noted problems.

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Doctors: We Can’t Leave It to Business to Educate Us

Recently I came across yet another media article with suggestions as to how digital health products can gain more widespread adoption. The writer notes that “we can learn a lot from the pharma and healthcare industries,” and goes on to discuss the importance of engaging the doctor.

This article, like many I read, doesn’t acknowledge the downsides of using pharma’s tactics.

I have to assume that this is because from a business perspective, there aren’t a lot of downsides to pharma’s tactics. Pharma, along with many other healthcare industry players (hospitals, insurance companies, device manufacturers) has overall been extremely successful from a business standpoint.

So if the intent is to help digital health companies succeed as businesses, then by all means one should encourage them to copy pharma’s tactics.

But as we know, what works for business has often not worked well for serving the needs of individual patients, or to society from a health services and public health perspective.

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Google, Whole Foods, and … Big Pharma?


Google’s informal corporate slogan is “Don’t be evil.” Whole Foods is a Fortune 500 company with a net revenue of 10 billion dollar that prides itself on a commitment to social responsibility. Both companies have pledged to do long-term good in the world, even at the expense of short-term gains, and both are wildly successful.

If corporations can be profitable as a result of their commitments to social justice and corporate ethics, why can’t this doctrine be extended to the pharmaceutical industry? Someday, a company called GoodPharma might reach the Fortune 500 on the basis of a pledge to improve access to medicine, conduct international research trials in accordance with the highest standards of research ethics, engage in research on orphan diseases, publish negative research findings, promptly report information about adverse effects, and generally act as a model for ethical industry practices. If this business model hasn’t been explored, it should be.

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Mission Critical: How Translation-Focused Disease Foundations May Save Medical Research

Patients waiting expectantly for medical research to produce important new cures are finding bad news almost everywhere they turn.

Pharmaceutical companies are suffering from a much-discussed innovation crisis, as old drugs lose patent protection without new drugs to replace them; meanwhile, the small biotechs that could potentially bail big pharma out struggle to raise capital .

University scientists, for their part, are beset by an unseemly credibility crisis, as the intrinsic fragility of medical research is now vividly apparent from the soaring number of high-profile retractions, and the well-documented difficulty of reproducing many published findings outside the originator’s lab.

At the heart of this crisis is the misalignment of two very different cultures.

Academic scientists tend to focus on publishing papers, and usually assume that the results will eventually be useful. They place a high value on novelty, and relatively less value on whether the data are robust, easily reproducible by others, or truly relevant to human disease. Captivating data from putative laboratory models of disease generate publications, even if the model is not very predictive of human disease – and unfortunately, most models aren’t.

Conversely, big companies traditionally focus on generating efficiencies through scale, and on developing reproducible processes. This works very well for manufacturing, reasonably well for large late-stage clinical trials, and essentially not at all for early-stage (discovery) research.

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