Recent quotes:

Texas Psychiatrist Karen Wagner Under Scrutiny - AHRPAHRP

co-authored the notorious, ghostwritten Paxil pediatric study #329, whose lead author, Martin Keller, MD, was replaced last month as chairman of psychiatry at Brown University. The Glaxo-paid authors of study #329 helped the company promote the myth that Paxil was "safe and effective" for use in children as early as 1998: in a poster presentation, Dr. Wagner claimed "The results of this study demonstrate the safety ofparoxetine in the treatment of adolescent depression. Side effects were modest with paroxetine." [2]  But internal Glaxo emails show the data from pediatric Paxil trials were negative.

Health care data-sharing rules touch off intense lobbying fight - POLITICO

But many in the industry say they have patients’ best interests at heart in asking for increased privacy protections as part of the rule. “The primary beneficiaries of this rule are venture capitalists and others taking advantage of patient data,” said Epic executive Sumit Rana in an interview Monday. Disclosing patient records in unfettered fashion can hurt patients, he said. The rule’s promise of eased access to a patient’s entire medical record through an interface is an invitation for app developers — well-funded and sketchy alike — to pick over patient data and commercialize it, he said. In that, he said the proposed rules “go well beyond the 21st Century Cures Act,” which sought to modernize health care with better use of IT.

FDA and NIH let clinical trial sponsors keep results secret and break the law | Science | AAAS

The University of Texas MD Anderson Cancer Center and the Mayo Clinic both failed to report results on time, or at all, in about two-thirds of their trials. Yale University failed to do so in 84% of its trials. NIH’s own institutes also had a bad record. They are directly responsible for reporting results when they sponsor studies done by agency staff or some grantees, and the top four NIH institute sponsors, taken together, reported results late or not at all in more than six of every 10 trials Science looked at. Contacted for comment, none of the institutions disputed the findings of this investigation. In all 4768 trials Science checked, sponsors violated the reporting law more than 55% of the time. And in hundreds of cases where the sponsors got credit for reporting trial results, they have yet to be publicly posted because of quality lapses flagged by ClinicalTrials.gov staff (see sidebar).

For Her Head Cold, Insurer Coughed Up $25,865 | Kaiser Health News

The third reason for the high bill may be the connection between the lab and Kasdan’s doctor. Kasdan’s bill shows that the lab service was provided by Manhattan Gastroenterology, which has the same phone number and locations as her doctor’s office.

Doctors Prescribe More of a Drug If They Receive Money from a Pharma Company Tied to It — ProPublica

“If there are physicians out there that deny that there is a relationship, they are starting to look more and more like climate deniers in the face of the growing evidence,” said Aaron Kesselheim, a professor of medicine at Harvard Medical School and an expert in pharmaceutical costs and regulation. “The association is consistent across the different types of payments. It’s also consistent across numerous drug specialties and drug types, across multiple different fields of medicine. And for small and large payments. It’s a remarkably durable effect. No specialty is immune from this phenomenon.”

Doctors Prescribe More of a Drug If They Receive Money from a Pharma Company Tied to It — ProPublica

On average, across all drugs, providers who received payments specifically tied to a drug prescribed it 58% more than providers who did not receive payments.

What These Medical Journals Don’t Reveal: Top Doctors’ Ties to Industry - The New York Times

“The system is broken,” said Dr. Mehraneh Dorna Jafari, an assistant professor of surgery at the University of California, Irvine, School of Medicine. She and her colleagues published a study in August that found that, of the 100 doctors who received the most compensation from device makers in 2015, conflicts were disclosed in only 37 percent of the articles published in the next year. “The journals aren’t checking and the rules are different for every single thing.”

Gilead, LGBTQ community ask Facebook to remove misleading PrEP ads | FiercePharma

More than 50 organizations involved with LGBTQ advocacy, public health and HIV/AIDS prevention have co-signed a letter to Facebook Chairman and CEO Mark Zuckerberg asking him to take down “dangerous and misleading” ads on Facebook and Instagram. By not doing anything, the social media companies are harming public health, the groups contend. Gilead, which makes HIV prevention drugs Truvada and Descovy, agrees with the effort and applauds the organizations standing up for their communities, it said. “We join calls to have any misleading advertisements related to Gilead’s HIV medications removed from Facebook," it added in a statement.

Announcing ICD-10-CM and RxNorm Ontology Linking for Amazon Comprehend Medical

Medical ontologies, such as ICD-10, make it possible to classify unstructured medical information into standardized codes that downstream healthcare applications, such as revenue cycle management tools (medical coding) can read. Amazon Comprehend Medical ICD-10-CM RXNorm Ontology Linking extracts medical condition and medication entities from medical text and links them to the relevant ICD-10-CM and RXNorm concepts respectively.   Using Amazon Comprehend Medical ICD-10-CM and RXNorm Ontology Linking APIs, developers can quickly and accurately extract codes (e.g. “R51” as the ICD-10-CM code for headache) from a variety of data sources, such as doctor’s notes or patient health records. Our deep learning approach to ontology linking provides much higher accuracy than existing rules-based systems by understanding the context each entity is found in.

dmca/2019-11-08-abbott.md at master · github/dmca · GitHub

It has come to Abbott’s attention that a software project titled “Libre2-patched-App” has been uploaded to GitHub, Inc.’s (“GitHub”) website and creates unauthorized derivative works of Abbott’s LibreLink program (the “Infringing Software”). The Infringing Software is available at https://github.com/user987654321resu/Libre2-patched-App. In addition to offering the Infringing Software, the project provides instructions on how to download the Infringing Software, circumvent Abbott’s technological protection measures by disassembling the LibreLink program, and use the Infringing Software to modify the LibreLink program.

New York Union Blames Out-of-Network Doctors for Millions in Costs - Bloomberg

“That raised a question for us as to whether there has been, implicitly or explictly, a business decision by Northwell to allow doctors to be out-of-network and to bill at really high rates,” Rothstein said. Northwell insists the answer is no. Outside doctors that have admitting privileges at Northwell bill the health plan separately and aren’t authorized to use Northwell’s name on their bills, Aviles said. “Legally we can’t tell another corporation what to do and how much to bill,” Aviles said. The union health fund said a handful of provider groups accounted for a disproportionate share of the  out-of-network bills. It declined to identify those groups but one provider-group billed 100% of its claims at Northwell as out-of-network, according to 32BJ.

Abbott Labs kills free tool that lets you own the blood-sugar data from your glucose monitor, saying it violates copyright law / Boing Boing

First, they say that creating a tool that interoperates with the Freestyle Libre's data is a copyright infringement, because the new code is a derivative work of Abbott's existing product. But code that can operate on another program's data is not a derivative work of the first program -- just because Apple's Pages can read Word docs, it doesn't mean that Pages is a derivative of MS Office. In addition, as Diabettech points out, EU copyright law explicitly contains an exemption for reverse engineering in order to create interoperability between medical devices (EU Software Directive, Article 6). More disturbing is Kirkland/Abbott's claim that the project violates Section 1201 of the Digital Millennium Copyright Act, which prohibits bypassing "access controls" for copyrighted works. Factual data (like your blood sugar levels) are not copyrightable -- and if they were, you would hold that copyright. It's your blood. What's more, DMCA 1201 also contains an interoperability exemption.

How have healthcare prices grown in the U.S. over time? - Peterson-Kaiser Health System Tracker

In 2016, while the average price paid by large employers for an admission for a full knee replacement was $34,063, 25 percent of admissions had a price of $24,734 or less and another 25 percent had prices higher than $39,786. […]Ten percent of admissions had prices in excess of $52,181 (53% above the average). For laparoscopic appendectomies, the average price paid for an admission was $20,192 in 2016; 25 percent of admissions had prices of $12,088 or less while another 25% had prices of over $24,847. Ten percent of admissions had prices in excess of $35,308 (75% above the average).

Four Reasons Drugs Are Expensive, Of Which Two Are False

Thus there is a lot of deliberate obfuscation of the real prices, net of rebates, discounts, clawbacks, budget caps, etc., that health systems actually pay. Elastic also loosens when there are barriers to trade. The European Union is a free trade zone. Therefore, if one sells pills into Greece, where prices are low, it is more profitable overall to make sure they are in Greek language-only packaging, in Greek language-only blister packs, with something obvious and Greek printed on the pills, and – if possible – in a dose that is subtly different from any dose that can be legally sold in the UK or Germany. This makes it tedious to repackage the pills, before shipping them to parts of the European Union where they compete with similar pills that the manufacturer is selling a higher price: Tedious but not impossible, as German friends taking re-exported Greek drugs recently told me.

Four Reasons Drugs Are Expensive, Of Which Two Are False

From the company’s perspective, the drug was much too cheap. Had Sanofi applied the cancer price to the multiple sclerosis dose, it would have been charging around $6,000 per year when multiple sclerosis drugs had annual prices closer to $60,000. So Sanofi withdrew Campath from commercial sale in late 2012 and re-launched it in 2013 in Europe and in 2014 in the US with a new name, Lemtrada, a new multiple sclerosis indication, and a list price rise of over one thousand – yes, one thousand – percent. The temporary withdrawal outraged neurologists who had been using Campath off-label for years, but who could not get the drug for their patients until the re-launch.

The drug development lottery

Nor, as we discuss later, is it necessarily good policy to attack the economics of the winners. This is because the majority of R&D projects fail. The failures cost investors and the industry a great deal of money, but because they fail, they are never scrutinized by suspicious members of Congress. If you just look at the winners, drug R&D will look wildly profitable. The same is true of all lotteries. People buy a ticket for a dollar and win a million. However, the economics of the winners is not representative the wider game. This is why, for example, the UK’s National Lottery is often called the tax on stupidity.

Venturing A Perspective On The Drug Pricing Debate | LifeSciVCLifeSciVC

There is often a large (and lately increasing) delta between the list price of drugs and the net price back to the manufacturer. This has created a “gross-to-net bubble” that’s enormous, and is also enormously distorting to a discussion about drug prices. In the past few years, we have seen very small increases in net prices (1-2%). In fact, net prices increased only 0.3% in 2018, according to IQVIA; this is below the rate of consumer price inflation. As an example, branded insulin prices are commonly cited as having had egregious increases over time, and it’s true the list price increases have been very aggressive. But the net prices sent back to Pharma have often been very small if not negative. For a shocking image of this, check out the list-to-net price comparison of Humalog 100: $594 list price and a $135 net price after rebates. That captures the absurdity of the system. Adding insult to injury, that gross-to-net price differential isn’t passed on to consumers – it’s captured by the middleman usurpers in the healthcare system.

Venturing A Perspective On The Drug Pricing Debate | LifeSciVCLifeSciVC

Over the past 20 years, Big Pharma revenue growth has become increasingly reliant on biannual US price increases, so much so the vast majority of revenue growth of the top 50 products last year was driven by price rather than volume. With industry branded drug volumes collapsing by 40% over the past six years (from 1B prescriptions in 2011 to 600M prescriptions in 2017), pricing in aggregate has been the only growth driver – either price increases of existing products, or higher pricing of new products.

Venturing A Perspective On The Drug Pricing Debate | LifeSciVCLifeSciVC

As an example, branded insulin prices are commonly cited as having had egregious increases over time, and it’s true the list price increases have been very aggressive. But the net prices sent back to Pharma have often been very small if not negative. For a shocking image of this, check out the list-to-net price comparison of Humalog 100: $594 list price and a $135 net price after rebates. That captures the absurdity of the system. Adding insult to injury, that gross-to-net price differential isn’t passed on to consumers – it’s captured by the middleman usurpers in the healthcare system.

Venturing A Perspective On The Drug Pricing Debate | LifeSciVCLifeSciVC

Almost every player in the healthcare system is actually incentivized for higher drug costs (e.g., PBMs, physician practices, hospitals, distributors, etc) because they get paid a percentage of list price value, or get rebates off of those values, or mark them up when they pass the bill onto patients’ insurers. Most players in the healthcare value chain, whether they admit it or not, financially benefit from high-priced drugs: the higher, the better.

Venturing A Perspective On The Drug Pricing Debate | LifeSciVCLifeSciVC

I can’t even recall ever building a spreadsheet model with revenues and drug prices in it for any of our new biotech investments. You simply can’t model with any accuracy what the revenues will look like in 15 years when a future drug launches. When we start a drug discovery company, the time to market is too long, the costs to get there too big, and the unpredictability too vast to build a model that is remotely useful. What we do know, with some accuracy, is what the real world unmet needs are for patients, and how we might address their mortality or morbidity. Our new startup investment theses are usually framed purely with that in mind.

Antibiotic prescribing without documented indication in ambulatory care clinics: national cross sectional study | The BMJ

Antibiotics were prescribed during 13.2% (95% confidence interval 11.6% to 13.7%) of the estimated 990.8 million ambulatory care visits in 2015. According to the criteria, 57% (52% to 62%) of the 130.5 million prescriptions were for appropriate indications, 25% (21% to 29%) were inappropriate, and 18% (15% to 22%) had no documented indication. This corresponds to an estimated 24 million prescriptions without a documented indication. Being an adult male, spending more time with the provider, and seeing a non-primary care specialist were significantly positively associated with antibiotic prescribing without an indication. Sulfonamides and urinary anti-infective agents were the antibiotic classes most likely to be prescribed without documentation.

23andMe vs. China's 23Mofang Review: What Do DNA Tests Tell You? - Bloomberg

When my reports came back, 23Mofang’s analysis was much more ambitious than its American peer. Its results gauged how long I will live, diagnosed a high propensity for saggy skin (recommending I use products including Olay and Estee Lauder creams) and gave me — an optimist not prone to mood swings — a higher-than-average risk of developing bipolar disorder. 23andMe doesn’t assess mental illness, which Gil McVean, a geneticist at Oxford University, says is highly influenced by both environmental and genetic factors.

The Price of Insulin Has Soared. Biohackers Want to Fix It | Time

Ultimately, it’s not clear that the Open Insulin Project’s real goal is to facilitate insulin minilabs across the U.S. The group intends to put the plan for their designer insulin-­producing yeast online as soon as it’s done, but only for “research purposes,” says Di Franco. And without brewing facilities or the ability to check and purify the hormone, the plans themselves are a long way—scientifically and legally—from the point where anyone will be injecting homegrown insulin. Di Franco has offered up his own body as a proving ground once the lawyers sign off: “I’d be thrilled to be the first person to take the insulin,” he says.

Patient charity settles allegations it helped MS drug makers pay kickbacks

The Assistance Fund, based in Orlando, says its mission is to help patients manage copays, coinsurance, deductibles, and other expenses related to their disease or chronic condition. But the government alleges that it conspired with Teva, Biogen (BIIB), and Novartis (NVS) to funnel money donated by the drug makers to MS patients to ensure the patients took their drugs, not their competitors’, regardless of price.

The medium is the medicine: a novel history

Before 1900, “many people thought of medicine as an inferior profession, or at least a career with inferior prospects,” according to Starr. The average American doctor earned less than “an ordinary mechanic,” riding miles each day on horseback to see just a handful of patients. The status of doctors changed dramatically in the first decade of the 20th century, when cars, telephones and urbanization made practicing medicine more efficient and therefore more lucrative.