Harlan Krumholz Profile picture
Jan 21 21 tweets 16 min read
Was watching #Dopesick, and I started reflecting on when I first learned IMS (now IQVIA) tracked every prescription by every doc &sold it to pharma so the doctors could be targeted for drug sales… and how inappropriate that seemed to me. And yet I didn’t do anything.
I was on a plane and a drug representative was sitting beside me going through the prescriptions written by doctors he covered - and there was so much detail. Data-drive marketing…& we docs had no idea the companies were tracking us in this way… & IMS was making billions on it.
It felt like an invasion of privacy… & I was puzzled that it could be legal…we were saying at the time that pharma should not be giving gifts…but we didn’t talk about tracking of individual MD's prescribing patterns by the sales teams - and how they acted on that information.
Watching the show about what Purdue did brought me back to that… how an industry spied on doctors to determine how they used products and sold the information to industry so that sophisticated targeting could be implemented. And I guess pharmacies were complicit by selling data.
And I think, what is going on today that I am not doing enough to expose and address. And the tracking of doctors… yes, even more than before.
And my daughter just reminded me about Sorrell v IMS Health: n 2007, the Vermont legislature passed a law that banned the sale, transmission or use of prescriber-identifiable data (''PI data'') for marketing or promoting a prescription drug without the consent of the prescriber.
But...'Three companies -- IMS Health, Verispan and Source Healthcare Analytics, a unit of Dutch publisher Wolters Kluwer -- that collect and sell such data and by a trade group for pharmaceutical manufacturers challenged the law.’ oyez.org/cases/2010/10-…
And...'The U.S. Court of Appeals for the 2nd Circuit struck down the measure, holding that it violated the First Amendment because it restricts the speech rights of data miners without directly advancing legitimate state interests.’ So companies could spy on doctors...
And @Scotus 'affirmed the lower court order in an opinion by Justice Anthony Kennedy.' "Vermont's statute, which imposes content-and speaker-based burdens on protected expression, is subject to heightened judicial scrutiny," Kennedy wrote. A 6-3 decision.
@Scotus Meanwhile, Justice Stephen Breyer dissented, joined by Justices Ruth Bader Ginsburg and Elena Kagan. "The First Amendment does not require courts to apply a special 'heightened' standard of review when reviewing such an effort," Breyer wrote. [Sigh] HT @becca_krum
@Scotus @becca_krum This from @JournalGIM … 'This is the story of a 2003 workshop designed to increase medical residents’ willingness to prescribe opioids for chronic pain.’ link.springer.com/article/10.100…
@Scotus @becca_krum @JournalGIM 'Resident attitudes toward prescribing opioids for chronic pain were changed by the workshop. They indicated increased willingness to prescribe opioids and less concern about addiction or side effects.’ -Diana Burgess,
@Scotus @becca_krum @JournalGIM 'I now see that concepts I included in my workshop, such as “pseudo-addiction,” were part of a marketing scheme to sell OxyContin ...now-defunct American Pain Society, whose guidelines formed basis for my workshop, received most of its support from Purdue Pharma…’ - Craig Roth
@Scotus @becca_krum @JournalGIM 'I regret not being able to discern appropriate information for providing best patient care & teaching..also felt remorse, guilt, embarrassment, & shame. Writing this piece provided 1st opportunity to give voice to these feelings & contemplate ways of dealing w/them.’ -Craig Roth
@Scotus @becca_krum @JournalGIM And this… by @RendonJim… How Nonprofits Helped Fuel the Opioid Crisis… need more disclosure among non-profits about where the money is coming from… why so much education they provide is sponsored by for profits… philanthropy.com/article/how-no… HT @thackerpd
@Scotus @becca_krum @JournalGIM @RendonJim @thackerpd 'A Chronicle investigation has found that patient-advocacy groups, physicians’ organizations, and other nonprofits became an integral part of the pharmaceutical industry’s efforts to sway doctors, patients, and policy makers to create broad new markets for opioids.’ @Philanthropy
@Scotus @becca_krum @JournalGIM @RendonJim @thackerpd @Philanthropy “What they were really doing was sponsoring this campaign to change culture of prescribing, to make doctors feel more comfortable w/ opioids as class of drug,” Kolodny says. Pouring money into nonprofits was one of key ways companies sought to boost opioid prescriptions & sales.
@Scotus @becca_krum @JournalGIM @RendonJim @thackerpd @Philanthropy 'Over the course of 2 decades, opioid manufacturers awarded >$60m to nonprofits, according to 2020 Senate Finance Committee, gaining influence with and access to patient advocates and physicians’ groups that could be credible messengers for the manufacturers’ business strategy'
@Scotus @becca_krum @JournalGIM @RendonJim @thackerpd @Philanthropy ‘...opioid manufacturers ...saw nonprofits as instrumental to achieving the business goal of boosting prescriptions and sales of opioids. Internal documents disclosed in lawsuits describe nonprofits as “partners” and refer to them in company business-strategy plans.'
@Scotus @becca_krum @JournalGIM @RendonJim @thackerpd @Philanthropy ' in 2018, McCaskill introduced legislation to expand a 2010 sunshine law to require pharmaceutical companies to disclose funding to patient-advocacy and education groups, physicians’ organizations, and others...legislation went nowhere.’ [Still seems like a good idea]
@Scotus @becca_krum @JournalGIM @RendonJim @thackerpd @Philanthropy Why wouldn’t credible non-profits, starting today, publicly report all their donations/revenue from industry… and make clear how the money is used… and what percent of its budget it constitutes. Wouldn’t that show be a start for transparency and trust?

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More from @hmkyale

Jan 22
Your data, packaged and sold by @IBM. 'Business analysts said the data dump instantly makes Francisco Partners a significant player in the multibillion-dollar business of buying and selling sensitive information about the care of patients.’ @statnews @caseymross
@IBM @statnews @caseymross How did IBM get all your sensitive health data to sell? They bought other companies that acquired your sensitive health data. And how did they get it? Mostly from 3rd parties who obtained it from health systems, insurers, & others you trust with your data. #privacy #digitalhealth
@IBM @statnews @caseymross And what is being done w/your sensitive data as billion dollar companies buy and sell it? [well, something that makes it valuable to people who want to buy it] And can you reclaim it or get access to it? [no] And is there consequences to orgs that share your sensitive data [no]
Read 9 tweets
Nov 29, 2021
So many questions still about med device regulation. In our @JAMAInternalMed article we take the Class I recall of Penumbra JET7 Reperfusion Catheter to explore oversight of med devices in the US. Led by star med student @ktkadakia jamanetwork.com/journals/jamai… @jsross119 @AdamLBeckman
@JAMAInternalMed @ktkadakia @jsross119 @AdamLBeckman "JET 7 device was subjected to class I recall following more than 200 adverse event reports, 14 of which involved patient deaths.” We explore the evidence at authorization that the catheter was safe and effective. The findings were disappointing. @YaleMed @YaleCardiology @US_FDA
@JAMAInternalMed @ktkadakia @jsross119 @AdamLBeckman @YaleMed @YaleCardiology @US_FDA "Regulatory analysis indicated that each of the Penumbra reperfusion catheters was cleared under the 510(k) pathway (which allows devices to be authorized with limited to no clinical evidence), with limited submission of either new clinical or animal data.” So this is an issue.
Read 4 tweets
Nov 22, 2021
Since I drink a lot of tea I really liked this @uk_biobank paper… I am usually skeptical of these types of studies, but this is a good one. “...drinking coffee and tea separately or in combination were associated with lower risk of stroke and dementia.” journals.plos.org/plosmedicine/a… Image
@uk_biobank I was just a little uncertain why people at the top end of coffee and tea consumption tended to have a higher risk… looked a bit like a j-curve. Image
@uk_biobank In the table the authors side-stepped it by considering the group with 4 or more cups a day as high coffee and tea consumption and lumped everyone together. For stroke, more dose response for tea than coffee with this approach, and ischemic stroke. Lots of comparisons... Image
Read 5 tweets
Nov 22, 2021
Glad to be part of an in-depth analysis of aortic valve replacement in US elderly, led by remarkable @mori_md & @aakriti_15 w/interdisciplinary team of cardiologists & cardiac surgeons. Findings highlight key trends in the TAVR era. jacc.org/doi/10.1016/j.… @JACCJournals @YaleMed Image
@mori_md @aakriti_15 @JACCJournals @YaleMed First, the Medicare beneficiaries receiving a new aortic value increased 60% from 2012, with increasing TAVR (percutaneous procedure) and decreasing SAVR (aortic valve surgery). TAVR up 680%; SAVR down 40%. Marked practice change. @YaleCardiology @ArnarGeirssonMD @ajaykirtane Image
@mori_md @aakriti_15 @JACCJournals @YaleMed @YaleCardiology @ArnarGeirssonMD @ajaykirtane This study took an approach to investigate total aortic valve replacement; often we are looking at the two procedures and comparing them, but missing overall growth of the total procedures and trends in outcomes. More people getting them…and mortality and readmission dropping.
Read 5 tweets
Nov 18, 2021
Lots of discussion about science journals…here’s the thing, they do not make it easy on authors. Each journal has their own format, they do not accept each others peer reviewers, they often ask authors to pay for privilege of publishing, and ask authors to donate time to review.
There are so many ways to make this easier… be flexible on format until you decide you want the paper… then you can ask authors to format according to your particular preferences.
Come to agreement about peer reviewers; with each journal starting over with peer reviewers it creates so much more work and delays. There are ways to share among the journals if author so elects.
Read 6 tweets
Nov 12, 2021
Great news… @califf001 nomination for @US_FDA seems imminent. And this is a wise choice for someone with the experience, skills and vision to lead at this critical juncture. Sooner we get confirmation, the better. politico.com/news/2021/11/1… Image
@califf001 @US_FDA It is rare to have a Commissioner who has the experience to hit the ground running, and the expertise on the far-reaching responsibilities of the agency, and deeply understands the science. He also knows the potential gamechanging nature of the digital revolution for regulation.
@califf001 @US_FDA To move forward we need a Commissioner who can bring people together and fight on behalf of patients for a system that better servess them. I believe that is what @califf001 can do. I have known him a long time, and can judge by actions, not just words.
Read 5 tweets

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