(draft notes for now, will complete with proper HTML later)
Dollars for Docs – an investigation into the financial relationships between doctors and pharmaceutical companies – is one of ProPublica's biggest and well-known investigative projects. It not only includes dozens of investigative stories from ProPublica's reporters, but a publicly-searchable database of financial transactions, which has attracted millions of users interested in their own doctors. The data was also freely shared with other news organizations, leading to hundreds of independently-reported stories.
Today, the consensus that transparency is important is so prevalent that the federal government has created its own impressive searchable payments site:
https://openpaymentsdata.cms.gov/
Though we have the ability to easily search millions of records from the convenience of our web browsers, it's important to realize how different it was just a few years ago. It's also important to realize that this debate over industry relationships has been going on for decades and is not-at-all black-and-white.
For our purposes specifically, it's important to understand that despite the interest in this issue, and despite the private nature of things relating to health and money – the data that made Dollars for Docs possible was out in the open, legally accessible to anyone, and yet untouched for years.
There's a big difference between being able to see data and being able to use data.
The 1993 Minnesota Law
Via the Star Tribune, in a 2008 article titled, Bill would expand law on medical disclosure
Fifteen years ago [1993], with little fanfare or notice, the Legislature adopted an unusual law requiring drug companies to publicly report gifts and payments to doctors in Minnesota.
As far as I know, the Minnesota state law is the earliest mandate for disclosures of doctor/drug company relationships. In subsequent years, between 2001 and 2005, individual states passed various disclosure laws, including California and Vermont.
The JAMA 2007 study
Minnesota's State Board of Pharmacy started collecting the drug/doctor data in 1993. But its director (in an interview in 2010) couldn't remember a single request by the public for the data until nearly a decade later, when Dr. Joseph Ross of Mount Sinai undertook a study to manually gather data from Minnesota and Vermont to see what that data consisted of.
You can read the full study here:
http://jama.jamanetwork.com/article.aspx?articleid=206127
Old school PDFs
The Minnesota Board of Pharmacy no longer publishes its records on its website. However, I found what appears to be a partial mirror at psychrights.org:
- http://psychrights.org/states/Minnesota/MinnPharmacyData/2000/
- http://psychrights.org/states/Minnesota/MinnPharmacyData/2001/
- http://psychrights.org/states/Minnesota/MinnPharmacyData/2002/
Each file contains a variety of reports in all kinds of forms. Imagine photocopying each page at 25 cents a page. And then having to hand-enter the data into a Microsoft Access database:
A lot of reports are empty as many companies had nothing to report:
Reports from big companies were usually typed out into the form, still require OCR/hand-transcription to bring into a database.
Here's a 2000 report from AstraZeneca:
A couple of other formats:
But there were a few reports that contained handwritten records:
With reports that hard and cumbersome to collect and parse, it should be little surprise that apparently, after a few years, companies just realized they could just not report anything at all, or maybe just forgot to do the paper work. A revealing table, via the JAMA report:
http://www.latimes.com/news/la-na-nih22dec22-story.html
http://www.citizen.org/Page.aspx?pid=740
Already, despite the limitations described below, these physician disclosure laws have yielded beneficial results. In Minnesota, the publication of our article in the Journal of the American Medical Association (JAMA; see Appendix 1)[11] in March 2007 and our provision of the underlying data to local newspapers have led to significant media interest and an undertaking by the Executive Director of the Minnesota Board of Pharmacy (to whom we also provided the data electronically) to post the data his office has collected on the internet. (We do not see such data posted at the present time.) After reading the press reports, which named specific doctors, several clinics contacted us, unaware that their physicians had been accepting such large payments from pharmaceutical companies. An article in the New York Times, using similar data, identified physicians being used by pharmaceutical companies to run clinical trials despite long histories of discipline for substandard medical care by the Minnesota Board of Medical Practice.[12] Another in the same series documented large payments to medical “thought leaders”[13] – those with a role in developing guidelines that might affect the prescribing of the company’s drugs.
Grassley Act, 2009:
http://www.grassley.senate.gov/news/news-releases/grassley-works-disclose-financial-ties-between-drug-companies-and-doctors
The Physician Payments Sunshine Act of 2009 would establish a nationwide standard requiring drug, device and biologic makers to report payments to doctors to the Department of Health and Human Services and for those payments to be posted online in a user friendly way for public consumption. It would establish penalties as high as $1 million for knowingly failing to report the information. The proposal incorporates many of the new recommendations of the Medicare Payment Advisory Commission, an independent congressional agency which advises Congress on issues affecting the Medicare program.
http://danwin.com/2010/04/pfizer-web-scraping-for-journalists-part-4-pfizers-doctor-payments/
Data quality
Data Integrity. For both Vermont and Minnesota, overall data quality varied. Whereas all Vermont disclosures had been typed and entered into a Microsoft Excel spreadsheet, some Minnesota disclosures were typed and others were hand-written (with varying degrees of legibility) by the reporting company. In both states, many individual entries described payments made to multiple physicians and/or health care professionals, whereas others described payments made to individual physicians or health care professionals. Few fields were missing information for substantial portions of the data, except payment recipient identity for Vermont.
In Vermont, 951 payment entries were for an amount less than $25; in Minnesota, 344 were for an amount less than $100. __In addition, for payment purpose in Minnesota, many entries were missing entirely or generically quoted the Minnesota gift disclosure law (eg, “reasonable honoraria or payment of the reasonable expenses of a practitioner…”).
Moreover, for Vermont, the definitions of payment type and purpose were vague and the purpose categories for both states were overlapping, making it difficult to differentiate between payments for contracted services vs gifts.
This limitation is also one of our central findings: the impact of disclosure laws on increasing transparency of physician-industry relations is compromised by incomplete disclosure as well as insufficient access to disclosed information. Making these payments publicly available will require more stringent laws with clear mechanisms for enforcement.
Financial Disclosures: Drs Ross and Krumholz reported serving as consultants at the request of plaintiffs for recent suits against Merck and Co related to Vioxx.
http://www.fiercepharma.com/story/merck-reaches-830m-settlement-long-running-vioxx-litigation/2016-01-15
http://www.fiercepharma.com/story/merck-pay-950m-vioxx-marketing-settlement/2011-11-23
Seven years after its painkiller Vioxx was yanked off the market, Merck ($MRK) has agreed to pay $950 million to resolve allegations about its marketing. The Department of Justice says Merck will pay a $321 million criminal fine, $426 million to wrap up federal civil claims and $202 million to state Medicaid programs. And in an arrangement familiar to anyone who's been following the saga of off-label marketing allegations and False Claims Act lawsuits, a Merck unit will plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act.
Results Access to payment data required extensive negotiation with the Office of the Vermont Attorney General and manual photocopying of individual disclosure forms at Minnesota's State Board of Pharmacy. In Vermont, 61% of payments were not released to the public because pharmaceutical companies designated them as trade secrets and 75% of publicly disclosed payments were missing information necessary to identify the recipient. In Minnesota, 25% of companies reported in each of the 3 years.
Conclusions The Vermont and Minnesota laws requiring disclosure of payments do not provide easy access to payment information for the public and are of limited quality once accessed. However, substantial numbers of payments of $100 or more were made to physicians by pharmaceutical companies.
ProPublica
Dollars for Docs, circa 2016
https://projects.propublica.org/docdollars/
Dollars for Docs, circa 2010-2013
https://projects.propublica.org/d4d-archive/
What We’ve Learned From Four Years of Diving Into Dollars for Docs https://www.propublica.org/article/what-weve-learned-from-four-years-of-diving-into-dollars-for-docs/
What to be Wary of in the Govt’s New Site Detailing Industry Money to Docs https://www.propublica.org/article/what-to-be-wary-of-in-the-govts-new-site-detailing-industry-money-to-docs/
https://www.propublica.org/article/as-full-disclosure-nears-doctors-pay-for-drug-talks-plummets/
https://www.propublica.org/nerds/item/heart-of-nerd-darkness-why-dollars-for-docs-was-so-difficult/
https://www.propublica.org/getinvolved/item/dollars-for-docs-how-to-evaluate-drug-payment-data/
https://www.propublica.org/article/senate-watchdog-targets-high-prescribing-medicaid-docs/
http://www.nytimes.com/2007/05/10/health/10psyche.html?pagewanted=all
Those who took the most money from makers of atypicals tended to prescribe the drugs to children the most often, the data suggest. On average, Minnesota psychiatrists who received at least $5,000 from atypical makers from 2000 to 2005 appear to have written three times as many atypical prescriptions for children as psychiatrists who received less or no money.
http://www.nytimes.com/2014/10/01/business/Database-of-payments-to-doctors-by-drug-and-medical-device-makers.html
http://www.nytimes.com/2007/06/03/health/03docs.html
A decade ago the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a “reckless, if not willful, disregard” for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that.
https://projects.propublica.org/d4d-archive/search?utf8=%E2%9C%93&term=Faruk+Abuzzahab&state%5Bid%5D=&company%5Bid%5D=&period%5B%5D=&services%5B%5D=
Asked about Drs. Garfinkel and Simon, Phil Belt, a spokesman for Eli Lilly, said that both doctors were licensed to practice medicine and that the company relied on doctors to report disciplinary actions or criminal convictions against them.
This got the ball rolling:
http://www.nytimes.com/2008/10/04/health/policy/04drug.html
http://projects.propublica.org/graphics/bigpharma
https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history
Justice Department Announces Largest Health Care Fraud Settlement in Its History; Pfizer to Pay $2.3 Billion for Fraudulent Marketing
"This historic settlement emphasizes the government’s commitment to corporate and individual accountability and to transparency throughout the pharmaceutical industry," said Daniel R. Levinson, Inspector General of the United States Department of Health and Human Services. "The corporate integrity agreement requires senior Pfizer executives and board members to complete annual compliance certifications and opens Pfizer to more public scrutiny by requiring it to make detailed disclosures on its Web site. We expect this agreement to increase integrity in the marketing of pharmaceuticals."
http://www.fda.gov/ICECI/CriminalInvestigations/ucm260715.htm
The FDA approved Actiq, a fentanyl product manufactured as a lollipop, for use only in opioid-tolerant cancer patients (meaning those patients for whom morphine-based painkillers are no longer effective). The drug is a strong and highly addictive narcotic, with significant potential for abuse. From 2001 through at least 2006, Cephalon was allegedly promoting the drug for non-cancer patients to use for such maladies as migraines, sickle-cell pain crises, injuries, and in anticipation of changing wound dressings or radiation therapy. Cephalon also promoted Actiq for use in patients who were not yet opioid-tolerant, and for whom it could have life-threatening results.
http://www.cbsnews.com/news/fentanyl-what-you-need-to-know-about-deadly-opioid/
http://www.newyorker.com/magazine/2014/05/05/prescription-for-disaster
http://www.chicagotribune.com/lifestyles/health/chi-drugs-doctor-reinsteinnov10-story.html
http://www.latimes.com/news/la-na-nih22dec22-story.html