A recent outstanding article in Bloomberg by Ben Elgin and Caroline Chen detailed how Alexion Pharmaceutical developed a drug called Soliris to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome (aHUS) (see: When the Patient Is a Gold Mine: The Trouble With Rare-Disease Drugs). The cost for this drug is astronomical but there are not many patients requiring treatment. Company reps therefore closely keep of track patients with the diseases. There is also a history of reps aggressively marketing the drug. Unfortunately, "partner labs" seem to have played a role in this tracking process. Below is an excerpt from the article with reference to these partner labs:
[Alexion] reps were instructed to urge doctors to send the tests to preferred “partner labs,” according to several former employees and internal documents. Unbeknown to patients and many of the doctors, several of these preferred labs have agreements with Alexion to provide it with a copy of the test results. These are “blinded” to remove the patient’s name, so they don’t run afoul of medical privacy laws. But in some cases the lab provides everything else: a patient’s age, gender, and ZIP code, the hospital and doctor ordering the test, and a summary of the results. For Alexion sales reps, this gave a map to the doorsteps of otherwise hard-to-find patients. When a result for PNH [paroxysmal nocturnal hemoglobinuria] or aHUS [atypical hemolytic uremia syndrome] came in to Alexion, the diagnostics team...passed the detailed information along to the sales staff, which descended on the doctor listed in the result....
Drug companies pressured labs for years for access to the testing data, but the labs pushed back, says Adam Tanner, a writer in residence at Harvard’s Institute for Quantitative Social Science and author of the book Our Bodies, Our Data. Around 2010, he says, the labs’ behavior changed. Seeking a way to fatten thinning profit margins and under the rationale of helping drug companies with research, labs began to sell blinded test results to data aggregators and drug companies. For Alexion, this arrangement started with a lab in Bangor, Maine, called Dahl-Chase, which helped develop the test to detect PNH. It expanded to other regional labs, including Machaon Diagnostics Inc. in Oakland, Calif., as well as national labs such as Laboratory Corp. of America Holdings, known as LabCorp, and Quest Diagnostics Inc. Even Mayo Medical Laboratories, a division of the not-for-profit Mayo Clinic, provides test information to Alexion.
When I served on my hospital institutional review board (IRB) some years ago, I become acutely aware that "anonymized" patient data could often be deciphered, particularly when a patient had a rare disease. As the quote above points out, reference labs were cooperating with the Alexion reps by providing patient lab data which then allowed Alexion to track patients to determine whether they were being treated with Soliris. I suppose it's also possible that some of these reference labs also notified Alexion when a particular patient showed test results diagnostic for PNH and aHUS. The financial returns for identifying such patients with rare diseases are enormous.
So what did the labs gain from the collaboration? There must certainly have been a charge to Alexion by the labs for the continuing supply of patient lab data. Moreover and as noted in the excerpt, the labs cited in the article were also probably interested in soliciting future clinical trial lab work. LabCorp, for example, acquired Covance in 2014 for $6.1B (see: LabCorp to Acquire Covance for $6.1B). Here's a quote from this latter article:
"This transaction provides LabCorp with immediate scale and a comprehensive market-leading platform in the $141 billion biopharmaceutical research and development market, while at the same time achieving the new sources of revenue, broader payor mix, and greater international presence we have long pursued," LabCorp Chairman and CEO David King said in a statement. "By joining our highly compatible and complementary capabilities, the combined company will be an industry leader in both the laboratory and CRO spaces, characterized by global scale, enhanced offerings, new efficiencies, broader and deeper customer relationships, and a differentiated business model," he added.
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