The Danger Within Us

by Jeanne Lenzer

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  About the Author

  Jeanne Lenzer is an award-winning medical investigative journalist and former Knight Science Journalism fellow. She is a longtime contributor to The BMJ (formerly the British Medical Journal), and her articles, reviews, and commentary have appeared in the New York Times Magazine, The Atlantic, the New Republic, Discover, Slate, Mother Jones, and many other outlets.

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  * Putting doctors on salary eliminates financial incentives to order more tests (or implant more devices). At the same time, a single-payer system removes pressure from insurers to do less or deny services. Instead the only consideration would be what each doctor believes is best for his or her patient—not how the treatment affects the doctor’s income.

  *For more about this, see Chapter Three.

  * Lee worked for Braunwald and, as such, may not be an objective observer.

  * From a phone interview with Hoffman on May 28, 2013.

  * For more on how devices are approved by the FDA, see Chapter Six.

  * The exact percentage of devices for which clinical data were submitted is uncertain; only 16 to 19 percent of all high-risk devices go through the PMA approval process. The only other pathway requiring testing data is one of four supplemental pathways, which was found to comprise only 0.3 percent of all approvals. No information is available on testing data submitted for that pathway.

  * In a $2.7 billion merger in October of 2015, Cyberonics joined with the Sorin Group to become LivaNova, which now sells the VNS device.

  * SUDEP can occur in the absence of a seizure, but most often it is associated with a grand mal seizure.

  * Interventional cardiovascular specialists are trained to assist surgeons as they conduct cardiac catheterizations. Parnis declined to discuss his role in evaluating Fegan’s asystole, and referred questions to Cyberonics.

  * This is a pseudonym.

  * Fabian testified eighteen months after his device was activated. It is impossible to know whether he continued to be seizure-free, because he is deceased and a close relative was unable to give any information.

  * According to Cyberonics’ SEC 10-K filing for 1996–97, the company identified one of the “key elements” of its marketing strategy as providing “education and support of patient advocacy groups such as the Epilepsy Foundation of America.” The Epilepsy Foundation’s annual reports reveal that by 2013, Cyberonics had contributed hundreds of thousands of dollars to the foundation (between $100,000 and 249,000 in 2013 alone). Cyberonics’ president and CEO at the time, Daniel Moore, was on the foundation’s board of directors, and three additional Cyberonics executives were serving on the foundation’s business advisory board.

  *Cyberonics didn’t use the same percentage to quantify increased seizures as it did to quantify decreased seizures, making exact comparisons impossible.

  * This may seem counterintuitive, but because so many more women (99 percent, to be precise) don’t have breast cancer than do (only 1 percent have it, because the prevalence is 1 percent), the false positive rate affects many, many more women (9 percent of the 99 percent), so the false positives far exceed the number of women who actually have breast cancer.

  * On the latter
point, the state’s investigator, Lance Sindo, accepted the form the company presented to him as proof that it had submitted a report.

  * Barkan died July 20, 2016.

  * The researchers did conduct what is called a “sensitivity” analysis in which they analyzed one of the three “outliers” and concluded that it did not affect their overall findings.

  * A spokesperson for the AAOS told me the “specific dollar amount is proprietary information.”

  * Tribology is the study of surfaces in relative motion as well as the effects of friction, wear, and lubrication.

  * Under the act, the payments are posted publicly by the Centers for Medicare and Medicaid Services and by the investigative journalism outlet ProPublica, at https://projects.propublica.org/docdollars/.

  * Wang is the surgeon who operated on Jerome Lew.

  * Kimberly Pickett v. Todd H. Lanman, M.D., Inc; Olympia Medical Center; Medtronic, Inc., Medtronic Sofamor Danek USA, Inc., and DOES 2-100. Filed December 10, 2013. Lanman has denied the charges in Pickett’s complaint.

  * Braunwald says that while he did receive payments from pharmaceutical companies, “Neither I nor my immediate family have owned stocks or stock options in the companies while studying their drugs. Nor did I ever receive salary support from them.”

  * Doctors and medical journals typically did not declare financial conflicts of interest at the time, making it difficult to know exactly when Braunwald first took industry funding for his research or other activities. He has declined to disclose this information.

  * While attending a journalism conference, I told Linda Marsa, who captured these comments for her book Prescription for Profits, that I was amazed that Grossbard would be so blatant about his concern for profits over the public health. Marsa said she had Grossbard’s comments on tape—and Grossbard never challenged the published quotations.