Mary Chris Jaklevic has freelanced for HealthNewsReview.org since 2016 and recently joined the staff as a full-time health care journalist. She tweets as @mcjaklevic.
As a new line of hip implants was about to be launched in 2000, a stunning email went out from the manufacturer’s marketing department. It described a “clinical research strategy” to pay orthopedic surgeons $400 for each patient they enrolled in a company-sponsored trial.
Ostensibly the trial was intended to measure how often liners of the Pinnacle Hip System, made by Johnson & Johnson’s DePuy subsidiary, stayed in place after five years. But according to a newly published review article, the trial was really a scheme to gin up sales momentum under the guise of scientific research.
Made public in court documents, the internal company email outlined a “strategy for collecting survivorship data on PINNACLE while maximizing our impact on the market.” It said the trial would include a large group of 40 surgeons in order to achieve “very fast patient enrollment” that would generate sales of 1,000 implants in a year.
While $345,000 would be paid to doctors, it said, “The sales revenue estimate for this study is $4.2 million.”
The scheme is an example of a little-known marketing ploy called a “seeding trial,” which is a clinical study that appears to be designed to answer a scientific question but really exists to promote a product.
“Seeding trials are one method by which drug or device companies can just pay physicians for using their products without calling it an actual bribe,” said Adriane Fugh-Berman MD, a professor of pharmacology and physiology at Georgetown University and director of Pharmed Out, a project that raises awareness of pharmaceutical company marketing practices.
While a handful of papers have described how pharmaceutical companies used seeding trials to increase demand for new drugs, this review is apparently the first to document a seeding trial for a medical device. It’s based on corporate documents made public in lawsuits against J&J by patients who claimed they were harmed by certain Pinnacle implants.
Quickly ramping up sales, as seeding trials aim to do, can be particularly hazardous when it comes to medical devices because they are less stringently regulated than drugs. “Many medical devices are put on the market before they are tested in humans, and when a medical device fails, it’s not an easy process to get rid of it,” Fugh-Berman said.
Calling seeding trials “malleable marketing projects, not rigorous scientific studies,” the article describes how the company offered financial incentives for doctors to enroll nearly 1,600 patients in the trial between July 2000 and June 2007, often without the approval of institutional review boards (IRBs), which are oversight bodies designed to ensure ethical research practices. According to the paper, the trial generated millions in sales but yielded no valid research findings, although the company heavily manipulated the data it did collect to show a false 99.9% success rate that was used in promotional materials.
J&J, which has been ordered to pay damages in three jury trials related to metal-on-metal versions of the device, did not respond to a request for comment. It has denied wrongdoing and claimed its implants are backed by strong clinical data. The company stopped selling metal-on-metal implants in 2013 after the FDA ordered manufacturers to prove they were safe or take them off the market. Other Pinnacle implants remain on the market, and to date more than a million Pinnacle implants have been sold.
Review co-author David Egilman, MD, a clinical professor of family medicine at Brown University, was an expert witness for patients who sued J&J alleging they were injured by Pinnacle implants. (Egilman was compensated for his testimony.) Egilman was also instrumental in revealing the details of a seeding trial for the arthritis drug Vioxx, based on internal Merck & Co. documents that were made public in litigation.
“I think it’s important to expose how companies manipulate data to create false marketing for products,” Egilman said. “You hope if people find out about these things, someone will do something about it.”
Pinnacle implants were allowed on the market under a provision known as 510(k), which enables manufacturers to sell devices that haven’t been tested in humans if they are “substantially equivalent” to an existing device. Shortfalls in medical device accountability are covered in HealthNewsReview.org’s tips for analyzing claims about medical devices and in a book by journalist Jeanne Lenzer.
According to the article, the company’s marketing department conceived the trial as both “a marketing tool and a profit-making venture.”
J&J violated its own clinical research guidelines in manipulating data, delaying reports of adverse events and failing to follow parameters established for the study, such as not reporting results until all patients had been enrolled for five years and not retrospectively enrolling patients, it says. In some cases there were no patient consents. One surgeon continued to enroll patients in the trial and submit data even after his hospital’s review board refused to approve his participation in the trial.
Further, the company went to elaborate lengths to show a 99.9% success rate for five years, using sleights-of-hand such as not including certain types of device failures and hiding the fact that just 21 patients had been followed for a full five years.
Eventually, the bogus trial data was used as the “fundamental selling point” in Pinnacle marketing, providing physicians and patients with “a false sense of security,” the article says. The incredible near-perfect track record appeared in ads in medical journals, patient brochures, and ads in consumer publications such as the Ladies’ Home Journal and Golf Digest.
“They used that study to say that there was a 99.9% success rate. There’s not a 99.9% success rate in making chocolate cake, never mind putting a device into sick old people,” Egilman said.
Some of those ads featured an endorsement from Duke University basketball coach and hip implant recipient Mike Krzyzewski, even though Krzyzewski didn’t have Pinnacle implants. Krzyzewski’s osteoarthritis awareness promotions were covered uncritically by USA Today, the Florida Times- Union, and CBS News, only the latter of which mentioned he was paid.
Tom Joyce, a professor of orthopedic engineering at Newcastle University who has written about the problems with medical device safety, called the review “remarkable” and said it deserves to be widely read. “As a result of the paper, I think some will ask the question if this was a one-off, or was it indicative of the whole industry?” Joyce said via email.
One study concluded that a fifth of pharmaceutical drug trials published in high-impact medical journals in 2011 appeared to be designed for marketing purposes.
But it’s difficult to know how common seeding trials are in the device industry, Joyce said. “To fully answer such questions, an interested party would likely need access to internal company documents. This is probably unlikely.”
One barrier to unmasking more seeding trials is that court records are sealed. Fugh-Berman said, “It would be nice if attorneys pushed harder for making documents public. It’s a really important information for researchers and for the public to know.”
The review takes issue with blanket confidentiality agreements that are standard practice in civil court cases, suggesting they “subvert public health.” The authors said they based the review on just a small portion of the evidence that was made public during four trials, and they had confidential access to much more data that they were not allowed to disclose.
But plaintiffs’ attorneys face an uphill battle fighting to make company documents public, said attorney Mark Lanier, who represents patients in the Pinnacle lawsuits. Lanier said making just some of the documents public took significant legal wrangling.
“Dr. Egilman has this zealous and well-placed desire to see that public health dangers are put in transparent sunlight where everyone can see them,” Lanier said. “The article itself is a product of us seeking to change the system.”
Egilman said he hopes his efforts to expose unethical practices will spur news coverage that will lead to legislative changes. “Most companies take lawsuits as the cost of doing business. The real way pressure is applied is when the public gets outraged,” he said.
Lanier said he’s “begged the media” to write about this case. “To me, this is an incredibly compelling story,” he said. “But it does take a lot of work to get to the root of it.”
Many news organizations depend on advertising, and Lanier thinks some might hesitate to cross potential sponsors like J&J, which spent $2.4 billion in global advertising in 2016. “It’s a complicated situation when you have a heavyweight like Johnson & Johnson,” he said.
One news organization that did laudable work is ABC’s Los Angeles affiliate, which ran a 15-minute investigation of the Pinnacle metal-on-metal implants, including embarrassing footage of a surgeon who received millions in royalties rallying the Pinnacle sales team. While the story didn’t mention the seeding trial, it did illustrate how the company rewarded doctors to promote its devices and ignored warnings that patients were being harmed.
The review asserts that IRBs and medical journals “are poised to play a vital role in weeding out seeding trials” and offers a list of red flags (see chart). It recommends that journal editors ask companies to submit underlying scientific data for studies suspected to be marketing vehicles.
Fugh-Berman offers a another suggestion: “I think we need to educate doctors to be suspicious of payments made to them for any reason by drug and device companies,” she said, adding, “I think teaching healthcare providers the difference between real research and sham research would be helpful.”
The Pinnacle seeding trial serves as another reminder for consumers to be wary of medical devices, particularly those devices that are new to the market. Few undergo rigorous trials before they are sold, and there are often cozy ties between doctors and device industry sales representatives.
“Medical device reps may be in the operating room assisting the surgeon and giving them skewed information about surgically implanted devices,” Fugh-Berman said. “It’s hard to protect yourself.”