Welcome to the latest edition of Investigative Roundup, gathering some of the best investigative reporting on healthcare each week.
J&J Hid Knowledge of Tainted Baby Powder
Darlene Coker wanted to understand why she was dying of cancer. Coker, along with her personal injury lawyer, suspected Johnson & Johnson’s Baby Powder was to blame.
Two decades ago, Coker sued the company, alleging that the talc powder she’d used on herself and her babies was tainted with asbestos, a known carcinogen. But, throughout the lawsuit, J&J denied the allegations. The company was not compelled to disclose internal documents and, without sufficient proof to back her claim, Coker had to abandon the suit.
Now, two decades later, J&J’s baby powder has come under renewed scrutiny. Internal documents from J&J, obtained by Reuters, tell a different story about the product’s safety — showing that, although most test reports did not find asbestos, “the company’s powder was sometimes tainted with carcinogenic asbestos and that J&J kept that information from regulators and the public.”
The first mention of needle-like contaminants occurred as early as 1957, and a J&J scientist’s lab notes from 1972 cites “incontrovertible asbestos.” Now, 11,700 plaintiffs are claiming the company’s talc caused their cancers.
New Probe for Disgraced Child Psychiatrist
Regulators in Illinois are investigating a once-prominent psychiatrist who resigned her post at the University of Illinois at Chicago in June after the school’s investigation found she had committed research misconduct.
In August and September, the state issued three subpoenas to the university regarding Mani Pavuluri, MD, and her research examining the effects of the lithium on children and teens with bipolar disorder, according to reporting by Propublica, The Chronicle of Higher Education and the Chicago Sun-Times. One subpoena, from the state’s medical disciplinary board, ordered the university to provide records related to the clinical trial on children with bipolar disorder and will evaluate whether complaints against Pavuluri require disciplinary action. The two other subpoenas seek Pavuluri’s “complete and unredacted personnel file” and her “application and credentialing file,” which includes background check information.
The university has already been dinged for Pavuluri’s misconduct. Last April, ProPublica Illinois reported that the National Institute of Mental Health demanded the university repay $3.1 million in grant money Pavuluri received for her research. Since leaving the University of Illinois at Chicago, Pavuluri has opened her own medical practice.
NIH Upgrades Policies after Alcohol Study Debacle
In June, the National Institutes of Health halted a study evaluating the benefits of moderate drinking after uncovering that the researchers had solicited funding from industry.
Now, the NIH is cracking down on similar practices that could compromise the integrity of its research, The New York Times reported. Last week, the NIH announced its new policies and recommendations to prevent corporate donations and interests from affecting the credibility of future research projects. The NIH report said that its “27 institutes must evaluate all current research projects that receive private donor support for conflicts of interest of the kind that compromised the alcohol trial.”
Francis Collins, MD, director of NIH, told the Times, “We have to do everything we can to ensure the integrity of the NIH grants process and the quality of our research is above reproach, which means worrying about conflicts.”
Some experts, however, do not believe the new policies go far enough. “These recommendations are weak and will not prevent industry influence,” said Adriane Fugh-Berman, MD, a professor at Georgetown University and founder of the industry watchdog group Pharmed Out.
Poor Device Regulation Laid Bare
“We have been shocked by the lack of transparency” when researching issues with medical devices, The Guardian said.
Earlier this year, The Guardian, in partnership with the International Consortium of Investigative Journalists (ICIJ), began exploring how poorly medical devices are regulated and what happens when medical devices fail. The international team has “ploughed through pages and pages of court documents and data released through freedom of information requests, spoken to surgeons and specialists around the world, and heard — often heartbreaking — stories from those who have suffered when things have gone wrong.”
As part of this effort, The Guardian reported that Johnson & Johnson (yes, again) sold vaginal mesh implants even after evidence emerged that the mesh could shrink and harden inside the body. The ICIJ team has also created an International Medical Devices Database to document recalls and safety alerts related to medical devices.