Tag Archives: medical devices

Study suggests FDA medical device approvals ripe for investigative dives

Tara Haelle

About Tara Haelle

Tara Haelle (@TaraHaelle) is AHCJ's medical studies core topic leader, guiding journalists through the jargon-filled shorthand of science and research and enabling them to translate the evidence into accurate information.

Photo: A.M.D. via Flickr

Medical devices — and the unrecognized or undisclosed risks some of them have — have been in the news quite a bit over the past few years, especially in the area of women’s health. The death of physician and activist Amy Reed last spring (and the push back she experienced from her advocacy) again drew attention to the dangers of power morcellation during gynecologic laparoscopies. Power morcellation during surgery has been used for two decades, but the research showing that they risk spreading an undetected cancer took much longer to appear, and controversy continues over the technique. Continue reading

How will the election affect the business of health care?

Joanne Kenen

About Joanne Kenen

Joanne Kenen, (@JoanneKenen) the health editor at Politico, is AHCJ’s topic leader on health reform and curates related material at healthjournalism.org. She welcomes questions and suggestions on health reform resources and tip sheets at joanne@healthjournalism.org. Follow her on Facebook.

trump-post-election

Donald J. Trump

The Washington Post has taken a post-election look at 15 major industries in a story aptly titled, “Mr. Business Goes to Washington. NOW WHAT?” The overview was written by Thomas Heath, with health care industry input from Carolyn Johnson.

The Post story divided industries into “winners” (assuming no major recession) and “it’s complicated.” Health care – naturally – fell under “complicated.” Continue reading

Evidence-based reporting leads to award-winning exploration of robotic surgery

Tara Haelle

About Tara Haelle

Tara Haelle (@TaraHaelle) is AHCJ's medical studies core topic leader, guiding journalists through the jargon-filled shorthand of science and research and enabling them to translate the evidence into accurate information.

Laura Beil

Robotic surgery has exploded in popularity in recent years, but is that because it actually improves patient outcomes over traditional surgery methods or because of marketing campaigns? That is one of the questions Laura Beil dove into in her award-winning story for Men’s Health, “What’s Wrong With Robotic Surgery?

In a story that involved months of reporting, Beil “used FDA and legal documents to explore concerns over the safety” of a prostate robotic surgery procedure and wove together her findings “into one concise narrative that engaged and informed Men’s Health readers.”

The reporting required FOI requests for adverse events from surgery (along with documents related to recent inspections and findings), legal documents from malpractice lawsuits and a class action suit against the manufacturer, and dozens of scientific studies to determine whether robotic surgery represented an advance in treatment.

Beil also describes the pushback after publication, adding that posting corporate responses online is a powerful way to expose unjustified pushback. Read about how she did her reporting.

Controversy over breast implants spreads across Europe

John Lister

About John Lister

John Lister, European web coordinator for AHCJ, has been a journalist for 35 years, specializing in reporting health policy in England. He is the author of "Health Policy Reform: Driving the Wrong Way?," a critique of market-style reforms, and "The NHS After 60: for Patients or Profits?," a critical history of the British National Health Service.

British clinics delivering cosmetic surgery were thrown into crisis by the decision last month of the French government to fund the removal of thousands of breast implants manufactured by the now-closed French company Poly Implant Prostheses (PIP). The implants were found to have used industrial grade silicone made for use in mattresses. Continue reading

New Wisc. rules lead to interesting disclosures

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism, and he has blogged for Covering Health ever since.

Thanks to new disclosure requirements from the University of Wisconsin’s doctor group, the Wisconsin State Journal‘s David Wahlberg was able to report that 10 UW-Madison doctors received $48,000 or more from drug and device companies.

Thomas Zdeblick, M.D., pulled in almost $1.7 million. In fact, most of them were orthopedic surgeons, a fact which shouldn’t surprise anyone who’s been following the State Journal‘s conflict-of-interest work, as well as that of the Journal Sentinel‘s John Fauber.

Before 2010, doctors only had to report that they’d received more than $20,000 from such industry associations. Now, they have to disclose specific amounts. The disclosure requirements are currently the most prominent component of the schools’ crackdown of conflicts of interest, but activists say conflict disclosure is only half the battle.

A policy adopted in 2009 by the UW Medical Foundation, the university’s doctor group, bans doctors from doing promotional speeches for companies and accepting gifts such as free meals. Surgeons, however, can use materials created by device companies to conduct government-required training sessions, Golden said.
The foundation’s policy prohibits doctors from receiving royalties for using products at UW Health, which removes any incentive to use the doctors’ products instead of others, Golden said.

An interesting side note: UW clinics post signs detailing how patients can obtain their doctor’s disclosure form, but such requests have been few and far between, Wahlberg found “14 in 2009, 18 in 2010 and seven” in 2011.