Investigating Pharma and FDA: A Reporter's "Shocking and Concerning" Experiences

Earlier this year, Milwaukee Journal Sentinel reporters Raquel Rutledge and Rick Barrett conducted a four-month investigation into manufacturing issues at the Hartland, Wisconsin facility of H&P Industries, which (until a recent consent decree) produced hospital wipes, cough syrups, ointments, creams, and other health products. The result of their work is “Shattered Trust,” a lengthy expose of the problems at H&P and its owner, the Triad Group, and their oversight by FDA. (Please read my recent commentary on the matter, including links to key FDA documents. Also, industry consultant Barry Friedman has been covering this saga, and his blog posts on the topic can be read here.)

I recently emailed Rutledge to ask about her experience covering this story. She and Barrett both had reported on FDA and healthcare-related topics previously but, she says, this particular experience was eye-opening:

P.T.: Looking back, what surprises or shocks you about the issues at the H&P facility and how they were handled by either the company itself or FDA?

R.R.: Certainly the employees’ accounts of conditions in the company’s various plants over the years was shocking and concerning. We didn’t just take the word of two or three workers. We heard from nearly a dozen people who worked at different plants, in a variety of areas, over many years. All told similar stories of the company’s disregard for sanitation and safety. FDA inspection records supported much of what they said.

Beyond that, the FDA’s oversight of Triad/H&P clearly fell far short of the performance an average person would expect out of the federal agency designed to protect public health. The fact that inspectors were in the plants for more than a decade and found major problems but failed to take any enforcement action shows a definite need for improvement.

P.T.: What, in your mind, needs fixing or changing about the way companies like H&P operate and are regulated?

R.R.: As you know, we are not policy makers. All I can say is that from our investigating and reporting it’s clear there are some serious gaps in the system that allow dangerous products to get into the market. From shoddy manufacturing, to questionable purchasing practices by hospitals and retailers, to the difficulty tracking products, to the lack of a nationwide early alert system, and ultimately lax enforcement and accountability by the FDA—problems abound.

P.T.: How helpful was FDA in supporting your investigation?

R.R.: Glad you asked. Dealing with the FDA in terms of public records and the Freedom of Information Act is a huge hassle. For starters, they require you to fax or use the U.S. Postal system to submit a request. They don’t typically accept electronic submissions. The agency’s responses are often incomplete. They don’t include all the documents you request and can take months to respond. In one case they lost one of my requests and didn’t realize it for about a month.

The records they do release are often heavily redacted for reasons that do not meet legal definitions for exemptions. For example, they redacted the name of the bacteria [Bacillus cereus] they found to be contaminating wipes in H&P’s plant, calling it a trade secret. We had to get our attorney to push them to release that, which they finally did two days before we published our story.

And finally, getting an interview with top administrators took weeks and constant pressing.

P.T.: Much of the feedback you've gotten to the article online, from readers, seems immature and politically charged. What's the best, most meaningful feedback you've gotten since the article came out?

R.R.: I would not say “much” of the feedback we’ve gotten is immature and politically charged. Unfortunately the first person to comment online on our story set that tone and a few people carried it on. If you read through all the comments online you can see there are some intelligent people who realize the gravity of this story. In addition, Rick and I have gotten many emails and phone calls from people expressing thoughtful comments. But I guess I would say the most meaningful feedback I have gotten is from yet additional sources who are sharing further insight. I can’t disclose those details at this point but we will publish them as soon as we can.

P.T.: Lastly, how did the paper support a four-month investigation on your part? Is the Journal Sentinel committed or recommitted to investigative journalism?

R.R.: The Journal Sentinel is absolutely committed to investigative journalism and has been for some time. Editors here realize it’s our obligation and it’s what sets us apart from other news organizations. We have a Watchdog Team of about seven reporters, but everyone on every beat is encouraged and allowed the time to go after anything that warrants investigating. While we dedicated four months to this investigation, Rick also juggled daily stories on other topics. I got involved with the story in early April and focused solely on the investigation. Readers in Milwaukee and elsewhere in Wisconsin have come to expect these types of reports from their newspaper and we continue to provide it.

--Paul Thomas

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