Tag Archives: fda

Getting past gatekeepers to cover research requires strategy

Brenda Goodman

About Brenda Goodman

Brenda Goodman (@GoodmanBrenda), an Atlanta-based freelancer, is AHCJ’s topic leader on medical studies, curating related material at healthjournalism.org. She welcomes questions and suggestions on medical study resources and tip sheets at brenda@healthjournalism.org.

Image by Eric Allix Rogers via flickr.

So you have a great medical study to cover – interesting topic, compelling results. All you need is an interview with the study’s authors to help bring the research home to readers.

That’s where things get tricky. The researcher you need to connect with before your oh-so-tight deadline has letters in his or her affiliation that don’t bode well for timely interviews: FDA, HHS, USDA, CMS.

Scoring an interview with a scientist who works for a government agency can be frustrating and full of dead ends. It shouldn’t be. AHCJ’s Right to Know Committee is working on improving reporters’ access to a number of government agencies.

But change is slow. And your deadlines won’t wait. What can you do today for a story that’s due tomorrow? Continue reading

Resources for reporting on compounding pharmacies

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

Seven patients in Tennessee are sick after injections from a compounding pharmacy, health officials say. AHCJ has some presentations from a recent panel, The Boston Globe’s award-winning coverage of a similar outbreak and a questionnaire about how they reported on it and more resources for reporters who are looking into compounding pharmacies.

Presentations from a panel at Health Journalism 2013:

From compounders to drug shortages: Covering pharmacies and pharmacists
• Michael R. Cohen, R.Ph., M.S., president, Institute for Safe Medication Practices
• William Churchill, M.S., R.P.H., chief of pharmacy services, Brigham and Women’s Hospital
• John Walczyk, pharmacy manager, Johnson Compounding and Wellness Center

Keldy Ortiz wrote about the panel for Covering Health: Growing challenges to safety, adequacy of drug supply

Previous coverage

The Boston Globe‘s coverage of a fungal meningitis outbreak tied to contaminated drugs won first place in the public health category of the 2012 Excellence in Health Care Journalism Awards. See the coverage as well as a questionnaire about how they reported on the topic.

FDA regulation

In her tip sheet on the anti-aging movement, Arlene Weintraub touches on compounding pharmacies. She notes that the U.S. Food & Drug Administration has tried unsuccessfully to put a halt to improper marketing claims by compounding pharmacists and its continuing efforts in this area are well worth following. In the aftermath of the earlier meningitis outbreak traced to a compounding pharmacy, at least two legislators said they will draft legislation to give the FDA more oversight of compounding pharmacies.

On April 26, senators introduced a draft bill to make clear oversight responsibilities for pharmaceutical compounding.

Budget Victim: Inspections For Compounding Pharmacies, WBUR, May 20

The FDA has a section of its website devoted to compounding pharmacies.

Transparency

This also might be a good time to remind public officials that there is now guidance on what information should be made public when someone dies or falls ill during a public health emergency. The document – developed by leaders in public health and health-care journalism – provides a framework for releasing such information as the age and location of private individuals who have been affected by an epidemic or other public-health event.

Pharmacy industry groups

… As we gather more resources, we will add them to this post …

Drugs remain on market despite fraudulent research; FDA withholds information

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

Despite concluding that a drug research lab’s violations “were so ‘egregious,’ and pervasive that studies conducted there between April 2005 and August 2009 might be worthless,” the FDA didn’t pull the drugs tested there from the market, according to a ProPublica piece by Rob Garver and Charles Seife.

pills

Photo by Grumpy-Puddin via Flickr

The FDA is refusing to release information about those drugs, saying that “We believe that this did not rise to the level where the public should be notified.”

A statement from the agency said, “The issue is not a lack of transparency but rather the difficulty of explaining why the problems we identified at Cetero, which on their face would appear to be highly significant in terms of patient risk, fortunately were not.” Continue reading

Experts say new tools, tougher government oversight can reduce foodborne illnesses #ahcj13

Lacey McLaughlin

About Lacey McLaughlin

Lacey McLaughlin is a features writer at The Daytona (Fla.) Beach News-Journal. She is attending Health Journalism 2013 on an AHCJ-Healthier Beat Fellowship, which is supported by the Leona M. & Harry B. Helmsley Charitable Trust.

Placing food safety above profits, and using new regulatory power and testing techniques could help protect consumers from foodborne illnesses, three experts in food safety said today.

The experts – an executive at America’s largest organic food producer, a food safety attorney and a federal food and safety regulator – discussed the challenges of protecting consumers from illnesses such as E. coli, salmonella and listeria on a panel called, “Why is food still making us sick in the 21st century?” during Health Journalism 2013 in Boston.

Bill D. Marler, managing partner at the law firm Marler Clark, began litigating personal injury cases related to foodborne illness cases in 1993 after E.coli-contaminated meat from the fast-food chain Jack in the Box resulted in the deaths of four children and illness in hundreds of consumers. Marler said that when companies take shortcuts, or focus on profits more than food safety, it can compromise consumer safety.

“Food production is a risky business with a competitive market,” said Marler, who started the website foodsafetynews.com. “Good safety practice isn’t always on everyone’s minds because of stockholder pressures.”

But even companies that follow strict food testing procedures can’t always stop outbreaks. Earthbound Farm Senior Vice President Will Daniels said despite following strict safety guidelines, his company had to recall spinach contaminated with E. coli in 2006 after three people died and 300 became sick.

“This changed my life,” Daniels said. “There was no smoking gun, no break in our system and no deliberate contamination. The source of contamination was never proven.”

Earthbound Farm is now a leader in the food industry when it comes to safety standards. By using the newest technology, Earthbound Farms is able to test food products twice before delivering them to consumers, he said. New technology has made it possible for the products to be tested in a 12-hour time frame, whereas older methods took three to five days.

“Before, I couldn’t wait five days to test results on the raw side of the product and then again at the end of the process,” he said. “That was almost half the life of the product.”

The Food Safety Modernization Act of 2010 shifts the role of regulators from responding to outbreaks to preventing them. For the first time, the law gives the U.S. Food and Drug Administration the authority to order recalls of contaminated food. But, with 80 percent of seafood and 20 percent of vegetables imported from overseas, FDA Deputy Commissioner Michael Taylor said there are even more obstacles for ensuring safety regulations are followed.

The law “creates a mandate for companies to meet comprehensive safety standards,” Taylor said. “It also strengthens government authority to make sure those standards are being met. But to build a national integrated food-safety system, we need aggressive partnerships between state and local governments.”

Reuters explains Big Food’s remarkable lobbying success

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.

Investigating for Reuters, Duff Wilson and Janet Roberts analyzed lobbying records and found that, in the past few years, the food industry has dramatically stepped up its spending in Washington and, they write, “largely dominated policymaking – pledging voluntary action while defeating government proposals aimed at changing the nation’s diet.” They give examples.


After aggressive lobbying, Congress declared pizza a vegetable to protect it from a nutritional overhaul of the school lunch program this year. The White House kept silent last year as Congress killed a plan by four federal agencies to reduce sugar, salt and fat in food marketed to children.

And during the past two years, each of the 24 states and five cities that considered “soda taxes” to discourage consumption of sugary drinks has seen the efforts dropped or defeated.

At every level of government, the food and beverage industries won fight after fight during the last decade. They have never lost a significant political battle in the United States despite mounting scientific evidence of the role of unhealthy food and children’s marketing in obesity.

That success has come through what the authors imply is a sort of big-tobacco model, in which the industry combines promises of self-regulation with huge amounts of money, and thus creates an irresistible package for lawmakers. For a blow-by-blow on how the lobbying muscle swayed the decision-makers in recent battles, I strongly recommend you read the full piece, which draws heavily from both data and extensive interviews. Particularly interesting? The examples of how the Citizens United decision has impacted far more than just election politics.

Case could set precedent for regulating stem cells

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.

On Forbes.com, Gergana Koleva digs deep into the ongoing court battle between Regenerative Sciences and the FDA over the question of whether stem cells “should be federally regulated as drugs.” While the treatment at issue isn’t generally a matter of life or death, the courts’ decisions in this case will have implications for other headline-grabbing stem cell treatments.

Human embryonic stem cells

(Photo: National Institutes of Health)

At the heart of the debate is a therapy that uses stem cells derived from bone marrow to repair damaged joints. It was developed in 2005 by the Colorado-based company, which began offering it to patients around 2007, and has since gathered a raft of clinical evidence and testimony about its safety and efficacy. The FDA is questioning its legality, alleging that the stem cells it uses are more than minimally manipulated drugs and should be regulated and subject to approval as drugs. In 2008, the agency accused Regenerative of practicing medicine without a license required for the introduction of a new drug, and in 2010 sued to stop it from performing the procedure.

Regenerative and its allies argue that, because the therapy re-injects a patient’s own cells, it creates, as Koleva writes, “fewer and less severe complications than the more invasive and costlier surgical procedures it helps many patients avoid.” For its part, the FDA calls the therapy unproven and not guaranteed to be safe. In the end, the FDA indicates, it boils down to semantics.

Regulators have argued that the Regenexx procedure is equivalent to the administration of a drug because the stem cells that are re-injected into patients constitute an “‘article’ that is intended to treat, cure, and mitigate diseases and to affect the structure and function of the patient’s body,” therefore fitting within the definition of “drug.”

Programming errors led to overdoses with pain-medicine pumps

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.

Building off a state health department report showing that, as The Morning Call‘s Tim Darragh wrote, “Nurses at St. Luke’s Hospital three times in 2010 and 2011 improperly programmed patient-controlled pumps to deliver pain medication, causing patients to overdose themselves,” Darragh dug deep into each incident, uncovering patient details and adding perspective to the errors, which were severe enough that the feds decided the hospital’s patients were in “immediate jeopardy” until steps were taken.

pumpPhoto by Felix42 via Flickr.

In each of those cases and in three others, the nursing staff failed to document the errors properly, state investigators found.

Employees told the investigators that St. Luke’s did not require annual competency training on the pumps. Unnamed employees offered conflicting statements about when and whether all the staff had received retraining in 2010.

For their part, hospital officials say they have bought new patient-controlled pumps, developed a restricted dosage plan and retrained staff.

“When St. Luke’s nursing staff members identified the dosing pump programming issues, the events were promptly reported to all the appropriate individuals and regulatory agencies as outlined in our Network Patient Safety Plan,” said Carol Kuplen, chief nursing officer for St. Luke’s Hospital & Health Network.

“There was complete transparency in these events,” she said in an interview Thursday.

Related

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, appeared at a newsmaker briefing at Health Journalism 2010 to announce an FDA initiative to reduce risks associated with infusion pumps. Log in to the AHCJ website to see his presentation and listen to his announcement.

Reporters find heart devices skipped FDA’s more rigorous approval process

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

Deborah L. Shelton and Jason Grotto of the Chicago Tribune couldn’t help but wonder: How does a medical device get implanted into patients without first getting FDA approval?

Tricuspid valve in a model heart
Tricuspid valve in a model heart. (Photo by robswatski via Flickr)

That question led to their two-day series in late May that reported for the first time that certain heart valve repair devices had been “down-classed” from class III to class II, a regulatory category that required that they undergo less scrutiny, even though the devices are permanently implanted and life-sustaining.

One of the annuloplasty rings had been stitched into the hearts of at least 700 patients in Chicago and elsewhere without going through proper channels. In fact, even though the company could have submitted both rings for clearance through a less rigorous regulatory pathway, it didn’t even do that. In these two cases, the process was skipped in its entirety.

In this article for AHCJ members, the pair explains how they reported the story, including finding documents and persuading affected patients to speak on the record.

Journal Sentinel details public health investigation into tainted alcohol wipes

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

Last week we shared the story of how MSNBC.com reporter JoNel Aleccia uncovered the FDA’s failure to take action on contaminated products manufactured by a Wisconsin company.

Shanoop and Sandra Kothari of Houston, claim the wipes led to the death of their son, Harrison Kothari, 2.
Shanoop and Sandra Kothari of Houston claim tainted alcohol prep wipes led to the death of their son, Harrison Kothari, 2. (Photo courtesy of MSNBC.com)

One couple believes alcohol prep pads used on their son were tainted with a bacterium, leading to his death. Aleccia shared with AHCJ members how she covered each step of the story, including what documents were useful and how she got them, to find that the FDA had known about problems in the manufacturer’s plant as early as 2009.

Now, Raquel Rutledge and Rick Barrett of the Milwaukee Journal Sentinel have written a detailed narrative about the FDA’s oversight of the Triad Group and H&P Industries, as well as the death of 2-year-old Harry Kothari and illnesses at the Children’s Hospital in Aurora, Colo.

Their narrative tells of the public health investigation, with FDA investigators visiting the factory day after day for weeks, children in Colorado getting sick and epidemiologists trying to find the source, the role of purchasing groups, Kothari’s death and the FDA’s heavily redacted inspection reports.

Beat reporter uncovers FDA’s failure to take action on contaminated products

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates social media efforts of AHCJ and assists with the editing and production of association guides, programs and newsletters.

What happens when health care products that are supposed to protect against infection and illness turn out to be contaminated with potentially deadly bacteria?

Shanoop and Sandra Kothari of Houston, claim the wipes led to the death of their son, Harrison Kothari, 2.
Shanoop and Sandra Kothari of Houston claim tainted alcohol prep wipes led to the death of their son, Harrison Kothari, 2. (Photo courtesy of MSNBC.com)

Even worse, what happens when the federal agency that’s supposed to oversee the safety of the products concludes that shoddy sterilization and known contamination don’t pose “an imminent health hazard?”

JoNel Aleccia, an MSNBC.com health reporter, unraveled the dual threads of human harm and regulatory mistakes.

In this article, she shares with AHCJ members how she covered each step of the story as it unfolded, including what documents were useful and how she got them.