Tag Archives: fda

Drugs remain on market despite fraudulent research; FDA withholds information

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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

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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

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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

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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

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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

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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

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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

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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.

Potential changes in regulation of medical devices would likely impact health care costs

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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.

As the medical device industry ramps up its campaign against further government regulation, Merrill Goozner takes stock of the regulatory and business environment in that arena and explains what is at stake. The key battleground at present is possible modifications to the 1976 law which allows devices to bypass some rigorous testing as long as they’re similar to something that has already been approved for market. The problem? That similarity doesn’t always mean they’re safe, as Goozner points out.

glucose-testing

Photo by AlishaV via Flickr

A study published earlier this year in Archives of Internal Medicine found that of 113 major product recalls between 2005 and 2009, only 19 percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.

Despite slipping onto market through the similarity provision, many of these new products claim to be improvements over their predecessors and thus come with commensurately higher price tags. According to Goozner and his sources, this little disconnect has done quite a bit to increase the cost of health care in America.

“Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,” said Rita Redberg, editor of the Archives of Internal Medicine and a cardiologist at the University of California, San Francisco. “There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.”

The device industry, often cited for its red-hot growth rates in the past, now posts numbers that, while huge, still lag behind the health sector at large. That may be why the industry is stepping up political pressure to reduce its regulatory burden and to sidestep a 2.3 percent excise tax that was passed as part of recent health care reform efforts. For more on the money and politics involved, see Goozner’s full piece, which was also published in The Fiscal Times.

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FDA creates embargo policy in response to reporter concerns

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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.

The Food and Drug Administration has adopted a policy on embargoes that permits reporters to share embargoed information with outside sources, provided the sources agree to uphold the embargo.

The policy explicitly supports embargoes as a way for reporters to add depth and detail to their stories, and conforms to common practice among medical journals and other sources of complex information.

The policy was shared with AHCJ this week after complaints from the organization earlier this year. In January, the FDA barred reporters from interviewing experts about new regulations on medical devices until the embargo lifted. AHCJ wrote to the FDA that such an approach created obstacles to serious journalism.

In an embargo, the group releasing information chooses the time and date that it will be made public, and reporters get an advance look as long as they agree to delay publication or broadcast until that time. Reporters are willing to do this because it allows time digest the information and seek comments from experts.

In a letter this week to AHCJ, the FDA outlined its policy going forward:

“A journalist may share embargoed material provided by the FDA with non-journalists or third parties to obtain quotes or opinions prior to an embargo lift provided that the reporter secures agreement from the third-party to uphold the embargo.”

The letter, from Meghan H. Scott, FDA’s acting associate commissioner for external affairs, said the FDA did not previously have a policy on embargoed news. After AHCJ’s inquiry, she wrote, the media staff met with AHCJ members, other journalists, and editors of medical and scientific journals as it worked to develop a policy.

“The FDA is committed to a culture of openness in its interaction with the news media and the public,” Scott wrote to Charles Ornstein, AHCJ president, and Felice Freyer, chair of AHCJ’s Right to Know Committee.

She specified that the FDA may provide embargoed information when:

  • the issue is not related to regulatory or enforcement issues and does not contain confidential, commercial information; and
  • the subject is complex or technical and early access to materials and subject matter experts will help reporters prepare their articles in a timely, accurate manner with the context needed to understand the material.

“We’re grateful that the FDA media staff took the time to study the issue and develop a suitable policy,” Freyer said. “The results are clear rules that are reasonable and workable – and a step forward in improving relations between the FDA and the media.”