Gays excluded from clinical trials
Thanks to an awards announcement from the National Lesbian & Gay Journalists Association, we just noticed Jen Colletta’s story in the Philadelphia Gay News about the exclusion of gays from clinical trials. Colletta won an Excellence in News Writing Award. The exclusion of gays in clinical trials is an issue that hasn’t received much mainstream attention, apart from a letter from Colletta’s sources in NEJM, a write-up by Ed Silverman and a story in The Philadelphia Inquirer.
According to Colletta, the data behind the story grew out of a chance discovery by researchers at the Fox Chase Cancer Center in Philadelphia.
“We review all the different trials that are proposed here, and they don’t necessarily open here, but a lot of them are multi-center trials so we do look at them. And I saw that we had been looking at a number of clinical trials that explicitly excluded gay people, and they didn’t necessarily open at Fox Chase, but I started to become more attuned to this and realized that this is a bigger, national issue,” (Brian Egleston, assistant research professor of biostatistics at the center) said.
The researchers analyzed trials listed in the ClinicalTrials.gov database, maintained by the National Institutes of Health and the Food and Drug Administration.
In particular, Colletta reported, homosexuals are excluded from studies about couples, especially those dealing with erectile dysfunction, which are often related to treatments for prostate cancer. It’s entirely normal for a drug trial to have exclusion criteria, but an oversight in NIH regulations mean that the exclusion of homosexuals, unlike exclusion along racial lines, can be implemented arbitrarily.
In the mid-1990s, Congress mandated that NIH establish a set of guidelines that would prevent it from excluding minorities, such as women and African Americans, from federally funded clinical trials unless there was a significant reason. There are currently no such rules regulating the inclusion of LGBT individuals.
The distribution of exclusionary studies is particularly interesting. To put it in perspective, here’s a quick visualization of the data put forth in the NEJM letter:
Identical tubing demonstrates FDA’s inaction
In The New York Times, Gardiner Harris outlines the problem of medical tubing that looks very similar – leading to medical errors – then deftly works his way up the chain in an attempt to find the source of device regulator’s failure to solve a problem that seems entirely solvable.
Many medical device tubing looks the same, which leads to horrific mix-ups like the delivery of food straight into the bloodstream. In 2007, The Wisconsin State Journal’s David Wahlberg earned first place in the medium newspapers category of AHCJ’s Awards for Excellence in Health Care Journalism for his Medical Misconnections series, which detailed the same problems. He even wrote an AHCJ article teaching journalists how to investigate patient safety problems.
Photo by bennylin0724 via FlickrSince then, not much has changed. Which is not all that surprising, when you consider that not much had changed in the decades before Wahlberg’s story either. Harris’ mission is to dig past the finger-pointing and figure out why. In the end, it all seems to point to some remarkable systemic flaws in the FDA’s device approval system, as well as an unwillingness on the industry to change without the threat of brute regulatory force. In addition to compelling analysis, Harris punctuates each argument with a few spicy quotes.
You’ll have to read Harris’ story to truly understand the perversity of the FDA system and how its lent such inertia to the status quo, but here’s a sample:
Dr. Robert Smith, an F.D.A. device reviewer who left the agency on July 31 and was among nine agency employees who in 2009 decried the agency’s device approval process as illegal and dangerous, said that the tubing problem, which has gone on for decades, was another example of how the agency failed to protect the public. “F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die,” Dr. Smith said.
And, from Nancy Pratt, a senior vice president at Sharp HealthCare in San Diego who believes that “Nurses should not have to work in an environment where it is even possible to make that kind of [tubing] mistake.”
“The regulators have been waiting for the manufacturers to come up with a solution,” Ms. Pratt said, “and the manufacturers won’t spend the money to design and produce something different until the regulators force them to. And now the international standards organization is taking forever to get the whole world onto the same page.”
Investigating, localizing salmonella outbreak
Filed under: Health data, Health journalism, Hot Health Headline
As some of you may have noticed, there’s an egg recall going on. It all began when the CDC’s PulseNet monitoring program noticed a fourfold jump in the number of salmonella cases being reported, which spurred investigations around the country. This jump is evident in the graph below. Don’t be fooled by the dropoff at the end, it has more to do with the reporting process than with an actual decrease in the number of salmonella cases (which clearly isn’t happening).
Image courtesy of the Centers for Disease Control and Prevention
Health officials then traced it all back to a man outlets love to describe as a sort of rogue Iowa egg magnate and his Wright Country Eggs (satellite view?).
As we stand now, the tainted eggs could have been distributed through any number of channels, but constitute a tiny fraction of the national egg supply.
For reporters digging into this national recall story, or looking to localize it to their coverage area, AHCJ has a strong archive of foodborne illness resources.
Start with a classic, the AHCJ article “Fatal Food: A study of illness outbreaks ,” in which Thomas Hargrove details SHNS’ massive investigation into the nation’s food safety monitoring system. Not only is Hargrove’s how-to instructive, his actual findings are useful examinations of state and local food safety systems around the country.
For your own investigation, look at Mining NLM databases: PubMed, Medline and more and the rich set of resources in the sidebar to Hargrove’s story.
If you’re looking for solid numbers and the most up-to-date national context, see Covering Health’s recent post on the CDC’s lates foodborne illness data, as well as our examination of 2009 foodborne illness rates.
Other relevant Covering Health posts include:
Schneider: FDA lacks resources to keep food safe
CDC assembles rogues gallery of food bugs
Private food auditors didn’t stop outbreaks
Lax oversight, complex supply chains aid outbreaks
CDC releases 2007 foodborne illness numbers
In the latest Morbidity and Mortality Weekly Report, the CDC has released the 2007 numbers on foodborne illness in the United States. Norovirus (39 percent) was the most common culprit, followed by Salmonella (27 percent). In terms of illnesses caused, poultry led the way, followed by beef and leafy greens. In the majority of the 1,097 reported outbreaks of foodborne illness, no agent was identified – a fact the CDC attributes to the small scale of many of those outbreaks. Here’s a breakdown of what investigators managed to find:
Those looking to dig a little bit deeper into the numbers should consult this four-page PDF, which breaks it all down by contaminant, food, number of outbreaks and number of illnesses caused.
Resources for covering food safety
Tip Sheets
- Lifting the shroud: Using multiple-cause-of-death data
- FDA Reform: The Time Has Come (Nancy Donley presentation)
- Why Is It So Difficult to Prevent Foodborne Illnesses? (Michael Doyle presentation)
- Reporting on the intersection of health and the environment
- Fatal Food: A study of illness outbreaks
Websites
- Center for Infectious Disease Research & Policy
- Outbreak Alert! Database
- Center for Food Safety and Security Systems
- FoodRisk.org
Related
- Recent stories and studies on foodborne illnesses
- Video study finds risky food-safety behavior more common than thought
- Airlines delay testing of onboard water
- A selection of stories about a 2008 salmonella outbreak
- Private companies, not the FDA, increasingly perform food safety inspections
Health IT moves forward, regulation doesn’t
Filed under: Government, Health policy, Hot Health Headline
Fred Schulte and Emma Schwartz report that while the Obama administration plans to create a digital medical file for every American by 2014, “the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows.”
Major HIT malfunctions continue – they focus on one of 10 hospitals in the Trinity Health System in the upper Midwest – and nobody has a grip on their location or frequency. Meanwhile, the administration has issued regulations for HIT implementation that make no mention of safety and quality standards, standards the FDA has been considering for some time.
FDA site tracks post-approval drug dangers
Thanks to new requirements, the FDA is now publishing updates on its safety evaluations of drugs that are already on the market. The evaluations get posted after the drug has been on the market for 18 months, or after 10,000 people have used it. It only includes drugs approved since Sept. 27, 2007.
The site also includes a full list of those drugs flagged by the FDA for various reasons, including ongoing safety alerts. Simply click on any drug in the list to find out what problems were identified and what action has been taken.
(Hat tip to The Plain Dealer’s Diane Suchetka)
Foreign trial data used in 4/5 of approved drugs
Filed under: Health data, Health policy, Hot Health Headline, Pharmaceuticals
FairWarning’s Lea Yu and The New York Times‘ Gardiner Harris drew our attention to a report from the HHS Office of Inspector General which reviewed 2008 data and found that “Eighty percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials.” Furthermore, the OIG found, “Over half of clinical trial subjects and sites were located outside the United States.”
The OIG expects the trend to grow in the future, writing that “Western Europe accounted for most foreign clinical trial subjects and sites; however, Central and South America had the highest average number of subjects per site.”
The FDA only inspected a minuscule percentage of these foreign test sites, but says it has taken the OIG’s advice and is stepping up efforts to put together agreements with its foreign counterparts and to figure out other methods to standardize and evaluate these foreign trials.
Factory that made recalled Tylenol was cited
Filed under: Government, Hot Health Headline, Pharmaceuticals
The U.S. House of Representatives’ oversight committee will hold a hearing today about an April 30 recall of children’s Tylenol and other medicines. In advance of that hearing, Alison Young of USA Today reports that the manufacturing place responsible for the medicine “was cited last year by regulators for ‘knowingly’ using a bacteria-tainted ingredient, according to a 2009 inspection report.”
The U.S. Food and Drug Administration also cited the McNeil Consumer Healthcare plant for a similar violation last month. The April inspection, which found serious manufacturing violations and drugs that were potentially too potent, prompted the current recall.
Young also reports that the FDA issued 43 warning letters since January 2009 to drug factories about poor practices that may have endangered patients.
Violations serious enough to prompt warning letters from the U.S. Food and Drug Administration include plants using equipment and ingredients contaminated with bacteria or insects, failing to do proper testing to ensure drug strength and purity, and ignoring consumer complaints that products were making them sick.
Among the cases Young cites are possible bacterial contamination of propofol, reports of bug parts in another company’s medicines and bacteria in calcium carbonate, which is used in antacids and a menopause drug.
That House hearing starts at 10 a.m. ET and will be webcast. To watch, click here.
NPR’s Scott Hensley has been staying on top of the recall story on the Shots blog.
(Hat tip to the Donald W. Reynolds Center for Business Journalism)
FDA to track media calls, develop policy
The FDA’s Transparency Task Force released 21 draft proposals [PDF] as part of its transparency initiative today. A just-released Perspective article in the New England Journal of Medicine [PDF] discusses the proposals.
A section of the report addresses concerns raised by AHCJ’s Right-to-Know Committee about the agency’s requirements that journalists and FDA employees notify or obtain permission from an agency official to conduct an interview. A letter sent in December to the FDA’s transparency committee, signed by AHCJ, 10 other journalism organizations and two dozen individuals, explained, “These relatively new practices hinder reporters’ ability to learn the truth by inhibiting and sometimes barring employees from providing essential information.”
From the FDA’s report on the drafted proposals:
Comments from some members of the media stated that FDA’s current procedures for dealing with the media restricted the flow of information between the public and FDA personnel. These comments stated that public affairs officials can play an important role answering questions and facilitating interviews, “[b]ut when they forbid, delay or monitor contact between reporters and employees, they interfere with the public’s right to know and can delay access to timely information necessary to protect and advance public health.” Comments stated that prior administrations allowed more communication between FDA employees and the media and that FDA’s practice is not universal among federal agencies.
A conference call was held on April 12, 2010 with representatives from the Association of Health Care Journalists and the Society of Environmental Journalists to follow-up on the comments they submitted to the Task Force. During the call, representatives provided suggestions on ways FDA can facilitate contacts with the press, including holding regular conference calls about activities at the agency, providing the press with a list of agency experts by topic area, and committing to return calls from the press within two hours. Participants stated that FDA would benefit from a written media policy. One participant noted that implementing a media policy is “harder at regulatory agencies,” such as FDA.
Given FDA’s regulatory authority and responsibility, it is very important that FDA provide information to the news media as promptly and accurately as possible. Like many other public agencies, FDA has a public affairs office to facilitate and coordinate requests from the media. On average, the public affairs office fields between 50 and 100 inquiries from journalists every day. FDA personnel may establish a record of what is discussed to improve their own understanding of issues and to identify additional information of relevance that can be shared with the journalists.
FDA plans to track and disclose measures of performance related to its interactions with the media and will start by tracking the number of press inquiries received each month. FDA will also draft a policy outlining FDA’s media process and post this policy on its Web site. FDA will continue to explore additional ways to make the Agency’s system as effective as possible.
In addition, the Department of Health and Human Services, as part of the President’s Open Government Initiative, is reviewing the media policies of various HHS agencies. FDA will participate in this process.
“We appreciate the FDA’s willingness to consider our concerns. We hope this process will lead to new policies that free the media to learn from and report on the work of federal experts – who are paid by taxpayers to serve the public,” said AHCJ president Charles Ornstein.
Popular salad option a possible culprit in outbreak
Bagged romaine lettuce, a time-saving option for many shoppers, is suspected in the latest E. coli outbreak that has caused illness in at least 23 people, reports Lyndsey Layton of The Washington Post.
Layton addresses the question of whether pre-cut and bagged produce is more dangerous than whole greens and why they “represent a disproportionate number of recalls.”
An FDA official says it is easier to trace bagged produce than it is whole produce, which might account for the difference. But the article also reveals that some practices involved in the processing of pre-cut and bagged produce could be more likely to contaminate lettuce:
Most processors of fresh-cut produce remove the outer leaves and core the heads of lettuce in the field, where cutting utensils can come into contact with soil and spread contamination from the dirt to the crop, [microbiologist Michael] Doyle said. In farming areas, especially in a region near cattle farms, it is not unusual to find E. coli in the soil.
(Hat tip to Susannah-Fox.
From Covering Health
• Little recent progress on foodborne illnesses
• Schneider: FDA lacks resources to keep food safe
• High cost of foodborne illness broken down by state
Tip Sheets
• Lifting the shroud: Using multiple-cause-of-death data
• FDA Reform: The Time Has Come (Nancy Donley presentation)
• Why Is It So Difficult to Prevent Foodborne Illnesses? (Michael Doyle)
Articles
• Fatal Food: A study of illness outbreaks
• A selection of stories about salmonella
Web sites
• Center for Infectious Disease Research & Policy
• Outbreak Alert! Database
• Make our Food Safe Coalition
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Spend a week at the CDC studying public health, meeting sources. Apply for the AHCJ-CDC Health Journalism Fellowships today!
- Reporting on the intersection of health, environment
- Tip sheet: Covering cuts to Medicare reimbursements
- Briefing: Reporting on health reform between now and 2014
- Covering high-risk insurance pools: Tips for reporters
- Health care reform has passed: What's next?
- Health and education: Covering these intersecting beats
- Reporting on the business of health care
- Health reporting resources for journalists on state and local government beats
