“Heartburn pills taken by thousands of women ‘raise risk of hip fractures by up to 50 per cent’,” the Daily Mail reported today. The headline is based on a large new study of drugs called proton pump inhibitors (PPIs), which are commonly used to treat heartburn, acid reflux and ulcers.
The study found that post-menopausal women who regularly took PPIs for at least two years were 35% more likely to suffer hip fracture than non-users, a figure that increases to 50% for women who were current or former smokers. However, although this increase in risk is large, the overall risk of fractures remains small.
This was a large, well conducted study that suggests that long-term use of PPIs is associated with a small increase in risk of hip fracture, although the researchers point out that the risk seems to be confined to women with a history of smoking. Unlike previous research, this study took careful account of other factors that might affect risk such as body weight and calcium intake.
Women who are concerned about their use of PPIs are advised to consult their GP.
Where did the story come from?
The study was carried out by researchers from Massachusetts General Hospital, Boston University and Harvard Medical School and was funded by the US National Institutes of Health. The study was published in the
peer-reviewed British Medical Journal.
Although the Mail’s headline is technically correct, it gives the impression that these drugs carry a very large increase in the risk of hip fracture. In fact, the study found that, in absolute terms, the increase in risk for regular users was small. Researchers found that among the women in the study who regularly used PPIs, about two in every 1,000 fractured a hip each year. In non-users, this figure was about 1.5 in every 1,000. This is a increase of about five fractures a year in every 10,000 women taking PPIs.
The Mail did point out this “absolute difference” towards the end of its story. Both the Mail and the BBC included comments from independent experts.
What kind of research was this?
The researchers point out that PPIs are among the most commonly used drugs worldwide. In the US they are available over the counter, but in the UK are available only on prescription. They are used for symptoms of heartburn, gastro-oesophageal reflux disease (GORD) and stomach ulcers. PPIs are thought to work by reducing acid production in the stomach. Concern has grown over a potential association between long-term use of these drugs and bone fractures, although the researchers say that previous studies have had conflicting results and many did not take other factors (called
confounders) that might affect the risk of fracture into account.
In their
cohort study of nearly 80,000 post-menopausal women, the researchers set out to examine the association between long-term use of PPIs and the risk of hip fracture. Unlike a
randomised controlled trial, a cohort study cannot prove cause and effect. However, cohort studies enable researchers to follow large groups of people for long periods and they are useful for looking at potential long-term risks and benefits of treatments. The study was
prospective, which means it followed participants in time, rather than collecting information retrospectively. This makes it more reliable.
What did the research involve?
This study took its data from a large ongoing US study called the Nurses Health Study, which began in 1976 and which sent health questionnaires every two years to 121,700 female nurses aged 30-55.
From 1982 participants were asked to report all previous hip fractures and in each biennial questionnaire, women were asked if they had sustained a hip fracture over the previous two years. Those who reported a hip fracture were sent a follow-up questionnaire asking for more details. Fractures from bad accidents, such as falling down a flight of stairs, were excluded from the study. A review of medical records for 30 of the women validated all self-reported fractures.
From 2000 to 2006 the women were asked if they had regularly used a PPI in the previous two years. In earlier questionnaires (1994, 1996, 1998 and 2000), the women were also asked if they had regularly used other drugs for acid reflux, called H2 blockers.
The biennial questionnaires also included questions on other factors including menopausal status, body weight, leisure activities, smoking and alcohol use, use of hormone replacement therapy (HRT) and other medicines. Researchers used a validated food frequency questionnaire to calculate the women’s total intake of calcium and vitamin D.
They then analysed the data for any association between regular use of PPIs and hip fracture, adjusting their findings for key confounders such as body weight, physical activity, smoking and alcohol and calcium intake. They also took into account whether the reasons for using a PPI might have affected the results.
Finally, they carried out a systematic review combining their results with 10 previous studies on the risk of hip fracture and the long-term use of PPIs.
What were the basic results?
The researchers documented 893 hip fractures during the period of the study. They also found that, in 2000, 6.7% of women regularly used a PPI – a figure that had risen to 18.9% by 2008.
- Amongst women who had regularly taken a PPI at any time, there were 2.02 hip fractures per 1,000 person years, compared with 1.51 fractures per 1,000 person years among non-users.
- Women who regularly used PPIs for at least two years had a 35% higher risk of hip fracture than non-users (age adjusted hazard ratio (HR) 1.35; 95%
confidence interval (CI) 1.13 to 1.62), with longer use associated with increasing risk. Adjustment for risk factors, including body mass index, physical activity and intake of calcium did not alter this association (HR 1.36; CI 1.13 to 1.63).
The increased risk did not change when researchers also took into account the reasons for PPI use:
- Current and former smokers who regularly used PPIs were 51% more likely to have a hip fracture than non-users (HR 1.51; (CI) 1.20 to 1.91).
- Among women who never smoked there was no association between PPI use and hip fracture (HR 1.06; (CI) 0.77 to 1.46).
- In a meta-analysis of these results with 10 previous studies, the risk of hip fracture in users of PPI was higher compared to non–users of PPIs (pooled odds ratio 1.30; CI 1.25 to 1.36).
The researchers also found that two years after women stopped taking PPIs, their risk of hip fracture returned to a similar level to that in women who had never taken them. Also, women taking H2 blockers had a “modest” increased risk of hip fracture but the risk was higher in women who took PPIs.
How did the researchers interpret the results?
The researchers conclude that their results provide “compelling evidence” of a risk between PPI use and hip fracture. They say the findings suggest that the need for long-term, continuous use of PPIs should be carefully evaluated, particularly among people who have smoked or are still smokers.
They suggest that PPIs may increase the risk of fracture by impairing the absorption of calcium, although in this study the risk of fracture was not affected by dietary calcium intake. The finding that the risk was confined to women with a history of smoking (an established risk factor for fracture) indicates that smoking and PPIs may act together (have a “synergistic effect”) on fracture risk.
Conclusion
This large study had several strengths. Unlike some previous studies, it collected information on and took into account other key risk factors for fracture, including body weight, smoking, alcohol use and physical activity. It also looked at the women’s use of PPIs every two years (rather than just asking them once) and took into account variations in use during this time in their analysis.
However, as the authors note, it also had some limitations:
- It did not ask about the brands of PPI used, nor the doses of PPI the women took, both of which could affect risk of fracture.
- The information about hip fracture was self-reported and not confirmed by medical records (although a smaller study has found self-reporting of hip fracture to be reliable).
- Also, the study did not record the women’s bone mineral density (BMD). Low[?] BMD is an important risk factor for fracture and adding a measure of this could have strengthened the study.
Finally, because this was a cohort study, other factors both measured and unmeasured may have affected the results, even though researchers took many of these into account in their analysis. Socio-economic status and education, for example, were not established. Because this was a study of registered nurses, the applicability of the results to other socio-economic groups might be limited.
This study found that the long-term, regular use of these drugs is associated with a small increased risk in hip fracture among older women, a risk that seems to be confined to past or current smokers. Women who regularly take PPIs and who are concerned about these findings are advised to talk to their GP. Whether any change in use of this commonly prescribed drug is needed requires further study.
Links To The Headlines
Indigestion drugs taken by millions linked to hip fractures. The Daily Telegraph, February 1 2012
Heartburn pills taken by thousands of women 'raise risk of hip fractures by up to 50 per cent'. Daily Mail, February 1 2012
Ulcer drugs 'link to fractures'. BBC News, February 1 2012
Links To Science
Khalili H, Huang ES, Jacobsen BC, et al.
Use of proton pump inhibitors and risk of hip fracture in relation to dietary and lifestyle factors: a prospective cohort study. British Medical Journal. Published online January 31 2012
foodborne pathogens dead in their tracks. And sometimes that sort of news appears in unexpected places.
Take, for example, the January edition of Popular Mechanics. In a section about the
"Ten Tech Concepts You Need to Know," readers learn that "this year's big ideas in tech will make your food safer, make hybrid cars more energy efficient, and sentence overpriced texting plans to death."
Right out of the gate, at the top of the list, is a USDA-approved food-safety process that the magazine refers to as "Pascalization," commonly known in the food industry as HPP, or high pressure processing. And while it's only been used on the commercial level for the past 2 decades or so, the technology has been around far longer than that.
Turns out that none other than French scientist, mathematician and philosopher Blaise Pascal (1623-1662) conducted research on food preservation. What he came up with -- high pressure processing -- is what Popular Mechanics describes as "changing the way we think about food."
This process doesn't rely on heat, such as pasteurization; or chemicals, such as preservatives; or irradiation to kill the harmful bacteria on food. And while heat and cooking are good ways to kill bacteria, they can also impair the flavor, texture, color and nutrition of the food. For the most part, the same is true of irradiation.
Under high pressure processing, already packaged products such as fresh hamburger and turkey; processed fruit such as apple sauce; oysters; fish; guacamole; and ready-to-eat meats such as sliced turkey, pastrami and beef are put inside a pressure chamber. Water is then added to the chamber before it is sealed. From there, the pressure is increased to the maximum desirable level and sustained for a set period of time. The chamber is then decompressed and drained and the packaged products are removed.
We're talking about a lot of pressure. For example, at sea level, air pressure is 14.4 pounds per square inch. In the case of products put under HPP, the pressure ranges from 60,000 to 87,000 pounds per square inch.
And while that sounds like enough pressure to squash or damage the packaged food, that doesn't happen because the pressure is applied equally on all areas of the product.
The good news is that the pressure zaps foodborne pathogens such as E. coli O157:H7, Listeria and Salmonella, as well as "spoilage" microorganisms such as molds and yeasts -- without affecting the nutritional qualities or the taste of the food products. That's because while it has enough force to significantly disrupt cellular activity, it doesn't affect the structures of the food components that are responsible for nutrition and flavor.
Another plus is that because HPP is applied when the products are already packaged, it eliminates the possibility of cross-contamination. In other words, the products are free of pathogens when they get to the customers, whether they be grocery shoppers, restaurants, schools or other institutions. Even so, people preparing the food must follow basic food-safety procedures, such as washing their hands and preventing cross-contamination with other foods or cooking utensils to keep the food safe from foodborne pathogens.
But HPP isn't a one-step-and-it's-safe sort of approach to food safety. Companies that use it also follow standard food safety principles all the way down the line.
Last year when Food Safety News wrote about
HPP, the big news was that meat-processing giant Cargill had introduced a patent-pending process for a new line of fresh hamburger patties produced under high pressure processing. At the time, the company hailed it as a "natural option for food safety" and a "technological breakthrough." Until then, no one had figured out how to use high pressure processing on fresh hamburger meat without affecting its taste, texture or appearance.
The patties were slated for the food service industry, with customers such as restaurants saying that they were looking for a "fresh hamburger" option with good shelf life. According to a
news release from Cargill, the HPP burgers have double the shelf life of non-HPP burgers. Yet the fresh flavor stays intact and food safety is enhanced.
The company's name for these HPP burgers is "fressure." The idea is that the fressure logo could be used on restaurant menus so customers would know the burgers were fresh, not frozen. And while the label advised that the meat be cooked to 160 degrees, the "fressure" burgers gave cooks and chefs the option to cook them to lower temperatures and therefore satisfy customers who wanted medium-rare burgers, for example. Even so, restaurant menus are required to carry a warning that undercooked or uncooked meats and shellfish can pose a risk to human health.
At the time, long-time HPP researcher V.M. Balasubramaniam, Department of Food Science and Technology at Ohio State University, told Food Safety News that this new development on the part of Cargill was "the most promising food-safety innovation in recent years." And he predicted that the technology would become a key player in food safety.
Ten months later, he echoed similar thoughts in the comments he supplied to Popular Mechanics, pointing out that sauces, fruit juices, guacamole, lunch meats, and fish hold up well to HPP and and that treated versions of these foods can be found in stores today.
He also pointed to falling equipment costs for HPP and the demand for longer shelf life, coupled with a poor consumer acceptance of food irradiation, which he referred to as "HPP's competition" as reasons that HPP will enter into the mainstream.
Indeed, it's almost there, with the industry having grown into a multi-billion-dollar business in recent years, he said.
Two Heavy-Hitters
As 2011 came to an end, more news about HPP found its way into mainstream media, thanks to two heavy hitters in the food industry.
The first of these is Cargill, which once again turned to HPP, this time for some of its ground turkey. Michael Martin, spokesman for Cargill, told Food Safety News that in the wake of the company's August and September 2011 recalls of millions of pounds of ground turkey (triggered by the possible contamination of the product by multi-drug resistant strain of Salmonella Heidelberg), the company explored all current food safety technologies to determine which could be effective at further reducing the potential for foodborne illness.
"One of those is high pressure processing (HPP), which we are using on some ground turkey products packaged in chubs," Martin said. Chubs are thin plastic packages containing ground meat or poultry, with the ends fastened together with a metal clasp.
Martin said the company continues to evaluate the food-safety value and consumer acceptance of the product undergoing HPP, which is being done by a third-party supplier.
The second heavy hitter to enter the HPP scene late in 2011 was none other than Starbucks. With its purchase of juice-maker Evolution Fresh in November, Starbucks cast its vote for HPP. In acquiring the company, Starbucks emphasized the competitiveness of high pressure processing since juices treated with HPP are never heated.
In the
Starbuck's news release about the purchase of the company, Jimmy Rosenberg, founder of Evolution Fresh and the newly named chief juice office of the company, said that using High Pressure Pasteurization (another term for HPP) to help ensure the inherent nutrients are kept intact during the juicing process is a key point of differentiation for a growing number of the company's juices.
Rosenberg founded Naked Juice, which is now owned by PepsiCo. Another juice contender, Odwalla, was bought by CocaCola. But companies pasteurize their juices. Starbucks plans to serve Evolution juices at juice and health bars, in stores, and also at its company-owned retail stores, thus bringing the HPP juices to the attention of about 60 million people worldwide each week. In an email to Food Safety News, a spokesperson for Starbucks said that juices processed with HPP will be noted as such on the bottle labels.
"As more information becomes available about HPP, we believe customers will seek out these juice products," said the spokesperson.
The news about Starbuck's plans for Evolution juices found its way into USA Today and the LA Times, among many other mainstream media outlets. "For us, this is exciting because Starbucks will be marketing the juice as HPP," Glenn Hewson, vice president of Global Marketing for
Avure, the global leader in HPP food processing equipment, told Food Safety News. Last year, Avure described HPP as "food safety's best kept secret" and pointed to $3 billion in food products worldwide created with HPP each year.
Among the companies using it for all or some of their products are Hormel, Fresherized Foods, Garden Fresh Gourmet, Perdue, Puro Fruits, SimplyFresco, Maple Lodge Farms, and Wholly Guacamole.
America is the leader in HPP, with Mexico coming in second. HPP products are also being produced in Europe, Japan, Australia, New Zealand and Korea.
And while there's an additional cost of using HPP, food companies are finding that consumers are becoming increasingly concerned about food safety and that many are willing to pay the extra cost.
Labels
When people learn about HPP, the first question they usually ask is how they can know which foods are processed with HPP.
Unfortunately, said Avure's Hewson, many companies don't include that information on their labels, although they do include it on their websites.
With that in mind, Hewson said that manufacturers of HPP products should consider joining the ranks of companies like
Fresherized Foods,
Maple Lodge Farms and
Ifantis in developing HPP branding that tells consumers about the benefits on the technology right on the package.
"Processors will find that branding cements consumer awareness and drives market demand for their products that stand out from the crowd," he said.
He predicts that before long, there will be an industry mark that signifies that HPP has been used to produce the food items that have undergone the process.
To watch some videos about HPP processing, go
here,
here, and
here.
Companies using HPP are invited to list the products they make with the technology in readers' comments at the end of the article.
The following letter to the president of Brown University requests that she writes to the editor of the Journal of the American Academy of Child & Adolescent Psychiatry supporting our request for retraction of a journal article that misrepresented the efficacy and safety of paroxetine for depressed adolescents. The letter was written by Healthy Skepticism members Jon Jureidini and Leemon McHenry and signed by additional Healthy Skepticism members and others. Jon and Leemon's campaign for retraction of the misleading article has been endorsed as a Healthy Skepticism campaign by the Healthy Skepticism international management group.
4 October 2011
President Ruth J. Simmons
Office of the President
Brown University
1 Prospect Street
Campus Box 1860
Providence, Rhode Island 02912
Dear President Simmons,
Study 329: A multi-center, double blind, placebo controlled study of paroxetine and imipramine in adolescents with unipolar major depression
We write to you about our ongoing concerns regarding a journal article that originated at the Department of Psychiatry and Human Behavior, under the leadership of Dr. Martin Keller.
Between 1993 and 1998, SmithKline Beecham (subsequently GlaxoSmithKline) provided $800,000 to Brown University for its participation in the above study.
[1] The results were published in 2001 by Keller et al. in a journal article, 'Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial',
[2] in the
Journal of the American Academy of Child & Adolescent Psychiatry
.
The article was ghostwritten by agents of the manufacturer, and seriously misrepresented both the effectiveness and the safety of paroxetine in treating adolescent depression.
While problems with study 329 and the Keller et al paper have been thoroughly exposed in legal actions,
[3] the bioethical and medical literature,
[4] a book,
[5] and a BBC Panorama documentary
[6], the paper continues to be cited uncritically in the medical literature as evidence of the efficacy of paroxetine for treatment of adolescent depression.
[7],
[8] Our main concern is that adolescents are being harmed because well-intentioned physicians have been misled.
Moreover, the misrepresentation has been compounded by the following:
1) The
Journal
was asked by two of the undersigned, Drs. Jureidini and McHenry, to retract the article, but has refused to do so.
2) In a letter of May 13, 2008, from Pamela D. Ring to Dr. David Egilman, Brown University refused to release information about its internal investigation into Dr. Keller's conflicts of interest and scientific misconduct.
Study 329 reveals the pervasive influence of GlaxoSmithKline's marketing objectives on the preparation and publication of a 'scientific' manuscript and peer-reviewed journal article. GlaxoSmithKline's own internal documents disclosed in litigation show that company staff were aware that the study 329 did not support a claim of efficacy but decided that it would be "unacceptable commercially" to reveal that.
[9]
The data were therefore selectively reported in Keller
et al
.'s article, in order to "effectively manage the dissemination of these data in order to minimise any potential negative commercial impact".9 As it turns out, the Keller
et al
. article was used by GlaxoSmithKline's to ward off potential damage to the profile of paroxetine and it was used to promote off-label prescriptions of Paxil® and Seroxat® to children and adolescents, some of whom became suicidal and self-harmed as a result.
[10]
The unretracted article is a stain on Brown University's reputation for academic excellence. The University cannot claim to be a leader in scientific research and moral integrity while failing to act to redress this article that negligently misrepresents scientific findings.
In its accreditation document for the New England Association of Schools and Colleges (NEASC), Brown University claims in relation to 'Standard Eleven: Integrity' that 'The institution manages its academic, research and service programs, administrative operations, responsibilities for students and interactions with prospective students with honesty and integrity', that it 'expects that members of its community, including the board, administration, faculty, staff, and students, will act responsibly and with integrity', and that 'Truthfulness, clarity, and fairness characterize the institution's relations with all internal and external constituencies'.
[11] The University's inaction in relation to study 329 casts doubt on the validity of these claims.
We ask that you write to the editor, Dr. Andres Martin,
Journal of the American Academy of Child & Adolescent Psychiatry
supporting our request for retraction of the journal article.
We are making this letter available to interested parties and it will be posted on the Healthy Skepticism website (
www.healthyskepticism.org).
Yours sincerely
Jon Jureidini
Child Psychiatrist
Clinical Professor, University of Adelaide
Leemon McHenry
Department of Philosophy, California State University, Northridge
Jerome Biollaz
Professor Emeritus of Medicine, Centre Hospitalier Universitaire Vaudois, Lausanne
Alain Braillon
Stephen Bezruchka
Senior Lecturer, School of Public Health, University of Washington
Ruud Coolen van Brakel, director
Sandra van Nuland, consultant
Martine van Eijk, MD PhD
Instituut voor Verantwoord Medicijngebruik (
Dutch Institute for Rational Use of Medicine)
Marc-Andre Gagnon,
Research Fellow, Edmond J. Safra Center for Ethics, Harvard University
Ken Harvey
Adjunct Senior Lecturer, School of Public Health, La Trobe University, Melbourne
David Healy
Professor in Psychological Medicine, Cardiff University School of Medicine
Andrew Herxheimer,
Emeritus Fellow, UK Cochrane Centre, Oxford
Jerome Hoffman
Professor of Emergency Medicine, University of Southern California
Joel Lexchin
Professor, School of Health Policy and Management, York University, Toronto, Canada
Melissa Raven
Adjunct Lecturer, Discipline of Public Health, Flinders University, Australia
Dee Mangin
Associate Professor, Director Primary Care Research Unit, Christchurch School of Medicine
Peter Mansfield
Director, Healthy Skepticism
Dan Mayer
Professor of Emergency Medicine, Albany Medical College, New York
David Menkes
Associate Professor of Psychiatry, University of Auckland
Robert Purssey
Senior Lecturer, University of Queensland
Nicholas Rosenlicht
Clinical Professor of Health Sciences, University of California, San Francisco
Jorg Schaaber
President, International Society of Drug Bulletins (ISDB)
Arthur Schafer
Director, Centre for Professional and Applied Ethics, University of Manitoba
Michael Wilkes
Professor of Medicine, University of California, Davis
Jim Wright
Co-Managing Director, Therapeutics Initiative
Liliya E. Ziganshina
Head, Professor, Department of Basic and Clinical Pharmacology, Kazan Federal University, Russian Federation
[1] Keller M. (2011). Martin B. Keller, MD. Providence, RI: Brown University; 2011.
http://research.brown.edu/pdf/1100924449.pdf
[2] Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller EB, Winters NC, Oakes R, McCafferty JP. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial.
J Am Acad Child Adolesc Psychiatry
. 2001 Jul;40(7):762-72.
[3]
The People of the State of New York vs. SmithKline Beecham
Corp.
(Case No. 04-CV-5304 MGC),
Beverly Smith vs. SmithKline Beecham Corp.
(Case No. 04 CC 00590),
Engh vs. SmithKline Beecham
Corp
. (Case No. PI 04-012879),
Teri Hoormann vs. SmithKline Beecham
Corp.
(Case No. 04-L-715) and
Julie Goldenberg and
Universal Care vs. SmithKline Beecham Corp.
(Case No. 04 CC 00653)
[4] Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329.
Int J Risk Saf Med
2008;20:73-81.
http://www.pharmalot.com/wp-content/uploads/2008/04/329-study-paxil.pdf
[5] Bass A. Side effects: A prosecutor, a whistleblower, and a bestselling antidepressant on trial. Chapel Hill, NC: Algonquin Books; 2008.
[6] BBC. Seroxat – Secrets of the Drugs Trials. Panorama. BBC one; 2007 Jan 29.
http://news.bbc.co.uk/2/hi/programmes/panorama/6291773.stm
[8] Jureidini J, McHenry L. Conflicted medical journals and the failure of trust. Accountability in Research 18:45-54.
[9] SmithKline Beecham, Seroxat/Paxil adolescent depression position piece on the Phase III clinical studies, October 1998, PAR003019178;
http://www.healthyskepticism.org/documents/documents/19981014PositionPiece.pdf
[10] Hammad TA, Laughren T, Racoosin J. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry. 2006 Mar;63(3):332-9
[11] Brown University. Standard Eleven: Integrity. NEASC Accreditation; 2008.
http://www.brown.edu/Project/NEASC/Standards/integrity_11.php
In the United Kingdom, the Food Safety Agency that was established in the wake of the "mad cow" disease outbreak, amongst other food safety scares, was essentially dismantled with its portfolio being returned to Ministry of Agriculture (DEFRA).
In Canada, the number of CFIA inspectors was increased following the listeriosis outbreak of 2008 in which contaminated deli meats resulted in 20 deaths. However, the Canadian government is now cutting over 200 inspectors in a bid to save $25 million from the federal budget.
In the United States, the cutbacks have been deeper, with over 260 USDA offices being closed for a savings of $150 million per year.
In reaction, many consumer groups, the press and unions have pronounced the cutbacks as placing the public in danger through the governments neglecting their responsibilities.
The old question is thus posed: Does more government involvement, specifically in relation to inspector numbers, lead to a more effective food safety system?
A similar question is posed by criminologists in relation to police numbers and crime rates. Those on one side of the argument use statistics to show that an increase in police numbers results in decreased crime rates. However, what is missed is that an increase in policing is commonly preceded by a major event, such as 9/11 or when pre-existing crime levels are high.
In other studies, where no major event has occurred, it has been found that there is no correlation between police on the ground and crime rates.
The theory goes that high numbers of police on the ground lead to an increased level of crime detection but do little to prevent crime from occurring. As sociologists will indicate, crime rates are mostly affected by the environment, such as socio-economic factors and community cohesion - in effect the existing culture. To take the argument further, it is thought that increasing the level of policing can bring a siege-like atmosphere to a community and negatively affect the community cohesion.
Returning to food safety, we can make parallels between the effect of policing on crime rates and superimpose on the number of food inspectors and foodborne illness outbreaks. Specifically, inspector numbers increase or reorganization of agencies occurs following a major foodborne illness outbreak.
Yet, what is missed is that in the event of an outbreak, it is the industry response that is primarily responsible for enhancing food safety and not visits by an army of food inspectors. Nevertheless, food inspection does play a major role in containing outbreaks and follow-up investigations, although this is different from prevention.
Industry-led initiatives are the only way to enhance food safety
In the 1980s, there was a diverse range of food safety issues of concern. Foodborne illness rates were increasing, virulent pathogens such as E. coli O157 were taking hold, not to mention the BSE and problems with the emergence of drug-resistant microbes.
In response, a directive from President Clinton's administration set to prioritize food safety risks, reduce red tape and bureaucracy. The directive essentially empowered the industry to take responsibility for food safety by introducing HACCP, amongst other initiatives.
There is little debate that the initiatives were highly successful in reducing the incidence of foodborne illness with a progressive decrease in numbers since implementation.
A more recent example of industry-led initiatives is in relation to the use of antibiotics in animal production. Antibiotics have been commonly used in animal production to prevent infections, thereby leading to high growth rates. However, a negative effect of antibiotics has been the emergence of lethal antibiotic strains of pathogens such as Salmonella, amongst others.
The FDA has debated the banning of antibiotics for promoting animal growth for over 30 years. In late 2011, the FDA somewhat unexpectedly stepped back from banning antibiotics in animal production, which is counter to the actions taken over in the EU.
Many commentators saw this as a capitulation of the FDA to the lobbying pressure from the meat industry. However, the reality is that the meat industry has been proactive in reducing the use of antibiotics in animal production on the understanding that a staged reduction is required. Of course, this is not well-publicized but illustrates that only a successful antibiotic reduction program can be achieved if led by industry and not by government.
Empowerment of food safety is the key
The empowerment of industry to self-regulate always comes under criticism in the event of a foodborne illness outbreak. The knee-jerk reaction always appears to be more testing, more inspectors, more agencies etc.
In many ways, "tinkering" with the food safety system by government hinders the progress that has been made since 1995. Ultimately, industry-led initiatives will always be the most effective approach to improve food safety. Consequently, rather than increasing government inspection a more productive strategy is how to remove the weak links in the chain to prevent outbreaks from occurring in the first place.
Such a strategy is far from straightforward, as there is a need to understand the underlying basis for decisions made that ultimately led to critical errors of judgment in foodborne illness outbreaks.
For example, why do processors send out product known to be contaminated or perform practices that represent obvious food safety risks? In a broad sense, it can be proposed that the actions are through ignorance (lack of knowledge is perhaps a better term) of the risk, economic factors or, in a relatively low number of instances, bioterrorism or criminal intent.
Ironically, it is the latter group who have the greatest perception of empowerment given they are controlling events. In contrast, those that lack knowledge may have good intentions in producing high quality products, although fail to see the consequences. It is almost akin to a thought pattern of "nobody told me not to do it."
The current trend of clean labels, along with producers of organic products, can be classed in this group, where attempts to produce additive-free foods leads to food safety risks (for example, omitting nitrites to control Clostridium botulinum). Also included in this group are food handlers, quality assurance personnel and management whose main focus is to produce product as fast as possible with little thought of ownership or empowerment.
Workers have a tendency to lack empowerment, as they are told what to do and when to do it. This ultimately leads to a disconnect between the product and food safety. In the processing environment, workers are judged on how quickly the product can be processed regardless if the production line is producing ready-to-eat deli meat, cars or paper-clips.
Even if food violations occur, there is little incentive for the worker to raise concerns or to be empowered to make suggestions. When visiting processing plants, I sometimes ask the workers if they consume the products produced in the facility. In the majority of cases, the answer is no, due to their prior knowledge of the history of the product. Clearly those workers have a disconnect or lack of ownership with the product.
Akin to when the industry is highly regulated by government, the lack of empowerment by food workers throughout an organization ultimately leads to essentially passing-the-buck when it comes to food safety - an "it is not my problem" attitude.
It could be argued that empowerment is encompassed in the concept of a food safety culture. Yet "food safety culture" remains a relatively woolly term that lacks the nuts-and-bolts on how to change the behavior of those working in the food industry. There is frequent reference to increasing knowledge by training. However, knowledge and empowerment are very different.
Frank Yiannas introduced the term food safety culture, and noted the major challenges in changing worker behavior - after all, it does take a generation. Still every road starts with a first step and rather than look at the loss of government inspectors as entering the Dark Age we should look at this as an opportunity for industry to be empowered to take food safety initiatives to the next level.
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Dr. Keith Warriner is an Associate Professor within the Department of Food Science at University of Guelph, Canada.
Two of the country's most respected hospitals: Which one has mastered the art -- and science -- of great website design?
In this week's Website Smackdown, I’m taking a look at the websites for two of the biggest hospital complexes in the world, the Mayo Clinic and the Cleveland Clinic.
You may be asking yourself, what can a small business learn from looking at the websites of two behemoth hospitals? Actually… plenty. One site understands its target audience and serves that audience’s needs extremely well, and the other just doesn’t get it.
The Mayo Clinic and Cleveland Clinic rank neck and neck (third and fourth respectively) on US News & World Report’s Honor Roll of Best Hospitals, but there’s a huge difference in the quality of their websites.
Let’s Take a Look
Most people coming to the website for a major hospital have health-related questions, require immediate need for a doctor, or need information about visiting (directions, visiting hours, etc.). Just as hospitals are in the business of patient care, their websites should reflect that same level of care for site visitors.
A hospital website should provide key information to site visitors and make it simple and intuitive to find that information. It should also reflect a level of care, professionalism, and respect upon which the hospital has built its reputation.
Take a look at the homepage for the
Mayo Clinic website.
As you can see from the Mayo Clinic’s homepage, the central images are of former patients who have found their “Answers” at the Mayo Clinic. To get to those “Answers,” you have to read the tiny print to the right and click on the case study.
There is virtually nothing on the homepage that is designed to help patients, families of patients, or people looking for assistance from the hospital. After much searching, you can find (in a tiny font and in a sub-navigation) “Request an Appointment” and “Find a Doctor.” What you won’t find is a phone number, directions, or anything else that might be of real use.
By way of contrast, take a look at the
Cleveland Clinic’s homepage.
The Cleveland Clinic keeps the homepage very simple. The main image rotates, showing research, technology, and patient care as the three central messages. Much more importantly, the primary navigation clearly leads you to “Locations and Directions,” “Find a Doctor,” “Patient & Visitor” information, and bold tabs for “Contact Us” and “Appointments.”
Now take a look how each site handles the critical area of “Health Information.”
The Mayo Clinic Health Information page isn’t particularly user friendly. It offers a solid A to Z search and also has searches for symptoms, drugs, tests, and healthy living. While this is all helpful, it is also (forgive the pun) very clinical. People who are looking for health information are often in crisis and the role of the healthcare provider should be to provide as much support as possible.
The
Cleveland Clinic "Health Information" page offers all of the same search functions, but also provides useful tools as a phone number to contact them and even the ability to “Chat Online with a Health Information Search Specialist.” This is far more consumer friendly and much more helpful for a person with real health-related questions.
Finally, let’s look at one more service provided by both websites: Find a Doctor.
The
Mayo Clinic "Find a Doctor" page (again clinical and unfriendly) features an alphabetical search by doctors and departments and nothing else. The page also features videos of three doctors telling us how wonderful the Mayo Clinic is a wonderful place.
The
Cleveland Clinic’s “Find a Doctor” page not only clearly lays out five useful searches, it includes a video that actually walks you through the search process. Rather than extol the virtues of the Cleveland Clinic, it provides a real service to site visitors.
So what can you learn from these hospital websites?
- Know your target audience and know why they are coming to your site.
- Prioritize your navigation to serve the biggest needs of your visitors.
- Make sure you have powerful calls to action and prominent contact information.
- Emphasize customer service!
- Your online messaging should reflect the messaging of your business. If you are a service provider then make sure your site is designed with your potential clients/customers in mind.
Remember, creating a great website for your business isn’t brain surgery. It’s just a matter of understanding, appreciating, and serving your target audience.
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