“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 2 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 5 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 with 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, Jacobson 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
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337 incidents represent a 16 percent climb from 2010. Miguel Santos, above, was a recent carjacking victim
Miguel Santos of Newark is seen at the corner of Chestnut St. and Pacific St. in Newark, where he was recently the victim of a carjacking.
NEWARK — Despite the creation of a task force that included State Police and federal investigators, carjackings in Newark rose for the third straight year in 2011, jumping 16 percent from the previous year, according to police statistics.
There were 337 carjackings in Newark last year, compared to 290 in 2010. Newark police did not track carjackings as an individual crime until 2010, when they surged, according to a police spokesman. However, the city’s 2010 total was 24.5 percent higher than the 233 carjackings in all of Essex County, which includes Newark, in 2009.
The increases have sparked concerns among business leaders and residents that the state’s largest city is once again becoming the "car theft capital of the world," a dubious monicker it earned in the 1990s.
As in 2010, last year’s increase was driven by organized teams of juveniles and young men who stole cars for quick joyrides before dumping the vehicles, Police Director Samuel DeMaio said. The crews seemed to strike at random, never targeting a specific type of vehicle, driver or neighborhood, he said.
"It’s affecting all businesses in Newark. People are afraid," said Juan Arias, president of the Newark Merchants Association. "When it gets dark, people are afraid to go out even to buy milk, bread, food, butter."
Even off-duty police officers fell victim and a botched gunpoint carjacking last July resulted in the death of Essex County Corrections Officer Debora Ferreira.
Despite the year-to-year increases, DeMaio noted carjackings fell in the second half of 2011 compared to the same period in 2010. However, police records show the number dropped by just three — from 202 to 199. There were also more carjackings during the second half of 2011 (178) than in the first half (159).
DeMaio said his department is working to eliminate as many carjackings as possible.
"Bottom line is, if we took it down to where we only had one carjacking, would we be happy? No. I don’t want any carjackings," DeMaio said.
Miguel Santos said he hasn’t slept since a man stuck a gun in his face in broad daylight two weeks ago and stole his 2009 Porche Cheyenne. Now, the 33-year-old is considering moving out of Newark.
Santos said he was driving on Chestnut Avenue in the Ironbound section around 1 p.m. on Jan. 22 when a car pulled up alongside his. Santos said the driver, wearing a mask and brandishing a gun, got out of his vehicle pointed the gun at Santos and his fiancee and motioned for them to get out of the car.
"I just kept screaming ‘Don’t shoot! Don’t shoot!’" Santos said.
Santos chastized Mayor Cory Booker for touting decreases in crime and argued that carjackings and robberies are causing panic in the normally docile Ironbound neighborhood.
"I would really like for him to acknowledge what’s going down, especially here in the Ironbound," Santos said. "People are scared. It’s getting crazy."
Booker said the city has invested a number of resources to reduce carjackings.
"Any incident of violent crime in my city will not be tolerated," he said. "Our carjacking task force has taken a number of these perpetrators off our streets and made sure they were prosecuted to the fullest extent of the law. We will continue to aggressively pursue and arrest those individuals who are responsible."
When carjackings soared in late 2010 — there were 80 in the last two months of the year — authorities created a task force made up of city police, the Essex County Prosecutor’s Office, the State Police and federal investigators to combat the surge. The task force ceased to be a day-to-day operation in May when the Essex County Homicide Task Force was created, said Anthony Ambrose, the prosecutor’s chief of detectives. In the event of a surge, Ambrose said, the task force would be "re-activated."
That surge occurred in November, when there were 45 reported carjackings — the worst month of 2011.
DeMaio said he immediately called on the task force to round up those responsible.
"As soon as we saw the carjackings went off the hook, I called Anthony (Ambrose) on a Sunday morning and said ‘Dude, let’s go,’" DeMaio said.
According to the data, the task force’s success has been mixed.
In February 2011, several weeks after it was originally formed, there were just six carjackings in Newark. But in May — the final month the original unit was active — there were 38, the second highest monthly total of 2011.
Thursday, a 20-year-old Newark man admitted his role in a carjacking ring that plagued Newark and other cities between November 2010 and February 2011, the U.S. Attorney’s Office said. The suspect, Gregory Brown, was arrested by the task force last year.
West Ward Councilman Ron Rice Jr. said carjackings often spread fear in the community quicker than other crimes because of their random nature. While statistics show most of Newark’s homicide and shooting victims have ties to gangs or drugs, Rice said carjacks can happen to anyone.
"It’s just a more personal crime," he said.
Related coverage:
•
Newark carjackings increase by 60 percent in past year
•
Feds to prosecute Newark carjacking suspects
•
N.J. carjackings on the rise as police arrest 2 teens for Irvington incidents
CHILE likes to see itself as a model of free-market efficiency in a region hamstrung by protectionism and collusion. That makes a ruling on January 31st by the country’s anti-trust regulator particularly embarrassing. After a three-year investigation, the regulator concluded that the pharmacy sector, supposedly a free market, was nothing of the sort. For four months from December 2007 to March 2008 (and perhaps for years before that) Chile’s three big pharmacy chains, which between them control 90% of the market, fixed the prices of 222 medicines, the regulator found. They included treatments for serious chronic diseases like epilepsy and diabetes. On average, the price of the drugs rose by 48% during the four-month period, while the cost of manufacture rose by just 1%. Some of the medicines tripled in price.
The regulator fined two of the companies, Cruz Verde and Salcobrand, $19m each, the heaviest penalties it’s ever imposed for price-fixing. The firms deny any wrongdoing and will appeal. The third company, Farmacias Ahumada, accepted a $1m fine in 2009 after turning whistleblower and providing evidence to damn its rivals. The companies are now likely to face a barrage of compensation suits from angry customers claiming, quite rightly, that they were overcharged for everything from anti-depressants to contraceptives.
Apologists may try to paint this as a one-off case, but that seems unlikely. In December state prosecutors asked the regulator to investigate alleged collusion between the country’s three biggest poultry producers, Agrosuper, Ariztia and Don Pollo, which breed 93% of the chickens eaten in Chile. The prosecutors say the companies agreed on quotas, deciding how much meat they would each supply to market. The companies deny the charges. And Three weeks after the alleged “chicken scandal” came to light, the regulator fined four bus companies for price-fixing. Others were accused of colluding to prevent new operators entering the market.
The government welcomed the antitrust ruling, saying it was proof the regulator was doing its job. “The social market economy that we’re building only makes sense…if the sacred rights of the consumer are respected,” said Sebastian Pinera, the president. But the proliferation of such cases will probably erode confidence in the private sector. Most Chileans take medicine, eat chicken and travel by bus. They can surely be forgiven for wondering if they’re being ripped off every time they do so.
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