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Many drugs are prescribed for conditions they weren’t tested for – here’s what you need to know

There is no legal duty to tell a patient they have been prescribed a drug ‘off label’.

All prescription drugs need a licence from a regulator to treat a specific condition. But licensed drugs can be prescribed for conditions they haven’t been tested for in a clinical trial. This is known as “off-label” prescribing – and it’s very common.

The UK doesn’t have current figures on overall off-label prescribing, but a US study found that one in five prescriptions was off label.

It is important to note that off-label medicine use is not the same as experimental use. Legally, once a medicine has obtained a licence, it can be used for any condition in any patient. A licence is evidence a medicine is safe, effective and of good quality.

So why is off-label prescribing so common? This practice is most common in children, older people, pregnant women and psychiatric patients, usually with changes in dosing and formulations. It is unusual for drugs to have been tested in these groups of patients.

Obtaining a new license for a medicine (to treat a different condition) is time-consuming, often taking up to eight years to get approval. It is also very expensive, with the new revenue for the additional uses often not being enough to offset the cost of running new clinical trials, marketing and re-labelling the drug.

To determine if a medicine can and should be prescribed off-label, a prescriber may consider several factors. There may be common features in two similar conditions that ensure there should be a degree of cross-effectiveness. For example, a medicine licensed for anxiety might reasonably be used to treat post-traumatic stress disorder. And a drug approved to treat one type of cancer could reasonably be expected to target other types of cancer.

Some off-label uses have been found by accident. Beta-blockers were licensed in the 1960s to treat heart conditions. People who were prescribed these drugs and who suffered from migraines found that their migraine symptoms improved after they started taking the drug. Today, these drugs are commonly prescribed for migraine.

On occasion, off-label medicine use can become the primary treatment option for a particular condition. Amitriptyline, an older type of antidepressant, is now often used to treat nerve pain.

Usually, a prescriber will have considered all other medical options for a patient and will have reviewed the evidence to support any off-label prescribing. This includes “evidence summaries” provided by the National Institute for Health and Care Excellence. These are available to GPs to support safe decision-making.

The summaries look at current guidelines and reviews as well as research studies, such as clinical trials and observational studies, and expert opinions. Although the guidelines mainly focus on licensed drugs, they also discuss off-label uses that are common in practice.

Some off-label drugs may also be listed in the British National Formulary, a reference book that contains prescribing information about drugs available in the UK.

Great responsibility

Whether there is a wealth of evidence or not, there is a greater responsibility for the prescriber when prescribing drugs off label.

One risk is the absence of information from the patient leaflet. The metformin patient leaflet, for instance, discusses its use in diabetes, but there is no information about its alternative use to treat polycystic ovary syndrome, which can confuse patients.

A bigger risk is the incidence of side-effects, which increase when off-label prescribing is not based on strong medical evidence. Alternatively, the drug may not work at all.

Despite being strongly advocated at the time by some doctors and politicians, a 2021 review debunked the use of hydroxychloroquine to treat COVID and found an increased risk of death with its use.


Read more: Coronavirus: scientists promoting chloroquine and remdesivir are acting like sports rivals


Recently, Ozempic (semaglutide) caused a storm, with celebrities promoting its miraculous weight-loss effects. This off-label prescribing has led to continuing drug shortages affecting people with diabetes. But it also to the development of Wegovy for weight loss.

No legal duty

While there is no legal duty to tell a patient they have been prescribed an off-label medicine, prescribers follow professional guidelines. These state it is good practice to tell patients if a drug is being prescribed off label.

Patients should be told information about the medicine, including potential side-effects and the reasons why they have been prescribed an off-label medicine versus a licensed medicine.

A patient who has been told or suspects their medicine is off-label should ask why they have been prescribed this medicine and what the risks versus the benefits are. They could ask what the likelihood is of this medicine working and what might happen if they do not have the medicine.

Off-label drugs do not have the same medical evidence as licensed drugs and inappropriate use could lead to more side-effects. However, for some people, off-label drugs could be the best or only option and they must receive honest and accurate information about their treatment.

Dipa Kamdar does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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What your sad desk sandwich says about your working habits

In-depth interviews explain what’s behind the ‘al desko’ stereotypes.

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How’s that sandwich? If you’re munching on a supermarket meal deal while reading this, well, I probably am too.

Brits in particular are known for their obsession with sandwiches, which they eat alone while continuing to work. This habit amuses but also disgusts our European counterparts. As one French scholar put it: “A sandwich or salad gulped down in front of a computer screen does not pass as a proper meal.”

Research has shown that 28% of British workers eat at their desks and 44% eat lunch alone, the highest rates in Europe. Sociologists have thoroughly researched family meals, children’s school meals, and even dining out in restaurants.

Only a handful of publications focus on the workday lunch, but studies have almost exclusively used large-scale surveys. While these are valuable in revealing patterns of behaviour and trends in how we eat, they do not help us understand why people eat the way that they do at lunch. For this, rich, in-depth interview data is required.

In my recently published research, I interviewed 21 people about what they ate for the workday lunch (and where and with whom). I found much greater variety in workday lunches than the solitary “al desko” sandwich. But there were shared understandings among my participants about how to lunch at work.

Most participants were willing to admit that the workday lunch was not exactly a premium gastronomic experience. One man described lunch as “my functional eating thing”.

Nevertheless, people greatly anticipated their lunch, seeing it as a reward or treat for a morning’s work, and noting that it was a time to eat what they wanted. One respondent, a teacher, confessed that she chose “carbs with carbs” and a cookie with custard from the canteen.

Unlike the family dinner where everyone tends to eat the same meal and the cook must cater to others’ tastes, the workday lunch was seen as a chance for personal indulgence, despite others’ distaste. Foods considered unacceptable in other circumstances (canned soup or microwave meals, for example) are acceptably convenient for the workday lunch because they are efficient. Couples I interviewed ridiculed each other for their “sad” or “terrible” lunch choices.

Efficient eating

My participants considered walking and waiting for food a waste of time. People reported using work breaks for a leg stretch and to buy lunch but, to minimise time away from work, ate back at their desks. Proximity and speed of service are deciding factors in where to eat out for lunch: you want to “go, eat and leave”.

And while it was not common among participants, the temporally efficient lunch par excellence is bringing food from home – you skip the queue altogether (not literally, Brits don’t like that).

As far as dining companions are concerned, there were mixed feelings among my participants. Eating with colleagues can be a good laugh peppered with lighthearted British banter and discussion of weekend plans. Sometimes though, being a good conversation partner and navigating the blurred line between friendly and professional with colleagues was seen as just more work.

A young woman sitting alone at a cafe with a slice of cake, scrolling on her phone.
Lunch can be a brief respite of alone time in a busy work day. Vovatol/Shutterstock

To avoid the emotional effort of eating with others, people would signal to their colleagues they wanted to be left alone by sitting by themselves and scrolling on their phones, hiding behind a computer screen or even retreating to a parked car to eat without disturbance. One woman summarised: “Eating with other people interferes with that kind of pleasure of just looking after yourself”.

Lunch and our working lives

My findings suggest that British lunch habits are not simply a matter of low standards for meals. They are about balancing the pressures of work and the need for efficiency with taking care of oneself and navigating social interactions. Like quiet quitting and the great resignation, putting minimal effort into lunch can be seen as yet another response to a working culture that is getting more demanding.

I conducted these interviews before the COVID pandemic. The rise in hybrid and remote working has, for many people, moved the workday lunch from the office to home. The commercial sandwich trade has been hit hard. But even before the pandemic, participants who worked from home ate at their desks, despite (you might expect) having a more pleasant space to eat. Perhaps the impact of the pandemic on our lunches is not so dramatic after all.

What we eat for lunch every day (and how we eat it) has an impact on our health. Some organisations and countries have recognised the importance of this. France, for example, has a labour regulation that bans workers from eating lunch in the workplace. Long lunches among French workers are linked to better food choices and health.

Improving lunchtime habits, therefore, is not necessarily down to whether you choose a salad or a slice of pizza. Your employer, through lower workload, or even the government, through labour laws, may have an influence on what’s for lunch.

This research was co-funded by the British Academy Postdoctoral Fellowship Scheme and the Sustainable Consumption Research Institute at The University of Manchester.

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Chlorogenic acid prevents ovariectomized-induced bone loss by facilitating osteoblast functions and suppressing osteoclast formation

“[…] chlorogenic acid appears to be a promising candidate for the management of osteoporosis.” Credit: 2024 Ho et al. “[…] chlorogenic acid appears…

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“[…] chlorogenic acid appears to be a promising candidate for the management of osteoporosis.”

Credit: 2024 Ho et al.

“[…] chlorogenic acid appears to be a promising candidate for the management of osteoporosis.”

BUFFALO, NY- March 26, 2024 – A new research paper was published in Aging (listed by MEDLINE/PubMed as “Aging (Albany NY)” and “Aging-US” by Web of Science) Volume 16, Issue 5, entitled, “Chlorogenic acid prevents ovariectomized-induced bone loss by facilitating osteoblast functions and suppressing osteoclast formation.”

Osteoporosis is a common bone disease in aging populations, principally in postmenopausal women. Anti-resorptive and anabolic drugs have been applied to prevent and cure osteoporosis and are associated with different adverse effects. Du-Zhong is usually applied in Traditional Chinese Medicine to strengthen bone, regulate bone metabolism, and treat osteoporosis. Chlorogenic acid is a major polyphenol in Du-Zhong. 

In this new study, researchers Chien-Yi Ho, Chih-Hsin Tang, Trung-Loc Ho, Wen-Ling Wang, and Chun-Hsu Yao from China Medical University, China Medical University Hospital and Asia University found chlorogenic acid to enhance osteoblast proliferation and differentiation. Chlorogenic acid also inhibited RANKL-induced osteoclastogenesis. Notably, ovariectomy significantly decreased bone volume and mechanical properties in the ovariectomized (OVX) rats. Administration of chlorogenic acid antagonized OVX-induced bone loss. 

“Taken together, chlorogenic acid seems to be a hopeful molecule for the development of novel anti-osteoporosis treatment.”

 

Read the full paper: DOI: https://doi.org/10.18632/aging.205635 

Corresponding Authors: Wen-Ling Wang, Chun-Hsu Yao

Corresponding Emails: supercocono1@mail.cmu.edu.tw, chyao@mail.cmu.edu.tw 

Keywords: chlorogenic acid, osteoporosis, ovariectomized, osteoclast, osteoblast

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About Aging:

Aging publishes research papers in all fields of aging research including but not limited, aging from yeast to mammals, cellular senescence, age-related diseases such as cancer and Alzheimer’s diseases and their prevention and treatment, anti-aging strategies and drug development and especially the role of signal transduction pathways such as mTOR in aging and potential approaches to modulate these signaling pathways to extend lifespan. The journal aims to promote treatment of age-related diseases by slowing down aging, validation of anti-aging drugs by treating age-related diseases, prevention of cancer by inhibiting aging. Cancer and COVID-19 are age-related diseases.

Aging is indexed by PubMed/Medline (abbreviated as “Aging (Albany NY)”), PubMed Central, Web of Science: Science Citation Index Expanded (abbreviated as “Aging‐US” and listed in the Cell Biology and Geriatrics & Gerontology categories), Scopus (abbreviated as “Aging” and listed in the Cell Biology and Aging categories), Biological Abstracts, BIOSIS Previews, EMBASE, META (Chan Zuckerberg Initiative) (2018-2022), and Dimensions (Digital Science).

Please visit our website at www.Aging-US.com​​ and connect with us:

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Click here to subscribe to Aging publication updates.

For media inquiries, please contact media@impactjournals.com.

 

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Goldman Sachs unveils commodity price targets ahead of rate cuts

Here’s what could happen to oil, gold, and copper prices next.

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Over extremely long periods – centuries – commodities prices are pure inflation hedges. That means their inflation-adjusted returns are about zero.

But over shorter periods, commodity prices are extremely volatile. For example, they tanked in early 2020 amid the pandemic outbreak. They climbed sharply from March 2020 to June 2022 and have mostly slipped since then.

Commodity investors maintain that the asset is uncorrelated to stocks and bonds and can thus provide a significant diversifier to your portfolio. But commodities often trade in line with the economy.

A strong economy stimulates demand for commodities, including oil, copper, grains and cocoa, because consumers and companies are flush with cash to spend. Similarly, a weak economy depresses demand for commodities.

Commodities prices are on the rise.

Investors have been buying commodities

The asset class has strengthened in recent weeks, as signs of economic recovery have emerged worldwide. The Bloomberg Commodity Index has ascended 3.5% in the last month.

Related: Analysts issue unexpected crude oil price forecast after surge

The two most-followed commodities, oil and gold, have helped lead the way. You may have seen the impact of rising oil prices at your gas pump. The national regular gas price averaged $3.53 Monday, up 8% from a month ago.

Gold has hit a record high above $2,200, buoyed by Chinese demand. The People’s Bank of China purchased more gold than any other central bank last year, according to the World Gold Council, an industry group.

It’s not just big-time commodities taking off. Cocoa prices have surpassed a 46-year-old record peak. Bad weather in West Africa crimped supply, while speculative fervor has sparked demand, according to The Wall Street Journal.

Goldman Sachs analysts weigh in on commodities

Goldman Sachs analysts believe the commodities rally will continue. Their reasons:

1. What they call “cyclical” support.

“With the trough in global manufacturing behind us and our economists’ strong conviction of interest rate cuts in the U.S. and Europe [starting in June], we expect further support to commodities demand and prices,” the analysts said. Lower rates generally lift economic growth.

Copper, aluminum, and oil products should show particular strength, they said.

More Economic Analysis:

2. Then there are “structural” factors. For example, strong demand for green metals, those that are used to make clean energy, and increasing supply concerns have pushed copper prices to a one-year high, the analysts said. They forecast a 40% increase for copper this year.

3. Geopolitical factors, such as the wars in Gaza and Ukraine, are also relevant, as they limit commodity supply.

“The ongoing Red Sea shipping disruptions and recent attacks on Russian oil-refining capacity” illustrate how geopolitical turmoil is boosting commodity prices, the analysts said.

Another commodity bull is Bruce Kamich, a technical analyst for TheStreet.com’s Pro service. He sees demographic trends supporting commodities.

“Since 2000, hundreds of millions of people have moved into the middle class, and that is fueling demand that we have never seen before,” he wrote.

“This insatiable demand is hitting against stagnant supplies of food and materials. I anticipate that commodities will be rationed by price in the years ahead.”

Kamich is looking for an upward move in commodity prices starting in August.

To be sure, the Goldman analysts warn against loading up on every commodity. They have a bearish view for this year on natural gas and lithium. And they see little change for nickel and zinc.

If you are going to invest in commodities, you might consider purchasing a mutual fund or exchange-traded fund ETF with a diversified portfolio. That can protect you against the plunge of an individual commodity.

Related: Veteran fund manager picks favorite stocks for 2024

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