NSAID’s in the News (again)

Let me start by saying, that despite spending the last 20-something years in or around the pharmaceutical industry, I don’t like taking pills. That said, I’m not particularly partial to pain either. So when my knees or back hurts or I’m doubled over with dysmenorrhea, like many other people, I’ll reach for the ibuprofen.

But that may be about to change. Results from a new, large international study of non-steroidal anti-inflammatory drugs (NSAIDs), showed that high doses of them increase the risk of a major vascular event such as heart attack, stroke or death from cardiovascular disease by around a third.

In other words, for every 1,000 people with an average risk of heart disease who take high-dose ibuprofen for a year, about three extra would have an avoidable heart attack, of which one would be fatal, the researchers said.

This puts the heart risks of generic NSAIDs on a par with Vioxx – the painkiller that U.S. drugmaker Merck famously pulled from sale in 2004 because of links to heart risks.

The study team from Oxford University in the UK, gathered data, including on admissions to hospital, for cardiovascular or gastrointestinal disease, from all randomized trials that have previously tested NSAIDs.

This allowed them to pool results from 639 trials involving more than 300,000 people and re-analyze the data to establish the risks of NSAIDs in certain types of patients.

In contrast to the findings on ibuprofen and diclofenac, the study found that high doses of naproxen, another NSAID, did not appear to increase the risk of heart attacks. The researchers said this may be because naproxen also has protective effects that balance out any extra heart risks.

Researcher, Colin Baigent stressed that the risks are mainly relevant to people who suffer chronic pain, such as patients with arthritis who need to take high doses of for long periods. “A short course of lower dose tablets purchased without a prescription, for example, for a muscle sprain, is not likely to be hazardous,” he said.

He also warns patients not to make hasty decisions or change their treatment without consulting a doctor.

“For many arthritis patients, NSAIDs reduce joint pain and swelling effectively and help them to enjoy a reasonable quality of life,” he said. “We really must be careful about the way we present the risks of these drugs. They do have risks, but they also have benefits, and patients should be presented with all those bits of information and allowed to make choices for themselves.”

Donald Singer, a professor of clinical pharmacology and therapeutics at Warwick University, who was not involved in the study, said its findings “underscore a key point for patients and prescribers: powerful drugs may have serious harmful effects.”

In the meantime, I for one, will be revising my pain versus pill-popping habit, or switching to naproxen.

Fighting Flu

Last night I participated in my annual healthcare lottery. Fortunately for my finances, this didn’t involve scratch cards, ticket stubs or wheel spinning of any kind, nor will it bring me great riches, a new car or a timeshare condo. Instead, if my gamble pays off, I might be spared the flu this winter season.

However, this may be one of the last years that I have to keep my fingers crossed that the vaccine might work.  In future years getting a flu shot may become a safe bet.

In a significant step against the disease that affects billions of people each year, scientists at Oxford University in the UK, just announced that they have successfully tested a universal flu vaccine that could work against all known strains of the illness.

This new vaccine targets a different part of the flu virus to traditional vaccines, meaning it does not need expensive reformulation and guess work  every year to try and match the most prevalent strains of the virus that are circulating the world.

The team, led by Dr Sarah Gilbert at the Jenner Institute, developed a vaccine that targets proteins inside the flu virus that are common across all strains, instead of those that sit on the virus’s external coat, which are liable to mutate.

If used widely, a universal flu vaccine could prevent pandemics, such as the swine flu outbreaks of recent years, and could even end the need for a seasonal flu jab.

A universal vaccine would save the time and money now needed to create vaccines to fight whatever particular virus has emerged in any given year.  The process of developing a seasonal vaccine takes at least four months and if the flu strain is highly pathogenic the delay means people get sick and die before the vaccine is ready.

“If we were using the same vaccine year in, year out, it would be more like vaccinating against other diseases like tetanus,” said Gilbert. “It would become a routine vaccination that would be manufactured and used all the time at a steady level. We wouldn’t have these sudden demands or shortages – all that would stop.”

While traditional vaccines prompt the body to create antibodies, Gilbert’s vaccine boosts the number of the body’s T-cells, another key part of the immune system which can identify and destroy cells that have been infected by a virus.

In her trial, Gilbert vaccinated 11 healthy volunteers and then infected them, along with 11 non-vaccinated volunteers, with a strain of flu virus.  She then monitored the volunteers’ symptoms twice a day.  Her results showed that the vaccine worked as planned.

“Fewer of the people who were vaccinated got flu than the people who weren’t vaccinated,” said Gilbert. “We did get an indication that the vaccine was protecting people, not only from the numbers of people who got flu but also from looking at their T-cells before we gave them flu. The people we vaccinated had T-cells that were more activated. The people we hadn’t vaccinated had T-cells as well but they were in a resting state so they would probably have taken longer to do anything. The volunteers we vaccinated had T-cells that were activated, primed and ready to kill. There were more T-cells in people we vaccinated and they were more activated.”

The trial proved two important things about the vaccine: First, it showed that it was safe; and second it proved that giving people flu virus in the presence of lots of T-cells induced by the vaccine was absolutely fine.

“What we’ll probably do is take the existing flu vaccine and mix in the new virus-vector vaccine, so you get both good antibodies and good T-cells. As well as giving you the antibodies for this season’s strain of flu, we’ll give you some T-cells that will cover this season, next year, and thereafter. It may not be 100% effective against all strains, but at least if there were a pandemic coming around, it would cover you for any strain.”

It is also believed that the vaccine could provide better protection against flu for older people. Traditional flu vaccines are effective in about 70-80% of young people, but only 30-40% of older people, because the older people’s immune systems are less efficient at making new antibodies.

The next step for the new vaccine is a larger scale trial comparing several thousand people who are given and not given the vaccine.

Although that means a commercial product is still some years away, this study represents some potentially very exciting findings not only for flu but possibly for other infectious diseases.

SRxA’s Word on Health looks forward to bringing you this news as it happens.

An aspirin a day keeps bowel cancer away?

Aspirin is not only an effective painkiller, it is thought to help fight conditions ranging from cardiovascular disease, cancer and stroke to migraine headache and high blood pressure in pregnancy. Some studies have suggested it can double the chances of a successful IVF pregnancy while others have suggested it may even block the spread of certain viruses.

Now, researchers at Oxford University have found that a daily aspirin tablet may help to prevent both bowel cancer and bowel cancer deaths.

The study followed over 14,000 patients for a period of 20 years.  The results, published in the current edition of The Lancet, show that low-dose aspirin reduced the risk of the incidence of bowel cancer by 24% and of dying from the disease by 35%.

“Aspirin taken for several years at doses of at least 75mg daily reduced long-term incidence and mortality due to colorectal cancer. Benefit was greatest for cancers of the proximal colon, which are not otherwise prevented effectively by screening with sigmoidoscopy or colonoscopy.” concluded the study authors.

The findings build on previous research on the issue and offer great hope for individuals with a high risk of bowel cancer, such as those with obesity or a family history of the disease.

One in 20 people in the US develops bowel cancer over their lifetime, making it the third most common cancer. Current figures from the National Cancer Institute indicate that there are more than 140,000 new cases of bowel cancer diagnosed in the US each year and more than 50,000 deaths.

Mark Flannagan, Chief Executive of Beating Bowel Cancer, said the study provided very positive findings.  “This was a big study over a long period of time and reinforces the message that aspirin may be important in significantly reducing the number of cases and deaths from bowel cancer.”

Aspirin is already one of the most widely used medications in the world.  An estimated 40,000 tons of it are consumed worldwide, each year.  SRxA’s Word on Health wonders just how much more will be sold as a result of this.

Let us know your thoughts.