Gynaecologists have used power morcellators on hundreds of thousands of women for years. These devices are used to grind up tissue internally and suck it out through tiny incisions during keyhole surgery. Morcellators make it possible for a woman with a uterus the size of a basketball to have minimal scarring after its removal.

These are mechanical devices not drugs. What could go wrong? Quite a bit apparently. Many candidates for hysterectomies have uterine growths called fibroids, and there are now suspicions that in as many as 1 case in 350 these growths are cancerous. And when you grind up a cancerous tumour inside the abdominal cavity, you . That’s what happened last year to 40-year-old , at the time an anaesthetist at a Harvard-affiliated hospital. She and her husband, then a surgeon at another Harvard hospital, where she had the surgery, have spent the past 12 months fighting to have the devices banned. She had been told the odds of fibroid cancer were 1 in 10,000.

Warning signs

In the last week of November, the US Food and Drug Administration (FDA) issued its long-awaited . In the end, it did not ban morcellators. Instead manufacturers were told to include a prominent warning on their products, saying that they should not be used in women near to or post menopause, or in any woman suspected of having cancer – in other words, the majority of those who will have surgery to remove uterine fibroids. The following day, , the largest for-profit hospital group in the US, said its facilities there would no longer use the devices. It has just banned them in its UK hospitals too. Though power morcellators are still in operating theatres, they will be .

This tale is the latest in a line of recent safety warnings about seemingly innocuous medical devices. There was the and the . All raise the question of whether approval systems are robust enough.

The morcellator story has chiefly focused attention on the US system, but similar questions will be asked elsewhere. In the UK, . Like many Americans, Reed and her husband, Hooman Noorchashm, believed that medical devices were carefully vetted. But when they started to look into how morcellators got on the market, and the kind of safety testing and follow-up that had been performed, what they discovered wasn’t comforting.

Safety last

The FDA has three categories for devices (not dissimilar to Europe), only one of which – Class III – requires . Those are things like implantable defibrillators and heart valves, and they are, as you’d expect, backed up with bench and animal science and clinical trials. They need pre-market approval.

But many more devices only need pre-market notification. Known as “510(k) clearance”, after the clause in the US law that permits this, the process involves simply showing that there are already similar devices on the market, so-called “predicate devices”. All manufacturers need do is notify the FDA before starting to sell these products. Many class II devices, such as artificial hip and knee joints, pacemakers, most contact lenses – and morcellators – come into use this way.

Take the morcellator that was used on Amy Reed, the Rotocut G1, made by Karl Storz Endoscopy. According to FDA , it was cleared on July 27, 2006. In giving it the go-ahead, the FDA wrote: “We … have determined the device is substantially equivalent … to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976 … or to devices that … do not require approval of a premarket approval application.” When asked, the FDA could not readily identify what the specific predicate device was, and told me I’d have to submit a freedom of information request, if I wanted to know.

Cleared without question

But it’s an interesting question. Given that the first power morcellators weren’t invented till the 1990s, using a predicate from before 1976 would be like arguing a sewing machine was “substantially equivalent” to a needle and thread. If its predicate is one of the first two power morcellators ever cleared for gynaecological use, it means the FDA has cleared dozens of devices used on hundreds of thousands of women based on testing in just 23 women. And that focused mainly on efficacy, not medium or long-term safety, demonstrating, for instance, the rate at which tissue was removed and the amount of blood loss.

510(k) clearance was supposed to be a temporary arrangement, but it has been in place for almost 40 years, and it doesn’t look likely to change anytime soon. About five years ago, the FDA asked an independent body, the Institute of Medicine (IOM), to look into whether the 510(k) process adequately protected patients and, if not, what would work better. The IOM committee’s was that 510 (k) did not provide protection, wasn’t designed to do so, and was so flawed that it should be scrapped.

It pointed out that there is no premarket safety testing, relying instead on a “weak daisy chain of predicates”, according to , a professor emeritus in health affairs at the University of Florida, Gainesville, and the man who chaired the IOM committee. The committee also highlighted the lack of mandatory post-market surveillance. After the report was published, there was pushback from industry, and nothing changed.

Fear of reprisals, institutional inertia and just plain laziness has made individuals reluctant to report their concerns, but Challoner still believes post-market surveillance is the best hope. The FDA has already begun attaching unique identifier codes to devices, he says, which, in time, will be scanned into electronic patient records. That will give us the data to at least do skilled and impartial post-market surveillance. “Something like that would have picked up this morcellator issue much sooner,” he says.

is a science writer based in Toronto, Canada

MY PATERNAL grandfather lived until he was 89; his brother outdid him by a decade. My grandmothers made it to 85 and 93. My parents are both alive and kicking at 73 and 82. The only people to die young in my family were killed in wars or industrial accidents. Maybe I am just clinging to the rosy bits, but this is the information I choose to employ when predicting my own longevity. I reckon the odds are with me, and I’m not interested in knowing if I’m wrong. My greatest fear about the timing of my death is that it will come many decades after I have exhausted my supply of money.

It seems I am unusual, however. Apparently many people are thirsting for a little extra information to help them calculate how long they have left. How else can you explain the burgeoning number of commercial enterprises promising to meet that desire? Already, gene-sequencing companies such as 23andme, deCodeMe and Navigenics can do a quick scan of your risk of developing everything from lung cancer to multiple sclerosis. Now two new firms are offering to tell us how well we are ageing, based on an analysis of structures at the ends of our chromosomes called telomeres.

If these developments continue, a person’s lifespan could become as quantifiable as the shelf life of a carton of milk. So instead of parading around blissfully unaware of how long we have left, we could find out our own use-by dates. For some, this knowledge would be a burden, while others may be glad of the chance to plan their future. But whether you find the prospect of being able to foretell your own death terrifying or enticing, how realistic is it? Are these new tests really a game changer? After all, we have long been able to test for life-threatening factors such as high cholesterol and blood pressure. And while a better understanding of the biology of ageing is bound to tell us even more, surely the date of one’s death will always remain the great unknowable?

This brave new age of scientific soothsaying began a few years ago with the invention of home genetics tests that promise to alert you to things that might contribute to your ultimate decline. It couldn’t be simpler. You order the kit online, receive it through the post, collect a cheek-swab sample of DNA while sitting on your own couch and then mail it off for analysis. The news comes back by email a few weeks later. In the interests of science I gave it a go.

You decide

I soon discovered a fundamental problem: the results are wide open to interpretation, making it easy to reconcile them with the views you already hold. Say you learn that, like me, you are one of those unlucky people whose risk of a heart attack goes up 60 per cent just by drinking a third cup of coffee every day. Bad though that sounds, the chances you will have a coffee-induced heart attack are still very low – and that it will kill you, lower still. Besides, if you scratch around enough, you can probably find something to offset even that small risk – such as your slightly lower-than-average odds of heart attack in general. That’s what I did. And I concluded that my grandparents might still be my best guide to my longevity.

To cut a long story short: except for finding out whether you are susceptible to a few single-gene killer diseases, an inventory of genes is not very informative for anyone wanting to know how long they have got. A big list of small risks simply is not going to tell you what your odds are of making it to 95, or even 60. Will something called gastric cardia adenocarcinoma be what takes me out – my risk of getting it is 0.08 per cent, compared with an average of 0.07 per cent? Or will it be the more common melanoma, which I am ignoring because my risk is 1.3 per cent, compared with an average of 0.7 per cent?

According to Timothy Caulfield, a bioethicist and lawyer at the University of Alberta in Edmonton, Canada, who has been looking into how people react to tests like these, my attitude isn’t uncommon. “People don’t seem to do much with this risk information,” he says. “They don’t freak out. And they don’t start exercising more, eating better or getting more screening.” This should not surprise us, he adds, since we have never responded much to other more traditional predictive information, such as weight, blood pressure and cholesterol levels.

In fact, our ostrich-like attitude to genetic warning signs may even be quite sensible. Eline Slagboom at the Leiden University Medical Center in the Netherlands and her colleagues found that healthy people in their 80s and 90s were no less likely than the rest of us to carry gene variants, or alleles, known to increase the risks of heart disease, cancer and type 2 diabetes (). “These people from long-lived families have exactly the same numbers of deleterious alleles,” she says. The difference, however, is that they probably possess other genes that keep the dangerous ones at bay. Although none of these have been identified so far, Slagboom and colleagues have discovered four separate areas of the genome that seem to be important. They suspect the critical genes will be unglamorous, controlling aspects of metabolism, inflammation and immunity.

At 23andme, I was tested for a “longevity trait” identified by the company. Apparently I don’t possess it and have merely typical odds of living to age 95 or 100. Again, I discount this. The trait is based on two studies of small numbers of subjects and controls, with ethnicities and genders that are different from my own. Even if it does correlate with longevity in some people, why should I trust the company, given that it got a few other traits wrong, including my eye colour and whether my hair tends to curl?

Accuse me of overblown scepticism if you like, but the most evangelical proponents of genetic testing cannot get around the fact that longevity is not simply genetic. It is largely down to myriad environmental factors, including lifestyle, the effects of which cannot be measured directly. At best, the particular genes you carry will only ever explain about 25 per cent of your propensity to live a long life, says Slagboom. So can the new telomere-based tests do any better?

“At best, the particular genes you carry will only ever explain about 25 per cent of your propensity to live a long life”

Like the plastic tips at the ends of shoelaces, telomeres keep your chromosomes from fraying and getting tangled up with one another. Every time chromosomes replicate during cell division the telomeres get a bit shorter. This process starts even before you are born and about a third of their length is lost in the first 20 years of life, says Calvin Harley, president and chief scientific officer of Telome Health, based in Menlo Park, California. As we age, the shortening continues – by about 9 per cent each decade, on average. It is not clear whether some people have a higher natural rate of loss but we do know that telomeres respond to lifestyle, and that smoking, heavy drinking, obesity and stress can all shorten them a little more quickly. That is bad news because short telomeres are associated with earlier death. One study by Richard Cawthon at the University of Utah, for instance, looked at their lengths in adults over 60. People whose telomeres were shorter than average for their age cohort were 3.18 times more likely to die of heart problems and 8.54 times more likely to die from infectious disease, than those who had longer than average telomeres for their age ().

It is easy to see why people trying to divine their own personal expiration date would be interested in knowing how long their telomeres are, and how they compare with other people of the same age. This is exactly the information offered by a Spanish company called Life Length, based in Madrid, which began selling its €500 test a year ago. Telome Health had also planned to offer a telomere test. Back in May, co-founder Elizabeth Blackburn – a Nobel laureate for her discovery of telomerase, the enzyme that stimulates telomere elongation – told żěè¶ĚĘÓƵ its test would be available for under $200 by the end of the year. However, Harley now says it will only be used for research purposes for the foreseeable future. He didn’t say why.

How short is too short?

Both tests base their analysis on measurements of the telomeres in a type of white blood cell called leukocytes. “It’s a good surrogate of what’s going on throughout the body,” says Harley. Both will compare the average length of your telomeres with those of your peers, although to begin with that comparison group will be very small. However, unlike Telome Health, Life Length also provides information about the abundance of critically short telomeres. This difference in approach highlights some key gaps in our understanding of telomeres. Harley says that most studies associating telomere length with health, use measures of average length. But Life Length scientists argue that the abundance of critically short telomeres – not averages – is what individuals really need to know about. Once they shrink to a certain point, telomeres can no longer do the job of capping off the chromosomes. Critically short telomeres cause cell death and ultimately senescence, says Maria Blasco, founder of Life Length and head of the Spanish National Cancer Centre in Madrid. However, even she acknowledges that there is a lot we don’t understand yet. “We need large population studies to find the actual meaning of telomere length,” she says.

Carol Greider at Johns Hopkins University in Baltimore, Maryland, who shared the Nobel prize with Blackburn, points out that there is no consensus yet on the best technique for measuring telomeres. In fact, her work on mice found no correlation between telomere length and lifespan () and she argues that little is known about how telomere length affects health and longevity in humans. “There’s a very wide distribution of telomere lengths,” she says, and they can vary a lot for any given age. If you fall below the first percentile, you are clearly at risk for age-related diseases, she adds, but the science hasn’t really established much beyond that. Greider concludes that telomere testing for the general public is premature.

So what about the idea that it can pinpoint your time of death? Harley plays down the notion, calling it “nonsense”. I had heard that a telomere test might be able to indicate a slim range – say, between ages 70 and 75 – with a 95 per cent chance of getting it right. But Harley insists it can only be used as an overall health indicator – a sort of “check engine” light. He likens it to a cholesterol test. I point out that at least with a cholesterol test, you know what you are measuring and so have some idea what to do if you get a bad result.

“If they could say 70 versus 90 with some degree of certainty, I think that would have an impact,” says Caulfield. People may alter their retirement age, spending patterns, travel plans and love lives. Their insurers and employers may make decisions based on this information, too, he adds.

For now, though, finding that you have short telomeres for your age might persuade you to adopt a healthier lifestyle, at best. I’m not convinced the test is for me. I already know to eat lots of greens, get lots of exercise and not live in the shadow of an industrial plume. My grandparents taught me.

An understanding of quantum gravity can only get you so far if your idea of communication is talking to your desk plant. Whether you want to stay in science or move elsewhere, having a robust set of transferable skills is essential for your career.

żěè¶ĚĘÓƵ looks at the ones you might want to arm yourself with.

Communication: Make yourself Understood

It’s not that scientists can’t communicate. Your very worth is measured in the number of papers published. Your livelihood hangs on carefully crafted grant proposals. Professional gatherings require you to present to rooms of people and guide strangers through the ins and outs of your posters. Let’s face it, scientists know how to communicate – with each other.

The problem comes when the rest of the world needs to know what is going on. The ability to convey ideas to lay people tops the list of skills scientists need if they want to be successful outside academia, says Cynthia Robbins-Roth, author of Alternative Careers in Science: Leaving the Ivory Tower (Academic Press, 2005).

The main problem, she says, is that scientists spend too much time speaking to people just like themselves. “You are talking to others who speak the language you speak,” she says. “You spend a lot of time with people who are focused on the same things you are.”

That leads not only to the widespread use of cliquish, specialist vocabulary, but also to the abandonment of context and logical connections. When speaking with the like-minded, there are common assumptions about what is obvious and well known, she says, which excludes outsiders.

“Communication is important whatever you do, but particularly in science,” says Justin Mullins, a journalist, including for żěè¶ĚĘÓƵ, who also co-runs a business called , which teaches scientists how to put their ideas down on paper more clearly. “The ideas are very complex. Being able to communicate them clearly is crucial.”

For many people, one of the upsides of choosing to study a science subject at university is that writing essays becomes a thing of the past. True, you might have been taught the rudimentary structure of a lab report or scientific paper but being trained to write well was usually left to the arts students. “Young scientists are expected to learn to write by osmosis,” says Mullins. He gets his pupils to organise their thoughts before they start writing them down, asking them to think about the structure down to each sentence.

Most of Mullins’s clients have been in Germany. But since 2002, British universities have been focusing much more on developing transferable skills like communication. This is thanks to a report by Gareth Roberts, which looked into ways to foster science, engineering and innovation, and a £185 million fund that was set up in its wake to help pay for skills training. This money runs out in April next year so take advantage of it while you can, says Stephen Tarling, head of talent management at the University of Southampton.

Many universities are now offering writing courses for their students and researchers. Others go further, giving training on presentation skills as well, recognising that effective communication requires a person not only to get across the technical details of their research, but also to convey an enthusiasm about the work. The University of Southampton, for instance, is among 18 British universities that have hired a company called to help researchers become better presenters. They use acting techniques to give researchers the confidence to let their personality shine at the lectern.

People skills: Sell yourself

Even if you find it easy to get the message across, there is another hitch. In academia, your ideas sell you. In the non-academic world, the opposite is true: you have to sell your ideas. It is not enough to come up with good ideas and demonstrate them to people who largely understand what they are about.

To cross the street from academia into the world beyond requires scientists to pitch ideas and themselves, build alliances and network. In short, people skills are essential. Building relationships, listening well and resolving conflicts are important people skills, says , a professor of healthcare administration at Simmons College in Boston, and author of the book Managing żěè¶ĚĘÓƵs (Wiley-Blackwell, 2004). “It is not rocket science to name them,” she says, “but it is to learn them.” Sapienza thinks that training courses could help scientists learn people skills but it has to start early.

Those who are not able to engage with others and market themselves will not be successful in the commercial world, says , a senior advisor at MaRS, an organisation based in Toronto, Canada, that helps transform scientific ideas into commercial enterprises.

McCulloch left academia in 1994 to join a company that invested in the life sciences and was “blown away” by the difference in culture. Anyone thinking of leaving the lab for the world of business or government should consider volunteering or doing an internship first, McCulloch says, just to see what the culture is like. “You might like it,” he says. “Or you might hate it.”

Teamwork: Play well with others – even if they are different

You only have to look at the number of authors on the average science paper to see that collaboration is a big part of research. Yet the ability to work in a team is often identified by companies as a skill that researchers lack. Why is this? The main problem is that teams don’t get tenure, individuals do, says Edward O’Neil, head of the Health Care Leadership Program at the University of California, San Francisco. In academia, he says, “you eat what you kill”.

The organisation , which helps scientists advance in their careers, recently brought out a to sum up the knowledge, behaviour and attitude that researchers need to be effective. In it, “working with others” is listed as a critical skill. The report also highlights the importance of recognising other people’s contributions to a team’s success, as well as the need for researchers to respect differences and work well with people beyond academia. These are two stumbling blocks many researchers routinely face.

“żěè¶ĚĘÓƵs are used to working with very like-minded people, sometimes extremely so,” says McCullough. “If you are a geneticist, you spend a lot of time not just around scientists but around geneticists – and almost no time around accountants, lawyers and marketing people.” But if you want to commercialise your scientific idea, then these people are vital.

Keri Damen, also at the MaRS Centre, says that there can be tensions between the technical and sales teams at a research-based company. “The sales people may be motivated by different things,” she says. “They are a different breed of person.” That is why they are good at selling things – and you are not.

Damen, who encounters a lot of scientists who want to launch their own companies, confesses that it is often hard to convince them to hire people with specialist skills in finance, human resources or sales. Many think they can do it all themselves, she says, or they want to hire people just like them.

Collectivism: No more lone genius

The toughest challenge of a switch from academia to the corporate world may be accepting your new identity. No longer are you working for your own glory. Instead, you are a part of a greater whole – and it is not your intelligence that will be valued the most. I know, I know. All your life, from your early school days to well past your postdoc, you were encouraged to believe that being the smartest, the most innovative, the most creative – in short, the best – was what was going to get you somewhere. But outside the lab, the rules are different.

“What is valued in academia is knowledge and insightful ideas,” says McCulloch. You do good work, you publish papers and that makes you successful in raising funds, so you get a permanent position. But in business you are part of a collective, and it is the entire collective that needs to function well.

Your contribution is just one small part of the whole. “At the end of the day, all that matters is that the enterprise is successful,” McCulloch says. This comes as a shock to many research scientists who make the switch. “As a scientist, I had been trained to figure out the closest thing to the truth,” says Robbins-Roth, who had a hard time figuring out where she fitted in when she first arrived at biotech start-up, Genentech. “Your job is to be an asset to the company – to help the company do well and meet its goals,” she says. It doesn’t matter how amazing your work is; what matters is how well you help the company with its agenda. “If you cause more trouble than you’re worth, it won’t matter how smart you are,” Robbins-Roth says.

żěè¶ĚĘÓƵs leaving academia need to nurture humility, says McCulloch. “Business people don’t get huge accolades for being smart, but for being effective,” he says. That is measured in things like increased sales, increased earnings and an increased number of licensing agreements. Not, alas, by the fruition of one employee’s great idea.

Management: Lead the team

People who rise to management positions in academia get there on the strength of their ideas, not on the strength of their management skills. If they happen to be good at managing, that is an added bonus and one that is not always necessary. That is because good research underlings shouldn’t need a lot of management. “The whole principle of academic research is independent research,” points out , also at MaRS. As an up-and-coming researcher, you are supposed to be finding your own path, not simply following orders.

Unlike in academia, management in the commercial world “is not just sitting down and scratching heads collectively about technical problems”, says Redpath. Nor is it doing the important work yourself and getting the others to be your worker bees. It is about overseeing the use of time, money, resources and personal talents to ensure they are being used in the pursuit of a common goal.

According to a carried out in 2010 by Vitae, only 32 per cent of PhD students were still working in research three years after gaining their doctorate – so two-thirds must be doing something else. Yet a study to be published in early 2011 by the found that while companies are interested in hiring people with both managerial and scientific skills, they are in short supply.

The problem is that scientific institutions don’t see it as their job to prepare scientists for the management part of their future career. “Traditionally there has not been much training in management and leadership,” says of King’s College London, which is trying to fill that gap through courses and workshops.

It is a situation that doesn’t make sense, says Sapienza. “Why would you expect somebody to be confident and competent manager if they have no training?” she says. “You wouldn’t ask someone without skills in mass spectrometry to do that bit of an experiment.”

Currently, much of the hands-on experience has to be gained outside academia. Organising annual conferences, running monthly meetings and managing people in a volunteer capacity are all ways scientists can gain some management experience, says Redpath. Price suggests keeping track of all your skills and experience, such as courses completed, duties taken on and hobbies that involve working in a group. You may find you have more experience than you realise, she says.

What is really needed, says Redpath, is a change in how scientists are educated. Skills like project management should be seen as course components for scientists in the same way that chemistry is for nurses and pharmacists. But in the US and Canada, management courses never seem to be de rigeur. “Business schools want $30,000 for that,” he says. In the UK, many universities offer science degrees with some integrated management component, but these are not compulsory.

Redpath points out that when he studied chemistry in the 1970s, he was required to learn a second language in order to graduate. “I don’t see why we can’t replace that with a management course.” It would simply recognise the skills needed to be a well-rounded research scientist these days.

The disease, caused by the bacterium Bordetella pertussis, is spread via coughing or sneezing and is highly contagious. On average, one infected person can spread the disease to 12 to 17 others, says at the University of Texas Medical School at Houston.

Eight people have died of it in California so far this year, and some 3000 cases have been reported – seven times the number over the same period last year. Idaho, Texas, South Carolina and Michigan have also reported increases.

at the University of California, Los Angeles, Medical Center says this looks set to be a particularly large outbreak, but it is not totally unexpected. Outbreaks occur every two to five years because the vaccine given to children is only 80 per cent effective and only protects up to about age 10, he says. What’s more, few adults receive boosters.

The greatest danger is to unvaccinated infants: seven of the eight deaths in California were babies under two months of age.

Some areas of California are vaccinating all family members who might be in routine contact with a baby in its first months – a strategy called “cocooning”. But all adults could do their part to minimise the outbreak, says Mazur. “Take a look at your immunisation record,” she says.