February2007

Top clichés of 2006

Feb 16, 2007
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The Wall Street Journal has published a list of the top clichés of 2006 based upon the number press citations. The undisputed leader, with 21,430 citations, was “at the end of the day.”

This was followed by such examples as “level playing field,” “time is running out,” and “outpouring of support.”

Clearly, the WSJ is “thinking outside the box,” although that tired phrase didn’t make the list.

How Australia’s drug approval process works

Feb 16, 2007
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By Mary Gabb

The Therapeutic Goods Administration (TGA) – the regulatory agency for medicines, medical devices, blood, and tissues in Australia – is part of the Department of Health and Ageing.

As a result of the Therapeutic Goods Act of 1989, the Australian Register of Therapeutic Goods (ARTG) was formed; it’s a database of information about therapeutic goods for humans that are “approved for supply in, or exported from, Australia.”

Therapeutic goods are those associated with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury; influencing, inhibiting or modifying a physiologic process; testing the susceptibility of persons to a disease or ailment; influencing, controlling or preventing conception; testing for pregnancy; or replacing or modifying parts of the anatomy.

The TGA outlines the requirements for inclusion in the ARTG as well as regulations on advertising, labelling, product appearance, and appeal guidelines. Requirements for safe storage or for scheduled substances are subject to State or Territory legislation.

Medicines included in the database are either registered (ie, higher risk medicines: prescription medicines, some nonprescription medicines) or listed (ie, lower risk medicines: some over-the-counter medicines, herbal medicines, ayurvedic, traditional Chinese, Australian indigenous medicines, other complementary medicines, vitamins and minerals, nutritional supplements, homeopathic medicines, and aromatherapy products).

When each medicine is approved for marketing, it is assigned either an AUST R number (registered) or AUST L number (listed medicines).

Drug review
During the review process, the TGA requirements for data follow those for the European Union; however, they will accept US dossiers (by prior agreement) for high priority drugs (eg, drugs to treat cancers).

Postmarketing activities of the TGA include investigating reports of problems, laboratory testing of products on the market, and monitoring to ensure compliance with the legislation. For these activities, the TGA has a problem-reporting system, a recall unit, and the Australian Drug Reactions Advisory Committee, which publishes a regular bulletin.

Coping with information overload

Feb 16, 2007
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By David Woods

62A little more than a decade ago, if you’d used words like google, blog, spam, email, internet, iPod, PDA, instant messaging, Blackberry (unless referring to the fruit) and e-zines, people wouldn’t have had a clue what you were talking about. In fact, this e-zine would have been almost impossible to produce… with its “home” in the United Kingdom and its editor in the United States.

Today, it’s not just that those items simply exist, but that they are growing exponentially – and creating information overload.

Consider for example a study by Professor Peter Lyman of the School of Information Management and Systems at the University of California, Berkeley; and Professor Hal R. Varian, of that University’s School of Information.

They note that the amount of new information stored on paper, film, and magnetic and optical media has doubled in the past three years. Instant messaging generates 5 billion messages a day, they say, and email generates 31 billion communications annually, or double the number in 2003. That’s 400,000 Terabytes of new information worldwide: a mere 2 Terabytes represents the content of an entire academic research library.

And it’s not that all of this overload has simply replaced paper. The researchers note that it takes 786 million trees to produce the world’s paper supply. Not only that, but more than 90% goes to produce office documents. Worse, it’s said that the average office worker is interrupted every three minutes by a phone call or an email.

How to cope with this avalanche of information without being buried in it?

There are several strategies for getting the information you want, and avoiding what gets in the way of finding it:

  • Have a clear purpose
  • Plan ahead
  • Prioritise
  • Don’t be tempted to go down blind alleys
  • Eliminate noise and interruptions
  • Use email filters
  • Use search tools effectively
  • Use abstracts, synopses, and executive summaries where possible.

Bruce DeBonis, a senior executive with international financial and advisory services company PriceWaterhouseCoopers, has a personal approach to information overload: “I tell the people who report to me,” he says, “about email and voicemail etiquette: put the action item in subject heading; use voicemail more. Pick up the phone and call; don’t be phone-phobic. Email can be cumbersome if it’s not streamlined and specific.”

Remember Sisyphus, who was forced by the gods to push a huge rock up towards a mountain top whence it would roll back down again? Don’t let information overload get you down. Keep focused and keep cool!

The rewards of research

Feb 16, 2007
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by David Woods

The chance to generate new knowledge, to resolve healthcare problems, to benefit mankind – perhaps even to acquire in the process a Nobel Prize and a measure of immortality – ought to make healthcare research a popular, even glamorous endeavour.

But it’s rarely perceived that way. What’s vital, says one ranking academic, is for would-be researchers to develop a “constructive discontent” about the state of knowledge in their particular field.

Another notes rather dryly that research is “narrow, slow, dirty, and inadequately funded, while offering few opportunities and while being conducted by sterile, reference quoting people.”

In fact, the stereotype of the researcher as a determined individualist working in solitary confinement may once have been true; these days, though, with research becoming ever more sophisticated, collaboration is essential. In fact, a large part of investigation is communication with other people.

The fact is, though, that there is money for well-planned, exciting, meaningful and original research. Still, some potential researchers are confused about the application process, or about which of the several agencies they should approach. Some may even be deterred by a notion that the scramble for financing is fiercely competitive, so they have to learn where to begin.

Getting started involves fuelling your idealism and scientific curiosity as early as possible. What that means is being acutely observant, asking intelligent and appropriate questions, gathering all the clues or data and drawing valid conclusions to solve a given mystery.

This begins with an unsolved problem… followed by asking the right questions about it, then developing a working hypothesis and a well reasoned theoretical answer. After that come the protocol, design, method, subjects and equipment for the investigation. And finally the data can be interpreted to answer the original question.

Good clinical investigation can elucidate the cause of the disease, reveal areas of inadequate knowledge and persuade a researcher to ask the basic question and thus get into the research cycle with experimental work. As the president of a British pharmaceutical company is reputed to have said: “You can’t ask mice if they’ve got headaches.”

Nonetheless, research isn’t simply about hard data. Many great discoveries owe themselves to serendipity – to chance, to lucky breaks. One example is Minoxidil. Originally discovered and used as an antihypertensive, it turned out to generate hair growth in its users… and became in addition a blockbuster treatment for baldness. Even so, as has often been said, serendipity comes to the prepared mind, to the researcher who expects the unexpected.

In essence, then, you’ll need to make the theory fit the facts, not the facts fit the theory; you’ll need a thirst for knowledge, and what one prominent researcher calls “a spirit of discontent.” And you’ll need partners.

To be successful you must be highly professional: develop your methodology to a fine pitch, and know unerringly what’s relevant. The professional sets out to answer a question; the amateur sets out to prove something.

Finally, make sure that some proportion of your reading relates to research articles – not just reviews, but specific reports of research activity in areas where you have a particular interest. Go to it!

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