Pharma companies vs. Clinical Studies

Despite the laudable trend of moving towards evidence-based medicine (at least in clinical practice), Pharma companies seem content to stay with profit-based medicine.

Read this excerpt from the NYT to see what I mean:

Two widely prescribed cholesterol-lowering drugs, Vytorin and Zetia, may not work and should be used only as a last resort, The New England Journal of Medicine said in an editorial published on Sunday.

The journal’s conclusion came as doctors at a major cardiology conference in Chicago saw for the first time the full results of a two-year clinical trial that showed that the drugs failed to slow, and might have even sped up, the growth of fatty plaques in the arteries. Growth of those plaques is closely correlated with heart attacks and strokes.

Merck and Schering-Plough, the companies that make Vytorin and Zetia, said on Sunday that despite the results of the trial, they would continue to promote their medicines as first-line treatments for high cholesterol.

The medicines are among the top-selling drugs in the world, with total sales of about $5 billion last year. About four million Americans take them.

You can read the rest of the article here.

How To Use Readability Formulas To Help You Write Better

By Jesse Dawson (Guest blogger)

We can dissect the term "readability" into "read" + "ability," which translates into the ability to read. Readability has nothing to do with either legibility or literacy. In fact, readability is more of a judgmental exercise for the targeted audience. George Klare (1963) defines readability as "the ease of understanding or comprehension due to the style of writing." We can consider readability as means to measure the difficulty of text or page layout, so the writer knows how effectively his text will reach his target audience before he publishes or distributes it.

We can assess readability through readability tests by applying readability formulas. Readability formulas are mathematical in nature; each formula's primary aim is to measure the grade level a person must have to read and comprehend a text. Writers consider readability formulas as simple ways to judge read-ability, i.e., the difficulty level of a text.

Readability formulas measure certain features of a text based on mathematical calculations. We base these readability measures on a handful of factors; the most common factors include the number of words in a sentence, as well as the number of letters or syllables per word. Most readability formulas are based on one semantic factor (i.e., the difficulty of words), and one syntactic factor (i.e., the difficulty of sentences). We don't need to calculate other factors, as they tend to make the formulas more complex and achieve little in return.

Another fact about these formulas is that you don't need readers to read out (or try to read out) the text. However, readability formulas don't always work with 100% accuracy.

Importance of Readability Formulas

It requires a great deal of effort to come up with some kind of text. This text may be unique in its contents, yet it fails to serve its purpose of making the reader understand and use it. The problem many writers face is how to assess the "readability" of their text. Readability formulas offer the solution. By applying these scientific and mathematical principles, the readability formulas aim to present an objective analysis about the readability of a particular text.

Commonly Used Readability Formulas

Researchers and writers have been using readability formulas since 1920 and, over the years, they have spent a lot of time devising the most accurate and scientific formulas to assess readability. Some of the popular and commonly used formulas include:

1. Rudolph Flesch's Reading Ease Formula; 2. Flesch's Grade Level; 3. J. Peter Kinkaid's Flesch-Kinkaid Index; 4. Robert Gunning's Fog Index; 5. The SMOG Readability Formula; 6. Fry's Readability Graph; 7. New Dale-Chall Formula; 8. Powers-Sumner-Kearl Readability Formula; 9. FORCAST Readability Formula; and 10. Spache Readability Formula.

Why Use Readability Formulas?

Despite their much-criticized shortcomings, many organizations consider readability formulas an important tool to evaluate the readability of text. Here are reasons why you should use readability formulas:

1. Most Americans have limited reading ability, which means their reading grade-level balances between average and poor. It makes sense to prepare text in plain English if your readers have limited reading capabilities. How do you determine if your text is readable from your readers' point of view? Simple. Use readability formulas.

2. If the text is not readable, the purpose of writing it in the first place gets defeated. For instance, let's assume you've written an instruction manual for your employees. If your employees cannot read this manual, they will never understand the true meaning of its contents; this will adversely impact their productivity. Using readability formulas can prevent such a scenario and tell you beforehand if your text is of any value to your employees.

3. Readability formulas help you to prepare a readable text. In other words, these formulas can save you time and money that you might have wasted in writing a complicated document, which is not useful for the target audience.

4. Just imagine how frustrated your target audience feels trying to read an ill-prepared document. Studies show that enforcing difficult text can have adverse effects on the overall mood and psychology of your customers. They may feel confused by a clumsily prepared text and opt for another provider.

5. Preparing text costs money. If you produce an unreadable text, you are increasing your organization's operating costs. By using readability formulas, you are almost 80% sure that your readers find your text useful; thereby, keeping your costs down.

6. Most reputable word-processors, like MS-Word, have a built-in readability formula feature that helps you to assess the readability of a document. If you can gain such a useful insight into the document without manually calculating the readability, why won't you use it?

The underlying message of each formula is the same: if you use shorter, average sentence lengths and fewer big-lettered words, you can reduce the reading level and increase the speed and ease of reading.

Jesse Dawson recommends using StyleWriter (http://www.StyleWriter-USA.com), a plain English style usage checker, to help simplify your writing. Dawson is the author of "Can YOU Read Me Now?," a free e-book on using readability formulas to write better, available at www.ReadabilityFormulas.com.

Health Insurance for Freelance Writers (Again)

I think this is my third post about this topic in the last year, but, hey, it's an important one (Read the other posts here and here). If you are a freelance medical writer in the United States, finding good, affordable health insurance is a must.

Check out this article in the NYT, and visit the sites they mention. Perhaps there is something for you.

Health and Web 2.0

During the National Immunization Conference last week, I heard a CDC communications specialist talk about the new ways to communicate health information to the public. CDC, for example, is experimenting with podcasts, widgets, and even cyber communities like Second Life.

Certainly the web is changing the way people obtain health information (read this article in the NYT and you'll see why). Medical writers should take notes. We may feel cozy writing the same old research papers and patient handouts, but there is more than that. Perhaps it is time we try something new. That's what I'm going to do!

Ineffective Drugs and the FDA

I just came across an interesting little piece in Slate about the herbal medicine Airborne. I may be biased because of this terrible cold I have right now, but I think the author is right. We shouldn't let untested, ineffective drugs clog the market.

Check it out and see what you think.

P.S. I'll be out of town at the National Immunization Conference next week, so I may not post anything for a week.

New Bonus for Becoming a Medical Writer

Last December, I posted a note about some updates I was going to add to my ebook, Becoming a Medical Writer. Well, the ebook is now updated with the latest salary information for medical writing jobs in the US and Canada, and has even more information on educational opportunities for medical writers (including online courses).

Plus, I have added an exciting new bonus for those who buy the book: The Concise Guide to Technical Writing by Susan Bilheimer (who wrote the latest post--see below). Susan is a successful technical writer with many years of experience in the field.

Although medical and technical writing are fields on their own, they sometimes intersect. For instance, if you work for a medical device company, you will need both medical and technical writing skills to develop a device's manual.

So, if you haven't gotten a copy of my book yet, check out www.becomingamedicalwriter.com to see if it is for you.

Breaking into Technical Writing

By Susan Bilheimer (Guest blogger)

Would you like to earn steady, dependable income as a writer?

If you answered yes, consider technical writing. It isn't sexy, and it won't make you famous. But working as a technical writer has provided me with an excellent, steady income, and greatly increased my creative writing skills.

The field of technical writing is exploding, due to the need to keep up with advancing technology, so there are plenty of opportunities. After all, SOMEBODY has to write the instructions for all the products and services we use. And age is NOT an issue! I began my technical writing career in my 40s, and know plenty of technical writers who began in their 50s.

In 2004, according to the Society for Technical Communication (from the U.S. Department of Labor's Occupational Outlook Handbook), the median annual salary for entry level technical writers was $42,500. The median annual salary for midlevel nonsupervisory technical writers was $51,500, and for senior nonsupervisory technical writers, $66,000. Rates for contractors are always higher at each level. In fact, I've earned as much as $38/hour.

While you do need good writing skills and the ability to communicate instructions clearly to become a technical writer, you do not need a specialized degree or certification. And you can begin in this field at any stage of your life. While some technical writing jobs will be way above your skill level (I’d never write a medical or legal manual, for instance), there are many types of documentation that may fit in with your own background (for instance, a former HR professional could write a Human Resources manual or a former accountant could write the documentation for a new Accounts Payable system).

Here's the best news: more and more, technical writers telecommute ... every writer's dream. In fact, I’ve worked remotely part-time or full-time since 2000. But don't get too excited yet. You will most likely have to earn this privilege by establishing your reputation first.

So, how DO you break into the field?

First, look at existing examples of technical writing, such as the Help section of programs you use, or even your car's owners' manual. You'll soon find that technical writing is simply documenting steps clearly.

Next, think about instructional writing experience you may have. If you've never written instructional material, do some on your current job. Volunteer to write instructions on office procedures, a quick-start guide for the voicemail system, or a how-to article for the company newsletter. If you aren’t currently working, I’ll bet you can get an opportunity if you offer to provide such services for free to a local business or non-profit organization.

Next, rewrite your resume, adding in this new experience. (But ALWAYS be honest. You’ll inevitably be tripped up if you don’t. It’s not worth the embarrassment.)

You'll need two copies of your resume. One will be nicely formatted. You'll present this resume to potential employers or when you mail the resume. The other must be saved as text. This is the copy you'll place online. (TIP! Use asterisks [*] instead of bullets in the Text Only copy.)

Next, the job hunt begins. Most job opportunities for technical writers are located online (see listings below), but newspaper Help Wanted sections are also a source. Check the online website for your local newspapers for jobs.

Here are some suggested web sites:

• CareerBuilder
• Monster
• Dice
• Jobsearch
• ComputerWork
• Guru

Since these are technology-oriented sites, entering "writer" in the search box will return technical writing jobs. Tip: You may even think about putting yourself on www.elance.com or even www.craigslist.com. Though there is a lot of competition, if your rates are reasonable enough, someone may just give you a chance.

Many sites allow you to place your resume online. Be prepared to spend some time (about 45 minutes) filling out questions on the forms. Once your resume is online, it's very likely that you will receive calls or emails from recruiters requesting more information, and maybe an interview, even if you are just starting out! Remember, recruiters make money by getting you hired and are hungry to find good talent.

So if you have writing talent, open your mind and increase your income by becoming a technical writer!

For more information on becoming a technical writer, check out Susan Bilheimer's website, www.becomeatechnicalwriter.com

Vaccines, Autism, and the Communication of Science

Just a few days ago I was working on an article about the National Vaccine Injury Compensation Program (VICP), so I became very familiar on how the court works. This is an excerpt of what I wrote:

The VICP compensates people a federal court determines to have met legal standards for having been injured by vaccines; these standards do not need to meet the standards of scientific causation. People who file claims are not required to prove negligence on the part of the health care provider or the manufacturer.

Funds from a tax on each dose of vaccine are placed in a trust fund to be used to pay the compensation awards.

The VICP is a no-fault alternative to the traditional tort system. The U. S. Court of Federal Claims decides who will be compensated. Some are compensated based on the Vaccine injury Table.

The Table—developed by a panel of experts—consists of a list of injuries and conditions presumed to be caused by vaccines, and the time periods in which the first symptom of these injuries and conditions must occur after receiving the vaccine. Unless a different cause is found, the court presumes that the condition was caused by the vaccine if the first symptom occurs within the listed time periods.

Earlier this week, a media report started circulating saying that a federal court had conceded that vaccines caused one child's autism. It turns out that the government cannot discuss the details of the case (for obvious privacy issues) so it cannot respond directly to the claims in the media. But here's what the Health Resources and Services Administration said in a press release:

HRSA has reviewed the scientific information concerning the allegation that vaccines cause autism and has found no credible evidence to support the claim. Accordingly, in every claim submitted under the Act, HRSA has maintained and continues to maintain the position that vaccines do not cause autism, and has never concluded in any case that autism was caused by vaccination.

HRSA will present its views on the allegation that vaccines cause autism in an "omnibus" autism proceeding in May of this year. The expert testimony in that proceeding will be available to the public, with the consent of the parties.

So what is this all about? In short, the court conceded that a nine-year-old Georgia girl's mitochondrial condition was worsened by the five childhood vaccines she was given on a single day eight years ago, leading to problems with brain function "with features of autism spectrum disorder."

As I said, all the details have not been released yet, but from my conversations with some of the people involved I assume that the Court awarded the claim based on a condition listed in the Table, such as encephalopathy. If you think about it, many brain function problems can be labeled as leading to ASD features--poor language and social skills, etc.

Does that mean that vaccines cause autism? Hardly, given the overwhelming scientific evidence collected so far that shows no causal association between vaccines and autism (See more info here).

This is a tricky vaccine risk communication issue, especially with the constraints that HRSA has in discussing the case and the complexity of communicating the role of the child's mitochondrial condition.

P.S. Here's a CNN article about this.

Call for Posters: AMWA Annual Meeting

AMWA has extended its deadline for poster proposals until March 20, 2008. From the AMWA Web site:

Do you have a good idea or some information that could enrich medical communication, or some research findings that would interest your fellow AMWA members, but not enough time to write a paper or create a formal oral presentation? Then don’t miss your opportunity to develop a poster for display at the 2008 Annual Conference.

The posters are designed to allow medical communicators to share their recent innovations, advances, and discoveries in editing/writing, education, freelancing, public relations/marketing, the pharmaceutical industry, and scientific research.

This year, for the first time, we are also soliciting poster presentations of empirical research that may be of interest to AMWA members, such as research in the medical sciences and in the areas of language and learning.

See more information and guidelines here.

How to Write a Lead-Generating White Paper for a Medical Device

By Alec Alpert (Guest blogger)

Unlike other products, a medical device presents unique challenges to a white paper writer. For example, writing methods that effectively sell car transmissions are ineffective for selling radiation therapy systems to hospitals. Why? Because a medical device directly interacts with human bodies, and therefore gives rise to risks of injury. Actually, the main concern of medical device manufacturers is to mitigate the risks to patients or users while delivering the maximum possible benefits. Hence, when writing for the medical technology industry, a writer enters a highly regulated world where even marketing collateral tends to be written in an academic style.

This means that to write a successful medical device white paper, a writer needs not only good writing and marketing skills, but also a thorough knowledge of engineering and the regulatory environment. A writer should be able to grasp the complex science and technology behind the device, and translate them into persuasive writing without any hype. The paper must appeal to the logical mind of scientific readers, not so much to their emotions, which is the opposite of methods used to sell consumer goods.

A lead generation white paper for a medical device is a hybrid between an educational essay and a sales brochure. It educates and gracefully sells at the same time. The writing process starts with determining the topic, the released device, or the scientific principles and technology used (or to be used) in the device.

The next step is to identify the ideal target reader. This is crucial. The writer must clearly see who the paper's audience will be. A medical device paper is usually written for a diverse audience of professors, doctors, medical physicists, scientists, technologists, hospital administrators and regulatory agencies. Knowing the audience sets the paper's level of sophistication, scope, tone, structure and vocabulary.

In the case of a medical device, a white paper usually talks to two predominant groups. One includes readers with a scientific mind who are mainly interested in the device's features and an in-depth analysis of its technology, often at the atomic level. The other group comprises administrators looking to grasp a device's business benefits and see how it can save labor, cut costs and improve regulatory compliance. Hence, a writer is challenged to strike a balance between discussing a device's benefits and features. In fact, it is not unusual for a writer to be pulled in opposite directions by a device's manufacturer; engineers and scientists want a technical paper, but marketing managers want a sales document. It's vital to get the balance right.

So how is a writer to successfully resolve this dilemma? A good starting point is to prepare an outline of the paper and discuss and approve it with the manufacturer. The writer, however, should advise these people that a lead-generating paper needs to focus on a device's benefits, rather than just its features, or how great the company is. The outline will establish the paper's direction, focus and final destination before the writing even begins.

Once the outline is approved, the next step is to interview subject matter experts who have an intimate knowledge of the topic. They are the design engineers, scientists and other professionals working for the medical device manufacturer. Nobody knows the device better than the people who designed and made it. For this reason, a writer must take these interviews seriously and allocate sufficient time for them. He has to polish his interviewing skills and prepare for the interviews well in advance.

Besides interviewing, a writer should also access the relevant product documentation. The law requires all medical device manufacturers to maintain a Design History File, which contains product development documents, such as product specifications, drawings, validations, operator manuals, and so on. Many questions also can be answered by simply searching the Internet. And, of course, a library or bookstore also provides valuable information.

What is a white paper's structure? It naturally begins with the title which is a crucial part of the paper. This can make or break the paper, and must be relevant, compelling, and engaging, enticing the readers to read further. It should be simple and focus on the benefits that the device delivers.

Then comes the first page, which sets the stage. The remainder of the paper evolves from the first paragraphs. The paper can be only as good as its first page. Readers will continue reading only if the first page convinces them to do so.

The rest of the paper is divided into manageable sections. As with any writing, the process is repetitive: writing drafts, refining, editing, and re-editing many times until the paper is nearly perfect. The writer must stay focused on appealing to the target audience, and strike the right balance between the benefits and features.

Sentences and paragraphs have to be concise, with wide margins around the page. Bullets and headlines should be used generously, instead of long passages of uninterrupted text. The paper needs to be laid out so that a reader can quickly grasp the gist of it just by scanning the sub-headlines.

The end of a white paper is a call to action, which asks readers to contact the manufacturer for a meeting, demonstration, evaluation, analysis, discussion or some sort of next step(s).

A lead generation white paper is typically 5 to 12 pages long, and mostly comprises text with minimal graphics.

Alec Alpert is a business-to-business copywriter specializing in white papers, case studies and articles for medical technology. Visit www.alecalpert.com to learn how his copy can turbo-charge your lead-generation campaign.