New England Journal of Medicine 2009 (Vol 361 No 25) Contents Page

Fade Fave: A Novel Influenza A (H1N1) Vaccine in Various Age Groups

Fade Skinny: This article looks at a clinical trial which evaluated the safety and immunogenicity of a split-virus, inactivated candidate vaccine against the H1N1 virus

(Print subscription held at Fade Library)

New England Journal of Medicine 2009 (Vol 361 No 24) Contents Page

Fade Fave: Dabigatran versus Warfarin in the treatment of Acute Venous Thromboembolism

Fade Skinny: This article looks at a random, double-blind trial involving patients with acute venous thromboembolism to establish whether dabigatran may act as an alternative to warfarin.

(Print subscription held at Fade Library)

Hey all,

Sorry that it has been so long since my last post.  I have been super busy some days, not feeling so well other days, and just finished Cycle 6!  I am a quarter through the Clinical Trial! 

Also, I had a girl’s night dinner at my house so you know I was busy scrubbing and frantically shoving mass quantities of junk into closets.  I am super excited and getting ready for my upcoming trip to Mexico.  My good brother is watching the house and taking care of the cat children.  Supposedly the resort has free internet so I plan some serious updates from Mexico…at the very least a photo story describing our days. 

Have a wonderful holiday season and here’s to blogging to you soon from Mexico.

Feliz Navidad!

KPS Clinical Services Pvt. Ltd. is pleased to announce the enrollment notification of Professional Diploma in Clinical Trial Management (PDCTM) for the Jan 2010 (8th Batch).

PDCTM is India’s premier Clinical Trial Methodology & Management training program in the auspicious of RAHE group, having an excellence in the health care field as Enrollment of >550 candidates from 228 Cities across 21 States of India and 4 Countries across overseas.

The Fee of this program is Rs. 7800/- and the last date of application is 25th of Dec. 2009. Application form can be downloaded from given web link http://www.kpsclin.com/cliical-training.html

Website: www.kpsclin.com

It doesn’t happen very often but for the fourth time this year FDA has issued a NIDPOE letter, Notice of Intitiation of Disqualification Proceedings and Providing Opportunity to Explain. This is only for the most serious breaches of FDA regulations by a clinical investigator. The most recent letter is to Dr. Daniel Berger of Chicago. The letter lists some very serious charges against Dr. Berger. The first one is:

“1. You repeatedly or deliberately submitted false information to the sponsor in a required report [21 CFR 312.70(a)].

Multiple documents contain falsified information. For example:

a. For Subject 010414, the following forms contained fraudulent signatures, which represented that the forms were signed by one of the sub-investigators: Northstar Healthcare form dated 7/29/08, Inclusion Criteria form dated 7/29/08, Exclusion Criteria form dated 7/29/08, Assessment of (b)(4) Illnesses/Events form dated 7/29/08, Medical/Surgical History form dated 7/29/08, Physical Examination form dated 7/29/08, and the report for the EKG performed on 7/29/08.”

The list goes on from there. There really isn’t much to say if the charges can be substantiated. The Blog is unaware of Dr. Berger;s respone, if any. It will probably come from his attorney. I have trouble inserting links into a post (thanks, WordPress). I will try it below and also on the Blogroll to the right under “1 FDA NIDPOE Letters.” This should be on everyone’s bookmark list.

Not so long ago,  I said:
“In my memoirs of deaning, I had written, ‘I would find myself thinking, Now I’ve seen everything; nothing can surprise me anymore, only to experience a novel surprise the next day or the next week’”.
That was in connection with an FDA panel recommending that the purported but unproven anti-cervical-cancer vaccine, which has been reported as responsible for some serious “side” effects including deaths, should be made available to vaccinate young boys to protect them — supposedly, unprovenly — against the less-than-worrying possibility of genital warts. I say “unproven” because the vaccine is only claimed to protect against HPV, the human papilloma virus (and not even all of its strains), and the connection between HPV and cervical cancer or genital warts is purely a matter of association, correlation: no causative relationship has been established. As I find myself repeating ad nauseam, correlation doesn’t prove causation.

So that FDA recommendation surprised even this cynical observer. But almost immediately I found myself gagging over a story (by Paul Basken) in the Chronicle of Higher Education of 18 September 2009, p. A10: “Ghostwriters Haunt the Integrity of Medical Journals — Company-sponsored contributors enhance, without disclosure, university researchers’ papers”.
The story also reveals that “enhance” is a misleading euphemism: the unnamed individuals actually did all the meaningful work.
Dr. Lisa M. Shulman, newly appointed assistant professor of neurology at the University of Miami and serving a fellowship on Capitol Hill “was overworked and under-resourced”. She accepted an offer of help in writing research articles from DesignWrite, a business employed by (among others) the drug company Wyeth. DesignWrite “select[ed] background information on connections between estrogen and Parkinson’s disease, and . . . draft[ed] a proposed summary of the existing data” whereupon Shulman “wrote” “her” article which failed to mention DesignWrite or Wyeth, which happens to sell estrogen pills.

There could hardly be a more obvious case of deceitful publication — excluding, that is, such corporate deceit as Elsevier’s publishing of no fewer than 6 “journals” that were actually “sponsored” by drug companies (“Merck published fake journal”; “Elsevier published 6 fake journals”).

If a student were to do what Dr. Shulman did, it would be labeled unequivocally as plagiarism or fraud, and it would lead at a minimum to failing the relevant course, at worst to suspension or even dismissal from the college. Yet this sort of thing has become so common in “medical science” as to be routine. “A study presented last week . . . found that in The New England Journal of Medicine, at least 11 percent of the articles had ‘ghost’ authors. Another study tracked attempts in the late 1990s by Parke-Davis, now a subsidiary of Pfizer Inc., to get articles published concerning its medication Neurontin. The pharmaceutical company succeeded in placing 11 articles in seven journals, none of which disclosed its role in authorship and only two of which acknowledged its financial support” (Basken, op. cit.).

Those who participated in these deceptive, potentially damaging practices emit “apologies” and “excuses” reminiscent of the words of politicians: use of the passive voice (“mistakes were made”) and failure to acknowledge wrongdoing, calling it mere negligence. Thus Dr. Shulman called her transgressions “an oversight”. She “sees little harm in accepting outside professional help, since she takes full responsibility for the published contents. Her article, she says, is a dispassionate examination of whether estrogen has any connection with Parkinson’s disease. The article opens by stating that ‘increasing evidence’ supports the use of estrogen for guarding against Parkinson’s, although it notes conflicting findings based on variations in age and dosage. ‘There is nothing in my paper that is favorable to Wyeth,’ says Dr. Shulman, who denies that her actions constituted ghostwriting” [emphases added].
Shulman might do well to bear in mind that when you’re in a hole, it’s best to stop digging. Even better, she should find a job she can do without outside help.

Barbara B. Sherwin, a psychology professor at McGill University, lent her name to an article written by a freelance author working for Wyeth: “I made an error in agreeing to have my name attached to that article without having it made clear that others contributed to it”.
NO: her “error” was in not doing the work that the article tried to disseminate.
If Shulman or Sherwin were to have given proper acknowledgment, they would not be able to cite those articles on their vitae as personal accomplishments. Indeed, their names would not appear in the authorship line at all; or if they did, it would be stated clearly in footnotes that their actual contributions were at most editorial.

Another attempt to make black seem white came from Matthew R. Weir, director of nephrology, University of Maryland Medical Center, who tried to minimize the fraud by saying that “such articles typically appear only in lower-tier medical journals, which are recognized as less reliable”. Again it’s not clear how that is supposed to be an excuse. “Dr. Weir has himself been . . . accused in a lawsuit against the drug maker Merck of signing his name to an article that played down the chances that the company’s Vioxx medication might raise the risk of heart attacks. The co-author on the report was a scientist employed by Merck. Dr. Weir says he stands by the data in that article”. It is nowadays common knowledge that VIOXX does indeed raise the risk of heart attacks.

Then there’s the attempted evasion that such “articles don’t mention specific drugs by name, and instead just give a general endorsement of a particular therapeutic approach that happens to align with the medication offered by the company”. Right; just happens to. Would the article ever have been conceived otherwise?

“Rogerio A. Lobo, a professor of obstetrics and gynecology at Columbia University, says DesignWrite contributed work, unattributed, to one of his published papers. But the company’s role was limited to assembling existing research on a subject, providing statistics and charts, and copy editing. He says he substantially changed the final version by cutting out entire sections and eliminating the endorsement of a particular product. ‘I don’t consider that ghostwriting,’ he says. ‘I’m the responsible person, and I stand by it, and I wrote it’” (emphases added; Basken, op. cit.). Thus Lobo admits clearly that his only contribution was editorial or secretarial, not the central and essential work of getting the data.

“Both ghostwriting’s detractors and its alleged participants agree that the difficulty of defining the practice makes it tough to eliminate”.
The only proper characterization of that statement, as of the “apologies”, is BULLSHIT — statements made without regard for their truth. Everyone who contributes to an article must be identified, and best practice has long been that on multi-authored papers the contributions of each individual are spelled out. In that case, the question of ghostwriting cannot even arise. No need to try to define it; just don’t do it. As pointed out by “Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic . . .  ‘No amount of editing,’ . . . can justify an author’s using an undeclared contributor”.

DesignWrite, a “medical-communications company”, “regards its service as providing a public benefit. ‘We stand behind the accuracy of every article we have been involved in,’ says the company’s president, Michael Platt”.
No surprise there. If the articles are accurate in every detail of their data but failed (happened to fail) to include existing but contrary data, his statement would remain technically correct while misleading in the most important way. Brings to mind the point made by Paul Halmos that lying is sometimes OK, but misleading never is (see p. 168 ff. in To Rise Above Principle: The Memoirs of an Unreconstructed Dean).

Present practices raise “the specter of hidden bias in published papers that favor the effects of the company’s drugs. Doctors rely on such papers when making life-or-death choices about treating their patients” (Basken, op. cit.).
There’s nothing trivial about this, and no lame excuses should be countenanced. Faculty who plagiarize and deceive in this manner should be disciplined even more harshly than students who plagiarize. Students do it often enough through ignorance rather than deliberately, but that cannot be said of these senior miscreants who even seek to justify their misdeeds. These people are a disgrace to the profession of medicine and to the scholarly academic profession.

The larger significance is that “research” nowadays is an activity engaged in by people who don’t belong there. Honest original research is very hard, and the rewards are few, far between, and anything but guaranteed (just ask Peter Duesberg, say). The only good reason for getting into it is because of an overwhelming desire to help gain new knowledge.
Publication should follow work, not precede it. It is preposterous for people like Lobo, Shulman, Sherwin, Weir, to be employed and described as researchers since their primary aim is clearly careerist, to amass publications rather than to advance knowledge. “Preposterous” in the sense Jacques Barzun explained:

That is preposterous which puts the last first and the first last. . . .
Valuing knowledge, we preposterize the idea and say . . .
everybody shall produce written research in order to live,
and it shall be decreed a knowledge explosion.
— Jacques Barzun, The American University (Harper and Row, 1968) 221

************************

Though there is no mention above of “HIV” or “AIDS”, the connection ought to be obvious enough: The manifold misdeeds of HIV/AIDS “researchers” are part and parcel of an overall corruption of medical “research”. People like Lobo et al., above, are, in the words of Susan Haack, “fake reasoners” who don’t care about the truth-value of what they put their names to; they emit bullshit. Mainstream HIV/AIDS “researchers” are what Haack calls “sham reasoners“, people who seek only to support a pre-existing belief (Susan Haack, “Science, scientism, and anti-science in the age of preposterism“, Skeptical Inquirer 21 #6, November/December 1997).

there is a fish in here somewhere

The old saying goes, “If life hands you a lemon, you make lemonade.” Sounds simple, but what if life hands you a kumquat? (I’ve always wanted to use that word in a sentence!). The point being, of course, that life isn’t quite so neat and black and white. It’s messy, gray and can get very complex. And, the same, I guess, could be said for lemonade — too much sugar and it’s sickly, stickly sweet, too little sugar and you get a fish-face.

Right now, I’m holding a virtual kumquat, not sure just where this little fruit will take me. I’ve started to feel more comfortable with this whole new world of blogging and looking forward to exploring alternative therapy and medicine through connections in the cybersphere. But a family matter will have to supersede things for a while. As always, there is irony: the situation will afford me more time to write (read properly edit, copy-edit, proofread); internet access will be limited (a 15 minute walk to a small town local library with wifi service that I hope is still up and running in these underfunded days). There is a natural foods store in town, a friend of a friend who does massage, weekly yoga classes, and a fitness center. So, I will just have to do some “real” as well as virtual research into alternative therapies.

Before I pack up my laptop, I did add two traditional medicine links to my blogroll.  The first is the National Institute of Health’s Pain Consortium website; the second is the same forum’s list of recent clinical trials (recruiting, ongoing, and completed). Participating in a clinical trial has its ethical dilemmas: who is actually underwriting the trial; as well as practical ones: what if I get the placebo? I’d be really interested in learning from someone who was/is a part of a clinical trial what the experience is like both from a physical as well as emotional perspective. Does a clinical trial drug “feel” like it offers more hope of pain relief/management? Guess I’d better get my Poll page up and running!

Update:

Wikipedia photo of a kumquat

This is a kumquat (should have thought to insert photo when I first posted). And, as has been commented the kumquat is both sweet and sour; a perfect allegory (?) for life. So, here’s to the kumquat!

I’m also going to update my links to include the American Chronic Pain Association and the American Pain Society; two sites which take a positive approach to pain management and provide links to various other resources such as clinical trials, professional organizations which deal with chronic pain, and current research. (A blog entry on these sites to follow)

the bitter and the sweet

{Thanks to Wikipedia for the images}

FDA posted a new Warning Letter on its website to ICON Clinical Research, the CRO responsible for many of the activities that led to the Johnson & Johnson sponsor Warning Letter last August (see previous posts). The heavily redacted document lists J & J only as “(B) (4)” but it is easy to compare the two and see that they are related. This is the first time in Years, someone correct me if I’m wrong, that FDA has gone after a CRO for their contracted responsibilities with a sponsor of clinical trials. It was ICON that performed the monitoring responsibilities that led to both Warning Letters.

Up until now it looked like FDA would only go after the sponsor when things went wrong at a clinical site. In the Sanofi Aventis Warning Letter of October 2007 the CRO was mentioned but no Warning Letter followed. In the J & J Warning Letter the CRO was redacted out and it has taken four months for FDA to write the CRO a Warning Letter. However, now that it is out, it is quite a doozy. Read for yourself:

Saw palmetto is a remarkable herb becoming famous for its uses in hair restoration and prostate health, particularly for relieving urinary discomfort caused by an enlarged prostate (BPH).

Saw Palmetto’s popularity has been on an extraordinary roller coaster ride throughout the 20th century. Widely used under the name “Serenoa” until World War II, it was then completely forgotten until its rediscovery in the 90’s.

Now it’s being evaluated by the U.S. Food and Drug Administration (FDA) for treatment of BPH. If approved, it would become the first herbal product to be licensed by the agency as a treatment for a specific condition.

Benefits for Enlarged Prostate

There is much scientific documentation outlining the effectiveness of the herb in treating irritable bladder and urinary problems in men with benign prostate hyperplasia (BPH), an enlargement of the prostate gland.

BPH results in a swelling of the prostate gland that obstructs the urethra. This causes painful urination, reduced urine flow, difficulty starting or stopping the flow, dribbling after urination and more frequent night time urination.

In addition to causing pain and embarrassment, BPH can lead to serious kidney problems if undiagnosed and left untreated. It is a common problem in men over the age of 40. Estimates are that 50-60% of all men will develop BPH in their lifetimes.

Saw Palmetto Clinical Trials

Since the 1960s, extensive clinical studies of saw palmetto have been done in Europe. A review of 24 European trials appeared in the November 1998 issue of the Journal of the American Medical Association. The trials involved nearly 3,000 men, some taking saw palmetto, others taking Proscar and a third group taking a placebo.

The men taking saw palmetto had a 28% improvement in urinary tract symptoms, a 24% improvement in peak urine flow and 43% improvement in overall urine flow. The results were nearly comparable to the group taking Proscar and superior to the men taking a placebo.

Saw palmetto does not reduce prostate enlargement. Instead, it is thought to work in a variety of ways. First, it inhibits the conversion of testosterone into dihydrotestosterone (DHT). BPH is thought to be caused by an increase in testosterone to DHT. Secondly, saw palmetto is believed to interfere with the production of estrogen and progesterone, hormones associated with DHT production.

In a controlled clinical trial with patients with enlarged prostate glands, 50 patients who received saw palmetto (320 mg per day – 4 tablets taken in two separate doses with meals) were compared to 44 patients receiving placebo. Patients treated with saw palmetto urinated less frequently, produced a better flow rate and amount of urine and had less pain and discomfort in urinating than control subjects. There were actually fewer adverse side effects in patients receiving saw palmetto than in controls.

May Help Prevent Prostate Cancer

Men who have taken Saw Palmetto for the purpose of treating BPH, have reported a reduction in painful urination, as well as minimized sensations of a full bladder. Some researchers believe this may be accomplished due to an anti-inflammatory ability of the plant to restrain hormones, such as testosterone. Testosterone is thought to contribute to multiplication of prostate cells.

There has also been speculation that the plant may play a vital role in protecting men against the development of prostate cancer. The plant is a popular treatment for BPH, due to the fact that it is typically much lower priced than other medications, tends to work much more quickly, and is less likely to cause reduced sexual drive and impotence.

It is also used to strengthen the thyroid gland, balance the metabolism, stimulate appetite and aid digestion.

Avoid If…
No known medical conditions preclude the use of Saw Palmetto. However, because of the herb’s hormonal effects, caution is advisable if you have any form of cancer that’s stimulated by hormones.

Special Cautions
At recommended dosage levels, side effects are rare. A few stomach complaints have been reported.

Possible Drug Interactions
Check with your doctor if you are taking any hormonal medications or adrenergic drugs such as the asthma medications Alupent, Brethine, Proventil, and Ventolin. Your dosage may need adjustment.

Saw Palmetto Herbal Supplement

Quup Herbal supplement containing saw palmetto, lycopene from tomatoes, selenium and zinc is an excellent nutritional support for men’s prostate health. If your sleep is regularly interrupted by midnight trips to the bathroom, if you find you have an urge to urinate and then when you get there you can’t start the flow, saw palmetto in Quup is likely to be of benefit.  See the Quup website for more information and to order.

OK, I said that I was going to take a break until New Year’s. However, the letter to the Teneo IRB is an interesting FDA Warning Letter for several reasons. First, the Center for Biologics, FDA’s smallest for human clinical trial regulation, wrote the Warning Letter and they don’t do that frequently to IRBs. Second, the IRB was found to have two sets of meeting minutes in an effort to keep some activities out of the regulatory realm. Third, FDA told the IRB to stop approving studies or having current studies enroll new subjects “until adequate correction is made.” This is about as tough as it gets for an IRB. I am attaching a Thompson link about the Warning Letter. Now I am going to take a break from blogging (I think).

Update: Another IRB, another Warning Letter. Centra IRB in Lynchburg, VA received a Warning Letter dated 20 November 09 from the Center for Devices. These folks violated a couple of Big Deals about IRB review of research. First, they forgot to review approved studies after a year. Remember the “Tuskegee Syphilis Study?” What went wrong there was no continuing review of research. Even after they discovered that penicillin worked wonders on syphilis. Then Centra forgot how many people were needed for a quorum. You need a minimum number of IRB members to approve research. Then they forgot to write down what they did. Their minutes didn’t describe what happened at the meetings. If you didn’t document it then its just a rumor. These are basic things that anyone in the IRB business should know about. Read for yourself on the FDA Warning Letter webpage.

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With all the talk of capital efficiency and extending a company’s “runway” in developing and commercializing new medical  devices, it pays to examine the clinical research process more closely.

Clinical trials are often planned based on (sometimes a minimum of) demographic information. A typical approach may go something like “I think we will need 200 patients to complete this trial. An average center may enroll 10 patients per year. So with 20 centers, I can get my trial fully enrolled within approximately one year once they are up and running.”

Then the company goes ahead, bringing 20 clinical research centers on board, trained, clinical research agreements signed, IRB approvals obtained etc, to proceed with the trial. And it never fails: at the end of the trial, 20% of the centers enrolled 80% of the patients. In other words, the most productive, “vital few” sites seemed more motivated, and were 16x more productive than the less “motivated” ones.

So how can medical device companies avoid investing in the less productive centers and utilize their resources more effectively?

Clearly, simple demographic information is not sufficient to make a determination as to who will enroll more patients or be more productive in a trial. What is needed is a more detailed model that maps out the complete decision making process of how patients end up in the trial, with measurable criteria — a “psychographic” model, if you will, not just of how enrollment decisions are made, but of the complete sequence of events leading to potential patients ending up in the trial.

Once this detailed map is constructed, a potential site can be evaluated against this model, and a more predictive evaluation can be made, before an investment is made to bring a clinical site on board. Not only does such a model help in choosing clinical research centers more effectively, it may also identify strategic points where a company may more effectively promote a trial, resulting in faster enrollment.

Are you about to engage in a clinical trial and would like to make sure you are using resources as efficiently as possible? Contact Guy Sohie via LinkedIn for a no-charge evaluation by clicking on the button below:

This is the Table of Contents of Clinical Research focus 20(11) issue for November 2009. Members of ICR can click the links below to log in and read the full text of each article.

Features

Challenges of Inter-Organisation Projects: What Factors Lead Towards Success?

Matthew Theobald

Working with partner companies to define, execute and deliver a clinical research project can be a challenge at the best of times. So what is it that sets successful projects apart from those that struggle to get started or lose focus during their execution? Recent ‘project fractures research’ into this topic reveals that the root causes of project failure (or significant variance) don’t lie in the project management methodologies or structure. The root causes actually lie in the people factors, such as how they engage in projects. Matthew Theobald presents some useful insights into how projects fail, and suggests how they might be planned and managed better.

An Unacceptable Conflict of Interest? The PharmaTimes Great Oxford Debate

Les Rose FICR

Arguably the world’s foremost debating chamber, the Oxford Union was the scene of this annual event, which always addresses contentious issues for the pharmaceutical industry. The Motion for this year’s debate was: “This house believes that there is an unacceptable conflict of interest when pharma conducts trials on its own drugs”. Les Rose was there, and presents the main arguments for and against the motion, and reveals the (not unexpected) result of the evening’s vote.

How Will Personalised Medicine Have an Impact on Clinical Trials?

Abel Ureta-Vidal

How can genomics have an impact on the management of your clinical trials? With the growing understanding of genetic code within personalised medicine, could this signal a change in the size and scope of clinical trials? What does this mean for the pharmaceutical industry and the patient? “Personalised medicine” is a current buzzword, but what does it actually mean? Some say it has the potential to affect the entire landscape of our healthcare system over the next ten to 20 years. Abel Ureta-Vidal explores the potential benefits, but also the risks and challenges.

A Marriage Made in Heaven or Grounds for Divorce: ICR Project Management Forum

Sarah Muller MICR

Christopher Colombus, Kevin and Perry, men from Mars and women from Venus were all mentioned at the ICR forum on ‘A Marriage Made in Heaven or Grounds for Divorce: Exploring the interface between Project Management, Data Management and Statistics.’ This forum took the form of a debate on the motion “The data management and statistics functions are well managed by project management”. Following the formal debate, there was plenty of time for discussion between the speakers and audience. Sarah reports…

People

Exploring an Innovative CRO Business Model: An Interview

Susan Ollier HonFICR CSci & Paul Thompson

Paul Thompson is Director of Business Development and Susan Ollier HonFICR CSci is Director of UK Operations at QED Clinical Services. Many readers of CRfocus will know Susan better as Chair of ICR until she reached the end of her term at this year’s AGM, but she also ran a consultancy which recently merged with QED Clinical Services. We discuss the company’s franchise business model, the importance of cultural fit and the importance of commercial and operational innovation in the CRO sector.

Prof. development

ASM Posters: 2009 Entries & 2010 Submissions

Andrew Smith

The Institute of Clinical Research is pleased to announce that its 31st Annual Conference and Exhibition, with an overall theme of “Science, Society and Economics: Shaping the Future of Clinical Research”, will once again include a poster session. In this brief introduction to the 2010 competition, we present some highlights from the 2009 competition and invite you to submit an abstract for a poster at this year’s event. You can submit your poster abstract for consideration using the online form at www.icr-global.org/community/conferences/31st-annual-conference-exhibition/poster-abstract-submission/. The deadline for poster abstract submissions is Friday 5th February 2010.

10 Things You Need to Know About… Being Resilient at Work

Helen Chapman

Resilience is the ability to stay balanced and to bounce back quickly from setbacks and adversity. Resilient people stay committed and increase their efforts when the going gets tough. Some people are born naturally more resilient than others, but anyone can improve their resilience through effective awareness and training. This article will give you ten simple ideas for becoming more resilient to the ever-changing world around you and reassure you that a key aspect of being resilient is knowing that although you may not be able to change the environment around you, you can change how you choose to let it affect you.

Regular update

The Challenges We Face: Varied but Interlinked: Message from the Chair

Janette Benaddi MICR CSci

It is impossible for anyone to replicate the direct experience of all our members, not having worked in every sector. However, as Janette explains, she tries to understand the major issues affecting you and encourage you to become more involved yourself as opportunities arise for influencing the shape of clinical research. It is always interesting to learn that the challenges we face are often similar despite our diverse therapeutic fields and specialisations.

It’s Not All Work, Work, Work…

Compiled by Andrew Smith

Our regular look at the lighter side of clinical research, including reality TV formats to raise the profile of clinical research, pharmaceutical brand names that never made it to market and “Ten things that shouldn’t be used as project performance metrics…”.

After the show with Ben - my hubby.

First Look - Rust Coat

This past Saturday I was able to participate as a model in the Mid-Atlantic Cancer Support Fashion Show at Lord and Taylor in the Annapolis Mall.  Along with myself, many of the other models were cancer survivors of varying types of cancer including breast cancer, male breast cancer, prostate cancer, and my own melanoma.  I was asked to be in the show and hesitated for all of two seconds before I agreed to be in it.  I hesitated because I did not want to be out of my comfort zone.

I want this dress!!

I ended up agreeing to be in the show for a few reasons.  1)  It is for a really good cause 2) They agreed to keep me in dresses or skirts so that I would feel comfortable and 3)  How many opportunities is a 5′2″ girl going to have to do runway?  I am really glad I participated in the show.

I not only got to have a lot of fun, but it helped raise money for a good cause.  www.macancersupport.org

The one thing people say the most to me when they meet me and find out that I was diagnosed with Melanoma at 25 is that they think I have such a wonderful attitude about everything.  I found when I met the rest of the survivors/models that the thing that makes us survivors is that vibrant, feisty, great attitude.  Everyone I talked to and got to know a little was so positive and encouraging of everyone else.  What an awesome group!!

So excited to see Grandma she joined her on the catwalk!

Playing around with our M.C. - Mrs. Maryland

Lord and Taylor did a wonderful job providing us with clothes, makeup, and accessories.  They thanked us with bags full of nice little goodies, and made the day exciting and fun for everyone.   Lord and Taylor provided gorgeous clothes for me to wear, but I already had the perfect shoes to go with them!

If you would like to see the rest of the pictures from the day you can view them at http://macsfashionshow.shutterfly.com

Thanks to all my family and friend who came out to the show to watch me and cheer me on as I strutted my stuff on the runway.  I am glad that you support me and encourage me to be a survivor.

My mom especially liked the goodie bags.

Response to Editorials article, 2009, Mind the spin, Nature, Vol 461 (29), 29 Oct, p1174.

URL: http://www.nature.com/nature/journal/v461/n7268/pdf/4611174a.pdf

In response to the editorial about the recent announcements and spin surrounding the HIV vaccine trial in Thailand, I think the issue of spin comes back to an ever present problem the relationship between science and society that is slowly being addressed. I believe a solution to reduce spin is to readdress the expectations about research from all parts of society – the public, the media, and the scientists themselves. Practitioners and researchers in science communication have been advocating various approaches to reduce the spin in science. My view is that we need to address the three stakeholders in communication of science – the scientists, the public, and the media. The public is one stakeholder, and there is a need to increase the public’s awareness that scientific results are not always simple to interpret and are not always clear-cut positive or negative. With the public’s increasingly easy access to scientific information I think we are getting to a more science-savvy society. However, sometimes the promises and hopes of “magic” cures may fog up the clear thinking that is needed to properly critique scientific discoveries. The scientific community is another stakeholder, and they should not fear positive or negative feelings about their results from the public. What they should care about is reporting the scientific truth of their results, and that all science is a “work in progress” with more work and fact-searching to come. However, I’m not sure how we can change the culture of spin and emphasising positive results in an ever more competitive funding environment that seems to reward “ground-breaking” and positive results. Finally, the third stakeholder, the media, needs to be trained to reduce sensationalisation of stories, and be trained to analyse and question the study methodology and findings more. Science communicators are training the media to be more science-savvy, and I think one important thing that journalists should learn from science is that scepticism is always a useful quality to start with when reporting discoveries, even in the face of what may seem like fantastic positive results. In the battle to reduce spin, these are only some of the things to consider.