Posted by & filed under About MedComDepot, Medical Writing, Travel.

Pedasi is in the Los Santos Province, Azuero peninsula, of Panama. It is the Southern-most part of the country in the what is known as the “Arco Seco” (dry arc). We chose this region as the location for our annual working abroad program. We close the office in the states and move everyone to the chosen destination once a year. Work continues however, but in fresh location. This is our third stay in Panama, but always in a different region. There was no rain for the month we were there, which is the case for 6 months of the year. Like clockwork, the rains returned the day we left.

We like Panama because of the weather, consistent 850 to 950, the currency-the US$, the cost of living-about 20% cheaper than the US, the beaches-some of the best in the World, the people-they actually like Americans, the beauty of the terrain, and I could go on and on.

We spent a few days in Panama City coming and going. To the surprise of many, Panama City is a thriving metropolis with beautiful sky-scrapers.

The house we rented was about 20 minutes south of Pedasi on Playa Los Destiladeros, a beach that was 3 miles long and totally deserted most of the time.  We walked the partially black sanded-beach early in the morning, worked 5 to 6 hours each day, then returned in the evening to watch spectacular sunsets.  There really wasn’t much else to do, which was fine with us. Occasionally, we would drive into town for groceries or to eat in one of the local restaurants. I think we eventually had at least one meal in all of them by the end of our stay.

 

 

We arrived in time for Carnival, a festival that the Panamanians take very seriously. It started 4 days before Ash Wednesday and was celebrated with the same revelry and abandon as New Orleans or Rio de Janeiro. Businesses close, people take to the streets, beer flows non-stop. In the little town of Pedasi, the people spend all year preparing for carnival as well as a fortune relative to their meager coffers. Two queens are selected representing the East and West sides of town (Pop. ~4,000). The people vote on the winner. This year the West side queen won and received a modeling contract.

The day we returned to the states, we wanted to go back. We look forward to next year’s sojourn. We are changing it up a bit and going to San Pablo del Lago, Northern Andes, Ecuador.

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Posted by & filed under About MedComDepot.

THE WRITING’S on the WALL

Maria Vinall and her husband, Phil, run a successful communication company specializing in the medical sector. Maria talks to us about the industry and how the company has grown over the years.

Medical Communications Depot, Inc. is a boutique communications company that specializes in preparing documents for companies and/or individuals with a need for life science, medical, or pharmaceutical information. Besides the pharmaceutical industry, the firm’s clients have included physician groups, educational institutions, advertising agencies, basically anyone with a need to communicate about health and medicine.

Managed by a husband and wife team, the company works with individual scientists, physicians, other medical communications companies, as well as directly with small and large pharmaceutical companies, and has been providing these services for clients worldwide for more than 12 years.

Maria B. Vinall is president of Medical Communications Depot and one half of the successful husband and wife team that runs the firm. She describes in more detail what her role entails.

“As with any small business,successfully running MedComDepot requires multiple skill sets. In our case, business is pretty evenly divided between doing the work and getting the work. Writing, science, and research are skills needed to do the work. Time/money management, networking, and marketing skills are needed to get the work and manage the business. We’ve always functioned as a team and this area is no exception – each of us does what they do best with support from the other. When we need an extra pair of hands we have a small group of colleagues on whom we can call.”

The firm was incorporated in 2004. Maria states that it hit its stride in 2006 and has continued to move forward ever since. “Neither of us can remember the day we decided we wanted to have our own business but we always find ourselves asking ‘Why didn’t we do this a lot earlier?’” she laughs.

Both Maria and her husband Phil started out on very different career paths that somehow merged to form the firm.

“Phil had been working in the field of medicine and science most of his adult life,” she explains. “He’s been a bench scientist where he has won awards and grants in the field of neuroscience and has published numerous manuscripts. He has received recognition and support for his work from the Rolex Foundation, the Sharpe Foundation, and Pennsylvania Hospital. As head writer at Wyeth Pharmaceuticals he led the development of a small group of writers whose responsibilities included developing clinical manuscripts, publication planning, writing SOPs, maintaining databases, liaising with outside vendors, and managing submission and compliance issues.

“l started out to be a nurse but quickly found that it just wasn’t for me. Reluctantly, I left the world of medicine and science to become a project manager in such diverse settings as law, insurance, and publishing. Eventually I joined Phil at Wyeth where I developed my skills as a publication specialist. During my 10 years there, I assisted in the preparation of numerous conference submissions and peer-reviewed manuscripts in addition to developing and managing publication plans for a diverse product portfolio. MedComDepot gives me the opportunity to combine the things I love – project management and science.”

The couple ensure that they stay up-to-date with the latest technology in order to keep ahead of the curve.

“We’ve invested heavily to be sure that the technology we use is current and flexible. We also stay abreast of changes in government regulations, particularly the FDA, but also the guidelines endorsed by professional organizations such as the American Medical Writers Association (AMWA), the National Association of Science Writers (NASW), the International Society of Medical Publications Professionals (ISMPP), and the International Committee of Medical Journal Editors (ICMJE). We scan the horizons for new breakthroughs in drug and device development, as well as changes in healthcare in general.

“With regards to following industry trends, membership in AMWA and NASW goes a long way to help us stay current. We attend the local and national meetings of both organizations where the latest industry trends are shared. In addition, we participate in online webinars to stay updated on existing areas of expertise and to grow our knowledge in new areas. Finally, because our work frequently allows us to attend major medical conferences worldwide, we are exposed to the latest in medical treatments and technology across a broad range of therapy areas.”

Maria and Phil have aspirations of growth for MedComDepot and Maria elaborates on a new service which should help them realize their goals.

“We are in the early phase of expanding our menu to provide a specific set of services to small/start-up pharmaceutical companies. These start-ups often have only one product in development and frequently they are looking for investors to fund the needed early clinical studies and/or for another company to take the product to launch. These companies, as well as many small pharmaceutical companies, rarely have and generally cannot afford a publication staff, yet publishing and presenting trial results are critical to a successful launch. Our low overhead, project management skills, and the depth and breadth of our experience will allow us to provide the services these companies need without breaking the budget and while allowing them to do what they do best.

“The number of individuals and companies looking for good medical writers is
enormous. There are all kinds of opportunities if you know where to look.”

Posted by & filed under Medical Writing.

Released January 2017
Introduction
This joint position statement of the American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) describes the appropriate role of professional medical writers in the development of medical and scientific publications, including:
* articles and supplementary content (eg, video abstracts) for publication in peer-reviewed journals
* abstracts, posters, and oral presentations for dissemination at scientific congresses.
This joint position statement is in line with up-to-date guidelines from several other international organizations.1–13
Responsibilities of professional medical writers
Professional medical writing support helps authors and sponsors to disclose their research in peer-reviewed journals and at scientific congresses in an ethical,14 accurate,15,16 and timely17 manner, with the ultimate aim of advancing patient care. Professional medical writers have extensive knowledge of ethical publication guidelines.18,19 When assisting authors with communication of the results of company-sponsored research, they must:
* follow Good Publication Practice (GPP3) guidelines and International Committee of Medical Journal Editors (ICMJE) recommendations1,2
* consult appropriate reporting guidelines (eg, CONSORT20 and others collated by the EQUATOR network21)
* ensure that the authors and sponsors are aware of their obligations under these guidelines1,2,20,21
* keep up to date with advances in medical communications ethics and best practices.
Responsibilities of authors who collaborate with professional medical writers
Authors who choose to collaborate with a professional medical writer on manuscripts or congress presentations must:
* ensure that they, as authors, have access to all relevant information (eg, protocols, statistical analysis plans, statistical analyses, and clinical study reports)
* provide intellectual input before writing commences and throughout content development
* ensure that the final text fully reflects the views of, and is approved by, all authors
* affirm the appropriateness of the final choice of journal or congress
* acknowledge the provision of medical writing support, including the nature of the support, and the name, highest relevant qualifications (eg, degree or professional credential), and affiliation of the professional medical writer accountable for the support provided, and acknowledge the funding sources for the provision of medical writing support (see Box)
* recognize as a co-author all contributors (including a professional medical writer) who meet the ICMJE authorship criteria.1
Box. Example of template disclosure statement for professional medical writing support.
“The authors thank [name and qualifications] of [company, city, country] for providing medical writing support/ editorial support [specify and/or expand as appropriate], which was funded by [sponsor, city, country] in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).”
References
1. International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. http://www.icmje.org/icmje-recommendations.pdf. Published December 2016. Accessed December 28, 2016.
2. Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163:461–464.
3. Clark J, Gonzalez J, Mansi B, et al. Enhancing transparency and efficiency in reporting industry-sponsored clinical research: report from the Medical Publishing Insights and Practices initiative. Int J Clin Pract. 2010;64:1028–1033.
4. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/. Updated October 2013. Accessed December 20, 2016.
5. World Health Organization. Statement on public disclosure of clinical trial results. http://www.who.int/ictrp/results/WHO_Statement_results_reporting_clinical_trials.pdf?ua=1. Published 2015. Accessed November 26, 2016.
6. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Japanese Pharmaceutical Manufacturers Association (JPMA), Pharmaceutical Research and Manufacturers of America (PhRMA). Joint position on the publication of clinical trial results in the scientific literature. http://www.efpia.eu/uploads/Modules/Documents/20100610_joint_position_publication_10jun2010.pdf. Published 2010. Accessed November 25, 2016.
7. Pharmaceutical Research and Manufacturers of America. Principles on conduct of clinical trials: communication of clinical trial results. http://www.phrma.org/sites/default/files/pdf/042009_clinical_trial_principles_final_0.pdf. Updated December 2014. Accessed December 20, 2016.
8. Hamilton CW, Royer MG. AMWA position statement on the contributions of medical writers to scientific publications. AMWA J. 2003;18:13–16.
9. American Medical Writers Association. Code of ethics. http://www.amwa.org/amwa_ethics. Updated June 2008. Accessed September 30, 2016.
10. Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin. 2005;21:317–322.
11. Norris R, Bowman A, Fagan JM, et al. International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer. Curr Med Res Opin. 2007;23:1837–1840.
12. International Society for Medical Publication Professionals. Position statement: the role of the professional medical writer. http://www.ismpp.org/assets/docs/Inititives/advocacy/ismpp_ghost_writing_vs_professional_medical_writing_oct_2011.pdf. Published 2011. Accessed September 30, 2016.
13. International Society for Medical Publication Professionals. Code of ethics. http://www.ismpp.org/ethics. Updated November 1, 2016. Accessed November 25, 2016.
14. Woolley K, Lew RA, Stretton S, et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin. 2011;27:1175–1182.
15. Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. Write Stuff. 2010;19:196–199.
16. Gattrell WT, Hopewell S, Young K, et al. Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study. BMJ Open. 2016;6:e010329.
17. Shah S, Nair S, Patil A, et al. Role of medical publication professional in timely dissemination and transparent reporting of clinical data. Curr Med Res Opin. 2016;32(Suppl 1):S12.
18. Wager E, Woolley K, Adshead V, et al. Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014;4:e004780.
19. Marusic A, Hren D, Mansi B, et al. Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications. BMC Med. 2014;12:197.
20. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.
21. Reporting guidelines for main study types. EQUATOR Network Web site. http://www.equator-network.org/. Accessed December 20, 2016.

Writers and Researchers-Partners

Posted by & filed under Medical Writing, News.

Why Use Professional Medical Writing Assistance for Scientific Publishing?

More than 1 million bio-science papers were published in 2015. However, the assistance of a medical writer was acknowledged in only 6% and 11% of these papers.(1,2) Given these numbers, it would seem fair to conclude that the writing needs of a large number of the individuals performing bio-science research at universities or government institutions are being under-served.


                    International Committee of Medical Journal
Editors (ICMJE) Criteria for Authorship

1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
2. Drafting the work or revising it critically for important intellectual content; AND
3. Final approval of the version to be published; AND
4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.


Failure to publish and the lengthy times between completion of a research study and publication are still problems in medical research. Studies report that 32% of trials remained unpublished 51 months after study completion.(3,4) Researchers often say they lack the time needed to adequately research the literature, prepare a first draft, and make the many revisions required to produce a submission-worthy manuscript or that they do not enjoy writing. Many would-be authors are not fully versed in the standards of good publications practice thus are unaware of reporting guidelines. Others find the submission requirements and process confusing. In addition, as the majority of peer-review journals are published in English, those without an adequate command of the English language are at a disadvantage without medical writing support.

Gattrell WT and colleagues (5) recently examined the impact of professional medical writing support on the quality of randomized controlled trial reporting. Their study concluded that articles produced with medical writing support more often adhered to the Consolidated Standards of Reporting Trials (CONSORT) Statement. For 6 of the 12 CONSORT items assessed, a higher rate of complete reporting was observed in articles with acknowledged medical writing support compared with those without support (39.1% vs 21.1%). In addition, articles with declared medical writing support were more likely than those without to have been rated as having acceptable written English during peer review (81.1% vs 47.9%).

A Lancet study (6) reported that editing for scientific content and written English, tasks that are often undertaken by medical writers, significantly improved the style and readability of manuscripts. Other often stated benefits of medical writing support include a trend toward shorter time to manuscript acceptance,(2,7) an increased rate of publication over time,(8) and a lower risk of publication retraction due to misconduct.(9)

According to two 2014 surveys, the majority of authors (84 – 88%) valued the assistance provided by professional medical writers, in particular, editing support and ensuring conformity with reporting guidelines such as CONSORT.(9,10)

The guidelines on Good Publication Practice support the use of professional medical writers for scientific manuscript writing.(11) Medical writers who specialize in developing peer-reviewed manuscripts and other scientific documents, commonly receive training in Good Publication Practice (12) and provide valuable services that have been shown to assist authors in their efforts to publish.(10)

Medical writers are also more aware of and more likely to comply with the International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals than clinical investigators.(3) The ICMJE 2015 specifically identifies writing assistance, if performed without fulfilling other requirements (see above), as an activity that does not justify authorship, but if substantial, should always be acknowledged in the manuscript. Unacknowledged writers are considered ghostwriters, an unacceptable practice according to ICMJE and American Medical Writers Association (AMWA) guidelines. Fortunately, this practice has decreased over the past few years and continues to decline, thanks to educational efforts on the part of the ICMJE and medical writing societies like AMWA.(13)

Manuscript preparation can be a daunting challenge for first-time and even experienced authors. However, researchers not affiliated with industry-funded trials, often struggle to fulfill their ethical and scientific obligations to share the results from their research, either due to lack of time or skill in manuscript preparation. Professional medical writers can help authors meet their obligation to prepare quality manuscripts that meet the guidelines for publication standards. Although the cost associated with writing assistance can be an issue for investigators who lack outside funding, this should not be a barrier to publication, as many writers can and do adjust their pricing to fit the circumstances. There are opportunities for both medical writers seeking work and scientific investigators needing writing assistance if they can only find each other. Maybe some sort of Match.com® is needed.

References
1. Nastasee SA. Acknowledgment of medical writers in medical journal articles: a comparison from the years 2000 and 2007. Curr Med Res Opin. 2010;26 (Suppl 1):6.
2. Woolley KL, et al. Declaration of medical writing assistance in international peer-reviewed publications. JAMA. 2006;296(8):932-934.
3. Hamilton CW, et al. Mythbusting Medical Writing: Goodbye, Ghosts! Hello, Help! Account Res. 2016;23(3):178-194.
4. Ross JS, et al. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA. 2008;299(15):1800-1812.
5. Gattrell WT, et al. Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study. BMJ Open. 2016;6(2):e010329.
6. Pierie JP, et al. Readers’ evaluation of effect of peer review and editing on quality of articles in the Nederlands Tijdschrift voor Geneeskunde. Lancet. 1996;348(9040):1480-1483.
7. Bailey M. Science editing and its effect on manuscript acceptance time. AMWA Journal. 2011;26(4):147-152.
8. Manring MM, et al. A framework for improving resident research participation and scholarly output. J Surg Educ. 2014;71(1):8-13.
9. Marchington JM, Burd GP. Author attitudes to professional medical writing support. Curr Med Res Opin. 2014;30(10):2103-2108.
10. Camby I, et al. Publication practices and standards: recommendations from GSK Vaccines’ author survey. Trials. 2014;15:446.
11. Battisti WP, et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015;163(6):461-464.
12. Wager E, et al. Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014;4(4):e004780.
13. Stretton S. Systematic review on the primary and secondary reporting of the prevalence of ghostwriting in the medical literature. BMJ Open. 2014;4(7):e004777.

Posted by & filed under Genetics.

CRISPR – a powerful DNA editing technology has been named Science magazine’s 2015 “Breakthrough of the Year.”

If you haven’t already heard of it, it’s a good time to do some web surfing, because CRISPR, short for clustered regularly-interspaced short palindromic repeats, is predicted to change the face of medicine and, some say, “the world as we know it.”

According to Dr David King, founder and Director of Human Genetics Alert, “This is the first step on a path that scientists have carefully mapped out towards the legalization of genetically-modified babies.”

Dr Fiachra O’Brolcháin, a Marie Curie/Assistid Research Fellow at the Institute of Ethics, Dublin City University, “We might find ourselves inaugurating an era of ‘liberal eugenics’, in which future generations are created according to consumer choice.”

Seth Shostak, Director of the Search for Extraterrestrial Intelligence (SETI) Institute, believes that we will finally understand biology at a molecular level. As a result humanity will be able to cure all diseases and usher in an era of ‘designer humans’.

CRISPR and CRISPR-associated (Cas) genes are essential to adaptive immunity in select bacteria and archaea enabling them to eliminate the genetic material of an invading virus then store bits of the virus’s DNA to be used to defend against future attacks. Cas9 (CRISPR-associated protein 9; Csn1) a part of this defense mechanism found in Streptococcus pyogenes (the bacterium that causes strep throat) has been shown to be a key player in certain CRISPR systems. A genome editing tool based on CRISPR- Cas9 has generated considerable excitement.

CRISPR tells Cas9 exactly where to snip. To achieve site-specific DNA recognition and cleavage Cas9 must be complexed with both a small CRISPR RNA (crRNA) and a separate trans-activating crRNA (tracrRNA) that is partially complementary to the crRNA. During the destruction of the target DNA, both DNA strands are cut, which generates double-stranded breaks (DSB). This occurs only in the presence of a protospacer-associated motif (PAM) sequence above the break and it triggers the activation of the DSB repair machinery, which begins the repair process to restore the strands to their original DNA structure. Conveniently, the genes that encode for Cas are always sitting somewhere near the CRISPR sequences. A number of variants of this system have been developed to simplify and make the process more site-specific.

CRISPR-Cas is a valuable strategy for targeted genomic engineering. Not only can faulty genes be repaired by cutting out bad genetic material and injecting a normal copy into the cell, the tool is seen as a way to induce gene inactivation or modification (useful for producing genetically modified animals for research or drug screening) or the insertion of heterologous genes that can regulate endogenous gene expression or label specific genomic loci in living cells. CRISPR is also being used to perform genome-wide screening, to insert fluorescent genomic loci into cells to visualize genomic elements, and for proteomic analysis of a single genomic locus.

Using a gRNA tailored to a specific gene the CRISPR-Cas system allows the cutting and pasting of bits of DNA sequence into the genome at any point. Not only is the tool relatively simple – it’s cheap and easy to get. Target sequences can be designed and ordered online together with matched gRNA. It takes no longer than a few days for the guide sequence to arrive by mail. The ubiquitous access to and simplicity of creating CRISPRs creates opportunities for scientists, as well as non-scientists, in any part of the world to do any kind of genetic experiments they want. Low cost and ease of obtainability of CRISPR kits have led to “biohackers” (i.e., amateurs) toying with gene rewriting in their garages and kitchens. Researchers often need to order only the RNA fragment; the other components can be bought off the shelf. Total cost: as little as $30.

Besides simplicity and adaptability, CRISPR-Cas systems are reported to have high targeting efficiency, ie, the percentage of desired mutation achieved. Unlike other genomic editing tools, the CRISPR-Cas9 system requires only the redesign of the crRNA to change target specificity. These positive characteristics have made CRISPR-Cas one of the most popular approaches for genome engineering. However, off-target mutations remain a stumbling block for wider use, especially in the clinic. Several groups have developed web based tools (CRISPR Design Tool and ZiFiT Targeter) to facilitate the identification of potential CRISPR target sites and assess their potential for off-target cleavage.

In 2015, Chinese scientists used CRISPR-Cas9 to edit the genome of human embryos for the first time provoking debates about the ethical implications of such work. The purpose of the experiment was to explore the possibility of modifying the gene responsible for β-thalassaemia, a potentially fatal blood disorder, using ‘non-viable’ embryos. Low success rate and a high number of off-target mutations quickly ended the experiment. The resulting paper was rejected by Nature and Science because of ethical concerns. Though the study was seen as a landmark, George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts, USA said, “Their study should be a stern warning to any practitioner who thinks the technology is ready for testing to eradicate disease genes.”

The debate continues with some scientists affirming that gene editing in embryos could eradicate devastating genetic diseases before a baby is born. Others have expressed concerns that any gene-editing research on human embryos could be a slippery slope towards unsafe or unethical uses of the technique. While most people think it is acceptable to fix faulty genes in somatic cells, the use of this technology in germline tissues (eggs, sperm, or tissues that produce those reproductive cells) that can be passed on to future generations crosses an ethical line for many.

CRISPR has been getting a lot of coverage as a future medical treatment. Last year, bioengineer Daniel Anderson of the Massachusetts Institute of Technology in Cambridge, USA and his colleagues used CRISPR in mice to fix a disease-causing mutation associated with a human metabolic disease called tyrosinaemia. Scientists at Temple University, in Philadelphia, Pennsylvania, USA used CRISPR to snip out integrated HIV-1 genes from human cells.

CRISPR may also have a major impact in ecology and conservation. Researchers at the University of California at Irvine and at San Diego, California, USA have used the CRISPR system to genetically modify mosquitoes to fight malaria in their bodies and pass that trait to 97% of their offspring. Genetic modifications usually take a long time to spread through a population because a mutation carried by one pair of chromosomes is inherited by only half the offspring. But a gene drive (“selfish” gene) allows a mutation made by CRISPR on one chromosome to copy itself to its partner in every generation, so that nearly all offspring will inherit the change. Gene drives use the cell’s own repair machinery to ensure that they show up on both chromosomes in a pair, giving them better than 50-50 odds of being passed on to future generations. This means that it will speed through a population exponentially faster than normal; thus a mutation engineered into a mosquito could spread through a large population within a season. If that mutation also reduced the number of offspring a mosquito produced, then the population could be wiped out, along with any malaria parasites it was carrying.

With CRISPR new genes can be slipped into the drive system to eliminate diseases, create hardier plants, or wipe out pathogens. Potential beneficial uses of such gene drives besides ridding the world of pest-borne diseases like malaria, dengue fever, and Lyme disease include reversing the development of pesticide and herbicide resistance, and locally eradicating invasive species, like rats. However, drives may present environmental and security challenges as well as benefits. Gene drives that have the ability to alter a substantial fraction of a wild population could have unpredictable ecological consequences, such as spreading to other species.

The simplicity, efficiency, and versatility of the CRISPR-Cas system has allowed for rapid progress in developing Cas9 tools for cell and molecular biology research and its use will likely be limited only by our imagination—ethical concerns remain, however. The National Academies of Sciences, Engineering and Medicine have launched a year-long public Consensus Study on Human Gene Editing to examine the clinical, ethical, legal, and social implications of the use of human genome editing technologies in biomedical research and medicine. Findings should be available by late 2016 and are expected to provide a worldwide framework for human gene-editing research.

Posted by & filed under News, Travel.

Medical Tourism
Medical tourism sounds exotic. In reality, however, the tourism part has little to do with most patients’ motivation. Unlike the past when traveling to receive medical treatments was the province of the wealth, today it is a response to 3 things, globalization, a general increase in travel, and the rising cost of medical care. Proximity has made it feasible for Europeans to travel outside their native country for medical procedures and treatments for years. Today many “medical tourists” are patients from countries with national health programs, like the United Kingdom or Canada, who travel to other countries to avoid long wait times. Americans are increasing jumping on the medical tourism bandwagon and it’s not just those without insurance. Patients with health insurance sometimes travel abroad to avoid high co-pays or to gain access to cutting-edge or experimental treatments, including access to drugs and procedures not yet approved in the US that may be available in the other countries. West to East travelers cite cost savings as the main reason for medical travel with saving of 40% to 80% often being reported, while those traveling East to West are often seeking improved quality of care.

Although in most situations, treatment received out of the country will not be covered by your health insurance there are a few exceptions: if your health insurer offers a global network option, if they have a relationship with a foreign provider, or if treatment is being performed in a foreign branch of a US hospital. Many overseas hospitals are establishing strong ties to American medical centers. For instance, Johns Hopkins Singapore International Medical Centre is a branch of John Hopkins University in Baltimore. Bumrungrad Hospital in Bangkok claims to employ over 200 surgeons who are board-certified in the United States. Most are English speaking.

The Joint Commission (TJC) is a nonprofit organization that accredits more than 20,000 health care organizations and programs in the United States. The Joint Commission International (JCI) is an extension of TJC that provides accreditation for hospitals and clinics, laboratories, long- and short-term rehabilitation facilities, primary care, home care, medical transport, and more, in 54 countries. Patients seeking medical care overseas, whether as a medical tourist, tourist in need of medical care, or as an ex-patriot, can use the JCI’s website to identify accredited facilities in their locale. Not all medical tourism destinations are outside the US, however, the Cleveland Clinical for example markets itself worldwide as a medical destination and has become a major center for inbound medical tourism in the United States. Below is list of popular procedures and destinations for medical tourists.

Specialties Popular Procedures Popular Destinations
Bariatric surgery gastric sleeve, gastric bypass Spain
Cardiology bypass surgery, heart valve replacement India
Dentistry dental implants, veneers, crowns Thailand
Dermatology mole removal, acne treatment Malaysia
Hair restoration hair transplant Turkey
Oncology breast cancer treatment, chemotherapy Germany
Ophthalmology Lasik, cataract surgery Hungary
Orthopedics knee or hip replacement, spine surgery United Arab Emirates
Plastic surgery liposuction, breast implants, rhinoplasty Poland
Reproductive medicine in vitro fertilization (IVF) Mexico

 

Medical travel agents are available to help research and book medical treatments, as well as make all travel arrangements. A search using the phrase “medical tourism packages” will return hundreds of entries. Careful research is needed. Several medical organizations and societies, including the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery have issued position statements on medical tourism. All recommend making the decision in conjunction with your physician, vetting foreign facilities, and traveling with all medical records. Poor physician training and shortened postoperative care are often quoted as potential risks of medical treatments abroad.

Medical tourism is increasing and becoming an important source of income for many foreign countries. All medical procedures carry the possibility of risk. While the risk associated with treatment received abroad may be somewhat different, do not imagine that you will be receiving treatment in a rundown clinic in a back alley of a third world country. Most of the facilities are modern, well-equipped, and staffed with well-trained medical personnel, many of whom trained in the United States or Europe. Before making a commitment, discuss your thoughts with your health care provider and insurance company and take the time to properly research your destination hospital/clinic and the staff.

Posted by & filed under Medical Writing, Travel.

St.Peter's Church and Vatican For our fourth stay abroad, we chose Italy. Our client, MD Conference Express®, had a contract to cover three conferences and agreed with us that it would be cost effective if they sent one team, especially a married team, to attend all three congresses. The first meeting was in Rome, the second two in Milan. We left the evening of May 31 and returned home on June 25.

For the first 9 days of our trip we rented an apartment from a friend. It was about one block from St. Peter’s Square and the Vatican so this was pretty much where all our days started. There were several good local restaurants right around the corner, a few mini-markets, and a Carrefour not too far away. Arriving the 1st of June, we had time to do some sightseeing before the start of the first conference. We toured the Vatican (awesome), had an audience with the Pope (along with another 2000 tourists in St. Peters Square), and visited the Sistine Chapel, Colosseum, Forum, Pantheon, Catacombs, and all of the great Piazzas and Basilicas we could walk to or get to by metro. Rome was crowded, hot, and filled with tourists, but I would put it on everyone’s must see list. The Vatican is amazing—so many paintings and sculpture stuffed into one place, representing thousands of years of history and the work of the best artists the world has ever created. Do the night tour if you can since it’s less crowded. Because it’s free, the lines for St. Peter’s are long (3 to 4 hours on some days) – check it out around 4PM on a Sunday afternoon, we somehow lucked into a

Maria attended the annual meeting of the European League Against Rheumatism (EULAR). We’ve covered this meeting several times in the past in Amsterdam, Stockholm, Barcelona, and Paris; this year it was in Rome from June 10th to the 13th. EULAR probably has some of the best science of any of the congresses we attend but unfortunately it is not the easiest conference to cover (more later). This year, coverage was made more trying by the location of the conference center, which is a good 45 minute chartered bus ride from most hotels, practically unreachable by public transportation, and a 45 Euro taxi ride. Despite this it was a good meeting and very well attended.

Galeria Vittorio Emanuele II While Maria remained in Rome I took the Frecciarossa train (travels over 200 MPH) to Milan to attend and capture content of the European Society of Hypertension (ESH) meeting, which took place June 12th to the 15th at the MICO Milano Congressi. The MICO is a brand new futuristic-looking congress center, the largest in Europe. It’s very pleasant and with the new metro stop, easy to access. BTW: Milan is very busy this year – from May 1 to October 31 it is hosting the Universal Exposition a non-commercial exhibition that encourages dialogue on hot global topics. This year’s topic is Feeding The Planet: Energy for Life (Michele Obama attended on the 17th of June).

We also rented an apartment for our stay in Milan – this time through VRBO. The apartment was well-equipped and in a nice residential area that was within walking distance of the MICO and also close to the metro. The ESH Congress was well-attended and focused on, besides hypertension, cardiovascular protection, diabetes, stroke, and the new oral anticoagulants.

Maria joined me at the apartment the following Sunday, exhausted and frustrated with the EULAR conference organizers. Ironically, she also managed to get tossed-out during the last day, last session of the conference. I say ironically, as this also happen to me the last time we covered EULAR in Paris on the last day, last session. EULAR has very strict rules for capturing content-you can’t. Without content (audio and visuals), there is really no reason for us to attend. Our job is to write up a review of the sessions assigned to us, as many as 12 or more (10,000 to 14,000 words). Sometimes these sessions have six or more presenters each with 30 to 40 slides and 20 minutes speaking time. If you are only interested in highlights, I guess you can write a story from press releases but that’s not what we do. For the articles we write, taping and photographing are necessary for a good write up.

After ESH we headed off for some sight-seeing: the Duomo (magnificent), the Last Supper painting (truly inspiring – and we are both convinced it is Mary Magdalen not John), Galleria Vittorio Emanuele, and lunch with the locals at Luini. It rained a couple of days, but this took the edge off the city heat. Some days the weather was quite good. Of note, the pizza in Rome was great everywhere we had it, while in Milan it was bad everywhere we had it. Don’t know the reason for this, maybe just the luck of the draw.

Grand Canal In the middle of week, we took the train to Venice, a lovely, charming city, with no cars, only boats and gondolas. Yes, we toured the Grand Canal, went to Saint Mark’s Square for lunch (paid way too much) and San Giorgio Maggiore, and went for drinks at Harry’s Bar (hard to find). Harry’s is famous for the Bellini and for having been the favorite spot of many writers – especially Hemingway. We stayed on Lido Island, home to the Venice Film Festival, and stuck our feet in the Adriatic Sea.

Back in Milan, we got ready for European Heart Rhythm Association (EHRA) meeting again at the MICO center. This 4-day conference ran from Sunday 21th to Wednesday 24th and emphasized a multidisciplinary and translational approach using modern electrophysiology in the diagnosis and therapy of arrhythmias and conduction disturbance. Maria and I covered this together splitting up the duties of photographing and recording. We made some interesting contacts that maybe will turn into long-term clients.

On our off time we enjoyed hanging in the apartment and visiting the neighboring cafes, which surprisingly offered some good food. However, the best meals we had in Milan were the ones Maria cooked in the apartment with fresh ingredients from the local market. It was good to get home. A month is just the right about of time to get to know a place and get homesick.

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Medical Writers Speak- Podcast Latest episode

In this episode, I talk to Maria and Phil Vinall, who both have backgrounds as medical writers in pharma and are now freelance. We talk about publications planning, what it’s like to work together as a married couple, and the joys of being able to work from anywhere – including an island off the coast of Panama! Their website is www.medcomdepot.com. They are members of the Delaware Valley AMWA chapter and happy to help new writers.

Please listen here. Please subscribe, rate, and review the podcast on iTunes

 

 

home health care devices

Posted by & filed under Home Health Care.

 

We take for granted many of commonly available home testing devices such as pregnancy and drug tests, digital thermometers, kits to monitor blood glucose levels, and portable blood pressure devices.

 

 

The next generation of devices will take us one-step closer to patient directed healthcare. The number of home, portable, and wearable smart devices that will interface with smartphone-based Apps and thus physicians and other caregivers is about to explode. Software companies are rushing to develop new apps and devices useful for monitoring a host of physiologic parameters. However, is there a danger we might go too far?

A digital home health care device is being tested that when pressed to the forehead that can measure a person’s heart rate, temperature, blood oxygen levels, respiratory rate, blood pressure, glucose, alcohol, and cholesterol levels, in addition the electrical activity of their heart and their level of emotional stress (reminds me of the tricorder Dr. McCoy used in Star Trek). The data is transmitted to a smart phone App which is easily available to your physician. An iPhone™ based otoscope App allows parents to upload images of their children’s inner ears when they show signs of infection, with the aim of avoiding unnecessary doctor visits. Other smartphone Apps have been developed to help radiologists read medical images and allow patients to track moles for signs of skin cancer.

One start-up company has been working on a device that connects to your iPhone and can identify smells—so you may one day ask “Siri, how does my breath smell?” while breathing into your iPhone. Besides detecting bad breath, future applications of the device may include detecting low blood sugar and high blood alcohol with just an exhale.

The AliveCor Heart Monitor consists of a case that snaps onto the iPhone with electrodes on the back. It reads heart rhythms and relays the recording to an iPhone App. With this ECG data you and your physician can determine whether your heart rhythm is normal or detect an atrial fibrillation (a leading cause of stroke). Results from a study published in the Wall Street Journal reported that the use of Smart phone technologies was associated with a significant reduction in patients’ Framingham risk score, which estimates the 10-year risk of a first heart attack.

How about smart pill bottles that ping you and your doctor to say how much of your prescribed medication remains. These are useful for monitoring when to refill prescription and to determine compliance with medication adherence. Besides smart phone Apps, a rapid at-home inexpensive test for early detection of pancreatic cancer, created by Jack Andrea when he was 15 years old, is in development. The device carbon nanotubes laced with an antibody that reacts to a protein—mesothelin—found in the blood of people with pancreatic cancer. The test uses paper sensor strips that costs 3 cents and are 90% accurate.
Funding from the Bill and Melinda Gates Foundation, has led to the development of a needle-free way to deliver vaccine directly into the skin. The technology consists of a disc-shaped micro needle array—very tiny projections made of sugar mixed with the vaccine. When the disc is pressed against the skin, the micro needles dissolve to deliver the vaccine. For people who do not have easy access to health services or people who continuously need to blood test or have injections for conditions like diabetes, this could be a lifesaver.
There are other devices in development whose usefulness can be debated. A Wellbeing Toilet that can analyze waste to detect disease, nutritional deficiencies, sugar levels, and pregnancy from the comfort of your bathroom may be in your future. It also takes your weight when you sit down. Again, the information can be sent to a smart phone and easily shared with a caregiver. There are smart belts that monitor the balance of the elderly and smart carpets that detect falls. Smart forks are available to inform us we are eating too fast. Smart toothbrushes urge us to spend more time brushing our teeth.

One important issue with all this technology is how long will it be before the self-tracking of our health (weight, diet, step taken in day) graduates from being a recreational novelty to a virtual requirement? Will these devices and Apps move from being optional to being mandatory for insurance or government reasons? The endpoint may not being helping individuals achieve better health behavior but social engineering disguised as product engineering.