Monthly Archives: October 2018

Breast cancer does not define you nor does it end your life!

Awareness Day/Month, , ,

The month of October is dedicated to breast cancer to create awareness regarding this prevalent cancer in women, globally. Breast cancer accounts for up to 25% of all new cancers diagnosed in women worldwide. With this being such a serious health issue, it is important to raise awareness about the same.

Here are few of the stories from some of the brave breast cancer survivors:

1. This story is of Kajal:

“My world fell apart on learning that I had breast cancer. It was discovered that my tumor was 1.2 cm and my cancer turned out to be both estrogen and progesterone positive. I cried my eyes out. I was only 24, it wasn’t the time for me to be dealing with cancer. I had different dreams and aspirations but now everything was so different.

I had no family history of breast cancer, so I never ever imagined that I would be going through this. My family and the doctors were my greatest support at this very terrifying phase of my life. Post discussions it was decided that I would be going through double mastectomy. My doctors weren’t concerned about the preservation of fertility until they discovered that I would be needing chemotherapy.

I was clueless when asked that whether I wanted to freeze my eggs, considering that I was so young. But I went on for it. I didn’t wanted to give up on my long hair locks but seeing them fall out in chunks was heartbreaking and I ended up shaving my head.

I was scared to look at myself in the mirror. I was frustrated, sad and miserable complaining why it had to be me! Life was so unfair. But I came in touch with other women who were fighting the same ailment as me. Slowly I began to regain the lost spirit and strength and was determined to defeat cancer. I decided to be a fighter. Everyone around me was so supportive.

It has been 1 year, and I have survived various round of chemo and radiations and I am still going strong. To all the young girls out there struggling with cancer, I would say that don’t let cancer break you, your dreams and your soul. Pull up your socks and fight back and you would emerge victorious.”

2. Neeta’s story:

“Life was going smooth. I got married to the love of my life at the age of 32. We were thinking of a beautiful future ahead, but my world flipped upside down on learning that I had breast cancer. I was noticing a lump on my right breast and ignored it for several days think of it as a normal cyst. My husband insisted that I once get it checked. I had an ultrasound, escalated to mammogram and then biopsy to confirm that I my diagnosis would be for stage 2 triple negative breast cancer.

I was shattered. I knew being a cancer patient means taking all those painful chemo sessions and a lot more and going through various side-effects of the therapies. All I could think of was that it couldn’t have happened to me. I felt helpless but my husband, family and the doctors comforted me and made me believe that I could be cured.

As the chances for pregnancy would eventually decrease with chemo, I went through IVF and got my eggs freezed in hopes of becoming a mother someday. It all began then. I have completed 17 rounds of chemo and dealt with various extra drugs helping me to fight cancer.

I cried seeing my hair fall. I sometimes didn’t had strength to even speak loudly and I ended up crying silently blaming god for my condition. I was dealing with fatigue, nausea and some neuropathy issues.

Undergoing 30 rounds of radiations was not half as painful as the mental and emotional pain I was going through. At one point I even stopped thinking of any future fearing that there might be no future for me. But the support I received from my family, husband, doctors and friends dragged me out of the big black hole of depression I was plunged into.

I came in contact with other cancer patients and interacting with them I learned many things that helped me cope up with this frightening disease. I learnt to be thankful for each day I was breathing, realizing how precious life was. I felt blessed to have such a supporting husband and lovely family and friends besides me, who stood out for me in my toughest times.

It has already been 4 years now and I am all better. I do visit my doctors for health checkups and other essential. I have learned to live even better post cancer. May be not in the best possible way, but I feel cancer has made me a better human being.

Never give up and keep up the spirit. Nothing can bring you down, not even cancer. Just learn how lucky you are to be alive. Learn to give and spread happiness all around.”

Turacoz Healthcare Solutions stands in support of all the women and men dealing with breast cancer and wants to convey them a message that:

“Cancer is not the definition of you. Cancer is just a situation that happened to you. It does not need to define you personally. Gather all your strength and courage and fight against it. No ailment is stronger than your will to live. Be brave, be bold. Wear your pink gloves on and punch the cancer in its face!”

Significance of Publication Planning

Publication Writing, , , ,

Publication planning is that part of the pharmaceutical landscape that ensures that data from pharma companies (clinical trials, commentaries on drug/device class, and other publications supporting the efficacy of drug/device) is disseminated through medical journal articles–an important aspect of pharma companies’ overall marketing strategy. To publish a mix of editorials, primary and secondary publication, and review papers is the goal of efficient publication planning. Strategic publication planning can maximize product visibility throughout its life cycle. The launch of new drug/device in the market can be successful if the key clinical messages reach the target audience at the right time, for which publication planning is essential. The most successful drugs launched in the last 10-15 years have ridden on the back of a very well-implemented publication strategies. Overall, publication planning aids in the accurate reporting of scientific research, thereby promoting ethical transparency at every stage of medical research through the involvement of investigators, journal editors, and publication professionals.

An effective publication planning team is the key to an efficient publication plan. It is the publication planning team that creates a proactive plan to deliver client‑focused solutions and enable strategic planning and timely implementation of the publication plan. The first step in a publication plan is a “GAP analysis”, which can identify gaps in the literature. Thereafter, the team does an analysis of strengths, weaknesses, opportunities, and threats (SWOT) comprising product strengths, weaknesses, market opportunities, and market threats to understand which areas need maximum focus during implementation of the publication plan. For example, if the product in question has more safety issues compared to its competitors, then the publications would mostly be aimed to showcase that the safety concerns are unfounded. The publication planning team also analyzes the Health Economics and Outcomes Research (HEOR) related to the product and various competitors available in the market. In addition, it is the responsibility of the publication planning team to discuss issues related to authorship and data interpretation, and to ensure all the professionals involved in the publication process meet scientific and ethical standards. A good publication planner gets the best key opinion leaders (KOLs), study investigators, and a publication agency (if needed) to write the papers. This allows authors to concentrate only on scientific discussion, and not on logistical issues. Moreover, it encourages transparent communication between researchers and contributors.

There are also a few ethical issues that the publication planning team needs to deal with. These are shown in Figure 1.

Figure 1: Ethical issues relating to publication planning

Apart from ethical considerations the publication strategy team should know the audience; whether they intend to reach out to primary-care physicians, specialists, allied health specialists, managed care specialists, hospital pharmacists, retail pharmacists, formulary managers, and calibrate their publication plan accordingly. Based on this, they should select the journals for publication. Although publishing in a top-tier journals is prestigious, and adds substantially to a product’s first impression, it should be balanced against the length of time to publication. Prestige cannot make up for a publication that arrives too late. Early publication planning helps to ensure both goals are achieved. Finally, ensuring that a publication coincides with important meetings is an important part of efficient publication planning. This can ensure that the medical representatives at these scientific meetings have evidence to back their claims regarding the drugs/devices they are promoting.

With new guidelines such as GPP3 in place, there is an increased scrutiny on publication planning. Therefore, understanding good publication practices for providing structure and ethical implementation of the publication plan are important.

Turacoz Healthcare Solutions (THS), a medical communication company, offers services to healthcare professionals in clinical research, regulatory writing, medico marketing writing, publication writing and support for conducting medical advisory board meetings. Turacoz understands the importance of a good publication which is in line with the new GPP3 guidelines. We follow the same updated guidelines for all our publications and comply with all legal, ethical and regulatory requirements. To know more about our specialization, please do visit our services section.

Are you at the risk of Breast Cancer? Read this & find out.

Health & Fitness, , , , ,

Breast cancer is the most prevalent form of cancer in women. Though it also affects men, the incidence rate is quite low. Early detection (be it any type of cancer) increases the chances of survival in case of this deadly ailment.

For better and timely diagnosis, it is very important to detect the early signs of breast cancer. In this blog we will be discussing the signs of breast cancer.

Have you ever paid attention to your breasts?

How often do you check your breasts?

Ever noticed anything unusual around that area?

These questions are very crucial when it comes to determining the signs and symptoms of breast cancer. Start with having a look carefully at your breasts.

How to check your breasts?

You don’t need any special training to check your breasts. Each woman has a different set of breasts and you should know how your breasts normally feel like or look like. When you know this, you will easily be able to spot anything unusual in your breast area.

Check the whole area around your breast including your armpits & upper chest and if you notice anything unusual, get yourself checked by a doctor.

What to check?

Check for any lumps around your breast area, upper chest or even around armpits. Lumps can be the primary symptom of breast cancer. Pain in breast can also be a sign of breast cancer but usually it is not in most cases. Pain in your breast can be due to other reasons as well but if an unexplained pain prevails over some time, it is advisable to get it checked by a doctor.

Checking your breasts for any signs of breast cancer follows a simple formula: TLC: Touch, Look, Check

  • Lumps are not visible, but they can be felt. Look for any lump or swelling in your breast, armpits and upper chest.
  • Check for any changes in shape or texture of your breasts. A change in size or shape of your breasts might be an indicator of something fishy, for instance one breast appearing larger than the other one.
  • Have a look closely at the texture of your breasts. Look for any puckering or dimpling of the breast skin.
  • Closely examine the color of the breasts. If you notice any redness or inflammation on your breasts, get it checked by a doctor.
  • Notice whether your nipples look different than usual. A change like inversion of one of the nipples if present (these are usually pointed outwards), then consult a doctor.
  • If there is any unusual discharge from your nipples, immediate action is required.
  • Check for any rashes or crusting on your nipples or the areas nearby.

If you notice any of the above symptoms (also presented in Figure 1), then go and see a doctor. It is not necessary that having any of these symptoms is the sign of breast cancer, but it is always safe to have a breast screening post consulting with a doctor. Doctor would examine and if further check-ups required, he will refer you to the specialists accordingly.

Are you at the risk of Breast Cancer? Read this & find out.

Figure 1: Symptoms of breast cancer in women

Do you need to check your breasts often?

Well, as a precautionary step or rather say to be on the safer side and to be aware of this disease you can check your breasts at regular intervals. You can check them monthly or bi-monthly or how often you feel like.

Once you start checking them regularly you will be able to identify even the slightest change taking place in them, be it due to age or at various times of a month. Your breasts can feel sore or heavy before or during your periods, heavier and bigger during pregnancy and you might notice this change if you know your breasts well.

In the similar way if anything is odd with them, it would be noticeable when you are aware of the normal/usual appearance of your breasts.

Breast cancer in men:

Men also have breast tissue, but they are very much less developed as compared to the ones of women. This is also the reason why breast cancer in men is a rare phenomenon.

But, still, we cannot feign ignorance to the fact that men too, are affected by breast cancer.

 

Signs & symptoms of breast cancer in men:

If someone in your family had breast cancer, you have some chances of getting it, but again it’s not definite that you will. Regularly checking your breast is a wise option especially if you have a genetic record of Klinefelter’s Syndrome (history of breast cancer in family).

The breast tissues in men are mostly behind the nipple area & the pigmented region known as areola. Breast cancer in men usually appears around the nipple area as a lump (Figure 2).

Are you at the risk of Breast Cancer? Read this & find out.

Fig. 2: (a) Shows changes in the look of the nipple or areola (direction change in nipple); (b) shows discharge from nipple or nipple ulcers; (c) Shows lump formation around nipple or armpit

If you find any of these symptoms, go and consult a doctor. In case cancer is detected, you can get an early diagnosis, ensuring better and faster recovery. If not, then, any other problem might also get solved in time.

Turacoz Healthcare Solutions requests every men & women to pay close attention to these specific parts of their body and help themselves in early detection of breast cancer, if present.

An early detection increases your chances for better treatment and recovery.

Ghostwriting in Medical Literature

Medical Writing, , , ,

With the advances in medical technology and innovations in field of medical sciences and drug development, there has been widespread increase in scientific research papers. These scientific papers not only add volume to the medical literature, but also greatly impact the decision making of doctors and regulatory authorities. Doctors might make decisions pertaining to treatment planning based on the updated information available. Regulatory authorities, on the other hand, use this literature for drug approval process or for formulating new policies. Thus, it is important that the scientific articles should be written and published in an ethical manner and should uncover all the advantages and disadvantages/side effects of newer treatment modalities/drugs so that the medical literature is free from bias.

Concept of Ghostwriting

Ghostwriting in medical literature is an awful breach to the ethics in dissemination of information obtained from scientific/medical research. This practice of ghostwriting has widely attracted the attention of medical writers and scientific community and has been greatly criticized by them. Ghostwriters are the ones who are hired by pharmaceutical companies for drafting scientific articles for purpose of marketing their product. Such papers incorporate good effects of product while making exaggerated promises and omit its side effects that might adversely affect its usage/ approval/marketing. The articles written in this manner are credited with the authorship of physicians and academicians in the field to enhance the credibility of given information projecting the same as an unbiased source.

As per a review paper by Górski A et al in 2010, approximately 10% of papers published in reputed journals were estimated to be ghostwritten. Furthermore, this rate was suggested to be even higher for some of the medical specialties. Ghostwriters have been defined by The International Society for Medical Publication Professionals as “individuals who contribute substantially to a medical publication but do not appear on the byline and are not acknowledged for their contribution.”

Concept of Authorship

Authorship makes a person/writer accountable for the published information. The onus of the integrity of information presented in the paper lies on its authors. A person/writer is considered an author as per ICMJE guidelines (available at http://www.icmje.org/) if he has substantial intellectual contribution towards the research or content of publication. For being an author to a document, one must fulfill four important authorship criteria. First criterion is substantial contribution to work either in form of its conception and design, data acquisition or its analysis and interpretation. Secondly, the author should have either drafted the manuscript or made critical revisions necessary for its intellectual content. Thirdly, the final version of the paper to be published should have been approved by the individual to qualify as an author. Lastly, the accuracy or integrity of the work should have been adequately investigated by the authors and issues if any should have been resolved by them. The European Medical Writers Association (EMWA) guidelines clearly state that a medical writers can be listed as an author, if they fulfils the authorship criteria; otherwise they must be acknowledged for their work.

Medical Writing vs. Ghostwriting

Medical writing is a dignified professional service provided by the medical writers from diverse fields of life sciences having a background knowledge of medical and allied sciences. Medical writing services can be utilized by pharmaceutical companies, researchers, doctors, and academicians as a process to disseminate their workloads thereby preventing wastage of research resources. It has been estimated that 6% of all papers in medical literature are developed by the help of medical writers and are based on studies sponsored by “nonprofit organizations”. Professional medical writers with their skills and expertise, can support the research by collating data, analyzing and interpreting it, and presenting the results in a clear and concise manner. They can provide intellectual help by writing publication manuscripts. Additionally, they can be hired by pharmaceutical companies for developing regulatory documents required for drug approval or research protocols, clinical trials and their results etc. In addition, professional medical writers can be hired for writing publication documents like original research articles, review papers, consensus statements, expert opinions, and clinical practice guidelines etc. While medical writers are hired for their skill, efficiency, speed, and expertise in the field, ghostwriting is perceived by scientific community as an intent to deceive.

Acknowledgement of Writing Services as a Solution to Ghostwriting

Acknowledgement of contribution by medical writers to the document/paper is believed to be the best method to tackle problematic ghostwriting in medical literature. Considering this, numerous journal’s, editor’s and medical writer’s associations including ICMJE, World Association of Medical Editors (WAME), EMWA, and American Medical Writers Association (AMWA) allows professional medical writers to contribute to the writing of papers even if they are not listed as authors provided their role is adequately acknowledged along with the funding source to receive these services, to improve transparency. Thus, medical writers can legitimately contribute to manuscripts and their contribution should be adequately acknowledged as recommended by ICMJE, EMWA, and AMWA. Ideally, the acknowledgement should reveal the necessary information to maintain transparency viz. name of the aiding writer and name of the person/company/organization who funded for the writing assistance.

It is the responsibility of authors to ensure that the medical writers whose help was sought while preparing manuscript do not remain as ghosts in the underworld. Instead, they should be brought into light by giving them adequate acknowledgment.

Turacoz Healthcare Solutions understands its professional responsibility and take an initiative to make authors and medical writers aware about drawbacks of ghostwriting and method of acknowledging dignified professional services. Turacoz is a medical communication company that provides scientific/medical writing support to the industry and academicians.