Bioengineering, and more specifically, tissue engineering, gives a new perspective to personalized medicine.

The use of cells and therapies has become a strong practice to get the body to heal itself, as it already happens with blood transfusions, bone marrow transplants, and autologous chondrocyte implantation to re-grow cartilage.

These procedures have prepared the road for over 2000 clinical trials linked to cell therapies, like stem cells for ischemic heart regions, neural precursor cells for Parkinson’s disease, and oligodendrocytes resulting from embryonic stem cells to heal spinal cord injuries.

The key to success is to detect the best mechanism to transfer these cells.  For example, cell-based therapy is employed to treat osteoarthritis of the knee, where the damage to cartilage and the subchondral bone produces less fibro cartilage repair than the mechanical properties of articular cartilage.  The majority of patients develop an acute degenerative joint disease, and over 250,000 knee replacements are done in a year.  In this case, injecting a suspension of autologous cultured chondrocytes into the problem area won’t work effectively because the cells have the tendency of forming fibro cartilage and of losing their round shape.  The best way to treat osteoarthritis of the knee is to embed the chondrocytes in the cartilaginous matrix that wears away just as the cartilage does.

If the chondrocytes are enveloped in gels, this permits the cells to maintain their rounded shape, and the properties of the gels can be controlled to let the tissue regenerate.  The mesh has to be small enough to hold up the cells, and open enough to get water and nutrients.  Equally, the gel structure has to disintegrate at the right rate so that the extracellular matrix that is secreted is not limited only to the area that surrounds each chondrocyte.

The cartilage tissue that is engineered can replicate the structural characteristics of native cartilage to such an extent that the cell orientation and the regenerated cartilage look like native cartilage.  The cells that are enveloped in this kind of matrix can migrate to and from the cartilage at the surface.

A vital matter brought up by cell-based therapy is how to make the most of the utility of cells delivered to an environment that is passive or tolerant, where there is context for the kind of cell required but in which very few biological signals are produced to support normal cell function.

In the end, bioengineers picture a material system in which the embedded cells emit a signal so that deeper cells form bone white cells close to the surface form cartilage.

Regenerative medicine anticipates several things:

-A rising impact of cell-based therapies in clinical medicine

-Methods that make it easy to regenerate skin, bone, cartilage, bladder, and trachea from bone marrow stem cells, and also the regeneration of blood vessels and heart valves

-The restoration of function in complex tissues like the spinal cord

-Going after the goal of regenerating more complex tissues and neo-organs

-Tackling big challenges, like the identification of cell sources and clinically relevant cell numbers, the integration of new cells into existing tissue matrices, and the accomplishment of functional properties of tissue equivalents using expanded range of biomaterials

Contact your life sciences consulting group for more information and guidance on how to make the most of the regenerative medicine market.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared.

An FDA inspection is basically a quality assurance process that is used to confirm clinical data management/integrity and regulatory compliance.  Here we show you how to make it a piece of cake for your site and your nerves.

Kinds of inspections

-The most common FDA inspection is the ‘routine inspection’, prompted by a New Drug Application (NDA) submission.  The typical candidates for a routine inspection are clinical sites that enroll the majority of patients in the NDA’s critical clinical  trials.

-‘For Cause inspections’ are not common, and are prompted when the FDA receives a report of, or becomes aware of, suspicious behavior.  Here are some reasons that may bring about such an audit:

_ The carrying out of many clinical trials

_ The carrying out of clinical studies outside of your specialization field

_ The reporting of much better effectiveness, less unfavorable effects, or different laboratory results from other sites studying the same drug

_ Having noticeable access to a large number of patients with a specific disease state for the setting

_ Complaints from a patient or sponsor in regards to regulations, protocol, or human rights violations

-Customer complaints that may trigger a product recall

How it all starts

It all starts with a phone call.  The FDA will call to program an inspection at a time that is agreed between both parties and that does not interrupt the site’s activity.  Nevertheless, they will only give you between 5 to 14 days notice, and will spend around 2 to 3 days on site.

You are entitled to ask what study they are going to inspect and who should be available during the visit, and contact the study sponsor immediately, because this sponsor can give you good suggestions and they are not directly notified by the FDA about clinical site inspections.

Before the inspection, gather these documents for the study in question:

-Protocol

-Investigator’s brochure and IND Safety Reports

-Form FDA 1572 with accompanying CVs

-IRB correspondence, including approval documentation and final report to IRB and Sponsor

-IRB-approved Informed Consent form

-IRB-approved advertising

-Correspondence related to the study, excluding investigator agreement and financial information

-Monitor sign-in log

-Laboratory certification documents

-Drug accountability records

-Each subject’s signed informed consent

-Assess support areas, like pharmacy or lab, to make sure they are properly prepared.  The FDA may tour the facility

Be ready to answer these questions:

-    Where was the study done?

-    What special equipment was used?

-    Who assisted in doing the study?

-    What were each person’s specific responsibilities?

-    Describe the sponsor’s monitoring procedures and your interaction with the monitor.

-    How did you account for the drug received, distributed to, or returned from subjects?  Were all drugs returned to the sponsor?

Train your personnel to relate to the FDA.  You must show you are a professional and should answer questions in a direct way, without giving information they haven’t requested.

When the inspector arrives

First, check his ID, because you don’t want an unauthorized person checking your files.  The inspector will fill a Notice of Inspection (FDA Form 482) and will hand it to you.

1.The inspector will begin by determining the nature of the investigator’s conduct of the study.  He may want to tour the facilities and talk to everyone who took part in the study.

His intention is to establish the level of delegation of the investigator’s authority, where specific procedures were performed, where and how the data was gathered, and where the drug was accounted for and stored.

These things are normally checked:

-Communication capability with the IRB, including the initial submission document, adverse event reporting, and progress reports

-Totality of accountability documentation for the receipt, storage, administration, and return of test article (drug, device, etc.)

-Compliance with the study protocol and documentation that each deviation/amendment received the approval of the IRB and the sponsor

-Aptness of the informed consent process

-Timely and full reporting of adverse events to the IRB and sponsor

-Compliance with the record retention requirements and that the investigator had instant access to the study records during the trial

-Ample monitoring of the site and communication with the sponsor

2.The inspector will move on to audit the data.  He will compare the data submitted to the FDA with the medical charts and source documents that support it.

He will review data from before and after the subject’s participation to make sure the subject had the medical condition under treatment and that excluded medications were not given to him or her during the study period.

3.After finishing the audit, the inspector will meet with the investigator to talk about the results.  Any inconsistencies will be registered on FDA Form 483, of which you will receive a copy.

4.The inspector will write an Establishment Inspection Report (EIR) that will be sent to the FDA for evaluation.  You will receive a letter after this evaluation is finished.

This letter may show one of three scenarios:

-It may simply recognize that the inspection was done and that nothing significant was found.

-It may list deficiencies found during the inspection, but may point out that no response is necessary.  Nevertheless, it is important that the site acts on these deficiencies in view of future inspections.

-It may point out serious negative discoveries.  The site and the data are at risk here, and you must answer immediately to clarify what steps you will take to solve the situation.

Get the help of your sponsor, because the pharmaceutical company has lots to lose too, and contact your pharmaceutical consultant for guidance and support.

If you do not respond correctly, you may be banned from performing other studies; your study data, or even the whole marketing application, can be rejected; and you may even face criminal charges.

The EIR is available, upon request, to the site, sponsor, and general public, after 4 to 6 months through the Freedom of Information Act.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain!

The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues.

For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and published in the open access journal PLoS Genetics, shows that a gene called ‘Smed-prep’ is crucial for the correct regeneration of the head and brain of planarian worms.

These worms have an incredible ability to regenerate body parts.  They contain adult stem cells that are incessantly splitting and are able to become all of the missing cell types; they have the correct set of genes at work to achieve this in the right way, so that when the body parts grow back, it happens in the right place and in the right size, shape, and orientation.

Dr. Abbobaker’s team has had the opportunity to see the tissue regeneration process in a very simple animal that is capable of regenerating itself to an amazing extent and that does it regularly.  They want to understand how it is that adult stem cells can work together in any animal to form and replace damaged or missing organs and tissues, because any new understanding in animals can be very important, very fast, for humans.

If scientists understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason.

This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the blood cell system, where rogue stem cells can cause Leukemia.

Smed-prep is vital to correctly differentiate and to locate the cells that compose the head of the planarian worm and to define where this organ is located in the worm.

The scientists have discovered that even though Smed-prep is crucial for the head and brain to be in the right place, the worm stem cells can nevertheless be persuaded to form brain cells due to the action of other unrelated genes.  However, without Smed-prep, these cells are unable to organize themselves to form a normal brain.

The team knows that it is crucial to understand the molecular basis for tissue regeneration and remodeling in order to advance in regenerative medicine.

The planarians are famous for their incredible regenerative capabilities, and these scientists have been able to characterize the first gene, the Smed-prep, that is necessary for correct anterior fate and patterning during regeneration.

Contact your pharmaceutical consultant for guidance and more information in regards to tissue regeneration milestones.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain!

The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues.

For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and published in the open access journal PLoS Genetics, shows that a gene called ‘Smed-prep’ is crucial for the correct regeneration of the head and brain of planarian worms.

These worms have an incredible ability to regenerate body parts.  They contain adult stem cells that are incessantly splitting and are able to become all of the missing cell types; they have the correct set of genes at work to achieve this in the right way, so that when the body parts grow back, it happens in the right place and in the right size, shape, and orientation.

Dr. Abbobaker’s team has had the opportunity to see the tissue regeneration process in a very simple animal that is capable of regenerating itself to an amazing extent and that does it regularly.  They want to understand how it is that adult stem cells can work together in any animal to form and replace damaged or missing organs and tissues, because any new understanding in animals can be very important, very fast, for humans.

If scientists understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason.

This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the blood cell system, where rogue stem cells can cause Leukemia.

Smed-prep is vital to correctly differentiate and to locate the cells that compose the head of the planarian worm and to define where this organ is located in the worm.

The scientists have discovered that even though Smed-prep is crucial for the head and brain to be in the right place, the worm stem cells can nevertheless be persuaded to form brain cells due to the action of other unrelated genes.  However, without Smed-prep, these cells are unable to organize themselves to form a normal brain.

The team knows that it is crucial to understand the molecular basis for tissue regeneration and remodeling in order to advance in regenerative medicine.

The planarians are famous for their incredible regenerative capabilities, and these scientists have been able to characterize the first gene, the Smed-prep, that is necessary for correct anterior fate and patterning during regeneration.

Contact your pharmaceutical consultant for guidance and more information in regards to tissue regeneration milestones.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

In April 2010, an important number of the world’s top experts in pediatric pharmacogenomics and personalized medicine came together at a unique conference to change the way childhood diseases are treated.

The conference was hosted by the Children’s Mercy Hospitals and Clinics, and its goal was to apply genomic tools to medical problems so as to tailor treatments to the unique requirements of children patients in order to improve results.

The conference’s organizer, Stephen Spielberg, MD, PhD, Director of the Children’s Mercy Center for Personalized Medicine and Therapeutic Innovation; Marion Merrell Dow Chair in Pediatric Pharmacogenomics; and Professor of Pediatrics, University of Missouri- Kansas City School of Medicine, stated that personalized medicine utilizes the latest developments in genomics and molecular data so that they can give the correct medication to the correct patient, in the correct dosage, and at the correct time.

He added that right now, a lot of medications work just for about 50% of the patients who take them, thus, personalized medicine shows high potential to transform the way in which they treat diseases.

During the conference, different experts from academia, government, and the private sector in the US, Canada, and Japan shared their knowledge of clinical applications, bioethics, and the development of pediatric personalized medicine programs.

Some of the clinical applications that were discussed were from the research programs being run at the Children’s Mercy, which tackle significant patient challenges like:

-Applying genomic strategies to improve the safety and efficiency of medications employed to treat cancer in children.

-Improving the effectiveness and benefit/risk percentage of a common therapeutic agent in treating Juvenile Idiopathic Arthritis, where inter-patient inconsistency causes 40% of the patients to fail to see results.

-Revealing genetic and developmental factors that contribute to the risk of serious adverse drug reactions in children.

-Identifying a non-invasive marker for inflammation concerning asthma, allowing doctors to predict correctly if the patients will respond to steroid treatment, and if not, guide them in the direction of better therapies.

-Utilizing genetic biomarkers to forecast which newborns are in danger of developing hyperbilirubinemia, which is the most common reason why newborns are hospitalized; up to 85% of readmissions during the first two weeks of life are due to this condition.

The occasion also prompted exchanges that help address crucial concerns created by personalized medicine, for example:

-Genetic discrimination
-Cost-benefit analysis
-Universal standards for managing genomic information in electronic medical records
-Biobanking
-Strategies to educate practitioners and patients

Children’s Mercy Hospitals and Clinics is a national leader in pediatric personalized medicine, and they are about to launch two new programs to increase medication safety:

-The outpatient Personalized Medicine and Therapeutic Innovation Clinic

-An inpatient adverse drug reaction program

Both programs will deliver first-class drug therapies, encouraging the use of discoveries to impact treatment decisions.  The clinics will be open to referrals of patients that show diagnostic and therapeutic challenges and are not responding to a therapy in progress or have had a sudden, unfavorable reaction to a certain medication.

The personalized medicine clinic will offer better therapies for children by using various approaches, which include genomic technologies and the cooperation between clinical pharmacologists and pediatric subspecialists.

Contact your life sciences consulting firm for more information about the future of personalized medicine.

If your company is associated with the pharmaceutical industry in any way, whether it be manufacturing, supplying, or research and development, there’s a pretty good chance that your company will be audited with some kind of FDA inspection down the line.  When by chance, your company is audited, they will have to pass a series of FDA inspection tests, to ensure that your company is running in compliance to FDA standards, and that all your research and manufacturing information can be verified.  But you may be asking yourselves, what are the reasons for pre-approval inspections anyways, and what can my company do to get through it, and pass it the first time around?

The purpose of a Pre-Approval Inspection is for the federal government to ensure that all manufacturing facilities, as well as development facilities, meet all current GMP codes of conduct and stipulations.  Their main purpose is to verify that your company’s procedural activities are in line with their own commitments to ensure the authenticity and accuracy of any data contained in your company’s submitted application file.  It is the inspector’s job to thoroughly inspect your facility, as well as any records or data you have available, to make sure that your site produces reliable data information, and that all key GMP systems are up to code with current GMP standards.

Thorough preparation work is absolutely paramount when ensuring that your company is successful in getting through its pre-inspection test.  For your company to prepare itself sufficiently, many pharmaceutical experts recommend that your company start preparing itself at least 12 months prior to the inspection date.  One of the best things your company can do to ensure maximum preparation, is to hire an outside pharmaceutical consulting firm, or life sciences consulting firm, that specializes in pre-inspection audits, and can help your company to prepare itself the best way you can for your pre-approval inspection.

Companies should always be aware that preparing for your pre-approval inspection is not a last minute activity, and takes months of comprehensive training to be adequately prepared.  It is also advisable to organize comprehensive training programs for all personnel that will be in any way associated with the inspection.  It is not unheard of that personnel behaving in an inappropriate manner, or providing misleading information to inspectors, can cause inspectors to ask further, more difficult questions, as well as cause them to look into areas they may have overlooked.

This is why any personnel staff that could potentially come in contact with an inspector, should be thoroughly trained and briefed well ahead of time, to avoid any possible problems.  Your personnel should be instructed on how to conduct themselves around inspectors appropriately, as well as how to appropriately answer questions.  Phrases like “I guess”, “normally”, “usually”, “I think”, and “most of the time”, should all be carefully avoided.  Because of the wide range of do’s and don’ts associated with pre-inspection protocol, preparing your entire staff well ahead of time will be your best chance to safely make it through the pre-inspection process unscathed.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

A study of almost 100 clinical trials that were stopped prematurely because they showed positive treatment effects has shown that a large number of those effects were exaggerated.

The study was published in the Journal of the American Medical Association and recommends that researchers do not fall for the temptation to end clinical trials prematurely but rather continue with them for longer periods of time before thinking about ending them.

Victor Montori, M.D., Mayo Clinic endocrinologist and one of the authors of the study, explained that they discovered that in the majority of cases where the clinical trial was stopped prematurely, the effects of the treatment were deceptive, and that these ambiguous estimations will most probably produce unwise decisions in regards to the estimation of the therapy’s risks and benefits.

He added that, “On average, treatments with no effect would show a reduction in relative risk of almost 30 percent in stopped early trials.  Treatments with a true relative risk reduction of 20 percent would show a reduction of over 40 percent.”

The clinical trials that were analyzed in the study were stopped prematurely due to a credible and normally large apparent difference between an experimental treatment and an established standard therapy.

The trials were stopped so that the people taking a placebo, or a medication that was less effective, could take the drug in trial.  In addition, this allowed doctors to prescribe the therapy earlier, since it would reach the market faster.

Dr. Montori explained that almost everyone doctors, researchers, investors, pharmaceutical firms, scientific journals, and even reporters benefits from the premature stop of a clinical trial; the only one that is affected is the patient, because he or she may wind up being treated with a therapy that is based on deceptive data in regards to its benefits.

The study investigated 63 medical questions about 91 trials that were stopped and compared them to 424 equivalent trials that remained active.  The discovery was that the trials that were prematurely stopped, especially small trials of a few hundred participants, showed effects that were exaggerated or deceptive, and these deceptive conclusions were aggravate over time because researchers wouldn’t go back to check what was previously considered a positive treatment.

It is recommended by the research team that clinical trials are stopped only when these are near the end and only for a very good reason, otherwise, patients, as much as doctors, will be making choices based on the wrong information and will be considering treatments that may not work as well as others.

The Medical Research Council of the U.K backed this study, and collaborated on it, together with Dr. Montori: Dirk Bassler, M.D.; Matthias Briel, M.D.; Qi Zhou, Ph.D.; Stephen Walter, Ph.D.; Gordon Guyatt, M.D.; and Diane Heels-Ansdell, all from McMaster University, Ontario; Melanie Lane, Mayo Clinic; and Paul Glasziou, M.B.B.S., Ph.D., University of Oxford, England.

Contact pharmaceutical consultants for more information, guidance, and to get the competitive edge you need to be the market leader in healthcare products.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

According to Mexican researchers, agave, the plant from which tequila is made, may help fight osteoporosis and other bone diseases through one of its components.

Agave, as well as artichokes, garlic, onions, and chicory, is a powerful natural source of fructans, non-edible carbohydrates that consist of molecules of fructose joined together into chains.

Experimental studies indicate that fructans could be helpful for patients with diabetes or obesity, to stimulate the immune system, to decrease levels of bacteria that cause intestinal illness, to relieve constipation, and to reduce the risk of colon cancer.

Fructans have also been shown to stimulate the growth of good bacteria in the large intestine, boosting the body’s assimilation of minerals, including calcium and magnesium, essential for bone growth.  So, even though it is not a tequila shot per se, fructans may do a lot of good to a sick person’s bones.

Mercedes Lopez, from the National Polytechnic Institute in Guanajuato, tested the agave fructans on mice bone growth.  The sample fed with agave fructans absorbed more calcium from food, expelled less calcium in their feces, and increased in 50% their levels of a protein associated with the development of new bone tissue, all three, conditions that were not observed in other mice.

The natural conclusion is that by enriching the mice’s normal diet with agave fructans, bone loss was prevented and bone formation was enhanced.  This suggests that agave fructans may play an important part in maintaining bone health.

Agave fructans can be used in many products for children and infants to inhibit several illnesses, and also used as a sugar substitute in ice cream.

Lopez clarifies that the conventional tequila shot is actually not an option, since fructans become alcohol when agave is processed into the drink.

Ask your pharmaceutical consultant for more information or research on agave fructans; there’s no better source of valid information and advice in the pharmaceutical industry.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

The time when body organs become replaceable is just around the corner.  Soon enough, scientists will be able to extend the life span of a human being dozens of years through his or her stem cells.

The first step has been taken already, with a 10-year-old boy receiving a revolutionary tracheal transplant in London, at the Great Ormond Street Hospital.

An organ that will grow inside the boy’s body through his stem cells has substituted the windpipe, bendable tube connecting the nose, mouth and lungs.

The boy was born with a condition known as long segment tracheal stenosis, which is a weakening condition that leaves the person with an airway of 1mm in width, putting him at risk of suffocation and death.

Previously, the boy was treated with stents, but these collapsed, interrupted the airflow and harmed the boy’s aorta.  After the child could barely breathe, his doctors called Paolo Macchiarini, at Careggi University Hospital in Florence, who decided to try a dangerous but bold procedure: re-growing the organ inside the boy’s body using stem cells.

Macchiarini’s team took a donor’s windpipe and removed all cells to prevent immune response.  The tissue was successfully implanted after having been seeded with the child’s stem cells and with a blend of chemicals that promote growth.  The patient responded well, he breathed normally and started talking right after the procedure.

This is truly a milestone in more than one way, because besides the implications it has for human life and health, this is the first time a child has received stem-cell organ treatment, it is the longest airway that has been substituted ever, and by letting the boy’s own cells re-grow the tissue, the costs were lowered considerably, by tens of thousands of pounds.

This success opens the door for stem-cell organ transplants to be performed in other medical facilities besides highly specialized hospitals, and although it won’t replace conventional transplants shortly, it most certainly can be applied to some aspects of these types of surgeries.

Regenerative medicine must become an important part of healthcare, and things are moving in that direction.  The next possible and intrepid step will be to perform larynx or esophagus stem cell transplants.

For now, doctors are waiting to see how the boy further responds to the transplant and if his recovery is as successful as expected.  If he recovers completely, as it is believed he will, we will have moved a step closer to immortality.

Talk to your life sciences consulting firm to learn about the latest developments in the pharmaceutical industry and to find the best ways to take advantage of the stem cell miracles that are unfolding around the world today.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

A recent CDC investigation shows that a measles outbreak in southern San Diego was caused by parents refusing to have their children vaccinated, even though it is required in many states by law.  Because measles is one of the world’s most highly contagious diseases, this new trend of refusing vaccinations is becoming more and more alarming to the CDC who fears a new, more powerful measles outbreak could be looming.  But how could this be?  Many are blaming ever increasing worry and misinformation about the overall safety of these vaccines.

The CDC is quite concerned about the signs that more and more important vaccinations are being outright refused by many concerned, and sometimes misinformed parents.  These parents in question believe that many of these vaccines for the measles, mumps, rubella, are as dangerous as these diseases themselves.  These beliefs have developed as a result of  the growing concerns over the overall safety of vaccines, and if they are really as effective as previously believed.  This recent trend, combined with more misinformation about the safety of certain vaccines has lead to a major drop-off in MMR vaccinations in certain places in the world, and this has corresponded to a subsequent return in the incidence of measles.

The CDC believes that much of this battle over vaccines is over more and more activist misinformation distributed about vaccine safety, and an overall growing distrust of the pharmaceutical industry as a whole.  When many of the parents refusing vaccinations were asked why they chose not to vaccinate their children they told officials that they were skeptical over the overall safety of vaccines, and skeptical about claims from the government.  When asked where they got this information, many were unsure, but many said they had heard varied concerns from other parents.

The CDC feels that because diseases like the mumps, rubella, even polio, have been absent from our modern day society for a long period, many feel that they are naturally impervious to these dangerous and deadly diseases.  And this simply is just not true.  Many respondents even felt that their natural lifestyles including prolonged breastfeeding and organic foods were enough to keep such dangerous diseases at bay.  Others felt that these said vaccines could potentially damage their child’s immune systems or even cause serious neurological complications such as mental retardation or autism.  But the CDC claims that these beliefs are simply unfounded on scientific evidence.

Despite the extraordinary efforts of health workers all around the world to advocate for the safety of these vaccines, many parents are still not convinced.  Even with the volume of scientific evidence supporting the safety of vaccines, many parents still feel that if they were to have a vaccine administered to their child, and something were to go wrong, they would be responsible.  However, many of those in the pharmaceutical and medical profession including doctors, health advocates, and life sciences consulting firms all agree that not doing anything is far worse than the possible side effects that vaccines may or may not have on your children.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).