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.

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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.

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A group of top researchers is focusing on understanding how an embryo’s developing pancreas recognize which cells produce insulin and which ones have other functions.  This understanding is crucial in the use of stem cells, developed into beta cells that produce insulin, to treat type-1 diabetes.

Today, Lund University scientists have new discoveries to announce in this regard, and they will do it in the journal Cell, which is one of the top biomedical journals.

Diabetes researcher Henrik Semb’s team has been analyzing two vital scientific questions:

1.    How are tubes formed in organs where they fulfill vital functions?  For example, the tubes that filter urine in the kidneys, the tubes that carry blood in the blood vessels, and the tubes that carry air in the lungs.

2.    How is the differentiation of cells, the development of immature cells into various mature ones, related to the formation of tubes?

These two processes are known to happen simultaneously in an embryo, but it was not known if they were related, until now.  Henrik Semb’s research team can explain step by step how certain cells in the developing pancreas form miniature cavities that join together to create a system of tubes, and how cells that end up in different parts of this tube system are exposed to different environments, thus they develop in separate ways.  Some produce insulin, others, enzymes that digest food in the intestines, and yet others take part in the tube’s construction.

This research team also discovered that there is a critical gene related to these processes, it is called Cdc42.  They found this out through knock-out mice that had this gene removed.  The lack of Cdc42 blocks the formation of tubes in the pancreas, thus, the dominant environment is like the one around enzyme-producing cells instead of the most important insulin-producing beta cells one.

These discoveries provide knowledge that is critical for the future of medical treatments.  A new door has opened for the research on stem cell treatment for type-1 diabetes, given the new understanding of how immature cells grow into beta cells.  This knowledge will also be valuable for diseases where cyst formation in the tubes produces organ failure, for example, in kidneys and liver.

Every important article published in Cell requires committed and lengthy research, and this is exactly what the Lund scientists have done.  They have devoted years to studying tube formation, cell differentiation, and the role of Cdc42 in the mentioned processes.

Their secret resides in the team itself, formed by amazing scientists capable of keeping their passion alive and energy focused even when they were tempted to publish several partial findings in other journals.  They definitely knew better.

If you wish to know more about stem cell research and their future medical potential, talk to your pharmaceutical consultants; they should be on top of the latest developments and market opportunities.

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A leader in vaccine design, development, and distribution, Inovio Biomedical Corporation, informed that its SynCon™ Chikungunya virus DNA vaccine generated protective neutralizing antibody responses in a monkey model.

The Chikungunya virus is a new alpha virus carried by mosquitoes that originated in tropical Africa and Asia.  It has been known to have an infection rate of up to 45%.  Although not life threatening, this virus causes acute human morbidity, presenting serious fever and weakening joint pain, and it could take over a year to cure.

It has been discovered that different mosquitoes normally found in developed countries, including Europe and the United States, can transmit the Chikungunya virus, making it a threat for people in other geographies outside its territories of origin.  The virus is already prevalent in several world regions and clearly has epidemic potential.

Currently, there are no vaccines in the market to treat this virus.  The truth is that very little is known about the disease, including the mechanism of viral clearance based on immunity and why it causes clinical symptoms.  Thinking about the potential the Chikungunya virus has for spreading disease globally, it is crucial to understand its pathogenic mechanism and to develop effective treatment alternatives.

Inovio used its SynCon™ approach to create a Chikungunya virus DNA vaccine that is delivered as a single DNA plasmid construct including harmonious sequences of key surfaces antigens.  Its design is based on the alignment of various primary sequences of key surface antigens and on the selection of the most common amino acid or base pair at each site.

In the study with money models, the entirety of the sample that was vaccinated developed protective neutralizing antibody responses against the original virus, demonstrating the vaccine’s effectiveness in a preclinical model.  This data presents solid evidence highlighting the likelihood of  nearterm future human clinical progress.

Inovio’s new SynCon™ technology allows them to design DNA-based vaccines that can protect against known or unknown pathogen strains.  It can synthetically define antigens and gene sequences that are common between different viral sub types or families of diseases like HIV, HCV, HPV, and influenza.

This company recently disclosed provisional information regarding a Phase I therapeutic HPV/cervical cancer vaccine test that showed important and strong immune responses from T-cells and antibodies, highlighting the possible broad use of its DNA vaccine technology platform and application to various diseases, among which is the Chikungunya virus.

This is a clear example of how pharma companies and pharmaceutical consultants who are on top of things win the race on innovation and market trust.

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From 2008 until 2023 there will be an improvement in vaccines, and their sale and use will experience a rebirth.  Vaccines will be one of the fastest growing areas of the pharmaceutical industry, and their profits will increase by the hundreds in percentage terms during this period.

The Global Vaccines Market, 2008-2023, is a report that describes the market trends in a qualitative and quantitative manner.  Vaccines have grown in importance in developed as well as developing countries because of the current epidemic patterns and healthcare needs.

The most important reason for the growth of vaccines is that they are extremely cost effective in fighting disease, thus, governments and private health providers will increasingly encourage their use.

There is increased awareness now in terms of  the benefits of preventive medicine relative to  the better quality of life and reduction of healthcare costs for consumers, and the vaccine industry is answering the call with new products, and making full use of the technological advances in biotechnology.  There is a lot of potential in this area, as much for therapeutics innovation as commercial return..  Currently, there are more than 1000 vaccine candidates in research and development around the world.

Therapeutic vaccines are different from the vaccines currently on the market.  These not only prevent infection, but work with the body’s immune system to fight disease and disorders, including cancer, addiction, and allergies.

The Global Vaccines Market report focuses on these aspects within the field of vaccines:

-    Sales projections for vaccines by disease area, brand and country, including new therapeutic vaccines

-    Analysis of strengths, weaknesses, opportunities, and threats in regards to the vaccine industry

-    Expert opinion from key leaders in the field

-    In-depth analysis of the vaccine pipeline

-    Analysis of the prospects for therapeutic vaccines

-    Geographical division of the vaccine market, including the leading emerging markets of China and India

-    Coverage of future trends in vaccine technology, formulation, and manufacturing

-    Identification of crucial industrial players in the vaccines market

This report gives a comprehensive analysis of the vaccines market using only primary and secondary research, and it includes full transcripts of interviews, company reports, filings, and industry databases.

This report, along with pharmaceutical consultancy, could mean the difference for the success of your business in the years to come.

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Very recently, Pfizer had to pay the highest amount ever, more than $2 billion dollars, to settle civil and criminal allegations in regards to federal violations ruling drug sales.  This pharmaceutical giant was accused of promoting the painkiller Bextra and three other drugs illegally, because it offered doctors benefits such as speaking fees and trips to resorts.

Although it is an important monetary amount, the price that Pfizer will pay indirectly due to lost shareholder value will be huge and more important than the dollar value.

A new research called “Regulatory Exposure of Deceptive Marketing and Its Impact on Firm Value” has put a price on the intangible costs a company has to pay when employing these dark marketing practices.  In order to do this, the research studies the declines in the financial market value of pharmaceutical companies that have been accused of dishonest marketing by the FDA.

In this case the amount Pfizer had to pay drew attention to the risks of employing deceptive marketing campaigns and served as an example to other pharmaceutical companies
.  It is possible that this outcome may help the industry by restoring some credibility towards pharmaceutical companies, which may effect the market value in the longer term.
This case is a  prime example  to illustrate how the FDA and the Justice Department are watching the industry with a view to protecting consumer interests.

The research recognizes that most marketing managers and researchers concentrate in finding ways to increase shareholder value instead of thinking about the consequences of dishonest marketing, which could end up costing much more.  Instead of focusing on value creation, this study evaluates marketing from a value destruction point of view.

The study states that pharmaceutical companies have been spending money on promotion at an annual growth rate of 10.6% since 1996, reaching $3 billion in 2005, and that since 1997, when the FDA allowed for direct costumer marketing, the average annual growth has been of 14.3%.  Merck, for example, in the year 2000, spent more on Vioxx than was spent on the megabrands Budweiser and Pepsi.

The reason why pharma companies invest so much on marketing is because R&D is not delivering enough new products. However, the question the authors ask is whether or not the punishment the industry is receiving is sufficient to discourage  dishonest practices?

In the case of this example it would seem so.
A comparison of the  stock prices before and after the exposure, resulted in important negative returns: a 1% drop in market value/$1 billion loss of shareholder value.

The indirect costs of negative events can really harm a company’s market value and will eventually lead to sharp investor’ response.

Three types of dishonesty were defined:

-    Omission of risk information
-    Effectiveness claims without support
-    Superiority claims without support

The level of value lost due to one or another varies, however it was found that in cases where  the less capable of understanding medical treatments and more vulnerable populations were the victims, the market consequences were worse.

The authors recognize that even though the FDA could catch dishonest companies, many may gain lots of added value from deceiving marketing practices before being caught.  In fact, many think the risk is worth it, since advertising has grown around 270% and the number of citations has decreased around 85%.  This makes pharma companies believe that the gamble may well be worth the risk.

Life sciences consulting firms strive to help companies be their best in an honest and responsible way.  Find someone who can really help your company succeed without sacrificing others’ lives, your personal integrity and your company’s reputation.

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