By Arezou Azarani | December 14, 2017 at 04:20 PM EST | No Comments
A temperature controlled truck was transporting expensive human Albumin and human Immunoglobin pharmaceuticals when it got into an accident. Human Albumin has numerous clinical uses. For instance, it is used in the emergency treatment of shock, where the restoration of blood volume is urgent. It is also used to prevent hemoconcentration (increased concentration of cellular elements in the blood resulting from loss of fluid to the tissues) and to maintain appropriate electrolyte balance in burned patients. Furthermore, it is used to treat hypoproteinemia (low concentration of plasma protein and a resulting decreased circulating blood volume) due to protein malnutrition, protein catabolism (breakdown of proteins into amino acids) postoperatively or in sepsis, defective gastrointestinal absorption, faulty albumin synthesis in chronic hepatic failure, and abnormal renal losses due to chronic kidney dieses. Human Albumin is purified from large pools of adult human venous plasma via a highly complex and expensive process. The human albumin solution is sterilized for usage in the aforementioned clinical purposes.
Human immunoglobulins are proteins (also called antibodies) produced by B-lymphocytes to help prevent and treat bacterial, fungal and viral infections. Human immunoglobulin solution is used as replacement therapy for primary humoral immunodeficiency (disorders that affect the cells, tissues, and proteins of the immune system) in cases such as the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Human immunoglobulin is manufactured from human source or recovered plasma and sterilized for clinical purposes.
Human Albumin and human Immunoglobin are packaged in glass bottles/vials and stored between 20-25ºC (68-77ºF) with short excursions permitted between 15-30ºC (59-86ºF). They should not be subject to drastic temperature changes or subfreezing temperatures, which might compromise their functionality. The vials should not be shaken vigorously and should be kept in their original carton to protect them from light.
When the trailer transporting 32 pallets of these plasma pharmaceuticals got involved in a collision it was heavily damaged and the refrigeration unit became inoperable. At the time of the accident, the outside temperature was well below 0ºC. As such the products were subject to both physical damage and long term temperature abuse. The plaintiff (pharmaceutical company) claimed that these products were rendered useless for pharmaceutical purposes and disposed all of the vials. The pharmaceutical company set the value of the products at $3.4 million and filed a claim against the freight company for this amount.
I was hired by the defendant (the law firm hired by the carrier’s insurance company) to first analyze all the data/facts and determine whether the pharmaceutical company’s claim of unusability of the product for clinical purpose was valid and also to determine whether the products could have been salvaged for other applications purposes rather than being destroyed by the pharmaceutical company.
After thorough examination of all the reports I determined that the products indeed could not have been used for clinical purposes. Most of the glass bottles/vials used for the storage of the products had visible cracks. These cracks exposed the solution to air and rendered the solution unsterile with a high chance of bacterial and viral contamination. Since these pharmaceutical products are used in human subject they can only be used sterile to prevent infections. Furthermore, drastic temperature variations, exposure to subfreezing temperature, light exposure (due to the breakage of the outer packaging), and vigorous shaking of the vials during the accident subjected the products to potential denaturation (a process by which the proteins became inactive) and product degradation.
However, while the products in question could no longer have been used for clinical purposes the pharmaceutical company should not have discarded the products since they could have been used in nonclinical applications. I provided a thorough list of molecular biology procedures by which the products in question could have been tested in order to determine their concentration, activity and possible contamination levels. I also provided a long list of life sciences research applications and cosmetic applications they could have been utilized in. Furthermore, I provided a molecular biology research price structure for the products in question and compared that to the clinical value of these products. For example, human Immunoglobin could have been sold for molecular biology research applications for a price seven times higher than if it was sold for clinical purposes. In conclusion, if the pharmaceutical company had not disposed the products in question they could have been analyzed by molecular biology assays to determine their activity level and sold into life sciences and cosmetic industry at a much higher price point. As a result of my contributions to this case the law firm was able to settle the case with the pharmaceutical company and reduce the claim by more than 1.5 million dollars (or by over 50%).
"HOW SAFE ARE YOUR ELDERLY LOVED ONES? There’s no way to know about abuse that goes unreported. But you can look up the name of a nursing home in federal inspection data and see whether it has been cited for sexual abuse or other issues in the past three years. Here's how:
On the first page of results, you will see a star rating for the facility based on factors such as staffing levels. A history of abuse or other inspection problems will typically be reflected in the "health inspection" rating.
Click on the health inspection rating to see a summary of the facility's most recent inspection.
From here, click on "View all health inspections." For details, go to a specific date and click "View full report."
From the main profile page for the facility, click on "Penalties" to see if an inspection resulted in fines or payment denials.
To view older citations, download archived reports here or file a public records request here. Some states may also offer detailed information. A list of state websites is here." From CNN
By Arezou Azarani | November 29, 2016 at 06:33 PM EST | No Comments
The world's largest dementia research experiment conducted by scientists at University College London, which takes the form of a video game called Sea Hero Quest, has indicated the ability to navigate declines throughout life. Players aged 19 were 74% accurate at playing the game, but accuracy fell year by year until it reached 46% at age 75. Read more....
I was highly disappointed and saddened to find this new negative venture from LinkedIn! While I have the greatest respect for leaders included in this list I find it very upsetting that there is age discrimination involved. I am a very strong advocate of equality. Why should there be an age component attached to leadership? What message are we sending to our society? That only people under the age of 35 can innovate and lead successful companies? When LinkedIn started, we all joined in to find connections, jobs, share our expertise and knowledge, form networks, and use it as a platform to share our voice with regard to issues that matter most in our fields and society. I never thought it would lead to our information being used to discriminate about our age!
Yesterday, I had a conversation with one of my great colleagues. When it comes to the biotechnology/pharmaceutical industry he is as accomplished and savvy as it gets. I have the outmost respect and appreciation for his expertise and many years of top notch experience in my filed. He was telling me that he, as I have heard from many other colleagues, is deeply disappointed in the way the employee selection in our industry is progressing for the past decade. He said that there is a lot of resistance toward hiring older employees at work. If you go through an extensive interview process and have all the qualifications necessary for a position, over 90 percent of the times you can be sure that a younger candidate gets selected over the older one. Why we discussed? Many theories came to our mind and we discussed the topic extensively. Whatever the underlying reason, I strongly believed that discriminations, including age discrimination is a very negative trend and something I strongly oppose. In my opinion, this new project from LinkedIn is sending the wrong message to our society. I am a very strong believer that innovation, professionalism, top expertise and great leadership are qualities that have nothing to do with age and everything to do with hard work, dedication, and selflessness. Furthermore, I believe that our great accomplishments and achievements in life are somewhat personal in nature and not a subject to brag about. Are we (or in this case LinkedIn) trying to prove something to ourselves or to our colleagues?
I do not wish to receive this list any longer from LinkedIn and strongly recommend that LinkedIn discontinues this controversial project. If you agree with me please write to LinkedIn and oppose this movement.
By Arezou Azarani | October 05, 2016 at 01:08 AM EDT | No Comments
A 2009 study found that participants who reported getting less than seven hours of sleep per night over the course of a 14-day period were nearly three times more likely to fall ill when exposed to the common cold virus than those who got at least eight hours. And a 2015 study came to similar conclusions. Participants who reported getting less than six hours of sleep a night over the course of just one week were more than four times more likely to come down with the common cold than those who slept more than seven hours -- and those who slept less than five hours were even more susceptible.
By Arezou Azarani | September 14, 2016 at 02:12 PM EDT | No Comments
Read The New Times Article about "Failure to Improve Is Still Being Used, Wrongly, to Deny Medicare Coverage". "Medicare beneficiaries often hear such rationales for denying coverage of skilled nursing, home health care or outpatient therapy: They’re not improving. They’ve “reached a plateau.” They’re “stable and chronic,” or have achieved “maximum functional capacity.” "The so-called "improvement standard" is no longer in effect."