Blog

Asthma and pre-term labor medication Terbutaline warning due to infant brain damage

Posted on December 1st, 2011 by Robert D. Rowland

Terbutaline, an asthma medication that’s commonly prescribed to halt pre-term labor and premature birth, has been shown to leave the brains of children susceptible to other chemicals ubiquitously present in the environment. A Duke University Medical Center study found that rats exposed to Terbutaline suffer greater brain cell damage than those not given the drug upon secondary exposure to insecticides.

Nearly 20 percent of all pregnancies in the United States result in early labor, and an estimated one million women are treated with Terbutaline or similar drugs to halt early contractions every year. The use of Terbutaline for use in pre-term labor and premature birth is not approved by the FDA. In fact, in 1997 the FDA issued its first warning concerning the potential dangers associated with the use of Terbutaline for the treatment and prevention of pre-term labor.

Studies show a link between the use of Terbutaline during pregnancy and an increased risk of brain damage and cognitive deficits, which may become noticeable at infancy, continue through adolescence and cause permanent disabilities. Researchers at Duke suggest that exposure predisposes newborns and infants to fall victim to particular ailments and medical conditions later in life.

The National Asthma Education and Prevention Program has now recommended women with asthma no longer take Terbutaline while they are pregnant, as the drug may penetrate to the fetus and affect brain development.

Terbutaline is sold under the brand names Brethine and Bricanyl. If you or a loved one has suffered from the effects of this drug, contact Robert D. Rowland.

Bladder Cancer Warning For Diabetes Drug Actos

Posted on October 26th, 2011 by Robert D. Rowland

In June of 2011, the FDA issued a new warning of increased bladder cancer risk associated with use of the diabetes drug Actos (pioglitazone), after analysis of a 5-year study of the drug by manufacturer Takeda Pharmaceuticals.

The results of the Actos study showed an increased risk of bladder cancer among long-term users of the drug, and a greater risk of bladder cancer among users exposed to the highest cumulative dose. The FDA is now requiring that new information about an increased risk of bladder cancer be added to the Warnings and Precautions section of the Actos label.

The FDA has also acknowledged a recent 10-years study in France, which suggests an increased risk of the bladder cancer with Actos use. As a result of this study, France has banned Actos, and Germany is advising doctors not to start Actos in new patients.

Symptoms of bladder cancer can include:
• Abdominal pain
• Blood in the urine
• Bone pain or tenderness
• Fatigue
• Painful urination
• Urinary frequency
• Urinary urgency
• Urine leakage (incontinence)
• Weight loss

If you or a loved one has suffered using Actos or pioglitazone, contact Robert D. Rowland.

New FDA Warnings for Vaginal Mesh Implant

Posted on October 24th, 2011 by Robert D. Rowland

In August 2011, the FDA issued new warnings for vaginal mesh – a medical implant designed specifically for repairs of pelvic organ prolapse (POP), as well as urinary stress incontinence. During pelvic organ prolapse, the internal structures that support the pelvic organs such as the bladder, uterus, and bowel drop from their normal position and “prolapse” into the vagina.

The FDA warns that the risks of placing mesh through the vagina to repair pelvic organ prolapse may outweigh its benefits, as the number of adverse events has increased since it first issued a safety communication in 2008.

The most frequent complications reported to the FDA for surgical mesh devices for POP repair include:
• Erosion or protrusion of the mesh from the soft tissues
• Pain, including pain with intercourse
• Infections in the area of the mesh
• Urinary tract problems
• Bleeding from the mesh site
• Damage to nearby organs

There have also been reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

In a study of almost 12,000 women, approximately 10% of women experienced mesh erosion within a year after surgery (Abed, 2011), and problems with the mesh tend to develop at least a month after surgery for POP (Caquant, 2008).

If you or a loved one have received a vaginal mesh implant and are experiencing issues, contact Robert D. Rowland to discuss your case.

World-renown diabetes researcher Dr. Camillo Ricordi speaks at GHAR-sponsored event

Posted on October 13th, 2011 by Thomas P. Rosenfeld

We were proud to welcome Dr. Camillo Ricordi to the Missouri Cures event, for a special presentation on his continued research for a cure for diabetes.

Dr. Ricordi, the University of Miami’s Scientific Director and Chief Academic Officer of the Diabetes Research Institute, discussed his work as one of the world’s leading scientists in cell transplantation and diabetes research.

Dr. Ricordi is known world-wide for inventing the Ricordi® Chamber, a device that isolates large numbers of insulin-producing, or islet, cells from the human pancreas for transplantation into diabetes patients. He has performed the first series of clinical islet transplants that reversed diabetes after implantation of donor purified islets into the livers of diabetics. This procedure is now used worldwide by laboratories performing clinical islet transplants (and for you television fans, was even featured on an episode of Grey’s Anatomy). Dr. Ricordi has also authored more than 600 scientific publications and has been awarded 11 patents. Today, his goal is to develop a cure for type 1 diabetes.

Dr. Ricordi recently answered questions that shed some light on what drove him to research diabetes, how he came to envision the Ricordi Chamber, and how he approaches the ethical issues surrounding the transplantation of embryonic stem cells.

Having trained as a surgeon, how did you become interested in diabetes as a research topic?

“Before the residency in surgery I graduated from medical school with a thesis on diabetes and spent 2 years volunteering as a medical student in the major diabetes institute in Italy, which was then at H. San Raffaele Institute in Milan. When I then switched to surgery, my little cousin Serena from Italy was diagnosed with Type 1 Diabetes. Transplantation in diabetes and cure focused research became quickly my professional life’s mission. I see cellular therapies and regenerative medicine as the future of transplantation and believe one day we will not need to perform organ transplants any longer but prevent and treat organ failure with cells, stem cells and other regenerative strategies.“

The device you invented, the Ricordi Chamber, isolates islet cells from the pancreas for transplantation, thus allowing people with diabetes to begin producing insulin. How did you first envision this method and how long did it take you to create a working model?

“My early research work after the medical degree was to isolate large numbers of intact insulin producing cells from the pancreas to obtain enough insulin producing cells to reverse diabetes after transplantation. I soon realized that all methods used then (in the 80s’) were very traumatic, including the one then used in Dr. Paul E. Lacy’s laboratories at Wash U, which was based on a sort of a meat grinder modified and renamed “tissue macerator”. The idea to separate pancreatic islets (microscopic structures containing the insulin producing cells) using a non-traumatic technology to “disassemble” the pancreas came to me when I was still in Italy immediately after medical school. My university hospital did not have the resources or infrastructure to support the development of the idea, but they allowed me to go to the number one center in the world in this field, which was then Washington University in St. Louis, where the “father” of islet isolation and transplantation was working, Prof. Paul E. Lacy.”

Briefly, how does the Ricordi Chamber work?

“The Ricordi method, whose heart is represented by a chamber, consists in a full immersion, continuous flow process through a chamber of a solution of enzymes that are also injected in the organ through a network of ducts that deliver the “disassembling” enzymes all over the exocrine pancreas (98% of the organ that works to produce digestive enzymes and juices draining them in the intestinal tract), but without arriving directly to the endocrine islets that are instead “plugged” into the vascular system (but not to the ductal tree). As the digestion process begins inside the chamber by progressive heating of the solution containing the enzymes to active them (these enzymes work better at temperatures close to 37oC), a screen retain the undigested pancreas for further enzymatic /mechanical gentle disassembling action inside the chamber, while a constant flow “rescues” the progressively released islets that can pass through the screen and are therefore saved from any further enzymatic action by cooling and dilution.”

When it became clear that the Ricordi Chamber was effective, what did you consider as next steps toward its wider use?

“When I realized the utility of the method and the chamber and we made the first successful clinical islet transplants, I begin to freely distribute the blue prints of the system and collaborated with all scientists, surgeons, physicians and groups who were willing to join the battle for the cure of diabetes. Still today, I renounced to any economic benefit, royalty or other compensation that could derive from the diffusion, distribution and teaching of the Ricordi method. This allowed everyone to access the technology and contribute improvements over the years, very much with an “open source” and collaborative approach that characterize all my research activities, from the Diabetes Research Institute Federation to the newly established Cure Focus Research Alliance.”

How many patients have been treated with the Ricordi Chamber to date and what progress are you making with the issues surrounding rejection of the implanted cells?

“Around 1,000 patients worldwide have been treated so far with this method. The procedure is still experimental and the results have been progressively improving over the past two decades, with now long term function of the transplanted islets being similar to that of a pancreas (whole organ) transplant. A multicenter FDA Phase III trial is now undergoing in North America and Europe to move islet transplantation as an approved, reimbursable procedure for patients with the most severe cases of Type 1 Diabetes. However, the requirement for treatment of the recipients with anti-rejection drugs severely limits the number of patients that can now benefit from this procedure, as the possible risks and side effects of immunosuppression must be carefully evaluated against the benefits of the islet transplant. All research is now concentrating on methods to avoid the use of continuous recipient immunosuppression, from tissue engineering and local immunomodulation strategies, to methods to re-educate the immune system not to attack the transplanted islet cells and nano-scale or conformal coating barrier technologies, to physically protect the transplanted cells from the immune attack.”

One possible source of cells for transplantation are embryonic stem cells, yet there are many ethical issues surrounding their use. How do you approach this and you working on alternative strategies as well?

“Once transplantation without immunosuppression will be successful it will be impossible to meet the demand for insulin producing cells to treat patients with diabetes worldwide. There are now a little over 1,500/year suitable pancreases from deceased organ donors that could be used for transplantation in the US. With 24 million patients in the US alone and 300 million worldwide (growing to become over 500 million in the next two decades) this treatment would risk to become like winning a lottery in the absence of an adequate source of insulin producing cells. Human stem cells offer more than a hope at this point, since they have been already successfully converted into insulin producing cells and have successfully treated experimental models of diabetes. With a patient dying every 4 seconds, any deliberate obstacle opposing and delaying cure-focused research could be considered criminal. Like in organ transplantation you can discuss the sources of organ or tissues to be transplanted. For example we condemn and do not allow transplantation of organs from executed prisoners, practices still performed in other continents, but we now all agree on the need and usefulness to transplant organs. Similarly, when we receive a heart from a deceased donor, we do not necessarily endorse the cause of death, which could be suicide or the result of driving under the influence. Still, the moment an organ or tissue becomes available it would be criminal not to use it to save, for example, a child dying from heart failure. In the same context, while I understand that some groups of people can support or oppose abortion, no informed human being should oppose rescuing cells from a trash can following in vitro fertilization (cells that will never, ever have a chance to become a human life, which so far has required in-vivo implantation in a uterus). One could oppose in-vitro fertilization, but once this is recognized as a legal and legitimate practice, the excess unused cells that are thrown away after life has been already successfully achieved, should and must be used if they can lead us one step closer to the cure of diseases now afflicting humankind. As human beings and as a physician, not doing this would be unethical and in my view, criminal. The reason an ever decreasing number of people still opposes stem cell research is because they are not informed appropriately or they do not think at the consequences of their actions two steps ahead.”

Where do you see diabetes treatment in five years? You’ve been very vocal about ultimately curing diabetes. What’s your prediction for making this happen?

“I have no doubt that the cure for diabetes, like the cure of many other devastating disease conditions is within our reach. However, I am also deeply aware that an increasing number of regulatory, political, religious, economic, academic and institutional impediments are creating barriers to innovation and to the development of cures in our Country. To overcome these barriers we have recently formed the Cure Focus Research Alliance, but given the current limitations, we can only work with as much intensity and dedication as we can. A cure could indeed be within the next 5 years, but we cannot generate hype or spread false hope, as we are fully aware that it could take even more than 10 years. The difference in how long it will take to get to a cure will largely depend on how effective we’ll be in overcoming the barriers to innovation and the development of cures. For example we have begun by braking the barriers to collaborative international research programs, through the expansion of the Telescience platform technology that now allow as assemble collaborative project teams across oceans that could work like if they are physically in the same lab, looking at the same microscope, working shoulder to shoulder at the same bench, or brainstorming together to overcome the next challenge.

“Besides funding and milestone based management of cure focused research programs, one of the major obstacles towards the development of cures is the public misconception that whether or not we’ll get to a cure in the fastest and most efficient way possible will largely depend on what they, we, do collectively in the next 5-10 years, not just the scientists, not the NIH, for sure not the FDA or the big Multinational Pharmaceutical companies.

“To give a practical example, I like to say ‘5 to 10 years from now you (or your child) will be diagnosed with a now incurable disease. Your chances to cure it and survive will depend on what happens between now and then’.

“Don’t wait for a tragedy to affect you or your family to open your eyes to what we need to do and how much we need to work together as a team. All polarizing ideologies and views are generally wrong and based on emotions rather than reasoning and truth. It was the case when medicine and science were halted because of the dogma that illness and terminal diseases were a punishment from God, for sins committed in this life. It would be a similar mistake to delay the applications of stem cell research and regenerative medicine now, when we are facing epidemics of unprecedented proportions that feed a market that in the US alone represents 2.5 trillion/year of healthcare costs, already over 16% of the GDP and projected to become 4.4 trillion/year by 2018. Why I understand there could be strong economic interests opposing the development of cures, opposition to stem cell research from the very same people who will benefit from them should not be a factor and I would predict that reasoning and information will soon prevail over misinformation and emotionally charged propagandas.”

Read more about the Missouri Cures Event here. If you have any questions, please contact Thomas P. Rosenfeld.

Estate Planning in a Digital World

Posted on October 10th, 2011 by Holly A. Reese, Teri Havron

Historically, estate plans contained two types of property—personal property and real property. As we continue to move more of our lives to the internet, we are quickly learning our online presence can outlive our physical presence. Our computers and online accounts contain a wealth of our personal information and it is increasingly becoming important to address how to handle these “digital assets” in your estate plans.

“Digital assets” are considered to be any online account that you store on your computer or server. Today, nearly everyone has some type of online account including, but not limited to: multiple email accounts; social media networks like Facebook, Twitter, LinkedIn; photos on Flickr or Shutterfly; videos on YouTube; music libraries; documents on Google docs; medical records; online bank and investment accounts, online bill pay accounts; online shopping accounts like Amazon; and blogs or websites.

Without the proper planning, these digital assets can be very difficult and overwhelming to manage and access after a person dies. Three main questions come to mind: Who do you want to leave in charge—spouse, family member, or third party? How will they locate all of the accounts? And, how will they gain access to each account?

The first step is to create an inventory of all your digital assets. From there, an attorney can help advise you as to whether a will, separate document, trust, or online afterlife company is right for your planning needs.

There are many benefits of planning for digital assets, including: making things easier on executors and family members; preventing identity and content theft; and preventing losses to the estate. Take a few moments and start on your digital estate plan today. As the old saying goes: “failing to plan is planning to fail”.

Should you have a question or would like to discuss your estate plan, please contact Holly A. Reese or Teri L. Havron.