Trasylol® (Aprotinin injection) is an amino acid that Bayer manufacturers, deriving it from the lung tissue of cows. In many instances doctors inject Trasylol to reduce blood loss and to lessen the need for blood transfusions during coronary artery bypass graft surgery (CABG). Over the years, Trasylol® has garnered much controversy, including whether it was much more expensive to use that two alternative substances, whether it might cause renal complications and more recently, whether Trasylol® might place patients undergoing GABG at a higher risk of fatal anaphylactic reactions, especially patients with prior exposure to Trasylol® within 12 months. (more…)

We as a society have never had so many choices on how to treat and or prevent illness and disease. I think it’s great that science has become so innovated that we are finding new ways to not only treat and prevent illness and disease holistically. But with all these choices it can be a daunting task to determine what is right for you and what is safe. With the use of Dietary Supplements and Pharmaceuticals issues of safety and interactions are crucial, in particular with the elderly. The Office of Dietary Supplements “ODS” has created a questionnaire for consumers to complete and consult with their health care professional in determining necessity and potential drug interaction. “What Dietary Supplements Are You Taking? Office of Dietary Supplements” (more…)

This is Part III of the series on Dietary Supplements addressing warnings, recalls and reporting. In my last Blog there were many helpful links to research individual supplements. So now that you are searching like a pro let’s look at product safety, contradictions, recalls and contamination. So put on your detective hat and read on! (more…)

In  Part II of a series of five on  Dietary Supplements here are some  helpful resources to go about researching and gathering important information on both the product as well as manufacturer. In an article written by the Mayo Clinic “What you need to know before You Buy Herbal Supplements” there are some great tips on how to get started in determining if a product is right for you. More than ever consumers must be their own best advocate. There are many consumer friendly websites and literature that offer information even more so since the FDA issued its Final Rule governing Dietary Supplements that became effective 6/1/08. (more…)

Before venturing into the world of Complementary and Alternative Medicine (CAM) some ground work needs to be explored to better understand the terms used in the industry. Knowledge is power and educating yourself on the various products, their origins, the relative safety of products and other vital information is an important foundation to understanding. As we will explore in a five part series that will span from defining terms, product origin, safety, recalls and ultimately the decision process for determining if CAM is right for you. The information I intend to provide will be based on the information available through web site sources that include the FDA, NCCAM, PubMed, Natural Standard, and Consumer Lab. Let’s get started with understanding the terms. Here are a few to give you a broad view and a little background. (more…)

It was not that long ago the herbal supplement industry was viewed as left wing subversive community of activists. Back in 1994 when the Dietary Supplement Health Education Act (DSHEA) was passed the supplement industry made a platform arguing that the FDA and pharmaceutical market were in conspiracy to keep a multi billion dollar business thriving by driving up prices of prescription drugs that were generally unsafe to the public and preventing the manufacturing and sale of less costly, safer and healthier herbal supplements. Since then, what is now commonly known as the Dietary Supplement industry or CAM (Complimentary Alternative Medicine) industry, has skyrocketed. No longer do you have to search out small mom and pop stores you can go right to your local pharmacy (ironically) to purchase your supplements. New products are flooding the market that claim to be as effective or better and less expensive than pharmaceuticals. (more…)

What is Big Tobacco doing in the Florida tobacco litigation now? They are sending out teams of lawyers and investigators to track down and interview each smoker’s sons, daughters, grandchildren, Aunt Mary, Uncle Bob, the third cousin twice removed, the neighbors, the neighbors neighbors—you get the idea. (more…)

Are They Timely Ortho-FDA Collaborative Warnings, Or Are They FDA Sanctioned Excuses for the Manufacturer

The FDA has been in the news quite often, recently. Lately, consumers have seen news about caustic and blinding eye care solutions (Bausch & Lomb’ ReNu MoistureLoc and AMO’s Complete MoisturePlus), E. coli in spinach, and most recently the Salmonella laced produce outbreak. The FDA first associated the Salmonella outbreak with tomatoes, but had a hard time determining which tomatoes were causing the problem. And now the FDA suspects that other fresh produce may also be contaminated, but cannot determine the source. (more…)

As if keeping up with what is a brand name versus what is a generic medication wasn’t enough, now you can’t even be certain whether what you’re handed by your local pharmacy is even the real deal anyway. Pretty scary stuff.

So the question is while we all are paying the highest prices in decades for our medication how does this happen? The industry and FDA indicate these are high quality fakes. Sorry, not good enough and I don’t buy it. Frankly, that is taking the easy way out. Consumers deserve better. The facts are in the ever expanding effort to lower costs; the pharmaceutical companies and the retail pharmacies, like so many industries, have defaulted to price and profit over quality and safety. Come on, I don’t care how good these pills look shouldn’t these big companies know and investigate who they are buying from? My late father, a very wise man, used to love to use the phrase “too good to be true”. One wonders if a new supplier comes in to the pharmaceutical market, with seemingly impossibly low prices, who is doing the testing of the product and the background check when the bells should be going off? I guess certain folks simply don’t want the answer to some obvious questions. According to the US News and World Report it is left to consumers like Arthur Soclof, an allergist in Livonia Michigan, who on his own discovered his cholesterol medication, Lipitor, sold to him by his local pharmacy, was a fake. (more…)

So, what is Big Tobacco doing these days in the Florida “Engle” litigation? Are they aggressively trying to bring cases to trial so they can be vindicated? Are they conducting important investigation and discovery in an effort to further justice? Ah, not so much.

I speak with clients each day who want to know why Big Tobacco is sending lawyers (or at least people representing themselves as lawyers) to speak with uncle Joe or their fourth cousin, twice removed, with whom they have not spoken since third grade. They want to know why Big Tobacco needs to know where they have lived through their entire 70+ years of life. Why Big Tobacco insists on bothering their neighbors with interviews?

Well, it is all part of a grand plan, I am sure—right? It is most probably a part of a grand, master plan; but is it one in which the purpose is to further justice? Ah, probably not so much.

In the ‘90’s, there was a movie called “Class Action”; in which Gene Hackman played a lawyer fighting for the rights of victims horribly injured and killed by a defective automobile. In one scene, after discovering the defect the car company president calls in his statistics people, or “bean counters”, as they are affectionately referred to by the president. He asks the bean counters whether lawsuits will cost him more than the cost to retool the line and they tell him that lawsuits will be cheaper than the cost to prevent injuries and deaths. The president decides to continue manufacturing the defective car.

In the Engle tobacco litigation, Big Tobacco faces some 8000 plaintiffs. Tragically and as a direct result of cigarette addiction, these folks are largely older, sick people. I would be quite surprised if Big Tobacco has not consulted the “bean counters” and asked them what number of plaintiffs can be “eliminated” through delay and aggressive litigation tactics. I would suspect the bean counters to let them know how long the litigation needs to be delayed to eliminate “X” numbers of plaintiffs.

Am I being unfair to Big Tobacco? Not so much.

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