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Posts with tag Genentech

The evolution of GM insulin 1983 - present

How did we allow insulin to evolve into a genetically modified hormone?

It all boils down to propaganda. If you're confident your current insulin surpasses former natural insulin in: purity, availability, allergy response, similarity and safety - I encourage you to review the following facts that were conveniently neglected or not available, due to restraints of time travel.

Purity: In the 1970s, a Genentech scientist stated that natural insulin was incredibly pure. In the 1980s, rDNA humulin insulins were less pure than the natural insulins of the 70s. The advertising campaign for rDNA insulin suggested otherwise. Here's a quote, as printed in the book, Invisible Frontiers: "They impressed upon us very, very clearly that this (human insulin) was going to be no advantage at all."

Supply and demand: A USDA scientist told the world the diabetic population's insulin needs would outstrip the supply of natural pancreatic glands. This was sensational propaganda. Have you visited McDonald's or Wendy's lately? There doesn't seem to be a shortage of Big Mac's, does there?

Allergy response: About 5-10% of the diabetic population is allergic to natural analog insulins. Today, based on 25 years of human diabetic experimentation, the diabetic population is showing the same 5-10% allergic response to all the new products. Maybe that aforementioned 5-10% is the same latter 5-10%? From the looks of it - they're just allergic to insulin, rDNA, GM or natural.

Similarity to own insulin: rDNA human insulin is just like the body makes. Who wouldn't want to take human insulin? That's the propaganda. A recent research article found in a large portion of the diabetic population, their own human insulin may actually be the cause of their diabetes. Something tells me the study included the same 5-10% of diabetics mentioned in the allergy response paragraph.

Safety: Drug companies touted rDNA insulins as providing a good a warning to diabetic patients as natural analog insulins regarding low blood glucose levels. Are you kidding me? Driver and workplace accident statistics regarding diabetics indicate that the rDNA insulins do not cross the blood-brain barrier in the same manner as natural analog insulins. The part of the brain controlling endocrine response lags because it doesn't get the signal until it's too late (if it ever gets the message). The increase of diabetes-realted deaths since the introduction of rDNA insulin is remarkable! (Center for Disease Control). How safe is that?

Fact versus fiction is a scary line to smear for the sake of business. I suggest doctors, diabetes educators, and patients review the facts today and compare it to the propaganda in the 80s. There is no suppressing the truth!

Off-label drug use - Would you do it?

Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label. The FDA requires numerous clinical trials to prove a drug's safety and efficacy in treating a specific symptom. Once deemed safe and effective, physicians exercise discretion for the use of the drug. It is entirely legal in the United States and in many other countries to use drugs off-label.

More physicians are discovering that many drugs are effective for off-label uses and apply to the needs of their patients. Off-label prescription drugs have become so popular that, today, 1 out of every 4 prescriptions written is off-label. The antiseizure drug gabapentin (Neurontin) is used off-label to treat people with diabetic neuropathy. Another drug used off-label is Lucentis, manufactured by Genentech. It was originally approved for age related macular degeneration, but is now in FDA trials for the treatment of diabetic macular edema. If Lucentis is approved, it would be the first drug to treat this debilitating complication of diabetes.

There are advantages and disadvantages to off-label uses. First (and foremost) is the risk versus reward. You could be the first to experience a breakthrough treatment or you could suffer irreparable consequences from the off-label use. Another consideration is feasibility - often times an off-label treatment may cost you substantially more than the other treatments approved for use. For example, without enrolling in an FDA trial to receive intravitreal injections of Lucentis - it would cost me $2,000 a pop. My peepers are precious, but my pockets aren't that deep! What off-label drug would you consider for use?(With your doctor's blessing, of course).

A Shot in the Eye for Diabetic Retinopathy

Treatments that use tiny amounts of new drugs injected directly into the eye are having a dramatic impact on diabetic retinopathy, the most common cause of blindness in middle-age Americans. Excessive capillary growth and fluid leakage are the culprits that gradually erase vision in many diabetics. The problem arises when the retina - a high-energy tissue requiring much oxygen and nutrition doesn't get the blood it needs, so it sends out a chemical signal ordering blood vessel growth. The new vessels formed will ultimately leak, causing vision loss.

The treatment is shown to halt abnormal blood-vessel growth that gradually destroys the eye's light-sensing organ, the retina. Unlike macular degeneration, which erases central vision, diabetic retinopathy starts by ruining peripheral vision. The injections are given with tiny needles and require only a local anesthetic. Several trials were done to test the safety and efficacy of Macugen and another new eye drug, Lucentis, which is made by Genentech. So far, no major side effects from treatments with Macugen and Lucentis have been noted.

Drug treatment slows macular vision loss in diabetics

Scientists at Johns Hopkins report a drug commonly used to slow the loss of central vision has shown promise in treating a common precursor of blindness in diabetics.

Researchers injected the drug into the eyes of 10 people losing their sight from macular edema, one of many complications of diabetes and a first stage of diabetic retinopathy. Over the course of several months of therapy, every patient in the study could read at least two more lines on the standard eye chart. The drug used in this study is called ranibuzumab. The researchers believe that ranibuzumab interferes with a protein that spurs the growth of unwanted blood vessels in the back of the eye. Vascular endothelial growth factor, or VEGF, is released when the oxygen supply in the eye is restricted by blood vessel damage related to diabetes. In a self-preserving attempt to acquire more oxygen, the VEGF signals for the creation of new blood vessels, which almost always damage, rather than improve, vision by blocking light's entry onto the retina.

I'm a perfect candidate for this therapy! Every 6 months, when I have my macular maintenance checkup -- I'm dilated, checked and sent on my way. I am going to do a little name-dropping on my next visit and see if I can't get myself one or two more lines on the standard eye chart.

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