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Freedom, Fireworks, Food, and Fun Facts! Happy 4th!


It's almost the 4th of July!  I suspect that this is a vacation week for many of you since the holiday falls on a Thursday, and I hope you are having fun, enjoying family, and surviving the heat!  The 4th is a celebration of our nation's independence and the freedoms we now take for granted; the holiday is also associated with fireworks and BBQs, and let's not forget the hot dogs and ice cream!  Admittedly, I love the July 4th fare, though it's not too great for the waistline! And since the long weekend in Charleston is also a time for boat rides and trips to the beach, the desire to have that beach-ready body is a concern for many, and hence the craze for drugs like Ozempic.

 

You are probably aware of my concerns over this class of drugs for weight loss based on my prior blogs.  However, I am circling back to the topic given some recent developments and I hope to provide more information about semaglutide and tirzepatide and some context for my concerns.  Both semaglutide and tirzepatide belong to a class of drugs called incretin mimetics, which is a fancy way of saying they are drugs that affect insulin and glucose metabolism.  In so doing, they are effective drugs for those with type 2 diabetes (but not type 1) and have proven effective in the management of this very serious disease.  The brand names of the semaglutide-containing drugs are Wegovy®, Ozempic®, and Rybelsus® (an oral formulation), and those with tirzepatide are Mounjaro and Zepbound.  Novo Nordisk produces the semaglutide drugs and Eli Lilly the tirzepatide varieties.  Interestingly, only Wegovy and Zepbound have FDA approval for weight loss indications, while the others are indicated for Type 2 diabetics.  This means that the use of Ozempic for weight loss indications is considered "off-label."  In medicine, drugs are often used in "off-label" ways, which can happen when a drug is found to have a positive effect in the treatment of a condition other than for which it was originally developed.  For instance, Botox was first approved for the treatment of strabismus (crossed eyes), though its use was expanded to treat facial wrinkles and by 2002, the FDA approved the cosmetic indication for Botox to treat the glabellar region of the face, those number 11 lines between the eyes.   Drugs can be used in an "off-label" manner as long as the patient is aware of the "off-label" status.  

 

The FDA also has strict rules and regulations regarding the advertisement of and disclosures about drugs, which seems to be how medispas who prescribe these incretin mimetics have found themselves in lawsuits with Eli Lilly.  Last week, there was an article in the Post and Courier about a recent legal settlement. It appears that at issue is the use of tirzepatide-containing compounds, but without the necessary disclosures that they are not Mounjaro or Zepbound and that the compounds are not FDA approved, which are no-nos by FDA rules.  Due to the shortage of these drugs and the high costs, these compounded versions are becoming increasingly popular.  The title of the Post and Courier article referred to the compounded drug as a "counterfeit," though I personally would have considered using the word "alternative."  However, with so much money at stake, I think the most important thing right now for the consumer/patient is to be informed about these drugs.  Big pharma has spent countless sums of money investigating, producing, and marketing these drugs, and of course, they don't want their profit margins negatively impacted by the compounded alternatives, which have not had to go through the same FDA approvals.  While the problem may also lie with our FDA, a massive bureaucratic agency, that adds to the tremendous costs of developing drugs, the safety issue of unregulated incretin mimetic compounds is worth considering when one is taking one of the substitutes, especially since even the brand name varieties also are associated with serious risks.  My goal here is not to take sides for or against big pharma or compounding companies but to provide information.  These drugs have definite benefits for the treatment of morbid obesity, cardiovascular disease, and type 2 diabetes, conditions which have a major negative impact on the health of our country.  In fact, there are even reports that the drugs may even be helpful for Alzheimer's and dementia; these drugs are thought to help reduce inflammation, and these anti-inflammatory properties are what are believed to be the reason for the benefits for Alzheimer's and dementia patients.  Unfortunately, as with any drug, there are negative side effects as well.  These include thyroid cancer, depression, and suicide, vision problems, pancreatitis, gallbladder issues, as well as slowed gastrointestinal motility.  I have attached a "Responsible-Use" letter from Novo Nordisk, the makers of Wegovy®, Ozempic® and Rybelsus® which is insightful about the use of these drugs versus compounded forms:



In another statement, Eli Lilly said the following about the settlement:

 

"Patient safety is Lilly’s highest priority. Lilly is deeply concerned that products fraudulently claimed by compounding pharmacies or counterfeiters to be FDA-approved tirzepatide, Mounjaro®, or Zepbound® may expose patients to serious health risks. Neither the FDA nor any global regulatory agency has reviewed these products for safety, quality, or efficacy, and unsafe products should not be on the market. Lilly has discovered products claiming to be compounded tirzepatide medicines that contain bacteria, high impurity levels, different chemical structures, and different colors than Mounjaro®or Zepbound®. In at least one instance, the product was nothing more than sugar alcohol."

 

It would be remiss of me not to acknowledge, however, that compounding pharmacies do play an important role in the delivery of healthcare.  For instance, when my husband was battling ALS, his doctors at Mass General advised the use of a highly concentrated version of B12, which was provided by a specialized pharmacy.  My hope is that this blog will help the patient/consumer better understand this new mega-industry of incretin mimetics and have the background and knowledge to ask the appropriate and necessary questions to ensure that these drugs are appropriate for them, are safe and that they are receiving the actual product being marketed to them.  I also refer everyone to research the Novo Nordisk and Eli Lilly websites which list the potential side effects of these drugs.

 

Before I leave everyone to enjoy the holiday, just a few friendly reminders...Don't forget your sunscreen, hats, glasses, and sun-protective clothing!  And while laser treatments are great for the fall when people start heading inside (to help repair the sun damage!), chemical peels can be a great option to keep your skin looking its best in the summer!  I'd like to put in a plug for Jeanne, who helps me with these blogs and newsletters.  As I have mentioned, she sells Arbonne, which just released some new body products to keep your skin moisturized, which is especially important if you've been in the sun!  Since the HW skincare line does not include body products yet, here is an alternative!  Next, I'd like to honor all of our military and first responders this 4th, so we are offering 15% off of products and services (excluding surgery, and not to be combined with other offers) for the month of July.  And as you know, it wouldn't be a blog without a song for the week.  In honor of the 4th, here we go! Please watch this video!  





'Til next time,

Heidi Williams

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Guest
6 hours ago

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