FDA Approves Absurd Drug to Delay Diabetes

A ahref=”https://www.theepochtimes.com/t-monoclonal-antibody”>monoclonal Antibody Type 1 injections have been approved Diabetes. It costs only $200,000 and has the potential for serious side effects.

• Tzield (teplizumab mzwv) was approved by the U.S. Food and Drug Administration for use in children and adults with type 1 diabetes. It is manufactured by Sanofi and Provention Bio.
• Tzield is a monoclonal anti-inflammatoric injection that does not treat or prevent type 1 diabetes.
• The treatment is designed to delay stage 3 type 1 diabetes by about 25 months.
• The drug’s wholesale cost is $193,900 for a 14-day supply, and it comes with a risk of unknown side effects.
• Tzield could cause cytokine-release syndrome (CRS), which is an acute systemic inflammation syndrome that can include fever and multiple organ dysfunction.
• Lymphopenia, which is a decrease in white blood cells, was seen in 78% of patients receiving Tzield.

The U.S. Food and Drug Administration approved the drug that delays the onset type 1 diabetes. (1) The American Diabetes Association referred to the approval as a “remarkable achievement.” “historic moment” (2) For those who have the condition. It is absurdity on steroids because it does not cure or prevent type 1. It delays the onset of type 1 diabetes for approximately two years.

Meanwhile, the drug’s wholesale cost is $193,900 for a 14-day supply, (3) and it comes with a risk of unknown side effects. Type 1 diabetes can be a serious condition. However, marketing the drug as a “savior” is misleading at best and dangerous at worst.

In the United States, Type 1 Diabetes affects nearly 2 million people. (4) It’s far less common than type 2 diabetes, and affects only about 5 percent to 10 percent of people with diabetes. (5) It’s believed to be caused by an autoimmune reaction, during which the body mistakenly attacks and destroys cells in the pancreas known as beta cells. Beta cells make insulin, so in type 1 diabetes, your pancreas doesn’t make insulin or doesn’t make enough insulin to keep you healthy.

Blood sugar can build up in the bloodstream without insulin. Insulin is essential for blood sugar entering cells to be used to produce energy. (6) While it’s thought that genetics play a role in type 1 diabetes, most people diagnosed do not have a family history of the disease. It can also be caused by environmental factors like viruses. This condition can be diagnosed at any age, but it is more common in young people and children. (8)

Type 1 diabetes is formally diagnosed in three stages. Stage 1 is when at least one autoantibody related to type 1 diabetes has been identified through screening tests. (9)

Stage 2 refers to the presence of two or more diabetes-related antibodies and abnormal blood sugar levels due to loss beta cells. Stage 2 has no symptoms. The stage 3 stage is when a clinical diagnosis can be made. The symptoms are usually present with severe loss of beta cells.

Type 1 diabetes can develop over a period of months or even years. Symptoms may not appear until later stages. By this time, the symptoms, which are caused by high levels of sugar in the blood, can be severe—even life-threatening. These are: (10)

• Extreme weakness and fatigue
• Extreme thirst
• Urethrination has increased.
• Abdominal pain
• Nausea and/or vomiting.
• Blurred vision
• Irritability.
• Quick mood changes.

Tzield (teplizumab–mzwv), a drug made by Sanofi and Provention Bio (11) was approved for use by adults and children aged 8 and over with stage 2 type 1 diabetes. Tzield, a monoclonal antibody injection, is not intended to treat or prevent type 1. Instead, it’s intended to delay the onset of stage 3, type 1 diabetes. The FDA says (12).

“Tzield binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells while increasing the proportion of cells that help moderate the immune response. Tzield is administered by intravenous infusion once daily for 14 consecutive days.”

The drug’s safety and efficacy were evaluated via a trial involving just 76 patients with stage 2, type 1 diabetes. Participants were administered Tzield once daily through intravenous infusions for 14 days. 45 percent of 44 patients who received the drug were later diagnosed with stage III diabetes after a median follow up period of 51 months. 72 percent of 32 placebo-treated patients were also diagnosed.

Tzield patients had a mid-range period of 50 months before they were diagnosed with stage 3 type 1 diabetes. The placebo group was only 25 months. “This represents a statistically significant delay in the development of stage 3, type 1 diabetes,” FDA made this observation. (13)

Tzield was associated with serious side effects, such as a decreased level of white blood cells and rash. According to the FDA, there are warnings and precautions regarding the use of Tzield. These include monitoring for the following symptoms:

• Cytokine release syndrome.
• High risk of getting serious infections
• A decrease in white blood cell counts, called lymphocytes.
• Hypersensitivity reactions are possible

Cytokine-release syndrome (CRS), an acute systemic inflammation syndrome, is characterized by fever and multiple organ dysfunction. (14) Cytokines, a group protein that your body uses in order to reduce inflammation. Your body releases cytokines when you have an infection, or receive immunotherapy drugs to combat inflammation. However, sometimes, it may release more than necessary.

The resulting chaos can be caused by a spiral in cytokine releases. “cytokine storm” Sepsis is a serious condition that can lead to death. (15) Provention Bio “CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration.” (16)

Because of this, patients are instructed to pre-medicate with antipyretics, antihistamines, and/or antiemetics before using Tzield—and use these drugs to treat any related symptoms that develop during treatment. Provention Bio continued: (17)

“If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.”

Provention Bio advised that patients with serious infections such as HIV, COVID-19, or other serious conditions should not be using Tzield. Those who are ill should also be closely monitored for signs and symptoms. Tzield was used to treat Lymphopenia (a condition that causes a decrease in white blood cell count, which is common with infections such as HIV, COVID-19 and tuberculosis). (18)

It may also affect the immune response to vaccination. The FDA stated that this is what the drug could do to interfere with vaccination. “all age-appropriate vaccinations” Must be taken care of “prior to starting Tzield.” Also, it is best to not use the drug concurrently with live, activated or mRNA vaccines.

Conventional medicine currently falls short in helping those with type 1 diabetes, but Tzield only delays its onset by about two years—at a significant monetary cost and risk of serious side effects. Other options deserve further scrutiny—options that have only positive related effects, such as intermittent fasting or time-restricted eating (TRE).

James DiNicolantonio (19), a noted researcher, discusses in the BMJ (19), the results of several studies showing that fasting infrequently can stimulate cell growth in pancreatic beta cells. The increased growth was associated with an increase in Ngn3 (21) which is a protein responsible for converting DNA to RNA. This is the cell responsible for insulin production in the pancreatic Langerhans cells.

Intermittent fasting caused an increase in beta cells in the islet. In animals, there was also a marked improvement on blood sugar control. These findings are of particular interest to people with type 1 diabetes because they often suffer from near-complete inflammatory destruction.

“With respect to Type 1 diabetes,” DiNicolantonio wrote, “production of new beta cells might enable its resolution if the autoimmune attacks that destroyed the original complement of beta cells can somehow be quelled.” (22)

Another option that’s free, safe, and available to everyone is simply changing the order in which you eat certain foods. It has been proven that children with type-1 diabetes can benefit from eating carbohydrates at the beginning of a meal. A related study included twenty patients with type 1 diabetes, aged 7-17 years. (23) They had two meals, each in a random order. The first meal consisted of the protein and fat first, followed by the carbohydrates fifteen minutes later.

In the other meal, carbohydrates, fat, and protein were all consumed together in the same way as they would in a typical meal. When carbs were last consumed, the mean glucose levels were 1 mg/L lower than in a typical meal.

Dr. Jason Fung (a kidney specialist and nephrologist) explained that you can achieve a more positive response by frontloading protein/fats in your meals and leaving the carbohydrates for later. (24) He continued: (25)

“This might mean a lot of things, including you, need less insulin, which might lead to less weight gain overall because we know that those high glucose levels, those high insulin levels, are going to drive weight gain.

“This actually has massive implications for the way we need to structure our meals … We might be able to take less medications. We may be able to lose weight, because again that lower level of insulin is going to cause less weight gain. And what it means is that you really have to frontload your meals so that you’re taking your protein, and your fat and your vegetables right upfront and leaving the carbohydrates to the end.”

To get the best results, he suggests waiting about 10 minutes before eating carbs. It is similar to when you eat an appetizer before you start your next course.

It’s unfortunate that a close-to-$200,000 drug is being heralded as a breakthrough for type 1 diabetes, especially since it only delays its onset and is so risky for overall health. What’s needed to truly help those suffering from this devastating condition is research into safe and effective modalities for prevention and treatment.

Research has shown, for example, that pregnant women are more likely to have a higher risk of developing breast cancer. Vitamin D needs should be met at the highest possible level significantly reduce their child’s risk of developing Type 1 diabetes. Carole Baggerly, founder and director of GrassrootsHealth Nutrient Research Institute (a non-profit public research organization dedicated to transferring public health messages regarding vitamin A from research into practice), noted that (25)

“We’re working with the Diabetes Research Center to see whether, even after the child is born, as long as they don’t have full-blown type 1 diabetes, what can we do to help stop it? And it turns out that the combination of vitamin D and omega-3 really matters.”

Special mention should be made of black cumin (nigella Sativa), as it has been shown to help prevent both type 1 diabetes and type 2. (27) Instead of focusing on toxic drug treatments, research into vitamin D, TRE and environmental triggers for type 1 diabetes could be a real opportunity for people with type 1 or at-risk.

Originally published Dec 13, 2022, on Mercola.com

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