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Clinical Drug

Story at-a-glance -

  • Bristol-Myers Squibb dropped their new hepatitis C drug – called BMS-986094 – after one clinical trial patient died from heart failure and others were hospitalized with heart and kidney problems
  • The new hepatitis C drug from Bristol-Myers Squibb was much anticipated, but now due to its apparently deadly risks, the drug will be discontinued and the company will take a $1.8-billion charge-off for it
  • Now trials for a separate hepatitis C drug in the same class, this one made by Idenix Pharmaceuticals, have been put on hold as participants have been reporting similar complaints to those suffered with the Bristol-Myers Squibb drug.
  • The newer drugs were supposed to provide an all-oral combination of pills that would cause fewer side effects than current treatments, such as Interferon therapy, which is riddled with serious side effects
  • Natural antioxidant treatment of hepatitis C may be effective, without side effects; up to 25% of cases of chronic hepatitis C also clear up on their own without any treatment
 

The Most Epic Drug Failure. Ever.

September 13, 2012 | 72,908 views

By Dr. Mercola

Only a week after the U.S. Centers for Disease Control and Prevention (CDC) advised all U.S. baby boomers to get tested for hepatitis C because it’s suspected that millions may be infected with it, a drug company with a hepatitis C treatment in the pipeline has suddenly abandoned the drug’s trials.

Bristol-Myers Squibb dropped the drug – called BMS-986094 – after one clinical trial patient died from heart failure and others were hospitalized with heart and kidney problems.

Failed Hepatitis C Drug Will Cost $1.8 Billion

The new hepatitis C drug from Bristol-Myers Squibb was much anticipated, but now due to its apparently deadly risks, the drug will be discontinued and the company will take a $1.8-billion charge-off for it.

BMS-986094 was part of a new class of hepatitis C drugs, known as nucleotide polymerase inhibitors, or nucs, which work by targeting the polymerase enzyme that’s essential for replication of the hepatitis C virus.

Now trials for a separate drug in the same class, this one made by Idenix Pharmaceuticals, have been put on hold as participants have been reporting similar complaints to those suffered with the Bristol-Myers Squibb drug.

These newer drugs were supposed to be “game changers” in the treatment of hepatitis C, which typically involves weekly injections with interferon, a treatment that causes significant side effects including depression, paresthesia (changes in sensation), impaired concentration, amnesia, anxiety, immune system disorders, heart problems and more.

The newer drugs were supposed to provide an all-oral combination of pills that would cause fewer side effects than current treatments, but already at least one death has occurred before the trial could even be completed.

What makes these dangerous treatments, and the CDC’s new push to have all baby boomers (not just those who have risk factors) tested for hepatitis C, all the more concerning is that treatment isn’t always necessary for this disease.

What is Hepatitis C, and How Common Is It?

Hepatitis C is a contagious liver disease that occurs when you’re infected with the Hepatitis C virus (HCV). Following initial exposure, you may get acute hepatitis C, which leads to flu-like symptoms such as fatigue, nausea, vomiting and abdominal pain. In about 75-85 percent of cases, an acute infection may lead to chronic infection, which usually has no symptoms.

Since the hepatitis C virus is spread through contact with infected blood, it’s typically spread through sharing needles for drug use, from a needle-stick injury if you work in a health care setting, or being born to a mother who has hepatitis C. Prior to 1992, screening was not available for donated blood or organs, so the infection was also spread through blood transfusions and organ transplants. 

More rarely, it’s also possible to get hepatitis C from sharing personal care items, such as razors or toothbrushes, or through sexual contact.

It’s estimated that 3.2 million people in the United States (2 million of them baby boomers) have chronic hepatitis C, but most are unaware since the disease typically causes no symptoms. 

However, because the virus attacks your liver and leads to inflammation, it can lead to liver failure, liver cancer and cirrhosis of the liver. Liver disease is, in fact, often the first sign a person has that they have hepatitis C. While antiviral medications are often prescribed, not everyone with hepatitis C requires treatment. According to the CDC:1

“…approximately 15%-25% of people who get Hepatitis C will clear the virus from their bodies without treatment and will not develop chronic infection. Experts do not fully understand why this happens for some people.”

And according to the Mayo Clinic:2

“A diagnosis of hepatitis C infection doesn't necessarily mean you need treatment. If you have only slight liver abnormalities, you may not need treatment, because your risk of future liver problems is very low.”

So, for reasons that aren’t entirely clear, a significant number of people who were once infected with hepatitis C no longer have any signs of the virus. Did they improve because they were given toxic chemicals or because their immune system fought the battle and won?

A Triple-Antioxidant Approach May Work Wonders for Hepatitis C

The current treatments for hepatitis C are seriously lacking. Interferon and antivirals have less than a 30% response rate,3 and if your liver is damaged enough to require a transplant, even this will not provide a cure, as the new liver will often become infected.

Dr. Burton M. Berkson was among the first to discover a natural treatment regimen. He is an internist and during his training was given several patients who were expected to die from hepatitis C. His job was to merely “babysit” them in the ICU and, basically, watch them die. He did not do that, but rather called his associate at the National Institutes of Health and used a combination of three natural antioxidants. These three patients, who were not expected to live more than a few weeks, completely recovered. What were the antioxidants?

Each possesses antiviral, free radical quenching and immune-boosting qualities. Dr. Berkson wrote:4

“The triple antioxidant combination of alpha-lipoic acid, silymarin and selenium was chosen for a conservative treatment of hepatitis C because these substances protect the liver from free radical damage, increase the levels of other fundamental antioxidants, and interfere with viral proliferation. The 3 patients presented in this paper followed the triple antioxidant program and recovered quickly and their laboratory values remarkably improved.

Furthermore, liver transplantation was avoided and the patients are back at work, carrying out their normal activities, and feeling healthy. The author offers a more conservative approach to the treatment of hepatitis C, that is exceedingly less expensive.

One year of the triple antioxidant therapy described in this paper costs less than $2,000, as compared to more than $300,000 a year for liver transplant surgery. It appears reasonable, that prior to liver transplant surgery evaluation, or during the transplant evaluation process, the conservative triple antioxidant treatment approach should be considered. If these is a significant betterment in the patient's condition, liver transplant surgery may be avoided.”

As with any viral infection, it is extremely important to nurture your immune system as much as possible. This includes:

You will want to work with a holistic health care practitioner who can help you to not only eliminate toxic deposits from your body that may further stress your liver, but also help you with proper dietary choices and the use of herbal and other natural treatments.

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