FDA Must Disclose All Potential Side Effects of Gilead's Harvoni and Other DAA's

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It is estimated that 150 million people world-wide may have the Hepatitis C Virus. On October 10, 2014, the FDA approved the fixed-dose combination capsule of ledipasvir plus sofosbuvir (Harvoni; Gilead Sciences) for the treatment of patients with chronic HCV genotype 1 infection. Ledipasvir plus sofosbuvir is the first combination tablet approved for the treatment of patients with chronic HCV genotype 1 infection, as well as, the first approved regimen that does not require the use of interferon or ribavirin. The FDA approved the drug under breakthrough therapy designation, which is intended to expedite the development and review of drugs for serious conditions.   

The FDA, in their own reporting system of adverse events (FAERS), show dozens of reports of  sudden death, respiratory failure, renal failure, cardiac failure, hepatic failure and as well as hundreds of reports of a myriad of other problems, yet the public hears none of this and doctors are denying problems.  

One can go on any Hepatitis C internet forum and read statements from patients taking or who have taken the drug of their multiple problems above and beyond those indicated by Gilead.   Some of those to include, but are not limited to, long-term problems of tinnitus, severe neuropathy, joint pain, muscle pain, constant headache, chronic fatigue, heart issues, lung issues, and vision problems.  More recently there are numerous reports of very aggressive cancers developing and patients dying within weeks after taking Harvoni.  A letter to the FDA asking them to inform the public of these problems resulted in a response that they informed the public about deaths resulting from an interaction with the drug Amiodarone, which causes a slowing of the heart.  When asked about all the deaths other than those in relation to Amiodarone being reported, there was no response.    . 

How can this be the only information provided to the public? What about those families who have lost loved ones taking only Harvoni, and the many who report long-term problems and decreased quality of life? The drug has been on the market since October 14, 2014; and the only warning is an interaction with Amiodarone? How many more have to die, be crippled or have loss of quality of life before the public is informed? I personally now suffer from a multitude of problems more than two years post treatment with a decreased quality of life, as do many others.  Although “virus free,” I personally would not have taken Harvoni had I known the potential additional dangers to my health.  The cost of the medication is ridiculous and then add the cost of losing one's life or quality of life.  We were assured the drug was safe so this is truly unforgivable.  And yet the truth is still not being told.       

The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.  FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.  New drugs and biologics must be proven safe and effective to FDA's satisfaction before companies can market them. FDA does not develop or test products. FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined the benefits of the product outweigh the risks for the intended use based on what the Pharmaceutical Company tell them in trials.   And why is it that Gilead is withholding the trial data and a lawsuit is pending on that.    Why is the FDA withholding information from the public so WE can weigh the risks? 

Harvoni’s efficacy prior to release was evaluated in three clinical trials enrolling only 1,518 participants.  Of those participants, a significant number were given a placebo, some only Harvoni, and others Harvoni with Ribaviran. Thus, there were very few individuals who actually took the drug before release to the public.   In contacting the manufacturer, Gilead Sciences, I was told that the company does not do any follow up of patients who take the medication.  The dispensing information lists fatigue, headache, nausea, diarrhea and insomnia as side effects.   In March 2015, after a reported death, the FDA released a warning to get medical help right away if you take Amiodarone with Harvoni as it may cause a serious slowing of the heart.  What about all the other problems people are suffering from during and post treatment?  Why has the public not heard about that?   Why are doctors not alerting us?  Why do we have to go to patient websites to find out the truth from other patients? 

In an article, “FDA’s Early Warning Signal is Broken” (http://rxview.adverahealth.com/fdas-early-warning-system-is-broken it states, “FDA was actually in violation of the law for the better part of 2015 (and 2012-2014 depending on how you read the law) by failing to post quarterly lists of emerging drug safety issues.”   

Two advocacy groups, Treatment Action Group and the Global Health Justice Partnership, asked Gilead for patient-level trial data for the Sovaldi and Harvoni drugs.  (http://blogs.wsj.com/pharmalot/2015/06/29/fda-is-sued-by-advocacy-groups-that-want-gilead-hepatitis-c-trial-data/ They sought the data, because the drugs are widely prescribed due to a very high cure rate, and because the FDA approved the drugs as part of a regulatory process known as a breakthrough designation, which accelerated the review process. This “may increase the risk of gaps in drug efficacy going undiscovered or that side effects or [interactions with other drugs] will go unnoticed,” according to a lawsuit now filed. “Independent analysis of patient-level clinical trial data is essential to identify and bring to light unresolved safety and efficacy issues.” Gilead Sciences did not respond to the request so they turned to the FDA in December 2014.  The FDA denied their expedited request and was told it would take 18-24 months before they could receive the information. 

Failure to timely disclose information on the potential dangers of Harvoni is unacceptable!  Gilead has released a new drug to treat Hepatitis C and again limits the listing of side effects.  And perhaps most horrible of all, these drugs are now being administered with approval of the FDA to children.       

Tell Dr. Robert M. Callif, Commissioner of the FDA, and Dr. Janet Woodcock, Director Center for Evaluation and Research (CDER) that as a matter of public safety the FDA must immediately release notices to the public about all potential side effects related to Harvoni and other Direct Acting Antivirals that treat Hepatitis C.   This will allow those patients considering taking Harvoni or other drug to be properly informed of the potential devastating side effects, so they can make an informed decision whether or not to take the drug.

 

 

 



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