Aa
Aa
A
A
A
Close
Avatar universal

Public Health Groups Sue FDA for access to HCV clinical trial data

Public Health Groups Sue FDA For Disclosure of Clinical Trial Data for Costly Hep C Drugs
FOR IMMEDIATE RELEASE: June 25, 2015 CONTACT:    Debra Kroszner (email address and phone number are on the linked page)

Public Health Organizations File Federal Lawsuit Seeking Access to Clinical Trial Data for Costly Hepatitis C Drugs

http://isp.yale.edu/node/5978

"Treatment Action Group (TAG) and the Global Health Justice Partnership (GHJP) have filed a federal lawsuit to obtain access to the information that Gilead Sciences submitted to the FDA to obtain approval of two new—and extremely expensive—hepatitis C drugs, Sovaldi (sofosbuvir) and Harvoni (sofosvubir/ledipasvir)."
excerpt

My brief summery
Basically Nov 2014 they asked Gilead Sciences to release data on Sovaldi and Harvoni but they didn't like other companies have. Dec 2014 they filed a freedom of information request to the FDA. The FDA response was maybe in 18 to 24 months.

The lawsuit was filed because doctors, patients, state healthcare programs and policy makers need more details to make better treatment choices.

Please go to the link for more details.  

Tip I have done it before myself "being lazy" and copied too much info
Remember most information is copyrighted so short quotes and brief summaries (rewording) are allowed under USA "fair use" but extensive word for word copying of articles, stories books etc is not legal.

Another Personal opinion not directly related to the above story.
I think that for any drug that is approved via FDA fast tract have post approval "real life use" requirements. There are some like severe adverse affects must be reported within a certain time frame.

I would make it a rule that all medical prescribers of newly approved fast tract HCV (or other condition applicable) drugs that are considered a cure or SVR be required to file a report to the FDA via either the manufacture, insurance provider or other. This report would be due within 4 months after the 12 week post EOT viral load test.  

no names but general info
GenoType, HCV Drugs taken, age, gender, race, Fibrosis score, cirrhosis status,  significant medical problems resulting from treatment etc
The big one 12 week post viral load report
1. SVR  2.relapse 3. discontinued during treatment (adverse effect or patient mia) 4. patient didn't get 12 week VL test because lost contact or other.

The drug manufacture would be responsible for the cost involved for the collection of this information.  The FDA would be required to make available to the public at least online of the cumulative results within 60 days after receiving the information. updated at least monthly  

This is just my non medical idea. Specific information, time frames etc are shown only for example. Professionals would have to come up with something that is doable.



6 Responses
Sort by: Helpful Oldest Newest
Avatar universal
Interesting information in the article about Harvoni failures only for African Americans. That kind of information really should be released as soon as possible and followed up on. I would think the insurers would be after this data too.

Mind, data can be skewed even on the slow track. What are the guidelines for example about appropriately reflecting a wide range of human  populations and genetics in trials in order to gain approval? If a drug company knows that it is likely that a certain variant of HCV won't respond to a drug for certain human genetic types, but the FDA doesn't know yet, there would be a temptation to exclude or minimise the number of likely to fail subjects in trials in the first place?
Helpful - 0
2059648 tn?1439766665
Helpful - 0
Avatar universal
It's more than just political.  It's about maximizing the resources to get the best possible treatment for patients  

link to another article about same story

http://blogs.wsj.com/pharmalot/2015/06/29/fda-is-sued-by-advocacy-groups-that-want-gilead-hepatitis-c-trial-data/

Health groups are concerned, the fast tract process “may increase the risk that gaps in drug efficacy will go undiscovered, or that side effects or [interactions with other drugs] will go unnoticed,” arguments in the lawsuit.

“This delay will leave doctors and patients in the dark for too long,” says Amy Kapczynski, a Yale Law School professor who heads GHJP, in a statement. “Doctors write thousands of prescriptions for these drugs every week, straining budgets of state health care programs. Prompt disclosure of this information, which the FDA already collects, will allow doctors and policymakers to make more informed treatment choices with real and immediate consequences for public health and spending.”

Helpful - 0
Avatar universal
Hi Jimmy,
I agree that there needs to improvement on reporting of drug effectiveness and side effects. It's very difficult to design an ideal system of accountability though. The administration and cost of the process will change behaviour. For example, a health care system that requires surgeons to publish success ratings for operations is likely to result in fewer surgeons willing to take on difficult procedures. That in turn, would result in less development and improvement of surgical technique.

After experiencing HCV treatment with Interferon and Ribavirin I was enraged about the way the healthcare system in my country managed HCV treatment systemically, and how drug companies and doctors could end up encouraging people to undergo a very difficult, and possibly damaging treatment when it was possible in some cases to obtain cold hard evidence that treatment would be unsuccessful prior to commencement. Healthcare systems routinely make people sicker, just because they involve imperfect processes, administered by people with varying degrees of intelligence and ethics.

I personally made the mistake of thinking that there were standards that protected us to a certain degree. Everything... trial design, interpretation of clinical trial reports, classification, approval and administration of drugs is deeply affected by human behaviour on a case by case basis. With doctor selection - caveat emptor - buyer beware is now my motto.

Having experienced more of healthcare systems, doctors, and clinical trials now, my anger is still there, but it is tempered by more understanding. If clinical trial design was an open collaborative affair, with results released in real time then maybe that bring improvement. However the system requires proof of effectiveness beyond the placebo effect and is a commercial rather than an altruistic activity.
Helpful - 0
2059648 tn?1439766665
I didn't know that this forum is a platform for legal or political issues.  Drug companies choose the best candidates for trials.  The information submitted to the FDA reflects the outcome of the best possible scenario. I expect that the information submitted to the FDA reflects few negatives.  So, the FDA
will wait 18 to 24 months to receive complaints and provide the real time effects.   There is problems but it sure isn't in this outcome that wasn't produced in a timely manner in December.  Random selection of trial participants would produce real time results.  I would expect the government is looking at this differently and not signing off and waiting for the outcome in real time.  FDA maybe looking at turning the lack of realtime outcomes back on the drug companies.  The government is paying a lot of money for this drug.  Maybe this is an attempt to test the real time results and not just except the written findings of the perfect participants in clinical trials.
Guess if we wait 18 to 24 months will know the real results.  The FDA then can sue the drug company for negligence.  

You Asked







Helpful - 0
Avatar universal
Noticed I left out length of treatment, prior treatment and others. A discussion of the specifics of my idea is not necessary.

Looking for comments about the lawsuit and or my general concept of requiring reporting of real use results in a timely fashion.  
Helpful - 0
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.