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?
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.”
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.
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
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.