How can we learn the actual benefits and risks of a new drug sooner?
Are there useful remedies out there that have been ignored due to lack of commercial interest?
Advance Science. Help your neighbors. Share your experience.
Drug companies have a conflict of interest between making a profit and uncovering the truth about whether these drugs really work. Within the ranks of Pharma executives, this conflict shifts into the highest gear after a drug is approved by the FDA. With hundreds of millions of dollars of income at stake, the motivation to uncover inconvenient truths is low.
If a drug is approved by the FDA, could we assume that the drug will actually work and will be safe? The answer is no. There are many examples of drugs that have been withdrawn from the market due to problems discovered after approval. The challenge is to discover these problems sooner.
In the past, the FDA has asked drug companies to conduct further studies after approval to better understand newly approved drugs. Unfortunately for patients, these studies take a very long time to complete. A recent example is Biogen Idec's Tecfidera, which was approved by the FDA in March 2013. FDA asked Biogen Idec to conduct a 5000 patient, 5-year observational study to detect serious adverse events. The final results is projected to be available October 2023.[Temple R FDA 2013]
Do we have to wait almost a decade to find out whether this drug really work?
In the era of the Internet and crowd-sourcing, we have the tools to learn actual patient experiences sooner.
Promoting a drug is an expensive endeavor. Funding a sales team plus advertising can be hundreds of millions of dollars per year. When drugs go off-patent, the profit picture changes and so promotional activities end.
When advertising ends, these "hidden gems" remain effective, but because they are no longer as profitable because of generics competition, drug companies turn their advertising to newer drugs. Over time, doctors’ and patients’ memories of the older drugs fade even though these older and now less expensive drugs may be equivalent or better than the new drugs for many patients. Newer, expensive drugs gain share-of-mind and market share. The older drugs become ignored.
Gaining FDA approval for a drug can require an investment costing hundreds of millions of dollars. For herbal remedies and drugs which cannot be patented, the cost makes pursuing FDA approval financially unfeasible. Since these products cannot be patented, investors will not stake hundreds of millions of dollars funding FDA approval just to let their products’ prices be undercut by generic manufacturers who did not fund the research studies.
Herbal remedies can still be marketed as dietary supplements. Because dietary supplements are not FDA approved to treat any specific disease, this poses special challenges for doctors and patients who are trying to make a decision.
Drugs that are not patentable may already be FDA approved to treat a different disease. Because the promotion of off-label use is illegal, doctors and patients need extra effort to learn about the drug.
We selected Petadolex as the first drug to study for this reason. As an herbal remedy, Petadolex is not FDA approved to treat migraine headaches and is largely ignored by doctors outside of a small circle of highly specialized neurologist who are the world's leading migraine headache experts. Our review of scientific literature [summarized here] and preliminary study report [summarized here] reveal the scientific evidence that Petadolex may indeed be a drug that should not be ignored.
For financial and FDA reasons, information about many useful drugs is not shared despite the Internet and all the amazing technologies at our disposal.
The future that we will create --with your help--will be a world where information flows more freely: Where doctors and patients can learn from actual experiences. Where we have more drugs and herbal solutions in the war to alleviate pain, suffering, and unnecessary medical costs.
This kind of information sharing is possible. People must be allowed to help people without artificial barriers.
Your experience is what the world needs.
All of us make decisions that directly affect our health everyday. There are few decisions that have greater impact than our choice of medication. Your gift will help your friends, neighbors, and countless others. There is only one way to know - and that is with your help. Thank you!
You will not be asked to register or sign-up for an account or anything. We want the process to be as simple as possible for you. We keep the number of questions as few as possible. They are intended to be the key questions that someone who is about to start taking the medication will want to know.
If you are willing to be contacted to provide more information, then we ask for your email address. This will be a way for us to follow up with you later, to find out whether anything changed after the first survey.
Do you have a medication that you feel will be important to study? Do you suspect a company is making questionable claims in advertising that should be verified by a study of actual users?
We are in the process of narrowing down the choices for our next study.