November 3, 2015
Doctors Desperately Seeking PCSK9 Eligible Patients
This is one drug that may be more dangerous than all the statins. Although the two drug companies will deny it, it is expected that type 2 diabetes will become more prevalent for those using this drug.
Amgen and Sanofi/Regeneron are expected to rake in many billions (yes, a B), but they need to find the patients who will take the drug. None of the current members of our support group has been contacted or has had the suggestion to consider this drug. I don't think any are considering it, but I could be wrong. Several of us have stated we will not.
To help find these patients, a central strategy of the companies involves giving hundreds of millions of dollars to a whole host of non-profit medical groups, commercial companies, and individual physician experts.
Amgen and Sanofi/Regeneron make the two newly approved cholesterol drugs -- evolocumab (Repatha) and alirocumab (Praluent). These companies are fueling an explosion of new programs, some of which utilize innovative data-mining techniques to gather massive amounts of data from new sources. If these programs work as intended, they will likely identify large numbers of new patients who are candidates for the expensive drugs. How many will be marginal patients remains to be determined, but with money as stake, the numbers will probably be more than expected.
“The sheer size and scope of these programs are not generally known. The activities funded by industry fall across the entire spectrum of basic and clinical research, continuing medical education for physicians, patient education, and support for not-for-profit groups and patient advocacy groups. Of course, the companies are also spending millions of dollars on all the more traditional sales and marketing avenues. The financial tsunami will undoubtedly help secure the close bond between the medical establishment, patients, and industry.”
People with familial hypercholesterolemia (FH) are the best early candidates for the new drugs. The vast majority of people with FH have never been diagnosed, and FH has not been on the radar screen of most physicians. Many of the new initiatives are designed to find these currently hidden patients.
Remember that the long-term clinical benefits with these drugs will not be known for another few years. Also not mentioned are the harmful side effects. These are not complete as of yet and some of them may be severe, especially in the elderly. There could be many problems from overuse of the drugs, the mistaken diagnosis of FH, an inflated perception of risk in some patients, or a lowered threshold for treatment.
There is talk about statin intolerance and once the PCSK9 inhibitors were approved, statin intolerance became a hot topic. Among people in the medical community the manufactured explosion of interest in the statin intolerance is widely known. Most in the medical community do not consider this controversial and it is something everyone knows and talks about, but seldom in public.
“In 2014, Amgen gave money to the American College of Cardiology (ACC) to support a new program called LDL: Address the Risk. An unusual and unique product of the program is the ACC Statin Intolerance App, for iPhone and Android, that "uses clinical guidelines and best practices to help" doctors evaluate, manage, and treat statin intolerance.”
For the new drugs, all you need to do is follow the money. This will show you what is happening in the medical community where everyone is reaching for their unearned share of the largess.