Would You Give Up Your Privacy for Free PCSK9 Copay Card?

This is what Amgen is asking people to do and for a very few, this might be something to consider. For the rest of the people, privacy should be carefully guarded. Amgen feels that its extremely expensive new cholesterol drug, Repatha, is worth surrendering your privacy.

“Doctors, pharmacists, patients, and others are now starting to learn that in order to receive financial assistance from Amgen for its expensive new cholesterol drug Repatha, patients are being required to surrender rights to their personal information, including their personal health information. The information will be freely available, with few restrictions, not only to the company, but to unspecified third parties.”

Marilyn Mann, a respected patient advocate who has family members who have familial hypercholesterolemia, suggests the policy be revised so that patients in financial need can receive assistance without having to agree to such a wholesale waiver of their privacy rights.

The Repatha copay program is part of the larger Repatha Ready program, which supplies "support services to help you start and stay on Repatha." They don't want to lose their lucrative profits. The supposedly most important part of the program is a copay card which gives patients access to the drug for only $5 a month. The program includes email reminders and a free needle-disposal (sharps) container. For patients to receive this, they must first sign over their rights to privacy to Amgen to use their personal information.

Some of the language should scare you. “I understand that Amgen may use my personal information, including my personal health information, for 10 years once I accept this Authorization or for a shorter time period if required by state law.” The agreement specifically states that by agreeing to the terms, patients may lose federal HIPAA protection. Further, the company specifically warns that there is nothing to prevent it from sharing your information with third parties:

Copay cards are normally used by patients to offset their out of pocket costs, and the companies used them as promotions to gain and maintain market share for the long term to maintain profitability.

The Amgen plan seems to be taking a different approach. They are seeking market domination and a novel data source. The use of patient data might well be part of the broader strategy to find more patients by mining new sources of data. This move by Amgen represents the next step in the merger of digital technology and biotechnology, i.e., if you' re not paying for the product, you are the product.

With your personal information, they can sell this to other companies looking at patient data-mining and you, as the patient will be bombarded with information to convince you that you need their products.

To this, I say – NO THANKS!

You may want to pass this information on to friends who may be at risk for diabetes.

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.

Read the full article here and a commentary by Dr. Malcolm Kendrick here.