The FDA has failed the public once again. As described in a June 15 press release, the FDA has signed a Research Collaboration Agreement with the for-profit organization, PatientsLikeMe®.
As reported by Reuters, “PatientsLikeMe® and the U.S. Food and Drug Administration (FDA) have signed a research collaboration agreement to determine how patient-reported data can give new insights into drug safety. Under the collaboration, PatientsLikeMe® and the FDA will systematically explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management.”(1)
Because the pharmaceutical companies are heavily involved in PatientsLikeMe®, this is an
other example of the pharmaceutical companies’ continued unmitigated push into the Internet’s ‘health space.’ They want to dominate the internet’s conversations and memes when it comes to their products and make sure that only pharmaceutical company approved data is discussed. Right now there are areas of the internet which are considered loose cannons from the drug company perspective, especially when it comes to discussing things such as adverse events, side effects, and patient opinions.
Current ‘gray area’ FDA regulations prohibit the pharmaceutical companies from just stampeding directly into places like Facebook and other social venues: but things are changing. Recently I wrote about how pharmaceutical companies are using companies such as WEGO Health as intermediaries. Under the guise of patient wellness, pharmaceutical companies are subtly and tacitly directing the pro-pharma spin.
Companies such as WEGO Health employ pharmaceutical company executives throughout their structure and in-turn promote pro-pharma marketing throughout the various patient groups, all under the guise of giving the patient a voice. I recently wrote how WEGO Health started infiltrating and influencing health space (2)(3), and even the Fluoroquinolone (FQ) community through innocent unsuspecting community members who graciously withdrew their WEGO involvement, and entities like the QVF, which was pre-warned about WEGO Health several months in advance and chose to continue to support WEGO Health Activist awards, despite the fact the WEGO Health is supported by pharmaceutical companies that produce and market FQs and also run by ex-pharma executives.
Do not expect this the pharmaceutical trend of pushing into health space to stop anytime soon.
PatientsLikeMe®
PatientsLikeMe® (www.patientslikeme.com) is self-described, “as a patient network that improves lives 
and a real-time research platform that advances medicine. Through the network, patients connect with others who have the same disease or condition and track and share their own experiences. In the process, they generate data about the real-world nature of disease that help researchers, pharmaceutical companies, regulators, providers, and nonprofits develop more effective products, services and care. With more than 350,000 members, PatientsLikeMe® is a trusted source for real-world disease information and a clinically robust resource that has published more than 60 peer-reviewed research studies.”
Just like WEGO Health, PatientsLikeMe® claims it is designed to connect patients, share personal health information and collaborate on drug side effects and safety. On the surface it seems like a very positive thing, until you dig a little further.
In the Reuters article entitled, “PatientsLikeMe and the FDA Sign Research Collaboration Agreement” (1). Under the collaboration, PatientsLikeMe and the FDA will systematically explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management.
Again, on the surface, a patient centered organization partnering with the FDA sounds like a good thing, right?… Wrong!
One does not have to look very far to see that PatientsLikeMe® lists as their partners Janssen Pharmaceuticals, Merck, Novartis, Avanir, AstraZeneca, Acelion, Robert Wood Johnson Foundation (J&J), Actelion, Boehringer Ingelheim, Bristol-Myers Squibb, and Sanofi (4)(5).
According to Reuters, PatientsLikeMe® Co-Founder and President Ben Heywood said the agreement, between the FDA and PatientsLikeMe®, is an unprecedented step toward enhancing post-market surveillance and informing regulatory science. “Most clinical trials only represent the experience of several hundred or at most several thousand patients, making it impossible to anticipate all the potential side effects of drugs in the real world. Patient-generated data give a more complete picture about a drug’s safety by providing a window into patients’ lives and healthcare experiences over time. We’re very encouraged by the FDA’s action to evaluate newer sources of data to help identify benefits and risks earlier.”
Just like WEGO Health, PatientsLikeMe® employs ex pharmaceutical executives or those with very close pharmaceutical ties in their top echelon.
Ed Godber, PatientsLikeMe®’s Executive Vice President of Life Sciences Ventures spent nearly five years at GlaxoSmithKline (GSK) as Senior Vice President (6).
Jason Johnson, PatientsLikeMe®’s Executive Vice President and Head of R&D is the former Associate Vice President for Scientific Informatics at Merck (7).
Martin Coulter, PatientsLikeMe®’s Chief Executive Officer served as a principal figure at both Parthenon Group and Bain & Company, both consulting firms with confidential clients in the pharmaceutical industry (8).
So besides having a majority of the world’s top pharmaceutical companies as company sponsors, PatientsLikeMe®, just like WEGO Health, employs former pharmaceutical company executives or those with ties to the pharmaceutical industry.
PatientsLikeMe® Source of Income, Your Health Data
In fact, according to the PatientsLikeMe® website, PatientsLikeMe® actually makes money by taking the information provided by patients about their drug adverse events and selling it to the drug companies. “We take the information patients share about their experience with diseases and sell it to our partners (i.e., companies that are developing or selling products to patients). These products may include drugs, devices, equipment, insurance or medical services. This is, in fact, the only way we make money.” (9).
According to Reuters, PatientsLikeMe® has collected more than 110,000 adverse event reports on 1,000 different medications, data that the FDA will now be able to access and analyze as a supplement to traditional sources, including FAERS.
Another FDA Failure
So that we have this straight, a company run by ex-pharmaceutical executives using their internet social
platform is collecting personal adverse drug reaction data, in addition to other health data, reselling that data to pharmaceutical companies, and also using that data to supplement the FDA’s FAERS data, which is supposed to be an unbiased, patient supplied, source of adverse reaction information, not run through a biased intermediary… outrageous!
The FDA would be better off looking at its FAERS data. If they did, they would see drug signals that they have ignored, especially for FQ’s. They have the data, they should look at it! They should analyze it!
I recently wrote about an outrageous FDA proposal that would let the pharmaceutical companies distribute their own, self-policed, drug literature claiming it’s their 1st amendment right. The FDA said it would allow distribution of new information published in medical journals showing that the severity or rate of a side effect is lower than described on the product label. The new data could even “call into question a causal relationship between a drug and an event in the approved labeling.” You can read the article here (10).
Why would the FDA make such an outrageous decision to enter into an unprecedented agreement to monitor post-marketing drug surveillance with a private company run by ex-pharmaceutical executives?
In my opinion, one reason is that the FDA is helping the pharmaceutical companies regulate and
influence the medical discussions taking place in health space.
Another reason is that the FDA is too lazy to analyze its own FAERS data so it will, in a round-a-bout fashion, let the pharmaceutical companies do it through an intermediary.
Some of the pharmaceutical companies that PatientsLikeMe® is doing business with, are companies that resist our media efforts, put pressure on researchers and doctors who support us, and have ignored our pleas for acknowledgement and help. Also, some of these companies continue to aggressively market and research FQ based products.
I believe that the pharmaceutical companies don’t want just a portion of health space, they want all of it. They want to control the conversation and the dissemination of approved data. In order to do so they are using intermediaries, now with the help of the FDA, to infiltrate under the guise of patient centric communication and reporting.
Some people view websites, such as PatientsLikeMe®, as excellent resources. I view it as just the opposite. It is a placating, palatable form of corporate manipulation and control. In this case it is more insidious than ever, in that it makes money from the patient’s data and in-turn indoctrinates the patient in a world of pharma defined reality.
Our community has made tremendous strides in awareness over the last year and a half. I believe the pushback will be strong, insidious and consistent. I also believe that the pharmaceutical companies are using shrewd tactics to control conversation, obtain information, and stop what they view as dissenting information. I believe the current peripheral neuropathy lawsuits will be used by the pharmaceutical companies to use those within our community just that way, but that is another article.
I have a pledge on my website that I follow and one of its elements is that “I pledge to be watchful and diligent against entities, whatever or whomever they may be, that seek to undermine, either directly or tacitly, the activities of the FQ community in the areas of advocacy, research, and or pursuit for justice.”
Please join with me to remain watchful. If we want to rise, as a community, out of the position that we have been relegated to, we must be diligent.
Stay vigilant, stay informed, and stay tuned to My Quin Story for timely updates on our interactions with the FDA, the Citizen Petitions, UMDF, and upcoming information on FQ community academic related research.
Excellent article David! You are a true watchdog for the FQ community.