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[hemantgoel]

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[marceloescritor]

🤔Bom dia de chuva em Salvador Dique do Tororó Instagram: marceloescritor🌹 #minhabahia #marceloescritor #salvador #qvf #bmb (em Dique do Tororó) https://www.instagram.com/p/CaHkB78LnJK/?utm_medium=tumblr

[fqtoxicity]

Yet Another FDA Failure: PatientsLikeMe® - My Quin Story

New Post has been published on http://www.myquinstory.info/yet-another-fda-failure-patientslikeme/

Yet Another FDA Failure: PatientsLikeMe®

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 another 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, 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 they are controlling the conversation and pushing their wares.

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. These are pharmaceutical companies that produce or market Fluoroquinolones. I recently wrote how WEGO Health started infiltrating and influencing health space (2)(3), and the Fluoroquinolone (FQ) community through innocent unsuspecting patients who graciously withdrew their involvement, and entities like the QVF, which was pre-warned about WEGO Health months in advance and chose to continue to support WEGO Health Activist awards .

Do not expect this trend 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 data.

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.

[fqtoxicity]

New Post has been published on My Quin Story

New Post has been published on http://www.myquinstory.info/why-i-have-withdrawn-support-from-the-qvf/

Why I Have Withdrawn Support From The QVF

It is my regret to inform those reading, as a founding member and first director of the Quinolone Vigilance Foundation (QVF), I am forced to withdraw my support of the QVF and have no confidence in its current leadership.

My history with the QVF goes back to a handful of floxed individuals who worked together fostering research and advocacy for Fluoroquinolone (FQ) Toxicity. We dreamt of starting a non-profit that would formally congeal this much needed research under one umbrella. Out of this dream the QVF was born and I was selected to be the first Director. Unfortunately, shortly after, changes at my job forced me to work long hours for many months, while floxed, in order to secure health insurance and income for my family. Doing this was detrimental to my health and forced me to step down and away from the QVF and FQ community. Leadership was turned over to others.

With that brief background as the context, my comments are being offered today knowing that I am intimately familiar with the impetus and goals that created the organization. The QVF, being a 501C3 established to foster research and advocacy for the entire FQ community, is held to a very high standard.  My comments are not designed to disparage any of those hard working individuals who, in the past, have labored long in the establishment of the QVF or those who have and do support the QVF publically.

Starting in January of 2015 I embarked on a personal undertaking to take a look at the FQ community. My main goal was to look at the community from behind the scenes, to get an idea who the leaders are within the community, communicate with those leaders, what their differences of opinion are, and what was driving those opinions and directions. Next, I ascertained the current state of FQ research. Finally, I then took a hard, long, unbiased look at how the QVF fit into that picture both from a research standpoint and a social standpoint of view.

My original intent was to assist the QVF in re-establishing FQ research ties that had been lost over the last couple of years. It was certainly not my intent to stop supporting the organization. However, after looking at the totality of the information, I came to startling and sad conclusion; the problems being experienced by the QVF, I felt, were mainly internal, as opposed to external.

This discovery ran counter to what I had expected to find. I was led to believe and assumed that external problems, such as strong community opinions, personalities, and motivations were the driving forces that were hampering the QVF’s meaningful forward momentum as a research driven organization. Although there are plenty of conflicting personalities and motives and there always will be, I was wrong in my initial assumptions.

It is my opinion that the organization, in its current state, runs counter to its founding premise and goals, has suffered from a form of mission drift and has morphed into an organization counter to its founding purposes. Wanting to remain truthful, I did not want my perceived public perception of the organization to run counter to my private feelings of non-support.

Keeping in mind that the QVF was originally designed to primarily initiate and foster FQ based research and to a lesser extent participate in advocacy, I formed several opinions as to why I felt that the organization is running counter to its original designs.

It is my opinion, that the current board, in its makeup and structure, creates an environment that does, and will, prohibit the fostering, creation, or support of viable FQ research, something that is needed to fulfill the goals of the organization.

It is my opinion, that the current board is too nepotistic in its make-up and does not contain an accurate reflection of the FQ community.

It is my opinion, that the organization’s leadership publically supports WEGO Health, a company with ties to pharmaceutical companies that manufacture and sell both name brand and generic FQs.

It is my opinion, that the current volatile state of the leadership has left many community leaders, former ambassadors, and participants feeling alienated and disenfranchised.

It is my opinion, that the organization maintains relationships that are too closely aligned with several large law firms and could create unnecessary misconceptions and perceptions about credibility.

It is my opinion, that the organization, is running too autonomously and lacks constructive ways to objectively look at critical feedback both internally and from the community and institute the necessary checks and balances in a fair manner to present factually accurate data regarding FQs in the public arena.

Although I found many, many more areas that I believe are in need of critical attention, these examples highlight some of the major issues.

At a time when we as an FQ community continue to expand our public recognition it is important for all entities in our community to explore collaborative approaches that promote the community’s goals.

The QVF was to undergird that process by acting as an umbrella to coalesce FQ research to support the community. It is my opinion that the QVF has failed in areas of community cooperation, research partnerships and transparency. Unfortunately, I believe, that the QVF’s public appearance runs counter to its actual current state, especially in the main area of FQ research, something I am very intimately familiar with. Unfortunately I believe the QVF’s problems, especially in the area of research, are irreparable without drastic organizational change.

I recognize that there are many good people who support and have contributed to the organization. I want them all to know that my regretful decision is not politically motivated but is based on my opinion of the ability of the organization to complete its mission as originally intended. I would be willing to civilly discuss my opinions with anyone who wishes more information or clarification.

Therefore, while withdrawing support for the QVF, I do support other groups and the many hard working women and men in our community that are working to end FQ toxicity, and advocate for the thousands of victims worldwide. I stand ready and willing to work constructively and cooperatively with those other entities to continue to promote the communities’ goals through a variety of means.

[folieabeux]

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[comunidadquesera-blog]

"La ruta del queso" iniciada por l'Espai Ermengol

Esta mañana nos hemos topado con la agradable sorpresa de conocer la Nueva ruta del queso que ha propuesto l'Espai Ermengol durante el mes de julio.

Durante tres domingos (1, 15 y 29 de julio) se pueden visitar tres queserías artesanas de la comarca. 

La ruta de las tres empieza a las 10 de la mañana en el Espacio-Ermengol-Museo de la Ciudad de la Seu d'Urgell, dónde se visita la segunda planta dedicada al queso. A continuación, los participantes pueden ver un audiovisual informativo sobre la Cooperativa Cadí y pueden degustar productos de esta productora de queso y mantequilla con denominaciones de origen protegidas. La salida finaliza con una visita a una quesería artesana de la comarca del Alt Urgell, como Mas d'Eroles (Adrall), Serrat Gros (Ossera) y Baridà (Bar).   Esta nueva propuesta se enmarca en la programación de Las Rutas Guiadas en La Seu d'Urgell y comarca de la edición de este año con el objetivo de dar a conocer este producto agroalimentario de nuestro territorio y sus productores.