Disease mongering

Le thé vert est loué pour ses bienfaits supposés sur la santé, voire pour prévenir le cancer. Mais aucune étude ne permet de montrer de telles propriétés.Le thé est la deuxième boisson la plus consommée dans le monde, après l'eau. Dans certains pays, sa consommation est un art de vivre faisant l'objet d'un cérémonial très codifié.Devenue un produit tendance chez les jeunes, cette boisson fait désormais l'objet d'une intense promotion de ses bienfaits présumés pour la santé et le bien-être (promesses de propriétés « détox », de drainage, etc.). Dans le cas du thé vert, de supposées propriétés « anticancer » sont également mises en avant. Qu'en est-il réellement ?

 

 

Infographie. Le Consortium international des journalistes d’investigation (ICIJ) a constitué une base de données des incidents survenus entre 2009 et 2017 aux Etats-Unis : en tête, les pompes à insuline.

Via Lionel Reichardt / le Pharmageek

Most patients will derive no health improvement from medication. We should tackle the root causes of disease instead

When former airline pilot Tony Royle came to see me last year to seek reassurance that it was OK to participate in an Ironman event, having stopped all his medications 18 months after suffering a heart attack, I was initially a little alarmed.

But after talking to him, I realised he had made an informed decision to stop the medication after suffering side effects, and instead had opted for a diet and lifestyle approach to manage his heart disease.

His case is a great example of how evidence-based medicine should be practised. This is the integration of clinical expertise, the best available evidence and – most importantly – taking patients’ preferences and values into consideration.

Via Lionel Reichardt / le Pharmageek

Most patient and consumer advocacy groups receive funds from the pharmaceutical industry, according to a new study released by the group PharmedOut.

 

Only a handful out of 7,685 health advocacy groups in the U.S. are completely independent of pharmaceutical industry money, according to a list the group released Oct. 13. PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates health-care professionals about pharmaceutical marketing practices.

 

And industry funding of patient groups, including websites and informational materials, is often not apparent to the average consumer, which could mislead consumers into believing they’re getting unbiased health advice.

 

“Industry funding is often not disclosed on websites or informational materials or is hidden,” PharmedOut Director Adriane Fugh-Berman told me in an Oct. 16 phone call. Funding and sponsorship is often very subtle and difficult to identify, she said.

 

In addition, she said, industry sponsorship can affect the stands patient and consumer groups are willing to take, she said.

 

Groups that accept industry funding are affected by that money, regardless of whether they think they are, she said.

 

"Look at the stands taken and not taken,” she said. “For example, where is the anger and outrage about drug costs?”

 

Fugh-Berman is an associate professor in the Department of Pharmacology and Physiology and in the Department of Family Medicine at Georgetown University Medical Center.

 

Further Reading:

• “Pharma 'Patient Centricity' Aids & Abets the Opioid Epidemic”; http://sco.lt/5RJse1

•  “93% of Patient Advocacy Groups Included in FDA Funding Discussions Receive $ from Pharma”; http://sco.lt/8jkvFh

• “Patient Advocacy Groups with Funding & Form Letter from @PhRMA Oppose Nevada Legislation”; http://sco.lt/6QlP9N
• “More Than Two-thirds of Patient Advocacy Groups Receive Industry Funding”; http://sco.lt/6Ftgzh

Via Pharma Guy, Giuseppe Fattori

Pharmaceutical companies can use social media to engage and educate patients as well as to provide reliable information about their products. But how do companies tap social media without running afoul of the Food and Drug Administration (FDA) and various regulatory requirements? To find out, I asked Colleen Tracy James, a partner in Mayer Brown’s New York office, where she is a member of the firm’s intellectual property practice and life sciences group.

Belbey: What are the challenges facing pharmaceutical firms when using social media?

James: The internet is the wild wild West. We are still figuring out how to maneuver and make sure information is reliable and trustworthy. This is especially important when it comes to pharmaceutical products because it impacts our health and well-being. Pharmaceutical companies face a lot of challenges on social media, such as how to handle incomplete and misinformation about their products. We all remember the famous Kim Kardashian Instagram post where she touted the benefit of a drug that treats morning sickness, but she did not disclose any of the side effects. According to the FDA Guidance, when you use social media, you need to include the ‘good, bad and the ugly' about your product. Your social media posts need to be fair and balanced.

Belbey: How can pharmaceutical companies control the message and the information?

James: One way to control the message is to create what the industry calls a “controlled environment” such as creating a company webpage for a drug or disease. In this way, firms can make sure information is accurate and complete. That keeps them in line with the FDA regulations. That’s very different from third party information, where the company does not have control over how its product are discussed.

Belbey: Can firms use controlled environments and social media to correct misinformation?

James: Yes. If patients are talking to each other and sharing a misconception of your product, you may want to, as a company, respond to that. You may decide to allow certain employees in the corporation to engage with potential consumers on social media and to answer questions. Or you could provide a chat room as part of your own platform. In that case, your obligation to correct misinformation may be heightened because now you have control of that website.

Belbey: How can pharmaceutical firms use Twitter?

James: Twitter is one of the areas where we’ve seen some specific guidance from the FDA. Due to its character limitations, the FDA is concerned that if you don’t have enough space, you can’t provide a fair and balanced (benefits and downsides) view of your drug. Pharmaceutical companies face serious penalties by the FDA if they don’t make the proper disclosures --  something that pharmaceutical companies want to avoid. If you are responsible for disseminating misinformation about your drug, and the wrong person takes it because he or she wasn’t aware of the contraindications or the side effects, the pharmaceutical companies open themselves up for liability. In short, pharmaceutical companies must be careful not to mislead consumers on Twitter.

Belbey: Given that there are real risks associated with not complying with advertising rules and regulations, how should firms move forward safely?

James: Pharmaceutical firms should develop clear and decisive social media advertising policies. First, they need to figure out which platforms they will use, how they will control their messages, whether they’re going to allow chat rooms, and how to manage comments from patients who want a dialog. If interactivity is permitted, companies need to clearly define which employees may interact with consumers, patients and doctors on social media.

The firm also needs a content strategy, so that responses are in compliance with what the FDA has approved the pharmaceutical company may say about their product. You also may need a team of legal advisers to confirm that content about your product is okay to put on social media. Pharmaceutical companies must be careful that employees don’t provide people with wrong information when responding on social media. For example, you can’t say, “This medication is for a headache but you can also take it for something else that’s not a headache.” That would be a violation, historically speaking, as firms are not allowed to market their drugs’ off-label uses or mention off-label uses. And finally, I also suggest that companies have a compliance officer tasked with making sure there’s a policy in place and it’s being complied with and updated with evolving FDA guidance.

Since the FDA was created, we’ve gone from radio to TV and to now social media. Just like the past when industry adapted to new forms of communications, pharmaceutical companies are now figuring out how to advertise and communicate using the latest media within the regulatory framework.

Contributor’s notes: For more information, read “5 Social Media Pitfalls In The Pharmaceutical Industry” by Henniger Bullock and Colleen Tracy James, Mayer Brown LLP. https://www.mayerbrown.com/files/News/29b609ec-4b5a-4ce3-950c-04026ef73f85/Presentation/NewsAttachment/39dca070-2b87-49a6-b03a-04e8e6f9bafc/5SocialMediaPitfallsInThePharmaceuticalIndustry.pdf

Here is guidance from the FDA pertaining to advertising and social media for your convenience:

Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Draft Jan 2017): https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537130.pdf

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers (Draft 2017): https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537347.pdf

FDA Draft Guidance for Industry Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014): https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm401079.pdf

FDA Draft Guidance for Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (June 2014): https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm401079.pdf

Fulfilling Regulatory Requirements for Postmarking Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (Draft Jan 2014): https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm381352.pdf

Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (December 2011): https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf

This blog appeared previously on Forbes.

Via Plus91

 

“Patient advocacy” groups have a unique power on Capitol Hill. They claim to represent the true voice of constituents, untainted by special interest bias. Politicians and the Food and Drug Administration use their endorsements as reflective of genuine public support.

 

But a new study shows that nearly all of these patient advocacy groups are captured by the drug industry.

 

David Hilzenrath at the Project on Government Oversight (POGO) reports that at least 39 of 42 patient advocacy groups who participated in discussions with the FDA over agency review processes for prescription drugs received funding from pharmaceutical companies. And at least 15 have representatives of drug or biotechnology companies on their governing boards.

 

The study is particularly notable now because Congress is poised to pass the 21st Century Cures Act, which trades temporary additional funding for the National Institutes of Health and the FDA for permanent weakening of the FDA’s approval process. Over 1,400 lobbyists have been working on this bill, which would be a major financial boon to the drug and medical device industries.

 

Patient advocacy groups have factored heavily into the lobbying effort. According to an analysis from research group Avalere in December 2014, 43 percent of public comments on the House version of the bill were from patient advocacy groups.

 

But those groups are not necessarily independent, POGO warns.

 

For instance, the National Health Council, a group that calls itself “The United Patient Voice” and has advocated before the FDA for faster drug approvals, includes on its board of directors leaders of the two main trade groups for the drug industry — Pharmaceutical Research and Manufacturers of America (PhRMA), and Biotechnology Innovation Organization (BIO) – along with executives from drug companies Sanofi, Johnson & Johnson, and Alkermes. PhRMA gave the National Health Council $1.2 million in 2014; in all, 77 percent of its funding came from the pharmaceutical and biotech industries, according to POGO. Its “Policy Action Team” also has a PhMRA representative on it, along with an employee of Johnson & Johnson.

 

Further Reading:

• “Pharma Turning Patients With Rare Diseases Into D.C. Lobbyists”; http://sco.lt/6wBAp7
• “PhRMA Deploys Scientists & Patients as Lobbyists on Capitol Hill”; http://sco.lt/5xer57
• “How a #pharma Funded ‘Grassroots’ Patient Advocacy Campaign Changed FDA's Approval Process”; http://sco.lt/4tqlbF
• “Pharma Lines Up Patient Groups to Fight for PDUFA Boondoggle”; http://sco.lt/6o27VZ

Via Pharma Guy