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  • About
    • Why We Matter
    • Testimonials
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    • Contact Us
  • Tools & Resources
    • AD Core Toolkits >
      • Inclusivity Toolkit
      • Opioid Safety Toolkit
      • HIV Prevention Toolkit
      • E-Detailing Toolkit
      • Materials Toolkit
    • AD Literature Archives
  • Webinars
    • Webinar Series
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  • Blog & E-News
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The DETAILS BLOG

Capturing Stories from the Field: Reflections, Challenges, & Best Practices

We Saw This Coming, and Now It's Here

7/18/2017

3 Comments

 
Tags: Evidence-Based Medicine, Health Policy, Jerry Avorn, Medications

​Listen closely, and you’ll hear the other shoe dropping.

​For several years FDA has been besieged by litigation brought by drug makers and their supporters which argued that the agency’s limiting companies’ promotional claims violated those corporations’ First Amendment-protected rights to ‘commercial free speech.’

​Then the 21st Century Cures Act signed by still-President Obama in December of 2016 authorized FDA to consider less demanding standards in approving medications. 2017 began with a new administration vowing to free the pharmaceutical industry from the onerous regulatory burdens of the FDA. Now all these forces are coming together in a worrisome confluence of regulatory derangement.  
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​The House Energy and Commerce committee in mid-July held hearings on how best to implement the Congressionally mandated loosening of drug approval standards set forth in the “Cures” act. At the same time, the new FDA Commissioner has argued that FDA’s “public health mandate” should be met by relieving manufacturers of some of those troublesome requirements to demonstrate clinical benefit, in order to get drugs to the public more easily. ​At the same time, he noted, as FDA reduces the complexity and duration of the drug approval process, this speeding of new drugs onto the market will help contain their high prices.

Nevermind that FDA’s approval process is already the swiftest in the world, clocking in at a mere 6 months for priority decisions. 

And nevermind that the cost of the regulatory process accounts for only a small portion of medication prices.
​

And just ignore the fact that worrying about cost never has been part of that agency’s mandate. ​
Justifying the reduction of FDA’s regulatory standards to meet its “public health mandate” is a troubling Orwellian development that is likely to have exactly the opposite effect. It is eerily reminiscent of the notorious Vietnam-era claim by the military that a village “had to be destroyed in order to save it.”  Invoking FDA’s public health mission to justify approving drugs that have not been adequately shown to help patients is both bizarre and irrational.
These developments raise the ante for evidence-based prescribing in general, and for academic detailing in particular.  Most clinicians and health care systems are not yet aware that FDA approval may become an eroded imprimatur to guide medication decisions, and most people will continue to believe that pharmaceutical company claims have to pass muster with FDA for their accuracy, even as this becomes less and less true in the coming years.
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​Even if we cannot stop these disturbing developments, we must at least make sure that they are understood by our colleagues in medicine, so that academic detailing services – by definition rigorously evidence-based and non-commercial – can play an increasingly large role in informing prescribing decisions, as an antidote to these worrisome ongoing developments.

Share your thoughts in our discussion forum below.

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Biography. Jerry Avorn, MD,​ Co-Director, NaRCAD
Dr. Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics (DoPE) at Brigham & Women's Hospital. A general internist and drug epidemiologist,  he pioneered the concept of academic detailing and is recognized internationally as a leading expert on this topic and on optimal medication use.
​
Read more.

3 Comments
Rosale Mata
1/19/2023 05:38:55 pm

What a great joy in my heart to share this to the entire public on how Dr Osato cured me from herpes1&2 with his herbs, I never believe it will work because the doctors keep saying there is no cure but I was desperate and needed to get this thing out of my body. I saw a comment online testifying how Dr Osato cure her from herpes and hpv and i contact Dr Osato and explain my problem to him and he prepare the cure and send it to me through UPS,which i use it just the way He instructed me and thank God today am a beneficiary to these cure. I went to my doctor for a checkup after 14days of taking the herbs and I did a blood test which i tested Herpes1&2 Negative and my doctor booked me for another appointment after 4 weeks to confirm my result and i retested again after 4 weeks and my result was still Negative and my doctor assured me that the virus is completely gone from my system. So I will tell you all who are looking for a cure to his/her HIV/AIDS and HERPES that Dr Osato took research before he could finally get the solution to it and a lot of people are benefiting from him right now. He also cured my Uncle and his wife from HPV. Dr Osato heals with natural herbs. Please i urge you to contact him now through his email address: osatoherbalcure@gmail.com or WhatsApp him on +2347051705853. His website is osatoherbalcure.wordpress.com and he is capable of curing HIV/AIDS, HERPES, HPV, HSV1&2, COLD SORE, CANCER of all kinds,DIABETES and so many other infections.

Reply
Amparo Parnell
1/27/2023 07:11:43 am

ATTENTION PLEASE!!! Am so glad to be expressing my profound gratitude to a man that is so concerned about other people's well being. I was suffering from (HERPES SIMPLEX VIRUS TYPE II) The doctors keep telling me that there is no cure but i believe that there is a cure somewhere and they don't want people to get cured. I tried searching online if i could see anything that will help me and i a comment on YouTube on how Dr Osato help to cure herpes with herbs and i also saw so many comments about him on many web pages on how he had helped and cured so many people suffering from HERPES 1$2, HPV, CANCER, HIV/AIDS, COLD SORE, DIABETES. So I contacted him through his email and I shared my problems with him and he sent me the herbs through UPS and gave me instructions on how to use it. It took me two weeks to finish the herbs and after I finished using it, he told me to go for a medical test, behold the result was Negative, now I am HERPES VIRUS free. I just want to use this platform to thank Dr. Osato for curing me from that horrible virus and also for exposing his herbal cure to the world at large, please you can as well contact Dr Osato on his email,website or WhatsApp below.....

Email: osatoherbalcure@gmail.com
Website: http://osatoherbalcure.wordpress.com
WhatsApp: +2347051705853

Dr Osato herbs is the perfect remedy for Herpes1&2, HPV, HIV, DIABETES, Penis Enlargement and other diseases. 

Reply
Ruth Cholay
2/2/2023 05:39:25 am

I'm here to let everyone know that there is a cure for HERPES1&2. The doctors have succeeded in letting people living with Herpes know that there is no cure for Herpes and they have been enslaved to the antiviral and other supplementary Orthodox medicine just to help suppress the virus and not a cure. I got diagnose of herpes1&2 and i did not believe in my doctor that no cure for herpes rather i went into research online and I was introduce to Dr Osato a herbal healer by a blogger who also narrated Her story online on how she was cured of Herpes after using Dr Osato Herbal Medicine. I got the herbal medicine from Dr Osato and made use of it as I was instructed. I went to the clinic for a checkup after two weeks of using the herbal product. My result came out Negative and I was booked for another appointment after 30days to confirm my result and the test still showed Negative and I was given the green light that I am fully free from herpes. All thanks to God for using this Great herbalist to heal me. You can contact Dr Osato by email: osatoherbalcure@gmail.com or WhatsApp +2347051705853. His website is osatoherbalcure.wordpress.com. I have promised to keep sharing my testimony, so people will know that there is a cure for herpes. 

Reply



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