959 petitions

Update posted 4 hours ago

Petition to Ben Fisher, Jeffrey Shuren

Ensure Ethical and Balanced FDA Mesh Research

The role of mesh in pelvic prolapse surgery has been under critical debate.  Many surgeons rely on these devices to provide an efficient, effective cure for complex or recurrent prolapse, and to allow the option of preserving the uterus rather than requiring hysterectomy. Numerous studies, including NIH sponsored trials, have established that current mesh procedures, such as Uphold Lite, have an excellent safety profile. In order to more fully assess the mesh procedures currently available and relied upon by many surgeons, and ultimately ensure the best array of surgical options for present and future patients, the postmarket -522 studies were mandated by the FDA.   These studies were fully enrolled with great effort, expense, and with an ethical understanding that the 3-year assessment described in the study protocols would provide the key outcomes required to answer clinical questions and determine the best regulatory decisions. On 4/16/19, the FDA abruptly mandated removal of Uphold and other prolapse mesh, based on interim review of 1-year outcomes and with no safety issues triggering concern.  The undersigned physicians believe this action occurred primarily due to outside pressures having no relationship to the scientific evidence, and that these factors have ethically compromised the planned interpretation of the -522 trials. The undersigned physicians consider the proper conduct and interpretation of these studies to be a critical ethical commitment to the human subjects that have been enrolled.  The 2010 Institution of Medicine Consensus Report stated:  "It is never ethical to involve research participants in a ... study that does not have a reasonable prospect of answering the research question under study.  In the case of postmarking clinical trials required by the FDA, that ethical precept requires further specification and strengthening.  It is also critical that the clinical trial be designed to provide precisely the data needed to facilitate the policy decision that needs to be made, aiming to challenge and improve the understanding and treatment of disease." The undersigned have organized to formally petition the FDA to protect the ethics and intent of the -522 studies, and to ensure these challenging circumstances result in the best outcome, by reserving final regulatory determinations until the 3 year study period has been reached.  Additionally, we believe the FDA should include proper representation from practitioners in our specialty, and also consideration of highly relevant non-522 clinical trials that provide critical insight into these procedures and their importance in women's healthcare. 

Specialists in Urogynecology
2,618 supporters
Update posted 6 hours ago

Petition to Mark C. Montigny, Patricia A. Haddad, Michael O. Moore, Jason M. Lewis, Danielle W. Gregoire, Antonio F. D. Cabral, David Allen Robertson, Steven Ultrino, Patrick M. O'Connor, Michael J. Barrett, Rebecca L. Rausch, Walter F. Timilty, Sal N. Didomenico, Joan B. Lovely, James K. Hawkins, Maura Healey

Urgent!! Stop Massachusetts SD1840: A Clear and Present Threat to Energy Work

URGENT AND TIME SENSITIVE: Energy work is under threat by a new law, An Act regulating Bodyworks, which, if ratified, would require licensure for all energy workers (see non-inclusive list below). Massachusetts SD1840 (previously submitted as 2599 and SB2621), a bill currently under consideration in Massachusetts, would severely restrict anyone without an existing licensed to practice any form of Energy Work.The bill has made it out of committee and is ready to move to the floor for passage. SD1840 provides for significant expansion of scope and power of The Board of Registration of Massage Therapy. It also renames them to The Board of Registration of Massage Therapy and Bodyworks. Lines 38-47 of the Act states: “Bodywork, bodyworks or bodywork therapy, the practice of a person who uses touch, words or directed movement to deepen awareness of patterns of movement in the body, or the affectation of the human energy system or acupoints or Qi meridians of the human body while engaged within the scope of practice of a profession with established standards and ethics; provided, however, that such services shall not be designated or implied to be massage or massage therapy; provided further, that “bodywork”, “bodyworks” and “bodywork therapy” shall include, but not be limited to: the Feldenkrais Method; Reflexology; the Trager Approach; Ayurvedic Therapies; Rolf Structural Integration; Polarity or Polarity Therapy; Polarity Therapy Bodywork; Asian Bodywork Therapy that does not constitute massage as defined in this chapter;  Acupressure; Jin Shin Do; Qi Gong; Tui Na; Shiatsu; Body/Mind Centering; and Reiki.” To be clear, this Act would make the use of “words” a Bodywork modality. This might include guided meditation. This Act would also make someone who uses "directed movement" a Bodyworker. This might include the teaching of dynamic qigong, or another style of moving meditative/healing movements. Practitioners found in violation of this Act might be subject to prosecution, fines, penalties, and the restriction or elimination of their practice! Solution: Oppose Massachusetts SD1840 and protect the people’s right to practice and access Qigong, Energy Work, and other safe methods of spiritual work. Please sign and share this petition!  

Bernard Shannon
13,670 supporters
Update posted 21 hours ago

Petition to Facebook, Google, Inc, Evan Spiegel, Reddit, Twitter, Apple, Microsoft, Mark Zuckerberg, Tim Cook

Save Future Generations! Sign the Social Media Health and Safety Petition! #SMHSP

Summary: We don't know where technology will take us, but perhaps being more cognizant and actively protecting ourselves from what we don't want from technology, such as lower productivity and social media addiction, can allow us to secure a brighter future. We want to urge technology companies to come together and create a set of conventions, that dictate how social media and interactive applications should be made, to keep users healthy and safe.  Background:  From startup unicorns to modern day behemoths, the tech industry’s star companies have arguably become some of the most influential organizations in our history. The 21st century brought in Bill Gates as the new Hammurabi, Steve Jobs as the new Da Vinci, Elon Musk as the new Tesla, and Mark Zuckerberg as the new Ford. It is because of this influence that Project MNMS and the signers of this petition request an establishment of a set of industry-wide conventions regarding the health and safety of all users on social media and interactive applications.  The shift to the digital age has seen many reformations of societal thought; Project MNMS believes that it is time for another shift of thinking regarding health and safety before a gradual but total transition onto the digital ecosystem. Social media and other interactive technologies have a very addictive presence in our society. The signers of this petition believe that it is the responsibility of the bigger players in the technology industry to help curb this presence and perhaps improve technology's impact as a whole. As organizations with great influence, companies like Facebook, Snap, Google, Apple, Microsoft, Twitter, and Reddit hold millions of users data to understand shoppers preferences and measure advertisement engagement. This collection of data not only has strengthened the relationship between the general public and businesses, but it is a contractual agreement that the data these companies have, which is probably more than any governmental agency has ever had access to, is protected and that the users who provided it are kept safe. It is the idea that the users provide the industry with treasure troves of data, so why don’t companies within the industry encourage the development of a set of mental and physical health safety conventions within their products?  The petition in question focuses on mental and physical health issues regarding social media and interactive applications. Some Examples of issues include:   -Setting programmatic limitations on Screen Time    -Setting Ages of Limitations on smartphone/smart-device usage      -The use of planned obsolescence      -Setting Restrictions on the types of user incentives per platform (how do platforms use likes and upvotes/downvotes)    These topics are rarely talked about and are the fundamental issues behind the severe cases of buzzing pockets, the frantic urge to hide your self behind a screen, the alarming rise of social anxiety and depression. Social Media is addicting, no doubt about it. The same way tobacco uses nicotine, social media and interactive application algorithms use likes and user interactions to make their products more attractive and addictive.  It is important for businesses to acknowledge that their products are extremely addictive and that too much of anything is bad for you. Children are being exposed to these addictive technologies alarmingly early and therefore may not be able to take the world as it is and live through the volatile lenses of the digital world.   As with any new technology, we must consider the ethics behind its development or use. Therefore the signers of this petition urge companies such as Facebook, Snap, Google, Apple, Microsoft, Twitter, and Reddit to come together to develop industry wide health/safety conventions in order to recognize that their users are their most valuable assets and that it is their number one priority to protect their users from possible current and future threats.  The signers of this petition suggest the conventions resemble these general examples:  -Programmatically limit use time on social media applications (for example a max of 2.5 hours a day), excluding calling and texting and other non-addictive technology  -Prevent the use of smart-devices by any individual 5 years of age or less, the overuse of smartphones at this age, to perhaps watch tv or videos, can lead to an overdependence.  -Place stricter limitations on the use of smart-devices by individuals 5–13 years of age, many times children of this age group resort to messaging as their main form of communication, this can lead to a decrease in productivity and health benefits, as well as cause an overdependence on social media and interactive technologies  -Limit the use of planned obsolescence to non-essential functionalities, technologies such as calling, texting, and other essential technologies should be built to last.  -Develop far superior censorship technologies, regarding sensitive material  -The funding of research into the addictive nature of social media and research into increasing individual productivity and limiting distractions -The development of more integrative technologies, that focus on productivity and real world use, rather than function as a gateway into another reality -Further topics can be added to the conventions that prioritize user health safety regarding social media and interactive applications.  The world is in a precarious situation. It is our duty to make sure that we dictate what technology means to us and not the other way around. Project MNMS was created to start a discussion about how technology is affecting future generations negatively and how we can fix it. This is why this petition means so much to us, and why we think that the signers of this petition will bring change. By signing this petition you are not only bringing awareness to these issues, you are starting a discussion about where humanity belongs and where humanity is going to go. By signing this petition and bringing these problems to the front doors of some of the greatest organizations in the history of mankind, we will be asking for responsibility and for ethics. We will be the voice of reason for years to come.

Project MNMS (Modern Nightmares Modern Solutions)
110 supporters