(Revised March 14, 2016)
WELCOME to the West Seattle Democratic Women’s website
…We’re always updating so come back often…
SEE MEETINGS PAGE FOR DETAIL ON MARCH 24TH’S MEETING.
MARK YOUR CALENDAR FOR APRIL’S UW 2016 HUMAN TRAFFICKING CONFERENCE – SUPPLY CHAINS, HUMAN RIGHTS & HEALTH —
Co-sponsored by WSDW
IT’S WONDERFUL NEWS….
From Vice Chair Rachel, (Also note Chair Ann’s comment below this email regarding related events happening later this month.)
WOW!! This is so exciting–thought I’d share the great news with you : D
I am sure some of you may have already heard about this, and for me and those of you who worked directly on this campaign, this news will be extra thrilling! We are now one step closer to helping to bring about the ultimate demise of the absolutely evil Citizens United decision! Hurrah, hurrah!
From: WAmend / I-735 <firstname.lastname@example.org>
Sent: Sun, Jan 3, 2016 1:49 pm
Subject: WE DID IT!
The fact that 335,000 signatures have been submitted in a timely fashion to the Secretary of State is important; however, of equal importance is that the Secretary of State by the end of this month will qualify the initiative by reviewing the signatures to insure they are authentic. This week I, as WSDW’s representative, will meet with the WAmends Steering Committeeto to talk about what’s going to happen this year. After the initiative is qualified and the Steering Committee meets, I’ll be giving everyone an update as to what’s coming. I’m looking forward to sharing with you with I’ve learned. Should be very very exciting. Lot’s to do as well!
GENERAL MEMBERSHIP MEETING INFORMATION
Meetings are typically a luncheon the 4th Thursday of the Month @ the West Seattle Golf Course banquet room. (Evening meetings occur quarterly.) An "open to all" discussion group proceeds the luncheon from 10:30 - 11:15 am. Registration is from 11:30 - 11:45 am and the meal is served at 11:45 am. Our program begins at 12:00 - 12:45 pm followed with a short business meeting and a For the Good of the Order ending at 1:00 pm.
The cost is $13.50 for members, $15 for non members OR $5 for attending the program......Coffee, tea, and dessert are included.
JANUARY’S MESSAGE FROM OUR CHAIR
Well, we’ve made it to the infamous 2016! Happy New Year! Now let’s get to work electing a president, senate, governor, and others who will work for social and environmental equity, address the climate crisis, protect women’s rights, lead responsible regulation and access to guns, reform our prison system, reduce the stranglehold of student loan debt, protect voter access to the ballot, fix our crumbling infrastructure, repair our immigration system and generally lead this country to a better place than where we are right now.
The West Seattle Democratic Women will bring insightful, informative programming to our community this year. We will examine the caucus/convention cycle so that you can better understand how to participate and take an active role in selection and election of our presidential nominee. Other programs will focus on specific issues as we invite expert speakers to help us understand in greater depth issues like climate change and how we can take action to tackle problems in our community.
To quote anthropologist Margaret Mead, “Never believe that a few caring people can’t change the world. For, indeed, that’s all who ever have.” Make it your New Year’s resolution to join us as we work to change the world!
Ann Martin, Chair
OF SPECIAL INTEREST —
WSDW'S 2015-2016 WSDW officers Chair: Ann Martin Vice Chair: Rachel Glass Secretary: Roberta Reed Treasurer: Mary Fisher Parliamentarian: Elizabeth Heath
CUDOS TO WSDW’S MEMBER LISA PLYMATE:
December 02, 2015, 01:00 pm
Deregulating the FDA: Back to thalidomide?
By Eileen Cronin, Ph.D. and Lisa Plymate, M.D.
The 21st Century Cures Act, which sailed through the House and is now in the Senate, calls into question the FDA’s current regulatory process. Its supporters claim the FDA process prevents innovation in pharmaceutical products. As someone injured by thalidomide in 1960, I (Cronin) am concerned that we’ll go too far in weakening the FDA approval process. My co-author (Plymate) has similar concerns. As a prescriber she may lose trust in the label “FDA approved.” Together we explored the history of the FDA as an agency, its purpose, why its regulations were instituted, and what could happen if we went back in time.
One of the greatest tragedies of the last century was the use of thalidomide during the Baby Boom. Its German developer, Grunenthal, and its U.S. distributor, Richardson-Merrell, touted thalidomide’s ability to soothe nerves, quash morning sickness, and thwart miscarriages. Richardson-Merrell executives forged a paper to market the drug as the “first safe sleeping pill” for pregnant women. Their “clinical trials” included 2.5 million tablets distributed to 20,000 U.S. patients in an uncontrolled fashion. Negative data from these trials were not reported, including infant mortality and birth defects. After pregnant women such as my mother were given this drug, many of their offspring were described as “monsters” with “flipper-like” arms and legs. I was born without lower legs and with missing fingers. Around the world, 10,000 babies were born with birth defects.
The U.S. tragedy was reduced by the FDA analyst, Dr. Frances Oldham Kelsey. Alarmed by the lack of scientific research to support thalidomide’s safety and despite pressure from the drug companies, she delayed approval, demanding more evidence. How many infants were affected in the U.S.? We will ever know, but after it was discovered that thalidomide caused major defects, the drug never received FDA approval.
Thus began a new era for the FDA. In 1962, Congress enacted laws setting up our modern FDA. The scientific and medical communities advocated that the FDA require “substantial evidence with effective data from adequate and well-controlled clinical trials” before giving its stamp of approval.
Now, some say the FDA process is too slow, keeping valuable products from patients who need them, even though the FDA has greatly sped up its process. It approves most drugs in 6-10 months, as fast as any other country. Today over 50 percent of approved drugs are fast-tracked through accelerated pathways. This year the FDA approved a record 89 percent of applications for new drugs. On top of that, the agency is in the process of streamlining its “compassionate use” pathways, allowing patients access to drugs still in investigational stages. It will soon take a physician only 45 minutes to complete such a request, and the FDA approves 97 percent of these requests. To us, this already looks more like a “rubber stamp” than a “bottleneck.”
To speed up the FDA further, the House version of the bill would mean physicians could no longer rely on “FDA approval” to ensure that antibiotics and other drugs or medical devices have been adequately tested for safety or effectiveness. The 21st Century Cures allows drugs to be approved if they are simply shown to be “non-inferior” to existing standard drugs. Medical providers need to know new drugs are “superior” to those already available, otherwise why prescribe them? But drugs could be approved based on information from test tubes, animal studies, or simply mathematical modeling. Devices might get through based on evidence from case studies or clinical experience, not aggregate data. Drafters of the bill would have us believe careful follow-up after approval would be an effective way to avoid large-scale disasters, yet the bill specifies no mechanism for the FDA to do so.
As a person injured by thalidomide, I can tell you that the FDA has never conducted a survey to locate victims. The Wikipedia estimate of 17 people injured in the U.S. is based on false data given to the FDA by Richardson-Merrell. But ask most people of my generation if they knew of someone who was missing digits or limbs, and they will reply affirmatively. We could be returning to a time in which physicians had little way of knowing if their prescriptions would help or harm their patients. We do not want the safety pendulum to swing to the extent that another thalidomide is released on the market.
Looking at the patient groups supporting 21st Century Cures, we should be able to say, “We should be leading the world in coming up with new treatments for your unmet medical needs.” We need to do that by strongly supporting innovative, scientific research through the NIH. Congress should save and strengthen the part of the bill which expands NIH funding. Let us, however, remove those sections of the bill that would allow more unsafe, ineffective drugs to be released without adequate testing.
Cronin, a practicing psychologist in Los Angeles, is the author of Mermaid: A Memoir of Resilience (W.W. Norton, 2014), which was chosen as one of The Best Memoirs of the Year by O Magazine. She won the Washington Writing Prize in Short Fiction, and her essays and stories have appeared in the Washington Post, the Huffington Post, the Daily Beast, and she’s had a Notable Essay in Best American Essays.
Plymate is an internist/geriatrician in Seattle and serves as co-chair of the National Physicians Alliance FDA task force. She has no financial or lobbyist relation to this topic