October 2017


Style Credit

Expand Cut Tags

No cut tags

November 12th, 2016

rthstewart: (Default)
Saturday, November 12th, 2016 12:17 pm
I regret to say that my experience with the bigotry, misogyny, and homophobia of the last few years prepared me for the US election results.  I found despair and disillusionment, and experienced the power of those voices, several years ago and so expected this result though I so wished to be wrong.  The only good news in this is that  this has meant my shock is not as acute because I've already been there for a while and, in my privilege, am not at risk.  Still, there has been a lot of stress baking, Corgi petting, and avoidance for the better part of 6 months.  So, I am so sorry that I've not responded to you and thank you so much for reaching out to me.  It will take awhile to get through 200+ emails and reviews on this account, never mind the dozens of unread stories.  But going forward, please understand that I can be here for you if you need it. 

So, watch this space.  I did a long blather cross-posted here on why I do not believe that women and families will lose altogether access to Plan B, drug-based contraceptives, and the pills that induce medical abortions because the process to remove FDA-approved drugs from the market when the manufacturer doesn't want to remove the product is very difficult and long.  In other words, I think for the time being, you can cross off your list, "stockpile Plan B."  That comment was long and blathery and I am not familiar with the processes by which medical devices are removed from the market, like IUDs and some implants, so I'll update with something concise soon.

When I was trying to comfort someone at 3 AM on Wednesday morning, I told him how important it was that he continue his creative efforts to tell others about the works of fiction that he enjoyed and found hopeful.  We need that more than ever, I told him, and don't let despair stop you.

I recognize in this a call to create in our fiction the world we want to live in.  The reason I returned to fandom in 2009 was that I thought we were on the cusp of creating that world in RL.  Alas, this is not true.  A quote I used in TSG attributed to Gandhi was "Be the change you wish to see in the world."**    And so, for me, it will become "write the world you wish to see."     

(**BUT, lots of people aren't ready for that call and commitment and may never be.  No pressure, OK?  This HURTS and is scary.  Grieve as you must and take your own damned time about it.)

rthstewart: (Default)
Saturday, November 12th, 2016 09:08 pm

Edited below with a good link and some additional thoughts-
After seeing the burgeoning worry regarding continued availability of access to contraceptives in this new climate, I wanted to offer some words that I started here but with the concern, thought I should expand and clarify.

Will I be able to get contraception? I know what Mike Pence did in Indiana. Will the pill be outlawed? Condoms? What do I do?
  • Get good information
Information about contraceptives medical abortions here, and here and here,

Planned Parenthood
Here, and here.

Manufacturer websites for particular products are very good for information (and regulated) and may have coupons and patient payment assistance information, for example

  • So what contraception are we worried about?
Drugs (implants, BC pills, Sponge, etc.) and medical devices (IUDs, cervical cap, condoms)
All these products are regulated by the FDA in the Center for Drugs, and the Center for Devices
  • What are we worried will happen? And my short answers
                   *Loss of coverage or I won't be able to afford what I use now because I'll lose my coverage (Yes, worry and act now)
                   *The products I use now will be made illegal (No, I don't think this will happen)
                   *I won't be able to buy the products I'm using because I won't be able to find them (This is potentially a concern and there are solutions.)

  • What you should do now if you are in danger of loss of health coverage.
There’ve been lots of posts about how women worried about losing healthcare coverage should contact their providers about getting a Long Acting Reversible Contraceptives (LARC) like an IUD or an implant. Yes, absolutely, do this if it’s right for you. If you’re on ACA or you work for an employer that might decide it doesn’t want to cover your pills, and you’re worried about affordability, yeah, get in and do this right now. Get as much as you can before your copays or deductibles go up or if you think your coverage might disappear.
  • Should I be worried they’ll be gone, like Elaine and the sponge?

[A digression about the sponge.] )

I don’t think you need to stockpile Plan B, condoms, a year’s supply of BC pills, or get an IUD because you are worried the new Pence administration will remove these products from the market. I believe these products will continue to be available. This has to do with a couple of things. TL, DR
  • TL,DR about why I think already approved products you can use now will likely stay that way
First, these products are all regulated by the FDA and once they are approved, it’s really, really hard to get them off the market if the manufacturer wants to keep selling them.

Some over the counter, non-prescription drugs (like Benadryl or acne medicine) can go onto the market because of some regulations. But every other drug has to be approved by FDA’s Center for Drug Evaluation and Research in a new drug application (NDA) for brand drugs and abbreviated new drug application (ANDA) for generic drugs. To get that NDA or ANDA approval, a pharmaceutical company has to, among conduct a lot of clinical research showing the product is safe and effective for the condition it’s supposed to treat or prevent. This takes many years and millions of dollars usually.

Medical devices are divided into Classes (more about that here) and the more invasive, sophisticated ones, like IUDs, go through a process similar to the NDA, called a PMA. Products like condoms, logically, don’t have as many legal requirements though they need a “clearance” from FDA which isn’t as difficult or expensive; they are cheaper to make and it’s easier for a company to get into the business of selling them, so it can be pretty competitive.

Key takeaway:  It’s so difficult and expensive and takes so long to get an NDA, ANDA or PMA approved by FDA, it is really, really hard for FDA to forcibly remove the product from the market if the manufacturer wants to keep selling it. It takes years and hardly ever happens. Like, hardly ever. It may not have ever happened for a PMA medical device and has only happened once for a drug – there are two others ongoing now -- over 40+ more years.
  • But, couldn't a BC Pill or IUD manufacturer decide to cave to political pressure?
Theoretically, yes, but not likely, again for several reasons. First, drug and device manufacturers make money selling their products and they’ve been in the reproductive space a long time. Moreover, they are represented by a very, very powerful and wealthy lobby that pay millions to congressmen and senators to make life easier for them. An easier time for them means a well-funded FDA to get their products approved quickly and to keep the agency off their backs once they are on the market. They don't pay Congressmen to ban their FDA-approved products that they make money on.

And even with political pressure, some of them actually really believe in what they are doing, or at any rate, that they'll make money at it. For example, with Plan B  the manufacturer fought for years, with both the Bush and Obama administrations, to get its NDA approved and it took a court case before it was finally available to switch and make the product available to women of all ages over the counter. The makers of condoms have been there for generations and I don’t see them stopping even if Mike Pence believes they don’t work.
  • But FDA could cave to political pressure.
And, a word about FDA. It is a science-based public health agency. And while some people come and go, and yes, some Commissioners and HHS Secretaries (HHS oversees FDA) are wretched, and priorities change, the essential mission of FDA and the people in it don’t. As one woman I know at the agency said this week, “I’ve been there 28 years and I’m not going anywhere.” The current head of the Center for Drugs, Dr. Woodcock, has been there since the 90s -- products like the Pill, the implant, and Plan B all were improved or developed and approved while she's been there. FDA is pharmacists, doctors, and scientists.

What all this means is that if Mike Pence or a Congressional committee tries to tell FDA that it should ban birth control pills because drug companies are lying and they are really abortifacients that make tiny dead babies fill women’s wombs, or that condoms don’t work -- and FDA's gotten this crap for YEARS -- the congress critter will eventually get a polite response from an FDA official saying, “With all due respect, sir, the clinical data developed over years of patient use do not support that conclusion” and the pharmaceutical company will quietly pay large sums of money to congressional committee chairmen to make the problem go away.
  • What should I worry about?
Lots of things, of course. In the area of reproductive health, no new products, decreased innovation, no easier access for already approved contraceptives, like making BC pills available without a prescription. While companies will zealously defend their right to make money by selling you as much of their products as they can, I would not expect any to embark upon new contraceptive research for the US market. However, due to the climate, the US has lagged behind the rest of the world for decades, so this will be more of the same. (The medical abortion pill manufacturer has an unlisted phone number and a PO Box).

Things at FDA in the reproductive health area may go slowly. Maybe the office of women’s health will have to disband. FDA may have to respond to lots of stupid congressional requests for information and petitions or even lawsuits by abortion opponents urging them to remove drugs, restrict products, etc. I don’t see FDA moving from its determinations that these products were safe and effective for their intended contraceptive use but it will distract and delay FDA.
  • Investigate your pharmacy access now
I’m worried about pharmacies who will invoke conscience clauses to stop carrying contraceptives. This won’t be a problem if you are in a city or suburb and have a car and access to a chain pharmacy or big retailer like Walmart or Costco (if you can afford a Costco membership, their prescription drug programs and pricing are terrific). But if your local, independent or rural pharmacy only carries Plan B or contraceptives now because your state law requires it, I think we’ll see more pharmacies refusing in the future and they'll get support they didn't have before. So, get educated about what’s up in your state. This is a start, though dated.

States may also try to put products like condoms or Plan B behind the counter, making it harder to get these products.

If you think Plan B or condoms are something you’re worried you won’t be able to get in a hurry when you need them, by all means get a package or two and keep it on hand, paying attention to expiration dates.  But you don't need to stockpile IMO.
  • If I can’t buy drugs or medical devices from my pharmacy, I can just buy it on the internet, right? And I heard I can get the medical abortion pill on the internet.

Stop. Many major pharmacy chains and retailers have reputable, US-based online pharmacies. The ONLY safe online pharmacies are in the VIPPS program HERE.
Do not assume that because it comes from Canada, it’s the same. It probably isn’t.

If it doesn’t come from a VIPPS pharmacy, there’s a high chance that the product is counterfeit. Certain internet drugs are almost certainly counterfeit. Unlike other parts of the world, we have very little counterfeit product in the US and when we do it comes from 2 places mostly -- people buy it from online fake foreign pharmacies or a hospital or pharmacy buys from a shady supplier because they can make money on the amount they purchased it for and the amount they get reimbursed by the health plan or government payor.

If you do buy something and it doesn’t look right or seem right, contact the manufacturer or FDA. They won't try to throw you in jail.  FDA and the manufacturer are worried about you and unsafe product hurting people, not looking to report you.

I know this is all really scary. I’m scared too. I’ll be glad to answer questions. And if I got anything wrong, do correct me.

First, there's a great comment below by a pharmacist about expiration dating of drugs.  The plan B my helpful pharmacy tech at the grocery store got from behind the counter for me to examine (it's for theft deterrent, unfortunately) showed a nice long expiration date of 01/2020.  I'm very confident that pressure to make FDA restrict or withdraw approval of these already approved products is not likely to succeed.  But, what about the blunt approach, Congress or a State legislature outright bans methods of birth control, like Plan B or BC pills.  Could that happen?  I'm thinking about it and will post after I do some research.  I'm not aware of any instance where a product, lawfully approved by a Federal agency, was banned by a State or by Congress.  Even tobacco and liquor remain available for sale, and those are known to have health effects and have never been approved by a US public health agency.  Marijuana is a bad example because it remains illegal under federal law and international treaty.  There are a number of issues here and I'll think about it.