Hers and Addyi in Action: Potentially Lax Screenings, Missing Warnings, and More

While I decided that testing if I would get Addyi prescribed to me by Hers was maybe not a good idea, it looks like reporters at the New York Times did test out the service! (and a few others like it), and well….they have a lot of concerns about the whole business model (not just it’s embrace of addyi).

You can find the full article here: “Drug Sites Upend Doctor-Patient Relations: ‘It’s Restaurant-Menu Medicine’ “

In particular, there were concerns about Hers’ Addyi in particular, and how important warnings about Addyi and Alcohol were deemphasized:

One drug, Addyi, which can cause fainting if taken with alcohol, arrived without the necessary safety warning protocols created by the drug’s manufacturer.

…..

A week or two after reporters were approved for prescriptions, the medications arrived in discreet packages.

A shipment of the Addyi libido pills, from Postmeds, a pharmacy based in Hayward, Calif., came with a colorful “usage guide.” “It’s time to get busy,” the guide said.

The Hers questionnaire, as well as an online message from the doctor, had explicitly warned about fainting risks that can arise from taking the drugs with alcohol. But the usage guide made no mention of it. That potential danger was included only in the required F.D.A. information insert printed in a tiny typeface.

Pharmacists dispensing Addyi “must counsel all patients on the need to avoid alcohol” with every prescription, according to protocols created by Sprout Pharmaceuticals, the drug’s manufacturer.

Instead, the pills came with a card providing a phone number for a “drug consultation” with Postmeds.

“The idea here is that there must be an added layer of professional counseling,” said Ned Milenkovich, a pharmacist and lawyer with the firm Much Shelist in Chicago.

Cindy Eckert, Sprout’s chief executive, referred questions to Hers and the pharmacies it uses. Hers referred questions to Postmeds. Umar Afridi, Postmeds’ chief executive, said the required medical insert contained the alcohol warning, satisfying the counseling requirements.

In addition, reporters and other interviewed who ordered viagra from Hims reported concerns about the lack of thorough questions and identification from the supposed medical professionals that the service connected them to.  (Hims is owned by the same company and operates in a similar manner to Hers, the company that supplies Addyi via similar methods).

Some states specifically prohibit doctors from relying solely on online questionnaires to prescribe drugs to new patients. Hims, Kick and Roman said their processes were interactive and should not be considered questionnaires.

In Ohio, state regulators said doctors must — at a minimum — communicate with patients in real time, through audio or video, to meet their standards.

But Spence Bailey of Columbus, Ohio, said he had never spoken to a doctor by phone or on video when ordering hair loss medication from Hims, communicating only through the site’s messaging system.

He said he was satisfied, but canceled his monthly subscription because it was too expensive.

Hims said it complied with state medical board rules.

On some sites, it can be unclear who is reviewing consumers’ health data and prescribing the drugs.

A reporter in California who requested generic Viagra through Roman received a message from a doctor, including his name and a link to a page listing his medical school, qualifications and state licenses.

But a different reporter in California, who requested generic Viagra through Hims, received a message without a doctor’s name.

After being asked about the interaction by a Times reporter, the company said it had changed its software to require doctors to include their medical credentials on such messages.


 

Also, in other news: while it’s still anecdotal at this point and thus should be evaluated with a grain of salt, there are reports of Addyi being prescribed off-label for post-menopausal women, despite the FDA approval contra-indicating that use.

I took a look and there have been two official trials by Valeant in post menopausal women – well, more like one and a half, since the second was stopped halfway after funding was pulled for reasons I am curious about but can’t find (maybe related to Valeant’s financial troubles?). Both seemed to show similarly limited efficacy and health concerns to the original research.  (Note that despite the abstracts touting proof of efficacy, the actual effects were minimal and by some measures not even statistically significant). It’s not clear whether Sprout is still actively pursuing this route after re-taking rights to the drug from Valeant, but it’s something to keep an eye on – as well as other possible off label uses.

On the Horizon: Bremelanotide and AMAG Pharmaceuticals

After delving back into the wonderfully frustrating and misinformation-filled world of HSDD medications, it looks like it’s not just Addyi that has new updates. It’s also probably a good time to start keeping a closer eye on Bremelanotide  / Vyleesi, a new proposed treatment for HSDD from AMAG Pharmaceuticals.

Unlike Addyi, Bremelanotide is designed to be used only as needed, about 90 min prior to sex. It’s currently being developed to be injected subcutaneously, after other methods showed too many side effects, in particular with worries about low blood pressure. Other common side effects were nausea, flushing, and headaches, which are sure to put you in the mood!

I haven’t had a chance to dig into the proposed method of action, but news articles seem to indicate that it’s neurological, and attempts to balance inhibitory vs. excitatory process in the brain.

It looks like it’s been submitted for new drug consideration by the FDA with an original expected approval announcement in March 2019, but is likely being delayed after the FDA requested more data on side effects.

They’ve also already set up their own website about HSDD as well at unblush.com. It even has it’s own quiz!

I’ve only spent like 20 minutes looking at it so far because I really need to pace myself with these, but here’s a few first impressions:

  1. If you indicate no recent drop in desire in the first question of the quiz, it cuts you off and lets you know that if there’s no decrease, it’s probably not HSDD – which is more than the addyi site is willing to do, so there’s that at least?
  2. On the other hand, if you indicate that your desire has decreased “maybe a little”, but in the questions about negative impact you only mark “I’m afraid my partner will cheat on or break up with me”….it tells you that’s “relationship impact”, a sign of HSDD.
  3. Also, this quiz is like a buzfeed quiz, it’s weirdly full of reaction images and gifs
  4. Both this and some of the ancillary materials for Addyi mention the Decreased Sexual Desire Screener (DSDS), so that’s something I probably want to look into more when I can.
  5. Overall, it’s still manipulative / kinda misleading, but doesn’t seem to be quite as pushy as the addyi site overall – but on the other hand they may just be biding their time because they don’t actually have a drug they can legally push yet.

 

Update: FDA updates labeling requirements on Addyi/Flibanserin, and new [horrible] Addyi Marketing Campaign

This post has two parts – updated labeling requirements from the FDA last month and a new marketing campaign from Sprout Phamraceuticals  (thanks to redbeardace for flagging it!)

I’m going to address the FDA changes first because I’ve had more time to read up on it, but I think the latter is going to be a bigger concern for ace activists moving forward.

Part 1: FDA Recommends Labeling Changes for Addyi

I missed this earlier, but apparently the FDA released updated labeling requirements for Addyi/Flibanserin last month:

https://www.fda.gov/news-events/press-announcements/fda-orders-important-safety-labeling-changes-addyi

I’ve only had a chance to skim it for now, but it looks like they are downgrading the original warning (which stated that women should not drink alcohol at all while using the drug) to a statement that women should avoid alcohol within a few hours of taking the pill, but may not need to avoid it entirely:

Based on the results of postmarketing studies, the FDA has determined that changes must be made to Addyi’s labeling to clarify that there is still a concern about consuming alcohol close in time to taking Addyi but that it does not have to be avoided completely. Specifically, the boxed warning, contraindication, warnings and precautions, and adverse reactions sections of labeling are being updated to reflect that women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime.

The FDA is ordering a safety labeling change requiring Sprout to make these changes because the agency was not able to reach an agreement with the company, which was continuing to request removal of the boxed warning and contraindication about alcohol completely from the product labeling. The FDA determined, based on a careful review of available data, that removing this important safety information was not acceptable for the protection of public health.

These changes were based on the results of two additional post-market studies of Addyi/Flibanserin, whcih sprout had requested, as well as additional lobbying from Sprout Pharmaceuticals (which sells Addyi) which wanted to remove alcohol warnings entirely. The FDA’s April 11 post stated:

In the FDA-required postmarketing trial in women who took Addyi and drank alcohol at the same time, there were missing or delayed measurements for blood pressure from when the women were first laying down to when they stood up that are critical in determining the risk of hypotension and syncope when taking Addyi and alcohol together. The FDA’s specific concerns with the trial included:

  • While there were no reports of syncope or hypotension needing intervention amongst women in the trial, the safety precautions built into this trial did not allow for an adequate assessment of this risk. For example, women with low blood pressure while lying down or with symptoms that could be related to low blood pressure (such as dizziness) were not permitted to stand up to have blood pressure measurements taken or had to have repeated blood pressure measurements while lying down until they were high enough for the women to safely stand up. As a result, the data collected had missing or delayed blood pressure measurements from these women while standing.
  • Many more women had missing or delayed blood pressure measurements when they took Addyi and alcohol together compared to when they received alcohol alone or Addyi alone.
  • The amount of missing blood pressure measurements peaked around the time when Addyi’s blood levels were highest in those taking Addyi with alcohol.

The pattern of the missing or delayed measurements provides further evidence of an interaction between Addyi and alcohol that can increase the risk of hypotension and syncope. Given these results, the FDA has determined that the boxed warning and contraindication continue to be warranted. Women at home will not have the safety measures that were included in this trial or necessarily have access to immediate assistance if they were to experience severe hypotension or syncope, which can lead to serious outcomes including falls, accidents and bodily harm.

Part 2: New marketing campaign from Sprout Pharmaceuticals

Addyi has launched a new “Right to Desire” campaign website [content warning: I strongly recommend not taking any medical advice or trusting any claims from this new site.].

This CNN Health article discusses the campaign in more depth and has some initial criticism.

It features a quiz that you can take, which I’m especially worried about based on what they did the last time they decided to have a quiz as part of the very misleading “Find My Spark” campaign.

I’m still looking into the new campaign and will probably need to make another post to actually evaluate it, but I’m like 3 questions into the quiz and we’re already off to a pretty bad start – despite the first questions at least allowing me to state that I have no sex drive* and no problem with that, Addyi doesn’t want to let me think of it as anything except a problem:

Addyi.PNG

It also still uses “HSDD” as their label for the low desire that they are trying to treat, despite the fact that as of the DSM 5 (released in ~2013), low desire is categorized as [M]HSDD only in men, and low desire in women is referred to as FSIAD or “Female Sexual Interest/Arousal Disorder”. Addyi is only marketed to and approved for women. (props to David Jay for pointing that out to me).

Also, I’m still mad that they decided to use purple for this. Adding insult to injury much?


*Technically I do personally consider myself to have a sex drive / libido, just not towards other people, but I don’t think that’s what Addyi’s asking about and I also wanted to see how it treats the many aces who really don’t have anything along those lines.

Addyi/Flibanserin mini-update

I haven’t had the time or energy to keep up as much as I’d like with developments with flibanserin/addyi (yay burnout!), but I was curious and decided to do a quick little search today – looks like the horrible “find my spark” promotion is gone now at least!

Unfortunately, it has since been approved in Canada, and without strong prohibitions against drinking alcohol – despite the fact that combining alcohol and flibanserin is known to cause dangerous side effects.

After valeant got sued for giving up on it, Addyi/Flibanserin rights have returned to a reborn Sprout, the company that originally launched the drug before being bought by valeant.

Their new site is only somewhat misleading instead of very misleading, but it’s also really ugly. It also worryingly (and perhaps dangerously) encourages women to bypass their usual physician to speak to a sprout-recommended telemedicine provider. As the Hastings center asks,

“Are the doctors on this telemedicine portal really going to counsel patients adequately and explore other options for addressing low libido (such as identifying whether the symptom is a side effect of a libido-killing medication or recommending sex therapy) or are they only going to prescribe Addyi?

The telemedicine portal is a way for Sprout to sell the drug directly to a patient without involving her possibly reluctant personal physician….“

Also, you’know, consider the fact that low libido itself often isn’t even a problem in need of treatment at all?

I worry that aces and others who may have a low libido or sexual desire for whatever reason might receive poor guidance from any medical professional not already familiar with them and their concerns, especially one who is being promoted (and perhaps directly or indirectly compensated?) by Sprout itself.  (On top of all the concerns that aces have with even regular medical practitioners.

(I’m tempted to submit a fake request or two just to see what they would tell me, but I need to think a bit about the risks/legality involved with that first and also I think there’s a ~$50 charge at some point in the process.)

There’s also this suspicious new marketing campaign, which could use more looking into.

SF Human Rights Commission report on “Alternative Families”

Some more interesting reading on the topic of the kinds of legal protections that QPs and other non-romantic partners may desire to seek out – there’s a lot to learn here from pre-existing LGBT activism around alternative families. One document that I consider a good read on the topic is the 2009 forum on “Alternative Families” by the SF Human Rights Commission:

Not all close human relationships fit into the mold of parent, child, sibling, or spouse. Many LGBT people, former foster or emancipated youth, seniors, and people from all walks of life are estranged from their biological relatives or have no surviving family. They have no spouse and rely on the protection of alternative families without the legal protection of blood relatives. These people are more than friends and they are not lovers. They are as brothers and sisters or adults with senior mentors, and they often become caregivers when illness and infirmity strikes, but have no legal standing in hospitals, employer benefits, or in the legal line of consanguinity.

Family law mechanisms focus on spousal and parental relationships through marriage, divorce, adoption, and the emancipation of minors. However, there is no easy way to convey a legal standing between friends similar to the family rights of siblings or non-spousal domestic partnerships. There are no simple legal mechanisms to aid in the formation of caregiving cooperatives for the purpose of including the quality of care for a single ill, disabled, or single person.

Of particular interest may be Section IV: Legislative Proposals (p. 35), which proposes possible legislative solutions that could give more caregiving protections to non-blood related, non-spousal relationships.

On a state level, their suggestions include:

  • State Caregiving cooperatives, in which rather than having a single designated caregiver (which is a role not all individuals may feel able to take on alone), a group of individuals could share a contract to act as caregivers, with rights and responsibilities such as hospital visitation, ability to discuss confidential health information, ability to act as a proxy desision maker, etc. (Power of medical attorney would still rest with a single individual for practical reasons)
  • State Designated Benefeciary registries, in which any two adults not in a marriage or domestic partnership could register with the state as designated benefeciaries, and also choose which specific benefits to include (examples include inheriting property, visitation rights, insurance beneficiaries, having the right to sue in the event of wrongful death, and more. Unlike standard marriages or even domestic partnerships, partners would not need to be in a romantic relationship and could pick and choose which benefits to include, rather than an all-or-none package option. Colorado already has an examples of such a law!
  • State Declarations of Kinship, in which an individual could register another such that they would have the same family law rights as a blood brother or sister (rather than being based on spousal or domestic partner rights) – similar in procedure to the state designated beneficiary registry above, but with a somewhat more limited package of available rights.
  • Expanding domestic parterships to eliminate intimacy requirements and make then available to opposite-sex parterns as well (note – this was proposed in 2009, before marriage equality became the law nationwide)States should remove [romantic] intimacy and same-sex requirements such that the only requirement would be that the partners are in a “committed relationship of mutual caring”

Failing that, their recommendations for steps that local (i.e. city or county) governments could take include:

  • More limited local declarations of kinship and domestic partnership expansions to non-romantic partners. While local governments have much less control over family law rights than states, they could mandate expansions to some things like visitation rights at hospitals within their jurisdiction and expansion of local benefits programs, like the SF Sick Leave Ordinance that I posted about a couple weeks ago.
  • Family Law Contracting Centers, which would give residents centralized access to legal advice, standard contract language, notarization, and other resources to help them take advantage of the few benefits (like power of attorney) that are already available. Even though local governments can’t change state family law provisions, they can help fund programs that will make residents more informed and more able to access existing provisions.
  • Designated advocates for educational decisions on behalf of a minor, which (if passed at a school district level) would allow parents and legal guardians to designated additional trusted adults, who would be able to pick small children up from school, attend parent-teacher hearings, etc.

Other suggestions which are floated but not discussed in depth include:

  • The right for adults to to “disown” other adult biological family members and revoke their kinship rights
  • Co-parenting and methods for granting full parental rights to more than two people

A Designated Person

“Per the San Francisco Paid Sick Leave Ordinance, employees that work in SF may use paid sick leave when they or a member of their family are ill or injured for the purpose of receiving medical care, treatment, or diagnosis. Family member is defined as child, parent, legal guardian or ward, sibling, grandparent, grandchild, and spouse or registered domestic partner under any state or local law. In addition, if any employee has no spouse, or registered domestic partner, he or she may designate one person for whom the employee may use paid sick leave to provide aid or care. If you would like to designate an additional person, you may sign this form and provide the designated person’s name.”

I was filling out some forms for work recently when I was reminded of the above section of the SF Paid Sick Leave Ordinance, which is a feature that I actually really like – the fact that this expands benefits not just to the typical family and married/romantic partner, but to literally anyone you choose to designate, regardless of relationship. (It would be even better if it could make this an option even for those who do have spouses or allow multiple designated persons, although I can see why they haven’t done so).

While there has been a general trend in some benefits programs to extend benefits to not just married but also unmarried partners, these tend to remain couched in terms associated with romantic relationships. What I like about this particular language in SF  -that I don’t see often elsewhere – is that it is very deliberately neutral about what relationship a person could have with said “designated person”.

It also reflects the “designated person” relationship narrative that I’ve encountered in aro communities (though unfortunately I can’t remember who I first heard it from), in which two (o more!) people might make a commitment to care for each other and prioritize the other person in their life – to be, for example, the “designated emergency contact” on those emergency forms, or the person you designate to take you home from the hospital when you’re drugged up after surgery, or the person you designate to make medical decisions for you if you’re incapacitated.

For many people, being a  “designated person” is just one of many elements of a standard relationship, alongside other things like co-parenting and romantic intimacy and sharing finances and living together. But there’s no reason it can’t be a form of relationship in it’s own right – it’s quite possible to have a “designated person” type relationship with someone without necessarily having any of those other common relationship elements that were just mentioned. A designated person could be a QPP, a romantic partner, a relative, a roommate, a trusted friend – whoever you feel comfortable making that commitment with. It also doesn’t necessarily need to be a symmetrical approach: the person you designate may have a different person who they choose to trust with that responsibility, and that’s perfectly fine. And the person you designate for one type of responsibility may not be the same as who you designate for something else.

Also, while this type of relationship approach may be particularly appealing to many aro people who may never have a spouse or romantic partner to list as their designated person, they are hardly the only ones for whom it is useful. For instance, in the example I mentioned above, I believe that that the addition of that language was likely heavily influenced by the experiences of San Francisco’s LGBT community during the AIDS crisis, as well as the experiences of LGBT elders now as they deal with aging and end-of-life care decisions. For many LGBT people during the AIDS crisis, they had lost touch with or could not trust their birth family and may not have any children; those who had romantic partners had no way of getting legal recognition for them, and many others did not necessarily have a designated romantic partner. As a result, many of the kinship and caregiving relationship that people formed were not based on blood relation or marriage – but they struggled to have these relationships recognized by hospitals who would deny access, employers who would deny leave, etc, just as many ace and aro people struggle to have their alternative relationships acknowledged now.

Because of this, this is an issue where I see a lot of opportunities for ace and aro communities to join with general LGBT organizationsto pursue shared goals.

Ace Competent Healthcare Resources

As some of you may have seen in my recent tumblr post, I’ve been working on developing a masterpost of ace healthcare related resources or writings that I could pass around as a reference for aces or allies interested in learning more about ace healthcare issues (for example, I was originally working on this for an LGBTQ health conference I was checking out, in case anyone I chatted up there might be interested in reading more). RFAS already has some great link posts for mental healthcare (that were a big inspiration for this!), but I was looking for something that covers physical healthcare as well.

Thanks to the help of everyone who responded to that post, I now have a working draft of a resources guide put together here.

It’s still not completely comprehensive (I really need to add more links to stuff about Addyi/Flibanserin and FSD, for example, and it’s heavier on mental healthcare than physical healthcare) but it’s decent enough that I’m starting to pass it on to people who express interest in working together to learn about ace healthcare issues, until a better alternative arises.

It’s also not at all polished or and not all the links have been thoroughly vetted, but it should hold until a more developed resource can be created. It’s designed as a living digital document, so it is constantly in a state of being revised and updated – so if you have feedback on how to make it better, I am always open to hear it!

If you are interested in ace healthcare, feel free to take a look now, and feel free to pass it on to anyone you know who might find it useful.

Drug Watch: New Addyi Marketing Campaign, “Find My Spark”

So for those of you who remember Addyi (aka Flibanserin, the anti-HSDD drug that went through a lot of controversy over it’s FDA approval and has been warily watched by the ace community), the company that produces it (Valeant) has launched a marketing campaign called “find my spark” (associated website is here).

The drugmaker also announced it would re-launch its sexual dysfunction pill Addyi. Separately, Valeant announced a new campaign, Find My Spark, that was developed in tandem with the American Sexual Health Association.

Valeant acquired Addyi in its buyout of Sprout Pharmaceuticals in 2015 for $1 billion. Addyi received FDA approval the same month as a treatment for hypoactive sexual disorder in premenopausal women.

The campaign’s website, findmyspark.com, offers a sex health quiz and talking tips for patients to discuss hypoactive sexual disorder with their doctor but does not specifically mention the drug. Valeant plans to kick off the re-launch of Addyi in March, according to its earnings presentation.

This is definitely something that the ace community should keep an eye on.

The site doesn’t sell Addyi specifically, but rather encourages women to talk to their doctors about FSD (female sexual dysfunction, the salesy term for HSDD, FSIAD, lubrication  or vaginal pain problems, and related sexual disorders that all get lumped together regardless of whether the etiology is at all similar) – which if anything is probably more concerning for us in the ace community. This big push is likely in response to the lackluster sales of Addyi so far (because, you know, it’s expensive, barely effective, and the problems it “treats” are half made up), and the fact that the FDA’s limits on early marketing have now long expired.

I haven’t had a chance to take  deep dive into the site’s contents yet, but at first glance it’s not encouraging.
Example: literally the first quote on their personal stories page is

“I wanted to want sex because my husband is very sexual and we had had a great sex life when we were younger.”

And if you’re thinking “well, it could be worse” the second quote is:

“I have an amazing husband, three incredible children and a wonderful life. The only thing missing: I never wanted to have sex…we had sex, usually a couple of times a week. And while I did it, part of me dreaded it. Every time.”

They also have a “my sexual health” quiz, and 95% of the results ended with the captcha code not working (bad web design?) or other technical glitches, but on the two that went through, one suggested that I probably did not have FSD, but one did. I’ll try to play around and see if I can figure out what responses trigger what suggestions. notably, it sends you to the “learn more about FSD” page no matter what answer you pick.

Result

Don’t hold us to this, but based on your score it seems likely that you don’t have a female sexual dysfunction (FSD or female sexual difficulty). Of course, only a licensed sex therapist or healthcare provider can tell you for certain. In the meantime, learn more about FSD.

Result

Excuse our bedside manner, but based on your results, something may be bothering you. Only a licensed sex therapist or healthcare provider can tell you what though. In the meantime, learn more about female sexual dysfunction (FSD or female sexual difficulties).

(These are the two answers I was able to see – not sure if there are additional options or not)

That actual “learn more” page is *slightly* better – it at least includes semi-acknowledgments like “There are some who are satisfied just getting their cuddle on”, but there’s still an overall theme of “sex is great! Everyone likes sex (at least a little)! And if you don’t, we can fix that!” that makes those comments a little too late.

The FAQ does include the question, “If I don’t want sex, is there something wrong with me?” to which the answer is:

Every woman’s libido is different. Some women keep their libido and some women experience dips as they age. Also, the stress of daily life, relationship issues, and hormonal changes as a result of menopause can impact your libido.

While it could have been worse (the lowest bar of all to pass), they rather conspicuosly don’t have anything that actually indicates “having low libido doesn’t necessarily mean something is wrong with you”. And of course, no acknowledgment of asexuality anywhere, but tbh I am less surprised by that – I don’t have high expectations from this group.

(on a side note, I am also a bit miffed that they seemed to be going for a black/purple/white color scheme. Like, really?)

I’ll try to post some more thorough commentary once I get a chance to explore things a bit more, but in the meantime, if anyone else has thoughts I’d love to hear about it in the comments.