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.

2 thoughts on “Hers and Addyi in Action: Potentially Lax Screenings, Missing Warnings, and More

  1. “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.”

    ???

    “there are reports of Addyi being prescribed off-label for post-menopausal women, despite the FDA approval contra-indicating that use.”

    Yeah, I remember early on people predicting that that would happen… iirc the reason it’s contraindicated is because they just didn’t do as much testing on that population.

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