Pfizer Takes Its Research DTC

Talk about eliminating the middle man. Pfizer is now conducting research on their bladder-drug Detrol directly with patients via the internet. (via Pharmalot and the WSJ)

Study participants are being recruited through Internet advertisements and directed to the study’s website, which explains the study and allows enrollment.

Patients who enroll in the study will be required to have blood drawn at a local clinic or during a home visit. Medications will be mailed to participants, something that’s rarely, if ever done in clinical trials. Patients will keep diaries using a mobile phone that has an application specifically designed to track symptoms of overactive bladder. Patients will fill out assessments on a secure website four times throughout the study.

A single study site medical team at UCSF will monitor the trial, which will replicate the original trial done for the drug, which is already FDA-approved

I could not find a copy of the study protocol or informed consent, so what follows is just my take from the study website…

From what I can tell, there will be no face to face contact with study subjects prior to enrollment, and I suppose, no physical examinations, except for subjects in California. I wonder how much work is going to be required of the patient’s own physician – release of records, physical exam, review of the study and approval of patient’s enrollment? And isn’t sending study drug to patients sort of like prescribing medication over the internet without the benefit of a doctor-patient relationship? Just asking – I’m no lawyer, but in general we tend to frown on this sort of thing in the medical circles I travel in…

Head on over to the study website yourself and check it out.  The study info video is more like a sales pitch than anything else, with a little cash registers ca-chinking noise every time a study survey is completed, and lots of fun cartoony things explaining the study logistics, making the whole thing look like a real blast and a fun way to make a little extra cash. Only at the very end of the three minute video do they tell you that you may end up getting placebo, and there is nothing of course, about the DRUG you’ll be taking, or it’s possible risks. To get that info, you’ll have to register, and live in a state where the study is being conducted. (I know because I tried to get a look at it, but apparently the study is not being done in New York State).

My Take as As an IRB member

I don’t think I would have approved that recruitment video. Too happy and cutesy, with statements like “You’re probably here because you have symptoms of overactive bladder syndrome, and you want to do something about it”  – implying treatment rather than research.

The study intro page states the study is about testing the efficacy of Detrol for reducing incontinence, but the video really has little about actually taking a drug, and more about the fun stuff that will happen over the internet.  There isn’t even a picture of a person actually taking a drug – everyone seems to be “receiving” a drug, but not “taking” anything. I swear, by the time I finished watching the video, the medication was the last thing I was thinking about.

Other statements that bothered me – “Lucky you – you’ll be getting three packages!” – implying that participating in the study will make you lucky, as opposed to having an adverse effect of the drug being studied (which would be unlucky…).

Then there is the introduction of the concept of informed consent  – “Sound intimidating? Don’t worry – it’s easier than it sounds!”.  “They’ll be  pop quiz at the end” and a cute pic of a teacher and an apple, as if signing the consent is being a good student, while not signing it means you’ve failed. Informed consent is the cornerstone of clinical research, even when it’s a study of a drug that is already FDA-approved. Let’s treat it with the seriousness it deserves.

The video does do a nice job explaining double-blinding, but not randomization, saying “there is a chance you’ll receive either study drug or a sugar pill”, but that’s not a chance, that’s the study. They also leave randomization to the end –  I would have put it earlier on in the video, since for many subjects, the chance of getting a placebo is a game changer.

I like that subjects have access to their study results, and, I assume, lab results along the way. Most studies allow this, but not with the kind of ease the internet provides.

Is this the End of the Multi-center Clinical Trial?

Centralizing the study team will no doubt save tons of money, move things along faster without having to clear dozens of institutions’ IRB and contracts offices, and give much desired consistency and control of the study’s conduct. I do find it hard to imagine some of the clinical trials out there being conducted without a local study doc to handle complications, physical exams, etc. So I expect that this model won’t translate very far in its entirely. But I do see this internet-based approach being used to substitute for a lot of what local study coordinators do, freeing up the study doc up to worry about what’s important – the patient.

I do worry, thought, that all this centralization could give too much control of research to a single site. In the case of this study, that site is located at a University which just partnered with Pfizer to the tune of $85 million. I’m not trying to imply anything about this study in particular, just using it as an example to note the potential for conflicts as the relationships between Pharma and Academic Medicine become cozier and cozier. (Pretty much every big center is partnering in a big way with Pharma these days…) Pfizer’s press release states that two institutions IRB’s approved the study, and that made me happy. Given the amounts of money changing hands now between Pharma and Academic Medical Centers, the use of independent IRB’s may become more important over time to avoid any concerns over conflicts in research.

Will Internet-based Research Expand Study Subject Populations?

Despite my reservations about the recruitment video, and the logistics of handling study complications, I think the idea of using the internet to facilitate research is an interesting one, and may expand the population of folks willing to participate in clinical trials. As medicine moves out of the office into the internet and into our patient’s homes, I see no reason why research should not follow. Just so long as we proceed with caution and safeguards.

One final thing

Kelsy, the NP on the the study (see her around 0:25 on the website video), reminds me of Pam from the Office. Uncanny…Especially when she talks. She seems really nice. So does the entire study team. I wish them the best on their project.

4 Responses to Pfizer Takes Its Research DTC

  1. Caveat emptor…

    You know, I am torn here. The legal requirements for pharma to interact with the healthcare community are so onerous anymore that I don’t blame Pfizer for getting around interacting with docs at all! Now, that’s not to say that the burden for ensuring safety to the patients is gone. They should properly inform and do so in a way that does not influence the patient.

    DTC is not new! I hear ads on the radio every day trying to recruit patients into a study. They don’t refer you to seeing your doc to get involved, they have the interested patient call the CRO who is arranging the study. How is it different? The radio ads usually sell fear since they don’t have the cutesie video to share, and likely have a smaller budget. Pfizer is instead, making it seem appealing. Just a different sales technique.

    Gain cash for the study? Also not new. I had fraternity brothers that sold blood plasma for $12/hour as often as possible! Did you hear about the teenager in China who sold a kidney for a video game?

    The fact that this is going DTC does not mean that the study is not completely up to snuff. This is just the recruitment side of things. My guess is the paper work to enroll is just as bad as if going through a clinic.

  2. Schrugglin’

    Was wondering when you would weight in. “Torn” is the operative word here, for both of us.

    DTC advertising and recruiting for studies is how it’s done, and using the internet for data collection is a great idea, and absolutely pay folks for participating. But there’s a way to present the study to them so it is non-coercive, genuine and not advertising. And never having a face to face or a physical exam takes the study doc so far out of the picture as to be just a figurehead. There’s a slippery slope here, and having Pharma leading the way down the hill just makes me a bit nervous.

    I don’t understand how one can prescribe a medication for a bladder problem without ever laying hands on the patient, unless they are relying on the patient’s own doc’s exam findings and office records, and then somehow engaging that person into the process (which may be what they are doing – as I said up there, I haven’t actually seen the study protocol…) The internet aspect of it which is cool, but actually not the study. The DRUG is the study, so let’s talk about that not how lucky you are to get three packages in the mail!

    Hello – throw down?….

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