Naked Medicine

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Category: Open Healthcare

Dream and Nightmare of Web-Scale Pharmacovigilance

I’m not going to tap into fear-mongering of why Microsoft is involved in the study that pulls adverse event (side effect) data from the internet, but I’m wondering what’s taken people so long to figure out the vast pool of patient experiences available online. Oh wait, those of us involved in industry know about this, only we don’t want to know about it.

There is at least one valid reason: you need to have a full picture of what is involved behind a side effect, to say with some level of confidence that your reported side effect experience came from the drug you said you took, not the other drugs you’re conveniently not saying you’re taking (especially the not-so-legal kind), or that you have a drinking habit (alcohol has major interactions with every drug under the sun), or that you’re taking 20 supplements you got from the nutritional store, and some prescription med you got off the internet by some shady doctor who asked you a few questions before writing you the Rx…

But reality check. Web-scale pharmacovigilance is here, and needs to be here, and should be leveraged conscientiously and systematically.

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Some years ago I gave a talk at a DTC conference in New Jersey about the patients’ voice when it comes to safety information. I am not in the business of web-based pharmacovigilance, nor did I set out to collect this information, but patients started sharing their personal experiences with an antidepressant on my mental health website. Yes, there are paroxetine/Paxil-related reports, but for the most part patients talk about bupropion/Wellbutrin, and over the span of many years there are hundreds of patient reports that are consistent in terms of their side effect experience.

This all started with one reader asking a question about a particular side effect of bupropion, and whether there were any published studies about a particular side effect. I’m sure there are scores of data from the manufacturer, but like much of drug data, these are kept “proprietary” with the ever-present “data on file” label on clinical slide presentations that the manufacturer supplies to a well-selected public (doctors).

Industry shouldn’t fear it or revile it: pharmacovigilance is critical for gathering drug information over time as part of safety monitoring, and the FDA sucks at making this an easy task for anyone with the desire to report adverse events with bureaucracy.

Read NYT’s take on web-scale adverse event reporting and drug safety monitoring.

Female Sexual Dysfunction: Pharma’s Next Lifestyle Market

I’m posting this from one of Steve Woodruff’s blog posts that I shared via my Facebook profile, which turned into a full blown debate between me, Dmitriy Kruglyak, and Yvette – one of my FB friends.

Jane Chin
I’m pro-pharma, but I’m NOT happy w/ female sexual dysfunction disease mongering I expect to see from pharmacos! http://ow.ly/4xQH

Dmitriy Kruglyak at 8:18am April 30
Where do you draw the line between “disease mongering” and “disease awareness”?

Jane Chin at 8:21am April 30
When the ‘awareness” generated makes patients who otherwise are not candidates for the drug pressure docs to write the Rx.

Dmitriy Kruglyak at 8:23am April 30
Ah, but who gets to decide “who are the candidates” and what qualifies as “pressure”? Especially if we are talking DTC, rather than Rx. Are there hard and fast rules?

Jane Chin at 8:25am April 30
that’s why I don’t think DTC is responsible for niche diseases. Pressure=if you don’t write it, I’ll go to another doctor who will.

Dmitriy Kruglyak at 8:27am April 30
Hmmm, seems to me “if you don’t write it, I’ll go to another doctor who will” can come from any kind of patient empowerment, not just driven by Rx advertising.

Jane Chin at 8:28am April 30
Yes it can, but true patient empowerment IS NOT “take this pill, fix your problem” when the problem is not always solved by “a” pill.

Dmitriy Kruglyak at 8:47am April 30
Patients just want to do what they want to do. People have, are and will always look for quick fixes. That’s human nature.

Jane Chin at 8:51am April 30
I know this is human nature, and one capitalized by advertising. But where health and human life are concerned, the ethical standards should be higher.

Dmitriy Kruglyak at 8:53am April 30
Seems to me advertising is simply fulfilling demand

Jane Chin at 9:02am April 30
No, advertising is meant to CREATE demand. Even better when advertising increases the market from perception-based v. needs-based demand. (more…)

Google Healthcare Ads and False Claims

Jeanne Sather has written a longer response to my post on Google Coop for Health. Instead of leaving it as a “comment” I’ve decided to post it here as an article, because she has raised an important issue about Google Ads, which this site uses. By the way I’d love to use blogads, if I can get an invite from someone, because I’ve written them several times and haven’t heard a peep from the admins.

Google has a lot to answer for in the ads that it runs on the Web. The company has been very irresponsible in carrying ads for products that are nothing more than snake oil. (more…)

New Google Co-Op for Health

Google has created clusters of online discussion format called Co-ops.

The Co-op is about “sharing expertise” (source: Google Co-Op website), I assume from whoever feel they have expertise to share. A Google employee posted general criteria about what posts would be stricken from a Co-op group:

  • The posting of commercial advertisements or other promotional material
  • Spamming/excessive multi-posting
  • Chain letters
  • Binary (non-text) postings
  • Forgery of another user’s identity

(Source: Thread ID c603a0b6578b735a)

Currently,”significant contributors” to Google Co-Op’s Health topic National Library of Medicine, Centers for Disease Control and Prevention, Health On The Net Foundation, Harvard Medical School, Mayo Clinic, University of California San Francisco, and Kaiser Permanente. (more…)

What Open Medicine Is and Is Not

A benefit – and side effect – of Internet culture is an embrace toward access and openness. I can access an abundance of free information on the web. I’ve always embraced open source applications, like the one used to create this website, and will continue to do so as long as it’s available.

However, a potential misconception called “Open Medicine” is a side effect of the Internet culture. I do not believe most people who advocate for “Open Medicine” on the web actually understand what “Open Medicine” really means, and all the ramifications and responsibilities that come with the term. When most speak of “Open Medicine” they refer to the idea that medical information should be freely available, transparent, and credible.

I don’t argue with the concept of making healthcare information available, transparent, and credible. After all, I created www.NakedMedicine.com to provide Accessibility, Honesty, and Integrity in healthcare information.

What I oppose is the misconception built around Open Medicine. In my opinion, here is what Open Medicine is NOT:

Open Medicine is not a blogging network, even if the blogging network is composed of a team of doctors, nurses, scientists, other healthcare “experts”, or anyone who has a burning desire to voice an opinion about a particular healthcare trend or drug.

In considering what Open Medicine really is, we only need to look at the basic definition of “Open” as it relates to this Internet phenomenon:

The basic idea behind open source is very simple: When programmers can read, redistribute, and modify the source code for a piece of software, the software evolves. People improve it, people adapt it, people fix bugs. And this can happen at a speed that, if one is used to the slow pace of conventional software development, seems astonishing. Source: Open Source Initiative.

In other words, Open Medicine can work only when we are allowing access to what is considered proprietary information or intellectual property, for the expressed purpose to enable collaboration to improve and innovate upon this “open” information. (more…)

Affordable Healthcare Dilemma

By Faiz Kermani

Healthcare can be an emotionally charged subject. Therefore, it comes as little surprise that most governments around the world struggle to implement a healthcare policy that is acceptable to all.

A growing component of healthcare expenditure is spending on pharmaceuticals, and this feature of medical care has received considerable attention.

Complex issues
Providing healthcare is expensive and requires ongoing investment. Governments have become alarmed at how much they must spend as their populations grow, and as demand for the newest medicines increases.

pills2.gif Furthermore, the rising elderly population and falling birth rates place a great strain on funding for public healthcare. As the elderly population grows, the number of potential workers whose tax contributions can help support their care will decline1.

The Organization for Economic Co-operation and Development (OECD), has warned that many countries are underestimating the future impact that such factors will have on healthcare spending. In a 2001 study OECD revealed that the over-65 age group accounted for 40-50% of healthcare spending and that their per-capita healthcare costs were three to five times higher than those under 652. (more…)

Public Access to Articles on Antidepressant Safety

Journal of Child and Adolescent Psychopharmacology is a peer-reviewed journal published by Mary Ann Liebert, Inc. The February/April issue (Volume 16, 2006) explored the controversial topic of using selective serotonin reuptake inhibitors, or SSRIs to treat depression in children and teens.

Peer Review: Peer review of a scientific publication is considered a rigorous process that makes a published scientific study a credible source of information. A panel of the researcher’s “peers” assess the submitted publication for scientific merit and objectivity.

This topic has been controversial because of the debate around safety and effectiveness of this class of drugs for what is considered a vulnerable population. Based on the potential impact of this controversy, the publisher has made this double issue free for viewing.

View: http://www.liebertonline.com/toc/cap/16/1-2

pills.gif The association between treating teens and children with SSRI drugs and an increased risk of suicide has made this a highly public controversy – including a past episode of Law & Order on television.

This journal is clearly aimed for healthcare professionals, researchers, and industry consultants. The publisher of the journal is a privately held media company that also publishes other magazines in biomedical research and biotechnology.

If readers are particularly interested in a specific article, I will be happy to help decipher it for you.

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