T. J. Kuhn | GxP Zone

Good Practice for the Pharmaceutical Industry from the Quality Assurance Perspective

Archive for October, 2008

Ignorance on the Placebo Effect

Posted by tjkuhn on October 17, 2008

I was reading some blog posts over at Wellsphere when I saw the following thoughts on the placebo effect from Seth Roberts

What Should Double-Blind Placebo-Controlled Trials Be Replaced With?

For a sick person, which is worse?

1. Getting better for the wrong reason.

2. Wasting a lot of money.

It sounds like a joke — #1 isn’t even harmful, whereas the cost of health care is a very serious problem. Yet the FDA and legislators with FDA oversight have been given this choice — and chosen #1. They have chosen to protect us against #1 but not #2.

If you get better from a placebo effect, that’s the wrong reason. How dare you! The requirement that drugs be better than placebo controls prevents this from happening. The requirement might have been — but isn’t — that a new drug be better than pre-existing alternatives. Many aren’t but they are always more expensive — not to mention more risky.

Now Seth has a Ph.D. in psychology, blogs on science-related topics, and seems like a smart enough guy, but his post is a bit misguided.

1) The reason that drugs are required to perform better than a placebo is because the placebo effect tends to only occur in a small set of patients. That is that the mental makeup of a specific patient is the cause of a placebo response (irregardless of the treatment). It is also not clear whether a placebo respondee is “actually getting better”. It is just as likely that they were not actually sick in the first place (or as sick as they thought).

2) Those patients who are not predisposed toward exhibiting placebo responses need to be given an actual effective treatment to “get better” and therefore deserve medications that exhibit “better than placebo” characteristics. Giving such a sick patient a sham treatment (rather than one that can actually work) can be very harmful in that the person’s condition can actually worsen.

3) There is a requirement from FDA (and regulatory agencies worldwide) that new drugs be as good or better than existing medications; or that they provide some sort of unique benefit (or reduced risk).

4) The expense of new medications is largely due to the high cost of research to make those medications (and fund future research). The low-hanging fruit is largely gone.



Posted in Bioethics, drugs, Economics, General Science, Health Care, Healthcare, Pharma, Pharmaceuticals, Safety, tjkuhn | Tagged: , , , | 2 Comments »

SQA Abstract – Clinical eData

Posted by tjkuhn on October 16, 2008

I’ve submitted an abstract for the Society of Quality Assurance conference this April (right at the Oct 14th deadline). I should hear back by the end of November. I’m not sure if it will be accepted as a full session or as a single presentation (or at all really), but I’m pretty excited about it. I’ll be giving a similar presentation internally at Celgene as part of ongoing training that our group provides, so a lot of the work for it is already done.

The Impact of Electronic Systems and eData on Clinical Research

Although the use of electronic data in the pharmaceutical industry is by no means a new phenomenon, its impact has evolved over time. Technology has revolutionized our lives in many ways; in the way we access information, in our entertainment, in the way we do business, and in the way we interact. This technological revolution has had very pronounced impacts on the GxP industries: eRecords, eData, eSignatures, Data Processing, Data Mining and the Regulatory Standards associated with them.

These impacts have been most apparent in the cGMP and GLP areas and there is a fair level of comfort with eData and Validation in those areas. Increasingly however, the impact of eData and the need for controls around its use can be seen in the GCP area. Due to its large reliance on external sources of data, Clinical Research has some unique challenges. This session will cover:

I. Technology in Pharma and Validation Overview: a discussion of these concepts (which are widely felt to be cGMP artifacts) and relating them to the GCP area through analogies.

II. Centralized GCP Technology: The use of centralized eData and eSystems, primarily on the “sponsor side” has some unique challenges due to very short timelines and the external nature of clinical data inputs. Also the challenges of study-specific validation activities will be addressed

III. De-Centralized GCP Technology – “Technology at the Clinic”: Source data at clinical sites varies widely in format, from purely paper systems through purely electronic integrated source systems. However, a large and growing number of sites use a hybrid paper/electronic model with various sources of data, scans of source destroyed by hospital systems, paper notes, dictated notes, email notifications, and central sponsor data collection systems. Some ideas on how to address various hybrid source data scenarios will be presented.


Posted in Data Integrity, GCP, GxP, Pharma, Pharmaceuticals, QA, Quality Assurance, Technology, tjkuhn | Tagged: | Leave a Comment »

Wellsphere Affiliation

Posted by tjkuhn on October 15, 2008

I was recently invited by Dr. Geoffrey Rutledge to join the Wellsphere Blogging Community. This was quite a surprise and I was quite flattered.

That being said I wasn’t really sure how I’d fit in at Wellsphere. GxP Zone is a bit of an odd-ball in that community, but I suppose GxP Zone would be a little odd in any blogging community…I really don’t know of any other blog that examines the same sorts of topics in quite the same way. I emailed Geoff and he apparently really liked the post I wrote on ALCOA. In any case, after emailing a bit with Geoff, I’ve decided to join and am excited about the affiliation. Thanks very much.

Top Health Blogger - Wellsphere



Posted in QA, Quality Assurance, tjkuhn | Tagged: , , , | 2 Comments »

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