Billy Tauzin, CEO of PhRMA, the US drug industry trade group, laid into the FDA's proposal for a Drug Watch site (see "FDA Drug Watch Site Guidelines") according to a Reuters story ("Drug Makers Object to U.S. Plan for Early Warnings").
Most of Tauzin's comments are predictable: According to Tauzin, the site
- could lead to unnecessary confusion and "irrational fears" about medicines,
- would be "too vague and preliminary to be of any value in making informed treatment and prescribing decisions," and
- may exceed the FDA's authority.
I am not sure how to interpret this comment.
On the one hand, Tauzin may be more worried about what bloggers do than what the FDA may do. On the other hand, Tauzin may be putting bloggers down. It all depends on which bloggers he's talking about.
He may be talking about patient bloggers writing about their experiences with Rx drugs, in which case he should be more worried about bloggers than about the FDA. These bloggers have as much, if not more, credibility with the public as does the FDA. That's due to the power of "buzz marketing" combined with the public's current low rating of the FDA's credibility.
Tauzin, however, may be talking about professional bloggers/critics like me who read his comment this way: "I'd rather have the FDA doing it than some scum of the earth pharma pundit on the Internet." I think I could be classified in that category of blogger ;-)
In any case, I happen to agree with Tauzin's first two objections. That's why I made a suggestion to the FDA on how they can improve their concept of the Drug Watch site. Namely, I proposed that a Drug Risk Advisory System be implemented through the Drug Watch web site (see "A Proposal for a Drug Risk Advisory System"). This, I believe, would take care of the first two of Tauzin's objections mentioned above.
As for the last objection, which PhRMA almost always raises -- i.e., FDA would be exceeding its authority -- only Congress can (and may) take care of that.
P.S. If you want to learn more about how blogging is affecting pharma and vice versa, take a look at the PharmaBlogging conference that I will chairing and speaking at.
The Prevention of Ignorance
ReplyDeleteHistorically, information sources provided to American citizens were limited due to the few methods available to the public. And also this information was subject to being filtered and, in some cases, delayed. This occurred for a number of reasons, which included political ones. What I am referring to is pre-internet sources , such as media souces in the form of radio, newspaper, and television, for example
Now, and with great elation (some may say), there is the internet.
Soon after the advent of the internet, web logs were created, that are termed presently and simply ‘blogs’. At that time, about a decade ago, the blogs were referred to as personal journals or diaries visible on line. As time passed, blogs became a media medium, and blog communities evolved on topics that often were not addressed in mainstream media. In addition, blogs provide immediate contributions by others instead of the cumbersomeness of opinion and editorial pieces historically and not always presented in such media forms as newspapers.
The authors of blogs vary as far as the backgrounds of the creators of these journals, as well as their true intent of what they choose to present to possible readers. Furthermore, they are not exonerated from the legalities of what is written, such as cases of libel or plagiarism, for example. While we can presume that blog creators have at least an interest in a particular subject, ideally they should also have an interest and ability to annotate the written word. As with other printed material, the quality varies, as editing, I believe, is rare as far as what is posted on blogs.
Yet presently, blogs have become quite a driving force for those with objectives often and apparently opposed by others, and are possibly and particularly a great threat to big business and politics- both of which have been known to often monitor often the progress and/or content of some blogs, which potentially provide instant and often accurate information for readers- which includes what is posted on blogs as well as what may be commented on these posts. Understandably, this weapon certainly has the potential to affect such groups unable to prevent or filter what could expose what has not been disclosed, and at times needs to be disclosed. Rarely do blogs involve trade secrets, for example, as far as I know
This also and fortunately includes information released from whistleblowers on certain blogs or directly to the creators of certain blogs- often and with good reason to remain invisible in doing so, as there have been such cases already through this blog medium- which is similar to YouTube, only blogs reflect what is written and not viewed.
Yet, blogs are not free of fallacies, as one disadvantage of blogs is the potential lack of reliability, blogs however do allow the posting of documents that typically are not created for view of others besides perhaps a select few. Furthermore, blog owners, as with journalists, strive to verify any premise stated on their blog. For example, blogger Dr. Peter Rost, a whistleblower himself, not long ago posted a newsletter on his blog site given to him by pharmaceutical maker AstraZeneca employees who called themselves the ‘AZ Group of Seven’ to bring to the attention to others the illegal activity of off-label promotion of one of their cancer drugs. Yet this is not what caught the attention of so many with all of the content of this newsletter posted in completion on Dr. Rost’s blog site, “Question Authority”. It was instead a comment that was annotated as being stated by former regional AZ manager Mike Zubalagga, who in this newsletter referred to doctors’ offices as ‘buckets of money’. Again, the statement was authentic and in writing in this newsletter. At the same time, the statement validated what others view of pharmaceutical companies in relation to their greed, perhaps
Mr. Zubalagga was fired the next day due to this comment. His manager resigned soon afterwards.
And there have been other whistleblower blog cases in addition to this one, so blogs have become a very powerful and threatening medium of information release that does not allow others to prevent such releases. This is true freedom of information, free of alteration or omission. One could say that blogs are reaching a form of some sort of communication utopia. Also, as with the case just stated about the newsletter, some are more careful what is written than others.
Yet again, the information on these blogs should not be taken as absolute truth without proof to verify claims that may be made. Of course, documents that are authentic are in fact proof, as illustrated with the above example. And this, in my opinion, is the blog’s greatest value, combined with the comments on blogs from the growing number of readers who are allowed to contribute to the subject matter so quickly, which fuels the objectives of the blogs, which clearly opens formerly closed loops.
Because we, the public, have a right to know what we are entitled to know and what we want to know. This is especially true if the information could potentially be adverse to our well-being.
Personally, I have no interest in the financial future of a company, for example. More important to me is the importance of knowing if others may potentially harm others with deliberate intent.
“Information is the seed of an idea, and only grows when it’s watered.” --- Heinz V. Berger
Dan Abshear
Author’s note: What has been written is based upon information a