Comments on: Ad Age’s Garfield: Pharma Must Clean Up Its Act

By: Dona Wheeler

Dona Wheeler — Thu, 24 Jul 2008 20:45:40 +0000

I was surfing, trying to locate a piece on the epidemic of controlled prescriptive drug abuse and addiction, by Joseph A Califano, Jr CASA, from 7/9/25
I agree with Bob’s piece, but let us be warned, we are now looking at a prohibition of alternatives, via CODEX. More on this at http://www.healthfreedomus.org With a plan in place to test every man, woman and child, called TeenScreen, precriptive medications have legally replaced and exceeded street drugs.
This makes the physician the pusher, as I called my last NP, and me very tired of being the “test dummy.
Every ailment I have can be linked to precritive medications, including being legally blind in my right eye. The horror is that often these health issues do not appear until later in life, a it can be too late.
Children are now the target, and one thing that is nerver discussed, please note, is prevention.

By: vince

vince — Wed, 09 Jul 2008 01:36:05 +0000

Adverse reaction complaints cannot be documented through chat rooms, even if the chat room is hosted by a pharm company and the “patient” is logged in. There are official routes that would need to be taken outside the chat room to document these issues.

Bob Garfield is right that the management of pharmaceutical companies (and government regulators) has become increasingly dubious and dangerous in recent years. I suggest it has everything to do with the rise of the new American culture that brought us the George W. Bush administration: anti-intellectual, bullying, self-absorbed, short-sighted and criminal. At my previous pharma company we had Republicans in management trying to coerce employees to financially support US candidates who “support” our industry… wonderful people like Conrad Burns.

By: pharma pr hack

pharma pr hack — Tue, 08 Jul 2008 01:59:13 +0000

Nathan,

Even if pharma was going to box itself in to avoid reporting AEs.. it is still out there being reported independently by consumers, by docs/nurses/hospitals anonymously through the MedMarx system.. It is ridiculous to think that pharma refusing to engage the discussion lowers the probability of an AE reporting. It isn’t as though pharmaceuticals are the only or even the primary reporting source for AEs. As for online assaults– I think that is the us against them mentality that keeps pharma trust factors in the tank.

A groundswell of negative reporting might not even be “fake” - I honestly think a lot of AEs are products of the manufacturing processes, of API or supply chain issues. You take a small subsample of batches to test but it isn’t like every drug I take or anyone else does has truly been tested individually.

When I bought my car, I knew it rolled off the assembly line pretty much good to go with most parts tested in the process. When I take my triptan, I only know that in the batch a random sampling of drugs turned out okay and mine hopefully was too and I really don’t have a clue where the API, the other ingredients came from or where the hell it was manufactured. It could be 250 mg of API, 260, 240 or who knows.

That is a whole lot of trust the American public gives pharma and sometimes it really hasn’t been earned.

By: Doc

Doc — Tue, 08 Jul 2008 01:44:56 +0000

AEs known to the company or any of its employees must be reported. Mr. Garfield is on target, the best thing pharma can do is be honest and straightforward with their data, AEs, promotion etc.

By: Nathan

Nathan — Tue, 08 Jul 2008 01:29:34 +0000

I can absolutely understand why reporting of AEs would be the “big elephant” in the room. In spite of the ridicule I received last time I brought this up, pharma (at least my company) takes AE reports very, very seriously. If I hear of a family member or friend that reports an AE that they suspect is due to my one of my company’s products, I *have* to report it. (granted, they would likely never know if I didn’t) My job would be at stake if company administration became aware that I withheld such information. So with an online forum, what do you do when an anonymous blogger reports a possible AE? Is it reportable? Probably so. How many disgruntled bloggers would it take to completely swamp a product with huge numbers of “false” AEs? Well… probably not too many.

(In my opinion) such a community forum would HAVE to involve registration with real (verified) names and addresses. Otherwise, the risk of an online “AE assault” is just too great.

That’s my take on it….

By: Ed Silverman

Ed Silverman — Mon, 07 Jul 2008 22:20:14 +0000

Hi Justice,

Yes, anytime a company is made aware of a possible adverse event, a report would have to be filed, as I’ve been led to understand this issue by numerous people. And yes, the concern is that discussions would, inevitably, give rise to situations where reporting would be required. As a result, whenever online efforts are explored, the regulations are like the big elephant in the room. If anyone from one of the companies would like to share their view, please feel free.

By: Justice in MI

Justice in MI — Mon, 07 Jul 2008 22:08:43 +0000

Thanks, Ed. I guess the “danger,” from co’s perspective, is pts talking about AEs. But if they don’t formally report them, would there be an FDA issue? Or perhaps the concern is that such discussion would provoke reporting, which is conceivable to me.

By: Ed Silverman

Ed Silverman — Mon, 07 Jul 2008 22:02:29 +0000

Hi Justice,

Good question. I think what I’ll do is go back and try to add some clarification, but Garfield is referring to online social networking, in which pharma could directly engage the public.

Hope that helps,
ed

By: Justice in MI

Justice in MI — Mon, 07 Jul 2008 21:46:07 +0000

I don’t follow this one bit:

“I know of one pharma company that’s pulling back from community conversations on line for fear of having to report negative outcomes to the FDA.”

How are “community conversations” (I’m not sure what that means) related to FDA reporting?

By: Jaynesday

Jaynesday — Mon, 07 Jul 2008 21:18:28 +0000

Thanks Bob, if you’re out there (and it sounds like you might be, given your understanding of the new world of social networking in pharma).
The passion and emotion working in this new world of pharma is generating a new power (Consumer Power) that I think will take the industry as a whole a while to deal with. The light has been turned on in the pharma world that will only get brighter and there are not too many places to hide anymore. As Bob says the pyramid has been turned upside down with the consumer on top.
The companies that accept this and address it head on rather than run from it will be the ones to bet on. Too bad for the others.