The bad workmen, er, bloggers, er, authors that blamed the tool - A tale of sidewikis and pharma.

Hey, when you cannot report actual news, you can simply make something up right? Even if it is not remotely connected? Even if you are attacking the wrong problem or providing the wrong suggestions?

So, I have decided to take the plunge as well. See, we are now on a 24 hour news cycle. Everyone needs to be yelling, yelping, blogging, vlogging, twittering, facebooking, other-anatomical-region-book-ing, and what not.

When there are no new protests to protect "innovation" (read old wine in new stents bottles), or no new articles that Merck never wrote, or no new medical device company "consultants" to write about...

Well, you make something up.

And so is born the great panic of 2012, er, "Sidewiki"!!!

Sidewiki

According to Google, "Google Sidewiki is a browser sidebar that lets you contribute and read information alongside any web page."

In an effort to take on the wikipedias of the world (hey, I can create panic too!), Google has created a tool that can run alongside IE and Firefox 2+ and allows you to add your own mis-truths, truthinesses, truthisms and possibly a few facts to web pages.

This will allow you to go on your favorite (or not) Pharma/Med Device Company's (or any other website for that matter) and leave notes about exactly what you think of them. You can also get creative and leave pieces of your mind as well. And other stick-yer-nose-where-it-don't-belongers sidewiki users can join you in further glorifying these websites with their own colorful interpretations.

Pharma Companies, FDA and the manufacture of news

Now, let's make that into news.

How?

1. Sidewiki is this evil tool that allows the evil patients suffering from mild side-effects of drugs and devices such as permanent disability, blindness, cancer etc., get a chance to go to the websites of the companies that defrauded and/or hid data, or never cared enough to perform studies on the cheap plumbing, I mean stents they make, or companies that made their hips squeak - and spew venom!

2. Sidewiki is also this charming, deceptive tool that will suddenly convert well-meaning, trained marketing folks who have hitherto shown such unparalleled levels of responsibility, to suddenly go on their own companies' sidewiki sites and exaggerate claims of what the devices and drugs can do.

3. The FDA, which is currently well equipped and is doing such an excellent job of regulating itself and the growing list of industries ranging from tobacco to drugs and food, being regulated under it's able command will suddenly loose direction and debilitated and miss out on just this one aspect - the regulation of pharma companies and how they interact on sidewikis!

Should we treat the symptom or the disease?

Wait you say. Isn't it possible for the genius marketing weasels to go and cook things up on the sidewiki and get their companies in trouble? Or for all these patients to go write about what happened to them and prevent these wonderful ineffective drugs and devices from making their investors stinking rich?

Well, yeah. The answer is in the famous words of the pithy cliche, "Your bathtub is overflowing, do you clear the water first or turn off the faucet first?"

Let's look at both possibilities:

You see, inappropriately trained employees who are told to take a laissez-faire attitude on ethics - marketing personnel, telemarketers, bloggers, Presidents, Fox News Reporters and even the unicorns could end up doing the wrong thing.

Merck did it with the fake publications...

Glaxo did it by hiding the news of Avandia..

Then there were Celebrex, Vioxx and Yaz...

The FDA and Congress with the knee implant approvals..

The Obama Administration's "tort reform" with it's misplaced and unfruitful love for "bipartisanship". (Well, then why not simply embrace Fox News? That would be one hell of a bipartisan move. Equally useless, but definitely bipartisan!)

You see, irresponsibility is omnipotent - the medium is not the problem.

The "new headache" that you will read about in the articles I will link below, are after all, not new headaches. If people decided to be ethical and make it policy, at the macro-level, not with individual policies for twitter and Facebook, then the problem is solvable.

A matter of shame

Being regulated and chastised by the FDA for ethical failures should be seen as a matter of shame by the company, not a bright, bubbly, cheerful "You might have recently seen some Yaz commercials that may have been misleading. The FDA, weak, useless and unable to actually do anything by way of real punishment, has asked us to further confuse you idiots.."

Only a bad workman or blogger blames his/her or someone else's tools. Others, try to keep going back to the central theme - the state of the industry, as it is, should have never come to exist.

There is still time to fix it.

Companies can still choose right against wrong.

Now, to the second issue:

Don't fight disgruntled patients and bloggers

Man up! There is bad news about you because YOU covered something up. You released the stent without ever bothering to find out if it worked. You knew your diabetes drug was causing heart attacks. You threw in Doctors' names when they did not even touch the publication. You paid people to "consult" and concoct data for you. You and your Congressman forced the approval of a dysfunctional device. You approved the device...

YOU are the problem. Not dead and dying patients.

Exhort that - don't simply look to score random, nonsensical brownie points dissing sidewiki or facebook.

Links to a couple of articles:

Story 1

Story 2

If you decide that you don't care much for ethics, then maybe Las Vegas is the place for you, not the pharmaceutical industry. It doesn't matter if you are manufacturing or "reporting".

Abbott the innocent fires Harrison the unrepentent? ...And some very disappointingly minimal actions by Obama

[Click on Post Title for Link to External Article]

If I were the lion from Narnia, I would name Abbott, "Abbott the innocent", that is, if my taxonomy went solely on the basis of companies' ostensible acts. Of course, I am not the lion of Narnia, and no one else should be buying this load of Humira either...

One classic political strategy used in many situations is - assuming the one to yell out loud and clear first is the one to blame.

Except, ahem, we understand politics. And it is "classic" which means old. How many Lucille Ball show endings surprise you anymore?

Here are some questions someone might have to put to the innocents here:

1. Do you review the ads that get put out for $70 million on your behalf?

If not, you are either too rich or, well you are you.

2. If you did review the ads, did you not check for the most fundamental aspect of what approval conditions the ad hints at? Examine this - you don't really get people with science education working for ad companies much. I would imagine not...

So, how did the decision to leave the final proofing for an ad to be displayed in a medical journal get left in the hands of an ad agency? Was the expectation that the ad agency would go hire some outside consultant that would clarify the language on FDA approvals?

If so, who thought that this was a great idea?

3. So, are we to assume, the ad agency, acting on its own poorly conceived cognizance decided to make the fine print, so fine that it is a blur at best, that even if, as suggested by bnet.com, you were to zoom in to 100% or more, the pink vs. white would nearly blind you?

May the cat-belling ceremonies begin

Alright, as another cliche goes, enough beating around the proverbial bush. What responsibility, if any is Abbott going to presume? What punishment if any, is the FDA going to dole out? I mean, the damage is done - right? People have already viewed the ad right? (This presuming those who read journals are incredibly stupid and will trust everything at face value - just ask those who invested in Wall Street).

An analysis

1. The Politics

So, for the last 8 years or so, we can argue, for certain inexplicable reasons (The Bush Presidency if that's what you want to call it), the FDA has been "Deadbeat Central". And now, we have hope and change.

Except it is coming at such a deliberate pace that our hoping and changing seems to need some "extreme enema". The FDA is headless (as of Saturday morning, it has a prospective head and a deputy, provided they have managed to pay taxes, something that Obama nominees have a chronic problem dealing with). Only the God (and not evolution because every alternate opinion, however incredible needs support) knows how much tax-paying and withdrawing drama the nominees will finally bring before they start at the FDA.

2. The Supreme Court

Meanwhile in a far, far galaxy, unkown to Obama and Pelosi (because they are too busy organizing Healthcare summits - because talking rather than doing your job is indeed the best way to get the job done!), the Supreme Court and other agents of spontaneous change will continue to constrict us. How did they figure that pre-emption works only for devices and not drugs?

Is the intention to demonstrate the FDA is good enough only for devices and not drugs? Or did they decided to demonstrate that they are so far removed from the lofty quanta of intellect and depth of understanding required for being at a minimum, a district court judge? Don't they have the responsibility to explain this mess they are leaving us in?

Or did I miss the memo that they don't have to? Looks Cheney-istic, n'est pas?

3. The joke FDA

To pre-empt or not pre-empt - is not the question. In every single way possible, the FDA has demonstrated its incapability at administering anything.

Wait, didn't they just yell at Yaz and Abbott?

Heard of too little, too late?

If no one remembers (and given our short term memory, no one does), here are a few things that the FDA has done to win accolades in the recent past, read my previous post here:

1. The website that the FDA put together on DTC ads to "inform" consumers was designed by a "non-profit" (which of course helps put all the good non-profits to shame) that is a front for the mob, er, pharmaceutical companies. This just makes me sound like one of those Area 51 conspiracy freaks, but this is real! :

http://www.pharmalot.com/2008/09/fda-tapped-pharma-consultant-for-dtc-web-site/

2. They have been so ineffective that companies openly disrespect them - before warning Bayer, the FDA did indicate to them that there was trouble brewing. Bayer didn't care. Take a look at the DTC ads by "Dr." Jarvik and how much pain even Congress had to go through to take him off air (yes, I was one of the folks duped by the ads with him as well, and I am still smarting!).

This is new:

3. Bayer misled customers on Yaz and it's capabilities. The FDA entered into an "agreement" with Bayer asking for a minor correction in the ad - something that appeared fleetingly and is nowhere to be seen. Of course, after the initial celebration of a watered down, ineffective response, no one is talking about it anymore:

http://www.medicalnewstoday.com/articles/138729.php

So, where does this all lead? It goes back to the same topic - the FDA, it's inherent weakness and the unwillingness of lawmakers to do anything about it.

Should we simply complain or come up with a strategy?

Yes, there are several strategies that can be employed - the least effective of which is the one President Obama wishes to employ: blindly continue the same course for the FDA and simply hope that dumping cash and new leadership on a dead mechanism will somehow fix things. Which, is exactly what he has done today. Given the level of promise for change, disappointment and frustration are on the rise.

Here are a few things Obama and Congress can do, at least in the future:

1. Stop thinking linearly as far as the FDA goes. In today's speech, Obama's primary focus was on food, probably motivated by the salmonella outbreaks. However, the FDA regulates much more - drugs, devices, food and a whole array of things. Today's speech confirms that even the President has a poor grasp of the FDA's reach and the necessity to stem it.

One single organization cannot regulate so many aspects of health anymore. Yes, yes, we all know they have subdivisions, but we also know that has basically done nothing. Food administration has to be separated from drug and device administration.

Given the fact that drugs and devices have to be regulated together, one organization should do it. However, they should be distinguished by separate administrations with distinct leadership and separate teams.

2. "Warning letters" and "agreements"

The FDA's business is regulation, not officious groveling to businesses. This is the key point missing in how the FDA is run and how it acts today. In the case of Dr. Jarvik, the Bayer Aspirin ads or even in the case of Yaz, there should have been stricter punishments handed out.

The FDA has failed to act appropriately on all counts. They did not identify the issues at all in some cases - Dr. Jarvik was a fall out of Congress begging and groveling in front of Pfizer for information. The ads kept running for a whole while before Pfizer removed them, almost as an act of condescension, not repentance. The same goes for Bayer with their "dietary supplement nonsense".

This is why the FDA has absolutely no standing anymore. Organizations continually paint outside the boxes and sometimes the paper itself, and they have very, very little to answer for.

How is simply appointing a new head of the FDA actually going to change this? A simple change in leadership is not going to eliminate the regulatory cancer we suffer from.

The solution exists. The strategy exists. However, a lot more action is needed for implementation, bold and quick and unfortunately the President does not seem to be up to it...