Saturday, October 31, 2009

The Stryker Brouhaha: How the FDA demonstrates that it was never loved as a child...

If you have not heard about Stryker's (latest) legal problems, the FDA is charging Stryker and a random collection of expendable Stryker executives with off-the-label marketing.

I will link one of the many reporting stories available on the issue at the bottom, and you can read for yourself as to how, apparently, Stryker executives knowingly promoted a cement approved with stringent restrictions on marketing for humanitarian use, for off-label use. They even provided Doctors with highly suggestive recipes and concoctions on how to use the cements.

As with most of Orthopedic products that have been riddled with poor design, kickback scheme accusations and marketing attitudes, a lot of patients suffered.

So, the FDA finally jumped in!

The charges and the possible punishment

And it has accused a total of 8 Stryker folks, half of whom are classed as "former" and include, among others a former president and a sales executive.

At the outset, this all seems like "action". The charges include "wire fraud, conspiracy, misbranding, and making false statements."

Take a closer look. What does it entail as an eventual form of punishment?

Nothing, er, next to nothing in the following order: Something, Nothing, Next to Nothing.

If convicted, Stryker will face the following extremely debilitating actions taken against it:

1. As quoted: "fines for Stryker of at least $500,000 for each count"

2. "Exclusion from federal and state healthcare programs".

Okay, you read it, now say it loud with me, "Are you joking"?

Is the FDA Joking?

With you, one who is not charged by the FDA, yes.

How far does $500,000 go in 2009?

For large companies, $500,000 is chuck change. Heck, it is lesser than any of the following:

1. The amount such companies pay for their lawyers (which didn't work for Pepsi whose lazy lawyers missed a court date and are now scrambling to get a $1.2bn charge dismissed) to simply go out and harass, among others, federal agencies, smaller companies, individuals (Charles Riegel anyone?) and such.

2. The amount medical device and pharma companies pay in a quarter to lobby Congress to forget patients and pass laws that will make sure the right amounts of donations are made to individual campaign funds.

3. The amount these companies spend in a year using weak patents and other methods to harass smaller companies.

4. The amount these companies pay their executives in a month!

5. The amount that will be spent in lawyers fees defending the current charges by the FDA!!

6. The amount device companies are paying to lobby against healthcare reform of any kind!!!

And, of course I can go on and on...

This clearly demonstrates something. The FDA is obviously out of touch with reality, somewhat like a bad parent in need of love from their children at all costs.

What should be the punishment?

You may even wonder if punishment is necessary. See a lot of these brazen executives move from company to company and take their despicable attitudes with them. They do not change, because there is nothing that makes it necessary. They then proudly promulgate and breed more such "executives".

Punishment needs to be debilitating.

Punishment should invoke shame.

Large organizations thrive on corporate image across several industries. Not so in medical devices. Take Orthrocare or Stryker for example - such companies have been involved in all kinds of lawsuits. They pay cursory fines and get away with anything. Many such companies then turn around and lobby against healthcare reform!

Punishment should invoke the need for attitude change.

The punishment needs to be proportional to the crime. It is one thing for Hollywood to make disturbingly emotional movies where one soldier, one victim is important and a whole town, a whole army rallies around them.

It is another, for companies to be let go for a small fine when they kill and otherwise disable patients with obvious disregard for law and ethics.

Growing up to the times

The meter-maids, not FDA, are supposed to hand out parking tickets. Companies need to be punished proportional to their crime. Crime, among medical device companies is systemic:

1. The entire Orthopedic industry (well, the 4 companies controlling 95% of the industry) was implicated in wonderfully disgusting "kick-back schemes". Nothing came of it, except minor fines.

2. Companies like Stryker have been abhorrent at clinical research (read my squeaky hips post linked below) or at respecting patents, and systematically get involved in lawsuits. As a result of the fact that every federal agency, including the judiciary system is filled with ineptitude to mete out the right amount of judicial punishment, they keep on, keeping on.

Sending the wrong message

With the current listness and a lack of any form of seriousness, the FDA is sending the following message: As long as you hang back and reserve a few million dollars in lawyer fees and a few hundred thousand dollars in fines for the FDA, you can get away with anything you want - cooking data, promoting off-label use, anything.

At this rate, you should soon see the bigger device companies to sell 5-hour energy pills, phallic extension pills and fake weight-loss drugs.

Heck, why not? Right?

Hope and Change

If Obama and Margaret Hamburg really want change, they need to start setting examples. As I stated above, the industry does have it's fair share of fearless, lying crooks. By cowering to the fact that these companies are large and fearless, the Government is doing no better than the previous administration, and is really not bringing about any form of measurable change.

When companies such as Stryker are brought to court based on real evidence of crime, they should be made to pay. There should be no room for such companies to express "disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter".

They should instead be "ashamed", rue the day they decided that bending the law was "cool", and should be forced to gouge themselves of their present attitudes.

If this is not what the Obama administration wants to do, then there will be no change, and soon the hope will whither away.

Grandma will have no insurance because that was lobbied against.

Grandma will get a squeaky hip that won't work and embarass her to no end.

Grandma will also get dysfunctional cements, stents and ICDs in her body.

And, instead of looking forward to their one hour of daily exercise, such "executives" will keep popping champaigne bottles everywhere...


1. On the charges against Stryker: Click here

2. On Stryker's squeaky hips:

3. On Acumed Vs Stryker:

4. On Stryker's previous kickback settlements:

Saturday, October 24, 2009

Starting up? How is your bootstrapping coming along?

You are motivated. You are passionate. You have the idea. You are backed by science. Yet, neither are the VCs caring much for you, nor is the Gates Foundation interested in funding your idea.

What do you do?

Well, for one you can blame the Government, the stars and everything in between and give up.

Or, you can bootstrap! Now, bootstrapping is easier said than done. How does one actually achieve the act of bootstrapping?

A couple of interesting articles

Let us go from the lateral to the core. The first article came out of which talks about how software companies are bootstrapping. Apparently, some of them (or at least the one fielded in the article) have an intriguing way of doing things. The software company does not actually design the software, but spends a few hundred dollars designing websites that tout the "potential" features of a product and wait till a customer actually demonstrates interest in "buying" the product.

It is not possible to wait for a patient to complain of pain till you design a device, I know, but remember, we are looking at analogies of intrigue, to prove the point - "it can be done".

The article goes on to describe the nitties and the gritties of software development by bootstrapping. Have a read (and don't touch that remote, we are not done yet):

Bootstrapping a biotech startup

You would think that a biotech startup would take a lot of investment, and would be impossible to start without VC or angel backing. I gave up on a few ideas myself. But, to even find an angel or a VC, you need a prototype, or some licensed IP and so on. Unless you have this, a bit of luck, a few PhDs, good luck, right?

Well, according to the article from The Scientist, Johnny Stine is out to prove you wrong. I am not going to refurbish the article and steal from The Scientist, but he has proven that "it" can be done. With about $45,000, he got the whole thing going. You should read and find out more about what and how he has managed to pull it off.

Here is The Scientist Article:

Bootstrapping Resources

eBay is a great source, but be sure to take a look at the following:

I Shopping Resources

1.1 Craigslist

Regardless of cheap efforts by attorney generals and ambitious Sheriffs, craigslist remains the best place to pick up stuff for free, or for nearly free prices. I have seen everything from microscopes to lathes being given away. Getting a fixer-upper is not a bad idea when you are bootstrapping.

1.2 Tech Recovery

A couple of years ago, there was a plant closure going on and someone told me about this website. They apparently buy stuff from plants or companies that are moving or going out of business and sell it to start ups and others for a really low price:

1.3 Google Product Search (formerly Froogle)

I am not sure if Froogle has been formally retired, but I always thought it was a great idea. What if the stuff you are looking for is not available used on Craigslist? Even if it is available on eBay, among the hundreds of stores online, how do you know if you are paying the lowest possible price? How do you automate comparative shopping? Google Product Search, still in beta (like most of their other products are) can be put to use:

1.4. Others

Search locally for stores that sell used or heavily discounted items. For example, if you are in the San Francisco Bay Area, Halted Electronics on Central and Lawrence Expressways can get you some good bargains for electronics. Similarly, from March through October, there is the Electronics Flea Market:

II Software and Internet Tools

As an entrepreneur, you need to be professional, and so you should not get into situations where you use any kind of "cracked" software and such. You are about to go and try have customers buy your products. How would you like it if someone walked off with your molecule or the catheter.

There are legitimate software applications out there that are either completely free or come for cheap. How can companies "give away" their product and still plan to stay in business? Well, they are hoping that you would do one or two things - either upgrade to their paid version when you can, or pay for service and support, or both.

Let us take a look at some that you already be aware of:

2.1 Clinical Trial Software

Within clinical trial software, my experience is limited, however, recently, FierceBiotechIT mentioned OpenClinica 3.0, which is an Open Source application (alongside a commercial enterprise version), that can be downloaded and modified for free.

2.2 Project Management - Open Workbench

Ah, the holy grail for a start up, especially for medical device and biotechnology companies. Open Workbench is an Open Source tool, and can be quite useful if you want to use some good practices and start dividing up your work into Projects and start the PM process sooner, rather than bandage it together later:

2.3 Brainstorming and Mind Mapping

Be it a better mousetrap or a new out-of-the-friggin'-box treatment for a disease that you plan to hash out, you need to create and protect your intellectual property. How do you brainstorm if your colleagues are out there, or if you want to do them on a laptop and you don't have access to the envelope or napkin, but a laptop...?

You mind map. Mind mapping software come in various sizes and shapes. Some allow you to make fish-bone diagrams, other allow you to perform free forms in other ways. I am providing you with a page that has a whole host of links here, some open source and some proprietary.

2.4 Document Creation and Storage

2.4.1 Google

Google constantly keeps updating their products - and I am not even talking off the paid version. You can simply use the free tools and you have a set of portable documents that can be shared and distributed online. Google Documents are no substitute for the industry standard Microsoft Office, but they can serve as an excellent, online repository for data that you use every day, effectively allowing you to work from home or elsewhere.

Other Google products such as Google Sites can also help you come up with quick and dirty websites if they are necessary.


Google is not the only company with tools for online document storage and such. The biggest advantage is, if you are an addicted Gmail user, you can integrate the documents into your email system directly.

2.4.2 Zoho

When I was first introduced to Zoho, I was impressed by the simplicity of the tools. Take a look here:

They offer everything from document storage to web conferencing and CRM with a lot in between.

2.4.3 OpenOffice

With Oracle's acquisition of Sun Microsystems, the future of OpenOffice is in question (as are the futures of MySQL, Java and several other products). However, for offline use, as a free office product, it is the best out there.

2.5 Free or Cheap Web Conferencing Tools

Through several helpful folks from my alumni list, I came across a handful of free to cheap web conferencing tools. Web conferencing allows you to work with folks across the globe and cuts down on meeting costs as well(remember, Zoho was already mentioned in the last section):

2.5.1 Dimdim

Dimdim is an open source tool, with a free basic web conferencing version and additional paid versions. I have not used this tool myself, so you will have to test this yourself.

2.5.2 Fuze Meeting

Again, a similar website, the free version does not appear to have as many features as Dimdim does, but it might be an alternative.

2.5.3 Vyview

This appears to be yet another elegantly designed, ostensibly free tool that PC World seems to have rated. The competition in this area must be truly high:

2.5.4 Open A Circle

Like Zoho, this company seems to offer a bundle that is not simply limited to web conferencing, but seems to extend to instant messaging, file storage, etc. They do recommend Internet Explorer or Firefox Mozilla, and a Windows Operating System (bootstrapping with expensive Apple computers would be paradoxical)

2.5.5 Jive

With so many free web conferencing tools, why bother mentioning something that is not free at a minimum? Because the base rate of $3 per user per month may be something you can think about if their product "suite" that seems to span across several verticals makes any kind of sense for you:

2.6 Other web collaboration

2.6.1 Zenbe

Zenbe appears to help teams collaborate over multiple projects without a bunch of different emails going back and forth. It appears to be a form of revision management without actual revision management:

2.6.2 Notaland

This is an interesting tool that allows multiple users to create and update web pages, chat etc., serving as an online whiteboard.

2.7 File Sharing and Storage

There are many file sharing and storage products out there, and many companies mentioned in prior sections also offer free storage, but just in case you need some more.

2.7.1 Yousendit

Yousendit Lite is a free file sharing mechanism for individuals that eliminates the need to buy online space or use an ftp application.

2.7.2 (free trial)

The company is offering a 30-day trial for what is otherwise a rather expensive proposition. However, the tool itself sounds like a very good idea - drop files worth 10OMB online and share them through multiple means.

2.7.3 SkyDrive

Obviously stung by competition (read Google), Microsoft is now trying to catch up. There could be some gold for you in the competition. SkyDrive offers 25GB of storage if you sign up with Windows Live!

2.8 CAD Tools

CAD Tools for medical device companies, should be chosen carefully. While there are free tools out there, CAD tends to be the backbone of product development and choices can affect you for a long time. CAD software do not play with each other all too nicely all the time, and if you choose the wrong application, you may have to spend a good deal of money on translation tools or simply, recreating your work.

That said, there are a couple of free tools worth mentioning with the above caution.

Google SketchUp

While this tool may not be very useful for the kind of serious CAD engineering typically requires, it is still a very easy one too use. So, take a look.

2.9 Free tools from Microsoft

I recently came across this at the Tech Republic, and I thought you might want to explore these and see if any may be of use to you:

III. Educational Tools

You have your start up. It feels great. But how about some "back to school" time? Well, here goes.

3.1 OpenCourseWare

MIT kept up with it's promise and revolutionized education with the OCW project. With this, you can now become an arm-chair and laptop MIT student!

3.2 Stanford Engineering Everywhere

My alma mater on the other hand has been standing around, with hands tied, fists clenched and more. Finally, they have opened up a few engineering courses and have had the gall to come out with a press release. For a left coast school alum, somewhat painful to sit and watch. In any case, the classes that are free, are excellent!

3.3 Entrepreneurship Thought Leaders Seminars

While I lament the fact that Stanford hasn't opened up as much as MIT has, the ETL seminars have been free forever, and they offer an entrepreneur with a treasure trove of speeches, revelations, do's, dont's and everything else.

3.4 Community Colleges

This may not pertain to entrepreneurs everywhere, but if you live in the US, there is probably a community college (or two) near where you live. If you are more of a hands-on learner, then your community college may be the one for you. Cheap and effective, enrolling can give you access to their classes, labs and libraries (be careful about software - licensing agreements will restrict you from using most educational software for commercial work).

3.5 Your Local Library

There have never been resources more useful than your local library. Your local library can be a city library, or even a library in a community college of University near where you live. With several ways to access materials from these libraries, you will save yourself a good chunk of change simply visiting and reading stuff off of libraries. You can also save on the lattes if you simply work from a library in case you are the kind of a person in need of "office space" (Moi, je suis flop myself in front of the TV tojours).

Local libraries may offer other benefits as well. For example, a local library belonging to the City of Menlo Park has a "free" bin of books donated by readers. If you are persistent enough, you could even pick up a copy of Science or the NEJM!

Friends of the Library

The Friends of City of Palo Alto Library, near where I live has a monthly book sales, where I have found several excellent books at throwaway prices.

City Libraries have "Friends" clubs that are usually registered as non-profits, which means you don't have to pay taxes when you buy from them. Recently, I found out that some of them also sell books at dirt prices online on!

3.6 Do-It-Yourself!

Hmmm, no, it's not late in the night or anything. Doing your own work can of course save you a lot of money and give you unparalleled insights into your ideas, it's pluses and minuses. A great starting point is the DIYBIO website. Ever since I joined the site, I have picked up so much! To be honest, I find their Google Group easier to use (I am an email jockey) than the forums that I rarely visit.

3.7 Blogs and Newsletters

Depending on how much time you have, blogs and newsletters can help you quite a bit. I am constantly accessing them and listing them here seems impractical. Please browse to the right hand side of this blog's home page, for a full list.

Shameless plug it is, but I have kept it updated pretty well, even with some that I don't agree with!

IV. Tech Shop and Make Co-Operatives

Alright, how about machine tools for prototyping? Do you need to buy a whole new lathe or milling machine? Not if you live in certain areas. For example, in the San Francisco Bay Area (okay, I am not showing off, I truly live here), there is the Tech Shop, where you can take classes and sign up for the use of machine time:

They also have locations in Oregon and North Carolina. There are also make shops and community workspaces probably coming up in an area where you live!

IV. Give me more - Market Research, researching and some more

This is a tail ender, but I am going to introduce you to a very nifty tool - "Google Alerts". Google Alerts constitutes the sharpest tool in my collection of online research tools. Do you need to keep tabs on your competitors, or just know what is being written about your own company or your disease area?

Go to

Set up an alert for say "Endometriosis" or "Medtronic", say what type of results you want - I usually choose "Comprehensive" to make sure I get everything on a topic. Then, you also want to say whether you want news items offered as they happen, or once a day. I tend to want to read things as they happen.

However, "as-it-happens" can overload your inbox. So, you might want to choose the digest form. You could also create filters and make sure the Google Alerts don't land on your inbox.

There, you now have your own, free of cost market research and competitive research tool!

V. Network, network, network

Yeah, what is "networking" doing in a post on bootstrapping? It is the old barn-raising again. You never know who has the answers to your problems and who may help you out. Bootstrapping means going beyond looking stuff up on Google and simply buying or renting them. There are dozens of companies and consultants who will offer free advice, solutions and products to make sure you give them a good hand and get to understand or buy them when you can or need them.

Most of the tools I have listed up here, I know of, only because I spend a lot of time on several odd networks, signing up for various types of blogs and constantly skimming and flipping through materials.

So, the next time you hear someone questioning the LinkedIns and the Facebooks of the world, you know what to say. Apart from the DIYBio, I have found the "sfmedengineers" Yahoo! Group to be quite useful:

If you are a young entrepreneur, especially looking for ideas, you may want to network and participate and/or volunteer in events. You will get to meet a number of terrific people and learn quite a bit. Trust me, networking can never be wasteful.


I wrote this list keeping a medical device/biotechnology company in mind. Most of the tools pertain to start-ups in other areas as well. I have not tested all of the tools in here, but I have tried my hand on many of them. If you have specifically liked any, or have had problems with any, please leave a note.

I am also certain that I left out a lot of tools in here. If you know of tools that may help, please let me know. I realize that a blog post is hard to update, and I thought of a wiki - I have been planning a medical devices wiki but it will have to wait. In the meanwhile, I will release all these tools in the form of a concise eBook that will make it easy for me to revision manage and update. So, please let me know of tools and gaps in tools that you may want to see here.

For my next few releases of this type, I plan to write about other useful resources such as specific books and such.

Friday, October 23, 2009

The Society for Partcipatory Medicine

I am not sure where it was (because it was everywhere), but I found a very interesting society, "The Society for Participatory Medicine". I became very intrigued and checked them out (and later joined the organization).

When I went to their "About" section, here is what I found:

"devoted to promoting the concept of participatory medicine by and among patients, caregivers and their medical teams and to promote clinical transparency among patients and their physicians through the exchange of information, via conferences, as well through the distribution of correspondence and other written materials."

I find this very interesting. As of now, I am not an ongoing patient, but I have felt that medicine needs to open up beyond the current structure of Government, Doctors and Insurers. Patients, after all, are the biggest stakeholder in the practice of medicine.

Patient Participation - A gap in need of filling

Among other things, one of the main drawbacks to the progress of medicine in the US and across the world, is the fact that most patients do not enroll in clinical trials. Of course, there are issues with patient education, advocacy, and yes, participation.

Thus, I found what the organization has as a goal, quite intriguing. While there are disease specific organizations and movements such as the American Cancer Society and societies for various diseases, there aren't many out there, explicitly advocating patient participation in general.

Apart from visiting Wikipedia and bugging their Doctors, patients need to pay more attention to how they are being treated, what treatments are being approved by the FDA, what standards the FDA is maintaining, the quality of the Doctors, the devices and the drugs used, Government, who is lobbying who for what (did you know that Bank Of America, a company you bailed out has been contributing to Congressmen and Congresswomen with your tax money?), what Congress is doing...

The list of what patients and the population (a.k.a. future patients) need to do make sure they have a say in the practice of medicine (or practice of health) is of course a mile long...

What else is Participatory Medicine?

Participatory Medicine is also Participatory Health. Responsibility is never a one way street (isn't that the cliche of the week?). Health involves eating right, exercising, staying away from recreational substances of all sorts. If we all did our bit, then we can participate in our health, which would reduce the need for us to participate as much in Medicine.

Interesting Fundraising Techniques

The Society for Participatory Medicine has a very interesting fundraising mechanism. Membership is paid, and if you join the organization in the fiscal first year, you get to call yourself a "Founding Member". I can only envision two results when you come across this - some intrigue and a sense of egoistic fulfillment.

Whatever be the case, I was intrigued enough to make myself a "Founding Member" without founding anything. In any case, I think the organization and it's objectives are very pithy. As a result, I have joined and hope that the organization achieves it's goals.

Fore more information:

Thursday, October 22, 2009

What? The FDA and disorganized? But, how can that be...?!!

Yes, how can that be, since the Democrats, in their infinite wisdom, decided to shore up a faltering agency by dumping money and responsibility (read tobacco) on it?

What the hell am I going on about? Well, the New York Times came out with a story today about how Congressional investigators (and who exactly are these people? Are they the same ones also doling out my taxes to the FDA on the side?) have concluded that the FDA is disorganized, inept and derelict.

Don't simply say "What's new about that?" and move on.

The prelude

Apparently, aside from regulating Food, Drugs, Devices and now Tobacco (because it is food, I guess), the FDA must also punish fraudulent investigators. Now that's a tall order, especially considering that the FDA has already demonstrated unparalleled ability in the following areas:

1. Failure in the regulation of food
2. Failure in the regulation of drugs
3. Failure in the regulation of devices

In May, when the Obama administration was bringing gifts to Maryland, I lamented, along with several others on the need for the break-up of the FDA:

Of course, no one in the Obama Administration wants to listen to you, unless you get on Fox TV and shout yourself hoarse. Some grass roots.

Anyhow, ours is not to ask, but to damn.

The problem:

The FDA is an overburdened organization with entrenched leadership. A bus load of NIH scientists and a truck load of cash will not solve the problem. Joint regulation of food, drugs, devices, tobacco, researchers and everything in-between is ridiculously infeasible.

While it is easy to make light of the FDA's failures, there is a reason why this problem happens:

1. The FDA has to take care of everyone of it's current burdens of making policy, coming up with regulations that enforce policies and rulings, report to Congress, etc.

2. The FDA has to deal with a global economy that results in devices and drugs manufactured in an an array of nations across Asia and Europe. The FDA needs to deal with fraud, counterfeit operations and GMP, GCP across the globe for anything used in the US.

3. The FDA is constantly dealing with issues and situations that have never been faced before. They need to hire and rely on outside "experts", who are usually non-existent. If they do exist, or thrust themselves in as subject matter experts, these experts usually come burdened with conflicts of interest.

All said and done, the main problem is an in-cohesive attitude towards the FDA, it's capabilities, the limitation and most of all, Congress doesn't really seem to care about action either.

While the last eight years were no party, I squarely blame the Obama administration for simply ignoring straightforward facts - the FDA is, er, "messed up".

Replacing a few embattled leaders doesn't mean much. It needs a thorough scrounging, from the inside out.

Reform the FDA

Reforming the FDA is not so tough:

1. Separate food, drug and device administrations into three separate federal organizations. Have the HHS directly, or through the CDC make sure they co-operate with each other. Or get a Czar, or a Don...whatever, just make it happen.

2. And yes, I may not be smarter than a 5th grader, but I do know that devices and drugs may sometimes be combined or classified differently. Fine - make sure that the agencies pick 50-50 on the committee for such special conditions and "deal with it". When Newton discovered gravity, people didn't run naked on the streets in shock (although, Archimedes did, well he was just crazy!)

3. Review who should be throwing "fraudulent regulators" out of business. I was a little beyond surprised to find out that the FDA was tasked with this. What about the justice department? After legalizing pot, crack, ganja, hashish, meth and moly, they do seem to have a lot of free time on their hands. Wouldn't preventing someone from doing research be something a bunch of lawyers did? Why is the FDA involved. Something is wrong here. I think even your golden retriever can see through this...

4. Do not simply pile stuff on the FDA and it's possible child organizations (if you take care of step 1, that is). It is not your once-a-week garbage truck. I cannot understand why the FTC couldn't take care of tobacco. Or maybe because it is not "food" and is directly related to "death and disease - in no particular order", why doesn't the CDC regulate this? Or maybe the HHS? I am not sure. But the FDA, to say this one more time, is not your "garbage truck".

5. More cash is not the answer. More cash means more taxes. More taxes mean more wastage. This is simply a case of divide and conquer.

6. With all the hope and change, I am sure we all got very teary eyed. Now, would be a great time to ground ourselves in reality. So, when people speak - LISTEN! If, in the course of discussions early this year, the Obama administration and/or Congress had paid any kind of attention to the clamor on splitting the FDA, all the world's Hernandezes and Campbells would now be out of a job.

Before we leave, here is some gobbledygook from the FDA as quoted by the NY Times Articles demonstrating unparalleled brain from body separation:

“The F.D.A. views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,”


“We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.”

Especially with the last comment pasted right above, who else thinks that rolling some StarTrek credit music is in order?

"We will take strong action"

Exactly when?

Two Saturdays from never?

Watch your tax dollars rotting....

The NY Times Article:

Sunday, October 18, 2009

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"!!!


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.


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".