Blog Action Day – Blogging for Food…

I am proud to be taking part in Blog Action Day OCT 16 2011 www.blogactionday.org
Today is blog action day and I received an email just last night about this. I don't have much by way of content, but I thought raising awareness is not much about content, but lending a voice. 

Food is one of the three essentials of life, as anyone would know. There is one fact I learned earlier this year, that has stuck by me and given me much reason to think. 
Did you know?

About 30% of the food prepared for human consumption is never consumed!

Now juxtapose with all the hungry people of the world, the children, the elderly and many in between that never will have access to good food. Is our waste warranted? 


Here are a few simple actions I pledge:

1. Plan ahead and only buy sufficient ingredients that will not be thrown away because of expiration.

2. Order only the amount of food I know I will be able to eat.

3. Try to cook only the quantity I know I will be able to eat.

4. Try to compost food that will be wasted no matter how many precautions I take.

5. Try to work towards technology and solutions that will help us to a world where hunger is no longer a world problem. 

Any other thoughts? Anything else that needs to be pledged?


Source:
http://chaaraka.blogspot.com/feeds/posts/default

Paul Root Wolpe: It’s time to question bio-engineering – Video

http://www.ted.com At TEDxPeachtree, bioethicist Paul Root Wolpe describes an astonishing series of recent bio-engineering experiments, from hybrid pets to mice that grow human ears. He asks isn't it time to set some ground rules?TEDTalks is a daily video podcast of the best talks and performances from the TED Conference, where the world's leading thinkers and doers give the talk of their lives in 18 minutes. Featured speakers have included Al Gore on climate change, Philippe Starck on design, Jill Bolte Taylor on observing her own stroke, Nicholas Negroponte on One Laptop per Child, Jane Goodall on chimpanzees, Bill Gates on malaria and mosquitoes, Pattie Maes on the "Sixth Sense" wearable tech, and "Lost" producer JJ Abrams on the allure of mystery

View post:
Paul Root Wolpe: It's time to question bio-engineering - Video

BioEngineering Associates, Inc. – Mad River Bluffs Stabilization Project – Video

Bioengineering is a well-tested method of restoring damaged terrrestial and aquatic ecosystems. It emphasizes structures built of live plants combined with technical fabrics, gravel, soil, wood, and rock, as the basic building blocks that establish the restoration process. These techniques create strong living structures that establish a powerfully resilient riverbank which grows even stronger over time, and on its own, continues the healing process that leads to a long-term stable, self sustaining, plant and animal riverside community that is uniquely fish-friendly

Follow this link:
BioEngineering Associates, Inc. - Mad River Bluffs Stabilization Project - Video

Destroying Humanity with Social

Bisphenol-A (BPA), known as the "gender bending" chemical because of its connection to male impotence, has now been shown to decrease sperm mobility and quality. The findings are likely to increase pressure on governments around the world to follow Canada and ban the substance from our shelves. BPA is used widely to make plastic harder and watertight tin cans

See the original post here:
Destroying Humanity with Social

There’s trouble ahead for Pharma…

Pharma, Drug Industry, or as many of us fondly refer to it as "Big Pharma" is headed for trouble. There are four main sources of trouble for the industry and while this is no uncommon knowledge, it is worth repeating here:

1. Size:

No one wants to admit it, but pharmaceutical companies have bloated to sizes that are unfathomable within the realms of meaning or logic. Once companies get this big, all they care about are Excel files in which employees are mere cells if not columns. Every effort to fight costs is seen as an exercise in employee reduction.

Recently, I came across a rather depressing rebuttal to Scientific American's "1,000 Scientists in 1,000 Days", by Josh Bloom, a former employee of Wyeth, with a PhD in Chemistry and more than a few years of experience to boot, that complained about the jobs moving to cheaper locations.

While he paints a sobering picture and may create the impression that building careers in science and engineering may not help kids in the future, the point that the layoffs in big pharmaceutical companies have gotten out of control.

Consequences of size

The large scale of the organizations in question exponentially worsen the problems they face. Instead of taking responsibility, executives appear to stake out defensive walls and target large swathes of employees and lay them off. It is not surprising then that scientists like Josh Bloom appear disenchanted.

2. The buck-passing routine

Blaming the FDA or the federal government or pretty much any other entity but themselves has become a favorite with executives in some of these companies. With Senators and Congressmen acting as mouthpieces to their donors, the executives and the organizations, this has only become too easy. The Supreme Court has not helped with its irresponsibility in assuming that a laissez-fair state of donations is somehow constitutionally acceptable.

Company executives should exercise and assume strategic vision and indulge in creative solutions, not pass the buck and appear spineless.

3. Loss of exclusivity - the patent "cliff"

With many patents about to expire in the near future, about 110 drugs will lose their exclusivity between 2012-2014. This represents a significant loss of income for various pharmaceutical organizations. Before you herald your sympathy though, you should realize that the fact that the companies will be affected by the patent "cliff" was in open view, and should not come as a surprise to anyone.

Relying way too much on one and only one strategy - exclusivity to "blockbuster" drugs has led to the issue at hand, again something that these high priced bell-hops executives should have hedged against with alternates.

Simply acquiring companies and slashing jobs has of course been the only and ineffective alternate.

4. Conservative R&D

"Throughout the centuries, there were men who took first steps, down new roads, armed with nothing but their own vision." -- Ayn Rand

Cheesy? Yeah, maybe, but here is the deal. Drugs were released, not by MBAs equipped with pretty PowerPoint slides, but by people who struggled through starting companies and double mortgaged their homes. When these companies became acquired by larger organizations, R&D turned to becoming conservatives.

In trying to come up with new drugs, organizations have adopted the same age-old strategies, and used smoke-screens instead of real and deliberate attempts at innovation. This of course, has meant that only 21 molecules were introduced last year, as opposed to 26 the year before.

The Dendreon success story

When Provenge finally won approval, it should have served as an eye opener for many pharma executives that status quo is not a good R&D strategy. There are so many avenues available in genetic repair, personalized medicine and others that remain unfunded or under-funded because everyone wants "someone else" to do it, so that they can swoop in later on, acquire them and lay people off..

Companies that buck the trend and take risks to forge new paths will succeed while others will be left behind to acquire their way to oblivion.

5. Falling, falling, falling...

So, between 2009 and 2010, R&D investments fell over 3%, down from $70bn to $68bn. While that might seem small, according to Reuters, it is bound to fall more.

There are fewer IPOs slated for biotech organizations this year.

Investment in biotech start-ups is also down.

Conclusion

It is time that pharmaceutical companies got serious and set the right priorities. Companies need to trim fat, starting at the top. Stop passing the buck and take responsibility to make sure investors get positive returns on their investments. Make sure there is enough R&D funding and finally, remember they are in the business to improve people's health...

References:

1. Some numbers:

http://www.reuters.com/article/2011/06/26/pharmaceuticals-rd-idUSL6E7HO1BL20110626?feedType=RSS&feedName=rbssHealthcareNews&utm_source=twitterfeed&utm_medium=twitter&utm_campaign=Feed%3A+reuters%2FUShealthcareNews+%28News+%2F+US+%2F+Healthcare+News%29&utm_content=Twitter

2. On vanishing science jobs:

http://www.nypost.com/p/news/opinion/opedcolumnists/america_vanishing_science_jobs_V3TzWwPRZsmTh1sGmtVr8L?fb_comment_id=fbc_10150227908749349_17158421_10150228481934349#f2951ecb507bb

3. Scientific American's 1000 scientists in 1000 days:

http://www.scientificamerican.com/page.cfm?section=calling-all-scientists

4. Genetic Editing:

http://www.guardian.co.uk/science/2011/jun/26/doctors-breakthrough-repairing-genetic-defects

5. On passing the buck:

http://chaaraka.blogspot.com/2011/06/on-scott-browns-unfactual-rant.html

http://www.boston.com/news/nation/washington/articles/2011/06/27/biotech_industry_lobbies_against_medicare_cost_panel/

The Acne Apps Scandal – how a select few make everyone suffer…

Lately, there has been so much yelling and screaming by concerned "non-profits" and their "friends" about how taxes kill innovation, patents kill innovation, regulations kill innovation and pretty much anything that the party they support does not endorse kills innovation (I don't care about your politics, but stop being so transparent, please!).

And yet, for all this noise they throw out, the signals in their brains appear too weak. On one end, they hark about taxes, and on the other end they hang on to aging, inconsequential CEOs. On the other hand, what the hell do people think when, 
1. They let people design and sell apps that "cure" Acne by pointing a cell phone at something? Why did the FTC have to intervene? What is fundamentally wrong with Apple and Google that they did not actively seek out this nonsense and stop it.
2. There were 15,000 downloads of the apps. I am hoping about 14,990 of these downloads were done for a joke? Yeah, I live in fantasy land. Well you know, if we weren't this silly, why would a Government need to regulate such fundamental things?
Irresponsibility - the origin of regulation
Pharmaceutical, device and now app regulations arise because companies act irresponsibly. Sometimes so gravely and with such transparency and ulterior motives that it causes one to pause. The two acne apps are excellent examples of such behavior.
The industry cannot condone such action on one hand, and continue to seek fewer regulations on the other hand. It is just not going to happen. There are more than the 15,000 geniuses that downloaded the apps, and some of us think! - And when we do, we think for all of us, just not some of us!
The few that ruin it for the many
If, among the whiners and complainers, there are ones that really want less regulation, they need to take on the few that ruin it for all of us. Don't simply stand by everyone that crosses your path. Take a stance, fight back and then maybe, we can get some of those regulations down. 
If you simply want to complain, good luck..
Reference:

Source:
http://chaaraka.blogspot.com/feeds/posts/default

Elan was recently asked: Your workers or your private jet..guess what they chose?

A quick note: This month has seen me suffer a lot through the loss of my favorite feline Squeaky. This was predated with our failed efforts at using veterinary medicine to save him. I will be writing about this and my plans in detail. In addition, new deadlines and an extremely tight schedule are making posting quite tough!

Elan: This name means eagerness and earnest..as it turns out, the Irish pharmaceutical company chose to turn it into irony...

Companies like Elan are a staunch reminder that nothing has changed. Business, is as usual - an old boy's club. All everyone did was hold their breath for a little while and now, we are back to business. It doesn't matter that Boston Scientific just needs to pay $196mn. for the Guidant mess. Yeah, don't hold your breath with the lawsuit the Justice Department has filed.

It also doesn't matter that J&J's quality problems haven't found a bottom yet.

And yet, Elan comes out swinging as the worst. As it turns out, not only did they fire a bunch of their R&D folks, but flew on their private jet to let investors know how they are "saving money" and "on track" for 2011 growth..!

The result?

One irked investor claimed that while this was troublesome, Elan was a great company with a great molecule. Bravo!

Of course I could go on and on about the need for ethics and shareholder activism, but I thought I would just stop here, and rush back to dinner giving you some pause for thought..

"Do you really think pharmaceutical and medical device companies are going in the right direction?"

No, this is not about innovation that the President preaches, as if all that is holding innovation back is people's desire to jump out and start sketching on the white board...

Can companies survive, let alone thrive with such poor ethics and morals?

Until next month...

On Scott Brown’s unfactual rant…

It is like a scene from a bad cowboy movie. Or, a Chuck Norris episode, with GMC trucks and everything. Scott Brown was probably "coached" by his friends at some of the Biotech companies which have impressed on how they have to "train" FDA officials who are regulating them.

Equipped with this, he went and stood in front of a whole bunch of his Biotech friends in some dog and pony show in Massachusetts in his probably inimitable style, that gives no credence to facts or reality.

Here is a dose of what he is purported to have set. "Whether it’s the FDA, EPA or the “ABCDEFG, you name it — there’s so much overregulation right now,” he said. “When you go overseas, the processes are down, they’re set.”".

Too bad, entry into the U.S. Senate is not even under-regulated you say?

Well, according to Scott Brown's constituents, you have to drive certain vehicles, and take money from donors and recite what they ask you to say. See, the process are down, they're set!

Fighting with facts!

You may not like how the FDA regulates things. And if you choose to do so, you can fight in a way that doesn't make you look like a special-plastic smelling aficionado! Just don't do what Scotty here has done - ranting so poorly that one of the FDA spokespeople who he might deem "lacking in mental capability" was able to come out and say that Scott Brown is mostly, if not completely wrong - without having to try hard! As to mental capabilities, what do they say about it taking one to knowing...

Given that more devices and drugs have been approved over the past decade than ever before, and given that the US is still one of the safest bets as far as medical standards go, Scott Brown's statements make him look very eligible to hire himself out to children's parties for some quality entertainment, which some cynical people might deem all politicians to be eligible for...

Cacophony

Armed with the unfortunate ability that renders any ill-minded person to register "non-profits" in the US, a couple of them have engaged in all kinds of cacophony about "over regulation", "loss of competitiveness" and other terms that they can express without developing even a superfluous understanding for.

While the people of a state should observe and regulate their regulatory agencies, it has to be done without rants and forged reports. Bring up the facts, and urge patient-oriented action, not profit or donor oriented action.

Consulting "Experts" - the wrong way

On the other hand, Senator Franken got too excited and has asked the FDA to consult "experts" in the device industry before making changes to device approval processes. Er., should the cop stop you on the freeway and consult you on whether you were speeding or how much the ticket should cost you?

The right way

Health advocacy agencies that don't take money from biotech and device firms; consumer non-profits and other members of the public who have an understanding that goes beyond the sound-bites handed to US senators should be the ones most actively engaged in discussing any industry's state of regulations.

Senators, biotech companies and others have a right to fight regulations too, if they plan to do it with facts, sanity and coherence. That day, pigs plan to fly...

References:

1. http://www.bostonherald.com/business/technology/general/view/2011_0622fda_fends_off_browns_attacks/srvc=home&position=also

2. http://www.fiercebiotech.com/story/sen-brown-accuses-arbitrary-fda-crushing-biotechs/2011-06-22?utm_medium=nl&utm_source=internal

3. http://www.medcitynews.com/2011/06/sen-franken-to-shuren-get-industry-input-before-changing-510k-system/

Blog Briefs: A great resource: The National Academies Press makes all pdf books free!

About Blog Briefs: Having become too busy to write a lot, I have decided to blog briefly, throwing out news and opinions that might interest people who stop by. Moving on...

The National Academies Press!

It is highly unlikely that you haven't heard about the NAP, a confluence of various US organizations that publish several reports a year. Whether you are in sciences, engineering, entrepreneurship or policy making, you would use any valuable information that comes your way for free, right? Well, I read this press release, and jumped on the NAP site to find out that there are over 4,000 books that are now downloadable for free!

I tested one and found it really simple to access a book by subject and launch the download. While you could register and access some of their deals and such, you could also just proceed as a guest..

Link: http://nap.edu

A heartwarming story, a foundation and a few medical device challenges for the future

It bodes well for my spirit to take a break from the usual tug-of-war nonsense between the regulators and the regulated and all that other stuff and rehash a great story from San Jose Mercury News about a man who has found new life through a new limb...

The Story

San Jose Mercury News carried a very intriguing and interesting story about Johnny Nguyen, a local man who went through a terrific accident and suffered from severe burn injuries and had to lose his left arm, an elbow and all the fingers of his right arm in the consequential surgeries.

You should really read the rest of the story in the article referenced below. It is well written with a human touch, something that is rare in journalism nowadays.

Finding a prosthetic

Postulated severally in science fiction and future facing non-fiction, the 21st century is a time where losing a limb doesn't necessarily have to be permanent. However, this is easier said than done.

For one, development of efficient prosthetic devices that mimic a functional human arm, as opposed to a rudimentary hook (which is what Johnny started wearing initially following his surgeries) is very expensive.

Secondly, one has to find a way to afford these devices. Here are a couple of observations I made from the article, which, of course I cannot substantiate with proof from elsewhere:

1. Johnny's friends tried to contact several organizations that make such prosthetic devices. Enigmatically, the article mentions that the company from Scotland responded. I wonder what happened to all the US companies that were contacted. I also wonder how many companies develop prosthetic devices in the US....if there are enough companies developing such prosthetic devices locally, why have they not responded?

2. Johnny appears to have been someone that interested the company that did pay for his device, so that they could use his case to study how to use the prosthetic devices in situations involving other fire injury victims. Given the paucity of people within the US that normally sign up for any experimental therapies or in many cases, clinical trials at all, shouldn't local companies scramble to enroll people like Johnny as quickly as possible?

Bionic Touch Foundation

Johnny's friends who successfully teamed up to get him his prosthetic have realized the challenge that the device is going to be expensive for most people who will need them. They have a lofty goal of helping anyone in need of finding an upper limb. They are also offering academic help with regards to the writing needs of those who are looking for a prosthetic. All their efforts deserve a sound pat on the back.

Future Device Challenges

Now that we have gotten all the inspiring stuff out of the way, I thought it might be worthwhile taking a look at some of the challenges facing people who NEED the medical devices and not the ones that MAKE them. The ones that make them, have enough help from dubious "non-profits" already!

Most of the challenges have been discussed previously, but I thought there would be no harm in presenting them again:

1. Accepting the need for trials and experiments: If there is one place where people seem to especially fail, it is in enrolling in new trials. If enough people do not provide support to new procedures and new experiments, science, engineering and medicine cannot progress adequately. Treat yourself less as a victim, and more as a patient and try to find out how you can help yourself and at the same time, if possible, lay the course for the future.

2. Advocacy: I know, I am not making my points in an ideal order, but if more people had paid attention to the healthcare reform debate rather than saying "eh, politics is not for me", maybe things would be better. The cost of devices is dictated by several factors and many of these can be controlled by a conscious citizenry. In other countries, similar struggles will start soon enough. Keep your eyes and ears open, and act, not react. I came across a Chinese proverb that says, "Dig the well before you are thirsty" - enough said!

3. Identify the true leaders among companies: If it takes a company from Scotland to respond to customers with the customer's interest in mind, so be it. Such a company has risen above it's former peers and should be recognized thus. It is also really important to point out which companies fail to respond to customers, at least to provide information. This will let people make their own judgment on who leads and who follows the 90-day magical number dance...

4. Fundraising: All said and done, there will always be therapies and devices that will be necessary, will ride ahead of the reimbursement curve and will be expensive no matter what. Patients and their friends must look to creative ways to engage the local community and the wider populace in raising funds. Look to stories of success to emulate and improve upon with brainstorming.

5. Support Science and R&D: It is appalling that even in this day and age, science faces the same threat as it did in what some folks fondly like to try and forget as the "dark ages". Having politicians dictate science policy has very few tragic parallels in human behavior. Seek, demand and support sound science, research and funding that foster medical progress.

It is very heartening to read such stories of success, and one would hope to see fewer accidents and more success stories of the sort outlined here...

References:

1. San Jose Mercury News: http://www.mercurynews.com/ci_16932213?source=most_viewed&nclick_check=1

2. Bionic Touch Foundation: http://www.bionictouchfoundation.org/

3. Touch Bionics: http://www.touchbionics.com/