Thursday, January 28, 2010

Small Steps and Giant Leaps in the battle against MRSA

Although they have been around since the '60s, MRSA, and in general Hospital Acquired Infections have taken on a new urgency in the medical research spectrum (if you want more basic information, I am linking my older posts below). This should not be very surprising, since you would want to leave the Hospital healthy, not trading in one bug for another to be re-gifted to anyone who comes in contact with you.

Getting to the roots

For the longest time, it was assumed that MRSA was a cause for worry to folks that visited Hospitals and the effects on the larger society were not known. However, Hospital/Healthcare Acquired Infections have found their way into communities" and are now called "Community MRSA" and other names. It has been noted that these drug-resistant strains are adding, and not taking away from the hospital strains. All this has resulted in a general sense of urgency to try and understand the disease much better.

With modern biological tools such as very high-throughput gene sequencing, getting to the pathological history of microorganisms has become more detailed, if not easy or expensive. This is exactly what a team of international scientists at Britain's Wellcome Trust Sanger Institute are purported to have done. They took 63 strains of MRSA from across the world, ranging a timespan of twenty years from 1983 to 2003 and used DNA to try and understand the spread and maturation of the bacteria.

The results can only be termed ground-breaking at the least. The study was able to make it's unique findings because earlier genetic study techniques, were unable to pick through the minute changes and differences in strains. Without identifying these minute changes, such research and conclusions were previously not feasible.

1. The disease, as predicted, started in Europe and spread through South America and Asia. Where North America fits in is not clear yet (I haven't read the Science paper yet), but the very origin of the disease appears to be in Europe, not so unusually, coinciding with the time when antibiotics first saw heavy use, in the 1960s.

2. The rate of mutation in the bacteria appears to be about six weeks.

3. MRSA appears to have been created out of patients or their visitors bringing non-resistant bacteria to the hospitals rather than via transfer from patient to patient. This is a key finding, and it still may need verification, yet, it represents a large opportunity spectrum to fend off the origin and spread of the disease. We will revisit this later.


There are unique opportunities here, from a biotechnology perspective:

1. This study, with 62 samples was merely proof of concept, a starting point for very high-throughput genetic sequencing. There is a lot more work to be done to identify the origin, spread and other aspects of MRSA. A smart company could develop set of protocols and develop niche leadership, in quickly identifying and laying out the modes by which MRSA and other Hospital Acquired Infections spread. Such data would be invaluable for government and private healthcare organizations in the fight to fend off the HAI from affecting large portions of the public.

2. There appear to be lots of opportunities for bioengineering solutions, or medical device solutions that can help at prevention. Device solutions could either be consumer based, providing solutions for public places where MRSA can be found, or they can be based in the hospital setting where they can provide much needed protection against increasing rates of infection.

More on the MRSA coming soon...

Previous Posts:








Monday, January 25, 2010

Challenging the Pre-Market Approval Process and a commentary on the future of FDA's public meetings

There are two things I would like to highlight in this post. Let us look at them one by one, even though there is a thread relating them out there.

Reviewing the 510(k) Process

The dust has settled on the results of the study that the Institute of Medicine made for the FDA. A few things, such as the Massachusetts vote have caused the "media frenzy" to move on to other much clichéd "low hanging fruits". If you haven't heard, the report concluded that the FDA was handing out 510(k) notifications like sugar to kids...

Seething from yet another thorn on it's side, in a quiet mode, the FDA has called for a public meeting on February 18, 2010 to discuss the challenges it faces with the more than 30-year old pre-market notification process (somewhat like the unkempt twin I almost never had), also know as the 510 (k) process.

The 510(k) approval process is used for medical devices that are claimed to be "substantially equivalent" to another medical device that did go through the more rigorous "Pre-Market Approval" process before heading out to the markets. If the FDA agrees that the device is substantially equivalent to an existing, approved device in the market, then it is pretty much smooth sailing through the 510(k) notification process.

If you are new to all this, and would like to hear it straight from the horse's mouth:

Here are a few predictions I have as to what will ensue on the 18th:

1. A few "non profits" of note will show up and claim that everything is "mighty fine" with the process as it is now, and that any changes will only "hinder innovation". Of course, we all know those who throw "innovation" around like monkeys lobbing something around quite well.

2. A whole host of lawyers from large lobbying firms will show up and argue that it is probably a bad idea for the above stated reasons.

3. In all likelihood, the FDA public meeting will end in a date being set for another public meeting.

4. A few years down the line, there will either be two line items added or an extra document added to the process, to tighten it, include superficial data and conclusions from studies, or initiate some limited edition, post market approval observations.

Of course, I hope I am wrong and something good comes out of it. Only time, as a consequence of the reports on the 19th of February can tell.

What should be done anyway?

1. It was 30 days overdue anyway. The FDA should re-classify the severity of diseases and create separate "channels". A dermatological device definitely deserves difference in treatment than a cardiovascular device.

2. The onus must be on the companies. I have mentioned several times that the Democrats' attitude of "FDA takes David, Goliath et. al" in terms of regulation is definitely not the right approach, not by a long haul. While there cannot be any immediate changes till they fail and find this out, they can at least use the "Divide and Conquer" approach for the smörgåsbord they have come to take on.

Companies need to do more to ensure that the FDA has good quality information. Any shenanigans must be punished aptly and well documented applications must be honored and rewarded.

3. The review process should probably be more frequent than "once in 30 years". All review processes, pre-market and post-market need constant reviews and refocusing. With specific failures such as the ones that have come out in the past year or so, the FDA can convert accident into opportunity and create case studies to ensure that mistakes don't repeat.

Conducting meetings that actually bring in public opinion

Washington D.C., has Capitol Hill and Maryland is the base for the FDA. Yeah, we get it. It does not mean that the FDA needs to conduct every one of it's meetings in Capitol Hill or near it.

I am wondering other than the luminaries (lobbyists) present in and around Washington D.C., where does the general public actually have a chance to comment about anything?

1. First off, written comments don't always cut it.

2. It is sad to see that the party which used the power of social networks, YouTubes and BooTubes first lost a senate seat without putting up even a passable fight. It is worse still to see that the whole shebang of using the internet and modern technology has not been pushed into how the Obama Administration runs Government.


How about changing the style of meetings? How about relying less on "industry experts"? That obviously hasn't worked - er, for 30 years and more! A change at the top, should also mean change of behavior. Good quality, meaningful change in the interest of the larger public and medical device companies (yeah, we care too) will come only through universal "out of the box" sourcing, and not the "lather, rinse, repeat" mode that the FDA seems to be stuck in.

Let us wait until after the 18th to see how much of what I predicted comes to be true.


Friday, January 22, 2010

Follow up - Venture Capital stats for 2009 track the prediction for "cautious optimism" in 2010

The first post of this decade and year had the following shimmering title, "Welcome to 2010: Biomed Research is down, Innovation is dying and healthcare is reform is dead".

While the title itself did not contain the words "venture capital", the post talked about venture capital in 2010. At the point when I wrote the article, we heard that venture capitals will shrink in 2010. I will attach a related article/blog post at the bottom.

Today, the National Venture Capital Association (which must be getting a lot of hits for a website on a Friday night) announced a summary of venture funding that went on in 2009. As anticipated, venture funding was down in 2009. Reporters and bloggers, including yours truly are still mulling the data and the interpretations to be made. Let us make a cursory examination as follows.

Positive Developments

One of the first things to strike me from reading an article on the report was the fact that venture funding actually picked up in Q4. This is still in line with the theory that there will be cause for "cautious optimism".

Key Conclusions

From the report and the few articles I have read so far that have been based on the released data, here are a few conclusions we can draw:

1. Biotechnology, just with the sheer size of the funding needs still led in 2009, a year which saw the lowest volume and dollars flow through the venture funding system.

2. Biotechnology funding through venture capital also rose in Q4 of 2009, a ver good development and prognosticator, in the face of falling NIH funding and such.

3. In the interest of those who believe that the location of startups matters or that one region is better for start-ups than the other - well, all of them did equally poorly. You could brag about Routes 128 and such, but the economy blessed its vagaries equally on everyone.

4. Funding also fell across various industries and stages of start ups. There was a very small increase in funding for early stage companies in terms of dollars, but fell steeply in terms of deal volume.

Let's read tea leaves

Over the weekend and the next few days you will see colorful charts with pies, lines and numbers all over. Does this mean much to you?

Not really. The economy worsened over 2008 and 2009, demand fell consequentially and thus venture funding also fell. You can call it "the great panic of 2008", or whatever else that comes to your mind, but the facts remain simple.

What happened last year, was a regular, cliched, run of the mill slow down. This year, in all likelihood will be different. Thus, there will be the much celebrated "cautious optimism" in 2010. What else did you expect?

We all knew. Now we have Excel sheets to prove the facts.

What should an entrepreneur do?

My advice from the previous post still holds true. Bootstrap, be stingy and spendthrift. And may science (or technology) and good horse sense be with you.


1. My post on the state of funding in 2010:

2. Link to NVCA reports, data, etc:

3. The Minnesota take:

4. The New England take:

Thursday, January 21, 2010

Restart reform? Restart what? Come again...?

In the aftermath of the Floridization of Massachusetts and the election of a rather unimportant and inexperienced, fake trucker to one of the senate seats among a 100, one thing has come to light for sure - in the 21st century, people and politicians alike, still lack a sense of size and proportion.

Low quality newspapers, news studios and pundits controlled by shady folks such as Rupert Murdoch have claimed the death of healthcare and of the Democrat administration in general. Except, if you actually look at it logically, it makes no apparent sense for all the obvious reasons - the Democrats hold majorities in both houses, the President is a Democrat and so on...

And today, USA Today polled the usual suspects, that is one thousand randomly selected people and about 55% percent of them claim that "Democrats must restart the reform process and make it inclusive for the Republicans".

Might as well ask for a horse with the thing on it's head...

Okay, let's look at it:

Today the voice of the Republican party borders on manic. There is a certain laissez-faire with which an issue that could potentially leave 30 - 40 million Americans without any respite for their health problems is treated by the "Republican" leadership.

While Grassley is involved in solo essay writing contests to companies (at least he is doing something), several Republican senators are simply jubilant, awaiting their chance to simply block any legislation put forth in the name of healthcare reform.

Acting Responsibly

If it is indeed true that the lofty minded folks of Massachusetts voted to mirror the "nation's anger" on the one-sidedness of healthcare reform, will these lofty people communicate with the Republican leadership and make sure that they don't simply stall any new "restarted reform" legislation that get's thrown their way?

Highly unlikely, right?

Then what is the point of misdirecting your anger at someone who is trying something rather than someone who is trying, er, nothing? At least nothing productive?

Think and vote.

Not, vote and ignore.

The role of the Democrats

In all this, the Democrats had a major role to play. When the tea parties and other drivel showed up last year, they did not mobilize themselves properly.

And, enough with the infighting already! They should have punished Joe Lieberman for going AWOL. They should have made Bob Nelson toe the party line. They should actually be doing this right now - he caused some major delays and played a large role in this PR debacle.

Finally, the Democrats really need to understand what they are reforming and market it properly to the voting public.

Oh, and someone should tell them, they have majorities in both houses and the President!

Will all this happen?

With so much time having been wasted on disconnecting themselves from the public and passing the reform, the Democrats have also fallen way behind in job creation, immigration reform and other key issues. It is close to impossible that they will get any important legislation passed this year, or through the first portion of Obama's Presidentship.

So, from the next post, we will be back to digging our heals into medical devices, whistle-blower lawsuits, medicine recalls and such...

Monday, January 18, 2010

Welcome to 2010: Biomed Research is down, Innovation is dying and healthcare is reform is dead

Welcome back everyone. It is a new year and a new decade - a time for hope and renewal.


Wrong, first of healthcare reform is dead, thanks to the Republicans and the Democrats. Since it is not fully well dead yet, I am going to hold my analysis till it's time to er, read the eulogy.

Additionally, it appears that we all like to swathe around in our own predictions - of reduced venture capital, stagnant FDA approvals and reduced biomedical funding.

I am sure there is definite truth to the studies and predictions. First, let's discuss them and get them out of the way.

The future belongs to the optimists. The others, well...

Venture Capital in 2010

The predictions are out. The wonder is - who is surprised? The VC industry will shrink this year. There will be guarded exuberance and there is the slim possibility that commonsense may have the ever so small, yet valuable role of playing a role in what companies will be funded.

Hopefully, this means at least a few well grounded ideas will get past the myriad of social networking sites, solar cell ideas, balloons coated with stuff and metal, er, stents coated with crap.

Is that such a bad thing?

Biomedical Funding is going down

Can you name the last blockbuster drug or device? The only ones I can think of are Provenge and Acclarent (their balloon sinusitis device was one of the first devices I reviewed when I was learning and trying to understand blogging - I will attach the post at the bottom for nostalgia).

If $101.1bn can barely bring two products to mind, both unrelated to the actual funding, you might worry as to where all the money went.

I am sure some of it went to enable high quality research, but when results are down, the motivation to fund something also goes down. Of course, one would be wise to look at other factors:

1. The economic reversal of the last two years

2. The ability of Government to understand science and it's willingness to fund it

Of course, it is always good to have a mix of private and public funding.

How about some austerity?

You know, fewer meaningless conferences in Hawaii and beer, and more spending on research? That should take care of any fall in funding. Right? Or did I touch some raw nerve?

How about infusing some pragmatism into the reason behind funding - not research, but product development. Tough times call for tough measures.

If you are such good scientists, then you should be able to find ways to cut corners, right?

The ones that do, will succeed.

Help, Medical Device Innovation is dying

Er, what innovation? Have you noticed how every "expert" that writes that healthcare reform (which is now being killed) will somehow kill innovation?

Which brings us to what these people think innovation is:

Is it related to the cardiovascular system?
Let's build a stent company
That won't work?
Let's throw balloons at it

Do we need to remove tissue?
Then let's try RF
RF won't work? How about monopolar?
Oh, that won't work?
Let's try bipolar.
Wait that won't work too?
Let's try microwave....

You get the picture right? All the lull in the economy has done is, it has slowed the barrage of stent and balloon companies.

I am not saying there is no innovation at all in the design and manufacture of medical devices, but most of the naysayers have no clue as to what innovation means. They just found a party line and stuck by it.

What is innovation to naysayers?

1. Do not take any risks - simply rehash a stent, balloon or an ablation company, throw single-use in the mix somehow.

2. Hire the same people who have "years of experience" designing the same old tried, tested and meagerly effective stents or balloons. (Did you know that to-date, not a single device has proven effective - in the real sense that is, against atrial fibrillation?).

3. In the name of R&D, run the hamster wheel. Follow the same procedures, the same paths that you have previously been down.

Why wouldn't such innovation be expensive, and, er, not be innovation at all?

Do you think stopping healthcare reform will save us from the free fall of such innovation?

The future

The future always belongs to the daring, not to the weak. So, if funding is down and the times are tough, well, it is time to buckle down and get things done! So, that should be the theme for 2010 - optimism, in the face of all that we see.

Ain't that a great way to start blogging in the new year, even if it is eighteen days too late?