The eCTD is a specification designed by the International Conference on Harmonization (ICH) to provide an interface for pharmaceutical companies to transfer regulatory information (such as marketing applications, renewals, variations, etc.) to health authorities.  The eCTD specification consists of five modules: 

1. Administrative Information and Prescribing Information
2. Common Technical Document Summaries
3. Quality
4. Nonclinical Study Reports
5. Clinical Study Reports 

Module 1 is regional in nature, and the requirements and structure of this module varies from country to country.  Modules 2-5 are the same for all countries that adhere to the specification. 

An application for marketing authorization may consist of hundreds to thousands of distinct documents (chemistry, manufacturing and control (CMC) information, benefit/risk analyses, labeling, study reports, etc.).  The eCTD specification outlines the types of files that are supported (PDF, RTF, JPEG, etc.), folder structure requirements, naming conventions for files and folders, metadata requirements (such as a table of contents) and stylesheet guidelines.  A submission that is structured according to the specification can be viewed using an eCTD viewer or even a standard web browser. 

The ICH consists of representatives from the big three regulatory bodies (US, Europe and Japan). So, of course, these agencies are leading the way toward fully electronic interfaces. 

• As of January 1, 2008, all marketing applications must be submitted in eCTD format to the FDA. Waivers are available by request.
• From July 1, 2009, the EMEA will strongly recommend eCTD format submissions for all approval routes. Exceptions may be granted by request.
• Japan’s authority (MHLW) accepts eCTD submissions, but adoption has been slow due to unique MHLW requirements for Module 1. 

Some other countries, such as Australia and Canada, have also taken steps toward eCTD requirements. 

The goal of the move to electronic submissions is to decrease the amount of time it takes for the health authority to review an application and its related lifecycle documents.  However, after the first six months of the FDA’s 01-Jan-2008 mandate, results were mixed (see “The eCTD - a Six-Month Checkup” on Bio-IT World.com).  The FDA received over 30,000 electronic submissions in the first six months, but many submissions were of poor quality (e.g. missing table of contents, missing Module 1).  These mistakes often result in application rejection, which in turn, ends up increasing the amount of time for review.  

Things are expected to get better, though.  The pharmaceutical companies will get better at electronic submissions (either through building skills in-house or outsourcing) and the tools for authoring eCTD-compliant repositories and managing changes to the application throughout its lifecycle will improve.  Electronic submissions are obviously a vast improvement over paper submissions on all fronts.  There will be growing pains, but we should see significant positive results before the end of the decade.

Sequenom is one such company on the list that I found particularly interesting. 

As I approach my mid-thirties, along with many of my friends, I find myself still at the early stages of raising my own familial unit, with future children on my mind.  This is in sharp contrast to the experience of our parents, who most likely at this point were finished with that stage of their lives and had children many years older than ours.  We all have our reasons for starting our families at a time that would be considered “late” by our parents’ standards, but one of the downsides is increased (albeit still small) risk to the baby for Down Syndrome.  Amniocentesis is one of the best accepted methods to screen for this disorder, but it carries with it a risk of miscarriage and can only postiviely identify 70 to 90 percent of the cases prior to birth.  Sequenom, however, has developed a method that could trump amniocentesis at identifying Down Syndrome cases — so far with 100% accuracy in clinical trials — and do so with minimal risk using only a prenatal blood test.

Sequenom’s technology, dubbed SEQureDx(TM), targets fetal DNA circulating in the mother’s blood to examine the genetic status of the fetus.  The first application identified a fetus’ risk for RhD disease, which occurs when the blood of an expectant mother is incompatible with her unborn child.  Jaundice, anemia, brain damage, heart failure and even death can result from the incompatibility, so identifying it early is crucial to taking measures against it.  Showing that it can additionally be applied as a method for testing a fetus for Down Syndrome would be an added incentive for any potential buyers for the company.

I am encouraged by the company’s charter to make “safe, non-invasive prenatal testing available to all women, independent of age and other factors that may contribute to pregnancy complications,” and am hopeful that the knowledge gained in this kind of research could lead to an increased understanding of the kind of defects that could affect the normal development of an unborn fetus.  As parents, knowing in advance how we should be prepared for any difficulties an unborn little one might have is invaluable and gives us the opportunity to prepare for what might be.

The obvious win for any pharmaceutical company that entertains the idea of Sequenom as an acquisition is an increase in the number of parents willing to run the test.  Like many parents, I fear the risks of amniocentesis, despite the information it will give me.  If the risk is mitigated, then wouldn’t more parents do it?  Would it just become part of the standard barrage of tests that expectant mothers are put through?

They say knowledge is power.  Today, we may be having our children later, but we know a lot more about them before they are born than our parents ever did.  Gender, heartbeat, skeletal development, and soon even certain genetic diseases can be safely screened well before the baby is born and steps can be taken to prepare for or even prevent hardship for the child later in life.  But does this take any of the excitement or anticipation out of child birth?  Does knowing any of this information change the way you feel about a child growing inside your wife (or you)?  Or does knowing the information help you prepare to be a better parent?

Your thoughts, as always, are welcome.

I was packaged April 28, 2008, in Puerto Rico. My Batch Number is AA6-73P008. I will expire on January 15, 2012. I am associated with 2-D barcode KBDCHDH1528. I was packaged for distribution in Canada. I can tell you as much information as you design me to tell. My codes are undetectable to the human eye so no one can copy me. I am traceable anywhere in the world. I will tell you and only you this information. And I can tell you all of this for less than a penny. (Image published with permission)

So read the ad for NanoGuardian, a state-of-the-art protection system against those who would hope to counterfeit real drugs for a quick profit, or divert real drugs from their intended destination. I found it in the August 2008 issue of Pharmaceutical Executive magazine and was so intrigued by the concept that I had to find out more. So I took note of the web site and immediately started an investigation.

The technology that makes tagging this pill possible, NanoEncryption(TM), was developed by a company named “NanoGuardian (a division of NanoInk).” Using this method, as the ad implies, pharmaceutical companies can add an invisible layer of encrypted data to each dosage of their medications, linking it to an authentication at every stage of their supply chain. Only special tools can actually decipher this code, which links the dose to the package using a proprietary nanolithographic encryption on the dose itself, and Radio Frequency ID tags (RFID) and bar codes on the package. Therefore, if the pill is separated from the package before it reaches the patient, there’s a way to find out.

The technology probably couldn’t have come soon enough, given the growing counterfeit market out there. Email marketing from dubious online pharmacies, which I explored on this blog before, is just one of the many ways these groups can hawk their bogus wares. To me, the biggest concern isn’t even the lost revenue that counterfeiters cause the pharmaceutical companies in creating these fake pills, which NanoInk estimates around $35 billion worldwide. The biggest problem are the patients who are getting their hands on these drugs and endangering their health by taking them.

The process does not chemically alter the drug, and implementing the technology in the manufacturing process requires minimal changes. In fact, a client of NanoGuardian has already submitted a plan to the FDA to implement brand protection through use of the product and has been approved. It wouldn’t surprise me, if this first implementation can be executed successfully, to see other companies start publicly touting the added protection they’re giving patients who rely on their products.

The whole thing actually reminds me a little of a story that came out earlier in the year, where a Silicon Valley company, Gemory, had developed a process for permanently inscribing microscopic versions of photos on a diamond. But while their process may be a novelty and something that is a luxury for people with the money to do it, NanoGuardian’s product seems to be almost a necessity.

The one thing that’s unclear to me is exactly how the patient ends up being protected in this process. The web site for the company is clearly designed to “sell” the product to the industry, which it completely should be. But how do I know as a consumer that what I’m buying is a legitimate drug? The NanoGuardian site indicates that the encryption can only be detected using specialized equipment at the NanoGuardian Authentication Centers…but does that mean that as a consumer I have to send my drugs there before using them? Do pharmacies need to authenticate their medications before stocking them on their shelves? And if it’s not a requirement, what is the impetus for sending the drug for authentication in the first place? If counterfeiters are really good enough to make drugs that look nearly identical to the product they’re duplicating, how would I know that I even need to authenticate? And what’s the cost of authentication? Putting the information on the pill may not cost much…but ensuring a pill has the right information before it reaches the consumer? What does that cost?

I’m sure some of these questions are obvious to some that are entrenched in the industry and familiar with the supply chain. And maybe my brief exposure to the process is naive in that I’m thinking the authentication will be applied in a singular place in the process. I’d love to understand this process more, and would welcome comments from anyone who understands its application better than me. In the meantime, I look forward to seeing the first real products that can ensure their quality because of the tiny writing on the pill.

That said, no other exercise gets me into shape more quickly. It gives me reason to hate it even more. I suppose it’s one of life’s cruel ironies that something I hate doing so much could be so good for me. I often wonder to myself (or aloud when I’m running, much to the dismay of passers-by), if there was some way I could get the benefit from my workout with less effort on my part. It is a paradoxical and unrealistic request given everything we know about exercising, but, believe it or not, there may soon be a pill for it.

A California research team doing tests on mice may have identified a method to activate compounds in the body that would increase fat burning ability and dramatically increase endurance, according to Boston.com’s White Coat Notes from Thursday, July 31st. The study, published on the same day in the journal “Cell,” shows that the PPAR-delta master gene, responsible for controlling metabolism and muscle fibers, can be reprogrammed to burn fat and increase exercise endurance using only drugs.

The study obviously has several moral and ethical implications, so much so that in anticipation of the Olympics, scientists in conjunction with the World Anti-Doping Agency have concocted a test for blood and urine that can test for even the tiniest traces of the two substances that make up the drug cocktail. The suspicion is that a lab somewhere may be able to reproduce the chemicals for competitive athletes, giving them an unfair advantage in competition. Any broken record is reason enough for suspicion, as Dara Torres is quickly discovering after she broke a US swimming record recently.

The other downside to the pill is getting the dosage right. According to the study, the month-long trial in the mice would translate to about a three-year regimen in humans. In treating diseases such as obesity, it might be too long a wait.

The process is activated through use of two drugs, AICR and GW1516, the former of which is currently licensed by Schering-Plough to help control bleeding in the human heart. It will probably be some time, however, before clinical trials of the two drugs in tandem can commence, and even longer before scientists understand the implications of changing how muscles function in the body. And I don’t know about you, but the thought of taking one or more pills for the rest of my life to maintain a svelte figure and a higher level of endurance isn’t appealing to me. Perhaps, if proven to be safe, whatever company decides to produce this drug can dangle it as a carrot to Mike Adams, sponsor of the $10,000 health challenge to big pharma.

The fundamental philosophical question is how far we’re willing to push to have something else do the work for us? We’re developing pills to make us younger, pills to make us healthier, pills to put us in better shape. What happened to eating right? Exercising? Scheduling enough time in what seems to be our infinitely busy lives to use the tools that nature gave us rather than looking for the quick fix? As time goes on, it seems more choices are developed by the pharmaceutical industry to circumvent a natural process to give us more time. As we get it, however, we lose sight the one basic principal through which appreciation of that time is developed: our patience.

I think I’ll take that run now.

But this week, we return to blogging with another entry into the virtual world of Second Life. I was excited last Wednesday evening, June 11th, to be able to attend a talk hosted by Simon Bignell, a lecturer at the University of Derby in the United Kingdom. Using his Second Life alter ego, Milton Broome, Simon gave us about an hour of his time as he told us about the research that’s being done in virtual worlds on Autism spectrum disorder and Asperger’s (to keep tabs on what Milton is up to, check out his web site).

This was my first experience using the voice features of Second Life, and I must say I was impressed by the fluidity of the lecture given that I could now hear the virtual presenter speak as opposed to just listening to text being typed on a keyboard before a paragraph appeared on my screen (to read more about the first lecture I attended, which was not voice enabled, click here). There were some technical difficulties to start (objects creating the ever-present sound of waves in the background, for example), but once the lecture began I thought things went very well; it was clear to me that Simon/Milton had done this before.

The objective of Simon’s project is to determine if Second Life, and virtual worlds like it, can be used as a medium to help develop the social and communication skills of those people who might be suffering with some form of Autism. Firstly, in spite of promoting its voice capabilities more and more, the ability to have typewritten conversations in Second life is really an advantage to people in this group; because of their difficulty at quickly and correctly interpreting social situations, the autism community has embraced this medium because it effectively slows down the social interaction to a point where they can keep pace and learn the dynamic skills necessary to react appropriately. Simon emphasized this by pointing out that the average colloquial conversation occurs at 150 to 200 words per minute; the typewritten conversation, at best, occurs at 15 to 20 words per minute, 10 times slower than a spoken conversation. Therefore, in spite of all the advances made with voice communications in Second Life, and the ability to have a real lecture in a virtual world, the autistic community might not be ready to embrace this kind of advancement as readily as some of their non-suffering counterparts.

In fact, most of the work Simon is currently doing revolves around understanding the needs and developing programs to assist the growing community of people living with Autism in Second Life and he’s clearly not alone. You may recall my blog entry in January, “Bridging Solitary to Social Via Virtual Reality,” where I wrote about Center for Brain Health at the University of Texas at Dallas, who developed a virtual town in Second Life as a kind of treatment area for Autsim. I’ve posed the question before: is there a possibility that a Second Life could serve as a therapeutic instrument for a First Life?

A critical component of that is better understanding the condition you’re trying to treat. To that end, I was pretty interested to hear that Simon is working on an “Autism Simulator,” similar in scope to the Schizophrenia simulator I visited very early in the existence of this blog (see: “Schizophrenia with a Technology Twist“). With it, Simon hopes to reproduce some of the sensations someone living with Autism might experience, including alterations in light, noise, touch, and even obsessions and comorbidity. Ultimately, he hopes to use this project as a platform for collaboration among the many groups in Second Life who strive to understand more about this condition and ways to treat it.

There is no doubt in my mind that Second Life and people like Simon Bignell provide novel ways to investigate and understand the challenges associated with social conditions such as Asperger’s and Autism. While I still feel today, as I did a year ago, that things are probably not yet where they need to be in order to bring the technology to the masses, I do feel that there is progress. The greatest difficulty, perhaps, is conveying the idea that places like Second Life are more than just a platform for gaming; they are worlds that can be shaped entirely by the power of human imagination — that is, of course, if the technology can keep up.

What do you think?

Surely, hard drives will continue to get smaller, and ways to transport the data we store on them will continue to become more convenient. Today I got a glimpse into that future when I read about scientists who have discovered a novel way to store data using DNA. According to an article on the “Science Daily” web site, researchers at the University of California at Riverside (UCR) have discovered a way to encode digital information into DNA. The methodology eliminates the need for expensive sequencing machinery, presumably making it a more accessible process and conducive to use within a mass audience. It was developed by Nathaniel G. Portney, Yonghui Wu, Stefano Lonardi, and Mihri Ozkan from UCR’s departments of Bioengineering, Computer Science and Engineering, Biochemistry, and Electrical Engineering, and the Center for Nanoscale Science and Engineering.

You can read more about the process in “New Way to Store Information Via DNA Discovered” on the Science Daily web site.

Reading about this whole methodology made me curious as to the practical applications of this type of discovery. Firstly, storing information in DNA seems to be something still out of the realm of science fiction…what kinds of side effects would occur in the DNA as a result of its manipulation in order to store data? Second, decoding the information still is a more complicated process, so we’re not quite at the point yet of being able to interface directly with a computer using our finger and a scanner to store data within our own bodies. Perhaps, however, this kind use of our DNA isn’t far off.

I don’t purport to know everything there is to know about this topic; admittedly, it was something I happened to glaze over while reading possible articles for this week. Therefore, if there’s anyone out there in cyberspace who can maybe provide more insight on this topic, I’d be happy to hear your thoughts. I am always fascinated with any attempt to use our unique human characteristics to take the next evolutionary step in our use of technology.

The Cleveland Clinic currently offers its patients an electronic personal health record system, called eCleveland Clinic MyChart®, on which participants can view portions of their personal health record and related information, request and cancel appointments (presumably within the Cleveland Clinic health system), request prescription renewals and review other medical information relating to health. There are currently approximately 100,000 users, but only between 1,500 and 10,000 patients will be able to participate in the pilot.

The goal of the project is to provide new features and services that will allow patients portability of their online records outside the Cleveland Clinic’s online system so that patients can take the information wherever they need it, even if that’s outside the Cleveland Clinic’s network. Google targeted the clinic in this partnership because of their existing online infrastructure and felt the transition to a nationally available system would be more easily accomplished. Specifically, the new service has three main objectives:

• National Access-A more efficient and effective healthcare system driven by a working interoperability model that moves electronic medical records from a closed model to one that is open and connected.
• Consumer Empowerment-A secure patient-centric, consumer-driven tool that will provide each consumer increased control of their medical care, without compromising their privacy. This will empower patients to actively manage their overall health.
• 24/7 Access/Portability-A web portal with 24/7 access, capable of providing the consumer with an opportunity to actively engage in their health care, heightening the importance of quality care and service by providers.(1)

This sounds like a perfect use of technology in today’s increasingly complex world of managed health care. I am, generally speaking, pretty healthy, and have no major issues on my medical history that I know of. But being able to access that medical history whenever I wanted to is an appealing prospect. Further, I see a tool like this more useful to those of us might have to deal with multiple doctors, or worse, multiple doctors who give multiple prescriptions. Being able to access your cart instantly via a web browser is priceless, and would likely offer the opportunity to cut down on mistakes that could occur from an unintentional omission of a critical piece of information from one’s medical history. This kind of tool would also be especially useful to someone who might suddenly find themselves needing to care for a loved one who is unable to do it themselves anymore — or to track their children’s ailments more readily and with fewer mistakes.

But does this kind of information and its availability come at a price? While the release touts the security being put in place to ensure a patient’s privacy, I question whether this kind of information online invites hackers to break into the system and invade sensitive information. I admit that though I am a staunch supporter of anything that can make my life easier online, I have also been very slow to adopt anything that will put my personal information out there, such as online banking, online bill pay, or even online trading. It would take some time before I’m convinced that such a service is truly private, and while nothing is completely hacker-proof it should make me feel comfortable that only the most brilliant programmer would be able to get their hands on my records.

Perhaps I’m being paranoid.  I’m not rich, famous, a politician, or otherwise visible in the public eye, so what good would my medical records be to somebody?  As long as someone wasn’t able to Google my name and find out even when my last doctor’s visit was, I would be comfortable that there wasn’t too much information about me out there.

What’s your take?

(1) See “Google, Cleveland Clinic Team Up On Patient Records,” BioSpace.com, Feb 21, 2008.

Dolly the sheep died in February 2003, a few months shy of her 7th birthday. She was euthanized because she suffered from an incurable lung disease, linked to a condition of premature aging that was believed to be a result of the cloning process. Dr. Harry Griffin, a scientist at the Roslin Institute in Scotland which was responsible for the cloning process, says that lung infections are more common in sheep housed primarily indoors and about 11 or 12 years old. You can read more about this remarkable animal on the Reuters.com web site, starting with “Dolly the sheep dies young,” published on February 14th, 2003.

From my own perspective, I was hoping that this kind of science would be relegated to the mind of Mary Shelly and other great authors of our past. At least, I was hoping cloning would be used to better understand the creation of life perhaps, but not to be subverted into a private commercial enterprise. A South Korean biotechnology company, however, has other thoughts. RNL Bio expects to deliver its first cloned canine in February 2009 to a US woman who had saved biological material from her pit bull that recently died, according to another Reuters article from February 14th entitled, “Retrieve a retriever from a Korean dog clone firm.”

When I first read about this new “service,” I was immediately reminded of Stephen King’s “Pet Semetary,” where the main character resurrects a pet cat by burying it in a local, somewhat magical cemetery. The cat does, in fact, rise again, but it is an empty shell of what it once was, changed into something more sinister, and a somewhat ominous sign of things to come. Now, I’m sure the US woman who ordered this clone will end up getting a pit bull that is every bit as lovable as the original, but the article doesn’t express her expectations from this animal that will be delivered to her. Is she expecting the exact same dog? How can that be even possible, when the environment in which the dog grew up cannot be replicated?

The most astounding part of all of this is the price tag: up to $148,000 for a puppy. While the article indicates that there are people who would rather clone a pet than to adopt a new one, it’s difficult for me to understand how strong that connection must be in order to justify such a cost. As I was reading this article, I remember asking my wife whether, cost notwithstanding, she would consider using the service herself. I asked her because she lost two dogs in the last four years to which she was strongly attached. She responded “no” quickly and decisively. She indicated that despite the fact the dogs would be genetically the same, they would not be hers, essentially lacking the souls that allowed her to connect with them in the first place.

In reaching out and attempting to transcend the death of a beloved animal through cloning, what does RNL Bio hope to accomplish? Are they promoting a service that will help people to avoid the pain of death? You may remember in my post, “Appreciating Happiness through Melancholy,” that the cost of eliminating pain in life might be the very happiness that we seek to preserve. I wouldn’t be willing to risk that happiness by preserving the physical presence of an old pet through cloning. I’d rather let them live more powerfully in my mind through cherished memories.

What do you think?

As you know from a number of posts on this blog, I’ve been writing extensively about my experiences in Second Life, and how pioneers in this virtual world are leveraging its unique characteristics to either further their educational mission or help people with what ails them. In my post entitled “Schizophrenia with a Technology Twist,” Dr. Peter Yellowlees was one of those pioneers in his work with schizophrenia and building an experience that communicates some of the sights and sounds a person suffering with schizophrenia might experience in their everyday lives. I wrote 2 posts on the Ann Myers Medical Center in Second Life, each focusing on different people within that group and how they’re leveraging Second Life for its educational values in a variety of areas in the medical field (see posts 1 and 2 by clicking on their respective numbers).

In addition, because of my young son, I’ve been profoundly interested in research on autism given its suggested link to vaccinations in children. I’ve explored this debate on a couple of occasions, both in my post on “The Vaccination Debate,” spurred by Jenny McCarthy’s appearance on the Oprah Winfrey show in September, and on last Friday’s post named, “Hot Spots, Hot Topic,” where I read and posted my thoughts on the recent confirmed link of 1% of autism cases to spontaneous defects in DNA that were not passed to children by their parents.

The convergence of the two topics occurred this week in the Information Technology section of the Chronicle of Higher Education, where the author Katherine Mangan writes about treating those afflicted with autism by using the facilities available in Second Life. In reality, I wasn’t really surprised that this had happened; I suggested that autism might be a good candidate for treatment in a virtual world at the end of “Schizophrenia with a Technology Twist.” But it was encouraging to see that there is a group currently working to apply the technology to real-world patients, and finding some success in the treatment.

According to Mangan, the Center for Brain Health at the University of Texas at Dallas has developed a virtual town in Second Life where patients suffering from Asperger’s disease, a milder form of autism marked by normal intelligence, can roleplay different, simulated scenarios that might have caused them stress in real life. According to the center’s director, Susan B. Chapman, the virtual world can be tuned by a clinician to match a patient’s needs, and statistics can be gathered easily measuring their response to the exercise. The safe environment gives the patients an opportunity to “do-over” if they deem the results of their exercise unsatisfactory.

Voice plays a role in these interactions, and bring a real-world feel to the virtual environment. On any given day, patients can be seen interacting in the fabricated world as if they were really meeting in a park, or a store, some other venue. Clinicians and volunteers also interact and assist patients with small talk and conflict resolution, apparently with some success.

One example of this success is Matt Kratz, a 35-year-old graduate student with Asperger’s syndrome. Treated by the program, he feels better prepared to interact socially with people in the real world, and is more capable of identifying situations in which something he says or does may be interpreted in a negative way. His experience is supported by brain-imaging and neurocognitive tests that were taken on patients before and after their virtual-world experience. The three patients tested so far have shown positive results in several areas where they may previously have been hindered, including, as the article puts it, “social appropriateness.”

I tried my hand at logging into Second Life and finding the center, but was unsuccessful in my pursuit. It’s likely been made private to keep out stray, prying eyes (like mine), who could interrupt the work that’s being done there. I will try to get a tour and write up my experiences here at some point in the future (perhaps this might be an interesting virtual field trip for the members of the New York Biotechnology and Pharmaceutical meetup group?). In the meantime, there appear to be several groups within the virtual world designed to support those who might be suffering with anything from severe autism to the milder Asperger’s disease. If you know someone who suffers from one of these disorders, it might be a benefit to them to explore this venue as a place where they can connect with others who better understand how they feel and what they experience daily.

Do you think that virtual reality is a good way to treat some of these mental disorders? What is your experience with autism, Asperger’s or any other mental disorder that might be appropriate for this model of treatment? I’d be curious to know if this kind of treatment needs to be perpetual, or if, at some point, a person is considered “cured.” Additionally, I’d be curious to know if researchers have considered the possibility that some patients might need a chemical component to their treatment, or if the virtual treatment would be enough. We certainly are embarking into an intriguing new therapeutic area as these worlds become more prolific, but for what consequences, if any, should we prepare ourselves as we delve in further?

As always, I welcome your thoughts.

Sound like science fiction? Much like the Microbots I described in my previous article, this may not be as far-fetched as it sounds. Philips recently applied for a patent for a remote-controlled pill that contains compartments for medication, electronically controlled release valves that can be operated via a timer or radio control, and a Radio-Frequency IDentification (RFID) chip for inventory tracking. The pill is a revolutionary step beyond existing time-released pills because they can be tailored to a patient’s specific body chemistry, releasing medication according to their body’s ability to absorb it. The pill’s unique properties don’t stop there, however.

The pill will also be capable of controlled release via remote radio control by doctors, such that medications distributed in a hospital, for example, will no longer require disturbing a patient’s sleep — doctors can simply press a button to release the appropriate amount of medication. Further, the pills can adopt to environmental factors as well, capable of perhaps determining pollen levels in the body and adjusting dosages of an antihistamine or other allergy medication based on those parameters. And one of the main objectives of Philips is to make the pill cheap and disposable, such that there won’t be any need to “recover” a used capsule.

Is there any downside to such a pill? I’d be curious to know what the pill is made of…and what kind of complications could result in taking the pill. Since this is a medical device, and not necessarily a new medication, how would something like this be regulated by the FDA? Would clinical trials be required before they could be distributed to the general public, and if so, how would you conduct such a trial? What would happen if the pill fails? Does it prevent any of the medicine from being dispensed? Does it alert the user that something is wrong? Once it’s in your system it’s clear that it can be controlled, but what kind of failsafe mechanisms are in place to prevent harm to the patient?

These types of pills would likely be a godsend to the groups that need to take a cocktail of medicines to stay alive, or at least lead a normal life. Cancer patients, AIDS sufferers, the elderly, and any number of other groups would benefit from the ability to take one or two pills a day that would handle the guesswork of what medicine needs to be taken when. And the cocktail could also be fine-tuned to their specific needs and environmental factors, distributing only as much medication as the patient might need.  I would have considered such a pill for us after our son was released from the hospital with his second bout of RSV, though it in reality it wouldn’t have been practical because of his age at the time.  He was on a number of medications that had different requirements for their dispensation, and we had to actually create a spreadsheet in order to keep track of them. The precision of a robotic pill would certainly mitigate the human error that could occur when so many dosages need to be tracked.

But, as with any technology, the risks need to be considered as well, and when dealing with human health, the consequences could be far more serious than the failure of a new piece of software to deliver on its promised functionality. Would you be willing to take such a pill that could regulate all your medications for you? Would any risk of failure of the device be acceptable to you?