Unfortunately, the Pharmaceutical and Biotechnology industries have not been immune to the collapse.  Since this all began a couple of weeks ago, it seems that many companies have seen a downward trend in their publicly traded stocks.  Schering-Plough (SGP) has seen its price drop from $18.08 on September 15th to $16.05 as of yesterday.  Sanofi-Aventis (SNY) has dropped from $34.98 to $30.90 in the same time period.  And even though Pfizer (PFE)  seems to have traded relatively steadily over the same time period, it is trading in a range that its not seen since 1997.  And biotechs like Celgene (CELG) and Genentech (GENZ) plummeted 7.5% and 7.9% yesterday alone.

All of this obviously induces stress and sleeplessness, and what could be takes the toll on the owners of small businesses.  Never before have I wished so badly that I could go to sleep and wake up to find my portfolio back to its pre-crisis state.  And you’d think a bunch of other bleary-eyed people would love to join me, if only insomnia would not rear its ugly head and keep these people awake.

And what about those who need that little extra something to help them to nod off?  You may recall last year when I cited a Northwestern University study indicating that a lack of sleep has a cumulative negative effect on our bodies.  Sanofi-Aventis’ Ambien and Sepracor’s Lunesta were two drugs I mentioned that help people transition from a waking state to a sleeping one.  Though Lunesta has recently had some difficulties in a market becoming increasingly saturated with competitors (like Ambien and generic formulations of the same), they all seem to be viable sleep options for some people (provided you don’t use them as a cure for insomnia and a substitute for self-induced sleep; if that’s the case then you should see your doctor for other remedies).

Personally, I’ve found a good cup of warm chamomile or warm milk with a little bit of honey always helps to relax me.  I’ve also read that Cognitive Behavioral Therapy, Visualization and Progressive Muscle Relaxation can act as powerful and natural tools for those who don’t wish to turn to drugs as the answer for sleep deprivation.  Even a good book, after a couple of chapters, weighs my eyes and lulls me into sleep.

When one is stressed, as it seems is always the case for many people lately, it is clear that sleep is critical for keeping those stress levels at bay and keeping your mind as sharp as possible to face the challenges on the horizon.  If you’re not sleeping, you should; your productivity suffers and in general you are likely to be less content.  And though forcing yourself away from work, especially when you are in a groove, may seem like the worst thing you could do, the sleep you get in return will certainly make up for it.

What kinds of remedies do you use for getting yourself to sleep at night?  Do you use any home remedies, take advantage of pharmaceutical sleep aids, or just stare at the wall?

I look forward to hearing your responses!

There are a number of strategies that the brand-name manufacturers have employed since the Hatch-Waxman Act in 1984 in order to stave off generic manufacturers and retain market exclusivity.  The most common tactic is a combination of “evergreening” and aggressive litigation.  With evergreening, the company stockpiles patents on as many aspects of the product as possible.  When a generic company attempts to get marketing authorization, the brand-name manufacturer takes the generic company to court over claimed infringements with some patented aspect of the product.  This allows the drug manufacturer to delay the entry of competition and retain its big profits (for up to 30 months or longer in the U.S.).

However, litigation is only a short-term strategy - eventually the generic drug makers will enter the market.  Other tactics meant to invoke a more gentle decrease in product price once the generics invade are: 

• Patents on new formulations / combinations - Coming up with better delivery methods, simpler administration routes (e.g. once a day versus three times a day), combination products and new isometric forms may stifle competition and keep doctors and patients coming back to the brand name
• Patents on improvements in the manufacturing process in order to decrease costs
• Aggressive advertising campaigns to keep their products fresh in the minds of doctors and patients. In addition, brand-name manufacturers jump on every opportunity to promote bad press about unexpected adverse events with generics (i.e. the heparin from China fiasco) or poor manufacturing controls (such as the FDA ban of 30 generics from Ranbaxy). These negative advertising campaigns are meant to scare consumers aware from generics.

Lately though, the market is starting to take a different turn. In a number of ways, the brand-name manufacturers are starting to play more of a hand in the generics market. 

• Some brand-name manufacturers have begun marketing their own “authorized generic” to compete with the first generic manufacturer to gain entry. This may be done through a subsidiary or through a licensing deal with another generic manufacturer. The brand-name manufacturer gets a slice of the pie while decreasing the profits for the first generic competitor. When paired with the delays and costs of an aggressive litigation campaign from the brand-name company, the generic drug maker may be deterred from entering the market at all.
• A number of big pharmas have started purchasing generic companies. This serves three purposes: (1) it allows the brand-name company to launch their own “authorized generics” through a subsidiary that is better suited for the generic business, (2) it enables brand-name manufacturers to have a presence in countries that cannot yet afford brand-name prices - such as Brazil - and (3) it decreases competition, allowing prices and profits to remain higher. This has started a domino effect as big generic companies are forced respond in kind - case in point: Teva’s recent purchase of Barr Pharmaceuticals.
• In some recent cases, the brand-name manufacturer has resorted to financial arrangements - or what some may call payoffs - in order to stifle competition. For example, see Pfizer’s settlement with Ranbaxy to delay their generic version of Lipitor by 20 months. While these arrangements may violate antitrust laws, the government has not levied any punishments yet.

So while the percentage of drug prescriptions dispensed for generics has steadily increased over recent years, the brand-name manufacturers have been able to keep their percentage of sales fairly high (84% in 2007, down from 88% in 1999).  Surely, this battle will continue to rage on for years to come. Hopefully, the generic industry will be strong enough to keep prices affordable for consumers, while the brand-name drug makers get enough market share to continue to bring innovative products to patients. Balance will be the key.

There was one registration status in the database that was specific to the FDA and struck me as somewhat odd: “approvable”. At first, I wondered if “approvable” was even a real word. Looking it up in the dictionary, I found that it meant “capable of being approved.” So, I asked myself the following question: if a drug is capable of being approved, why wouldn’t the FDA just approve it? I found solace in the fact that I was not the only one confused by this term - much of the industry was also puzzled as to its meaning.

On August 11, 2008, a new FDA policy went into effect that removed the term “approvable” from the FDA drug review process. The remainder of this article reviews the changes and the impact to the industry.

The FDA’s Drug Review Process - Then and Now

When the FDA receives a New Drug Application (NDA), it has 60 days to perform an initial review and determine if the application is worth moving to a full review. If the application is incomplete (e.g. required studies were not performed), the FDA will reject it.

Prior to August 11, 2008, there were three possible outcomes of the full application review for accepted submissions:

• an “approval” letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States
• an “approvable” letter, meaning that the drug can probably be approved, provided that some issues are resolved first
• or a “not approvable” letter, meaning that deficiencies are significant enough that it is not clear that approval can be obtained in the future, at least not without substantial additional data

The FDA would issue an “approvable” letter for any number of reasons, from small modifications such as changes to the labeling to large undertakings such as additional clinical trials. The majority of “approvable” drugs eventually go on to win approval. However, in a number of cases, the changes required for approval were too expensive or time consuming for the sponsor, and the project was killed.

With the new policy, there are now two possible outcomes of the full application review:

• an “approval” letter
• or a “complete response” letter, meaning that there are deficiencies in the application such that the application cannot be approved in its present form

The Intent of the New Policy

The FDA’s stated intent behind the change is two-fold:

• Consistency - The FDA has been using “complete response” letters in lieu of “approvable” and “not approvable” letters in the Biologics License Application (BLA) review process for some time. This change brings the NDA review process in line with the BLA process.
• Neutrality - The FDA no longer wishes to imply whether or not a drug is eventually approvable; instead, it only wishes to inform the sponsor of the changes that are required for approval.

The Impact of the New Policy

The most notable difference is the discontinuation of the “not approvable” letter. In the old policy, the “not approvable” letter was effectively a rejection letter - not in all cases, but most. To investors, it was fairly clear that the drug was not going to make it to market, and the stock price of the sponsor company would fall accordingly. The sponsor’s hands became tied as Wall Street had already made the decision as to the future of the drug.

Since the content of a “complete response” letter, as with the old “approvable” letters, is proprietary to the sponsor, it will be more difficult for investors to immediately determine how close a drug is to approval or, conversely, application withdrawal by the sponsor. This is good for pharmaceutical companies. In case of bad news, they will have more time to do damage control before the content of the FDA’s response is known.

However, in the end, the “complete response” letter is not much different than an “approvable” letter. The “complete response” letter still leaves the drug company in limbo as to the future of the product. How much more money must be spent for approval? How much patent time will be lost? Will the product be able to recover the cost and effort necessary for approval?

Since the year 2000, the number of “approvable” letters issued by the FDA has been on a steady rise. The FDA issued 35 “approvable” letters from 2001 to 2004, 13 in 2006, and 23 from Jan 2007 - Sep 2007 (see the “FDA’s Approvable Problem” from Pharmaceutical Executive magazine). There are a number of theories as to why this increase has occurred, but regardless, it is a real phenomenon that is costing sponsors money and killing potentially useful drugs.

In the eyes of the pharmaceutical companies, real change will only come if the FDA reduces the number of “complete response” letters that it sends and increases the number of “approval” letters for first-time submissions. It is doubtful that this will happen anytime soon, but we’ll have to wait and see.

The kicker is that ROXRO has only six employees. Six employees?!?!  Did I hear that correctly? How does a company with six employees get a drug through Phase III trials and on the doorstep of marketing approval?  Doesn’t it take a small army of people to get a drug to market in the United States of America?  I decided to dig a little deeper and find out how they do it.

ROXRO states that it was one of the first pharmaceutical start-ups built upon the “virtual company” business model.  They operate under a highly experienced senior management team with little to no administrative or professional staff.  Since they have only a small number of employees, there are almost no infrastructure costs.  There’s no need for a HR department, or an IT team or a Finance division.  There’s no need for a company headquarters.  Communication is done through cell phone and email.  Documents are shared via an online file storage site.

OK, but what about the drug development process?  How do they do it with six executives?  First of all, ROXRO is not in the business of trying out thousands of compounds in order to discover a new chemical entity.  They leave that type of work to the big pharmas.  Instead, ROXRO in-licenses promising drug candidates for rapid development in acute medical conditions.  They engage their scientific advisors and a global network of external experts in academia and other small pharmas or biotechs to find and acquire discarded or failed drugs that still have marketing potential.  Then, they figure out how to tweak the product so that it can be successful.

In the case of ROX-888, ROXRO took Ketolorac, a well-known molecule for the treatment of acute pain, investigated why it didn’t work in an oral dosage, and saw the potential for it to be successful in an intranasal form.  Then, they outsourced the drug development, manufacturing and clinical trial programs to external vendors.

Of course, ROXRO needed money to do all of this.  Investors were willing to invest for a number of reasons: ROXRO’s experienced management team and network of experts in the therapeutic area (pain management), their low overhead costs due to their virtual model and the ability to keep their risk profile low by acquiring known - albeit failed - drugs for a more rapid progression through the clinical process.

The final piece of the puzzle is to find a partner (or buyer) in big pharma that has the pocket book and the resources (e.g. employees) to get the drug to market and keep it there.  ROXRO’s plan is to stay small and let the partner handle the resource-intensive operations such as sales & marketing, regulatory affairs, pharmacovigilance, manufacturing, legal, etc.  At present time, ROXRO is seeking U.S. partners for ROX-888.

So, that’s how it’s done.  If you are a scientist with a great drug product idea but think that you do not have the means to get your product to market, perhaps you should think again.  Start up a virtual pharmaceutical company with a few of your experienced and motivated colleagues, get some venture capital, outsource the development and clinical trials, find a big pharma partner, and the next thing you know, you’ve got a product in the game.  Piece of cake, right?

The work a CEO does is undoubtedly important. There is the tangible work, which includes making difficult decisions for which no one else in the company can (or would want to) take responsibility. There are also intangible qualities which cannot be necessarily quantified on a test or on paper: the ability to lead, and to inspire employees to do their best work for the benefit of the company. I believe, therefore, that the compensation a CEO receives should be commensurate with the kind of leadership and inspiration they bring to their position of power, and they should not be undervalued for the work they do.

That said, I was a little taken aback when I read that the Johnson & Johnson CEO received an estimated $25.1 million in compensation in 2007. According to a Boston.com article, “J&J CEO got $25.1M in 2007 compensation,” William C. Weldon, who started his career at the pharmaceutical giant in 1971, received a base salary this year of $1.73 million, then received $7.7 million in stock options in February 2007, a $9.19 million bonus, and other dividends and various perks to make up the rest, including $29,753 for a car and driver.

All of this is in the face of a plan to cut up to 4% of J&J’s workforce in its biggest restructuring move ever. Now, while I believe part of this 4% is likely a reduction of duplicate positions after acquiring Pfizer’s consumer health division in 2006, the article states that

The company’s restructuring plan, announced last July, calls for eliminating up to 4,820 jobs. It is aimed at boosting the bottom line by cutting costs to compensate for safety concerns reducing sales of its No. 2 drug, anemia treatment Procrit; patent expirations this June for its top seller, antipsychotic treatment Risperdal, and next year for Topamax, which treats epilepsy and other disorders; and slumping sales of its heart stents. (1)

What message, exactly, are those 4,820 people going to get when they leave? I’m sure there will be some sort of severance package, but if the CEO is making a $9.19 million bonus, doesn’t that imply the company should be doing well enough to support fewer job cuts? I’m not saying that the company isn’t doing well, but have we become a society that expects to be patted on the back, even when we don’t do so well?

Steve Jobs is no saint, but when he returned to Apple Computer as its prodigal CEO in 1997 he did so at a $1/year salary. For him, I believe, it was a matter of pride steering the company he founded back into steady waters. Since Apple returned to profitability and a business model that reaps rewards for both its employees and stock holders, Steve has seen his own benefits from the success in the form of bonuses and other incentives — but still earns only $1/year in salary. He is motivated to success by the very fact that if there is no profit, there is no bonus, and no reward.

I can’t afford to pay myself only $1/year. But both my partner and I have always been the lowest-paid people in the company. If we make a profit, we reap rewards, but so do the rest of our employees, and if we don’t then we just have to get along with the salary we have. The concept of a bonus, I believe, is a pat on the back to let someone know how much a company appreciates the work they do, how much they dedicate to their job, and any sacrifice they made for the success of the company. It is a measure of value associated with success.

But it seems like something these days that isn’t a perk, it’s an expectation, and especially as you move up in the corporate ladder. Isn’t there a value in risk and reward anymore? Dangling a bonus in front of someone is a good motivational tool to get the work done, but if it becomes an expectation, how does it motivate?

There are lots of people in the workforce who have worked hard for what they have. Using their position as a proving grounds, they sacrifice their time and energy in the hopes of moving up quickly and reaping rewards from the top. But few will reach the top, and it’s not for lack of motivation, work ethic or effort; some of it is just plain luck. So, perhaps growing into the role of CEO of a company is sort of like winning the lottery; if you’re at the right place at the right time, you’ll be rewarded regardless of how well or poorly you perform.

(1) See, “J&J CEO got $25.1M in 2007 compensation,” Linda A. Johnson, AP Business Writer, Boston.com, March 12, 2008

Because I’m paranoid, if I were in need of either of these medications it would be unlikely that I would risk taking them. However, because this is a label, and not a full withdrawal from the market, there must be a value for both patients who need the drug and the pharmaceutical companies who manufacture it. So how do you market a drug that has been given this serious warning? “Out of the Black Box: Marketing a Product with a Warning Box,” an article in this month’s Pharmaceutical Executive Magazine, explores that very issue and gives some interesting insight into the reasons why the Black Box is not automatically a death sentence for the drug.

Kathy Magnuson argues in her piece that communication is the key to making a drug a success once it has been labeled with a black box. If it’s an entire class of drugs that is in question, such as the warning to pregnant women against taking any ACE inhibitor because of increased fetal risk, she indicates that the challenge to marketing groups is differentiating products from their competitors. For example, ACE inhibitor Altace, distributed by King Pharmaceuticals, reduces the risk of heart attack, a characteristic that isn’t shared by other drugs in the same class. King used this information to partner with the American Heart Association and help disseminate information on the risk of heart attack and, one would presume, boost sales of its own drug.

Warnings on individual drugs can be more complex. Novartis’ Zelnorm was specifically cited by Magunson as an example of a withdrawn drug that returned to the market with a black box warning in spite of increased risk of heart attack, stroke and unstable angina to its patients. In spite of this, benefits of the drug to its patients may have outweighed the risk in many cases, which consequently led the FDA to permit the restricted use of Zelnorm under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome (IBS) and other symptoms linked to IBS. In order to get the drug now, patients must sign consent forms indicating they have received a comprehensive review of Zelnorm’s potential risks and benefits. It is this level of communication that can effectively negate the concerns raised by a black box warning, giving a drug a better chance at success in a more challenging scenario.

Magnuson offers some sage advice in a three-part approach when mounting an effort to sell your drug that has been hindered by a black box. First, drug companies should be able to disseminate information clearly and effectively to the intended audience for this drug. Crucial to this is full disclosure of clinical trial results, with especially succinct presentation of risks to patients. Brands that downplay or withhold this kind of information will be exposed, and ultimately find it difficult to follow the second step in Magnuson’s plan, which is to develop a genuine trust with customers in order to gain their loyalty. It is through this trust and open dialog that customers, both in the form of patients and regulatory agencies, will feel compelled to support companies’ efforts to keep brands in the market.

Finally, an ongoing review of brand performance will extend an image of responsibility to the public for a brand that will continue to provide some relief or solution to its patients. Both honesty and consistency are imperative in order to achieve long-term success in spite of the short-term stumble of a black box.

When I saw Celebrex stumble with its other CO2 inhibitors, it was during the time that I was consulting at Pfizer. I didn’t want to believe that a company for which I was consulting could possibly keep information from the public that could endanger its patients without their knowledge. Thankfully, this article implies that Celebrex is among those medicines that was able to successfully communicate with its patients and buck the black-box with good information and an undeviating effort towards patient safety. I believe that medicine with risk can, in some cases, be extraordinarily beneficial to the patients that need it, and now have a clearer understanding as to why a black box isn’t the same as a withdrawal from the market.

I believe that Magnuson hones in on important points in how effective patient communication can make or break a drug. The same line of thinking can be applied to many areas in life, and it seems to me that an open line between a company and its customer can nearly assure success. In a few instances in my life, I’ve attempted to avoid confrontation by withholding truth and it’s never ended well. Someone once said to me that I wasn’t actually protecting anybody by following that methodology and likely would end up making matters worse, so I should just suck it up, disclose everything, and deal with the consequences, because it would be better in the long run.

So I swallowed that pill a long time ago, and never looked back. According to Magnuson, there were 45 products between 1975 and 2000 that carried the black box, a sharp contrast to the 91 that were labeled with it between 2004 and 2005. Chances are, drug companies are going to increasingly be challenged with this type of scenario, and those who may not have adopted a model of open communication with their clients will have to swallow the same pill sooner than they think.

(1) See “Out of the Black Box: Marketing a Product with a Warning Box“, Kathy Magnuson, Pharmaceutical Executive Magazine, February 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?

I believe at some point in my life I will need glasses. I’ve been lucky so far, being nearly 34 and having avoided them thus far, but if family history dictates the need, then I’ll probably need a pair sometime in my early 40s (or, with denial, late 40s). I wonder if I’ll opt for LASIK eye surgery, the popular surgery used to correct vision problems. As I write this, I’m checking out the FDA web site describing the procedure and the risks associated with it, and wonder how the procedure and studies will change by the time I need to consider it.

But that’s not what I’m focused on tonight. Long before I lose my vision, I’ll squint to read. Squinting will contribute to the wrinkles that I can already see forming around my eyes. Wrinkles that mean I’m getting old.

I know that my concern about staying young only plays into the increasing obsession we have in America with keeping people guessing as to how old we are. We want to look good for our age, as opposed to looking aged. And we are so desperate to retain our youthful looks that we’ll put our own bodies at risk with extreme makeovers, which can include broken bones radical surgical procedures.

Botox, an injectable serum made from the botulism toxin and produced by Allergan, Inc., is somewhat less radical than surgery but shown to be effective and popular for treating wrinkles. While I admit I’ve been curious about this drug and how it works, I read today that the FDA announced this week that they’re reviewing the safety of Botox.

While the base toxic ingredient is normally lethal to humans, drug maker Allergan has concocted a dose that can be used to target a specific muscle or group of muscles and render it essentially immobile by its application. The drug appears to be relatively benign in cases where it’s used for its intended cosmetic uses. Problems seem to arise, however, when doctors prescribe it for off-label uses, that is, medical applications of the drug not yet approved by the FDA. Most commonly, Botox is applied in these cases as treatment for limb spasms in cases of cerebral palsy and for treating cervical dystonia, or rigid neck muscles. These also, however, were the cases that had reported adverse events, the most serious of which occurred in children.(1)

The article goes on to indicate that problems likely occurred because of over use and overdosing of the medication, and the likelihood that any adverse reaction would occur in a cosmetic application are slim. Still, the article warns that people should pay attention to symptoms that could be related to botulism, such as weakness or trouble swallowing or breathing.

I would love to be forever young, and take advantage of my youth all over again. As I look at myself in the mirror every day, I see changes in my body that indicate I’m no longer the 20-year-old that looked back. The hair is thinning, the wrinkles are starting to form, although I have to squint now to actually see them. What might I be willing to do in order to recapture some of that youth that is slowly melting away before my very eyes?

Then again, I look at the things that make me feel young without the use of any drugs; my son and my wife. The days that are most special, the days that I can cling to unlike my thinning hair, are days when he points to my MP3 player, asks for music, and insists that my wife and I dance with him as he makes up his own dance moves reminiscent of the southern Italian Tarantella.

And I don’t need to squint to see it.

(1) See “FDA reviewing safety of Botox and rival product,” Lisa Richwine, Reuters, Feb 8, 2008.

I decided to do a search on Google for “superhuman biotechnology” when I found an article written by Brian Alexander on MSNBC.com entitled, “Is there a human right to be superhuman?“  The article was a bit dated, published on May 31 of 2006, but it was an interesting analysis of the concept of transhumanism, which seeks to augment human abilities through use of emerging technologies.  It describes a meeting that took place at Stanford University sponsored by its Center for Law and the Biosciences, its center for Cognitive Liberty and Ethics and the Institute for Ethics and Emerging Technologies.  The leaders of the latter two organizations had some surprising assertions that were discussed as part of the meeting; specifically, it seems they not only believe that enhancements to the human body is a possibility, but it’s a right.

The article goes on to describe some new drugs and technologies that were being developed at the time that would fall under the category of science fiction only a few years prior.  And with some of the research we’ve even discussed on this very blog, it would appear that we aren’t far off from the day where medical procedures and drugs will be developed that will help bring augmentations to the human body to reality.

However, what happens when we do?  What kind of implications will that have for our race?  Will the ability to augment one’s own body be tied to money?  Does this thrust towards a bigger divide among people who achieve success because they have the means to do so, and those who cannot because they do not have the resources to realize that success?  And what happens if augmented abilities do become more prolific?  How would our measure of success change as our path to it becomes easier?

When I was small, I had frequent dreams of being Superman, using my powers to help people in need.  Even now, the thought of pushing my body beyond the capabilities with which I was born is an intriguing thought.  However, if everybody shared the same kinds of abilities I did, how would those powers differentiate me from anyone else?  And how would they offer protection against those who might use them for more nefarious purposes?  These questions may seem like they belong in the realm of comic books and science fiction, but if scientists continue to explore at the rate they have over the last 10 years, the bridge between fiction and reality may be completed sooner than one might think.

I do wonder sometimes if it was so apparent to me because I happened to know the project manager who was leading the effort, or if I picked up the various cues on my own. I still remember that the only way to know that you’ve thoroughly cleaned your hands is to recite the alphabet as you’re doing it, but as I get further away from that point in my life I realize that I only get to about “N” before I stop. The fact is, the bird flu hasn’t yet become the pandemic some scientists have promised, and as we often do in the American media, since there’s no pending disaster, and we’re over what “could” happen, we’ve sort of moved on.

That sentiment was evident to me today as I perused Boston.com today and found an article entitled, “Bird flu continues march 4 years later.” The article opens stating that “[f]ears of a global bird flu pandemic that once dominated headlines have largely vanished in the West…” confirming that I was not the only one who felt that it just wasn’t a big deal anymore. According to the article, even some scientists are considering the possibility that they overemphasized the impact the disease could make when it was first identified as a threat. Though devistating to bird populations (hundreds of millions in more than 60 countries have died or been slaughtered because of the disease), there are few regions of the world where the virus has altered itself enough to become a widespread threat, and a relatively small group of people — approximately 220 — have died from those variations of those disease. Still, some recent trends in the article are reason for renewed concern:

• This week marked the 100th death in Indonesia since the virus was first reported in humans there in 2005.
• India is battling its worst-ever poultry outbreak. No human cases have been reported, but experts are scrambling to keep the disease from reaching crowded Calcutta and its 14 million people.
• Pakistan and Myanmar both reported their first human infections in December. That brings to 14 the number of countries where the virus has jumped from poultry to people.(1)

Though the World Health Organization (WHO) contends that the threat has not lessened, it’s become clear to them that the public has grown weary of continuing threats without any evidence of outbreak. In spite of public sentiment, they seem to remain vigilant in their mission to keep the public informed and urge continued efforts to prepare for the omnipresent possibility of an outburst of the virus.

What I believe is scariest about this disease is its aggressive nature among birds and the mortality rate for those it infects. A small change in the genetic code could result in the kind of pandemic for humans that has devastated bird populations in many areas of the world. But to what end should we be receiving warnings? To what end should we prepare for the “imminent” threat? This reminds me very much of the threat of terrorism — when it became apparent in 2001 that we were vulnerable, we were concerned about the level of security at airports, we sought information on how to better prepare ourselves for threats, and even adopted a new government department for homeland security. But what about now? Does anybody pay attention to our current terrorism threat? How often will the sentiment of feeling safer subdue our frustration for long lines at the airport? How much longer will the government be allowed to go on securing our borders through our activities overseas? Even after a terrible event such as the attack of September 11, 2001, who could argue that after getting over the initial threat we continue with life as usual?

Then again, perhaps this is different. Most people had no idea that terrorism was a threat before 2001, and therefore there was no way we, as individuals, could defend ourselves against it effectively. With an evolved avian flu, we can’t argue that we didn’t know the threat, because the WHO has been telling us about the possibility of the threat for years, and have been giving us the best advice it can in terms of prevention in lieu of an actual vaccine. Do we have any excuse for not being prepared if the knowledge has been offered freely and preemptively?

Perhaps its time I practiced my alphabet…and washed my hands.

(1) See “Bird flu continues march 4 years later,” Margie Mason, AP Medical Writer, Boston.com, January 31, 2008.