FDA – A Bump in the Genomic Road to the Future?

This week I received two detailed reports from 23andMe (23andMe.com), the genomic organization I wrote about in an earlier blog. They sent a LOT of information, and I am still working through. The first report was about strengths and weaknesses in my health plus information about how my body might respond to various medications. The second report related more to ancestry and genealogy.
Three days later there was an email announcement, apparently sent to all 23andMe customers. 23andMe, in response to a letter from the Food and Drug Administration;
If you are a customer whose kit was purchased before November 22, 2013, your 23andMe experience will not change. You will be able to access both ancestry and health-related information as you always have.

 23andMe has complied with the FDA's directive and stopped offering new consumers access to health-related genetic results while the company moves forward with the agency's regulatory review processes. Be sure to refer to our 23andMe blog for updates.

I beat the deadline and received the complete reports and will (I understand) continue to receive updates. Apparently customers of 23andMe who ordered after November 22 will receive the genetic results relating to health and medications, but without the helpful interpretations provided by 23andMe.

 My first reaction was hostile to the FDA. I had received what I believe is valuable information and the government doesn’t want me to know what’s going on in my own genome! Then I saw Mathew Herper’s article in Forbes- “23andStupid: Is 23andMe Self Destructing?” Herper pointed out that the FDA letter stated that 23andMe had stopped communication with the FDA in May!

Here’s part of the FDA letter, with link:
"Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA." (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm37629...)

But enough of legal and political maneuvering. What about the future of personal genomics? Frankly, I was impressed with the reports I received. Impressed enough that I planned to order 23andMe kits for our children and grandchildren.

To be specific, the 23andMe “drug response” report showed an “Increased” response to Warfarin. Coincidentally, my cardiologist had recently started me on a standard dose of blood thinner, then quickly reduced the dosage. He may have had similar information.
The Drug Response report was the report I was most interested in when I ordered the 23andMe kit, as I have family members who are over-responsive to multiple medications and feel this is an area that should be of greater concern in the medical community, as “standard” dosages can be way too much, or too little. The only problem I have had (so far) has been with beta blockers. Reading the report and the postings from other people revealed that a lot of people have trouble with standard dosages of beta blockers.

In the “Health Risks” report, my first three risks were Gout, Atrial Fibrillation, and Prostate Cancer. No problems with gout and my doctor been monitoring PSA and other tests for years, so no surprises there. But I had no clue, no education, no preparation for Atrial Fibrillation, so my education came from a team of doctors at the foot of my bed after a long night in the emergency room. A few years advance notice from a report like this would have been very valuable.

When I ordered the 23andMe kit, I didn’t expect many surprises. I’m 78, so I’ve already experienced most of the conditions that a genomic report would reveal, but I wanted to learn what genome testing can do for individuals. As I said earlier, I am impressed by the information I received. This is helpful information on many fronts, and we are still very early in the game—only 10 years since Dr. Collins report to Congress. Still a lot to learn about the human genome that will be added to future reports. Imagine what new information will be available over the next ten years!

But what about the FDA’s stated concern that individuals will “self-manage” their medications. Might knowledge and awareness of medical risks also help patients to better communicate with their physicians about their responses to medication? Do some physicians hesitate to vary from “normal” dosages because of legal risks? It would seem that an informed patient is the best solution to many potential problems.

And what about the problem between the FDA and 23andMe? Is this politics, bureaucracy, lobbying or something else at work? Or is this a legal challenge to the FDA? How will this play out? Lots of possible scenarios for this new industry. Some clues may come from a new book by Peter W. Huber, The Cure in the Code (reviewed in the December 4 Wall Street Journal by Ronald Bailey).
I have to believe that there is far more going on in this interaction between this young business and federal regulators than is apparent yet. We’ll have to wait for the next chapter!

Ten Years after his forecast...

In May of 2003, Dr. Gary Collins testified before a House Subcommittee on Health and included his vision for the future of genomic medicine, as follows.

“While it always is somewhat risky to predict the future, I want to leave you with my view of where I believe genomic medicine is headed. In the next ten years, I expect that predictive genetic tests will exist for many common conditions in which interventions can alleviate inherited risk, so that each of us can learn of our individual risks for future illness and practice more effective health maintenance and disease prevention. By the year 2020, gene-based designer drugs are likely to be available for conditions like diabetes, Alzheimer's disease, hypertension, and many other disorders. Cancer treatment will precisely target the molecular fingerprints of particular tumors, genetic information will be used routinely to give patients more appropriate drug therapy, and the diagnosis and treatment of mental illness will be transformed.”

As a new graduate in Futures Studies from UHCL, I was excited by Dr. Collins vision, and could hardly wait to see the benefits of the race to sequence the human genome. I had family members that I felt would benefit in several ways, but most specifically in knowing how their bodies would react to different medications and dosages.

One thing that Dr. Collins did not mention in his vision was that DNA testing would become very important in criminal cases in a very few years, leading to convictions for some and freedom for others, including freedom for many who had been erroneously convicted, sometimes for very long periods.

Well. It’s been ten years now, and coincidence or not, last week I received a letter from Anne Wojcicki, CEO of 23andMe, inviting me to order a DNA test kit for $99. I ordered two test kits the same day.

Just ten years after the completion of the genome sequencing project and Dr. Collins presentation to the House subcommittee, I ordered an analysis of my personal DNA for about $100.00. Right on schedule!

Will the information be useful or valuable? I’m in my late seventies, so have already learned a lot about my health and medications. For example, standard dosages of beta-blockers seem to affect my system differently than they do other people. I’ve suspected that about other medications, but have never been certain. I’m hoping the information from 23andMe will tell me something about how my body will react to different medications.

But the truth is, I’m curious. What will a DNA report actually be able to tell me? Will it offer information that will be valuable to our children or grandchildren? Will it confirm information I already know about? What is the potential for everyone?

I’ll write another blog on this subject after we get our test results, but in the meantime, Fast Company has a feature article titled “The Most Daring CEO in America” about Wojcicki and 23andMe. My issue arrived the day after I placed our order.

If you have comments or suggestions for the follow up blog, please post them below and I will have them in mind when I write that blog.

 

Leadership and Long-Term Perspective

Leadership and Long-term Perspective

 

Type the word “leadership” into a Google search and you will get over 400 million returns. Overwhelming! This article is about just one component of leadership— long-term perspective.

Most people will agree that the primary responsibility of a leader is to lead, and in order to lead, you must know where you and your organization are going. Not just to the next quarter, but over the next ten years or more.

 The term “long- term perspective” implies a viewpoint and an understanding of the future that you expect to achieve, either personally or for your organization. People who think about where their organization is headed and specifically what it will achieve over the next ten years or more are often called “visionaries” because they have a vision or image in their mind of where they are going and what they must achieve to get there. Not everyone in a leadership position has that.

When I was a child, we played a game called “Follow the Leader.”  One child would be selected to be the leader, and the rest of the group would follow. Many “leaders” didn’t know what to do, and just ran around in circles until the group chose another leader. Some leaders simply did what the previous leader had done. Then, occasionally, a new leader would take all of us on an interesting journey around the playground or field or park— wherever we happened to be. Those occasional leaders, young as they were, knew where they were going. They had a destination.

Futurists and strategic planners talk a lot about “vision” or “visioning.” Sometimes they speak in almost mystical terms, but there is nothing mysterious about visioning. A vision is your (or your organization’s) image of the future, usually at least ten years away. If “image” is no more helpful to you than “vision,” think of both as a destination in the future. The place you want your organization or your life to be ten years from now.

When I talk to audiences or workshops about vision, I offer an analogy, suggesting that if you were to plan a family vacation for next summer, the most important decision would be your destination. Where will you go? Until you settle on a destination, you really cannot make plans for your vacation. Once you decide on the destination, then you can decide how you will travel (car, ship, airplane, etc), where you will stay, and what you will do. But you really can’t plan a vacation until you decide on a destination.

The same is true of business and strategic planning. You cannot make an effective strategic plan until you have a vision —a destination in the future. Which brings me back to my main point: Good leadership requires the ability to know where you are going, to have a destination in the future —a vision. Others agree.

Kouzes and Posner, authors of The Leadership Challenge (2002) conducted considerable research on leadership, stating that “More than 70% of our most recent respondents selected the ability to look ahead as one of their most sought-after leadership traits.”(italics are mine). In the same paragraph, the authors add “…leaders must know where they‘re going if they expect others to willingly join them on the journey.” (p 28).

But this raises the question, “How does an individual acquire a long term perspective?”

I suggest that you start by learning about, understanding, and thinking about the future. To understand the long-term future, it’s helpful to start with the concepts that futurists rely on.

First, the future is not predetermined. That suggests that more than one future is possible, which is the basis for the theory of alternative futures. If the future is not predetermined then there are possibilities of multiple futures or alternative futures. Some of those futures will be better or worse than others. You may be able to choose!

Second, the future cannot be known. Yet, it is possible to make educated guesses about the future. We can guess, with reasonable accuracy, what is the best future or worst future in specific areas.

     Third, the future can be influenced by the actions of groups or individuals. Very important, futurists recognize that actions we take in the present will affect the future.

Think about that third concept for a moment. If you make an airline reservation for next week, you have changed your future. If you agree to meet a friend for dinner this evening you have changed your future. We usually take these small, short-term changes in the future for granted, but if we can change the short-term future, why not change the long-term future? Futurists believe that we can. Actually, this is the theory that underlies strategic planning; the ability to take actions over a period of time that will change (or create) the long-term future. This is where and why you design a vision, a vision of the future you want to be living or working in ten or more years from now, for yourself, your business, or an organization.

In short, you can change the future. Short term or long term. To do so, you will have to think about the future and make decisions about what you want the future to be. Keep in mind that going into the future will not happen in a straight line toward your destination, but will be more like sailing a small boat and tacking back and forth across the wind. The important thing is that you have a destination toward which you are always moving. That is the start of developing a long-term perspective.

In future articles we’ll explore the future, visions, strategies, and long-term thinking in more detail.

 

What if EVERYONE was a futurist?

What if everyone understood the concepts of futuring? Can you imagine if everyone thought about and understood the consequences of their actions before they acted? That one, tiny piece of future thinking would probably have a sizeable impact on the world, because people do a lot of dumb things simply because they have not thought about the consequences.

Let’s take it another step. What if most people seriously thought about their own futures, understood the potential, and acted to achieve the future they wanted. That might change the world!

When I was a student in the Futures Studies graduate program at the University of Houston Clear Lake, I spent a summer with a dozen other students from all over the U.S and many parts of the world, learning about the methods and tools of foresight and futures studies. I remember very clearly that students would say, “Everyone should know this!” This happened when we were studying Systems, Strategic Planning, Scenario development, Visioning and other classes. “Everyone should know this!” It made a strong impression on me. But everything about my studies at UHCL made an impression.

It was very clear to me that futures  methods worked, and worked well. Certainly, there was a lot of discussion and some dispute among authors and experts about strategic planning (for example), but even they agreed that the methods worked when executed correctly. Or maybe I should say that the methods worked well for large organizations, because when I tried to apply all my newfound knowledge to my own life, there were problems. The methods just didn’t fit… They were developed by and for very large organizations, not for individuals.

After completing my studies at UHCL, I signed up to conduct PhD. research under the direction of Graham May at Leeds Metropolitan University. My research topic became Personal Futures; Foresight and Futures Studies for Individuals (available as a free PDF download at www.personalfutures.net). The research was exciting for me, and I learned a great deal about applying futures methods to individuals. The first was that biology is the primary driving force in human lives. We all go through a series of stages in life, and each stage represents substantial change, much of which can be anticipated.

I felt that the traditional life stages used by modern psychologists and dating back to the ancient Greeks were valuable, but I also found that in one respect they were outdated. In the classic stages, Old Age started at about age 50 or 55. I don’t think any modern person at that age feels they are old since we are living much longer, healthier lives. So I substituted “Independent Elder” as the stage following Middle age, then added three optional stages, all related more to declining health than biological change.

Next, I realized that we are all naturally multi-taskers. From birth to death, in every corner of the world, there are six groups of forces in our lives that we manage every day. I called the six groups “personal domains” and they include: Activities, Financial, Health, Housing, Social, and Transportation.

From there, my research was mostly a matter of scaling existing futures methods down to fit individuals and organizing everything into a practical, easy to use system. That effort resulted in a workbook and personal futures workshops. The concepts and the workbook were given their first international test at the World future Society Conference in Toronto in 2006. Participants representing many countries (Turkey, Mexico, UK, Canada and the US that I remember) were enthusiastic with the all-day workshop, and many are prominent futurists today.

That was the start. Since then thousands of copies of the Personal Futures Workbook have been printed and downloaded (it’s a free PDF at www.personalfutures.net) all over the world. My book, It’s YOUR Future…Make it a Good One! has also gone around the world and has already been translated into Turkish and Spanish with several other translations underway now. The book was even awarded the Association of Professional Futurists 2012 “Most Important Futures Work”.

So back to the original question, “What if EVERYONE was a futurist?” I think it’s a worthy goal, and I believe that we have a good start on the tools that can make that happen. Already, enough people are aware of futuring to start making a difference in the way people think about the future (there are more than two dozen universities worldwide offering masters degrees in Foresight and Futures Studies). We are a long way from a tipping point, but the progress is encouraging!

That’s a long way from “Everyone.” But it’s a start. Seven billion to go!

Futurists and strategic planners talk a lot about “Visions.” What is a vision and how can you create a vision of YOUR future?

The first thing to understand is that a "vision" is a destination in your future. A vision is what you see as your life in the future. If you haven’t thought about your life in the future, now is a good time!

In my workshops, I tell people that creating a vision of your future is like planning a vacation. You must decide where you want to go before you can realistically think about how you’re going to get there. If you decided that you want to go on vacation this July, where would you go? Paris, Rome, Beijing, San Francisco? Before you make any other plans, you must decide where you’re going. Once you decide on the destination, you can start making plans.

The same is true when you start thinking about your vision of your future. What is your destination? What do you want your life to be in 10 years? I realize that’s a difficult question because the future is a big place to try to think about so I suggest that you break it down into six parts. In Personal Futures Workshops, we look at the six personal domains in your life: Activities, Finances, Health, Housing, Social, Transportation. Now, ask yourself, for each personal domain, what should my life be like 10 years from now?

Start with Activities, all the things you do; school, work, religion, sports, hobbies — the things you do. What do you want to be doing in your life 10 years from now? Think about this one carefully because our activities tend to fill our days, and if we don’t fill our days with something interesting life may start getting boring. If you are under 60, you will probably still be working, which will keep you busy. If you expect to retire within the next 10 years it’s important that you have enough activities in mind to keep you active most of the time. When I talk to people about their future in retirement, I often hear, “I want to play golf every day.” Or “I want to go fishing every day.” Keep in mind that when you retire, you may be retired for several decades, so you want to plan a life that has enough activities in it to keep your life interesting.

Next, consider Finances. What do you want your financial condition to be in 10 years?

Health. What do you want or expect your health to be like in 10 years?

Housing. Where do you want to be living 10 years from now, and what kind of the home do you expect, a castle or a condominium?

Social. Where will all your family members be living 10 years? Who will be your close friends? Do you see any significant changes in your social circles over the next 10 years?

Transportation. What will be your transportation requirements or needs in 10 years? Will you be commuting? Will your transportation needs change over the next 10 years?

You can probably see that creating a vision of your future is not terribly complicated, but it will require you to actually think about your future. That is probably the most important part of futuring — taking the time to think about what you want your future to be. Once you make the decisions about what you want your life to be like 10 years from now, you will have a destination in the future. Then you can start thinking about how you are going to achieve your vision.

We’ll do that in the next post!

There are two types of forces in your life. You need to understand both kinds

The two types of forces that will affect your life are the internal forces and the external forces. The internal forces are the forces that are part of your life, every day, throughout your life. The external forces are found in the world around you and may occur locally, nationally, or internationally. These are the forces of change in your life, and each will have an impact over time.

Internal forces. When I was conducting research related to personal futures some years ago, I found that each of us is managing our lives on multiple levels. We are all multi-taskers and have been since long before that term came into existence. As part of my research, I identified six different categories of forces in everyone’s life, in effect dividing life into six parts. The six categories are:

Activities- Everything we do. This includes schooling, employment or career, hobbies, religion, travel, sports, and other activities in life.

Finances-  Everything to do with your money, including income, expenses, taxes, credit cards and insurance, among others.

Health- Everything related to your physical and mental health. Hygiene, diet, exercise, medicines, and medical care are some examples.

  Housing- The Housing domain begins with your home, but includes your neighborhood, community, country and climate.

 

Social- The Social domain begins with close family and friends and expands outward to include all the people (and stakeholders) you interact with in your work or your community.

 Transportation and mobility-  Includes all available means of mobility beginning with walking and including all forms of personal and public transportation.

 These descriptions of the categories of forces are not cast in stone! They are flexible, so you can arrange the definitions any way you want, but you should try to be consistent. For example, I’ve shown religion as an activity, but some people prefer to put religion in the social domain. That’s OK. Whatever works for you, because it’s your life that you are thinking about.

As for the external forces, the names of the categories can vary, but I prefer the STEEP categories, because they are easy to remember. The descriptions are broad and obvious

Social

Technology

Economic

Ecology

Political

These are categories of forces outside your life that can, and probably will, have impacts on you. These forces may be active locally, nationally or anywhere in the world. A government overthrown in the Mid-East, the landing of an exploratory rover on Mars, failure or corruption in foreign banks, the election of a new government in Europe; all have the potential to have an impact on your life. A decision in the national government to raise taxes or cut spending may affect your life. A decision by your city government  to put up stop lights, paint pedestrian lines at crossings, create bicycle lanes on roadways, or to repave the street in front of your home may also have impacts on your life.

All of these examples show the forces of change in action, sometimes with large impacts and sometimes with no impact on you at all, but always with the potential to bring about change that will affect you and your life.

None of this should make you nervous in any way, as all these forces have always been there, and will remain. On the other hand, your awareness of these eleven categories of change may have been heightened, and that is the intent of this piece. To help you be fully aware of the potential for change in your life and in the world that can affect you. Because you are now aware, you should be able to deal with all these changes more effectively, possibly turning some in your favor.

Understanding these forces of change should help you anticipate how change will impact you and where it will take you into the future.

 

If you want to learn something about where your future is headed over the next ten years, take a close look at the stakeholders in your life and your career.

Stakeholders are the people (and sometimes the institutions) who can have an impact on your life and your future. Stakeholders are also those who will be impacted by your life and your actions, now and in the future.

Start with your family and close friends. If you have children who are under ten years old, during the next ten years they will become teenagers. That will have an impact on your life! If you have children who are already teenagers, over the next ten years they will be going through big changes in their own lives, and those changes will have an impact on you. Over the next ten years, today’s teenagers will probably complete their education, start work or begin a career, move out of the family home, begin a marriage or other relationship and may start a family—your grandchildren.

Over the next ten years, your parents, grandparents and other relatives will be getting older. Will they retire? Will they move from their home to another city or country? Will they be healthy? What will your relationship be with them and with your spouse’s parents? What will you feel will be your responsibilities to them, and how will you manage those responsibilities?

What about your best friends? They may move to a different area and drift out of your life, or you may still be connected electronically, while others may remain close throughout your life. I have friends from high school (sixty years ago) that I haven’t seen for twenty years, but who still exchange emails with me on a regular basis. Which close friends will still be in your social network ten years from now.

Consider the obvious, the people in your work and career life. How will ten years affect those relationships? If you have a mentor or a tormentor, is that person likely to still be around in ten years? If your best friends are the people you work with, what will happen when you retire?  Most of those relationships may end, leaving a large hole in your social network.

Businesses, institutions, and organizations can be stakeholders in your life. Your employer, your banker, the mortgage holder on your home, your credit card company all have a stake in your life, and can have positive or negative impacts over the next ten years.

As you consider each of the stakeholders in your life and your future, how might your relationship change in each case? Which can get better, which can deteriorate, and why. There may be actions can you take now to insure positive relationships and outcomes. By exploring these relationships now, you can learn something about your future, and find ways to make your future a good one!