For me, November’s Man of the Month needs no introduction (… because he is my father). For the rest of you for whom he is not a genetic relation, here goes…

The Disruptive Women in Health Care team is pleased to introduce our November Man of the Month — Dr. Peter Ditto, Department Chair and Professor of Psychology and Social Behavior at University of California, Irvine and a leading authority on the psychology of advance medical directives and end of life decision making.

Dr. Ditto is best known for the series of studies he conducted examining key psychological assumptions underlying the effective use of advance medical directives, so much so that he was one of the few psychologists invited to participate in the 1993 Squam Lake conference convened to establish a national agenda for research on advance care planning. He is also a member of the Advisory Panel for the American Psychological Association’s Ad Hoc Committee on End-of-Life Issues.

I sat down with Dr. Ditto (who I more commonly refer to as Dad) to learn more about the psychological aspects of end of life decision making, his research on the subject and more.

You often use the Terri Schiavo case  as an example of the decision making challenges families who must make choices about the use of life-sustaining medical treatment for an incapacitated loved one face. In what ways does the Schiavo case encompass your “traditional” case? In what ways does it diverge?

In many ways, the Terri Schiavo case is not at all typical.  She was a young woman who was struck down unexpectedly in her 20’s. Most end-of-life decision making occurs with elderly people, often with a lot of advance warning that a situation is approaching where the person is going to lose decision making capacity. It is actually interesting that the cases that have most captured the public’s attention and most shaped law and policy on end-of-life decision making have involved these quite rare and unusual cases of young people left in persistent vegetative states (Schiavo, Karen Ann Quinlan, Nancy Cruzan). This is likely because these are cases where the issues are displayed most poignantly – a person who has lost the ability to speak for themselves, about whom everyone is uncertain what the incapacitated person would want done if they could speak, and where family members (and public opinion more broadly) have strong and differing opinions about what is the morally appropriate course of action.

But it is important to point out that these are exactly the problems that occur writ small – in less dramatic and less poignant forms – in homes, hospitals and hospices every day in the US. It is typically older people who have become too sick to speak for themselves, have not completed a little will or conveyed their wishes in any way to their loved ones, and this uncertainty can easily lead to family conflict because people have differing beliefs about the person’s likelihood of recovery, and bring different moral views and emotional vulnerabilities to the situation.

You say that, while many think the presence of a living will would have negated what quickly disintegrated into an ugly situation for the Schiavo and Schindler families, it is not always that simple. What steps can people take to avoid (to the extent it is possible) leaving their loved ones in a similar situation?

In many ways, my scientific work on end-of-life decision making can be seen as a psychological critique of living wills. The problem with living wills isn’t the idea – it is a wonderful and noble concept to try to honor people’s wishes near the end of life by having them record those wishes while they are still able – it is the execution. Quite simply, it is just a really difficult situation to find oneself in, and there are no simple band aids that are going to fix it all up.

I remember during the height of the Terri Schiavo controversy watching an attorney on the Today Show saying that spending 15 minutes filling out a living will would have solved the whole thing. Nothing could be further from the truth. Our research identified a whole host of problems with this idea – people often complete living wills that are very vague (“no heroic measures”), people’s preferences of life-sustaining intervention change over time as people’s health waxes and wanes, and even a quality living will doesn’t necessarily communicate wishes in a way that helps your loved ones (what we refer to as surrogate decision makers) predict your wishes any more accurate than they can without having seen that living will (could give you a paper site if you want one).

The best advice I can give is to talk to your family about your end of life medical wishes. This is especially crucial if you develop a medical condition where one possible trajectory is that it might leave you unable to communicate. I really don’t believe it is cost-effective to try to develop policy and law to encourage every 20-year-old to write a living will or take other elaborate measures like that. It is so unlikely that a Schiavo-like incident will happen to them, and even if it does, the situation they are trying to make decisions about is so inconceivably different from their current situation as a healthy 20-something, that it just isn’t worth a major societal investment to encourage that level of planning [editorial note: forget 20-year-olds -- an AP article published this week suggests that 64% of baby boomers also feel this way]. But as one gets older, and especially if future incapacitation is one possible outcome, that is the time when talking with your loved ones and your physician about your wishes for end-of-life treatment make sense, and it is a time when it all becomes psychological “real” enough to allow someone to really make reasonable wishes.

Let me also say though that completing a living will is not sufficient all by itself, but it helpful to think of it as a means rather than an end. The key is to make completing a living will the process that stimulates you to think about what you would really want – for both yourself and your loved ones – if you lost the ability to speak for yourself. And, most importantly, to make this an opportunity to talk to your loved ones – your spouse, children, whoever – and try to convey to them the core values and feelings that motivate your wishes.

Do you have any advice for families who find themselves in this situation but whose loved one did not leave a living will? Is there a precedent that should be used to guide decision-making in that case?

The advice I always give people is to simply try your best to take your own feelings out of the situation, and try to make the decision for your loved one that they would make for themselves if they were able. This is both something that I think makes good common sense, and if precisely consistent with the fundamental ethical principles that have always been held to guide end-of-life decision making.

That is, the goal of living wills and other forms of advance directives has always been to maintain an incapacitated person’s personal autonomy, their right to self-determination that is enshrined in the Constitution. But how can a person in a coma make decisions for themselves? They can’t directly, but if you make the decisions for them that they would have made for themselves, they your judgment can be substituted for theirs (hence the technical term substituted judgment) and it is as if they are making the decision for themselves.

It is a beautiful, elegant idea – especially if your substituted judgments are informed by documents or discussions completed prior to the person losing their decision making capacity – and as I said before it is terribly difficult to actually bring to fruition in real life. We are often not very good at predicting our loved ones wishes – think about the last time you totally miscalculated on a birthday or anniversary gift for your spouse – and complicated medical situations flooded with emotion are not likely to maximize the accuracy of your predictions.

But another finding from our research is that many, perhaps most people are more concerned with who makes judgments for them than in trying to micromanage the judgments that will be made. Many people say that the most important factor for them is that they want someone they trust to make judgments for them. They are happy in fact to let those people make judgments in real time, with all of the information available to them, and thus are more interested in appointing a trusted loved one as a designated surrogate rather than completing a detailed living will where they feel like they are ill-equipped to address specific and inherently probabilistic medical decisions.

This is why I think policy should be focused on encouraging opening up dialogue between physicians, patients and their loved ones – and encouraging the completion of durable powers of attorney for health care (legally appointing a surrogate/proxy) rather than long, complicated advance directive documents.  The focus should be on discussion not documents, and documents are most useful as a stimulus to dialogue.

Obviously the cost of care is a factor in any medical situation no one wants their family to become destitute as a result of paying for their care. How do you think changes to Medicare/Medicaid and long-term care [i.e. the repeal of the CLASS Act] might affect the public’s end-of-life wishes?

I will say upfront that I don’t know a lot about specific policy details, but regardless, here is what I do know.  No one wants to mix up end-of-life decisions with financial considerations. It is not about saving money, it is about allowing people to make their own decisions about prolonging their own lives versus letting go and not prolonging the process of dying. And versus someone else making that decision for them – whether it is ending their life prematurely, or the problem that most people really care about – which is continuing treatment past the point that it makes sense and leaves people suffering or losing their essential dignity. That is why end-of-life decision making works best in the context of a situation where medical care costs are irrelevant. It is only when people know they can get all the care they need, that they will be comfortable making decisions to forgo that care. It is important the people are provided the ability to get the care they need at the end-of-life, and that physicians are incentivized to discuss end-of-life concerns issues with their patients – not to counsel them to check out early, but to help that make the end-of-life as dignified and free of unnecessary suffering as it can be.

The ironic thing about all this is that virtually every analysis shows that the key problem in end-of-life care is overly aggressive treatment that has little chance of success and that the patients likely would not want if we could ask them. So if people are allowed to make their own decisions, and we invest resources in helping them do that in the most effective possible way, it actually would cut the exorbitant costs of end-of-life care in a natural, humane way that honors every American’s right to make their own choices about their own lives.

Thank you Dr. Ditto, we appreciate you taking the time to discuss this important element of the End of Life with us.

What do you think about living wills and advance directives? Do you and/or your loved ones have them? Do you know what your loved ones would want, should they [heaven forbid] be unable to speak for themselves? Tell us in the comment section below!

You can read the full HuffPost story here: http://www.huffingtonpost.com/2011/08/20/dolphin-with-prosthetic-tail_n_927463.html#s330792&title=Dolphins_Fake_Tail

How do you feel about health-related social networking? Would you join an online health program? What concerns – privacy, quality of service, etc. – do you think this presents?

Read the full text of the Healthcare IT News post here: http://healthcareitnews.com/news/social-media-tools-may-reduce-attrition-online-health-programs

The new apps (FaceDecide & BreastDecide) come in addition to their six existing Orthopedic patient education apps — including an orthopedic app called ShoulderDecide, which was recently reviewed by iMedicalApps.com. While these latest apps are obviously less focused on chronic medical conditions than the original six, they do call attention to just how great the extent of the potential for mHealth seems to be.

In the next few weeks, Orca MD will be rolling out additional features, including an introduction and some infographics dealing with Orthopedic & Cosmetic Surgery. To keep up with these releases, check out their apps, and more, ‘Follow’ @OrcaMD on Twitter, ‘Like’ OrcaMD on Facebook  or check out their YouTube Channel.

Health-related smartphone apps are a relatively recent innovation, and there is no telling what will come. What do you think about the BreastDecide and FaceDecide apps? Would you download them? As the field of mhealth begins to evolve and mature, how do you think apps like this will fare? Do you think these present privacy concerns for users?

This is not a new concept: ten years ago, the IOM’s seminal report, Crossing the Quality Chasm: A New Health System for the 21st Century, called for “patient-centeredness.”

What is patient-centered care? Bertakis and Azari call out four communication behaviors:

1. Eliciting understanding and validating the patients’ perspective
2. Understanding the patient within his or her psychosocial context
3. Reaching a shared understanding with the patient of the problem and its treatment
4. Creating a partnership in which “activated” patients share in decision making, power and responsibility.

These four precepts were codified in a 2007 publication from the National Cancer Institute, Patient-centered communication in cancer care: promoting healing and reducing suffering.

Health Populi’s Hot Points: Adopting a patient-centered approach isn’t solely about reducing health care costs: it’s about patient empowerment, effective communication between doctor and patient, and participatory medicine. The secret in this sauce is in the communication between the partners: greater sharing of information from each side of the conversation, building greater trust, and leading to a decreased use of unnecessary diagnostic testing, hospital care, and specialty referrals. While long-term outcomes haven’t yet been quantified in the patient-centric approach, this study adds to the growing evidence base that participatory medicine is a win for the patient, a win for the physician, and a win for the larger health system and health economics.

Originally posted on Health Populi on July 19th.

By Elizabeth Cohen. As much as she would like to, Dr. Lissa Rankin, a gynecologist, will never forget the woman who planned her wedding while lying naked on her examining table.

“Every 15 seconds, her cell phone was going off, and she was answering it!” Rankin recalls. “It was like, ‘That’s not the cake I ordered,’ and, ‘No, it’s the other gown,’ and I said to her, ‘Is this a bad time? Should I come back later?’ ”

The bride may have been doing great things for her wedding, but she was sabotaging her own care — and it was a really important visit, as she was newly pregnant.

Talking on your cell phone in the examining room, forgetting what medicines you take and lying to your doctor about your personal health habits are all ways of compromising your health.

“The doctor-patient relationship is like a business partnership,” Rankin says. “We need to work together. Trust me to guide you but be willing to do your part.”

From interviews with a gynecologist, a cardiologist, a rehabilitative medicine specialist, a fertility doctor and an internist, here are the Top 10 things patients do to mess up their own care.

1. You talk on your cell phone.

This is your health we’re talking about. Other calls can wait. Turn the thing off.

2. You lie.

“I need to treat you the best way I can, so if you’re gay, tell me. If you drink a bottle of tequila every night, I need to know. If you’re having an affair and not using condoms, let me know,” says Rankin, who blogs at “Owning Pink.” “I promise I won’t judge you.”

3. You do a sloppy job describing your pain.

Is it stabbing or burning? Sudden or constant? Tingling or hot? The answers will help your doctor make the right diagnosis.

“You should describe the exact location, how intense the pain was, what provoked it and how long it lasted,” says Dr. Nieca Goldberg, director of the New York University Women’s Heart Program.

The week before your appointment, keep a diary of your pain and your other symptoms, too, advises Dr. Loren Fishman, a clinical professor of rehabilitative medicine at Columbia University College of Physicians and Surgeons. He suggests using this time to also think about the questions you want to ask your doctor and what you hope to get out of your appointment.

4. You don’t state up front all the reasons for your visit.

If your ear hurts, your knee pops out when you run and you have a sty in your eye, state all three concerns at the beginning of the appointment so your doctor can plan your visit efficiently, advises Dr. Howard Beckman, an internist and clinical professor of medicine at the University of Rochester.

5. You don’t state up front your expectations for your visit.

If you have certain hopes or expectations — the doctor will pop that sty in your eye or prescribe antibiotics for your sore ear — say so. The doctor can then explain if your expectations are realistic, and you’ll be happier in the end.

“Sometimes patients are out of proportion to what the reality is, like the 44-year-old woman who hopes to get pregnant in one IVF cycle,” says Dr. Jamie Grifo, program director of the New York University Fertility Center. “If they don’t communicate their expectations, then I can’t address them.”

6. You don’t know what medications you’re taking.

“Patients should bring a list of medications they’re actually taking, not what they believe they are supposed to be taking, or what they think I want them to take,” Beckman advises.

If you take supplements, Rankin suggests you bring them in, since supplements aren’t standardized like prescription drugs, and your doctor will want to see all the ingredients.

7. You leave with unspoken questions and concerns.

If a question’s in your head, ask it, even if you think the doctor is rushed. If you’re worried your headache might be a brain tumor, say it even if you think you sound like a hypochondriac.

8. You don’t bring your medical records or images with you.

Yes, even in this day and age, many doctors rely on the fax machine to send medical records to and fro. Faxes goof up, so unless you absolutely, positively know your doctor has your records and images from another office, bring them with you, doctors advise.

9. You’re too scared to disagree with your doctor.

If your doctor suggests you need an antidepressant and you don’t want to take it, say so instead of nodding your head, taking the prescription and throwing it away the minute you’re out the door. Or if she suggests a medication you can’t afford, just say so.

“I know many of you are programmed not to question your doctor, but we can’t read your mind, so we need you to communicate,” Rankin says. “If the treatment plan I suggest doesn’t resonate with the intuitive wisdom of your Inner Healer, please tell me, instead of ignoring what I suggest.”

10. You don’t comply with the treatment plan.

For doctors, this is the granddaddy of them all. If you’ve followed all the advice above, you should have a treatment plan that makes sense to you and one you’re able to execute.

“Please follow through and do what you’ve agreed to do,” Rankin says. “And if you don’t, please tell me so I don’t mistakenly assume the treatment failed. I won’t jump all over you. I just need to know.”

We won’t pound a single nail into the walls to hold the art.  This shall be The Walking Gallery.  That night dozens of people will walk into the space wearing business jackets or doctor’s lab coats.  That alone is not unusual.  It would be a daily occurrence in this dual-use space.  But these jackets will be works of art.  Each one shall be painted with the story of a patient or an element of medical advocacy by me or another artist.  These masterpieces will be worn on the backs of government employees, technology gurus, medical professionals, social media activists, CEO’s of companies and artists.  It shall be a great meeting of the minds.

The Walking Gallery will happen because Jen McCabe followed me on Twitter on May 30th 2009.    That was the day before I placed the Medical Facts Mural in Pumpernickels Deli on Connecticut Ave.  That was a day when my Fred was still alive and could speak and eat again because of the wonderful care he was receiving in Washington Home Hospice.  Jen was one of my first followers on Twitter and is such a glorious spark of life.  

On August 20th she emailed me after I had posted a comment on her blog and asked me if I would paint a series of paintings on the back of her blazers to wear to upcoming health meetings.  I told her I would be honored to paint jackets for her.  Jen responded, “Symbols and talismans mean quite a bit to me, and having things constructed by friends is one way to remind myself why I do the work I do and forego so many of the other things I enjoy.  I’m so happy to have a wearable badge of courage – just wrote an index card for myself to remind me of the importance of patient advocacy by “any means necessary.”  Art is another one of those means.”

I finished the second mural “73 Cents” on September 30th 2009.  It was my feverish obsession in the weeks after Fred’s death.  “73 Cents” was a thing that I had to do.  It soothed my soul; it spoke to me and calmed my aching heart.  It gave me a reason to leave the solitary confines of my mind and my widowhood.  It gave me permission to stand on the street and talk with complete strangers about the grief roaring within me.  I often go to social justice events and hear about the chronically homeless on the street.  I hear workers complain that they find small single apartments for these folks to live in, but instead many return to the street.

I think I know the reason why. 

It is hard to be alone when sadness is engulfing the mind.  The street is alive, and there the broken congregate and help each other.  Each day I painted I made many new friends, but those who came back and spoke to eye to eye were often the most dispossessed and the homeless. 

Without Jen’s suggestion that I paint jackets, I would have gone home, my Magnum Opus done, to loneliness and grief.  Yes, I was still blogging, but that was not enough.  I had to paint.  I had to spread the word through art.  Jen had provided a new “wall,” and that wall could walk into the Mayo clinic or the National Board of Medical Examiners and remind everyone of those patients who suffer in a system without real time data access.

I would paint and post images of three jackets for Jen:  “Data Prison” on October 5th 2009,

“Titanic” on December 14th 2009

“First Responder” on January 12th 2010.

As Jen and I began to tweet about the jackets, Elizabeth Cohen from Empowered Patient on CNN would see our twitter stream.  She said she would write a piece about the jackets on CNN health as they captured the zeitgeist of the patient data access movement that @ePatientDave had so apply entitled: “Give Us Our Damned Data.” 

Due to Jen’s very public appearances wearing patient advocacy jackets, two other thought leaders would contact me to obtain images they too could wear.  Chiara Bell from Enurgi, later to become part of Univita Health, would ask to have a jacket of her own.  She wanted to show the importance of the caregiver in patient care.  I made for her the “Caregiver’s Clock” a painting that depicts both the family member as caregiver and the professional caregiver caring soothing the terminal patient.

Finally, Roni  Zeiger from Google Health would contact me.  He wanted a jacket that depicted the passionate need for data access felt by the patient/caregiver.  I painted for him “Data Cloud” that recreated my desperate feelings to find out the truth via the Internet.  Roni Zeiger then wore that jacket at the Community Health Data Initiative event on June 3rd 2010 before a crowd of hundreds including Secretary of HHS Kathleen Sebelius.  Roni would finish his presentation about the Combining of HHS Hospital Compare with Google’s Fusion Tables Cloud Database App, by turning his back on the audience and saying, “The last thing I would like to mention is that, let’s not forget all of these data points tie back to individual people and their stories.  And many of you probably know of the work of Regina Holliday.  She is an incredible woman I met recently.  An artist. She made- I am not a fashion guy, but she made this jacket for me.  Feel free to come up after to get a closer look.  We made a deal.  She would make this jacket for me, if I would wear it at important conferences.   This is the first time I am wearing it.   And it is about the importance of data and the importance of talking about data and the importance of technology in the future if health care.”

So, that is the story of five jackets that I painted to spread awareness.  Five jackets. They bring the “patient” into the room and onto the panel, when no patient was invited to attend.  They remind me of the encaustic mummy paintings from 1st century CE found in Egypt.  These amazingly real and poignant faces stare out above dried sinew, wrappings and bone.  Their eyes sear our souls and remind us, I was once one of you who lived and played, who laughed and loved before I met this fate.   They transcend the dust and the darkness of the ages, and make the lives lost long ago so very real.  The jackets worn by these brave few do the same for data, and pie charts and graphs. 

When you sit in an audience listening to a power point presentation, and the faces on these jackets stare back at you; it changes things.  It adds an edgy sense reality to dry recitation of data.  It wakes you up.

Perhaps you will have the honor to wear one of these creations.  It can be quite unsettling.  People will stop and stare.  You can now enter a conference and feel like an outsider.  Ostracized.  You can be given the gift of experiencing the disconnected feelings of the ignored patient in the room.   People will point and talk about your back like you are not even there.  You are a “case,” an object, you exist to be described and critiqued.   And after being at a conference all day, you can take that jacket off, and be normal again.  Or not.  You can “come out.”  You can let go of that other title, be it, Techie, Doctor, CEO or founder of a non-profit.  You can cease to be defined as the cog you appear to be in the machine called medicine.   You can be simply patient.  You can tell your personal story and reach your inner center as a patient.

Perhaps my painting will help you.  Perhaps it will be the icebreaker you need to let go of the ubiquitous black suit that blends in at a medical conference.  Perhaps it will be way to open up about why we are doing all of this important work.  We are doing this to help patients heal.  We are doing this so we can all live happier lives.

So… CALLING ALL JACKETS!  CALLING All ARTISTS! I need your jackets, I need your stories.  I need other artists who would like to join a movement.  Never let anyone tell you, that you do not have a voice.  Step up and Speak out.  We get great change by doing great things.  I need you to show up at The Walking Gallery At Kaiser Permanente Center For Total Health between 6:00 to 9:00pm on June 7th.  That night you will be surrounded and loved by others just like you.  It shall be a great fellowship of those deeply invested in patient empowerment.   

And then you shall go forth and wear your jacket at other conferences spreading the word about the importance of patient data access and truly patient centered care.  And sometimes you will be the only “patient” in the room.

But you will be brave and you will be proud, for you are a member of The Walking Gallery.

The firestorm that followed created some heat but none sufficient to help relieve the shivers. Others might declare the outcome a “win” but the more I read, the worse it seems. I’m not privy to what really happened, only what the press reports. It does not look good… for virtually anyone of the players involved, especially the critics. 

Those critics raised tough questions and to date only the company has faced them. It’s about time the critics themselves –and perhaps others as well – face some.   

For those who’ve missed the story, on February 3, 2011, the FDA approved a drug intended to reduce the risk of certain pre-term births in women who’d already had at least one pre-term birth. 

In truth, a number of treatments are already available for women in this situation. None of them sound easy. They include certain other medications (including IV medications) and restricted activity (like bed rest) that prevent women from going to work, making meals or providing care for other children or family members. Oh, and they can’t have sex, either. In some cases, women are hospitalized and, when all else fails the birth is premature. If they survive, the babies then receive care in neonatal intensive care units at the high costs we all know and frequently bemoan. 

One of the treatments already available was an injection that compounding pharmacies—perhaps one down the street from you—made at a fairly low cost. Though there is no indication the FDA had concerns about this particular pharmacy-compounded product, the American Journal of Perinatology in March 2009 reported on a study of OBs saying they were “very concerned;” apparently it made care for these women more difficult. Perhaps understandably, the women did not want to take a product the FDA had not approved. Add to that, other FDA studies had indicated a third of pharmacy-compounded products (in general) had doses higher or lower than the physician prescribed. Perhaps that is why FDA was interested in a product they could regulate.     

NIH had been interested, too, had studied the drug in question and apparently found it was effective and prevented premature labor. 

Somehow a company got involved, but then it sold its rights to another company. Press reports don’t say why. That second company bought the rights, paying $92M up front and promising another $107M in payments over time. 

The second company then committed over $250M, including more than $60M in research and clinical trials involving multi-year follow-on studies of 1,700 mothers and 500 babies. The second company says the studies were four times larger than the previous NIH studies and twelve times more expensive. When it appeared the FDA would approve their version, they built relationships with specialty pharmacies to make sure that patients could get access, set up patient assistance programs and started the launch. 

All hell broke loose when the price was announced – a price not worth talking about now, though it may well be justified on several grounds: 

• The company invested substantial funds to buy and then further develop the drug;  
• The company pursued FDA licensure, which is costly and come with no guarantee of success; and  
• The company, unlike compounding pharmacists, will likely be held legally liable for any problems related to the use of the product, including any claim that it was not safe or was not effective in preventing some premature births. The company will also liable if decades from now the product comes under suspicion for consequences no one can imagine today.   

And let’s not forget as well that a week’s supply of the drug is probably cheaper than one day in a NICU, making it cost-effective by keeping babies with Moms longer and out of NICUs. 

The firestorm resulted in company policy changes: a price reduction of 55%. The company will as pay Medicaid rebates and in addition a supplemental Medicaid rebate of 32.1%; it will cap the cost for insurers and Medicaid and will remove income caps required for women to qualify for patient assistance programs. Going forward, 85% of patients will pay less than $20 per injection—essentially what they were paying before for an untested, unapproved, unregulated, uninspected product. 

I don’t know this company or anyone in it and as near as I can tell, their biggest mistake was not preparing everyone in advance for the initial price. As I think about them today, I imagine they’re reeling: share prices were down 48% at one point and finally “settled” at a 20% decline. No good deed goes unpunished, it seems. 

To make matters worse, FDA says it “does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually-identified patient, unless the compounded products are unsafe, of substandard quality or are not being compounded in accordance with appropriate standards for compounding sterile products.”  I’ll bet that felt like a “kick in the gut” back at the company. 

I wonder if those company folks wake up some mornings – or in the middle of the night – wondering why they bothered. 

Some senators have called for an FTC investigation and, who knows, even Congressional hearings might result. This is far too juicy a political issue after all and we’re nearing an election. 

Since the company has already addressed their issues, I’ll offer some issues for the panel to consider when they speak with the others involved. They’ve “got some explaining to do” as well. 

For NIH: 

• If the NIH study was adequate to secure FDA’s review, why didn’t NIH itself pursue licensure? FDA offers special help for those unaccustomed to pursing approval; NIH could have availed itself of that help. Why didn’t it? 
• If approved, NIH could then have licensed the product to any number of companies, including generic companies, who could have manufactured and delivered it to pharmacies for dispensing and probably at substantially lower prices given that private company risk and investment would not have been involved. Did NIH consider that option? If not, why not? What might the price have been if the NIH had taken that route? Further, any licensee would have played royalties back to the government? What amounts would have been returned to taxpayers had NIH followed that route? 
• NIH has recently decided to pursue the drug development arena, filing in gaps it feels the private sector last left in its wake. Would this product have fit the profile for such an effort? If  so, and this was such an “easy target”, why didn’t NIH pursue it when it had the chance? If the NIH was not capable of pursuing such an apparently easy target, how can it now be trusted to try with other, more challenging therapies?  
• What other research studies of this type has NIH conducted (or is it now conducting) that might result in a similar outcome? Are there other companies who should be prepared to face the backlash from using NIH research or research collaborations to pursue licensed therapies,  including rare disease therapies?  
• What protections will the NIH put in place to assure this does not happen again? 

For FDA: 

• If FDA had such confidence in the ability of compounding pharmacies, why did the agency encourage a company to pursue the additional studies and activities to secure licensure? 
• If there was no public health need for an FDA regulated product, why did the agency go to the trouble to grant Orphan Drug Status, review the filing under the accelerated approval program and grant it expedited review? Why didn’t FDA turn its limited resources – and those of industry – to other, more important, drug treatments?  
• If NIH studies were adequate, why did FDA require more studies of the company? What then was the purpose of the unnecessary research required of the company, research costs which obviously had an impact on the price of the product? 
• After having previously expressed concerns about the quality of compounding by pharmacies, does the FDA decision against enforcement in this case seem inconsistent and even mean-spirited?  
• Does FDA’s decision against enforcement apply to other medications? If so, to which other medications? Which otherwise patented or unpatentable-but-Orphan Drug-designated products will not receive enforcement action protections regarding pharmacy compounding?  
• Should companies, as they figure the future of enforcement into the mix of product development decisions In the future, assume that FDA will suspend enforcement actions when NIH funds are involved in preliminary research?   

Congress: 

• Congress granted companies market exclusivity on drugs for rare diseases and for compounds that might otherwise be unpatentable through the Orphan Drug Act. This provision is one of the drivers of successful of the Act’s components. Does Congress now wish to reverse the terms of the Act?  
• If so, will products currently under development be grandfathered and can those academic institutions and companies who invested in good faith to proceed do so knowing the terms of the old Orphan Drug Act will apply?  

For Drug Developers: 

• Developing drugs for rare diseases is a cousin to personalized medicine, touted as the “next generation” of advancement for public health. Will this action play a role in how your companies approach personalized medicine projects? We all know these products will be more costly. Can you envision a market willing to pay?  

For Orphan Drugs Developers: 

• For PhRMA member companies – currently with over 450 drugs in development for rare diseases – will the facts in this case align with those of projects you have underway? Does this change your commitment for moving forward?  If you need to pull the plug on a project, will this event increase the likelihood that one or more of those will before rare diseases? 
• For BIO member companies who no doubt are developing biological products for rare diseases (sorry, but I can’t find numbers on the products in development for rare diseases by BIO members), do any of the facts in this case align with those of projects now underway? Does this change your commitment for moving forward?  

For Academics: 

• For academics working in labs with NIH funds (most likely), hoping not only to find treatments and cures to but to license those to companies at sometimes lucrative rates for yourselves and your institutions, how does this sit with you? Afraid you’ll get caught in the crossfire?  

For the rest of us: 

• Are we willing to sort through the facts, learn the details and suspend harsh judgments awaiting the right time to pass judgment? Or are we willing to allow policy makers bully the very people who are trying to make our lives better? 

Who was right? Who was wrong? I don’t know. I don’t have all the facts. I’m living with the ambiguity. But I do know some things from experience:

• Drug development is risky.
• Drug development for rare diseases is riskier still.
• NIH research is not always good enough for FDA purposes.
•  FDA resources are limited.
•  It all costs more than most of us know.
•  It’s easy to see only part of the issues and ignore many of the others.
•  It’s impossible to please Wall Street, Main Street, Capital Hill, regulators, clinicians and patients.

Lots of people made some choices these past few weeks. Rather than wait to sort it all out, far too many went witch-hunting, it was not a fair fight for the company involved and it sent a clear signal, not just to the one that shepherded Makena all the way through to eventual approval but to all the others as well.

Bundle up orphans.  It may be spring for others, but a long winter is on the way for us.  

Donna Cryer, JD

The following is a guest post by Donna Cryer CEO of CryerHealth.

By Donna Cryer, JD. There are countless articles and books on innovation – incremental innovation, radical innovation, disruptive innovation.   I would argue however, with a nod to the authors of Blue Ocean Strategy, that unless innovation is value innovation, providing some deliberate and distinguished combination of factors or service to improve the experience or effectiveness for relevant stakeholders, while reducing costs, it is not innovation at all, but simply something new.

That said, I am eager to make the case for personalized medicine as a value innovation.

The most common definition of personalized medicine is genomic-based risk assessment, diagnosis, treatment.  Personalized medicine, broadly construed, also comprises technology-supported medical practice able to aggregate data on a population level to a degree that positive or adverse outcomes can be spotted in sub-populations of patients.   Personalized medicine also provides for care in the context of an individual’s culture, values, and health literacy levels.  The uniting concept is a health care framework that gets the right treatment for the right patient at the right time, creating a safer, more effective, more cost-efficient health care system.  Think of personalized medicine as producing Me drugs rather than Me-too drugs.

The value of personalized medicine is best perceived using a systems view of cost and experience across identification, diagnosis, and treatment of a disease.  Imagine oncology today without personalized medicine:  A young woman would not know that she has a genetic predisposition to a cancer, (especially if she has no family history to raise red flags). Because neither she, nor her physician have this personal genetic information available, they do not start an early or aggressive schedule of mammography or other screening. A lump in her early 30s is dismissed. When she does develop cancer, there is no way of determining what type of specific cancer it is; she is given a treatment she does not respond to; other treatments are attempted, but ultimately she dies.  Without personalized medicine to help inform her health care decisions, the cost of her care is needlessly expensive and the clinical outcome is tragic.

The greatest threat to continued value innovation in personalized medicine is the lack of coherent reimbursement and regulatory frameworks that recognize the value of genomic-based diagnostics and therapies.

A personal example – as a liver transplant patient, I have blood analysis done several times a year to review my liver enzymes, levels of medication, and other markers. Recently, my physician and I have added a test that provides an assessment of my immune system’s individualized response to the immunosuppressive medications prescribed.  This test gave unique information — despite my dosage, my immune system was still very active, putting me at possible risk for rejection of my organ.  Where traditional tests would have led to reduction of my immunosuppression, given my apparent stability using traditional tests, the personalized test compelled a different treatment decision. Without this test it was likely that, as in the past, I (and my insurance company) would have incurred tens of thousands of dollars for liver biopsy; greatly increased dosages and numbers of  IV medications; hospitalization; and the extreme but foreseeable possibility, rejection or retransplantation which would put the dollar figure in the hundreds of thousands.  Avoidable for about $600.

Although my personalized immune test has been FDA-cleared, current Centers for Medicare and Medicaid coverage and reimbursement determinations under the constraints of the laboratory fee schedule processes (i.e., cross walks, gap fills, or code-stacking), basically attempts to match this sophisticated new technology to old payment systems. The result: a level of reimbursement that does not even cover the costs of performing the test correctly, let alone reflect its value.  The likely consequence of this inadequate reimbursement level is that despite the overall system-wide cost savings the test could provide (i.e., decreased need for additional liver biopsies and hospitalizations), hospitals will stop performing the test because they lose money each time they perform it.  The bottom line: patients and physicians will lose access to this test and the important clinical decision support it provides.

The Bible warns against pouring new wine into old wineskins as unworkable.  Our current system for determining the reimbursement for personalized therapies is just as unsustainable.

* This post is part of the Disruptive Women series on innovation.

So I decided to create a medication chart that allowed her to track her medications more easily and ensure she was taking them correctly. We then showed the chart to each of her physicians and pharmacist.  The result was a dramatic change in my mother’s medication regimen.  The chart enabled her physicians to view what they and all her other doctors were prescribing. They soon realized just how many medications she was on and that some medications were actually counteracting others.  Many prescriptions were changed or stopped and over time she went from taking 16 medications to nine.

Adverse events related to medications are the fourth leading cause of death in U.S. for patients over the age of 65.  This startling statistic led me into the patient-advocate role.  Since that time my own experiences have continued to reinforce my belief that individuals need to take control of their health and work to make sure all their healthcare providers, caregivers, and/or family members are working together as a team.

After being faced with several health scares in 2008, I decided to have an MRI breast scan for peace of mind.  I had learned that the scan was the best diagnostic and screening tool for women with large, dense breasts and a family history of breast cancer.  Since I had a mammogram six months earlier, which was normal, my physician did not think the MRI was necessary.  However, I decided to have one to be certain I was breast-cancer free.  To everyone’s surprise, the scan revealed three spots that biopsies confirmed to be multifocal breast cancer.  Since I knew my own body and had educated myself about available screenings, I may have saved my life because I was told a mammogram might have taken years to pick up the spots. This may not be the right course for every woman, but everyone should know that this tool exists.

I made the decision to undergo a double mastectomy and because it was caught early, I did not need chemotherapy or radiation.  However, I was prescribed Tamoxifen, which is a drug that can help prevent cancer from reoccurring. Like many medications, you must be careful about what other medications you are taking.  I discovered that the anti-depressant I was on counteracted the benefits of Tamoxifen.  Again, I acted as my own advocate.  Remember: Medications can save your life.  However, you must take them correctly and be very careful about what else you are taking, eating, or drinking in combination with your prescription.

Medical errors by physicians and hospitals are still prevalent and a staggering number of patients are misdiagnosed every year.  Compounding the problem is the fact that numerous prescriptions prescribed by various physicians are not being reviewed on a regular basis and patients self-medicate.

Patients should not just depend on a physician’s files of their medical information but take it upon themselves to create their own permanent medical records.  Before going into a medical appointment, everyone should be prepared with the following information:

• List of current medications and dosage
• List of ailments
• Medical history (if seeing a new physician)

A patient should also be prepared to explain to the doctor exactly what their problem is and offer an overall view of their health.  If a serious condition exists, perhaps they should bring someone else to the appointment.  In many cases a friend or loved one can interpret the information the doctor provides more objectively and be ready with questions that someone in an emotional state might have difficulty asking.

Ultimately, it is the responsibility of the individual to be their own advocate, know their own body, ask questions, and make sure everyone that is part of their healthcare “team” is communicating and basing decisions on the current, accurate medical information.

There are two ways to listen and/or participate in what will be fascinating conversations — listen online at http://www.blogtalkradio.com/realwomenonhealth or call toll-free (646) 929-2625.

And speaking of Patient Advocacy and Empowerment, Disruptive Women in Health Care is working on its next e-book which is all about Patient Advocacy.  Start looking for posts later this month.

If you have stories or tips to share on this subject, we invite you to send them in.

My second thought concerned forests, falling trees and sounds we may or may not hear.

The history of health care in the United States is, in large part, defined by sound policies and vital programs that are not accompanied by effective outreach to  the patients and consumers who have the most to gain from these innovations.  Thus, new provisions expanding preventive coverage have the potential to be like the proverbial tree falling in an empty forest.  If we don’t do a good job letting people know these services are more accessible, will they take advantage of them?

I think of the millions of people who are eligible for Medicaid or for Children’s Health Insurance Programs who aren’t enrolled.

I think of the widespread confusion that existed in the early days of the Medicare Part D prescription drug program until several organizations stepped in to conduct coast-to-coast information sessions with seniors.

And I think of the story that just appeared in the New York Times (http://www.nytimes.com/2010/07/15/health/15chen.html?_r=2&ref=health&pagewanted=print) regarding the growth in usage of the “medical home” model for health care.  (I prefer the term health home, but that’s for another post.) As Dr. Pauine Chen pointed out in the Times, empirical evidence is showing that the medical/health home – shorthand for greater care coordination between the patient’s primary care physician, specialists and other health care professionals – is working.  A demonstration project sponsored by the American Academy of Family Physicians showed that the new model was improving quality of care, efficiency of operations and physicians’ job satisfaction.

But patients hated it, because no one bothered explaining to them why their one-on-one relationship with their health provider was being replaced by a one-in-three or one-in-four relationship with multiple providers, even if it resulted in better care.

And, thus, does this new innovation in health care delivery fall within the proud history of U.S. health care in which great ideas are not linked with communication to the patient.

As health reform is implemented, both the public and private sectors need to do better, beginning with outreach to let people know about the new preventive care coverage and, more importantly, to ensure that Medicaid expansion and the new subsidies to help make private health insurance more affordable affect the people for whom they are intended.

L to R: Julie Murchinson, Robin Strongin, Indu Subaiya, Fran McMahon

You may be asking what the term Health 2.0 means and luckily for you Indu Subaiya Co-Founder of Health 2.0 provided us with an answer. Health 2.0 applies the same social networks and user-generated focus as Web 2.0 (which has been around since 2003) to the world of health care. It began as a consumer-driven movement with providers becoming involved a bit later. More recently the concept has grown as a result of its partnership with health care reform. Another noteworthy aspect is its ability to foster data-driven decision-making. Currently, there are about 1000 companies actively engaged in Health 2.0.

Bottom Line: Health 2.0 gives you (the patient, caregiver, provider, payer) the tools to be able to get the information to make better decisions.

To better illustrate Health 2.0, the panelists discussed their companies’ developments. Dr. Marlene Beggelman founded Enhanced Medical Decisions which developed an online medical solution that uses “natural language” search technology, to enable users to quickly and easily find accurate information on drug interactions and reactions.. Linda Von Schweber the Co-Founder of Surveyor Health discussed their software’s ability to create an online medicine cabinet for consumers where they can learn the various side effects and interactions of the drugs they are taking. Eliza Founder and President Alexandra Drane detailed the personalized voice-based service they developed that helps consumers make better health care decisions. All of these technologies are innovative, put consumers in the driver’s seat and support efficient, safe and quality health care.

Julie Murchinson the Managing Director of Manatt Health Solutions and the Founder of Health 2.0 Accelerator detailed a workshop that took place at yesterday’s Health 2.0 Conference during which federal government representatives interacted with the companies on how they could address chronic disease, vulnerable populations and personal health management. Robin Strongin noted how critical it is for the Inside-the-Beltway health information technology and health reform decision makers to be engaging with the Health 2.0 developers and innovators as an important step towards insuring meaningful use – for patients.

The most important take-away message from this morning’s breakfast: Health 2.0 technologies empower consumers to get involved and take control of their health care; they provide the information to give patients the courage to not only ask questions…but to push back and engage with their health provider when something just doesn’t seem right.

Sharon was recently announced as an Ashoka Fellow for improving health outcomes for patients who have genetic diseases by aligning incentives and structures so that they facilitate, rather than obstruct, the continuum of research, drug development, treatment, advocacy, and support.

Ashoka is the largest association of leading social entrepreneurs in the world that strives to enable the world’s citizens to think and act as changemakers. Working in over 60 countries around the globe in every area of human need, Ashoka Fellows demonstrate an unrivaled commitment to bold new ideas through a combination of compassion, creativity and collaboration. Fellowship is a distinguished lifelong position attained only after a rigorous selection process.

You can share Sharon’s Ashoka journey by following her on Twitter at @sharonfterry.  She will also be blogging about her Ashoka experiences on Disruptive Women.

I’ll dispense with ‘rare’ right away.  If by rare, we mean single gene disorders, then perhaps it is a useful designation.

If by rare, we just mean the equivalent of the US definition of orphan disease, i.e., less than 200,000 people in the US, then we should ask a few questions. In the old model of test and drug development, the ‘block buster, body count’, model, rare was a useful designation.  In a system built for BIG, then rare needed a boost.  In the new age of personalized medicine, all conditions are rare. In fact, they are usually an N of 1 after factoring in the myriad of genes involved, epigenetics, environment and so on.  As we enter new ways of dealing with common conditions, they too will be fragmented into dozens, sometimes hundreds, of rare conditions.  Thus rare and common conditions have similar challenges in that realm.  For these reasons, I recommend we lose the word ‘rare’.  I know it has a rich and abundant history in the Orphan Drug Act, but in addition to the aforementioned issues, I think siloing our thinking around disease into these social constructs of abundance of disease misses opportunities that would blossom were we to consider gene families, pathways and targets instead of incidence and prevalence.

Let’s move then to single gene disorders.  Comparative effectiveness would have to go on unemployment if it depended on single gene disorders for its first tasks.  Most single gene disorders do not have a treatment, let alone several.  And once one is developed, it is hard for a second one to be developed given the lack of financial incentives in the old paradigm.  Perhaps a first step in comparative effectiveness for single gene disorders is creation of ANY treatment for these conditions.

On to genetic conditions.  I think genetic conditions have already been spoken for in all of the preceding posts – because all disease is a mix of genes and environment, and so all of the conditions spoke about, either explicitly or implicitly, are genetic to some extent.  That said, I believe genetic diseases, and genomic signatures of attributes of disease, like tumors, offer ways to quantitatively measure expression thereby offering a new level of scientific scrutiny for disease.  While most genetically and genomically authored tests and treatments are nascent and have not yet been scrutinized, we are seeing some assessments of genetic tests, at least.  These are not complete comparative effectiveness studies, but they use methodology that might offer something to the field of comparative effectiveness.  If the field does use methodologies like those of EGAPP, then it will be important to do a broader assessment of the methodology before wide spread implementation.  From the website, “The project’s goal is to establish and evaluate a systematic, evidence-based process for assessing genetic tests and other applications of genomic technology in transition from research to clinical and public health practice.”  There are those who ask why almost all tests that EGAPP has assessed have failed to meet the requirements to pass into clinical practice, when some of these tests have done so in a variety of ways.  EGAPP is a good example of how hard it will be to do comparative effectiveness, since its assessment (far from comparative effectiveness) is so difficult, resource and time consuming.

However, I look forward to our foray into comparative effectiveness.  I believe it is time for the practice of medicine to move from being a cottage industry.  Comparative effectiveness, coming of age in the genomic/informatics era, while we move toward individualized medicine (commonly known as personalized medicine), will be an effective tool if, in the words of the post by Randel before me:

“A fair, open, cooperative public/private process, if designed properly will enhance the information needs of patients, physicians, and scientists and eliminate wasteful and ineffective medical technologies and procedures. Implemented without a fix of the payment system, however, the fear that this may stifle access and innovation will be realized.”  If we wish to move medicine out of the cottage industry realm, reimbursement has to come too.  There are exciting months ahead of us – let’s not call each other names like rare or common, genetic or infectious, popular or unpopular.  No disease, condition, or disorder should be left standing around the edges of the dance floor while the rest are dancing.

Stay tuned to the collaborative discussion about health reform resulting from the flash mob on June 17, 2009.

Inform Health Reform

http://fastercures.blogspot.com/2009/06/fastercures-joins-healthcare-advocates.html

To learn more, read on:

It is so important to me that awareness be created regarding the Ryan Dant bill as well as rare diseases such as Gaucher’s Disease. That is why I’ve dedicated my blog not only to sharing updates with family and friends, but to create awareness for rare diseases, legislation, and other life experiences raising a child and family with unique special needs.

Here are some details regarding the Ryan Dant bill. I have actually been emailing with Mark Dant, Ryan’s Dad, about getting Hannah very much involved.

Basically, the bill will remove the income requirement for Medicaid if the applicant’s medical treatment would cost more than $250,000 a year (Hannah’s medication will cost about $250,000 to $300,000 a year as an adult, and that doesn’t include doctor’s fees, other procedures, therapies, and surgeries). If Hannah was a young adult, she would have to get a low-paying job (poverty level) in order to get Medicaid for her treatments because there are very few insurance companies that would accept an adult with that kind of insurance cost.

Here is a copy of my letter.

Dear Congressman,

One of my cherished roles in being a mother is to guide my three children on the path to following their dreams and to pursue the career of their choice. For my two oldest children, I can encourage them to reach for the stars and dream big. For my youngest daughter, I have to tell her that she cannot dream.

My youngest daughter, Hannah, is six months old. She was born with an enlarged spleen, enlarged liver, and extremely low platelets. She has suffered through numerous procedures (IVIg transfusions, platelet transfusions, skeletal surveys, skin biopsies, etc.) and probably has had more blood draws than most adults. Finally, after five months of searching for a diagnosis, we now have one. Gaucher’s Disease, type 1 or type 3.

Hannah has one of the most severe forms of Gaucher’s disease, as her body produces absolutely no enzyme to help break down the fat in her body, so it gets stored in her spleen, liver, and possibly her brain (type 3). It is incredibly rare for a newborn to display this disease, so we feel we are travelling a road that very, very few have travelled before us.

For the physical aspects of this disease, she will be starting Cerezyme treatments via IV infusion every two weeks for the rest of her life. Picture if you will, an infant baby girl having to be painfully pricked with an IV and attached to a machine for 3 to 4 hours every two weeks in order to save her life. How does a mother explain this to a baby, a toddler, or even a young girl?

Cerezyme is one of the most expensive drugs on the market today. As an adult, the cost of her treatment will average about $250,000 to $300,000 a year by today’s standards. Even as an infant, the Cerezyme alone will cost over $30,000, and this doesn’t include other related medical bills such as doctor visits, use of the infusion center for the treatments, possible upcoming surgeries, etc.

Because of the numerous doctor appointments, weekly therapy sessions, and Cerezyme treatments every month, I am unable to return to work. We are now living off our small personal savings along with my husband’s income from his job to raise our three children in addition to dealing with our mounting medical debt.

We applied for Supplemental Security Income to give us a little assistance. We were immediately turned down once I shared what our current income was. Just like that, our chance for any help was dashed. What was even more shocking is that our income is not that great compared to most families of five. My husband and I have both been regularly employed for over 20 years, never needing government assistance. We have been “paying into the system” for years, and now when we need help from the system we have been funding for over two decades, the door gets slammed in our face.

Our family has gone from living a comfortable two-income middle-class lifestyle with a small savings to now being faced with possible future bankruptcy because of the cost of medical treatments and procedures for our daughter.

What makes matters worse is that Hannah is never going to get the chance to make a decent income as an adult. Since most insurance companies would probably not insure her because of the cost of her treatments, she is going to have to rely on Medicaid to cover her treatments. In order to qualify for Medicaid, she has to settle with only being able to work a low paying job.

How do I tell my daughter that her brother and sister can strive for any job in the world, but you have to resign yourself to the fact that you can’t have a “dream job” and instead will have to take a low-paying job for the rest of your life just to save your life?

Because of her Gaucher’s Disease, she has already been given monumental life obstacles to deal with over her lifetime. But this disease does not take away her ability to dream. You have the opportunity to give my daughter the chance to dream and to be anything she wants to achieve by supporting bill HR5748.

Thank you,

Carrie

Mom to 3 including Hannah, 6mo with Gaucher’s Disease

My Top 10 Priorities for the Next HHS Secretary (NOTE: this was written prior to the selection of Tom Daschle–not surprisingly, I was holding out hope for a woman–no offense to Mr. Daschle):

The next Secretary of the US Department of Health and Human Services (DHHS) will have a plate that is not only full, but is overflowing. While all the political rhetoric is focused around access—health insurance for all—there are a number of other critical areas that need immediate attention as well.

Clearly there are many more than 10 priority areas. However, if I just so happened to find myself sitting across from the next Secretary of HHS, I would remind her (just indulge me on that) that she is the Secretary of Health AND Human Services—that for her to make a dent on the health side of things, she must take into account whether people have: the support systems they need, heat, a home, transportation, enough to eat.

Here is my list of the top 10 priorities, in no particular order:

1. Human Services—In other words, just because someone finally has access to health care, it may not be enough. Madam Secretary: Please consider creating a new position: the Assistant Secretary of Human Services to oversee the coordination of services that will surely make a difference in the outcome of someone’s health: From a process systems standpoint, Does the patient have transportation to get to a health provider? Will that patient have a working refrigerator to store medications that require colder temperatures? Is the patient able to feed himself? To understand all the discharge instructions? Is the patient living in a clean, warm, place? You get the point.
2. Mental Illness—Columbine/VA Tech shootings; depression in epidemic proportions; what will it take to get us to improve services, coordinate care, and erase the stigma.
3. Research—It is unconscionable to not: pursue to the fullest extent possible, the promise of stem cell research; fully mine the treasures that genomics, proteomics, and personalized medicine hold within our reach; create incentives for researchers and innovators to focus on rare diseases; develop exciting competitions for young scientists; include with greater frequency children, minorities, the elderly, and women in ethically sound and appropriate trials—we get sick too, you know.
4. Electronic Health Records/IT—Enough already with the red flags. Privacy is critical—but it shouldn’t be the distraction we have allowed it to be—there are ways to address the privacy concerns (look at other sectors, look at legislation such as GINA, the Genetic Information Nondiscrimination Act of 2008, and look at the American Medical Informatics Association concept of data stewardship).
   And, while Congress is twisting itself in knots in the name of privacy, (which I agree is of critical importance), there are thousands of patients and caregivers, especially those battling life-threatening illnesses, who are putting all their personal information on the Internet—they believe that by engaging with others globally, treatments and cures could come about faster. Sites such as Patients Like Me are gaining traction.
5. Adolescent Health (binge drinking, unsafe sex, obesity, stress, body image)—I have an 18 year old son and a 14 year old daughter; I am here to tell you it’s a scary world out there for adolescents and their parents and guardians. It would be fantastic to see a full blown Public Awareness/Education Campaign that addresses underage and binge drinking—(these college presidents who want to lower the legal drinking age should be ashamed of themselves).
6. Disparities—It is a national disgrace that in 2008, “despite continued advances in health care and technology, racial and ethnic minorities continue to have more disease, disability, and premature death than non-minorities.” We can no longer afford to wait to correct this injustice.
7. Workforce—We have documented shortages of nurses, of primary care physicians and certain specialties. We have shortages of provides in rural areas. And yet, we still can’t figure out a way to all get along—how about a real integrated team approach where multiple providers work together for the good of the patient? For that to happen, Madame Secretary, it is imperative that you strive to maintain a diverse health care workforce. I know, I know, there are some models out there, but so far, not much real progress. I know, I know, reimbursment’s an issue—for that, please see priority #9.
8. Health Literacy—In April 2004, the Institute of Medicine released a report entitled Health Literacy: A Prescription to End Confusion which found that “Nearly half of all American adults—90 million people—have difficulty understanding and using health information, and there is a higher rate of hospitalization and use of emergency services among patients with limited health literacy…Limited health literacy may lead to billions of dollars in avoidable health care costs.” For more information, check out http://nnlm.gov/outreach/consumer/hlthlit.html.
9. It’s the Reimbursement, Stupid—(Not you, Madame Secretary, it’s just an expression). Until we figure out how to pay all providers fairly, equitably, and dare I say simply (this SGR business is for the birds), it will be challenging indeed to move the health care needle forward.
10. Patient-Centered Care—With all the policies, politics, and regulatory hurdles that come along with the job, please don’t loose sight of the fact that at the end of the day it is about people. People who are frightened, who are in pain, who need to know there is someone out there who they can depend on when they need it most.

Hubert Humphrey once said, “The moral test of government is how it treats those who are in the dawn of life—the children; those who are in the twilight of life—the aged; and those who are in the shadows of life—the sick, the needy and the handicapped.”

Looks like you’ve got your work cut out for you.

I sometimes see genetics as a leading edge, a knife that is cutting through the old, crusty, barriers.  It does this perhaps because it is new, but after leading with the novel edge, it has a great deal more punch.  I believe it will be an innovative disruption (a la Clay Christensen) because the health care system will not be able to adjust enough to fit its value inside the system (or lack thereof).

Starting with the power of understanding family history (still perhaps the most powerful genetics tool) to the sophistication of personalized medicine (using genetics and genomics to tailor diagnosis and treatment), genetics and genomics will both buoy and stress an overstressed healthcare system.  It is time for change.  It is in the works, on the drawing tables and in people’s hearts and minds.

Genetics is about both difference and sameness.  We are fond of saying we are 99.9% the same as the next person (and 50% the same as a banana:-).  And we are excited about the fact that our genome can make the difference for us when it comes to how we metabolize a medication, or what treatment is best for an individual.  That duality is one that western civilization is not normally comfortable with – it is something that challenges us to understand both public health and individual health in the same breath.  Literally.

I believe genetics offers us a new paradigm on a number of levels.  Certainly the science is ready to take us to new places.  But I recommend we ponder what it means to balance the collective and the individual needs in health services, privacy, research and public health.  I think if we begin to see these not as two sides of a coin, or as a dichotomy, but as yin yang, we will have a basis for a transformational system that will focus on prevention, and obliterate disparities.

I had a tangible experience of this during the week.  My daughter Elizabeth turns 21 on December 12th.  She, and my son, have put up with a great deal of my time being focused on not only the 3,000 or so people that have the condition they do – pseudoxanthoma elasticum (PXE) – but on the 25 million or so individuals with genetic conditions. Elizabeth cam to me this weekend and asked if she could put up a donation page for support for PXE International.  The page is an example of the balance of both personal and global participation in health, community and life.  http://www.firstgiving.com/elizabethterry

I believe we are building a community, and I am delighted to be a part of it, here and elsewhere.  Where do you see boundaries dissolving?  Where do you see the tensions in public and personal health, in inequities in the system?  Let’s solve this together – lay it out, so we can all participate!

Medical homes are proposed to be primary care practices where people can get help with coordinating their care, particularly for chronic illnesses. The U.S. health care system emphasizes specialty practice rather than primary care. It’s one of the reasons why we pay more than any other nation for health care but have outcomes that lag behind those of even moderately developed nations. If I have diabetes and heart failure, I go to one specialist for treatment of my diabetes, the cardiologist for my heart failure, the gynecologist to get my annual GYN exam, a podiatrist, a retinopathist or ophthamologist, a dentist who may prescribe medications before and after procedures, a shrink to help me cope with this mess, and possibly others to screen my various body parts for myriad diseases. Each is prescribing medications that may interact in adverse ways. In fact, I may end up with a costly hospitalization because of these adverse effects. No one knows all of me or focuses on my overall health—unless I have a primary care provider who can oversee all of these specialties, follow all of my treatments and medications, and coordinate my care.

Unfortunately, Medicare, Medicaid, and private payers have heretofore refused to pay for such care coordination. So primary care physicians have been loathe to spend their time doing this and, I would argue, it’s probably not a good use of their time to do. First, there aren’t enough primary care physicians to meet the nation’s need, with only 1% to 2% of physicians are going into primary care. But nurse practitioners (NPs) and physicians’ assistants (PAs) are filling the gap. In some rural areas of the country, NPs and PAs are the only primary care providers available. They may have a consulting physician to whom they refer complex cases or use telehealth technology to get advice from physicians in academic medical centers. NPs have demonstrated that they have outcomes similar to if not better than primary care physicians, so it’s not second-rate care, as organized medicine likes to claim.

Second, registered nurses are educated in care coordination but physicians are not. Some people are proposing that physicians get trained to coordinate care but it’s not a good use of resources that are getting scarcer every day. While it might make sense for a physician in solo practice in a rural area to do so, it would be more economical for that physician to hire an RN to coordinate the care for patients in the practice. Nurses are also more likely to focus on promoting the health of individuals and families, educating and coaching them in how to develop healthier lifestyles, reduce their risk for disease, and better manage their chronic illness.

One fine example of this care coordination is Evercare, a nurse-led service available in 35 states aimed at keeping older adults healthy and out of nursing homes. Developed by two nurse practitioners in Minnesota, Evercare has reduced hospitalizations for nursing home residents by 45% and emergency room visits by 50%; kept people out of nursing homes, and saved the state of Texas $123 million in Harris County alone during a two-year period. (For more information on Evercare, go to www.aboutevercare.com; or go to www.aannet.org and read about the Raise the Voice initiative by the American Academy of Nursing that highlights Evercare and other innovative models of care developed by nurses.)

Minnesota has decided that a focus on health rather than illness is just what it needs, so it’s using the phrase “health” home in recognition that many people think of nursing homes when they hear “medical home.” And health promotion should be the mantra if we want to have healthy citizens while reducing the cost of health care.

So I was stunned to learn that both Cigna and the Commonwealth Fund are supporting a number of demonstration projects for “medical” homes that all focus on physicians as the providers who will do the care coordination, rather than RNs, NPs, or PAs. And a study of the adoption of “medical” home concept in physician group practices published in the September/October issue of Health Affairs concluded that “The level of adoption of PCMH [primary care medical home] infrastructure components among large medical groups is low.”

When will the “reformers” in health care learn that we must break out of traditional models of care and stereotypical notions of who should do what and be paid for what? We need a health care system that focuses on health, pays for health promotion, expects excellent outcomes, and uses and pays for the skills and knowledge of all providers who can help us meet this goal.