Henna, Xeloda, Roche, Europe, August

Monique Doyle Spencer's Op-Ed about the use of henna as an antidote for a known side-effect of Roche Pharmaceutical's important cancer drug, Xeloda, has been picked up and published by the International Herald Tribune. Roche is based in Europe, so maybe the article will get more attention there. On the other hand, it is August, and people in Europe often take off the whole month. That probably would explain why I have received no reply to my note to the CEO of Roche on the same topic.

Meanwhile, even though it is August, Monique did receive an apologetic note from a staff person at Roche, particularly for the part about inquiring about her long-dead mother, but the person missed the point again. With her permission, I include excerpts from a follow-on note from Monique:

I appreciate the kind letter you sent. I understand how mistakes like this happen and I'm sure everyone felt chagrined....

I have exactly one issue. I am deeply frustrated that no one has answered my question: Does anybody at Roche seek remedies for side effects due to Roche's products? Is that anybody's job?

To be honest, I have no interest in becoming a henna poster child. Yet ... when henna came my way, it made a great difference in my ability to tolerate Xeloda. The Xeloda will extend my life and the henna is the ONLY reason I can tolerate the Xeloda....

In New England, the Boston Globe and WBZ radio reach a broad audience, so I am receiving phone calls and letters asking for my help. I've created a web page to send people to, giving them full instructions about henna. Elderly people often do not have internet access, so in some cases I've given people henna or sent them printed instructions.... I expect word to continue spreading. I've already noticed the story appearing on cancer bulletin boards, and I've posted on a few to pass information along.

My point is that people really suffer from HFS. For some it keeps them out of their favorite sports, for others it is crippling pain. I just want somebody with the means to help them! I hope that Roche will look into it, or fund a study to prove or disprove henna's efficacy.

Can you help?

Thanks again for your kind letter.

Regards,
Monique Doyle Spencer

Sunrise over Pamet Harbor

Exercise equipment secondary market?

Pictures from a recent visit to the Town of Truro solid waste transfer station. Note, in this pile of stuff, the disproportionate representation of exercise equipment, whether stationary bicycles, stair steppers, or other varieties. I don't know if these are thrown out by year-round residents or by the summer "wash-ashores" in this Cape Cod community. I wonder if all those people who have been laid off this year by those secondary market mortgage investment companies would want to think about creating a secondary market in this equipment.

Facebook for my generation

Can't wait to add some friends, but I keep forgetting my password.

(Click on the image to enlarge so you can read the entries.)

Summer term is over

A picture from a farewell luncheon for our Summer Health Corps high school volunteers who have spent the last six weeks working at our hospital. They found themselves in a variety of settings, from the GI unit to the post-op area to radiology. We were happy to have them here, and we hope that the experience promotes a longer term interest in hospital and health care for at least some of them.

Which people?

"There are many people who would prefer to see this site never get off the ground, and as participants in the system, there are dozens of ways to delay and roadblock development and implementation."

Wow. This is a pretty important statement by Charlie Baker, CEO of Harvard Pilgrim Health Care. He was talking on his blog about continuing delays in the public posting of payment information by the MA Health Care Quality and Cost Council. The information would indicate how much individual hospitals get paid for particular services by the state's insurance companies. Charlie is a member of the Council and has been working for months in trying to move this along.

Let's think this through. Which people could possibly have an interest in slowing down the publication of this information? You can post your answers below.

(Disclosure: Charlie is a member of the BIDMC Board of Trustees, an advisory body to our hospital, not the fiduciary governing body.)

3v3 Soccer Tournament to benefit AIDS programs

Finally, I get to combine my soccer and work interests! A note from Nadia Ouhib, on our Neurology staff, but also a student at Boston University. We are happy to help sponsor this event, and I encourage you to join in for this worthwhile cause:

I am responsible for a tournament that I have been organizing with the BU Soccer Club, called the "Lose the Shoes" tournament on September 27th. It will be a series of 3 v. 3 matches where students from schools all over the Boston area will compete, enjoy live music, and free food with their $5 registration fee at BU.

This tournament, however, is no ordinary event. It is being held in cooperation with Grassroots Soccer, an organization committed to fostering AIDS awareness and prevention in Africa. A charity event, all proceeds will go to Grassroots Soccer and their beneficial efforts to help those less fortunate. The theme of the tournament, "Lose the Shoes," requires students to play barefoot (or with socks) on our brand new turf field, similar to games played in the streets of Africa. We anticipate a fun and successful event.

Check out details on the tournament and other events! Our BU Soccer Club event website.

Lusaka Sunrise: Watch this YouTube video to learn about the program in ways words can not describe.

Surprising use of Lean

A note from one of our rehabilitation staff, who had gone through an exercise in learning and applying Lean principles in the occupational therapy clinic:

The Lean organizational concepts have been helpful for me with patient care and in one case recently in particular!

Recently I treated a young patient with early Alzheimer's who needs to organize home etc. to help him with memory impairments. It was very helpful to show him some of the ways we have organized our department to improve our efficiency, particularly with the labeling. I feel that those same concepts will be helpful for him to organize in his home environment as it needs to be extremely organized to help him with memory impairments.

I don't know if people elsewhere have used this approach in a therapeutic way and put this story out there to see if so and to welcome comments if you have. (Mark Graban or others, do you have examples of this from your extensive experience?)

More on henna

Monique Doyle Spencer shared with me a letter she received after writing her recent op-ed about the potential value of henna in ameliorating side effects of an important cancer drug. I reprint it with permission of the author:

I was very interested in "Anybody Want a Zillion-Dollar Cure Idea" (Globe Op Ed 8/1/08). My twin brother was diagnosed with colon cancer and was also put on chemotherapy using Xeloda. He suffered mightily with the same side effects as Ms. Spencer. We constantly asked "Can't something be done to relieve this torture?" After four years of suffering, he died last May. It is sad to know that the drug company could have conducted a study of this simple antidote or noted on their website the relief that some people had received. Shame on Roche Pharmaceuticals and the industry.

When I wrote about this below, at least one commenter suggested that it would be difficult for Roche or a similarly situated pharmaceutical company to make recommendations about this or another antidote, citing legal and regulatory issues. I don't know enough of the law to address that. I also have to assume that the response Monique received to her queries never made it up the full chain of command in the company and so might not have been reflective of the view of senior management. So to be fair about all of this, I am going to do my best in the next few days to contact my CEO counterpart at the company and make him aware of all this and see if he is interested having some of his folks brainstorm with our people and others like Monique about how to get the word out or do more research on this matter.

Don't blame me. I'm from Massachusetts.*

I recently wrote about the large sums of money being spent by the SEIU to influence current elections and raised the question about when and if the topic of the so-called Employee Free Choice Act would enter the candidates' debates.

Around Boston, these kind of comments have been used by some to portray me as out of touch with the traditionally liberal bent of Massachusetts politics. Now, to my rescue comes none other than -- tah dah! -- George McGovern. In an August 8 op-ed in the Wall Street Journal, he raises exactly the same issues.

Here are the final two paragraphs in his article:

I worry that there has been too little discussion about EFCA's true ramifications, and I think much of the congressional support is based on a desire to give our friends among union leaders what they want. But part of being a good steward of democracy means telling our friends "no" when they press for a course that in the long run may weaken labor and disrupt a tried and trusted method for conducting honest elections.

While it is never pleasant to stand against one's party or one's friends, there are times when such actions are necessary -- as with my early and lonely opposition to the Vietnam War. I hope some of my friends in Congress will re-evaluate their support for this legislation. Because as Americans, we should strive to ensure that all of us enjoy the freedom of expression and freedom from fear that is our ideal and our right.


*To assist those readers under a certain age, this was a popular bumper sticker in 1973 and 1974, after the 1972 Richard Nixon Presidential election victory. McGovern only won one state's electoral votes, Massachusetts. Nixon resigned the presidency this week 34 years ago after it became clear that he had authorized or condoned illegal activities against his opponents during that election.

Seals in Motion

A video of some of those seals I mentioned several days ago on a sand bar just off of Head of the Meadow Beach in Truro. The cows are quick to head to the water when approached. The bulls stand firm!

Real baseball

Player and crowd scenes from a playoff game between Orleans and Harwich at the Cape Cod Baseball League tonight. This is real community baseball, where college kids are given local housing and part-time summer jobs so they can play for several weeks at fields where the fans can sit close and meet the players and the mascot. After each game, a local restaurant, business, or family treats the players to dinner. One in 7 of all Major League Baseball players played in the Cape Cod league!

August self-portrait

Eat your heart out, Rembrandt!

Outer Cape box turtle

Budget Time

It's budget-making time in the hospital world, as many of us prepare for the fiscal year starting October 1. I suppose there was an era when this was easy, but those days are long gone. To put it simply, the cost curve is going up faster than the revenue curve. Other types of business deal with this by adding new product lines, enhancing the value of those products already offered, increasing marketing to gain market share, and garnering efficiencies in the production process. Most of those options are not so available in the hospital sector, and particularly for academic medical centers.

Like other hospitals, we at BIDMC have five revenue sources, in size order, clinical services, research, current use philanthropy, investment returns on our cash assets, and royalty or equity payments from the sale or licensing of intellectual property. Of our $1.2 billion in revenues, though, the first two predominate by far. About $1 billion comes from delivery of inpatient and outpatient care, and $200 million comes from research grants. The remaining three items are measured in the $10's of millions, all together.

The business model for academic medical centers has been to enhance clinical revenues by building sufficient bed and clinic capacity to increase both the volume and acuity of patient visits. On the research side, the business model had been to take a loss-leader for several years by providing laboratory space and salary support for the best scientists, with the expectation that they will be sufficiently productive over time to cover both their direct costs and also contribute to overall corporate revenues through indirect cost recovery.

Thus, hospitals faced a clear growth imperative. As long as your incremental revenues from treating more patients exceeded the incremental costs of treating those patients, each year could show improvement over the last. Likewise, as long as you could count on those new researchers to get off the dole and eventually cover their space and personnel expenses with ever-increasing grant revenues, all would be fine. Indeed, the expanding research enterprise would contribute enhanced indirect revenues to help offset the hospital's fixed overhead costs.

For years, all was well on the clinical side of the house. While government payers (Medicare and, especially, Medicaid) did not cover their full cost of service, payments from private insurers would make up the difference. Now, though, we can project a declining rate of payment increase from both the federal and state governments, increasing the needed subsidy for those elderly and poor patients -- but precisely at the time private insurers are recoiling from doing so because of pressure they feel from their business and individual subscribers. Private insurers are making clear that they don't want their rates to increase faster than their estimate of overall (not health care) inflation, and, also, they feel less obligation to make up the shortfall in government payments.

The private payers are also more and more interested in move towards some kind of capitated rate system (i.e., paying $x per year for the full spectrum of medical care) for those patients covered by their insurance products. In the past, if their rate was a bit too low, selling more units of care to an ever more service-demanding population could make up the difference. Now, though, they are looking to control the product (rate X units) and therefore want to move to a more global fee per patient per year.

On the research front, a dramatically slower growth rate in NIH funding for biomedical research means that many more of those bright researchers you recruited or were just about to recruit into the research labs you just constructed will find themselves unfunded for longer periods of time. You either have to cover their salaries, lab expenses, and space costs from general hospital revenues, or lay off scientists and just cover their now empty space costs -- all the while explaining to your highly skeptical faculty that you remain fully committed to a strong research program.

What, then, is a business plan that is most likely to produce overall positive net income for a hospital over the coming years, income that is essential for capital investment for renewal, replacement, and enhancement of clinical and research functions? (For the accountants out there, think about a target of funding 130% to 140% of depreciation each year -- requiring an operating margin of at least 4%. Please note that I am talking about a hospital in good standing, not one that is engaged in a financial turnaround.)

1) Focus on growth in clinical services that are most suitable for a high level tertiary facility, those that coincidentally produce the best margins. Meanwhile, stabilize, reduce, decant, or eliminate those that do not. But decisions here must reflect the interdependencies of low-margin and high-margin specialties. For example, you cannot eliminate the low-margin nephrology division if you intend to expand your high-margin kidney transplant program. And, you can't eliminate money-losing psychiatry at all, given the pervasive co-morbidity of mental illness with many physical illnesses, especially among the elderly.

2) Optimize use of space. To the extent you can avoid expensive new construction (currently priced at over $1000 per square foot for construction costs alone) by reconfiguring space use, you avoid new fixed costs and are able to expand volume at lower incremental cost.

3) Achieve operational efficiencies. No, not by an administrative fiat that reduces staffing, but by application of LEAN methods or other improvement programs that tap the know-how and creativity of your front line staff. But, you need to aim for double-digit improvement, not just 1 or 2 percent per year.

4) Work to eliminate preventable harm. When hospital acquired infections, for example, are avoided, the extra costs of extended lengths of stay are also avoided. Even under most current insurance payment methodologies, the business case for harm-avoidance is compelling.

5) To the extent insurance rates move toward capitation, learn to coordinate and manage care across the spectrum of services. This is really hard when you don't control, say, that nursing home that receives your discharged patients. But get ready for the day, by enhancing interoperability of medical record systems and building cooperative relationships among the physicians along the spectrum of care.

6) Meanwhile, research must also be managed, not just to produce higher revenue per square foot, but also to ensure that the research agenda is consistent with the hospital's clinical priorities. There is probably, too, an optimum range in the overall size of the research program for a given overall hospital size. Analyze this, and head towards that target over time.

7) Understand that philanthropy is the fourth line of business -- along with clinical care, research, and teaching -- if an academic medical center is to thrive in doing those functions society expects of it. Whether enhancing the income statement with current-use unrestricted donations or relieving capital budgets with restricted-use investment gifts, philanthropy is an essential component of hospitals' futures given other economic trends. Generally, investments in philanthropy yield about 16 times their annual cost and therefore represent one of the highest and best uses of operating funds.

I don't think that anything I have said here is new or controversial among hospital administrators or their Boards. However, it has become clear to me that many of these concepts are outside of the realm of experience of many hospital doctors, scientists, and other staff. If you are reading this and it is new or strange to you, please comment. If you are reading this and are involved in hospital management or governance and have something to add or subtract, please comment, too.

Henna, ha, hai na*?

Monique Doyle Spencer offers a damning op-ed about the unresponsiveness of Roche Pharmaceuticals to an off-the-shelf remedy (henna) for a widely known side effect (hand-and-foot syndrome) of its cancer drug Xeloda (capecitabine). The fact that she does so with her usual dry humor should not disguise that fact that she has a very serious and important case to make.

Putting aside the bureaucratically ham-handed response from the company to her suggestions, there is a real substantive issue here. Why isn't the company helping to tell the story of a low-cost, easily available antidote to that side effect? The drug they sell is an important and good one. The uncomfortable, and sometimes painful, side effect is openly acknowledged. The antidote works in at least some cases and clearly has no adverse impact on patients. (If henna has a major side effect, millions of Indian brides are at risk!) Why not tell them about it, or at least encourage others to do so?

Meanwhile, Monique herself has begun a small campaign to spread the word about this particular remedy. Check out this new blog she has set up, where she notes:

"I want to spread the word about this treatment. It's simple and cheap. By the way, I don't own any henna companies or websites of any kind. I'm a cancer patient trying to help anyone with this syndrome. If you have it, you understand why."

Pharma companies have all kinds of ways to get their message out when it comes to selling their products. Surely a clever person at this firm could figure out a way to do so here that would enhance their public image and not put them at legal risk. Maybe, as a start, Roche should link their website to Monique's blog.

Disclosure: I have not contacted anyone in our hospital to determine if we have any financial dealings with this company. We are often engaged in clinical trials with pharmaceutical companies, and we may or may not be with this company. As should be evident from what I have just written, any such relationship that might exist has had no influence on the content of this blog posting.

* = Hindi slang for "Yes, is it not?" Sorry, couldn't resist.

Next stage of transparency

Several months ago, we announced some audacious goals for BIDMC that were established by our Board, including elimination of preventable harm by 2012. We also promised that we would publish our progress towards that goal. We have now set this up on our website here. You can watch to see our data each quarter in each of the several categories listed.

When we were getting ready to publish these numbers, some of our trustees asked if we could put the numbers in terms of the percentage of cases in which there was preventable harm. By that measure, the number would be very, very small, about 40 cases out of over 200,000 in a calendar quarter, about 2/100's of a percent.

We said, "No, the point is to emphasize that each of the case involved an actual human being." Describing them as a percentage would dehumanize the physical impact on a real person, someone's mother, father, sister, or brother.

Last week, I was invited to give a lecture on this topic at the Harvard School of Public Health, and a different question was posed by a doctor in the class. "How can you set a target of zero," he asked, "when we know that zero is impossible?" I replied, "Putting aside the question of whether zero is impossible, the most motivational target is zero. If you say that we are trying to reduce, say, infections by 20 percent per year, people will feel satisfied if they meet that target. The idea is to establish creative tension for the organization by adopting an audacious goal. And, by the way, in certain areas, other hospitals have shown that zero is attainable for extended periods of time for certain types of error-avoidance."

At the other end of the spectrum, we are taking criticism from some people who see an inconsistency between these efforts at transparency and our lack of discussion or disclosure about particular cases. But we need to do that for reasons of patient privacy or for other legal reasons. For example, when a malpractice case is filed, we cannot and will not discuss that case publicly. For one thing, any comment we make can be construed as a violation of the patient's privacy. For another, as any lawyer will tell you, it is simply bad policy to discuss issues of this kind of litigation in a public forum. The plaintiff's attorney faces no such constraints, of course, and might perceive some benefit in holding a press conference to discuss the case. While we understand a reporter's desire to write a balanced story, our reply usually has to be, "No comment."

But outside of a particular lawsuit story, what are we going to say and disclose about all these cases of harm that are summarized on our website? The answer is that it depends. You can see from the chart that there are currently over 100 cases of preventable harm per year spread over several categories. As we have recently, when we think a specific case warrants wide public disclosure to help our staff be alert to a major challenge or teaching opportunity, we will give it wide circulation. Other specific cases will be given more limited distribution among our staff, consistent with their value in teaching about the need and means for quality improvement in a given sector of our hospital. And, in other situations, a pattern of several cases of a certain type might be presented to particular segments of our staff as a warning of a problem area.

We understand that our inclination towards transparency will garner criticism from some who think we are not being transparent enough when they have an issue or curiosity about a particular case. That is a by-product of what we have chosen to do, and we accept that.

Another by-product is that publication of these numbers may give the impression that we harm patients more than other hospitals. After all, we publish our numbers, and they do not. And many cases we publicize to our staff will inevitably be considered newsworthy by the local media. This, in fact, is why doctors and hospitals often don't like to talk about this stuff. Fundamentally, they don't want to be judged by the general public and the media, whom they deem to be unqualified observers of the medical scene.

Anyway, I want to assure you that there is no indication whatsoever that we harm patients more than other hospitals. (In fact, we know that our figures for certain types of hospital acquired infections are well below average.) But please remember that every study or analysis ever done indicates that hospitals rank highly among the country's public health hazards. Don't think that you are more safe in a place just because they don't talk about their errors. We believe that the only way to improve in this arena is to be open and honest about your mistakes and thereby enable people to learn from them.

Cape Cod Seals

Seals (300 of them!) on a sand bar near Head of the Meadow Beach in Truro. Click on the picture to get a close-up view. Below, boy approaches carefully to get a good shot.

Where's Wally?

I know people from outside New England will believe that I am absurd in saying this, but the resident of this bedroom is one of the luckiest and happiest children in the region. This mural was produced by Emergency Department X-Ray staff member Amanda Martin (seen above). I am pleased to note that she even included the BIDMC logo on the jumbotron, once again reiterating our presence as the Official Hospital of the Boston Red Sox and of Red Sox Nation.

A REAL premier gold card

How many of those credit card offers do you get in the mail each week? I can't keep count anymore. You might never believe there is a crisis in the capital markets associated with inadequate due diligence before offering people credit.

But every now and then one comes through that you are tempted to sign. This one wended its way to my office, having first been mailed to me at our division of otolaryngology. That alone should have given me a hint. (Not being an MD, I am not anything close to an otolaryngologist and have always had trouble pronouncing the word.)

It was a premier gold card from Capital Network Leasing Corporation, aka CAPNET. It offered me $100,000 in available credit -- 0.0% interest or no payments for 90 days; no activation or annual fees; and seasonal promotions for preferred customers. In small print, it said "We will not require financial statements or tax returns for any transaction under $100,000, but do reserve the right to request and verify your financial statements and tax returns for all transactions over $100,000.

I'll keep my transactions under $100,000 so I don't have to provide proof of creditworthiness. I hear that you can get good deals on HumVees right now. Maybe I can squeeze in two under the limit.

But, boy, if you get $100 grand with a gold card, imagine what platinum would bring!