U.S. Department of Health and Human Services.  HHS.gov  Secretary Mike Leavitt's Blog

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July 2008

Alaska Blog II- Yakutat Tingit Clinic

The sign on the outside of the airport building said, “Food, Shelter and Booze.” Before leaving to visit the Yakutat Tingit Tribe’s clinic, I told the pilots of our plane I would be gone a few hours and suggested they step inside for two of the three featured amenities.

It was a drizzly afternoon, but life in Alaska just carries on. This was July and the weather was good, during which not an hour can be spared as they get ready for winter. Twenty hours of daylight helps, but knowing winter comes soon keeps people moving.

Yakutat is has a population of about 900 right now. A few years ago it was over a thousand. Victoria Demmert, President of the Yakutat Tlingit Tribe, explained as she drove us on their only oiled road, that when the timber industry went flat, some were forced to leave.

Yakutut is considered a larger village by comparison to most in Alaska. I’m guessing they are one of the villages that are better off. I drove past a fish plant where locals are able to bring their fish for processing before the fish are flown to Seattle on Alaska Airlines, which stops regularly. Still, government jobs are the biggest source of employment.

At the clinic, I met Leslie Jones, the Director of the Clinic. She introduced me to Dr. John Bacicocco, who actually lives in Sitka, Alaska but travels as an Itinerant doctor, visiting Yakutat about one week every three months to do face-to-face patient visits. The rest of the time, health care in Yakutat is provided through two Community Health Aides, Mina Adams and Becky Nickles. Each has completed a four-part training and certification process and they essentially operate as extensions of Dr. Baccicocco.

Mina and Becky operate using a book of medical protocols called the Community Health Aide Manual. It is a brilliantly constructed instruction manual that provides diagnosis and treatment algorithms, and tells them when to call the doctor for further instructions. They have the equipment to provide Dr. Bacicocco with information he needs to treat the more serious cases. They are his hands, eyes and ears. It’s less than ideal, but when your doctor is an hour away by air, living in a village of less than a thousand, it’s the best you’re going to get and much better than most of the remote world gets.

The big news in Yakutut health care for the coming year is the extension of basic dental services in the clinic. I met 21 year old Sheena Nelson, who is finishing a two-year dental training in Anchorage. In a few months she will return to her village as a dental health therapist. She will occupy a small dental operatory inside the clinic. Like Becky and Mina, the health aides, she will work as an extension of a dentist who resides in Sitka. She is being trained to provide oral health education and prevention, fill teeth and perform basic dental repairs. Once a procedure gets to a level of sophistication requiring a dentist, her job will be to stabilize the patient until the additional treatment can be arranged, often weeks later.

Sheena Nelson talks with Secretary Leavitt about her training to become a dental health therapist.
Sheena Nelson talks with Secretary Leavitt about her training to become a dental health therapist.

Sheena’s story appears to be fairly typical. She was considered one of the more serious and able students at her high school in Yakatut, but wanted to stay in the area and took employment as a waitress. When the Yakatut clinic was provided a slot for a dental health therapist, she was nominated and, after a series of interviews, selected. She will now return with a job that will dramatically enhance the quality of life in Yakatut, and she has a job that will pay $18 an hour.

Understandably, this program has been enormously controversial among the dental community in Alaska and elsewhere around the country. On more than one occasion, dental professionals have come to express genuine concern about people with only two years of training filling teeth and performing other non-reversible procedures. This visit confirmed my instinct and previous expressions to the dentists. The Professionals aren’t willing to live there and this is giant step ahead from no care at all.

While I was in Central America visiting with health ministers from that region, they expressed a desperate need for this kind of help. The alternative there is a family member using a pair of needle-nosed pliers to provide relief.

After my visit at the clinic, I was treated to a delightful community gathering where villagers, both young and old performed, in colorful native regalia. The dances they perform preserve the stories of their culture and history.

Yakutat villagers dancing in native regalia.
Yakutat villagers dancing in native regalia.

It was a valuable insight into the importance of family and community in surviving the brutal conditions of remote Alaska. Not only do they survive, most find happiness there.

Alaska Blog 1- Gumboot Determination

Along streambeds in Alaska, the Gumboot, a small black snail like creature, attaches itself to rocks and clings with the might of superglue. To Alaska Natives, Gumboot is a delicacy worth the considerable effort it takes to pry it off the rocks. The Gumboot hangs on with determination.

When Ethel Lund, a woman of small stature in Juneau and a group of other tribal leaders (mostly women), decided the region needed better health care they knew it would require tenacity. The tiny Gumboot became their inspiration.

For thirty years, they stuck to the task with Gumboot determination. The result of their efforts is the Southeast Alaska Regional Health Consortium (SEARHC), an Alaska Native health organization which now has 700 employees and provides care to thousands of Alaska residents who belong to 18 different tribes.

I met Ethel Lund and several others when I visited them in Juneau to learn about the unique challenge of getting health care to the tens of thousands, mostly tribal members, who live in hundreds of villages throughout Alaska. They have written the history of SEARHC in a volume appropriately titled Gumboot Determination.

The history tells of SEARHC’s formation in 1975 as a non-profit tribal health consortium of 18 Native communities throughout Southeast Alaska. It was one of the first organized under the Indian Self-Determination and Education Assistance Act, which allows the Indian Health Service to turn programs and facilities over to tribal management.

I have come to admire community health organizations. Each has a story. Rarely were they formed by government. Typically, like SEARHC it was a group of people getting together to help others. Nearly all of them have something in common. Developed by dedicated people who didn’t know what they were getting themselves into when they started but through Gumboot determination, they got it done.

SEARHC operates under a board selected by tribal leaders in each of the communities served. They appear to be moving aggressively into use of technology. Roald Helgesen, the President and CEO, told me they were at the early stage of implementing a comprehensive electronic medical record system. This makes a lot of sense given their treatment model. They are treating through Community Health Aides/Practitioners, people in many different parts of the region. (I plan to write about this model tomorrow.)

Leadership_team_for_searhc_with_sec

Leadership team for SEARHC with Secretary Leavitt
CLOCKWISE FROM TOP: Mark Gorman, Vice President, Community Health Services, SEARHC; Andy Jimmie, Chairman, Alaska Native Health Board; Bill Martin, President, Central Council Tlingit Haida Indian Tribes; Roald Helgesen, President/CEO, SEARHC; Norman Sarabia, Vice President, Douglas Indian Association; Jan Hill, Chairperson of the Board, SEARHC; Ethel Lund, President Emeritus, SEARHC (with red jacket and white blouse); Doloresa Cadiente, President, Tlingit and Haida Indians of Juneau; MOL; Chris Mandregan, Acting Deputy Director, Indian Health Service, DHHS; Ken Truitt, General Counsel, SEARHC.
CENTER: Janis Sheufelt, Medical Director, Ethel Lund Medical Center, SEARHC.

I also learned about their deployment of a remote pharmacy program. Using a device that resembles a large soft drink vending machine, prescription drugs can be dispensed in remote areas. The drugs are pre-packaged. The patient punches prescription number and other information. The information is vetted three times before it is released by a licensed pharmacist remotely, who talks to the patient on the phone. There were other innovations I will write about later in the week many of which, I think could/should be used to make health care delivery more efficient in less remote medical settings.

Safety at the Speed of Life- Blog 7

Last week, I began a blog series on the importance of building safety into our global trade processes. I discussed the scope of our trading in the global markets, our response to the need for new tools and strategies and the importance of collaboration in implementing these new strategies. I would like to close this series by sharing one more story about safety, speed, and Olympic athletes. This one is a tale of devotion to the safety of our country and sheer speed on ice. It is about a true hero of the 2002 Olympic Winter Games — Derek Parra, a Mexican-American speed skater from San Bernardino, California.

Prior to the Games, Derek was an employee at Home Depot working in the flooring and electrical department. He is a regular guy who at the time would eat Fig Newtons the night before each race.

This regular guy represented our country during the 2002 Games in two monumental ways. In the opening ceremony, Parra was chosen as one of eight U.S. athletes who carried in the tattered flag that flew over the World Trade Center. In his book, Reflections on Ice, he wrote about this experience. Let me include an excerpt:

When it came time to begin the procession I touched the flag for the first time and felt a physical sensation unlike anything I had ever experienced. If it is possible to feel your soul being touched that is what I felt. As we carried the flag out before the capacity crowd and worldwide television audience the silence was deafening. I’ve never before heard such stillness. I was some place emotionally I had never been before; some place spiritually I didn’t know existed. While in this instance that flag represented so much death, it seemed also to stand for life, love and the hope of a nation.

I was there and he is right.

Powerful words about the safety of our homeland from a great Olympian.

A few days later, Parra fulfilled the hope of a nation by demonstrating that nice guys do finish first. He had a breathtaking and world-record-setting performance in the 1,500-meter race. In a stunning time of 1 minute 43.95 seconds, he bested the favorite skater from the Netherlands and captured gold for the United States.

Derek Parra carrying United States flag.
Derek Parra carrying United States flag.

After winning the race Parra said, “You give up so much, hoping for a moment like this, and it happens.”

He skated the perfect race. He embraced safety, mastered the ice, and skated at the speed of life. His fleet power made him at that moment the best in the world … ever.

In the next 12 to 24 months something far more significant than an Olympic gold medal is at stake. It is the future of product safety in the United States. There are two competing and divergent philosophies ready for battle. This battle is not entirely about safety; it is a surrogate battle about U.S. philosophy on trade.

I believe that opening world markets has brought enormous benefits to consumers — lower prices, greater variety, and more choice. We will achieve safety and speed by harnessing the power of consumers who rapidly and harshly punish those who produce poor products. The game plan is to develop high, science-based standards, demand absolute transparency, reward independent certification, and rigorously enforce high-risk products.

Others would have government inspect everything. They want to stop products at the border and increase point-of-entry government inspection. Not only does such a course mean higher costs and taxes, it means consumers would be denied timely access to an abundance of safe products at lower prices. Frankly, underneath their government-centric view lurks the spirit of protectionism and the illusion that they can use the inspection process to slow or reverse global trade.

If you care about the future of the United States in the global market, you have to weigh in here. Now is the time. This is the medal round.

In a global market there are three ways to approach change: You can fight it and fail; you can accept it and survive; or you can lead it and prosper.

We are the United States of America; let us lead.

Safety at the Speed of Life- Blog 6

I mentioned at the end of my previous post in this series on import safety that FDA’s role in global trade will be changing. FDA’s work is often underappreciated in this country. Nations around the world recognize FDA as the “gold standard” when it comes to food and drug safety. Under Commissioner Andrew C. von Eschenbach’s leadership, FDA is building on that “gold standard” by reaching out to new frontiers and globalizing the FDA.

FDA is opening an office in China with staff in three cities: Beijing, Shanghai, and Guangzhou. We are currently negotiating to do the same in India, with plans for additional FDA offices in multiple areas of Latin American, Europe, and the Middle East.

And we are changing how we do business. The traditional role of FDA as approver stands strong. How and where we do that is undergoing change.

The origin of all product standards, certification and inspection of goods does not need to start with FDA; it can start with the industry and in other countries as it did with shrimp.

This is a fundamental shift in government’s role. The 21st century role of FDA is as convener and arbiter as well as verifier and enforcer.

Will FDA be an aggressive enforcement entity? Yes. In fact, FDA’s enforcement resources will be better funded and more focused on the producers who have not demonstrated trustworthiness.

Will FDA be adopting safety standards as a regulator? Yes. But we will encourage industry to collaboratively develop standards for FDA to review. If they don’t meet the scientific rigor, we won’t accept them until they do.

While the United States is the largest economic player in the food and drug market, there are other nations with excellent systems in which we have great confidence. In the past, each nation has conducted separate inspections. The result is great redundancy as several countries inspect the same plant — for essentially the same things, while too much time lapses between visits.

We are going to change that.

I announced recently a policy initiative where FDA will work more closely with foreign regulators who have systems of inspection and regulation we trust. The principle will be collaborative information gathering, individual decision making.

As part of that effort, FDA has initiated a pilot project with our colleagues in the European Union and Australia to jointly plan, allocate, and conduct international pharmaceutical inspections. This will begin with inspections of active pharmaceutical ingredient manufacturing. These are the “starting products” of many of the medicines we all use.

Through this new collaboration, FDA and these trusted colleagues can spread our inspection net wider by leveraging our respective resources. We will be inspecting some, the Australians others, the European Union still others. We will then share information. This just makes good sense. Facilities will be inspected more often and we can all focus more resources on those products that present higher risk.

This is a very exciting vision: common standards, common certification, and shared inspections. Safer products. Lower costs.

Finally, we need the private sector to step up big-time to initiate, lead, and participate in the development of consensus-based standards and independent certification. You have a responsibility to your consumers and to the integrity of your industry.

I will conclude this series in my next entry, sharing my final thoughts on how, together, we have a unique opportunity to influence the future of product safety.

Safety at the Speed of Life- Blog 5

In my previous post in the series I began last week on the safety of imported products, I brought up the importance of collaborative skills in solving complex problems and working on global issues. In my 16 years of public service, every significant step of meaningful progress has come as a result of collaboration.

Collaboration does not eliminate tensions, but it minimizes them.

Collaboration does not take away hard choices, but it improves the acceptance of the decisions made.

Collaboration does not create instant success, but it has accelerated progress.

In the context of product safety, collaboration will not only be necessary for developing product standards, but in implementing many other parts of the plan as well.

Governments must collaborate with governments. Departments within governments — law enforcement, trade, border security and health agencies, for example — must collaborate with each other. Even competitors must cooperate in some circumstances.

And, in my judgment, a collaborative spirit, skill set, and commitment is a pre-requisite for leadership and success in the 21st century global marketplace.

When we presented our import safety plan to the President, I told him it would require additional money. The President committed to seeking additional funding. Congress has made a down payment that will support crucial steps, including expanding FDA’s international presence and improving its scientific and information technology infrastructure. But it will require sustained investment over the next several years to achieve long-term import safety.

Legislative action is also needed.

We need Congress to provide the FDA with authority to mandate third-party certification in certain high-risk categories when voluntary measures aren’t working.

Having laid out a long-term vision and strategy, I want to acknowledge that changes of this magnitude take time. Solutions take time to implement. But we have to keep steady pressure on the change pedal.

In the limited time left in this Administration, there are several things I plan to complete.

In the United States, our biggest trading partners are now Canada, China, and Mexico, in that order. Chinese products made up about one-sixth of all U.S. imports. Recognizing that, we have signed and begun to implement two landmark Memoranda of Agreement with the Chinese government: one concerning food and feed, and the other, drugs and medical devices.

These strong, action-oriented documents call for specific steps and set clear deadlines for achieving them. Once implemented, they will enhance the safety of scores of items the American people consume on a daily basis.

We recently signed a Memorandum of Understanding with the Vietnamese government. We are working with Indian authorities to support their pharmaceutical regulatory priorities. We have committed to share information and collaborate with our Mexican and Canadian partners on food and drug recalls. And we are developing an agreement with Central American governments that will improve product safety for consumers in the U.S. and abroad.

The role of FDA will change in regard to the issue of import safety. I will explain my vision for this role in more detail in my next entry.

Safety at the Speed of Life- Blog 4

As a continuation of my blog series on the safety of our product imports, I want to illustrate the change in our basic strategy by talking about the shrimp business. I was in Vietnam and Central America recently— both are big producers and exporters of shrimp. I met with representatives of the shrimp industry in both places.

We talked about the impact on their product when a shipment gets detained at our border. Delays create huge costs and often disrupt or even close affected businesses.

Members of the shrimp industry independently decided that they needed to develop a set of quality and safety standards, and a way to verify compliance with those standards. They did this because their consumers needed to know that their products were safe and of high quality. They developed a formal, voluntary collaboration that produced a set of industry standards and certification process.

A centerpiece of our new strategy is to encourage, leverage, and build upon such voluntary third-party efforts. We are not inventing a new concept. It already exists. And it works.

We observed independent certification being used in many sectors of the import world. Until now, we have not integrated this capacity for improvement into our regulatory responsibility. This needs to be a government-wide strategy; ultimately, it should apply to all product lines.

Since FDA has responsibility for the safety of a significant share of our imports, I would like to outline the way we are transforming the Food and Drug Administration to harness the power of this new vision.

In the future, products from those firms that have standards and certification processes that we trust will be given expedited entry and access to U.S. consumers. The FDA will be freed to focus its enforcement resources on those suppliers that don’t have certified products. FDA is establishing a pilot with the shrimp industry to help learn how to evaluate third-party certification programs, and implement them in the field.

So we are saying clearly: “We want you to have access to American consumer markets — we want to have access to yours. To do so, you need to meet American standards of quality and safety. If you can demonstrate through a process we trust, that your products meet the safety standards that we have mutually agreed upon, we’ll be your partners in speed.”

Can you see the linkage that connects speed and safety?

Speed is accomplished when trust has been established. Trust happens only with complete transparency. Transparency requires standards, and standards require collaboration.

This is a key point — a change born of the global market — collaboration is the new frontier of human productivity. I believe learning better collaborative skills is a requirement for success in this century. It is a proven method of solving complex problems, and it’s hard work. I want to write more about the importance of collaboration with other governments around safety in a global market, and I will pick up here in my next entry.

Safety at the Speed of Life- Blog 3

I ended my last post in this series by introducing the need to develop new tools and strategies to ensure the safety of the products we import for American consumers.

A year ago, President Bush directed a working group of his Cabinet to conduct a comprehensive review of our import safety practices. He appointed me Chair. Our review involved teams from throughout the federal government, with extensive help from the private sector. We conducted the most complete policy review ever on this subject by our government.

In my role as Chair, I visited ports and post offices, freight hubs and fruit stands, supermarkets and seaports. I listened, probed, toured, and took in the totality of America’s import system.

I met with leaders from India, Vietnam, People’s Republic of China, Australia, Mexico, Canada, El Salvador, Costa Rica, Panama, Nicaragua, Guatemala, Honduras, Singapore, the largest economies of the European Union and the European Commission to discuss import safety.

The scale and complexity of global commerce amazed me. So did the need for change. We provided a comprehensive report to the President; the most important thing we said was this:

Mr. President,

We have a good system of product safety today, but it is not adequate for the future and we need a fundamental change in our strategy.

In the past we have stood at our borders attempting to apprehend products that don’t meet our expectations.

We cannot inspect our way to product safety without bringing trade to a standstill. Our new strategy must be to extend our borders and ensure that quality and safety are built into the products we import.

We will do this by rewarding producers that have products certified to meet our standards. Their goods will receive expedited entry into our country.

We will make clear to those who don’t that they can expect enhanced scrutiny.

You can read the report and the 50 specific recommendations we made at importsafety.gov. They are important, but the real transformation comes from the change in our basic strategy. I will share an example in my next entry of how a change in strategy can improve safety.

Safety at the Speed of Life- Blog 2

Yesterday, I began a blog series on the need to ensure the safety of imported products as global commerce expands the volume of imported products Americans enjoy.

This opening of world markets has brought enormous benefits to consumers: lower prices, greater variety, and more choice. Nowhere is this more evident than in the produce industry.

I met a produce manager named Dan in Detroit. I can remember his name because he told me he was “Dan the produce man.” He has been in the grocery business for three decades.

I asked him what has been the most significant change he has seen. He immediately responded with four words, “It’s what consumers want.”

It used to be a big deal each year when fresh peaches arrived. They would put up signs and place ads in the local paper. Not anymore.

Now he sells peaches almost every month of the year. During the winter, plums, nectarines, and grapes pour into this country from Latin America. We eat big, bright red strawberries in January without a second thought.

Americans walk into almost any produce department in the country and purchase what used to be seasonal items, at a reasonable price, any time of the year. It is the speed of life — our lives, our demands on an ever-growing global market.

It’s anything, anywhere, anytime.

My point is that as long as Americans want to enjoy fresh produce from around the world, buy needed medicines, wear low-cost clothing, drive foreign-made cars, use electronic products designed and built off our shores, purchase affordable furniture, and otherwise participate in the bounties of a global economy, our import system will become increasingly complex.

This is the value of global trade. The challenges we face are the result of a global market beginning to mature. Last year, the United States imported more than $2 trillion worth of products, an amount that exceeds the entire gross domestic product of France. This is approximately $6,500 for every man, woman, and child in the U.S.

These products were brought into the United States by more than 800,000 importers, through over 300 ports-of-entry. All projections indicate that this volume will continue to skyrocket over the coming years.

Just as the volume of trade has changed, so must the strategies to regulate safety. Simply scaling up our current inspection strategy will not work. This is not a problem unique to the United States. It is a fundamental challenge for all nations. We need to develop new tools and strategies equal to the new challenges we face. In my next post, I will share what we have done over the past year to assess and improve our strategy to ensure import safety.

Safety at the Speed of Life- Blog 1

Next month, the world will gather for the 29th Olympiad in Beijing, China. Those who participate and watch these games will be a part of the largest, most extraordinary collaboration of nationhood and humanity that exists in our world today.

Three out of every five people on the planet will watch as athletes from 200 countries join in this peaceful celebration of sport and personal achievement. It is a marvelous moment for mankind and a force for good in our world.

During my service as Governor of Utah, I witnessed, in a powerful way, the effort, strength, sheer talent, beauty, and grace of Olympic athletes. The setting was the 2002 Olympic Winter Games in Salt Lake City. It was the first major world gathering after September 11th.

The Olympic motto is three Latin words — “Citius, Altius, Fortius” — which mean “Faster, Higher, Stronger.” These words capture the spirit of the Olympic movement, a movement that dares people to break records and to achieve their personal best.

The first of the words in the Olympic motto has particular importance to the topic of my remarks on import safety. That word is citius. It means faster, swifter, quicker. It is the Olympic aspiration of speed. Speed is a value that is engrained in many Olympic athletes, but victory requires another virtue — safety.

Apolo Anton Ohno is arguably the finest short-track speed skater who has ever lived. Short-track speed skating is one of my favorite Olympic sports, a cross between ballet and roller derby. Short-track racers sprint around an oval track wearing helmets and skintight suits. The grace and swiftness of their movement is counterbalanced by some quite spectacular crashes that occur at high speeds.

During the 2002 Games, I watched the 1000-meter, medal-round race where five skaters participated, including Apolo Ohno and a very colorful Australian named Steven Bradbury. What Ohno and Bradbury had in common were colorful personalities. Ohno sported a signature goatee, and Bradbury displayed spiky blonde hair.

I spent time with both of them, and they are terrific guys. Ohno was the most likely to win, Bradbury the least. In fact, Bradbury’s presence in the medal round involved luck. He advanced from the first trial round because of a disqualification. He got through the second round because three skaters crashed. The skaters took their marks. The starter gun sounded. The skaters sprinted through the first straightaway and then fell into a ballet-like glide for eight laps, leaning in unison around each curve.

Going into the last turn of the final lap, Ohno and another skater were stride for stride. The crowd was on its feet. Suddenly, skates bumped, legs flared, and a domino collision left four skaters sprawled on the ice, each banging into the sideboards, just feet from the finish line.

Apolo_ohno_crashing_with_two_other_
Apolo Ohno crashing with two other speed skaters.

All but Steven Bradbury, who up to that point, was a distant fifth. He skated by the wreckage to victory as the first Australian to ever win a gold medal at the Winter Games.

As a side note, I spoke with Steven the next day in the athletes’ village. I wished him good luck in his next race, to which he replied, “You know mate, I think I’ve used all of my lucky charms.” We later joked that he was “slow enough to win the gold.”

This illustrates an important lesson. In the Olympics, athletes will take extraordinary steps to achieve maximum speed, sometimes sacrificing safety. This produces both heroic results of victory and dramatic crashes.  Great sport, but dramatic crashes — when you are dealing with people’s health — are not an option — we must combine both speed and safety. 

An executive of a large American retail firm told me that one of its core values is represented by the phrase, “Speed is life.”  This connotes the need to be nimble, innovative, and responsive to the need for change in both business operations and consumer preferences.

Too frequently we see product safety problems resulting in unnecessary expense, sickness, injury, and even the loss of life. To the consumer the result is harmful, even tragic. To countries, companies and categories of products, the impact on a reputation can be devastating. In global commerce, as in the Olympics, things happen fast, they have to — but speed without safety carries great risk.

The unsettling stream of product safety problems we are experiencing are a reflection of the most profound changes in commercial patterns in human history — the globalization of trade. This week, I am beginning a blog series on the safety of product imports in a global market that demands speed. I will continue the series in my next post and discuss the impact of global commerce on the need to ensure the safety of imported products.

Medicare Bill

I was disappointed by Congress’s vote to override the President’s veto of the Medicare bill. Congress has shown an unwillingness to change the program’s path and take on the important task of entitlement reform. I wrote more about this in the following op-ed, which ran in The Washington Times:

Yesterday, the president vetoed a Medicare bill that columnist Paul Krugman calls "enormously encouraging for advocates of universal health care." The battle lines could not be clearer. Any member of Congress who believes in the free market or who takes seriously the need for entitlement reform should vote to sustain the president's veto.

The primary objective of the bill is to prevent a scheduled 10.6 percent reduction in physician payments under Medicare. No one objects to fixing this problem. We support fully reimbursing physicians at pre-reduction levels and fixing the fee schedule formula. Doing so is sensible and unobjectionable — we only wish that it didn't have to be done year in and year out.

What is not sensible or unobjectionable is the rest of the bill, which hurts both taxpayers and Medicare beneficiaries. Driven by election-year politics and a strong ideological preference for government-run health care, Democrats in Congress have loaded this bill with provisions that undermine consumer choice and, worse, pave the way to still more government control of Americans' personal health-care decisions.

First, the bill undermines the very successful Medicare Part D prescription-drug benefit. Part D works when seniors have plenty of choices so that drug plans and companies must compete for their business. Over 85 percent of Part D enrollees say they are pleased with their plans. Average monthly premiums have come in below expectations for three years running, and overall costs have been $150 billion less than originally estimated.

But the Democrats' bill would require the secretary of Health and Human Services to force Part D drug plans to cover all drugs within certain "protected classes" of drugs — for example, all statins used to control cholesterol. This would mean that drug plans could no longer use the threat of exclusion from the formulary to negotiate the lowest possible price for drugs like Lipitor and Zocor. The provision is a windfall for certain drug makers, but a hard pill to swallow for beneficiaries and taxpayers.

The provision would also give drug makers and other special interests a powerful incentive to lobby to have their drugs included in protected classes. Part D would become politicized, and government bureaucrats would begin deciding which drugs will be covered, instead of allowing the free and informed choices of American seniors and the competition of the free market to decide the matter.

Second, the bill lays the ax to the popular Medicare Advantage program, which gives seniors the option of receiving their care through private health plans. Medicare Advantage offers more choices and better care than government-run Medicare, often including preventive screenings that can save them money and help them avoid serious health problems later. It is especially popular with low-income beneficiaries. In fact, 49 percent of Medicare Advantage beneficiaries earn less than $20,000 per year, and many live in rural areas where doctors accepting Medicare patients are hard to come by.

The bill, however, would eliminate many of the options that make Medicare Advantage so popular and would force about 2.3 million Americans from their preferred private plans to the standard government-run Medicare, according to the Congressional Budget Office.

Third, the bill aborts a major money-saving reform for consumers and taxpayers — by effectively killing a new program for the purchase of durable medical equipment (DME). Since the 1980s, Medicare has been paying for DME according to a government-fixed fee schedule. The reform opens Medicare purchases up to competitive bidding. This program is already underway in 10 areas, and it's already saving Medicare and its beneficiaries 26 percent on average. Annual savings are estimated at $1 billion when fully implemented.

I can't explain why some members of Congress think that is a bad deal, except that some seem to believe it's always better to have government set a price, however high, than for the market to decide the matter. The bill would kill the contracts Medicare has already signed with DME suppliers. Adding insult to injury, it would also require my department to spend Medicare Trust Fund money to pay for any damages resulting from the cancellation of those contracts.

When Congress votes again this week on the deeply flawed bill, what is at stake is far more than whether the president's veto will be upheld. What is at stake is whether our country lives under a system focused on one-size-fits-all coverage and price-fixing, or whether it embraces free-market incentives, competitive bidding, and consumer choice.

If we want a health-care system that promotes value — that promotes the highest quality care at the lowest possible prices — Congress simply must do better.

Nicaragua

Written June 30, 2008

This was my third trip to Nicaragua. The place has started to be quite familiar to me, and I am beginning to develop what feels like a good relationship with many of the people there, including President Daniel Ortega and his wife Rosario.

President Ortega has perspectives different than those of many people in the United States, but I have always appreciated the fact that he treats me personally with dignity, and in a friendly, open way. We have developed the capacity to talk privately about our differences, and in the health field, we have common interests and aspirations for the people of Nicaragua.

This trip was actually fulfilling a commitment I had made to President Ortega when I saw him in January this year, at the inauguration of President Colom of Guatemala. During that conversation, we discussed the connection between clean water and air and general health. I committed to bring some people from the Environmental Protection Agency and the HHS Centers for Disease Control and Prevention to consult with the Nicaraguan Government on how to deal with the challenges they face with Lake Nicaragua, a large lake near the city of Granada.

People in the United States might reasonably ask why the United States Secretary of Health and Human Services spends time in Nicaragua worrying about the water. There are several reasons. My primary purpose for being in the region was the safety of products (especially food) imported into the United States. We are changing our strategy to make sure quality is built into the food we consume and a significant amount of our fresh fruit and vegetables is produced in Central America. One of the most significant components of food safety is the quality of water. If we want to have Central American fruit during the winter months, it is important the water they use in Nicaragua and elsewhere in the region to grow the fruit is clean.

Another reason is the success of Nicaragua as an emerging democracy. Our nation cares about the people of Nicaragua, and sees delivering on health and basic social services as important for elected governments to succeed, which further supports the stability of that region.

In the evening, President Ortega and I spent about an hour and a half talking together about the lake and ways we could work together to improve it. The lake has a fascinating history. President Ortega invited some knowledgeable local experts who are working hard to save the lake. I had invited Ben Grumbles, the Assistant Administrator for Water at EPA, to accompany me, and Captain Craig Shepherd from HHS/CDC, the Chief Environmental-Health Officer of the U.S. Public Health Service. We agreed to spend some time the next day actually on the lake to help us devise ways of working together.

Following our meeting, President Ortega drove me in his car to a local hospital, where we talked to patients, doctors and families about the quality of care they were getting and what needed to be done to improve their health system. There are a lot of needs in Nicaraguan hospitals.

Thursday morning we spent time on the lake itself, aboard a steamship. After the tour of the lake, the President and I drove around an island, and then settled into a meeting to outline a process for the U.S. Government to help Nicaragua, technically, in their clean-up. The Nicaraguans are aware of the progress we have made in the United States with our Great Lakes. When I was Administrator of the EPA, I organized the Great Lakes Collaboration, which has developed a master plan to further improve the lakes. We talked some about that process, and agreed to send a technical team to Nicaragua at the end of July.

President Ortega brought Secretary Leavitt and Captain Craig Shepherd on a boat tour of Lake Nicaragua to work on a plan to analyze the condition of Lake Nicaragua
President Ortega brought Secretary Leavitt and Captain Craig Shepherd on a boat tour of Lake Nicaragua to work on a plan to analyze the condition of Lake Nicaragua.

I met with several other groups while I was in Nicaragua, including people from the business community and a large group of students at the medical school of the National Autonomous University. I enjoy my encounters in other countries with students. They have straightforward questions, and I’ve found they appreciate straightforward answers.

Regional Health-Care Training School

About two years ago, while attending a meeting of the Health Ministers in Central America, I listened to a discussion related to a common need they have for skilled medical workers. The Minister of Health of Panamá at the time was Camillo Alleyne. He proposed at the meeting the creation of a regional center where the countries could jointly train workers.

As I listened to the discussion, I could see the vision of the school was smart, and it represented a way the United States could help the entire Central American region at the same time. I began to help them with their proposal, and now, less than two years later, we have a functioning school with a terrific facility, offering training to students all over the region.

There is a long story here that I hope to write at some point, but I just want to say that Friday while in Central America, I visited the school and attended the first meeting of its Board of Directors. I was able to visit a class of forty students from four countries who couldn’t have been more excited about what they were learning and the relationships they were making.

Students from Costa Rica, El Salvador, Honduras, Guatemala and Panama listen to Secretary Mike Leavitt at the Regional Health Care Training Center in Panama.
Students from Costa Rica, El Salvador, Honduras, Guatemala and Panama listen to Secretary Mike Leavitt at the Regional Health Care Training Center in Panama.

This school is going to be a major source of good in the region and I couldn’t be more proud about the United States’ prominent role.

Later in the day, President Torrijos invited me to the Presidential palace for a meeting. He has been supportive of the center. We spoke for about 40 minutes about a wide range of subjects.

Central America Blog II

Written June 26, 2008

Wednesday morning, we drove two hours from San Salvador to Acajutla, a community in El Salvador of about 75,000 people on the Pacific coast where the USS Boxer had visited to care for patients as part of the mission, “Continuing Promise,” in May of this year. The Health Minister of El Salvador met us there to tour a public clinic. While the USNS Comfort had visited a different part of the coast last year, some of the health care professionals around Acajutla have also participated in trainings offered by the Comfort crew.

Like public clinics I have seen in other countries, including our own, people with various needs lined up early in the morning to see one of the doctors or nurses. They are served on a first-come, first-served basis, advancing along a series of benches. There is no air conditioning, the temperature is hot and muggy and patients are served with a wholesale mentality but seem grateful for the help. This is the way health care delivery happens in their world.

There are 369 such clinics like this in El Salvador, the Minister told me, plus another 171 smaller rural health posts. In this particular clinic, there were 25 doctors and a similar number of nurses. There are about 5.4 million people in the nation, about 439,000 of whom live in the department, or province, in which Acajutla is located.

In addition to the clinics, El Salvador has a system of referral hospitals and other public health functions. One of them is a network of health promoters in the neighborhoods who teach healthy practices, encouraging those needing care to get it. For example, women of childbearing years are asked to report the date of their last period so the health promoter can get them into prenatal care if they prove to be pregnant. They know every child under five, watch for signs of communicable disease and generally “promote healthy practices."

I spent an hour talking to some of the doctors, nurses and health promoters, trying to understand what motivates them and their general outlook. The main reason I chose to visit Acajutla was to get a reading on the impact of the USNS Comfort and the USS Boxer a few months after their visits.

What a powerful testimony I heard from these people about the value of these efforts by the U.S. Government. They could not find adequate words to cover the sense of gratitude and professional fulfillment they felt. It was simply inspiring to hear them talk about all they had learned from the doctors on the ships, and the appreciation they felt for the dignity and care with which they felt our crews treated their patients, friends and neighbors.

As moving as I found the meeting with the doctors, the most significant experience of the day was meeting with about 10 patients who wanted to tell me about their cataract surgery, hernia operation or the care given to their children on board the Boxer. Each story related a changed life with a renewed sense of purpose and self-worth.

One woman told me how her blurry eyesight, which was now cured, no longer caused her to fall. She threw her arms around me saying, “Thanks be to God for the United States.”

Another woman told me about reading to her grandchildren for the first time. Another older woman, who was caring for three small, abandoned grandchildren, talked about the difference the visit had made to the little girl with cerebral palsy and her able-bodied brothers.

A man in his late thirties pulled up his shirt to show me the scar of his repaired hernias, and then demonstrated how his mobility and strength had returned, which allowed him to work again.

One after another, they used different words to talk about how the Boxer had restored the productivity of their lives. Those who had cataract surgery particularly moved me. Cuba has aggressively provided this rather simple surgery for tens of thousands all over Central America. The Cubans call the campaign "Operation Miracle," and it has built a reputation for Cuba in the arena of health diplomacy.

Secretary Leavitt and a Salvadoran boy share a laugh at a clinic in Acajutla, El Salvador
Secretary Leavitt and a Salvadoran boy share a laugh at a clinic in Acajutla, El Salvador.

Our hospital ships will return to the region this summer. Doctors and patients of El Salvador are anticipating these visits. This is a powerful tool for our nation, and we need to do more of it.

Central America

Written June 25, 2008

Yesterday, we held an all day session on product safety with representatives of the Central American countries and the Dominican Republic. We had Health Ministers from several of the countries and representatives of Agriculture and Commerce Ministries as well. I met with President Antonio Saca of El Salvador for about 30 minutes in advance of the meeting. He formally opened the meeting.

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Secretary Mike Leavitt (2nd from left of those seated) listens as President Antonio Saca of El Salvador addresses attendees at the Product Safety Forum.

Our purpose was to begin a conversation with the participating nations on changing our collective strategy related to the safety of food. Central America and the Dominican Republic have become a major factor in U.S. food production. Collectively, these countries rank just behind Mexico and Canada in importation of food into the United States. A trip to the grocery store fruit and vegetable section will confirm that.

These countries properly fear any kind of import quality problem because it is seriously disruptive to their economy. The U.S. is 80% of their market. A situation like the melon problem we had in Honduras or the tomato situation in Mexico also damages their national brand.

In previous blogs, I have discussed our nation's strategic change. Our efforts are focused on preventing problems before they happen. Our best tactic to accomplish that is the establishment of quality standards and the continual monitoring of them through independent certification. I explain in my blog on the Red Pepper Principle, how implementing new practices can make crops attractive because of higher quality.

We had five panel discussions, all of which went well. Just before lunch, I asked the participants to consider an idea that I wanted to discuss during the afternoon. The idea was to create a U.S./ Central America/ Dominican Republic Memorandum of Understanding (MOU) on food and drug safety. Under this MOU, we would engage in regional capacity-building, joint standards-development, development of accreditation arrangements for certifiers and training at the Regional health-care Training center we have developed in Panama. I suggested that we identify a couple of product categories to start with. After lunch, the panel discussions began to center around the MOU idea. By the end of the session, we had devised a strategy to move the idea forward, with a goal of completing the MOU this fall. The meeting was a big success from my point of view. We didn’t conclude anything, but we were able to start a serious process. I still have a significant amount of work to do in making contact with other important players.

Dinner last night was terrific. Ambassador Charles Glazer and Mrs. Glazer invited a local mayor and two prominent business executives over. It was a chance for me to learn more about El Salvador. We talked about the challenges of local government and the upcoming national elections.