Pfizer Receives FDA Approval for Exubera, the First Inhalable Form of Insulin for Controlling Type 1 and Type 2 Diabetes in Adults

This should be welcome news to the milions of diabetes sufferers, however it's important to note the following cautions as stated in the press release:

"Exubera may affect lung function so patients need to have their lungs tested before starting Exubera, and periodically thereafter, as directed by a healthcare provider. The test involves exhaling into a measuring device. Exubera is not recommended for people that have chronic lung disease (such as asthma, chronic obstructive pulmonary disease or emphysema). Also, Exubera should not be used at all by people with unstable or poorly controlled lung disease."


NEW YORK, January 27 -- Pfizer Inc said today that Exubera® (insulin human [rDNA origin]) Inhalation Powder has been approved by the U.S. Food and Drug Administration for the treatment of adults with type 1 and type 2 diabetes. Exubera was found in clinical trials to be as effective as short-acting insulin injections, and to significantly improve blood sugar control when added to diabetes pills. Exubera, which is expected to be available for patients by mid-year, is the first inhaled form of insulin and the first insulin option that does not need to be administered by injection in the United States.

"Exubera is a major, first-of-its-kind, medical breakthrough that marks another critical step forward in the treatment of diabetes, a disease that has taken an enormous human and economic toll worldwide," said Hank McKinnell, chairman and chief executive officer of Pfizer. "The global incidence of diabetes is currently at epidemic levels. Millions of patients are not achieving or maintaining acceptable blood sugar levels, despite the availability of current therapies. Exubera meets a critical medical need by offering a highly effective and needle-free alternative to diabetes pills and insulin injections to manage this complicated, debilitating disease."

Exubera is a rapid-acting, dry powder human insulin that is inhaled through the mouth into the lungs prior to eating, using the handheld Exubera Inhaler. The Exubera inhaler weighs four ounces and, when closed, is about the size of an eyeglass case. The unique Exubera Inhaler produces in its chamber a cloud of insulin powder, which is designed to pass rapidly into the bloodstream to regulate the body's blood sugar levels.

Exubera Meets Medical Need
"Many people who could benefit from insulin are fearful of injections, so they delay treatment five years or ten years, placing them at risk for serious complications. Now, for the first time patients can improve blood sugar control with fewer or no painful injections," said Dr. William Cefalu, Exubera investigator and chief of the division of nutrition and chronic diseases at the Pennington Biomedical Research Center, a campus of the Louisiana State University System, in Baton Rouge... Full News Release

Researchers find effective, cheap treatment for cystic fibrosis lung disease

The following two news releases may offer new hope for Cystic Fibrosis patients. A must read for CF families.

From the University of North Carolina at Chapel Hill
CHAPEL HILL, Jan. 18, 2006 -- Working half a world away from each other, two teams of medical scientists have identified what they believe is a simple, effective and inexpensive treatment to reduce lung problems associated with cystic fibrosis, the leading fatal genetic illness among whites.

The new therapy, identified through studies supported chiefly by the Cystic Fibrosis Foundation and the National Heart, Lung and Blood Institute, also appears to be safe and easy to take.

By inhaling a saltwater aerosol solution almost twice as salty as the Atlantic Ocean for between 10 and 15 minutes at least twice a day, young patients should be able to avoid a significant part of the damage the disease causes to their lungs, the researchers said. That’s because the aerosolized saltwater restores the thin lubricant layer of water that normally coats airway surfaces. This water layer promotes the clearance of the naturally occurring mucus the body uses to trap harmful bacteria, viruses and other foreign particles...
Full news release


From The Cystic Fibrosis Foundation
Bethesda, MD, January 18, 2006 —An observation by surfers in
Australia has led to a simple, inexpensive hypertonic saline therapy. This concentrated saltwater solution improves airway clearance for patients with cystic fibrosis (CF), according to research reported in the Jan. 19 issue of the New England Journal of Medicine.

The idea for the study, supported by the Cystic Fibrosis Foundation, began when the Australian surfers with CF told their doctors that their airways felt clearer after exposure to the salt spray. The medical team was aware of some evidence that in CF, salt is depleted from the liquid that lines the airways. The team thus hypothesized that sterile saltwater may be a useful therapy. They were right. Now CF patients worldwide may benefit from this “low tech” treatment... Full news release

Major advance in diabetes treatment

This announcement from Pfizer indicating that the new inhaled form of insulin, Exubera, has been approved by the European Commission is terrific news for those affected by diabetes. Hopefully North American approvals will be coming soon.

NEW YORK, January 26 -- Pfizer Inc said today that the European Commission has approved Exubera (inhaled human insulin) for the treatment of adults with type 1 and type 2 diabetes. Exubera is the first non-injectable, inhalable form of insulin to be approved since the discovery of insulin in the 1920s, and represents a major advance in diabetes treatment.

According to the World Health Organization (WHO), diabetes has reached epidemic proportions and affects approximately 48 million people in Europe alone. People with diabetes often suffer from debilitating complications due to uncontrolled blood sugar levels including heart disease, amputation, blindness and kidney failure. The direct healthcare costs associated with diabetes are estimated to be around $286 billion worldwide, with the majority of these costs linked to treating diabetes-related complications.

Since its discovery more than 80 years ago, insulin has been the gold standard treatment for diabetes. In order to achieve tight blood sugar control, insulin is often administered before meals to mimic the body's natural insulin response to food. Healthcare providers and patients have been reluctant to initiate or intensify insulin therapy when it is required due to the need for daily injections.

"Exubera is a major, first-of-its-kind, medical breakthrough that marks another critical step forward in the treatment of diabetes, a disease that has taken an enormous human and economic toll worldwide," said Hank McKinnell, Pfizer chairman and chief executive officer. "The global incidence of diabetes is currently at epidemic levels. Millions of patients are not achieving or maintaining acceptable blood sugar levels, despite the availability of current therapies. Exubera meets a critical medical need by offering a highly effective and needle-free alternative to diabetes pills and insulin injections to manage this complicated, debilitating disease."

Exubera is a fast-acting, dry powder formulation of human insulin that is inhaled into the lungs via the mouth before meals using a simple-to-use, hand-held device that does not require batteries or electricity. The device, which weighs four ounces and is about the size of a carrying case for a pair of eye glasses, is designed to deliver an accurate and precise dose of insulin each time it is used.
Read the full press release

Inhaled cyclosporine may stave off long-term rejection and improve survival

As a lung transplant patient anything that offers hope for the prevention of long-term rejection and improves survival is something that catches my attention. As the investigators state, more studies are needed but these results should be received enthusiastically.

From Transplant Living
January 12, 2006
NEW YORK (Reuters Health) - Use of inhaled cyclosporine, in addition to other immune-suppressing drugs in pill form, does not help prevent the early rejection of lung transplants, but it does seem to stave off long-term rejection and improve survival, according to a report in The New England Journal of Medicine.

Conventional immunosuppressive drugs do not prevent long-term rejection after lung transplantation, lead author Dr. Aldo T. Iacono, from the University of Maryland in Baltimore, and colleagues note. Delivery of cyclosporine directly to the lung transplant, through the use of an inhaler, may help cut the rates of both early and long-term rejection.
Full news article

Catholic priests hear the organ and tissue donation story

As you know, I've been actively promoting organ and tissue donation awareness via speaking engagements at churches, service clubs, social organizations and businesses. The message has been generally well received but none more so than today's talk with Catholic priests who attended a meeting at Our Lady of Lourdes church in downtown Toronto. It was heartwarming to see such keen interest from these respected religious leaders who touch the lives of so many and are in a position to inform a great number of people about organ and tissue donation.

Father Pat O'Dea, Chair, Zone 1 Catholic Parishes, Dicoese of Toronto, organized the event with Trillium Gift of Life Network (TGLN). Pictured with Father Pat are Brian Kellow, educator with TGLN and myself.

I spoke about my lung transplant experience and Brian Kellow gave a comprehensive and well received overview of organ and tissue donation in Ontario and the role that Trillium Gift of Life Network (TGLN) has in planning, promoting, coordinating and supporting activities related to organ and tissue donation, education and research.

The priests asked many questions and some commented that the personal story of a transplant recipient had a huge impact on their thinking and motivation to promote organ and tissue donation. If your group or organization would like to hear the organ donation message TGLN will be very happy to provide speakers and support for your event. Contact Trillium Gift of Life Network

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Magna promotes Organ & Tissue Donation

Presstran Industries, St. Thomas, Ontario is one of the Magna Group of companies manufacturing auto parts. It was my pleasure to be part of a Trillium Gift of Life Network presentation that was heard by almost all of their 800 employees in a series of staggered meetings January 17th to accommodate various shifts. Shown are Sam Barraco, General Manager and Lisa Borg, Human Resources Manager, who are strong supporters of organ and tissue donation awareness.

Being an advocate for organ donation awareness has given me the opportunity to not only deliver the message but I've also met some great people and enjoyed new learning experiences that have enhanced my life. Yesterday my visit to Presstran turned out to be one such experience.

In previous articles I've written about how royally I'd been treated by the medical community. From the moment I arrived at Presstran I was greeted warmly and in a friendly manner by everyone that met me. I wrote some of their names down; Donna Wood, Char (didn't get the last name), Gina Alexandre, Hans Szlavik, Lisa Borg, Joanna Mudge and general manager Sam Barraco.

In addition to the friendliness of the staff, another thing that made a big impression on me was the company's emphasis on safety and cleanliness. I have never been in a manufacturing plant that was so absolutely clean. It's a huge, metal stamping and fabricating operation yet everything was clean, neat and tidy (including the employees!). Safety is number one at Presstran; no one is allowed in the plant area without safety glasses, safety shoes and ear plugs. This rule is rigidly enforced.

Our organ and tissue donation message was very well received. Brian Kellow, Trillum educator and Rizwana Ramzanali, kidney/pancreas transplant recipient, were the other Trillium Gift of Life Network participants.

Between sessions, General Manager Sam Barraco, Assistant General Manager Hans Szlavik and Human Resorces Manager Lisa Borg spent quite a long time chatting with me and showed a genuine interest in my transplant story as well as the importance of promoting organ and tissue donation awareness. Hats off to Presstran Industries. It's no wonder that Magna is such a successful auto parts manufacturer. They've got it right, in my opinion.

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Buy a raffle ticket to help heart transplant research

The Heart Transplant Patients group, HeartLinks, will be selling raffle tickets in the Eaton lobby of the Toronto General Hospital between the hours of 10am and 3pm on January 19th and 26th, February 2nd, 9th and 14th (the draw will take place at 1:30pm on the 14th). All proceeds will go to Heart Transplant medical research and related projects.

The heart group has always been very supportive of our lung transplant initiatives and I encourage you to support this worthwhile cause of theirs. They have worked very hard to get some great prizes and sponsorship (more than 30 at last count) which include hotel stays, tv sets, cameras, Raptors and Maple Leafs tickets, gift certificates for retail stores and restaurants, plus much more. A full list is posted throughout the hospital.

The draw will take place in the Eaton Lobby, Toronto General Hospital, Valentine’s Day, February 14th at 1:30pm.

Tickets are $2 each, 3 for $5 or a booklet of 20 for $30. They can be purchased directly from the Transplant Clinic on the 12th floor, NCSB. You can also get tickets by phone or email: 416-351-0793 or Raffle Tickets

If you would like to help sell tickets your support will be appreciated. Let the organizers know ASAP at the above contacts.

In Praise of The Lung Transplant Team at Toronto General Hospital

I've come a long way since these first days of my "second chance". This April 20th will mark the four-year anniversary of my single-lung transplant. And what a wonderful four years it's been! I experienced the miracle of receiving life from where there was virtually no life and this has changed me forever. I feel better today than I have for many years with boundless energy and a feeling of overall well being. I will be eternally grateful to my donor and his or her family and the wonderful Lung Transplant Team at the Toronto General Hospital division of the University Health Network.

This year's Rose Parade theme was "It's Magical" and the Donate Life float's theme was "Life Transformed". This could not be more apt or appropriate, at least in my case. My transplant touched my life by giving me the "Gift of Life". It has transformed me physically, emotionally and spiritually. My lung transplant has had a profound, and yes, magical, impact on my life, as I'm sure organ and tissue transplantation has helped hundreds of thousands of people regain their health with the same impact on their lives, families and friends. Speaking of friends, many of the best friends I have ever known I only met since my transplant, through the special bond that exists in our transplant community.

A noted cardiologist said on TV how impressed he was with the monitoring and follow-up transplant patients receive and how he wished all patients could have the same attention.

That got me to thinking about the follow-up I've received as a pre and post lung-transplant patient and it's been absolutely second to none. I have never been more impressed with any group more than with The Lung Transplant Team at Toronto General Hospital, from the doctors to the nurses, transplant coordinators, the Support Group, physiotherapists, respiratory and pulmonary function technologists, and other support staff and technicians. This also includes the staff at Toronto Western Hospital where I have various tests and procedures from time to time. At first, because I was treated so royally, I thought they might have mistaken me for a Head of State or other V.I.P. until I learned that every patient is treated this way. It is very obvious they are not just doing a job, but have a compassionate interest and dedication to their patient's optimal recovery and well being.

In addition to my regular clinics and visits, I received a steady stream of calls and messages from "the team" since my discharge. This was further emphasized for me recently; I missed getting my monthly blood work done when it was scheduled and sure enough, my transplant coordinator was on the phone to find out why. With all this attention it would be easy to think I was the only patient they had. But I happen to know The Lung Transplant Team has a caseload of hundreds of patients at various stages of follow-up and treatment. How they do it I don't know, but it must involve a lot of hours, passion for their career and hard work.

Not only have I been given the gift of life but is very comforting to know that there is a team of people monitoring and watching over me to make sure that my gift of a single-lung transplant survives and stays part of me for a long time to come. So, whether you are waiting for a transplant, post-transplant or a support person or friend, I feel you and yours could not be in better hands than those of the Toronto General Hospital Lung Transplant Team!

New hope for idiopathic pulmonary fibrosis patients?

When I was diagnosed with idiopathic pulmonary fibrosis in the fall of 1999 there was no hope for slowing or stopping the progression of the disease. The only option was a lung transplant.

The following news release describes a University of Pittsburgh study that suggests standard anti-inflammatory therapy may not be appropriate for many interstitial lung disease patients such as those with idiopathic pulmonary fibrosis (IPF) and a related study suggests that a protein known as osteopontin may be a target for therapy.

The investigators suggest that if their findings hold up in further, larger studies, doctors may be able to slow or stop the progression of this deadly disease. This is probably a long way from reality but at least there's a glimmer of hope for the future.

PITTSBURGH, Jan. 11, 2006 – In an article in the Jan. 15 issue of the American Journal of Respiratory Critical Care Medicine, University of Pittsburgh researchers report that a serious, life-threatening form of pulmonary fibrosis, called idiopathic pulmonary fibrosis, lacks all the hallmarks of inflammation and is probably unnecessarily treated with anti-inflammatory drugs. Moreover, in a related study, (see below) the investigators identified a protein found in excess amounts in the lung tissue of patients with idiopathic pulmonary fibrosis, which may be a more appropriate target for therapy.

Interstitial lung disease describes a diverse set of chronic lung conditions that often have strikingly similar symptoms but different clinical courses. However, all are characterized by differing degrees of progressive scarring of lung tissue between the air sacs, or the interstitium. With repeated damage, the interstitium becomes thickened and stiff, or fibrotic, making it increasingly difficult for the individual to breathe. Some forms of interstitial lung disease, particularly idiopathic pulmonary fibrosis, which has no known cause, have a very high death rate due to respiratory failure. Effective treatment, however, is complicated by the fact that a definitive diagnosis often requires a lung biopsy.

“Unfortunately, many patients do not receive lung biopsies. As a result, about one-third of patients who come to our clinic have previously been misdiagnosed, and many have been treated with the wrong medications,” explained James Dauber, M.D., medical director of the University of Pittsburgh’s Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease, and professor of medicine, division of pulmonary, allergy and critical care medicine...Read the full news release


This release also refers to another study offering additional potential hope for IPF patients. It goes on to say:

"Although there currently is no effective treatment for idiopathic pulmonary fibrosis, results of another study suggest help may soon be on the way. Dr. Kaminski and his colleagues reported in the Sept. 6 online edition of PLoS Medicine that idiopathic pulmonary fibrosis lung tissue samples display an “over-abundance” of a protein known as osteopontin, which other studies have implicated in the growth and progression of tumors. In further examining the potential role of osteopontin in idiopathic pulmonary fibrosis, Dr. Kaminski’s group found that it directly increases the proliferation and movement of fibroblasts, cells centrally involved in lung fibrosis"... Full News Release

Important dates for our transplant community in 2006

Please make a note of the following dates in your 2006 calendars. More information and details are provided by the links.

April 23 to April 30 National Organ and Tissue Donation Week in Canada

April is National Donate Life Month in the United States

Birthday Ball Wednesday, April 26, 2006

Transplant Open Golf Wednesday, June 7, 2006

US Transplant Games, Louisville, June 16-21, 2006

Lung Transplant Picnic June 18/06

Canadian Transplant Games, Edmonton, Aug 8-13, 2006

The following is for your 2007 advance planning.

World Transplant Games 2007, Bangkok Aug 25-Sept 3