A Failed Distribution System and a Time for Change
Good afternoon. I’m Dr. Mark A. Piasio, a practicing orthopedic surgeon from DuBois and also President of the Pennsylvania Medical Society. I’m here today to represent the Pennsylvania Medical Society.
Let me begin by thanking Chairman Civera and Members of this committee for holding this hearing on the influenza vaccine and its distribution. The Pennsylvania Medical Society appreciates the opportunity to speak on this subject.
If our flu vaccine distribution system were in perfect working order, we wouldn’t be here today. I’m willing to bet that some of you likely heard from constituents who informed you that they had problems getting their annual flu shot. I promise you that the Pennsylvania Medical Society has heard from both patients and physicians about problems associated with the vaccine’s distribution.
Before I get into details of the distribution problem, let me share with you some information from a report from the Centers for Disease Control and Prevention (CDC) on influenza activity for the last week of 2005. This will help paint a picture of the current clinical situation.
According to the CDC, during week 52 of 2005, flu activity continued to increase in our country. The proportion of patient visits to sentinel providers for flu-like illness was above the national baseline. During the last week of 2005, of all deaths reported by the vital statistics offices of 122 U.S. cities, 6.8 percent were due to influenza or pneumonia.
The CDC provides a national map of activity and provides six categories of flu activity including no report, no activity, sporadic activity, local activity, regional activity, and widespread. For Week 52, Pennsylvania fell in the “local activity” category.
This information from the CDC clearly demonstrates that Pennsylvanians are not immune from catching the flu. And, as a physician, let me say that within the high-risk patient population, there is a sizable mortality associated with influenza infection.
According to the American Medical Association in late December, throughout the country many physicians were still waiting for their supply of influenza vaccines, even after many supermarkets and other retail stores obtained doses. Of course, the most vulnerable patients are those with higher odds of complications or death from the flu. It’s likely that those patients can’t wait in line at the grocery store as there are many homebound or bed-stricken elderly patients at the highest risk of complications.
Now, I don’t want to denigrate the opportunity to hit mass populations through retail outlets. They do serve a purpose that helps many. However, the most vulnerable patients are those who are probably already working directly with their physicians. They have an established physician-patient relationship, and they trust that working relationship. Unfortunately, while supplies were sent to larger outlets, small operations such as private practice physician offices had difficulty receiving full orders. Wherever proper triage can take place, and patients at most risk can be served is where you want the first available batches of the vaccine heading.
The urgency of this matter prompted the AMA and the CDC to move up their 2006 National Influenza Vaccine Summit from May to January 24-25. At that time, they hope to evaluate the results of a random scientific survey to gain a better understanding of the problem.
Right now, we are in the middle of flu season. And with the threat of avian flu looming in background, the Pennsylvania Medical Society believes the country’s system of distributing flu vaccines deserves attention. Proper distribution channels should be developed and universally applied as future public health hazards may be much more dangerous.
During the past several months, the Pennsylvania Medical Society received numerous phone calls from members in different parts of the state who indicated they were not receiving their supplies as ordered. We’ve noticed, based upon these calls, that there is no rhyme or reason to shortages based upon geography, but rather distribution problems exist based upon the size of the orders. Smaller practices were particularly ignored within the distribution system because they ordered relatively smaller levels of supplies.
This season our country had essentially two major firms distributing 73 million doses. I would note that in 1999-2000, the United States had four major producers distributing 50 million doses.
This year, it appears that while adequate supplies should have been available, the distribution system clearly demonstrated flaws in reaching high-risk populations. Distribution appears to have favored big purchasers including large, public promotional vaccination events instead of high-risk populations and the physicians who serve them.
The Pennsylvania Medical Society supports legislative and regulatory efforts to reform the vaccine production and distribution system. We propose that the federal government be allowed to control the system to the extent necessary for production at sufficient levels and distribution that assures that persons at highest risk become the first priority for vaccination. The Medical Society also supports legal protection for manufacturers of vaccine that follow proper manufacturing practices and for health care personnel who provide or withhold vaccinations in accordance with CDC guidelines.
Better collaboration and cooperation among many different groups involved in influenza vaccination are necessary. A more effective program that prioritizes existing supplies for high-risk patients should be put in place.
I’ll conclude by mentioning that this requires a national solution including reasonable legal protection for responsible manufacturers and health care personnel as I just mentioned. But we shouldn’t ignore the ability of the states to leverage reform. The Commonwealth of Pennsylvania is a major purchaser of pharmaceuticals. As such, in addition to applying pressure to federal officials, the state may want to investigate creative ways through its strengths as a purchaser to solve this problem for Pennsylvania’s most vulnerable patients.
Again, on behalf of the Pennsylvania Medical Society, I thank you for the opportunity to present testimony today on this very important subject.
Last Updated: 7/31/2008