Tuesday, October 20, 2009

More on (Moron?) CDC's Botched Flu Efforts: Rep. Cancels H1N1 Event After Family Catches Flu

As reported in Politico today, Rep. Melissa Bean (D-IL) cancelled a scheduled H1N1 prevention event in her district after her 16-year-old daughter and her husband were diagnosed with likely cases of swine flu, her office reports. Bean spokesperson Jonathan Lipman is quoted as saying: "We've been planning this for weeks. The irony is just ridiculous." Check the story out here.

Meanwhile, shortages of the vaccine continue to grow. Just a couple of weeks ago, when it already knew there was a growing shortage, the Centers for Disease Control (CDC) estimated there'd be 40 million available doses by the end of October. Then, on October 16--two weeks later--it cut its estimates by over 25%. Here's what CDC spokesperson Anne Schuchat had to say on October 16. (Emphasis added. However, the text is cut and pasted directly from the CDC Web site at http://www.cdc.gov/media/transcripts/2009/t091016.htm )
Anne Schuchat: Yeah. You know, vaccine production for influenza is pretty complex. And the complex process this year is taking a bit longer than we would hope. The companies are making unprecedented amounts of vaccine and the yield of the antigen has been lower than had been hoped for. They need to do potency testing and purity testing and that takes time and of course there's lot release testing that the manufacturers do and that the FDA does. We are not cutting any corners in the safety of the production of this vaccine or the testing and oversight of the vaccine and it's very important to us that this process be done carefully and safely. And so those are the major factors. We had hoped and i think our last estimate about expected vaccine that we made several weeks ago was that by the end of the month we might be around 40 million doses. What i can say is that it's really hard to predict exactly how many we'll have by that point. So i need to caveat the estimate of the decrease in availability. We think at most it might be about a 10--about a 10 to 12 million doses less than that by the end of the month. You know, that's still quite a bit of vaccine to have out there. I need to say that those numbers could change every day. So that's what we know as of today. And we're committed to share with you what we know. These numbers are such that it will have impact for the states and when they can offer the large-scale vaccination plans. I want to let the folks on the line know that Dr. Jesse Goodman from the FDA is also listening into the call. As questions come up, I will occasionally let him amplify on the answer. So let's go to a question from the phones.
And the flu clinics are being cancelled right and left. Just a few recent samplings:
Fairfax cancels two swine flu vaccine distributions
By Derek Kravitz
The Washington Post
Tuesday, October 20, 2009 1:01 PM 

Fairfax County has canceled two mass swine flu vaccine distributions after the Washington region's most populous locality was told it would receive only a fraction of the vaccine doses it had expected. Officials had originally planned on administering 50,000 H1N1 flu vaccine shots to schoolchildren next weekend at 10 public middle schools. Instead, a smaller, targeted distribution for infants and pregnant women has been scheduled for 9 a.m. to 5 p.m. Saturday at the Fairfax County Government Center. Children ages 6 months to 36 months and pregnant women are eligible. Health officials had been expecting about 120,000 vaccine shots by the end of the month but now anticipate only about 10,000 vaccine doses will be delivered. The Centers for Disease Control and Prevention announced last week that the flu vaccine shots were taking longer to produce and that only 28 million to 30 million doses, instead of the planned 40 million doses, would be delivered to local and regional health departments by the end of October.
And if you think that the elderly (the focus of this blog) are getting the vaccine, think again. Here's a story from WJAC TV in Johnstown, Pennsylvania:
Many Seniors Still In Need Of Season Flu Vaccine

Posted: 12:45 pm EDT October 20, 2009
Updated: 1:46 pm EDT October 20, 2009
A shortage of seasonal flu vaccinations in some areas is affecting senior citizens who have not yet been able to obtain the vaccines. Flu shot clinics scheduled for this month and next month at the Johnstown Senior Center were canceled because of a vaccine shortage and officials there said the clinics will not be rescheduled. Area on Aging officials said it's still important that seniors find a way to get shots as soon as possible. "Elders don't have the strength in their immunity system that they had when they were younger. It's so important for them. In many cases, they may be living alone, they may not be eating properly," said Dr. Veil Griffith, Area on Aging administrator.
This fiasco makes it difficult to develop a warm and fuzzy feeling about the government's ability to help citizens protect their health.

Friday, October 16, 2009

Another Year, Another Botched Flu Program by the CDC

Well, if this is October, that must mean:
  • Halloween is right around the corner?
  • Ads promoting Christmas shopping will appear any day now?
  • The weather is turning colder?
Yes, but . . .

If this is October, it means we have another shortage of flu vaccine. This time, though, with both the "regular" flu and the swine flu, we're doubly blessed. We have a shortage of both. Again. As usual. For years now. You can set your watch by the predictability of the shortage.

Except the Centers for Disease Control (CDC) doesn't always call it a shortage. Some years it's just a distribution problem. Some years it's increased demand. Some years it's a manufacturing problem. Some years, it's that the flu season began earlier than expected. Some years it's something else. Point is: There's seldom enough, early enough.

It reminds me of a little kid who gets "Fs" in all his classes. The teacher doesn't like him. He forgot his books one day. The dog ate his homework. He missed the school bus. The assignment was confusing. There were some pop quizzes he hadn't expected. The other kids cheated. It goes on and on and on. But the result is always the same: Failure.

Let's take this year first.

Here's the official CDC line. This is from a telephone news conference on October 6. Thomas Frieden is the CDC spokesperson. I've added the bold/italic for emphasis:
Mike Stobbe: Thank you. Mike Stobbe from the AP. Doctor, can you give us an updated number about how many doses will be available this week? Also, is demand outstripping supply. Is supply outstripping demand at this point?

Thomas Frieden: This week, as of yesterday, about 2.4 million doses were available for ordering. About 2.2 million of them had been drawn down or ordered by this week. Each day, as more vaccine is clear, more vaccine becomes available for ordering, each Friday we'll provide the totals. Some which would have become available that Thursday or Friday. We're trying to make sure that we cut as much time as possible off the cycles to get it out and available for providers to vaccinate. To do that, means a little bit of messiness on how it comes out. If there's a minor problem with any of the vaccine in any of the warehouses, we don't have it available for ordering. We have to make sure it's safe and temperature-controlled. Before it will be released to the states. Some lack of certainty. We have a high degree of confidence by middle October, we'll have substantial amounts of flu vaccine available. Clearly at this point, only some vaccine and not everyone can receive that vaccine. Demand is outstripping supply. We expect that fairly soon, supply may well outstrip demand. The challenge will be to try to ensure the people who benefited the most have every opportunity to be vaccinated. On the phone?

Operator: Our next question is from "Time" magazine.

Alice Park: A question about the supply issue. Looking ahead, did the calculations that the CDC made as far as the ordering include the potential that more and more individual entities would mandate the vaccine for their health care workers. In New York, mandated it for the entire state that right now, we're having problems with getting the seasonal vaccine in enough supply? More entities demanding the vaccine, therefore a higher rate of compliance or demand for the vaccine than you have had in previous seasons?

Thomas Frieden: We're very confident that there will be plenty of vaccine for everyone who wants to be vaccinated. It won't be available when everyone wants to be vaccinated. Providers will receive it from directly from the manufacturer. Information should be available to the public through the state health department, to find out the details of where it will be available. That's not ready quite yet. Because, there are not large quantity -- there is not a large quantity of vaccine available today. Out there to be given H1N1. Seasonal flu vaccine, some areas have had less. They're well over 50 million doses distributed earlier. We're particularly Prioritizing those key groups I spoke about earlier.
And here's how it's being reported in the media from around the country:

CVS Ending Flu Shot Clinics Early
(Chicago, IL) -- CVS is ending its seasonal flu shot clinics ahead of schedule due to a shortage of the vaccine. The drugstore chain announced this week that the clinics will only run through October 22nd instead of lasting until the end of November as planned. A spokesperson for CVS blamed the vaccine shortage on manufacturer delays and consumer demand that was much higher than the drug store anticipated when it started the inoculation program last month.

Seasonal flu vaccine shortage hits Long Island
The seasonal flu vaccine is in short supply or out of stock across Long Island, forcing the suspension of flu clinics at pharmacies and malls, and causing frustrated doctors to add patients' names to ever-growing waiting lists. The shortage is attributed to the struggle by manufacturers to produce vaccines this year for both seasonal and swine flu amid unusually high demand for the seasonal flu shots. The shortage is being felt nationwide and is expected to continue until next month, federal health officials say. "There is also a greater awareness of influenza this year and a desire among people to get their influenza vaccinations earlier and for providers to get the seasonal out of the way so they can focus on H1N1," said Donna Cary, spokeswoman for Sanofi-Pasteur in Swiftwater, Pa., the nation's largest flu vaccine maker.

Seasonal flu vaccine shortage across Southeast Texas, U.S.
If you're on the hunt for the seasonal flu vaccine, you may have a tough time. Two of the nations largest drug store chains are reporting shortages at some of their stores and dozens of pharmacies around the Golden Triangle say if they're not completely out of the shot at this point, they're getting close. The amount of phone calls to King's Pharmacy in Beaumont hasn't changed lately, despite the fact that the answer to the most popular question... has changed. Pharmacist Greg Hamby said, "I've had the story several times that they find someone and by the time they get there the supply is exhausted." And it's the same story most pharmacies are hearing from families in search of the seasonal flu vaccine. This year, the shot has garnered some of the highest demand in years. The problem is... the supply can't meet that demand.

Flu vaccine shortage widening
One major supermarket chain is canceling in-store seasonal flu vaccines later this month, while other retailers say their supplies are also dwindling. Still need an annual flu shot? Good luck. Spot shortages in seasonal vaccine in the Philadelphia region are expected to worsen with three major supermarket chains anticipating they'll likely run out before the end of the month. Local pharmacies report they've been bombarded with people unable to get a routine flu shot at private health care providers because of shipment delays and incomplete orders. Now Giant Food Stores and Martin's Food Markets Friday announced its in-store pharmacy flu clinics will end after Oct. 22. Company officials say their distributor has informed them several winter vaccine orders previous promised will be unfilled.
This isn't the first time--or the second time--or the third time--or the fourth time--that there's been a shortage of the flu vaccine. It happens nearly every year.
Let's take a trip down memory lane.
 
2004-2005
From a report by the Government Accountability Office:
For the 2004-2005 flu season, despite early indications that one manufacturer was having production difficulties, CDC published guidance in September 2004 stating that it did not envision any need for tiered vaccination recommendations or prioritization of vaccine for those at higher risk of flu-related complications. Following the suspension of one manufacturer’s license and the announcement it would not supply any vaccine to the U.S. market this season, CDC revised its recommendations and took steps to mitigate the vaccine shortage.
2004
From a report by the Government Accountability Office:
Although these actions helped achieve vaccination rates approaching past levels for certain priority groups, such as those aged 65 years and older, several lessons emerged, including some that could help with future shortages. First, unless planning for problems is already in place, action is delayed. CDC’s lack of a contingency plan contributed to delays and uncertainty about how to ensure that high-risk individuals had access to vaccine. Second, when actions occur late in the influenza season, they are likely to have little effect. Third, effective response requires communication that is both clear and consistent. CDC has taken a number of steps, including issuing interim guidelines in August 2005, to respond to possible future shortages. It is too early, however, to assess the effectiveness of these efforts in coordinating actions of federal, state, and local health agencies and others.
And this from the New York Times:
In recent years there have been many significant disruptions of vaccine supplies. Between November 2000 and May 2003, there were shortages of 8 of the 11 vaccines for childhood diseases in the United States, including those for tetanus, diphtheria, whooping cough, measles, mumps and chicken pox. There have been flu vaccine shortages or miscues for four consecutive years.
2003-2004
From a report by the Government Accountability Office:
For the 2003-2004 flu season, shortages of vaccine were attributed to an earlier than expected and more severe flu season and to higher than normal demand, likely resulting from media coverage of pediatric deaths associated with influenza.
2000-2001 
From a report by the Government Accountability Office:
In 2000-2001, when a substantial proportion of flu vaccine was distributed much later than usual due to manufacturing difficulties, temporary shortages during the prime period for vaccinations were followed by decreased demand as additional vaccine became available later in the year.
I could go on and on, but the point is: There's always an excuse. Sometimes two or three excuses. Demand was higher than anticipated. There were manufacturing difficulties. There were distribution difficulties. The flu season began earlier than expected. Or the CDC's non-shortage approach: There will be plenty; it just won't be there when people want it.

This isn't an argument for or against the use of the vaccine itself. Some folks won't use it for a variety of reasons. That's their decision. But for those people who do want it, why can't the CDC do it right for once? And since this blog primarily focuses on the elderly--who are judged to be among the categories most at risk--the debate about the availability of both the regular flu vaccine and the H1N1 vaccine is highly relevant.

The CDC is doing a fine public relations job with social media: buttons and badges, e-cards, Twitter, online videos, podcasts, Facebook, MySpace, Whyville, and more. See more details here. But you can't make a silk purse out of a sow's ear. Or a silky image out of swine flu.

Friday, October 9, 2009

Death Panels and the American Enterprise Institute

The American Enterprise Institute just came out with a new paper in its AEI Outlook Series: "The Living Truth About 'Death Panels'"  by Scott Gottlieb and Elizabeth DuPre. It's an interesting read, and makes some valid points. Here's the AEI's summary of the paper:
The controversy over aspects of the House health care legislation that have been inappropriately equated with "death panels" has obscured the real problems with these provisions. While equating these proposals with death panels is a careless exaggeration, the legislative language about end-of-life counseling is disturbing because of the intrusion it represents into patients' discretion and the way doctors practice medicine. The provisions are needlessly prescriptive, and they invite the government into private and complex health matters. Proponents believe these policies can save substantial money, but this will not occur. Congress can fix the problem by simplifying the legislation and making the principal goal ensuring patients' autonomy and providing high-quality care at the end of life.


Key Points in this Outlook:

  • The end-of-life provisions in HR 3200 were not an eleventh-hour endeavor, but the product of longstanding political concern over the costs to Medicare for patients with terminal illness.
  • The accusations that the bill contains provisions to create money-saving "death panels" are factually incorrect. But the provisions are based on an economic premise that they can help save significant money on end-of-life care, which is also incorrect.
  • The inclusion of these measures represents a troubling intrusion into medical practice.
  • The provisions are unnecessary. Doctors can already receive compensation for providing end-of-life counseling. The provisions also usurp traditional state prerogatives and may actually discourage doctors from providing counseling.
  • Congress can fix the end-of-life provisions by making them voluntary and general in scope.
Still, there are some significant flaws in AEI's argument.

The first are some clearly bone-headed, amazing statements that destroy the credibility of what otherwise is a biased but thoughtful argument. Here's my favorite:
Moreover, when a private insurer chooses not to cover a specific service, patients presumably understood the service fell under a noncovered category when they chose that particular insurance plan.
In what fantasy world are Gottlieb and DuPre living? First, it's darn near impossible for a patient to actually get a copy of the actual plan. (I know. I've tried.) You get, at best, a non-binding summary of what's covered and what's not. Second, there are plenty of gray areas. [A plan may not cover "experimental" procedures. But what's "experimental" to one plan may be well-established and accepted by other plans.] Third, there are tons of rules and regulations that may, in fact, exist, but aren't spelled out in those summaries. [Simple example: Sometimes a plan will cover Procedure A and it will cover Procedure B. But it won't cover both performed during the same visit.] Fourth, insurance companies have been known, on occasion, to deny coverage for services which are, in fact, actually covered by the policy.

OK. Enough silliness.

Gottleib and DuPre argue that the provisions contained in HR 3200 are far more detailed, far more prescriptive, far less flexible, than has been employed before. They say:
On the surface, the advance-care planning provisions broadly mirror smoking-cessation provisions that the Bush administration implemented in March 2005 when Medicare Part B coverage was expanded to include smoking- and tobacco-cessation counseling. Both the end-of-life and smoking-cessation measures are aimed at providing physicians with a way to bill, and receive reimbursement, for providing prespecified counseling to patients
And they may be correct, although the provisions they themselves cite regarding the smoking-cessation counseling sound pretty darn narrow to me:
Medicare will cover 2 cessation attempts per year. Each attempt may include a maximum of 4 intermediate or intensive sessions, with the total annual benefit covering up to 8 sessions in a 12-month period. The practitioner and patient have flexibility to choose between intermediate or intensive cessation strategies for each attempt. . . . Intermediate and intensive smoking cessation counseling services will be covered for outpatient and hospitalized beneficiaries who are smokers and who qualify as above, as long as those services are furnished by qualified physicians and other Medicare-recognized practitioners.
Still, let's give Gottlieb and DuPre the benefit of the doubt. What they're complaining about here isn't restricted to just health. It's found in all areas of government activity. State educational testing standards (for instance, Virginia's Standards of Learning) are in part a reaction to government promising one thing (higher educational standards) but with no accountability or measurability. And a lot of these standards, including Virginia's SOLs, have come under fire, in large part being attacked by those who would be held accountable (the teachers).

It's a dilemma, to be sure. On the one hand, we want our professionals (teachers, doctors, etc.) to have discretion in how they approach their tasks. We assume they know more than we about their areas of technical knowledge. On the other hand, we know that our kids have been getting dumber. And we know that our health has been declining. That's particularly true, in both cases, when we compare the United States with other countries. So the public reacts: "If those professionals won't do what we're paying them to do, then we're going to demand that if they want to get paid, they'll do it our way and we'll have a way of determining if they've done it right."

Gottlieb and DuPre observe:
Language in HR 3200, for example, couples quality reporting measures to the end-of-life counseling provisions. It requires Medicare to collect "measures on end-of-life care and advance-care planning that have been adopted or endorsed by a consensus-based organization" for tracking the "quality" of care delivered by providers. "Such measures shall measure both the creation of and adherence to orders for life-sustaining treatment." These measures create the possibility that--under a scheme in which physician pay is eventually tied to performance measures--providers could be penalized if, for example, they did not hit certain targets with respect to the number of patients they provided counseling to or if they had a large number of patients under their care opting to forgo advance directives.
Yup. That's absolutely what could happen, and it's probably what some of the drafters of the legislation intended. It's called accountability, and it's born out of frustration that more voluntary measures--whether in health care or in education--don't really achieve much. And I can understand why professionals would feel that such language is intrusive and micromanaging. But that seems to be the game we play today. (And not just in those areas. Look at campaign financing. Or financial regulation.) There are laws and regulations designed to achieve a specified purpose. Those being regulated resist and figure out ways around them. So the regulators or legislators come out with even tighter regulations, which those being regulated circumvent. And so on ad infinitum.

And as the pressure grows, those on both sides resort to simplistic (and often misleading) arguments to sway public opinion. Thus, the fear of "death panels" which even Gottlieb and DuPre comment upon: "The accusations that the bill contains provisions to create money-saving 'death panels' are factually incorrect."

Except, of course, I return to a charge I made in an earlier posting: Death panels already exist. They're housed within the insurance companies which decide--based on coverage they claim one is or is not entitled to--who will live and who will die.

Is there a solution? It's difficult to see one. At least one with our current health care structure.