H1N1/swine flu: Mathematics of death as doctors, governments forced to gamble

Hello? Hello? Is there anybody home at Homeland Security?

I'm getting my exercise these few days from pounding the lectern and shouting myself hoarse, as I deal with the rising number of news reports about the terrible choices governments are now having to make -- choices that are no more than a gamble.

All this could have been avoided if governments in countries with heavy international air traffic had extensive air passenger surveillance in place after SARS. In this way they could have bought themselves more time for vaccine development and testing when a real pandemic virus appeared. Beep this is a recording.

And I do not want to hear again, 'Oh Pundita it's too late now.'

What happens if this virus mutates itself into a more virulent form? What happens if it mutates into a Tamiflu-resistant strain? Oh but that's right I forgot: There's already a resistant strain on the loose. If airports were set up to do extensive surveillance they could catch the strain, instead of governments the world over having to cross their fingers and pray the thing dies out.

However, China's government is set up to do extensive airport surveillance, which is how the Tamiflu-resistant mutation was spotted.

July 12: Published comment from Pundita reader "DocJim," a practicing physician, in reply to New Scientist mention that swine flu seems to be pushing out the seasonal influenza strain in a number of countries:

The winter flu season in the northern hemisphere did not wind down this year. It is continuing through the summertime and a similar pattern was seen with the old 1918 Spanish flu. That is not to say that it is not less than it will be in the fall, but there are lots of Type A influenza cases occurring this summer in the USA and the UK. It is VERY unusual. The SECOND WAVE will come in the fall.

2) Dr. Edwin Kilbourne, emeritus at NY Medical College, was the person most responsible for selling the idea of the 1976 swine flu vaccine. (May symposium at NY Academy of Sciences) He says we simply didn't realize that 1 in 100,000 people vaccinated would develop Guillian-Barre syndrome. Data had not been put together to notice such a rare event and link it to vaccinations until 1976.

If the USA vaccinates the population of 300,000,000, there "should be" about 3,000 cases of Guillian-Barre. Some of those will die. IF we do NOT vaccinate, then with an attack rate of 20% and 1% death rate, 600,000 people in the USA will die of swine flu. These numbers won't be perfect, as not everyone will take the vaccine. It doesn't look very good anyway you run the numbers. By the way, these should be called dead customers for the global business world. That kind of talk makes sense to the finance people and money talks.

July 13, Associated Press, Maria Cheng:

"WHO: No licensed swine flu vaccine til end of year"

LONDON (AP) -- A fully licensed swine flu vaccine might not be available until the end of the year, a top official at the World Health Organization said Monday, in a report that could affect many countries' vaccination plans.

But countries could use emergency provisions to get the vaccines out quicker if they decide their populations need them, Marie-Paule Kieny, director of WHO's Initiative for Vaccine Research, said during a news conference.

The swine flu viruses currently being used to develop a vaccine aren't producing enough of the ingredient needed for the vaccine, and WHO has asked its laboratory network to produce a new set of viruses as soon as possible.

So far, the swine flu viruses being used are only producing about half as much "yield" to make vaccines as regular flu viruses.

[...]

In a presentation to WHO's vaccines advisory group last week, Kieny said a lower-producing vaccine would significantly delay the timeline for vaccines. That could complicate many Western countries' plans to roll out vaccines in the fall.

British Health Minister Andy Burnham promised that vaccines would start arriving in the U.K. in August — and predicted the country could see up to 100,000 cases a day by the end of that month. [Exponential Grain of Salt Alert]

Before countries can start any mass swine flu vaccination campaigns, the vaccines need to be vetted by regulatory authorities for safety issues. That means testing the vaccines in a small number of humans first, which can take weeks or months.

"I think it will be a very significant challenge to have vaccines going into peoples' arms in any meaningful number by September," said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota. "At this point, it is still is an issue of when will it be available, who will get it, and what will be the dose?"

Kieny said many of those questions remain unanswered at the moment. But she said WHO's vaccine advisory group recommended that health care workers receive the first swine flu shots since they are on the front lines of the global outbreak.

[...]

WHO's vaccine experts recommend that countries decided that certain groups should get the vaccine first — like pregnant women, people with chronic respiratory problems or obesity, children, and possibly young to middle-aged adults, who have been disproportionately affected by the virus.

The decision to start vaccinating people against swine flu -- which so far remains a mild virus in most people -- will ultimately be a gamble, since there will be limited data on any vaccine. Until millions of people start receiving the shots, experts will not know about rare and potentially dangerous side effects.

The public health community may still be scarred by the U.S.' disastrous 1976 swine flu vaccination campaign, which was abruptly stopped after hundreds of people reported developing Guillain-Barre syndrome, a paralyzing disorder, after getting the flu vaccine.

Several drugmakers are currently considering using adjuvants, ingredients used to stretch a vaccine's active ingredient, which could allow for many more vaccine doses. But little or no data exists on the safety of vaccines with adjuvants in populations including children and pregnant women. And in the U.S., there are no licensed flu vaccines that use adjuvants.

July 14, The Washington Post, Rachel Saslow:

Swine Flu? Don't Ask: Doctors Usually Can't Tell for Sure.

Sheila Morris is almost certain her 13-year-old son Evan got the H1N1 influenza virus at summer camp two weeks ago -- but she'll never know for sure. And neither will the Centers for Disease Control and Prevention.

The Fairfax County mother suspected H1N1, or swine flu, when her son came home with a temperature of 104. An e-mail from the camp director confirming eight cases of H1N1 among campers solidified her hunch.

"That night we called the doctor's office, and she said, 'Sure, it's probably swine flu,' " Morris says. But the doctor did not suggest that Evan come in for testing. "She didn't think the CDC was interested in anything unless you died."

Parents in the Washington area and beyond are having similar experiences, leaving some angry and others, like Morris, confused.

Private doctors, such as Morris's pediatrician, can't run their own tests for H1N1. That falls to private laboratories and the public-health system, which wants to track the pandemic, not help doctors make treatment decisions.

As of Friday, the CDC had reported 37,246 cases of swine flu and 211 deaths from the illness nationwide. The District has 45 confirmed cases of the virus, Maryland has 686 and Virginia 306, but officials have said the actual number is probably much higher, because not everyone who gets sick goes to the doctor and because it's not practical to give an H1N1 test to everyone with a flulike illness. The CDC estimates that more than a million people worldwide have contracted H1N1. [Er, that's interesting; it seems just the other day CDC was estimating a million cases in the USA alone. Exponential Grain of Salt Alert or reporter mistake]

Last Thursday, the federal government hosted a "flu summit" to talk about vaccinations and preparedness. Health and Human Services Secretary Kathleen Sebelius called H1N1 "a serious virus capable of causing severe disease and death" and said, "We must avoid complacency and ensure we are prepared to deal with whatever the fall flu season brings."

Diane Dubinsky, the medical director of Fairfax Pediatric Associates, gives her patients with flu symptoms a rapid diagnostic test: a nasal swab that detects all flu, including swine flu. (Dubinsky is not Morris's doctor.) The results are clear in about 10 minutes, and if the test is positive for influenza A, she assumes that the patient has the H1N1 virus, which is a type of influenza A.

On a conference call with reporters on June 26, Anne Schuchat, a CDC physician helping to lead its pandemic response, said virtually all of the influenza circulating this summer is the H1N1 variety; 99 percent of the positive samples tested by the CDC are H1N1. Schuchat said the CDC is performing "virologic sampling" to get infection numbers rather than testing every single person with a flulike illness. [Reference Doc Jim's comment about seasonal flu this year]

"We've had cases where patients have been angry, demanding to get tested for swine flu," Dubinsky says. "We calm them down and say who we test and who we don't test."

Today, a month after the World Health Organization declared a swine flu pandemic, the CDC recommends H1N1 testing only for people with flulike symptoms who are at high risk for complications, including infants, the elderly, pregnant women and those with chronic illnesses. The D.C. health department adopted those guidelines June 22.

Not all doctors are following the guidelines. Foxhall Pediatrics in Northwest Washington sent influenza A-positive swabs to a private laboratory for testing through the end of June, even for children older than 5, according to an administrator at that office. The practice did it because doctors and patients both wanted to know the results. Still, the practice plans to follow the CDC guidelines for all future patients.

Diane Helentjaris, the acting director of the Virginia Department of Health's Office of Epidemiology, guesses that some patients are eager to get the swine flu test because they're curious, even "a little excited about having something new." [I can think of other reasons why patients would want to get tested]

Conducting the H1N1 test is not simple. Doctors must transport samples in special containers; the test costs $40 to $200, depending on the exact type and various laboratory issues; and the whole process can take a week. By then, most patients are on the mend. Compare that process with the 10-minute rapid flu test, which costs about $15.

In this context, many local doctors, including Dubinsky, have been telling any patient who tests positive for influenza A that he or she probably has swine flu.

Doctors recommend that patients treat flu symptoms by taking over-the-counter medicines and staying home for a week after falling ill. The antiviral drug Tamiflu is recommended only for at-risk patients who seek treatment within the first 48 hours of symptoms, Dubinsky says.

In Morris's case, she picked her sick son up from camp and prepared for the flu to spread through her family. She kept her son at home and monitored him closely. She bought Tamiflu for her elderly father, who lives with her and is in fragile health. She acted as if her son had swine flu, even though she probably would never know for sure. So far, nobody else in her family has gotten sick.

July 14: I showed the Wapo report to a physician friend in the Greater Washington, DC area. Here are his comments about the doctors' recommendations quoted in the report :

Yes, this is the appropriate medical response.

Rarely does any Type A flu circulate at this time of the year. New kits for distinguishing Type A vs Type B show swine flu as Type A. Older kits show no reaction, as they didn't pick up this new swine flu Type A. So knowing the capabilities of the testing system, a physician must predict.

It is hard to fault the reasoning that kids who are not very sick don't need antivirals, they need oral fluids, Tylenol and bedrest until better. On the other hand, a few will die, if not treated with Tamiflu or Relenza.

We have passed the point of no return in the epidemic in the USA, it is here and growing. Treatment based on clinical description is adequate now. Doing PCR tests on all cases is a big waste of time and money. That kind of testing is useful at the start to see what is evolving. Now we know. We have epidemic swine flu in the DC metro area.

I plan to give Rx for Tamiflu to every patient who calls with symptoms that fit. Doing less seems unwise, though we will spend a huge amount of money on Tamiflu to save a "few" lives. I hope to save lives among my patients, rather than blow off the low chance of doing so as uneconomic.