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11/13/2009

For Christian Putensen, the head of the surgical intensive care unit at the Bonn hospital, such a dramatic progression of the illness is nothing new. "Again and again, we see young people, previously completely healthy, with pneumonia and sudden lung failure," he says. "This can also happen without any evidence of swine flu."

Wolfgang Becker-Brüser of Arznei-Telegramm, a magazine aimed at doctors and pharmacists that has been critical of the pharmaceutical industry, says: "The problem is that we are not placing the swine flu in relation to other infectious diseases. If we were to pay as much attention to the normal winter flu as we are now paying to the swine flu, the media would be reporting dozens of deaths every day. People are being frightened, so that they are no longer making rational decisions."

The chaos surrounding vaccination contributes the general feeling of uncertainty. Local health authorities are still relatively effective in their processing of large numbers of people seeking vaccinations. But in many cities vaccinations are not offered by local health authorities, but in doctors' offices. Because of this inconsistency, many patients are unsure where to go to be vaccinated. In the northern German state of Schleswig-Holstein, for example, the Health Ministry has published a list of doctors' offices where the vaccine is supposedly available. The only problem is that not all of the doctors on the list are in fact participating.

The situation in the northwestern state of Lower Saxony is even more confusing. There, patients must first call one of the 11 district offices of the state Association of Statutory Health Insurance Physicians to find out which doctors offer the vaccinations. But this approach also covers up the fact that in some parts of the state almost all doctors have refused to provide the vaccinations. The additional expense and risk is a deterrent for some family physicians. Others, like Wolfgang Schneider-Rathert, a general practitioner in Braunschweig, are refusing to participate out of principle. "In the event of a real catastrophe, it would certainly be reasonable to use the vaccine," says Schneider-Rathert. "But that is by no means the case now."

'Poorly Organized'

On the other hand, many doctors willing to provide vaccinations have run into difficulties getting the vaccine. "Instead of the 1,000 doses that were ordered, we received all of 160 on Monday," reports Thorsten Ottlewski, a general practitioner from the town of Burgwedel near Hanover. He had no choice but to cancel hundreds of appointments, mainly with police officers and firefighters. "I would never have thought that the whole thing would be so poorly organized," says Ottlewski.

To complicate matters, the pharmaceutical company GlaxoSmithKline has only delivered about half as much vaccine as expected by now -- and that vaccine remains highly controversial, because of possible side effects.

Because of the problems with the vaccine, many German doctors are now envious of their counterparts across the Atlantic. None of the vaccines used in the United States contain controversial ingredients, known as adjuvants, intended to enhance their effect. The US vaccines are manufactured in precisely the same way as the seasonal flu vaccines, which have been tried and tested for years.

An Unnecessary Risk?

The German government, on the other hand, signed a contract in 2007 that requires it to use Pandemrix, a new type of vaccine containing AS03, an adjuvant that has only been used in clinical trials until now, in the event of an influenza epidemic. If the type of influenza in question had been a deadly avian flu instead of the still relatively mild swine flu, this approach would have made sense.

But now many doctors feel that the use of Pandemrix poses an unnecessary risk. To make matters worse the vaccine, which tests have shown is less well tolerated than seasonal flu vaccine, was never extensively tested with the chronically ill, a group that health officials are now recommending should be vaccinated first.

Pandemrix could also pose as yet unknown risks for healthy individuals. Is there an elevated risk that the vaccine could cause Guillain-Barré syndrome, a disorder of the peripheral nervous system that results in muscular weakness? "We won't know that until several months from now, when people are no longer thinking about this swine flu season," says Wolfgang Becker-Brüser from Arznei-Telegramm. The Paul Ehrlich Institute, an agency of the German Health Ministry, is conducting an extensive study on the problem, but it doesn't end until September 2010.

"In the United States, anyone can get vaccinated without hesitation," says Becker-Brüser. In Germany, on the other hand, the uncertainties surrounding the vaccine have led to every expert making a different recommendation. German virologists and internists have always favored mass vaccination. Pediatricians and the German Medical Association, initially critical of the vaccine, have since changed their minds, because of the rising numbers of cases.

But Michael Kochen, president of the German College of General Practitioners and Family Physicians (DEGAM), remains as skeptical as Becker-Brüser -- for now, at least. "I would only recommend vaccination with the adjuvant vaccine if severe cases begin to spread rapidly," he says.

Pregnant Women Neglected

Pregnant women, with whom Pandemrix was never tested, are particularly worried. "The focus of preparations for a pandemic was not on pregnant women," concedes Johannes Löwer, the outgoing head of the Paul Ehrlich Institute, which is responsible for vaccines.

All of this has led to considerable confusion. While the European Medicines Agency has approved Pandemrix for pregnant women, Germany's Standing Committee on Vaccination advises against it and recommends that pregnant women receive vaccines without adjuvants -- which, as it happens, are not available yet.

A vaccine suitable for pregnant women, probably from Australia, is not expected until the end of November.

PHILIP BETHGE, ANDREA BRANDT, MICHAEL FRÖHLINGSDORF, VERONIKA HACKENBROCH

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• Part 1: Panic in Germany as Swine Flu Spreads
• Part 2: 'People Are No Longer Making Rational Decisions'