Roche’s Tamiflu Not Proven to Cut Flu Complications

The effectiveness of Roche Holding AG’s Tamiflu in treating flu complications in healthy adults can’t be determined because the Swiss drugmaker wouldn’t supply data from eight studies, an independent research group said.
The exclusion led the Cochrane Collaboration to reverse its previous finding that the pill warded off pneumonia and other deadly conditions linked to influenza. Tamiflu has been the mainstay of treatment for swine flu, which has killed almost 9,000 people since April, according to the World Health Organization. Roche said the drug is effective.
An analysis of 20 studies showed that Tamiflu, which is expected to generate 2.7 billion francs ($2.64 billion) in sales this year, eased and shortened symptoms if taken quickly. It found no clear evidence that the drug prevented lower respiratory tract infections or complications of influenza, according to the nonprofit research group in a review published in the British Medical Journal.
“We have multibillion-dollar public health policies in place that rely on evidence not available for independent analysis,” Tom Jefferson, the lead researcher from the Cochrane Collaboration in Rome, said in a telephone interview.
The report, an update of a 2005 analysis by Cochrane, excluded eight studies funded by Roche that haven’t been published and whose full data wasn’t given to the researchers. The exclusion reversed the group’s earlier finding that Tamiflu protects against complications.
Insufficient Evidence
“We now conclude there is insufficient evidence to describe the effects of Tamiflu on complications of influenza or the drug’s toxicity,” Jefferson said.
The group, which reviews medical evidence, excluded the eight studies, involving 2,500 patients, because it couldn’t get satisfactory access to the data involving the healthy adults in the study, he said.
Roche, based in Basel, Switzerland, defended the drug’s benefits and its research, saying confidentiality agreements with patients enrolled in the trials kept the company from giving the investigators unreserved access to the findings.
“We fully stand behind the robustness of the data and the integrity of that data, particularly the efficacy and safety of Tamiflu, the conduct of our studies and publication policies,” David Reddy, head of the company’s global pandemic task force, said on a conference call with reporters. “We believe this drug is playing a pivotal role in the management of the current pandemic.”
Roche Offer
Roche offered to give the full findings to the researchers if they signed a confidentially agreement, Reddy said. The researchers declined the offer, he said.
Two published trials show Tamiflu reduces complications in patients with seasonal influenza, while an observational study suggests it may lower death rates, Reddy said. Data emerging from the swine flu pandemic shows giving the drug within two days of symptoms appearing is the only effective way to help patients, he said.
The Cochrane report raises questions about how drugs are reviewed, approved and distributed, Fiona Godlee, the British journal’s editor in chief, wrote in an editorial. The studies originally used to establish the benefits of Tamiflu were written by Roche employees and paid consultants, under-reported serious side effects and failed to clearly identify all the authors, she wrote. In at least one case, a study was attributed to a researcher who disavowed any involvement to the journal, Godlee wrote.
‘Taken on Trust’
Governments relied on the studies to justify the widespread use of Tamiflu, known chemically as oseltamivir, she said. The reviewers were unable to find any independent studies of the drug in healthy adults, she said.
“This case exposes how much of the evidence on drug safety and effectiveness is taken on trust,” Godlee wrote. “Governments around the world have spent billions of pounds on a drug that the scientific community has found itself unable to judge.” She called for more independent research, greater access to raw data used to license and sell drugs and stricter regulations on the conduct, review and publication of medical research.
More than 8,768 people worldwide have died from swine flu since it was first identified in Mexico and the U.S. in April, according to the Geneva-based WHO. More than 68 million people have taken Tamiflu since it was approved a decade ago. Influenza kills as many as 500,000 people worldwide each year.
WHO Recommends
The WHO recommends giving Tamiflu to infected people with a high risk of developing complications, including pregnant women and people with underlying medical conditions. The researchers said there is little evidence now available to show that otherwise healthy people should be routinely given Tamiflu.
In the U.K., patients can get a Tamiflu prescription by calling a national hotline or filling out an online questionnaire about their symptoms.
“The evidence shows that if taken within 24 hours, Tamiflu reduces symptoms of influenza by about a day,” Jefferson said. “It may reduce transmission. But we could not verify the claims that Tamiflu reduces complications. Once you took out the eight unpublished studies, the data relating to healthy adults that weren’t published, what remained showed no effect.”

Flu vaccine clinic turnout lower than expected

Kyle Kelley of West Roxbury put on a brave face as a public health nurse wiped a spot on his arm and gave him a quick shot of the H1N1 vaccine.

“Good boy’’ said his mother, Tracey, patting his back as her other two children watched in amazement.

But try as he might, Kyle could not hold back the tears.

“It didn’t hurt at first,’’ explained the 8-year-old. “Usually [the needle] stays in four seconds, but I counted it and it was two seconds. But it didn’t hurt that much.’’

Inside the gymnasium at Hyde Park High School, there were squeals, tears, brave faces, and shirt sleeves rolled up as hundreds came out to get the H1N1 vaccine.

Boston public health officials had hoped to inoculate 5,000 residents in Hyde Park yesterday against H1N1 - and another 5,000 today in West Roxbury - as part of a community vaccination drive that targets people most at risk for getting swine flu. The H1N1 vaccine is only being offered to those at greatest risk of complications and viral illness - people age 3 to 24, and adults 25 through 64 who suffer from asthma, heart disease, diabetes, and other chronic conditions. Regular seasonal flu shots were not offered this weekend.

By 3 p.m. yesterday, 715 people in Hyde Park had gotten their shots or nasal spray.

Ann Scales, spokeswoman for the Boston Public Health Commission, said the turnout was lower than expected because fewer reported cases of flulike illnesses have been reported recently and because many city residents are already vaccinated.

“That has suppressed interest in the vaccine,’’ she said.

Panic about the swine flu is waning as many people with symptoms are opting to stay home and ride out the illness rather than going to their doctor, she said.

For the past two months public health officials have been teaming with the city’s community health centers to hold free H1N1 flu clinics, and more than 12,000 Boston residents have received shots or nasal sprays to fight swine flu, said Barbara Ferrer, the health commission’s executive director.

Public health officials decided to hold the massive flu clinics in Hyde Park and West Roxbury because neither have health centers.

“These residents want easy access to public clinics,’’ said Ferrer. “Many people can go to see their health care providers . . . but in every neighborhood we’ve promised public clinics.’’

Since April, 1,867 confirmed cases of swine flu have been reported in Massachusetts, and 25 people have died from it, according to the latest flu report from the Massachusetts Department of Public Health last week.

For about five hours yesterday, a steady stream of Boston residents lined up, filled out health-related questionnaires, and got shots or nasal spray.

To keep the lines moving, more than 150 health workers in blue and green vests answered questions in multiple languages and steered residents in the right direction. They also posted reminders and updates, along with photographs, on Twitter.

The weekend flu clinics come two days after the state released a report that showed swine flu is loosening its grip on Massachusetts patients. According to the report from the Department of Public Health, the number of patients complaining of flu-like symptoms has fallen to its lowest level in a month.

Last week, influenza accounted for 3.55 percent of visits to a representative sampling of Massachusetts physicians. In early November, nearly 10 percent of the visits were attributed to the flu, the Globe recently reported.

Swine flu scare tightens borders around Ukraine

LVIV, Ukraine — Russia and Slovakia tightened their borders with Ukraine on Tuesday as the World Health Organization began investigating a suspected swine flu outbreak.

The death toll from flu has climbed to 71 since the outbreak struck last week in the western city of Ternopil, Prime Minister Yulia Tymoshenko said.

Blood tests have yet to determine how many of these deaths were from the new and aggressive H1N1 strain. But the WHO said in a statement on Tuesday that most flu cases in Ukraine can be assumed to be H1N1, "as the pandemic virus has rapidly become the dominant influenza strain worldwide."

As a precaution, schools and universities across the country will remain closed this week, and officials urged people in western Ukraine to travel only when necessary and stay away from public places.

Slovakia, which lies on Ukraine's western border, closed two of its five border crossings with Ukraine to keep the infection from spreading. In Russia, where there have been 14 confirmed swine flu deaths, the Health Ministry said it would examine anyone crossing the border from Ukraine and quarantine people with severe symptoms.

The World Health Organization sent a team to Kiev on Monday to assist local health officials with the epidemic. It recommended against restricting travel or closing borders, calling such measures ineffective in preventing the spread of the virus.

The Ukrainian government's precautions have been reasonable considering the potential threat, WHO spokesman Gregory Hartl said.

"By closing schools and canceling mass gatherings in the early stages of an event ... you can slow down the transmission of the virus," Hartl said by phone from the organization's headquarters in Geneva. "So far there is only one confirmed death (from H1N1 in Ukraine), but there is a big event going on there."

The WHO is focusing its efforts on the western city of Lviv, "where reported numbers of cases showing severe manifestations of acute respiratory illness have been especially high," it said.

The government has already urged cafes, cinemas and theaters to close indefinitely in Lviv, and roughly a third of the people in the streets on Tuesday wore surgical masks to avoid inhaling the virus, as did the Ukrainian guards on the border with Belarus.

But the emergency ward of the central hospital in Lviv saw no shortage of available beds, even as patients trickled in complaining of flu symptoms on Tuesday. All of those accepted for treatment were quarantined.

Compared to last year, the total number of flu deaths in Ukraine has actually dropped by 10 percent, the UNIAN news agency quoted Deputy Health Minister Vasily Lazorishinets as saying.

This led some Ukrainian officials and medical experts to accuse the government of exaggerating the outbreak for political gain ahead of presidential elections to be held in January.

In January, Tymoshenko and President Viktor Yushchenko will face off for the presidency. That election could overturn the 2004 Orange Revolution that swept a pro-Western government to power in Ukraine for the first time. Leading in the polls is Viktor Yanukovich, who was beaten in 2005 by Yushchenko, but has pulled ahead on a platform that emphasizes closer ties with Russia.

H1N1 vaccine received, clinics set

The shipment included 500 doses of the H1N1 injectable vaccine and 1,500 doses of the nasal spray (Live Attenuated Influenza Vaccine -LAIV).

Clinics have been scheduled for health care workers and first responders starting on Tuesday, Oct. 20.

The Winnebago County Health Department also will offer the vaccine to pregnant women and infants who are current WIC and Family Case Management Service clients during scheduled appointments starting this week.


Initially, the vaccine will come in small quantities, weekly. As the vaccine arrives, the health department will begin the planned vaccination program for children in Winnebago County schools and daycares. Plans for community vaccination clinics for others who are at risk of complications from the flu will be conducted at a later date.

“Again we ask members of our community who want to receive this vaccine to be patient as this program begins. There will be enough vaccine for all who wish to receive it, but initially we must protect those who are at greatest risk,” said Mike Bacon, Winnebago County Public Health Director.

The nasal spray (LAIV) vaccine is for healthy, non-pregnant people between the ages of 2 and 49, including healthy, non-pregnant health care workers who do not work with severely immunocompromised persons.

The Rock County Health Department has scheduled an H1N1 vaccination clinic in Janesville from 9 a.m. - 2 p.m. Nov. 14 at the Rock County Job Center, 1900 Center Ave.

The Rock County Health Department has scheduled several school H1N1 clinics in the area. They include:

3 - 7 p.m. Oct. 27 at Clinton High School.

3 - 7 p.m. Oct. 28 at Powers School in the Beloit-Turner School District.

3 - 7 p.m. Nov. 3 at Converse Elementary School in Beloit.

3 - 7 p.m. Nov. 4 at Aldrich Middle School in Beloit.

3 - 7 p.m. Nov. 5 at Parkview Junior/Senior High School, Orfordville.

After Nov. 1, those who meet one of the risk factors for H1N1 flu can schedule an appointment to get the shot by calling the Rock County Health Department at 608-757-5440.

Those in the risk factor group include: pregnant women, people who live with or care for children younger than 6 months, healthcare and emergency medical personnel, people ages 6 months to 24 years and people with chronic health conditions such as diabetes, heart disease, asthma and kidney disease.

The Winnegabo County Health Department will offer the H1N1 vaccinations free of charge. For more information on H1N1, visit the Winnebago County Health Department’s Web site at www.wchd.org., or call the Health Department at 815-720-4000.

Illness, death and the impact of the H1N1 pandemic will differ dramatically from country to country

Dr. Margaret Chan, Director-General of the World Health Organization, said Tuesday that this disparity is because the pandemic is spreading in a world where differences in health status, in access to care, in quality of that care, and in resources for health, are greater than at any time in recent history.

The Swine Flu pandemic will be a public health turning point around the globe because the consequences are likely to be so uneven and so unfairly felt depending on where you are.

Speaking to the WHO’s Regional Committee of the Americas, the director predicted that the overwhelming majority of cases will experience mild illness with spontaneous recovery.

However, she cautions that as the illness increases, this somewhat rosy picture will differ because of extremes in the clinical spectrum of disease, in public opinion, in access to vaccines, in ability to respond and in impact.

“The world will see proof of the validity of arguments public health has been making for decades,” she said and added that “Weak health systems cost lives. Equity matters in health in a life-and-death way.”

She calls H1N1 a “virus of extremes” that doesn’t “seem to have a middle ground.”

At one extreme are the mild cases, she said. At the other extreme is a small subset of patients who rapidly fall seriously ill, sometimes going from normal respiratory function to multi-organ failure within 24 hours

When exactly the same virus causes manageable disruption in wealthy countries, but devastation for health care elsewhere, we will see what inequity really means in a measurable way, the physician explained.