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.