UPDATE 3-Dutch pull Pfizer vaccine batch after infants die

(AFP) – 1 day ago

GENEVA — Swiss pharmaceutical group Novartis said Tuesday that it would invest 1.0 billion dollars (680 million euros) in research and development in China to latch on to growing demand for health care.

The five-year investment will include an expansion of the company's Institute for BioMedical Research in Shanghai (CNIBR) which specialises in basic research and developing new drugs, Novartis said in a statement.

"We are confident that our expanded investment in R&D will result in innovative therapies for patients in China and other countries nurtured by the growing scientific excellence in China," said chief executive Daniel Vasella.

The institute is to become the third largest research facility for the group after centres at its headquarters in the Swiss city of Basel and in the United States, employing about 1,000 researchers instead of the current 160.

Another 250 million dollars will go to a new global technical centre which is opening in Changshu.

Novartis said the demand for health care in China was growing rapidly, as the population suffered from a greater burden of chronic diseases associated with lifestyle choices.

The Chinese government has announced a 124-billion-dollar plan to expand access to affordable health care over the next three years, it added.

A new study from the HHS inspector general's office has found that while overall reporting of medical device adverse events increased significantly between 2003 and 2007, the Food and Drug Administration's Center for Devices and Radiological Health, or CDRH, has done an inadequate job of using those reports to detect and address product safety concerns.“We found that CDRH has not documented follow-up on adverse events, nor does it consistently read adverse-event reports for the first time in a timely manner,” wrote HHS spokesman Don White in an e-mail sent to reporters. “In addition, CDRH rarely acts when manufacturers and user facilities submit reports late.”

Two months after my FOI request, the CDC has yet to produce any of these easily retrievable materials. Sadly, this is of little surprise. This has become standard operating procedure in Washington… read the full story HERE.

WASHINGTON -- The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn't extend patients' lives, say congressional investigators.

FDA Approves Use of Experimental Antiviral For H1N1 Flu

By JENNIFER CORBETT DOOREN

WASHINGTON -- The U.S. Food and Drug Administration is allowing the use of an experimental antiviral drug to treat severe cases of H1N1 or swine flu.

The drug, peramivir, is currently being developed by BioCryst Pharmaceuticals Inc. and is undergoing testing required for regular FDA approval.

The FDA issued a so-called emergency use authorization late Friday that allows doctors to use peramivir, which is delivered intravenously, in certain hospitalized adult and pediatric patients with confirmed or suspected H1N1 influenza.

A handful of doctors have already treated patients with severe cases of H1N1 using peramivir obtained through the agency's expanded access rules that allow individual patients to obtain experimental drugs if certain conditions are met. The emergency-use authorization allows use of the drug without prior FDA approval.

The FDA said there's only limited clinical data about whether peramivir is safe and effective, but "based upon the totality of scientific evidence available, it is reasonable to believe that peramivir IV may be effective in certain patients."

The company said it is completing production of approximately 130,000 courses of peramivir and is prepared to make more, if required.

The FDA said peramivir should only be used in patients who have not responded to or can't take the oral antiviral drug Tamiflu, made by Roche or Relenza, which is an inhaled drug made by GlaxoSmithKline PLC. Like Tamiflu and Relenza, Peramivir works by inhibiting neuraminidase, an enzyme that's involved with the spread of the influenza virus within the body.

The federal Centers for Disease Control and Prevention asked the FDA to grant peramivir emergency use to help cope with the influenza pandemic which has killed more than 1,000 people in the U.S. since April and hospitalized thousands more. The CDC will control and track distribution of peramivir to hospitals.

As of Oct. 17, 46 states were reporting "widespread" influenza activity and many doctors offices have been swamped with swine-flu patients. The CDC said more than 7% of outpatients visits in the week that ended Oct. 17 were attributed to influenza-like illnesses -- a rate higher than during the peak of the last few seasonal influenza seasons. The CDC said "many millions" of Americans have been sickened with H1N1 influenza since the virus was first discovered in April.

The U.S. government has ordered enough vaccine to make up to 251 million doses if needed, but production has been slower than originally anticipated.

A total of 11.3 million doses of vaccine had been shipped to U.S. doctors, hospitals, and clinics as of Wednesday, according to the CDC, out of a total of 14.1 million doses that manufacturers had shipped to warehouses by that time. By Friday, 16.1 million doses of vaccine had been shipped to warehouses, the CDC said.

The total is far below the government's most recent estimate that by the end of this month, about 28 million to 30 million doses would be shipped to warehouses for further distribution. That estimate itself is a revision, made last week, from a prior expectation of about 40 million doses by the end of the month. In July, the government had predicted that about 100 million doses would be ready in October.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com

Europe Takes Closer Look At Tysabri

By THOMAS GRYTA

A European panel has started a review of the controversial multiple sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan PLC, citing a higher rate of a rare brain infection than previously disclosed.

The additional cases are important because they may increase the drug's risk profile and raise questions about the companies' responsibility in updating the market on the safety record of Tysabri, a product that generates nearly $1 billion in yearly revenue.

The European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, reported there have been 23 cases of progressive multifocal leukoencephalopathy, or PML, a number that the Food and Drug Administration later confirmed, adding that those cases were after Tysabri returned to the market in 2006. The FDA said it is continuing to assess the situation.

Previously, there had only been 13 confirmed cases of the infection since the drug re-entered the market in 2006, after being removed for 18 months because of a link to three other PML cases.

Tysabri was allowed back on the market after patients and physicians pushed for its return. The drug, despite the PML risk, is seen as one of the most effective MS treatments on the market, especially for those with severe cases who have few other options.

The European panel said its review will discuss "any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment."

Christopher Raymond, an analyst with Robert Baird, said European regulators are unlikely to remove it from the market, but they may recommend that long-term patients take a break from using the drug to help balance risk. Duration of use is seen as raising the risk factor for PML.

Earlier this week, Biogen acknowledged that it is talks with the U.S. Food and Drug Administration to amend Tysabri's label to reflect increased PML risk with longer-term usage. Changing the label marks a shift for Biogen, which has long maintained there was no clear connection to duration and increased risk of PML.

The increased potential of patients taking a break, or "drug holiday," from Tysabri could affect its sales growth, and that prospect weighed on shares of Biogen and Elan on Friday. Shares of Cambridge, Mass.-based Biogen fell 5.8% to $44.49, while the American depository receipts of Dublin-based Elan plunged 20% to $5.17 in Friday afternoon trading.

Biogen spokeswoman Naomi Aoki said the incidents of PML remain rare, reiterating the company's contention that the rate remains within the 1-in-1,000 patient level implied by its label.

As of Sept. 30, about 46,200 people world-wide were taking Tysabri with about 13,400 patients on the drug for more than 24 months. Because duration is seen as an issue, there is a debate as to which number to compare to the number of PML cases—either the total number of patients or those on Tysabri for two or more years.

Ms. Aoki stressed the strong effectiveness of the drug in treating the debilitating disease and said the risk-benefit profile remains favorable. Ms. Aoki, citing company policy, declined to comment on the number of PML cases reported by the European agency.

"We don't think it is beneficial to comment on the numbers because it is within the [label's] rate," she said.

Officials from Elan weren't immediately available to comment.

Sanford Bernstein analyst Geoffrey Porges said the significance of the cases is hard to gauge without further details, but valued Biogen's stock at $41 without Tysabri.

"These new cases are likely to alarm physicians whose comfort with the product had been increasing in recent months, and should catalyze academic and regulatory discussions about more active risk mitigation strategies," he wrote in a note to clients.

The new cases also might reignite a debate over disclosure of new PML cases. Neither company regularly provides such updates, which has caused some frustration on Wall Street.

Biogen was giving weekly updates until July 24, the third anniversary of Tysabri's relaunch, but now maintains that disclosing such information isn't helpful because the PML rate is already on the label and FDA is aware of all new cases. Thus, the new information only creates fear among patients and physicians.

Furthermore, Biogen has said, such negative information can be used by other drug makers in the increasingly competitive MS treatment market.

Write to Thomas Gryta at thomas.gryta@dowjones.com

By JEFF OSTROWSKI

Palm Beach Post Staff Writer

Sunday, October 25, 2009

Kicking Formaldehyde Out of Bed

By ANJALI ATHAVALEY

A bill backed by industry and environmental groups would set federal limits on a potentially dangerous chemical inside your home: formaldehyde. But it could mean a small increase in furniture prices for consumers.

The bill, introduced last month by Sens. Amy Klobuchar, D-Minn., and Mike Crapo, R-Idaho, would reduce indoor emissions of formaldehyde, a chemical used in adhesives found in domestic and imported composite wood products. The standard for formaldehyde proposed in the bill would apply to particleboard, plywood and medium-density fiberboard, all commonly used materials in household furniture. Formaldehyde-based adhesives have been a component of composite wood products for decades and are considered cost-effective by manufacturers.

Currently, there is no federal standard for formaldehyde emissions in most homes. The Department of Housing and Urban Development has set limits on formaldehyde in plywood and particleboard, but they apply specifically to materials used to build prefabricated and mobile homes. Under the proposed legislation, composite wood products sold in the U.S. would have to meet formaldehyde-emission standards of about 0.09 parts per million by January 2012, matching standards recently adopted by California.

Formaldehyde is found in products ranging from pressed wood to cosmetics and is classified as a carcinogen by the International Agency for Research on Cancer, part of the World Health Organization. Supporters of the Senate bill say they are concerned about other side effects as well. Last year, the Centers for Disease Control and Prevention issued a report on high formaldehyde levels in trailers where Katrina victims were living and recommended that the Federal Emergency Management Agency move occupants. Some of the victims complained of symptoms such as respiratory problems, headaches and bloody noses. According to the Environmental Protection Agency, formaldehyde can cause burning sensations in the eyes and throat, nausea and difficulty breathing in some humans exposed at elevated levels. High concentrations may also trigger attacks in people with asthma.

Formaldehyde is a volatile organic compound, meaning that it vaporizes and turns into gas at room temperature. Pressed-wood products made with formaldehyde can off-gas, or release gas into the air, says David Jacobs, director of research at the National Center for Healthy Housing and an adjunct professor in environmental health at the University of Illinois at Chicago.

Off-gassing has become more of a concern because some energy-efficient homes may provide less ventilation, says Dick Titus, executive vice president of the Kitchen Cabinet Manufacturers Association, a trade group for cabinet manufacturers and suppliers. In homes with less ventilation, consumers could be breathing in more concentrated amounts of toxic substances.

Indeed, consumers say they are worried about air quality in their homes. Chris VanArsdale 42, a developer in Washington, D.C., says he and his wife are "extremely concerned, particularly about formaldehyde in composite wood."

Mr. VanArsdale says that after hearing about high formaldehyde levels in the FEMA trailers, he specifically looks for low-formaldehyde furniture (there is a trace of naturally occurring formaldehyde in wood itself). He also uses other techniques, such as letting furniture sit outside in the shed for a few months before bringing it into the home.

But the Formaldehyde Council Inc., the trade group for producers of the chemical, says its product is safe at the low levels to which people are typically exposed. "It is important for Congress to consider that formaldehyde is a necessary ingredient used safely in making thousands of essential materials," the group said in a statement. A spokesman said the group had yet to take a position on the Senate bill.

Still, many domestic manufacturers are already using low-formaldehyde adhesives following limits set by California in 2007 that took effect this year. (Any newly manufactured products exceeding those limits can't be sold in the state.) They hope a national standard would push foreign suppliers to follow suit. "We believe if the U.S. industry has been asked and has stepped up to improve its manufacturing processes, that the rest of the world needs to have to do the same thing," says Tom Julia, president of the Composite Panel Association, a trade group representing the North American composite-wood industry. Composite-wood manufacturers say that California's standard has already limited how many overseas suppliers they can use.

Some furniture companies expect costs to go up for consumers because low-formaldehyde products are more expensive to manufacture. "To use another agent besides formaldehyde has added 5% to the cost," says Ray Steele, executive vice president of Ultimate Accents, a Kernersville, N.C.-based importer of hand-painted furniture. "We'll absorb some [of the increase] but it's ultimately going to be passed on to the consumer."

But Brad Thompson, chief executive of Columbia Forest Products, says that no-added-formaldehyde products are what consumers want as they become more health and eco-conscious. "In 2005, we began to realize this issue of formaldehyde was going to be one in the future," Mr. Thompson says. The company has phased out formaldehyde in adhesives in wood manufactured domestically, and is using a soy-based resin. "The best case was to take it out of the product all together."

Indeed, furniture buyers say they want to know that their products are safe. Gail McKinley of Chapel Hill, N.C., last year purchased cabinets by Executive Kitchens, a cabinet manufacturer in Simpsonville, S.C., that were made from the wood supplied by Columbia Forest Products. "I did a lot of shopping around on the Web for green kinds of products," says the 64-year-old retired program manager for the Department of Energy. "I do have a history of asthma. I wanted to avoid the formaldehyde issue."

Write to Anjali Athavaley at anjali.athavaley@wsj.com