April 9, 2010
By: Ethan A. Huff
The U.S. Food and Drug Administration (FDA) recently issued new restrictions for four popular long-acting asthma drugs. Novartis AG’s Foradil, GlaxoSmithKline’s Serevent and Advair, and AstraZeneca’s Symbicort, all contain an ingredient that relaxes airway muscles in the lungs which can cause asthma-related death. If not accompanied by other asthma drugs to offset this life-threatening side effect, the consequences could be fatal.
These drugs have long contained a label that reads, “increases risk of asthma-related death”, but apparently this warning is not enough for this extreme class of medications. Known as long-acting beta-agonists (LABAs), these asthma drugs are used by roughly six million asthma sufferers to combat asthma symptoms. Ironically, LABAs are so dangerous that, if not combined with other asthma drugs, can actually cause an asthma attack.
It defies logic to try to figure out how asthma drugs that can kill people by causing severe asthma attacks are considered to be useful and effective medicine. Instead of pulling these dangerous drugs from the market entirely as it should, the FDA is ordering that stronger labels be affixed to warn doctors and physicians about the extreme risks associated with taking the drugs. It is unclear from the agency’s press release exactly how it intends to strengthen the drugs’ current death warning.
The FDA has indicated that it will require the drugs’ manufacturers to conduct education campaigns for medical professionals about how to safely use the LABA asthma drugs. The agency is also mandating that each manufacturer conduct additional studies to verify the safety of their drugs.
Since 2002, the FDA had continually rejected all of the overwhelming evidence presented to it that LABAs are inherently dangerous. Only in 2008 did the FDA first admit that the drugs were dangerous, particularly for children and some adults. Prior to that, the agency seemed to be in agreement with a series of industry spin pieces concocted by the drug industry to defend the alleged safety of the drugs; this alone exhibits the FDA’s lunacy in asking the industry to conduct more of its own safety studies.
While warning that the drugs should only be used “as necessary” seems like a step in the right direction, the FDA should be taking a leap to pull these drugs off the market. Many experts agree that these drugs are wholly dangerous, and that the industry has been aware of these dangers for nearly a decade. Once again, the FDA is giving lip service to the public it is supposed to be defending while protecting drug industry interests instead.
November 30, 2009
By Bruce Japsen
Deerfield-based Baxter International Inc. says it is looking into building a cell-based vaccine manufacturing plant in the U.S. to produce seasonal and pandemic flu vaccines.
The company won’t say when a plant could be built because the timing would depend on the outcome of a government-funded clinical trial of its seasonal product, which is in its final stages. A timetable will be clearer when the company can determine the success of its seasonal and pandemic flu vaccine development program.
Baxter is the latest drugmaker to express interest in the potentially lucrative business of producing vaccines in the U.S. Although companies historically have complained of little profit from flu vaccines, increased government subsidies are making the business more attractive. And Baxter’s cell-based technology would speed up the production time.
Swiss drug giant Novartis AG earlier this week began design and construction on a $1 billion cell-based manufacturing plant in North Carolina, which is backed by more than $400 million in federal funds. But the plant won’t be running at full-scale commercial production until 2013, the company said, though it could produce vaccines in an emergency as soon as 2011.
Drugmakers are building or considering vaccine plants as capacity issues stymie governments worldwide, causing shortages and rationing of vaccines for seasonal and pandemic viruses.
But critics say more should be done.
“America needs to produce vaccines and therapeutics faster and less expensively than we have been because we might not have six months of advance warning for the next pandemic,” said retired Col. Randy Larsen, executive director of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, a bipartisan group created by Congress that is advocating more money for vaccine development. “We need more capacity.”
Larsen said the commission is pushing the U.S. to spend $3 billion a year — 10 times the annual spending currently budgeted — to enhance “U.S. vaccine preparedness.” The commission also is trying to mobilize the public behind its effort through its Web site, FasterVaccines.org.
“Whether the threat is from naturally occurring disease or bioterrorism, the United States needs to be able to produce vaccines and other medicines faster and less expensively,” said former U.S. Sen. Bob Graham, chairman of the commission. “Creating the infrastructure for rapid development of large quantities of safe vaccines and medicine is a win-win for public health and national security.”
Baxter and Novartis are among those companies that have benefited from federal dollars and are considered furthest along using cell-based technology, which allows manufacturers to cut production times in half compared with the 1940s-era processing by hand of millions of chicken eggs. The cell-based method can generate yields in about 13 weeks, compared with 24 weeks in egg-based manufacturing — the U.S.-approved method of making pandemic and seasonal vaccines.
Both are making vaccines to prevent the spread of the H1N1 virus in Europe, where the cell-based method is approved. Baxter executives said their plant in the Czech Republic is running at capacity, filling contracts for vaccine with a half-dozen countries overseas.
In the U.S., more is expected to be known by next flu season with Baxter conducting final stage clinical trials for its seasonal flu vaccine this year. Companies that won U.S. contracts to make the H1N1 vaccine were those that already produce seasonal vaccines for Americans with the older, egg-based method.
“Although Baxter is not supplying H1N1 vaccine to the U.S., the company has been keeping the Department of Health and Human Services fully briefed on its progress with its Celvapan H1N1 development program,” Baxter said in a statement to the Tribune. “From Baxter’s perspective, the Department of Health and Human Services and the U.S. government have done an excellent job of exploring ways and implementing partnerships to advance and adopt new vaccine technology in the U.S. The funding, and development challenges are many and simply take time.”
For its part, the FDA said it can’t comment on Baxter’s trial or any expected application for approval.
In general, however, the agency said a standard review of a company’s application for a drug or vaccine can take 10 months before a product is licensed. Expedited reviews are common and can be completed in six months, but the agency would not speculate on whether Baxter or other vaccine-makers would be granted such priority.
“FDA does not approve or license a facility separately from the product itself,” an FDA spokeswoman said. “The facility, manufacturing protocols, data and final product are all part of the approval or licensing package.”