No proof of drug industry sway on WHO in pandemic: report
(Reuters) – Independent experts who examined the World Health Organisation’s handling of the H1N1 pandemic said on Thursday they had found no evidence of drug industry influence on the U.N. agency’s decision-making in the crisis.
But in a draft report made public, the panel said WHO had failed to recognize and manage conflicts of interest among some experts on its advisory Emergency Committee who had disclosed their ties to pharmaceutical companies.
The world remains “ill-prepared” to face a severe influenza pandemic or similar public health emergency, the experts added.
The United Nations agency announced in June 2009 that the newly-emerged H1N1 swine flu virus was causing the world’s first influenza pandemic in more than 40 years. It declared the pandemic over in August 2010, saying that the global outbreak had turned out to be much less severe than was feared.
“WHO performed well in many ways during the pandemic and confronted systemic difficulties and demonstrated some shortcomings,” the panel said in a 33-page report. “The Committee found no evidence of malfeasance.”
“As far as the Review Committee can determine, no critic of WHO has produced any direct evidence of commercial influence on decision-making,” it added.
Critics who have suggested ‘invisible commercial influences’ may account for WHO’s actions ignored the agency’s core public health values to prevent disease and save lives, according to the panel headed by American flu expert Dr. Harvey Fineberg.
The Review Committee, composed of 27 experts, holds its last meeting in Geneva on March 28-30 to finalize its report which is to be submitted to WHO’s annual ministerial meeting in May.
The panel criticised the WHO’s lack of a consistent and measurable description for judging a pandemic’s severity which had created confusion. It suggested a scale of three phases rather than the current six-phase scale which is under revision.
WHO bureaucracy had also prevented a timely distribution of donated vaccines in poor countries during the pandemic, it said.
GlaxoSmithKline and Sanofi-Aventis are among major producers of influenza vaccines.
“The world is ill-prepared to respond to a severe influenza pandemic or to any similarly global, sustained and threatening public health emergency,” it said, citing the risk of massive disruption, suffering and loss of life.
GSK’s Benlysta: The new face of a ‘blockbuster’ drug (with more to come)
Years before Benlysta’s approval as the first new lupus treatment in more than 50 years, GlaxoSmithKline (NYSE:GSK) signed a development and commercialization agreement with Human Genome Sciences (NASDAQ:HGSI) in which the two companies would share equally in the costs of developing a new drug and any net proceeds that come from a commercialized product.
That 2006 agreement was preceded by a collaboration between the companies dating back to the 1990s. Back then, there was no way of knowing that the biologic compounds that HGS discovered would become the first lupus drug candidate in decades to advance into a phase III clinical trial. Benlysta, which was approved by the Food and Drug Administration on Wednesday, is now touted as the next blockbuster drug with analysts projecting annual sales ranging from $3 billion to $7 billion. GSK will get half of that under the agreement with Rockville, Maryland-based HGS.
Half of a blockbuster drug is still a substantial chunk of change. One thing’s for sure, though, it will be a very different kind of blockbuster for London-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina.
Consider GSK’s blockbuster drugAdvair, approved by the FDA in 2000 to treat asthma and chronic obstructive pulmonary disease (COPD). The market was eager for a new asthma treatment and within five years, Advair’s annual sales grew to $5.6 billion on 21.1 million prescriptions in the United States, according to IMS Health.
The market is also eager for a new lupus treatment. Aspirin was approved to treat lupus in 1948. Plaquenil, an anti-malarial and anti-rheumatic drug, was approved as a lupus treatment in 1955.The Lupus Foundation of America estimates that 1.5 million Americans suffer from some form of lupus. Worldwide, that figure grows to 5 million. The autoimmune disease, in which the body attacks its own tissues causing inflammation and pain throughout, disproportionately affects women. It is also more prevalent among African Americans.
Although African Americans are more more likely to be diagnosed with lupus, they are also less likely to benefit from Benlysta. Clinical trials found that African American patients and patients of African heritage did not appear to respond to the drug. The FDA instructed HGS and GSK to conduct more studies to find out why. But those clinical trial findings so far further limit the pool of patients who could benefit from the new drug.
Advair became a blockbuster because GSK could sell a lot of the product to the millions who have asthma or COPD. It became a blockbuster because it was a drug that could be sold to many.
Benlysta will become a blockbuster as a drug sold to the few. The drug will be sold to the targeted group of patients who will benefit from it. Those patients will pay a premium for it. On a conference call discussing the FDA approval of Benlysta, HGS Chief Commerical Officer Barry Labinger said the annual cost for the drug would be $35,000, which he noted is in line with other biological drugs. For example, some multiple sclerosis patients face annual costs of $40,000 for their drugs, he said.
Keeping Advair in mind, if every patient paid full price for the Benlysta drug, GSK and HGS would be treating just 200,000 patients each year to reach a $7 billion annual revenue stream.
The two companies say they don’t want cost to be a barrier to a drug that could help lupus patients. Labinger said that the company would have programs to help patients least able to afford Benlysta.
“Our goal is to prevent affordability from getting in the way of access to Benylsta as much as possible for appropriate patients,” he said.
HGS and GSK are both quickly ramping up their Benlysta sales teams. The companies still await European approval for Benlysta, which could come later this year. HGS has set up a headquarters in Switzerland, as well as commercialization teams in Germany, France and Spain. In the rest of Europe, the company will rely on GSK’s sales force.
Benlysta is expected to be available in the United States by the end of March. The company’s sales push for Benlysta will be far and wide even if it’s impact will be felt by a relatively narrow piece of the overall lupus population.
So that’s the picture of the new blockbuster drug: expensive products targeting ever more specific segments of the patient population. And as GSK and other pharmaceutical companies continue working on biologics, expect more of this to come.
The Wall Street Journal pointed out the GSK pipeline for Benlysta-style wins is thick thanks to its long-ago HGS partnership. Darapladib, a cardiovascular drug that blocks a protein that contributes to plaque buildup in the arteries, may be able to cut the risk of heart attacks and strokes. Another, albiglutide, is an injectable drug that maintains blood-sugar levels.
“This business development activity which the pharmaceutical industry has been doing now for 20 years, 25 years, is a long-term game,” Ad Rawcliffe, Glaxo’s head of worldwide business development, told The Journal on Thursday. “And you need to have long-term commitment.”
Drug shortage putting Houston patients at risk
Houston hospitals are struggling to cope with an unprecedented national shortage of drugs that industry officials concede is putting public health – and lives – at risk.
Hospital pharmacists and doctors in the Texas Medical Center said this week they are managing the crisis without incident so far, but acknowledged it’s causing delays in procedures, the substitution of alternative medication and prioritizing which patients get the drugs in short supply.
“It’s been quite the challenge,” said Dan Metzen, director of Methodist Hospital’s pharmacy. “It’s kept us busy – up late at night, in constant meetings – trying to figure out what drugs each new patient needs and where we can get it if we don’t have it.”
The shortage has grown progressively worse the last five years, but Houston pharmacists called the last two months the worst period yet and said no end is in sight. The FDA’s official shortage list now includes 57 drugs, as many as were typically amassed in an entire year prior to 2005. The Food and Drug Administration reported a shortage of 178 drugs last year and the 2011 list is on pace for more than that.
In 2010, most respondents to a national survey of health-care providers were “perplexed” why the United States is experiencing drug shortages of “epic proportion that are often associated with Third World countries.”
Many are cancer drugs
Nationally, at least a handful of deaths have been attributed to the shortage, and an official with the American Hospital Association says the real number is likely significantly more, particularly since many of the drugs treat cancer.
One, cytarabine, is considered indispensable to the treatment of leukemia – it cures the disease 40 percent of the time. Without it, patients typically don’t survive.
“It’s a national tragedy, given there are 30,000 leukemia patients around the country who need the drug,” Dr. Hagop Kantarjian, chairman of the University of Texas M.D. Anderson Cancer Center’s department of leukemia, said. “It’s unconscionable that nobody’s been paying attention. I get calls every day from doctors in other cities who don’t have cytarabine to treat a patient.”
Kantarjian said that so far MD Anderson has not suffered a shortage of cytarabine. Smaller hospitals have been the most affected.
Though cancer medicines have been hit the hardest, the shortage cuts across all drug types, said Rosylne Schulman, the AHA’s director for policy development. They range from drugs that fight infections to those used to restart the heart in emergency rooms to anesthetics used in surgery to the popular blood-thinner heparin. She described many of the drugs – older drugs given by injection – as “life-saving.”
Supply and demand
Experts say there is no single cause of the shortage, but ultimately the problem is one of supply and demand. Factors include stepped-up FDA public safety enforcement, manufacturing difficulties, unexpected demand and a consolidation of the generic-drug industry that’s resulted in many of the drugs being made by only one or two companies.
Part of the problem is unpredictability. In a survey of health-care providers by the Institute for Safe Medicine Practices, more than 80 percent of respondents complained that they were given no advance notice of an impending drug shortage and little information thereafter about how long the drug was likely to be scarce.
The frustration has led to legislation in Congress this year that would require pharmaceutical companies to notify the FDA when they decide to limit or discontinue the production of drugs and penalize those that fail to comply.
Importing from Europe
But the law would do little to solve the problem, which the Institute for Safe Medicine Practices’ survey found has caused more than 1,000 adverse events, near misses and errors. The deaths came as a result of the misuse of a substitute for morphine and the resistance of infections to substitute drugs.
Texas Medical Center hospital pharmacists say they’ve managed the crisis by getting rare FDA exemptions to import drugs from Europe; moving medications between flagship and suburban facilities; waiting to treat some patients until stockpiling all the medication needed for the treatment; and determining which patients can be cured with a particular drug and which can be treated with alternative drugs.
“This is no question this is not the way we’d like to practice oncology,” said Dr. Karin Hahn, chief of oncology for the Harris County Hospital District. “But as long as this shortage continues, this is the world we’re living in.”