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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 06-07-2007

FDA: 'Black Box' for Avandia
USA Today, 6-7-07

Editor's Notes:

The Avandia saga continued this week with a heated Congressional hearing and the FDA issuing black box warnings for Avandia and a related drug Actos.

The FDA has set an advisory panel meeting for July 30 to discuss heart attack and other heart–related risks of Avandia and Actos, the other drug in its class. A third drug in the class, Rezulin, was banned in 2000 because of liver toxicity.

In his written testimony, von Eschenbach said the FDA has asked GlaxoSmithKline, maker of Avandia, and Takeda, maker of Actos, to strengthen its existing warnings about congestive heart failure. A black–box warning is the strongest type of warning. Both drugs have had warnings about the risk of heart failure for several years, but still, von Eschenbach said, "these drugs were being prescribed to patients with significant heart failure."

A senior FDA scientist had recommended a black-box warning on Avandia in February 2006, according to a letter to von Eschenbach from Sen. Chuck Grassley, R–Iowa. The letter does not identify the scientist, but Grassley spokeswoman Jill Kozeny confirmed that she is Rosemary Johann–Liang. Johann-Liang could not be reached for comment.

Grassley, whose office released the letter Wednesday, asked von Eschenbach to respond to allegations that Johann–Liang had been reprimanded for agreeing with her staff's recommendation that Avandia needed a black–box warning about congestive heart failure and stronger warnings about macular edema, a serious eye condition.

The FDA, which had received data from Glaxo last August suggesting a 30% increased risk of heart attacks in Avandia users, did not alert patients and doctors about that possibility until Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, reported a similar finding, posted May 21 on The New England Journal of Medicine's website.

Glaxo's and Nissen's studies pooled data from 42 clinical trials that, individually, were too small to tell whether Avandia raises heart attack risk. To answer that question definitively, Nissen said, Glaxo should have begun enrolling high-risk diabetes patients in a large, long-term study when Avandia was approved in 1999. By now, Nissen said, the results would be in.

The issue will be revisited again when an FDA advisory panel convenes in late July, but in the meantime we've already established the precedent of "regulation by publication".

The point of having the FDA is to have a single, clear standard for safety that applies to all stakeholders; ironically, as the industry becomes more transparent and discloses more clinical trial data, there will be much more second–guessing of the FDA's analysis and decisions, leading to less predictability and clarity for doctors, companies, and patients.

Thanks to growing Congressional pressure, the FDA is also likely to ask for many, many more routine postmarketing trial commitments and marketing restrictions on new medicines, driving up the cost of drug development and slowing down the uptake of new medicines.

This strategy will be sure to protect bureaucrats' reputations, but is unlikely to help patients who desperately need access to improved medicines.

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Deal for Smallpox Vaccine Could Jump-Start BioShield
Washington Post, 6-7-07

Editor's Notes:

The Washington Post reports that the federal Bioshield program is trying to salvage its reputation (and its program) with a new contract for a type of smallpox vaccine that should be safer for individuals with compromised immune systems.

The government has agreed to spend as much as $1.6 billion to buy millions of doses of a smallpox vaccine tailored for people with impaired immunity.

In a step toward getting the troubled Project BioShield program back on track, a Danish company, Bavarian Nordic, will begin delivering 20 million doses of the vaccine, enough for 10 million people, in 2008 under an initial contract worth $500 million. The deal could be extended to cover an additional 60 million doses as Bavarian completes clinical studies proving its safety for children, the elderly and people with HIV.

"We are on the road to having a countermeasure for smallpox" beyond the large vaccine stockpile that already exists for people with normal immunity, said Sen. Richard Burr (R-N.C.), who pushed legislation to revamp the BioShield program. "Smallpox is a top priority for the country in terms of threats."

The announcement, made Monday, followed several stumbles for the $5.6 billion BioShield program, one of President Bush's signature efforts to ensure the country's defense against terrorists. The program has been plagued by delays, scientific hurdles and management problems and has completed few of its goals, prompting sharp complaints from both parties on Capitol Hill.

Last year, the Department of Health and Human Services scuttled the largest BioShield contract, an $877.5 million deal with a small California firm, VaxGen, to develop an anthrax vaccine after the company missed a deadline to begin human testing. In March, the department withdrew plans to buy 100,000 doses of a radiation sickness treatment, saying none of the available drugs met requirements. Even the lengthy bidding process for the smallpox contract, started in 2005, has come to exemplify the program's problems.

In recent months, the department has moved to improve the program, issuing a plan outlining its priorities and taking initial steps toward contracting for a next-generation anthrax vaccine and a radiation sickness drug.

"We're applying all the lessons that we have learned in the... history of Project BioShield, the lessons from VaxGen," said Carol Linden, acting director of the Biomedical Advanced Research and Development Authority, the Health and Human Services unit that has assumed responsibility for BioShield.

Perhaps this means that the project has turned a corner, but we're skeptical.

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Researchers Detect Variations in DNA That Underlie Seven Common Diseases
The New York Times, 6-7-07

Editor's Notes:

The Times reports that researchers have uncovered two dozen genes linked to common ailments like diabetes and rheumatoid arthritis.

Applying a new genomic technique to a large group of patients, researchers in Britain have detected DNA variations that underlie seven common diseases, discovering unexpected links between them.

The variations pinpoint biological pathways underlying each of the diseases, and researchers hope that as the pathways are analyzed, new drugs and treatments will emerge.

The seven common diseases are bipolar disorder, coronary artery disease, Crohn's disease, hypertension, rheumatoid arthritis, and Type 1 and Type 2 diabetes. Unveiling the complex genetics of common diseases was the promised payoff of the $3 billion human genome project, completed in 2003, but progress was slow until the recent development of devices that in a single operation can read the DNA sequence at up to 500,000 points across an individual's genome. With the devices, called chips, researchers can compare large numbers of patients with healthy individuals, looking for points of differences in their genomes that may be associated with disease.

The approach is known as whole genome association, and studies on Type 2 diabetes, heart disease and breast cancer have been reported within the last few weeks. Those and the new study, which was financed by the Wellcome Trust of London, demonstrate the power and reliability of the whole genome association method, which stands in contrast to the many uncorroborated claims of disease genes made previously.

"It's now absolutely clear that this is a new dawn in the genetics of common human diseases," said Peter Donnelly, a statistical geneticist at Oxford University who was chairman of the consortium of 50 institutions involved in the Wellcome Trust study.

The consortium compared 2,000 patients with each disease from across Britain with 3,000 healthy individuals as controls, half of whom were born in a single week in 1958...

The consortium discovered some 24 variants strongly linked to disease, about half of which have been found already by other groups and half of which are new.

Among its most interesting findings is that genetic variants close to a gene known as PTPN2 are associated with both Crohn's disease and Type 1 diabetes. The link may be that both are autoimmune diseases and that the gene helps regulate the immune system. Researchers hope that analysis of the gene's operations may produce a treatment for the two diseases.

The consortium also found a genetic variant on chromosome 7 that carries a high risk of rheumatoid arthritis for women, but none for men. Very few such variants are known in diseases common to both sexes, Dr. Donnelly said.

Anne Bowcock, a geneticist at the Washington University School of Medicine in St. Louis, said the Wellcome Trust study was a "tour de force" that established how large–scale studies should be conducted.

[permanent link]

Drop in Cardiac Deaths Tied to Better Treatments, Lifestyles
Forbes, 6-7-07

Editor's Notes:

Researchers report that the mortality rate from heart disease fell in the U.S. by almost 50% during the last two decades of the 20th century, thanks to better medical treatments and improved health habits. The bad news: gains are being partially offset by increases in obesity and diabetes, which are powerful risk factors for heart disease.

The death rate from heart disease in the United States was cut nearly in half from 1980 to 2000, and that drop was largely due to better medical treatments and a reduction in cardiac risk factors, a new study found.

But, that good news was tempered with some caution, because obesity and diabetes are increasing dramatically, and cardiac complications as a result of those factors could offset the dramatic gains already made.

"This study helps to underscore the importance of risk factors themselves. In a culture where there has been a tendency to rely on miracle drugs and new surgical techniques, we found that as much as half of the decline in coronary heart disease was due to risk reduction," said one of the study's authors, Dr. Darwin Labarthe, director of the division for heart disease and stroke prevention at the U.S. Centers for Disease Control and Prevention in Atlanta.

"While this study shows our strategy is valid and working, we have a long way to go. Many will die immediately from a first heart attack and have no opportunity to benefit from the available treatments. We need to increase our investment in prevention efforts," said Labarthe, adding that prevention would likely be more cost effective than treatment. "You don't have to pay to treat a heart attack that doesn't occur," he said.

Direct and indirect costs of coronary heart disease totaled about $142.5 billion in the United States in 2006, according to the study, which is published in the June 7 issue of the New England Journal of Medicine.

Previous studies had already shown that cardiac deaths had decreased dramatically between 1980 and 2000. But the authors of the new study wanted to gain a better understanding of what factors brought about that reduction, so they could see what works and better allocate health–care resources.

They used a statistical model called IMPACT that incorporates risk factors, such as smoking, high blood pressure, high cholesterol, obesity, diabetes and exercise habits, as well as medical and surgical treatments used to treat heart disease.

How to empower further gains? Deregulate health care markets, and let insurers and physicians bring new products and services to consumers that focus on preventing and controlling chronic illness.

[permanent link]

Drug companies' patents are under attack. Will this really help the poor?
The Economist, 6-7-07

Editor's Notes:

The short answer here: probably not. This article points out that the international assault on drug patents is being led by middle-income countries like Brazil and Thailand that could easily afford to pay higher prices for medicines than the poorest nations in, say, Sub-Saharan Africa. Reading between the lines, Brazil and Thailand—abetted by NGOs who dislike patents on principle—are cynically trying to promote domestic drug manufacturing capacity at the expense of multinational firms.

A perverse result of this trend is that middle–income countries are getting cheaper drugs, whereas quieter and perhaps more deserving neighbors are not. Thailand's poor no doubt need treatment, but the military regime is wealthy enough to spend more on health care. Richard Epstein of the University of Chicago law school has observed that there is nothing to stop AIDS organisations or foreign governments from buying these products at a negotiated price and then giving them away free. "Charity can come from anywhere, not just drug companies," he notes.

Even experts devoted to the cause of helping the poor get access to drugs see the trend as worrying. "Brazil is not Rwanda, which cannot afford to pay," says Tadataka Yamada of the Gates Foundation, a giant charity. Victoria Hale, head of OneWorld Health, an innovative non-profit pharmaceutical firm, reckons that compulsory licensing could prove "the last blow" that pushes the drug industry away from looking for cures for diseases of the poor world, which are already woefully neglected.

Whether or not the poor end up suffering in the long run from diminished innovation, a sure winner from the trend towards compulsory licensing is the generic-drugs industry. Under a provision of the TRIPS treaty, countries that invoke compulsory licensing but lack domestic manufacturing are allowed to import generic drugs from another country.

This promises a gold rush for generics firms. Canada encourages domestic firms to produce copycat drugs for precisely this reason. But their costs are so high that such exports cannot hope to compete with the cheaper pills produced by India, argues Amir Attaran of the University of Ottawa. Small wonder that executives at Cipla, one of the Indian firms already making generic versions of HIV drugs, warmly applaud the trend and welcome Brazil's support for compulsory licensing, which they say "helps protect the rights of citizens".

Does the future therefore belong to compulsory licensing? If so, there may be trouble ahead for both pillmakers and punters. Dr Yamada fears that compulsory licensing could prove "lethal" for the industry. He suggests that drugs firms and middle-income countries ought instead to use a sliding scale, based on GDP per head, to determine prices. Bruce Lehman, a lawyer who worked on the TRIPS accord in the Clinton administration, thinks it is cynical for middle-income countries "to avoid paying their fair share of drug-discovery costs". In doing so, he fears, they risk provoking a backlash from Americans who will, in effect, have to pay more as a result.

Will this deter innovation? Only time will tell. Much of the pharmaceutical industry's revenues already come from the U.S. market, which still eschews price controls. Should Atlas shrug and follow the lead of its wealthy competitors in the EU and Canada and institute price controls, global pharmaceutical innovation will surely take a serious hit.

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