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A Bicycle Evangelist With the Wind Now at His Back
By CORNELIA DEAN, The New York Times, January 13, 2009
PORTLAND, Ore. — For years, Earl Blumenauer has been on a mission, and now his work is paying off. He can tell by the way some things are deteriorating around here.
“People are flying through stop signs on bikes,” Mr. Blumenauer said. “We are seeing in Portland bike congestion. You’ll see people biking across the river on a pedestrian bridge. They are just chock-a-block.”
Mr. Blumenauer, a passionate advocate of cycling as a remedy for everything from climate change to obesity, represents most of Portland in Congress, where he is the founder and proprietor of the 180 (plus or minus)-member Congressional Bicycle Caucus. Long regarded in some quarters as quixotic, the caucus has come into its own as hard times, climate concerns, gyrating gas prices and worries about fitness turn people away from their cars and toward their bikes.
“We have been flogging this bicycle thing for 20 years,” said Mr. Blumenauer, a Democrat. “All of a sudden it’s hot.”
But Mr. Blumenauer’s goals are larger than putting Americans on two wheels. He seeks to create what he calls a more sustainable society, including wiser use of energy, farming that improves the land rather than degrades it, an end to taxpayer subsidies for unwise development — and a transportation infrastructure that looks beyond the car.
For him, the global financial collapse is “perhaps the best opportunity we will ever see” to build environmental sustainability into the nation’s infrastructure, with urban streetcar systems, bike and pedestrian paths, more efficient energy transmission and conversion of the federal government’s 600,000-vehicle fleet to use alternate fuels.
“These are things that three years ago were unimaginable,” he said. “And if they were imaginable, we could not afford them. Well, now when all the experts agree that we will be lucky if we stabilize the economy in a couple of years, when there is great concern about the consequences of the collapse of the domestic auto producers, gee, these are things that are actually reasonable and affordable.”
All this might still be pie-in-the-sky were it not for one of Mr. Blumenauer’s fellow biking enthusiasts, Representative James L. Oberstar, a Minnesota Democrat, avid cyclist and chairman of the House Committee on Transportation and Infrastructure, which has jurisdiction over surface transportation.
“He’s been wonderful,” Mr. Oberstar said of his Oregon colleague. And as support for cycling grows, he said, builders, the highway construction lobby and others have stopped regarding biking as a “nuisance” and started thinking about how they can do business.
With an eye on the potential stimulus package, cycling advocates “have compiled a list of $2 billion of projects that can be under construction in 90 days,” Mr. Oberstar said, adding that prospects are “bright.”
In addition, after many attempts, this fall Mr. Blumenauer saw Congress approve his proposal to extend the tax breaks offered for employee parking to employers who encourage biking. The measure, which Mr. Blumenauer called a matter of “bicycle parity,” was part of a bailout bill.
Mr. Blumenauer has spent a lot of time on another issue that ordinarily draws little attention: the federally subsidized flood insurance program. The program serves people who own property along coasts and rivers who otherwise would pay enormous premiums for private flood insurance, if they could obtain it at all.
The insurance “subsidized people to live in places where nature repeatedly showed they weren’t wanted,” he said. They might be better off if they did not live there, he said, but “it’s un-American to say, ‘Get out.’ ” Politicians who should confront the problem “are betting Nimto, not in my term of office,” he said. They hope that disasters will spare their districts or, if they strike, that the government will come to the rescue, Mr. Blumenauer said.
A Portland native, Mr. Blumenauer, 60, has spent his adult life in elective office. He graduated from Lewis and Clark College in 1970 (after organizing an unsuccessful 1969 campaign to lower the state’s voting age to 18) and worked until 1977 as assistant to the president of Portland State University. In 1972, he won a seat in the Oregon House of Representatives. He moved to the Multnomah County Board of Commissioners in 1978, and from there, in 1986, he won election to the Portland City Council. Though he lost a mayoral election in 1992, he easily won election to the United States House in 1996 and has not faced serious opposition since.
Mr. Blumenauer entered Congress just after Newt Gingrich, the Republican speaker, killed a stopgap spending measure, shutting down much of the government, out of pique over his treatment on Air Force One. “Partisan tensions were very raw,” Mr. Blumenauer said. The bicycle caucus was “a way to bring people together.”
Sherwood Boehlert, a Republican and fellow bicyclist who represented upstate New York in Congress until 2007, agreed. When “partisanship was at an all-time high and tolerance of another point of view was at a longtime low,” he wore the bike caucus’s plastic bicycle lapel pin. “Bicycling unites people regardless of party affiliation,” he said.
In addition to bicycles, Mr. Blumenauer is particularly interested in public broadcasting and the plight of pollinators like honeybees. He is a founder of a “livable communities task force” whose goal, he said, is to educate members of Congress and their staffs on the benefits of transportation alternatives, open space, sustainability, vibrant downtowns, affordable housing and transparency in government.
Initially, he said, these interests marked him as “kind of left coast.” Not anymore. “They are becoming very mainstream,” said Adam B. Schiff, a Democrat who represents in Congress the area around Pasadena, Calif., and who, with Mr. Blumenauer’s bicycle advice, now regularly rides to work from his home in Maryland. “He has been way out in front of the Congress,” Mr. Schiff said. “Now the rest of us are trying to catch up.”
When Mr. Blumenauer is in his Portland district, he usually gets around by bike, cycling about 20 miles in a typical day. He has three bikes in Washington and five here, and he cycles in all weather, even in the unusual snow Portland has had recently. “In falling snow you can get some traction,” he said.
But the surge of bicycling in Portland has not been free of incident. The Oregonian newspaper and bloggers have reported on “bike rage,” drunken biking, hit-and-run bicycle accidents and other problems. Drivers complain about bikers who ignore traffic rules or hog narrow roads, phenomena some irritated motorists attribute to feelings of entitlement or moral superiority.
Mr. Blumenauer brushes off this criticism. “They are burning calories, not fossil fuel, they are taking up much less space, they are seeing the world at 10 miles per hour instead of 20 or 30,” he said. “And even though there are occasionally cranky or rude cyclists, they are no greater a percentage than cranky or rude motorists.”
Plus, he added, “they have really fought for their place on the asphalt.”
A Breakthrough in Imaging: Seeing a Virus in Three Dimensions
By JOHN MARKOFF, The New York Times, January 13, 2009
For the first time, researchers at an I.B.M. laboratory have captured a three-dimensional image of a virus.
The technique used by the I.B.M. scientists has some similarity to magnetic resonance imaging, or M.R.I., now routinely used by physicians to peer inside the human body. But the results were 100 million times better in terms of resolution with the new technique, magnetic resonance force microscopy, or M.R.F.M. The team of researchers, based at the computer maker’s Almaden Research Center in San Jose, Calif., reports in the The Proceedings of the National Academy of Sciences that they have captured a 3-D image of a tobacco mosaic virus with a spatial resolution down to four nanometers.
Techniques like atomic force and scanning tunneling microscopes have provided images of individual atoms. (An atom is about one-tenth of a nanometer in diameter). But these techniques are more destructive of biological samples because they send a stream of electrons at the target in order to get an image. And these microscopes cannot peer beneath the surface of the Lilliputian structures. The researchers said that many of their ideas had evolved from earlier work on atomic force microscopes. “The one thing that has always intrigued me, is, can we take the same idea and do it in three dimensions?” said Daniel Rugar, an I.B.M. physicist who helped design the first M.R.F. microscope in 1993. “We’d like to be able to take pictures of atomic structures like molecules. That’s been our motivation.”
The development of M.R.F.M. as a three-dimensional microscope actually began in 1991 with publication of a speculative paper by a theoretical physicist, John A. Sidles, who was then searching for new tools to help design drugs to combat the AIDS virus. After reading about atomic force microscope research at I.B.M., Dr. Sidles, who is a professor of orthopedics at the University of Washington School of Medicine, called Dr. Rugar and proposed a related tool that measured minute magnetic fields to construct images of biological structures.
“He realized that many of the diseases that they see are molecular-based,” Dr. Rugar said. In research in 2004, Dr. Rugar and others were able to make an image of a single electron with the new technique. The new achievement is the dimensionality of the image.
Magnetic resonance force microscopy employs an ultrasmall cantilever arm as a platform for specimens that are then moved in and out of proximity to a tiny magnet. At extremely low temperatures the researchers are able to measure the effect of a magnetic field on the protons in the hydrogen atoms found in the virus.
By repeatedly flipping the magnetic field, the researchers are able to cause a minute vibration in the cantilever arm which can then be measured by a laser beam. By moving the virus through the magnetic field it is possible to build up a 3-D image from many two-dimensional samples.
The researchers said they believed the tool would be of interest to structural biologists who are trying to unravel the structure and the interactions of proteins.
It would be particularly useful for biological samples that cannot be crystallized for X-ray analysis. Although the structure of DNA molecules has already been characterized by other means, it will be possible to use the system both to look at the components that make up the basic DNA structure as well as to make images of interactions among biomolecules, Dr. Rugar said.
In F.D.A. Files, Claims of Rush to Approve Devices
By GARDINER HARRIS, The New York Times, January 13, 2009
An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.
The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation.
Nine agency scientists complained in May to Andrew C. von Eschenbach, the F.D.A. commissioner, and the agency began an internal review. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one. Last week, the scientists wrote a similar letter to President-elect Barack Obama’s transition team.
Agency documents that are part of the internal investigation, including e-mail messages, were provided to The New York Times. Details of the investigations have not previously been made public.
The documents show that front-line agency scientists, like many outside critics of the agency, believe that F.D.A. managers have become too lenient with the industry. In medical reviews and e-mail messages, the scientists criticize the process by which many medical devices gain approval without extensive testing. And in e-mail correspondence, they contend that an agency supervisor improperly forced them to alter reviews of the breast imaging device and others.
William McConagha, the agency’s assistant commissioner for integrity and accountability, said he was continuing to investigate the scientists’ claims. Mr. McConagha said that Dr. von Eschenbach had offered to meet with the nine scientists before Friday, his last day in office.
“We in the Office of Commissioner are extremely concerned about allegations like this,” Mr. McConagha said.
In the documents, Representative Christopher Shays, a Connecticut Republican who lost re-election in November, is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that is supposed to help radiologists detect breast tumors.
The device, the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, is used with screening equipment made by Fujifilm Medical Systems.
Fujifilm Medical is based in Stamford, Conn., the heart of Mr. Shays’s former district. In the documents, Mr. Shays is referred to as “Congressman Fuji.”
“I am the Fuji congressman because I represented that district,” Mr. Shays said in an interview Friday.
Mr. Shays said he had called the agency supervisor only to demand that the agency make a final decision, not that it approve the product.
He scoffed at suggestions in the documents that his call led the supervisor to overrule scientists and approve the device. “That would be idiotic for someone to approve something they don’t think should be approved,” he said.
A spokeswoman for Fujifilm Medical, Courtney A. Kraemer, said the company had called its “local Congressional offices to ask them to help us get clarification on the F.D.A. process.”
The dissenting scientists protested, according to the internal documents, that “iCAD never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all F.D.A. submissions.”
An internal review said the risks of the iCAD device include missed cancers, “unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation.”
Ken Ferry, iCAD’s chief executive, said, “We have done all the appropriate testing to get the product approved.”
Mr. Ferry said that F.D.A. scientists were increasingly asking for more rigorous testing of devices, and that his company complied with those demands.
Diana Zuckerman, president of the National Research Center for Women and Families, said the Bush administration had “finally made the device approval process so meaningless that it’s intolerable to the scientists who work there.” Ms. Zucker, a longtime critic of the agency’s device approval process, particularly as it relates to breast implants, added, “Virtually everything gets approved, no matter what.”
The F.D.A. has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.
A growing chorus of critics contends that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had abbreviated reviews.
According to internal documents, some scientists in the agency’s device division seem to agree with these critics. One extensive memorandum argued that F.D.A. managers had encouraged agency reviewers to use the abbreviated process even to approve devices that are so complex or novel that extensive clinical trials should be required.
For instance, Shina Systems, an Israeli company, applied for approval for AngioCt, a device that combines CT images with X-rays to help guide cardiac surgeons during angioplasty and stenting procedures. The company sought an abbreviated review, according to the documents.
An F.D.A. reviewer said the company should conduct a clinical trial to prove that the device works since it is novel and risky.
“Should the images be misleading,” Dr. Brian Lewis, an agency cardiologist, wrote in a memorandum, “F.D.A. could expect immediate misguidance of catheters and possibly puncture of coronary vessels or overaggressive, inappropriate or inadequate stent or balloon use.”
Nonetheless, an F.D.A. supervisor — after meeting with Shina representatives — pressed scientists to consider allowing an abbreviated review, according to the documents. The agency’s decision on the device is pending, according to the documents.
Dr. John Smith, a lawyer for Shina, wrote in an e-mail message that he would not comment on “ongoing regulatory matters.”
By CORNELIA DEAN, The New York Times, January 13, 2009
PORTLAND, Ore. — For years, Earl Blumenauer has been on a mission, and now his work is paying off. He can tell by the way some things are deteriorating around here.
“People are flying through stop signs on bikes,” Mr. Blumenauer said. “We are seeing in Portland bike congestion. You’ll see people biking across the river on a pedestrian bridge. They are just chock-a-block.”
Mr. Blumenauer, a passionate advocate of cycling as a remedy for everything from climate change to obesity, represents most of Portland in Congress, where he is the founder and proprietor of the 180 (plus or minus)-member Congressional Bicycle Caucus. Long regarded in some quarters as quixotic, the caucus has come into its own as hard times, climate concerns, gyrating gas prices and worries about fitness turn people away from their cars and toward their bikes.
“We have been flogging this bicycle thing for 20 years,” said Mr. Blumenauer, a Democrat. “All of a sudden it’s hot.”
But Mr. Blumenauer’s goals are larger than putting Americans on two wheels. He seeks to create what he calls a more sustainable society, including wiser use of energy, farming that improves the land rather than degrades it, an end to taxpayer subsidies for unwise development — and a transportation infrastructure that looks beyond the car.
For him, the global financial collapse is “perhaps the best opportunity we will ever see” to build environmental sustainability into the nation’s infrastructure, with urban streetcar systems, bike and pedestrian paths, more efficient energy transmission and conversion of the federal government’s 600,000-vehicle fleet to use alternate fuels.
“These are things that three years ago were unimaginable,” he said. “And if they were imaginable, we could not afford them. Well, now when all the experts agree that we will be lucky if we stabilize the economy in a couple of years, when there is great concern about the consequences of the collapse of the domestic auto producers, gee, these are things that are actually reasonable and affordable.”
All this might still be pie-in-the-sky were it not for one of Mr. Blumenauer’s fellow biking enthusiasts, Representative James L. Oberstar, a Minnesota Democrat, avid cyclist and chairman of the House Committee on Transportation and Infrastructure, which has jurisdiction over surface transportation.
“He’s been wonderful,” Mr. Oberstar said of his Oregon colleague. And as support for cycling grows, he said, builders, the highway construction lobby and others have stopped regarding biking as a “nuisance” and started thinking about how they can do business.
With an eye on the potential stimulus package, cycling advocates “have compiled a list of $2 billion of projects that can be under construction in 90 days,” Mr. Oberstar said, adding that prospects are “bright.”
In addition, after many attempts, this fall Mr. Blumenauer saw Congress approve his proposal to extend the tax breaks offered for employee parking to employers who encourage biking. The measure, which Mr. Blumenauer called a matter of “bicycle parity,” was part of a bailout bill.
Mr. Blumenauer has spent a lot of time on another issue that ordinarily draws little attention: the federally subsidized flood insurance program. The program serves people who own property along coasts and rivers who otherwise would pay enormous premiums for private flood insurance, if they could obtain it at all.
The insurance “subsidized people to live in places where nature repeatedly showed they weren’t wanted,” he said. They might be better off if they did not live there, he said, but “it’s un-American to say, ‘Get out.’ ” Politicians who should confront the problem “are betting Nimto, not in my term of office,” he said. They hope that disasters will spare their districts or, if they strike, that the government will come to the rescue, Mr. Blumenauer said.
A Portland native, Mr. Blumenauer, 60, has spent his adult life in elective office. He graduated from Lewis and Clark College in 1970 (after organizing an unsuccessful 1969 campaign to lower the state’s voting age to 18) and worked until 1977 as assistant to the president of Portland State University. In 1972, he won a seat in the Oregon House of Representatives. He moved to the Multnomah County Board of Commissioners in 1978, and from there, in 1986, he won election to the Portland City Council. Though he lost a mayoral election in 1992, he easily won election to the United States House in 1996 and has not faced serious opposition since.
Mr. Blumenauer entered Congress just after Newt Gingrich, the Republican speaker, killed a stopgap spending measure, shutting down much of the government, out of pique over his treatment on Air Force One. “Partisan tensions were very raw,” Mr. Blumenauer said. The bicycle caucus was “a way to bring people together.”
Sherwood Boehlert, a Republican and fellow bicyclist who represented upstate New York in Congress until 2007, agreed. When “partisanship was at an all-time high and tolerance of another point of view was at a longtime low,” he wore the bike caucus’s plastic bicycle lapel pin. “Bicycling unites people regardless of party affiliation,” he said.
In addition to bicycles, Mr. Blumenauer is particularly interested in public broadcasting and the plight of pollinators like honeybees. He is a founder of a “livable communities task force” whose goal, he said, is to educate members of Congress and their staffs on the benefits of transportation alternatives, open space, sustainability, vibrant downtowns, affordable housing and transparency in government.
Initially, he said, these interests marked him as “kind of left coast.” Not anymore. “They are becoming very mainstream,” said Adam B. Schiff, a Democrat who represents in Congress the area around Pasadena, Calif., and who, with Mr. Blumenauer’s bicycle advice, now regularly rides to work from his home in Maryland. “He has been way out in front of the Congress,” Mr. Schiff said. “Now the rest of us are trying to catch up.”
When Mr. Blumenauer is in his Portland district, he usually gets around by bike, cycling about 20 miles in a typical day. He has three bikes in Washington and five here, and he cycles in all weather, even in the unusual snow Portland has had recently. “In falling snow you can get some traction,” he said.
But the surge of bicycling in Portland has not been free of incident. The Oregonian newspaper and bloggers have reported on “bike rage,” drunken biking, hit-and-run bicycle accidents and other problems. Drivers complain about bikers who ignore traffic rules or hog narrow roads, phenomena some irritated motorists attribute to feelings of entitlement or moral superiority.
Mr. Blumenauer brushes off this criticism. “They are burning calories, not fossil fuel, they are taking up much less space, they are seeing the world at 10 miles per hour instead of 20 or 30,” he said. “And even though there are occasionally cranky or rude cyclists, they are no greater a percentage than cranky or rude motorists.”
Plus, he added, “they have really fought for their place on the asphalt.”
A Breakthrough in Imaging: Seeing a Virus in Three Dimensions
By JOHN MARKOFF, The New York Times, January 13, 2009
For the first time, researchers at an I.B.M. laboratory have captured a three-dimensional image of a virus.
The technique used by the I.B.M. scientists has some similarity to magnetic resonance imaging, or M.R.I., now routinely used by physicians to peer inside the human body. But the results were 100 million times better in terms of resolution with the new technique, magnetic resonance force microscopy, or M.R.F.M. The team of researchers, based at the computer maker’s Almaden Research Center in San Jose, Calif., reports in the The Proceedings of the National Academy of Sciences that they have captured a 3-D image of a tobacco mosaic virus with a spatial resolution down to four nanometers.
Techniques like atomic force and scanning tunneling microscopes have provided images of individual atoms. (An atom is about one-tenth of a nanometer in diameter). But these techniques are more destructive of biological samples because they send a stream of electrons at the target in order to get an image. And these microscopes cannot peer beneath the surface of the Lilliputian structures. The researchers said that many of their ideas had evolved from earlier work on atomic force microscopes. “The one thing that has always intrigued me, is, can we take the same idea and do it in three dimensions?” said Daniel Rugar, an I.B.M. physicist who helped design the first M.R.F. microscope in 1993. “We’d like to be able to take pictures of atomic structures like molecules. That’s been our motivation.”
The development of M.R.F.M. as a three-dimensional microscope actually began in 1991 with publication of a speculative paper by a theoretical physicist, John A. Sidles, who was then searching for new tools to help design drugs to combat the AIDS virus. After reading about atomic force microscope research at I.B.M., Dr. Sidles, who is a professor of orthopedics at the University of Washington School of Medicine, called Dr. Rugar and proposed a related tool that measured minute magnetic fields to construct images of biological structures.
“He realized that many of the diseases that they see are molecular-based,” Dr. Rugar said. In research in 2004, Dr. Rugar and others were able to make an image of a single electron with the new technique. The new achievement is the dimensionality of the image.
Magnetic resonance force microscopy employs an ultrasmall cantilever arm as a platform for specimens that are then moved in and out of proximity to a tiny magnet. At extremely low temperatures the researchers are able to measure the effect of a magnetic field on the protons in the hydrogen atoms found in the virus.
By repeatedly flipping the magnetic field, the researchers are able to cause a minute vibration in the cantilever arm which can then be measured by a laser beam. By moving the virus through the magnetic field it is possible to build up a 3-D image from many two-dimensional samples.
The researchers said they believed the tool would be of interest to structural biologists who are trying to unravel the structure and the interactions of proteins.
It would be particularly useful for biological samples that cannot be crystallized for X-ray analysis. Although the structure of DNA molecules has already been characterized by other means, it will be possible to use the system both to look at the components that make up the basic DNA structure as well as to make images of interactions among biomolecules, Dr. Rugar said.
In F.D.A. Files, Claims of Rush to Approve Devices
By GARDINER HARRIS, The New York Times, January 13, 2009
An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.
The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation.
Nine agency scientists complained in May to Andrew C. von Eschenbach, the F.D.A. commissioner, and the agency began an internal review. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one. Last week, the scientists wrote a similar letter to President-elect Barack Obama’s transition team.
Agency documents that are part of the internal investigation, including e-mail messages, were provided to The New York Times. Details of the investigations have not previously been made public.
The documents show that front-line agency scientists, like many outside critics of the agency, believe that F.D.A. managers have become too lenient with the industry. In medical reviews and e-mail messages, the scientists criticize the process by which many medical devices gain approval without extensive testing. And in e-mail correspondence, they contend that an agency supervisor improperly forced them to alter reviews of the breast imaging device and others.
William McConagha, the agency’s assistant commissioner for integrity and accountability, said he was continuing to investigate the scientists’ claims. Mr. McConagha said that Dr. von Eschenbach had offered to meet with the nine scientists before Friday, his last day in office.
“We in the Office of Commissioner are extremely concerned about allegations like this,” Mr. McConagha said.
In the documents, Representative Christopher Shays, a Connecticut Republican who lost re-election in November, is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that is supposed to help radiologists detect breast tumors.
The device, the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, is used with screening equipment made by Fujifilm Medical Systems.
Fujifilm Medical is based in Stamford, Conn., the heart of Mr. Shays’s former district. In the documents, Mr. Shays is referred to as “Congressman Fuji.”
“I am the Fuji congressman because I represented that district,” Mr. Shays said in an interview Friday.
Mr. Shays said he had called the agency supervisor only to demand that the agency make a final decision, not that it approve the product.
He scoffed at suggestions in the documents that his call led the supervisor to overrule scientists and approve the device. “That would be idiotic for someone to approve something they don’t think should be approved,” he said.
A spokeswoman for Fujifilm Medical, Courtney A. Kraemer, said the company had called its “local Congressional offices to ask them to help us get clarification on the F.D.A. process.”
The dissenting scientists protested, according to the internal documents, that “iCAD never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all F.D.A. submissions.”
An internal review said the risks of the iCAD device include missed cancers, “unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation.”
Ken Ferry, iCAD’s chief executive, said, “We have done all the appropriate testing to get the product approved.”
Mr. Ferry said that F.D.A. scientists were increasingly asking for more rigorous testing of devices, and that his company complied with those demands.
Diana Zuckerman, president of the National Research Center for Women and Families, said the Bush administration had “finally made the device approval process so meaningless that it’s intolerable to the scientists who work there.” Ms. Zucker, a longtime critic of the agency’s device approval process, particularly as it relates to breast implants, added, “Virtually everything gets approved, no matter what.”
The F.D.A. has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.
A growing chorus of critics contends that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had abbreviated reviews.
According to internal documents, some scientists in the agency’s device division seem to agree with these critics. One extensive memorandum argued that F.D.A. managers had encouraged agency reviewers to use the abbreviated process even to approve devices that are so complex or novel that extensive clinical trials should be required.
For instance, Shina Systems, an Israeli company, applied for approval for AngioCt, a device that combines CT images with X-rays to help guide cardiac surgeons during angioplasty and stenting procedures. The company sought an abbreviated review, according to the documents.
An F.D.A. reviewer said the company should conduct a clinical trial to prove that the device works since it is novel and risky.
“Should the images be misleading,” Dr. Brian Lewis, an agency cardiologist, wrote in a memorandum, “F.D.A. could expect immediate misguidance of catheters and possibly puncture of coronary vessels or overaggressive, inappropriate or inadequate stent or balloon use.”
Nonetheless, an F.D.A. supervisor — after meeting with Shina representatives — pressed scientists to consider allowing an abbreviated review, according to the documents. The agency’s decision on the device is pending, according to the documents.
Dr. John Smith, a lawyer for Shina, wrote in an e-mail message that he would not comment on “ongoing regulatory matters.”
