Power morcellation ban unlikely, but other FDA restrictions coming soon
The doc spearheading the antimorcellation campaign says FDA is divided, as are gynecologists
Showing posts with label Food and Drug Administration (FDA). Show all posts
Showing posts with label Food and Drug Administration (FDA). Show all posts
Sunday, November 9, 2014
Power morcellation ban unlikely, but other FDA restrictions coming soon
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| Johnson & Johnson's Ethicon division's power morcellation device, which has been recalled since the controversy errupted--Courtesy of Johnson & Johnson |
Cardiac surgeon Hooman Noorchashm and wife, Amy Reed, an anesthesiologist, have led the charge against the controversial surgical technique performed using the drill-like power morcellator. Power morcellation can upstage preexisting uterine cancers like uterine sarcoma to fatal levels.
Noorchashm and Reed have sparked public outcry, an FDA safety notice and a recall of power morcellators by former market leader Johnson & Johnson ($JNJ) via efforts like a petition on Change.org. Now they are aiming to take the campaign to its logical conclusion by securing an FDA ban of the device. That does not appear likely, according to information Noorchashm has received from a source within the FDA, who he wouldn't name during an interview.
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"The imminent plan that the CDRH has is to sugarcoat this thing using a probationary mechanism. That would deflect any sort of criticism away from 510(k). It would deflect public criticism of anyone who says FDA didn't do anything. CDRH can comes out and says, 'Well we did something. We put out an FDA advisory and we put the device under probation.' That basically will give industry a chance to recover from an absolute medical atrocity," he said.
It is unclear what a probation would entail. During the FDA's public hearing on power morcellation, the agency discussed solutions such as enhanced informed consent requirements, the use of a surgical bag during morcellation and the need for improved testing of uterine sarcoma prior to surgery. A ban of power morcellators was also on the table, although agency officials didn't seem too intent on that option.
Central to the debate is the prevalence ratio of uterine sarcoma prior to power morcellation. The FDA estimates that the ratio is one women in 350.
A well-publicized paper in the Journal of the American Medical Association estimated that the rate of uterine cancer in women who underwent morcellation was one in 370. However, uterine sarcoma is a rare subset of uterine cancer that is more difficult to detect prior to surgery than other cancers of the uterus. Uterine sarcoma specifically is the main cause of concern among the FDA and other public health experts.
The paper's author, Dr. Jason Wright of the Columbia University College of Physicians and Surgeons, said in an email to FierceMedicalDevices that he is unable to separate sarcomas or other subtypes of uterine cancer based on the insurance database. But he added, "I would assume that most cancers (in the sample) were not known preoperatively in women who underwent morcellation."
"Physicians who are defending this are saying the incidence (of uterine sarcoma in women undergoing morcellation) is one in 7,500," Noorchashm said, referring to research by obstetrician-gynecologist Elizabeth Pritts of the Wisconsin Fertility Institute.
Pritts spoke at the FDA public hearing and believes the agency is wildly overestimating the prevalence of uterine sarcoma because the agency used confirmation bias in its literature review used to arrive at its estimate of one in 350 women.
To add to the complexity, most experts assume that power morcellation poses a great chance of upstaging preexisting uterine sarcoma to fatal levels because it shreds and spreads the cancerous tissue to new parts of the body. However, in October Pritts and medical colleagues published a paper in the Journal of Minimally Invasive Gynecology concluding "there is no reliable evidence that morcellation (power or otherwise) significantly results in tumor upstaging."
"The new data by Dr. Pritts et al reveal that there is no proof that uterine morcellation upstages cancer. This is a critical discovery and changes the framework for discussion of how to care for the 31 million women with symptomatic fibroids," said gynecologic surgeon Antonio Pizarro in Shreveport, LA in an email. "Dr. Wright has issued a report of lapses in preoperative diagnosis for women with detectable cancers, not a report on sarcoma on women with fibroids."
Other members of the field favor strict action against power morcellators. "What you do about it is: you stop," said Robert Graebe, chairman and program director of the Department of Obstetrics and Gynecology at NJ-based Monmouth Medical Center in a prior article in The Wall Street Journal, adding "it's not worth playing Russian roulette with the patient."
So far the FDA has only banned one device. In 1983 it outlawed prosthetic hair fibers.
"The FDA is considering a great deal of information, including the panel's input, all comments from the public docket, and all relevant available data, in determining any future regulatory action. If the FDA decides to take further action, we will issue communication to inform manufacturers and the public, including notice in the Federal Register," said an FDA spokeswoman in an email to FierceMedicalDevices.
Meanwhile, the Democrat & Chronicle reports that a third Rochester, NY, woman has recently died of an undetected cancer two years after undergoing power morcellation.
- here is the email
- here's the article in the Democrat & Chronicle
- here's Dr. Pritt's paper abstract
Related Articles:
Physicians defend power morcellator devices amid industry fallout
Johnson & Johnson pulls power morcellator devices amid industry and regulatory backlash
Upcoming study to dispute FDA's data on power morcellation risk
FDA panel recommends stronger labeling, limiting use of power morcellation--agency may go further
Power morcellator fallout continues after FDA advisory warning
Tuesday, October 28, 2014
The medical establishment values profits over patient lives, as seen in Morcellation procrastination
After
George Leuzzi pays final respects to his wife on Tuesday at her
funeral, he will turn his attention to caring for their young daughter
and bringing an end to a procedure that claimed 44-year-old Brenda.
"Now that she's passed I will do my part to carry on what she started," he said. "I will help as much as I can to get this removed."
Brenda Leuzzi died 25 months after fibroid surgery through minimally invasive procedure that involved power morcellation. At the time, no one knew the fibroids, thought to be innocent growths, were cancerous. There is no definitive pre-surgery test to determine whether fibroids are benign. Power morcellation shreds tissue so that it can be removed through small incisions of minimally invasive surgery. In so doing, it can send bits of cancer to other parts of the abdomen, where they can "seed."
A grassroots effort to end power morcellation has been going on for just about a year, since the problem was brought to light by a physician whose wife had an undetected cancer worsened by the procedure.
The Food and Drug Administration has issued advisories against the procedure and the leading manufacturer, Johnson & Johnson, has asked providers to return the devices. But other manufacturers have them on the market. The FDA held hearings in July about the safety of the procedure.
The same day that George Leuzzi buried his wife, Morgan Liscinsky of the FDA press office answered a request for an update with, "I have no new information to share since you contacted me last month."
Sens. Chuck Schumer and Kirsten Gillibrand wrote in August to FDA Commissioner Margaret Hamburg. That letter was on behalf of Jim Leary of Greece, whose wife, Barbara, died last year after having undergone a procedure that involved morcellation.
Asked what the senators are doing to step up pressure, Gillibrand spokesman Jacob Fromer responded: "It is deeply frustrating to the Senator that while the FDA discourages the use of these very devices they won't take the necessary action to ban them. She will continue to communicate her concerns to the commissioner. Kirsten's thoughts and prayers are with the Leuzzi family, particularly their young daughter, Peyton."
Schumer spokesman Max Dworin said the office "followed up with the FDA (Monday), urging them again to call on manufacturers to voluntarily recall these devices, and we will continue to push."
Schumer's statement Monday read, ""The passing of Brenda Leuzzi is tragic and further underscores the urgency for all firms to voluntarily recall these devices until more thorough testing can be done. The FDA should act before another family has to experience what the Leuzzi family is going through right now. My thoughts and prayers go out to the entire Leuzzi family."
George Leuzzi is more adamant than Schumer. "I'm very disappointed in the FDA. They should have banned this by now. They're just stalling and finding some other way to convince themselves it's OK. If anybody saw Brenda and the way she died, it's pretty far from OK. I wouldn't wish it on my worst enemy."
George Leuzzi said he's received an uncountable number of texts and emails since he posted on a leiomyosarcoma Facebook page news of Brenda's death.
"Cancer is the enemy, but any procedure that would enhance it and make it worse and put someone in a position to have no way of rebounding from it is criminal," he said.
As it was during Brenda's illness, her husband's focus is on his wife.
"I want her to be remembered. I don't want her to be forgotten, especially because what she died for was completely unnecessary."
"Now that she's passed I will do my part to carry on what she started," he said. "I will help as much as I can to get this removed."
Brenda Leuzzi died 25 months after fibroid surgery through minimally invasive procedure that involved power morcellation. At the time, no one knew the fibroids, thought to be innocent growths, were cancerous. There is no definitive pre-surgery test to determine whether fibroids are benign. Power morcellation shreds tissue so that it can be removed through small incisions of minimally invasive surgery. In so doing, it can send bits of cancer to other parts of the abdomen, where they can "seed."
A grassroots effort to end power morcellation has been going on for just about a year, since the problem was brought to light by a physician whose wife had an undetected cancer worsened by the procedure.
The Food and Drug Administration has issued advisories against the procedure and the leading manufacturer, Johnson & Johnson, has asked providers to return the devices. But other manufacturers have them on the market. The FDA held hearings in July about the safety of the procedure.
The same day that George Leuzzi buried his wife, Morgan Liscinsky of the FDA press office answered a request for an update with, "I have no new information to share since you contacted me last month."
Sens. Chuck Schumer and Kirsten Gillibrand wrote in August to FDA Commissioner Margaret Hamburg. That letter was on behalf of Jim Leary of Greece, whose wife, Barbara, died last year after having undergone a procedure that involved morcellation.
Asked what the senators are doing to step up pressure, Gillibrand spokesman Jacob Fromer responded: "It is deeply frustrating to the Senator that while the FDA discourages the use of these very devices they won't take the necessary action to ban them. She will continue to communicate her concerns to the commissioner. Kirsten's thoughts and prayers are with the Leuzzi family, particularly their young daughter, Peyton."
Schumer spokesman Max Dworin said the office "followed up with the FDA (Monday), urging them again to call on manufacturers to voluntarily recall these devices, and we will continue to push."
Schumer's statement Monday read, ""The passing of Brenda Leuzzi is tragic and further underscores the urgency for all firms to voluntarily recall these devices until more thorough testing can be done. The FDA should act before another family has to experience what the Leuzzi family is going through right now. My thoughts and prayers go out to the entire Leuzzi family."
George Leuzzi is more adamant than Schumer. "I'm very disappointed in the FDA. They should have banned this by now. They're just stalling and finding some other way to convince themselves it's OK. If anybody saw Brenda and the way she died, it's pretty far from OK. I wouldn't wish it on my worst enemy."
George Leuzzi said he's received an uncountable number of texts and emails since he posted on a leiomyosarcoma Facebook page news of Brenda's death.
"Cancer is the enemy, but any procedure that would enhance it and make it worse and put someone in a position to have no way of rebounding from it is criminal," he said.
As it was during Brenda's illness, her husband's focus is on his wife.
"I want her to be remembered. I don't want her to be forgotten, especially because what she died for was completely unnecessary."
Sunday, August 12, 2012
Did the FDA go rogue to protect X-ray equipment sales? FDA created enemies list and spied on scientists
In Vast Effort, F.D.A. Spied on E-Mails of Its Own Scientists
By ERIC LICHTBLAU and SCOTT SHANE
July 14, 2012
A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show.
A list names three of the 21 people said to be collaborating in criticism of the F.D.A., including employees and outside contacts.
A memo reports that monitoring software had been placed on the laptop of an agency medical officer.
What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort.
Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.
F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.
While they acknowledged that the surveillance tracked the communications that the scientists had with Congressional officials, journalists and others, they said it was never intended to impede those communications, but only to determine whether information was being improperly shared.
The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show.
The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.
By ERIC LICHTBLAU and SCOTT SHANE
July 14, 2012
A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show.
A list names three of the 21 people said to be collaborating in criticism of the F.D.A., including employees and outside contacts.
A memo reports that monitoring software had been placed on the laptop of an agency medical officer.
What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort.
Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.
F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.
While they acknowledged that the surveillance tracked the communications that the scientists had with Congressional officials, journalists and others, they said it was never intended to impede those communications, but only to determine whether information was being improperly shared.
The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show.
The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.
This San Diego doctor accepts checks from drug company representatives
I had an interesting experience on July 24, 2012 when I drove a friend to the doctor.
The receptionist said the doctor doesn't accept checks, so my friend paid with a credit card.
Then I saw one of those drug company representatives walk through the door. If you don't know what I mean, then you might have a particularly ethical doctor. The representatives are young and good-looking. This one was a man in a suit with the posture as straight as a marine's. He strode in pulling his black case on wheels, and was immediately ushered inside.
In my experience, the representatives are more often very attractive young women.
As I was leaving, I noticed a check lying on the receptionist's desk. I saw it was for $30.00. Apparently the doctor does accept checks--from drug representatives. I assume he was being paid to listen to the agent.
The receptionist saw me looking at the check, and she grabbed it quickly, then she couldn't seem to think of any good place to hide it, so she set it back down.
Years ago I had a neighbor who was prescribed an off-label drug (meaning used for a condition for which it was not approved by the FDA) she didn't need. That doctor's office was crawling with representatives almost all the time. Both the drug company and the doctor got in trouble with the law.
I wonder if my friend's doctor will prescribe unnecessary drugs after his discussion with the drug company agent.
The receptionist said the doctor doesn't accept checks, so my friend paid with a credit card.
Then I saw one of those drug company representatives walk through the door. If you don't know what I mean, then you might have a particularly ethical doctor. The representatives are young and good-looking. This one was a man in a suit with the posture as straight as a marine's. He strode in pulling his black case on wheels, and was immediately ushered inside.
In my experience, the representatives are more often very attractive young women.
As I was leaving, I noticed a check lying on the receptionist's desk. I saw it was for $30.00. Apparently the doctor does accept checks--from drug representatives. I assume he was being paid to listen to the agent.
The receptionist saw me looking at the check, and she grabbed it quickly, then she couldn't seem to think of any good place to hide it, so she set it back down.
Years ago I had a neighbor who was prescribed an off-label drug (meaning used for a condition for which it was not approved by the FDA) she didn't need. That doctor's office was crawling with representatives almost all the time. Both the drug company and the doctor got in trouble with the law.
I wonder if my friend's doctor will prescribe unnecessary drugs after his discussion with the drug company agent.
Monday, February 8, 2010
Monsanto: The evil corporation in your refrigerator
Monsanto: The evil corporation in your refrigerator
Bob Cesca
Wallet Pop
Feb 4th 2010
When we consider the rogue's gallery of devilish, over-sized, greedy and disproportionately powerful corporations, we generally come up with outfits like Microsoft, Bechtel, AIG, Halliburton, Goldman-Sachs, Exxon-Mobil and the United States Senate.
Yet somehow, Monsanto, arguably the most devilish, over-sized, greedy and disproportionately powerful corporation in the world has been able to more or less skulk between the raindrops -- only a household name in households where documentaries like Food Inc. are regarded as light Friday evening entertainment.
...But for the most part, if you were to ask an average American for their list of sinister corporations, Monsanto probably wouldn't make the cut.
It should.
Founded by Missouri pharmacist John Francis Queeny in 1901, Monsanto is literally everywhere. Just about every non-organic food product available to consumers has some sort of connection with Monsanto.
Anyone who can read a label knows that corn, soy and cotton can be found in just about every American food product. Upwards of 90% of all corn, soybeans and cotton are grown from genetically engineered seeds, also known as genetically modified organisms (GMOs). These genetically enhanced products appear in around 70% of all American processed food products. And Monsanto controls 90% of all genetically engineered seeds. In other words, Monsanto controls -- and owns patents on -- most of the American food supply.
When you consider, as Walletpop originally reported, that one-in-four food labels is inaccurate, that the F.D.A.'s testing is weak at best, then how can we trust one corporation to have so much control over our produce? The answer is, we can't.
Recently, a study by the International Journal of Biological Sciences revealed that Monsanto's Mon 863, Mon 810, and Roundup herbicide-absorbing NK 603 in corn caused kidney and liver damage in laboratory rats.
Scientists also discovered damage to the heart, spleen, adrenal glands and even the blood of rats that consumed the mutant corn...
MORE ON FOOD CORRUPTION:
Tomato bribery probe just the beginning, prosecutors say
By P.J. Huffstutter
LA Times
February 8, 2010
Amid concerns about corrupt practices in the food industry, nine people have pleaded guilty to charges including racketeering, money laundering and bid-rigging in a federal probe of SK Foods.
To his friends, Randall Lee Rahal was just a food salesman, someone who routinely left his home on Shadyside Road in Ramsey, N.J., to crisscross the country hawking California tomatoes.
The 61-year-old sold them pureed. He sold them crushed. He sold them roasted and mashed into paste. His clients were food manufacturers, supermarket chains and other commercial buyers who turned his products into soup, ketchup and salsa.
But in the eyes of the Justice Department, Rahal was Tomato Enemy No. 1 -- a produce scofflaw who allegedly peeled off $100 bills and carried cash-stuffed envelopes to bribe buyers from leading food companies in a decade-long racketeering scheme that may have led to higher prices for consumers at the grocery store.
In a series of court filings starting in 2008, federal prosecutors in Sacramento allege that Rahal, nine others and SK Foods of Monterey, Calif., used more than $330,000 in bribes from 1998 to 2008 to subvert competition and nail down deals to sell the company's tomato paste, peppers and other products to Kraft Foods Inc., Safeway Inc., Frito-Lay North America and B&G Foods, among others...
Bob Cesca
Wallet Pop
Feb 4th 2010
When we consider the rogue's gallery of devilish, over-sized, greedy and disproportionately powerful corporations, we generally come up with outfits like Microsoft, Bechtel, AIG, Halliburton, Goldman-Sachs, Exxon-Mobil and the United States Senate.
Yet somehow, Monsanto, arguably the most devilish, over-sized, greedy and disproportionately powerful corporation in the world has been able to more or less skulk between the raindrops -- only a household name in households where documentaries like Food Inc. are regarded as light Friday evening entertainment.
...But for the most part, if you were to ask an average American for their list of sinister corporations, Monsanto probably wouldn't make the cut.
It should.
Founded by Missouri pharmacist John Francis Queeny in 1901, Monsanto is literally everywhere. Just about every non-organic food product available to consumers has some sort of connection with Monsanto.
Anyone who can read a label knows that corn, soy and cotton can be found in just about every American food product. Upwards of 90% of all corn, soybeans and cotton are grown from genetically engineered seeds, also known as genetically modified organisms (GMOs). These genetically enhanced products appear in around 70% of all American processed food products. And Monsanto controls 90% of all genetically engineered seeds. In other words, Monsanto controls -- and owns patents on -- most of the American food supply.
When you consider, as Walletpop originally reported, that one-in-four food labels is inaccurate, that the F.D.A.'s testing is weak at best, then how can we trust one corporation to have so much control over our produce? The answer is, we can't.
Recently, a study by the International Journal of Biological Sciences revealed that Monsanto's Mon 863, Mon 810, and Roundup herbicide-absorbing NK 603 in corn caused kidney and liver damage in laboratory rats.
Scientists also discovered damage to the heart, spleen, adrenal glands and even the blood of rats that consumed the mutant corn...
MORE ON FOOD CORRUPTION:
Tomato bribery probe just the beginning, prosecutors say
By P.J. Huffstutter
LA Times
February 8, 2010
Amid concerns about corrupt practices in the food industry, nine people have pleaded guilty to charges including racketeering, money laundering and bid-rigging in a federal probe of SK Foods.
To his friends, Randall Lee Rahal was just a food salesman, someone who routinely left his home on Shadyside Road in Ramsey, N.J., to crisscross the country hawking California tomatoes.
The 61-year-old sold them pureed. He sold them crushed. He sold them roasted and mashed into paste. His clients were food manufacturers, supermarket chains and other commercial buyers who turned his products into soup, ketchup and salsa.
But in the eyes of the Justice Department, Rahal was Tomato Enemy No. 1 -- a produce scofflaw who allegedly peeled off $100 bills and carried cash-stuffed envelopes to bribe buyers from leading food companies in a decade-long racketeering scheme that may have led to higher prices for consumers at the grocery store.
In a series of court filings starting in 2008, federal prosecutors in Sacramento allege that Rahal, nine others and SK Foods of Monterey, Calif., used more than $330,000 in bribes from 1998 to 2008 to subvert competition and nail down deals to sell the company's tomato paste, peppers and other products to Kraft Foods Inc., Safeway Inc., Frito-Lay North America and B&G Foods, among others...
Wednesday, October 29, 2008
FDA ignores science regarding BPA
Do incidents like this mean you can't trust anything the FDA says?
Experts: FDA ignored evidence when calling BPA safe
Oct. 29, 2008
By Liz Szabo
USA TODAY
The Food and Drug Administration ignored evidence when concluding that a chemical in plastic baby bottles is safe, according an expert panel asked to review the agency's handling of the controversial substance.
The Food and Drug Administration ignored evidence about the danger posed by a chemical in plastic baby bottles, according a report released Wednesday.
The excluded studies suggest bisphenol A, or BPA, could pose harm to children at levels at least 10 times lower than the amount the agency says is safe, according to the report written by outside scientists asked to review the agency's handling of the controversial substance.
Excluding evidence of harm "creates a false sense of security" about BPA, the panel's report says.
The scientists took the FDA to task for basing its safety decision in August on three industry-funded studies. Another government agency, the National Toxicology Program, decided many other independent studies deserved consideration. The toxicology program concluded last month there is "some concern" that BPA alters development of the brain, prostate and behavior in children and fetuses.
The expert panel also found the FDA underestimated how much BPA babies ingest on several counts. For one, the agency failed to consider the cumulative effect of being exposed to BPA from dozens of products, a fundamental error that "severely limits the usefulness" of the FDA's safety estimate.
An advocacy group, the Natural Resources Defense Council, believes BPA is too toxic to use in baby products at all. The group formally has asked the FDA to remove BPA from food and beverage containers.
The new report was written by a subcommittee of the FDA's outside science board, experts who advise the FDA on complex issues. The full science board, scheduled to meet Friday, can endorse the subcommittee's report or write its own..
Experts: FDA ignored evidence when calling BPA safe
Oct. 29, 2008
By Liz Szabo
USA TODAY
The Food and Drug Administration ignored evidence when concluding that a chemical in plastic baby bottles is safe, according an expert panel asked to review the agency's handling of the controversial substance.
The Food and Drug Administration ignored evidence about the danger posed by a chemical in plastic baby bottles, according a report released Wednesday.
The excluded studies suggest bisphenol A, or BPA, could pose harm to children at levels at least 10 times lower than the amount the agency says is safe, according to the report written by outside scientists asked to review the agency's handling of the controversial substance.
Excluding evidence of harm "creates a false sense of security" about BPA, the panel's report says.
The scientists took the FDA to task for basing its safety decision in August on three industry-funded studies. Another government agency, the National Toxicology Program, decided many other independent studies deserved consideration. The toxicology program concluded last month there is "some concern" that BPA alters development of the brain, prostate and behavior in children and fetuses.
The expert panel also found the FDA underestimated how much BPA babies ingest on several counts. For one, the agency failed to consider the cumulative effect of being exposed to BPA from dozens of products, a fundamental error that "severely limits the usefulness" of the FDA's safety estimate.
An advocacy group, the Natural Resources Defense Council, believes BPA is too toxic to use in baby products at all. The group formally has asked the FDA to remove BPA from food and beverage containers.
The new report was written by a subcommittee of the FDA's outside science board, experts who advise the FDA on complex issues. The full science board, scheduled to meet Friday, can endorse the subcommittee's report or write its own..
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