Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Saturday, May 29, 2010
Friday, September 18, 2009
Tuesday, March 24, 2009
Monday, February 09, 2009
The FDA's prasugrel hearing was "breathtakingly incompetent"
CardioBrief's Larry Husten writes:
As a journalist and editor who’s covered the cardiovascular arena for more than 25 years I’ve tried as much as possible to avoid taking positions on the major controvesies that have appeared over the years. I’m proud that during the “TPA wars” I remained on good terms with not only Eric Topol, Rob Califf and Eugene Braunwald, but Peter Sleight, Charlie Hennekens, and Gianni Tognoni. More recently, as we’ve been engulfed by the Vioxx, Vytorin, and COURAGE controversies, among others, I’ve been pleased to maintain good working relationships with all the mainstream protagonists.
I have no intention of breaking this tradition over prasugrel.
The players in this drama are all far smarter about this kind of stuff than I could ever hope to be, and the subtle statistical and clinical issues are extremely difficult to evaluate and assess. But there is one aspect of the prasugrel story that I do feel competent to comment upon.
The FDA handling of this hearing was breathtakingly incompetent.
Let me explain:
As first reported here previously, less than 48 hours before the advisory committee hearing new member Sanjay Kaul was “uninvited” from the meeting. Now I’m no expert on the criteria for serving on FDA advisory committees, and it’s possible that Kaul’s previous statements represented a legitimate reason for excluding him, but there is absolutely no reason for this to have been done immediately prior to the meeting. It’s not like Kaul was hiding anything. Any reasonable exercise of due diligence– just google “Kaul and prasugrel and you’ll see what I mean– would have revealed his outspoken position. Since Kaul was removed so close to the meeting, and after publication of the roster, FDA officials need to publicly apologize to Kaul and to provide a full explanation for the reasons for his dismissal, and in fact provide an account for the entire sequence of events leading to this last minute debacle.
It’s also not clear what constitutes “intellectual conflict of interest.” But even if there were general agreement that Kaul’s previous positions disqualified him to vote, wouldn’t the committee have benefited from his expertise as a nonvoting member? Other outspoken experts have criticized the FDA hearing for having the atmosphere of a “family picnic.” At the very least, inclusion of someone like Kaul in the proceedings would have allowed the FDA to escape the charge of cronyism and disregard for dissent.
I’m also surprised that there has been little public discussion about the FDA briefing document, which contained apparently redacted content that was easily recovered in the PDF document originally posted on the FDA website. One important point here: some of the redacted content in the document, which appeared to contain information that might have identified patients in clinical trials, or genuine trade secrets, was fully scrubbed from the PDF document and was not recoverable. The recoverable content was more “political” in nature, and appeared to represent a last minute, incompetently executed attempt by top managers at the FDA to stifle opposing views. This pathetic effort to create a sense of unity appears to be typical of the type of managerial problems that have beset the FDA in recent years.
I can’t say for sure whether the prasugrel hearing is a demonstration of intellectual dishonesty or corruption. But I think I can say for sure that it is certainly a clear demonstration of incompetence.
Source
As a journalist and editor who’s covered the cardiovascular arena for more than 25 years I’ve tried as much as possible to avoid taking positions on the major controvesies that have appeared over the years. I’m proud that during the “TPA wars” I remained on good terms with not only Eric Topol, Rob Califf and Eugene Braunwald, but Peter Sleight, Charlie Hennekens, and Gianni Tognoni. More recently, as we’ve been engulfed by the Vioxx, Vytorin, and COURAGE controversies, among others, I’ve been pleased to maintain good working relationships with all the mainstream protagonists.
I have no intention of breaking this tradition over prasugrel.
The players in this drama are all far smarter about this kind of stuff than I could ever hope to be, and the subtle statistical and clinical issues are extremely difficult to evaluate and assess. But there is one aspect of the prasugrel story that I do feel competent to comment upon.
The FDA handling of this hearing was breathtakingly incompetent.
Let me explain:
As first reported here previously, less than 48 hours before the advisory committee hearing new member Sanjay Kaul was “uninvited” from the meeting. Now I’m no expert on the criteria for serving on FDA advisory committees, and it’s possible that Kaul’s previous statements represented a legitimate reason for excluding him, but there is absolutely no reason for this to have been done immediately prior to the meeting. It’s not like Kaul was hiding anything. Any reasonable exercise of due diligence– just google “Kaul and prasugrel and you’ll see what I mean– would have revealed his outspoken position. Since Kaul was removed so close to the meeting, and after publication of the roster, FDA officials need to publicly apologize to Kaul and to provide a full explanation for the reasons for his dismissal, and in fact provide an account for the entire sequence of events leading to this last minute debacle.
It’s also not clear what constitutes “intellectual conflict of interest.” But even if there were general agreement that Kaul’s previous positions disqualified him to vote, wouldn’t the committee have benefited from his expertise as a nonvoting member? Other outspoken experts have criticized the FDA hearing for having the atmosphere of a “family picnic.” At the very least, inclusion of someone like Kaul in the proceedings would have allowed the FDA to escape the charge of cronyism and disregard for dissent.
I’m also surprised that there has been little public discussion about the FDA briefing document, which contained apparently redacted content that was easily recovered in the PDF document originally posted on the FDA website. One important point here: some of the redacted content in the document, which appeared to contain information that might have identified patients in clinical trials, or genuine trade secrets, was fully scrubbed from the PDF document and was not recoverable. The recoverable content was more “political” in nature, and appeared to represent a last minute, incompetently executed attempt by top managers at the FDA to stifle opposing views. This pathetic effort to create a sense of unity appears to be typical of the type of managerial problems that have beset the FDA in recent years.
I can’t say for sure whether the prasugrel hearing is a demonstration of intellectual dishonesty or corruption. But I think I can say for sure that it is certainly a clear demonstration of incompetence.
Source
Sunday, February 01, 2009
"A long-coveted parting gift"
In the waning days of the Bush administration, the Food and Drug Administration completed new guidelines to make it easier for drug manufacturers to promote "off-label" prescription drug uses, which can be deadly for patients.
The move came despite criticism from Bush's own Department of Veterans Affairs, which said the change "favors business interests over public safety" and could lead to a "decline in drug safety." It was also crafted despite efforts by state and federal law enforcement experts to clamp down on off-label drug marketing.
As the Obama administration reviews all the midnight rules that the departing Bush administration issued, it will have to decide whether to try to modify or reverse this last-minute change in the FDA's oversight of off-label drug marketing.
Congressional leaders from both parties criticized the guideline when it was proposed last year.
Sen. Charles Grassley, an Iowa Republican who has repeatedly investigated the FDA, said he had serious concerns about the proposal, which he said would deem appropriate something that "the FDA once considered evidence of unlawful marketing."
In the House of Representatives, Rep. Henry Waxman, a California Democrat, called the guideline a "long-coveted parting gift" for the pharmaceutical industry that "fundamentally undermines" the FDA's authority.
More at The Baltimore Sun
The move came despite criticism from Bush's own Department of Veterans Affairs, which said the change "favors business interests over public safety" and could lead to a "decline in drug safety." It was also crafted despite efforts by state and federal law enforcement experts to clamp down on off-label drug marketing.
As the Obama administration reviews all the midnight rules that the departing Bush administration issued, it will have to decide whether to try to modify or reverse this last-minute change in the FDA's oversight of off-label drug marketing.
Congressional leaders from both parties criticized the guideline when it was proposed last year.
Sen. Charles Grassley, an Iowa Republican who has repeatedly investigated the FDA, said he had serious concerns about the proposal, which he said would deem appropriate something that "the FDA once considered evidence of unlawful marketing."
In the House of Representatives, Rep. Henry Waxman, a California Democrat, called the guideline a "long-coveted parting gift" for the pharmaceutical industry that "fundamentally undermines" the FDA's authority.
More at The Baltimore Sun
Friday, January 30, 2009
Support the "FDA 9" dissident scientists
“It has been brought to our attention that F.D.A. management may have just recently ordered the F.D.A. Office of Criminal Investigations (O.C.I.) to investigate us rather than the managers who have engaged in wrongdoing!”
NYT
NYT
Tuesday, January 20, 2009
Nissen on the FDA
"I think the FDA has lost its way in terms of its mission. ... It is truly a failed agency. We have to change the culture." -- Dr. Steve Nissen, chairman of Cleveland Clinic's department of cardiovascular medicine.
Monday, December 08, 2008
Rost's FDA push makes PharmaTimes
A leading US politician has told President-elect Barack Obama that “a complete change” is needed in the leadership of the Food and Drug Administration (FDA), as the agency’s current senior staff are “too close with the industries they regulate, creating a question of whom they are working for.”
“I would encourage you not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA,” writes Bart Stupak, the Democratic Representative for Michigan, in a letter to Mr Obama released last Friday. While he names no agency officials in his letter, Rep Stupak’s plea to the incoming president is being widely seen as an attempt to counter support for Dr Janet Woodcock, head of the agency’s Center for Drug Evaluation and Research (CDER), to be the next Commissioner, or to take the post on an interim basis, when Dr Andrew von Eschenbach steps down.
Commissioner von Eschenbach, who has held the post since September 2005, has made no announcement about his future plans, but his resignation is expected shortly.
Rep Stupak has been a member of the House Energy and Commerce Committee for 12 years, during which time he has been involved in “numerous” investigations of the FDA, he tells Mr Obama. Also, for the past two years has chaired the panel’s oversight and investigations subcommittee, which has primary oversight of the FDA, and: “since February 2007, I have held 16 hearings into the inadequacies of the FDA to protect Americans from unsafe food, drugs and medical devices. The subcommittee’s investigations revealed how the current FDA senior management blocked clinical trials, drove dedicated medical professionals out of the agency and lined their pockets with outrageous bonuses. The agency has abandoned its core mission of protecting Americans from contaminated food, unsafe drugs and medical devices,” he writes.“A new Commissioner or Interim Commissioner must bring the agency back to the forefront of science, integrity and transparency,” Rep Stupak urges the incoming president.
CDER director Dr Woodcock is widely reported to be the industry’s choice to lead the Administration. This fact alone could be enough to wreck her chances of landing the post, and her 22 years at the agency also means that she is not regarded as a likely force for reform.
Meantime, a new name in the frame for FDA Commissioner is Peter Rost, the controversial former Pfizer vice president who is currently involved in long-running whistleblower litigation against his former employer. He has made public his interest in the agency top job and is being supported by Democrat Sherrod Brown, the junior Senator from Ohio, with whom he has campaigned for imports of cheaper prescription drugs from Canada, and by Missouri Democrat Representative Jo Ann Emerson. Rep Stupak is also reported to be backing Mr Rost.
By Lynne Taylor
PharmaTimes
“I would encourage you not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA,” writes Bart Stupak, the Democratic Representative for Michigan, in a letter to Mr Obama released last Friday. While he names no agency officials in his letter, Rep Stupak’s plea to the incoming president is being widely seen as an attempt to counter support for Dr Janet Woodcock, head of the agency’s Center for Drug Evaluation and Research (CDER), to be the next Commissioner, or to take the post on an interim basis, when Dr Andrew von Eschenbach steps down.
Commissioner von Eschenbach, who has held the post since September 2005, has made no announcement about his future plans, but his resignation is expected shortly.
Rep Stupak has been a member of the House Energy and Commerce Committee for 12 years, during which time he has been involved in “numerous” investigations of the FDA, he tells Mr Obama. Also, for the past two years has chaired the panel’s oversight and investigations subcommittee, which has primary oversight of the FDA, and: “since February 2007, I have held 16 hearings into the inadequacies of the FDA to protect Americans from unsafe food, drugs and medical devices. The subcommittee’s investigations revealed how the current FDA senior management blocked clinical trials, drove dedicated medical professionals out of the agency and lined their pockets with outrageous bonuses. The agency has abandoned its core mission of protecting Americans from contaminated food, unsafe drugs and medical devices,” he writes.“A new Commissioner or Interim Commissioner must bring the agency back to the forefront of science, integrity and transparency,” Rep Stupak urges the incoming president.
CDER director Dr Woodcock is widely reported to be the industry’s choice to lead the Administration. This fact alone could be enough to wreck her chances of landing the post, and her 22 years at the agency also means that she is not regarded as a likely force for reform.
Pfizer whistleblower says: “I want to be FDA Commissioner
Meantime, a new name in the frame for FDA Commissioner is Peter Rost, the controversial former Pfizer vice president who is currently involved in long-running whistleblower litigation against his former employer. He has made public his interest in the agency top job and is being supported by Democrat Sherrod Brown, the junior Senator from Ohio, with whom he has campaigned for imports of cheaper prescription drugs from Canada, and by Missouri Democrat Representative Jo Ann Emerson. Rep Stupak is also reported to be backing Mr Rost.
By Lynne Taylor
PharmaTimes
Thursday, December 04, 2008
Is faster better?
There are concerns that pressures on regulators to approve new drugs more quickly have reduced the focus on patient safety, and this problem is exacerbated by new efficiencies in drug marketing which can quickly expose large numbers of patients to unknown risks, warns a researcher writing in this week’s British Medical Journal (BMJ).
New medicines which receive approval by the US Food and Drug Administration (FDA) up to two months before the deadline set for a decision are more likely to be subsequently withdrawn from the market on safety grounds or to have to carry safety warnings, writes David Kao, fellow in cardiovascular medicine at the University of Colorado Health Sciences Center, USA in the current BMJ (BMJ 2008;337;a2591).
For example, he says, it is estimated that 20 million patients were prescribed Merck & Co’s non-steroidal anti-inflammatory drug (NSAID) Vioxx (rofecoxib) over five years before it was taken off the market, and events attributable to the drug “may number in tens to hundreds of thousands.”
Dr Kao points out that, as a result of the US Prescription Drug User Fee Act (PDUFA), FDA approval times for new drugs more than halved, from an average of 33.6 months during 1979-86 to 16 months by 1992-2007. Moreover, regulators in the USA, European Union (EU) and UK are “somewhat dependent on the industry for funding,” given that user fees account for 43% of the FDA’s drug oversight budget, 75% of European Medicines Agency (EMEA)’s funding and 100% of that for the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), he says.
At the same time, drugmakers’ marketing techniques are now so sophisticated that a new product can be released onto websites within 90 minutes of being granted approval, says Dr Kao, and he calls for these techniques to be used to improve post-marketing surveillance and adverse drug reaction reporting.
By Lynne Taylor
More at PharmaTimes
New medicines which receive approval by the US Food and Drug Administration (FDA) up to two months before the deadline set for a decision are more likely to be subsequently withdrawn from the market on safety grounds or to have to carry safety warnings, writes David Kao, fellow in cardiovascular medicine at the University of Colorado Health Sciences Center, USA in the current BMJ (BMJ 2008;337;a2591).
For example, he says, it is estimated that 20 million patients were prescribed Merck & Co’s non-steroidal anti-inflammatory drug (NSAID) Vioxx (rofecoxib) over five years before it was taken off the market, and events attributable to the drug “may number in tens to hundreds of thousands.”
Dr Kao points out that, as a result of the US Prescription Drug User Fee Act (PDUFA), FDA approval times for new drugs more than halved, from an average of 33.6 months during 1979-86 to 16 months by 1992-2007. Moreover, regulators in the USA, European Union (EU) and UK are “somewhat dependent on the industry for funding,” given that user fees account for 43% of the FDA’s drug oversight budget, 75% of European Medicines Agency (EMEA)’s funding and 100% of that for the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), he says.
At the same time, drugmakers’ marketing techniques are now so sophisticated that a new product can be released onto websites within 90 minutes of being granted approval, says Dr Kao, and he calls for these techniques to be used to improve post-marketing surveillance and adverse drug reaction reporting.
By Lynne Taylor
More at PharmaTimes
Abbott - Xience: safety first!
Abbott Laboratories said it will embed safety information about its Xience heart device into a YouTube video spot, a disclosure made hours after a consumer group complained the spots ran afoul of U.S. Food and Drug Administration rules on product marketing.
"Abbott's practice is to comply with all regulatory requirements and to provide patients and consumers with accurate and complete product information," Abbott said in a statement to the Tribune on Wednesday, adding that it had done nothing wrong. "All Abbott's Xience V videos on YouTube were posted in July 2008 with prominent links to the 'Brief Summary of Instructions for Use,' which details the product's risk and safety information. To avoid any problems in the future, we will embed safety and risk information in the videos moving forward."
The Boston-based Prescription Project, long a critic of drug and medical device industry marketing, said Wednesday that such videos should be regulated by the FDA and include safety warnings like other health industry products marketed in other venues.
Wednesday, November 19, 2008
Guess what's on the FDA's mind in this post-Vioxx world?
The rise of serious heart risks in drugs that treat chronic conditions has become one of the U.S. Food and Drug Administration's top worries and is changing how the agency weighs new medicines, a top FDA official said on Tuesday.
The agency is thinking about how to weigh such possible side effects as more drugs that treat diabetes, pain and other conditions also appear linked to heart attacks and other complications, Dr. John Jenkins, director of the FDA's Office of New Drugs, told the Reuters Health Summit in New York.
"That has been the biggest safety shift in the last few years, and it's also, I think, a driver for a lot of the public concern about drug safety," he said.
"We are thinking about what the implications of these new data and these new findings are for all chronically-used drugs," he said.
The agency has already said that it plans to give specific advice to drug makers about what kinds of data they will need to sell diabetes drugs in the United States.
The FDA's recommendation, or guidelines, will be released "very soon," Jenkins said.
In July, an FDA panel of outside advisers said companies should have to conduct long-term studies of cardiovascular effects or provide equivalent evidence to rule out an "unacceptable" risk of heart problems.
Source
The agency is thinking about how to weigh such possible side effects as more drugs that treat diabetes, pain and other conditions also appear linked to heart attacks and other complications, Dr. John Jenkins, director of the FDA's Office of New Drugs, told the Reuters Health Summit in New York.
"That has been the biggest safety shift in the last few years, and it's also, I think, a driver for a lot of the public concern about drug safety," he said.
"We are thinking about what the implications of these new data and these new findings are for all chronically-used drugs," he said.
The agency has already said that it plans to give specific advice to drug makers about what kinds of data they will need to sell diabetes drugs in the United States.
The FDA's recommendation, or guidelines, will be released "very soon," Jenkins said.
In July, an FDA panel of outside advisers said companies should have to conduct long-term studies of cardiovascular effects or provide equivalent evidence to rule out an "unacceptable" risk of heart problems.
Source
Friday, October 17, 2008
Join the FDA and see the world
The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world.
After opening its initial office in Beijing, the FDA expects to post eight US staffers to China next year and open additional outposts in Shanghai and Guangzhou.
More
After opening its initial office in Beijing, the FDA expects to post eight US staffers to China next year and open additional outposts in Shanghai and Guangzhou.
More
Lilly - prasugrel: the FDA's dilemma
A serious internal disagreement has developed within the FDA over whether to approve the new blood thinner as it stands, sources tell the IN VIVO Blog:
The decision to grant priority review in the first place suggests that the top review managers—namely, Office of Drug Evaluation I director Bob Temple and director of the division of cardio-renal drug products Norman Stockbridge—are excited about the potential for the drug.
However, it appears that another party has made a compelling argument against approval of the application in its current state.
Three issues appear to have impeded an FDA decision: (1) the increase in minor and major bleeding and concerns of related deaths in the prasugrel arm; (2) more cancers discovered in the prasugrel group compared to clopidogrel in the TRITON study; and (3) a recent formulation issue either related to the active ingredient or excipient substance.
Bottom line: A delay until spring next year.
More
The decision to grant priority review in the first place suggests that the top review managers—namely, Office of Drug Evaluation I director Bob Temple and director of the division of cardio-renal drug products Norman Stockbridge—are excited about the potential for the drug.
However, it appears that another party has made a compelling argument against approval of the application in its current state.
Three issues appear to have impeded an FDA decision: (1) the increase in minor and major bleeding and concerns of related deaths in the prasugrel arm; (2) more cancers discovered in the prasugrel group compared to clopidogrel in the TRITON study; and (3) a recent formulation issue either related to the active ingredient or excipient substance.
Bottom line: A delay until spring next year.
More
Wednesday, September 17, 2008
Quotes of the week
``The firm is sufficiently out of control that we think an import alert should be put into place until these deficiencies are corrected.'' - FDA on Ranbaxy
``The FDA is not doing its best to protect the medicines that Americans depend on for their health. We can no longer leave the methods of assuring drug safety up to discretion of this agency.'' - Dingell on FDA
Bloomberg
``The FDA is not doing its best to protect the medicines that Americans depend on for their health. We can no longer leave the methods of assuring drug safety up to discretion of this agency.'' - Dingell on FDA
Bloomberg
Saturday, September 06, 2008
The list
Story
R-Gene 10: A growth hormone, paediatric overdose due to labeling/packaging confusion.
Suprane: An anaesthetic, cardiac arrest.
Cymbalta: For depression and other conditions, urinary retention.
Intelence: An HIV medication, bleeding into joints.
Carac and Kuric: Creams for skin conditions and fungal infections, name confusion.
Heparin: A blood thinner, serious allergic reactions.
Extraneal: Used in kidney dialysis, low blood sugars.
Humilin R: For diabetes, dosing confusion.
Stromectol and Warfarin: An anti-parasite drug and blood thinner, drug interaction.
Tykerb: For advanced breast cancer, liver damage.
Revlimid: For multiple myeloma, severe skin blistering and bleeding.
Tysabri: For multiple sclerosis, skin melanomas.
Nitrostat: For angina, overdose due to labeling confusion.
Sandostatin LAR: For abnormal bone growth, bowel obstruction.
Oxycontin: A pain killer, drug misuse, abuse and overdose.
Definity: Used in cardiac imaging, cardiopulmonary reactions.
Dilantin injection: For epileptic seizures, serious skin reaction.
Seroquel: For bipolar disorder, overdose due to sample pack labeling confusion.
Tyzeka: For chronic hepatitis B, nerve damage.
Tumor Necrosis Factor (TNF) Blockers: For juvenile arthritis, cancers in children and young adults.
R-Gene 10: A growth hormone, paediatric overdose due to labeling/packaging confusion.
Suprane: An anaesthetic, cardiac arrest.
Cymbalta: For depression and other conditions, urinary retention.
Intelence: An HIV medication, bleeding into joints.
Carac and Kuric: Creams for skin conditions and fungal infections, name confusion.
Heparin: A blood thinner, serious allergic reactions.
Extraneal: Used in kidney dialysis, low blood sugars.
Humilin R: For diabetes, dosing confusion.
Stromectol and Warfarin: An anti-parasite drug and blood thinner, drug interaction.
Tykerb: For advanced breast cancer, liver damage.
Revlimid: For multiple myeloma, severe skin blistering and bleeding.
Tysabri: For multiple sclerosis, skin melanomas.
Nitrostat: For angina, overdose due to labeling confusion.
Sandostatin LAR: For abnormal bone growth, bowel obstruction.
Oxycontin: A pain killer, drug misuse, abuse and overdose.
Definity: Used in cardiac imaging, cardiopulmonary reactions.
Dilantin injection: For epileptic seizures, serious skin reaction.
Seroquel: For bipolar disorder, overdose due to sample pack labeling confusion.
Tyzeka: For chronic hepatitis B, nerve damage.
Tumor Necrosis Factor (TNF) Blockers: For juvenile arthritis, cancers in children and young adults.
Wednesday, August 27, 2008
Thoreau-FDA - the videos
.
Link
Transcript - video 1.
What if you were asked to do something you knew was likely to make someone sick or dead – would it matter if that "someone" were a person you love, or a pet, or a total stranger on the far side of the world? –What if many people could be harmed by your actions?Now suppose your manager or boss asked or pressured you in a way that makes it look like the “something” was your own idea, not his or hers?
That is the situation faced by some Federal workers whose job it is to protect public health. Over the past few years, civil servants in the United States Food and Drug Administration (FDA) were pressured or verbally directed by higher-up managers to "recommend" approving new drugs, "tone down" or ignore signs of health dangers, and disregard track records of defective manufacturing safeguards. These instructions are known as undocumented top down approve directives. We don’t know how many occurred since the mid- 1990’s -- mainly because they are verbal and go unwritten. Recent headlines about terribly defective and dangerous, yet approved, products can be the result of these flawed drug review processes that I am talking about.
Now, you're probably thinking that the FDA must certainly have administration wide policies to prevent this kind of drug application review abuse by US FDA managers. The fact is, such life saving policies have neither been instituted nor announced. As a starting point toward needed reforms, you can send a letter to US FDA Commissioner Von Eschenbach, urging him to reform the review process and bring a swift and sure end to dangerous practices in the drug review system. The letter also requests Commissioner Von Eschenbach to answer questions about his “Values and Vision” effort to stop professional oppression by US FDA managers. Commissioner Von Eschenbach, the first of several questions over the coming weeks to you is:
“How does your Values and Vision effort, as initially announced to US FDA staff in the September 19, 2007 web cast and subsequent March 2008 updates, prevent future undocumented top-down approved directives and more retaliation against US FDA staff who publicly expose deadly human and veterinary products?”
Thoreau-FDA.org presents a letter you can review, edit, sign and send to halt top down pre-determined outcomes and to stop FDA management retaliation against US FDA staff who try to do their job and protect the public health. That is why I am in the shadows, but these practices can no longer be in the shadows. In the coming weeks, we will ask more questions of Dr. Von Eschenbach with the goal of ensuring actions that secure the US and global public health safety. Please, take the first step in protecting public health and keeping harmful products off the market. Urge the US FDA adopt proactive and meaningful drug review policies by signing and sending an email to Commissioner Von Eschenbach today.
Transcript - video 2
Hello, and welcome to Thoreau-FDA.com. Our web site, has been operating for about three weeks. This is our second video.
First, we thank all who have forwarded our web site letter to our US FDA Commissioner. Our records show 20 copies, including one from another country, have been sent to his e-mail address. The end of the letter poses a question which I will ask again at the end of this video.
Commissioner Von Eschenbach, we and the citizens of the United States and now one citizen from another country, are awaiting your response. Thank you in advance for your answer. Your answer will maximize the effectiveness of your Values and Vision program and optimally, ensure that safe and effective medical products reach people in this and other countries, a goal we know you want to achieve.
Second, we thank our fellow citizens who alerted us to medical products that have reached the marketplace and caused harm, loss of life, wasteful litigation and lost time and money in our court system. These dangerous products already have had extensive media coverage. We in Thoreau-fda.com want to ensure that, in the future, such products never reach the US or global market. Or, if such products, do, that they are marketed with the truth of fully disclosed warnings that have passed through a valid and transparent pre-approval process with traceable accountability to all decision makers. And a first step to block more dangerous deadly products from the market or to ensure adequate label warnings is the receipt of an answer from Commissioner Von Eschenbach to our question.
Third, we have received quite a few comments and some blogs. We are considering posting these at a future date when we open FDA-blog.com for all to see. One comment asks that we address the public’s need to be forewarned of dangerous deadly products, indeed the responsibility and job of the US FDA. Thoreau-FDA finds it difficult to fulfill this need at this time, due to our extremely limited resources, small group size, and our often adversarial position against US FDA upper managers, who cut us out of information networks in the agency. Indeed, the Ordeals hyperlink on the Thoreau-fda web site, presents evidence that US FDA staff have been side lined and ostracized for doing the US FDA’s job of publicly exposing harmful or deadly products. We want to ensure Commissioner Von Eschenbach stops this abuse of US FDA staff who do their jobs. And, if we should become aware of deadly or harmful products, we will make them public, after confirmation .
I now restate the goal of Thoreau-fda, in different words than those stated in the web site’s Purpose and Goals. We of Thoreau-fda work to eventually eliminate the need for the public to be forewarned of dangerous products by ensuring the US FDA’s review process prevents such products from ever reaching the market place or that they enter the market with labeling that discloses full warning, when appropriate, of side effects or adverse reactions found in clinical trials. These changes will take time. And as a first step, we ask our fellow citizens to forward the Letter on our site to the US FDA Commissioner.
Finally, to all the reporters who have asked for an interview and story. Please be patient. In the meantime, the current story is – People are waiting. Will the US FDA Commissioner answer the question that has been forwarded to him by nineteen of our fellow citizens and one fellow global citizen from another country? Or will he leave it for the next US FDA Commissioner to answer ? Again, Commissioner Von Eschenbach, the question is -
"How does your Values and Vision effort, as initially announced to US FDA staff in the September 19, 2007 Webcast and subsequent March 2008 updates, prevent future Undocumented Top Down Approve Directives or Requests, and more retaliation against US FDA staff who publicly expose deadly human and veterinary products?"
Hat tip: http://sstrumello.blogspot.com/
Monday, August 18, 2008
Preemption: "The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety,"
In a brief filed with the US Supreme Court, six current and former editors of the New England Journal of Medicine stated that consumers should be allowed to sue pharmaceutical firms for failing to warn about a drug's dangers, even if its prescribing information was approved by the FDA. The brief was filed in case being reviewed by the Supreme Court in which a jury awarded $6.8 million to a plaintiff who had her arm amputated after being injected with Wyeth's nausea drug Phenergan (promethazine).
The Vermont Supreme Court upheld the jury award in the case, which is now before the Supreme Court, and the lawsuit is expected to test whether federal drug laws should pre-empt state laws. In an interview, journal editor Jeffrey Drazen noted that "even if the FDA is doing the best it can, it simply can't see the future clearly enough to pre-empt manufacturers from litigation. The (court) system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public."
"The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety," the editors noted in the brief. The journal editors added that without the discoveries uncovered during liability litigation, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."
Along with the journal editors, 47 state attorneys general and two former FDA commissioners also support the plaintiff's position in the case. Opening arguments before the Supreme Court are scheduled to be heard on November 3.
by Anna Bratulic
Link
The Vermont Supreme Court upheld the jury award in the case, which is now before the Supreme Court, and the lawsuit is expected to test whether federal drug laws should pre-empt state laws. In an interview, journal editor Jeffrey Drazen noted that "even if the FDA is doing the best it can, it simply can't see the future clearly enough to pre-empt manufacturers from litigation. The (court) system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public."
"The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety," the editors noted in the brief. The journal editors added that without the discoveries uncovered during liability litigation, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."
Along with the journal editors, 47 state attorneys general and two former FDA commissioners also support the plaintiff's position in the case. Opening arguments before the Supreme Court are scheduled to be heard on November 3.
by Anna Bratulic
Link
Tuesday, July 29, 2008
Quote
Back in the 1970s, the FDA ranked among the most respected public agencies, with a public confidence rating of 80 percent. By 2000, that level had dropped to 61 percent; last year, it was just 36 percent. Quite clearly, the conservative movement has accomplished its mission of causing the general public to share its hostility toward what was once an admired governmental institution.
Greg Anrig in The American Prospect,
Greg Anrig in The American Prospect,
Thursday, May 22, 2008
Evelyn Pringle - Bush's FDA: Big Pharma Insider Information Scam
The steady leaking of insider information about products under review by the FDA has caused enormous losses for average American investors since the Bush Administration took control of the agency six years ago.
There are several ways that investors can profit from this type of insider information. The first is obvious, buy the stock because approval of a product will almost certainly raise a company's stock value. Investors who know about the decision ahead of time can bet the farm based on that information.
But investors who are tipped off that a product will not be approved can do the opposite. They can bet that company's stock value will fall by selling the stock short knowing full-well that the minute the news of non-approval becomes public, the stock's value will drop like a rock.
When the leaking of this type of information occurs, the losers are always the investors who play by the rules and make bets based on the best public information available. Unfortunately, in many instances, these are the very people who can least afford the loss.
More
There are several ways that investors can profit from this type of insider information. The first is obvious, buy the stock because approval of a product will almost certainly raise a company's stock value. Investors who know about the decision ahead of time can bet the farm based on that information.
But investors who are tipped off that a product will not be approved can do the opposite. They can bet that company's stock value will fall by selling the stock short knowing full-well that the minute the news of non-approval becomes public, the stock's value will drop like a rock.
When the leaking of this type of information occurs, the losers are always the investors who play by the rules and make bets based on the best public information available. Unfortunately, in many instances, these are the very people who can least afford the loss.
More
Wednesday, April 30, 2008
Are you a scientist who has just been laid off by Big Pharma?
The Food and Drug Administration on Wednesday said it will hire more than 1,300 biologists, chemists, medical officers and others over the next several months.
The FDA said it was granted special authority by the Office of Personnel Management to expedite the hiring, which is done when a severe shortage of candidates exists.
The agency - which is also seeking consumer safety officers, nurse consultants, mathematical statisticians, epidemiologists, pharmacologists, pharmacists and veterinary medical officers - will hold job fairs nationwide.
Don't get mad, get even!
The FDA said it was granted special authority by the Office of Personnel Management to expedite the hiring, which is done when a severe shortage of candidates exists.
The agency - which is also seeking consumer safety officers, nurse consultants, mathematical statisticians, epidemiologists, pharmacologists, pharmacists and veterinary medical officers - will hold job fairs nationwide.
Don't get mad, get even!
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