The Alliance For Human Research Protection
A Federal Lawsuit charges Dr. Margaret Hamburg, former Commissioner of the Food and Drug Administration (FDA) with conspiracy, racketeering & colluding to conceal deadly drug dangers – under the federal Racketeer Influenced and Corrupt Organizations law (RICO) law. The amended RICO lawsuit was filed on April 11, 2016 in the U.S. District Court in Washington DC on behalf of eight plaintiffs who claim they have suffered severe harm by ingesting the drug, Levaquin whose deadly risks were concealed to protect financial interests.
The drug is one of the controversial group of antibiotics, including Levaquin, Cipro, Avelox and other fluoroquinolones. Public Citizen petitioned the FDA in 1996 and again in 2006, to issue Black Box warnings for tendon rupture and tendinitis. Had warnings been issued, the death toll from Levaquin– reputedly more than 5,000 — and the tens of thousands who were debilitated with life-threatening diseases would likely have been averted.
The article is here.
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Friday, June 24, 2016
Thursday, May 19, 2016
FDA Reconsiders Training Requirement for Painkillers
BY Matthew Perrone
AP HEALTH WRITER
Originally published April 29, 2016
The Food and Drug Administration is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses, according to federal documents.
The review comes as regulators disclosed that the number of doctors who completed voluntary training programs is less than half that targeted by the agency.
A panel of FDA advisers meets next week to review risk-management plans put in place nearly four years ago to reduce misuse and abuse of long-acting painkillers, powerful opioid drugs at the center of a national wave of abuse and death.
The article is here.
AP HEALTH WRITER
Originally published April 29, 2016
The Food and Drug Administration is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses, according to federal documents.
The review comes as regulators disclosed that the number of doctors who completed voluntary training programs is less than half that targeted by the agency.
A panel of FDA advisers meets next week to review risk-management plans put in place nearly four years ago to reduce misuse and abuse of long-acting painkillers, powerful opioid drugs at the center of a national wave of abuse and death.
The article is here.
Friday, March 18, 2016
Off-label Promotions: Pharma Wants More Freedom to Pitch Durgs
By Ed Silverman
Stat News
Originally published February 29, 2016
Drug makers have long argued that the Food and Drug Administration is squelching their free speech rights by barring off-label promotion of their medicines. A new proposal may give them a voice.
This month, a think tank at Duke University called for a new independent entity to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors.
Companies say current regulations prevent them from distributing important data to physicians about unapproved, off-label uses of their medicines. The FDA worries public health can be compromised if marketing claims aren’t backed up by solid evidence. A neutral third party, the authors of the white paper say, could provide much-needed arbitration.
The article is here.
Stat News
Originally published February 29, 2016
Drug makers have long argued that the Food and Drug Administration is squelching their free speech rights by barring off-label promotion of their medicines. A new proposal may give them a voice.
This month, a think tank at Duke University called for a new independent entity to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors.
Companies say current regulations prevent them from distributing important data to physicians about unapproved, off-label uses of their medicines. The FDA worries public health can be compromised if marketing claims aren’t backed up by solid evidence. A neutral third party, the authors of the white paper say, could provide much-needed arbitration.
The article is here.
Wednesday, October 7, 2015
What the FDA’s approval of “pink Viagra” tells us about the problems with drug regulation
by Julia Belluz
The Vox
Originally published on September 18, 2015
Here is an excerpt:
The episode raised hard questions about the changes wrought by the patient movement and other reforms that have followed. There were excellent reasons for the FDA to bring HIV-positive patients into its deliberations in the 1980s — they provided a crucial perspective that the agency's in-house scientists and officials lacked. But these days, some critics argue that those listening sessions have been hijacked by drug companies. As I found in my reporting, the patients who had lobbied the FDA to approve pink Viagra were often sponsored by the drug's manufacturer.
"The role of pharma in patient groups in the contemporary era is entirely fraught," says Yale Law School's Gregg Gonsalves, who was once one of those HIV activists in the 1980s. "[Drug companies] learned from the early days of the AIDS epidemic that the patient community could be useful allies, and they've poured money into patient groups here in the US and around the world."
So is the FDA approving drugs too easily? Has the push for speed and efficiency now undermined the agency's ability to protect public health? To find out, I took a closer look at the approval of "pink Viagra," which offers a vivid illustration of just how much the FDA has transformed over time — and why those changes worry many experts.
The entire article is here.
The Vox
Originally published on September 18, 2015
Here is an excerpt:
The episode raised hard questions about the changes wrought by the patient movement and other reforms that have followed. There were excellent reasons for the FDA to bring HIV-positive patients into its deliberations in the 1980s — they provided a crucial perspective that the agency's in-house scientists and officials lacked. But these days, some critics argue that those listening sessions have been hijacked by drug companies. As I found in my reporting, the patients who had lobbied the FDA to approve pink Viagra were often sponsored by the drug's manufacturer.
"The role of pharma in patient groups in the contemporary era is entirely fraught," says Yale Law School's Gregg Gonsalves, who was once one of those HIV activists in the 1980s. "[Drug companies] learned from the early days of the AIDS epidemic that the patient community could be useful allies, and they've poured money into patient groups here in the US and around the world."
So is the FDA approving drugs too easily? Has the push for speed and efficiency now undermined the agency's ability to protect public health? To find out, I took a closer look at the approval of "pink Viagra," which offers a vivid illustration of just how much the FDA has transformed over time — and why those changes worry many experts.
The entire article is here.
Sunday, April 5, 2015
Compliance with Results Reporting at ClinicalTrials.gov
By Monique L. Anderson and others
N Engl J Med 2015; 372:1031-1039
March 12, 2015
DOI: 10.1056/NEJMsa1409364
Here are two excerpts:
The human experimentation that is conducted in clinical trials creates ethical obligations to make research findings publicly available. However, there are numerous historical examples of potentially harmful data being withheld from public scrutiny and selective publication of trial results. In 2000, Congress authorized the creation of the ClinicalTrials.gov registry to provide information about and access to clinical trials for persons with serious medical conditions. In 2007, Section 801 of the Food and Drug Administration Amendments Act (FDAAA) expanded this mandate by requiring sponsors of applicable clinical trials to register and report basic summary results at ClinicalTrials.gov. Such trials generally include all non–phase 1 interventional trials of drugs, medical devices, or biologics that were initiated after September 27, 2007, or before that date but that were still ongoing as of December 26, 2007, have at least one U.S. research site, or are conducted under an investigational-new-drug application or an investigational-device exemption. The FDAAA also mandates that trial results be reported by the sponsor within 1 year after the completion of data collection for the prespecified primary outcome (primary completion date) or within 1 year after the date of early termination, unless legally acceptable reasons for the delay are evident.
(cut)
In conclusion, despite ethical mandates, statutory obligations, and considerable societal pressure, most trials that were funded by the NIH or other government or academic institutions and were subject to FDAAA provisions have yet to report results at ClinicalTrials.gov, whereas the medical-products industry has been more responsive to the legal mandate of the FDAAA. However, industry, the NIH, and other government and academic institutions all performed poorly with respect to ethical obligations for transparency.
The entire article is here.
N Engl J Med 2015; 372:1031-1039
March 12, 2015
DOI: 10.1056/NEJMsa1409364
Here are two excerpts:
The human experimentation that is conducted in clinical trials creates ethical obligations to make research findings publicly available. However, there are numerous historical examples of potentially harmful data being withheld from public scrutiny and selective publication of trial results. In 2000, Congress authorized the creation of the ClinicalTrials.gov registry to provide information about and access to clinical trials for persons with serious medical conditions. In 2007, Section 801 of the Food and Drug Administration Amendments Act (FDAAA) expanded this mandate by requiring sponsors of applicable clinical trials to register and report basic summary results at ClinicalTrials.gov. Such trials generally include all non–phase 1 interventional trials of drugs, medical devices, or biologics that were initiated after September 27, 2007, or before that date but that were still ongoing as of December 26, 2007, have at least one U.S. research site, or are conducted under an investigational-new-drug application or an investigational-device exemption. The FDAAA also mandates that trial results be reported by the sponsor within 1 year after the completion of data collection for the prespecified primary outcome (primary completion date) or within 1 year after the date of early termination, unless legally acceptable reasons for the delay are evident.
(cut)
In conclusion, despite ethical mandates, statutory obligations, and considerable societal pressure, most trials that were funded by the NIH or other government or academic institutions and were subject to FDAAA provisions have yet to report results at ClinicalTrials.gov, whereas the medical-products industry has been more responsive to the legal mandate of the FDAAA. However, industry, the NIH, and other government and academic institutions all performed poorly with respect to ethical obligations for transparency.
The entire article is here.
Thursday, November 7, 2013
The Not-So-Hidden Cause Behind the A.D.H.D. Epidemic
By MAGGIE KOERTH-BAKER
The New York Times
Published: October 15, 2013
Here are two excerpts:
Of the 6.4 million kids who have been given diagnoses of A.D.H.D., a large percentage are unlikely to have any kind of physiological difference that would make them more distractible than the average non-A.D.H.D. kid. It’s also doubtful that biological or environmental changes are making physiological differences more prevalent. Instead, the rapid increase in people with A.D.H.D. probably has more to do with sociological factors — changes in the way we school our children, in the way we interact with doctors and in what we expect from our kids.
Which is not to say that A.D.H.D. is a made-up disorder.
(cut)
This lack of rigor leaves room for plenty of diagnoses that are based on something other than biology. Case in point: The beginning of A.D.H.D. as an “epidemic” corresponds with a couple of important policy changes that incentivized diagnosis. The incorporation of A.D.H.D. under the Individuals With Disabilities Education Act in 1991 — and a subsequent overhaul of the Food and Drug Administration in 1997 that allowed drug companies to more easily market directly to the public — were hugely influential, according to Adam Rafalovich, a sociologist at Pacific University in Oregon.
The entire article is here.
The New York Times
Published: October 15, 2013
Here are two excerpts:
Of the 6.4 million kids who have been given diagnoses of A.D.H.D., a large percentage are unlikely to have any kind of physiological difference that would make them more distractible than the average non-A.D.H.D. kid. It’s also doubtful that biological or environmental changes are making physiological differences more prevalent. Instead, the rapid increase in people with A.D.H.D. probably has more to do with sociological factors — changes in the way we school our children, in the way we interact with doctors and in what we expect from our kids.
Which is not to say that A.D.H.D. is a made-up disorder.
(cut)
This lack of rigor leaves room for plenty of diagnoses that are based on something other than biology. Case in point: The beginning of A.D.H.D. as an “epidemic” corresponds with a couple of important policy changes that incentivized diagnosis. The incorporation of A.D.H.D. under the Individuals With Disabilities Education Act in 1991 — and a subsequent overhaul of the Food and Drug Administration in 1997 that allowed drug companies to more easily market directly to the public — were hugely influential, according to Adam Rafalovich, a sociologist at Pacific University in Oregon.
The entire article is here.
Wednesday, October 30, 2013
Pharmaceutical firms paid to attend meetings of panel that advises FDA
By Peter Whoriskey
The Washington Post
Originally published October 8, 2013
A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request.
The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.”
Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States.
The entire article is here.
The Washington Post
Originally published October 8, 2013
A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request.
The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.”
Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States.
The entire article is here.
Wednesday, October 9, 2013
F.D.A. to Regulate Some Health Apps
By SABRINA TAVERNISE
The New York Times
Published: September 23, 2013
The Food and Drug Administration said Monday that it would regulate only a small portion of the rapidly expanding universe of mobile health applications, software programs that run on smartphones and tablets and perform the same functions as medical devices.
Agency officials said their goal is to oversee apps that function like medical devices, performing ultrasounds, for example, and that could potentially pose risks to patients. Tens of thousands of health apps have sprung up in recent years, including apps that count steps or calories for fitness and weight loss, but agency officials said they would not regulate those types of apps.
The entire story is here.
The New York Times
Published: September 23, 2013
The Food and Drug Administration said Monday that it would regulate only a small portion of the rapidly expanding universe of mobile health applications, software programs that run on smartphones and tablets and perform the same functions as medical devices.
Agency officials said their goal is to oversee apps that function like medical devices, performing ultrasounds, for example, and that could potentially pose risks to patients. Tens of thousands of health apps have sprung up in recent years, including apps that count steps or calories for fitness and weight loss, but agency officials said they would not regulate those types of apps.
The entire story is here.
Saturday, September 7, 2013
Institutional Corruption and Pharmaceutical Policy
Institutional Corruption and Pharmaceutical Policy
An Edmond J. Safra Center Symposium
(forthcoming)
Journal of Law, Medicine and Ethics
Vol. 14, No. 3 (2013)
The goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. The pharmaceutical industry’s own purposes are often undermined. In addition, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, and the Food and Drug Administration’s oversight of pharmaceutical marketing.
As a result, practitioners may think they are using reliable information to engage in sound medical practice while actually relying on misleading information and therefore prescribe drugs that are unnecessary or harmful to patients, or more costly than equivalent medications. At the same time, patients and the public may believe that patient advocacy organizations effectively represent their interests while these organizations actually neglect their interests.
The entire journal is here.
The articles are organized into five topics: (1) systemic problems, (2) medical research, (3) medical knowledge and practice, (4) marketing, and (5) patient advocacy organizations.
An Edmond J. Safra Center Symposium
(forthcoming)
Journal of Law, Medicine and Ethics
Vol. 14, No. 3 (2013)
The goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. The pharmaceutical industry’s own purposes are often undermined. In addition, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, and the Food and Drug Administration’s oversight of pharmaceutical marketing.
As a result, practitioners may think they are using reliable information to engage in sound medical practice while actually relying on misleading information and therefore prescribe drugs that are unnecessary or harmful to patients, or more costly than equivalent medications. At the same time, patients and the public may believe that patient advocacy organizations effectively represent their interests while these organizations actually neglect their interests.
The entire journal is here.
The articles are organized into five topics: (1) systemic problems, (2) medical research, (3) medical knowledge and practice, (4) marketing, and (5) patient advocacy organizations.
Tuesday, August 27, 2013
U.S. Probes Use of Antipsychotic Drugs on Children
By LUCETTE LAGNADO
The Wall Street Journal
Originally published August 12, 2013
Federal health officials have launched a probe into the use of antipsychotic drugs on children in the Medicaid system, amid concern that the medications are being prescribed too often to treat behavioral problems in the very young.
The inspector general's office at Department of Health and Human Services says it recently began a review of antipsychotic-drug use by Medicaid recipients age 17 and under. And various agencies within HHS are requiring officials in all 50 states to tighten oversight of prescriptions for such drugs to Medicaid-eligible young people.
The effort applies to a newer class of antipsychotic drugs known as "atypicals," which include Abilify, the nation's No. 1 prescription drug by sales. The drugs were originally developed to treat psychoses such as schizophrenia, but some now have Food and Drug Administration approval for treatment of children with conditions such as bipolar disorder and irritability associated with autism.
The entire story is here.
The Wall Street Journal
Originally published August 12, 2013
Federal health officials have launched a probe into the use of antipsychotic drugs on children in the Medicaid system, amid concern that the medications are being prescribed too often to treat behavioral problems in the very young.
The inspector general's office at Department of Health and Human Services says it recently began a review of antipsychotic-drug use by Medicaid recipients age 17 and under. And various agencies within HHS are requiring officials in all 50 states to tighten oversight of prescriptions for such drugs to Medicaid-eligible young people.
The effort applies to a newer class of antipsychotic drugs known as "atypicals," which include Abilify, the nation's No. 1 prescription drug by sales. The drugs were originally developed to treat psychoses such as schizophrenia, but some now have Food and Drug Administration approval for treatment of children with conditions such as bipolar disorder and irritability associated with autism.
The entire story is here.
Thursday, July 25, 2013
Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs
Light, Donald W., Lexchin, Joel and Darrow, Jonathan J. , Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs (June 1, 2013). Journal of Law, Medicine and Ethics, Vol. 14, No. 3, 2013.
Abstract:
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.
The entire article is here and available for download.
Abstract:
Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board.
The entire article is here and available for download.
Sunday, December 30, 2012
Amgen Agrees to Pay $762 Million for Marketing Anemia Drug for Off-Label Use
By ANDREW POLLACK and MOSI SECRET
The New York Times
Published: December 18, 2012
The biotechnology giant Amgen marketed its anemia drug Aranesp for unapproved uses even after the Food and Drug Administration explicitly ruled them out, federal prosecutors said on Tuesday.
The federal charges were made public as Amgen pleaded guilty to illegally marketing the drug and agreed to pay $762 million in criminal penalties and settlements of whistle-blower lawsuits.
Amgen was “pursuing profits at the risk of patient safety,” Marshall L. Miller, acting United States attorneyin Brooklyn, said in a telephone news briefing on Tuesday.
David J. Scott, Amgen’s general counsel, entered the guilty plea at the United States District Court in Brooklyn to a single misdemeanor count of misbranding the drug, Aranesp, meaning selling it for uses not approved by the F.D.A.
Amgen agreed to pay $136 million in criminal fines and forfeit $14 million, with about $612 million going to settle civil litigation.
The entire article is here.
Friday, September 7, 2012
Do Post-Market Drug Trials Need a Higher Dose of Ethics?
Patients who sign up for trials testing more than one already approved intervention do not always know if one is being tested for harmful side effects
By Katherine Harmon
Scientific American
Originally published August 23, 2012
Here is an excerpt:
What you might not know—even after you sign up for the trial and have inked the informed-consent form—is that scattered reports are starting to suggest that the new medication might occasionally cause severe side effects. And the real reason the trial is being conducted with these previously released drugs is to test whether the new medication really is a lot riskier to everyone or just to a subset of patients.
This is one of the big ethical holes often left open in post-market trials, says Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics, who co-authored a new essay on this topic in The New England Journal of Medicine, which was published online August 22. She and a team of co-authors released a formal Institute of Medicine (IOM) report earlier this year recommending that the FDA improve this and other ethical aspects of post-market trials—especially those it requires.
Creation of a Central Management Plan for Every New Drug Needed to Strengthen FDA's Oversight of Approved Drugs' Safety
National Academies of Sciences
Released May 1, 2012
The entire news release is here.
Released May 1, 2012
Although the approval of a new drug is based on evidence that its benefits outweigh its risks, the full range of a medication's effects may not become apparent until a product has been used by a larger, more diverse population over an extended period of time. Problems associated with the anti-diabetes drug Avandia, pain reliever Vioxx, and cholesterol-reducing drug Crestor illustrate the challenges and underscore the need for a more systematic and transparent process to collect, assess, and act on data about a medication's benefit-risk profile throughout its entire "life cycle" from approval until it is no longer marketed, says a new report by the Institute of Medicine.
According to recent estimates, nearly half of all Americans take at least one prescription drug daily and many older people use five or more, noted the committee that wrote the report. The report's recommendations build on the new authorities and tools provided to the U.S. Food and Drug Administration through the Food and Drug Administration Amendments Act of 2007, which increased the agency's capacity to monitor drugs after approval and act if signs of safety problems appear.
One of the committee's key recommendations is that FDA should create a benefit and risk assessment and management plan for each drug. This would be a single, comprehensive, publicly available document that serves as a central repository of information for each product from its approval throughout its entire time on the market. The document should include a description of any safety questions that exist when a drug is approved or that emerge over the course of the product's use, as well as benefit and risk assessments specific to these questions. It should also include details on regulatory actions taken on the medication, such as restrictions on its use or the decision to require further research, as well as the results of these actions. Much of this information is already being gathered by FDA, but it is currently scattered across multiple records. Putting the information into an accessible format in a single document would make FDA's commitment to the life-cycle approach concrete and improve its transparency by giving the public easier access to useful data.
The entire news release is here.
Sunday, July 22, 2012
Investigation Sought of Extensive F.D.A. Surveillance
By Eric Lichtblau
The New York Times
Originally published July 16, 2012
Federal health officials faced pressure from Capitol Hill and outside groups on Monday to investigate a wide-ranging surveillance program that the Food and Drug Administration mounted against a group of its scientists who raised warnings about the safety of medical imaging devices.
Representative Chris Van Hollen, a Maryland Democrat, sent a letter on Monday to Kathleen Sebelius, the secretary of health and human services, calling on her to conduct a full investigation into whether the surveillance program violated federal employee protections and whistle-blower laws.
“The tactics reportedly used by the F.D.A. send a terrible message to those who are prepared to expose waste, abuse or wrongdoing in government agencies,” wrote Mr. Van Hollen, whose staff communications were monitored by the F.D.A.
The entire story is here.
The New York Times
Originally published July 16, 2012
Federal health officials faced pressure from Capitol Hill and outside groups on Monday to investigate a wide-ranging surveillance program that the Food and Drug Administration mounted against a group of its scientists who raised warnings about the safety of medical imaging devices.
Representative Chris Van Hollen, a Maryland Democrat, sent a letter on Monday to Kathleen Sebelius, the secretary of health and human services, calling on her to conduct a full investigation into whether the surveillance program violated federal employee protections and whistle-blower laws.
“The tactics reportedly used by the F.D.A. send a terrible message to those who are prepared to expose waste, abuse or wrongdoing in government agencies,” wrote Mr. Van Hollen, whose staff communications were monitored by the F.D.A.
The entire story is here.
In Vast Effort, F.D.A. Spied on E-Mails of Its Own Scientists
By Eric Lichtblau and Scott Shane
The New York Times
Originally published July 15, 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.
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.
The New York Times
Originally published July 15, 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.
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.
Saturday, August 13, 2011
Useless Studies, Real Harm
By Carl Elliot
The New York Times
LAST month, the Archives of Internal Medicine published a scathing reassessment of a 12-year-old research study of Neurontin, a seizure drug made by Pfizer. The study, which had included more than 2,700 subjects and was carried out by Parke-Davis (now part of Pfizer), was notable for how poorly it was conducted. The investigators were inexperienced and untrained, and the design of the study was so flawed it generated few if any useful conclusions. Even more alarming, 11 patients in the study died and 73 more experienced “serious adverse events.” Yet there have been few headlines, no demands for sanctions or apologies, no national bioethics commissions pledging to investigate. Why not? One reason is that the study was not quite what it seemed. It looked like a clinical trial, but as litigation documents have shown, it was actually a marketing device known as a “seeding trial.” The purpose of seeding trials is not to advance research but to make doctors familiar with a new drug.
In a typical seeding trial, a pharmaceutical company will identify several hundred doctors and invite them to take part in a research study. Often the doctors are paid for each subject they recruit. As the trial proceeds, the doctors gradually get to know the drug, making them more likely to prescribe it later.
In an age of for-profit clinical research, this is the new face of scandal. Pharmaceutical companies promote their drugs with pseudo-studies that have little if any scientific merit, and patients naïvely sign up, unaware of the ways in which they are being used. Nobody really knows how often companies conduct such trials, but they appear with alarming regularity in pharmaceutical marketing documents. In the marketing plan for the antidepressant Lexapro for the 2004 fiscal year, Forest Laboratories described 102 Phase IV trials — the classification under which seeding trials fall — in a section labeled “Marketing Tactics.”
Oversight bodies like the Food and Drug Administration generally don’t view seeding trials as research scandals: seeding trials are not illegal, and the drugs in question have already received F.D.A. approval. But even after particularly egregious seeding trials have been exposed, the F.D.A. has not issued sanctions. Take the notorious Advantage study, a seeding trial of the pain reliever Vioxx conducted by Merck. According to a 2008 report in the Annals of Internal Medicine, litigation documents show that the Advantage study was conceived and managed by Merck’s marketing department. Three subjects died in the Advantage trial; five more subjects experienced heart attacks. Oversight bodies should treat the Advantage study as a violation of research ethics.
The entire story can be read here.
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