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The Food and Drug Administration (FDA) routinely fails to report evidence of fraud or misconduct when it inspects the way researchers conduct clinical trials, leaving the public unaware of which research is credible and which isn’t.
Researchers at New York University found that in dozens of published papers where the FDA had uncovered faults in clinical trials, only three ever indicated that violations occurred. In a stem cell trial, for example, all patients were said to have experienced improvement – despite one having a foot amputated.
The New York University study examined 57 clinical trials that received a notice of violation from the FDA for poor record keeping, false information, and poor patient study. Researchers found that findings from those clinical trials were used in 78 published papers – but only in three instances were the faults in the clinical trials mentioned in the papers.
In the other cases, none of the published papers containing data from faulty trials were corrected or retracted.
“These are major things,” Professor Charles Seife, the study’s author, told Reuters. “No one really knows unless you go through these documents that anyone is question the integrity of the trials.”
In one case, an entire clinical trial was considered unreliable by the FDA, but the published paper didn’t mention the violation at all. In another trial, researchers covered up a patient’s death.
Of the 57 published clinical trials, 39 percent had evidence of false information, 25 percent reported adverse events, 61 percent had record keeping problems, and 35 percent failed to protect the safety of the patient or had issues with oversight or informed consent.
“The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market,” Seife wrote at Slate. “For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.”
Seife said his team could have uncovered even more instances from the 600 clinical trials mentioned in the documents, but most of the documents obtained from the FDA were heavily redacted. “In some cases, you can’t even tell which drug is being tested,” he said.
Every year, the FDA inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of violations of good clinical practices and misconduct. The study said, however, that the FDA has no systematic method for communicating these findings to the scientific community, and its findings go unremarked in peer-reviewed literature.
In a statement to Reuters, the FDA said it is “committed to increasing the transparency of compliance and enforcement activities with the goal of enhancing the public’s understanding of the FDA’s decision, promoting the accountability of the FDA, and fostering an understanding among regulated industry about the need for consistently safe and high-quality products.”
The FDA/CVM: From: http://www.governmentguide.com/govsite.adp?bread=*Main&url=http%3A//www.governmentguide.com/ams/clickThruRedirect.adp%3F55076483%2C16920155%2Chttp%3A//www.fda.gov
Center for Veterinary Medicine
The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. (Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats.)
The "Mission Statement" claims: "The Center for Veterinary Medicine is a consumer protection organization. We foster public and animal health by approving safe and effective products for animals and by enforcing other applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities."
Monitors approved veterinary drugs and food additives to assure their continued safety and effectiveness.
From: GingerLSanchez@aol.com [mailto:GingerLSanchez@aol.com]
Sent: Thursday, October 14, 2004 9:48 PM
Subject: Information RequestDo you have or are you allowed to provide what the annual user fees for 2005 will be for a specific drug? If you have the information and are allowed to provide it to me, I would like to know how much Pfizer Drug Company will be paying for the 2005 user fee for the drug "Rimadyl", as well as what their user fee for the same drug was in 2004. Thank you.Ginger Sancheze-Mail [ONLY]: GingerLSanchez@aol.com
Dear Ginger,The FY2005 ADUFA fees were published in the Federal Register on August 2, 2004, and can be obtained either through the Government Printing Office websitehttp://www.gpoaccess.gov/fr/index.html) or through the CVM websiteThere is only one annual sponsor fee. The annual products and establishment fees are based on the number of products and establishments, respectively. The application fee is charged per applicationThis information is public.Sincerely,Margaret Zabriski
Margaret A. Zabriski, Ph.D.FDA/CVM ADUFA AdministratorData Applications Staff, HFV-0167519 Standish PlaceRockville, MD 20855e-mail: CVMADUFA@FDA.govvoicemail: (301) 827-3845fax: (301) 827-4064
The Animal Drug User Fee Act of 2003 (ADUFA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and authorizes FDA to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications, in support of the review of animal drugs. These additional resources will support FDA’s responsibilities under the FFDCA to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption.
This program is similar to the very successful program for human drugs that has been in place for over ten years. Like the Prescription Drug User Fee Act, and the recently enacted Medical Device User Fee and Modernization Act, this legislation will help FDA expedite and improve its review of applications for new animal drugs so that safe and effective new products will be available more quickly.
FDA is working to prepare for the implementation of the user fee program. A significant part of the preparations include determining the fee levels for fiscal year 2004. That work is underway. The ADUFA provides for four fees: 1) a sponsor fee, 2) an establishment fee, 3) a product fee and 4) an application fee. The bill also provides for specific waivers and exemptions from fees. FDA is working to prepare guidance for the industry regarding the fees, billings and submission of fees, as well as waivers and exemptions.
The total amount of money that would be collected if the bills are enacted would be $5 million in fiscal year 2004, $8 million in fiscal year 2005, and $10 million in each fiscal year 2006 through 2008. About 25% of the total amount to be collected will be received through each fee type. So, in fiscal year 2004, we expect to receive $1, 250,000 from sponsor fees and the same amount from establishment fees, product fees and application fees. Accordingly, the fees that will be assessed will be substantially lower than those collected through the Prescription Drug User Fee Act.
The animal health industry is a $4 billion industry. The user fees will be used to achieve shorter, more predictable review times by increasing the review staff at CVM and building better management systems. As a result, we anticipate substantial savings to the industry in regulatory review and developmental expenses.
The Agency animal drug pre-market review program strives to provide an adequate supply of safe and effective drugs to meet the therapeutic and production needs of animal owners. By doing so. the public health is protected by providing safe and effective animal drugs with labeled directions for safe use. FDA is committed to making this operation as effective as possible. With the advent of user fees, FDA is looking forward to a new opportunity to make substantial improvements in the animal drug review processes.
CVM Update - FDA Announces FY 2005 Animal Drug User Fee Rates, August 2, 2004
Federal Register Notice - CVM 200461. Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2005. Pages 46147-46151 [FR Doc. 04-17441] August 2, 2004 [TXT] [PDF]
CVM UPDATE - FDA Announces Animal Drug User Fee Rates for FY04, February 18, 2004
Federal Register Notice - CVM 20049. Establishment of Animal Drug User Fee Rates for Applications for Fiscal Year 2004 and Payment Procedures. Pages 7646-7649 February 18, 2004 [FR Doc. 04-03410] | htm | | pdf |
The Animal Drug User Fee Cover Sheet - is required for your Animal Drug Application Submission. By completing this cover sheet, you will be assigned a unique Payment Identification Number that distinguishes your fee payment and submission.
Guidance for Industry #173- Animal Drug Sponsor Fees under the Animal Drug User Fee Act (ADUFA), Draft Guidance, Spetember 28, 2004 | pdf| | doc | Appendix | pdf | | doc |
Guidance for Industry #170 - Animal Drug User Fees and Fee Waivers and Reductions, Final Guidance, March 15, 2004 | pdf |doc |
Draft Guidance Available on Sponsor Fees Under ADUFA, September 28, 2004
FDA Announces FY 2005 Animal Drug User Fee Rates, August 2, 2004
ADUFA Cover Sheet and Guidance Available, March 16, 2004
FDA Announces Animal Drug User Fee Rates for FY04, February 18, 2004
Federal Register Notice
CVM 200450. Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act; Availability. Pages 57941-57942 [FR Doc. 04-21677] | htm | | pdf | Comments due October 28, 2004
CVM 200461. Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2005. Pages 46147-46151 [FR Doc. 04-17441] August 2, 2004 [TXT] [PDF]
OC 2004100. Establishment of Animal Drug User Fee Rates and Payment Procedures for Product, Establishment, and Sponsor Fees for Fiscal Year 2004. Pages 22846-22849 [FR Doc. 04-09565] April 27, 2004 [TXT] [PDF]
CVM 20049. Establishment of Animal Drug User Fee Rates for Applications for Fiscal Year 2004 and Payment Procedures. Pages 7646-7649 February 18, 2004 [FR Doc. 04-03410]
CVM 2003137. Animal Drug User Fee Act of 2003; Interim Procedures. Page 2146
[FR Doc. 04-00812] | htm | | pdf |
Public Law 108—130 (Animal Drug User Fee Act of 2003), 108th Congress
November 18, 2003 | pdf |
FDA News Releases
President Signs New Law Providing User Fees to Improve Animal Drug Review -
November 19, 2003
ADUFA Implementation Letter
Important Information: Passage of the Animal Drug User Fee Act of 2003
Animal Drug User Fee Act Performance Goals and Procedures
Presidential Signing Statement
Statement on Signing the Animal Drug User Fee Act of 2003 - November 18, 2003
"Statement on Signing the Animal
Drug User Fee Act of 2003
November 18, 2003
Today, I have signed into law S. 313, the
‘‘Animal Drug User Fee Act of 2003.’’ The
Act is designed to expedite the animal drug
development process, while continuing to ensure
the safety and effectiveness of animal
Section 4(a) of the Act purports to require
the Secretary of Health and Human Services
to submit legislative recommendations to the
Congress and to establish procedures by
which the Secretary must formulate such recommendations.
The legislative power does
not extend to requiring the Executive submit
legislative recommendations to the Congress
nor to specifying procedures by which the
Executive must formulate any legislative recommendations
that the Executive makes.
The executive branch shall execute section
4(a) in a manner consistent with the Constitution’s
exclusive commitments to the
President of the authority to submit for the
consideration of the Congress such measures
as he judges necessary and expedient and the authority to supervise the unitary executive branch.
George W. Bush
The White House,
November 18, 2003.
NOTE: S. 313, approved November 18, was assigned
Public Law No. 108–130.
Message to the Congress
Transmitting the National Money
November 18, 2003
To the Congress of the United States:
Consistent with section 2(a) of the Money
Laundering and Financial Crimes Strategy
Act of 1998 (Public Law 105–310; 31 U.S.C.
5341(a)(2)), enclosed is the 2003 National
Money Laundering Strategy, prepared by my
George W. Bush
The White House,
November 18, 2003.]
Other User Fee Info:
For general questions regarding ADUFA, please send your inquiries to firstname.lastname@example.org
Web page updated by mdt, September 28, 2004, 12:06 PM ET
By Dennis Cauchon, USA TODAY
More than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions, a USA TODAY study found.
These experts are hired to advise the Food and Drug Administration on which medicines should be approved for sale, what the warning labels should say and how studies of drugs should be designed.
The experts are supposed to be independent, but USA TODAY found that 54% of the time, they have a direct financial interest in the drug or topic they are asked to evaluate. These conflicts include helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug.
The conflicts typically include stock ownership, consulting fees or research grants.
Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but the FDA has waived the restriction more than 800 times since 1998.
These pharmaceutical experts, about 300 on 18 advisory committees, make decisions that affect the health of millions of Americans and billions of dollars in drugs sales. With few exceptions, the FDA follows the committees' advice.
The FDA reveals when financial conflicts exist, but it has kept details secret since 1992, so it is not possible to determine the amount of money or the drug company involved.
A USA TODAY analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through last June 30 found:
At 92% of the meetings, at least one member had a financial conflict of interest.
At 55% of meetings, half or more of the FDA advisers had conflicts of interest.
Conflicts were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts.
At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.
"The best experts for the FDA are often the best experts to consult with industry," says FDA senior associate commissioner Linda Suydam, who is in charge of waiving conflict-of-interest restrictions.
But Larry Sasich of Public Citizen , an advocacy group, says, "The industry has more influence on the process than people realize."
By Dennis Cauchon, USA TODAY
In October, pharmaceutical giant Johnson & Johnson sent a team of executives to a Holiday Inn ballroom in Silver Spring, Md.
Their job: persuade the Food and Drug Administration's panel of independent experts that an expensive antibiotic, Levaquin, should be the first drug approved to treat penicillin-resistant pneumonia.
For Johnson & Johnson executives, the FDA's Anti-Infective Drug Advisory Committee included some familiar faces. At least two of the experts were paid consultants to the drug company and had worked on the very same medicine that they were being asked to evaluate for approval in an important new market.
The expert panel's "consumer representative," whose assignment is to defend consumers' interests, had the most extensive financial relationship with Johnson & Johnson. Keith Rodvold, a pharmacy professor at the University of Illinois-Chicago, serves on a company anti-infective drug advisory board, according to Johnson & Johnson spokesman Marc Monseau. Rodvold advised the company on how to design and analyze the clinical trials that got the drug approved. In 1999, he designed a study to measure how Levaquin is absorbed in the lungs. The company also uses him regularly as an consultant on a variety of issues, Monseau says.
Rodvold declined to discuss his relationship with Johnson & Johnson and his work on Levaquin. The company declined to say how much Rodvold had been paid during the five years he has consulted for it.
The case of Levaquin reveals how deeply pharmaceutical industry money and influence penetrates the drug approval process. FDA advisory committees consist almost entirely of pharmaceutical industry consultants and researchers. Even consumers' and patients' representatives on the committees often receive drug company money.
At least one committee member had a financial stake in the topic under review at 146 of 159 FDA advisory committee meetings, according to a USA TODAY study of advisory committee meetings held from Jan. 1, 1998, through June 30, 2000. At 88 of those meetings, at least half the advisory committee members had financial interests in the topic being evaluated.
Eighteen FDA advisory committees play a crucial role in nearly every major decision on drug regulation. They help decide what drugs should be approved and how the pharmaceutical industry should be regulated. In recent years, the FDA has followed every advisory committee recommendation to approve or reject a medicine - except once, FDA spokeswoman Susan Cruzan says. (The FDA approved the flu drug Relenza in July 1999 despite an advisory committee voting 13-4 against approval.)
Investors follow advisory committees closely. A committee vote can add or subtract hundreds of millions of dollars from a drug company's stock market value.
The FDA is required by law to screen all committee members for financial conflicts. The law says members have conflicts when committee action could have the "direct and predictable effect" of causing the member a financial gain or loss. The federal agency is forbidden from using experts with financial conflicts unless a waiver is granted, usually on the grounds that the experts' value outweighs the seriousness of the conflict. The FDA grants these waivers routinely.
In the period analyzed by USA TODAY, the FDA granted 803 conflict-of-interest waivers. Seventy-one other times, members had financial conflicts that were voluntarily disclosed but did not require a waiver. In the 746 other member appearances on the committees, there was no conflict of interest.
The FDA says granting waivers lets it tap the nation's leading researchers, most of whom do work for the pharmaceutical industry.
"The system is designed to bring together the best scientific experts we can find," says FDA associate commissioner Linda Suydam, who approves waivers.
She says conflict-of-interest waivers go through as many as eight levels of review before they are granted. But Larry Sasich, a pharmacist who works for the Ralph Nader-founded Public Citizen's Health Research Group, says, "It is outrageous that the pharmaceutical industry's influence is so great that even some consumer representatives are on drug companies' payrolls."
Sasich says it might sometimes make sense to let experts with financial conflicts participate, but "it should be rare and that person should not be allowed to vote."
Financial conflicts were most common when committees considered broader issues, such as warnings labels for pregnant women or how cancer studies should be designed. At the 57 meetings on regulatory policy, committee members had conflicts 91% of the time.
At the 102 meetings involving specific drugs, 33% of committee members had a direct financial stake in the outcome.
It is impossible to determine how advisory committee decisions might have been influenced by the financial relationships its members have. The FDA stopped making details of financial conflicts public in 1992, after controversies about whether the financial interests of committee members had biased decisions on breast implants, Prozac and a drug to treat Alzheimer's disease. The FDA says it stopped releasing details on conflicts because of concerns about violating the privacy rights of committee members, not because of the controversies.
Types of conflicts
Financial conflicts include stock ownership, consulting fees, research grants, a spouse's employment and payments for speeches and travel. The conflict could be a tie to the company whose drug is under consideration or to a company that sells a competing drug.
Many financial conflicts are considered too small to require disclosure or a waiver and were not counted in USA TODAY's study. For example, a committee member can be paid up to $50,000 a year by a drug company without any financial conflict being disclosed if the work was on a topic other than what the committee is evaluating, according to FDA guidelines. Committee members also can own up to $5,000 in stock in the company appearing before the committee.
Advisory committees include many of the nation's leading researchers. The pay is not high considering the stature of many members: about $400 a day for meetings, plus travel expenses, and nothing for work done outside a meeting. However, the assignments are prestigious, and committee members, whose terms last four years, are in heavy demand as industry consultants.
Conflicts are most common on the committees that consider heart drugs. Forty-eight percent of experts had financial conflicts when considering the worthiness of specific heart medicines.
"The greater degree of expertise, the greater the potential for conflicts," says Milton Packer, chairman of the Cardiovascular and Renal Drugs Advisory Committee.
Packer is a good example. He is a leading figure in cardiovascular research and has helped pioneer the development of drugs to treat congestive heart failure. Last year, he led an effort by 150 leading cardiac researchers to establish consensus guidelines on how to treat congestive heart failure, which is suffered by 5 million Americans.
But his work with pharmaceutical companies creates many financial conflicts. The FDA granted him a waiver that allowed him to participate in a meeting May 2 on the drug Refludan, which treats clotting. (Packer says he doesn't recall what the conflict was.) And Packer did not participate in a meeting May 1 on the heart drug Altace because of a financial conflict. (He declines to say what the conflict was.)
Packer says consolidation in the pharmaceutical industry has increased the potential for conflicts because there are fewer companies and nearly all have heart drugs.
Financial conflicts are so common that eight of 10 members who evaluated the drug Aggrastat, made by Merck, had conflicts of interest.
Packer says he doesn't believe that financial conflicts distort the recommendations of advisory committees: " There are so many checks and balances, it would be almost impossible for a single individual to steer the committee."
At the meeting on October 20, 1999, on Levaquin, the chairman of the committee and one other member stepped aside because of financial conflicts.
Of the 10 members remaining, four had received conflict-of-interest waivers from the FDA.
In addition to Rodvold, New Jersey physician Carl Norden had consulted for Johnson & Johnson in 1997 on the design of Levaquin studies for illnesses other than the treatment of penicillin-resistant pneumonia, the company said.
Johnson & Johnson says having its consultants on the advisory committee didn't create bias.
"We don't believe (advisory panel members) would let a consulting arrangement compromise their reputation and stature in the medical community," says Monseau, the Johnson & Johnson spokesman.
The advisory committee voted unanimously to recommend that Levaquin, an $8-per-pill antibiotic, be approved for treatment of penicillin-resistant pneumonia. The FDA ratified the decision in February. Levaquin has been on the market since 1997, but the FDA's action allows Johnson & Johnson to market the medicine as the first antibiotic approved for the more than 25% of pneumonia cases that are resistant to penicillin.
Industry influence on advisory committees will increase later this year. As required by a law approved in 1997, the FDA will add official industry representatives to the committees. The industry officials will participate in deliberations, but they will not be allowed to vote.
These articles originally appeared in the USA TODAY September 25, 2000 edition on-line.
|FDA under pressure for rehab|
Scrutiny after Vioxx focuses on turf battles, independence
The greatness of a nation and its moral progress can be judged by the way it's animals are treated.
-- Mohandas Gandhi
May my beloved partner ROMI rest in peace - no matter wherever her bits and pieces/frozen carcass may be held hostage.
[what's in YOUR "urn" ?]