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 February 10, 2015 - It's been a little over 10 years since ROMI was killed by a greedy and corrupt lying veterinarian via the greed, lies and corruption of the FDA, and NOW . . .

WHAT . . . .
 
 
THE FDA LIES AND COVERS STUFF UP ?
 
 

     I can see clearly now . . .  

http://rt.com/usa/230807-fda-coverup-faulty-trials/

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.

READ MORE: GMO potato seeks FDA approval, opponents say safety risks remain

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.

READ MORE: Millions of GMO mosquitoes may be released in Florida neighborhood

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.”

READ MORE: US spends most on this drug… and no one knows how it works


       
 
-----Original Message-----
From: LuSwinton <LuSwinton@aol.com>
To: doghealth2 <doghealth2@yahoogroups.com>
Sent: Tue, Feb 10, 2015 5:30 am
Subject: OT: Fwd: FDA fails to report fraud in clinical trials – study — RT USA

For your information/cross posting.
Jean
(Always for George - Always for the Rimadyl Dogs)

Sent: 2/10/2015 12:30:14 A.M. Eastern Standard Time
Subj: FDA fails to report fraud in clinical trials – study — RT USA

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

Information About
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.)

Mission Statement

Poster of CVM's Mission Statement

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.


-----Original Message-----
From: GingerLSanchez@aol.com [mailto:GingerLSanchez@aol.com]
Sent: Thursday, October 14, 2004 9:48 PM
To: cvmadufa@fda.gov
Subject: Information Request


Do 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 Sanchez
e-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 website
http://www.gpoaccess.gov/fr/index.html) or through the CVM website
(http://www.fda.gov/cvm/index/adufa/adufa.htm)
 
There 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 application
 
This information is public.
Sincerely,
Margaret Zabriski
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Margaret A. Zabriski, Ph.D.
FDA/CVM ADUFA Administrator
Data Applications Staff, HFV-016
7519 Standish Place
Rockville, MD 20855
e-mail: CVMADUFA@FDA.gov
voicemail: (301) 827-3845
fax: (301) 827-4064

from: http://www.fda.gov/cvm/index/adufa/adufa.htm
 
Animal Drug User Fee Act of 2003 (ADUFA)

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.

Fees

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 |

Forms

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 Documents

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 |

CVM Updates

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 |

The Law

FDA News Releases

ADUFA Implementation Letter

  • Important Information: Passage of the Animal Drug User Fee Act of 2003

  • Performance Goals

  • 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

from: http://www.fda.gov/cvm/index/adufa/Pres%20signing%20statement.pdf

"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
drugs.
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
Laundering Strategy
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
Administration.
George W. Bush
The White House,
November 18, 2003.]

Other User Fee Info:

Contact Information:

For general questions regarding ADUFA, please send your inquiries to cvmadufa@fda.gov

Web page updated by mdt, September 28, 2004, 12:06 PM ET


CONFLICTS OF INTEREST

from: http://mercola.com/2000/oct/1/fda_drug_approvals.htm

FDA Advisers Tied to Industry

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."

Number of drug experts available is limited

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.

Powerful panels

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.


http://www.marketwatch.com/news/yhoo/story.asp?source=blq/yhoo&siteid=yhoo&dist=yhoo&guid=%7B9ECFFAB0%2D8A2E%2D44CC%2DBD0E%2D55FE76280493%7D
 
FDA under pressure for rehab
Scrutiny after Vioxx focuses on turf battles, independence
By Laura Gilcrest, CBS MarketWatch
Last Update: 5:12 PM ET Dec. 7, 2004 

WASHINGTON (CBS.MW) -- The recent fiasco over the Vioxx recall has exposed the U.S. Food and Drug Administration to broad-based charges that the agency is less an independent regulatory body than an old-guard bureaucracy where senior officials snuff out dissenting voices among its scientific staff members.

With prescription drug safety under renewed scrutiny following the recall of the painkiller by Merck & Co. (MRK: news, chart, profile), pressure is mounting in Washington to revamp an agency accused of making its rank-and-file scientists tow the party line.

"If you're not with the wagon riders, you're outside looking in," said Larry Pilot, a former FDA official who now represents drug companies doing business before the agency. "In a bureaucracy [like FDA], it's easy to push people aside and keep them quiet."

At stake is the future of an agency overseeing an industry with annual revenues exceeding $200 billion. The FDA handles dozens of applications for new drugs each year, any one of which could turn into a treatment with blockbuster sales potential.

However, some critics say that when FDA officials find an approved drug may need to be pulled off the market, their conclusions get swept up in turf battles inside the agency's sprawling Center for Drug Evaluation and Research.

Moreover, some observers believe that the bureaucracy is underfunded and overly reliant on a budget backed by industry-paid fees.

In late 2002 and 2003, the agency approved 55 new drug applications that were submitted sometime during 2002. Last year, the FDA received 113 applications.

Since 1990, 14 approved drugs have been taken off the market for safety reasons, according to Public Citizen, the Washington watchdog group.

But as in the Vioxx case, it's usually the pharmaceutical companies themselves, not the FDA, that take the drugs off the market. If follow-up tracking by companies points to a problem with a drug, the companies consult with the FDA and then call for a voluntary recall.

Outside agency?

A number of reform scenarios are being debated. One option could be to create an independent body charged with monitoring drug risks after they hit the market, an idea supported by Sen. Charles Grassley, R-Iowa, chairman of the Senate committee that heard Graham's testimony, and the editors of the Journal of the American Medical Association.

Currently, the Office of Drug Safety, a unit of the FDA's powerful Center for Evaluation of Drug Research, monitors potential post-market risks or problems that went undetected in clinical trials.

The concept of a new oversight arm gained momentum after an Office of Drug Safety whistleblower's widely publicized testimony on Capitol Hill last month laid bare divisions within the bureaucracy that employs more than 9,000 people.

Having FDA officials review the safety of drugs that are already on the market creates a conflict of interest, the plan's proponents say. It means the agency must second-guess its own initial findings that a drug is safe.

Agency critics including Sidney Wolfe, director of health research at Public Citizen, say top FDA officials have failed to back up findings of the Office of Drug Safety when its staff people raised red flags over risks of certain pharmaceuticals.

Whistle-blower

In the most explosive such charge to date, David Graham, associate director of science and medicine at the Office of Drug Safety, went before Congress last month to declare that the agency's structure isn't equipped to protect the public from another Vioxx debacle.

Graham reportedly could face retaliation for speaking out on Capitol Hill, and higher-ups quickly sought to undercut his testimony,

Graham had led an FDA post-market study of Vioxx and first warned of the drug's link to an increased risk of heart attack and stroke with long-term use.

"One employee in the agency was saying that something needed to be done," Pilot said. "You must pay attention to these messages."

Mark Mansour, another Washington, D.C.-based regulatory attorney, said dissenting opinions at the agency often don't see the light of day.

"I've seen that with less important situations and I wonder if it represents something broader," he said.

The Vioxx affair was only the most recent case in which minority voices were drowned out by a consensus view that a new drug was safe for the marketplace.

Earlier, an agency staff member had tried to warn superiors after a new class of antidepressants -- known as selective serotonin re-uptake inhibitors -- was linked to an increased risk of suicidal behavior in children, Pilot noted.

"There was one voice crying in the wilderness [but] FDA didn't listen," he said. "It's another black mark on the agency."

Industry lobbyists say that although creating a new independent agency might increase oversight, they worry about adding another layer of red tape to the existing bureaucracy. And there's nothing to prevent bias in what is supposed to be an independent agency, they say.

"The notion that something is structurally wrong [with FDA] is fundamentally misguided," said Stuart Pape, a lawyer who represents drug companies.

Balancing act

Pape says to separate pre-market drug review from post-market drug monitoring would dismantle the classic risk-benefit analysis, the underlying balancing act at the heart of every drug safety assessment.

Taking the post-market monitoring function out of the FDA's hands would result in a lopsided analysis that focuses on a drug's risks without considering its benefits, he contended.

In monitoring a drug after it's on the market, the agency determines whether its risk-benefit profile has changed since it was first approved, which is often the case as new side effects emerge that were not seen in the drug's clinical trials. Pape said.

On the other hand, the FDA could do a better job of scrutinizing marketed drugs, especially the ones that turn out to be more widely prescribed than originally contemplated, he added.

Public Citizen's Wolfe said that whether post-market drug monitoring is taken out of FDA altogether or merely split off from the agency's Center for Drug Evaluation and Research and given a separate office, the real issue is one of power.

"There's an extraordinary imbalance of power at FDA," he said.

As it now stands, the agency doesn't decide that a particular drug poses a problem until thousands of people are injured or killed, Wolfe said.

A separate drug-oversight arm won't make any difference in public safety if the Center for Drug Evaluation and Research can still trump its decisions about marketed drugs, he said. What's really needed is more congressional oversight of FDA and an end to the drug review system's reliance on industry-paid fees, Wolfe argued.

"The power of CDER is funded in large measure by industry," he said.

Drug act

Under the Prescription Drug User Fee Act of 1992, drug companies pay pre-set fees with new drug applications that help FDA speed application review times by, for example, hiring additional medical reviewers.

But while the law has cut drug review times significantly, groups like Public Citizen claim the law actually allows industry to trade cash for favorable decisions on new products.

Wolfe said that FDA's mission in ensuring drug safety is too important to be left to industry funding, and should instead be adequately funded by Congress.

At the very least, many observers say, the FDA needs to strip away redundant layers of bureaucracy that hinder communication and give its dissenting scientists more say about a particular drug's safety.

Pilot, who worked as a special assistant to FDA commissioner for 10 years, said it should foster an atmosphere where scientists know they'll get a fair hearing when they express minority views about a drug.

"Why be frightened of the possibility that maybe there was a mistake made?" he said.


from: http://www.billingsgazette.com

http://www.billingsgazette.com/index.php?id=1&display=rednews/2004/12/08/build/nation/40-heart-drug.inc

Billings Gazette

Last modified December 8, 2004 - 12:35 am
 
FDA to warn against heart drug after delay

WASHINGTON - After a delay of more than a year, the Food and Drug Administration has approved publication of new patient warnings for a potentially risky heart drug that millions of Americans are taking.

Patients taking amiodarone can read the new warnings on the Internet at www.wyeth.com beginning next week and will soon start receiving paper copies when they get or refill prescriptions.

The FDA's action comes two weeks after Knight Ridder reported the delay, prompting an outcry from readers who said they've lost loved ones or suffered side effects from the drug, and as the agency is under fire for failing to protect consumers from dangerous drugs.

FDA officials had no comment Tuesday. The agency hasn't responded to Knight Ridder's repeated requests for information about why publication of the amiodarone medication guide - planned since October 2003 - has taken so long.

The guide is undergoing a final edit and will be posted on the Web sometime next week, said Chris Garland, a spokesman for Wyeth, the drug maker assigned to write it. Details of the guide's contents weren't available Tuesday.

In general, such guides contain detailed warnings about potential side effects, how the drug should be used and what conditions the FDA has approved it to treat. Amiodarone, also sold under the brand names Cordarone and Pacerone, has numerous serious and fatal side effects, including lung toxicity, thyroid problems and liver damage.

Because of its dangers, the FDA approved amiodarone only as a drug of last resort for specific life-threatening heart rhythm conditions, called ventricular arrhythmias. But over time, it's gained favor with cardiologists as a treatment for atrial fibrillation, a common and less serious heart rhythm condition it was never approved to treat.

According to recent pharmaceutical industry data, doctors wrote more than 2 million prescriptions in a single year for atrial fibrillation and other heart conditions that the drug wasn't approved to treat. For the year ending July 31, 2003, 82 percent of the drug's retail sales were for unapproved uses, a Knight Ridder analysis found last year.


 


 

 
 

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" ?]


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