Avon Breast Cancer Walkers: A Scientist Was Jailed For Faking Cancer Research Results
London England, UK ( AP ) Barron's Medical Journal Reports the first scientist to be sent to jail for faking 
the results of scientific research is a person by the name Steven Eaton From Europe.Steven Eaton faked research data for experimental anti-cancer drugs has become the first person in Britain to be jailed under tough safety laws. Steven Eaton, 47, was jailed for three months at Edinburgh Sheriff Court for falsifying test results.
The court had earlier heard how Eaton was working at the Edinburgh branch of the American pharmaceutical firm Aptuit in 2009 when he came up with the scam. He was hoping to generate funding to allow the experimental drug he was working on to be tested on human patients, so he concocted information.
Barron's Medical Journal wanted to ensure the folks in the United States, that we have one of the best if not the 
best in the world drug approval processes. This responsibility falls under the directions of the Food And Drug Administration ( FDA). Let's start by out lining the process in which a Company has to follow to get a drug from concept to bedside medicine.
Preclinical (animal) testing.
1.An investigation new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
2.Phase 1 studies (typically involve 20 to 80 people).
3.Phase 2 studies (typically involve a few dozen to about 300 people).
4.Phase 3 studies (typically involve several hundred to about 3,000 people).
5.The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
6.Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
7.After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
8.If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
9.The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
10.The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
11.FDA reviewers will approve the application or issue a complete response letter.
Though FDA reviewers are involved with a drug's development throughout the IND stage, the official review time is the length of time it takes to review a new drug application and issue an action letter, an official statement informing a drug sponsor of the agency's decision Traditional approval requires that clinical benefit be shown before approval can be granted.
Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available.If the FDA decides that the benefits of a drug outweigh the known risks, the drug will receive approval and can be marketed in the United States. But if there are problems with an NDA or if more information is necessary to make that determination, the FDA may issue a complete response letter
The FDA Approval Process in detail:
Clinical Trials--Drug studies in humans can begin only after an IND is reviewed by the FDA and a local institutional review board (IRB). The board is a panel of scientists and non-scientists in hospitals and research institutions that oversees clinical research.
IRBs approve the clinical trial protocols, which describe the type of people who may participate in the clinical trial, the schedule of tests and procedures, the medications and dosages to be studied, the length of the study, the study's objectives, and other details. IRBs make sure the study is acceptable, that participants have given consent and are fully informed of their risks, and that researchers take appropriate steps to protect patients from harm.
Phase 1 studies are usually conducted in healthy volunteers. The goal here is to determine what the drug's most frequent side effects are and, often, how the drug is metabolized and excreted. The number of subjects typically ranges from 20 to 80.
Phase 2 studies begin if Phase 1 studies don't reveal unacceptable toxicity. While the emphasis in Phase 1 is on safety, the emphasis in Phase 2 is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For controlled trials, patients receiving the drug are compared with similar patients receiving a different treatment--usually an inactive substance (placebo), or a different drug. Safety continues to be evaluated, and short-term side effects are studied. Typically, the number of subjects in Phase 2 studies ranges from a few dozen to about 300.
At the end of Phase 2, the FDA and sponsors try to come to an agreement on how large-scale studies in Phase 3 should be done. How often the FDA meets with a sponsor varies, but this is one of two most common meeting points prior to submission of a new drug application. The other most common time is pre-NDA--right before a new drug application is submitted.
Phase 3 studies begin if evidence of effectiveness is shown in Phase 2. These studies gather more information about safety and effectiveness, studying different populations and different dosages and using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people.
Post market requirement and commitment studies are required of or agreed to by a sponsor, and are conducted after the FDA has approved a product for marketing. The FDA uses post market requirement and commitment studies to gather additional information about a product's safety, efficacy, or optimal use.
New Drug Application (NDA)--This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured. When an NDA comes in, the FDA has 60 days to decide whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete. For example, some required studies may be missing. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA's Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later than 10 months after the applications are received. The review goal is six months for priority drugs. (See "The Role of User Fees.")
"It's the clinical trials that take so long--usually several years. The emphasis on speed for FDA mostly relates to review time and timelines of being able to meet with sponsors during a drug's development," she says.
More Information on Eaton.
Eaton had been selectively reporting research data since 2003
A scientist who faked research data for experimental anti-cancer drugs has been jailed for three months for falsifying test results. Eaton, 47, was working at the Edinburgh branch of US pharmaceutical firm Aptuit in 2009 when he came up with the scam.
If it had been successful, cancer patients who took the drug could have been harmed, the court was told.Edinburgh Sheriff Court heard how Eaton had manipulated the results of an experiment so it was deemed successful when it had actually failed.
Stopped work, When bosses at his firm scrutinized his work, they noticed that it was fraudulent.
They stopped work on the project that Eaton was involved in, and reported him to watchdogs at the Medicines and Healthcare Products Regulatory Agency.Investigators there discovered that Eaton had been selectively reporting research data since 2003.
Jim Stephenson Defence solicitor Defence solicitor advocate Jim Stephenson said his client had given up working as a scientist.
He said: "He is unlikely to ever undertake this type of work ever again."
The story emerged after Eaton was convicted under legislation called the 1999 Good Laboratory Practice Regulations.
Sheriff Michael O'Grady said: "I feel that my sentencing powers in this are wholly inadequate. You failed to test the drugs properly - you could have caused cancer patients unquestionable harm.
"Why someone who is as highly educated and as experienced as you would embark on such a course of conduct is inexplicable."
Speaking after the case, Gerald Heddell, the Medicines and Healthcare Products Regulatory Agency's director of inspection, enforcement and standards, said he welcomed the conviction.
He added: "This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health."
The Drug Approval Process In Europe many think can use a re engineering of their process. The Process works. There are different systems within the EMA that pharmaceutical companies can use to license drugs.
The first is called the centralized, or community, system. Orphan drugs and any medicines for a number of conditions including Cancer, neuro degenerative conditions, diabetes, viral diseases, or auto immune and other immune conditions have to be licensed this way. The committee that reviews drugs for human use (the CHMP) assess the application, and then recommend whether a drug should have ‘marketing authorization’ (a licence) or not. This takes 210 days, and their opinion is passed to the European Commission who make the final decision. The marketing authorization is valid for all 27 EU countries as well as Iceland, Norway and Liechtenstein.
The second way that pharmaceutical companies apply for a license is the decentralized system. They can use this system for medicines that don't fit into the categories within centralized system listed above. With the decentralized system, the company applies to several member states at the same time. One member state assesses the application (this is the MHRA in the UK). If they recommend that the drug be licensed, the other member states then either agree or object. If everyone agrees, the drug is given marketing approval. If someone objects, the CHMP will step in and decide. They then advise the European Commission whether to license the drug or not.
The third system is the mutual recognition system. This means that if a company has a medicine that is authorized in one EU member state, that member state can apply for the authorization to be recognized in other EU countries.
Once a drug has EU marketing authorization, it is ‘licensed’, ‘registered’ or ‘approved’. All these terms mean the 
same thing. Once the medicine has been authorized, the CHMP publish a European Public Assessment Report (EPAR) which gives the reasons for their decision and information for patients.
When a drug has marketing authorization, it is not available straight away. The company first have to apply to market their product in each individual country. In the UK, they will apply to the MHRA. When this last small step is done, the product is ‘launched’, and doctors can prescribe it. Having authorization means the company can market the drug in any EU country - but they don’t have to. For one reason or another, they may choose to market the drug in some countries but not others.
The FDA is one organization no one in the United States will published any false information in fact Barron's Medical Journal can say without any concerns is that The FDA is the most feared organization in Washington DC.
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