FDA - ending the atrocities

They block badly needed drugs and approve dangerous ones. They are a sort of public medicine Mafia, judging from their behaviour

A startling number of reports reveal the FDA is in far worse shape than originally thought. Few people comprehend that they are likely to suffer and die prematurely as a result of FDA’s failures.

The media does a decent job reporting on FDA disasters. The apathetic public, however, often forgets what they read the next day. That is, until they are diagnosed with a serious illness. Then they go into a panic mode to find an effective treatment. All too often, however, the cure does not exist because of FDA bureaucratic roadblocks. In other cases, the FDA-approved drugs available induce horrific side effects.

It is our mission to memorialize these tragedies to demonstrate the urgent need to radically reform the FDA. This “state-sponsored” carnage of the American citizenry must be stopped!

FDA Disseminates Fraudulent Safety Data

Ketek (telithromycin) is a drug the FDA approved to treat mild-to-moderate pneumonia. Ketek can also cause sudden and serious liver damage. In some cases, complete liver failure develops necessitating the need for a liver transplant. Some patients die before a liver transplant can be performed.1-5. The risks of liver failure (and other toxic side effects) were known before the FDA approved Ketek. In order to convince an outside scientific advisory committee to recommend that Ketek be approved, the FDA knowingly allowed a fraudulent safety study to be presented. Here is what the Senate Investigative Committee uncovered:6

* FDA accepted the resubmission of a new drug application, which included safety data that were fraudulent, in whole or in part.

* FDA employees presented the fraudulent study data to the advisory committee that was tasked with recommending Ketek’s approval or disapproval.

* FDA instructed its employees preparing to appear before the advisory committee that they should present these fraudulent safety data.

* FDA approved a pediatric clinical trial of Ketek, involving infants as young as six months old, despite concerns related to known toxicities affecting the heart, eyes, liver, and vascular system.

* FDA continued to knowingly cite the fraudulent study data in publically released safety information on Ketek.

How fraudulent were these data? While the FDA was presenting these fake data, a criminal investigation was simultaneously being conducted that found the clinic where the “safety” study allegedly occurred was closed during the time the study was supposed to have taken place. It was also determined that documents relating to the safety study had date modifications and signature inconsistencies.

Shortly after the advisory committee meeting where the fake safety data were presented by FDA employees, the person who conducted the study was criminally indicted, pled guilty, and was sentenced to almost five years in jail.

It is even more shocking that the FDA continued to cite this safety study long after the principal investigator admitted it was fraudulent. While the perpetrator of this “safety” study was in prison for falsifying the data, the FDA used the very same study to issue a Public Health Announcement stating:

“Based on the pre-marketing clinical data it appeared that the risk of liver injury with telithromycin [Ketek] was similar to that of other marketed antibiotics.”7

The “pre-marketing clinical data” FDA cited to mislead the public about Ketek was the fraudulent study, a study that may never have actually occurred. According to the Senate Investigative Committee report, “it defies explanation why the FDA would continue to cite” this fraudulent study to the American public to imply that Ketek is safe.8

The Senate Committee report concluded by stating that, “Retaliation against these individuals, or any other FDA employees who communicate with the committee with reference to Ketek will not be tolerated.”8 Based on the tone of the Senate investigative report, it would appear that the FDA functioned as a continuous criminal enterprise in this instance.8,9

The Revolving Door

You may wonder why certain officials in the FDA would go to such extreme lengths to get a lethal drug like Ketek approved. Look no further than the gargantuan economic benefits drug companies reap when a patented compound like Ketek receives the FDA seal of approval. When we first exposed the revolving door of FDA employees going to work for companies they regulate, virtually no one believed us. Back in the 1980s, most Americans were deceived by FDA propaganda stating that the agency “is responsible for protecting the public health by assuring the safety…of human drugs.”12

The harsh reality is that the FDA functions primarily to protect the financial interests of the pharmaceutical industry, not the public’s health. If anyone ever questioned this, look no further than the FDA’s attempts last year to ban the safest form of estrogen (estriol). The FDA has no qualms about publically stating that its ban on estriol was based on a petition filed by Wyeth, the maker of dangerous estrogen drugs like Premarin and Prempro.

There are a number of estrogen drugs that have not been shown to increase stroke or breast cancer risk.13 The FDA, however, has done nothing to remove Premarin or Prempro. Instead, the FDA openly seeks to protect Wyeth’s market share by denying American women access to natural estriol. According to the FDA, “bioidentical hormone products are unsupported by medical evidence and are considered false and misleading by the agency.”14 The truth is that bioidentical hormones are far less expensive and pose a major competitive threat to Wyeth, ergo the FDA’s aggressive attempts to disallow them.

In a report issued by the Associated Press just last year, it was revealed that a record number of FDA employees are leaving the agency to go to work for pharmaceutical companies. According to the Associated Press, these FDA staffers are resigning in order to go into “the more lucrative side of the business…”15

The FDA’s Brain Drain

As experienced FDA scientists leave the agency to work for Big Pharma, the remaining staff is leaner and less competent to approve new life-saving medications. As reported by the Associated Press, a consequence of FDA employees going to work for pharmaceutical companies is a clogging of the drug approval pipeline.

As long time Life Extension members know, the FDA drug approval process has always been a bureaucratic quagmire, where life-saving medications languish for years, decades, and sometimes forever. The drug pipeline has been “clogged” for almost 50 years. We are deeply disturbed that it is now taking even longer for life-saving medications to become available to those in need.

The Wall Street Journal continues to support our position with blistering exposes describing human beings who suffer horrendously and die while potential life-saving therapies languish at the FDA. An article published last year titled “Sick Patients Need Cutting-Edge Drugs” disclosed heart-wrenching reports of young cancer patients who were denied compassionate-use access to experimental drugs. The Wall Street Journal article raised the logical questions: “Why do terminally ill patients have to wait so long to get access to the only treatments that hold any promise of saving their lives? And why is it not their right to decide?”16

These very issues have been discussed in Life Extension’s publications for nearly 30 years. We have analogized in previous articles how it is perfectly legal to engage in all kinds of risky activities, such as parachuting from high bridges, but it is illegal to make experimental medications available to terminally ill people without the FDA’s permission.

According to the Wall Street Journal, the drug delay problem is getting much worse. The problem has been magnified in recent years as the number of new drug approvals has fallen dramatically. The FDA approved just 16 new drugs in 2007 and 24 in 2008.17,18 That’s down from 139 in 1996.

With the approval of life-saving drugs grinding to a snail’s pace, the moronic cruelty of denying experimental drugs to terminal patients must stop. Each day a life-saving drug is delayed, human beings perish. The case for radical reform of the Food, Drug, and Cosmetic Act and the FDA itself has never been stronger.

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Negligent NHS hospital nearly gets healthy baby aborted



Baby Deacon Lewis is a lively, healthy baby who sleeps right through the night and is a joy to his proud parents. But Deacon, who is now six months old, was almost aborted after doctors told his mother he almost certainly suffered from a chromosome disorder that would eventually kill him.

Dawn Lewis, 26, says she was advised to have an abortion when a routine 12-week scan showed her child had Edward's syndrome. The condition causes serious heart and kidney problems with less than half of babies surviving beyond eight weeks.

After four years of trying for a baby, Miss Lewis and her partner Jonathan Blemmings, 26, a construction worker, were devastated. But Miss Lewis, a childminder, refused to have an abortion and decided to seek a second opinion on her baby's condition. She was referred to the specialist maternity hospital where a more sophisticated test found no evidence of the disorder. She said: 'I was absolutely delighted to find my baby was healthy but also horrified that I could have had him aborted. 'I was shocked that I had been advised to have a termination without first being offered a second scan and further tests. 'Thankfully we decided to pursue a second opinion because if we hadn't then Deacon may not have been here today.'

The couple have now made an official complaint to Rochdale Infirmary in Greater Manchester over the severe distress caused by the alleged mistake. They also want to warn other prospective parents that medical advice to terminate a pregnancy may not always be correct.

Miss Lewis, who has a six-year-old daughter Ayla, said: 'Many people would have taken the doctors' advice and never have known they had aborted a healthy child. It is only because of our determination to have another child that our son is with us today. 'We are really shocked that the experts we trusted got this so badly wrong and we think it's important to let other people know they don't always get things right.'

The saga began in March last year when Miss Lewis, of Rochdale, went to the hospital for a routine 12-week scan. As well as checking the baby's heartbeat and size, the scan also measures the amount of fluid at the back of the baby’s neck. Known as the nuchal translucency test, the measurement, along with the mother's age, the age of the baby and the presence or absence of the baby's nasal bone, can calculate the likelihood of the baby having a chromosomal abnormality.

'The doctor told me he was 99 per cent sure my baby had a chromosome 18 abnormality which was Edward's syndrome,' Miss Lewis said. 'He told me there would be absolutely no quality of life for my baby and told me the best thing to do would be to have a termination. 'But Jonathan and I had been trying for a baby for four years and we were not going to have an abortion so we sought a second opinion.'

A scan at St Mary's Hospital in Manchester followed four days later. She added: 'Because my pregnancy was too early for a amniocentesis test, doctors tested a tiny sample of tissue from the placenta. After a nail-biting two days the results came back that my baby did not suffer from the abnormality.'

The boy was born in Rochdale in September without complications and is now doing well

Edward's syndrome is a genetic disorder caused by the presence of all or part of an extra chromosome resulting in heart abnormalities, kidney malformations, and other internal organ disorders. It affects around one in around 3,000 babies with less than 10 per cent of sufferers surviving beyond their first year.

Mr Blemmings said: 'Even after the tests at St Mary's it was always in the back of our minds that our baby might be seriously ill, even when he was born we were really anxious. It took me a few weeks to accept he was really okay.' Deacon was born at Rochdale Infirmary and the couple have no complaints about their treatment during the birth.

A spokesman for Pennine Acute Hospitals, which runs Rochdale Infirmary, said: 'We will be conducting a full investigation into this complaint. We will make a formal response to Miss Lewis when our investigation is completed.'

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