FDA weighs approval of adult psychiatric drugs for children

Officials have concerns about exposing younger patients to the drugs’ side effects.

AP | Jun 5, 2009

By MATTHEW PERRONE

WASHINGTON (AP) — Three blockbuster psychiatric drugs currently approved for adults also appear to work in adolescents, though federal health officials have concerns about exposing younger patients to the drugs’ side effects.

The Food and Drug Administration is reviewing drugs from AstraZeneca PLC, Eli Lilly & Co. and Pfizer Inc. for use in patients between the ages of 10 and 17. The drugs — already approved to treat schizophrenia and bipolar mania in adults — had combined sales of more than $7.4 billion last year, according to IMS Health.

FDA reviewers on Friday said they were wary of exposing youngsters to the drugs’ side effects, including weight gain and high blood sugar, “because they may be exposed for many decades.”

“These risks are of particular concern in pediatric patients because of the lifelong nature of these disorders,” FDA director for psychiatric products, Dr. Thomas Laughren, wrote in documents posted online.

The FDA released its review of the drugs ahead of a meeting Tuesday where outside experts will weigh in on the drugs’ risks and benefits. The agency is not required to follow the group’s advice, though it usually does.

Many doctors already prescribe the medications to children and adolescents, although regulators have not officially cleared that use. Physicians are free to prescribe medicines as they see fit, though companies can only promote them for FDA-approved indications.

AstraZeneca and Lilly are seeking permission to market their drugs for adolescents with schizophrenia and bipolar mania, also called manic depressive disorder. Pfizer is seeking a pediatric bipolar disorder indication for its drug.

FDA drug reviewers noted that the “safety profile of the pediatric population is very similar compared to that of the adult population.” And while there were no side effects unique to younger patients, there were differences in the frequency of the effects compared with adults.

In schizophrenia studies of Lilly’s Zyprexa, more than 30 percent of adolescents gained weight, compared with just 6 percent of adults. On average, adolescents gained nearly 10 pounds, compared with 6 pounds for adults.

Lilly is seeking FDA approval to market the drug as a second-line treatment, or a second option after other drugs have been tried.

Adolescent patients taking Pfizer’s Geodon were more likely to report sleepiness and dystonia, a movement disorder that causes muscle spasms. AstraZeneca noted higher rates of increased appetite and blood pressure among children and adolescents taking Seroquel compared with adults.

Despite concerns over the side effects, Laughren and other FDA officials acknowledged the need for additional drugs to treat schizophrenia and bipolar disorder in teenagers and older children.

“Schizophrenia and bipolar disorder are serious illnesses in pediatric patients and represent substantial burden for both patients and their families,” Laughren said.

Currently only two drugs are cleared for those uses: Bristol-Myers Squibb’s Abilify and Johnson & Johnson’s Risperdal. Abilify was the second best-selling anti-psychotic drug in the U.S. last year with sales of $3 billion. Risperdal was fourth with $1.6 billion in sales.

Schizophrenia affects about 2.4 million Americans and is characterized by hallucinations, delusions and social withdrawal, according to the National Institute of Mental Health. About 5.7 million Americans experience bipolar disorder, which causes rapid mood swings and shifts in energy.

U.S. military: Heavily medicated and armed

Prescription pill dependency among American troops is on the rise

MSNBC | May 19, 2009

U.S. military: Heavily armed and medicated

By Melody Petersen

Marine Corporal Michael Cataldi woke as he heard the truck rumble past.

He opened his eyes, but saw nothing. It was the middle of the night, and he was facedown in the sands of western Iraq. His loaded M16 was pinned beneath him.

Cataldi had no idea how he’d gotten to where he now lay, some 200 meters from the dilapidated building where his buddies slept. But he suspected what had caused this nightmare: His Klonopin prescription had run out.

His ordeal was not all that remarkable for a person on that anti-anxiety medication. In the lengthy labeling that accompanies each prescription, Klonopin users are warned against abruptly stopping the medicine, since doing so can cause psychosis, hallucinations, and other symptoms. What makes Cataldi’s story extraordinary is that he was a U. S. Marine at war, and that the drug’s adverse effects endangered lives — his own, his fellow Marines’, and the lives of any civilians unfortunate enough to cross his path.

“It put everyone within rifle distance at risk,” he says.

In deploying an all-volunteer army to fight two ongoing wars, in Iraq and Afghanistan, the Pentagon has increasingly relied on prescription drugs to keep its warriors on the front lines. In recent years, the number of military prescriptions for antidepressants, sleeping pills, and painkillers has risen as soldiers come home with battered bodies and troubled minds. And many of those service members are then sent back to war theaters in distant lands with bottles of medication to fortify them.

According to data from a U. S. Army mental-health survey released last year, about 12 percent of soldiers in Iraq and 15 percent of those in Afghanistan reported taking antidepressants, anti-anxiety medications, or sleeping pills. Prescriptions for painkillers have also skyrocketed. Data from the Department of Defense last fall showed that as of September 2007, prescriptions for narcotics for active-duty troops had risen to almost 50,000 a month, compared with about 33,000 a month in October 2003, not long after the Iraq war began.

In other words, thousands of American fighters armed with the latest killing technology are taking prescription drugs that the Federal Aviation Administration considers too dangerous for commercial pilots.

Military officials say they believe many medications can be safely used on the battlefield. They say they have policies to ensure that drugs they consider inappropriate for soldiers on the front lines are rarely used. And they say they are not using the drugs in order to send unstable warriors back to war.

Yet the experience of soldiers and Marines like Cataldi show the dangers of drugging our warriors. It also worries some physicians and veterans’ advocates. “There are risks in putting people back to battle with medicines in their bodies,” says psychiatrist Judith Broder, M. D., founder of the Soldiers Project, a group that helps service members suffering from mental illness.

Prescription drugs can help patients, Dr. Broder says, but they can also cause drowsiness and impair judgment. Those side effects can be dealt with by patients who are at home, she says, but they can put active-duty soldiers in great danger. She worries that some soldiers are being medicated and then sent back to fight before they’re ready.

“The military is under great pressure to have enough people ready for combat,” she says. “I don’t think they’re as cautious as they would be if they weren’t under this kind of pressure.”

Brought more than memories back

When Cataldi talks about what happened to him in Iraq, he begins with an in incident that took place on a cold January night in 2005, when he and five other Marines received a radio call informing them that a helicopter had disappeared. The men roared across the desert of western Iraq and found what was left of the chopper. Flames roared from the pile of metal. Cataldi, 20, was ordered to do a body count.

The pilot’s body was still on fire, so he shoveled dirt on it to douse the acrid flames. He picked up a man’s left boot in order to find the dog tag every Marine keeps there. A foot fell to the ground. “People were missing heads,” Cataldi remembers. “They were wearing the same uniform I was wearing.”

The final death toll from that crash of a CH-53E Super Stallion was 30 Marines and one sailor.

For days, Cataldi couldn’t escape the odor of burning flesh. “I had the smell all over my equipment,” he says. “I couldn’t get it off .”

When he returned to his stateside base at Twentynine Palms, California, he knew he’d brought more than memories back from Iraq. He would cry for no reason. He flew into fits of rage. One night he woke up with his hands around the throat of his wife, Monica, choking her.

“It scared the crap out of me,” he says.

He went to see a psychiatrist on base. “He said, ‘Here’s some medication,’ ” Cataldi recalls. The prescribed drugs were Klonopin, for anxiety; Zoloft, for depression; and Ambien, to help him sleep.

Later, other military doctors added narcotic painkillers for the excruciating pain in his leg, which he’d injured during a training exercise. He was also self-medicating with heavy doses of alcohol.
Those prescriptions didn’t stop the Marine Corps from sending Cataldi back to Iraq. In 2006, he returned to the same part of the Iraqi desert to do the same job: performing maintenance on armored personnel carriers known as LAVs. He also took his turn driving the 14-ton tanklike vehicles, one of which was armed with a 25 mm cannon and two machine guns and loaded with more than 1,000 rounds of ammunition.

Marine Major Carl B. Redding says he can’t talk about the medical history of any Marine because of privacy laws. He says the Corps has procedures to ensure that service members taking medications for psychiatric conditions are deployed only if their symptoms are in remission. Those Marines, he says, must be able to meet the demands of a mission.

But it’s difficult to square those regulations with Cataldi’s experience. His medications came with written warnings about the dangers of driving and operating heavy machinery. The labels don’t lie.

One night, Cataldi took his pills after his commander told him he was done for the day. Five minutes later, however, plans changed, and he was told to drive the LAV. He asked the Marine sitting behind him to help keep him awake. “I said, ‘Kick the back of my seat every 5 minutes,’ and that’s what he did.”

Cataldi says he managed on the medications — until his Klonopin ran out. The medical officer told him there was no Klonopin anywhere in Iraq. So the officer gave him a drug called Seroquel. That’s when Cataldi says he started to become “loopy.”

“I’d go to pick up a wrench and come back with a hammer,” he says. “I wasn’t able to do my job. I wasn’t able to fight.”

Soldiers on medication

Soldiers have doped up in order to sustain combat since ancient times. Often their chosen drug was alcohol. And Iraq isn’t the first place U. S. military doctors have prescribed medications to troops on the front. During the Vietnam war, military psychiatrists spoke enthusiastically about some newly psychiatric medicines, including Thorazine, an anti-psychotic, and Valium, for anxiety. According to an army textbook, doctors frequently prescribed those drugs to soldiers with psychiatric symptoms. Anxiety-ridden soldiers with upset bowels were sometimes given the antidiarrheal Compazine, a potent tranquilizer.

But the use of those drugs in Vietnam became controversial. Critics said it was dangerous to give soldiers medications that slowed their reflexes, a side effect that could raise their risk of being injured, captured, or killed. That risk was real. In a report supported by the U. S. Navy 14 years after the United States withdrew from Vietnam, researchers looked at the records of all Marines wounded there between 1965 and 1972. Marines who’d been hospitalized for psychiatric reasons before being sent back to battle were more likely to have been injured in combat than those who hadn’t been hospitalized.

Critics of medication use in Vietnam also said that a soldier traumatized by battle may not be coherent enough to give his consent to take the drugs in the first place. Plus, a soldier would risk court-martial if he refused to follow orders, they said, making it unlikely he could make a reasoned decision about taking the medications.

After the war, the practice of liberally giving psychiatric drugs to warriors fell out of favor. In War Psychiatry, a 1995 military medical textbook, a U. S. Air Force flight surgeon warned about the use of psychiatric drugs, saying they should be used sparingly.

“Sending a person back to combat duty still under the influence of psychoactive drugs may be dangerous,” he wrote. “Even in peacetime, people in the many combat-support positions… would not be allowed to take such medications and continue to work in their sensitive, demanding jobs.”

Colonel Elspeth Cameron Ritchie, M. D., M. P. H., a psychiatrist and the medical director of the strategic communication directorate in the Office of the Army Surgeon General, acknowledges that writing more prescriptions for frontline troops was a change in direction for the Pentagon. “Twenty years ago,” she says, “we weren’t deploying soldiers on medications.”

Today it’s not uncommon for a soldier to arrive in Iraq while taking a host of prescription drugs. The Pentagon explained its new practice in late 2006, stating that there are “few medications that are inherently disqualifying for deployment.”

According to Colonel Ritchie, military officials have concluded that many medicines introduced since the Vietnam War can be used safely on the front lines. Military physicians consider antidepressants and sleeping pills to be especially helpful, she says. Doctors have also found that small doses of Seroquel, an anti-psychotic, can help treat nightmares, she says, even though the drug is not approved for that use.

Full Story

After suicide of 7-year-old, agency finds serious shortcomings in monitoring of foster children on psychotropic drugs

Review finds shortfalls in monitoring of foster children on psychiatric drugs

13.19 percent, are taking one or more psychotropic medications

St. Petersburg Times | May 29, 2009

By Kris Hundley

Spurred by the shocking suicide of a 7-year-old on psychiatric drugs, the agency in charge of Florida’s foster children has discovered serious shortcomings in its monitoring of kids on such powerful prescriptions.

After reviewing its files, the Department of Children and Families determined it had undercounted the number of foster kids on such medications as Risperdal and Adderall, overlooking hundreds of cases.

It also has failed to meet its legal requirement that such prescriptions be given only after parental consent or court order.

On Thursday, DCF said a review of the files of more than 20,000 children currently in the state’s foster care showed 2,669, or 13.19 percent, are taking one or more psychotropic medications.

That compares with about 4 or 5 percent of children in the general population who are on such prescriptions.

Of those foster children taking drugs, DCF discovered 16 percent had no proof either a parent or judge had signed off on the prescription, as required by a 2005 Florida law.

“That is unacceptable,” said DCF Secretary George Sheldon. “We’re going to bring every single case of a foster child on drugs into compliance with the law.”

Concerns about pediatric use of antipsychotic and antidepressants such as Adderall and Risperdal have been growing along with increased warnings of such side effects as suicide, diabetes and weight gain. Few of the drugs have been tested or approved by the FDA for children, though physicians can prescribe them for this age group.

Robin Rosenberg, a Tampa lawyer and deputy director of Florida’s Children First, said advocacy groups like hers have been fighting for oversight of psychotropic drugs for years. “We’re not as far along as we should have been if the state had followed up on serious concerns starting in the late 1990s,” she said. “It’s a shame we’re in this place today.”

Sheldon, who was named to the top job at DCF in October, left no doubt that he had been deeply affected by Gabriel Myers, the 7-year-old who hanged himself on a shower hose in South Florida in mid April. The boy was in his third foster home and on Vyvanse, a medication for ADHD, as well as Symbyax, a combination antipsychotic and antidepressant.

Though his caseworker repeatedly said Gabriel’s mother had agreed to the medications, that was not true. The boy’s psychotropic medications also had not been entered in the state’s tracking system.

To correct ongoing problems, Sheldon set a deadline of June 5 for action on cases without consent. This could include scheduling new doctors’ appointments, gaining informed consent from parents or expediting a judge’s review of the prescription.

Sheldon said he also was going to focus on the cases of 73 children under age 6 found to be on psychotropic drugs.

“I want a sense of urgency, but I also want to get it right,” he said. “I want to move forward, but I think it’s important for the agency to apologize for misinformation it may have put out in the past.”

Flaws in DCF’s record-keeping became clear in the immediate aftermath of Gabriel’s death. An initial review of the state’s database showed only 1,950 kids on psychotropic prescriptions. After a thorough review of individual records, however, that number grew by more than 700.

Preliminary data released in mid May also showed some questionable dates on judicial consent. Though it’s not inconceivable a judge might sign an order on a Saturday or Sunday, early returns showed weekend consent orders on 129 occasions.

The final database, including information on types of drugs and diagnoses, was not available Thursday. Sheldon said a summary of the drug data would be posted on the DCF Web site and updated weekly.

“I’ve got a lot more confidence in these numbers than I had two weeks ago,” he said. “But any database is only as good as the quality of the information being put into it.”

One ongoing area of concern, Sheldon said, is the validity of any consent given by parents whose kids are in the state’s custody.

“A parent whose child is taken into our care is going to sign virtually anything and that’s not informed consent,” he said. “My preference is that the biological parent have a dialogue with the psychiatrist.”

Now that DCF has a handle on the number of foster children on psychotropic drugs, Sheldon said the department can begin to address the bigger issue of the efficacy of such drugs.

He has asked an independent panel investigating Gabriel Myers’ death to make recommendations on improving DCF’s oversight of these medications. Sheldon said a second-party review of all such prescriptions might be necessary; currently, only prescriptions for kids under age 6 require such review.

DCF has set up a page on its Web site that tracks the progress of the panel investigation into the boy’s suicide. The page includes a photo of the smiling boy.

“We have his face on the screen watching us to see how well we learned from his life and death,” Sheldon said. “We cannot let him down.”

Nanotechnology allows vaccines to be forced through the skin without needles

High-frequency sound waves interact with an emulsion containing polymer, medicament, and fluorescent dye to form spherical nanoparticles, which are then harvested, charged, and applied to foil-backed film. After applying this film to the skin, a pulsed electric field opens pores and drives nanoparticles toward the waiting dendritic cells. Diagrams courtesy of Mark Horenstein and David Sherr.

Hate Needles? No Problem

New pulse-patch system could make vaccines cheap, fast, and easy

BU Today | May 27, 2009

By Mark Dwortzan

For all the advances of modern medicine, today’s drug and vaccine delivery methods still have their drawbacks: hypodermic needles, medicated patches, and ultrasonic methods may offer a range of options, but all lack speed and precision.

Plus, there’s another fact of life: needles can hurt.

Since the dawn of modern medicine — well, maybe since the days of Star Trek — doctors and patients have wished for an easy, injection-free option, a device that goes on your arm, and zap, you’re done.

Now a team of Boston University researchers is developing just that: an electrostatic nano-pulse method for rapidly delivering vaccines and drugs through the skin. Funded in its pilot stage by BU’s Center for Integration of Medicine & Innovative Technology, the team aims to develop a clinical device with widespread applications, including low-cost inoculation in developing countries and rapid antidote dispersal in the event of an epidemic.

Conceived by principal investigators Mark Horenstein, a College of Engineering professor of electrical and computer engineering, and David Sherr, a School of Public Health professor of environmental health, the idea is to put a drug or vaccine inside a biodegradable nanoparticle as small as a human pore. Then, an electrostatic voltage pulse drives it through the skin, where dendritic cells transport it to lymph nodes and generate the immune system’s response.

Sherr has developed plans to evaluate the nano-pulse method in laboratory mice by tracking fluorescent nanoparticles and adjusting the pulse strength. “If we can get the nanoparticles at about one-fifth the depth of a typical human hair and into a layer of skin called stratum corneum,” he says, “that layer has a direct line to the lymph node system.” The team will soon embark on a six-month pilot study to test the concept.

A key challenge is the electric current needed for delivery.

Horenstein is trying to design a device that will drive nanoparticles (seen through a scanning electron microscope, left; fluorescent dye, shown under UV light, helps track the nanoparticles’ movement, right) into the skin with fewer than 50 volts of electricity, the maximum level thought safe for humans. “Usually when you’re trying to drive particles with this level of force, you need thousands of volts,” Horenstein says. “So it all comes down to designing the right methods and structures.”

ADHD treatment causes young boys to develop female breasts

3news.co.nz | May 26, 2009

In Janssen's own clinical trials, 43 children developed the abnormal breasts

A drug used to treat ADHD children is causing concern in the United States.

It is called Risperdal and it is supposed to be used primarily for adults with sever psychological problems.

But last year it was prescribed more than 6.5 million times.

The side effects include young males developing female sex organs.

Nineteen-year-old John was just seven when he began taking Risperdal for ADD.

Even though the FDA approved the drug only for adult patients who were psychotic, John’s doctor and others widely prescribed it to kids for less severe behaviour problems.

Once taking Risperdal, John’s mum says he became aggressive, sleepy, and developed bowel problems. But the biggest shock came when he was 14 and started developing women’s breasts.

“He asked me if he was a girl,” she says.

It turns out Risperdal can increase production of a hormone called prolactin, which stimulates breast growth. It is called gynecomastia – and it is irreversible.

Risperdal and other so-called “atypical anti-psychotics” have exploded in use.

Hundreds of thousands of kids have been prescribed Risperdal in the 14 years it has been on sale – long before the FDA approved it for very limited pediatric use in 2006.

John and most of the other children were not psychotic at all, but were given Risperdal for behaviour disorders including autism and ADD.

Attorney Stephen Sheller is suing Janssen, which makes Risperdal. He claims Janssen marketed Risperdal for unapproved uses in children, downplayed serious risks like diabetes and seizures.

Janssen would not agree to an interview but told us the breast growth risk is “clearly stated in the FDA-approved” labelling, and “we only promote our products for their FDA-approved indications.”

Nobody knows how often it happens. But in Janssen’s own clinical trials with fewer than 2,000 children (1,885), 43 developed the abnormal breasts.

Mr Sheller represents John and nine other boys – one of whom was only four when he developed a breast on one side and began producing milk.

The treatment for the unbridled breast growth is as unthinkable as the disorder: painful removal of the breasts.
Eventually, the boys can appear normal again.

The family’s lawsuit is still in court.

But John’s mother says surgery did not fix all of the problems from the medicine.

When asked if John still thinks he’s a girl his mother wells up and cries before answering, “yes.”

As for Risperdal – it’s still on the market.  And families say putting even more children at risk.

Children who have flu jab ‘three times more likely to need hospital care’

“Diet, injections, and injunctions will combine, from a very early age, to produce the sort of character and the sort of beliefs that the authorities consider desirable, and any serious criticism of the powers that be will become psychologically impossible.”

- Bertrand Russell, “The Impact of Science on Society”, 1953, pg 49-50

WDDTY | May 20, 2009

Children who have the standard flu jab are three times more likely to end up in hospital. The vaccine is also useless at preventing the disease, new research has discovered.

Children with asthma are especially vulnerable after being given the annual flu vaccine, TIV (trivalent inactivated flu vaccine). Children aged from six months to 18 years are recommended to have the vaccine each year.

Researchers from the Mayo Clinic in Rochester made the discovery after studying 263 children who had had flu, and whether or not they had been vaccinated.

They discovered that children who had been vaccinated were three times more likely to need hospital care than those not vaccinated, and the risk was even higher in children who had asthma.

It was also clear that the vaccine had not protected the children against flu, the researchers told a conference this week.

(Source: 105th International Conference of the American Thoracic Society in San Diego).

Aspartame: One Man’s Poison, Another Man’s Profit

“Diet, injections, and injunctions will combine, from a very early age, to produce the sort of character and the sort of beliefs that the authorities consider desirable, and any serious criticism of the powers that be will become psychologically impossible.”

- Bertrand Russell, “The Impact of Science on Society”, 1953, pg 49-50

Aspartame: One Man’s Poison … Another Man’s Profit

Part 1 of a series

DORway | May 17, 2009

By Paris Reidhead

Methanol is the chemical cornerstone of the world’s predominant artificial sweetener: aspartame (also know as NutraSweet and Equal). Any ingested product that contains methanol (methyl alcohol) will, at some point, cause adverse health problems for persons consuming it. Aspartame contains 10% methanol, 40% aspartic acid, and 50% phenylalanine. However, in proteins amino acids are in balance. Some such as aspartic acid and phenylalanine found in aspartame cannot be isolated because they become excitotoxic and neurotoxic. They cause metabolic and physiological disorders in humans, which I will address later.

Of these three aspartame components, methanol has the longest history – a history of politics and greed going back to the Prohibition Era. In 1919, with passage of the 18th Amendment, the federal government outlawed the production and consumption of grain alcohol (ethanol). Organized crime’s illegal activities broke and circumvented the new laws during the fourteen years of that era. Central to those illegal activities was the notorious, ever-present, organized bootlegging.

The United States’ mandated withdrawal from the alcohol vice led to widespread corruption of politicians and law enforcement agencies. Prohibition also helped finance powerful crime syndicates: money which would have been collected as liquor tax wound up in the wrong hands. Besides the murders of law enforcement officers, bootleggers more commonly caused death and disability through methanol poisoning.

Methanol – highly-toxic wood alcohol – found its way into much bootleg liquor. When methanol denatured industrial alcohol was not sufficiently diluted, or was consumed in large quantities, paralysis, blindness, and death resulted. In 1927, almost 12,000 deaths were attributed to alcohol poisonings, many of these among the urban poor who could not afford imported liquors. In 1930, U.S. public health officials estimated that 15,000 persons were afflicted with “jake foot,” a debilitating paralysis of the hands and feet brought on by drinking denatured alcohol flavored with ginger root.

Politics greased FDA’s Aspartame approval

After Prohibition, wood alcohol poisoning cases nearly vanished. Since there was plenty of ethanol, there was no need to stretch it with methanol. The following high spots were compiled by Jim Turner in his “Aspartame Timeline,” which detailed just how methanol resurfaced, this time legally. Turner is a Washington DC-based consumer advocate attorney, whose public advocacy career began with Nader’s Raiders. Turner’s work was instrumental in getting cyclamate taken off the market in 1970 (Examine his timeline in depth at www.holisticmed.com/aspartame/history.faq). Here are the lowlights from Turner’s aspartame history:

1965: While working on an ulcer drug, Dr. James Schlatter, a chemist at G.D. Searle Company, accidentally discovered aspartame. He was constructing a new molecule out of methanol and two amino acids (aspartic acid and phenylalanine). Some of the white precipitate ended up on his finger. Instinctively, he licked it off (generally not a good practice in chemistry labs). That powder was extremely sweet, measuring 180 times the sweetness of sugar. But that new substance had no calories!

1970: Cyclamate, the #1 low-calorie artificial sweetener, was pulled off the market by the federal Food and Drug Administration after some scientists found that cyclamates caused cancers. The only other artificial sweetener, saccharin, also became suspect as a cancer-causer, thus leaving the field wide open for aspartame. Searle Company executives contrived a “Food and Drug Sweetener Strategy,” propaganda which they hoped would positively spin aspartame to the FDA.

1971: Neuroscientist Dr. John Olney [whose pioneering work with monosodium glutamate (MSG) was responsible for removing that chemical from baby foods] informed Searle that his studies showed that aspartic acid caused holes in the brains of infant mice. One of Searle’s researchers confirmed Olney’s findings. Both MSG and the aspartic acid in aspartame are biochemically categorized as excitotoxins. (An excitotoxin is a substance added to foods and beverages that literally stimulates neurons to death, causing brain damage of various degrees.)

1974: Attorney Jim Turner met with Searle representatives to discuss Dr. Olney’s 1971 studies. None-the-less, the FDA granted aspartame’s approval for use in dry foods. Jim Turner and Dr. John Olney filed the first objections against aspartame approval.

1977: FDA requested the U.S. Attorney’s office to investigate whether indictments should be filed against Searle for knowingly misrepresenting research findings pertaining to aspartame safety tests. This was the first time that FDA ever requested a criminal investigation of a manufacturer. Searle then hired prominent Washington insider Donald Rumsfeld as its new CEO to turn the company around. A former member of congress and Secretary of Defense in the Gerald Ford Administration, Rumsfeld brought in several Washington cronies as top management. Both U.S. Attorneys Sam Skinner and William Conlon hired on with the defense team, and the statute of limitations expired.

1980: The FDA’s Public Board of Inquiry (PBOI) concluded that NutraSweet should not be approved, pending further investigations of brain tumors in animals. PBOI stated that “it has not been presented with proof of reasonable certainty that aspartame is safe for use as a food additive.”

1981: On January 21, the day after Ronald Reagan was inaugurated as President, Searle Company resubmitted its petition for approval of aspartame. According to former Searle salesperson Patty Wood- Alcott, Searle’s President (and then former Secretary of Defense) Donald Rumsfeld had claimed that, if necessary, “he would call in all his markers and that, no matter what, he would see to it that aspartame would be approved that year.” Ronald Reagan had to decide between Rumsfeld and George H.W. Bush as running mate during his 1980 campaign. Bush got V.P. and Rumsfeld got owed a favor. True to Rumsfeld’s word, FDA approved aspartame for use in dry products on July 15, 1981.

1983: Attorney Jim Turner (Community Nutrition Institute) and Dr. Woodrow Monte (Arizona State University’s Director of Food Science and Nutrition Laboratories) filed suit against the FDA, objecting to aspartame approval, alleging unresolved safety issues. That fall, carbonated beverages containing aspartame were, for the first time, sold for public consumption.

1985: May and August, U.S. Congressional hearings on NutraSweet: Health and safety concerns. Scientists and physicians spoke out.

1987: Another Congressional hearing was held on aspartame, “NutraSweet: Health and Safety Concerns”, chaired by Senator Howard Metzenbaum, Chairman of the Committee on Labor and Human Resources.

1998: Monsanto petitioned FDA for approval of Neotame, approximately 10,000 times as sweet as sugar. Monsanto created Neotame by taking aspartame and adding to it one molecule of 3-dimethylbutyl. The EPA lists 3-dimethylbutyl as “a most hazardous chemical.”

1999: Monsanto sold its sweetener division (NutraSweet) to four entities: Merisant (a group of Monsanto managers), Ajinomoto Company, J.W. Childs Partnership, and Michael Dell.

2002: FDA approved Neotame, despite formal objections by scientists, physicians, and activists.

To the present … March 2009: National Milk Producers Federation (NMPF) and Independent Dairy Foods Association (IDFA) proposed that the FDA include non-nutritive sweeteners in the standards of identity for 17 different dairy products, to encourage children to consume low-fat dairy products.

Full Story

_________

Related

The link between aspartame and brain tumors: What the FDA never told you about artificial sweeteners

The truth about aspartame – Dr Russell Blaylock



Aspartame Disease: An Ignored Epidemic

Sweet Misery

The artificial sweetener, aspartame, is the bedrock of the diet industry. Found in everything from fizzy drinks to vitamin pills and marketed under a variety of different names, it is difficult to detect and even harder to avoid. But how safe is it? Does it really cause brain tumours, blindness and other serious illnesses? This shocking documentary investigates how the FDA came to approve such a potentially dangerous product.

ASPARTAME: HOW SWEET IS IT?

Aspartame: What You Don’t Know Can Hurt You

Rat Study Links Aspartame to Cancer
Lymphoma, Leukemia in Rats Fed Sweetener; Industry Group Says Aspartame Is Safe

Aerosol delivery of drugs via nanoparticles to increase patient compliance

Aerosol Delivery of Antibiotics via Nanoparticles Provide a Means to Improve Drug Delivery

AZoNano | May 19, 2009

Aerosol delivery of antibiotics via nanoparticles may provide a means to improve drug delivery and increase patient compliance, thus reducing the severity of individual illnesses, the spread of epidemics, and possibly even retarding antibiotic resistance.

Delivery of antibiotics via nanoparticles has shown promise as a drug delivery mechanism, particularly for controlled release or depot delivery of drugs to decrease the number of doses required to achieve a clinical effect. The effectiveness of this delivery mechanism has not been confirmed directly either in infection models or in patients, but according to new data to be presented on Tuesday, May 19, at the American Thoracic Society’s 105th International Conference in San Diego, this delivery technique appears indeed promising.

Carolyn L. Cannon, M.D., Ph.D. from Washington University School of Medicine, and colleagues from the Center for Silver Therapeutics Research at the University of Akron in OH investigated the efficacy of nanoparticle-encapsulated silver-based antibiotics for treating pulmonary infections in a mouse model of pneumonia. Treatment with antibiotic-laden nanoparticles effectively eliminated respiratory infections in mice that had been inoculated with Pseudomona aeroginosa, a common bacterial species that often infects the respiratory tract in humans, particularly immunocompromised patients, ventilated patients or those with cystic fibrosis.

Infected mice that inhaled aerosolized nanoparticles encapsulating silver carbene complexes (SCCs), a novel class of silver-based antimicrobials with broad-spectrum activity, showed a significant survival advantage over the control mice that received nanoparticles without the SCCs. Treated mice also had decreased lung bacterial burden and spread, compared to the control mice. Moreover, the treatment with nanoparticles occurred once every 24 hours, a regimen that is known to increase compliance in human patients, versus the usual dosing interval of inhaled antibiotics for P. aeruginosa, which is twice daily.

“We were surprised and thrilled to see a 100 percent survival advantage in mice treated daily with SCC22-loaded nanoparticles at doses significantly lower than those used to achieve a similar survival advantage in twice-daily dosing of unencapsulated SCC22. During a 72 hour period, all of the infected control mice died, whereas all of the mice that received just two doses of SCC22-loaded nanoparticles spaced 24 hours apart survived.”

“My collaborators, Wiley Youngs, Ph.D., and Yang Yun, Ph.D., and I are eager to complete toxicity studies that would enable us to start clinical trials,” said Dr. Cannon. “While the mouse studies are tantalizing, the goal that propels our research is realizing the promise of these novel antibiotics and delivery mechanisms through an analogous survival advantage in patients.”

2 Billion Infected? WHO Stokes Swine Flu Fear

Disease Experts Say Dedicated Swine Flu Vaccine Is Becoming More Likely

The Obama administration may be considering a vaccination plan this fall for Americans that would involve a battery of three shots, two of which would be against the new viral threat.

ABC News | May 7, 2009

By DAN CHILDS and MICHELLE SCHLIEF

The World Health Organization may have inadvertently triggered a new wave of fear over the threat of a swine flu pandemic today by suggesting that up to 2 billion people could be infected if the current outbreak worsens.

“If the situation continues to evolve and the virus does become established in other countries, and we do move into a pandemic, we would expect the virus to infect many people,” said WHO chief Keiji Fukuda at a press conference today. “Perhaps a third of the world’s population could be infected with this virus, based on previous pandemic.”

Fukuda quickly noted to reporters that he was making statement based on data from past pandemics and was not a predicting what would happen with the current swine flu outbreak.

“I do not want you to walk out of here saying that there is an estimate that 2 billion will get infected in the next year or so,” he said. “Please do not interpret this as a prediction for the future.”

The comment immediately ignited debate among infectious disease experts.

“I think that WHO could serve the world health better by providing a more evidence-based, sensible ‘benchmark’ of H1N1 infection,” said Ed Hsu, associate professor of public health informatics at the University of Texas School of Health Information Sciences and School of Public Health. He argued that the 2 billion figure, based on past pandemics, does not take into account recent public health improvements. Moreover, his own research has suggested that the rate of swine flu infection in the United States may have already stabilized.

“One could reasonably question the reliability of WHO’s statement of mass infection,” he said. “By making such statement without strong backing WHO may risk putting its accountability on the line.”

On the other side of the argument is Dr. Christian Sandrock, assistant professor of clinical medicine in the Division of Infectious Diseases at the UC Davis School of Medicine. He said the numbers cited by Fukuda are less important than the overall message, which is that we should be prepared for a second wave of swine flu later this year.

“I think this is an important discussion — not the numbers, but the likelihood of larger spread in the second wave,” he said, adding that such a discussion is crucial for vaccine development and other issues of preparedness. “Much better to do this now than later.”

The Swine Flu Vaccine Question

Still, the question of whether the public and the medical community should worry about a possible swine flu pandemic has big implications for preparing for such an event — particularly in regard to vaccines.

As drug makers await the viral “seed strain” they need to begin manufacturing doses of swine flu vaccine by the millions, health officials are mulling what form the jabs might take — and if Americans may be facing up to three needle jabs this fall.

The debate is not a trivial one. While infectious disease experts have said that there is much about the new strain of the H1N1 virus that they still do not know, government agencies must decide soon whether or not a swine flu vaccine will be needed — particularly because such a vaccine would take months to develop and produce.

The risk of moving forward is that the virus will fizzle, making such a vaccine unnecessary. This would cost millions and, for pharmaceutical companies, waste precious time and resources.

The risk of delaying, on the other hand, is that the virus will resurge later this year and spread viciously through an unprotected populace.

Dr. Peter Katona, for one, believes one of these sets of risk far outweighs the other.

“To have a non-pandemic and waste the effort is worth it, compared to having a pandemic and not being optimally prepared,” said Katona, an associate professor of clinical medicine at The David Geffen School of Medicine at UCLA.

“It would take a brave soul to operate under the impression that we’re not going to see this [swine flu] again in the fall,” agreed former CDC director Dr. Julie Gerberding. “Ideally, we want a just-in-case vaccine. Even it is no worse than seasonal flu, we will want a vaccine.”

Drug makers already are preparing for such an effort. Pennsylvania-based Sanofi-Pasteur, the only U.S.-based manufacturer of injectable seasonal flu vaccine, said that it is in daily contact with the U.S. Centers for Disease Control and Prevention, waiting for the green light to begin the process.

“We expect in the next couple of weeks that the decision will be reached to make a pandemic flu vaccine,” said Rick Smith, vice president of Strategic Programs and Projects for Sanofi-Pasteur. “Right now, we’re getting everything ready — getting raw materials, getting eggs, assessing production schedules.”

But the exact form which such a vaccine would take — specifically, whether it is lumped into the usual seasonal flu vaccine or offered as a separate shot or series of shots — is still in question. And while this detail may seem trivial to some, it could well determine how effectively it is used.

Related

Antiviral prescriptions spike after flu scare-data

Three’s a Crowd? Concerns of Multiple Jabs

The question of what form a swine flu vaccine might take hit headlines late Tuesday when The Washington Post reported that the Obama administration may be considering a vaccination plan this fall for Americans that would involve a battery of three shots, two of which would be against the new viral threat.

Dr. Greg Poland, director of the Mayo Clinic’s Vaccine Research Group, said he believed a swine flu vaccine would almost certainly have to take this form.

“Three shots are definitely possible,” he said. “I think it is the only route we can go.”

Poland added that manufacturers are already in the process of making the seasonal flu vaccine in preparation for the next regular flu season. Adding protection from another viral strain into this vaccine would involve a new layer of approval from regulatory authorities — a complex step that could cost precious time.

Dr. D.A. Henderson, a distinguished service professor at Johns Hopkins University and an infectious disease expert, agreed.

“The production of the trivalent seasonal vaccine is now under way and continuing,” he said. “To me, it would make sense to advise giving one dose of the [seasonal flu vaccine] and two doses of the new H1N1.”

But not all agree that this is the best option. Dr. Pascal Imperato, chair of the department of preventive medicine and community health at SUNY Downstate Medical Center in Brooklyn, N.Y., said that in a perfect world, one shot would serve a dual purpose of protecting against both seasonal and swine flu.

“The best option, if possible, would be to incorporate the H1N1 antigens into the usual annual vaccine and recommend only one inoculation,” he said, adding as a caveat, “Whether or not this is scientifically feasible remains an open question.”

Swine Flu Vaccine: Is It Worth It?

Another open question is whether the threat posed by swine flu actually warrants its own vaccination. As much media coverage that swine flu has generated over the past couple of weeks, case and casualty figures remain low when compared with other diseases.

“If [the U.S.] decided to make the vaccine investment,” Hsu noted, “the administration would have to make a stronger case, at some point, why a disease that caused two deaths and less than 500 cases in the U.S. in a two-week period — with a risk not greater than seasonal flu — would warrant the multibillion dollar investment, versus other prevalent diseases such as hepatitis, cancer or [cardiovascular disease] that each caused dozens of thousand deaths and affects millions of Americans each year.”

Dr. Harley Rotbart, professor of microbiology at the University of Colorado School of Medicine and author of the book “Germ Proof Your Kids — The Complete Guide to Protecting (without Overprotecting) Your Family from Infections,” said that the effort to produce a special vaccine would be a massive undertaking — especially considering that such an effort would take place at the same time that companies are manufacturing seasonal flu vaccine.

“How to fit an ‘emergency’ additional vaccine into the mix without disturbing what we do well is … [a] challenge,” Rotbart said.

And even with all drug makers producing the vaccine, it is unlikely that there would be enough to protect everyone.

“World ability is about one billion doses,” Poland said. “That is not enough. There are priority tiers on who gets vaccine. Little or no [vaccine] will go to underdeveloped countries.”

Americans May Not Get Their Shots

Domestically, the questions over how many Americans will accede to three needle pokes instead of just one is another part of the equation, of course. In a Gallup poll released today, only 46 percent of respondents said they would get a swine flu vaccine shot if available, while 52 percent said they would not.

And though the medical community at large is in general agreement that vaccines are notably safe, the jabs are not without their possible side effects and risks.

Notably, during the 1976-1977 flu season, those who received a vaccine for swine influenza appeared afterward to have an increased risk of Guillain-Barre syndrome (GBS) — a disease in which the body damages its own nerve cells, leading to muscle weakness and occasional paralysis. According to the CDC, between 5 and 6 percent of all patients with GBS die from it.

“Many will remember reports of this complication from 33 years ago, and most will certainly be reminded of it by the press and media,” Imperato said.

Health officials emphasize that this risk is no longer an issue, thanks to improved safety testing and additional research. Still, many of those who remember the episode may be reticent to opt for the shot, some doctors worry.

“There is not enough time or a large enough sample to test any vaccine before we will need it this fall,” Olds said. “That will create uncertainty and decrease coverage. … Most people will likely not take it for fear of the neurologic side effects unless they are facing a major swine flu pandemic with a higher-than-currently-observed mortality rate. Most would prefer to sit back with some Tamiflu in their pocket and wait and see.”

And then there is the question of whether people will be willing to visit the doctor multiple times for multiple shots — particularly in light of the common complaint among infectious disease experts that not enough Americans get their single seasonal flu shot already.

Still, Henderson said he believes that even if vaccinating the public against both seasonal flu and the swine flu takes multiple jabs — and multiple visits the doctor — a properly conceived public health effort could protect much of the public from illness.

“I would speculate that the [seasonal flu vaccine] and one dose of the H1N1 could be given at the same time, but that needs to be confirmed,” he said. “Thus, it might be possible to deliver the needed vaccine with just two visits.

“Yes, I’ve dealt with a number of vaccine campaigns, and I know the potential confusion that could and will result in some instances. However, this is not exactly rocket science. It can be done.”

Corporate Swine Project Significant Profits for Toxic Flu Vaccines

OpEd News | May 5, 2009

by megan kargher

Disease is big business and pharmaceutical corporations are cashing in on the destruction of health worldwide.  Akin to their sinister forbearers at IG Farben, who were convicted of crimes against humanity at the Nuremberg Trails, today’s pharmaceutical corporations are now perpetuating genocide on a global scale.

Millions are spent funding candidates from both political parties ensuring that no matter who is in office the laws enacted favor them.  Pharmaceutical firms contributed $1,995,384 on the Obama campaign alone. These corporations purchase, sorry, “fund” not only the government officials, but also most of the institutions who are supposed to safeguard the public health, which means all of these institutions have been affectively subverted.  In fact the major pharmaceutical firms and their corporate partners in crime fund everything from medical schools to the American Dietetic Association to United Nations sponsored programs like Codex Alimentarius (international agreements controlling production and distribution of food and supplements).

Companies like Monsanto have not only been profiting from the poisoning of the people of the world, (giving us dangerous products like agent orange and aspartame,) but have been for many years buying and working in partnership with major pharmaceutical firms and therefore also profit on the treatment of the symptoms caused by their poisons.  One pharmaceutical company purchased by Monsanto in 1985 was G.D. Searle & Company.  Donald Rumsfeld was CEO of G.D. Searle & Company at that time and he played a major role in Monsanto’s acquisition of the company.  Searle is now Pfizer.

Many medications and vaccines potentially cause more problems than they solve.  This is not a side effect, this is part of how big pharmaceutical companies make their money.  There is far more money in keeping patients dependent on expensive drugs than there is in curing them.  If a drug causes more illness, (particularly one which seems unrelated,) the new symptoms must then be treated.  The more problems a patient suffers from, the more drugs you can sell them.  These companies are pushing the deadliest and most addictive substances known to man and they do it legally.

Vaccines are out and outright toxic.  Here is just a short list of some of the chemicals and heavy metals commonly found in many vaccines: formaldehyde, aluminum hydroxide, aluminum phosphate, aluminum sulfate, sorbitol, bensethonium chloride, and phenol.  Some vaccines such as GalaxoSmithKline’s Havrix for hepatitis A contain diploid cells from aborted fetal tissue.  In addition there are the vaccines which get accidentally, so they claim, contaminated.  Oops, was that bird flu we put in there?

Full Story