FDA Approves Tamiflu for Newborns

FDA Approves Tamiflu for Newborns Despite No Safety Evidence

January 6, 2013

On December 21, 2012, the

FDA expanded use of the anti-viral drug oseltamivir, known by the brand name Tamiflu,

to children as young as two weeks old.

Crazy?

Absolutely.

Surprising?

Not in the slightest.

While shocking, this recent move is yet another demonstration of the FDA’s unrelenting spiral to complete and utter lunacy in its decision making.

How the FDA could approve a drug like Tamiflu for children so young when it is already under scrutiny in Japan for a possible link to suicide and other abnormal behavior in children is totally incomprehensible.

As recently as April 2012, the FDA even recognized that oseltamivir, the active ingredient in Tamiflu, was associated with ”abnormal behavior, delirium, including symptoms such as hallucinations, agitation, anxiety, altered level of consciousness, confusion, nightmares, delusions” as possible side effects of pediatric patients taking the drug.

The most compelling reason which calls into question the FDA’s approval of Tamiflu for infants is a 2010 study published in the The Pediatric Infectious Disease Journal which found that off label use of Tamiflu in babies resulted in 84 of the 157 infants (average age 6.3 months) experiencing complications from the medication the most serious being meningitis (1%), pneumonia (6%), and otitis media (1%). 

No Safety Studies on Tamiflu for Babies

There are certainly no controlled, randomized, placebo-controlled trials on the safety of Tamiflu for babies as testing on babies is obviously considered unethical – so what possible evidence could the FDA have used for this unfathomable decision?

Did the FDA just extrapolate data from previous studies on Tamiflu use in adults and older children to justify the decision?  Is this possible despite the fact that infants have not yet developed a blood-brain barrier that is able to keep a chemical out of the brain, which grows at its most rapid rate the first year of life? In addition, a baby’s detoxification mechanisms are also inadequately developed to remove a chemical out of the body quickly enough to prevent damage.

Neither of these biological facts were obviously considered in the decision.  Babies were simply assumed to handle the drug in a similar manner to adults or adolescents!

It is abundantly clear in the rendering of this decision that the FDA was only attempting to please Roche, the manufacturer of the active chemical ingredient in Tamiflu, whose shareholders are undoubtedly extremely concerned about the December 15, 2010 report from the World Health Organization (WHO) that viral resistance to Tamiflu is growing.

The FDA was not in any way attempting to protect the public or help save babies’ lives from the flu by expanding Tamiflu to infants.  Rather, it seems quite apparent that the move is an attempt to boost Roche’s short-term profits from the drug before expanding viral resistance renders Tamiflu ineffective and it becomes yet another Blockbuster drug relegated to the Big Pharma dustbin.

Didn’t know that your tax dollars are being used to pay the salaries of Federal bureaucrats who frequently operate as de facto corporate employees rendering decisions solely to benefit the bottom line of private companies?  Welcome to the Brave New World of Corporate Socialism.

Sarah, The Healthy Home Economist

Sources: Tamiflu Side Effect Concerns Grow After Japan Deaths

FDA Approves Neurotoxic Drug for Infants Less Than One

FDA Expands Tamiflu’s Use to Treat Children Younger Than 1 Year

Picture Credit

SSRIs: Poor Students in Poor Schools!

Poor Kids Getting Prescribed ADHD Meds They Don’t Need, Against Their Will
October 10, 2012

Doctors are prescribing prescription pills like Adderall to low-income kids even if they don’t “need” drugs to function because it’s often the only realistic way to help them do well in school.

“I don’t have a whole lot of choice,” one doctor who treats poor families outside of Atlanta, Georgia, told the  New York Times . “We’ve decided as a society that it’s too expensive to modify the kid’s environment. So we have to modify the kid.”

It’s easy for those of us without kids struggling to succeed in inadequate schools to act horrified about the way A.D.H.D diagnosis rates are rising as school funding drops — because it  is horrifying to imagine a bunch of elementary schoolers hopped up on speed that’s doing god knows what to their little brains (well, we know that some reported side effects include growth suppression, increased blood pressure and psychotic episodes; we’ll get to that in a second) — but it all depends on how you measure success. Is the end goal a perfectly clear blood stream or good grades against the odds? Some parents (and doctors) would choose the latter.

“We as a society have been unwilling to invest in very effective nonpharmaceutical interventions for these children and their families,” Dr. Ramesh Raghavan, a child mental-health services researcher at Washington University in St. Louis and an expert in prescription drug use among low-income children, told the  Times. “We are effectively forcing local community psychiatrists to use the only tool at their disposal, which is psychotropic medications.”

(Read Full Article)

Cancer Drug Reverses Alzheimers in Mice

Cancer Drug Reverses Alzheimers in Mice
Februray 11, 2012
By Joseph Brownstein, MyHealthNewsDaily

A cancer drug has succeeded in reversing Alzheimer’s disease in its early stages in mice, according to a new study.

The drug, bexarotene, is designed to reduce levels of amyloid beta, the protein whose presence in the brain has been most closely tied to the development of Alzheimer’s.

In a new study, mice treated with bexarotene saw their amyloid beta levels drop 25 percent within six hours and, importantly, they showed a corresponding improvement in their cognitive function.

“The data we provide here really suggest that Alzheimer’s could be, in the early stages, a reversible disease,” said study author Paige Cramer, a doctoral student in neuroscience at Case Western Reserve School of Medicine.

The researchers used mice that had a mouse model of Alzheimer’s disease. After the researchers administered varying doses of bexarotene, they measured levels of amyloid beta in the brain and tested the mice for their abilities in maze running, nest building, smell, and fear conditioning, which is a type of learning.

“They did a lot of different tests of learning and memory and they saw an effect on every single one of them,” said Michael Sasner, a research scientist and associate director at the Jackson Laboratory in Bar Harbor, Maine.

Bexarotene is already approved by the Food and Drug Administration for the treatment of cutaneous T-cell lymphoma, a type of skin cancer, and so it may be able to proceed through clinical trials more quickly than drugs not already known to be safe to administer to people.

The study appears in the Feb.10 issue of the journal Science.

A new way to target Alzheimer’s

Sasner, who was not involved with the new study, said it overcomes some of the weaknesses of previous Alzheimer’s work, in which only one or two tests of cognitive improvement were conducted.

Bexarotene is not the first attempted Alzheimer’s treatment to target amyloid beta. But past research has aimed at removing the plaques that amyloid beta can form in the brain, which has not shown any effect on the disease itself.

The difference now, researchers say, is in a better understanding of amyloid beta and the various forms it can exist in. Rather than focusing on the plaques, researchers now think it is the active, soluble form of the protein that is at work in Alzheimer’s.

While there are various views on the causes of Alzheimer’s, “the predominant view right now is that it’s the soluble forms of amyloid beta that are causing the impaired brain function,” Cramer said. “Plaques are just sinks, just tombstones that gather amyloid beta.”

Bexarotene works by promoting the production of another protein, called Apolipoprotein E, which binds to and clears amyloid beta from the brain.

“This paper lends a lot to the mechanism of how ApoE may be involved in Alzheimer’s,” Cramer said.

Hurdles remain

It remains to be seen whether the benefits of bexarotene in mice would translate to humans.

“Because we’re using an FDA-approved drug, this allows us to translate these basic science findings to the clinic; that’s our next goal,” Cramer said.

Figuring out the correct dosing presents another challenge. Researchers found that in one case, giving bexarotene over several doses appeared to be less effective than giving it once. Cramer said the reason may be that the drug degrades itself within the body.

Cramer said she and Gary Landreth, the senior investigator on the study, hope to begin a preliminary trial this year, in which they will look for the same changes in beta amyloid levels in humans. If successful, the testing would move to clinical trials.

Bexarotene is currently sold as Targretin; patents on that drug will expire in April.

“There’s a long way to go to prove this treatment in humans, but it seems like an exciting thing to follow up on,” Sasner said.

Article Link: http://vitals.msnbc.msn.com/_news/2012/02/09/10365068-cancer-drug-reverses-alzheimers-in-mice

Seven Diseases Big Pharma Hopes You Get in 2012

Seven Diseases Big Pharma Hopes You Get in 2012 | | AlterNet.


Seven Diseases Big Pharma Hopes You Get in 2012

By Martha Rosenberg, AlterNet
Posted on December 6, 2011,

It used to be joked that a consultant is someone who borrows your watch to tell you what time it is. These days, the opportunist is Big Pharma, which raises your insurance premiums and taxes while providing you “low-priced” drugs that you paid for.

How did Pharma get a good third of the United States taking antidepressants, statins, and Purple Pills, albeit at low prices? By selling the diseases of depression, high cholesterol, and gastroesophageal reflux disease, or GERD. Supply-driven marketing, also known as “Have Drug — Need Disease and Patients,” not only turns the nation into pill-popping hypochondriacs, it distracts from Pharma’s drought of real drugs for real medical problems.

Of course, not all diseases are Wall Street pleasers. To be a true blockbuster disease, a condition must (1) really exist but have huge diagnostic “wiggle room” and no clear-cut test, (2) be potentially serious with “silent symptoms” said to “only get worse” if untreated, (3) be “under-recognized,” “under-reported” with “barriers” to treatment, (4) explain hitherto vague health problems a patient has had, (5) have a catchy name — ED, ADHD, RLS, Low T or IBS — and instant medical identity, and (6) need an expensive new drug that has no generic equivalent.

Here are some potential blockbuster diseases Pharma hopes you get in 2012.

Adult ADHD

Everyday problems labeled as “depression” sailed Pharma through the last two decades. You weren’t sad, mad, scared, confused, remorseful, grieving, or even exploited. You were depressed, and there was a pill for that. But depression peaked just like the Atkins Diet and the Macarena. Luckily, there is adult ADHD (Attention Deficit Hyperactivity Disorder), which has doubled in women 45 to 65 and tripled in men and women 20 to 44, according to the Wall Street Journal.

Like depression, adult ADHD is a catch-all category. “Is It ADHD or Menopause?” asks an article in Additude, a magazine devoted exclusively to ADHD. “ADD and Alzheimer’s: Are These Diseases Related?” asks another article in the same magazine.

“I’m Depressed. Could it be ADHD?” says an ad in Psychiatric News, showing a pretty but pouting young woman. In the same publication, another ad titled “Broken Promises” says, “Adults with ADHD were nearly 2x more likely to have been divorced,” while exhorting doctors to “screen for ADHD.”

Adults with ADHD are often “less responsible, reliable, resourceful, goal-oriented, and self-confident, and they find it difficult to define, set, and pursue meaningful internal goals,” says an article cowritten by Harvard child psychiatrist Dr. Joseph Biederman, who is credited with putting “pediatric bipolar disorder” on the map. They “show tendencies to being self-absorbed, intolerant, critical, unhelpful, and opportunistic,” and “tend to be inconsiderate of other people’s rights or feelings,” says the article, describing most people’s brothers-in-law.

Adults with ADHD will have trouble keeping a job and get worse without treatment, says WebMD, tapping into the second requirement of a blockbuster disease — symptoms worsen without pills. “Adults with ADHD may have difficulty following directions, remembering information, concentrating, organizing tasks, or completing work within time limits,” according to the website, whose original partner was Eli Lilly.

How did Pharma get five million kids and now, maybe, their parents on ADHD meds? Ads on 26- by 20-foot screens in Times Square that ask “Can’t focus? Can’t sit still? Could you or your child have ADHD?” four times an hour couldn’t hurt. (Bet no one had trouble focusing on that!)

Still, convincing adults they aren’t sleep deficient or bored but have ADHD is only half the battle. Pharma also has to convince kids who grew up diagnosed as ADHD not to quit their meds, says Mike Cola of Shire (which makes the ADHD drugs Intuniv, Adderall XR, Vyvanse, and the Daytrana patch). “We know that we lose a significant number of patients in the late teen years, early 20s, as they kind of fall out of the system based on the fact that they no longer go to a pediatrician.”

A Shire ad in Northwestern University’s student paper this year takes the issue head on. “I remember being the kid with ADHD. Truth is, I still have it,” says the headline splashed across a photo of Adam Levine, the lead singer of Maroon 5. “It’s Your ADHD. Own It,” was the tagline. (Was “Stay Sick” the runner-up?)

Of course, pushing speed on college kids (or anyone, for that matter) isn’t too hard. Why else do meth dealers say, “First taste free”? But Pharma is so eager to retain its pediatric ADHD market, it has funded for-credit courses for doctors, such as “Identifying, Diagnosing, and Managing ADHD in College Students” and “ADHD in College: Seeking and Receiving Care During the Transition From Child to Adult.”

To make sure no one thinks ADHD is a made-up disease, WebMD shows color-enhanced Pet scans of the brains of a normal person and an ADHD sufferer (flanked by an ad for Vyvanse). But it is doubtful the scans are really different, says psychiatrist Dr. Phillip Sinaikin, author of Psychiatryland. And even if they are, it proves nothing.

“The crux of the matter is that there is simply no definitive understanding of how neuronal activity is related to subjective consciousness, the age-old unsolved body/mind relationship,” Sinaikin told AlterNet. “We have not advanced beyond phrenology, and this article in WebMD is simply the worst kind of manipulation by the drug industry to sell their overpriced products, in this case a desperate effort by Shire to maintain a market share when Adderall goes generic.”

Rheumatoid Arthritis

Rheumatoid arthritis is a serious and dangerous disease. But so are Pharma’s immune-suppressing biologic drugs like Remicade, Enbrel, and Humira, which are pushed to treat it. While RA attacks the body’s own tissues, leading to inflammation of the joints, surrounding tissues, and organs, immune suppressors can invite cancers, lethal infections, and activate TB.

In 2008, the FDA announced that 45 people on Humira, Enbrel, Remicade, and Cimzia died from fungal diseases, and investigated Humira’s links to lymphoma, leukemia, and melanoma in children. This year, the FDA warned that the drugs can cause “a rare cancer of white blood cells” in young people, and the Journal of the American Medical Association (JAMA) warned of “potentially fatal Legionella and Listeria infections.”

Immune-suppressing drugs are also dangerous to the pocketbook. One injection of Remicade costs up to $2,500; a month’s supply of Enbrel costs $1,500; and a year’s supply of Humira costs up to $20,000.

Once upon a time, RA was diagnosed from the presence of “rheumatoid factor” and inflammation. But, thanks to Pharma’s supply-driven marketing, stiffness and pain are all that are required for the diagnosis today. (Athletes and people born before 1970 — line forms to the left!)

In addition to diagnostic wiggle room and a catchy name, RA has other blockbuster disease requirements. It  will “only get worse” if untreated, says WebMD, and it is often “misdiagnosed” and underreported, says Abbott’s Heather Mason, because “people often don’t know what they have for a while.”

So serious a disease, it costs over $20,000 a year to treat but so subtle you may not know you have it? RA sounds like a blockbuster.

Fibromyalgia

Another underreported disease is fibromyalgia, characterized by widespread. unexplained bodily pain. Fibromyalgia is “almost a textbook definition of an unmet medical need,” says Ian Read of Pfizer, which makes the first drug to be approved for fibromyalgia, the seizure pill Lyrica. Pfizer gave nonprofit groups $2.1 million in 2008 to “educate” doctors about fibromyalgia and financed PSAs (pharma service announcements) depicting sufferers describing their symptoms without mentioning a drug. Lyrica now makes $3 billion a year.

Still, Lyrica has to fight Cymbalta, the first antidepressant to be approved for fibromyalgia. Eli Lilly prepositioned Cymbalta for the physical “pain” of depression in a campaign called “Depression Hurts” before the fibromyalgia approval. Treatment of a fibromyalgia patients with either Lyrica or Cymbalta hovers around $10,000, say medical journals.

Pharma and Wall Street may be happy with fibromyalgia drugs, but patients aren’t. On askapatient.com, the drug-rating website, patients on Cymbalta reported chills, jaw problems, electrical “pings” in their brain, and eye problems. This year, four patients reported the urge to kill themselves, a frequently reported side effect of Cymbalta. Lyrica users on askapatient reported memory loss, confusion, extreme weight gain, hair loss, impaired driving, disorientation, twitching, and worse. Some patients take both drugs.

SLEEP DISORDERS

Middle of the Night Insomnia

Sleep disorders are a goldmine for Pharma because everyone sleeps — or watches TV when they can’t. To churn the insomnia market, Pharma rolls out subcategories of insomnia, such as chronic, acute, transient, initial, delayed-onset, terminal, early-morning, menopausal, and the master category of nonrestful sleep. This fall, Pharma rolled out a new version of Ambien for “middle-of-the-night” insomnia called Intermezzo, even though Ambien is paradoxically notorious for middle-of-the-night awakenings: people “waking up” in an Ambien blackout and walking, talking, driving, making phone calls, and eating food.

Many became aware of Ambien’s “lights-on-nobody-home” effect when former Rhode Island Representative Patrick Kennedy drove to Capitol Hill to “vote” at 2:45 a.m. in 2006 on Ambien and crashed his Mustang. But it was Ambien’s EWI effect — eating while intoxicated — not DWIs that gave the pill its worst rap. Fit and sexy people awoke amid mountains of pizza, Krispy Kreme, and Häagen-Dazs cartons, their contents consumed by their evil twin on Ambien.

Excessive Sleepiness and Shift Work Sleep Disorder

Needless to say, people with insomnia won’t be bright-eyed and bushy-tailed the following day —  whether they didn’t sleep or whether they have sleeping pill residues in their system. In fact, they are actually suffering from the underrecognized and underreported epidemic of Excessive Daytime Sleepiness. The main medical causes of EDS or ES are sleep apnea and narcolepsy, but last year Pharma rolled out a lifestyle-caused “Shift Work Sleep Disorder.” (No, it doesn’t meant you can’t sleep because your partner “shifts” in his or her sleep.) Ads for Provigil, a Schedule IV stimulant that treats EDS along with Nuvigil show a judge in his black robe, nodding out on the job, with the headline “Struggling to Fight the Fog?” (“Yo! Your Honor! I’m trying to plead!”).

Of course wakefulness agents contribute to insomnia, which contributes to wakefulness problems in a kind of perpetual pharmaceutical jet lag. In fact, the sleeping pill/alertness aid habit is so common, it threatens to create a new meaning for “AA” — Adderall and Ambien!

Insomnia That Is Really Depression

Sleep disorders have also given a new lease on life to antidepressants. Doctors now prescribe more antidepressants for insomnia than they do sleeping pills, according to CNN. They also often combine them, since “insomnia and depression often occur together, but which is the cause and which is the symptom is often unclear.”

WebMD agrees with doubling the drugs. “Depressed patients with insomnia who were treated with both an antidepressant and a sleep medication fared better than those treated only with antidepressants,” it writes. Ka-ching!

In fact, many of the new blockbuster diseases from adult ADHD and RA to fibromyalgia are treated with new drugs piled on top of existing ones that aren’t working, a Pharma contrivance called polypharmacy. It brings to mind the store owner who says, “I know that 50 percent of my advertising is wasted — I just don’t know which 50 percent.”

Martha Rosenberg frequently writes about the impact of the pharmaceutical, food, and gun industries on public health. Her work has appeared in the Boston Globe, San Francisco Chronicle, Chicago Tribune, and other outlets.

© 2011 Independent Media Institute. All rights reserved.
View this story online at: http://www.alternet.org/story/153332/

7 Blockbusters’ Patents Expire Soon!

7 Blockbusters’ Patents Expire Soon – Drug Prices Will Plummet For Millions Of People.

 

7 Blockbusters’ Patents Expire Soon – Drug Prices Will Plummet For Millions Of People

26 Jul 2011

By the end of next year, 7 of the 20 top selling medications will lose their patent protection, making way for much cheaper generic versions. This is a godsend for patients, and a serious concern for the pharmaceutical industry which depends so much on high incomes for research and development.

It won’t be long before super-blockbusters Lipitor, a cholesterol-lowering drug, and blood thinner Plavix lose their patent protection. Lipitor in the USA alone is taken by 4.3 million patients, and Plavix by 1.4 million.

Lipitor is the world’s top selling medication. It will lose its patent in November this year.

Antipsychotic drug Zyprexa loses its patent in October 2011. Plavix’s goes in May next year. Psoriasis and rheumatoid arthritis drug, Enbrel will give way to generics in October 2012.

It is estimated that $225 billions’ worth of annual global sales of drugs will go off patent by the end of 2015.

Generics will be entering several medical areas in a big way, including treatments for HIV, depression, diabetes, asthma, bipolar disorder, hypertension and high triglycerides.

Over the next decade approximately 120 brand names will no longer dominate the market, experts say.

Patients, taxpayers, businesses and health insurance companies will save billions. A generic drug can cost up to 80% less than the brand name version.

US health experts say that a significant number of people who cannot currently afford to pay for their medications, will soon be able to do so. The USA is one of the most expensive countries in the world for prescription medications.

In America today, many people even with private health insurance or Medicare cover are not getting their prescriptions because they simply do not have the money.

Studies have shown that generic drugs are just as good as the brand name ones, says the FDA (Food and Drug Administration). As long as the active ingredient is the same, the medication is just as effective. Some argue that generic versions have uneven safety records. However, studies have shown that brand named drugs have the same risk of contamination due to some bad manufacturing practice, or another reason.

Some experts have dispute this, however. A study performed by scientists at Johns Hopkins University and published in Annals of Neurology found that switching to an anti-epilepsy generic version of a drug carried with it a 10% risk that peak concentrations in the body occurred at different times.

Written by Christian Nordqvist
Copyright: Medical News Today


Article URL: http://www.medicalnewstoday.com/articles/231690.php 


Drug Safety and Availability > FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)

Drug Safety and Availability > FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs).

FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)

Proton _Pump_Inhibitors

PPIs


Safety Announcement

Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary

 


Safety Announcement

[3-2-2011] The U.S. Food and Drug Administration (FDA) is informing the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. In 2009, approximately 21 million patients filled PPI prescriptions at outpatient retail pharmacies in the United States.2 Patients who take prescription PPIs usually stay on therapy for an average of about 180 days (6 months).3

Prescription PPIs include Nexium (esomeprazole magnesium), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium), and AcipHex (rabeprazole sodium). Vimovo is a prescription combination drug product that contains a PPI (esomeprazole magnesium and naproxen). Over-the-counter (OTC) PPIs include Prilosec OTC (omeprazole), Zegerid OTC (omeprazole and sodium bicarbonate), and Prevacid 24HR (lansoprazole).

In contrast to prescription PPIs, OTC PPIs are marketed at low doses and are only intended for a 14 day course of treatment up to 3 times per year. FDA believes that there is very little risk of hypomagnesemia when OTC PPIs are used according to the directions on the OTC label.

Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. Treatment in patients taking a PPI and who have hypomagnesemia may also require stopping the PPI. (Read more)

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