There are so many safe things women can do to support their mood, as needed, during pregnancy.  Psych meds are not one of them.  I explain what the Mother’s Act is all about in a posting I did titled, Branding Pregnancy as Mental Illness. 

Sulfa drugs are the oldest antibiotic – made by the Germans and derived from coal tar.  The FDA has never made the German drug companies prove they were safe.  Instead, when the FDA got actual regulatory power in the late 1930s they immediately allowed coal tar derived food coloring as an approved food additive, and the Germans proceeded to dump 39 billion tons of this toxic garbage into the U.S. food supply the first year – a problem that has only gotten worse. 

It should not be short on the memory of any American that these drug companies (Bayer, BASF, & Hoechst) worked hand-in-glove with Hitler and were instrumental in funding the build up of the Nazi war machine and WWII (thanks FDA).  These drug companies also invented the coal tar derived nerve gas that was used in Hitler’s concentration camps.  Following WWII the same toxins became the first pesticides used on U.S. crops, starting the first Green Revolution (and the decline in health of Americans).

The fact that German drug companies have been poisoning pregnant mothers with Sulfa drugs for over 75 years, while the inept FDA allows the sales while spending its time targeting competition to such toxic drugs, is exactly what is wrong with the FDA. 

Creating a market demand for this fraud is a health care system that blindly pays for it.  This issue is causing millions of injuries a year and tens of thousands of deaths.  It makes the Ponzi scheme run by Bernie Madoff pale in comparison.  It is ruining the legitimate health care needs of a nation.  Any expansion of mandatory health care funding will only make it worse, since the current scheme is set to feed off patients who don’t pay full price (or often any price) for the medications they “need.”

The scandals involving inappropriate use of medications are so numerous they defy believability, with FDA management either tacitly allowing or actively helping the various drug companies.  The FDA has a long history of pretense dating back to its inception over 100 years ago.  It is part of the DNA of the FDA’s dysfunctional culture.  FDA managers act in a revolving door capacity with the various industries they are supposed to be regulating.  What FDA mangers actually do is more akin to the activities of a police-force bully.  They seek to knock out competition for their friends in Big Pharma, Big Biotech, and Big Food, while acting as the gatekeepers of profits for the chosen few – often in disregard of the health consequences. 

It was only a few years ago that the FDA didn’t even know what drugs it had approved to be on the market.  Far worse, the FDA is quite lax on requiring the mandatory follow-up safety testing for the drugs that have been approved.  On October 26, 2009 the Government Accountability Office released a report blasting the FDA on this issue.  The lack of FDA due diligence has resulted in a situation wherein doctors and patients do not have a clear picture of the actual risks of virtually any drug, including the blockbusters in common use (such as birth control pills).  Big Pharma would rather not do these studies because when they do they often show the drug is far more dangerous than previously thought – which typically causes a drop in sales.  Why would any drug company want to shoot itself in the foot? 

The negative data submitted to the FDA during the drug approval process is seldom ever published in any meaningful way or context.  Rather, Big Pharma ensures that mostly the positive studies submitted to the FDA find their way into the literature.  Again, this skews the public understanding of the drug.  FDA management has been known to coerce and threaten its scientists to suppress negative news about drugs, often over-ruling their scientists so that a dangerous drug can be put on the market.  Such FDA management coercion of its own scientific staff came into full public view when it was discovered how Avandia, a diabetes drug, could get on the market without any warning that it causes heart failure

A classic example of Big Pharma intentionally suppressing the negative studies so as to paint a false rosy picture of a medication’s benefits are the anti-depressants.  In fact, the entire theory of the use of antidepressants upon which FDA-approved drug dispensing is based has recently been called into question.  Yet, these near-useless drugs are top sellers to our children.  The FDA yawns when antidepressant use is strongly linked to heart disease.

The issue is complicated by the fact that the scientific literature was intended as a communication format between doctors, scientists, and other health professionals.  It was never intended to have defense mechanisms against large financial interests trying to game the system for profit.  The pharmaceutical industry ghostwrites many of the studies that promote the values of its drugs.  Doctors and scientists put their names on the studies for a fee.  Celebrity doctors are paid large amounts by Big Pharma to act as sales reps at “scientific” conferences.  Universities and researchers who might publish negative data know they will be blacklisted from Big Pharma research spending in the future.  Many doctors are on the Big Pharma payroll, taking what amounts to bribes, kickbacks, and other “gifts.”  All doctors are subjected to intense Big Pharma propaganda as a major part of their training in medical school. 

A drug company doesn’t even have to prove a drug fixes anything.  Drugs simply have to prove they can move numbers on paper (surrogate endpoints).  This lax standard of effectiveness causes individuals to go on drugs to change numbers, take more drugs due to the side effects of the ones they are taking, and before long they are on ten drugs that don’t fix anything – piling on cost to the health care system and taxpayers.

Once drugs are on the market, Big Pharma uses all manner of illegal marketing to create buzz and demand for their drugs in ways that have never been tested for safety (off-label use).  Some regulatory action has been taken in recent months against these crimes, although the damage is already done and the false markets have been created as doctors seem to have little ethical concern writing prescriptions for uses that have never been demonstrated as safe or effective.  And then the Big Pharma lobby goes to work trying to get laws passed to expand its market (even tagetting children).

Big Pharma builds the cost of the fines into the cost of the drugs, which are paid for in higher health care costs and taxes.  It is how Big Pharma does business.  The FDA is impotent in defending the public from harm.  It has been proven that all the newer drugs of the past decade are twice as likely to injure.  While the FDA manages to report on the problem, it fails to do anything effective about it (which is how they plea to get more funding from Congress to spend on their pet projects, not safety).

This shifts the burden of demonstrating proof of harm to lawyers representing individuals who have been harmed and independent, poorly funded researchers who must risk the wrath of their colleagues to shine a light lot on huge problems.  Such researchers are often operating without the original data submitted to the FDA.  It takes years to pin down a problem.  By then, the drug in question has already made its money (and caused its harm) or its patent is about to expire (meaning it is no longer a top priority for the drug company).  Even when researchers present their findings of rather alarming harm, the FDA management yawns, drags its feet several more years, and then waters down its findings on the obvious problems so as to limit legal liability for its friends.

The examples of the drugs involved in this fraudulent charade are numerous, and especially involve drugs known as blockbusters (the big sellers).  One of the most egregious examples is the atypical anti-psychotic medications – poisoning our children and elderly with unthinkable off-label use that is incredibly damaging to health.  The atypical anti-psychotics include Zyprexa (Eli Lilly), Seroquel (AstraZeneca), Risperdal (Johnson & Johnson), Geodon (Pfizer), and a handful of others.

Since Eli Lilly knew that Zyprexa caused diabetes and didn’t let patients know this, they have already settled numerous “failure to warn” lawsuits totaling 1.2 billion dollars.  This year they agreed to another 1.42 billion, $615 million to settle the Justice Department’s criminal investigation and approximately $800 million to settle the civil investigations brought by the states for Medicaid fraud.  “Specifically, the plea states that Lilly promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia, although Zyprexa is not approved for such uses,” the company said in a statement.  Eli Lilly agreed to a misdemeanor charge, which is apparently the new standard for what a drug company gets when it kills elderly Americans (previously it was nothing).  A May 2009 study published in the Archives of Internal Medicine shows that even a single dose of anti-psychotic medication to an elderly patient doubles the risk of a serious adverse event leading to hospitalization and/or death. 

Anti-psychotics have become popular for their off-label use as the “drug of obedience.”  If you want a zombie, give the person an atypical anti-psychotic.  They became incredibly popular in nursing homes, especially if a senior citizen arrived upset at the idea of being put in a nursing home.  Or to keep patients with dementia from stirring up trouble.  Likewise, children in orphanages are another popular target.  These are extremely expensive drugs paid for by Medicare and Medicaid (taxpayers).

On October 29, 2009 AstraZeneca reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits regarding Seroquel.  One of the investigations was over improper activity of physicians involved in Seroquel clinical trials, apparently hiding the results of a negative drug trial prior to FDA approval and the other was over off-label use resulting in many children and elderly taking Seroquel.

Pfizer has agreed to pay $2.3 billion to settle criminal and civil liability due to its illegal off-label promotion of Bextra (a painkiller already pulled from the market), Geodon (like Zyprexa, an atypical anti-psychotic that injures children), Zyvox (an antibiotic), and Lyrica (an epilepsy drug).  Pfizer will plead guilty to one felony count violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud.  Geodon has a smaller percentage of the 12-billion-dollar-a-year poisoning campaign of our children and elderly, pulling in around $750 million.  It was widely promoted in an off-label manner for ADHD and behavioral issues facing children - a market that has been fraudulently created and continues to rack up sales.

And this past week Risperdol went on trial for its off-label uses.  The opening day of testimony saw one of its salesman admit he promoted the drug for off-label uses and did so knowing what he was doing was illegal – expect another large settlement.

While these settlements seem large they are costs that are passed on to the health care system as part of the price of the drug.  Off-label financial penalties are nothing more than a marketing cost.  And once the market is created doctors keep prescribing the medications for off-label use, thereby sustaining sales far in excess of any penalty.

None of these financial penalties is as the result of FDA actions.  To the contrary, in the midst of major controversy the FDA was found encouraging the use of these drugs on children!  It is the lawsuits that are defending public safety because the FDA does not do its job. 

And then there are the independent studies that finally prove what the FDA likely knew over a decade ago.  This past week a study in the Journal of the American Medical Association showed that children taking atypical anti-psychotic medication gained on average 18 pounds in 12 weeks.  The shocking part of the study was not the massive weight gain – it was that it took over a decade for independent researchers to prove what the FDA and Big Pharma already knew.  Needless to say, these children are on a fast track to heart disease, as changes in their LDL cholesterol and triglycerides clearly indicated.

The anti-psychotic medications serve as an example of the disregard for human health on the part of Big Pharma, the FDA, doctors and psychiatrists on the take, and those standing ready with their off-label Rx pads.  Tens of billions in fraudulent profit has been made and continues to pile up.  There are numerous other blockbuster drugs with similar sordid tales.  This is how business is done.  It is fraud.  The FDA drags its feet and will continue to drag its feet, regardless of what studies are published.  The FDA management is part of the fraud.

In the short term the only way to stop this fraud is to prevent federal programs (Medicare and Medicaid) and insurance companies from paying for any off-label medication use.  Also in the near term, off-label prescribing laws need to be drastically changed to protect the public.  The use of all types of psychotropic medications on children needs to be drastically curtailed or outright banned.  Over the next five to ten years medications already on the market need to prove their safety and actually prove they fix something in a definable period of time.  If all a drug can do is change numbers it is, once again, nothing that taxpayers and insurance companies should have to pay for. 

If people want to use drugs to change numbers, suppress symptoms, and conduct an experiment on themselves – fine – let them do so at their own expense.  The problem with health care reform is that President Obama is in a big hurry to pass legislation with this system of fraud built in.  In fact, the entire system is positioned to benefit thanks to the financial support Big Pharma is lending the administration, as the administration tries to make insurance companies out to be the villain.  Unless fraud is tackled head on, including the White House truly cleaning up its own FDA, there is no chance for containing health care costs in the current system or in anything currently proposed by the House or Senate.

Right now antidepressant medication is being massively over-prescribed to children throughout the country, even though it is clear from other data that these drugs have very limited usefulness.

Redei explains the importance of the study, “This is a huge study and statistically powerful.  This research opens up new routes to develop new antidepressants that may be more effective. There hasn’t been an antidepressant based on a novel concept in 20 years.”

Redei and her team meticulously created and analyzed two distinct animal study populations, one that was depressed and one that was stressed.  Using sophisticated gene array analysis she then went on to show which sets of genes were activated in each group.  There was virtually no overlap.  This proves for the first time that being stressed out does not cause and is not the same thing as being depressed.  Furthermore, drugs for depression are more targeted for stress, not depression.  Her gene analysis showed that neurotransmitters were not the issue in depression, rather, they were relevant to stress.

“The medications have been focusing on the effect, not the cause,” Redei said. “That’s why it takes so long for them to work and why they aren’t effective for so many people.”

The genes related to depression were more fundamental than the neurotransmitters.  They had more to do with the development and functioning of neurons.  In other words they have more to do with generating nerve network connections, new nerve cells, and nerve plasticity.  And now we are into the study of glial cells, BDNF, immune/nerve cytokine cross talk, brain inflammation, the ability of the brain to recover from inflammation, and a whole host of topics that quality nutrition excels at addressing. 

Quality nutrition could readily replace 95% of brain medication in use today – with no side effects and far less cost.  A good diet and consistent exercise would keep many people from needing help in the first place – as would good parenting, improved problem-solving, and better stress management skills. 

Hypocrisy at the FDA runs deep in their culture.  The organization fails to warn the public of the known immunosuppressive effects of commonly used drugs such as antacids and statins – drugs that have been shown to increase the risk for infection.  At the same time, the FDA has branded all nutrition as fraud.  What right does the FDA have to brand nutrition as fraud?  Nutrition has been battling influenza since humans have been around.  Without nutrition humans would have never survived any flu pandemic.  Nutrition is harmless to human health and invaluable to survival.  In the FDA’s mind it is illegal.  Rather, human experimentation is now deemed legal by the FDA.  It’s all about protecting and expanding the profits of Big Pharma and Big Biotech.

Like Tamiflu and Relenza, Peramivir is a neuraminidase inhibitor.  Neuraminidase (the N part of H1N1) is a viral protein that must be active in order for new viruses to emerge from a virally infected cell.  If it can be blocked, then viral spreading can be reduced.

Tamiflu and Relenza only bind to neuraminidase for a brief period of time, limiting their biological activity against a virus.  In contrast, Peramivir binds very tightly to neuraminidase and is longer lasting – meaning it is a much more potent drug.  The FDA has approved it for use in advanced Swine Flu cases that are not responding to Tamiflu or Relenza. 

On the one hand, this sounds like a reasonable approach to helping people with extreme Swine Flu.  What is likely to happen in actual practice is another matter entirely.  Doctors will hear on the grapevine how well Peramivir seems to work and it will be used on more and more patients.  And what’s wrong with that?

It is a human experiment.  Human experiments are against the Nuremberg code, which has been agreed to by the world following the atrocities of Nazi Germany.  Human experiments run counter to the basic decency and morality of any culture – except the culture of the FDA and its profit-driven pharmaceutical allies.

The problem with neuraminidase blocking is that there are four known human genes that utilize neuraminidase for normal and healthy cell function (NEU1, NEU2, NEU3, NEU4).  The next problem is that these genes are not passive and secondary in cellular function.  They regulate carbohydrate-related communication taking place on human cell membranes (glyconutrition and glycobiology).  In other words, they are instrumentally involved in how cells talk to each other, as well as in many processes of a cell’s internal communication.  Any neuraminidase blocking drug runs the risk of interfering with general communication needed for healthy cell function.

The adverse side effects of Tamiflu are in many cases rather extreme and include panic attacks, delusions, delirium, convulsions, depression, loss of consciousness, and even suicide.  Oxford researchers have publicly warned that Tamiflu is not for children.  Tamiflu is a relatively weak binder of neuraminidase. 

What is going to happen when a strong binder of neuraminidase, Peramivir, latches on to the human cellular communication system based on neuraminidase genes?  The FDA has no idea, but their unelected bureaucratic management team has decided in their infinite wisdom that the benefits outweigh the risks, even though they have no way of knowing.  The era of sanctioned human experimentation is upon us. 

What if there was a substance that blocked neuraminidase regarding viral activity and left human neuraminidase alone?  Wow, what a breakthrough that would be.  Welcome to the world of nutrition.  The real fraud can be found in the management team of the FDA.

On September 21, 2009 a stunning shot was fired across the bow of Monsanto and its new legion of Frankenfood sugar beet growers. Judge Jeffrey S. White of Federal District Court in San Francisco said the Agriculture Department should have done an environmental impact statement as required by law. He said it should have assessed the consequences from the likely spread of the genetically engineered trait to other sugar beets or to the related crops of Swiss chard and red table beets.  He said that the potential elimination of farmer’s choice to grow non-genetically engineered crops, or a consumer’s choice to eat non-genetically engineered food constituted a significant effect on the environment that necessitated an environmental impact statement. The case is ongoing, with the next phase scheduled for October 30.

Meanwhile, Monsanto is attempting damage control during the second growing season of this genetic monstrosity masquerading as food. The judge hasn’t banned the current year’s crop or the sale of Halloween candy which is now full of GMO sugar.  Of course, GMO sugar, like other GMO “foods,” doesn’t need to be labeled as such (because nobody in their right mind would buy it if it were). Half the refined sugar in the U.S. is from beets – and insiders say the industry has quickly converted to the GMO Frankenfood beets, estimating up to 95% of farmers are now using them.  Beet sugar is often mixed with cane sugar, meaning that unless a product lists the ingredient as cane sugar or organic cane sugar then it now likely contains GMO mutant beet-derived sugar. 

Only the biotech industry and its financially-associated friends believe GMO Frankenfoods are safe to eat. The despicable management at the FDA approved them, while squashing and hiding from public view the numerous safety objections of their scientific staff.  Common sense will tell virtually anyone that having foreign organism DNA spliced into the essence of food is an atrocity. 

Earlier this year the American Academy of Environmental Medicine (AAEM) called on physicians to educate their patients, the medical community, and the public to avoid genetically modified foods and provide educational materials concerning GM foods and health risks.  They called for a moratorium on GM foods, long-term independent studies, and labeling. AAEM’s position paper stated, “Several animal studies indicate serious health risks associated with GM food, including infertility, immune problems, accelerated aging, insulin regulation, and changes in major organs and the gastrointestinal system…There is more than a casual association between GM foods and adverse health effects. There is causation.”

All of these Round Up ready Frankenfood crops are leading to unprecedented use of Round Up (glyphosate). In 1994 glyphosate pesticide use was 7.9 million pounds. By 2005, with the widespread use of Round Up, that number jumped to 119.1 million pounds. This is breeding super weeds that require ever increasing amounts of Round Up, not to mention other new “super toxic” pesticides just to keep up with the war on weeds.  The environmental impact of glyphosate overuse has been reviewed in an article published by Organic Consumers Association.

In August of 2009 French researchers reviewed the evidence showing how glyphosates disrupt human reproductive hormones (androgens and estrogens). Their data indicates that glyphosate-based herbicides residues in food, feed, and the environment should be considered and classified as carcinogens and reproductive toxins – not unlike the PCBs of years gone by. Once again Monsanto sits in the middle of the controversy with human health hanging in the balance. Does anyone trust Monsanto?

Avoid GMO food like the plague. Don’t buy any product made with GMO food or any product made by a company that uses any GMO food. Demand that GMO food be labeled so that consumers have a clear choice.  And look out for sugar, the latest food to undergo Frankenfood mutation.

America’s sugar crop is under GMO assault and the FDA has begun a new era of human experimentation. America is in dire need of a new super hero – and he has arrived. It is Larry Leptin, defending your right to be healthy.
See Larry Leptin’s first episode:  Halloween fun as he takes on the GMO mutated sugar beets.
www.LarryLeptin.com

The latest study on this topic was presented this week at the annual meeting of the Society for Neuroscience in Chicago.  The study shows that rats exposed to amphetamines at an age that corresponds to the later years of human adolescence display significant memory deficits as adults - long after the exposure ends.  Lead researcher Joshua Gulley concludes “This tells us that their working memory capacity has been significantly altered by that pre-exposure to amphetamine.”

The simple fact of the matter is that ADHD meds are like using a credit card, over-exciting nerves so they seem to perform better.  However, the friction created by this process is highly inflammatory and has long term consequences that signify accelerated nerve decline in older age.

This is not the first study on this subject and it won’t be the last.  There have been a number of animal studies showing these drugs induce long-term nerve damage.  Numerous other adverse side effects have been reported including stunted growth, cardiovascular disease, psychosis, mania, hallucinations, seizures, liver toxicity, and suicidal behavior.  (Studies and data are in Chapter 3 of Fight for Your Health:  Exposing the FDA’s Betrayal of America.)

The take home message is clear:  “Do as I do – not as I say.”

If we are going to redo healthcare we need to be sure that the quality of care in top hospitals is maintained and that cost-cutting measures to serve more people don’t bring the quality in the whole system down.  Rather, an all out effort should be made to bring care quality higher in many hospitals.

These numbers are mind boggling. 

The problem of these drugs is compounded by their flagrant illegal marketing. Neurontin was approved by the FDA for epilepsy back in 1994.  The drug underwent massive illegal off-label promotion that cost Warner-Lambert 430 million dollars (the very first big fine for off-label promotion). The drug is now owned by Pfizer. Pfizer also owns Lyrica, a super-potent version of Neurontin. It has been approved by the FDA for various types of pain and fibromyalgia.  Lyrica is one of four drugs which a subsidiary of Pfizer illegally marketed, resulting in a $2.3 billion settlement against Pfizer.

Even though the marketing of these drugs has been heavily fined, they continue to rack up billions in sales from the off-label uses. Doctors use them for all manner of nerve issues because they are good at suppressing symptoms. However, such uses can no longer be justified because the actual mechanism of the drugs is finally understood and they are creating a significant long-term reduction in nerve health.

The researchers in the above study try to downplay the serious nature of the drugs by saying “adult neurons don’t form many new synapses.”  That is simply not true. The new science is showing that brain health during aging relies on the formation of new synapses. Even these researchers managed to question the common use of these medications in pregnant women. How is a fetus supposed to make new nerve cells when the mother is taking a drug that blocks them?

These are the kind of situations the FDA should be all over. As usual, the FDA is sitting around pondering a suicide warning for Lyrica while its off-label uses include bi-polar disorder and migraine headaches. The FDA is likely to twiddle its thumbs for the next decade on the brain damage issue. Consumer beware.