Medical Industrial Complex

The politics and economics of the profit-driven food and medical industries

picture of peopleTHS reader Christopher Lane brought this article to my attention, and asked me to forward it on to my readers. Yet another tragic consequence of dangerous and overused psychiatric drugs.

Mary Weiss, a mother in Minnesota, was one such person who wrote me last month. I’d been on the radio, talking about issues tied to my book. Ms. Weiss wrote an email afterwards, telling me about her son, Dan Markingson, who’d been diagnosed with schizophrenia, though she herself has serious doubts that the diagnosis was accurate.

Her son was encouraged to participate in a clinical trial at the University of Minnesota and other campuses comparing Seroquel, Risperdal, and Zyprexa for schizophrenia, schizoaffective disorder, and schizophreniform disorder, a loosely defined diagnosis for people suffering from “mood disorders with psychotic features.” The trial was sponsored by AstraZeneca, maker of Seroquel, which put the researchers and university in an obvious conflict of interest. Dan was given 800 mg of the drug.

Over 70% of patients in the trial dropped out. But Dan was strongly dissuaded from doing so and remained in it for five months. He’d been given a directive warning that if he failed to continue in the trial, he would be put in a regional treatment center. His mother did not know about the directive until it was too late.

Follow this link to read the full story.

big pharma cartoonA new report due to be published in the May issue of the American Journal of Psychiatry shows that antidepressants aren’t all they’re cracked up to be.

But, faithful readers, you already knew that. Right?

The report is part of the National Institute of Mental Health-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project – the largest study of the treatment of depression conducted in the United States. It showed that findings from clinical studies used to gain FDA approval of antidepressants are not applicable to most patients with depression.

Researchers at the University of Pittsburgh Graduate School of Public Health compared symptoms and outcomes in depressed patients who met phase III study inclusion criteria to those who did not. Phase III studies for antidepressants determine the effectiveness of the drug in comparison to a placebo.

The inclusion criteria for these studies aren’t standardized or subject to any federal guidelines. Typically this means that patients with milder forms of depression, chronic depression, or other psychiatric or medical conditions in addition to short-term depression are excluded from studies.

In other words, the majority of “real world” patients with depression who end up taking antidepressants are excluded from clinical studies. It should be obvious why this is a problem. In a normal, clinical setting many patients with depression do also have other illnesses, such as diabetes, chronic fatigue syndrome or irritable bowel syndrome (IBS). It’s not unusual for them to have anxiety and insomnia, as well. In fact, it wouldn’t be presumptuous to expect that a depressed person might be suffering from a number of conditions that are either contributing to or caused by their illness.

Yet the only people that “qualify” for the clinical trials which determine whether antidepressants get approved by the FDA are those with short-term depression, no history of depression, no other psychiatric conditions such as anxiety, and no physical illnesses like heart disease or diabetes. This is the only subgroup of the general population for which we have any data on the efficacy of antidepressants.

By the same token, this means is that we have almost no clinical data on how antidepressants work for the “real world” patients who are most likely to be taking them. Indeed, after assessing 2,855 patients treated with citalopram (Celexa), the study authors found that fewer than one in four, or 22.2%, of the patients met the usual criteria for inclusion in phase III clinical trials.

According to study lead author, Stephen Wisniewski, Ph.D., professor of epidemiology and co-director of the Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, “This raises major concerns about whether results from traditional phase III studies can be generalized to most people with depression, who also often suffer from anxiety, substance abuse and other medical and psychiatric problems.”

When Wisniewski and his colleagues looked at the efficacy of antidepressants in those who did not meet phase III inclusion criteria – meaning the majority of people who take the drugs in real life – they found that their outcomes were much worse than those who did qualify for the trials. The depression remission rate in the patients who met the criteria was 34.4 percent, compared to only 24.7 percent in the ineligible group.

So, here’s the bottom line: antidepressants are nowhere near as effective as research suggests.

And that is really bad news for the drug companies, because research already suggests that antidepressants aren’t very effective at all. In fact, as I explained in a previous article, antidepressants are no more effective than placebo for most people. If antidepressants are no more effective than placebo in the patients that do meet phase III criteria, and we know that antidepressants are less effective for patients who don’t meet phase III criteria (the vast majority of “real world” depression patients), then couldn’t we assume that antidepressants are less effective than placebo for most patients?

Yes, we could.

For more information on this topic, check out this index of my articles (as well as selected off-site resources) on depression and antidepressants.

bandaidDrugs comprise the major treatment modality of scientific medicine. A recent article in the New York Times revealed that over half of Americans regularly take prescription drugs for chronic health problems. Sadly, many people don’t realize that the drugs they’re taking could be making their condition worse.

Most drugs don’t cure illness. They just suppress symptoms. Unfortunately, drugs also suppress functions. Though drugs provide symptom relief in the short term, over time they may worsen the underlying condition because they interfere with our body’s self-healing mechanisms. For example, many people take ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) to cope with arthritis and inflammatory conditions. While NSAIDs are effective in reducing pain and inflammation in the short-term, they are also known to reduce blood flow to cartilage. Since blood carries all of the nutrients and immune substance necessary for tissue repair, NSAIDs can actually worsen the original problem when taken chronically.

The second problem is that, by definition, drugs correct a specific imbalance by causing at least one other and often several other imbalances. When a drug is introduced into the body to address a malfunction in one biochemical pathway, that drug inevitably interacts with many other pathways.

The mapping of these pathways in recent genetic research underscores the danger of pharmaceutical drugs. The diagram below shows the interactions among a small set of cellular proteins found in a fruit fly. Proteins encased in ovals are grouped according to specific pathway functions. Connecting lines indicate protein-protein interactions. Protein interconnections among the different pathways reveal how interfering with one protein may produce profound “side effects” upon other related pathways.1

protein map
Complicating the phenomenon of so-called “side effects” is that biological systems are redundant. The same protein molecule may be used in several different systems of the body, but it has a completely different function in each of them.

Histamine is a perfect example of this. Histamine is a chemical that initiates the cell’s stress response. When histamine is present in the bloodstream of the arms and legs, it starts a local inflammatory reaction in those tissues. But if histamine is present in the blood vessels of the brain, it enhances the growth and function of specialized neurons there.

One of the most amazing features of the body’s signaling system is its specificity. When you have a poison oak rash on your arm, histamine is released in that specific area only to activate an inflammatory response to the allergen. Likewise, if you’re under significant stress, histamine is released only in the brain to enhance the function of neurons.

Unfortunately, pharmaceutical drugs have no such specificity. When you take an antihistamine to deal with the itchiness of an allergic rash, the drug is distributed systemically. It affects histamine receptors wherever they are located throughout the whole body. So, while the antihistamine will curb the blood vessels’ inflammatory response and reduce the allergic symptoms of the rash, it will also enter the brain and affect nerve function – which causes drowsiness.

The recent hormone replacement therapy (HRT) debacle is a tragic example of the inherent risks of pharmaceutical drugs.  Estrogen is best known for its function on the female reproductive system.  However, more recent studies have shown that estrogen also plays an important role in the normal function of blood vessels, the heart and the brain.  That ‘s why synthetic estrogen hormones that were prescribed to alleviate menopausal symptoms ended up causing cardiovascular disease and neural dysfunctions such as strokes.

No matter how “targeted” drugs are, they are still relatively crude, blunt instruments when compared to the body’s highly sophisticated immune system. Prescription drugs are are much more like sledgehammers or shotguns than the “magic bullets” they are made out to be.

In the next article, we’ll take a closer look at the consequences of side effects caused by prescription drugs. Until then, I welcome your questions and comments!

  1. Lipton, B. H. (2008). The Biology of Belief: Unleashing the Power of Consciousness, Matter, & Miracles (illustrated edition.). Hay House.

failureThe U.S. spent 16 percent of its Gross Domestic Product (GDP) – a cool $2 trillion – on health care in 2005.1 Considering this enormous expenditure, we should have the best medicine in the world. We should be reversing disease, preventing disease, and doing minimal harm. However, careful and objective review shows the opposite.

The U.S. ranks just 34th in the world in life expectancy and 29th for infant mortality. Of 13 countries in a recent comparison, the United States ranks an average of 12th (second from bottom) for 16 available health indicators.2

40 million people in this country do not have health insurance. The exorbitant cost of health care seems to be tolerated based on the assumption that better health results from more expensive care, despite studies that as many as 20% to 30% of patients receive contraindicated care.3

Even worse, a recent study by Dr. Barbara Starfield published in 2000 in the prestigious Journal of the American Medical Association demonstrated that iatrogenic incidents (events caused by medical intervention) are the 3rd leading cause of death in this country, causing more than 250,000 deaths per year. Only heart disease and cancer kill more people.

Dr. Starfield estimates that, each year, medical errors and adverse effects of the health care system are responsible for:

  • 116 million extra physician visits
  • 77 million extra prescriptions
  • 17 million emergency department visits
  • 8 million hospitalizations
  • 3 million long-term admissions
  • 199,000 additional deaths
  • $77 billion in extra costs

As grim as they are, these statistics are likely to be seriously underestimated as only about 5 to 20% of iatrogenic incidents are even recordedanalyses which have taken these oversights into consideration estimate that medical care is in fact the leading cause of death in the U.S. each year.

Starfield believes that a major contributor to the poor performance of the United States on health indicators is the high degree of income inequality in this country. Countless studies in the medical literature document the adverse effects of low socioeconomic position on health. New research suggests the adverse effects not only of low social position but, especially, low relative social position in industrialized countries.6

Perhaps the words “health care” have given us the illusion that medicine is about health. In fact, western medicine is not a purveyor of healthcare but of disease-care. When the number one killer in a society is the health care system, that system has no excuse except to address its own urgent shortcomings. Unfortunately, until this happens partaking in allopathic medicine itself is one of the highest causes of death as well as one of the most expensive ways to die.

  1. Park, A. America’s Health Check Up. 11/20/2008. Time Magazine Online.
  2. Starfield B. Primary Care: Balancing Health Needs, Services, and Technology. New York, NY: Oxford University Press; 1998.
  3. Schuster M, McGlynn E, Brook R. How good is the quality of health care in the United States? Milbank Q. 1998;76:517-563
  4. Leape LL. Error in medicine. JAMA . 1994 Dec 21;272(23):1851-7.
  5. injuryboard.com. General Accounting Office study sheds light on nursing home abuse. July 17, 2003 . Available at: http://www.injuryboard.com/view.cfm/Article=3005. Accessed December 17, 2003
  6. Wilkinson R. Unhealthy Societies: The Afflictions of Inequality. London, England: Routledge; 1996.

pill bottle with warningI’d like to bring your attention to two recently published studies which highlight the dangers of antidepressant drugs and maintaining low cholesterol levels.

Low Serum Cholesterol May Be Associated With Suicide Attempt History

I’ve written before about the association of low cholesterol with aggressive and violent behavior as well as an increased risk of suicide. A recent study published in the Journal of Clinical Psychiatry adds weight to the already considerable body of evidence suggesting that low cholesterol is dangerous to your health.

In this study ‘low cholesterol’ was defined as less than 160mg/dL (4.16 mmol/L). This level has been noted several times in the medical literature as a level below which suicide is more likely. And you should note that this level is well within what is considered ‘healthy’ by a cholesterol-lowering, drug pushing health industry.

This is consistent with studies showing that low blood cholesterol levels are associated with suicide and that cholesterol levels in certain areas of the brain are lower in those who commit suicide by violent means than in those who commit suicide by non-violent means.

Cholesterol is a health-promoting substance. It is a critical component of cell membranes, the precursor to all steroid hormones, a precursor to vitamin D, and the limiting factor that brain cells need to make connections with one another called synapses, making it essential to learning and memory.

If you understand the vital role cholesterol plays in health – especially in the brain – it’s not difficult to figure out why low cholesterol could increase the risk of suicide and violent behavior.

This is yet another reason to avoid cholesterol-lowering statin drugs. If you haven’t read it already, you might want to check out my post called Cholesterol Doesn’t Cause Heart Disease.

(J Clin Psychiatry October 21, 2008: e1-e8; pii: ej07m03866)

Two Antidepressants Taken During Pregnancy Linked To Heart Anomalies In Babies

In another disturbing study, researchers from Israel, Italy and Germany found that pregnant women taking two popular antidepressants, paroxetine (Paxil) and fluoxetine (Prozac), were three and four times more likely to give birth to children with heart problems.

Researchers have advised women taking the drugs to continue unless they are advised to stop by their doctor or consultant.

I’ve written extensively here about the risks of antidepressant drugs, especially for pregnant women. In my recent post Statins For Pregnant Women and Kids? I presented evidence that statin drugs can cause birth defects and changes in the brain that predispose the child to emotional problems later in life. Here’s a brief excerpt:

Back in 2004, a report in the New England Journal of Medicine showed that the use of statins in the first trimester of pregnancy was associated with birth defects, especially severe central nervous system defects and limb deformities. In fact, 20 out of 52 women exposed to statins gave birth to offspring with such defects, which represents a birth defect rate of 38 percent, nearly 20 times the background rate of birth defects!

If you’re pregnant or considering getting pregnant, please – for the sake of your baby – speak to your psychiatrist or doctor about getting off antidepressant drugs before you conceive.

One of my favorite researchers, Chris Masterjohn, has just launched a new blog called “The Daily Lipid” where he writes about fats, cholesterol and health. Chris is pursuing a Ph.D. in Molecular and Cell Biology and is one of the most knowledgeable contemporary writers on cardiovascular health that I’m aware of. With his permission, I am cross-posting the first two articles on his blog – which you should definitely consider adding to your blogroll!

pregnant woman

Statins for pregnant women?

Statin manufacturers, the sycophantic researchers they pay, and the shameless hucksters who sell them are always up to no good, but their recent attempts to market them to pregnant women are simply horrifying.

According to a recent news article published in Mail online, researchers from liverpool believe that taking statins during pregnancy might help women avoid caesarean sections by promoting more robust uterine contraction. They hope to begin human trials in three to five years.

Somehow, the author of this article failed to react with the shock and horror appropriate to the situation — which should be the same shock and horror with which we would react to the suggestion that pregnant women should take thalidomide to avoid morning sickness.

Back in 2004, a report in the New England Journal of Medicine showed that the use of statins in the first trimester of pregnancy was associated with birth defects, especially severe central nervous system defects and limb deformities. In fact, 20 out of 52 women exposed to statins gave birth to offspring with such defects, which represents a birth defect rate of 38 percent, nearly 20 times the background rate of birth defects!

Even before this report was published, researchers already knew that statins caused birth defects in animal experiments, and the FDA already required the drugs to carry a label warning pregnant women to stay away from them. The article linked to above stated the following:

“FDA took this action because it was recognized that fetal cholesterol synthesis was essential for development, and because animals given statins during pregnancy had offspring with a variety of birth defects,” [one of the study's authors] said.

Less than a year later, Merck and Johnson & Johnson jointly asked the FDA for permission to market an over-the-counter statin. One of the concerns about the proposal was the risk to pregnant women. USA Today reported:

The FDA classifies Mevacor and other statins as pregnancy category X, which means they are not supposed to be taken by pregnant women. Not only have category X drugs been linked to fetal abnormalities in animal or human studies, but the FDA also has declared that the benefits of taking them do not outweigh potential risks.

According to the same article, Merck made a disturbing admission:

“Of course, there will be women who take it off-label,” acknowledges Merck executive Edwin Hemwall, referring to the use of non-prescription Mevacor by women under 55.

And what could prompt women to use statins during pregnancy against recommendations? Certainly a news article declaring that statins might prevent the need for caesarean sections and their associated complications could prompt some women to do so.

So what ground-breaking research made these Liverpool researchers so confident that taking drugs associated with twenty times the normal rate of major birth defects during pregnancy might be a good idea that they put out a press release declaring this confidence to the public before any trials were even under way?

Well, according to the article:

Tests have already shown that raising levels of cholesterol interferes with womb tissue’s ability to contract.
Really. Raising levels of cholesterol. You might wonder how they accomplished that. Did they use cholesterol-raising drugs? I don’t know of any drugs that do that. Did they use egg yolks, or the dreaded dietary villain — gasp — saturated fats?

No, the story is quite different.

The apparent basis for this ridiculous statin cheerleading is a 2004 study published by researchers from the University of Liverpool in the American Journal of Physiology — Cell Physiology entitled “Increased cholesterol decreases uterine activity: functional effects of cholesterol alteration in pregnant rat myometrium.”

Rather than feeding anything to pregnant women or pregnant rats, the researchers took pregnant rats and killed them. So the first thing we can say is that statins might help you deliver a baby if your doctor kills you first.

Then they extracted the uterine tissue and either extracted cholesterol from it with a chemical solvent called methyl beta-cyclodextrin, or enriched it either with cholesterol mixed with this solvent or with LDL (which they didn’t measure for oxidation prior to use). Then they added drugs to induce contraction under either cholesterol-depleted or cholesterol-enriched conditions, and found that contraction was greater under cholesterol-depleted conditions.

So now we know that — wait, what is it we know?

Well, quite clearly, we don’t know anything that we can have any confidence has any physiological relevance at all. That is, except the fact that statins cause birth defects in animals, and they increase the rate of birth defects in humans by nearly twenty times, primarily by causing severe defects of the central nervous system and limb deformities.

To add to that, we also know that the vast majority of humans conceived with Smith-Lemli-Opitz Syndrome (SLOS), a genetic inability to synthesize enough cholesterol, die of spontaneous abortion in the first 16 weeks of gestation. Those who live long enough to be born suffer from mental retardation, autism, facial and skeletal malformations, visual dysfunctions and failure to thrive.

Statins for pregnant women? I don’t think so.

Article written by Chris Masterjohn

Statins for 8-year old children?

child with drug

The American Academy of Pediatrics recently announced new recommendations for giving cholesterol-lowering drugs to children as young as eight years old. They also recommend giving low-fat milk to infants as young as one year old.

The New York Times published several articles on this, first announcing the recommendation the day the academy made it, then describing the backlash of saner doctors and other members of the public against it, and finally editorializing that while they were first “appalled” at the recommendation, after reading the report they were more dismayed at the state of our children’s health.

Concerning this frightful state of children’s health, the Times reported the following:

“We are in an epidemic,” said Dr. Jatinder Bhatia, a member of the academy’s nutrition committee who is a professor and chief of neonatology at the Medical College of Georgia in Augusta. “The risk of giving statins at a lower age is less than the benefit you’re going to get out of it.”

Dr. Bhatia said that although there was not “a whole lot” of data on pediatric use of cholesterol-lowering drugs, recent research showed that the drugs were generally safe for children.

An epidemic of what? High cholesterol? Not according to the academy’s report, which states that cholesterol levels in children declined between 1966 and 1994 and stayed the same between 1994 and 2000.

No, we are in an epidemic of obesity. As the Times reported:

But proponents say there is growing evidence that the first signs of heart disease show up in childhood, and with 30 percent of the nation’s children overweight or obese, many doctors fear that a rash of early heart attacks and diabetes is on the horizon as these children grow up.

Is there any evidence that statins lead to weight loss? If there is, I am not aware of it.

The point is immaterial, because the academy doesn’t claim to have any evidence for its position in the first place. For example, its report states the following:

Also, data supporting a particular level of childhood cholesterol that predicts risk of adult CVD do not exist, which makes the prospect of a firm evidence-based recommendation for cholesterol screening for children elusive.
And further down:

It is difficult to develop an evidence-based approach for the specific age at which pharmacologic treatment should be implemented. . . . It is not known whether there is an age at which development of the atherosclerotic process is accelerated.

In other words, they don’t know what level of cholesterol is risky and at what age it starts posing a risk, but they will nevertheless assume that there is some level that does start to pose a risk at some age and they will thus have to make a guess just what that level and what that age is.

The report discusses evidence that the “metabolic syndrome” and the “recent epidemic of childhood obesity” are tied to the risk of diabetes and heart disease and evidence that even modest weight loss at a level of five to seven percent is sufficient to prevent diabetes. Yet somehow instead of making a recommendation about how to more effectively lose weight the authors derive from this data a much less logical but much more profitable conclusion that 8-year-olds should be put on statins.

As to the recommendation to feed infants low-fat milk, the Times reported the following:

The academy also now recommends giving children low-fat milk after 12 months if a doctor is concerned about future weight problems. Although children need fat for brain development, the group says that because children often consume so much fat, low-fat milk is now appropriate.

This is rather remarkable, because the academy attributed the drop in childhood cholesterol levels to the successes of the anti-fat, anti-cholesterol campaign that began in the 1950s. But now children no longer need milkfat because they are getting plenty of fat. Well which is it? Are they getting more fat now or less fat?

Of course milkfat is also a source of choline, along with liver and egg yolks, which is essential to brain development.

But even this misses the point. Cholesterol is essential to brain development!

One of the first articles I added to my section on the functions of cholesterol was an article entitled “Learning, Your Memory, and Cholesterol.” It discusses the evidence uncovered eight years ago that cholesterol is the limiting factor for the formation of synapses, which are the connections between neurons that allow learning and memory to take place.

Lowering brain levels of cholesterol can be detrimental at any age beacause of this, but the consequences for children — whose brains are still developing at a much more rapid rate — could be much more dire.

No doubt, most researchers and medical doctors mean well and are honestly trying to help our children. But surely someone in these drug companies must know that cholesterol is necessary for brain development, and that cholesterol-lowering drugs reduce mental performance in adults. Surely they must know that if we raise our next generation of children on statins during the critical periods of brain development, we may raise a whole generation with compromised intelligence.

And if that’s the case, are they trying to dumb us down? Sometimes it seems like that’s the case.

Article written by Chris Masterjohn

pile of pills I just came across a recently published study which revealed that SSRIs (the most popular class of antidepressants) can cause gastrointestinal bleeding. The first thing I always do when reading a study is check to see who the authors are, where they receive funding from and who the sponsor is.

So you can imagine my surprise when I learned that this study, which casts antidepressants in an unfavorable light, was sponsored by a large pharmaceutical company (AstraZeneca).

Could drug companies be experiencing a change of heart? A pang of conscience? Could this mark a new era of integrity and honesty in the reporting of results from drug trials?

Not so much.

Being the skeptic that I am, I thought for a moment about why a drug company would sponsor and then publish a study investigating the side effects of antidepressant when the results are so clearly negative? We know from my previous article on conflicts of interest in the medical field that drug companies are under no obligation to publish study results – and often they do not when the results are unfavorable.

One reason came immediately to my mind: what if that company happened to manufacture a drug that could be used to counter the side effects antidepressants? And what if their study not only demonstrated the side effect antidepressants, but also the effectiveness of their drug in mitigating or treating that side effect?

Turns out that’s exactly what’s happening here. AstraZeneca is the manufacturer of Nexium, one of the most popularly prescribed medications for heartburn. Nexium works by inhibiting the production of acid in the stomach.

Now, check out how the study was designed. There were three groups. The first group was people taking SSRIs only. The second group was people taking SSRIs and NSAIDs (ibuprofen, aspirin, etc.) and other anti-inflammatory drugs known to be harmful to the stomach lining. The third group took SSRIs along with acid-suppressing agents (agents like Nexium, for example).

People taking the SSRIs were more likely to have G.I. bleeding than people on placebo, and those taking both SSRIs and anti-inflammatory drugs were even more likely to bleed than people on SSRIs alone.

But guess what? Acid suppressing agents (like, um, let’s say… Nexium) were associated with a reduced risk of upper GI bleeding in those taking SSRIs.

We can see where this is leading, right? The solution to the G.I. bleeding caused by SSRIs is not to stop taking the SSRIs. The solution is to take another drug! In this case, a drug that is manufactured by the company who sponsored the study.

Unfortunately, this vicious cycle of medication use is very common. A common scenario might be someone takes an SSRI for depression, but it causes anxiety. So the doctor prescribes something for anxiety. Unfortunately, many medications for anxiety also cause constipation. But there’s a pill for that too, which the doctor also prescribes. Then the patient finds they’re getting some acid reflux (a side effect of some of the medicines for constipation), so the doctor prescribes an acid-suppressing agent.

You might be laughing (or crying) as you read this, but I am not exaggerating. This is very often how it works, especially in the elderly who now take an average of 6-8 medications every day.

And this is bound to continue to happen as long as research is primarily sponsored by pharmaceutical companies. The author of the study, Dr. García-Rodríguez, has received “unrestricted research grants from Pfizer Inc., AstraZeneca and Novartis Pharmaceuticals Group”.

There’s no way to prove that Dr. Garcia-Rodriguez’s work is being unduly influenced by his close connection with drug companies. But common sense, as well as many published scientific studies, indicates that this is very likely. For example, several studies have shown that researchers who produce data that is contrary to the interests of the pharmaceutical industry risk legal, professional, or even personal attack – directly or indirectly financed by the industry. (Bosley, 2002; Healy, 2002; Monbiot, 2002).

Fortunately, many influential leaders are calling for changes to be made to the way medical research is performed and distributed. But they are facing the opposition of a $500 billion dollar industry with more lobbyists than there are members of Congress. It’s not going to be easy.

corn kernelsThis week I’d like to bring your attention to three articles I came across on the web which illustrate the utter madness of mainstream medicine and nutrition.

The first article, “Beware of New Media Brainwashing About High Fructose Corn Syrup“, appeared on Mercola.com, a health advocacy site run by Dr. Joseph Mercola which I recommend. I agree with Dr. Mercola on most things, and even when we don’t agree the differences are relatively minor.

In his article Mercola warns consumers that The Corn Refiners Association is spending $20 to $30 million dollars on an advertising campaign to “rehabilitate” the reputation of high fructose corn syrup (HFCS), claiming that the product is “no worse for you than sugar.”

HFCS is now the #1 source of calories for children in the U.S., a staggering fact when research has clearly linked HFCS to obesity, diabetes, metabolic syndrome, high triglycerides, liver disease and more. On top of that, HFCS is almost always made with genetically modified corn.

Head on over to Mercola.com to read the rest of the article and learn why you and your children should be avoiding HFCS as much as possible. HFCS is found primarily in processed foods (in everything from hamburger buns to soda), so if you follow my general recommendation of eating a whole-foods diet you should have no trouble avoiding it.

The second article, “8-Year-Olds on Statins? A New Plan Quickly Bites Back“, was published in the New York Times on July 8. It describes new guidelines issued by the American Academy of Pediatrics recommending that statin drugs be prescribed to kids as young as 8 years old!

While some doctors applauded the idea (which is incomprehensible to me), others were “incredulous”. Why are they incredulous? Because there is absolutely no evidence suggesting that treating children with statins will prevent heart attacks or reduce mortality from heart disease. Furthermore, there are no data on the possible side effects from taking statins for 40 or 50 years. Since statins have caused cancer in several animal studies, there is no reason to assume that this is not a risk in humans – especially with such long-term use of the drugs.

If you’re not familiar with the dangers of statin drugs, I suggest you read my recent article “The Truth About Statin Drugs“. Not only are statins nowhere near as effective as claimed, they have serious adverse effects and risks – including death.

What’s more, statins have been neither studied nor approved for use with children. In other words, the American Pediatric Association wants to perform an uncontrolled experiment with statin drugs and our children. This is completely unacceptable in light of what we already know about these drugs.

This is yet another obvious example of how the massive conflicts of interest in the medical field, which I described in a previous article, cloud the judgment of otherwise well-meaning physicians and health organizations.

Head over to the New York Times to read the rest of the article.

The third article, “Popular Fish, Tilapia, Contains Potentially Dangerous Fatty Acid Combination” which appeared on ScienceDaily.com, revealed that farm-raised tilapia has very low levels of beneficial omega-3 fatty acids and, even worse, very high levels of omega-6 fatty acids.

This is particularly troublesome because tilapia has become one of the most highly consumed fish in the U.S. (mostly due to its low price), and that trend is expected to continue through 2010.

Researchers have found that tilapia has higher levels of omega-6 fatty acids than doughnuts. That’s scary.

The health risks of excessive amounts of omega-6 fatty acids in the diet are well established. In short, they are significant contributors to both inflammation and oxidative damage in the body. Inflammation and oxidative damage are major risk factors for heart disease, diabetes, cancer and many other diseases.

Wild-caught oily fish, on the other hand, contain a favorable ratio of omega-3 to omega-6 fatty acids and may actually protect against inflammation and oxidative damage?

So what’s the problem with tilapia, you ask? The problem is that they are raised on a “fish farm” where they are fed inexpensive corn-based feeds which contain short chain omega-6 fatty acids that the fish convert and store in their tissues. While this practice has kept the price of tilapia low, it has also transformed it into a toxic food.

Repeat after me: fish don’t eat corn. Fish don’t eat corn. Fish don’t eat corn.

(Cows don’t normally eat chicken parts, gummi bears and garbage, either; but they do in commercial feedlots where most of the meat in the U.S. is produced. I’ll save that for another day, though.)

What all of these articles share in common is 1) further evidence of the rampant conflicts of interest in our medical care system, 2) the complete lack of an objective, independent regulatory body that can protect consumers from the malfeasance of Big Pharma and Big Agrobusiness, 3) the general departure from common sense and traditional wisdom when it comes to health care and nutrition.

It’s absolute madness.

dollar signIn a recent post, I discussed the consequences of the massive conflicts of interest that exist between researchers, doctors and the pharmaceutical industry in the U.S. and abroad.

On June 8th the New York Times published an article underscoring these consequences and illuminating the risks that inevitably come with financial ties between researchers and drug companies.

The article revealed that Dr. Joseph Biederman, a world-renowned child psychiatrist at Harvard, accepted at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but did not disclose any of this income to university officials. By failing to report this income, Dr. Biederman and colleagues may have violated both federal and university research rules designed to prevent conflicts of interest.

Dr. Biederman is one of the most influential researchers in child psychiatry. Although many of his studies are small and often financed by pharmaceutical companies, his work has nevertheless directly contributed to a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a concurrent rise in the use of powerful antipsychotic medicines in children.

We know from my previous post that it has been shown that studies funded by pharmaceutical companies are more likely to show positive results for the drug. We also know that the veracity of clinical trials which are the basis of approval of new drugs by the FDA has been called into question in recent studies because of three major flaws: conflicts of interest on the part of investigators (like Biederman); inappropriate involvement of research sponsors (drug companies) in study design and management; and publication bias in disseminating results (if a study has negative results, the drug company doesn’t publish it).

When a researcher like Dr. Biederman is paid millions by a drug company to study it’s product, we must wonder whether we can expect his work to be objective and accurate. But when that researcher repeatedly lies about the money he received, the integrity of his work should be in serious doubt.

In one revealing example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with Harvard University. When asked to check again, he said he received $3,500. But Johnson & Johnson told Congressional investigators that Mr. Biederman was paid $58,169 in 2001.

The consulting arrangements of Dr. Biederman’s entire research group at Harvard were already controversial because of the researcher’s advocacy of unapproved (”off-label”) uses of psychiatric medicines in children. Dr. Biederman and his colleagues have promoted the aggressive diagnosis and treatment of childhood bipolar disorder with antipsychotic drugs – although these drugs have never been approved for such use. In fact, neuroleptic drugs have not been approved for use in children at all.

As a result of Dr. Biederman’s promotion of both the diagnosis and treatment for childhood bipolar disorder, antipsychotic drug use in children has exploded. Roughly half a million children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.

The dramatic increase in antipsychotic prescriptions in children has occurred despite the lack of evidence that these medication improve children’s lives over time. On the contrary, it is well known that children are susceptible to the weight gain and metabolic problems caused by the drugs. Children typically gain twice as much weight in the first six months on atypical neuroleptic drugs (risperidone, olanzapine, etc.) as they should through normal growth, adding an average of 2 to 3 inches to their waistline. This is mostly abdominal fat, which also increases their risk of diabetes and heart disease.

There is also some evidence which suggests that these drugs may cause permanent changes to the structure and function of the brain (Breggin 1997). In other words, they cause brain damage.

The research of Dr. Biederman’s group, which has served as the basis for the rise in bipolar diagnoses and antipsychotic use in children, has been widely criticized by other psychiatrists and researchers.

The studies published by Dr. Biederman’s group were so small and “loosely” designed that they were largely inconclusive. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale, which is well below the 50 percent change that most researchers use as the standard.

Controlling for bias in these types of studies is particularly important, given that the scale is subjective and depends on reports from physicians, parents and children.

More broadly, psychiatrists have said that revelations of undisclosed payments from drug makers to leading researchers are especially damaging for psychiatry.

“The price we pay for these kinds of revelations is credibility, and we just can’t afford to lose any more of that in this field,” said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. “In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money.”

I couldn’t have said it better myself.

money in pill bottleI’m preparing for an upcoming presentation in September called “The (Hidden) Truth About Antidepressants”, so I will be writing frequently about issues related to the definition, cause and treatment of depression in the weeks to come.

Much of what I write may challenge your current beliefs and contradict what you’ve heard about depression and antidepressants. My hope is that today’s post about the influence of the pharmaceutical industry on doctors, researchers and patients will inspire you to re-examine what you’ve been told so far and approach everything you hear in the future with a “healthy skepticism”.

The truth is that all of our beliefs about depression have been tainted, quite intentionally, by the more than $20 billion spent each year by pharmaceutical companies to promote their drugs (an amount greater than the gross domestic product of all but 70 of the world’s richest nations). In 2000, the pharmaceutical industry had a combined lobbying and campaign contribution budget of $200 million – larger than any other industry (Wayne & Peterson, 2001). The industry has 625 registered lobbyists, more than there are members of congress (Wayne & Peterson, 2001). The industry also underwrites about 70% of clinical drug trials in the United States (DeAngelis et al., 2001).

Consumer Reports has detailed the marketing strategies used by drug companies, including:

  • giving free samples and information to doctors
  • advertising in medical journals
  • using “ask your doctor” media advertisements aimed directly at the consumer (the U.S. and New Zealand are the only two countries that allow this)
  • sponsoring promotional dinner meetings with substantial gifts or even cash provided for attendees
  • paying consultants to speak at scientific meetings where it is possible to circumvent FDA guidelines that require disclosure of side effects
  • funding only those research projects that have a high likelihood of producing favorable results for a particular drug company’s product
  • terminating negative studies before they are ready for publication
  • not publishing studies with negative results
  • offering to pay journalists to cover their products
  • helping to fund patient advocacy and other public interest groups so the consumer group appears to be publicly carrying the banner of a particular drug

How can we possibly rely on information that is so inexorably intertwined with corporate interests? Corporations have very little motivation to share information that could harm sales of their products, as they are required by law to maximize profits for their shareholders. On the contrary, they have much incentive to do everything in their power to suppress such information. Several studies have shown that researchers who produce data that is contrary to the interests of the pharmaceutical industry risk legal, professional, or even personal attack – directly or indirectly financed by the industry. (Bosley, 2002; Healy, 2002; Monbiot, 2002).

As researcher David Antonuccio points out in his excellent article Antidepressants: A Triumph of Marketing over Science?:

“Company-sponsored experts, whether they are researchers or educators, are by definition company employees. They will be retained only if they offer consistently favorable treatment to the company’s products. It could be argued that their efforts on behalf of antidepressants often fit more properly under the rubric of marketing or advertising, not science or education.”

Clinical trials are the basis of approval of new drugs by the FDA, but their reliability is seriously in doubt because of three major flaws: conflicts of interest on the part of investigators; inappropriate involvement of research sponsors in their design and management; and publication bias in disseminating their results. (Quick, 2001)

The situation has become so dire that in September of 2001 the editors of 13 leading medical journals published a joint editorial in which they said:

“Research contracts should give the researchers a substantial say in trial design, access to the raw data, responsibility for data analysis and interpretation, and the right to publish”

Huh? Wouldn’t you expect researchers to have these rights already? In many cases, they don’t.

The editor of the prestigious New England Journal of Medicine argued in a separate editorial that the editors didn’t go far enough in their rebuke:

“The entire system of clinical investigation is driven by profit. We are seeing the corruption of a system of research that used to have high ideals and be clearly in the public interest.”

The conflicts of interest between researchers and drug companies is bad enough. But what’s even more distressing is that many doctors do not even read the research to learn about the drugs they are prescribing. Jerry Avorn, a Harvard Medical School professor and drug researcher is a leading authority on how physicians are educated about new drugs. He acknowledges that most physicians have only minimal knowledge about drug studies. Instead, Dr. Avorn has this to say about where most physicians get their knowledge about drugs:

“Pharmaceutical marketing is about the most important source of knowledge about new drugs for most physicians, and a major form of continuing education as well.”

There are now over 90,000 pharmaceutical reps walking the halls of medical offices around the U.S. Since there are less than 600,000 office-based doctors in the U.S. today, there is approximately one full-time drug rep for every six physicians. The drug reps bring free food for office staff, free samples for distribution to patients, free pens, free textbooks and other free gifts. They are also sometimes authorized to provide free vacations for physicians who would enjoy spending a weekend with other physicians in places like Hawaii or the Caribbean hearing the latest “research” on the effectiveness of a drug. In 2006, the pharmaceutical industry spent $2 billion on these types of events alone.

Does all of this advertising and promotion actually influence doctors? You bet it does. A government report found that in just one year the most heavily advertised drugs had prescription increases of 25% (U.S. General Accounting Office, 2002). There is even a formula that generally applies to drug advertising: each dollar spent on advertising increases sales by $4.

Even more discouraging than the influence of drug companies on doctors is the influence of patients who’ve been subjected to drug company advertising on doctors! A study published in the Journal of the American Board of Family Practitioners reported that 49% of patient requests for drugs or other requests prompted by “direct-to-consumer” advertising were not clinically appropriate. Yet 7 out of 10 times, physicians gave into the requests. (And that is by their own admission; there is likely a percentage of physicians who do not want to admit they write prescriptions or order tests on the basis of patient requests.)

The influence of advertising on doctors and patients is particularly relevant in the case of antidepressants. By a wide margin the largest amount spent on advertising by drug companies was on antidepressant promotion – a whopping $367 million dollars per week!(U.S. General Accounting Office, 2002) In fact, it appears that DTC advertising may be the single most effective way a drug company can increase the number of people who are diagnosed with depression and then will begin taking antidepressants (Donohue, 2004).

I could go on, but I think you get the point. As consumers and patients we simply cannot rely on profit-driven drug companies to give us accurate information about their products. And unfortunately, because of the massive conflicts of interest that exist between researchers, physicians and the pharmaceutical industry – we cannot necessarily rely on our doctors or even scientific studies to show us the way.

Luckily for us, there are still studies being done by independent researchers and those brave enough to risk the ire of the drug companies that we can turn to for honest, unbiased data. Unsurprisingly, these studies often have very different results than those sponsored by the industry. Thanks to the Freedom of Information Act, some researchers have even been able to access the studies done by the drug companies that they never published (obviously the ones that were least favorable to their drugs).

When these independent and unpublished studies are analyzed, a very different picture of depression and the efficacy of antidepressants begins to emerge.

Contrary to popular belief:

  1. There is no evidence that depression is caused by a “chemical imbalance” (which is the rationale behind prescribing antidepressants).
  2. Recent meta-analyses of the research data show that antidepressants have no clinically meaningful advantage over placebo. Therefore, the term “antidepressant” is a misnomer and should be abandoned.
  3. Poor study design may account for the small degree of superiority shown over placebo
  4. Claims that antidepressants are more effective in more severe conditions have little evidence to support them.
  5. Antidepressants have not been shown to affect the long-term outcome of depression or suicide rates.
  6. It is now recognized that SSRIs (the most widely used class of antidepressants) increase the risk of suicidal behavior in children and adolescents, and there is legitimate concern that the same is true for adults.
  7. Given doubt about their benefits and concern about their risks, current recommendations for prescribing antidepressants should be reconsidered.

You might be shocked by some of these statements. Though I was already very skeptical about antidepressants before beginning this research, I myself have been blown away by the complete lack of evidence supporting the theory that depression is a biological disease and the very strong evidence that antidepressants are no more effective than placebo.

I’ll be writing in more detail about several of the points to come in the coming weeks, so please stay tuned!

capsulesA recent article in the New York Times revealed that over half of Americans are taking prescription medication for chronic health problems.

The numbers were gathered last year by Medco Health Solutions Inc., which manages prescription benefits for about one in five Americans.

The data indicates that 51 percent of American children and adults were taking one or more prescription drugs for a chronic condition, up from 47 percent in 2001. The use of drugs to treat health problems was seen in all demographic groups:

  • Almost two-thirds of women 20 and older
  • One in four children and teenagers
  • 52 percent of adult men
  • Three-quarters of people 65 or older

28 percent of women and 22 percent of men over 65 take five or more medicines regularly.

Exactly what medications are people taking? In 2006, the top five drugs by sales were Lipitor, Nexium, Prevacid, Advair Diskus and Singulair. Lipitor lowers cholesterol, Nexium & Prevacid lower stomach acid, and Advair Diskus and Singulair address asthma and allergies respectively.

The drugs on this list reveal much about the weakness of the mainstream medical model. Cholesterol and stomach acid are both normal, protective substances in the body. Cholesterol is no more the cause of heart disease than stomach acid is the cause of GERD or ulcers. But one of the fundamental flaws of western medicine is its tendency to treat the symptom or effect rather than the cause. Unfortunately for patients, doing so can actually make things worse, not better.

Cholesterol plays many essential roles in the body, and and lowering it arbitrarily not only doesn’t prevent heart disease, but can actually increase the risk of dying from a heart attack in elderly people. Likewise, stomach acid is crucial in protecting us from the pathogens we might otherwise ingest with food. Stomach acid is also required for protein digestion. It is well-established in the scientific literature that the primary cause of ulcers is a bacterium called h. pylori – not stomach acid. And there is also evidence suggesting that GERD (gastro-esophageal reflux disease) is caused by low – not high – stomach acid.

But I digress.

The scariest part of this study is the surge in children’s use of medicines to treat weight-related problems and other illnesses previously considered adult problems. Medco estimates about 1.2 million American children now are taking pills for Type 2 diabetes, sleeping troubles and gastrointestinal problems such as heartburn.

The majority of these conditions – diabetes, sleeping troubles and gastrointestinal issues – can be treated by simple diet and lifestyle changes. These changes have none of the adverse effects and risks of drugs, and their benefits extend far beyond the potential therapeutic action of the medications.

Medication has improved and even saved the lives of many in this country and around the world. Yet there’s a difference between drugs that are “medically necessary” and drugs that are prescribed in lieu of other less harmful and risky – but more labor intensive – interventions such as diet and exercise.

But as Dr. Robert Epstein, cheif medical officer at Franklin Lakes, N.J.-based Medco said, ‘We’ve become a couch potato culture (and) it’s a lot easier to pop a pill” than to exercise regularly or diet.

I couldn’t have said it better myself.

One reason for the increase in medication use is the pharmaceutical industry’s “relentless advertising”. Since that is unlikely to change anytime soon, experts say the proportion of Americans on chronic medications can only multiply.

“Unless we do things to change the way we’re managing health in this country … things will get worse instead of getting better,” predicted Daniel Jones, a heart specialist and dean of the University of Mississippi’s medical school.

Luckily, we don’t have to wait around for that to happen. As individuals we can take responsibility for our own health care using diet, exercise and lifestyle changes. We can choose to use “alternative” modalities such as acupuncture and homeopathy to keep us healthy. And we can take action to reduce stress and promote emotional and psychological well-being.

Recommended Links

  • Americans Taking Prescription Drugs in Greater Numbers

morgueThe popular perception that the U.S. has the highest quality of medical care in the world has been proven entirely false by several public heath studies and reports over the past few years.

The prestigious Journal of the American Medical Association published a study by Dr. Barbara Starfield, a medical doctor with a Master’s degree in Public Health, in 2000 which revealed the extremely poor performance of the United States health care system when compared to other industrialized countries (Japan, Sweden, Canada, France, Australia, Spain, Finland, the Netherlands, the United Kingdom, Denmark, Belgium and Germany).

In fact, the U.S. is ranked last or near last in several significant health care indicators:

  • 13th (last) for low-birth-weight percentages
  • 13th for neonatal mortality and infant mortality overall
  • 11th for postneonatal mortality
  • 13th for years of potential life lost (excluding external causes)
  • 12th for life expectancy at 1 year for males, 11th for females
  • 12th for life expectancy at 15 years for males, 10th for females

The most shocking revelation of her report is that iatrogentic damage (defined as a state of ill health or adverse effect resulting from medical treatment) is the third leading cause of death in the U.S., after heart disease and cancer.

Let me pause while you take that in.

This means that doctors and hospitals are responsible for more deaths each year than cerebrovascular disease, chronic respiratory diseases, accidents, diabetes, Alzheimer’s disease and pneumonia.

The combined effect of errors and adverse effects that occur because of iatrogenic damage includes:

  • 12,000 deaths/year from unnecessary surgery
  • 7,000 deaths/year from medication errors in hospitals
  • 20,000 deaths/year from other errors in hospitals
  • 80,000 deaths/year from nosocomial infections in hospitals
  • 106,000 deaths a year from nonerror, adverse effects of medications

This amounts to a total of 225,000 deaths per year from iatrogenic causes. However, Starfield notes three important caveats in her study:

  • Most of the data are derived from studies in hospitalized patients
  • The estimates are for deaths only and do not include adverse effects associated with disability or discomfort
  • The estimates of death due to error are lower than those in the Institute of Medicine Report (a previous report by the Institute of Medicine on the number of iatrogenic deaths in the U.S.)

If these caveats are considered, the deaths due to iatrogenic causes would range from 230,000 to 284,000.

Starfield and her colleagues performed an analysis which took the caveats above into consideration and included adverse effects other than death. Their analysis concluded that between 4% and 18% of consecutive patients experience adverse effects in outpatient settings, with:

  • 116 million extra physician visits
  • 77 million extra prescriptions
  • 17 million emergency department visits
  • 8 million hospitalizations
  • 3 million long-term admissions
  • 199,000 additional deaths
  • $77 billion in extra costs (equivalent to the aggregate cost of care of patients with diabetes

I want to make it clear that I am not condemning physicians in general. In fact, most of the doctors I’ve come into contact with in the course of my life have been competent and genuinely concerned about my welfare. In many ways physicians are just as victimized by the deficiencies of our health-care system as patients and consumers are. With increased patient loads and mandated time limits for patient visits set by HMOs, most doctors are doing the best they can to survive our broken and corrupt health-care system.

The Institute of Medicine’s report (”To Err is Human”) which Starfied and her colleagues analyzed isn’t the only study to expose the failures of the U.S. health-care system. The World Health Organization issued a report in 2000, using different indicators than the IOM report, that ranked the U.S. as 15th among 25 industrialized countries.

As Starfied points out, the “real explanation for relatively poor health in the United States is undoubtedly complex and multifactorial.” Two significant causes of our poor standing is over-reliance on technology and a poorly developed primary care infrastructure. The United States is second only to Japan in the availability of technological procedures such as MRIs and CAT scans. However, this has not translated into a higher standard of care, and in fact may be linked to the “cascade effect” where diagnostic procedures lead to more treatment (which as we have seen can lead to more deaths).

Of the 7 countries in the top of the average health ranking, 5 have strong primary care infrastructures. Evidence indicates that the major benefit of health-care access accrues only when it facilitates receipt of primary care. (Starfield, 1998)

One might think that these sobering analyses of the U.S. health-care system would have lead to a public discussion and debate over how to address the shortcomings. Alas, both medical authorities and the general public alike are mostly unaware of this data, and we are no closer to a safe, accessible and effective health-care system today than we were eight years ago when these reports were published.

Recommended links

  • Is US Health Really the Best in the World?

A recent article reported on the results of a trial of the cholesterol-lowering drug Zytorin, which is a combination of Zocor and Zeita – made by Merck and Schering-Plough.

Zocor and Zeita lower cholesterol by different mechanisms, so the idea was that combining them into a single drug (Vytorin) would dramatically lower cholesterol and, they assumed, reduce heart disease.

They got the first part right. Vytorin did indeed lead to dramatic reductions in cholesterol levels in those who took the drug. However, it also increased the risk of heart disease – exactly the opposite result they were hoping for.

The worst part about this is that Merck & Schering-Plough sat on this data for almost two years, while over five million people around the world continued to take a drug that was proven to nearly double the risk of heart disease. Congress has launched a full-scale investigation and the NY Times is publicly demanding a new law to prevent this from happening again.

Yesterday another article was published in the Times with an update on the investigation, including emails sent by the lead investigator on the Vytorin trial indicating that Merck & Schering-Plough were deliberately delaying publication of the results of this trial.

Yet another case of gross malfeasance by the pharmaceutical industry. Consumers beware.

Related articles

  • Accusations of Delays in Releasing Drug Results
  • Doubt Cast on Two Drugs Used to Lower Cholesterol
  • Editorial: Overpromoted Cholesterol Drugs

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