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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.

pregnant womanBack in July I posted an article called Statins For Pregnant Women and Kids? criticizing a research study that actually recommended statins for pregnant women.

Well, it appears that even mainstream scientists are beginning to acknowledge the very real risks that statins present for pregnant mothers and fetuses.

Current clinical guidelines already recommend that women who are pregnant should stop taking statins but the advice is based on the knowledge that cholesterol is essential for normal fetal development.

But new research from The University of Manchester has shown that even water-soluble or ‘hydrophilic’ statins, such as pravastatin, can affect placental development leading to worse pregnancy outcomes.

According to Dr. Melissa Westwood, a Senior Lecturer in Endocrinology based at the Maternal and Fetal Health Research Centre at St. Mary’s Hospital, Manchester:

“Our study examined the effects that both lipophilic and hydrophilic statins had on a key biological system that is crucial for maintaining the normal function of the placenta, which acts as the nutrient-waste exchange barrier between mother and fetus.”

Fat-soluble statins like cerivastatin were already known to adversely affect the placenta, resulting in reducing growth. But the researchers also found that pravastatin – the water-soluble statin thought to be potentially compatible for use in pregnancy – had the same detrimental effect.

“These results clearly show that the effect of statins on the placenta is not dependent on their lipophilicity as had previously been suggested,” said Dr Westwood, whose findings are published in the Journal of Cellular and Molecular Medicine.

“While hydrophilic statins have not been reported to increase the incidence of fetal malformations, our research suggests that they will have a detrimental effect on placental growth, which is likely to result in poor pregnancy outcome.

“Healthcare professionals should continue to advise women to avoid the use of any type of statin once they plan to start a family or when a pregnancy is suspected or confirmed.

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.

New research has just been published in the Journal of the American Society of Nephrology that questions the long-held popular belief that drinking eight glasses of water a day benefits our health.

According to Dr. Stanley Goldfarb and Dr. Dan Negoianu of the University of Pennsylvania in Philadelphia, there are four prevalent myths about water intake:

  1. Leads to more toxin excretion
  2. Improves skin tone
  3. Makes one less hungry
  4. Reduces headache frequency

Dr. Goldfarb and Dr. Negoianu reviewed all of the published studies which examined the health benefits of water consumption. They concluded that people in hot, dry climates, athletes or people with certain diseases might do better with increased fluid intake, but for average healthy people, more water did not mean better health.

“There is no clear evidence of benefit from drinking increased amounts of water,” Dr. Goldfarb wrote, but he also added, “There is also no clear evidence of lack of benefit.” In other words, the scientific research doesn’t tell us one way or the other whether there’s a benefit or not.

Fortunately, nature has endowed us with a mechanism that can in fact help us determine how much water we need to be drinking per day. It’s called thirst. If we simply pay attention to our thirst and respond appropriately, it’s likely that we will take in as much water as we need. Four to six glasses per day is probably sufficient for most people; but then again, the evidence indicates there is no harm in drinking more, so if you enjoy drinking a lot of water then knock yourself out!

There is no evidence that increased water consumption helps to excrete toxins. The kidneys perform that function in the body, and as long as they are healthy they do it very well. Dr. Goldfarb: “The kidneys clear toxins. This is what the kidneys do. They do it very effectively. And they do it independently of how much water you take in. when you take in a lot of water, all you do is put out more urine but not more toxins in the urine.”

There is no evidence supporting the other three myths either; namely, that it improves skin tone, reduces hunger and alleviates headaches. But again, if your experience is different and you find that water does help with these conditions – then there is absolutely no reason not to continue what you’re doing now (other than perhaps more frequent trips to the bathroom!) Just don’t go crazy with the water intake, because extremely high levels of water consumption can affect the fluid balance in the body, causing “water intoxication” and even death.

Finally, I’d be remiss if I didn’t emphasize that the quality of the water we drink is much more important than the quantity. My recommendation is that you invest in a high-quality water filter and install it in your home. Avoid bottled water, which is often simply tap water packaged in a plastic bottle that can potentially leach toxins into the water – especially when left in the sun. (You know that “plasticky” smell when you drink water from a plastic bottle that has been around for a while? Not good. Not good at all.) Nalgene bottles should also be avoided as they can leach another unsafe chemical called BPA into your water. Instead, buy a stainless steel water bottle and fill it up with your filtered water at home before you go out.

Also, both tap water and filtered bottled water contain fluoride, a highly toxic bone poison that should be avoided at all costs. Many commercial water filters unfortunately do not remove fluoride, which is present in our water supply because of the gross misconception that it supports dental health. But more on that myth in another article.

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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