December newletter about probiotics, evolution, depression, placebos, heroes, self-publishing and a treatment for cancer

American Institute for Technology and Science Education Newsletter	Dec, 2011

Greetings!

Greetings! Hope your holiday preparations will leave you time to read about probiotics, evolution, depression, placebos, heroes, self-publishing and a treatment for cancer. If not, come back later--but be sure not to miss the coupon at the end of this newsletter!

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Finally, as we approach 2012, please consider AITSE in your year-end giving. We have great plans for the New Year and have entitled our strategy, Dream Big: Scientific Integrity is Possible. More information is available on the AITSE website.

Lactobacillus
Probiotics
Good, Bad, or Indifferent?

If you spend any time in grocery stores, and most of us do, you will know that probiotics ("good" germs) and prebiotics (bacteria food or fiber) are all the rage. So, do bacteria really "do you good?"

According to a report in the Medical Journal of Australia, sometimes they do and sometimes they don't. This is why it is important to have access to accurate and balanced sources of information. An average human being has over 500 species of bacteria living in their intestinal tract, a veritable community, all seeming to work in cooperation with each other and with their host (a person)--unless of course there is a shift in the balance of power. Then, like can happen in politics, there is trouble.

For example, if a person takes antibiotics, comes down with a tummy bug, gets food poisoning, or suffers from an inflammatory bowel condition, the microbial balance of power can shift, resulting in diarrhea and/or other uncomfortable conditions. Some of the good bacteria die and some less helpful ones flourish. Lactobacillus and Streptococcus thermophilus (bacteria found in all yogurts) to the rescue?

Apparently, yes, at times. Probiotics, administered together with rehydration therapy significantly reduce the duration and risk of virus-induced diarrhea. Similarly, taking yogurt or a probiotic drink together with necessary antibiotics diminishes the risk of having diarrhea as a side effect from 34 to 12%. Finally, some studies suggest that probiotics may even reduce one's chances of getting traveler's diarrhea. However, do be aware that one brand of yogurt is much like another--they are all "live," unless they have been heat-treated (unlikely).

So, are probiotics a cure for all ills? No. Studies on the beneficial effects of probiotics on allergies, Crohn's disease, ulcerative colitis and necrotizing enterocolitis are unconvincing. In addition, probiotics are definitely contraindicated for newborns and those who are immune compromised. But, for the rest of us? Go ahead. Enjoy your yogurt (the brand does not really matter). It won't hurt and might even help.

Depression
Cures or Cold Comfort?

Did you know that 25-50% of college students, 23% of middle-aged women, and 11% of Americans take anti-depressants
like Lexapro, Celexa, Prozac, Effexor, Paxil and Zoloft, otherwise known as Selective Serotonin Re-uptake Inhibitors (SSRI's)? This is despite some disturbing facts. First, the self-same drugs have been banned for use in children in the UK because they increase the risk of suicide and the FDA has issued a black box warning that they may have the same effect in young adults. Second, although these medications may help those who are very severely depressed, the data suggest that they only help 30% of others, which is the same as placebo--in other words, they don't work. Third, up to 38% of people taking SSRI's experience a serious side effect, the most common being sexual dysfunction, drowsiness, or weight gain--all rather depressing in themselves. Finally, even though 14% of the people taking antidepressants take more than one type, less than half of them have seen a mental health professional in the last year.

Patient information sheets also raise questions-if indeed a person bothers to read them. Take this, quoted directly from a Mayo Clinic publication, "Precisely how SSRIs affect depression isn't clear. Some research suggests that abnormalities in.... SSRIs seem to relieve symptoms of depression ... SSRIs are called selective because they seem to affect only serotonin." Despite this fact, SSRI's are the third most commonly prescribed drug type, even being given to infants and small children.

Now, we are not ruling out the possibility that many pharmaceutical company researchers and executives may have good intentions. But, it is also very possible that, in some cases, the pressures inherent in the system might result in bowing to an underlying financial motive that outweighs possible risk to patients. After all, as editor Boseley observes, the "data which suggests the drugs could be causing children to feel murderous and suicidal [were] in drug company hands for several years" before being published. Recommended for further reading, Psychology Today's Five Reasons not to take SSRIs.

Avastin
A Bad Idea!

Avastin used to be FDA approved for treatment of breast cancer, but no more. Why? Why approve it and then not? What is this Avastin and what does it do? Could we have anticipated the problems and side effects?

Avastin (bevacizumab) is an antibody that binds to vascular endothelial growth factor-A (VEGF), a "word" in the "language" that cells use to communicate with each other. Since one meaning of this "word" is "grow blood vessels," Avastin inhibits the formation of new blood vessels that supply tumors with their source of oxygen and nutrients. Seems like a great idea. But is it?

The problem is that VEGF is just one word in the entire cellular language. And, just as "pretty" means something very different from "pretty ugly," so VEGF does different things in different contexts. Besides the above function, VEGF also "speaks" to the immune system, "tells" platelets to form plugs, inhibits cellular suicide, plays a role in bleeding, and more. Taking this word out of the body's language is bound to have profound, and possibly devastating, effects.

Avastin has been regularly prescribed for use in patients with metastatic breast cancer, having been approved by the FDA in 2008 via their accelerated approval process. It is still used in treatment of lung, kidney, brain and colon cancer (approved 2004). But, on November 18, 2011, the FDA released a statement saying that Avastin is neither safe nor effective in delaying cancer growth and improving quality of life. Not surprisingly, Genentech, the sponsor of the clinical trials and the manufacturers of the drug, did not agree with the FDA's actions.

Frankly, a quick perusal of Genentech's patient information website makes one wonder why Avastin was ever approved for treatment of anything. The side effects include heart attack or stroke in 2.4% of patients, high blood pressure in up to 18% of people, serious bleeding, gastrointestinal perforation, slow wound healing and more. And, in Genetech's own words, "no data have shown whether or not Avastin improves disease-related symptoms or survival in people previously treated for [brain cancer]." In patients with lung, kidney or colon cancer, Avastin is prescribed alongside other drugs, making it a little challenging to determine how helpful Avastin itself is. To sum up, it looks like Avastin probably won't help, but it definitely will hurt.

So, why was Avastin approved for use in breast cancer in the first place? Apparently, an advisory panel voted 5-4 that it not be. Well, the FDA wants to bring cancer drugs to the market as soon as possible, it sounded like a good idea, and so they approved it. Fortunately, the FDA also required two additional clinical trials, the results of which did "not justify the continued approval of the drug," thus approval has been withdrawn.

So, they made a mistake. A costly, even deadly, mistake for many. But, it is important to be aware that the FDA decision-making individuals are no more capable of predicting the future than the rest of us. Moreover, they were and still are under tremendous pressure. There is the inevitable outcry from desperate patients after hearing that this drug is being withdrawn. They had pinned their hopes on it and now feel they are being left out in the cold. In addition, the decision makers are doubtless being pressured by the people at Roche Holding AG, which stands to lose $873 million in revenue. But, if the facts advertised on the Genentech website are accurate, the FDA made the right decision and AITSE congratulates them for practicing integrity in pharmaceutics.

Evolution?
The Sickle Cell Enigma

In 1954 Dr. Anthony Allison published that
people who have one gene for a mutated form of hemoglobin are protected from getting malaria, a disease that kills a million people every year. Therefore, this change in the DNA, which leads to sickle cell trait, has been touted as a positive mutation, particularly for people who live in areas where malaria is endemic. It is thought that this beneficial effect is why 40% of Africans and 10% of African Americans have a defective hemoglobin gene. Of course, children born to those individuals, otherwise known as sickle cell carriers, have a one in four chance of having two genes coding for the disease. This means that they will suffer from full blown sickle cell anemia, which is an extremely debilitating disease that decreases average life expectancy to 45 years of age. The mutation somehow renders red blood cells "sticky" so they clog up the blood vessels, leading to pain, breathlessness, fever, stroke, and organ failure. Seems to be a no win situation. If a person has the mutation, they are protected from malaria, but they also run the risk of having offspring who will suffer from a painful and ultimately deadly disease.

A recent article in the Nature magazine reports that researchers have now discovered how the hemoglobin mutation prevents malaria. A bit of cell biology is necessary at this point--please refer to the diagram above, which illustrates one method whereby cells transport their products from the place where they are manufactured (ER) and refined (Golgi) to the cell surface. Basically, the cell builds bridges made of actin, puts the product in a vesicle, and moves the vesicle to the cell surface, where it is released in response to a signal. A simple analogy is a country. Products for export are manufactured and refined inside the country. They may then be loaded into railway cars and trains; the boxcars run along railway tracks to the borders using diesel as fuel. Of course, completion of the export process may require other communication.

So, how does this apply to malaria and sickle cell trait? Apparently, the usual course of infective action is that the parasite will enter a red blood cell and cause it to build a bridge (made out of actin) to transport a sticky substance or protein to the surface of the cells. But, in people with sickle cell trait, the mutant hemoglobin prevents the building of the bridge, so that the vesicles that normally carry the protein to the cell surface float freely within the cell. They never get to the surface. The product is not exported because the railway lines could not be built; there was a pile of rubble in the way. This prevents the red blood cells from becoming sticky and clogging the vessels. Thus, sickle cell carriers are resistant to malaria.

Some would assert that this is an example of evolution in action. After all, the organism has mutated to increase fitness for its particular environment. But, does being a sickle cell carrier, which can be symptomatic in some circumstances and gives a 25% chance of having sick offspring, really increase fitness? And why, in the many, many years that man has been plagued by the malarial parasite, have we not evolved a type of resistance that does not cause illness or has the parasite not evolved a way to overcome these mutations? For an excellent analysis of these and other questions, read The Edge of Evolution by Dr. Michael Behe who, by the way, compared positive mutations to blowing up bridges way back in 2007. Almost prophetic!

Quote of the Month nautilus

Heresy or Heroes?

Excerpts from Scientific Heresy by Matt Ridley:

Lesson number 1: "the stunning gullibility of the media. Put an "ology" after your pseudoscience and you can get journalists to be your propagandists."

Lesson number 2: "Debunking is like water off a duck's back to pseudoscience."

Lesson number 3: We can all be both [heretics and heros].

Lesson number 4: "The heretic is sometimes right."

Lesson number 5: "Keep a sharp eye out for confirmation bias in yourself and others."

Lesson number 6. "Never rely on the consensus of experts about the future."

In order for science to advance and provide maximum benefit to the public, science must be conducted with integrity and not be narrow-minded or controlled by financial, political or religious motives and heroes must not be labelled as heretics. We must be Free to Think (see coupon below). AITSE is working to make sure that we are.

But I Feel Better

The Placebo Effect

Moms, dads and grandparents are known for kissing it better. And, even though, as adults, we are aware that there is no scientific basis for the resultant positive experience, how many of us would attest that being consoled does not make us feel better, even when the ailment is physical?

In the same way, research has shown that just thinking you are receiving medical treatment makes you feel better. For this reason about half of US doctors prescribe placebo (sham medicine) at least once a month--in effect, deliberately deceiving their patients. The question is: is it better for a physician to be truthful or for him or her to make you feel better?

The first question to ask is: what is the "medicine" that they prescribe? Apparently, the only sugar pill available for prescription today is Obecalp (read backwards). So, those members of the medical community who feel use of a different placebo is in order may inject their patient with salt water or prescribe antibiotics, vitamins, pain relievers, or even sedatives, sometimes doing more harm than good. Alternatively, they may recommend their patients seek help from various alternative medicine therapists, which are another story entirely.

One must also ask whether placebos actually work. The answer is yes and no. Placebos are

effective in reducing pain, actually reduce depressive feelings in 45% of patients (about the same as SSRI's), and have been shown to suppress allergic symptoms, provided that they are administered in a supportive

setting, that is, the clinician tells them that the placebo will reduce pain, etc. Amazingly, research has shown that the "placebo" effect is not just in the patient's mind, but that placebo treatment can change release of endogenous opioids and neurotransmitters. Of course, placebos do not work to address genuine bacterial infection, heart disease, cancer, and those diseases that have minimal psychological components.

So, what course of action will a physician of integrity choose? That they should, "provide a supportive clinical encounter that relieves anxiety and promotes positive expectations..." goes without saying. But, is it ethical for a physician to prescribe unneeded antibiotics, sedatives, and pain relievers or to recommend acupuncture, homeopathy, or a visit to a chiropracter? The former, being drugs, can cause adverse effects and the latter therapies are all known to work by a placebo effect. When one realizes that many of these treatments cause actual damage (e.g. chiropractic can cause severe injury), possibly not. Seems like we would be better to stick with real medicine combined with kissing it better.

Can't Get Published?

Do It Yourself

According to a BBC article, Nature magazine is being sued by Dr. Mohamed El Naschie's after they wrote that Dr. El Naschie's "scientific journal" contains a disproportionate number of articles written by--Dr. El Naschie. In response to his legal actions, Nature Magazine stated that their claims were not, as the scientist claims, "despicable and defamatory," but "true and in the public interest." Apparently Dr. El Naschie has published 60 of his own papers in the last year, claiming that he discussed them with colleagues, but bypassed peer-review.

Professor Otto Rossler, a friend of his, explained that Dr. El Naschie's work is too complex and important for peer-review and that prohibiting him from publishing would be "dangerous" because "peer review delays progress in science." Sounds like a good friend, but it does raise an interesting question. If these assertions are true (unlikely based on the fourth AITSE Bunk-Detecting Principle), what should Dr. El Naschie have done?

it is well known that the peer-review process is far from perfect. Sometimes papers that should be accepted are rejected because the ideas contained therein are new or threatening to the status quo. Sometimes papers that should be rejected are accepted because they have been submitted by a prestigious group or a friend of the editors. Much could be gained from raising the profile of the importance of integrity in science.

In closing, as always, thank you for your past gifts and support. It is a fact that AITSE cannot function in its efforts to educate to increase scientific understanding and integrity without contributions. Please consider helping us with a special donation or a commitment to give on a monthly basis. Please make checks payable to AITSE and send them to PO Box 15938, Newport Beach, CA 92659. Alternatively, you can donate on line through PayPal or credit card.

Sincerely,

Caroline Crocker
American Institute for Technology and Science Education

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