Archive for the 'Science' Category

03
Jul
14

Expected this of Facebook, but PNAS? What Were You Thinking?

Retraction countdown commences now.  It’s pretty clear that Facebook, Cornell and PNAS violated the spirit of human subject research laws, if not the letter of those laws (may have done that, as well).

If we start to accept that clicking ‘yes’ to a privacy policy equals adequately informed consent, we might as well scrap the whole system designed to prevent the research atrocities of the past. Do you feel your physician should be able to replace your standard medication with an experimental drug as part of a study that you are not aware you are participating in and never consented to because you signed his boilerplate privacy policy? Of course not. He/she would end up losing their license or in prison for this sort of conduct. Social science research IS human subject research and it requires the same level of concern for the rights of participants.  I’m not angry about the nature of the study. I am angry that these researchers felt so comfortable manipulating people without their knowledge or consent. It is a slippery slope and minimizing it is not helpful.

People clearly were harmed by this study. In fact, that was actually one of the study goals–see if it was possible to make them feel bad by artificially manipulating their exposure to negative comments– and ultimate ‘findings.’ That alone should have prompted better ethical oversight. This is not the same as retrospectively data mining de-identified static patient records, regardless of whatever rationale Cornell uses. This was real time emotional manipulation of actual people who had no idea it was going on. Bad form all around and I hope OHRP gets involved.

03
Jul
14

(AB)Use of Statins the Next Big Pharma Scandal?

No one can say for sure and that is a scandal in itself.

For anyone who has been paying attention to the growing controversy related to the ever-expanding prescribing guidelines for statins, Ben Goldacre makes some very good points in this post.

Worth noting that none of this would be an issue if we mandated trial transparency. The fact that bad data can be hidden and good data cherry-picked to artificially manipulate prescribing decisions is a big problem that results in lack of confidence across the board.

03
Aug
10

Yes Virginia, We Do Need an Ad-Ed Wall

It’s all about the Benjamins

I’m not entirely sure why the New York Times decided to take up this issue in their Sunday New York Magazine, but it seems there is quite a kerfuffle whipping up in the scientific blogosphere over whether or not it is appropriate to allow company-sponsored ‘nutrition’ scientists (Pepsico® formerly owned and has a lifetime interest in Yum! Brands, the people who recently brought us the KFC Double Down, a so-called sandwich consisting of two fried chicken breasts stuffed with bacon and cheese–540 calories and 1380 gram of sodium in each–fat content not listed, go figure).   Traditional scientists come from a background of academic publishing where advertising is viewed with suspicion and industry-sponsored data is considered suspect until it can be independently verified.  This is a good thing–a safeguard against corporate bias polluting pure science in the interest of profits–but, sadly,  it is disappearing.   Many scientists object to the loss of this so-called ad-ed wall, so it is not surprising–or should not have been–that there was a mass exodus of credible bloggers from one of the most popular science blogging sites on the Internet, ScienceBling, when the site owner opted to allow PepsiCo® to host a blog on nutrition science (isn’t that a little like asking Sarah Palin to host a blog on the beauties of the wildlife she likes to shoot?  Oh wait, someone [TLC] actually did that?  Alrighty, then).

Enter Virginia Heffernan of the New York Times.  She just doesn’t understand what the fuss is all about and took to old-fashioned print to bemoan the ‘cacophony’ and messiness of science blogging.  If you really want straight answers and easy-to-understand prose, she recommends several blogs including one run by a climate science skeptic (not that there’s anything wrong with that, but if she is despairing of the ‘noise’ in the scientific community, could she have picked a worse, more noise-inducing topic than climate change?).   And the PepsiCo® kerfuffle?  Just carbonation in a tea cup.  Nothing to see here folks,  move on.

I am on the fringes of the scientific community, having become involved as a lay person in many aspects of clinical research through my work with a patient research advocacy organization, so my perspective is a little bit different than that of the scientists who wrote critical reviews of Ms. Heffernan’s piece.  I would like to add a lay person’s voice to this debate (no comments were allowed on the online version of her article) and it goes something like this:

“Yes, Virginia, it does matter if the ad-ed wall is breached because, outside of scientific integrity and rigorous attempts to avoid bias, the scientific community has another obligation–protecting a scientifically illiterate public from corporate and money-driven efforts to alter scientific reality.  They are the only ones who can do this, as the public has and little or no education on how to interpret data and detect bias and should not be expected to do so. ”

And, for good measure, I’d throw in a recent example of how  so-called corporate scientists manipulate public ignorance of science for purely financial gain using an MLM supplement company called MXI* (based in Nevada).  MXI’s marketing is a case study in how a bold group of charlatans can mislead the public using false claims of scientific rigor.  MXI is on my radar screen because I have two sisters who have MLM businesses selling their products which consist of various concoctions of high-antioxidant (or as we call it in our house ‘magic’) chocolate.  This stuff can do EVERYTHING and it is clinical proven with many ‘studies’ run by actual ‘doctors.’ Dismayed by my stubborn refusal to want to magically lose weight, grow hair, clear up my skin, improve my digestion and bolster my energy (all claims this company makes in its marketing materials) with this clinically proven product, one of my sisters resorted to actually sending me the study ‘data,’ which was top secret and meant only for product reps.  Here is this amazing clinical data (copied directly from the email with no effort to correct grammar or spelling):

Those who work hard to lose weight their whole lives …. and those who lose weight the new, easy way.

The Xocai meal replacement shake is hitting the market next week.  If you know of someone that would like to lose weight, or would like a quick nutritious meal on the run, or just wants more energy, see if they would like give this a try.  The clinical trial has had even better results than were expected.

And, if you’re thinking you might like to fire your boss and build your own business earning big money, now is the time.  Someone will tell your friends and neighbors about this shake – it may as well be you!

CLINICAL TRIAL RESULTS

Mike Kennedy MD
Steven Warren MD DPA

Study Medical Directors
High Antioxidant Wellness System
July 30, 2010

Dear MXI Associates:

Six weeks ago, we selected 50 individuals who wanted to lose weight by using a High-Antioxidant Wellness System. We have now successfully reached the halfway mark in this Wellness System Study. The participants selected filled a wide scope of categories, males and females ranging in age from 26-76, from different parts of the country, all desiring to achieve a weight loss goal from 20-100+ lbs. These 50 study participants have been following the protocol, which involves substituting two meals a day with the X-ProteinMealTM Replacement Shake, three pieces of XocaiTM chocolate and other healthy snacks, and a high-protein/complex carbohydrate meal for a total of 1,200 calories for women and 1,500 calories for men. The program includes walking or other forms of exercise, drinking water, sleeping 7-8 hours per day, keeping a food dairy, and participating in a weekly accountability call.

We are excited to report at the halfway point of this 12-week study the total weight loss of the 50 participants is nearly 1,000 pounds—half a ton! That’s a lot of extra weight no longer being carried around! The really exciting news is they are full of energy, have no muscle aches, no longer experience carbohydrate cravings, and feel better than they have ever felt. They are even having a hard time consuming the required daily calories because they feel full and have no hunger. Everyone is losing weight and abdominal inches without even feeling like they’re on a diet. When asked if they would stop the protein shakes, their response is they “could not live without it.” When they look over their previous dieting experiences and food intake, they realize why they were gaining and not losing weight. By recording and reporting their total daily calorie intake, they’ve had great success in controlling their calorie intake and remaining compliant with the weightloss protocol. The shakes provide the necessary proteins, fats, carbohydrates, fiber, and vitamin and minerals, which give the participants two nutrient-rich meals and helps them avoid the consumption of empty calories. To date, not a single participant has dropped out of the study, which is unheard of in clinical studies. The participants are ecstatic with the success they are experiencing.

This is a very simple system that can be utilized by anyone. Results in the past six weeks have supported the principles of this system:

1.    Use of a protein shake with cocoa and complex carbohydrates reduces the normal pain in the body usually experienced after vigorous exercise.

2.    Increased levels of omega 3 assist in weight loss.

3.    Whey protein isolate is very effective in weight loss.

4.    Reporting to an interactive web page or participating in a weekly call increases compliance.

5.    Socially interactive programs maximize weight loss.
We feel this is truly the first weight loss system that leads to maximal success!

We know you may not reach the “perfect” BMI, but we know you will feel better than before and maximize your health. We have had reports of increased hair growth, smoother skin, decreased depression, and unbounded energy! Prior to the study, some participants were consuming over 2,500 calories per day. Now, several report having a hard time consuming the required 1,200 or 1,500 calories per day that are needed in order to lose, as any less may result in weight gain. When have you ever been told to eat in order to lose weight? Several participants report they are now able to walk with their spouses, and other people are noticing and acknowledging their weight loss. The satisfaction of others seeing your body transform is priceless! The key to this system is the high antioxidant power of chocolate combined with other antioxidant fruits. Over 50,000 total ORACfn and 1,200 mg of flavonoids are provided per shake. The synergistic power of whey protein isolate, fiber, minimal sugars, complex carbohydrates, and vitamins and minerals with the high-antioxidant mix is amazing!

Chocolate is a miracle food and its benefits are numerous.

The X-ProteinMeal™ Replacement Shake, the newest product to join the Xoçai™ Healthy Chocolate Family will be available for pre-order on August 2, 2010 at 12:01a.m. E.S.T. Shipping to North America will begin August 16, 2010. We are confident by following this wellness system you will be successful and able to achieve your weight-loss goals. It is up to you to start the program and become the person you have always wanted to be. We wish you the best in your wellness efforts and know this system will help you.

With great success to you,

Mike Kennedy, M.D. Steven Warren MD DPA*
Your partners in obtaining and maximizing your wellness dreams.” [end]

The authors throw in a few legitimate looking data points (that add nothing to the analysis but are at least official looking numbers) to offset the fact that they have extrapolated (also magically, it seems) all their proof from study participant self-report–or so we must assume since no actual data is presented.  Outside of cringing in shame that my two actually very bright sisters accept this as ‘evidence,’ I think it highlights a major reason why we need the scientific community to be on guard against a wholesale corporate takeover of science.  My sisters swear they are experiencing the powerful effects of magic chocolate, but seem unaware than anyone on a 12-1500 calorie diet would be losing weight, regardless of chocolate intake and they are totally unfamiliar with the powerful placebo effect that muddies up even rigorously designed studies from time to time.

Granted, PepsiCo(R) is not an MLM outfit, but it is naive in the extreme to think that a profit motive (or even just a ‘keeping my job’ motive) will have no impact on the sort of data that is collected, presented and interpreted even by the most sincere corporate scientists.  Speaking as someone who witnesses the devastating effects of clever, scientific-sounding sales pitches on an unwitting patient population desperate to believe in magic cures, we need the scientific community to be more vigilant and protective of their turf–not less.

*MXI is one of several  MLM supplement marketing schemes run by Jeanette Brooks whose failed companies have been cited by the FDA for false advertising in the past. Go figure.

**Dr. Warren apparently had his license put on probation in Utah for one year due to sloppy record keeping.  In the interest of full disclosure, I was not able to independently verify this, however.  It came from trusted site scam tracking sites (Quatloos [requires registration] and the UK Business Opportunity Watch site) , but in order to verify it with the Utah State Board of Professional Licensing  I would have had to pay for a report, which I’m not really interested enough to do.  I already know he’s a lousy scientist based on his ‘clinical results’ email.  ‘Nuff said.




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