Archive for the 'medicine' Category

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.

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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.

19
Dec
09

CDC Report: 1 in 110 Children Diagnosed with Autism

Given the appalling statistics regarding the misdiagnosis of autism, this headline is a little misleading. It represents the number of children ‘diagnosed’ with autism, which may or may not represent the number of children who actually have it. The definition of ‘autism spectrum disorder’ is a fluid target and is far more inclusive than it ever used to be. It has essentially become a dumping ground diagnosis for any and all disorders of social and/or intellectual dysfunction that can’t be categorized elsewhere. The diagnosis has become so pervasive that actual experts in the disorder have lost the floor to the ‘anyone can diagnosis it in anybody at any time’ crowd. That’s why statistics like these are so irresponsible. They unnecessarily frighten parents who are at the whims of movement that has lost its perspective in the rush to jump on the bandwagon. Classic autism is a devastating developmental disorder, which is why labeling children with other more benign behavioral disorders is such a huge disservice to the autism community. Being a little different or a little difficult is not a disease. One would hope our government’s main epidemiological clearinghouse would demand better evidence than the subjective diagnosis of millions of children by practitioners who often don’t even agree on what constitutes true autism themselves. I have an autistic niece. She is clearly and profoundly disabled and, at age 18, we have accepted that she most likely will be all of her life. Obviously, there is a spectrum of severity in autism and her experience is not necessarily the norm, but it is extremely irritating to me to hear from parents who “cured” their child’s autism or whose child “outgrew” their autism. Their success is probably more a reflection of a bad diagnosis than of any miraculous recovery due to diet or therapy. These pretenders to the autism label (especially celebrity ones) diminish the true devastation of autism and spread dangerous misinformation.

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25
Oct
08

Dear Governor Palin…

October 25, 2008

 

Dear Governor Palin,

I applaud your interest and stated commitment to improving the quality and availability of care for children with special needs. As the mother of a now grown special needs child and the founder and director of an organization dedicated to research on her disorder, I know firsthand the challenges families of these children face. Unlike trisomy 21 (Down syndrome), my daughter’s disorder, a rare genetic disease called primary ciliary dyskinesia (PCD), does not enjoy broad public awareness, which makes finding  health services and funding for research even more difficult.

Last week in a policy speech you indicated that certain research expenditures were wasteful and foolish. The specific example you used was fruit fly research. Because I want to believe you are sincere in your desire to help those with special needs, I was dismayed to hear your perspective on basic science research. When my daughter was diagnosed in 1991, we were told that her disorder was so rare there would never be genetic research done on it.  Finding a patient group large enough for human genetic studies would most likely be an insurmountable challenge.  But people were working on PCD genetics–albeit indirectly. Scientists were unraveling the genome of a single-celled algae called Chlamydomonas. This organism was simple and plentiful and scientists could grow pools full of it for research. In 2002, the first PCD gene was discovered in an ortholog (human equivalent) of Chlamydomonas. Since then, several more have been identified, resulting in the first-ever genetic test for PCD and the promise of genetic therapies for this incurable condition in the future. It can not be overstated that these advances are the direct result of research on, quite literally, pond scum. It was heartbreaking to hear a candidate for national office make a joke of these efforts simply to score political points and I was saddened beyond measure for the families relying on basic science research in fruit flies that you chose to single them out for this unwarranted ridicule.

Translational research, applying the discoveries of basic science to human populations, is a critical element of medical science advancement.  In this country, we have suffered through the William Proxmire “Golden Fleece” awards and other attempts by politicians to gain political points by criticizing science they simply don’t understand. Because I was hopeful that you would be a true ally to special needs community, I was particularly dismayed to see you participate in this activity and ask you to spend some time speaking with individuals involved in basic science research and educating yourself on the promise these activities offer to people with rare, genetic and incurable diseases.

A recent article by the Massachusetts General Cancer Center published in the peer-reviewed journal Current Opinion in Genetic Development states that “more than 60% of genes implicated in human disease have Drosophila (fruit fly) orthologues.” A very short list of human diseases with fruit fly genetic correlates includes neurological and neurodegenerative disorders (including Parkinson’s, Alzheimer’s and spinal muscular atrophy), birth defects, developmental delays (including autism), tumor suppressor genes (ironically in melanoma, your running mate’s genetic curse), infertility, polycystic kidney disease, deadly and catastrophic lipid metabolism disorders, and Huntington’s chorea. Again, this is a short list.  I am not an expert in fruit fly research, but was able to compile this list in about five minutes by doing a simple Internet search of the government-maintained, freely available National Library of Medicine database of scientific publications (PubMed:http://www.ncbi.nlm.nih.gov/sites/entrez?db=PubMed&itool=toolbar). I do not think it is too much to ask our national leaders who will be responsible for establishing crucial health and science policies to do at least that much.

Special needs communities have never had adequate representation in this country. Attempting to manage the extraordinary challenges of caring for chronically or catastrophically ill family members leaves us short of the financial resources and time required to mount effective lobbying efforts. As a result, we do not wield political clout and end up being an invisible minority group with few supporters. Your high-profile status gives you the opportunity to change that for us and I ask you to consider working with the groups who are engaged in daily efforts to improve the lives of special needs individuals through important research initiatives rather than attacking these efforts for political gain. We truly need and would welcome your support.

 

MM, Executive Director
Primary Ciliary Dyskinesia Foundation

For more information on PCD: http://www.pcdfoundation.org

 


19
Apr
07

More on the Feds and Prescription Drug Tracking

From Americablog:
Bush is Prying Into Your Medical Records

I’m sure they’re only using the information in legitimate ways and that friends of the administration like Big Pharma and Big Health Insurers have no access to this private information for marketing purposes or for denial of benefits.  It is no doubt just a coincidence that 50 million Americans can’t get insurance because of excessive premiums or pre-existing conditions, right?

So now the incredibly ineffective and mindless “War on Drugs” has morphed, thanks to our do-nothing Congress, to the “War on the Sick and Depressed.”  Geesh.

What’s even more frightening than the existence of this database is the fact that so few of our fellow Americans seem to be concerned about it.  My God we learn hard.

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18
Apr
07

The Feds Are Tracking Depressed People

Does this scare you?  It should:

From ABC News, regarding the VA Tech shooter:

Some news accounts have suggested that Cho had a history of antidepressant use, but senior federal officials tell ABC News that they can find no record of such medication in the government’s files. This does not completely rule out prescription drug use, including samples from a physician, drugs obtained through illegal Internet sources, or a gap in the federal database, but the sources say theirs is a reasonably complete search.

I noticed that in the ABC report yesterday, but hoped it was just some kind of reporting error. Garden-variety depression is not a reportable illness and, supposedly, pharmaceutical companies don’t have the names of patients who use their products. Assuming that’s true, the only other source for this information would be physicians and pharmacies. I have a hard time believing that there would be full compliance by these groups without some sort of public disclosure. Very strange. I wonder
what the ABC reporter was talking about?

Also, other than health insurance discrimination, I wonder what the purpose of such a database would be? With the exception of involuntary commitment, you can’t be forced to take psychoactive medications, so showing up the database would not necessarily indicate that you are on medication. In some states, even if you ARE involuntarily committed, you can’t be forced to take medication.

In any case, IF such a database exists, the VA Tech case shows it clearly is of little value for protecting the public safety.

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