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Drug Research

Mesa AZ Back Pain Doctor Response to Medication Study

September 25, 2018 by James Bogash

Medication Is NOT The Way To Go

MEDICAL ERRORS KILLS A 747’S WORTH OF PASSENGER PER DAY?  To many, this data is not a surprise.  And keep in mind that 98,000 deaths and 1 million injuries per year is, by most estimates, a very, very conservative number because it only includes errors, and does not include deaths that result from properly performed surgeries and proper medications.  Medicine is, without a doubt, a dangerous game to play.  The problem we see in this study is that, since the IOM’s report came out in 1999, there has been no improvement in the error rate.  And, considering that our country’s prescription drug use is going nowhere but up, we can expect to see these numbers either stay the same or worsen.  It is times like this that I am truly glad that I am a chiropractor who does not have the responsibility of prescribing a drug because it is considered the “standard of care” and not because it is the best thing to do. Read More…

Filed Under: Drug Research, Environmental, Healthy Living in a Toxic World, Toxicity

Joint Pain Doctor Mesa AZ Provides Research

September 16, 2018 by James Bogash

Caution! Drugs May Be Deceiving!

DON’T ALWAYS BELIEVE WHAT YOU READ ON THAT LITTLE SLIP OF PAPER THAT CAME WITH YOUR DRUG…We’d like to believe that all the info that our doctors and we get when we get a prescription is truthful and not deceitful by omission.  But alas!!  The world of pharmaceuticals is fraught with half truths and bloated outcomes.  In this particular study, the authors looked for the printed incidence of cough associated with the use of ACE-inhibitors for high blood pressure that is given to the patient vs the actual incidence in clinical trials.  One drug’s actual incidence was 9X higher in the study than in the print, another was 31X higher.  Talk about deception! Read More…

Filed Under: Drug Research, Environmental, Healthy Living in a Toxic World, Toxicity

Pain Relief Chiropractic Mesa AZ

September 5, 2018 by James Bogash

Drugs and Their Effects

SOOOO…THE DRUG MY DOCTOR WANTS TO GIVE ME WORKED IN A CLINICAL TRIAL..BUT COMPARED TO WHAT?  This is, arguably, one of the more important questions we can ask.  In randomized, placebo controlled trials we compare a pill with the active “drug” ingredient to an inert pill with nothing in it (a “sugar pill”).  Or so we thought.  I just found out last night that in the early studies approving Prozac for use here in the US, that when participants in the trials experienced side effects like agitation, they used benzodiazepines (like Valium) to control the side effects!!  This was not disclosed in the study.  We could easily argue that we NEED to know what the active pill is being compared to.  What if there are other components in the placebo that also have clinical effects, like the benzodiazepines used in the Prozac studies (I’m not saying that this was in the placebo, but you get the idea)?  Than how accurate is the comparison?  If the placebo contains some harmful tableting chemicals that will make 20% of the patients who take it ill, and 21% of the patients got ill from the active drug, the study will say that there was no difference in side effects between the placebo and the active drug!  Makes it sound safe, huh?  This particular study looked at how often drugs trials described what was in the “sugar” pill.  In only a meager 8.6% of the studies looked at did they disclose what the “placebo” was.  You cannot get a good idea of whether a drug is effective or has too many side effects without knowing what the placebo fully is.  Period.  What was YOUR drug compared to? Read More…

Filed Under: Drug Research

Antidepressants in Children; the Big Lie that They Don’t Want to Admit

October 9, 2015 by James Bogash

depression risk factors
serotonin and depression

In 2001 there was a large study (called study 329) published by GlaxoSmithKline that essentially gave the green light to the use of antidepressants (specifically paroxetine) in adolescents.

This green light led to pediatricians whipping out the prescription pads in an attempt to help manage depression in adolescents.  This was to the tune of a whopping two million prescriptions in a single year written for children and adolescents with depression in the United States.  Since the drug had not been officially approved by the FDA for this indication, all of these were prescribed off-label.

And how did this happen?  Through a well-planned marketing blitz that called the results of Study 329 as demonstrating “REMARKABLE Efficacy and Safety.”

There was a problem, though.  A big one.

Turns out that the negative side effects were severly downplayed and the study was actually written by a ghostwriting firm hired by GSK.  Despite what the original study authors concluded, later reviews of the actual trial evidence concluded something entirely different.  Turns out that the combination of paroxetine and adolescents led to an increase in suicidal ideation and attempts.

Yes–the trial that was promoted to provide “remarkable efficacy and safety” not only did not help with depression, it actually increased the risk and thoughts of suicide in adolescents.

It is clear that GlaxoSmithKline went out of their way to deceive pediatricians and the adolescents they serve.  And, when all is good and right with the world, GSK should’ve paid the price.  And they did pay out on numerous lawsuits brought about by families of 450 children who had committed suicide, the US Department of Justice and the New York attorney general.  But the billions paid out in lawsuits did not exceed the billions of dollars made on sales of paroxetine.

It was clearly a net profit.

Despite all of this, you would think the original publishing journal, the Journal of the American Academy of Child and Adolescent Psychiatry, would have retracted the original study.  But despite multiple re-evaluations of the trial date, including this particular article, the original article has never been retracted.

If this was an isolated incident, I think we’d all be ok.  But, given that this is not the first time an incident like this has occured, I think we can assume that this is business as usual among the pharmaceutical companies.

With this in mind, how many other drugs out there that are used day in and day out have been built upon lies?

The problem is that we really do not have any idea how many of the drugs out there in common use has been promoted to doctors and the general public using data that has been either made up, twisted, hidden or surpressed.

This particular case with paroxetene may be an isolated event.  Far more likely this is representative of how the drug industry works.  The data and research over the decades has suppported this later view.

I have frequently referred to our system of medicine as having been built on a house of cards supported entirely by massive dollars from the drugs companies.  And it’s working for them.  They get slapped for fines in the hundreds of millions while they make money by the billions.

Filed Under: Drug Research Tagged With: adolescent depression, drug research, paroxetine, study 329

FDA and Drug Research: Watching Our Backs or Asleep at the Wheel?

March 26, 2015 by James Bogash

FDA inspections hidden
apops/Dollar Photo Club

Our world of medicine is dominated by drugs.  Drugs are the foundation upon just about every treatment that mainstream medicine offers.

The entire Affordable Care Act (aka Obamacare) was passed so that patients could now have access to doctors.  And by “access” I mean have someone else pay for services.  And by “services” I really mean drugs.

While this sounds simplistic and singleminded, think about it for a second.  If you KNEW you had high blood pressure, high cholesterol or were overweight and did not want to use drugs, would you make an appointment with your primary care doctor to find out how to change your lifestyle for the better?  Typically not.

No, the creation of the Medicare Part D program, the expansion of Medicaid across the country and the creation of the Affordable Care Act were all about one thing: getting access to doctors to get prescriptions for drugs.  Prescription drugs are the #3 most expensive line item in health care costs (and its growth is by far outpacing the #1 and #2 slots), with #2 being physician costs (the gatekeeper to get the drugs) and #1 being hospital costs.

At the heart of all the research and safety and protection for these drugs to the public is the Food and Drug Administration.  The FDA, as it became officially known as in 1930, has, for over a century, been a government watchdog for the safety of the general public.  One of the largest roles of the FDA is to oversee the approval and use of pharmaceutical drugs used on you and I.

And lord knows we need it.  Drug companies fulfill the archetypical big corporation in the most evil Hollywood blockbuster stereotype, using bribes and seedy marketing techniques to get patients to request their drugs and doctors to prescribe them.  There is little doubt that illegal activities and the fines that accompanying them (when caught) are just a part of the general business plan and put in as a line item expense.

With this business model, the FDA is the only thing standing between your safety and the pharmacetical industry’s desire to turn a massive profit.  And for many years the FDA has done an arguably wonderful job at this task.  However, in recent years, the industry has been plagued with less-than-adequate funding as well as internal influence from the very drug companies they were designed to oversee.

One of the ways that the FDA provides oversight on the drug companies is to inspect several hundred clinical sites performing biomedical research on human participants.  They will occasionally find evidence of substantial departures from good clinical practice and research misconduct. This is really good information for other researchers, grant agencies and regulators to know about.

But what if this information was essentially kept secret?  What if this important information never had an effect on that trial getting published and the study data used to drive your doctor’s opinion on how he or she should treat you?  That’s exactly what researchers looked at in this particular study.

They spent time digging around the FDA’s inspection documents that could be linked to a specific published clinical trial.  In comparing the inspection documents, the researchers looked for whether there was a mention in the published clinical trial of problems the FDA had identified.  Here’s what they found:

  • 57 trials were identified for which an FDA inspection of a trial site had found significant evidence of at least one problem.
  • Falsification or submission of false information was found in 22 trials (39%).
  • Problems with adverse events reporting was found in 14 trials (25%).
  • Protocol violations were found in a big chunk (42 trials or 74%).
  • Inadequate or inaccurate record keeping was found in 35 trials (61%).
  • Failure to protect the safety of patients and/or issues with oversight or informed consent in 30 trials (53%).
  • Other violations not otherwise categorized in 20 trials (35%).

Ok.  So they made some mistakes.  Haven’t we all faked the data on a lab report or lied about how bad we felt to get out of school?  And to heck with protocols–we all just make stuff up as we go along to the outcome is more likely to be in our favor.  And who REALLY cares about the safety of the patients?  It’s all about what’s good for everyone, right?

But none of this matters so long as you come clean in the end with the people you have deceived or lied to.  Unfortunately, the researchers found that this was a rarity.  Only 3 of the 78 publications (a measly 4%) mentioned the misconduct found during the inspection.

So what is the point of having these FDA inspections if the findings are essentially kept a big secret?  Just remember this little study the next time your doctor tells you about how clinical studies have shown that Drug X was safe and actually helped patients with your condition.

 

Filed Under: Drug Research Tagged With: drug company, drug research, FDA, FDA inspections

Cholesterol Lowering Drug (Jupiter) Trial Shenanigans

March 17, 2015 by James Bogash

ARE THE DATA FROM ASTRAZENICA, CRESTOR JUPITER TRIAL ON STATINS LOOKING FISHY?

Wow.  I really think if most of the American public knew the real story of what goes behind some of these trials we’d all be sickened.  In it’s essence, the Jupiter trial looked at the prevention of heart disease in patients who had NORMAL cholesterol, but elevated inflammation.  Essential understanding that the “cholesterol blame game” was going away and they needed to find a new lab value that they could use the drug for.

The study was stopped early and declared a rousing success.  Much fanfare was heard and the medical journals and editorials sung it’s praise.  Oops.  A little too soon.  A closer look at the data raises some serious suspicions.  Basically, the trial was stopped early when predetermined events occurred just 2 yrs into the trial.

Furthermore, when you look at a population, certain statistics are expected.  Here’s the quick details:

  • The study found that statin drugs did NOT protect against deaths from heart attack and stroke.
  • In the general population, cardiovascular deaths account for about 40% of the total number of deaths.  Of these heart attacks, around 50% of these are fatal.

But in the Jupiter trial?  Apparently miracles occurred.  Cardiovascular mortality accounted for under 20% (instead of 50%) of the deaths, and the fatality rate of these heart attacks was very low (instead of the expected 50%).  This raises serious questions about the validity of the data and suggests that funding of the trial may have had a strong influence on the interpretation of the data.

Read More

Filed Under: Cholesterol, Drug Research, Heart Disease, Stroke Tagged With: cholesterol, Cholesterol Lowering Drugs, Jupiter Trial, statin

The Polypill–One Pill to Control Them All?

March 7, 2015 by James Bogash

BRAVE NEW WORLD?

Hollywood and literature has been hyping the idea of a medicated, controlled society for as long as we can remember.  But it seems to hard to believe that society would give up it’s freedom of choice to surrender to this type of control.  Right?  There has been steady promotion of a “polypill” to prevent heart disease over the past decade.  The “polypill” originally included niacin, but I guess no one had enough money to make off of it so they replaced it with another blood pressure drug.

These researchers are suggesting that the use of a polypill could reduce society’s burden of cardiovascular disease.  The number of people they say should take them?  83 million.  83 million US residents should be medicated.  Wow.  The arrogance of medicine is appalling.  Forget that each of these drugs’ effectiveness is questionable.  Forget the side effects that would likely override any benefit.  Remember that lifestyle trumps EVERY application of this drug in human physiology.  Society is seemingly continually trying to medicate the population when lifestyle is the only answer.  This attitude sickens me.

Read More

Filed Under: Drug Research Tagged With: heart disease, polypill

Paying More for Less; US Healthcare in a Nutshell

December 27, 2014 by James Bogash

health care spending
Kenishirotie/Dollar Photo Club

There has certainly been no shortage of discussion on who should pay for healthcare in this country.  But never once has anyone seemed to question whether or not who pays is the problem.

This is the exact topic that the entire Obamacare administration will be known for, for good or for ill.  To date, however, the discussion has been all about the financial side of health care and not the efficiency and efficacy of health care.

There are unquestionably people who believe that health care is a right and should be provided for everyone, regardless of financial means.  If they can’t pay for it, someone else who does have the money should foot the bill.  And if you’ve happened to fall into a discussion with someone who believes this way, it can be a difficult one.  I should know–I have a close family member who feels this way.

The argument that health care is a right is purely an emotional argument because when you try to look at it from a logical standpoint it just does not make sense.  I have said time and time again that we cannot afford healthcare for a population that is one of the sickest in the developed world and has a sense of entitlement that is second to none on this planet.

We want MRIs, ER visits, that new medication we saw on TV, we want very expensive and toxic cancer treatments that will provide additional life extension measured in weeks and we want it all without a wait.  Even worse, we want all of our medications in lieu of making simple lifestyle changes that would otherwise completely erase the need for that new fancy medication.

Our health care system is broken and it has nothing to do with who’s paying.  If we want to meet halfway, what about making the diabetic exercise routinely and avoid processed foods, refined carbs and hydrogenated oils in order to have his or her medications paid for?  Does this sound unreasonable?  It will to those who do not feel like personal responsibility should be a requirement for getting your healthcare paid for.

I had a patient in the other day who, prior to the Affordable Care Act, paid $3 or 4,000 a year in premiums for him and his wife (I can’t remember which one it was).  After Obamacare, they are still paying the same amount of money for the same coverage, but the REAL price tag on the premiums is something like $11,000.  He gets a massive subsidy to pay for his health insurance premiums.

Those of you who were never good at math would look at say how wonderful everything is under the Affordable Care Act because now this person can get insurance.  On the other hand, those of us who did pay attention in 4th grade are scratching our heads trying to figure out where the extra $7 or 8,000 went?  Who gets this extra money??  We all know who is paying for it–all of us.  But who is making the extra money??

I just don’t understand it.

Just in case you still don’t get my point, I bring you this particular study looking at life expectancies based on GMP of countries across the globe.  Here are some interesting points:

  1. It is clear that higher healthcare spending (as a percentage of GDP) does NOT lead to higher life expectancies.
  2. Among the 25 highest income states in the US there is also no correlation between higher spending and life expectancies.
  3. Among the 25 poorest states, higher spending actually leads to LOWER life expectancies.
  4. Colorado, the state that spends the least on healthcare, STILL spends more (again as a percentage of GDP) than the Netherlands on healthcare.
  5. To put it clearer, if the US controlled health care spending to match that of the next highest country, there would be an extra TRILLION dollars to spend elsewhere.

And remember, all of this spending is not getting us anywhere.  We are the most medicated country on the planet (we consume a massive 52.9% of the WORLD’S prescription drugs) and it’s getting us nowhere except more sick.

 

Filed Under: Drug Research, Health Care Costs Tagged With: health care spending

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