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Drug Research

INDUSTRY SPONSORSHIP AND SELECTION OF COMPARATORS

November 21, 2011 by James Bogash

Drug research a house of cards? I know most of us look at the drug companies with a certain degree of skepticism, but if the general public knew the full truth they’d be disgusted. Drug trials started but never published because the data was not good, marketing departments actually conducting clinical trials, poor choice of comparible interventions or placebos…and on and on.

This particular study looked at how many studies out of 577 were funded by more than one drug company and compared two products from different manufacturers head to head.  The likelihood of a really meaningful outcome in this scenario is higher.  So how many trials met the criteria?  18.  Just a hair over 3%.  Remember that when you see that drug commercial..

Read entire article here

Filed Under: Drug Research Tagged With: clinical trials, drug research

BASIS FOR MANY DRUGS FLAWED?

November 20, 2011 by James Bogash

Basis for many drugs flawed? I’ve mentioned before the idea of using surrogate end markers in studies to say a drug is effective. Basically, we ASSUME that if a marker (like blood pressure, cholesterol, blood sugar, A1C, plaguing in the carotid arteries in the neck or HDL level) gets better, then we jump up and down and say the drug is effective and we’re saving lives. Perfect example is statin class of drugs and cholesterol. Looking at the numbers of actually preventing cardiac deaths, statins really suck, but they ARE good at lowering cholesterol!!

The bottom line is that the only way to ensure that an improved marker will lower your risk of something is to do it with lifestyle. Anything else may kill you faster than it saves you.

Read entire article here

Filed Under: Drug Research Tagged With: A1C, blood pressure, blood sugar, cholesterol

BUT MY PRESCRIPTION IS FDA APPROVED…

October 10, 2011 by James Bogash

Apparently, there are still many people who believe that, because a drug is approved, that it must be both really effective and without serious side effects. Must be pretty dark in that cave.

The reality is far from the perception. There are no shortage of accusations and historical examples that the FDA’s job of regulating drugs is under strong influence from the drug companies themselves. Kind of like the proverbial fox guarding the hen house.

Many drugs that are approved are later pulled off the market or giving black box warnings years after their initial approval. Frequently, much damage occurs before the mistake is realized. Vioxx was a perfect example, with estimations of over 100,000 heart attacks related to its use before it was pulled off the market.

As far as efficacy, many times a drug is approved without any advantage over currently available, cheaper drugs. These are referred to as the “me too” drugs.

So, in this particular study, authors questioned almost 3,000 adults and found that misinformation is quite common. 39% believed that the FDA only approves drugs that are extremely effective. One quarter of the group believed that the FDA only approves drugs that are without significant side effects. A little misguided, but probably not surprising given the money the drug companies spend on direct to consumer advertising to steer the sheep towards new drugs.

Furthermore, when these participants were educated about the realities, they were more likely to chose a drug with a longer history of safer and a drug with documented positive outcomes (in this case a drug preventing heart attacks vs just lowering cholesterol).

Filed Under: Drug Research Tagged With: black box warnings, FDA approval, prescription drugs

September 4, 2000 Research Update

October 3, 2011 by James Bogash

 

Physicians’ Group Complains About ‘Milk Moustache’ Ads

As many of you may have figured out, I am no big fan of milk. It has probably been one of the best marketing campaigns of the 20th century, and yet there is no data to support benefits of milk. On the contrary, many studies point to the harmful effects of the allergens, pesticides, hormones and other chemicals in cow’s milk.

For the second time, the Physicians’ Committee for Responsible Medicine has filed a petition with the US Federal Trade Commission complaining that the “milk moustache” advertisements produced by the National Fluid Milk Processor Promotion Board amount to false advertising. The group says that the ubiquitous ads send the false impression to minorities and women that cow’s milk is healthful. It has sent the FTC an 11-count petition questioning the validity of scientific research that links milk consumption to a lowered risk of osteoporosis. The complaint also asks for a ruling on whether the advertisements ignore the possible dangers of milk’s high fat content. At least one independent organization appears to support the physicians’ group’s position on the accuracy of the ads. “nutrition Navigator,” Tufts University’s online rating guide to nutrition Web sites, rates the Web site of the National Fluid Milk Processor Promotion Board as “not recommended — unacceptable accuracy.”

Effect of a fish-oil on serum lipids in postmenopausal women

Yet another study pointing to the benefits of fish oil on health. I usually recommend patients to use flax seed oil, as it is a plant source of the same type of fatty acids without the possibility of contamination with heavy metals. AJCN — Abstracts: Stark et al. 72 (2): 389

Soy phytoestrogens protect against LDL cholesterol damage

Soy appears to have many routes by which it improves human health. This study suggests that one of these routes is by protecting LDL damage. The “bad” cholesterol can not increase risk of heart disease if it itself is not first damaged. AJCN — Abstracts: Wiseman et al. 72 (2): 395

Magnetic fields and abnormal cell growth

There has been much controversy about the potential dangers of magnetic fields and human health. This article introduces some concepts as to how that may occur. While reading this, you must also consider that cell phones and magnets emit a magnetic field. http://www.ncbi.nlm.nih.gov/pubmed/15238230

Physical activity and peptic ulcers

Ulcers are still a major scourge in today’s society. Many of the acid blockers were designed for short term use only, and can have long term negative health effects. This study suggests that exercise can reduce the incidence of ulcers. Combine this with the use of cabbage extract or licorice and we have a very viable solution to ulcers without harmful medications. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1071012/

Antibiotics and acute bronchitis

Numerous studies have shown that antibiotics have no effect on the course of acute bronchitis. This was an analysis of several studies, once again showing that antibiotics are not needed for acute bronchitis. Not to mention the harmful effects of destroying off the body’s normal protective flora. http://www.ncbi.nlm.nih.gov/pubmed/11034678

James Bogash, D.C. Mesa, AZ
info@lifecarechiropractic.com
www.lifecarechiropractic.com

 

Filed Under: Asthma, Cholesterol, Drug Research, Healthy Kids Tagged With: peptic ulcers, soy phytoestrogens

DID YOU RECEIVE A SCRIPT FOR THIS MED? IF SO, YOUR DOCTOR WAS TRICKED

July 19, 2011 by James Bogash

I call them the “drug of the week.”  I’ve been in practice long enough to see patterns of patients that come into my office.  There are times when it seems like every other patient coming into my office is on a hot new drug.  Many times the condition they are put on the drug for is not really what the drug was originally approved for.

A pretty strong glaring example that I remember distinctly was Neurontin (gabapentin).  Within a period of a few months, I saw a surprising number of patients who were given this prescription, and none were for the indicated use of the drug (originally seizures, then post-herpetic neuralgia, which is when the boom started).  I remember a particular patient who was put on this by her PCP for sciatic pain.  Two problems…it wasn’t sciatic pain (it was meralgia paresthetica and responded well in a few visits), and, even if it was, this is a very poor use for Neurontin.

So, when the prescriptions go up, I am usually thinking it’s the drug reps doing a great job.  In the particular case of Neurontin, this is a vast understatement.  The entire marketing and study of Neurotonin beyond the approval of its use for post-herpetic neuralgia was a massive scam on a massive scale.  The company netted billions.

Here’s how it worked.  The was a study named the STEPS (Study of Neurontin: Titrate to Effect, Profile of Safety).  This study was what is referred to as a seeding trial (we saw this before on a very large scale with Vioxx and Celebrex).

In a seeding trial, the goal is NOT to gather information, but to get patients and providers used to prescribing the drug so it becomes habit.  The providers are frequently paid to participate in the trial, so there is incentive to start the habit.

The problem?  The drug company Pfizer cared little about the science of the study and how the drug may or may not have benefited patients.  They cared little about the side effects.  This trial was developed, in part, through the MARKETING department, not the research department.  This is an exceedingly unethical method of marketing a drug by masquerading it as science.

And the medical community was deceived as well and went for it hook, line and sinker.  This is just one of many documented examples that have come out as a result of lawsuits that put documents of drug companies into the public domain.

This just exemplifies why our society’s heavy reliance on drugs to fix our woes is so problematic.  The entire system is based on weak, questionable and, as in this case, unethical evidence. 

Lifestyle, however, is the way we were designed.  No one needs a study to determine that eating more fruits and vegetables are good for us.

http://archinte.ama-assn.org/cgi/content/abstract/171/12/1100

Filed Under: Drug Research Tagged With: gabapentin, nerve pain, neuralgia, Neurontin, seeding trial, seizures / epilepsy

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