Category Archives: Health

Does Ethics Play a Role in Drug Trials Anymore?

In the January 19, 2008 issue of the British medical journal The Lancet, author Samuel Lowenberg brings up a number of serious questions relating to ethics and drug trials done by the pharmaceutical industry. After reading his brief two page review, it is apparent that a major overhaul in the way clinical trials are done is in order. The trail of abuse is international in scope and has possibly caused the deaths of innocent children.

According to Tikki Pang, the World Health Organization’s director of Research Policy and Cooperation, “The trials that are being done overseas by drug companies are in a sense secret, because they do not share the information, they site confidentiality and patient protection.” He further goes on to say “Anecdotally, we have heard many, many instances in India, China and other countries of the possibility of ethical safeguards not being followed.” In Nigeria, a number of children died of an experimental anti-meningitis drug Trovan and Pfizer, according to a lawsuit, destroyed data from the trial and gave some of the children a dangerously low dose of Rocephin, a known treatment for meningitis.

It is time for Congress to enact a bill demanding that all drug trial, in the U.S. or abroad, be registered and the results must be shared with the FDA regardless of outcome. The data then must be shared with the public without prejudice and in a timely manner. The nonsense that is pharmaceutical research has got to change. People’s health is at risk and lives are at stake. They are treating third world people like lab rats and this has got to stop.

Cholesterol Lowering Drugs are Worthless in Most Cases – Part Three

Before I get into today’s discussion on inflammation, please go to this link put up by Chance News, a group dedicated to reviewing information about the use of statistics in the news. They review the cholesterol news and and the statistics behind it. Go down halfway down the page to see the report.

Inflammation. That is the key driver of many disease progressions. From arthritis to coronary heart disease and from cancer to many neurological disorders, if you control inflammation, you control the disease. Two things are important in determining what to do when it comes to your, or your patient’s inflammatory issues. First is proper laboratory testing is lifestyle changes.

The tenet of biochemical individuality is that each person must be dealt with as a unique being. By suggesting that everyone who has a risk of coronary heart disease (CHD) should take one drug or one supplement is an insult to Dr. Roger Williams concept. The only way to determine what is going on is to do the appropriate lab tests.

When looking for markers of inflammation as they relate to coronary heart disease, one jumps out as being a primary marker and that is C-Reactive Protein. CRP is a protein produced by the liver and is increased during inflammatory processes. People with elevated levels are more likely to have a coronary event than people with low levels. It is important to note that a single high reading is not a good marker for CHD, a number of elevations (>3.0 mg/L) would signify a problem. ZRT Laboratories is a place to get a simple, in-home test (Cardio/Hormone Risk Test) that uses blood spot and saliva to test not only for CRP, but a number of other coronary risk factors as well as hormone levels.

What would cause an elevation in inflammatory markers? Toxicity is one so testing for urinary markers of petrochemicals which is done only by US Biotek, is a good place to start. By seeing if you are excreting chemicals like benzene, styrene, xylene, toluene, phthalates or parabens, you can find out where your exposures might be coming from. Another good test to run is a Hair Elements test from Doctor’s Data to determine possible heavy metal exposure. To help you better understand the report, I suggest Dr. Andrew Cutler’s book – Hair Test Interpretation: Finding Hidden Toxicities.

Another source of inflammatory triggers is food and the best test I have ever found in determining which foods can cause inflammation is the LEAP MRT. Developed by Signet Diagnostics, it can pinpoint the foods that cause the body to release pro-inflammatory prostaglandins, leukotrienes and cytokines that drive the inflammation process. It was the one test that helped my daughter control her seizure activity as well as behavioral issues. It has a great track record in relieving irritable bowel syndrome as well as migraines, both driven by inflammatory triggers.

If you want to become heart healthy, you need to find out whether your body is inflammed and if so, what is causing it. Once you do that, you reduce your risk of developing not just heart disease, but a number of other health conditions.

Cholesterol Lowering Drugs are Worthless in Most Cases – Part Two

This past Friday, I talked about the issues with Lipitor® and the lack of the association between high cholesterol and coronary heart disease. Now let’s talk about real problems that comes up by taking this drug.

Say the side-effect rate is 3-5% (which is the pharmaceutical industry line) which means that given one-percent of people get a benefit, five-percent get side-effects that can be rather serious. Guess what? That estimate is way under what practitioners in the field are seeing. Reports indicate that in the real world the side-effect rate is closer to 15%.

Obviously, this would mean that we need to move away from pharmaceutical intervention to lower cholesterol to alternative, “natural” ones right? Wrong. Turns out cholesterol levels in people with heart disease are not really much higher than people without heart disease. Also, low cholesterol (under 160mg/dl) may increase the risk of a number of health disorders like stroke, cancer, depression, and suicide. Lowering cholesterol is not the issue, in spite of what the nutraceutical industry would like you to believe. They are being no different in their claims than the pharmaceutical industry.

The real culprit in heart disease is inflammation. Lower inflammation and not only do you lower the real risk for heart disease , you lower the risks for a myriad of other diseases from diabetes to arthritis, from cancer to migraines, seizures and irritable bowel syndrome to name a few.

In tomorrow’s blog, I will discuss tools that will help you determine your level of inflammation along with things you can do to alleviate it.

Cholesterol Lowering Drugs are Worthless in Most Cases – Part One

Some of you may have noticed a lack of posts from me this week well I have a pretty good reason. My 86-year old father underwent triple-bypass surgery due to three 90%+ clogged arteries. Since this makes two parents out of two having this dangerous procedure, I wanted to research heart disease a bit. Then I saw an article in Business Week magazine while walking through the SeaTac Airport that made me smile as it was saying what I have been saying for years, which is, statin drugs really don’t prevent heart disease.  

Aside from the Vytorin®/Zetia® debacle, the whole idea of lowering cholesterol (LDL especially) to prevent heart disease is nothing less than a scam. In my upcoming book, Achieving Victory Over a Toxic World, I devote a few pages on the medical communities fascination with LDL and heart disease and how bogus the idea is. Well, the evidence is coming in that I was indeed right, as were a number of researchers I mentioned like Dr. Ufe Ravnskov and Dr. John Abramson.

When I make my comments at lectures around the world about the lack of a real link between LDL cholesterol and heart disease I get mixed reactions. Knowledgeable health care practitioners nod in agreement with big smiles; others grimace with a backdrop of anger and disbelief. Individuals look mystified, bewildered and highly skeptical. How can a guy with a doctorate in business be right when so many physicians who have studied heart disease be wrong? If you stay on the side that thinks statin drugs and lowering cholesterol are proven preventive treatments for coronary heart disease after reading this three-part blog, either you are in a major state of denial or you are on the payroll of a pharmaceutical company that is benefiting from the sale of these ill-conceived toxins.

An important concept to understand is a number called the NNT (Number Needed to Treat). This number tells us the number of people that must take a drug for one person to benefit. If a drug is perfect, than that number should be one, which means for every one person who takes the drug, one person will benefit from it and prevent or successfully treat the disease or syndrome.

For people taking an antibiotic cocktail to kill off the bacterium (H pylorii) that causes ulcers, the NNT is 1.1, which is pretty darn good.  For Lipitor®, whose sales last year for Pfizer was about 13 billion dollars, the NNT is between 16-23 for people who have had a heart attack or have definitive signs of heart disease. Not horrible, but an ok number.

So what does that number mean? To prevent one person having a heart event 16-23 people need to be taking the drug. To prevent a death, 48 people would have to take the drug for 5 years to save one life. But we are saving lives would (and is) the industry answer. Guess what? Change your lifestyle just a little bit (eat better, exercise more, stop smoking, etc) and you’ll do much better than that and you won’t have any nasty side effects.

For those of you with a risk factor like high blood pressure and no existing heart disease or heart attack history, the NNT goes to 75-200. If you have no risk factor except what the medical community would deem “high” cholesterol (over 220 mg/dl) the NNT is a ridiculous 500+ as there is no measurable reduction in deaths or serious events. Very little potential benefit, lots of profits for the pharmaceutical industry.

What about Zetia®? The NNT is an astounding 1000+. It is basically worthless. No benefits seen at all. The same can be said for the diabetes drug Avandia® which does lower blood glucose, but does not prevent any disease caused by diabetes.

“Lipitor® reduces the risk of heart attack by 36%… in patients with multiple risk factors for heart disease.” This is what Dr. Jarvik claims (as does Pfizer) in that insipid ad he appears on TV. Now let’s talk about the real numbers. In the clinical trial he mentions, three percent (3%) of the people taking placebo had a heart attack while two percent (2%) of the people taking Lipitor® had a heart attack. So, 99 people had to take Lipitor® for five years with no benefit for one person to gain a benefit over placebo to prevent a heart attack. I don’t know about you, but that isn’t a 36% improvement. Statistics lie when put into the hands of people with an agenda, especially a multi-billion dollar one.

Come back on Monday to find out how this is only the tip of the iceberg. On Tuesday I’ll be discussing the laboratory tests necessary to help prevent heart disease and help improve your overall cardiac health.

Seminars I Will Be Speaking At

Well, its almost time to get back on the road. I start on February 22nd in Seattle, WA for the American Academy of Neural Therapy, followed the next day in Las Vegas, NV which will kick off the Food First half day seminars. Robert Crayhon will be doing 12 of the seminars and I will be joing him at 4 of them. Here are a list of all of the cities this seminar will be coming to (I will be at the ones in bold):

Las Vegas, NV (February 23rd) — Orange, CT (March 1st) — Northampton, MA (March 13th) — Boston, MA (March 15th) — Princeton, NJ (March 22nd) — Denver, CO (March 29th) — San Francisco, CA (April 5th) — Los Angeles, CA (April 6th) — Stamford, CT (April 12-13), Philadelphia, PA (April 19th) — Tarrytown, NY (May 3rd) — Montreal, Quebec (May 10th) — Burlington, VT (June 7th)

Also, don’t forget Boulderfest 2008 which should be the best one ever held in Broomfield, Colorado. I, along with 15 other world class speakers will provide any and all healthcare practitioners who attend, clinically relevant information that you won’t find anywhere else.

April 26th and 27th, 2008 will be the first Healing Journey seminar in Boulder, Colorado which while I won’t be speaking at, is filled with phenomenal speakers. Go to one, go to all you can, it’s well worth it.

The Vytorin Scandal – Just the Tip of the Iceberg

Now with the scandal involving Scheering-Plough and Merck, two pharmaceutical giants becoming the biggest news story of the day I have to comment. Do you really think that the study that Vytorin is not beneficial is an isolated incident? If you do, you are sadly mistaken. When I worked for a company that sold clinical trial software to the pharmaceutical and medical device industry, I was involved in talking to a number of researchers employed by these companies and some of the things I heard made me realize that the focus of these companies was not your health but their profits.

Here are some of the details of the Vytorin story you may not know about.

  • The data that showed that Vytorin was not beneficial in the lowering of the risk of heart disease was known almost 2 years ago by people at Merck and Scheering-Plough.
  • The CEO of Merck ??? sold $29 million dollars worth of stock in her company last year, after she had to have known the results of the drug trial. 800,000 prescriptions a week are written for Vytorin which provides billions of dollars of profit to these two companies.
  • Worst of all, and something that Congress will be looking into is the fact that after the drug companies found out that Vytorin wasn’t showing up as well as expected they tried to manipulate the data to change the end points which would hopefully show the drug actually worked.

It is this last issue I have my greatest concerns about. When I taught a class to a medical device company in Cleveland, Ohio, I was asked by one of the primary investigators whether they could change the data once it was entered into the program. I made sure they understood that this would be illegal and immoral as well. Often times, I found out that many researchers (not all) in the pharmaceutical industry manipulate data end points and use other statistical machinations to create findings that are positive instead of properly studying results and reporting good and bad regardless of the financial ramifications.

With the recent research saying that there is no link between autism and thimerasol in mercury it was apparent that the researchers manipulated the end points to come up with a result they wanted to come up with. They claim that there was no relationship because there is no change in autism rates recently since thimerasol was removed from vaccines. Problem is that the number of years since the mercury laden vaccines have been removed are not sufficient to see a change in autism rates. Most autism is diagnosed at 4-5 but the removal of thimerasol was only done 2-3 years ago so how could they see a difference. This is known as changing the end point to create a result you want. It is immoral and dangerous.

It is time the FDA and our government do what they are charged with doing, protecting the citizens from dangerous drugs. The pharmaceutical industries money first attitude needs control and must be stopped. It is time for a major overhaul of the drug research and approval system.

Antipsychotic Drugs – No Better Than Placebo for Some

In the January 5th, 2008 issue of the British medical journal The Lancet, researchers in the UK did a study to determine if the antipsychotic drugs haloperidol or risperidone were helpful in controlling the behavior of intellectually disabled people exhibiting aggressive behavior. After looking at the results the authors came up with a surprising finding, there were no benefits over placebo from either drug. In actuality, the placebo was more effective than the drugs at reducing aggressive behavior. The placebo showed no negative reactions or lowering of effect at any time during the trial which is quite significant.

So who would physicians prescribe this drug to that the study found no benefits for? Typically autistics and epileptic children who have had a significant number of seizures. Others might include those with Down’s syndrome as well.

The authors interpretation of the data was as follows: ” Antisychotic drugs should no longer be regarded as an acceptable routine treatment for aggressive challenging behavior in people with intellectual disability” Considering the significant side-effects these drugs pose, I would avoid using these drugs at all costs and would recommend anyone with intellectual disabilities be taken off the drug (carefully and with full physicians care).

A Crayhonism – Robert Crayhon Word of Wisdom

Robert Crayhon, a noted clinical nutritionist, author and lecturer, was with me at the latest A4M meeting (anti-aging medicine) in Las Vegas and he, as he is want to do, had a profound statement about health and diet that I want to share with my readers. His comment was as follows:

“Biochemical individuality is the royal flush in the poker game of health. The Paleolithic/No-Grains diet may be the full house of 4-of-a-kind.”

I couldn’t have said it better myself.

CME’s – The Pharmaceutical Industries Way to Get at your Doctor

CME’s, aka Continuing Medical Education credits, is supposedly the way to make sure your physician is keeping up with the latest in medicine. Instead, it is the way that the pharmaceutical industry is using this tool as a way of “reallocation of marketing money” according to Dr. Jerome Kassierer former editor of the New England Journal of Medicine.

In the November 22nd issue of the esteemed science journal Nature, reporter Jim Giles show how drug companies who “sponsor” the CME classes, are getting undue influence over the speakers and topics despite supposed firewalls put in to prevent this. All of the drug companies are up in arms over the research presented by Drs. Jatinder Takhar and Daniel Carlat in separate papers.

The suggestion made in the article that drug companies should pool their CME support money for distribution by an independent body to reduce corporate influence. This would be a good first step.

Another issue that needs to be addressed is the influence these multi-billion dollar companies have in our medical schools. It is my understanding that representitives from these companies continue to infiltrate medical schools influencing the educational process undertaken by the students. This kind of bias building is wrong and needs legislative pressure to come to bear to stop it.