Tag Archives: Drugs

New Epilepsy Drug – Vimpat

Finally, after 6 months of waiting, we were able to see a new neurologist and she suggested that we try Tasya on a new drug called Vimpat®. We were desperately trying to get our daughter off of Topamax® as it was hurting her cognitively and she was beginning to have breakthrough seizures again.

So one day on it shouldn’t make much of a difference but something happened that hasn’t occurred ever before. Tasya was about to have a seizure upon waking (her most common type) but it didn’t happen. I rushed to the room hearing the cry that she has right before a seizure and there she was, clear eyed and talkative. She told both my wife and I how different she felt and that she felt clearer and sharper than before.

Vimpat’s® mode of action supposedly is to stop a seizure by changing the sodium channel slowly as opposed to older drugs which did it very quickly. Side-effects seem to be less than other drugs which try to dampen the entire brain like Topamax®.

While we are in the early stages of trying this med out on Tasya and the fact that it is only approved for people over the age of 17, we remain hopeful but not fully convinced of Vimpat’s® efficacy. Still, the fact that Tasya showed such a quick positive reaction makes us feel that maybe, just maybe, we have the answer to help stop her seizure activity completely.

Another Series of Pharmaceutical Studies in Question

I know I sometimes harp on the pharmaceutical industry and how so many studies that show negative effects or less than positive ones, but a report out of Massachusetts has me very concerned about the validity of many studies out there. If you read this report from MSNBC.com, you can see why I am so disturbed.

It seems that Dr. Scott Reuben was fabricating data about the effectiveness of a number of drugs, including the pain killer Celebrex made by Pfizer and the antidepressant Effexor XR made by Wyeth among others. While this is certainly bad news for the two pharmaceutical companies, it should make us wonder how pervasive this is not only in the pharmaceutical world but also in the nutraceutical community.

I have often times railed against outrageous claims made by the makers of supplements that seem to be heavily anecdotal and curiously non-scientific. One case is the zeolite claims of chelating heavy metals. Still waiting for that study that is due any day showing how great it really is. Been waiting for over three years for something that was supposed to be out already. I’ve heard doctors get on stage and claim super high “cure” rates for autism, only to hear different numbers every conference he spoke at.

Research fraud is more common than you might think which means you need to read the studies with a more critical eye and not to jump on the latest hot drug or supplement. The studies have to make biochemical sense and not just report possible effects that seem too good to be true. There are a lot of Bernie Maddoff’s in science so approach those claims from the pharmaceutical and nutraceutical companies with a grain of salt. The life you save could be your own.

Another Reason Not To Take Antidepressant Drugs

In an article from Discover Magazine, Ben Harder reports on an important study published in PLoS Medicine by Irving Kirsch, et al that basically says that antidepressant drugs pretty much don’t work any better than placebo. This is just another in a series of papers that suggest that you try other alternative methods like Omega 3 fatty acids, amino acid and nutrient therapies before you try meds.

My suggestion would be to run a plasma amino acid test before even thinking about antidepressant medications and see if a customized amino acid supplement might help. Far fewer side-effects and a lot of positive effects on energy and general well-being might just happen.

More Deceit From the Pharmaceutical Industry

It just keeps coming it seems, the pharmaceutical industry has stooped to levels even I didn’t think possible. Merck was just found to have paid academic scientists to put their names on papers they didn’t write. Who wrote the papers? Company hired medical writers of course.

According to Dr. Catherine DeAngelis, JAMA’s editor-in-chief, “The manipulation is disgusting. I just didn’t realize the extent.”  I think her use of the word disgusting pretty much sums up my opinion of this revelation. The article about this scandal is in today’s Journal of the American Medical Association. You can read the two articles, one by Ross, Hill, Egilman, and Krumholz and the other by Psaty and Kronmal. 

One JAMA report says internal company data showed in 2001 that Vioxx patients in two Alzheimer’s studies had a higher death rate than patients on dummy pills. Merck didn’t publicize that “in a timely fashion” and provided information to federal regulators that downplayed the deaths, the report said. It’s time to reign in the industry through Congressional legislation.

Lest you think that only Merck is guilty of this deception, think again. I am sure that you will see more of this cropping up in the coming months. In my opinion, this type of behavior is driven by executives of pharmaceutical companies need to impress Wall Street and fluff up their balance sheets instead of having patient’s health in mind.

Here is the result of a paper done by Choudry, et al published in JAMA about how pervasive the industry’s hooks into medicine is:

“Eighty-seven percent of authors had some form of interaction with the pharmaceutical industry. Fifty-eight percent had received financial support to perform research and 38% had served as employees or consultants for a pharmaceutical company. On average, CPG authors interacted with 10.5 different companies. Overall, an average of 81% (95% confidence interval, 70%-92%) of authors per CPG had interactions. Similarly, all of the CPGs for 7 of the 10 diseases included in our study had at least 1 author who had some interaction. Fifty-nine percent had relationships with companies whose drugs were considered in the guideline they authored, and of these authors, 96% had relationships that predated the guideline creation process. Fifty-five percent of respondents indicated that the guideline process with which they were involved had no formal process for declaring these relationships. In published versions of the CPGs, specific declarations regarding the personal financial interactions of individual authors with the pharmaceutical industry were made in only 2 cases. Seven percent thought that their own relationships with the pharmaceutical industry influenced the recommendations and 19% thought that their coauthors’ recommendations were influenced by their relationships. “

What is truly sad is how many people have suffered health and financial wise due to the greed and immoral behavior by the pharmaceutical industry.

Why Is Our Health Care is So Expensive? Someone Finally Got It!

In the February 7th, 2008 issue of the New England Journal of Medicine, page 549, a perspective written by Robert Kuttner should be mandatory reading for every politician, doctor, patient and anyone else who avails themselves or is involved in the United States health care system. In this brilliantly written article, Mr Kuttner, co-editor of the American Prospect, talks about the real reason our health care system is so ridiculously expensive. 

He writes “The extreme failure of the United States to contain medical costs results primarily from our unique, pervasice commercialization. The dominance of for-profit insurance and pharmaceutical companies, a new wave of investor-owned specialty hospitals, and profit-maximizing behavior even by nonprofit players raise costs and distort resource allocation.” Basically these profit hungry organizations cost you the patient between a staggering 400-500 billion dollars annually.

His comments and insight into the reasons why market optimization and competition does not mean greater efficiency in delivering health care and does not lower cost as with other industries is a must read. Do whatever you have to, to get a hold of this article.

His last paragraph was so telling. “Sometimes, we Americans do the right thing only after having exhausted all other alternatives. It remains to be seen how much exhaustion the health care system will suffer before we turn to national health insurance.” I have always been against this idea until I read this article. Maybe it is time to stop the greed and redo our failing and overly expensive health care system.

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 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.

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.

Top Science Stories of 2007

Every year Discover Magazine puts out a list of the top 100 science stories of the year. As I did last year, I want to relate those which relate to issues I deal with on my blog. Please pick up a copy of the January 2008 issue to read the full article.

#1 – China’s Syndrome – From tainted products to their terrible pollution problem, this story ranked first is one that will be with us for many years.

#4 – Artic Thaw – Climatologists are deeply concerned about the melting ice caps in the Arctic and its effects on global warming.

#5 – Rx for the FDA – If there was a governmental agency that needed fixing, it is this one. It needs to be overhauled with no industry say or influence.

#6 – Conservation Gets A Green Light – Switching from incandescent bulbs to the newer generation fluorescents would be a big boost in protecting our environment. Yes, they have a little bit of mercury in them but the reduction of pollution, and the release of mercury from coal-burning power plants makes up for that in buckets.

#8 – Can Vitamin D Save Your Life – You know how I feel about this nutrient, now the world is finding out how much we need it. Get your 2,000 IUs a day and your body will be happier and healthier.

#11 – Hormone Replacement Therapy Linked to Breast Cancer – We’ve known this for years but the drug companies were reticent to let this one out. HRT’s are bad for you, period.

#17 – Is Pollution Weeding Out Male Babies? – Worldwide we are seeing a serious threat to human survival from our insistence on polluting without regard. If we don’t do something soon, this topic will unfortunately become #1.

#21 – Quantifying Global Warming – Denialists need not go any further, we don’t want to hear the nonsense. Global warming is a reality and humans are a major part of the problem.

#22 – Pesticide Effects on Sex Last Generations in Rats – Yes, the epigenetic effect is upon us. Toxins don’t just cause health disruptions now, they seem to follow us for generations to follow. This is one of the scariest stories of the year.

Tomorrow I will go through #s 26-50