Despite research showing that the drug Avandia causes an increased risk of heart disease in patients with diabetes, the FDA yesterday voted to allow the drug to remain on the market. So how is this protecting the public? Isn’t part of the job of the FDA to protect us from drugs that can harm us? Apparently not. BTW a scientist from the FDA supposedly was taken off the case when he or she found information that suggested that the drug was not safe. Read the article here.
Is this an FDA problem or an issue that goes much deeper. My opinion is the latter. It is a system that no longer holds the pharmaceutical companies accountable in a real world manner. The FDA is shorthanded, under-budgeted and faced with billion dollar lobbyists pressuring them to “fast-track” their next blockbuster drug. This is a huge problem and will likely not get fixed any time soon. People I’ve talked to with an inside knowledge of the FDA tell me that there is a growing frustration level at the agency because they feel like they are being lied to and deceived by some of the pharmaceutical companies when it comes to adverse event reports and followup efficacy research.
What is needed is independent research into drug on the market. My proposal is to create a government agency under the FDA which would give out grants to universities to study the effects of drugs on patients, kind of a Phase IV research program. The research would be funded by the pharmaceutical industry in a pooled manner. You sell 1 billion dollars worth of a drug, you put in 3% into the pool. All the companies are mandated to put the money in depending on the sales figures for their drugs in the U.S. In the case of Avandia, since they sell 3 billion dollars a year of the drug, Glaxo would be forced to fork over 90 million to the project.
From this, we could have a top notch monitoring system to oversee the safety of the drugs being marketed to physicians. The other overhaul would be to severely curtail advertising of drugs to the consumer. The crap from the industry that they are just educating the public is just that, crap. The education, and I mean education not bribery, should be focused strictly on the physicians, with strict guidelines. No trips to the Bahamas to hear a sales pitch, just local lectures and information passed on in a professional manner. One other issue, no more marketing to physicians about off label uses of drugs. The sales rep should be banned from touting a drug for treatment of a disease that has not been approved by the FDA. This is dangerous and unscientific and needs to be prosecuted if found.
This issue is not going away anytime soon as long as the pharmaceutical industry is not run just for profit. Time for a change.
In an article on CNN.com, Carl Pesmen from Health Magazine details 5 common surgical procedures that are overused in America. Some of the interesting information he presented includes the surprising fact that over 12,000 Americans die each year from unnecessary operations. Here are the 5 surgeries, Mr. Pesmen’s alternatives and mine.
- Hysterectomies – According to the article, of the 617,000, between 468,000 and 524,000 are unnecessary. It is necessary for ovarian cancer but it is mainly used to remove fibroids and stop persistent vaginal bleeding. According to the article, there are a number of alternative. Dr. Tori Hudson, ND has a nice article here, that has can help women before they need this unneeded surgery.
- Episiotomy – Cutting the vaginal opening before childbirth is considered by some to be a way of making for a more comfortable birth but with post surgery symptoms like pain, irritation, muscle tears, and incontinence doing the alternative, which is Kegels, I think women would be far better off avoiding this. The unfortunate part is that 73 percent of the women who had the surgery, didn’t have a choice. This means, before going into the hospital, tell your doctor not to do it unless absolutely necessary. Emphasize absolutely as they are typically men and they may not listen.
- Angioplasty – One million two hundred thousand operations using angioplasty are done annually and they have not been proven to help with non-emergency patients any better than standard drug treatment. It does make for a nice home and car for the surgeons, but if you want to avoid the knife, this article suggests making sure you stay on the drugs. Better yet, go to Dr. Jeffrey Dach’s website and learn how to naturally avoid heart disease. Take some responsibility and you’ll stay healthier, longer.
- Heartburn surgery – Amazingly enough, this surgery often times doesn’t even work. Lifestyle changes and acid reducing drugs are their alternatives. I agree with the first but vehemently oppose the second. Natural remedies include, Alka Seltzer Gold (yeah it is pretty natural), proteolytic enzymes, probiotics and even hydrochloric acid.
- Back surgery – Many people who have the surgery only report a short term relief. Unless there is real damage done to the spine, exercise, weight loss and lifestyle changes are far better long-term solutions. Here I wholeheartedly agree with Mr. Pesmen.
Bottom line on alternatives for all of these surgeries is changing your lifestyle. Get off your butt and get working. You’ll be happy you did.
This is simply getting ridiculous. Every few weeks the Bush Administration calls out another scare to take our minds off of serious issues. Remember the bottles of liquid gang who were going to blow up planes? Not so. Unfortunately we can’t take water on planes anymore even though the threat wasn’t real. Now the latest “dry runs” being done by potential terrorists may not be real either. In San Diego, they claim that there were no dry runs being done in their airport despite media claims otherwise. Click here for the story.
My mother told me the story of Peter Wolf and I feel that our government is crying wolf too often. Is there a terrorist threat? Of course. Is there concern amongst travellers? Yes again. Do we need to have “gut feelings” made public by the head of Homeland Security? Why? Our democracy is at a crossroads. Do we continue to become more and more paranoid and act like Chicken Little’s and start banning everything from being carried on airplanes for safety purposes?
I am saddened by the way this administration is handling our country and this is another example of the distance they have with reality. As a proud American, I hope we as a people have the guts to stand up and say enough is enough. We want the respect the rest of the world once had for us back.
To see how the obesity epidemic has accelerated, CNN and their Fit Nation series has an interesting map of the U.S. and how, since 1985 we as a nation have gotten fat. Click here to see the map.
Mention sorghum to the average person on the street and you will likely get a blank expression and a “what is that” comment. In the United States alone, over 9.8 metric tons of this member of the grass family is produced annually, mostly for feed for farm animals. Sorghum is grown in over 66 countries and is used to produce gluten-free products like beer for people with celiac’s disease.
A new finding, presented at the April 29th Experimental Biology ’07 meeting, showed that sorghum bran reduced white blood cells’ production of a number of inflammation-linked chemicals including tumor-necrosis-factor-alpha (TNF-alpha) and interleukin-1-beta (IL-1-beta). TNF-alpha was reduced by 80 percent and IL-I-beta was reduced by more than 99 percent in mice when exposed to a sorghum bran mixture. Wound swelling on mice was reduced by 60 percent when an extract of the grass was applied within 6 hours of occurence.
Although this is early in the research game, sorghum may turn out to be an important player in anti-inflammatory medicine instead of harsh painkiller drugs filled with side-effects.
Vitamin D, as many of my regular readers know, is one of my favorite supplements. Research keeps on coming on all the good results scientists keep coming up with. Here is a small list from recently published articles:
Still, there are times when you can get too much of a good thing. In the July 19th 2007 issue of the New England Journal of Medicine, a letter to the editor pointed out a case where a women developed a series of life threatening toxic effects from taking Solutions IE Ageless Formula II supplement from Aloe International which contained 186,906 IUs of vitamin D. The symptoms she suffered included nausea, fatigue, constipation, back pain, forgetfulness and vomiting. It is known that long-term daily vitamin D consumption of 40,000 IUs of vitamin D3 can cause hypercalcemia in health patients so the amount this women took was obscenely high.
Of course, this is an isolated instance and not the standard in the nutritional supplement business. This is an example though of why the industry needs to make sure it regularly checks each batch for quality. This is not being done unfortunately and the FDA was forced to step in and create a rule that the manufacturers of nutritional supplements must test their products. Some advocacy groups bristled at the thought of FDA control and rolled out the dreaded term CODEX to scare the public but sad to say, it was a necessary evil to bring some sanity to the nutritional supplement industry. I have personally seen products, like an electrolyte product on the market claiming 136 mgs of magnesium in each serving but when I checked out their label claim through an independent lab, they only had 32 mgs of magnesium. That is only one-third of the label claim. This same company has already been admonished twice by the FDA for other offenses (like selling a product that could cause miscarriages) yet they stay in business.
There are many good companies out there but consumers must be wary. Hopefully, the new regulations will mean better and safer products on the market.
Dr. Morris White, a Howard Hughes Medical Institute investigator at Children’s Hospital in Boston led a group of researchers who discovered in rat studies that the lower the level of insulin that reaches the brain, the longer the rats lived. One of the surest ways to do this is through regular exercise and dietary reform (I love that term). If we eat right and exercise we can live longer. Imagine that. Here is the Reuters story about the study.
What is interesting is that even people who don’t exercise now, they can get the benefits of lower insulin and perhaps a longer and healthier life if they start right away. Change your diet, stop eating junk food and lots of sugar. It will take work but you’ll be happier and feel better. It just takes that one step to get going.
Researchers, looking at medical records of 13,116 children from Manitoba and saw that infants who had more than four courses of antibiotics in the first year of their life were 1.5 times more likely to develop asthma by the age of 7 than kids who did not get the drugs. This finding was published in the June issue of the journal Chest.
The authors offered two possibilities for this happening, first is that early exposure to toxins made by the infectious microbes may help an infant’s immune system to develop normally. Second is that the antibiotics may kill off the friendly bacteria in the gut which is also crucial in the developing immune system. If this is the case then adding probiotics to infants who have taken antibiotics may help them avoid developing asthma which is often times caused by a overreaction of the immune system.
Bottom line here is that the overuse of antibiotics is causing more health problems than physicians had originally expected. Patient’s who come into the physicians office with a virus, walk out with a useless antibiotic which causes bacteria to develop a resistance to that drug over time. Antibiotics used in animal food production which leeches into our water supplies is becoming a real problem in the U.S. It is time for the government to step in and start a massive education program to put a halt to this growing problem.
Data on the negative effects of the common plasticizer phthalates keeps on coming. Last month, it was the relationship between phthalates, insulin-resistance and male waist circumference and this month it is the effect of this toxin on thyroid function in men. The journal Environmental Health Perspectives has published numerous articles on the subject but the last two issues seem to really bring home the fact that we need to look at phthalates more closely and avoid exposure as much as possible.
The June 2007 article, authored by Stahlhut, et al, shows a link between levels of urinary excretion of phthalates and insulin resistance as well as obesity in males. The gist of the article found here, is that phthalates may be anti-androgenic, meaning it blocks the production of testosterone. We know that by depressing testosterone you see an increase in cholesterol and a decrease in the ability to regulate blood sugar.
This month, researchers Meeker, Calafat and Hauser report on a study they did which looked at 408 men and measured their urine output of two forms of phthalates. There conclusion was that there may be an association between phthalate concentrations and altered free T4 and/or total T3 levels. This is the first time that human studies were conducted on this relationship and it seems to back up the limited animal research that showed this same correlation.
To find out where your levels are, have your doctor call Lab Interpretation LLC at 775-851-3336 and ask about the Environmental Pollutants Panel and you can check not only your phthalate level, but a number of other petrochemical solvents (benzene, toluene, xylene, parabens, trimethylbenzene and styrene), Phthalates are commonly found in drinking water as well as cosmetics, shampoos, perfumes and other skin and hair care products. Go to the Environmental Working Groups website (click the link) and go to their Skin Deep database. There you will find out where your exposures may be from.
According to the journal Cancer Epidemiology, Biomarkers and Prevention, people who have hepatitis B may benefit from folic acid supplementation because it may protect them from the development of liver cancer which is common with people who have hepatitis B.
Coenzyme Q10 Supplementation May Protect Against Statin-Induced Liver Disease – At this point in time, with all of the research done about the need for Coenzyme Q10 and statin use, wouldn’t you think that every doctor in America would just put the two together for all of their patients? Sad to say, they don’t. In Europe its mandatory, in the U.S. we have such an anti-supplement bias fueled by misdirected reporters that people may be developing life-threatening diseases because of it. This is just another study showing real benefits to CoEnzyme Q10 use.
High Dietary Vitamin B-6 Intake May Lower Colorectal Cancer Risk in Men – In a very large prospective cohort study (81,184 subjects) it was noted that those men in the highest quartile for B6 intake had a 31% decreased risk for developing colorectal cancer. For men who drank more than 150 grams of alcohol a week the benefits were even greater.
Vitamin B6, Conception, and Early Pregnancy Loss – In yet another human study, researchers have shown that those women with the highest plasma levels of vitamin had a higher level of conception and a lower level of early pregnancy termination (spotaneous miscarriage).
These three studies show how much human research is going on regarding the benefits of nutritional supplement. I bring this up because of communications I had with a reporter from CNN I lambasted in an earlier blog. I challenged him saying that I could produce ten human studies showing the benefits of supplements for every one negative study. Caleb, here is just a smattering of evidence for the use of supplements. Of course, they need to be done in a biochemically individualized manner but when you claim there are no known benefits to the use of nutritional supplements, you kind of lose all credibility.