Immunization in infants and children has become a hot topic of conversation. Some believe the shots can cause developmental disorders such as autism in children. They find security in believing that the immunizations are not necessary because the diseases they address have been all but eradicated in this country.
It’s not that these diseases no longer exist, but we have created communal immunity due to the immunization schedule. Therefore, as more and more people choose not to give their children shots the diseases can return to our communities. Research continues to provide data that there is no link between immunizations and autism spectrum disorders. All medical foundations continue to recommend that these shots be given to all children.
The latest guidelines for cholesterol treatment recommends more seniors need to be on statin medications to lower their risk of heart disease. This is an interesting article because there is a misconception that statins are dangerous drugs. When they were first introduced in the 1980’s, the FDA initially required every patient to see an eye doctor yearly because of a possible risk of cataracts. This was quickly reversed as the target patient group was itself at a high risk of developing cataracts. For years, we had to monitor liver functions and patients were worried about liver damage. This is so rare (even though statins can harmlessly elevate liver enzymes a little bit) that a few years ago the FDA withdrew the requirements of regular monitoring of liver functions.
This is a direct quote from the article:
“Many side effects such as myopathy, fatigue, muscle aches, and rhabdomyolysis, and memory loss have been commonly attributed to statins, but the researchers found that these were no more common among patients taking statins than among those taking a placebo. The withdrawal rate from trials was also similar for statins and placebo, at around 12-15%.” There was a slight risk of developing diabetes: 3% of statin patients vs 2.4% incidence in the placebo group.
Please be reassured that taking statins are safe and, to date, there is NO evidence that any OTHER cholesterol lowering medication (herbal or prescription) have ever been shown scientifically to decrease the risk of cardiovascular disease.
OVER THE COUNTER CHOLESTEROL MEDICATIONS?
Pfizer (LIPITOR) wants to sell their blockbuster drug to patients without requiring a prescription. They say that this will allow more people at risk to lower their chances of getting heart disease. As expected, the American College of Cardiology and the American Heart Association are against this because the newest guidelines don’t recommend treating to certain LDL cholesterol levels but rather to 10 year cardiovascular risk.
One can say that low dose Zocor has been OTC in England for the past 10 years but no one reports on any benefits to patients when self-treating their lipids. On the other hand, skeptics may think that physicians want to control all drugs and would lose money if patients would decide on what medicine to get. My concern is that the only reason Pfizer wants Lipitor to go OTC is that generic atorvastatin is cutting into their profits and they stand to make millions if they could sell direct to consumer. (Look at Claritin or Advil, for example.) Of course, it’s ultimately the consumer that gets screwed because once it goes OTC, the insurance company will no longer pay for it.
So, forget health benefits: as always this is about “big pharma” and their $$$$$.
Many patients complain about the high costs of their prescriptions. We always try to prescribe generics when possible, but sometimes the brand name actually is better. Other times, there are NO generic equivalents to treat certain illnesses. I believe the main cause of the increased cost is due to the hidden premium increases in your health insurance. Not only have drug deductibles gone up but many insurance plans have limited how much they are going to pay for drugs.
Many pharmaceutical companies have hardship programs where they will supply medications at a greatly reduced cost to the patient. Also, almost every branded drug utilizes various coupon and voucher programs to help pay for the medicine.
ALL patients can use the vouchers-which usually allow you to get a 30 day supple for free from any pharmacy. The coupon program works differently. There are many BRANDED MEDICATIONS that will cost the consumer only $5-$10/month BUT these programs are only valid for commercial plans only. This means that the government forbids the use of coupons for any patient on a federal insurance program-including MEDICARE. Also please be aware that NOT every pharmacy or insurance company will let you use these coupons and that ALL drug deductibles must be paid before the savings are passed along to the consumer.
Several years ago the sleeping pill, LUNESTA came with a $0 copay coupon but most patients could not use it because of insurance company formulary policies which require the patient to BUY a “preferred” drug instead.
ENBREL, which is a wonderful treatment for psoriasis would cost most commercial patients less than $25/month but seniors would have to either pay whatever MEDICARE PART D would cover or the entire price of almost $3000.
If you are upset about these policies, I would recommend that you call your Senator or Congressman and ask them why.
The Nexium that is currently being prescribed is esomeprazole magnesium. This is going generic in the next month or two. There is going to be confusion over the NEW “NEXIUM” which esomeprazole strontium. The brand will be called STRONTIUM and 49.3 mg will be equivalent to 40mg of Nexium.
What’s important to know is that these drugs are NOT being made by the same company and that STRONTIUM is the result of a loophole in patent laws. I’m sure it will work just as well and have a similar side effect profile, but it will cost $150/month and most likely will NOT be covered under most insurance plans
If there is anything constant about the practice of medicine is that nothing stays the same. The latest blood pressure guidelines were published by JNC 8 (Joint National Commission) suggesting that higher blood pressures were acceptable in patients older than 60. They claim that our goal should be readings of 150/90. The problem with this is that it is controversial and contradicts generations of conventional thinking about blood pressure control. The concern is that systolic readings of 150 will lead to more heart attacks and strokes.
This is one study that I don’t have faith in and I will continue to use the old guidelines. The only exception is when I think lowering the blood pressure too much will lead to an increase in dizziness and falls in the elderly.
As our patients and readers of the Kaizen Total Wellness blog already know, I have been on this bandwagon for years! Supplements are often useless, not regulated properly, and generally not beneficial!! Much has been written lately confirming my opinions – and the following editorial in the Herald Tribune states it thoroughly and clearly!
A portion of this editorial has been printed here. To read the entire editorial, go to this link:http://www.heraldtribune.com/article/20131227/OPINION/312279997?p=1&tc=pg
Published: Friday, December 27, 2013 at 1:00 a.m.
Last Modified: Thursday, December 26, 2013 at 6:10 p.m.
Dietary supplements, whose makers make health-related claims ranging from mundane to miraculous, are a $32 billion industry in the United States.
Yet, since a deregulation law was passed in 1994 and signed by then-President Bill Clinton, supplements that include potent drugs or fillers largely escape inspection by the Food and Drug Administration — until users become sick or die.
New data — released last month and reported Sunday by the New York Times — suggests that dietary supplements account for nearly 20 percent of drug-related liver injuries in hospitalized patients. That percentage is up from 7 percent a decade ago.
The Times told the story of a 17-year-old Texas boy who had taken a concentrated green tea extract, purchased at a nutrition store and labeled as a “fat burner.” The boy’s liver had sustained so much damage that a transplant was required.
Since the Dietary Supplement Health and Education Act was passed nearly two decades ago, physicians, researchers and the FDA have steadily reported adverse reactions and issued warnings about supplements. For example:
• In November, the Times reported that Canadian researchers used DNA testing to check the ingredients of 44 bottles of popular supplements sold by 12 companies. In one-third of the bottles, the tests showed not a single trace of the herb listed on the bottle label. Others were mixed with filler ingredients not listed on the label.
• In April, U.S. regulators found that “workout-booster” and “fat-burning” products sold as Jack3d and OxyElitePro contained a stimulant called dimethyamyamine (DMAA). The stimulant was linked to heart problems, high blood pressure and at least five deaths (reporting remains sketchy and likely underestimates the problems).
• In 2011, investigators found Pai You Gho — a weight-loss supplement from China that contained two drugs, including a suspected carcinogen — on store shelves, even though the product was recalled in 2009.
• In 2009, the FDA issued a public warning about the “Xtreme” line of body-building products, which improperly contained synthetic steroids. StarCaps, made in Peru and promoted as an all-natural weight-loss supplement, was found to contain bumetanide, a potent diuretic. Hydrocut, another supposed fat burner, was recalled after the FDA linked its use to liver and muscle damage and heart problems.
At the time, the FDA warned that 70 brands of pills illegally contained prescription-drug ingredients.
• In 2004, the FDA banned the use of supplements containing ephedra, a class of natural, amphetamine-like substances found in plants. Unfortunately, the ban didn’t occur until after the administration cited “substantial evidence of harm,” based on a study that showed “more than 16,000 adverse events associated with the use of ephedra-containing dietary supplements, including heart palpitations, tremors and insomnia.”
The dangers of such products made national headlines in February 2003 when a Major League Baseball player — attempting to lose weight during spring training — died after using ephedra three times per day. (Ironically, after 2004, Hydroxycut created a whole line of “ephedra-free” products.)
For the rest of the editorial, you can find it in the Dec. 27, 2013 edition of the Herald Tribune or click on this link:
Reproduced from Dece,ber 14, 2013 article in New York Times su
By PAUL A. OFFIT and SARAH ERUSH
Paul A. Offit is chief of the division of infectious diseases at the Children’s Hospital of Philadelphia, where Sarah Erush is the clinical manager in the pharmacy department.
December 14, 2013
PHILADELPHIA — PARENTS whose children are admitted to our hospital occasionally bring along something extra to help with their care: dietary supplements, like St. John’s wort to ameliorate mild depression or probiotics for better health.
Here’s the problem: The Joint Commission, which is responsible for hospital accreditation in the United States, requires that dietary supplements be treated like drugs. It makes sense: Vitamins, amino acids, herbs, minerals and other botanicals have pharmacological effects. So they are drugs.
But the Food and Drug Administration doesn’t regulate dietary supplements as drugs — they aren’t tested for safety and efficacy before they’re sold. Many aren’t made according to minimal standards of manufacturing (the F.D.A. has even found some of the facilities where supplements are made to be contaminated with rodent feces and urine). And many are mislabeled, accidentally or intentionally. They often aren’t what they say they are. For example:
In 2003, researchers tested “ayurvedic” remedies from health food stores throughout Boston. They found that 20 percent contained potentially harmful levels of lead, mercury or arsenic.
In 2008, two products were pulled off the market because they were found to contain around 200 times more selenium (an element that some believe can help prevent cancer) than their labels said. People who ingested these products developed hair loss, muscle cramps, diarrhea, joint pain, fatigue and blisters.
Last summer, vitamins and minerals made by Purity First Health Products in Farmingdale, N.Y., were found to contain two powerful anabolic steroids. Some of the women who took them developed masculinizing symptoms like lower voices and fewer menstrual periods.
Last month, researchers in Ontario found that popular herbal products like those labeled St. John’s wort and ginkgo biloba often contained completely different herbs or contaminants, some of which could be quite dangerous.
The F.D.A. estimates that approximately 50,000 adverse reactions to dietary supplements occur every year. And yet few consumers know this.
Parents of children admitted to our hospital often request that we continue treating their child with dietary supplements because they believe in them, even if that belief isn’t supported by evidence. More disturbing were the times when children were taking these supplements without our knowledge. Doctors always ask parents if their children are taking any medicines. Unfortunately, because most parents don’t consider dietary supplements to be drugs, we often never knew about their use, let alone whether they might react dangerously with the child’s other treatments.
The F.D.A. has the mandate, but not the manpower, to oversee the labeling and manufacture of these supplements. In the meantime, doctors — and consumers — are on their own.
Our hospital has acted to protect the safety of our patients. No longer will we administer dietary supplements unless the manufacturer provides a third-party written guarantee that the product is made under the F.D.A.’s “good manufacturing practice” (G.M.P.) conditions, as well as a Certificate of Analysis (C.O.A.) assuring that what is written on the label is what’s in the bottle.
The good news is that we’ve been able to find some vitamins, amino acids, minerals and a handful of other supplements that meet this standard. For example, melatonin has been shown to affect sleep cycles and has a record of safety, and we identified a product that met manufacturing and labeling standards.
The bad news is that this was a vanishingly small percentage of the total group. Around 90 percent of the companies we reached out to for verification never responded. They didn’t call us back, or their email or manufacturing addresses changed overnight. Of the remainder, many manufacturers refused to provide us with either a statement of G.M.P. or a C.O.A.; in other words, they refused to guarantee that their products were what they said they were. Others lied; they said they met G.M.P. standards, but a call to the F.D.A. revealed they had been fined for violations multiple times. Perhaps most surprising, some manufacturers willingly furnished information that their product didn’t meet standards — like one company that provided a C.O.A. showing that its product contained 47,000 International Units of beta-carotene, when the label stated 25,000.
Now, when parents in our hospital still want to use products whose quality can’t be assured, we ask them to sign a waiver stating that the supplement may be dangerous, and that most have not been studied for their effectiveness. “Use of an agent for which there are no reliable data on toxicity and drug interactions,” the waiver reads, “makes it impossible to adequately monitor the patient’s acute condition or safely administer medications.”
What can other individuals who are concerned about supplement safety do? They can look for “U.S.P. Verified” on the label — this proves the supplement has been inspected and approved under the United States Pharmacopeial Convention. Unfortunately, fewer than 1 percent of the 55,000 or so supplements on the market bear this label. The real answer is that, until the day comes when medical studies prove that these supplements have legitimate benefits, and until the F.D.A. has the political backing and resources to regulate them like drugs, individuals should simply steer clear.
For too long, too many people have believed that dietary supplements can only help and never hurt. Increasingly, it’s clear that this belief is a false one.
The American College of Cardiology and the American Heart Association has changed their guidelines for medication treatment for patients with high cholesterol.
1. Patients with known ASCVD (Atherosclerotic Cardiovascular Disease) should be treated.
2. All patients with LDL (BAD) Cholesterol levels greater than 190. At one time patients with levels greater than 160 would require treatment and levels between 130-160 would be considered for treatment.
3. ALL Diabetics with LDL levels greater than 70
4. ALL patients with a 10-year cardiac risk of 7.5%. This is very controversial: Virtually everyone older than 60 would then require a statin, and many doctors think that only those patients with a 10-year risk of heart disease greater than 20% should be treated.
With few exceptions, use of lipid-modifying drugs other than statins is discouraged.
This guideline represents a paradigm shift for most clinicians and patients. Some patients currently on statins may NOT need to be on them.
For more information, call your MaxHEALTH physician for further advice
The FDA has recently lifted warnings about the diabetes drug AVANDIA. There were concerns about heart safety and strong prescribing restrictions were instituted in 2010.
Recent studies from DUKE have shown that AVANDIA DOES NOT increase the risk of heart disease when compared to other diabetes medications like metformin and glimepiride. This is important because it reintroduces to us another effective agent in the treatment of diabetes. Avandia is not for everyone and before trying it, the patient should be aware that it may cause leg swelling and weight gain.
So now the big question is, what happens to all the class action suits advertised on TV by those advertising lawyers in 2010? Just another reason health care costs so much more in the US than other countries.