by: Dr. Craig A. Maxwell
Especially if those drugs have been obtained overseas.
How many times have you been to the pharmacy to pick up a new medication only to be told, “Your insurance will cover this for a $5.00 co-pay, but if you want the name brand, it will cost you $85.00”?
Over the years, insurance companies changed a physician’s ability to write “DAW” (Dispense as Written) on a prescription by simply refusing to cover the name brand if it was available in generic form. This increased profits for the insurance companies who, in turn, forced you to gamble with your health with some questionable generic medications.
Ranbaxy – Indian Generic Drug Manufacturer – Sued for Fraud
It is estimated that more than 80% of active pharmaceutical ingredients prepared for use in the United States have come from overseas. Finished pills and capsules also come from overseas where the FDA is unable to safely regulate them. This means even if the generic active ingredient, the drug itself, comes from America, it could still be placed in an unregulated gel-cap that comes from another country. The FDA only inspects off-shore pharmaceutical manufacturing plants about every 7-13 years. Pharmaceutical plants in the United States are inspected every two years.
The danger of taking any generic medication from a foreign pharmaceutical company is the incredible negligence with which some of these manufacturers practice. Ranbaxy, a well-known Indian generic drug manufacturer, has recently been fined $500M dollars for drug fraud.
This company manufactures generic Lipitor, Accutane, anti-retroviral drugs, antibiotics, and diabetes medications, just to name a few. Each of these generic drugs have been known to cause side effects, break down more quickly than their branded counterparts or simply not work at all. This means you could be taking an antibiotic for a particularly nasty bacterial infection or even nightmare bacteria and the medication might be no more effective than a sugar pill!
They also often smuggled brand-name drugs into the country where they would use them as stand-ins for their own bioequivalence studies. They were given the stamp of approval by the FDA and allowed to carry on dispensing dangerous generic drugs to pharmacies and clinics all over the world. Ranbaxy is a giant pharmaceutical company. Chances are, you’ve taken their medicine, or are taking it now.
Since it is simply not possible to provide the type of oversight, testing, and approval that the FDA does with manufacturers in the United States, Ranbaxy and facilities like it often get away with these illegal activities for years before being caught.
“The reality is that we simply don’t know what we’re dealing with,” says Dr. Roger Bate, an international pharmaceutical expert. “No one has actually gone into these sites to expose what’s going on.”
This is not just a case of a company cutting corners and being lax about their practices. It is outright fraud, in which the company knowingly manufactured and distributed sub-standard generic drugs while doing whatever they could to deceive regulators.
When Ranbaxy opened several corporate facilities in the United States, they recruited pharmaceutical veterans to work for them. One of these veterans was Dr. Kathy Spreen, a 15-year veteran of Wyeth and AstraZeneca. After questions arose about Ranbaxy’s generic version of Accutane, she asked their Global Manufacturing Director to send documentation showing the drug was created using good manufacturing practices.
“There was a total lack of understanding,” she says, “of what it meant to be ethical and what it meant to actually protect the patient.”
Even though Ranbaxy’s version of the drug, Accutane was found to degrade far in advance of its expiration date and despite that fact that in 2012, an entire batch of generic Lipitor was recalled due to the finding of glass shards in the pills, Ranbaxy is still going strong!
They were granted the right to produce new drugs within months of the misconduct even though the company manipulated nearly every aspect of its manufacturing process. They were finally fined in May of 2013. The company had anticipated this, and set aside 500 million dollars to pay the fine. Despite this, Ranbaxy’s generic drugs are still on your pharmacist’s shelf.
Doctors Are Trained To Prescribe
Many conventional doctors prescribe medication unnecessarily and it can be easy to demonize the practice. I don’t believe this is the case. Most physicians I know came into medicine to heal the sick. They wanted to make lives better for others.
Unfortunately, by the time they were finished with medical school, they were filled with training, protocol, and procedures that went directly against their original healing intention. Doctors are not trained in medical school to get to the root cause of disease and offer preventative medicine, they are most often trained to prescribe based on a patient’s symptoms. The longer the list of symptoms, the longer the list of medicine…..instead of “connecting the dots” to find the root cause of all the symptoms, which often has a single cause.
Stranger still, is the use of medicine when your “numbers” are just a little high, instead of lifestyle changes and nutritional supplements.
For example, I often see patients with a cholesterol of 201-210 and no history of coronary artery disease immediately placed on a statin medication. How about giving the patient the opportunity to get the level below 200 with lifestyle changes such as diet, exercise and supplementation?
Another thing I commonly see is someone with a slightly elevated glucose or A1C (in the pre-diabetic range) immediately placed on diabetes medication. Once again, how about giving the patient the opportunity to reverse this with lifestyle changes before considering medication?
Take a cardiologist colleague of mine, for example. He’s been practicing for 25 years and in a recent conversation with him I discovered that he places virtually everyone on generic Lipitor. Even patients with perfectly normal lipids such as a total cholesterol of 170-180, triglycerides of 70, LDL of 100, etc.
I asked him why he did this and he simply said, “Because they are free at Meijer”. Meijer is a large grocery chain here in the Midwest and it has a policy of giving away prescriptions of 20-30 of the most popular generics as a loss – leader to get folks in the door. Guess who makes many of their generic products? Ranbaxy!
Because he was trained to.
Have you ever heard of polypharmacy? It’s where patients end up on lots and lots of medications. Many of the patients I see take anywhere between 5 and 10 medications, or more, each day. I find that many of the medications are prescribed, often unknowingly, for side effects of the other medications.
It’s easy to see how it happens. Say you are placed on Lipitor. A month later, you develop muscle pain, a known side effect of Lipitor. Unless you or your doctor are paying close attention to the cause, the doctor may prescribe an anti-inflammatory for the muscle pain. The anti-inflammatory may give you heartburn or gastritis, and the doctor gives you Nexium. And there is often more than one doctor involved, so things can get confusing very quickly. And around and around we go!
The number of prescriptions Americans are taking has risen 100% in 10 years. That’s right, it has doubled. Now you know why there are so many pharmacies, and how they all seem to stay so busy.
The Dangerous Side Effects of Some Generic Drugs
When you go to your local pharmacy to pick up a medication your doctor has prescribed for you, you expect it to be safe. You may talk with the pharmacist about possible side effects or interactions but you expect it to work the way your doctor described.
If you get a prescription that has been distributed from an overseas manufacturer like Ranbaxy, which had intentionally adulterated its products, you could be doing serious harm to your health.
Even though generic medications are required to contain the exact same amount of active ingredient as the brand-name, the fillers, binders and dyes can be quite different. This is allowed by the FDA, but can be a common cause of reactions. Also, the active ingredient, even though it is supposed to be identical to the brand-name, is often not. To you and me, identical means exactly alike. But the FDA gives generic manufacturers a little lead way. Using the brand-name product as the 100% standard in testing, generics are allowed to vary between 80%-125% in their bioequivalence—the way it is released into your body. So one time you could get a generic that is 80% as strong as the brand-name, and the next time you could get one from a different generic manufacturer that is 125% as strong. This is perfectly legal!
And we are talking about the generic companies that follow the law.
Other problems with some generic medications:
They break down/expire too quickly
Generic Accutane was shown to break down way before the expiration date. Expired medications, whether topical or oral, can be dangerous to take. They can increase in potency to toxic levels, leading to kidney damage and kidney failure.
Generic Lipitor from Ranbaxy was recalled in November of 2012 due to shards of glass being found in the pills.
Filler side effects
No matter who makes a generic, it is difficult to tell what type of binders, fillers or coloring agents are being used. Allergic reactions, anaphylaxis, headaches, muscle weakness, gastrointestinal problems, mood swings, irritability, and chronic fatigue are just a few of the possible side effects to these additives.
Avoid the Side Effects of Generic Medications
If you take any type of generic medication, I would strongly advise talking with your pharmacist about where the medication came from. If you are experiencing any unusual side effects, talk with your doctor immediately.
To avoid the side effects of generic medications:
Ask Your Doctor to Write “Dispense as Written”
Most doctors prescribe generic medication by default. It makes the insurance company happy, too. It’s important you ask that she prescribe a branded medication to avoid negative side effects. Most likely, depending on your insurance company, your doctor will have to pre-authorize your medication by telling the insurance company it is important to your health that you have a brand name.
If cost is prohibitive for you, there are several pharmacy assistance programs to cut costs. Try looking into Partners for Prescription Assistance, RX Assistance, or Needy Meds.
Oftentimes, we are placed in a position where, due to cost or insurance formularies, taking a generic is the only reasonable option. So check your prescription bottle and locate the name of the manufacturer. You can also ask your pharmacist. A quick search on the Internet will reveal whether the company is in good standing with the FDA, or has had recalls, fines, or letters of reprimand.
There are good generic manufacturers… you just have to be proactive and do your research. Remember, though, that the binders fillers and dyes are likely to be different, as might be the bioequivalence.
Make Dietary and Lifestyle Changes
Many chronic conditions like high cholesterol, high blood pressure, and adult-onset diabetes can be managed through dietary and lifestyle changes. Highly-processed foods contain dangerous additives, synthetic sweeteners, fillers, binding agents, and trans fats that lead to the development of chronic disease.
I advise all of my patients to slowly transition from a junk-food diet to a whole-food diet. This means eating more organic vegetables, fruits, beans, legumes, meat, poultry, and wild-caught fish. I also highly advise using spices to treat certain conditions naturally. For example, garlic and cayenne can lower high cholesterol levels while cinnamon has been shown to be effective for getting diabetic blood sugar stabilized.
Lifestyle changes are just as important as dietary changes when it comes to improving your health without the need for medications. I advise all my patients to quit smoking, lose weight the healthy way, and get regular exercise.
For many conditions that can be treated with prescription medications, there’s a quality supplement that can provide similar results without the side effects.
Diamond Nutritional’s Foundation Vitamins
Even if you eat a very well-balanced diet, you may still have some nutritional gaps. This is why I recommend Diamond Nutritional’s Foundation Vitamins. This healing formula contains a health-promoting blend of vitamins and minerals your body needs to function at its best.
These ingredients include:
Vitamin A – 7,500 IU
Vitamin C – 500 mg
Vitamin D3 – 500 IU
Vitamin E – 100 IU
Vitamin K – 50 mcg
Thiamine – 25 mg
Riboflavin – 25 mg
Niacin – 25 mg
Vitamin B6 – 38 mg
Folic Acid – 400 mcg
Vitamin B12 – 500 mcg
Biotin – 200 mcg
Panthothenic Acid – 150 mg
Calcium – 100 mg
Iodine – 113 mcg
Mannesium 200 mg
Zinc – 10 mg
Selenium – 100 mcg
Copper – 1 mg
Manganese – 2.5 mg
Chromium – 200 mcg
Molybdenum – 25 mcg
Potassium – 50 mg
Choline Bitartrate USP – 50 mg
Inositol – 50 mg
Mixed Tocopherols – 50 mg
Lipoic Acid – 25 mg
N-Acetyl-Cysteine USP – 25 mg
Rutin – 25 mg
Lutein – 3 mg
Boron – 1.5 mg
Lycopene – 1 mg
Vanadyl Sulfate Hydrate – 1 mg
Diamond Nutritional’s Vitamin D3 5,000 IU
Vitamin D deficiency is the number one vitamin deficiency in the United States and Canada, affecting about 85% of the population. It has been linked to the development of autoimmune disease, mental health problems, cognitive dysfunction, and even melanoma skin cancer.
Conventional medicine suggests that vitamin D supplementation should be 400 IU for an adult. However, though my decades of experience working with patients suffering from chronic disease, I’ve discovered this is not nearly enough, as lab results have revealed.
This is why I offer Diamond Nutritional’s Vitamin D3 5,000 IU. This formula contains vitamin D3 which is quickly bioavailable to your body for easy absorption and quality immune system support.
Diamond Nutritional’s Cholesterol Support Formula
Statin drugs can be dangerous for your health, whether they are generic or not. This is why I made it a priority to offer a cholesterol support formula that addresses your health needs without the alarming side effects. Diamond Nutritional’s Cholesterol Support Formula offers a proprietary blend of herbs and minerals designed to safely lower your cholesterol.
These ingredients include
Chromium – 90% of American adults are deficient in this essential mineral. Low chromium levels contribute to the development of high cholesterol, diabetes, and heart disease.
Guggul Resin – This small, thorny Middle Eastern tree offers guggul resin to stimulate the thyroid gland, which helps lower serum cholesterol levels.
Sytrinol – These citrus and palm fruit extracts act as a powerful antioxidant to decrease arterial inflammation and lower your cholesterol naturally.
Guar Gum – This powerful fiber improves your digestion, relieves inflammation, and increases “good” (HDL) cholesterol while lowering “bad” (LDL) cholesterol.
Artichoke Leaf Extract – Artichoke leaf extract contains cynarin, a compound that has been scientifically-proven to lower blood serum cholesterol levels.
Diamond Nutritional’s Diacose
For my diabetic patients, I recommend Diamond Nutritional’s Diacose. It’s an all-natural diabetic support supplement designed to lower your blood glucose levels and improve the way your body uses insulin. It’s synergistic blend of ingredients work in harmony to get your body back in balance.
These ingredients are:
Biotin – Often associated with treating brittle hair and nails, biotin supports glycolysis in the liver and pancreas by promoting the enzyme, glucokinase.
Chromium – Chromium encourages your cells to increase their natural uptake of glucose as it works naturally with your body’s own insulin.
Gymnema Sylvestre – According to studies, this woody climbing plant native to India and Africa has been shown to not only treat type 2 diabetes but type 1 as well by causing a regeneration of beta cells within the pancreas. Most participants were able to lower their medications, while 25% of study participants were able to come off all of their oral diabetes drugs completely!
Lipoic Acid – Used successfully for over 30 years in Germany, lipoic acid balances blood sugar and maintains microcirculation on account of its rich antioxidant levels.
Cinnamon – Cinnamon has long been used by natural health enthusiasts to lower blood sugar without the side effects of diabetes drugs. This potent spice not only decreases blood glucose levels but has a positive effect on heart health!
Vanadyl Sulfate – This compound has a similar function to chromium in that it helps cells actively transport proteins for glucose uptake.
With your effort and the help of your doctors, it is often possible to taper off many maintenance medications and eliminate your need for them. The healthier your diet, lifestyle, and overall outlook on life, the less you’ll likely you’ll have to rely on prescription medication.