The Truth about Generic Drugs

When you go to the grocery store, you can often buy “brand X” or the store’s own version of a variety of products ranging from potato chips, salsa and packaged or fresh cheese to bread, paper goods, laundry detergent, cosmetics and much more. These “generic” products are of varying quality, sometimes as good as the name-brand items you may have been purchasing for years, sometimes not as good. The price difference, however, is usually significant, and it’s often well worth the savings.

Can the same comparison be made for generic drugs?  Yes – but with a huge caveat:  What makes generic food and paper supplies different from generic drugs and medicines is strict federal oversight. The generic drugs often are being made by the same pharmaceutical companies as their more expensive brand-name cousins, or by other companies once patents on the brand-name drugs have expired. Proven quality, consistency, strength and testing by the Federal Food and Drug Administration (FDA) assures the consumer that the generic being substituted for the brand-name drug is safe, effective and just what the doctor ordered.

In fact, eight out of 10 brand-name drugs are now available in generic equivalents. Generics are, on average, 80 percent to 85 percent cheaper than brand-name drugs, saving U.S. consumers close to $200 billion annually.

Pharmaceutical companies mark up their proprietary brands to reflect the upfront costs involved in research, testing, clinical trials, manufacturing, distribution and marketing and advertising. Marketing and promotion is a huge expense, which is reflected in the purchase cost of brand-name drugs. Drug manufacturers are allowed to protect that brand for a certain number of years to recoup their investments. Once that patent protection expires, other companies are allowed to produce the product without the costly start-up charges or advertising, and the price drops due to competition.

When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand-name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable, and monitors those differences.

Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand-name product. Generic drugs do not need to contain the same inactive ingredients as the brand-name product, though.

To ensure quality and performance, the generic drug manufacturer must prove its drug is the same as (or bioequivalent to) the brand-name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured.  If the levels of the drug in the bloodstream are the same as the levels found when the brand-name product is used, the generic drug will work the same. Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand-name product. This standard applies to all generic drugs, whether immediate or controlled release.

Additionally, all generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand-name drugs, and the generic products must meet the same exacting specifications as any brand-name product. In fact, many generic drugs are made in the same manufacturing plants as brand-name drug products.

When to be cautious

With the proliferation and availability of drugs sold online, consumers must be careful that the products they’re buying – especially those created and shipped from other countries – meet the same standards as American generic drugs. It’s one thing to apply an adhesive bandage made abroad, another to ingest a medicine critical to your recovery from an illness, maintenance meds for a chronic condition, or vitamins and supplements that could be harmful or result in death.

The reason for caution is that the FDA often does not regulate, review or test these drugs that come from potentially nefarious sources in India, China, South America and the Far East.  Oftentimes, drugs that are advertised “made in Canada,” for example, actually come from other countries. And manufacturers are expert at using similar-sounding names for better-known drugs to confuse consumers. They also prey on the elderly, less-educated and needy.

The cash price for online drugs might be right, but the physical price could be extremely costly. When in doubt, consumers can visit the U.S. Food and Drug Administration website for safety information, alerts and pharmaceutical product details.

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Be sure to check out the CBIA Healthy Connections wellness program at your company’s next renewal. It’s free as part of your participation in CBIA Health Connections!

Heart Health: About Cholesterol and Statins

Every February there’s plenty of talk about hearts – loving hearts, broken hearts, chocolate hearts and tiny candy hearts with heart emoticons and goofy sayings like “text me”– but there’s rarely talk about healthy hearts, and the things we can be doing to help keep them that way.

Coincidentally, February is American Heart Month and a perfect time to remind people of one of the major contributors to cardiovascular disease: Too much bad cholesterol, or not enough good cholesterol. It’s also important to talk about one of the primary medicines millions of Americans consume to help their bodies regulate or offset the negative effects of cholesterol – a widely prescribed class of drugs called statins.

A brief primer on cholesterol

Cholesterol is a waxy substance found in all parts of the body. It is critical to the normal function of all cells. The body needs cholesterol for making hormones, digesting dietary fats, building cell walls, and other important processes. Our body makes all the cholesterol it needs, but cholesterol is also in some of the foods we eat.

When there is too much cholesterol in our blood, it can build up on the walls of the arteries (blood vessels that carry blood from the heart to other parts of the body). This buildup is called plaque. Over time, plaques can cause narrowing or hardening of the arteries – a condition called atherosclerosis – which can clog our arteries and keep our heart from getting the blood it needs.

Keeping our cholesterol levels in check is one of the best ways to keep our hearts healthy, and to lower our chances of getting heart disease or having a stroke. The American Heart Association recommends all adults age 20 or older have their cholesterol, and other traditional risk factors, checked every four to six years. It typically only requires a simple blood test. Our total cholesterol and HDL (good) cholesterol are among numerous factors our doctors can use to predict our lifetime or 10-year risk for a heart attack or stroke. Other risks include family history, if you are a smoker, your diet, the amount you exercise, and if you have high blood pressure.

With HDL (or “good”) cholesterol, higher levels are better. Low HDL cholesterol puts us at higher risk for heart disease. People with high blood triglycerides usually also have lower HDL cholesterol. Genetic factors, type 2 diabetes, smoking, being overweight and being sedentary can all result in lower HDL cholesterol. A low LDL (“bad”) cholesterol level is considered good for our heart health.

Statin drugs work by blocking the action of the liver enzyme that is responsible for producing cholesterol. Statins lower LDL cholesterol and total cholesterol levels. At the same time, they lower triglycerides and raise HDL cholesterol levels. Triglycerides are another type of fat, and they’re used to store excess energy from our diet. High levels of triglycerides in the blood, which are associated with atherosclerosis, can be caused by being overweight or obese, physical inactivity, cigarette smoking, excess alcohol consumption and a diet very high in carbohydrates (more than 60 percent of total calories).

People with high triglycerides often have a high total cholesterol level, including a high LDL cholesterol (bad) level and a low HDL cholesterol (good) level. Many people with heart disease or diabetes also have high triglyceride levels.

Statins help stabilize plaques in the arteries. Since their arrival on the market, statins have been among the most prescribed drugs in the United States, with about 17 million users. The statin medications that are approved for use in the U.S. include Lipitor, Livalo, Mevacor (or Altocor), Zocor, Pravachol, Lescol and Crestor. There also are generic versions available.

The down side to statins

Most people who take statin drugs tolerate them very well. But some people experience side effects. The most common statin side effects include:

  • Headache
  • Difficulty sleeping
  • Flushing of the skin
  • Muscle aches, tenderness, or weakness
  • Drowsiness or dizziness
  • Nausea or vomiting
  • Abdominal cramping, pain, bloating or gas
  • Diarrhea or constipation

Statins also carry warnings that memory loss, mental confusion, high blood sugar, and type 2 diabetes are possible side effects. Due to the possibility of side effects that can damage the liver, patients taking statins are required to have periodic blood tests. It’s important to remember that statins may also interact with other medications.

If you experience any unexplained joint or muscle pain, tenderness, or weakness while taking statins, you should call your doctor immediately. Pregnant women or those with active or chronic liver disease should not use statins. Also, if you take a statin drug, tell your doctor about any over-the-counter or prescription drugs, herbal supplements, and vitamins you are currently taking or plan on taking.

Give yourself the best Valentine’s Day gift possible by keeping your heart and body healthy. Even if your physician recommends you take a statin, maintaining a healthy lifestyle while taking one of these drugs can improve its effectiveness. Be sure to eat a balanced, heart-healthy diet; get regular physical activity; limit alcohol intake; and avoid smoking. Over time – and with sustained healthy weight loss and regular exercise – some patients are able to go off statins, but always speak with your physician before stopping any prescribed medication.

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Be sure to check out the CBIA Healthy Connections wellness program at your company’s next renewal. It’s free as part of your participation in CBIA Health Connections!

The History of Valentine’s Day

Although February 14th may be welcomed by many and reviled by others, it’s hard to ignore.  In fact, it is hard to imagine another day in the year that is simultaneously revered and dreaded . . . and so misunderstood! Sure, we love the chocolate and flowers, romantic dinners and Hallmark missives. There also are plenty of closeted treasure chests filled with children’s painted hand prints and hand-drawn cards. But why does Valentine’s Day actually exist, other than as a blessing for retail stores and our economy?

The history of Valentine’s Day — and the story of its patron saint — is shrouded in mystery. February has long been celebrated as a month of romance, and St. Valentine’s Day, as we know it today, contains vestiges of both Christian and ancient Roman tradition.

The Catholic Church recognizes at least three different saints named Valentine or Valentinus, all of whom were martyred. One legend contends that Valentine was a priest who served during the third century in Rome. When Emperor Claudius II decided that single men made better soldiers than those with wives and families, he outlawed marriage for young men. Valentine allegedly defied Claudius and continued to perform marriages for young lovers in secret. When his actions were discovered, Claudius ordered that he be put to death.

Other stories suggest that Valentine may have been killed for attempting to help Christians escape harsh Roman prisons, where they were often beaten and tortured. According to one legend, an imprisoned Valentine actually sent the first “valentine” greeting himself after he fell in love with a young girl –possibly his jailor’s daughter — who visited him during his confinement. Before his death, it is alleged that he wrote her a letter signed “From your Valentine,” an expression that is still in use today.

Some historians claim that the Christian church may have decided to place St. Valentine’s feast day in the middle of February in an effort to upstage the pagan celebration of Lupercalia, a fertility festival dedicated to Faunus, the Roman god of agriculture, as well as to the Roman founders Romulus and Remus.

At the end of the fifth century, Pope Gelasius declared February 14 St. Valentine’s Day. It was not until much later, however, that the day became definitively associated with love. During the Middle Ages, it was commonly believed in France and England that February 14 was the beginning of birds’ mating season, which added to the idea that Valentine’s Day should be a day for romance.

Valentine greetings were popular as far back as the Middle Ages, though written valentines didn’t begin to appear until after 1400. The oldest known valentine still in existence today was a poem written in 1415 by Charles, Duke of Orleans, to his wife while he was imprisoned in the Tower of London following his capture at the Battle of Agincourt. And the expression, “wearing your heart on your sleeve” was because young men of that era would pin a piece of paper on their clothes with the name of a woman they were interested in, and parade outdoors.

In addition to the United States, Valentine’s Day is celebrated in Canada, Mexico, the United Kingdom, France and Australia. In Great Britain, Valentine’s Day began to be popularly celebrated around the 17th century. By the middle of the 18th, it was common for friends and lovers of all social classes to exchange small tokens of affection or handwritten notes, and by 1900 printed cards began to replace written letters due to improvements in printing technology.

Americans began exchanging hand-made valentines in the early 1700s. In the 1840s, Esther A. Howland began selling the first mass-produced valentines in America. Howland, known as the “Mother of the Valentine,” made elaborate creations with real lace, ribbons and colorful pictures known as “scrap.” Today, according to the Greeting Card Association, an estimated 1 billion Valentine’s Day cards are sent each year, making Valentine’s Day the second largest card-sending holiday of the year. Women purchase approximately 85 percent of all valentines.

Why chocolate?

In the 1840s, Richard Cadbury, descendant of a British chocolate manufacturing family, was responsible for sales at a crucial point in his company’s history. Cadbury had recently improved its chocolate-making technique to extract pure cocoa butter from whole beans, producing a more palatable drinking chocolate than most Britons had ever tasted. This process resulted in an excess amount of cocoa butter, which Cadbury used to produce many more varieties of what was then called “eating chocolate.” Cadbury recognized a great marketing opportunity for the new chocolates and started selling them in beautifully decorated boxes that he himself designed.

While Richard Cadbury didn’t actually patent the heart-shaped box, it’s widely believed that he was the first to produce one. Cadbury marketed the boxes as having a dual purpose: When the chocolates had all been eaten, the box itself was so pretty that it could be used again and again to store mementos, from locks of hair to love letters. The boxes grew increasingly elaborate until the outbreak of World War II, when sugar was rationed and Valentine’s Day celebrations were scaled down. But Victorian-era Cadbury boxes still exist, and many are treasured family heirlooms or valuable items prized by collectors.

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Be sure to check out the CBIA Healthy Connections wellness program at your company’s next renewal. It’s free as part of your participation in CBIA Health Connections!

Are You Maximizing Your Health Benefits?

Earlier this month, someone incredibly lucky – a $63 million lottery winner in California – failed to step up and claim his or her grand prize prior to the closing date, forfeiting the fortune. We can only speculate why they didn’t cash in. Maybe they were ill or had died. Maybe they didn’t need – or want – the money. Or maybe they just threw the winning ticket into the garbage accidentally, never checked the winning numbers, or washed it in their jeans.

Most of us will never walk away from a fortune, or even from an opportunity to save. We clip coupons, fight the Black Friday crowds, shop online, and check the prices of everything we consider purchasing. Yet, there’s one area where many people often fail to think about missed value, lost opportunities and missed savings – and that’s their health and wellness benefits.

Employers can reinforce the value of employees’ “hidden paycheck” through regular reminders, updates, benefit education sessions and by encouraging employees to touch base with their benefit provider’s website, telephone resources, and customer service support. The more employees understand their benefit offerings, the more they can utilize the full spectrum of valuable services, which can include annual health screenings, fitness center discounts, smoking-cessation programs, vaccinations, eye exams, nurse-call lines, disease-management programs and much more.

Most benefits providers reach out regularly to members. But employers also can encourage employees to visit their benefits websites and, if they haven’t already, establish an account. Suggest they review the full range of health and wellness benefits available throughout the year, instead of just tuning in during open-enrollment season. It’s easy to keep track of your progress against a benefits deductible, or to monitor how much you have in your health savings account. And there may well be unexpected surprises for those users willing to take a few minutes to review their plans in more detail.

Though benefits vary widely from plan to plan, here are a few examples of potential missed opportunities:

  • Keeping track of balances (deductibles, health savings accounts, etc.) and claims helps you monitor your healthcare spending, and know when insurance benefits will kick in more fully following completion of deductible requirements as applicable.
  • By knowing what your plan covers, in detail, you will be better able to take advantage of important benefits such as covered annual physicals, OB/GYN visits, mammograms, eye exams and more.
  • Pharmacy benefits such as tiered drug coverage, 90-day mail-order prescriptions, and generics can represent significant cost savings.
  • Many insurance benefits providers offer online or telephone-based services such as nurse help lines, online question and answer forums, and disease-management programs for medical conditions such as asthma, diabetes, heart disease and respiratory illness.
  • Many benefits providers offer obesity-reduction and nutritional information, educational materials for expectant or new mothers, stress-reduction guidance and a variety of classes.

Reminding employees to complete their online health assessment and access healthcare educational information are simple steps we all can take to become more engaged in helping to manage health and wellness for ourselves, our families, and our employees.

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If you’re not enjoying the benefits of a wellness program at your company, join CBIA Healthy Connections at your company’s next renewal. It’s free as part of your participation in CBIA Health Connections!