For the roughly three million Americans who have been taking the brand-name drug Lipitor to reduce their cholesterol, the day they’ve been waiting for has come. On November 30, 2011, this statin drug—which rings up annual sales in the neighborhood of $8 billion for Pfizer, its manufacturer—lost its patent protection, meaning that many different manufacturers can now compete to make the drug in a generic version called atorvastatin. This is good news for consumers because generics tend to be much cheaper than brand-name drugs, and Lipitor itself costs $115 to $160 a month, depending on the dose. But if you are on Lipitor, you may wonder, Is the generic really the same as the brand-name drug?

To talk through how similar (and how different) Lipitor and generic atorvastatin are likely to be, I called William Pong, PharmD, administrative director of pharmacy services at Loyola University Medical Center in Maywood, Illinois, who regularly handles patient concerns and questions about generics versus brand-name drugs. The answer is a bit complicated, as you will see, but it is mostly reassuring. To receive FDA approval, generic drugs must meet a variety of criteria, including the following.

A generic drug must have:

• The same active ingredient or ingredients as the brand-name drug.

• The same strength as the brand-name drug.

• The same route of delivery (oral, topical, injectable, etc.).

• The same dosage form (capsule, tablet, etc.).

So, looking at that list above, you might think that it tells you all you need to know…generics are essentially identical to brand-name drugs…yay, generics! But that’s not the case, as Pong rightly pointed out—and it’s not all that you need to know.

The fact is, there is some wiggle room. When the FDA says that active ingredients need to be the same in generic and brand-name drugs, what it means is that the ingredients have to be what’s called “bioequivalent.” The allowable amount of the active ingredient in the generic drug can be within 5% of what’s in the brand-name drug. And the amount of the active ingredient in a generic drug that gets absorbed in your bloodstream usually falls within 10% of what’s absorbed from the brand-name drug (on average, research shows that the difference is within 3.5%). In other words, compared with a brand-name drug, you could potentially absorb 90% of the active ingredient in the generic drug…or 110% of it…or any amount in between.

So generics are not the same after all. The good news, though, is that Pong said that having a little bit more or a little bit less of the active ingredient in your bloodstream usually doesn’t matter, and here’s an example of why. Suppose that you decide to stop taking Lipitor and take generic atorvastatin instead, and you absorb only, say, 90% of the active ingredient that you were getting from Lipitor. The worst that could happen, Pong said, is that your cholesterol rises a point or two. Now say that you’re taking a different generic version of atorvastatin and you absorb 110% of the active ingredient that you’re used to getting—then your cholesterol might drop a point or two. Neither situation would be cause for concern, said Pong, because the differences are “clinically insignificant in terms of both efficacy and safety.”

The situation is worrisome, said Pong, if you’re taking one of the relatively few drugs that are considered critical-dose medications. With those, you may need to stick with the brand-name drugs. Lipitor is not a critical-dose drug…but to find out if any of your drugs are, talk to your doctor. Pong said that some examples include seizure medications and lithium for bipolar disorder.

Although the active ingredients are basically the same in brand-name and generic drugs, there are also a host of inactive ingredients, which are not necessarily the same. This means that you could have new side effects, depending on which generic you take, due to a new inactive ingredient. So if you switch to a generic and have a very mild reaction, Pong said to give yourself a day or two, because your body might adjust. But if mild symptoms persist or if you have a more severe reaction, call your doctor right away.

Also: Don’t be surprised when you first see your generic drug—it may have a different size, shape and/or color than what you’re used to, because the look of Lipitor is trademarked. And don’t get too used to your new generic version either—because if a generic manufacturer quits making it or raises the price, your pharmacy might start getting a generic from a different manufacturer. So your pills could even look different from month to month. (See Daily Health News, March 26, 2011, “Why It Matters What Your Pills Look Like.”)

All in all, if you switch to a generic version of Lipitor, you’ll probably be paying less—but prices aren’t going to drop significantly immediately. In an unusual deal, during the first six months that Lipitor is off-patent, the FDA has given permission to make and sell generic versions of the drug to a limited number of manufacturers—a partnership between the companies Ranbaxy and Teva…and also the generic division of Pfizer—yes, that Pfizer. So look for the price to start tumbling around May, when the race to produce generic atorvastatin becomes wide open.

Source:

William Pong, PharmD, administrative director, Pharmacy Services, Loyola University Medical Center, Maywood, Illinois.

What if I were to tell you that there is a life-threatening disease out there that usually has no symptoms and now kills more Americans than HIV — and that most of the people who die from it are middle-aged? Unfortunately, this is all true. Ironically, we’ve all heard of this disease — it’s hepatitis C — but few of us appreciate how dangerous it has become.

To learn why hepatitis C (or “HCV,” with a “V” for virus) is on the rise and why it hits middle-agers the hardest, I called John A. Donovan, MD, a hepatologist and an assistant professor of medicine at the University of Southern California’s Keck School of Medicine in Los Angeles.

HCV is a bloodborne infection that can be transmitted through a needle (like a drug or tattoo needle). from mother to child during birth… through unprotected sex with an infected partner… and you may remember that in a recent Daily Health News story (see the January 2, 2012 issue) I told you that, though it’s not as common, you can even get HCV at a barbershop or a nail salon if the manager doesn’t impose strict hygiene rules and a contaminated instrument nicks your skin.

But why is HCV on the increase? According to Dr. Donovan, the reason is that until 1992, there was no test to detect HCV in the blood, so it was also transmitted in hospitals through blood transfusions and organ transplants. “There has been a delay in the outbreak of the disease because it can take decades for HCV to quietly cause significant liver disease — the first symptom is often a serious health problem like cirrhosis” (when scar tissue replaces normal liver tissue), said Dr. Donovan. Before 1992, the dangers of bloodborne infections weren’t nearly as well-known as they are today — so there weren’t programs in place to warn people about the risks. “In other words,” said Dr. Donovan, “this is a tsunami wave that started decades ago but is now cresting.”

Dr. Donovan said that the HCV upsurge mostly affects baby boomers (as opposed to older people) because in the 1960s, 1970s and 1980s, there was a rise in intravenous (IV) drug use, and during those years, baby boomers were in their teens, 20s and 30s and most likely to participate in risky activities like that. People older than baby boomers who missed the drug culture of those eras might have contracted HCV through a blood transfusion or an organ donation, for example, but since it can take decades for the disease to develop, HCV isn’t affecting as many in that population — probably because they will likely die from something else before HCV manifests itself.

Testing for HCV is currently recommended by the US Preventive Services Task Force and National Institutes of Health only for people with known past exposures or risks, such as IV drug use and those who got blood transfusions or organ transplants before 1992. But since baby boomers are at higher risk and the disease can progress without symptoms, some doctors, according to Dr. Donovan, are more aggressive and prefer to test everyone born between 1946 and 1964.

If you are too embarrassed to talk to your doctor about some previous risky behavior and ask for an in-office blood test, donate blood. All donated blood is screened for HCV. If screening shows that you have HCV antibodies in your blood, you will be told, and you will need more tests to determine whether your liver function is compromised and how much of the virus is in your blood.

But don’t panic. Only about 20% of people with HCV develop cirrhosis, and only 1% to 5% of that group dies from its consequences (liver cancer or liver failure). Meanwhile, even if your liver is healthy, it’s important to know whether you have HCV because certain habits, such as consuming alcohol, can accelerate its progression. So the earlier you know, the earlier you can start protecting yourself with lifestyle changes.

Source:

John A. Donovan, MD, assistant professor of clinical medicine, department of medicine, Keck School of Medicine, University of Southern California, Los Angeles.

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Source(s):

Michael J. Decker, PhD, RN, RRT, D.ABSM, Byrdine F. Lewis Chair in Nursing, associate professor, nursing, neuroscience, respiratory therapy, Byrdine F. Lewis School of Nursing & Health Professions, Georgia State University, Atlanta. Dr. Decker is a spokesperson for the American Academy of Sleep Medicine.

Brett Levinson, MD, ophthalmologist, Select Eye Care, Baltimore, clinical instructor in ophthalmology, University of Maryland School of Medicine, Baltimore.

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Source(s):

Hugh S. Taylor, MD, chief of reproductive endocrinology and infertility, director, Yale Center for Reproductive Biology and professor of obstetrics, gynecology and reproductive sciences at the Yale University School of Medicine, New Haven, Connecticut.

• Parkinson’s disease. It appears that exposure to pesticides may trigger Parkinsons’s disease in genetically predisposed people. In a large 2006 study, researchers at Harvard School of Public Health found that participants exposed to pesticides (specifically, farmers, ranchers, fishermen and people who used pesticides in their homes or gardens) had a 70% higher incidence of Parkinson’s than those who weren’t exposed. The latest research, reported in February 2011 and conducted by the National Institute of Environmental Health Sciences, shows that people exposed in their professions to the pesticides paraquat or rotenone developed Parkinson’s approximately 2.5 times more often than people who were not exposed. Both pesticides cause cellular damage. Paraquat, in particular, is an extremely toxic substance originally developed as an herbicide.

• Dementia. A study that collected data between 1997 and 2003 from French vineyard workers who spent at least two decades applying pesticides to plants or working in buildings where pesticides were housed showed that these workers scored low on a test of memory and recall. Researchers speculate that the changes demonstrated in the mental functioning of these people indicate that they may eventually develop a neurodegenerative disease, such as Alzheimer’s.

• Infertility. In a 2008 review of studies on pesticide exposure, epidemiologists showed a decline in the semen quality and quantity of farm workers, which impaired male fertility by 40%. “Infertility, especially in men, is increasing in proportion to greater exposure to pesticides,” said Dr. Pimentel.

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Source: Julie L. Ryan, PhD, MPH, is an assistant professor of dermatology and radiation oncology at the University of Rochester Medical Center in Rochester, New York, and author of a study of 644 cancer patients, most of whom had breast cancer.

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Source: Stacy Drinkut Smith, LAc, Dipl OM (diplomate in Oriental medicine), is a licensed acupuncturist and herbalist specializing in women’s health. She is the cofounder of Points of Health, a clinic in Santa Barbara, California. www.PointsOfHealth.org

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When was the last time you tried something new and different, something you didn’t already know how to do? If it has been a long time, consider what might be holding you back. Challenge yourself to create a vision for a new and different future — what might it look like and what you would like your vision to achieve or gain. Would you like to change careers? Overcome your fear of flying so that you can take an overseas vacation?

Does change — no matter where or what kind — scare you? Do you avoid potentially fun or enriching experiences so you don’t have to risk the unknown?

Complete this sentence: “I need courage to __________.” Perhaps that would be speaking up to your boss next time he/she speaks disrespectfully to you… going to a meeting of Weight Watchers or Overeaters Anonymous… pushing yourself to buy workout wear and go to a Zumba class… or even dating again after a painful divorce. Whatever your need for courage might be, filling in the end of that sentence will give you a good idea of where in your life you may want to think about practicing courage now.

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• Stop when tired. Pitchers who end up needing surgery as a result of overuse tend to be the ones who kept pitching when they were fatigued.

• Rest is important. Pitchers should avoid overhead throwing completely for at least two to three months a year — although a four-month break from competitive baseball pitching every year is preferred.

• Keep track of innings pitched. Learn and adhere to the recommended limits for pitch counts and days of rest (one to four days, depending on the number of pitches). You can find details on the ASMI Web site, http://www.asmi.org/asmiweb/position_statement.htm.

• Do not pitch on multiple teams with overlapping seasons unless you can keep to the guidelines above.

• Learn and use good throwing mechanics (just as pro pitchers do). There are many young pitchers who are effective on the mound — for now — but whose pitching form is almost guaranteed to overstress their arms and shoulders. Working with a fitness coach and pitching coach/instructor is a good idea.

• Avoid using radar guns to frequently measure the speed of young pitchers’ throws. This may lead them to focus too heavily on speed at the expense of protecting their arms.

• Do not pitch and catch in the same game.

• Don’t “push through” pain. If a pitcher complains of pain in his elbow or shoulder, get an evaluation from a sports medicine physician.

• Encourage young pitchers to have fun playing a variety of sports so that they strengthen different combinations of muscle groups and avoid overuse.