Health

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Do You Know Where Your Prescription Drugs Come From?

Have you looked at the fine print on your prescription drug bottle lately?

drug origin

MrConsumer decided to check his bottles and made a surprising discovery.

*MOUSE PRINT:

drug origin closeup

What? These pills purchased from CVS/Caremark mail order came from India? Yep. And apparently this is not an isolated case. For many generic drugs today, either the main ingredient or the finished pills themselves come from either India or China. Who knew? (You knew if you saw the story about the book, China Rx, a few weeks ago in Consumer World. The book describes lax inspection of pharmaceutical factories in foreign countries, including inadequate inspections by the FDA.)

While this particular manufacturer put its full address on the bottle as the law seems to require, some others just list the manufacturer’s name leaving you, the customer, to guess what the country of origin really is.

Don’t you want to know where the pills you take come from?

For more on the hiding of the origin of foreign-manufactured drugs, see David Lazarus’ column in the LA Times.

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Is This Stuff Really “Ice Cream?”

A new brand of “ice cream” called “Enlightened” has hit the market claiming only 60 – 100 calories per serving, with “more protein and less sugar.”

They picture 27 varieties of pints of ice cream in fancy flavors like this on their website:

Enlightened 4 pints

Each of the descriptions under those containers, and even the containers themselves call the product “ice cream.” And on individual product pages, the manufacturer repeatedly refers to the product simply as “ice cream.”

Red Velvet on web

Under federal law, a “standard of identity” defines when you can label a product as “ice cream”:

“Ice cream” is a frozen food made from a mixture of dairy products, containing at least 10 percent milkfat. It also cannot be aerated (“overrun”) by more than 100%. And a gallon must weigh at least 4.5 pounds. [language simplified]

Their nutrition label on the red velvet “ice cream” flavor, for example, reveals a fat content of only 2 grams in a 70 gram (half cup) serving:

nutrition label

So clearly, there is not at least 10% milkfat in this product, and therefore legally it cannot be simply labeled “ice cream.”

You can’t tell looking at the pictures of the pint containers on the website, but a visit to a grocer’s freezer case reveals a secret on the package.

*MOUSE PRINT:

fine print

At the very bottom of the container in the tiniest print, which many people might miss, it says “low fat ice cream.” And that is completely different from plain old “ice cream.”

Federal law requires conspicuous disclosure of the legal name of the product, the statement of identity:

…be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed. 21 CFR 101.3

And under separate FDA rules, products can be labeled as lower in fat if they meet these requirements:

  • “Reduced fat” ice cream contains at least 25 percent less total fat than the referenced product (either an average of leading brands, or the company’s own brand).

  • “Light” or “lite” ice cream contains at least 50 percent less total fat or 33 percent fewer calories than the referenced product (the average of leading regional or national brands).

  • “Lowfat” ice cream contains a maximum of 3 grams of total fat per serving (½ cup).

  • “Nonfat” ice cream contains less than 0.5 grams of total fat per serving.

    • Because this flavor of Enlightened has less than three grams of fat per serving, it can and must be labeled as “low fat ice cream” and not merely “ice cream.”

    We asked Enlightened how the company could refer to these products merely as “ice cream” under the standard of identity and it referred us to the above chart.

    Is the fine print disclosure they make on the container sufficient disclosure to purchasers? Are repeated references merely to “ice cream” in marketing materials and on the package misleading? We filed a complaint with the FDA asking them to look at this case, and we’ll report their findings (if any).

    We’re not alone in raising questions about these newfangled “ice creams.” A class action lawsuit was filed last month against Halo Top, the most famous of these new lower calorie brands, making similar allegations as we have about Enlightened. (Hat tip to TruthinAdvertising.org for this lawsuit.)

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    Is Your Pharmacy Tattling on You to Your Doctor?

    This week’s story questions whether a druggist who believes that a patient is not taking their prescription should squeal on them directly to their doctor.

    A couple of weeks ago, MrConsumer got an unexpected letter from his primary care physician (PCP). It said:

    Letter from doctor


    Say what? My mail order pharmacy, CVS/Caremark, wrote to my PCP to tell her I might not be taking my medications properly, urging her to be in touch with me (hence she sent the letter above).

    Here is the fax they sent her:

    CVS Caremark fax

    Apparently, this is what happened. For years, I have been taking simvastatin to help lower cholesterol. I get 90-day prescriptions filled via mail order from Caremark, and the last time I ordered it was January 15th. Sometime shortly after April 15th, when I had not yet reordered it from them, CVS/Caremark took it upon themselves to notify my doctor. In turn, she sent me the above letter expressing concern.

    No, MrConsumer is not having a problem taking the drug daily. He simply had several weeks of pills left over since prior prescriptions were received in advance of them actually being needed. We have all experienced the practice of pharmacies telling us way in advance that it is time for a refill when we still have plenty of pills left from the last one.

    On one hand, maybe Caremark should be thanked for putting the patient’s health ahead of privacy concerns. But on the other hand, it feels like the company was overreaching, going behind the back of the patient to his PCP to tattle on him, without asking the patient first if he was having a problem. Of course, they did send me refill reminders.

    A quick review of CVS/Caremark’s terms and conditions and privacy policy on its website did not reveal any specific disclosure that such contacts would be made. However, in its HIPAA policy, it made this broad disclosure:

    *MOUSE PRINT:

    Uses and Disclosures of Your PHI for Treatment, Payment and Health Care Operations

    We may use and disclose your PHI for treatment, payment and health care operations without your written authorization.

    PHI is information about you that we obtain to provide our services to you and that can be used to identify you. It includes your name and contact information, as well as information about your health, medical conditions and prescriptions. It may relate to your past, present or future physical or mental health or condition, the provision or health care products and services to you, or payment for such products or services. [Definition inserted to guide readers.]

    The following categories describe and provide some examples of the different ways that may use and disclose your PHI for these purposes:

    Treatment: We may use and disclose your PHI to provide and coordinate the treatment, medication and services you receive. For example, we may:

    Use and disclose your PHI to provide and coordinate the treatment, medication and services you receive at CVS Health. Disclose your PHI to other third parties, such as pharmacies, doctors, hospitals, or other health care providers to assist them in providing care to you or for care coordination. In some instances, uses and disclosures of your PHI for these purposes may be made through a Health Information Exchange or similar shared system. Contact you to provide treatment-related services, such as refill reminders, adherence communications, or treatment alternatives (e.g., available generic products). [Emphasis added.]

    This says that your personal health information, including your prescriptions, can be disclosed to third parties, such as doctors, to assist them in providing care to you. However, it says Caremark may contact YOU, the patient, with “adherence communications.” It doesn’t explicitly say, however, that they can contact your doctor with respect to your staying on your regimen.

    Mouse Print* contacted CVS/Caremark to get an explanation of their practice of contacting doctors to report patients who may not be adhering to their prescriptions. Here are excerpts from their response:

    Taking medications as prescribed is one of the most important things patients can do to get and stay on their path to better health. Non-adherence to prescribed therapies comes at a significant cost to patients’ health and finances, as well as to the entire health system.

    One of the ways we encourage adherence is through our clinical program that reviews members’ prescription refill behavior for maintenance medications, including drugs prescribed to help manage a patient’s cholesterol. Through this program, we send refill reminders and late-to-fill outreach to plan members and engage prescribers when members are past due for refills.

    Our adherence outreach program is consistent with HIPAA and our own privacy policy… -Mike DeAngelis, Senior Director, Corporate Communications

    I really have mixed feeling about this, as expressed above. What do you think? Do you want your druggist to notify your doctor when you don’t get a timely refill of a maintenance drug?