Are Generic Drugs Different? You Bet!

Posted 05/19/2014

Bob lay wide awake at 2 AM, wondering if he’d even taken his Ambien. Melissa’s hands and feet felt cold and she was losing hair. She knew these underactive thyroid symptoms well and quickly scheduled an appointment to ask about increasing what she thought was her Synthroid prescription. Despite enjoying a relatively calm life, Peggy’s panic attacks were back and one morning she realized they’d re-started just a few weeks after her familiar Lexapro tablet began looking different, the label on the bottle now reading “escitalopram.”

Welcome to the world of generic drugs, “world” a completely accurate term when you consider that pharmaceutical companies, both brand-name (Big Pharma) and generic (Generic Pharma), market their products globally and that every country has its own rules and regulations regarding drug patents and generic drugs.

And yes, using generic drugs can save you a bundle, provided–and this is a big caveat—that what you’re taking is actually doing its job.

Bob, Melissa, Peggy, and hundreds of millions of patients around the world are on the sidelines of the incredibly complex dance among Big Pharma, Generic Pharma, and those who pay for their goods. This third group may be a health insurance company, a country’s government, or you yourself, paying out-of-pocket after shopping around for the best price.

Generics

Generic drugs have been around for decades, first appearing in the 1930s when the patents on wonder drugs like antibiotics expired and smaller drug manufacturers were allowed to copy the formula to produce generics. It wasn’t long before the wonder drugs of the 1930s morphed into the out-of-the-park cash cows of the late 20^th century. This occurred because the right of Big Pharma’s brand-name drug to exclusivity, while varying from country to country, generally runs for nine years before the generic companies can move in and flood the market with their own less expensive product.

Except for comparatively low co-payments, most people have their drug costs covered by health insurance and therefore you’ll rarely know the actual price of a brand-name drug unless a particular one isn’t covered at all. In this case, you’ll experience sticker shock extraordinaire, as I did when a small tube of ointment had an out-of-pocket price of $1200.

A more familiar example is the $7-per-tablet (not a misprint) antidepressant Lexapro, the brand-name version of generic escitalopram. With millions of people taking Lexapro and its earlier version, Celexa, insurers were pouring money into Forest Labs until the generic became available at (ready for this?) two cents per tablet.

Big Pharma justifies its mind-boggling prices by claiming it’s simply recouping its research, development, advertising, and distribution costs as well as storing up money to cover the cost of drug flops. These are drugs they develop that ultimately fail in clinical trials or for whatever reason aren’t approved by the Food and Drug Administration (FDA).

You can imagine the bevy of Generic Pharma companies salivating as the patent protection clock ticked down on lottery-winning drugs like Lipitor (atorvastatin), Ambien (zolpidem), or Lexapro. You can also imagine that Big Pharma regards the Generics as a swimming pool filled with thrashing piranha. Witness the 12% drop in fourth-quarter profits at Eli Lilly when duloxetine, the generic version of Cymbalta, hit the market.

Are brand-name and generic versions the same?

We want them to be because it’s hard not to love that 99.97% price drop from Lexapro to generic. The answer, though, is slightly more complex. By law the two versions of the same drug must be close, but not necessarily identical. Big Pharma’s original version, for better or for worse, is the one you take during the first nine years of patent exclusivity.

When that ends, Generic Pharma certifies to the FDA that its version is bioequivalent (biologically equivalent) to the brand-name version. This means their product acts in your body almost like the original.

Almost?

The concept of bioequivalence has been bandied about among attorneys for Big Pharma and the FDA (and similar regulatory agencies worldwide) for years. Currently, a generic drug must work at least 80% as well, or 125% better, than its brand-name counterpart.This means if you think of the brand-name drug as 100% (Lexapro is 100% Lexapro, n’est-ce pas?) then a generic can be as low as 80% of the brand-name drug or as supercharged as 125% of the original.Some observers, myself included, have issues with the honesty and openness of virtually all drug studies, whether they’re being performed by Big Pharma or Generic Pharma. A generic product may contain the right amount of medication, but its tablet coating or binding ingredient may not release the active ingredient as efficiently as the original. We won’t know this, however, until enough Bobs report insomnia, enough Melissas lose their hair, and enough Peggys report panic redux.

For a long time, when drugs weren’t as insanely priced as they are now, health insurance companies simply bit the bullet and covered expensive brand-name drugs as they were brought to market. But as prices kept escalating and more and more generics became available, insurers dug in their heels and made it difficult for doctors to prescribe new drugs.

If, for example, a new antidepressant hit the market, the insurance company would demand a good explanation from the prescribing doctor for why she chose the new one over a cheaper generic. To get the new medication covered, a doctor either had to show she’d tried two or three other drugs first (called “step therapy,” which I wrote about in an earlier Health Tip) or complete pages of paperwork or write appeal letters. This excellent physician behavioral modification program actually worked. Many doctors simply don’t bother to write prescriptions for new drugs, and the pharmaceutical reps who once filled doctors’ waiting rooms have gone the way of the passenger pigeon.

In addition, most health insurers no longer give you, the patient, an option to choose brand-name over generic. Let’s face it, if you owned an insurance company would you pay $7 a pill or opt for a version that cost two cents?

How to protect yourself when taking generics

To avoid the miseries of Bob, Melissa, and Peggy, keep these ideas in mind:

• It’s likely not your imagination if a generic medication seems not to be working as well as its brand-name counterpart. If the FDA allows the generic to be 80% as effective as the brand-name, you may well feel that difference.
• You’ll notice this difference only for drugs taken to relieve specific symptoms, like insomnia, anxiety, or underactive thyroid. Your doctor will have to unearth other areas where a drug may be failing you, such as blood pressure or blood sugar creeping upward and out of control. (“Are you really taking your medicine every day?” your doc may ask.)
• If a generic drug is not on target, it’s usually because it’s weaker rather than stronger. In some cases, this can be offset by increasing the dose (10 mg of Lexapro often requires 15 mg of escitalopram). Your doctor should make this decision.
• In other situations, you really don’t want to keep increasing your dose because then the drug starts losing its effect altogether. The sleep drug Ambien (zolpidem) is a good example. One solution might be to switch to a different drug in its class, like Lunesta. Another is to do some homework and find out which of the generic zolpidem products works most like the original. Interestingly, you can uncover this information in internet chat rooms in which patients share information. It was from a chat room that I learned a company called Qualitest made a zolpidem most equivalent to the original Ambien. From the website www.stopthethyroidmadness.com I learned the best form of thyroid replacement was either from Canada or from two small companies, Nature-Throid and Westhroid. The now-departed Dominick’s Pharmacies stocked Qualitest zolpidem, but today you’ll find it mainly at independent stores like Braun PharmaCare.
• If you know your body and know you felt best with a brand-name medication but can’t afford America’s egregious pricing system, buy it online from a Canadian pharmacy. A branded drug from Canada is exactly the same as the branded one in the US, but a fraction of the price (30 tablets of Canadian Lexapro 10 mg is $40, while the same amount of US Lexapro is about $200). To order your meds in Canada, go to this website and click the “How to Order” tab. The pharmacists are very helpful, Canada-nice, and will verify that what you’re buying is precisely the same product as the brand-name version in the US. You then get a prescription from your doctor, fax it to Canada, and your drug appears in about three weeks.
• If you’re happy with generics but want the best price, use Costco (you needn’t be a member to use the pharmacy), Walmart, Sam’s Club, or Target. Be aware that if you’re paying out-of-pocket for your generic, Walgreen’s is dramatically overpriced. CVS and Osco are a bit better, but not much.

This has been an unusually long Health Tip and I assume if you don’t take any prescription drugs you pressed the Delete button paragraphs ago. Remember, as always, that by keeping yourself active and healthy you’ll be less likely to be involved with the pharmaceutical industry at all, an ideal state of affairs.

Be well,
David Edelberg, MD