June 25--The seizures are less frequent for Melissa Linz since her radical brain surgery in December, when 3 inches of gray mater were removed from her skull. But the Shaler woman is convinced she might not have needed that surgery in the first place if her anti-seizure medication hadn't been changed by her health insurance company.

She, along with millions of other patients and policyholders each year, found herself the unwilling casualty of prescription switching -- a doctor prescribes one medicine, but the government or a health insurer wants you to use another, usually a generic brand, because it's cheaper.

And usually, that's a good idea. Using the cheaper medicine tempers the growth of pharmaceutical expenses across the system, saving American consumers tens of millions of dollars a year. It's why most health plans, both private and government-run, have "preferred" drug lists and specific formularies detailing what drugs will be covered by which policies under which circumstances. And it's why the Drug Price Competition and Patent Term Restoration Act was approved by Congress in 1984 to make generics more widely available to U.S. consumers.

Often, the generic substitute is chemically indistinguishable from the prescribed brand-name drug. Within the industry, that would be called a "therapeutic equivalent."

But sometimes -- and more often, it is claimed, in the case of patients with epilepsy, and with endocrine and thyroid drugs -- switching a prescription can have unintended health effects. The medicines aren't always identical; switching to those drugs is called "therapeutic substitution."

"You pick a brand-name drug you feel would be best for the patient," said Dr. Anthony Uberti, who has a practice in New Wilmington, Pa., north of New Castle. "The pharmacist calls us back and tells us, 'We have to try another one.' "

In Ms. Linz's case, she'd suffered seizures for years, but after much searching had found a medicine that seemed to control them. Following the removal of a benign brain tumor, Ms. Linz, now 25, was seizure-free for about 21/2 years while using Trileptal (product,search), an anti-seizure medication made by Novartis. She'd graduated from Duquesne University, had a full-time job and was able to drive a car (state law requires drivers with histories of seizures to be seizure-free for at least six months before they are able to legally drive).

But one day, "my medication came in the mail as usual. I called my neurologist," because her usual Trileptal prescription had been changed -- without her knowledge, and not at her doctor's request -- to generic oxcarbazepine.

Her seizures returned just a few weeks later. She and her doctor tried different combinations of medications for the next few years -- including, with Highmark Inc.'s approval, an eventual return to Trileptal -- but nothing worked, she said.

"I couldn't get back under control," she said.

And that led to her second brain surgery, last December.

In trying to save money -- and promote patient well-being -- insurance companies establish various care and prescription drug protocols. Just as a doctor can sometimes be overruled when he or she wants to administer a certain test, the same can happen when the doctor prescribes a certain drug.

But because so much of today's health-care system is pharmaceutical-based, on a daily basis doctors and insurers are more likely to butt heads over prescriptions than quality-of-performance protocols.

Insurers (and the employers providing the health insurance policy) set up formularies and drug tiers, and patients are steered to generic tiers initially. If an insurance company, or employer, makes changes to a policy, brand-name drugs that formerly had been OK to prescribe can be shifted to a "not-preferred" or "not-covered" list. That can change the availability of certain medicines midtreatment. Doctors and patients can appeal the decisions, but that can be a time-consuming process, taking months to try out various drug combinations, working your way up from the generic list to brand-preferred drugs, to brand-not-preferred, to drugs that aren't covered.

Still, in most instances, this works out; in Pennsylvania, generic substitutes are required to be offered to patients as they come onto market.

Yet in some cases, the generic version could be less effective than the brand-name, according to Big Pharma. That's because the Food and Drug Administration allows generics to be substituted for brand names so long as the drug is at least 80 percent as effective as the original. It's called the "plus-or-minus 20 percent" rule -- if the generic differs by more than 20 percent by way of the dose absorbed or the absorption speed, the FDA won't approve it as a substitute.

Usually, the swing in efficacy isn't big, just a few percentage points. The FDA's website says the "average difference in absorption into the body between the generic and the brand-name was only 3.5 percent," according to studies.

But brand-name pharmacology companies, naturally, say that window leaves too much room for error. They spend billions every year advertising their products directly to consumers, and historically have lobbied doctors and pharmacists about the alleged dangers of switching to generics. (In 2008 alone, 80 bills were introduced in 35 state legislatures, seeking to exempt -- or "carve out" -- specific classes of drugs from the states' substitution laws.)

It's a stigma that health insurers and generic drug makers have been fighting for decades, as brand-name companies try to protect their turf.

The generics drug makers call it a misinformation campaign. And when you see campaign activity spike, "you can usually correlate that to seeing the brand product or patent about to expire," said Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association.

"Everyone needs the right medicine for the right condition, absolutely. But if a generic is available, and it's out there," the science shows that generics are generally just as effective as brand-name drugs, she said.

Physicians -- who say they want the freedom to treat patients as they see fit -- often side with the major drug companies on this issue, arguing performance-bonus programs that reward doctors financially for prescribing generic drugs are not in the best interests of patients. Last month, the American Medical Association (a trade group for physicians) issued a proposed "health insurers code of conduct." Included was a section on medical necessity, recommending that insurers "must not use financial incentives that discourage the [prescribing of] medically necessary care."

In the same month, the Epilepsy Foundation of Georgia won the passage of a state law that will require Georgia pharmacies to indicate on the bottle label if the pharmacy, at the insurer's request, has switched from a brand name to a generic.

But generic-drug makers say that for every case like Ms. Linz's, there are millions where the generic medication provided the desired pharmacological effect, at a fraction of the cost. The Generic Pharmaceutical Association says that over the last 10 years, generic substitutes for brand-name drugs have saved the insurers and the U.S. health system $731 million.

Dr. Uberti said he realized that insurance companies must do all they can to cut costs, including drug costs, but he also said the current insurance appeals system is too cumbersome and takes too long. The initial appeals are usually made to someone with limited medical knowledge; only later can the prescribing physician talk to a staff doctor or the insurer's medical director about a patient's specific needs and symptoms, he said.

"I'm not naive. I know these insurance companies can't cover everything. But there's got to be a better way than what we're doing," he said.

"It costs my practice a ton of money. If I'm on the phone, I'm not seeing patients."

Bill Toland: btoland@post-gazette.com or 412-263-2625.

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