In August, the U.S. Food and Drug Administration granted approval to a first-of-its-kind medication — an epilepsy drug created with a 3D printer.

3D printing could help lower drug costs, but even with better technology, many patients feel medicines are still too costly. Politicians in Washington, D.C., and in state capitals are floating a potential solution: price controls on certain expensive drugs.

Though well intentioned, these proposals are disasters in the making for patients with epilepsy and other serious diseases. There’s no surer way to eliminate the next generation of breakthrough treatments than to deprive research companies of the possibility of making a return on their investment.

Epilepsy is as widespread as it is serious. Today, more than 2 million Americans suffer from epilepsy. Roughly 200,000 people will receive an epilepsy diagnosis this year. And as many as 50,000 Americans will die due to epilepsy-related seizures this year.

The disease is a financial as well as health burden on patients. Medications cost thousands of dollars a month, and epilepsy-related ER visits cost hundreds of dollars out of pocket even for those with insurance coverage. Annually, the United States spends more than $15 billion on epilepsy care.

Despite the prevalence of epilepsy, there have been few recent advances in epilepsy treatment. Many new drugs are just re-purposed versions of older treatments, and most have significant side effects. Some patients must take as many as a half-dozen medications and still can’t do the kinds of things most people take for granted — hold their children, travel alone, or drive a car.

New treatments are desperately needed.

Epilepsy patients deserve affordable medications. And there’s no question that many drugs can be expensive. But those calling for price controls fundamentally misunderstand the drug development and pricing processes.

Simply put, medicines are expensive because research and development is expensive. According to a Tufts University study, creation and approval of a new drug takes on average more than 10 years and costs roughly $2.6 billion.

Drug companies must develop hundreds or thousands of compounds in the lab until they find one promising enough to enter human testing. Barely one-in-10 of those drugs in human testing goes on to win FDA approval. So new drug prices are based on the need to recover the costs of not only the drugs that make it to market, but the many more that don’t.

With price caps, pharmaceutical companies will have a worse chance of earning back their development costs. Thus, they’ll be reluctant to properly fund future research and development.

Our nation is the most important pharmaceutical developer in the world, partly because price controls in other countries have impeded their drug development efforts. Since the 1970s, America’s share of total new medicines developed has virtually doubled, from 31 percent of global drugs to 57 percent.

Proposals to implement price controls here in the United States could reverse our progress.

Many in Washington want the government to negotiate drug prices for Medicare Part D — the federal insurance program which provides drug coverage to 37 million seniors and people with disabilities. Given the government’s ability to deny coverage to a drug unless pharmaceutical firms offer a certain price, these negotiations would essentially function as price controls. In Massachusetts and Pennsylvania, lawmakers are debating bills that would set caps on drug prices.

Price controls will prevent the development of breakthrough treatments for epilepsy and other diseases. Ironically, the effort to cut costs via price caps could increase overall health care spending.

That’s because prescription drugs drive down long-term health care expenditures by helping patients manage their conditions. A 2011 study published in Health Affairs reveals that patients with chronic diseases such as congestive heart failure, hypertension and diabetes reduce medical spending by as much as $7,800 a year when they properly follow a prescription drug regimen.

In short, better pills result in fewer trips to the doctor’s office and emergency room.

To deliver better treatments to patients with epilepsy and other diseases, politicians could speed up the approval process for new medicines. And to deliver cheaper treatments, they can prohibit insurers from forcing people to pay astronomical out-of-pocket fees.

However, price controls won’t result in better or cheaper treatments. They’ll simply ensure that new treatments never materialize.

Kristine Binette serves as Maine field service coordinator for Epilepsy New England, which seeks to find a cure for, overcome the challenges of, and stop deaths related to epilepsy.

Printing prescription pills

The prescription pill, Spritam levetiracetam, will be used to treat certain types of seizures in epilepsy patients. The drug’s manufacturer, Aprecia Pharmaceuticals, says it makes the oral medication through a three-dimensional printing process, which builds the pill by spreading layers of the drug on top of one another until the right dosage is reached.

That technique allows the pill to deliver a higher dosage of medicine — up to 1,000 milligrams — while being porous enough to dissolve quickly. Those attributes can be particularly beneficial for patients who have a hard time swallowing their medication.

Aprecia expects the drug to be available early next year for adults and children.

Source: Money Magazine