Thursday, May 29, 2008

Ethics of Branded vs. Generic Drugs

On May 15, 2008, an article in the Wall Street Journal reported that a United States appeals court upheld a lower-court ruling striking down patents for Lovenox, an anticoagulant manufactured by Sanofi-Aventis. This may clear the way for generic competition.

When a pharmaceutical company discovers or develops a promising new compound, they apply for and receive patent approval, which provides for 17 years of patent protection and exclusivity. This gives them the sole right to sell the drug while the patent is in effect. However, as the patent nears expiration, other pharmaceutical companies are able to applications to the Food and Drug Administration to obtain approval to market generic versions of the brand-name drug.

The pharmaceutical companies claim that the period of market exclusivity enables them to recoup the cost of developing the new drug. However, pharmaceutical companies often try to extend the period of exclusivity by obtaining approval for their own generic version of the branded drug, which provides an additional 6-month marketing exclusitivity period. Also, they may try to obtain an extension on exclusivity by targeting special populations such as children.

The ethical dilemma raised here is how this marketing exclusivity for the pharmaceutical company affects the patients, those individuals with medical condition who need the drug. The availability of generic equivalents for brand-name drugs makes it easier for patients with low incomes or no health insurance to get the medications that they need. Very often, brand-name drugs are priced well beyond their means.

My mother had deep vein thrombosis and a pulmonary embolism 7 years ago and consequently has been on daily anticoagulation therapy ever since. She is at high risk for having another pulmonary embolism and approximately 30% of people who have pulmonary emboli die. When she was recently scheduled to have a hysterectomy, her hematologist recommended that she transition to Lovenox (enoxaparin, Sanofi-Aventis) during the week before her surgery and the week after the surgery. Subcutaneous Lovenox has a much shorter onset of action and half-life (12 hours) compared with the oral anticoagulant warfarin (4 to 5 days). So, this would enable her to receive anticoagulation therapy up to 12 hours before her surgery and again within 2 days after the surgery, reducing the amount of time that she'd be at risk for developing deep vein thrombosis or pulmonary embolism.

The real surprise came when my mother tried to fill her prescription for Lovenox. She is retired, but she does have prescription drug coverage. However, her co-payment for a 10-day supply of Lovenox injections was $900. That's right, $900. The insurance company was also paying $900. It turns out that Sanofi-Aventis does provide assistance for some patients who are unable to afford needed medication. However, when I downloaded the forms and helped my mother complete them, it turned out that her annual income was $1500 too much to qualify for assistance. So, she had to pay the $900 for the Lovenox. In her case, the risk was too great to go without the medication. However, now that she's had the surgery, she doesn't know how she's going to manage to pay her co-payment for all of the other related expenses--the hospital, the surgeon, the operating room, the anesthesiologist. She hadn't expected one medication to take all the money that she'd been setting aside in preparation for the surgery expenses.

So, I was pleased to read the news article about Sanofi-Aventis and to learn that generic versions of Lovenox might soon be available. Lower-priced generics will make it easier for patients like my mother to obtain the medication that they need for anticoagulation.
Hopefully, fewer patients will have to take pause to consider whether or not the risk of dying is worth the price of the drug.

No comments: