News of Note this past week

~ Gender disparities persist in treatment of stroke. Guess which direction this one cuts.

~ TANSTAAFL: Pfizer to disclose payments to doctors, researchers starting in 2010. All right, let’s hear it!

~ Second Stryker sales rep pleads guilty to misbranding a medical device. A

felony.

~ Ovaries can be safely saved in some endometrial cancers.

~ 9 flawed genes found in risk of heart attack. Ah, the plot thickens!

~ Are you what you eat?: Mediterranean diet could cut risk of dementia. Quick! Get me some fish and olive oil.

~ Bone drugs may help fight breast cancer. Nice added benefit.

~ Damaged spinal cords in mice improved by transplants of neural stem cells produced with human induced pluripotent stem cells. We can rebuild them .

~ Are fears over bioterrorism stifling scientific research?

~ Naturally occurring brain protein may slow or stop the progress of

Alzheimer’s.

~ Gene therapy offers hope of cure for HIV: bone marrow transplant breakthrough.

~ GM goats raised to produce human breast milk. Just had to include this

story, in light of the one right below!

~ FDA approves drug made in milk of genetically altered goats. This is the first time such a drug has been approved. They also looked back at 7 generations of the goats to look for adverse effects on the animals.

~ Epilepsy group asking lawmakers to prohibit pharmacies from switching prescribed meds to generics amid reports of increased seizure incidence with generics over brand name epilepsy meds. Hmmm . . .thought generics were supposed to be bioequivalent. Seems that is not always the case!

~ Wacky names for newly discovered fruit fly genes. Examples? “Cheap Date,” “I’m not Dead Yet” (otherwise known as INDY). Who said scientists have no sense of humor?

[Thank you to Lisa von Biela, JD candidate, 2009, UMN, Editor of the BioBlurb, from which this content is partially taken and edited. BioBlurb is a weekly electronic publication of the American Bar Association's Committee on Biotechnology, Section of Science & Technology Law. Archived issues of the BioBlurb, as well as further information about the Committee on Biotechnology, are available here.]

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.