Should Patients Take Prescription Statins without Physician Supervision?

In November, the patent protection of the statin and world’s best selling drug, Lipitor (atorvastatin) is set to expire. With 4.3 million people in the US taking Lipitor, how much could this impact their quality of life? Would they remain on the drug, or would their physicians decide to prescribe them another statin?

Initially released in 1998, Lipitor had reached earnings of up to $12.9 billion in 2006, accounting for 27% of Pfizer’s total revenue. In 2010, it had earnings of $10.8 billion and accounted for 15.8% of total revenue even after the merger with Wyeth Pharmaceuticals.

Now that its patent protection is looming, the Wall Street Journal first reported that, according to unnamed sources, Pfizer is considering whether or not to pursue an over-the-counter (OTC) version of Lipitor as a way to “retain some of the $11 billion in annual revenue.” However, this pursuit will not happen overnight.

In order for this opportunity to occur, Pfizer will have to “convince the Food and Drug Administration that consumers could take the drug without a doctor’s supervision” — a difficult task, to say the least. Shelly Burgess, FDA spokeswoman said that “prior research on proposed over-the-counter statins hasn’t proven that most consumers will make correct decisions about taking the drugs,” but that “the agency is open to discussing OTC statins, as long as companies are ready to demonstrate that consumers will make the right decisions.” In fact, Merck and Bristol-Myers Squibb have failed to win the FDA’s approval for OTC versions of statin drugs Mevacor and Prevachol.

Although Pfizer has yet to announce its intent to pursue Lipitor as an OTC, MacKay Jimeson, the company’s spokesperson, wrote in an email that Pfizer has “strategic plans in place for Lipitor’s loss of exclusivity and will comment on further at this time.”

Reactions to this report

“I do not think it would be wise,” said Brian Strom, a professor of public health and preventive medicine at the University of Pennsylvania School of Medicine. He said patients taking statins should have periodic blood tests to gauge the impact on cholesterol levels, and people taking OTC versions might not get those tests.

Dr. Nieca Goldberg, director of The Women's Heart Program at NYU Langone Medical Center in Manhattan, worries about patients who are skipping checkups and halving pills to pare costs. "You can pretty much tell by the numbers when I check the patient's blood pressure or cholesterol levels that they've not taken their medications as often as prescribed,” said Goldberg.

"I'm a little concerned about it because it's a medication that has to be taken under the supervision of a physician," said Dr. Sachin Navare, staff physician, Providence Saint Joseph Medical Center.

"Even if the drug is safe in 99.9 percent of patients, there's a point-one percent chance you could have a serious side effect from the medication," said Navare. "I think you should be under the supervision of a physician."

"I'm happy about it," said patient Lydia Espinoza. "Because the cost of medication is extremely high, even when you do have insurance."

Kevin Pho, MD, founder and editor of KevinMD.com, wrote, “I think it’s unlikely that the FDA would approve OTC Lipitor. Not much has changed since the FDA rejected OTC Mevacor years ago. Patients still cannot make informed decisions as to when to take a statin, and high cholesterol doesn’t generate symptoms like, say, allergies. That’s why you can’t compare a potential OTC Lipitor with Allegra, Zyrtic or Claritin.”

Cardiologist Westby G. Fisher, MD, FACC, editor of the blog Dr. Wes, believes that it is time to let Lipitor go over the counter. “Give patients the benefit of the doubt regarding their intelligence and offer them an opportunity to drive down prices by having more options for their lipid management. Let them follow their own lipid and hepatic panels with home testing. I know it will be hard not to send all those electronic prescriptions via electronic medical records to all those pharmacy benefit managers in charge of all of those pharmacies out there, but maybe this is exactly the innovation our health care system needs to cut costs."

On his blog, internist Dr. Matthew Mintz wrote, “The reason why Pfizer wants Lipitor OTC is for one reason: to make more money. They can argue that cardiovascular disease is the number one killer in the US, and by having Lipitor OTC, it will be available to more patients. However, because statins require blood work and medical consultations, the risk of harm to patients outweighs the potential benefits of greater availability.”

Do you think Lipitor should be approved as an OTC?

Are the concerns brought to light by the FDA legitimate?

Do you think the FDA might be more lenient in approving Lipitor as an OTC because it is a blockbuster drug?

Would you recommend that your patients purchase Lipitor as an OTC? Would you decide on a case-by-case basis?

Are you more apt to discourage patients from taking an OTC drug even if it’s a standout like Lipitor?