Parker Waichman LLP

Vytorin Cancer Study Blasted in NEJM Editorial

Vytorin is in trouble again. An editorial in the New England Journal of Medicine (NEJM) has blasted an analysis that dismissed the cholesterol drug’s possible link to cancer. Concern about Vytorin and cancer surfaced in July, when the SEAS study was published, but since then, the makers of Vytorin have insisted that a higher incidence […]

<"https://www.yourlawyer.com/topics/overview/vytorin">Vytorin is in trouble again. An editorial in the New England Journal of Medicine (NEJM) has blasted an analysis that dismissed the cholesterol drug’s possible link to cancer. Concern about Vytorin and cancer surfaced in July, when the SEAS study was published, but since then, the makers of Vytorin have insisted that a higher incidence of cancer seen among patients taking the drug was an anomaly.

The SEAS study investigated the effects of Vytorin in patients with partial blockages of the aortic valve of the heart, known as aortic stenosis . According to the SEAS findings, Vytorin did little to help patients with aortic stenosis avoid other heart problems.

But even more disturbing, SEAS also found that Vytorin patients in the study had higher rates of cancer and cancer deaths. In the trial 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo. Of those, 39 people taking Vytorin died from their cancer, compared with 23 taking placebo.

Merck and Schering-Plough downplayed the SEAS findings, however, by using an analysis of SEAS conducted by Richard Peto, an Oxford University statistician. According to an article in Forbes, Peto “pooled data from two much larger ongoing studies of Vytorin and said they showed that the cancer risk was a statistical fluke. He called the contention that Vytorin could cause cancer ‘bizarre’.”

But the editors at the NEJM apparently aren’t satisfied with those findings. A link to cancer deaths “should not be assumed to be a chance finding until further data are in,” the editors wrote, adding that doctors and patients “are unfortunately left for now with uncertainty about the safety and efficacy of the drug.”

Vytorin is a combination of cholesterol-lowering Zetia (ezetimibe) and the statin Zocor (simvastin). As mentioned in the NEJM editorial, some have theorized that Zetia could cause cancer because it blocks chemicals called plant sterols, which may cause heart disease but could also have some anti-cancer effect. Unfortunately, some experts feel that Zetia’ potential cancer connection hasn’t been studied enough.

“ is certainly worthy of ongoing study, but it should not be used in clinical medicine until the justifiable and substantial cloud of uncertainty over it is resolved,” Allen Taylor of the Walter Reed Army Medical Center, told Forbes.com.

For his analysis, which was published in this month’s NEJM, along with the entire SEAS study, Peto lumped together data from two ongoing studies, SHARP and IMPROVE-IT, and found 97 cancer deaths on Zetia vs. 72 on placebo or Zocor. However, had he lumped the SEAS data together with SHARP and IMPROVE-IT, the cancer findings for Zetia would have become statistically significant.

The editors at the NEJM think he should have combined all three studies. Dr. Stephen Nissen, the prominent Cleveland Clinic cardiologists whose studies of drugs like Avandia have raised important safety issues, agrees. Nissen told Forbes that the cancer risk – along with a lack of evidence showing that either Zetia or Vytorin is more effective at stopping heart attacks than other cholesterol drugs – raises serious questions about whether either should be used.

It took years before a big study was launched to prove Vytorin does anything more to prevent heart attacks than statins alone –and it won’t be done until 2012. In January, a smaller study, ENHANCE, found that Vytorin was no better at preventing clogged arteries than statins.

Nissen obviously feels more studies on Vytorin’s effectiveness should have been done before it went on the market. But instead, Nissen told Forbes, “What they did was spend hundreds of millions of dollars annually on direct-to-consumer advertising.”

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
My daughter was in a bad car accident and I was so overwhelmed by everything happening. Ms. Josama and Gillian made me feel at ease during that process and worked their best on my daughter's case. I would surely work with Parker Waichman again. Thanks guys.
Marjorie Rene
5 years ago
5 Star Reviews 150
The Law firm of Parker Waichman has been very professional in keeping me updated with all of my legal issue. They have been very informative and also showed empathy towards me. My paralegal Tina has been excellent and shows a caring spirit. From the beginning she has been on top of her game. Tina is a great asset to the law firm
Ryan Howell
5 months ago
5 Star Reviews 150
Settled my case faster than expected! I didn’t have to deal with the paper work it all! PW is fantastic!
Erik Little
7 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038