Baum, Hedlund, Aristei & Goldman is interested in representing people who have taken Vytorin and live in any of the following areas in California: Los Angeles County; San Luis Obispo County; Ventura County; Santa Barbara County; or the San Francisco Bay Area.

The cholesterol lowering drug Vytorin and its parent companies Merck and Schering-Plough are facing several congressional investigations and proposed class action lawsuits. This controversy stems from the long awaited and possibly suppressed results of a clinical study made public on January 14, 2008 comparing the benefits of Vytorin with one of its components, Zocor. http://energycommerce.house.gov/Press_110/110nr171.shtml

Vytorin, a heavily marketed combination drug made up of Schering-Plough’s newer drug Zetia (ezetimibe- intended to cut cholesterol levels) and Merck’s older generic drug Zocor (simvastatin), has been advertised as a "highly effective cholesterol lowering drug." It is also three times more expensive than Zocor, which has remained on the market as a well studied and cheaper generic cholesterol lowering pill.

The controversial "ENHANCE" clinical trial was originally formulated in 2004 to show the benefits of taking the combination pill Vytorin over Zocor alone. Once the results were finally made public, it was apparent that the study did just the opposite. Results showed that Vytorin did, in fact, do a better job at lowering cholesterol levels but it failed to decrease plaque build up more than Zocor did by itself. Plaque build up in the arteries is a key factor in heart disease that can lead to heart attacks or strokes. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01784.html

Lowering plaque build up in the arteries is a very important factor in cholesterol medication since high cholesterol alone is not a killer, but the effects of it can be, i.e. heart disease and stroke. These results mean that Vytorin is not more effective in reducing heart disease than Zocor alone, and may, in fact, put users at risk.

Contact Baum Hedlund
today for a free consultation
if you took Vytorin.


The ENHANCE study, which lasted two years, began in 2004. It wasn’t until after Congress demanded results that the information was released.
http://energycommerce.house.gov/Investigations/DrugSafety.1211047.Merck.ltr.pdf

Rep. Bart Stupak, Chairman of the Subcommittee on Oversight and Investigations, has announced he will hold hearings into what Merck and Schering-Plough knew and when.
http://www.newsweek.com/id/94969

Chairman John Dingell of the House’s Committee on Energy and Commerce also sent a letter to the CEOs of Merck and Schering-Plough on February 11, 2008 investigating whether anyone within Merck or Schering-Plough knew the results of the ENHANCE trial prior to the official release of data in the January 14, 2008 press release. The Committee is concerned about the withholding of clinical trial data since postings appeared on a pharmaceutical sales representative website as early as March 13, 2007 revealing the ENHANCE trial results, nine months before Merck/Schering-Plough released the unblinded data.
http://energycommerce.house.gov/Press_110/110-ltr.021108.ENHANCE.ScheringMerck.pdf

Congress is also investigating the truthfulness in direct-to-consumer ads promoting Vytorin since studies existed suggesting the drug may perform no better than generic cholesterol medicine. Congressmen from the House of Representatives' Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations sent letters to the companies probing the "withholding of clinical trial data that may significantly affect the medical management of hypercholesterolemia, as well as the use of misleading statement in direct-to-consumer advertisements for prescription medicines."
http://energycommerce.house.gov/Press_110/110-ltr.011608.ScheringPloughMerck.pdf

Officials are also reviewing whether sales of stock by certain insiders were appropriate, since the revealing of results have caused the companies' stocks to sink. Merck’s stock has dropped 20% and Schering-Plough’s stock has dropped 30%. Many are wondering if the companies’ statements to investors were accurate in the past couple of years, and are seeking answers. The Chairman of the House Committee on Energy and Commerce sent a letter on January 22, 2008 to Merck/Schering-Plough investigating the fact that a Schering-Plough officer sold a significant number of shares of Schering-Plough in the time between the end of the ENHANCE study and the release of the results on January 14, 2008, raising the question as to whether this sale was related to any knowledge of the study’s results. 
http://energycommerce.house.gov/Investigations/DrugSafety.012208.ScheringMerck.ENHANCE.ltr.pdf

The Senate Finance Committee, led by Sens. Max Baucus (D-Mont.) and Charles Grassley (R-Iowa), has made similar requests regarding Vytorin, including asking the companies to explain when they first unblinded their controversial ENHANCE study data, and to account for sales and payments made for the cholesterol drug to Medicaid. Senator Grassley is continuing his inquiries related to Vytorin and has asked the drug makers for documents and a list of all company statisticians who had access to the ENHANCE trial data. Grassley has expressed concern that individuals who had early access to this data could have learned that Vytorin did not offer more value than an inexpensive statin. http://www.senate.gov/~finance/press/Gpress/2008/prg021208.pdf

In the recent backlash and media storm, other officials are taking notice. The Attorneys General of New York and Connecticut  are launching investigations against the companies to determine if they deliberately concealed the results of the ENHANCE study in order to profit from its sales. Sales of Vytorin and Zetia (a component) were up to $5 billion last year.
http://www.oag.state.ny.us/press/2008/jan/jan28b_08.html
http://www.pharmalot.com/2008/01/connecticut-ag-is-the-latest-to-probe-vytorin/

Perhaps the most important critics, and those most affected by this controversy, are those who trusted Merck and Schering-Plough and used Vytorin to lower their cholesterol. In a statement, Director of Public Citizen’s Health Research Group Sidney Wolfe, M.D. said:

Users of the prescription cholesterol medicine Zetia and Vytorin received some troubling news from the makers of the drug today: Although the pills they're taking lower their cholesterol, there is no evidence that they reduce the risk of heart attacks and strokes, and may, in fact, be putting them at risk.

We first warned against using Vytorin, a combination of Zetia and the cholesterol drug Zocor (now generically available as simvastatin), in December 2004 on our Web site, www.WorstPills.org. At the time, we said that people should wait at least seven years before taking this new drug, considering that Vytorin wasn’t a "breakthrough" drug, which offers a documented advantage over older, proven drugs.
http://www.citizen.org/pressroom/release.cfm?ID=2586

Consumer fraud lawsuits are being filed across the country as a result of company claims about Vytorin’s efficacy. One class action suit against Merck and Schering-Plough claims that the companies have known the clinical trial results for two years. Another class action claims that the trial results were purposefully concealed.

Links to Senator Grassley's Vytorin Investigation:

Sen. Grassley asks questions about controversy over delayed release of drug study involving Vytorin

(*) Grassley letter to the American Heart Association
(*) Grassley letter to the American College of Cardiology
(*) Grassley letter to Schering-Plough
(*) Grassley letter to Merck
(*) Grassley letter to the Securities and Exchange Commission