Statins Harm Mitochrondria
Written by Sadaka Associates
Wednesday, 27 February 2008 20:47
Statins, the wildly popular cholesterol-lowering drugs, may interact with at least one blood pressure drug to damage the mitochondria, the powerhouses of cells, the researchers reported in the journal Nature Biotechnology.
The mitochondria are structures in cells that make adenosine triphosphate, or ATP, which helps power cells. Mootha’s team tested more than 2,000 drugs on cells to see how they might interfere with this process. Their test looks at gene function, ATP levels and other measures of how well the mitochondria are working.
Many patients who take statins have reported side-effects that include muscle pain and weakness. The cause is not well understood but Mootha has long suspected the mitochondria are involved.
The effects have been hard to pin down because studies of different groups have produced conflicting results. Mootha’s team said their findings showed some statins lower ATP levels and interfere with the mitochondria.
“Of the six statins present in our screening collection, three (fluvastatin, lovastatin and simvastatin) produced strong decreases in cellular ATP levels and (mitochondrial) activity,” they wrote. Fluvastatin is sold by Novartis under the brand name Lescol, lovastatin is sold under the brand name Mevacor and simvaststin is sold as Zocor.
Three others —atorvastatin, made by Pfizer under the brand name Lipitor, pravastatin or Pravachol, made by Bristol Myers Squibb and rosuvastatin, sold under the Crestor brand name by AstraZeneca —had little effect, they said.
Merck and Schering-Plough Continue to Feel the Heat
Written by Sadaka Associates
Friday, 15 February 2008 02:08
A House committee implied today that Merck and Schering-Plough were aware months before they issued preliminary results of the ENHANCE study in a press release that the trial was negative.
The committee made public several anonymous emails posted on an industry chat site suggesting knowledge up to nine months before release of the preliminary data that ezetimibe/simvastatin (Vytorin) had fared no better in the trial than simvastatin alone for familial hypercholesterolemia.
The preliminary results, disclosed in the press release on Jan. 14, suggested that the combination reduced LDLs by 58%, but with no significant reduction in atherosclerotic-plaque progression.
The press release had been preceded by questions from the committee about why it took nearly two years to obtain results from the study, which ended in April 2006. The committee alleged that the companies were intentionally withholding the results of the ENHANCE study.
At an FDA press conference on Jan. 25, where the agency announced it will review the safety and efficacy of ezetimibe/simvastatin, John Jenkins, M.D., director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, said the data were not unblinded until December 2007, a delay that he said was not unusual in “a complicated trial.”
Now Rep. John D. Dingell (D-Mich.), chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-Mich.), chairman of the Oversight and Investigations Subcommittee, have revealed what they say are emails suggesting the companies knew of the trial’s bottom line as early as last April.
The emails on a Web site called cafepharma.com, said the committee, included anonymous posts that state:
April 13, 2007 “Have a buddy at [Schering-Plough Research Institute]. He says the study is a bust. Adding Zetia to already maxed-out statin is useless.”
June 3, 2007 “Heard it crashed and burned.”
Sept. 10, 2007 “One of my docs is a very good friend of the PI overseas. I’m told that the study IS negative in that there is absolutely no difference in carotid IMT between simva 80+placebo vs. simva 80+Zetia 10.”
Nov. 14, 2007 “Word of mouth from investigators involved in running the trial is that it’s a negative study. We and Merck both talked up this study publicly a bunch before the results were known internally. Now both are stone cold silent.”
The committee sent letters to Cafepharma and both pharmaceutical firms asking for details and explanations.
A Merck spokesperson said the company will cooperate with the committee. “Merck stands by the safety and efficacy profiles of both Zetia and Vytorin,” the spokesperson said. “The company acted with integrity and in good faith in this clinical trial.”
Learn More: MedPage Today
Contact Us | Vaginal Mesh Injury | Help for Gardasil Injury
Copying text from this site is prohibited by copyright law.
Please note that you are not considered a client until
you have signed a retainer agreement and your case has been accepted by us. Prior
results do not guarantee or predict a similar outcome with respect to any future matter.
ATTORNEY ADVERTISING
Law Offices of Sadaka Associates represents drug injury clients in drug injury lawsuits nationwide, including Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.
We also serve the cities of New York, Los Angeles, Chicago, Houston, Phoenix, Philadelphia, San Antonio, San Diego, Dallas, San Jose City, Detroit, Jacksonville, Indianapolis, San Francisco, Columbus, Austin, Memphis, Fort Worth, Baltimore, Charlotte, Boston, Seattle, Washington, Milwaukee, Denver, Louisville, Las Vegas, Nashville, Oklahoma City, Portland, Tucson, Albuquerque, Atlanta, Long Beach, Fresno, Sacramento, Mesa, Kansas City, Cleveland, Virginia Beach, Omaha, Miami, Oakland, Tulsa, Honolulu, Minneapolis, Colorado Springs, Arlington and Wichita.
__________________________________
Law Offices of Sadaka Associates LLC
20 North Van Brunt Street
Englewood, NJ 07631
Phone: 201-266-5670 Fax: 201-266-5671
