• Skip to main content
  • Skip to primary sidebar

An Inconvenient Truth: This Is a Woman

Don’t Get Angry, Get Active!

Hide Search

Vytorin — Another FDA Failure To Protect Public

H. Sandra Chevalier-Batik · April 8, 2008 ·

Big Pharma Giants Schering and Merck

Take Heavy Criticism Over Vytorin Failure

This week Merck executives are very grateful for the revenue predictions for their blockbuster HPV vaccine, GARDASIL. Profits are predicted to climb from $300 million to $4 billion over the next year. After the Vytorin debacle —they’re going to need the cash.

So lock up your daughters, bought and paid for Politicians like Texas Governor Rick ‘Executive Order’ Perry[1] are perfectly willing to help out their generous friends in the “name of good public heath policy”

Barbara Loe Fisher, in her powerful November 06, 2007 Blog, Vaccine Awakening

summarized the issue in one insightful paragraph:

“One day enough voters will figure out that vaccinating 300 million Americans and 33 million Canadians with multiple vaccines from cradle to the grave has more to do with keeping drug companies in the money than keeping people healthy. Then the politicians, who have committed hundreds of millions of taxpayer dollars to underwrite new product rollouts for pharmaceutical companies selling vaccines while shielding them from all liability for vaccine injuries and deaths, will be looking for another job.”

Vytorin — The Latest FDA Failure To Protect the Public

On Sunday [3/30/08], executives at Merck and Schering-Plough were visibly shocked when an expert panel here at the American College of Cardiology meeting told thousands of doctors not to use their top-selling drugs, Zetia and Vytorin. That night, at a press conference, they strongly contested arguments that they had not proved the drugs were safe.

On Monday morning, things got worse. Rival AstraZeneca said it had stopped its 15,000-patient clinical trial of its Crestor because an independent safety committee said there was proof the drug prevents heart attacks, strokes and deaths. The result came six months ahead of schedule.

For the medical community, the Crestor news is a big deal for two reasons. First, it provides definitive proof Crestor has lifesaving benefits like other statin drugs, such as Lipitor, Zocor and Pravachol. Second, it provides key evidence that these medicines can prevent heart attacks even in patients who have normal cholesterol but have other risk factors for heart disease.

In particular, the patients in the Crestor trial had high levels of C-reactive protein (CRP) in the blood. The protein is thought to be a measure of inflammation in the arteries, and inflamed arteries are more likely to develop the clots that cause heart attacks and strokes. The experiment was designed to test whether people who had normal levels of bad cholesterol but high CRP could be helped by statin therapy. Up until now, evidence for statins has been mainly in people with high “bad” cholesterol, properly known as low-density lipoprotein (LDL).

“It’s splendid news, and that’s sort of what they were waiting for to decide where CRP fit,” says Roger Blumenthal, who directs preventative cardiology at Johns Hopkins University. “This is a boon to AstraZeneca and the field.”

Weighing the proof that high CRP is a risk factor for heart disease that should be treated will have to wait until the study’s results are analyzed and presented. But the study could also be a big victory for Paul Ridker, the Brigham and Women’s Hospital cardiologist who headed up this trial and has spent a lot of his career doing pioneering work on CRP.

The study is more bad news for Merck and Schering-Plough , though. The American College of Cardiology panel and two editorials in The New England Journal of Medicine recommended sidelining use of Zetia, a kind of cholesterol drug that works differently from statins, and Vytorin, a combo pill of Zetia and the statin Zocor. Instead, they said, push the doses of statins where there is proven evidence.

“We now have data for every statin marketed that shows a reduction in morbidity and mortality,” says Steven Nissen of the Cleveland Clinic, who had recommended Zetia be treated as a “last resort” months ago. “This really does emphasize what the panel said yesterday. Whatever statins do, and however they do it, it really works across the entire class. It really is a tremendous emphasis that statins are the first choice and why they are the first choice.”

Nissen has a somewhat tangled history with Merck and Schering-Plough. He raised concerns about Merck’s Vioxx in 2001, before the drug was yanked from the market. And Merck and Schering-Plough scrapped plans to do a Vytorin imaging trial with him.

But the emerging consensus about Zetia has been striking: The majority of cardiologists interviewed at the American College of Cardiology meeting foresee a pullback in use of the drug until there is more science about how exactly it works. Merck and Schering-Plough have one trial testing whether Zetia prevents heart attack and stroke, and the study is not expected to end until 2012. The Zetia trial started exactly three years after the Crestor trial that was just halted, according to http://www.ClinicalTrials.gov.

[1] From Wikipedia

On February 2, 2007, Perry issued an executive order mandating that Texas girls be vaccinated with Gardasil, a newly approved drug manufactured by Merck that protects against some strains of the human papilloma virus which causes cervical cancer. The move made national headlines.[30]

Perry’s move has been criticized by some social conservatives and some parents due to concerns about the moral implications of the vaccine and safety concerns. On February 22, 2007, a group of families sued in an attempt to block Gov. Perry’s executive order.[31] Several financial connections between Merck and Rick Perry have been reported by news outlets, such as a $6,000 campaign contribution, as well as Merck’s hiring of former Perry Chief of Staff Mike Toomey to handle its Texas lobby work.[32]

Adding to the criticism of Perry’s order is what is viewed by some as a high price of the vaccine which is approximately $US360 in Texas.[33] Gardasil is a patent-restricted vaccine and Merck is the sole producer.

On May 9, 2007, Perry allowed a bill to go into law that would undo his executive order.[34]

Source: Forbes.com Matthew Herper, 03.31.08

Share

Filed Under: Big Pharma Watch, FDA Clinical Trials, Follow The Money Tagged With: Big Pharma Watch, FDA Clinical Trials, Follow The Money

Primary Sidebar

Categories

  • Attention-Deficit/Hyperactivity Disorder Medications
  • Big Pharma Watch
  • Biotech Industry
  • Birth Control
  • Breast Cancer
  • cáncer de cuello uterino
  • Cancer Research
  • Cervarix
  • Cervical Cancer
  • Clinical Trials
  • Diabetes
  • Domestic Violence
  • Drug Approvals
  • Emotional Health
  • FDA
  • FDA Black Box Warning
  • FDA Clinical Trials
  • FDA Failure To Protect
  • FDA Product Recall
  • Follow The Money
  • Gardasil
  • Gardasil®
  • Gender Bias
  • Gender Politics
  • genital warts
  • Guillain-Barre Syndrome
  • Hormone Cycle
  • HPV Infection
  • HPV Vaccine
  • HRT
  • HRT Side Effects
  • Influenza A Virus H1N1 Strain
  • Mammograms
  • Mandatory HPV Vaccination Policies
  • Medical Technology
  • Menopause
  • MERCK Watch
  • MMR vaccine
  • National Vaccine Injury Compensation Program
  • PAP Test
  • Prescription Drug Side Effects
  • Proactive Nutrition
  • Product Recall
  • Reproductive Health
  • Sexual Dysfunction
  • Sleep Loss
  • STD Infection
  • Stroke
  • Take Action!
  • Uncategorized
  • Unwanted Pregnancy
  • Vaccination Policy
  • VAERS
  • vaginal yeast infection
  • Virginity
  • Weight Gain
  • Women's Health
  • Women's Rights
  • Work Place Issues
  • World Health Organization
  • Yeast Infection
  • Your Body/Your Self

Archives

  • February 2010
  • October 2009
  • September 2009
  • August 2009
  • July 2009
  • June 2009
  • May 2009
  • April 2009
  • March 2009
  • February 2009
  • January 2009
  • December 2008
  • November 2008
  • October 2008
  • September 2008
  • August 2008
  • July 2008
  • June 2008
  • May 2008
  • April 2008
  • March 2008
  • February 2008
  • January 2008
  • December 2007
  • October 2007
  • September 2007
  • August 2007
  • July 2007
  • May 2007
  • April 2007
  • March 2007
  • February 2007
  • January 2007
  • December 2006
  • November 2006
  • October 2006
  • September 2006
  • August 2006
  • July 2006
  • June 2006
  • May 2006
  • March 2006
  • September 2005
  • June 2005
  • May 2005
  • December 2004
April 2025
S M T W T F S
 12345
6789101112
13141516171819
20212223242526
27282930  
« Feb    

Breast Cancer

  • Cancer Advocacy

Health Advocacy

  • Women’s Universal Health Initiative

Syndication

  • FDA MedWatch

Tags

Big Pharma Watch Birth Control Breast Cancer Cancer Cancer Research CDC Cervarix Cervical Cancer Children's Health Exploitive Behavior FDA FDA Approvals FDA Clinical Trials FDA Failure To Protect FDA Press Release Follow The Money Gardasil Gardasil Adverse Event Gardasil® GlaxoSmithKline GlaxoSmithKline Cervarix Gynecology H1N1 "swine flu" virus H1N1 pandemic influenza preparedness efforts Health Advisory HPV HPV-Associated Cervical Cancer HPV-Vaccination HPV Infection HPV Vaccine HRT Human Papillomavirus (HPV) Infection Merck PAP SMEAR PAP Test Proactive Nutrition Questionable Medicine STD Infection STD Vaccination swine flu vaccine Swine flu vaccine production Take Action! Uncategorized Woman’s Health Your Body/Your Self

Copyright © 2010-2025 Hands On WordPress · All Rights Reserved