The DOJ decision has been handed down. Merck Co. will pay $321.6 million in criminal fines and $628.4 million as a civil settlement agreement. It also will plead guilty to a misdemeanor charge stemming from the premature marketing of the market-recalled drug targeted to treatment of rheumatoid arthritis, usurping FDA approval for that indication.
Merck agreed to pay an undisclosed sum to the states of Florida, New York and South Carolina to resolve suits alleging the drug maker failed to adequately warn patients of Vioxx’s risks before halting sales in 2004, Russ Herman, a lawyer for former users of the drug, said in the Nov. 10 filing.
For those who have already forgotten, Vioxx was yanked from the pharma marketplace in 2004 after evidence showed the drug doubled the risk of heart attack and stroke. In 2007, three years later, the company paid $4.85 billion to settle approx. 50,000 Vioxx-related lawsuits. | LINK
With the recent story of Vioxx — and its potentially troublesome adverse effects possibly being known to its pharma company before initial launch — hitting the wires yesterday, there is renewed concern of the process by which study results, both public and non-published, be made available for public vetting.
Merck, the pharma company behind Vioxx, has stated that – from study results it commissioned at the time — that its decision to release the drug was based upon sound trial data obtained from carefully analyzed and interpreted information from pooled meta-analyses. Of course, it is now known that these security measures did little to prevent the deaths directly attributed to Vioxx — a problem the FDA has since countered by setting up its own internal resources for analyzing data from meta-analyses.
But, it doesn’t appear to be enough. Some members of Congress are mulling ways of providing drug data transparency, via the FDA, directly to consumers and healthcare providers once a new drug hits the marketplace. Sounds good in theory, but the costs to institute such primary evaluation points for every single new drug application would probably be prohibitive at the very least. | LINK
Pharma company Merck withdrew the popular anti-inflammatory agent Vioxx (rofecoxib) from the marketplace in 2004 for increased risk of death due to adverse cardiovascular events, including death. This followed testimony from that company’s CEO before a committee in the Senate in which he said that there was no difference in cardiovascular risk between this drug and placebo — based upon “combined data from randomized controlled clinical trials”.
Could the CEO have been relaying data based upon selective manipulation or interpretation of trial results? This combined data he was referring to was the result of meta-analyses, or pooled trial results from several smaller studies utilized to obtain more favorable results better than individual trials alone. Increasing the statistical power meant that this statement could have been made, as trials involving rofecoxib up to late 2001 had results based upon outcomes data involving bleeding — but not clotting (the major risk associated with the cardiovascular deaths in the plaintiffs’ cases against Merck).
Continue reading »
How can a drug’s study results involving just over 200 or so participants shake up healthcare policy? If the name of that drug is Zetia, there’s already enough political baggage that is making that happen. Statements like the following from the study’s lead investigator are pretty definitive — and to Merck, pretty damning:
“The results are very clear,” says lead investigator Allen Taylor of the Medstar Research Institute. “Niacin was superior.”
You read right. Niacin, a commonly used (and cheap) B vitamin did a significantly better job of shrinking artery plaque than the billion-dollar blockbuster ezetimibe (Zetia), also a component in the top-selling agent, Vytorin. Critics may claim — and rightly so — that this trial, involving just 208 people — is just too small to have a significant impact on clinicians who prescribe Zetia and/or Vytorin to treat this country’s number one killer — heart disease. However, there is no denying that the impact beyond this result is huge and is based upon the fact that ezetimibe’s lackluster trial data was the third iteration in two years[1] to challenge the effectiveness of one of the world’s most popular heart drugs, with $21B in sales since it was introduced in 2003.
The result was so pronounced that the study was stopped in 14 months. Although the use of ezetimibe, an expensive branded drug not automatically covered on all drug plans, was not found to be superior to the much, much insanely cheaper niacin, it does represent a niche for doctors treating patients who have yet to reach cholesterol goals and who cannot tolerate some of the more bothersome adverse effects[2] of niacin. Of course, Merck “stands by” Zetia, but they have to be preparing themselves for the inevitable onslaught of patient concern of paying in a major way for a drug found to be no better than a lowly B vitamin in the treatment and secondary prevention of heart disease. | LINK
Pharma giant Merck created a completely bogus medical journal creatively entitled the Australian Journal of Bone and Joint Medicine to publish data favorable to its products. This really comes as no surprise at the hands of a pharma company whose faulty data (which probably had its genesis in other phony peer-reviewed throwaways) led to the yanking of Vioxx from the pharma marketplace almost five years ago and its current struggles with personal injury payouts to this day. As much as it is tremendously easy to point the finger at the pharma company in instances like these, some of the fault has to lie with physicians and healthcare organizations who, without sound policies policing the matter, lend their (financial) resources to these shady projects. | LINK
It’s a marriage of self interests among Pharma and Big Insurance. Merck and Cigna just announced a partnership which involves the applications of drug discounts from the pharma company as a benefit to the healthcare payer if patients “perform” well on those covered drugs.
What are those drugs? Two key players in the next generation of agents Merck is positioning for heavy market growth and consumer use — Januvia and Janumet, both of which contain the main chemical ingredient, sitagliptin. Merck is not requiring that those drugs be solely repsonsible for good diabetes control in patients on other anti-diabetic drugs, of course; but the designation of Januvia and Janumet as “perferred agents” in the Cigna formulary makes this sort of surveillance a little easier — which is why the insurer is in talks with three other drug classes. | LINK
Originating from Saint Paul, Minnesota, [doctorpundit.com] is a weblog about the policy of healthcare and where it intersects with politics and public opinion; it is edited by Michael Douglas, MD, MBA. Welcome, and please consider my take on what is Healthcare 2.0, complemented by a few of my thoughts on my personal avocations and guilty pleasures: music, prose, and writing. Follow Doctor Pundit via RSS above.
Infographic: Learn about the rise of the digital doctor http://t.co/XRefG3sk #Hcsm #Hc
RT @reedsmith: Infographic: Rise of the Digital Doctor http://t.co/FgZuSXL0 #hcmktg #hcsm #mccsm #mdchat
RT @LavaLandBlog: #HIPAA Compliant Email Solution By MostHost: http://t.co/I127VLzM
RT @LavaLandBlog: #HIPAA Compliant Email Solution By MostHost: http://t.co/I127VLzM
RT @LavaLandBlog: #HIPAA Compliant Email Solution By MostHost: http://t.co/I127VLzM
DOCTOR PUNDIT @ ONE YEAR | An occasional DP series from 2010 highlighting healthcare policy trends over the period from 2009-2010 in a compare/contrast format.
