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

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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

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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).

Trials whose outcomes were based upon the effects of bleeding (but not clotting) allowed the pharma company to compare the drug to other agents which could cause bleeding, improving its safety profile at the time of approval. Investigators yesterday published results (from the Archives of Internal Medicine) based upon their research on trial meta data which showed an increase in adverse cardiovascular effects and death in over 70% of those trials done as of 12/2000.

Cumulative pooled analysis of all randomized, placebo-controlled trials demonstrates a trend toward increased cardiovascular risk associated with rofecoxib compared with placebo as early as December 2000, the comparison reaching a P value of .05 by June 2001, nearly 3

1/2

years before the manufacturer’s voluntary market withdrawal.

In response, Merck stands by its claim that it acted responsibly in removing the drug when it did (after results of the APPROVE trial, the study which demonstrated reofecoxib’s risk of causing clotting), refuting the Archives results yesterday as reaching “incorrect conclusions”.

Lost in all of this could be faults in the drug approval process itself. If Vioxx wasn’t fast-tracked for FDA approval, could there have been greater transparency in the approval process — delaying release of the drug to the marketplace after it was more thoroughly surveilled? Was Merck fully aware of the adverse events in found in 2000 trial data, thereby allowing selective publication of favorable results on a potential blockbuster drug? Most importantly, is this still happening? | LINK

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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

1. Last year, the ENHANCE trial showed Vytorin, made of ezetimibe (Zetia) and simvastatin (Zocor), did no better job of treating clogged arteries than simvastatin alone.
2. These include diarrhea; dry skin; headache; itching; stomach upset; temporary skin redness, tingling or feelings of warmth and flushing.

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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

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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

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• Apparently not much is being done to to force fiduciary relationships between pharma companies and the physicians who study and test devices on their patients as subjects. A report [PDF] commissioned by the HHS Dept. confirms the findings.
• FT Editorial: Time for a stronger FDA.
• A parting gift of sorts for Pharma from the outgoing Bush administration? Congressional Democrats decry the FDA guidelines which will allow pharma companies to advise physicians on off-label uses of medications described in the medical literature. Since these guidelines do not represent FDA-approved indications for the drugs, Democrats are calling foul, implying a carte blanche atmosphere for ultimate sanctioned widespread utilization of treatments not appropriately studied and vetted normally.
• Citing “computer failures”, Indiana-based Wellpoint (the nation’s largest insurer via revenue) tries to explain why it has cut off prescription drug access to its elderly beneficiaries.
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