Did The ENHANCE Trial Enhance Anything?
10 CommentsBy Ed Silverman // April 7th, 2008 // 9:39 am
A loaded question, no doubt. And the answer depends on who you ask. Late Friday, the National Lipid Association reacted to the ruckus over the Vytorin study by issuing a statement saying that “nothing in this study has changed our position about the necessity for lipid lowering or the need to treat patients to established National Cholesterol Education Program goals.”
We were implored by some to mention this statement over anger at the ACC presentation last week of the Enhance trial, which found Vytorin failed to show any benefit over the much cheaper Zocor in reducing plaque in the carotid artery, and even showed a statistically insignificant buildup, although it did a better job of lowering LDL in a small group of patients with inherited high cholesterol. We were also asked whether this is a front group for pharma. The NLA notes that all nine of those who signed the missive have ties to Merck and/or Schering-Plough. So judge for yourself.
Meanwhile, Schering-Plough ceo Fred Hassan tells The Star-Ledger of New Jersey how he scrambled after the cardiology meeting and the subsequent plunge in the drugmaker’s stock price to axe more than 5,000 jobs. “It’s really very refreshing and energizing to see people just come together and in a very good way,” he tells the paper. “We had the whole team there working together” to draft the cutback plan.
However, Joel Hay, professor of pharmaceutical economics at the University of Southern California, tells Investor’s Business Daily that the real issue raised by the debacle is less about treating cholesterol than the way the drugmakers handled the trial data. “Clearly, they were reluctant to give up the $5 billion Vytorin franchise. Every month they can keep people thinking this is a useful drug, it benefits them.”
“The longer they could keep sales up, the more tens or hundreds of millions of dollars they’d bring in. It took them two years to release the clinical trial results. That gave them huge additional dollars of revenue. In the case of Merck you really have to wonder. This isn’t their first situation along these lines. It’s really starting to hurt their reputation. They seem to get into a stonewalling mode, which is not in the best interests of the company. It needs to promote science above all else.”
Lisa Van S
Im curious,… Has the National Lipid Association received financial contributions from industry? Like NAMI !
Bob Freeman
Lisa, I have no answer to your question but will offer some generalizations about the Ally Development function.
1) Ally Development is the function within a company that makes grants to patient groups, physicians associations, etc. Their budget comes from product teams, and most marketing people still view relationships as transactionsal: i. e., I give you $$$ and you do this for my product.
2) Patient groups and others resist direct pressure to take on product advocacy with these exceptions: 1) programs to give open access to all drugs within the therapeutic category are usually OK and 2). early access to new technologies are usually OK. The problem emerges when ally groups are encouraged to lobby the FDA for rapid approval or pressure state legislators to keep cost containment policies off the agenda. In other words, companies use ally groups for lobbying purposes when there’s agreement on strategy.
3) Most Ally Development people want long-term relationships whereas marketing people (who again control grants/budgets) want an ROI and there is usually a fair amount of friction between the groups.
It’s a messy area, one with which I have grave reservations about manipulation, etc., especially when it involves drugs that are still under FDA review.
Lisa Van S
Bob,
Thanks I appreciate that. This Vytorin issue hits home with me. My Mother has had carotid artery replacement, and has been on Vytorin, since Zocor and Lipitor provided no benefit. She suffered a stroke and a blood cot to her colon. She has had severe cardiovascular disease for many years. Its a damned if you do, and damned if you dont situation.
Bob Freeman
I’m very sorry to hear that, Lisa.
We are dealing with a crisis down here. One of our best and brightest young faculty members complained of an infected tooth and collapsed in the dentist’s office prior to having a root canal. He apparently is in septic shock with multiple organ failure. Very disturbing news and we’re all holding our collective breath.
Lisa Van S
Hope, all goes well.
MDMD
Ah, many members of the very wealthy “lipid mafia” weigh in. This members of this group of individuals has personally benefited dramatically over the past 20 years. many have them have made their personal fortunes as investigators, consultants, speakers and opinion leaders for the pharmaceutical companies that develop and market these products.
The money that has changed hands on individual and organizational levels will astound. They have no choice but to defend their income flow.
Farmanux News
[...] Carrie can help you Fred - or this.Ed at Pharmalot has the latest twist in the sorry tale. Source: [...]
Diogenes
“An important question is why these changes did not result in a more robust reduction in the rate of progression of coronary atherosclerosis . One potential explanation is the high rates of administration of other beneficial therapies in the study population. More than 80% of patients were receiving statins at baseline….”
Is this more excuses for the ENHANCE Trial?
No, actually this is Dr Steve Nissen trying to explain away the results of his negative STRADIVARIUS Trial in the current issue of JAMA.
HaHaHA. So when Dr Nissen finds it convenient to explain away his own results he uses the same argument he dismisses summarily for the ENHANCE trial. He also touts the effects on biomarkers which he dismisses as meaningless in the ENHANCE trial.
So much for the scientific integrity of Dr Nissen and his friend in Vioxx litigation, Dr Krumholz. These guys have have no credibility as they just have an axe to grind with Merck and Schering. They keep touting all the supposed misconduct of the trial and don’t really want to address a scientific discussion of the trial that others are now turning to.
SP 1
Thank God for the NLA. Bought and paid for, but money well spent. They want to protect their bank accounts as well.
harpy
“It’s really very refreshing and energizing to see people just come together and in a very good way,” he tells the paper. “We had the whole team there working together” to draft the cutback plan.
That’s the spirit! Nothing like the bonhomie created by laying off workers.