Cardiology Group Backpedals On Vytorin Flap
13 CommentsBy Ed Silverman // January 25th, 2008 // 12:25 pm
In an e-mail to its 34,000 members, the American College of Cardiology tries to walk a fine line. In its statement last week, the ACC urged doctors and patients not to panic over the results of the controversial Vytorin trial, which found no statistical difference in plaque in arteries being measured.
Since then, the ACC has become ensnared in investigations by the House Energy and Commerce Committee and the Senate Finance Committee as they probe how Schering-Plough and Merck handled the release of Vytorin trial data and the marketing of the widely promoted and expensive cholesterol med. In particular, the committees want to know the interplay between the drugmakers and the ACC, as well as the American Heart Association, both of which receive support from pharma.
Among those involved in drafting the ACC statement was Roger Blumenthal, a professor of medicine at Johns Hopkins University, who chairs the ACC’s committee on prevention of cardiovascular disease. However, Blumenthal is also on the speaker’s bureau for Merck and Schering-Plough, and has received unspecified research grants from Merck. An ACC spokeswoman last week told us the statement didn’t reflect the views of any one person.
Now, though, the ACC does a little backpedaling in its note by making clear its statement wasn’t an endorsement of Zetia, which along with Zocor comprises the Vytorin combo pill. Here’s the text of the e-mail….
By now you may have heard through media reports or word-of-mouth that the ACC is receiving inquiries from Congress and others regarding the release of a January 15 public statement regarding the Enhance trial. The College’s intent in issuing this statement was to advise our physician members looking for guidance in light of the Enhance trial data release. A long delay in the release of the data and highly focused media attention led to questions and concerns from our members and their patients. Our statement was designed to minimize undue panic and guide our physicians in communicating with patients about the new data.
The following statement further clarifies our position in light of recent inquiries and news reports:
“The American College of Cardiology (ACC) is concerned that recent news reports and advertisements for ezetimibe (Zetia) and ezetimibe/simvastatin (Vytorin) could be misinterpreted by patients as an ACC endorsement of ezetimibe for first-line treatment for high LDL (bad cholesterol) or to reduce further risks of coronary heart disease.
The ACC and American Heart Association have published guidelines which recommend that a statin be given as first-line treatment and that alternatives be used only when statins fail to be effective or are associated with significant side effects. The benefits of statins have been proven in large studies, while the effect of ezetimibe is unproven.
Nonetheless, if patients taking medications have questions about their treatment, they should discuss concerns with their physician before making any changes.
The ACC has provided guidance to all our members regarding the recent findings.”
The ACC will of course cooperate fully with all congressional requests for information related to the January 15 statement, including sharing our commitment to patient-centered quality and a high standard of professional ethics.
Thank you for your attention to this important matter.
Cardiology Group Backpedals On Vytorin Flap | Pharmacy Tips
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CVMD
The ACC is making a step in the right direction. I believe that they need to reveal who wrote the statement in the first place, their ties to the companies involved, and how much money that the ACC receives from those companies. It will be very interesting - I can promise you that. These opinion leaders and scientific societies have been out selling their allegiances to Big Pharma companies for many years! The numbers being bought will be shocking!
Nathan
“However, Blumenthal is also on the speaker’s bureau for Merck and Schering-Plough, and has received unspecified research grants from Merck”
It’s great to look for a smoking gun — but don’t always assume that you’ve found it. We in big pharma invite academic speakers all the time. We typically pay them their travel expenses along with a $1000-$2000 honorarium. We also give research money to academic researchers — usually that is considered a good thing by the public, but that money is rapidly drying up because of belt tightening and because sometimes it gives the appearance of a conflict of interest. Now it will be entirely up to your tax dollars to fund the research instead.
Do you know when that money was given? Was it while he was in a leadership role at the ACC? If not, then it is irrelevant.
Ed Silverman
Hi Nathan,
The issue is full disclosure, transparency and the ability to make disinterested decisions. This is not a new issue involving so-called key opinion leaders and the pharmaceutical industry.
To answer your question about timing, click on the link provided in the post that takes you back to my previous post, where the links to the disclosures are provided. Those links indicate ‘existing’ relationships. The first CME link is from 2006 and the other CME link is from July 2007. It is January 2008. In my view, that is very close timing.
I applaud the disclosure, but the existence of these relationships, I believe, is sufficient reason to question whether this particular physician should be in a position to have a significant role in making influential decisions on behalf of the ACC. That is the issue raised here.
Hope this helps,
ed
ol cranky
Nathan:
Just to add to what Ed said, some physicians are specifically courted by companies because they are or are expected to play significant and influential roles in medical societies. This has become really big business that has grown exponentially in the 15+ years that I have been in the industry and has gotten to the point that some docs negotiate by play companies against each other (i.e. they’ll say well X company gave me this . . .).
Even advocacy groups have gotten into the mix. Some advocacy groups get so much from one company that they won’t work with a smaller company (I heard of one that turned down a small grant from one company out of fear that their largest donor would withdraw their funding). Since non-industry grant funding has dried up, medical schools and other institutions are afraid to bite the hand that feeds them so there are now rumors that one company that has been known to throw their financial weight around to the point they essentially bought a department chairmanship. [These are things you're more likely to hear about in wars between mid-size companies against smaller competitors]
Atlex
I still don’t get it. I can’t imagine that there is anyone knowledgable about the healthcare industry who wouldn’t have already known that AHA and ACC receive signficant support from the pharma industry. They also receive support from other industries (eg, medical devices and probably health plans), as well. This feigned surprise is simply ridiculous.
More importantly, I still can find no place in the AHA or ACC statement where there is a full endorsement of Zetia or Vytorin, certainly not as 1st line treatment. Both organizations discuss the Enhance study and its merits (the study’s not the drug’). Both suggest that the study should not be used to draw firm conclusions (given the size and scope of the study). Both indicate, though, that Enhance raises a very legitimate possibility that the LDL reduction value of Zetia (and that portion of Vytorin) may not exist. That’s a reasonable conclusion. However, the study does not suggest any added harm and that’s a significant point.
Most importantly, both organizations suggest that patients should not make the decision to stop therapy without consulting their physician. No clinical harm is being done by using Vytorin or Zetia. Significant clinical harm could occur by stopping treatment without consulting a physician. From an adherence perspective, a patient stopping on his or her own will very possibly not go back to his or her physician and get a new script for a statin that they may need to reduce cholesterol. Their CV risk will, in most cases, increase as their cholesterol increases.
Personally, if I was on Vytorin, I’d probably discuss with my physician the possibility of switching to statin monotherapy. However, based on the responsible statements of these organizations and others, I’d keep taking my medicine until I had that discussion.
My final point, as I’ve said before, is this: what would you have wanted these organizations to state–”everyone panic, stop taking your medicine and don’t discuss this with your physician”?
In the end, would the AHA or ACC have said anything different if all of its money came from the man in the moon? Or, did they simply make prudent statements that were in the best interests of public health?
Ed Silverman
Hi Atlex,
I have no argument with prudent and conservative medical opinions. The issue that was raised with the AHA and ACC has to do with better disclosure. Not everyone, actually, was or is aware of the backing such groups receive from industry.
And right or wrong, the Vytorin maelstrom now causes all sorts of questions to be raised concerning anyone or any organization remotely connected to the affair.
Cheers
ed
Atlex
Ed,
It’s not as though the AHA is hiding anything. While it doesn’t list it’s donor list on every press release, it takes about 2 seconds on its website to find a list of pharma company donor along with amounts assocated with each company. Moreover, there is a pie chart showing what percentage of the organization’s total income is associated with pharma companies. This information goes back to 2004.
I’m beginning to believe that this is no longer about transparency. It’s just become another way to skewer the pharma industry and tarnish any organization willing to collaborate in any way. While critics of S-P/Merck and the industry have legitimate concerns (as I do about the way Enhance was handled), I also believe that much of this is pure politics–demonize an industry and anyone associated with it for political gain.
By the way, you write fairly regularly about compliance issues. Should every one of those entries mention that your website receives ad dollars from Seton Hall Law School for Compliance Certification Programs or is it enough that the average reader should be able to figure it out from looking at your website? I doubt that you’ve even thought about that as an issue; I also doubt that it has anything to do with your opinions. But, I bet I could convince someone already suspicious of the media that the ad dollars are influencing your viewpoint.
Atlex
Lisa Van S
Atlex
I think Im about to shock many!!! My Mother suffers from “severe” cardiovascular disease, and she has taken Zocor and Lipitor w/no benefit, and has suffered from a lot of side effects. She is now on Vytorin and doing exceptionally well w/ no side effects. Of course Im not promoting/just voicing personal experience. Still despise the prescribing of SSRI’s in kids!!!…
Ed Silverman
Hi Atlex,
Fair enough. But given the concern with transparency and the escalating controversy over Vytorin, taking an extra step in such situations isn’t a bad thing. And the issue that’s being raised is whether the AHA is sufficiently disinterested and credible. I’m not making a judgment; I’m reporting the connections and the interest in the connections.
As to demonization, I understand your point - some people do demonize the industry. And yes, this can be done for political gain. On the other hand, some of the questions being raised are legitimate and, perhaps, if these were raised earlier by elected officials over the past decade or more, the issues that now plague the industry and the public may have been headed off, or at least altered in ways that don’t result in a lack of confidence and, conversely, charges of demonization.
As for advertising, I’ve worked as a business journalist for large newspapers, and now run this web site, for more than 25 years and have heard the accusation before. In fact, I covered retailing for New York Newsday during the early and mid-1990’s, when many department-store chains were in bankruptcy or facing financial difficulties. That was a difficult time to pursue good stories, but that was my job - regardless of whether advertising dried up.
I do know this much - if this site, or any media outlet, were to studiously avoid writing provocative pieces about an advertiser on an ongoing basis, when such stories are warranted, it would eventually be noticed by astute readers, or viewers. The risk to credibility isn’t worth it, at least not in my view.
In short, I can only say what I’ve said all these years - I personally don’t solicit advertising and, at least, the public can see who is advertising with us, which is to say they can see where the dollars are coming from. Is that full disclosure? It’s there to be seen. And from that point on, readers/viewers can hopefully decide for themselves.
Does this help?
ed
Laurie
“It’s there to be seen. And from that point on, readers/viewers can hopefully decide for themselves”
And that’s the big difference. It’s there for all to see…not something we see in alot of industries.
Atlex
Ed,
First, and foremost, I hope you read my comment close enough to recognize that I was not making an accusation, but trying to be provocative. I absolutely understand and respect your positions and, for the most part, recognize that your role as a journalist requires you to view the world through a skeptical lens. Having a journalism degree (among others) myself, I am well aware of the dilemma faced by journalists working in media that accept advertising. Interestingly, it is rare for journalists to be questioned about slanted views due to advertising dollars. More often, media bias has other motivations– for instance, consider Fox News as a prime example. Of course, it should be pointed out that your industry, the media, was a prime supporter of continuing DTC advertising. I’m sure that the motivation came from advertising dollars, as well as public health and 1st amendment concerns.
My point is that we all have our own biases, driven by both monetary and nonmonetary motives. How far do we have to go to be transparent? Do we only have to mention our biases when we say something favorable? Or, should we be just as transparent when we speak negatively? As much as I disagree with Lisa, she’s made her bias fully transparent; reading her posts, I am fully aware of her motivations. I know that she’s going to blast the industry about anything related to mental health treatments. However, on every occasion where she is quoted in the press, should she have to state and should the reporter write that Lisa has a bias against the industry and why? This should be a two way street, but isn’t. Critics are rarely questioned about their motivations; very often altruism isn’t at the root of their criticisms.
I look forward to continuing this discussion.
Atlex
Ed Silverman
Hi Atlex,
No worries. I understand. I used myself as an example because I’d rather speak for me than anyone else. Besides, others who stop by may want to know what I think after reading the question you posed.
And yes, the media biz did, indeed, lobby DC about preserving DTC ads. No one consulted me, however, and so I had no input, before or after, although it would have been fun to be included in the process. Sailor vee, as they say in Texas.
And I agree - more questions should be asked about motivations or connections concerning all those involved or inserting themselves into a fracas. In my 12-plus years following pharma, including the past year running Pharmalot, I’ve noticed more journalists asking these questions recently and, gradually, extending their queries to a wider group of sources. But the key word is gradually.
I think it takes time for such practices to sink in, especially when editors and reporters rotate in and out of assignments or jobs. And there are no rules, as I’m sure you know, so determining when such info should be included as relevant is going to continue to be a judgement call. But I do think journalists need to be mindful of such things.
Didn’t know you had a journalism degree. I guess that makes you a ringer :)
Cheers
ed