Senate Wants Schering-Plough ‘49 Plan’ Papers
14 CommentsBy Ed Silverman // March 13th, 2008 // 2:47 pm
Citing a report in Pharmalot, the Senate Special Committee on Aging wants the drugmaker to hand over documents about its recently launched ‘49 Plan,’ a seven-week schmoozefest in which Schering-Plough reps are being encouraged to wine and dine docs over lunch or dinner. The idea is to remind them that the Zetia cholesterol pill is worth prescribing. The move comes after a big drop in Zetia scrips over the last several weeks.
Why the decline? The drugmaker’s controversial Enhance trial found that its Vytorin cholesterol pill 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. The results created a debate about the merits of using Vyotrin, which includes Schering-Plough’s Zetia and Merck’s Zocor.
And so Herb Kohl, the Wisconsin Democrat who chairs the committee, sent a letter today to Schering-Plough seeking details about the plan - a written description, the number of reps involved and their compensation, details on how the plan complies with industry guidelines and ethics, and any info on internal oversight. “I am troubled by any attempts to persuade physicians to prescribe a drug for any reason other than the patient’s condition and the drug’s effectiveness in treating it,” Kohl writes in the letter. “Unfortunately, it appears that your “49 Plan” may do exactly that.”
Coincidentally, Kohl held a hearing yesterday on a federal academic detailing plan, which some view as an alternative to the prevailing practice of giving docs the latest info on new drugs directly from drugmakers, mostly by way of sales reps. Academic detailing would use nothing but straight talk from specially trained medical professionals, who would distribute info researched independently by a team of doctors. Kohl plans to introduce a bill to create a federal program, much like one under way in Pennsylvania.
“Pharmaceutical reps often confuse educating with selling, and evidence shows that doctors’ prescribing patterns can be heavily influenced by these sales representatives,” Kohl said at the hearing. “Without academic detailing, physicians may not have access to information about the full array of pharmaceutical options, including low-cost generic alternatives. However, research has shown that when they do, doctors prescribe the best drug—not just the newest one—and healthcare spending is lowered.”
Last year, Kohl and Chuck Grassley, the Iowa Republican and Senate Finance Committee member, introduced the Physician Payment Sunshine Act, which requires drug and device makers to disclose the amount of money they give docs through payments, gifts, honoraria, travel and what-not. Pharma argues the bill will potentially restrict their ability to inform docs about new drugs, but Kohl says the academic detailing legislation under consideration will address the complaint.
Chris
Kohl says “Research has shown that when they do (have access to academic detailing) doctors prescribe the best drug - not just the newest one - and healthcare spending is lowered”
What research and how does he - a politician - judge “the best drug”? What on earth defines the best drug?
In his letter to Hassan he assumes wrongdoing with no evidence to suggest that any of the presumed misdemeanors are intended. I would like to see the same degree of enthusiasm given to introducing preventative plans that would reduce healthcare costs significantly more than this.
Ed - should ‘professioanals’ be hyphenated?
Ed Silverman
Hi Chris,
Yes, ‘professioanals’ must be hyphenated. I wish I rememebered to do so.
As to your observations, I can’t speak for Kohl, of course, and can only presume, for the moment, that he’s referring to the same research that Pennsvylvania officials have cited, according to what I remember reading. Not the most definitive response, I’m afraid.
And I don’t know more about the ‘49 plan’ that what I already wrote. I don’t know that Kohl is flatly stating that wrongdoing took place, but he wants to find out, right? Hence….the letter.
Now, back to the spelling bee.
ed
Doc
Chris and Ed,
As much as I hate to agree with Kohl, he is right on. The 49 Plan is a “soft kickback”. I can’t pay you outright anymore doc, but come to Ruth’s Chris and get ‘educated’ about the Enhance Trial. Wake up to what the industry is doing, helping millions of patients? Yes. But what percentage of the time is the data that is detailed slanted to show best effect with little to no fair balance? At least 50%. Oh and by the way remember, don’t compare pharma sales to other products, the patient doesn’t really decide or prescribe their therapy, eventhough thru DTC Big Pharma is trying to change that as well.
Laurie
“Oh and by the way remember, don’t compare pharma sales to other products, the patient doesn’t really decide or prescribe their therapy”
Thank you for giving me a single sentence that expresses my sentiments exactly!
Chris
Hi Doc,
Just wondering what is your role in pharma. Presumably it does not involve approval of the materials referred to, 50% of which are outside compliance with fair balance.
Somebody is approving the programs, materials, supporting data, and ultimate messages put out by your employer.
If it’s so troubling aren’t there confidential ways for you to sort out these transgressions?
The industry exists to make money but it must comply with systems that ensure ethical behavior.
If your company doesn’t, the decision ought to be easy.
Doc
Chris,
I have been involved with regulatory and legal approval of promotional materials. The industry has made big strides in recent years to try and assure that materials are fair and balanced, that I do not argue. However, once those materials hit the field you are dealing with an entirely different problem. My contention, based on considerable field experience with several companies, is that the incentive style programs and incessant drive to be number 1, along with sales administration’s zealous focus on profits and representative goal attainment, makes many reps go beyond their knowledge and understanding in their promotional efforts. Coprorate oversight has improved due to strict government oversight, but many sales reps still present an unbalanced view of their products efficacy and safety to physicians. This type of ‘hype promotion’ is virtually impossible to document, and in fact is ignored by many middle and low level managers in their quest for performance rankings within their company. Profits are good things, as long as they are not made at patient’s expense.
Robyn
Chris,
“What on earth defines the best drug?”
The best treatment is decided by looking carefully at and comparing the evidence for all of the therapies available (including non-drug therapies) for a given condition.
Drug reps cannot be educators because they are obliged by their employers only to present one aspect of the whole story, and that in a way that is most likely to gain them sales.
Academic detailers are able to help doctors examine the evidence more fully, with their primary interest being the welfare of the patient not the bottom line of a pharmaceutical company.
Chris
Robyn,
You are right of course and my question was rhetorical. The drug rep is required to present info supportive of her/his employer and for sure they will never be taken for academic educators. But who is going to pay for all the replacement academic educators? If pharma companies withdrew their financial support from ‘education’ there would be many holes opening up which neutrals would find hard to fill: so much non-promotional education is underwritten by pharma as others on here have pointed out. Are cardiologists going to pay for their annual conferences out of their own pockets? I doubt it. So I’m saying there is a role for pharma and pharma’s reps as well as educators, but I just don’t see the logistics and resources to make it happen.
Chris
Oh, and one further thought on this: How much time in front of the doctor/PA will an academic detailer get? In order to present evidence for all the therapies available for any given condition - and retain the busy doctor/PA’s attention - these people are going to be very special and very persuasive. I suspect they’ll need more than the 90 seconds that seems the norm for a call. What exactly is the real incentive to have these academic educators visit anyway?
JM
I have a question for the Pharmalot regulars out there (including Ed)….
If Pharma was told that they could not directly pay for CME or other “educational activities” but that they could pay into a fund that might be controlled, administered, and managed by a state medical board, would they still pay?
SP 2
I believe that this is just the tip of the iceberg at Schering-Plough. If Congress really started to investigate and take a look inside this company, I think they would find much, much more that they would be very concerned about.
AAU
In my mind, these Big Pharma companies are becoming too bold and brazen in their total disregard of rules and regulations. This plan is very mild compared with what I’ve seen in the industry. I believe that a little digging into Schering-Plough’s records will reveal a whole lot more.
BPW
If Congress is interested in getting some tips, then they should check out CafePharma. The sales representatives, current and former, are giving them multiple examples of Big Pharma misdeeds that may be very helpful for investigative efforts. These are the people that know what’s being done!
Disgusted
In my experience, I beleive that this program is nothing compared to some of the other programs that have been run by Big pharma in the past. I simply won’t see reps anymore because they’re always trying to influence my prescribing in ways that I’m not comfortable with as a professional.
At least half of them aren’t qualified to talk about the prescription drugs. many of them are straight out of college, do a few week training course, and then hit the streets. They have their rehearsed talk that they can parrot, but ask them a question and they’re lost.