29 March 2000
PROJ00\AMWACME.MS--
13,250 words
When you finish this story, you will be able to answer the following questions:
NEW YORK--In most states, doctors must complete continuing medical education (CME) courses to keep up with current practice.
For the medical writer, this $3 billion industry is a big market. For the patient, it helps keep the doctor current. For the doctor, CME at its best is the best, most effective learning experience possible, and hopefully enjoyable as well. What could be a more pleasant way to take a break from the practice of medicine than a good dinner with your colleagues followed by an intellectually stimulating presentation on the newest developments in your profession? CME at its best uses the latest, best educational pedagogy and technology. Cost is almost no object (since pharmaceutical companies and medical device manufacturers pick up most of the bill). CME rises to the elite of education.
The New York Chapter of the American Medical Writers Association (AMWA-NY) brought three top CME practitioners together for a panel here at the Cornell Club on 15 February 2000, to talk about current issues in this sometimes-controversial industry, and to give advice for experienced CME writers and for those who want to break into the field (although lacking corporate support, AMWA members had to pay for their own dinner).
"It's not just about teaching," said Dominic De Bellis, PhD, president-elect of AMWA-NY and moderator. "It's teaching in an effective way, in a way that uses various media, in a way that takes technical information and makes it practically usable," he said. "And for the writer, that's the key. Is what we create usable for the audience?"
"Our goal is to translate new, often complex content into a form that will be understood and acted upon by clinicians," said Richard Weyland, a long-time writer for medical film, video and new media. "Everything is subsumed in this goal. I see myself as a translator and as an educator."
But Weyland also sees himself as a story-teller. A medical education piece is structured with a dramatic tension, he said. The disease is the problem. The new treatments are the solutions that resolve this tension.
Easy lessons take hard planning. Karen M. Overstreet, EdD, MS, RPh, ELS, president of Meniscus Educational Institute , Bala Cynwyd, PA, outlined the development of a CME program from the perspective of her organization. CME programs must go through a standardized, structured development process, which is required for certification. "Documentation and paperwork really is the key to CME," she said. Sometimes it seems very tedious and time consuming, she acknowledged, but it's the only way to be sure you meet all the requirements.
Meniscus Educational Institute is a CME provider, which means that they are accredited to directly sponsor programs that award CME credits to doctors and other health professionals. Meniscus is a for-profit provider, as distinct from traditional non-profit providers such as medical schools and professional societies. CME vendors are subcontractors who produce CME programs under the sponsorship of an accredited provider. And grantors, usually pharmaceutical companies, are the ones who provide financial support for the programs.
The CME industry has had its own dramatic tension and resolution. Some of the past practices of payments to doctors, ghostwriting, and aggressive drug promotion are now regarded as unethical. Rules and procedures have been established to avoid these excesses. And a big part of the job in CME development is to follow those rules and procedures.
Pharmaceutical and medical device products are regulated by the U.S. Food and Drug Administration (FDA). Every medical claim the company makes about their product must be in the FDA-approved labeling. In contrast, CME programs are not limited to the labeling. That's because CME programs are not supposed to be under the control of the pharmaceutical company. CME programs are supposed to be balanced and objective. CME programs are not supposed to promote the grantor's products, except under very specific restrictions.
Evelyn D. Albu, PhD, now a freelance writer, formerly employed by pharmaceutical companies and agencies, told medical writers what they had to do to comply with the new rules for accuracy and fair balance, how to objectively report the scientific results, and how to write CME programs under the direction of doctors without crossing the professional line into telling the doctors what to say. CME is not marketing. In addition, she explained how every important step must be documented.
Overstreet also explained the role of the Accreditation Council for CME (ACCME) in accrediting CME providers. The ACCME has formalized the requirements, or what they call the "Essentials," of CME programs. She and Albu reviewed those Essentials.
This report deals below with the present regulations and the past abuses they are intended to prevent, and the lawsuit that led the FDA to turn regulation of CME courses over to a private accrediting agency. It then deals with (1) CME requirements and sponsors (2) Steps in the development of a CME program (3) Improper influence and fair balance (4) ACCME essentials (5) The writer's point of view and (6) Questions from the audience.
Can the drug companies pay the piper without calling the tune? Some critics argue that, if the pharmaceutical companies pay for programs, the programs will favor the companies' drugs. See Sidney M. Wolfe, et al., Medical Education Services Suppliers: A Threat to Physician Education, Public Citizen's Health Research Group, (July 2000), for an analysis of the $1 billion industry (whose identification of the major companies is also useful for marketing purposes).
In the 1970s, back in the heyday, pharmaceutical companies would pay PR firms and other vendors to produce complete CME presentations, with scripts and slides, about the company's drugs. They would pay a doctor to lend his name as author, and deliver the presentation, with no more input than Ronald Reagan reading from a teleprompter. Pharmaceutical companies would create seminars with doctors favorable to their products, chosen by their marketing department. They would send doctors (and their wives) to meetings, all expenses paid. The excesses led the FDA to try to regulate the commercial support of CME, with a series of draft policy statements that the courts subsequently ruled unconstitutional.
But still it happens. When they get caught, the FDA can take action against the pharmaceutical companies, which some companies regard as a slap on the wrist. But the sponsor of the CME program can lose its accreditation, a much more serious penalty that will put the sponsor out of business. Yet, the pharmaceutical company sometimes pressures the vendor or sponsor to cross a line that isn't too clear to begin with.
So when you write a CME presentation, you must write more than just a clinically accurate presentation--you must write a presentation in a certain CME style and format, you must be balanced and objective, you must help the doctor but you can't write his presentation for him, and you must comply with the rules that prevent the pharmaceutical company from having improper influence. Finally, you must document all that compliance, with paper trails of correspondence.
"If we're working for CME vendors, the people who work for CME providers, our role in keeping their paper trail clean is very important," said Albu, who spoke about CME from the pharmaceutical company and agency viewpoint.
"Because if we do anything to muddy the paper trail, or the vendor does anything to muddy the paper trail, and it ends up with the CME provider, the CME provider is in jeopardy and could lose their accreditation," said Albu. "So it's really important that we watch the paper trail." After you speak to a doctor who suggests a program and agrees to chair it, you send him a letter saying, "Thank you very much for suggesting this idea, and agreeing to chair the program, and working with us to develop this wonderful program."
Back in the '70s, pharmaceutical companies were extremely generous to physicians. Some companies did a good job of education, while others encouraged overprescribing. ( See Bridging the Ethical Divide, Tamar Hosansky, Medical Meetings, December 1999 , for an account of an American Medical Association CME task force meeting, and a summary of the Washington Legal Foundation lawsuit.)
"Back in the heyday, when I was doing CME at a pharmaceutical company, where we did the all-expense-paid weekends for physicians and spouses, we actually ran some good quality medical education programs, some seminars with a lot of meat and a lot of content, and they were very very good," said Albu.
"But unfortunately many, many companies were extremely violative" and were promoting drugs out-of-label and pre-launch, said Albu.
"This went on for about 10 years before the FDA caught up to recognize what was going on," said Albu. And the FDA said, "You know, there's a lot of stuff going on out there that's pretty dirty and we better do something about that."
The FDA established regulations to deal with these violations, but those regulations were thrown out of court.
Free speech is protected by the First Amendment, although commercial speech has less protection. After the FDA imposed new regulations on pharmaceutical marketing, the Washington Legal Foundation (WLF), a conservative free-market organization that regularly places anti-regulatory ads on the New York Times Op-Ed page, sued the FDA in the U.S. District Court for the District of Columbia to have the regulations thrown out as an infringement of free speech. WLF v. Friedman, 94-1306 In the broader debate, the WLF, and other conservatives, argued that pharmaceutical companies should be free to give peer-reviewed journal articles to doctors. The critics argued that pharmaceutical companies subsidize sympathetic journals and professional associations with peer reviewers who rubber-stamp poor-quality research. ("Conflict of Interest and Cost-effectiveness Analysis," Sheldon Krimsky, PhD, JAMA, 282(15))
The court scaled back the FDA's authority, and the FDA ceded much of the oversight to a private accrediting group, the Accreditation Council for CME (ACCME) , which has been accrediting CME sponsors for many years. (For details, see "FDA Restrictions on Off-Label Education Ruled Unconstitutional," Medical Meetings, September/October 1998 and "Court's FDA Ruling Puts the Squeeze on CME," Tamar Hosansky, Medical Meetings, December 1998 ).
The process of becoming accredited is lengthy, usually 1 1/2 to 2 years, said Albu. The accredited provider has to show the ACCME that it has the administrative and financial resources to run the programs, and the ACCME reviews the provider's records. "And the accreditation now is for no more than 5 years, so you have to be reaccredited as a CME provider, inspected to make sure you're doing things correct, that your paper trail is clean, or you don't get reaccredited," she said.
Finally, recalled Albu, paraphrasing the FDA's policies, the FDA said, "We can't really watch all of this because we're kind of getting into the freedom of speech arena," because of the WLF lawsuit, "but we will grant ACCME the right to watch this on our behalf. But we reserve the right to jump in whenever we happen to feel like it. And by the way if you violate we'll tell you. And we can tell you after the fact. And even if you did everything right, if after the fact we decided you violated, too bad, you violated."
"So if you go down to FDA and ask them for guidelines," said Albu, they'll tell you, "We'll know it when we see it, if it's wrong."
Physicians, said Overstreet, are required to take CME (25 hours a year) by the state legislatures of 36 states, pharmacists in 49 states, and nurses in 22 states. Live programs at meetings are still the most common way that physicians get CME, she said, citing data from Medical Meetings ( "The Sixth Annual Physician Preferences in CME Survey: Docs Plug In for CME," David Erickson, Medical Meetings, January/February 1999 ). "These numbers are dropping a little bit because travel budgets are being cut," she said.
"The use of Internet and electronic media such as CD-ROM are increasing, said Overstreet. "People are talking a lot about it but there's still not a lot of good CME available on the Internet." The standards for Internet CME are "pretty much the same" as other types of CME. The ACCME and AMA have task forces looking at the issue, but they have no definitive statements.
(For a comprehensive list of Internet CME, see Medical Computing Today, "Online CME: Web-based Resources" ).
The traditional CME sponsors include medical schools, universities and professional societies, said Overstreet. The non-traditional sponsors are for-profit providers.
"Hospitals and medical schools tend to provide mainly live programs," said Overstreet. "The mission of these organizations includes educating their alumni and their attending physicians, so they traditionally have done this as sort of a good-will PR-type of activity." They might simply be run by an administrative secretary. But increasingly, they must bring in revenue. "So they're expanding from their traditional focus on grand rounds and other types of live activities, and starting to do enduring materials and CD-ROM, and some of the other types of activity in which they might need the services of a medical writer."
Specialty societies and state medical societies are the other traditional providers of CME, said Overstreet. They tend to have larger CME departments than hospitals and medical schools, with continuing education experts, and may have meeting planners and medical writers on staff. State medical societies can also accredit CME providers, but only for credit within that state.
"The newest player in the CME arena is the for-profit organization," said Overstreet, "particularly communications companies, divisions of ad agencies, and publishing companies.
"There are a lot of for-profit CME providers," said Albu, "and they come in 2 categories."
Some of the hospitals have CME departments that are for-profit, said Albu. They will tell you they're for-profit, and they'll say, "I'm going to charge an extra 20 grand to do this program because I'm a money-making department."
There are also strictly for-profit CME provider medical organizations, like the Annenberg Center at Eisenhower Medical Center , like the Dannemiller Memorial Educational Foundation , and the Institute For Medical Studies .
"And there's nothing wrong with that," said Albu. "CME credit is CME credit no matter where it comes from. It has to adhere to the same rules and regulations, and the same criteria, and it is just as, quote, clean, regardless. And yet some of the pharmaceutical companies who provide the grants to underwrite these programs have regulations that they will not do a program with a for-profit CME provider. You just have to deal with that, but basically there really isn't any rationale to it. A lot of hospital departments are for-profit but the pharmaceutical companies don't want to know that."
"There's been a lot of controversy going on in the world of CME in the last 2 years," said Overstreet. "The Society for Academic CME is trying to force the ACCME to not allow these types of organizations to be accredited," she said. "Fortunately the ACCME is not going along with this wish, and in fact the Society has decided not to vote on it. So for the time being the playing field is equal. And CME credit offered by whichever type of organization is exactly the same. (See "Who Has the Right to Teach? The ACCME has always been willing to accredit any organization that can prove it lives by the Essentials and Standards. The SACME says that's no longer sufficient," David Erickson, Medical Meetings, May/June 1999 )
"More and more of these [for-profit] organizations are going through the accreditation process, and they tend to be looked at a little more strictly than some of the traditional providers just because they are a little bit different," said Overstreet. "These types of providers tend to do a lot more of the Internet programs, monographs, CD-ROMs, and have a lot of potential work for medical writers, particularly freelancers. And most of those organizations do fund all of their programs through pharmaceutical companies, biologic companies or medical device companies."
"Providers of CME get a lot of benefit from having commercial support," said Overstreet. "It does create a lot of headaches sometimes. There's a lot of additional paperwork every time a grant comes in from a pharmaceutical company. But these grants do allow for a lot of innovation, a lot of creativity, and a lot of flexibility that wouldn't be there without the grant."
Programs with commercial support have funds to bring in an expert speaker from across the country, said Overstreet. They have funds for innovations like CD-ROM. "They really give a lot of flexibility that benefits the sponsor of CE as well as the participant--the physician."
"Industry, the providers of the grant, also have access to market research data that the sponsors don't have access to," said Overstreet. "And they can have their sales reps, if their regulatory departments allow it, distribute information about the program, which help drive recruitment for the program.
"So there are benefits for the providers for getting a grant from industry," said Overstreet.
"But there are some benefits for industry as well, said Overstreet. "Having certified credit attached to an activity enhances the credibility of that activity. It's pretty universally known throughout the United States that a CE activity has to go through a lot more rigorous steps than one that doesn't have credit."
"So physicians are more likely to participate in an activity that has credit whether they need it for their state or not," said Overstreet.
"CE is still the only FDA approved way to talk about off-label information," said Overstreet.
"And finally CE serves a very positive PR function for the pharmaceutical company," said Overstreet. "Physicians recognize that a pharmaceutical company is promoting their education, is acknowledging their need for further information by supporting a CE program."
Overstreet and Albu described in detail the steps in the development of a program. The steps are: (1) Needs assessment (2) Determine target audience (3) Choose sponsor (4) Obtain funding (5) Develop goals and learning objectives (6) Choose faculty (7) Develop and review program (8) Recruit participants (9) Give the program (10) Program evaluation and outcomes assessment. Much of this follows from the formal ACCME standards, discussed further below.
"We're going to call maybe 10 doctors, and send out some letters, get some feedback, and do a literature search," said Albu. She wants to be able to document the need with a statement like, "Based on the literature, and based on feedback, there's definitely a need, there's a gap in the knowledge, physicians say they need to know something about this topic."
"No program can start without a needs assessment," said Albu. "The idea of education is that it must serve a need. And you have to address that need. And you have to document that need. And in the last few years the emphasis primarily at ACCME has been heavily on needs assessment. Because frankly it's the area that we've all kind of pushed aside. And it's really important that we don't just do programs for the sake of doing programs, but that they meet a learning objective, that they are filling a need, and that physicians have an interest in doing these programs whatever medium they take, because they are going to get something out of it and it's going to change their behavior or practice of medicine."
Albu is not accredited, so she needs a CME sponsor. "We now can approach a CME provider," profit or non-profit, with the documentation and say, "We've done our needs assessment, this is what the literature shows, this is what doctors are telling us. We have doctor so-and-so who wants to be the chair, who owns this great idea of a program, would you provide CME credit?"
The CME provider approves the concept and say, "Yes we think this a great idea, we're going to provide credit for this program."
A program must have learning objectives, said Albu. "You have to say this program is here to accomplish these 5 learning objectives. And you have to be able to measure against these objectives. The physician wants to know that they've accomplished something against these learning objectives. And the CME provider wants to know that."
"We always hold a conference call with the faculty for our programs," said Overstreet, "to make sure that their content doesn't overlap too much, that it's put in the proper order, to see what questions the faculty members have for each other, to make sure that we have a very comprehensive and unbiased program."
The chair can select the topics and the faculty, although that is the decision of the accredited provider.
However, under the new final guidelines, said Albu, you can, as the CME provider, or as the vendor executing the program on behalf of the CME provider, go to the pharmaceutical company and say, "We're soliciting ideas and input for this program, if you have any suggestions."
It's also a good idea, said Overstreet, to go to the other companies that are working in the same field and ask the same question, although it's not required.
As you work with your chair, and you select your topics and faculty, everything has to be done under the direction of, and on behalf of, the chair of the program, said Albu. You must be sure that you, as a vendor under hire for your CME provider, are not initiating anything yourself, and your paper trail must reflect that.
The CME provider also has to review and approve everything at every step, said Albu. "They have to approve your program, your agenda, your content, your slides if you have slides, your invitations, your handouts, they will give you their accreditation statement, they will give you their logo, they will give you whatever they want put on there."
Overstreet showed "one of my favorite cartoons," from Nursing Spectrum. A woman is saying to her colleague, "And this is a new form showing the number of forms you use each day." (The joke falls flat when you realize that the ACCME actually has a form like that: "Documentation Review for a CME Activity" )
"Documentation and paperwork really is the key to CME," said Overstreet. "Sometimes it seems very tedious and very time consuming, but documentation is the name of the game to make sure that you meet all of the essentials."
The vendor can offer to assist in the preparation of the materials, said Albu. Under the new regulations of June 1998 the vendor is a joint sponsor of the meeting. "The vendor can prepare literature searches for the doctor, can send material out, can assist in preparing slides, can ask for material to make slides, can help by saying, 'Here's some information you may not be aware of. You may want to know about it. Can I help you do the slides?'"
"The vendor can't just write a talk, make the slides, write the script, send it out and say, 'Hey doc, here's your program,'" said Albu.
"But it's really important that ultimately the presenter, if it's a live program, or the author, if it's a print program, reviews and approves everything, has full ownership of the material, and fully believes in the materials," said Albu.
"Because they can whistle-blow on you too," said Albu. "There have been things you've read in the papers, I've read in the papers, where a physician has gone to the FDA, has gone to the New York Times, and said, 'A company made me do this,' 'A company told me what to write,' 'A company gave me slides,' 'A company tried to influence my talk.'"
"So it's really important as you prepare these, that this is truly a partnership, that a physician is truly directing you, and truly approving and reviewing and buying into it," said Albu.
"And when you're up against a deadline and the doctor hasn't returned your 25th phone call, and you've got to get something ready for the program, you have to do some fancy footwork, sometimes, to get this to happen," said Albu, "including saying, 'You know, it's getting late, and you didn't get around to it, so I kinda took a shot at it, would you take a look at it and let me know whether you like it.'"
"But ultimately you have to make sure this person accepts it, said Albu, "because you can get in big trouble otherwise."
"We all know CME should be accurate and fair balanced," said Albu. "But what does that really mean? That means that if you're going to talk about safety you've got to talk about efficacy; if you're going to talk about efficacy you've got to talk about safety. You can't be one-sided. You've got to have balance. If there's something good you've got to tell the bad."
"If you're going to do comparative data your comparative data has to be fully comparative," said Albu. "In other words, I can't compare myself to the package insert of the competitor only on the basis of the 3 items that I do the best on comparison, and ignore the 7 that I don't do well on."
So if you're doing comparisons from literature, "you have to make sure they're comparable trials, the same criteria, the same baselines, the same patient population," said Albu. "Or you have to put in a lot of caveats. You can't talk about partial data. You can't talk about something in progress, unless you're very clear about, 'this is partial,' 'this is interim,' 'this is incomplete.'"
"And you really have to state all your disclaimers," said Albu. "Your financial support, your incomplete studies, anything quirky about this study, anything that really is unusual that you need to call to their attention, even though you'd love to hide it under the rug."
So accurate and fair balance is more than, "Did I accurately represent this paper?" or, "Did I accurately represent the 10 papers?" said Albu. It's really, "Am I using them in the right way?" "Am I talking about the good and the bad?" If it's a 3-drug comparison, "you can't only talk about 2 drugs and throw the third in the garbage. You really have to accurately represent everything you're utilizing as a tool," she said.
"Obviously, generic names only," said Albu, "except where one generic may have more than 2 or 3 brand names, and you can clarify by putting that in."
"And it's really important that you put in all your disclaimers in terms of your financial support, your funding, the fact that you're out-of-label," said Albu. "Please look at package insert for full prescribing information." You must now, under CME, state that clearly.
The CME provider requests the funding from the corporate grantor. So if a pharmaceutical company comes to Albu and says, "I want to do a program," she then has to have the CME provider write a letter to the corporate grantor--the pharmaceutical company--requesting funding for the program. Different companies have various policies. "Some of them then take that request to a legal review to make sure that's all clean."
The money flows from the pharmaceutical company, to the CME provider, to the vendor, to the freelance writer, said Albu. Vendors like Albu sometimes tell freelance writers, "We can't pay you yet because we haven't gotten the money from the CME provider, who hasn't gotten it from the pharmaceutical company."
"So sometimes this becomes a problem," said Albu. "Monies do get tied up. I've had some companies that haven't paid until 6 months after the program's complete."
Technically, according to the guidelines, the money's supposed to be in the hands of the CME provider before the program happens. In reality, "that rarely happens."
The financial standards are set by the ACCME. At the end of the program you must have a financial reconciliation. You must show your CME provider, who usually in turn must show your pharmaceutical grantor, where all the money went. You must document all of your out-of-pockets. "A lot of the CME providers now are asking now to get money back from the vendor if you didn't spend all the money," said Albu. A lot of pharmaceutical companies are asking the same thing.
"Your fee's your fee unless you tell me in advance that it's going to go above or below," said Albu. "And if it's going above you'd better be prepared to tell why. There's a strong reconciliation, it's supposed to be done in 90 days, it often isn't, I must say."
"Joint sponsorship is permitted," said Albu. "Which means that the CME provider and the vendor who is working with the CME provider are at equal risk." That means, "if I'm a vendor and I mess up and cause a problem for my CME provider we're both liable," she said. "So my CME provider is going to be very careful about what vendors he works for. Because my vendor can put me in jeopardy as a CME provider. And I'm not going to take that chance."
"And I've had CME providers tell me that they will only work with certain vendors and not others because some vendors will put them at risk," said Albu, "because they don't understand the regs and they don't keep a good paper trail."
"And again as a freelancer working in this network it's just as important what your paper trail is as what the vendor's is who's hiring you or the CME provider who's hiring you," said Albu.
Overstreet reviewed the ACCME requirements for continuing education, which are a formal way of defining the steps in the development of a CME program.
The ACCME has set standards by establishing what they call the "Essential Areas" and "Elements" that a CME program must meet in order to qualify for accreditation. These standards are outlined in an ACCME document, "The ACCME's Essential Areas and their Elements," .
Overstreet organized the standards into 7 Essentials and 2 standards for commercial support. Actually, the 7 Essentials have been renumbered into 3 Essentials, "but I think it's easier to conceptualize the rules sticking with the original 7 essentials," she said. Some of them apply directly to writers, and others are important for writers to know in order to understand the context of their writing.
Essential #2: Needs assessment. "This is a very key area for CME, and medical writers can go a long way to helping accredited sponsors document needs assessments," said Overstreet. "This essential requires that the sponsor document why the target audience needs the specific information that's included in the program. This process includes identifying specifically who the target audience is." Is it physicians right out of medical school? Is it people who have been in practice 20 years or more? "You have to be really specific defining the audience," she emphasized.
"Another component of needs assessment is showing a variety of methods that point towards that same need," said Overstreet.
Some of the methods used in needs assessment are literature searches, documentation from published data, prevalence of a particular disease, or an increase in prevalence, said Overstreet. "What are the problems with the therapies that are available now? How many new therapies are under development and what might their impact be? What is patient satisfaction with current therapies?"
"Another very valuable tool for needs assessment is looking back at previous programs to determine what participants of those programs still need," said Overstreet.
Essential #3: Learning objectives. These are common with many types of educational activities. "The trick with CME objectives is to have them very specific and very measurable," said Overstreet. With enduring materials, "you actually have to go back at the end of the program and test participants on how they met the learning objective."
The learning objectives must be very specific and very measurable. It's not enough to say, "At the conclusion of this program AMWA members will have increased knowledge about CME," said Overstreet. You would have to say, "At the end of this program participants will be able to compare and contrast the ACCME regulations with the AMA guidelines and discuss how they can be applied to their particular practice."
Essential #4: Educational design. This means putting together a program that meets the needs of the audience with content that will help the participants achieve the learning objectives. "This is probably the main area of focus for medical writers," said Overstreet. "This is putting the content together--helping the faculty for a live program develop their slides and their outline in a way that will meet the objectives and meet needs of the participants and the learning objectives. Communication and documentation are really the key for meeting this essential."
Essential #5: Evaluation. "With the new accreditation system this is a very key area," said Overstreet. It's not enough any longer just to have participants fill out a checklist and say, "Yes the room was warm enough and the food was good and the speakers were excellent." We must now go a step further and evaluate the faculty. "Were they good speakers? Were their materials clear?" Overstreet likes to have the faculty evaluate the program.
"And finally we need to look very carefully at outcome," said Overstreet. "So what if the objectives were met. Did the practice, did the behavior of the participants actually change based on this educational initiative?"
"This is becoming more important to pharmaceutical companies, many of whom are looking for return on investment related to their grants," said Overstreet. "So sponsors are having to come up with ways to go back to participants to determine the durability of the learning. This is pretty easy for hospitals to do. You have the patient charts right there, you can see the physicians change. It's a little more difficult for the non-traditional, more entrepreneurial type of sponsors." A common way to do that is to surveys participants a few months later to see if they changed their practice based on the CE program.
Essential #6: Administration and resources. Sponsors have to document to the ACCME that they have adequate staff, resources and facilities to carry out a quality CE program, said Overstreet.
Essential #7: Joint sponsorship. Joint sponsorship means that an accredited provider works with another organization that is not accredited to produce a CE program.
"Violations of this essential are the most common reason that providers are put on probation by the ACCME or actually lose their accreditation," said Overstreet. "And a number of very prominent medical schools have lost their accreditation because of the way they worked with non-accredited providers. So it's a very, very important issue."
Commercial support. "The ACCME developed the standards for commercial support based on the FDA guidelines and the many iterations of that that occurred over the last 10 years," said Overstreet. And because these standards were in place the FDA was more willing to back off from their draft guidelines and and not appeal the Washington Legal Foundation lawsuit. "So the FDA from this point forward is no longer involved in CME," she said.
"The standards for commercial support govern how pharmaceutical company or device company grants are handled by an accredited provider," said Overstreet. "The CME programs that have commercial support have to be free of bias, have to be objective, and have to be well-balanced."
The standards also govern how an accredited sponsor works with the pharmaceutical company for the development of the activity. "And it's no longer the case that they have to be completely separate," said Overstreet. "It's perfectly appropriate for an accredited provider to ask for assistance from the pharmaceutical company. They can ask for suggestions for speakers, or suggestions for content. Often the pharmaceutical company has the best data. They know who the key opinion leaders are. They have more updated information than is available in the literature. So it's very appropriate to have that collaboration as long as it's documented. Documentation is really the key."
"The relationship between the accredited provider and the grantor has to be documented with a letter of agreement," said Overstreet. "This specifies the amount of the grant and specifies that the provider will be responsible for all content development, faculty selection, and the use of funds related to the program."
"Commercial support also has to be acknowledged," said Overstreet. "It's always surprising to me that some companies that support these programs don't want to be acknowledged, and other companies want their logos and brand names all over the pieces." You have to say where the support comes from. That's usually done at the very beginning of the conference before the content begins and it's done only once.
"The accredited providers can also authorize representatives of the grantor to disseminate information about the program," said Overstreet. "This is perfectly acceptable, assuming the pharmaceutical company's regulatory department allows it. But again this can only be done through the authorization of the accredited provider.
Enduring materials. "The standards for enduring material have always been a little surprising and a little troubling to me," said Overstreet. "Coming from a publishing background, enduring materials are sort of second nature, so I've been surprised that there's a separate standard developed for this. I think the rationale was that traditional sponsors normally didn't do monographs and audiotapes and videotapes. This was a new thing for them. So to make them feel more comfortable the ACCME developed standards to help them with the publishing effort."
"Enduring materials are developed very much like other types of programs such as seminars and workshops. But they have to have a date of original release and an expiration date." They must also include a disclosure statement.
"In live meetings, sometimes speakers are asked to disclose their financial relationship with the grantor of the program," said Overstreet. "With an enduring material this has to be put in writing at the beginning of the program before content starts. Other things that have to be disclosed are the unapproved or investigational uses of any product in the program."
"The disclosure issue has been very controversial topic in the last few years within CME," said Overstreet. "There was a lawsuit with a couple of orthopedic and spine societies that did a CME program on an off-label use of a medical device." (U.S. Court of Appeals for the Third Circuit, 97-1783, In Re: Orthopedic Bone Screw Products Liability Litigation, U.S. Law Week )
"And millions and millions of dollars and several years of time that made a couple of lawyers very wealthy was used by the CME provider defending their right to do a program with off-label use," said Overstreet. "So the only way for sponsors really to protect themselves from this sort of legal issue is to disclose everything. Anything related to finances and the faculty has to be disclosed."
Richard Weyland discussed CME from the writer's point of view.
"For my temperament, I find this is a satisfying way to earn a living," said Weyland. "It's challenging, it's rewarding."
Weyland discussed what we as writers do in CME, what the advantages and disadvantages are of doing this work, what the client expects of us, the basic structure of the programs, the various roles the writer plays, the media we use, and the opportunities for writers in this field.
On pricing issues, Weyland recommended a new book, What to Charge: Pricing Strategies for Freelancers and Consultants," Laurie Lewis, Aletheia Publications, 1999, $19.95.
Weyland gave the advantages and disadvantages of writing CME. "Why do I like it? Because I'm always learning and getting paid for it. Life-long learning, life-long student, forever."
You can be well-paid, said Weyland. There's almost always work there. The assignments are usually long term." You work with varied content, varied media. "You're always solving unique problems." You're dealing with others. "Gets you out of the house."
"You're working with leaders of the profession, because those are the people you're translating from," said Weyland. It's "medicine without the blood," he said. "I love the field of medicine, but I can't deal with blood."
"And there are societal benefits," said Weyland. "I like to believe that the results of what I'm working on actually can improve the care of patients.
The disadvantages are, first, "It's extremely labor-intensive," said Weyland. "Draft after draft after draft." And as you write, you have to minimize the risk of future inaccuracies, by anticipating possible misunderstandings. "So you're not just responding to other people's criticisms, you are constantly your own critic."
There are extremely tight schedules," said Weyland. "Even though it's labor-intensive." And then, there are extremely long delays "that have nothing to do with you."
"An advantage is long-term assignments," said Weyland. "A disadvantage is long-term assignments."
"An advantage is that you're dealing with many people," said Weyland. "A disadvantage is that you're dealing with many people."
"As a translator, you must get the knowledge from the consultants and turn it into some useful form," said Weyland. "Well, it's impossible to do that if the consultant is invisible, or makes him or herself invisible. The important ones are often so busy that they're very hard to get," he said. "It's a problem."
"And one of the last disadvantages is something that I feel sad about," said Weyland. "I feel that our industry has not been fair over the last decade to the young people entering our profession, especially those on the administrative track," he said. "Bright young people as recently as 10 years ago would be hired and trained and moved along as they were ready and eventually with enough experience they would become the project directors who would hire you, supervise you, direct you."
"In the last decade or so that hasn't been the case," said Weyland. "I feel that they haven't been fairly treated because they haven't been properly trained. The result is that their employers are not being properly served, they themselves are not being properly served. And insofar as they're dealing with writers and other suppliers they are very often not experienced enough to administer the project."
"Now that is a problem," said Weyland, "but in a sense, it's also an opportunity for the writer. In addition to the writer just following a subcontractor model, we now need to follow the model of the good physician."
The good physician model: She listens very carefully to the patient's complaints, makes a good diagnosis, lets the patient know the diagnosis, gives the patient options, explains all the consequences of the options, and lets the patient make the decision. "There's a lot of that handholding that's required now on the part of the writer for the project administrators," said Weyland. "It's value added."
The last disadvantage is lack of validation assessment. "I'm happy to hear that there's a greater emphasis than in the past on evaluating the material," said Weyland. "All I've been able to find out in the long term about the efficacy of the work I've done have been the results of questionnaires, that tell you what was reported by the participants. But what really matters to me is changes in clinical behavior on the part of physicians and improvements in patient outcomes. I haven't got that. I want to improve my writing based on the clinical results. It's frustrating not to have those results.
Weyland described the process of writing educational material and the basic structure of an educational piece for doctors.
As writers, said Weyland, "we receive the assignment, the directions, the background materials." We obtain additional materials. "There's always additional materials we need no matter what we're told."
"We digest, we assimilate," said Weyland. "We interview those who know. We write a content outline. We revise it. We write a treatment if it's a video. We revise it. We deliver an approved content outline. We deliver an approved manuscript or script. We deliver articles to support this."
Weyland described what he saw as the basic structure of medical educational materials.
"I see us as story tellers," said Weyland. "If there's no story there, then it's not going to be interesting to our audience. I see it as a dramatic tension and I work in that model."
In addition, we write all the usual material: The faculty, the educational and performance objectives, the references, the post-test, and sometimes a pre-test.
"We play many roles, or depending on the project, we can be asked to play many roles, wear many different hats," said Weyland.
"In one sense we're a link in the production chain," said Weyland. "We're also members of the production team." There are "virtual members you work with but never see.
Weyland gave his version of the development of a CME program from the writer's perspective. Someone has the idea of what kind of educational topic is to be prepared. Someone makes the decision that it is going to be done. It gets funded. It gets contracted. It gets sub-contracted. "That's about where we come in," he said. It gets written. After our scripts or manuscripts are approved then it gets produced by somebody else. "And it gets distributed and gets in the hands of the audience."
"You as the writer interact with the writer's client, which is in practice usually the project manager," said Weyland. You may have contact with the client's client, which could be the pharmaceutical company. You have contact with the medical experts. You may have contact with the reviewers. You may have contact with the accrediting organizations. You may have contact with the video production firm, if it's video; graphic designers; printers if it's print; programmers if it's computer-related; statisticians. "Your material will, and you personally sometimes may, have contact with the sponsor's medical and legal department."
"So the hats that I found myself wearing at different times in these projects," said Weyland, are "a student, a teacher, a translator, a storyteller, an interviewer, a researcher, a negotiator, a problem-solver."
One of the most important roles is "a surrogate," said Weyland. "Because when I'm writing I'm always writing for someone in my mind," he said. "I invent someone in my mind, related to the audience for this project. So if it is a typical clinician in practice I have in my head that clinician. I consider myself a surrogate for this person, this ghostly person sitting next to me. Everything I write has to be clear for this person. That I see as one of my ongoing permanent roles."
Weyland then described how to tell whether you are qualified for this kind of work, how to become qualified if you're not, and how to get the work when you are qualified.
The best qualification is, "You've done it before," said Weyland. "Nothing beats that."
"You should be suited for it if you have advanced training in any of the medical professions," said Weyland, "if you have an academic temperament."
"I'm a dismal failure writing medical ad copy," said Weyland. "I'm incapable of writing that way." In contrast, "Some of the people who are brilliant medical copywriters can't for the life of them do this kind of writing."
"You have to be able to write clearly, simply, and accurately" said Weyland. "Which sounds easy but it ain't."
"You need the ability to synthesize complex content," said Weyland.
"You have to be a crackerjack interviewer, even with reluctant experts," said Weyland. "You have to get out of every expert, the good ones and the bad ones, the gems you need. And this is possible with expert interviewing skills."
And you have to have a high frustration tolerance. For all the reasons that are obvious.
Weyland answered one of the job-seeker's questions: "How do I become qualified if I'm not?"
"Look at your current skills," said Weyland. "Let's say you're a good editor and you want to go into writing. Or you're a good proofreader. Use what you're good at to get yourself to learn what you have to learn. And some form of apprenticeship will be needed. Which means use your current skills to get yourself a staff job."
"Make your own apprenticeship program by getting yourself the right kind of staff job at the right place," said Weyland. "Go to a place that wants your skill. Go to a place that you have determined does CME, tell them that's exactly what you want to do, and take a job with someone who wants your skill who does this kind of work and work towards learning from them. It's your own do-it-yourself apprenticeship program."
"I wish I could give you an easier answer," said Weyland. "That's the best one I could give. Once you finish your apprenticeship program you can be a free agent. You have a marketable skill."
"Once you have the marketable skill, how do you get the work?" said Weyland. "There's the easy way and a hard way."
"The easy way is to be hired by a relative in the business," said Weyland. "Every other way is the hard way. Networking. Word of mouth. Everybody says it and it's true."
"I find potential clients in the Medical Marketing and Media annual ad agency review," said Weyland. "There's the Red Book of Advertisers. There's the AMWA Pink Sheets sent to AMWA members." For those who are not already AMWA members, he recommended joining AMWA. "There's a lot of job information that's coming over the Internet," from sources like this email list.
--Norman Bauman
The panel, and AMWA members in the audience, answered the following questions:
Q: What kind of writing samples do we send?
Albu: I've been a pharmaceutical company person, a vendor and a freelancer so I look at it from all 3 perspectives. From my vendor perspective, when I ran a company, frankly I didn't want your sample. Because I didn't know from your samples how many hands touched it, how many editors edited it, how many times it's been purified. I just tend to want to talk to people, and I'll give them a shot, usually on a job that isn't on a tight deadline so if it's not good I can redo it. So I used to tell people, don't send me anything. Let me talk to you and then I'll give you something.
Overstreet: I agree with you entirely. Even if somebody says, this is a manuscript right from my word processor there's no way to document that. I think talking with someone, carrying on a short chat by email or the phone, to prove that you can talk the talk and walk the walk, is the most important thing.
Weyland: I'm not always asked to send samples and that's fine with me. When I'm asked to send samples I only send a couple, and even then I only send a cover page and maybe the first couple of pages and that's it.
Q: I've edited a lot of CME programs and I like to understand that in the standard for post-test for a lot of materials, they require 10 questions or 20 questions. All of the answers must be in the materials. I don't understand why they're required to get only 70% right. If my doctor learned only 70% I wouldn't want to go to him.
Overstreet: That's a great question. It's up to the accredited sponsor to determine what their policy for the learning assessment is. The standards for commercial support in all of the ACCME regulations say nothing about what the passing score is. They only say that you have to determine whether the learning objections were met. And most sponsors choose to use some sort of test, a multiple-choice test, because that's the easy, traditional pedagogical way to test that kind of stuff, and most arbitrarily use the score 70%. My organization tends to use a test like that. We tried to raise the bar a little bit and used a passing score of 80. Lot of the physicians failed. Scary as that is.
Albu: They don't require you to get any score. They don't even require that you take the test if you want to get your credit. You have to submit a piece of paper. Interestingly pharmacy demands a score. And they're quite strict about it. But physicians don't. In fact a number of CME providers that I've worked with do not ask for any score. It's just, Take the test. So it's very arbitrary. I think 80 is becoming more the norm but some of them say, I don't care, you don't have to get any score.
Weyland: One of the programs that I really enjoyed working on was a computer-based training program for cardiologists. It had a computerized test at the end. In order to pass you had to properly diagnose and treat every single patient. But you could try as often as you needed. So maybe you killed the second computer patient, but then you were given another chance. They were brought back to life, and you could do it a hundred times. But you couldn't get any of your credit until you totally cured every single patient. There's something appealing about that
Q: I worked for an ACCME accredited provider. We would give them multiple choice, yes, but they wouldn't be parroted out of the text of the monograph, but rather they would be applications to cases. So a patient comes up to you and provide clinical choices which were referenceable in the text of the monographs. Then in addition we included the answers. We folded the answers up with an answer key. Because if you don't know the answers right there you've lost the ability to close the learning experience, which the key points of learning. So we basically figured on good faith that anyone who had access to that could have gotten 100.
Q: If a pharmaceutical company gives an unrestricted clinical grant to an activity, and then at a later time want to take that program and put it on the web, say for example a symposium at a medical meeting, and they want to later put that on the web, can you see any conflict with there being a link from the pharmaceutical web site?
Overstreet: That's happening more frequently with the increased use of Internet CME. I have 2 comments.
First the accredited sponsor has to take full responsibility for the activity and any further use of that activity. That has to be spelled out in the letter of agreement for the grant. So if the pharmaceutical company wants to do that they could go back to the accredited sponsor and work together with them to do another certified CME activity for the Internet. So as long as they work together that's OK. You probably want to do another certified activity unless the original activity was completely on label.
Second, if they want to do a CE program, the requirements for the Internet aren't written down on paper anywhere. What the groups are saying is that the CE site has to be 2 clicks away from the pharmaceutical company site. So Pfizer could have a CE button on their web page, that connects them to the CE provider's web page, and from there they go to the CE activity. There can be links but there has to be some sort of buffer in between. But again this is not written down anywhere. This is just opinion.
Albu: And some of it varies by pharmaceutical companies. And I'll put on my pharmaceutical hat, having spent a lot of my life there. A lot of the pharmaceutical companies will allow you to go from the pharmaceutical company out to the CME but not from the CME back to the company. The thought is, if you went to the CME site first they don't want to commercialize that by bringing you back into a corporate site. That's sort of an internal regulation of their regulatory department.
Every pharmaceutical company has a regulatory committee that is making decisions as to how they interpret the regs, and each company will interpret them differently, and if you're working under a grant from that company that's what you're working under. It just varies all over the place. Everybody reads it differently. For example some will let their reps distribute material if they're shrink wrapped. Some will let them distribute them if they're wafer sealed. And some will never let them distribute them. you really have to deal with your vendor or your pharmaceutical company and find out how they're interpreting the regs because they're the ones that you're going to get in trouble.
Weyland: Yes I agree. Things are in such a state of flux, and permanently will be that there's no single answer to that question. However there's one very specific thing that freelance writers can do to help protect themselves. It's often come up at these meetings how we'll sometimes be presented at the beginning of a project, or before we get into a project, with a boiler plate corporate agreement. And buried down there in the boiler plate agreement is, "The writer will be legally responsible for every word that the writer writes." Every time it's come up in our discussion, we always say, cross it out, don't sign such a thing. Since we don't have total control, then we shouldn't assume total legal responsibility. That is one specific thing we can be alert for during this period of change.
Q: Do you ask for indemnification from the company?
Weyland: That's an interesting question. I never thought of that. It would be fair in terms of what we're discussing, but I doubt whether any company would agree to those terms.
Q: It has come up in AMWA. You can file any suit you want. It can be a nuisance suit. A woman was involved, she wrote for a medical communications company, that company was sued by, I guess, a pharmaceutical client or whatever, she was the writer, there was no guilt, she spend thousands of dollars on lawyers, they had depositions, and she's asking us, should we as AMWA members ask the company to indemnify us for our legal expenses in nuisance suits? And your answer certainly was sound, that it's a wonderful idea and no one's going to do it.
Q: We're doing CME for over 12 years. Theoretically the pharmaceutical client has medical/legal to protect themselves. But they're not supposed to get involved in the revisions. But what is the rules for once the project is in the working stage? Can they look at all? What can they say?
Overstreet: That's a great question. From the ACCME's perspective the pharmaceutical company should hand over the check and that's it. There should be no medical/legal review. And some clients deal with it that way. A number of our clients literally will give us a check. They might talk about what they want to see in the program at the beginning, and it goes no further than their desk in the company. Some pharmaceutical companys really follow that.
We're trying to balance making our clients happy with meeting all the ACCME guidelines.
If we send something to a client we try to make very clear to them this is for information only. We don't say that we'd like your comments by next Friday. There can't be any documentation that we're giving it to them for review. It's simply a courtesy for their review. And most of them seem to respect that.
Albu: I go along with that. That goes along with what I was talking about earlier, the paper trail. Technically, and most companies are really good about this, they don't ask to review it because they know they can't.
Some companies will ask their medical people to review for potential lawsuits, if there's something in there that could get them in trouble, because it's misrepresenting or misclaiming on a product. So one of the things I have done is send it to the physician in charge of the product for accuracy review from a medical/legal perspective only.
But that paper trail I think is acceptable. And I have done that frequently. Just send it to the physician and say, "We just want to make sure that there's nothing in here that will get the company in trouble. Check it out." And that's legal.
Q: Adding one comment to that. Having been in clinical regulatory on the pharmaceutical industry side. Usually when they say clinical/regulatory/legal, there's a particular committee, and if you're working on the marketing arm, they'll give it to clinical just as a courtesy, same as regulatory, but it won't go for that formal legal regulatory review, and there wont be any particular documentation in addition to, Thank you.
Weyland: Paper trails. In addition to the paper trail that's been discussed so far that are required in terms of the accreditation process, I would like to recommend to medical writers in any area at any time to make it a habit to have your own paper trail. That is, every time you send a manuscript in, you have a cover letter that says what you did why you did it, what you didn't do why you didn't do it, and you keep those pieces of paper.
Every time there's an important conversation with your clients, even if it's not necessarily part of the accreditation paper trail, you confirm that with a memo. I recommend that as a general practice for all the obvious reasons.
Q: And keeping all your revision. Locked up.
Q: And all the stuff that came in to you locked up.
Q: From the point of view of liability documentation, and mutual fact checking, the writer writes using source material, the editor, someone, usually fact checks it just as a double check, because someone needs to know that everything can be found in a published source. I have 2 questions.
Where does that requirement originate? Is that from the client, the pharmaceutical company, the medical education company?
Is there a set place where that's supposed to be done? Because I've done it after it's been edited, before it's been edited, and I wonder if there's anything formalized about it.
And finally I guess I'm amazed at how often I fact check something where the sources haven't been highlighted by the writer. Sometimes it's understandable. It's passed through so many hands and been rewritten so many times that nobody knows where it originated.
But sometimes it seems that this requirement has not been met or asked for, which is when a writer brackets the source material to indicate where they got it from. When you fact check an article, the difference between looking at the source to see where that writer highlighted it, or having to find it somewhere in an entire article, Where did this come from, it's night and day. It's an amazingly different process. One can take a few hours. and the other can take days. I'm an editor, and I wonder from the point of view of writers, and from the point of view of the people who require the documentation being used, where does it come up and where does it get messed up?
Q: All of my clients not only require it. We have to return the source material and we have to return it highlighted and the manuscript highlighted. What I was going to ask was should we keep a copy of those cited and hilighted references? I'm astonished.
Q: It represents many hours of additional work by the writer but it's obviously very important and then it goes back to the client.
Weyland: There was a time when the project director would set it up in advance so that your kind of problem never took place. Everyone would know at the beginning what had to be done, how it had to be done, and who did it. So what you're describing happens because of administrative weakness.
Q: Poor project management.
Weyland: I know that the medical journals have been stating this as a requirement for journal articles more and more. But in answer to your other question. I keep a copy of everything that leaves my hands. Not because I'm told to but because that's the way I am. And surprisingly some small proportion of the time I wind up as the only one who has it when they're dying for it five years later.
Albu: One of the origins of this referencing, underlining where the quote came from, goes back to promotional education. Back in the days when you did promotional education, and it went through those committees in the pharmaceutical corporations, the regulatory legal review. They insisted everything be referenced with a page number and you could go to that reference and it was underlined and you could find it. As we've gone further into CME each vendor--I've worked for a number of them now and they have different sets of regulations. I don't want to say better vendors, but those vendors who want to protect themselves are very clear to give you clear direction, but unfortunately I agree with Richie, project management ain't what it used to be. But those who want to do it right will give you very clear directions. They want their reference set back, underlined with a straight-edge ruler, black pencil, in your text you cite the reference, you cite the page, somebody could check it.
Vendors are also very different about who does the checking. Some of them have editors, some of them have medical associates or medical directors. Some of them have very formalized reviews, others don't review at all, they don't care, they don't even look.
In my current role as freelancer I ask for 2 sets of references. I keep one set as working copy, I send back the nice clean set that's nicely underlined, so I always have a set. I highlight my own in yellow hilighter--of course they don't want yellow hilighter because that doesn't photocopy.
Q: More and more I'm getting confidentiality, separate contracts saying all materials that are given to you must be returned with no exceptions. And I give them back gratefully but I certainly keep my own revisions and documents. So you break a rule. I do give them all that stuff back otherwise.
Weyland: Relating to when you're doing original negotiations and original agreements. One of the many critical questions you need to consider before you make the commitment is to find out what their requirements are in terms of what you're supposed to deliver in terms of articles and markups.
I have no problems doing it as long as I know it, which means I take into account the time and effort to do it. What happens all too often, the answer is "No" when I ask them at the beginning, and then by the end they suddenly say that it's got to be done and they think that it takes zero time and zero money.
Albu: I do it as a routine. I build it into my estimate whether they want it or not. I've done it.
Overstreet: From a CME perspective the medical writer's and vendor's role in assuring accuracy doesn't exist. The ACCME traditionally has said that it's the sponsor's responsibility to achieve accuracy and objectivity and all these other things. Recently the ACCME has sort of backtracked from that. Sponsors don't want to be held legally responsible for the accuracy of the material, because they feel it's up to the faculty. It's up to the physicians who are putting their names on the papers to be responsible for that. So at this point in time the ACCME has withdrawn their requirement that sponsors put, on their materials, that they are the ones responsible for accuracy and content. Has yet to be decided. Another one of those ongoing controversies.
Q: On fact checking and highlighting references. As someone who is in on both sides as a editor/writer and editorial director. It has to be spelled out clearly in the contract. If that clause is violated--if you have 3 references, it probably takes less time for the editor to check it him- or herself. But if you have 30 references you have to bounce it back to the writer and say, "I need highlighted or underlined references, that's all, because I can't have this take 3 or 4 hours of an editor's time."
De Bellis: Most of the time clients want this kind of reference hilighting whether they ask you for it or not.
Q: Sometimes we've also drawn on promotional materials that is still educational, based on CME programs. So having those references highlighted and filed away is a big help.
Albu: And I'd like to add, although the faculty is responsible in CME, I find more and more the faculty is looking for the writer to give them that, so they can check it and put their name to it. They're not going to sit there and do it. I just do it as a routine. Whether they tell you to do it or not. I think that's a really smart thing to do. I think Richard hit it on the head. They're going to come back afterwards and ask you, and you didn't build it into your estimate. So you may as well build it in and do it up front.
Q: This is a followup about the problem of hanging on to your revisions. How long after publication do you hold on to your whole file?
Overstreet: ACCME requires the sponsor maintain their records for 6 years. So that might be a benchmark.
Q: I feel a wave of guilt. When I save all my revisions I'll save it for maybe up to 2-3 years maximum. Because I live in a very small house. And my house fills. But what do you do with a big pile of revisions, say it's a large project you've worked on for 4 months. You can't put them in the garbage. You can't put them in the recycling bin. You've got to shred them or burn them. Otherwise you don't know what you're dealing with. You've signed a confidentiality agreement. Look at the people who go looking through our garbage. It sounds absurd. Does anyone else do them?
De Bellis: I have lot of file cabinets.
Q: On the ACCME enduring material, date of original release and expiration date. Is there an average length of time? I know for example the ACC at the conference is 3 years although you are supposed to be reviewing it periodically.
Overstreet: So much of this is up to the accrediting sponsor to determine how long the information is good for. I find it hard to believe that anything we produce today would be valid 3 years from now. The world is changing so rapidly, new data is being produced all the time. To me it's unethical to have anything that lasts that long.
A lot of people do 2 years across the board. We send things out to our educational committee and ask them how long they think this is going to be valid for. Some of our programs were cutting back to 12 months, some are even less than that. If it's a really high tech area and there's a lot of work in development, we'll shorten that.
Q: What would you disclose in the financial disclosure and faculty statement, in writing, for example, a monograph?
Overstreet: We would say all faculty are required to disclose any significant relationship between the supporter of this program or any supporters who have similar products. And then we'll list each speaker. And you don't just disclose that Dr. Jones is a consultant for Glaxo Welcome. But you have to say that other speakers have nothing to disclose, or that people refuse to disclose, or don't send the form back, you have to disclose that as well.
Weyland: And what stock they own.
Overstreet: It's up to the faculty members to determine what's significant. Again there are no guidelines on this. If they own 1,000 shares of some company and if the faculty member feels that's not significant, they don't have to disclose it. But it's up to them to determine that, not the writer and not the accredited sponsor.