The Food & Drug Administration is currently putting the finishing touches to new guidelines that will severely restrict both professional and public access to important medical information. If the agency goes ahead with the most extreme proposals under consideration, the access of consumers to information that could help them receive better medical treatment and perhaps even save their lives will be severer curtailed.
The FDA appears to be politically motivated in this action. Certainly, it must require an effort of conscious will to ignore the enormous benefits to public health wrought in the past decade by numerous education campaigns conducted on behalf of and financed by the pharmaceutical industry in this country or to be prepared to sacrifice those benefits to halt a few minor abuses when even the FDA cannot find any evidence that those "abuses" have caused any harm.
Says Jack Angel, president of Greenwich-Aire Associates and spokesman for the Coalition of Healthcare Communicators: "The FDA construes industry's interest in scientific exchange solely as a promotional vehicle. This is unfair. There are endless examples of companies sponsoring programs for professionals and the public that have no relation to their products. It happens every day and contributes significantly to scientific exchange and better healthcare.
"Hampering medical communications hurts more than just pharmaceutical companies. Medical communications accelerates the acceptance of new forms of treatment and drugs. It accelerates the diffusion of medical innovations both to doctors and also to the American consumer who is hungry for information."
It is interesting to note, however, that the Coalition of Healthcare Communicators is taking an eleventh hour stand. The pharmaceutical companies and their PR agencies have largely failed to make this case, fearful perhaps that the FDA will retaliate against them by slowing the approval of their products.
Yet examples of public relations programs, sponsored by pharmaceutical companies, that have had a beneficial impact on the nation's health abound.
Bill Cox, head of the healthcare operations in Porter-Novelli, cites a program has firm conducted for menopausal woman. Working hand in hand with local hospitals, Porter Novelli has gone into local communities, addressing audiences of women—sometimes as large as 700—about the changes that take place during menopause on behalf of a menopause drug produced by Ciba Geigy. The program used a non-medical spokeswoman, actress Shirley Jones, in its early stages, something Ciba-Geigy will not now do because of the FDA's apparent disapproval of celebrities.
Ilyssa Levins, president of GTFH Public Relations, points to programs the agency worked on to educate the public about the dangers of cholesterol, for Merck among others. More than 30,000 people were screened for their cholesterol levels after one publicity blitz; materials prepared by the agency appeared in hospitals and physicians' offices all over the country.
And Gil Bashe, president of the PR division of Medicus, points to a program the agency conducted for an imaging scanner produced by client DuPont. The scanner detected significant differences between the brains of healthy people and those of cocaine users, and was able to produce photographs demonstrating those differences. Medicus then built a program, "Your Brain on Cocaine" directed at school children and using video in an attempt to discourage drug use.
"It has been a tremendously effective program," says Bashe. "The response we have had from teachers is amazing, and the use of these illustrations makes the lesson very effective."
It is not difficult to imagine that such a program, for all its obvious benefits, might be difficult to sell to a client today, however. There might be questions about whether use of the scanner for diagnosing drug abuse was outside of labeling, or whether a video sent to schools was advertising and needed FDA pre-approval.
Gil Bashe speaks for many public relations professionals when he says: "What the FDA has to understand is that most of us are in this business, the health care business, because we wanted to help people. Many of these programs do have life-enhancing and even life-saving aspects, and the FDA needs to remember that."
Bashe himself was an army medic before coming into the PR field, and he says he—and most of his colleagues—bring the same kind of commitment to public education that motivated him to help people then.
If the results of these individual programs were not convincing enough, a recent study by Johns Hopkins has indicated that those who are better informed about health issues get significantly better health care.
On the other hand, Wayne Pines, executive vice-president at Burson-Marsteller, and a former director of consumer education and information at the FDA, says the agency has no evidence to support the idea that promotional abuse, even if it does exist, is a public health issue.
"There is no documented evidence that this is a health issue, that there are any harmful health consequences caused by pharmaceutical promotion," says Pines. "The FDA's response to that is that there is a trend in terms of health claims about drugs that mirrors the deceptive claims being made by some food companies, but I do not see any evidence of that."
Since the FDA appears unable to provide evidence of any harmful abuse, and since such clear educational good is resulting from the efforts of the pharmaceutical industry, it is worth asking whether the FDA and its new chief might not have some ulterior motive for their attacks on PR activity.
When Dr David Kessler took over as commissioner of the FDA in April, public and Congressional confidence in the agency was at an all time low. In one of his earliest speeches, to the Food Drug & Law Institute, he acknowledged the FDA's image problems, the result of scandals alleging favoritism in the approval of generic drugs and failure to get new, potentially life-saving drugs to market in a timely fashion.
It was clear from these pronouncements, and swift actions such as the impounding of Procter & Gamble's Citrus Hill Fresh Orange juice (actually made from concentrate) for breach of labeling guidelines, that the FDA under Dr Kessler would be a more activist organization than it had been under his predecessor.
However, many of the challenges facing the new FDA—restoring confidence in its impartiality, speeding the new drug approval process—defy easy answers. They require long term, incremental changes in organizational culture. So in order to make a more immediate impact, Dr Kessler and his staff searched for an issue that would demonstrate to legislators that the new FDA was an agency with real teeth, unintimidated by the corporate Colossuses it faced.
The issue on which the FDA zeroed in was the alleged abuse of promotional techniques other than paid advertising by pharmaceutical companies. The agency has very precise guidelines regarding what drug manufacturers must, may and may not say in their advertising, but it suggested that the manufacturers were using sophisticated modern public relations techniques to circumvent those guidelines.
Kessler told Congressional hearings on the issue that most firms adhered to regulations and were waiting for the FDA to codify guidelines, but added, "Some in the prescription drug industry have gone over the line. Consumers are being misled by new public relations initiatives."
Not surprisingly, many public relations professionals regard the current situation and the FDA's proposals somewhat differently. Bill Cox of Porter-Novelli says the agency appears to be opposed not only to bad promotion, but to promotion in general.
"No one in public relations is going to say they don't believe in fair balance," Cox says. "We would be delighted if the FDA came up with guidelines that ensured fair balance, that companies did not misinform. But the FDA wants to devise guidelines that are so onerous they will stop communication entirely."
This is the crux of the argument between the pharmaceutical and communications industries and the FDA. The FDA has previously defined the debate in terms of "promotional" activity and "educational" activity, although no-one has successfully defined the dividing line between the two. The FDA is now concentrating, at least in the area of symposia, on the idea of "independence," while PR professionals believe the agency should be more interested in accuracy.
"If the information companies are disseminating is honest and accurate, it shouldn't matter whether it also happens to be in their interest to disseminate it," says Cox. He dismisses the notion that "promotional" public relations can be distinguished from "educational" programs. "Everything we do has an element of education in it. If a program prompts more people to talk to their doctors about a problem, that serves a purpose, regardless of whether it also promotes a specific treatment."
Like almost everyone else in the communications business, Cox points out that even the most egregious examples of over-promotion cannot put the wrong drugs in patients' hands—the patient's own physician can explain why a particular treatment is not appropriate—and that the damage promotional abuses can cause is limited.
One of the specific areas that the FDA has said it will regulate is the use of video news releases.
Beverly Simon, head of PR operations at healthcare agency Barnum & Souza, recently participated in a "VNR day" at the FDA in an attempt to explain to regulators how a VNR is produced, the process that leads to its airing, and why it constitutes news rather than a form of "free" advertising.
"Most VNR producers have followed the FDA's guidelines for a long time," she says. "We feel it is important to identify the source of the the information and to include labeling information. And the fact is that most of the material we send out is educational. Very little is about a specific product. We learned long ago that producers are not interested in openly promotional VNRs. They just don't get used."
Simon says her research shows that 80% of VNRs used by news producers are edited for use, further supporting the argument that they are used in the same way print press releases are used, and should not be treated differently in terms of regulation.
The FDA has suggested that viewers should be able to tell that they are watching a company sponsored VNR rather than news that the reporter has researched independently. Simon argues that print reporters do not identify information that comes from print press releases, and further that this is a mat ter for the news stations themselves, rather than a condition that should be imposed on them by PR people or by the government.
Others point out that the FDA appears not to understand the process by which public relations materials reach the media.
"The FDA seems to indicate that it wants to decide what is news," says Ilyssa Levins. "Media—not a company, or the government—decide if something is news. The FDA needs to realize that because of the nature of our relationship with reporters, PR practitioners can't afford to mislead the media. We can't get away with overpromising or covering up information, because reporters conduct their own investigation. PR practitioners cannot control message content or output."
The agency also appears to see a difference between medical media and consumer media, suggesting that some stories may be appropriate for the New England Journal of Medicine, but not for The New York Times or The National Enquirer.
Beverly Simon responds: "Consumer reports can give hope to patients and their families: hope that a new drug will help them fight the debilitating effects of AIDS or endure cancer therapy. Reports in consumer media can also feed that hunger for knowledge from an overgrowing segment of the public that wants to know more about the rapid changes in medical science. And it can alert physicians to a new drug's development and availability."
The FDA has also threatened to prosecute individual physicians who promote unapproved drugs or approved drugs for unapproved uses "with the full force of the law." In what many considered a bizarre statement, Dr Kessler said that to minimize any "chilling effect" on scientific discussion, the agency had not previously targeted individual physicians, but that it would no longer exercise such restraint: presumably indicating that the FDA had decided a "chilling effect" on scientific discussion was an acceptable by-product of a more aggressive approach.
The federal government is apparently considering a civil suit against Johnson & Johnson subsidiary Ortho Pharmaceutical for allegedly promotion retin-A, an acne medicine, as a wrinkle preventative. The company had sponsored a news conference announcing research showing that the drug was effective in reducing wrinkles and, according to the FDA, paid for physician media tours.
Johnson & Johnson communications chief Robert Kniffen argues that the company's involved the release of scientific information to the public. The FDA has said that it does not wish to impede the free flow of scientific information. "Ortho's dissemination of information about research in sun-damaged skin was proper and insured that balanced, medically accurate information was made to meet broad scientific, medical and public interest concerns," says Kniffen.
Arguing that the FDA's position is too extreme, Porter-Novelli's Bill Cox points out that there are often patients who are eager to try "experimental" treatments, and who may—in the case of a disease such as AIDS—die without treatment, however experimental.
"Since companies cannot say anything about experimental uses, or unapproved uses of approved drugs, what the FDA seems to be saying is that if people find out about it from some third party source they can try it, but the company can't actually communicate anything about it to anyone."
And while the FDA seems to be making it more difficult for physicians to take on public relations roles, it is also attacking the use of celebrities. The case often cited by the agency (and currently under criminal investigation by the U.S. attorney) is that of Mickey Mantle, who as a spokesman for Ciba Geigy's arthritis drug voltaren made certain claims for the product that went beyond the labeling and who did not make it clear that one of the reasons he had benefited from treatment was that it was the first drug he had ever used.
Ciba-Geigy has agreed to stop using celebrities as spokespeople, admitting that the physicians it had accompanying celebrities were often overshadowed and unable to provide "fair balance."
However, Barnum & Souza's Beverly Simon argues that: "If the fact that it was Mickey Mantle got more people to listen, and if it brought more people into the healthcare system to be diagnosed or treated, with voltarin or with something else, is that such a bad thing? The fact is that using celebrities is a great way to get the patient's side of the story and attract people's interest."
Having said that, most PR people agree that companies must take responsibility for what their spokespeople—celebrities or medical experts—say, particularly if they go beyond labeling.
One area in which draft guidelines have already appeared is that of company-sponsored seminars. The guidelines say that sponsors should have no role in the selection of presenters, must focus on broad aspects of a disease and non on a specific drug product, should not script or edit papers or presentations, should not hold ancillary promotional activities in the vicinity of the event and should not ghostwrite or edit or "otherwise influence the content" of scientific or educational articles written about company products.
The major aspect of the first draft guidelines with which many communicators are uncomfortable is the agency's insistence that such events be planned by scientific rather than by marketing or PR departments, and similarly that materials be prepared by and requests for information be answered by scientific departments.
Some are disturbed that the FDA should be telling corporations who within their organizations should be responsible for a particular function, others believe that such strictures would slow the flow of information and certainly reduce the quality and accessibility of that information. The suggestion has also reawakened debate about the nature of public relations, the argument being that in this context it is a management rather than a marketing function.
Merck has taken a leadership position within the pharmaceutical industry, announcing that it will no longer pay for physician travel, lodging or entertainment associated with symposia, thus switching the balance back to "pure" education away from what one practitioner calls the "quasi-educationa/promotional resort junkets" of the last decade.
A recent poll indicated that 95% of physicians say they are willing to pay their own expenses to attend symposia. Of course, that means that five per cent fewer physicians will soon be attending symposia from which they could glean valuable information.
Burson-Marsteller's Wayne Pines, for one, sees disturbing implications if the FDA's new guidelines do result in curtailed educational activity on the part of the pharmaceutical industry.
"There is a lot of information about health issues and health concerns out there," Pines points out. "Only a small portion of it is coming from the pharmaceutical industry, and that is the portion the FDA can control, the portion that is regulated and responsible. If that portion is decreased because of these guidelines, others will step in: authors and other self-styled experts, individuals who appear on talk shows representing their own interests, a less well informed media, activist organizations."
And there is evidence that the confusion over what the FDA will allow and will not allow is already having a chilling effect on medical communication. GTFH president Ilyssa Levins says the whole industry is very jumpy about undertaking large-scale communications programs. "It's like driving down the highway with a police car behind you. You know you've done nothing wrong but you're still nervous about being pulled over," she says.
"We are seeing some disconcerting patterns emerging," says Jack Angel, of the Coalition of Healthcare Communicators. "Some physicians are now refusing to participate in information sharing programs because they are afraid they may be publicly charged and tried by the media. The industry is being diminished in the public's eyes through accusations of promotional abuse. FDA deeds and words are producing a chilling effect on medical dialog and scientific exchange."
Another danger is that stricter regulation of healthcare promotion will impact disproportionately the poorer and less well-educated segments of society, in the same way that the recent restrictions on the kind of birth control advice statefunded clinics can offer their patients will impact mostly the poor. The well-educated will continue to get their information from "serious" magazines, while the same information will not appear in supermarket tabloids and on television.
Almost everyone connected with the video news release industry reports that the flow of information by that medium at least has slowed to a trickle.
Different public relations people envisage different worst-case scenarios. Pines and Beverly Simon define worst case in terms of the FDA demanding pre-approval of video news releases and other public relations activities, slowing the process and making it excessively costly. Others see a more damaging impact.
"The worst case is that consumers will not receive information that enables them to ask the right questions of their health care professionals," says Porter-Novelli's Bill Cox. "The worst case is that they don't spot symptoms, they don't seek help early enough, they don't get treatment early enough."
Having said that, there is cause for optimism in the long-term.
"My own view is that the trend towards consumers and health professionals demanding more information about drugs and health issues generally is a long term trend," says Wayne Pines. "It's a mega trend, and it will survive whatever the FDA does in the short term. The information will still be provided."