On the Food and Drugs Administration (FDA) website is an article on: “The Impact of Direct-to-Consumer Advertising.” It stated that doctors, for the most part, believe that direct-to-consumer advertising for drugs has both positive and negative effects. This conclusion was based on a survey of physicians released by the FDA in 2004. Most physicians thought direct-to-consumer (DTC) advertising stimulated their patients to ask thoughtful questions and become more aware of possible treatments. “Many physicians thought that DTC ads made their patients more involved in their treatment.” As I was reading this article, I had the distinct feeling that Rod Serling was giving his commentary over the opening music for his show and then he said: “Your next stop, the Twilight Zone.”
Although the above FDA page was last updated on 10/23/2015, the American Medical Association (AMA) publically called for a ban on direct-to-consumer advertising for prescription drugs and medical devices on November 17, 2015. The AMA news release said: “Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially-driven promotions, and the role that marketing costs play in fueling escalating drug prices.” Writing for STAT, Ed Silverman said he thought the chances of an advertising ban happening were negligible. Lawmakers have attempted to ban drug ads before without success; and court rulings recognizing the free speech rights of pharmaceutical companies could thwart any new attempts.
A public opinion poll done by the Kaiser Family Foundation was cited by Silverman as finding that about half of its respondents thought prescription drug advertising did a good job describing the potential benefits and side effects; and was mostly a good thing. Based on the Kaiser poll, Silverman concluded that most Americans believe drug ads allow patients to have greater involvement in their health care decisions. A spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA) agreed: ““It’s not a bad thing for patients to bring questions to the doctor’s office.”
This Kaiser poll echoed a 2011 article in Pharmacy and Therapeutics, by C. Lee Ventola, “Direct-to-Consumer Pharmaceutical Advertising.” Ventola concluded the available evidence indicated there were both positive and negative effects on consumers from DTC advertising. He thought a ban or severe curtailment was unlikely. But remedies that maximized the benefits and minimized the risks of DTC advertising with prescription drugs were possible. “It is hoped that these measures will allow this controversial, but powerful, medium to be better utilized for the improvement of public health.”
However, STAT seems to have developed doubts about the validity of those findings. In conjunction with The Harvard T.H. Chan School of Public Health, they recently published the results of a poll on American’s attitudes towards changing regulations about prescription drugs.
The STAT-Harvard poll found that 57% of adults in the U.S. supported removing prescription drug advertising from television. Almost the same percentage (58%) opposed changing government standards to speed up the process of developing new prescription drugs and medical devices. Only 7% said they considered taking a drug they saw advertised on TV and 14% said they had experienced a serious side effect from taking prescription drugs in the past five years. Robert Blendon, a professor of health policy at Harvard who oversaw the poll, said: “There is a cautiousness about safety and efficacy here that people hadn’t realized before.”
The World Health Organization (WHO) noted that attempts to establish DTC advertising for drugs in Europe were “doomed to failure.” Back in 2009, 22 of the 27 European Union member states opposed the “information to patients” strand of a proposal for new pharmaceutical legislation. “This despite the fact that the legislation would have limited pharmaceutical companies to using the internet and specialist health publications to disseminate information.” According to Dr. Dee Mangin, an associate professor at the Christchurch School of Medicine and Health Sciences in New Zealand: “The truth is direct-to-consumer advertising is used to drive choice rather than inform it.”
However, the situation is different in the U.S. The STAT-Harvard poll comes just as lawmakers begin to grapple with whether to approve legislation to change government regulations, ones that are blamed by Pharma for slowing the approval process for new drugs and medical devices. The House passed H.R.6-the 21st Century Cures Act, in July of 2015. Among other things, H.R.6 seeks to revise government safety and effectiveness standards to speed up the approval process for new prescription drugs. It also includes more than $8 billion of additional funding for the NIH. However, disagreement between Democrats and Republicans in the Senate over how to pay for H.R.6 led to an impasse. So the House bill was broken up into several smaller ones.
Dr. Robert Califf, the newly appointed FDA commissioner, expressed concern that if the pending legislation was not carefully crafted, it could pose significant risks for the FDA and American patients. “Innovative therapies are not helpful to patients if they don’t work, or worse, cause harm.” But there is a concurrent series of judicial actions that could make the regulatory situation even more chaotic.
On March 8, 2016, the FDA agreed that Amarin could promote its drug Vascepa for off-label use. This was the end result of an August 2015 ruling by a judge that Amarin could market its product to a broader patient population than the FDA had originally approved. The heart of the company’s argument was that it had a first Amendment right of “commercial free speech” to market Vascepa off-label to a broader patient group. See “Opening the Off-Label Floodgates” for more on this issue. Given the recent court rulings in favor of the commercial free speech of pharmaceutical companies, the FDA needs to revise its regulations regarding off-label marketing. But it seems that some members of Congress are getting impatient with the time the agency is taking.
STAT indicated that two members of Congress have accused the Department of Health and Human Services (HHS) of delaying guidelines for off-label marketing of drugs and medical devices. They wrote they were “perplexed” the FDA had not yet issued new guidelines and thought a disagreement between HHS and FDA leadership was the reason for the delay. “They also attached a draft bill that would allow companies to market products for unapproved uses.” Michael Carone of the Public Citizen Health Research Group said: “The threat to patient health posed by the draft bill attached to their letter is tremendous.” According to STAT, one source said:
HHS leadership doesn’t trust industry to do the right thing … HHS leadership believes off-label speech will lead to more aggressive marketing of new products that will raise costs to [Medicare and Medicaid]. They are allowing both their prejudices [industry as the bad guy] and priorities [keeping spending down] to get in the way … The White House shares these fears, and as a result the FDA’s desire to issue guidance is stymied.
Not surprisingly, three of the interest groups contributing heavily to the reelection campaigns of these Congressmen were related to healthcare, according to MapLight. From April 1, 2013 to March 31, 2015 Joe Pitt’s reelection campaign received $256,150 from Health Professionals, $178,500 from Pharmaceuticals/Health Products, and $69,600 from Health Services/HMOs, for a total of $504,250. Fred Upton, who is chair of the House Committee on Energy and Commerce, received $304,700 from Pharmaceuticals/Health Products, $301,051 from Health Professionals, and $94,350 from Health Services/HMOs—for a total of $701,101.
The 21st Century Cures Act has a carrot-and-stick approach for health care reform embedded into it. The ‘carrot’ is a $9 billion increase of funding to the National Institutes of Health budget over the next five years. But the funding is attached to the ‘stick’ of faster approval of prescription drugs and medical devices. Ed Silverman said the House bill would allow the FDA to approve added uses for a drug WITHOUT relying on a randomized clinical trial. Daniel Carpenter, a Harvard political scientist who studies the FDA called the 21st Century Cures Act “the 19th Century Fraud Act” because of this provision. “This is a part of the bill that threatens to take us back more than a century.”
Instead of requiring a randomized clinical trial, the agency could base their decision on “clinical experience,” which essentially means anecdotal observations from physicians and patients. The unreliability of basing judgments of drug effectiveness on anecdotal observations was why randomized double blind placebo-controlled method became the “gold standard” for clinical drug trials in the first place. Removing this requirement would be like returning to the time of patent medicines or stepping into the Twilight Zone of drug approvals. As he did when narrating the original show, Rod Serling has some words of wisdom we need to remember: “It may be said with a degree of assurance that not everything that meets the eye is as it appears.”