Healthy Skepticism Library item: 19415

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Lilly Pulls Down Strattera Web Site In China
Pharmalot 2011 Mar 21
http://www.pharmalot.com/2011/03/lilly-pulls-down-strattera-web-site-in-china/

Full text:

Over the past week, a note has been circulating on the Internet about the web site that Eli Lilly created for its Strattera ADHD medication for consumers in China. Specifically, the missive points out that the Strattera site offers very different info about the risks and benefits of the medication. As an example, the US Strattera site warns patients of suicide risk, but not the Chinese site.
“Lilly’s web site in China says nothing about this risk; patients are told nothing about any Strattera side effects at all. Chinese readers are warned instead about the dangers of ADHD (deliquency, substance abuse, unemployment, depression and other serious problems, both personal and social) unless treated with medication,” according to the note that was distributed by Ben Hansen, a Michigan resident and self-styled mental health advocate, who runs a web site called “Institute for Nearly
Genuine Research” by Dr. Bonkers (background here).
He also complains Lilly boasts Strattera is the first “‘FDA-approved non-stimulant to treat ADHD,’ but fails to mention an FDA-required black box warning for Strattera. Lilly does mention side effects of competing drugs (stimulants like Ritalin and Vyvanse may be habit forming and commonly cause tics), while claiming that Strattera ‘will not lead to drug dependence and will not induce or aggravate tics.’ Beyond claiming Strattera neither causes nor exacerbates tics, Lilly recommends Strattera for treating tics. This despite another FDA warning that Strattera is not approved for the treatment of tics.”
Hansen obtained the comparisons by using Google to translate the Chinese web site and, while he acknowledges the translation is imperfect, he labels the omissions an instance of ‘criminal conduct’ (compare the web sites and read his comments here). Allegations aside, we asked Lilly for an explanation about the differences in web sites and whether the drugmaker disputes the essential discrepancies that were highlighted. This is what we were told…
“We have reviewed the information you sent to us and we have a number of concerns. Mainly, the statements don’t adequately recognize that there are differences in regulations and product labels from country to country,” a Lilly spokeswoman wrote us. “Based on the questions that you have raised, and the potential for misinterpretation of the information on the Strattera product page on the China website, we are using this as an opportunity to thoroughly review the content from an external viewpoint and have temporarily taken the product page down.” [UPDATE: A reader writes in to say the web site apparently is, as of 2 pm EST, still accessible (see this), although we are told Lilly is working to take it down. AND, as of Tuesday, March 22, it is down.]
This is not the first time that Lilly has removed Strattera web pages. Following the aforementioned 2008 FDA warning letter, Lilly took a similar move after discovering that offending Strattera.com webpages continued to circulate on the Internet through indirect links. “Once Lilly became aware of this issue, the webpages and pdf files were removed from the internet,” wrote Cherri Miner, senior medical director for neurosciences in the US medical division (read the letter).
In removing the Chinese site, however, Lilly points specifically to differing regulations among countries as a reason for disseminating different info. Nonetheless, this raises a question about responsibility to patients, irrespective of the country in which they reside. So we asked Erick Turner, an assistant professor in the psychiatry department and senior scholar at the Center for Ethics in Health Care at Oregon Health & Science University, for his thoughts. This is what he wrote us…
“The information made available on this webpage would seem to skew the risk-benefit ratio. One cannot be sure of the quality of the Google translation, so it’s not clear whether claims are being made that would be considered off label in the US. The Chinese labeling contains references to tics, Tourette’s syndrome, anxiety, oppositional defiant disorder, and conduct disorder. The US labeling mentions the first three, in that these can be co-morbid symptoms or diagnoses in patients with ADHD.
“The other conditions mentioned in the Chinese labeling, oppositional defiant disorder and conduct disorder, are not mentioned at all in the US labeling. It is unclear whether Lilly is suggesting efficacy for these conditions or whether they are merely saying that these are additional co-morbidities in ADHD patients. If these are indeed efficacy claims, they would be off label claims, and they would be grounds for disciplinary action by the FDA.
“What is clearer is that the other part of the risk-benefit ratio is not being presented: safety information appears to be entirely absent. This is obviously not allowed in any labeling or advertising in the US. How is a Chinese prescriber to make a risk-benefit assessment without any information on risks?” he asks before continuing…
“…The webpage contains some material that may lead to an inappropriate level of fear in parents who might be questioning whether their children truly need a prescription: ‘If untreated, ADHD, then [sic] it will affect a person for life in all aspects of life…there will be a series of problems such as substance abuse (illegal drugs and alcohol), antisocial behavior, truancy, and even dismissal.’
“Yes, different countries do have different requirements. But the question should not be what do they are legally required to do, but rather what should they do. In the interest of the public health, there is an obligation to provide full and balanced disclosure.”
Turner notes that Lilly is a member company of the International Federation of Pharmaceutical Manufacturers & Associations, a trade group that stipulates “promotional activities (marketing practices) must be consistent with high ethical standards and information should be designed to help health care providers to improve the services provided to patients…Claims for therapeutic indications and conditions of use must be based on valid scientific evidence and must include clear statements with respect to side effects, contra-indications and precautions…The same high standards of ethical behaviour should apply to the marketing of pharmaceutical products in all countries, regardless of the level of development of their economic and health care systems” (read here).
Then, there is a link to another IFPMA page that discusses consistent info and asks this:
“Q: What level of detail is required to be included on labeling, packaging, leaflets, data sheets and all other promotional material in a developing country where there are no or very limited national laws and regulations regarding the form and content of such product information?
A: Where possible and within the context of national requirements, companies should provide the same core product information (such as contraindications, warnings, precautions, side effects and dosage) as it provides in developed countries” (read it here).
In other words, an industry trade group appears to suggest that patients in China are entitled to the same level of disclosure as those in the US or elsewhere, according to Turner. Of course, he also notes that these are voluntary guidelines.