Should companies promote their products, I think the answer for any rational person is yes, they should that is how people come to buy them.
Apparently Senator’s Kohl (D-WI) thinks differently and has leaked a confidential marketing plan for Forest Lab’s Lexapro in an effort to discredit the company and pharmaceutical marketing practices in general.
In today’s New York Times Gardner Harris (the ardent anti industry writer) released a report on Lexipro marketing and included the companies marketing plan from 2004 written in 2003.
The Article Starts out with this statement:
“The pharmaceutical industry has developed thousands of medicines that have saved millions of lives, but it has also used its marketing muscle to successfully peddle expensive pills that are no more effective than older drugs sold at a fraction of the cost.
Skip to next paragraph No drug better demonstrates the industry’s salesmanship than Lexapro, an antidepressant sold by Forest Laboratories. And a document quietly made public recently by the Senate’s Special Committee on Aging demonstrates just how Forest managed to turn a medicinal afterthought into a best seller”
Science
Harris then goes on to outline how Lexapro is no better than other Selective serotonin reuptake inhibitors (SSRI) but is that true? According to an analysis published in the Lancet which looked at 117 controlled trials and found that there are significant clinical differences between the various antidepressants, and that Lexapro (escitalopram) and Zoloft (sertraline) stood out as better than the other drugs in their class. (this fact did not make the news paper article, I am sure it must have been an oversight or the editors edited it out).
Marketing
They include the 2004 marketing plan of Lexapro (provided by Senator Kohl's office) an outline of the many steps Forest used to make Lexapro a success. Because of concerns from Forest, the Senate committee released only 88 pages of the document, which may have originally run longer than 270 pages. “Confidential” is stamped on every page. (I guess the stamp Confidential doesn’t mean anything to a Senate Committee)
This may come to a shock to the readers but the marketing plan reads, well like a marketing plan.
The Senate staff should not be shocked that companies would have a plan to market their drugs. In the plan (which was obviously written by a consultant) It includes the previous years marketing spends and reach of all other companies producing SSRI’s.
FDA Regulated Dinner Meetings
The plan includes dinner meetings and lunches (lots of them) for physicians to the tune of spending $34.7 million for 2,000 physicians to deliver 15,000 marketing lectures on the drug to their colleuges (promotional talks).
The article states that “the plan make clear that one of the principal means by which Forest hoped to persuade psychiatrists, primary care doctors and other medical specialists to prescribe Lexapro was by finding many ways to put money into doctors’ pockets and food into their mouths. “
For years lunches and dinners are how drugs are marketed to physicians to educate them on how the drugs works, these talks include on label information and discussions about side effects they are all approved by the Medical Legal departments to ensure that they meet FDA guidelines for promotional education. Today many Risk Evaluation and Mitigation Strategy (REMS) programs mandated by the FDA require that companies educate physicians on new products.
Meal times are typically the only time a physician has to learn about products, would the government and their patients prefer that physicians gave up time set aside for patient care to hear product lectures, my bet is no.
The article goes on the state that:
Psychiatrists make more money from drug makers than any other medical specialty, according to analyses of payment data. And Forest gives more money and food to doctors than many of its far larger rivals. Vermont officials found that Forest’s payments to doctors in 2008 were surpassed only by those of Eli Lilly, Pfizer, Novartis and Merck — companies with annual sales that are five to 10 times larger than Forest’s.
Several reasons that psychiatrists make more than any other specialty is that they are:
A) The largest “specialty” (primary care is not a specialty) with over 40,000 of them
B) Many of their patients are referrals from primary care physicians, who are not extensively trained in the psychiatric diseases (outreach lectures make sence).
C) In 2004 it was a very competitive market with over 12+ branded drugs competing in the depression market alone.
Why would officials be shocked that a small company (trying to compete with the larger companies) would spend significant funds on marketing to make up for their lack of sales force and ability to pay for DTC advertising? Given the results of the sales $2.3 billion they should be applauded as heroes not villains for beating the big companies in market share and bringing a good drug to market in a crowded market place.
CME
The article and marketing plan include information on CME:
An entire section of the marketing plan, titled “Continuing Medical Education,” outlines how the company intended to use educational seminars for doctors to teach them about Lexapro. The Senate’s Special Committee on Aging held a hearing in July on whether industry funding of medical education classes leads to tainted talks.
“At our recent hearing we asked the question, ‘Is the line between medical education and marketing blurred?’ ” said Senator Herb Kohl, a Democrat from Wisconsin who is chairman of the committee on aging. His panel was given the Lexapro document by the Senate Finance Committee, which has long been investigating drug maker marketing efforts. “These documents show that for these companies, there is no line,” Mr. Kohl said.
But is this a fair statement to say that there is no line. Yes, it is true in the Summer of 2003, when the 2004 plan was developed the OIG Final Guidance on CME was just released that May, and prior to that time almost all commercially supported CME was paid for through marketing plans like the one released by Kohl’s office.
To somehow imply that commercial support of CME is a bad thing just because it showed up in someone’s marketing plan in 2003 is ludicrous. There has been no proof that any harm was done to patients by manufactures support of continuing medical education.
Because nothing changes overnight, companies spent most of the year 2004 re-tooling their CME departments, relocating them into the medical affairs departments away from marketing. By the time the 2005 marketing plans were in place at most companies CME was for the most part pulled out of the plans. I would venture to say that since 2005, all companies have separated marketing from CME.
In addition there have been many changes to the rules governing CME since 2003 including the 2004 ACCME revised standards of commercial support. CME providers and supporters have spent millions to ensure independence from commercial supporter influence on content and freedom from bias.
Conclusion
In the end leaks of old marketing plans to the press prove nothing more than companies engage in marketing which at the time was very normal and legal.
Rather than using the press to intimidate companies and imply wrong doing, Congress would be served by focusing on the bigger picture in health care reform and come up solutions that make sense. This is merely a side show, and those of us who collaborate with industry should see it as just that, more grand standing from the elected officials to secure a quote in the New York Times at our expense.
P.S.
Danny, if this makes you sick (which is something you suffer from on a regular basis, I suggest you take a PPI, oh but those were developed by pharmaceutical companies, so you will just have to suffer through it)