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Wednesday, June 28, 2006

Consumers International Report Contrasts Drug Companies' Conduct With Their Stated Ethics Policies

Consumers International, an international federation of consumers' organizations, just published a report on pharmaceutical company practices. CI affiliates in several European countries assessed how 20 major international drug companies marketed their products and upheld their own codes of ethics. As the Guardian summarized its results:


Drug companies use unscrupulous and unethical marketing tactics not only to influence doctors to prescribe their products but also subtly to persuade consumers that they need them, a report claims today.

Consumers should be concerned because time and again the companies violate their own industry's ethical marketing codes.
The report examines the marketing practices of 20 of the world's biggest drug companies. It alleges that:

· Drug companies are promoting their products through patients groups, students and internet chatrooms to bypass the ban on advertising except to doctors.

· They offer information to the public on "modern" lifestyle diseases, such as stress and poor eating habits, to encourage people to ask their doctors for medicines.

· They make inaccurate claims about the safety and efficacy of their drugs.

· Doctors are offered incentives to prescribe and promote drugs including kickbacks, gifts, free samples and consulting agreements.

· Many companies have been implicated in anti-competitive strategies, including cartels and price hikes.

Drug companies are not permitted to advertise products to the public. But companies are increasingly looking to influence consumers directly through funding patient groups and launching 'disease awareness campaigns', which do not name a product but are likely to encourage patients to seek treatment.

'This type of 'nice-and-friendly' marketing is often disguised as corporate social responsibility and has been shown to create a subtle need among consumers to demand drugs for the conditions, while giving consumers a sense of trust in the pharmaceutical companies,' says Consumers International.

Best placed to persuade doctors of the merits of a new drug are other doctors. Drug companies often pay specialised medical communication agencies to recruit and train leading doctors, specialists and academics as 'key opinion leaders', or KOLs, as they are known in the business. These people will be paid to promote drugs to other doctors through presentations, research papers, discussions and debates.

'The relationship between companies and KOLs is not explicitly transparent,' says the report. 'As a consequence, consumers and patients, and in some cases health professionals, may not always be aware how motivation for individual profit could play into the drug information they receive via the KOLs.'
Violations of industry-wide drug promotion codes occur with regular frequency, says the report. The 20 companies were involved in 972 breaches of the ABPI's rules on ethical drug practices between 2002 and 2005. More than 35% of those breaches, the largest category, had to do with misleading drug information.

More than half of the 20 companies whose marketing practices are examined in the report have been implicated in controversies regarding free samples, kickbacks and gifts to medical professionals, it says. Half have breached the ABPI code of practice on the conduct of the medical representatives who visit doctors.

Most of them - 17 out of 20 - have been involved in publicising irresponsible or controversial promotional materials. Only two companies, GSK and Novartis, are transparent in reporting the number of confirmed breaches of marketing codes and any sanctions imposed.

This record raises questions about the efficacy of self-regulation.
The full report includes an appendix, stratified by company, listing instances of questionable marketing practices contrasted with each company's relevant ethical codes, and comments on any discrepancies. The incidents listed are international in scope, mostly, but not exclusively European, including a few which have appeared on Health Care Renewal, but many which are new to me.

As an aside, we have posted about how some leaders of US health care for-profit corporations are now under fire from their own stock-holders for compensation that seems exaggerated compared to their companies' financial performance. One of these leaders was the CEO of Pfizer, Henry McKinnell (see post here). Recently, as reported by Reuters, McKinnell defended his compensation because it was based on his total performance, not just the stock price: "So what is performance? Is it current share price? I don't think so. It's long term value." Furthermore, McKinnell asserted that only the Pfizer board of directors is competent to judge that value because it "knows about the business, sets tough standards for the CEO and rigorously evaluates that performance."

I wonder if the board was aware of the list of questionable marketing practices attributed to Pfizer in the CI report when it assessed McKinnell's performance. They included:

- In 2004 Pfizer pleaded guilty on charges of falsely marketing its epilepsy drug Neurontin for off-label uses.[1]
- The Dutch Code Commission granted a complaint by a doctor against Pfizer in 2004. The doctor had filled a complaint about an invitation that he had received from Pfizer for a informational meeting about Celebrex. Pfizer promised to cover expenses by giving 200 euro for doctors signing up to the meeting.[3]
- In two advertisement for Norvasc (amlodipin) in Germany in 2004, Pfizer left out important findings from the ALLHAT-study that was referred to. It claimed 'equal value' of Norvasc when compared to diuretics, whereas this could not be concluded on the basis of the research findings.[4] The American College of Cardiology (ACC) cooperated with Pfizer and issued a statement urging doctors to stop the use of the competing drug Cardura.[5]
- Published data on Pfizer's anti-depressant Zoloft has claimed that it reduces the likelihood that people will harm themselves. However, data from clinical trials indicated the opposite, namely that people continue to harm themselves.[6]
- The MHRA ruled that in a promotional letter, sent to healthcare professionals in the UK in November 2004, information about Celebrex was not balanced or accurate. The MHRA required that Pfizer would send a corrective statement, but after a publication by the MHRA on the use of selective COX-2 inhibitors in general, this requirement was dropped.'[7]
- Pfizer has sponsored an Impotence Association campaign in which the logo of Pfizer figured prominently on the advertisements. The UK Prescription Medicines Code of Practice Authority (PMCPA) ruled that this was inappropriate and could encourage patients to ask doctors specifically for Viagra.[8]
- In 2004, Pfizer was criticized by the Federation of German Consumer Organizations for illegal direct-to-consumer advertisements in newspapers. According to the NGO, Pfizer claimed in advertisements targeting market German drug regulations that Sortis is the best cholesterol-lowering medicine available.[9]
- In 2005, the Dutch Code Commission (CGR) ordered Pfizer to shut down a website about erectile dysfunction that it sponsored, because the company was promoting of its prescription drug Viagra to the general public.[10]
- In Spain, Autocontrol judged in 2005 that Pfizer had violated articles 3.8 and 7 of the Farmindustria Code. It had made an unfair comparison between its drug Viagra and Eli Lilly's Cialis and illegally promoted the drug to the general public. The company was fined €90.000.[11]
- In September 2005, the Prescription Access Litigation project (PAL) filed a class-action lawsuit in the US, accusing Pfizer of a deceptive advertising campaign for Lipitor.[12]
If not, they should have been. See the CI web-site for more details.

Post Title Consumers International Report Contrasts Drug Companies' Conduct With Their Stated Ethics Policies