Regulatory Agencies Up Against Big Pharma and Disease Mongering

April 13th, 2010. By janem

The Food and Drug Administration’s mandate is to protect and promote public health through regulation of pharmaceuticals, etc. But critics question the agency’s lack of attention to prescription drug promotion and disease mongering- the latter described as “widening the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments,” which might in part account for the increasing drug litigation in the US…

And the US, unlike other countries, allows unbranded disease-mongering advertising, the TV ad that doesn’t come right out and mention the drug: instead it ends with “patients are advised to see their doctor”, maybe with a happy family, blue skies and kittens in the background.

In 2004, the FDA stated that unbranded adverts that are perceptually similar or otherwise linked to branded adverts are subject to FDA regulation, as are unbranded adverts by the manufacturer of the only drug in its class. But apart from that, the FDA has no authority over the content of disease-oriented advertising. Obviously, a drug is only worth considering if potential benefits outweigh potential harm. But with ads targeting healthy people, are there added benefits? Where is the FDA?

The FDA vs Other Regulatory Bodies

Worldwide, regulatory agencies have differed in their response to manufacturers’ bids to market their drugs and the major gap appears to be the FDA vs everyone else.

The World Health Organization argues that governments should take a more active role in regulating disease-awareness campaigns to prevent misleading information from reaching the public. The Europeans state that advertising of medicinal products “must encourage the rational use of the product and may not be misleading”. And Canada’s Food and Drugs Act prohibits advertising of a drug that is “false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, merit or safety. ” But the FDA seems to lag and fails to treat regulation of drug promotion as a public health concern. Especially when compared with Therapeutics Initiative.

The University of British Columbia’s Therapeutics Initiative comprises a group of researchers who provide independent evidence-based advice about prescription drugs. “I cannot speak too highly of the Therapeutics Initiative,” said Dr. Sidney Wolfe, a member of the drug safety committee of the FDA and head of the Public Citizen’s Health Research Group.

Not only has the TI saved lives, it has also saved British Columbia taxpayers a lot of money. For example, TI researchers warned Canadians about the arthritis drug, Vioxx, before it was removed from the market for safety reasons. TI assessed the diabetes drug Avandia and cited side effects such as heart attack and angina. As a result, the drug was prescribed much less in British Columbia than the US.

TI has been hailed as “a critical counterbalance to the most profitable industry in the world.”

And with the FDA’s decision to speed up the drug approval process, access to accurate clinical trial information and systematic drug reviews that the TI provides is even more important: increasingly drug manufacturers withhold critical data from the public, resulting in misleading information and potential harm.

Forms of Disease Mongering Used to Expand Drug Sales

• Promotion of anxiety about future ill-health in healthy individuals
• Inflated disease prevalence rates
• Promotion of aggressive drug treatment of milder symptoms and diseases
• Introduction of questionable new diagnoses-such as PMDD or social anxiety disorder-that are hard to distinguish from normal life
• Redefinition of diseases in terms of surrogate outcomes (i.e., osteoporosis becomes a disease of low bone density rather than fragility fractures)

Canadians argue that it is necessary to have an independent body such as the TI to analyze drugs so that they can be treated appropriately, rather than American drug recommendations that are often driven by the drug companies. I wonder how many Americans know about the TI?  But TI might have a short shelf life if pharmaceutical companies have their way. In 2007,  a pharmaceutical task force-INCLUDING SEVERAL REPS OF THE DRUG INDUSTRY-called for an end to the TI’s role in approving drugs (or not). Health critics charged that this decision was putting private interest ahead of public interest-a criticism often thrown at the FDA. Let’s hope that the TI doesn’t get swallowed up by big pharma, like its American counterpart.

This was posted on Tuesday, April 13th, 2010 at 3:32 pm and is filed under Emerging Issues . Feel free to respond, or trackback. Read our comments policy.