In a disturbing turn of events, Big Pharma pushes to hijack informed consent by removing side effects from direct-to-consumer pharmaceutical advertising.
Direct-to-consumer pharmaceutical advertising (DTCPA) has exploded during the past several decades and is now the most prominent type of health communication the public encounters. DTCPA has been legal in the US since 1985, but exponentially expanded in 1997 when the Food and Drug Administration (FDA) changed a rule that once forced drug companies to offer a detailed list of side-effects in their long format commercials. The impact was immediate. Spending by drug companies on TV ads hit $664 million within a year. By 2005, the industry was spending more than $3 billion annually on televised direct-to-consumer (DTC) ads. 2008 saw Big Pharma post just under $5 billion. Spending on DTCPA rose 9% to $5.6 billion in 2016 and expected to rise further in 2017. To date, the US and New Zealand are the only two countries that allow DTCPA.
In what appears to be a coordinated effort both the FDA and the UK’s Academy of Medical Sciences (AMS) have each announced their intentions to hide or eliminate side effects from DTCPA and patient information leaflets (PIL). Lending credence to larger picture unfolding, both the FDA and the AMS announced their intentions to toy with further concealing drug and vaccine side effects on the same day [June 19].
Hijacking Informed Consent
The FDA announced it will begin a study titled Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads. To fulfill the regulatory requirements for fair balance and the brief summary (the part of the ad which lists side effects, contraindications and effectiveness) drug companies must included risk information about their product in DTC print ads both in the main part of the ad where the product claims appear, and in a separate brief summary page. The FDA’s rationale for its new study claims that listing the unfavorable risks and side effects of a drug may be ‘overwarning’ consumers in addition to potentially leading to habituation. The agency’s Office of Prescription Drug Promotion is planning to test what happens when the side effects are reduced or eliminated from DTC television ads.
The AMS is a self-proclaimed “independent body in the UK representing the diversity of medical science” who, according to their website, is funded by GlaxoSmithKline, Amgen, Merck Sharp and Dohme, and Roche. Their recent project was “…to examine how the generation, trustworthiness and communication of scientific evidence can be enhanced [key term] to strengthen its role in decisions by patients, carers, healthcare professionals and others about the benefits and harms of medicines.” In other words since the UK can’t market drugs and vaccines directly to the consumers the AMS has set out to see how eliminating informed consent by hiding product side effects from patients will boost pharmaceutical product uptake. Their report starts out with perhaps the most important statistic to date showing widespread rejection of Big Pharma and its influence on the medical community:
“Only about a third (37%) of the public trust evidence from medical research, compared to approximately two-thirds (65%) who trust the experiences of their friends and family, according to a report launched today.”
In a rational health world focused on true healing, such dismal percentages would be evidence to rework a broken medical system, remove Big Pharma conflicts of interestin research and medical practice and begin to listen to patients. Instead, the AMS report goes on to call for “improvements” to the PIL and “a bigger role” for UK’s National Health Service to be a “source of trusted information online”. The report calls for the European Commission and the European Medicines Agency (EMA) to work with pharmaceutical companies to “reform” PIL’s.
Currently the EMA has two open complaints against it by the Nordic Cochrane Centre over maladministration, conflict of interest, secrecy and unprofessionalism concerning the handling of HPV vaccine safety data, research and whistleblowers. What kind of improvements in the PIL are being suggested? The AMS is calling for a more “balanced view” because there is too much focus on the potential side effects of drugs and vaccines on the PIL’s and not enough on their benefits. The rationale for reworking the PIL is not rooted in reality. The broken peer-reviewed process and pharmaceutical industry influence on medical research has continually omitted both greater incidences and number side effects along with exaggeration of benefits.
Disaster in the Making
The moves by the FDA and the AMS could be considered beta tests to gauge how the public, medical communities and regulatory agencies react to attempts at the further erosion of informed consent. Years prior, Ireland began its HPV vaccination program throughout the country’s school systems. Ireland’s Health Service Executive (HSE) specifically instructed schools and their staff to not include the PIL. Shortly after in 2014, Assistant National Director of the HSE Kevin Kelleher was recorded at a conference admitting:
“Part of it is equally us being able to put in place a system where they have enough knowledge to undertake the decisions that are appropriate. Now that’s quite a paternalistic approach as well. Cause actually what I’m saying is, I want to give them [parents] the knowledge to make the decisions I want them to make.”
How did Ireland’s ‘improvements’ to the PIL and informed consent within the context of their HPV vaccine program turn out? The country is on their second HSE director who officially blames parents and their daughters for the severe adverse reactions from the HPV vaccine claiming the injuries are “psychosomatic” or all in their heads. The parents of a growing number of HPV vaccine-injured girls continue to state they would never have consented to the shot if they were able to read the risks on the PIL.
Reducing proper informed consent is a historically dangerous slipperily slope yet in the current atmosphere it borders on insanity. On May 31, 2017, Attorney General Mike DeWine of Ohio filed a lawsuit against five drug companies: Teva, Allergen, Johnson & Johnson, Purdue, and Endo. The suit accuses the drug makers of contributing to the state’s opioid and addiction epidemic explaining, “The total number of opioid doses prescribed to Ohio patients soared to 793 million—enough to supply every man, woman and child in the state with 68 pills each.” The suit’s accusations include deceiving, misleading and conspiring to influence many levels of the medical community. The lawsuit claims the drugmakers fraudulently broke pharmaceutical marketing laws and “helped unleash” a “catastrophic” opioid crisis in the state.
The rules and ethics governing informed consent are the last bastion of sacred protection between humanity and notoriously criminal drug companies who continually prove by their actions that profits are greater than patients.
By: Jefferey Jaxen