The Fraudulent Nature of Big Pharma’s Science

When The Media Says "Experts" They Mean Paid Corporate Shills (Part 40)

The common belief that modern medicine is evidence based medicine done objectively with double blind RCTs in pursuit of the best treatments and practices is an over glorified half truth. A profit motivated industry’s primary motive is to maximize profits and when the truth becomes a hurdle to protecting a company’s bottomline it gets sidelined. The medical industry is no different than the pesticide industry or the food industry in this regard. They are interested in patented brand treatments not necessarily because patented brand treatments are always the most effective or affordable for patients but because patents limit competition; less competition is more profitable which makes shareholders happy. Even when a new brand drug isn’t actually better than older and cheaper generics, the brand drug maker still has several methods at their disposal to manipulate how the clinical trial data is released to regulators and journals.

Data Fishing and Suppression

Even clinical trials with mixed or negative outcomes for the tested product are spun as being effective when published in peer reviewed journals. This is done by 1) failing to report data from all participants, 2) reporting data from only one site of a multi-site trial 3) only reporting data from an “efficacy subset” scrubbed of inconvenient data and 4) switching primary outcomes/endpoints post hoc.

In their examination of internal industry documents obtained through discovery in class action litigation against certain pharma corporations, Spielman and Perry relate two prominent examples of pharma corporations using data fishing and suppression to make new anti-psychotic drugs seem more efficacious to regulators and the medical community than they actually were.

In the early 2000s, GSK used one of these data suppression/selective reporting methods to publish a positive review of one of their new SSRIs, Paxil, in a clinical trial conducted among children suffering from major depression. They published an article in a peer reviewed journal claiming this new SSRI is generally well tolerated and effective for major depression in children. Closer inspection of their data revealed that this new SSRI failed to demonstrate efficacy across 8 different pre-specified end points in the study protocol and increased the incidence of suicidal ideation.

AstraZeneca suppressed data from 3 different clinical trials conducted with one of their new antipsychotic drugs. They omitted evidence that their antipsychotic brand drug, Seroquel, had lower efficacy than an older generic called haloperidol. They did this by cherry picking end points in a clinical trial comparing Seroquel and haloperidol wherever the former performed better while omitting evidence of higher psychotic relapse rates and worse self-reported symptom measures for the group administered Seroquel.

Ghost Writing

Corporations often pay "independent" academics to put their names on studies their employees design and conduct themselves. Often the published articles for these studies are written by third party writing firms. The academic authors of these studies rarely have access to the raw data from the study because it is considered proprietary information. At least 10% of published studies are ghost written. Pfizer had 18-40% of journal articles about Zoloft written by a writing firm called Current Medical Directions and attributed them to academic authors.

Investigator Initiated Trials

While investigator initiated trials are not technically ghost writer studies, the outside clinician who writes the study doesn't control or have access to the raw data, only data tables the pharma corp provides them.

Placebo Washout Phases

The dishonesty of pharma corps, particularly those selling antidepressants, isn't limited to data fishing, data suppression and ghost writing. They will also count negative outcomes that occur during the placebo washout phase, before participants are randomized, against the placebo group after randomization to make their product look more efficacious. An academic author conducting an investigator initiated trial at the behest of GSK used this tactic to make it seem like paroxetine reduces suicidality.

Legal Bribery of Doctors

Another ubiquitous tactic pharmaceutical corporations use to ingratiate themselves to doctors is by giving them gifts in hopes they will reciprocate by prescribing their brand of drugs more frequently.

2 out of 3 physicians receive non-research related payments from Pharma. In some specialties 4 out of 5 physicians receive non-research payments from Pharma. Within a systematic review of studies assessing the relationship between non-research payments from industry to doctors and prescribing behavior (n = 37) 11 out of 15 studies with a moderate risk of bias found a positive association between non-research industry payments and prescriptions of the payers brand name drugs. 5 studies found that food and beverage payments had a strong influence on payment-prescribing association and 25 studies that assessed payments and brand prescriptions as a monotonic function found a significant dose response relationship in 1 or more primary analyses. 6 out of 9 studies that evaluated the temporal relationship between non-research payments and prescribing found that higher prescriptions of certain brands proceed from payments made by manufacturers of those brands. 3 studies which conducted time series analyses found substantial increases in prescribing certain brands after receipt of each industry payment.

A combined analysis of Medicare Part D claims, CMS open payments program and D.C. AccessRx program marketing data for 2013 found that gift recipient prescribers made more than twice the number of medicare claims (892) as non-gift recipient prescribers (389), made significantly more claims per patient (8.8 vs. 6.5), with a $50 greater cost per claim ($135 vs. $85). Gift recipient prescribers were also significantly more likely to prescribe brand name drugs (1 out of 3 prescriptions) compared to non-gift recipient prescribers (1 out of 4 prescriptions). Gift acceptance was associated with a significantly higher average cost per claim in at least 6 specialities and even prescribers who received small gifts of less than $500 per year (n = 789) ‘had a significantly larger average cost per claim in comparison to non-gift recipients ($114 vs. $85).’ While this analysis cannot prove causation they do note that graduates of 14 medical schools that restricted Pharma gifts were less likely to prescribe 2 out of 3 new psychotropic medications after the gift restriction than before the policy went into effect.

As I reviewed in (Part 30), Propublica conducted two similar combined analyses of CMS Open system payment data and the 50 most prescribed brand drugs for Medicare Part D beneficiaries in the Medicare part D database in 2016 and 2019 and also found that any industry payment to a doctor was associated with a 30% increase in prescriptions they wrote for a particular drug or an additional 10 medicare claims; doctors who received payments from brand drugmakers were 2-3x more likely to prescribe brand name drugs than doctors who did not receive payments, and doctors who were paid for promotional speeches (honoria) had higher rates of brand drug prescribing than doctors who only received other types of payments such as reimbursement for travel expenses or lunches/dinners.