By Kennedy Shelley
If a big drug company thinks they have a good drug and sponsors three studies to show it is effective, but one of the studies is inconclusive, another shows no effect and one shows some promise, does the company have an obligation to let everyone know about the first two studies?
While doctors and the public at large would argue that “yes the public should know about the first two studies” big pharma was not under any obligation to report negative studies, and often didn’t.
It costs a great deal of money to get a new drug to market, and most don’t work as hoped. But when studies that show bad side effects or ineffectiveness are not released doctors are not getting all the available information about drugs they were prescribing to their patients.
When doctors noticed that big pharma was only releasing studies that touted the benefits of their drugs, they started insisting that all studies had to be released.
The push for more transparency began in the 1990’s when Dr. Archie Cochran began his crusade for better reporting and more uniform reporting of results of studies.
This led to a new program called Consolidated Standards of Reporting Trials (CONSORT).
By the early part of the 21st century, nearly all Randomized Clinical Trials started being registered before it began in order to have any chance of future publication.
The effect of this was studies that showed positive benefits of a drug fell from 57% to 8%.
The study’s conclusion was:
“17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ2 =12.2, df= 1, p=0.0005). There has been no change in the proportion of trials that compared treatment to placebo versus active comparator.”
In other words, when all the studies have to be released, we find that many so-called “super” drugs are often not much better than doing nothing at all.
There is a strong bias with many scientific journals not to accept any data from a study that was not registered because that signals an attempt to hide studies that are not positive.
This has led to more transparency and hopefully, an end to positive study bias from completely dominating publications.
But this should call into question studies on drugs released before 2006 when this standard was created.
Statin drugs were released with much fanfare as a way to reduce the so-called bad cholesterol in the blood.
But what many people don’t realize is that there were a number of studies that were not released that questioned just how effective the drugs actually were at doing things like preventing heart attacks.
When rosuvastatin was released in 2003 as Crestor, it was supposed to reduce heart attacks by up to 50%. But after 2006 when CONSORT started, the effects of the drug were not as positive.
This called into question just how many negative studies were just never released.
There has been no doubt that Crestor was a wildly successful money-making drug for AstraZeneca, and it became the fourth most prescribed drug in the US. This so-called “super statin” had nearly $5.2 billion in sales the first year.
Yet any studies that showed negative effects of the medicine were not released including some studies that showed tremendous negative side effects of the medication.
All of this was swept under the rug, as were studies that showed Crestor did not do much to prevent heart attacks in the average person.
This does not mean that Crestor is not a good drug for some who are at high risk. It just means that because not all the data was released doctors could not make a good decision regarding if the potential side effects were worth risking for the benefits of the drug.