The Guardian, a British daily newspaper, recently published an edited extract of a forthcoming book by Ben Goldacre, a physician, with the headline: "The Drugs Don't Work: A Modern Medical Scandal." Goldacre's "Bad Pharma," which the extract came from, is set to be published this week.
The extract provides a unique perspective with respect to the pharmaceutical industry: from a doctor fed up with the pharmaceutical industry's lies. According to Dr. Goldacre, not only are consumers misled about the drugs they take, but doctors too, are told drugs are effective and have few side effects, only to find out (sometimes years or even decades later), that these assurances are completely untrue.
Goldacre begins with a tangible example: After examining clinical studies, pharmaceutical literature and conducting a proper risk-benefit analysis based on the information available and intended to aid physicians in making prescribing decisions, Dr. Goldacre prescribed a patient the anti-depressant Reboxetine. Reboxetine, produced by Pfizer, has never been approved in the U.S. because it has failed the FDA's efficacy tests.
However, the drug having been approved in the U.K., and based on the aggregate evidence available to Dr. Goldacre, he made the decision to prescribe it after discussing the drug with his patient.
Unfortunately, Dr. Goldacre's careful and calculated decision was based on false and inaccurate data--a widespread problem overwhelmingly threatening the health and safety of all drug consumers regardless of where they are located. In October 2010, Dr. Goldacre discovered that a group of researchers who had investigated the drug uncovered evidence that not only was the drug ineffective for its approved and promoted uses (mainly, depression, panic disorder, and ADHD), but it was significantly more harmful to consumers than placebos. All news to Dr. Goldacre.
Specifically, the researchers discovered that out of seven Reboxetine trials, only one had found evidence that the drug was safe and effective and this was the only study--again, out of seven--that was published for doctors and researchers to read. And the one published study was based on clinical trials for a relatively small group of participants (254), whereas the other studies conducted included 10 times as many participants. The other six studies were never published. As Dr. Goldacre states, he never knew they even existed. In other words, nearly 86% of the research available on the safety and efficacy of the drug was never publicized, published, or even identified as having been conducted. And taking into account the number of participants omitted from the published material, that percentage increases dramatically.
The idea that physicians and the healthcare community often receive only half of the story with respect to prescription drugs is not surprising given the profit-driven nature of the industry. But the idea that they only receive a mere fraction of the information known about a drug (in this case, 14% or less) is shocking.
And in the case of Reboxetine and Dr. Goldacre, it only got worse. Of the seven studies revealed to him in October 2010, six found the drug no more effective than a "dummy sugar pill". Thus, Reboxetine consumers, government agencies, and the healthcare community itself were deceived into purchasing likely millions of dollars--including taxpayers' money--of sugar pills, all under the assumption they were treating serious and potentially life-threatening mental health disorders.
What's worse you might ask? When looking at the trials comparing the drug against other similar drugs, the same deceptive strategy surfaced: three small studies including 507 total patients showed Reboxetine was as good as any other drug. But data of studies including 1,657 total patients showed the exact opposite. The "bad drug" data was never published; only the "good drug" data was. And the unpublished studies also showed patients treated with Reboxetine were more likely to have side-effects, drop out of using the drug, and withdraw from the studies due to the side effects.
In Dr. Goldacre's own words:
"I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished."
Source: The Guardian, http://m.guardiannews.com/business/2012/sep/21/drugs-industry-scandal-ben-goldacre?cat=business&type=article
The article and Dr. Goldacre's extracted portion convey the anger and essential powerlessness that a physician may be subject to when only provided misleading and false information concerning prescription drugs.
In the U.K. and in the U.S. particularly, drug information remains in the hands of pharmaceutical companies whose only incentive is to profit from their products. This control leads to an obvious paradox: consumers, the federal government, the healthcare community and the public at large are intended (by policy) to place their trust in corporations that are driven by profit. Yet it is those same corporations that are supposed to also protect the health and wellbeing of consumers.
Dr. Goldacre continues, in the extract, to describe the deficiencies in the industry leading to distorted evidence that doctors are intended to rely upon when prescribing drugs. According to him, most of the time, positive studies surface that have been funded and conducted by the pharmaceutical companies themselves. And it is often only these positive studies that are released. He notes that research from Toronto and Harvard investigators indicates that industry-funded studies are 20 times more likely to find positive results on the effects of any given drug, showing industry-funded studies are not as objective as the healthcare community and the public are led to believe.
Control and distortion of drug information is just another way the pharmaceutical industry deceives us. And it's about time the healthcare community takes note of this.
The defective drug lawyers at JONES WARD are dedicated to bringing you the most up-to-date information regarding dangerous drugs and medical devices, as it comes out. Our office handles a variety of drug and device cases. If you or a loved one has been injured, please give us a call. For more information, contact attorney A. Layne Stackhouse at 502.882.6000 or layne@jonesward.com.
