Product News and Recalls

New safeguards needed for pharmaceutical companies

An opinion piece in The Atlantic about the $3 billion settlement against GlaxoSmithKline makes the point that even a relatively large financial penalty is unlikely to stop a company that still makes a profit from illegal activities. The solution, The Atlantic says, is to change a system that essentially allows companies to monitor themselves.

The British drugmaker’s agreement with the U.S. Justice Department to pay $3 billion in criminal and civil fines marks the largest settlement ever involving a pharmaceutical company. Federal prosecutors say the company illegally marketed several drugs and intentionally withheld safety concerns from regulators.

A number of studies link antidepressants classified as selective serotonin reuptake inhibitors – such as Prozac and Zoloft – with potentially dangerous birth defects.

The recent settlement includes allegations that GSK illegally marketed two antidepressants. One has been shown to have significant side-effects, including triggering suicidal thoughts and behavior, and neither antidepressant is much more effective than a sugar pill for the vast majority of depressed patients, The Atlantic reports.

The Atlantic says GSK’s actions with regards to its diabetes drug Avandia were even more potentially harmful to patients. When a new drug comes on the market, sometimes the Food and Drug Administration will ask or require the manufacturer to do a study called a post-marketing trial. That’s meant to uncover potential health hazards that may not have shown up in the initial clinical trials, which aren’t of sufficient scope or duration to uncover long-term health effects.

GSK distorted the results of those post-marketing trials, concealing potential links between Avandia and heart attacks or other cardiac diseases.

The Atlantic notes that the post-marketing trials are now in the hands of companies that have every incentive to fudge results, and that the $250 million GSK was assessed for the Avandia portion of the settlement represents a slap on the wrist in light of the fact that the company earned $2.2 billion a year from the drug at its peak.

The opinion piece says:  “The solution isn’t stiffer punishments for fraud — we should take away the power to do harm in the first place. That means we need to stop giving drug companies the opportunity to sell out patient safety in exchange for another few months or years on the market. The simplest way to do that is to have automatic, external post-market surveillance for all new drugs.”

Patients should consult their doctors before making any changes in their medication. A consultation with an SSRI lawyer is also important if there are significant injuries from SSRIs.

See the piece here: