Tag Archives: Doug Bremner

Truth In Media: How Big Pharma Avoids Accountability With ‘Off Label’ Drugs

The Truth In Media Project has released the last segment of of its newest series Truth In Media: Big Pharma, The FDA & Health Propaganda. Part 4, titled How Big Pharma Uses Off-Label Drugs, illustrates how pharmaceutical companies have made massive profits in spite of being ordered to pay enormous settlements related to harmful side effects of certain drugs.

Truth In Media’s Ben Swann first discussed the case of Peggy Ryan, a pharmaceutical sales representative for Endo Pharmaceuticals, who spent a decade undercover gathering information and ultimately blowing the whistle on corruption within the company.

Ryan, described as a rising star at Endo, said that she had been directed to push a product called Lidoderm, which was initially created to treat a specific condition called post-herpetic neuralgia. Since Lidoderm was approved to be prescribed only for this condition, the drug was classified as an “orphan drug,” which qualifies a drug to be subsidized by taxpayer dollars in its approval and production process to offset low profits related to producing a product that is prescribed to a limited number of patients.

Swann pointed out that the FDA does not monitor orphan drugs for side effects after their approval.

Ryan said she was instructed to sell the drug “off-label,” which means to sell the drug to be used for conditions outside of its intended use. Lidoderm ended up being prescribed for a plethora of health issues including back pain and carpal tunnel syndrome. Many of these prescriptions were covered by Medicare and Medicaid.

“She had access to a lot of information, and she provided that to the government. But then they asked her to wear a wire and obtain audiotapes of the people that she reported to telling her and other employees to essentially to break the law,” Judy Hoyer, a whistleblower attorney whose firm represented Ryan, told Swann.

Endo was ordered to pay $193 million in penalties in a settlement; $21 million was allocated to settle criminal charges, and $172 million was paid out under the False Claims Act. While $193 million is certainly a large sum of money to be paid, Endo made at least $1 billion selling the drug off-label; the penalty paled in comparison to the profits made.

In a separate case that also involved massive drug sale profits in light of little government oversight, highly-cited researcher, doctor and Emory University Professor Doug Bremner discussed the acne drug Accutane with Swann. Bremner, who has spent a great deal of time researching PTSD and depression and the brain, served as an expert witness in litigation proceedings associating depression and suicide with Accutane.

Bremner was asked by a concerned parent to research Accutane. “I was doing research on depression and the brain so I was working in a similar area. So the question was whether the same kind of changes that we see in the brain in depression would be seen in kids taking this medication. So the idea was if the same brain areas are affected, then that could explain why some teenagers were developing depression and even some of them killed themselves,” Bremner told Swann.

Hundreds of reports of depression while using Accutane were seen between 1982 and 2000, and included 37 suicides. Accutane ended up being recalled in 11 countries and at least 7,000 lawsuits were filed against Roche, the manufacturer of Accutane. Millions of dollars were paid out in settlements, yet the sales of Accutane had reached nearly $800 million and the FDA never pulled the drug or classify it as deadly.

During discussion of FDA oversight on drugs such as Accutane, Bremner told Swann that “in all fairness to the FDA, they have a budget to approve drugs and there’s a lot of political pressure for them to approve as many medications as possible, as quickly as possible,” and there is a limited budget for continued surveillance and oversight regarding medications after they’re approved.

Despite the challenges presented to the FDA regarding the costs and time spent on the drug approval process, Swann pointed out that when the agency “only studies cherry-picked information, has agents who are promised future jobs with big pharmaceutical companies, and doesn’t seal with a drug after it’s been approved— even then that drug is causing birth defects or even death— then, quite candidly, what good is the FDA in the first place?”

 

 

Truth In Media: Big Pharma’s Influence Over The FDA

The Truth In Media Project has released the first segment of its latest Truth In Media episode: Big Pharma, The FDA & Health Propaganda. The first segment of this episode, Big Pharma’s Influence Over The FDA, examines how the pharmaceutical industry exerts heavy influence over the FDA as well as the media and the medical community.

In this segment, Ben discusses the multi-million dollar lawsuit launched earlier this year by eight plaintiffs against Johnson & Johnson, former FDA Commissioner Margaret A. Hamburg and her husband, Peter F. Brown. The plaintiffs claim that Hamburg was the “instrumentality” in covering up the harmful, and sometimes fatal, side effects of the once-popular blockbuster antibiotic Levaquin to maintain a high number of the drug’s sales, as well as to secure and protect private financial interests.

This segment also illustrates the consequences of demanding faster drug approval from the FDA. Doug Bremner, a physician and professor of Psychiatry at Emory University, tells Swann that Congress has reduced funding of the FDA’s budget while also ordering the agency to expedite its approval of drugs. “The number of people working on new drug approval has been increasing at the expense of those who are supposed to be watching drugs after they come out on the market,” says Bremner.

Swann also examines the problems that arise when FDA regulators, who are tasked with maintaining oversight of the pharmaceutical industry, are wooed by these companies. Laurie Powell, a former medical brand strategist, says that a career in the pharmaceutical industry is much more lucrative than a lower-paying government job, and that pharmaceutical companies regularly approach FDA regulators hoping to attract them to serve on the industries’ regulatory committees.

According to Powell, working for the FDA is sometimes merely a “jumping off point” for some employees before moving on to work in the pharmaceutical industry, which leads to the question: should FDA employees be able to work for the very industries they were once in charge of scrutinizing?