Category Archives: Big Pharma, The FDA & Health Propaganda

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: How Big Pharma Manipulates Physicians and Corrupts ‘Best Practices’

The Truth In Media Project has released Part 3 of its latest series Truth In Media: Big Pharma, The FDA & Health Propaganda. Part 3, titled How Big Pharma Manipulates Physicians and Corrupts “Best Practices,” discusses how companies in the pharmaceutical industry influence doctors’ “best practices” as well as offer funding for research and court physicians and their staff in hopes of gaining loyalty.

Devon Beasley, a registered nurse, has spent years in her field and told Truth In Media that she has seen representatives for pharmaceutical companies “wine and dine” an entire medical office in the midst of promoting various products. “Some of the offices that I would apply for would actually tell me ‘hey, we have catered lunches three times a week.’ That’s directly from pharmaceuticals. You also get materials for your office that make your office look really great,” said Beasley. “They will bring in supplies that make your office look like you have a lot of money.”

Beasley went on to say that medication samples, which are common in the doctors’ office and part of the pharmaceutical companies’ strategy to promote certain products, are highly sought after by patients and can conflict with the pursuit of proper medical care. “No one is asking which is the safest medication, which is the best for me, which is best for the patient. It’s all about ‘do you have samples, do you have coupons? Can you prescribe me something that does have a coupon? Can you prescribe me something that does have a sample?’ And it has nothing to do with which one is best, most effective or safest,” said Beasley.

Sen. Chuck Grassley (R-IA) has voiced concern in the past over this issue. Grassley provided Truth In Media with a statement regarding a bill he had co-authored called the Sunshine Act, which aimed to address this problem:

“The purpose of the Sunshine Act was to disclose drug and medical device company payments to doctors for public discussion. As data is released, investigative reporters and analysts are able to study the information and look for trends that patients, doctors and policy-makers might want to know.”

Truth In Media’s Ben Swann also discussed the pharmaceutical industry’s impact on the medical community’s procedures known as “best practice,” which is the name for a system of policies that have been agreed upon by doctors and regulatory agencies such as the FDA. Swann explained that “the problem with best practices is how it is manipulated by big pharma. Research that best practice is based on is heavily funded by big pharma.”

Swann noted that it’s common for pharmaceutical companies to pay the cost of educational institutions and private institutions conducting research for them.

Part 3 illustrates why the public should be aware that pharmaceutical companies regularly shower medical offices with various perks and benefits in exchange for offering certain drugs; fund a great deal of medical research; and exert influence over best practices agreed upon between doctors and government regulators.

“It’s sad when pharmaceutical industries are involved in the research. They have relationships with the regulatory agencies, and then they also heavily influence the education the physicians are getting,” said Beasley. “And they’re priming the market for the patients, so they are directly involved in every part of the medical industry and are benefiting from it.”

Truth In Media: Understanding Big Pharma’s Propaganda Machine

The Truth In Media Project has released Part 2 of its new 4-part Truth In Media episode Big Pharma, The FDA & Health Propaganda. In Part 2, Understanding Big Pharma’s Propaganda Machine, Ben Swann discusses the how companies within the pharmaceutical industry are able to attract positive media surrounding its drugs, regardless of whether or not their claims are founded.

Laurie Powell, a former medical brand strategist, spent a decade identifying drugs that would have the potential to treat prevalent and widespread medical issues, and persuading physicians to believe that these drugs were valuable, even if their effectiveness or overall safety was not yet proven.

According to Powell, ad agencies work with pharmaceutical companies to create ghostwritten articles that praise certain drugs utilizing cherry-picked data, and these articles are provided to medical journals. These “scientific articles” are not truly scientific, says Powell, but are actually forms of advertisements created to convince physicians to believe in a certain drug’s potential as well as influence their colleagues.

“It would start with New England Journal of Medicine, JAMA, those kinds of large publications,” says Powell, as well as communicating with smaller publications more specifically tailored to certain medical conditions. “We’d plan out over the next few years how we’re going to take the messages that come from the data— which we’d slice and dice that up— and disseminate those messages throughout those publications over a course of years.”

Marcia Angell, the former editor of the New England Journal of Medicine, strongly criticized this practice.

“This is corrupting research and making the public— and doctors— think that prescription drugs are much better and safer than they really are. I saw an enormous change in the relationship pf academic medicine and clinical research to the drug companies. And I saw more and more bias introduced into the research. And one of the worst forms of bias is that the drug companies will not permit researchers to publish negative results. If the drug doesn’t look good, it’s not published. It’s buried.”

It’s common knowledge that corporations have long created advertisements tailored to shining a positive light on their products in order to attract consumers. However, companies pushing to influence consumers to buy a certain brand of soda or shampoo is clearly not in the same realm as a pharmaceutical company controlling the entire message when it comes to the safety and effectiveness of its drugs, particularly when the FDA has been tasked with making sure that drugs are held under a high level of scrutiny.

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?

New Truth In Media Episodes: Confronting Big Pharma’s Manipulation, Influence

Many Americans have become increasingly aware that U.S. government agencies often fall short in providing transparency to its citizens, leading to failure in fulfilling their mission to adhere to policies for the protection of the American people.

Over the last few years, Truth In Media has discussed multiple instances in which agencies including the IRS, DEA, FBI, NSA, VA and others have been placed under public scrutiny in recent years for numerous cases of questionable conduct.

Many of these agencies, funded by taxpayer dollars, frequently claim to serve as a crucial safeguard, yet far too often they have been found to be serving outside interests at the expense of citizens.

When it comes to providing transparency and following proper procedure in protecting the health of the American people, where does the FDA stand? Has this agency maintained its integrity in maintaining oversight of drug companies? Is this agency doing its job to the best of its ability in assuring that our medicines have been rigorously tested, and is it making sure that drugs found to be dangerous are assigned proper warnings or removed from the market?

Truth In Media will be asking these questions in a brand new series: Truth In Media: Big Pharma, The FDA & Health Propaganda, seeking to provide a more thorough look into the relationships between FDA employees and the pharmaceutical industry, as well as the ways in which big pharma holds an enormous amount of influence over not only the FDA, but also physicians, medical journals, politicians, drug research, and ultimately millions of Americans.

This 4-segment series begins with Part 1 premiering in the first week of June. Stay tuned!