Ghost in the Machine, Part 1 — Drug Safety and Media Shaped by Big Pharma

December 27, 2017 • 57,247 views

Story at-a-glance

Drug industry representatives sit on the boards of major TV and print news outlets, shaping and sometimes blocking reporting about drug safety and effectiveness
Academic institutions, many government agencies and NGOs are financially beholden to Big Pharma, and most academic medical centers have drug company reps on their boards
“Sponsored content,” also called branded or native content, is now the prevailing online advertising model making drug advertisements and Pharma messages look like real news

By Dr. Mercola
If you have noticed that prescription drugs are becoming more dangerous — and more expensive — you are right. As the drug industry’s influence over the U.S. Food and Drug Administration (FDA) increases, dangerous drugs are approved and marketed despite their clear risks to patients.
Recent examples include the aggressively promoted blood thinners Xarelto and Pradaxa which cause uncontrollable bleeding, the testosterone drug Androgel, for “Low T” linked to noncalcified plaque buildup in coronary arteries, and fluoroquinolone antibiotics. When warnings are added to these dangerous drugs or they are withdrawn, like 28 popular drugs have been, many wonder why media failed to report the safety risks while they were occurring.¹
Of course, the reason is obvious. Mainstream media is essentially owned by the drug industry, so positive messages about new drugs are unfiltered Pharma messages.² The New York Times has had on its board Schering-Plough and Eli Lilly affiliates and The Washington Post, Johnson & Johnson affiliates.³
Even so-called “public” media like PBS and NPR have accepted money from GlaxoSmithKline and UnitedHealthcare.⁴ No wonder the dangers of the bone drugs bisphosphonates, hormone replacement therapy, statins, SSRI antidepressants (especially Paxil), heartburn drugs (PPIs), antibiotics such as Levaquin and arthritis drugs like Humira seldom reach the public.
Sadly, when makers of dangerous drugs admit their products caused harm, the settlements usually include gag orders so that new, unwitting victims are no safer. Conflicts of interest are hardly limited to media companies. Government agencies, from the FDA to the Centers for Disease Control and Prevention (CDC) also have disturbing financial conflicts of interest that make a mockery out of objectivity.

Yes, the FDA Can Get Worse

When Robert Califf was confirmed in 2016 as FDA Commissioner despite 23 financial links to Pharma and cheerleading for Vioxx and Xarelto, many felt the industry taint at the FDA could not get worse.⁵ But the likely new FDA Commissioner, venture capitalist Dr. Scott Gottlieb, is so enmeshed with Pharma profits, conflicts of interest at the FDA could definitely get worse. The New York Times reports:⁶

“From 2013 to 2015, for example, Dr. Gottlieb received more than $150,000 to advise Vertex Pharmaceuticals, a company whose two approved drugs are seen as breakthrough treatments for cystic fibrosis but carry list prices of more than $250,000 a year.

He’s the acting chief executive of Cell Biotherapy, an early-stage cancer biotech firm that he helped found. He has served for years as a consultant to pharmaceutical giants like GlaxoSmithKline and Bristol-Myers Squibb and is paid by other companies for his expertise ...

In 2007, Dr. Gottlieb returned to the private sector, becoming a partner at New Enterprise Associates, where he advised the firm’s health care team, and began consulting for a range of companies. Dr. Gottlieb also held seats on a number of corporate boards, including Tolero Pharmaceuticals, a Utah company working on cancer treatments, and MedAvante, which assists pharmaceutical companies with clinical trials.”

When Gottlieb was first considered for an FDA post as deputy commissioner for medical and scientific affairs in 2005, the then-editor of The New England Journal of Medicine, Jerome Kassirer, said, “Gottlieb has an orientation which belies the goal of the FDA.”⁷ “The appointment comes out of nowhere,” said former FDA Commissioner Donald Kennedy. “Anything but a reassuring signal,” said Time magazine. And Gottlieb’s financial links to Pharma have only deepened since 2005.

Other Government Conflicts

The military serves as a reliable revenue source for the drug industry thanks to conflicts of interest at the highest levels. In just nine years, the U.S. Department of Veterans Affairs (VA) spent $717 million on risperidone, the generic form of Risperdal, to treat post-traumatic stress syndrome (PTSD) in troops — even though it worked no better than placebo.⁸
In a video (which has since been taken down), Matthew Friedman, former executive director of the VA's National Center for PTSD, admitted receiving money from drug giant AstraZeneca⁹ on whose drugs the VA spent $125.4 million in 2009 alone.¹⁰ Elspeth Ritchie appeared in a webcast funded by AstraZeneca and Eli Lilly while serving in the U.S. Army Surgeon General's Office, praising the drugs made by the companies.¹¹
Mark Hamner directed PTSD clinical care at Ralph H. Johnson VA Medical Center in Charleston, South Carolina, while publishing AstraZeneca-funded research about PTSD clinical care.¹² Questions also persist about industry relationships at the CDC. According to the BMJ:¹³

“Despite the agency’s disclaimer, the CDC does receive millions of dollars in industry gifts and funding, both directly and indirectly, and several recent CDC actions and recommendations have raised questions about the science it cites, the clinical guidelines it promotes and the money it is taking ...

The CDC’s director, Tom Frieden, did not respond to a question about the disclaimer. He told The BMJ by email, ‘Public-private partnerships allow CDC to do more, faster.’”

Frieden’s report “looks like classic stealth marketing, in which industry puts their message in the mouth of a trusted third party, such as an academic or a professional organization,” wrote the BMJ’s Jeanne Lenzer. Not-for-profit organizations that work closely with government are also Pharma funded. The National Council on Aging's (NCOA) 2016 corporate sponsors is a who’s who of Pharma companies.¹⁴

Academics Paid to Ghostwrite for Pharma

Recently, Pro Publica¹⁵ and Consumer Reports¹⁶ reported how Big Pharma is surreptitiously enlisting professors at the nation’s top universities to write blogs and articles, and even host conferences to defend its new sky-high drug prices which are climbing to $1,000 per day and $40,000 to $94,000 for a course of treatment. Pro Publica wrote:

“To persuade payers and the public, the industry has deployed a potent new ally, a company whose marquee figures are leading economists and health care experts at the nation’s top universities. The company, Precision Health Economics, consults for three leading makers of new hepatitis C treatments: Gilead, Bristol-Myers Squibb and AbbVie.

When AbbVie funded a special issue of the American Journal of Managed Care on hepatitis C research, current or former associates of Precision Health Economics wrote half of the issue. A Stanford professor who had previously consulted for the firm served as guest editor-in-chief.”

Even before the extreme-priced drugs of the past few years, “research” has often been ghostwritten by the drug industry with a media professional or professor’s name attached for credibility. The popularity of the withdrawn Vioxx,¹⁷ the birth defect-linked Paxil,¹⁸ Neurontin¹⁹ and cancer and heart disease-linked hormone replacement therapy²⁰ drugs were all courtesy of ghostwritten papers.

Shocking Partnerships Between Academia and Pharma

Thanks to the Bayh-Dole Act of 1980, which enabled lucrative academic/Pharma partnerships and “technology transfer” (even though most drug development is funded by taxpayers and profits should belong to the public) medical centers are unapologetic arms of the drug industry.
A 2014 research letter in the Journal of the American Medical Association (JAMA) revealed that almost all large U.S. drug companies have leaders in academic medical centers on their boards including deans, chief executive officers, department chairs, trustees at academic medical centers, school of pharmacy officials and university presidents.²¹
Susan Desmond-Hellmann was invited to apply to be Chancellor of the University of California, San Francisco (UCSF), which includes a medical school, while serving as president of product development at Genentech.²² No conflicts there. She remained at UCSF until 2014 and went on the Gates Foundation.²³ Northwestern University made so much money selling the anti-seizure drug Lyrica to Pfizer it built an entire new research building on the money it made.²⁴
In 2010, it was reported that Thomas Insel, director of the National Institute of Mental Health (NIMH), assured the University of Miami’s medical school dean that NIH grant money would flow if he hired Charles Nemeroff despite Nemeroff’s $9 million NIH grant having been terminated because of wrongdoing.²⁵ (Since then, Insel has joined a semi-secret Google life sciences venture headed by former chairman and CEO of Genentech, Art Levinson).²⁶
While I applaud the scrutiny in recent years on doctors receiving free lunches and other perks from Pharma reps, the exchanges are minor when you consider entire wings of medical centers are funded by Pharma. (In one Chicago-area NorthShore University HealthSystem hospital,l there are six Searle wings.)²⁷

Drug Safety Is Now in Pharma’s Hands

Clinical trials were once hosted by hospitals or medical centers but now are run by for-profit groups hired by Pharma. The organizations, called contract research organizations (CROs), are experts at the "game" of bringing a drug to Wall Street as soon as possible. They also free Pharma from the cost of maintaining its own clinical trial staff. CROs provide drug companies with a drug trial design, recruitment, enrollment and consent of subjects and preparation of the final FDA submission package for approval.
They will even do the marketing and branding of the new drug. One reason so many dangerous drugs are now brought to market despite clear safety signals is the ability of CROs to speed drug approvals.
Institutional review boards (IRBs), groups of medical professionals, laypeople and ethicists to monitor human safety in trials are also no longer conducted in academic or hospital settings, but have become for-profit. What is wrong with a for-profit IRB? It is the same ethical problem of a stock rating agency being paid by the companies it is supposed to rate objectively. This is how a Public Library of Science (PLOS) article puts it:²⁸

“Anyone who can bring together five people, including a community representative, a physician, a lawyer and an ‘ethicist,’ can set up shop and start competing for business ... The problem is that commercial IRBs are paid in full by the very companies conducting the research. What is more, those companies are free to shop around for any IRB whose reviews they find congenial.

Research participants who are worried that they may face death or injury in a study sponsored by a pharmaceutical company are unlikely to feel more secure knowing that their safety has been entrusted to a panel of paid experts whose financial livelihood depends on a company paycheck.”

IRBs have become such shams, one recently agreed to participate in a phony study concocted by a federal undercover investigation in a sting operation. The fake study purposely included multiple characteristics of "significant risk" from existing FDA guidance but one IRB was still willing to be involved.²⁹

‘Sponsored Content,’ Once Known as Advertorials, Has Invaded Health News Sites

Do you sometimes find yourself reading a health article that promotes a product or therapy so enthusiastically you realize it is not real journalism? That it is completely one-sided? Before the internet, there was a strict firewall in newspapers and magazines between news and ads and ads were even marked “advertisement” to leave no doubt. Not anymore.
Thanks to the internet, sponsored content, also called native or branded content, written by marketers passes as real journalism. (The internet has also brought us “programmed” ads based on your personal searches and buying habits which have been spied upon.) While native content, often videos, is the hallmark of young companies like Vice and BuzzFeed, established outlets like The Atlantic, Slate, The Huffington Post, The Washington Post, Business Insider and The New York Times have also climbed aboard.³⁰
In fact, in one quarter in 2015, The New York Times earned $9 million from such ads, though it was soon forced to drop the word “Stories” from its label “Stories From Our Advertisers.” Readers charged the title was misleading and the content was just advertising.³¹ The Times had just hit its 100th such native ad at the time.³²

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Wednesday, December 27, 2017