The Anatomy of Big Pharma’s Political Reach (I)
After graduating from Columbia University with a chemical engineering degree, my grandfather went on to work for Pfizer for almost two decades, culminating his career as the company’s Global Director of New Products.
I was rather proud of this fact growing up – it felt as if this father figure, who raised me for several years during my childhood, had somehow played a role in saving lives. But in recent years, my perspective on Pfizer – and other companies in its class – has shifted. Blame it on the insidious big pharma corruption laid bare by whistleblowers in recent years. Blame it on the endless string of big pharma lawsuits revealing fraud, deception, and cover-ups. Blame it on the fact that I witnessed some of their most profitable drugs ruin the lives of those I love most. All I know is, that pride I once felt has been overshadowed by a sticky skepticism I just can’t seem to shake.
In 1973, my grandpa and his colleagues celebrated as Pfizer crossed a milestone: the one-billion-dollar sales mark. These days, Pfizer rakes in $81 billion a year, making it the 28th most valuable company in the world. Johnson & Johnson ranks 15th, with $93.77 billion. To put the dots into perspective, that makes said companies wealthier than most countries in the world. And thanks to those astronomical profit margins, the Pharmaceuticals and Health Products industry is able to spend more on lobbying than any other industry in America.
While big pharma lobbying can take several different forms, these companies tend to target their contributions to senior legislators in Congress – you know, the ones they need to keep in their corner, because they have the power to draft healthcare laws. Pfizer has outspent its peers in six of the last eight election cycles, coughing up almost $9.7 million. During the 2016 election, pharmaceutical companies gave more than $7 million to 97 senators at an average of $75,000 per member. They also contributed $6.3 million to president Joe Biden’s 2020 campaign. The question is: what did big pharma get in return?
ALEC’s off-the-record sway
To truly grasp big pharma’s power, you need to understand how The American Legislative Exchange Council (ALEC) works. ALEC, which was founded in 1973 by conservative activists working on Ronald Reagan’s campaign, is a super secretive pay-to-play operation where corporate lobbyists – including in the pharma sector – hold confidential meetings about “model” bills. A large portion of these bills is eventually approved and become law.
A rundown of ALEC’s greatest hits will tell you everything you need to know about the council’s motives and priorities. In 1995, ALEC promoted a bill that restricts consumers’ rights to sue for damages resulting from taking a particular medication. They also endorsed the Statute of Limitation Reduction Act, which put a time limit on when someone could sue after a medication-induced injury or death. Over the years, ALEC has promoted many other pharma-friendly bills that would: weaken FDA oversight of new drugs and therapies, limit FDA authority over drug advertising, and oppose regulations on financial incentives for doctors to prescribe specific drugs.
But what makes these ALEC collaborations feel particularly problematic is that there’s little transparency – all of this occurs behind closed doors. Congressional leaders and other committee members involved in ALEC aren’t required to publish any records of their meetings and other communications with pharma lobbyists, and the roster of ALEC members is completely confidential. All we know is that in 2020, more than two-thirds of Congress – 72 senators and 302 House of Representatives members – cashed a campaign check from a pharma company.
Big Pharma funding research
The public typically relies on an endorsement from government agencies to help them decide whether or not a new drug, vaccine, or medical device is safe and effective. And those agencies, like the FDA, count on clinical research. As already established, big pharma is notorious for getting its hooks into influential government officials. Here’s another sobering truth: the majority of scientific research is paid for by the pharmaceutical companies.
When the New England Journal of Medicine (NEJM) published 73 studies of new drugs over the course of a single year, they found that a staggering 82% of them had been funded by the pharmaceutical company selling the product, 68% had authors who were employees of that company, and 50% had lead researchers who accepted money from a drug company.
According to 2013 research conducted at the University of Arizona, College of Law, even when pharma companies aren’t directly funding the research, company stockholders, consultants, directors, and officers are almost always involved in conducting them. A 2017 report by the peer-reviewed British Medical Journal (BMJ) also showed that about half of medical journal editors receive payments from drug companies, with the average payment per editor hovering around $28,000. But these statistics are only accurate if researchers and editors are transparent about payments from pharma. And a 2022 investigative analysis of two of the most influential medical journals found that 81% of study authors failed to disclose millions in payments from drug companies, as they’re required to do.
Unfortunately, this trend shows no sign of slowing down. The number of clinical trials funded by the pharmaceutical industry has been climbing every year since 2006, according to a John Hopkins University report, while independent studies have been harder to find.
And there are some serious consequences to these conflicts of interest. Take Avandia, for instance, a diabetes drug produced by GlaxoSmithCline (GSK). Avandia was eventually linked to a dramatically increased risk of heart attacks and heart failure. And a BMJ report revealed that almost 90% of scientists who initially wrote glowing articles about Avandia had financial ties to GSK.
But here’s the unnerving part: if the pharmaceutical industry is successfully biasing the science, then that means the physicians who rely on the science are biased in their prescribing decisions.
Where the lines get really blurry is with “ghostwriting.” Big pharma execs know citizens are way more likely to trust a report written by a board-certified doctor than one of their representatives. That’s why they pay physicians to list their names as authors – even though the MDs had little to no involvement in the research, and the report was actually written by the drug company. This practice started in the ’50s and ’60s when tobacco execs were clamoring to prove that cigarettes didn’t cause cancer (spoiler alert: they do!), so they commissioned doctors to slap their name on papers undermining the risks of smoking.
It’s still a pretty common tactic today: more than one in 10 articles published in the NEJM was co-written by a ghostwriter. While a very small percentage of medical journals have clear policies against ghostwriting, it’s still technically legal –despite the fact that the consequences can be deadly.
Case in point: in the late ’90s and early 2000s, Merck paid for 73 ghostwritten articles to play up the benefits of its arthritis drug Vioxx. It was later revealed that Merck failed to report all of the heart attacks experienced by trial participants. In fact, a study published in the NEJM revealed that an estimated 160,000 Americans experienced heart attacks or strokes from taking Vioxx. That research was conducted by Dr. David Graham, Associate Director of the FDA’s Office of Drug Safety, who understandably concluded the drug was not safe. But the FDA’s Office of New Drugs, which not only was responsible for initially approving Vioxx but also regulating it, pursued to sweep his findings under the rug.
“I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference,” he wrote in his 2004 U.S. Senate testimony on Vioxx. “One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting.”
Eventually, the FDA issued a public health advisory about Vioxx and Merck withdrew this product. But it was a little late for repercussions – 38,000 of those Vioxx-takers who suffered heart attacks had already died. Graham called this a “profound regulatory failure,” adding that scientific standards the FDA apply to drug safety “guarantee that unsafe and deadly drugs will remain on the U.S. market.”
This should come as no surprise, but research has also repeatedly shown that a paper written by a pharmaceutical company is more likely to emphasize the benefits of a drug, vaccine, or device while downplaying the dangers. Because of this practice, a former ghostwriter outlined all the ethical reasons why she quit this job, in a PLOS Medicine report. While adverse drug effects appear in 95% of clinical research, only 46% of published reports disclose them. Of course, all of this often ends up misleading doctors into thinking a drug is safer than it actually is.
Big Pharma influence on doctors
Pharmaceutical companies aren’t just paying medical journal editors and authors to make their products look good, either. There’s a long, sordid history of pharmaceutical companies incentivizing doctors to prescribe their products through financial rewards.
For instance, Pfizer and AstraZeneca doled out a combined $100 million to doctors in 2018, with some earning anywhere from $6 million to $29 million in a year. And research has shown this strategy works: when doctors accept these gifts and payments, they’re significantly more likely to prescribe those companies’ drugs.
Novartis comes too – the company famously spent over $100 million paying for doctors’ extravagant meals, golf outings, and more, all while also providing a generous kickback program that made them richer every time they prescribed certain blood pressure and diabetes meds.
Side note: the Open Payments portal, in US, contains a nifty little database where you can find out if any of your own doctors, if you live in America, received money from drug companies. Knowing that my mother was put on a laundry list of meds after a near-fatal car accident, I was curious – so I did a quick search for her providers. While her PCP only banked a modest amount from Pfizer and AstraZeneca, her previous psychiatrist – who prescribed a cocktail of contraindicated medications without treating her in person – collected quadruple-digit payments from pharmaceutical companies. And her pain care specialist, who prescribed her jaw-dropping doses of opioid pain medication for more than 20 years (far longer than the 5-day safety guideline), was raking in thousands from Purdue Pharma, aka the opioid crisis’ kingpin.
Purdue is now infamous for its wildly aggressive OxyContin campaign in the ’90s. At the time, the company billed it as a non-addictive wonder drug for pain sufferers. Internal emails show Pursue sales representatives were instructed to “sell, sell, sell” OxyContin, and the more they were able to push, the more they were rewarded with promotions and bonuses. With the stakes so high, these reps stopped at nothing to get doctors on board – even going so far as to send boxes of doughnuts spelling out “OxyContin” to unconvinced physicians. Purdue had stumbled upon the perfect system for generating tons of profit – off of other people’s pain.
Documentation later proved that not only was Purdue aware it was highly addictive and that many people were abusing it, but that they also encouraged doctors to continue prescribing increasingly higher doses of it (and sent them on lavish luxury vacations for some motivation). In testimony to Congress, Purdue exec Paul Goldenheim played dumb about OxyContin addiction and overdose rates, but emails that were later exposed showed that he requested his colleagues remove all mentions of addiction from their correspondence about the drug. Even after it was proven in court that Purdue fraudulently marketed OxyContin while concealing its addictive nature, no one from the company spent a single day behind bars. Instead, the company got a slap on the wrist and a $600 million fine for a misdemeanor, the equivalent of a speeding ticket compared to the $9 billion they made off OxyContin up until 2006. Meanwhile, thanks to Purdue’s recklessness, more than 247,000 people died from prescription opioid overdoses between 1999 and 2009. And that’s not even factoring in all the people who died of heroin overdoses once OxyContin was no longer attainable to them. The NIH reports that 80% of people who use heroin started by misusing prescription opioids.
Former sales rep Carol Panara told me in an interview that when she looks back on her time at Purdue, it all feels like a “bad dream.” Panara started working for Purdue in 2008, one year after the company pled guilty to “misbranding” charges for OxyContin. At this point, Purdue was “regrouping and expanding,” says Panara, and to that end, had developed a clever new approach for making money off OxyContin: sales reps were now targeting general practitioners and family doctors, rather than just pain management specialists. On top of that, Purdue soon introduced three new strengths for OxyContin: 15, 30, and 60 milligrams, creating smaller increments Panara believes were aimed at making doctors feel more comfortable increasing their patients’ dosages. According to Panara, there were internal company rankings for sales reps based on the number of prescriptions for each OxyContin dosing strength in their territory.
“They were sneaky about it,” she said. “Their plan was to go in and sell these doctors on the idea of starting with 10 milligrams, which is very low, knowing full well that once they get started down that path – that’s all they need. Because eventually, they’re going to build a tolerance and need a higher dose.”
Occasionally, doctors expressed concerns about a patient becoming addicted, but Purdue had already developed a way around that. Sales reps like Panara were taught to reassure those doctors that someone in pain might experience addiction-like symptoms called “pseudoaddiction,” but that didn’t mean they were truly addicted. There is no scientific evidence whatsoever to support that this concept is legit, of course. But the most disturbing part was that reps were trained to tell doctors that “pseudoaddiction” signaled the patient’s pain wasn’t being managed well enough, and the solution was simply to prescribe a higher dose of OxyContin.
Panara finally quit Purdue in 2013. One of the breaking points was when two pharmacies in her territory were robbed at gunpoint specifically for OxyContin. In 2020, Purdue pled guilty to three criminal charges in an $8.3 billion deal, but the company is now under court protection after filing for bankruptcy. Despite all the damage that’s been done, the FDA’s policies for approving opioids remain essentially unchanged.
Purdue probably wouldn’t have been able to pull this off if it weren’t for an FDA examiner named Curtis Wright, and his assistant Douglas Kramer. While Purdue was pursuing Wright’s stamp of approval on OxyContin, Wright took an outright sketchy approach to their application, instructing the company to mail documents to his home office rather than the FDA, and enlisting Purdue employees to help him review trials about the safety of the drug. The Food, Drug, and Cosmetic Act requires that the FDA have access to at least two randomized controlled trials before deeming a drug as safe and effective, but in the case of OxyContin, it got approved with data from just one measly two-week study – in osteoarthritis patients, no less.
When both Wright and Kramer left the FDA, they went on to work for none other than (drumroll, please) Purdue, with Wright earning three times his FDA salary. By the way – this is just one example of the FDA’s notoriously incestuous relationship with big pharma, often referred to as “the revolving door”. In fact, a 2018 Science report revealed that 11 out of 16 FDA reviewers ended up at the same companies they had been regulating products for.
While doing an independent investigation, “Empire of Pain” author and New Yorker columnist Patrick Radden Keefe aimed to gain access to documentation of Wright’s communications with Purdue during the OxyContin approval process.
“The FDA came back and said, ‘Oh, it’s weird, but we don’t have anything. It’s all either been lost or destroyed’,” Keefe told Fortune in an interview. “But it’s not just the FDA. It’s Congress, it’s the Department of Justice, it’s big parts of the medical establishment, the sheer amount of money involved, I think, has meant that a lot of the checks that should be in place in society to not just achieve justice, but also to protect us as consumers, were not there because they had been co-opted.”
Big pharma may be to blame for creating the opioids that caused this public health catastrophe, but the FDA deserves just as much scrutiny – because its countless failures also played a part in enabling it. And many of those more recent fails occurred under the supervision of Dr. Janet Woodcock. Woodcock was named FDA’s acting commissioner mere hours after Joe Biden was inaugurated as president. She would have been a logical choice, being an FDA vet of 35 years, but then again it’s impossible to forget that she played a starring role in the FDA’s perpetuating the opioid epidemic. She’s also known for overruling her own scientific advisors when they vote against approving a drug.
Not only did Woodcock approve OxyContin for children as young as 11 years old, but she also gave the green light to several other highly controversial extended-release opioid pain drugs without sufficient evidence of safety or efficacy. One of those was Zohydro: in 2011, the FDA’s advisory committee voted 11:2 against approving it due to safety concerns about inappropriate use, but Woodcock went ahead and pushed it through, anyway. Under Woodcock’s supervision, the FDA also approved Opana, which is twice as powerful as OxyContin – only to then beg the drug maker to take it off the market 10 years later due to “abuse and manipulation.” And then there was Dsuvia, a potent painkiller 1,000 times stronger than morphine and 10 times more powerful than fentanyl. According to a head of one of the FDA’s advisory committees, the U.S. military had helped to develop this particular drug, and Woodcock said there was “pressure from the Pentagon” to push it through approvals. The FBI, members of Congress, public health advocates, and patient safety experts alike called this decision into question, pointing out that with hundreds of opioids already on the market there’s no need for another – particularly one that comes with such high risks. Most recently, Woodcock served as the therapeutics lead for Operation Warp Speed, overseeing Covid-19 vaccine development.
Big Pharma lawsuits, scandals, and cover-ups
While the OxyContin craze is undoubtedly one of the highest-profile examples of big pharma’s deception, there are dozens of other stories like this. Here are a few standouts:
In the 1980s, Bayer continued selling blood clotting products to third-world countries even though they were fully aware those products had been contaminated with HIV. The reason? The “financial investment in the product was considered too high to destroy the inventory.” Predictably, about 20,000 of the hemophiliacs who were infused with these tainted products then tested positive for HIV and eventually developed AIDS, and many later died of it.
In 2004, Johnson & Johnson was slapped with a series of lawsuits for illegally promoting off-label use of their heartburn drug Propulsid for children despite internal company emails confirming major safety concerns (as in, deaths during the drug trials). Documentation from the lawsuits showed that dozens of studies sponsored by Johnson & Johnson highlighting the risks of this drug were never published.
The FDA estimates that GSK’s Avandia caused 83,000 heart attacks between 1999 and 2007. Internal documents from GSK prove that when they began studying the effects of the drug as early as 1999, they discovered it caused a higher risk of heart attacks than a similar drug it was meant to replace. Rather than publish these findings, they spent a decade illegally concealing them (and meanwhile, banking $3.2 billion annually for this drug by 2006). Finally, a 2007 New England Journal of Medicine study linked Avandia to a 43% increased risk of heart attacks, and a 64% increased risk of death from heart disease. Avandia is still FDA approved and available in the U.S.
In 2009, Pfizer was forced to pay $2.3 billion, the largest healthcare fraud settlement in history at that time, for paying illegal kickbacks to doctors and promoting off-label uses of its drugs. Specifically, a former employee revealed that Pfizer reps were encouraged and incentivized to sell Bextra and 12 other drugs for conditions they were never FDA approved for, and at doses up to eight times what’s recommended. “I was expected to increase profits at all costs, even when sales meant endangering lives,” the whistleblower said.
When it was discovered that AstraZeneca was promoting the antipsychotic medication Seroquel for uses that were not approved by the FDA as safe and effective, the company was hit with a $520 million fine in 2010. For years, AstraZeneca had been encouraging psychiatrists and other physicians to prescribe Seroquel for a vast range of seemingly unrelated off-label conditions, including Alzheimer’s disease, anger management, ADHD, dementia, post-traumatic stress disorder, and sleeplessness. AstraZeneca also violated the federal Anti-Kickback Statute by paying doctors to spread the word about these unapproved uses of Seroquel via promotional lectures and while traveling to resort locations.
In 2012, GSK paid a $3 billion fine for bribing doctors by flying them and their spouses to five-star resorts, and for illegally promoting drugs for off-label uses. What’s worse – GSK withheld clinical trial results that showed its antidepressant Paxil not only doesn’t work for adolescents and children but more alarmingly, that it can increase the likelihood of suicidal thoughts in this group. A 1998 GSK internal memo revealed that the company intentionally concealed this data to minimize any “potential negative commercial impact.”
In 2021, an ex-AstraZeneca sales rep sued her former employer, claiming they fired her for refusing to promote drugs for uses that weren’t FDA-approved. The employee alleges that on multiple occasions, she expressed concerns to her boss about “misleading” information that didn’t have enough support from medical research, and off-label promotions of certain drugs. Her supervisor reportedly not only ignored these concerns but pressured her to approve statements she didn’t agree with and threatened to remove her from regional and national positions if she didn’t comply. According to the plaintiff, she missed out on a raise and a bonus because she refused to break the law.
At the top of 2022, a panel of the D.C. Court of Appeals reinstated a lawsuit against Pfizer, AstraZeneca, Johnson & Johnson, Roche, and GE Healthcare, which claims they helped finance terrorist attacks against U.S. service members and other Americans in Iraq. The suit alleges that from 2005–2011, these companies regularly offered bribes (including free drugs and medical devices) totaling millions of dollars annually to Iraq’s Ministry of Health in order to secure drug contracts. These corrupt payments then allegedly funded weapons and training for the Mahdi Army, which until 2008, was largely considered one of the most dangerous groups in Iraq.
Another especially worrisome factor is that pharmaceutical companies are conducting an ever-increasing number of clinical trials in third-world countries, where people may be less educated, and there are also far fewer safety regulations. Pfizer’s 1996 experimental trials with Trovan on Nigerian children with meningitis – without informed consent – is just one nauseating example. When a former medical director in Pfizer’s central research division warned the company both before and after the study that their methods in this trial were “improper and unsafe,” he was promptly fired. Families of the Nigerian children who died or were left blind, brain damaged, or paralyzed after the study sued Pfizer, and the company ultimately settled out of court. In 1998, the FDA approved Trovan only for adults. The drug was later banned from European markets due to reports of fatal liver disease and restricted to strictly emergency care in the U.S. Pfizer still denies any wrongdoing.
But all that is just the tip of the iceberg. If you’d like to dive a little further down the rabbit hole – and I’ll warn you, it’s a deep one – a quick Google search for “big pharma lawsuits” will reveal the industry’s dark track record of bribery, dishonesty, and fraud.
In fact, big pharma occurs to be the biggest defrauder of the federal government when it comes to the False Claims Act, otherwise known as the “Lincoln Law.” During our interview, Panara told me she has friends still working for big pharma who would be willing to speak out about crooked activity they’ve observed, but are too afraid of being blacklisted by the industry.
A newly proposed update to the False Claims Act would help to protect and support whistleblowers in their efforts to hold pharmaceutical companies liable, by helping to prevent that kind of retaliation and making it harder for the companies charged to dismiss these cases. It should come as no surprise that Pfizer, AstraZeneca, Merck, and a flock of other big pharma firms are currently lobbying to block the update. Naturally, they wouldn’t want to make it any easier for ex-employees to expose their wrongdoings, potentially costing them billions more in fines.
Something to remember: these are the same people who produced, marketed, and are profiting from the Covid-19 vaccines. The same people who manipulate research, pay off decision-makers to push their drugs, cover up negative research results to avoid financial losses, and knowingly put innocent citizens in harm’s way. The same people who told America: “Take as much OxyContin as you want around the clock! It’s very safe and not addictive!” (while laughing all the way to the bank).
So, ask yourself this: if a partner, friend, or family member repeatedly lied to you – and not just little white lies, but big ones that put your health and safety at risk – would you continue to trust them?
Read the second part of the article
Author: Rebecca Strong
September 23, 2022