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Investigations   04.24.2018

Industry-Funded Studies and the Skewing of America

As companies fill the research void at the federal level, the incentives are stronger than ever to manipulate data and methodology, say critics.

For decades, the titans of industry, from sugar producers to tobacco companies to pharmaceutical giants, have quietly funded studies on their products in a bid to sway public opinion, win regulatory approval, and stave off competition.

The practice can have deadly consequences.

For Robert Ernst, Merck’s removal of Vioxx from the market in 2004 was too little, too late. The husband and father died of a cardiac arrhythmia in 2001—one of an estimated 55,000 premature deaths and 100,000 strokes and heart attacks with suspected links to the controversial arthritis drug.

In 2005, his widow, Carol, was the first to sue Merck over the medication’s potentially dangerous side effects. The lawsuit alleged that the drug manufacturer withheld critical safety information about Vioxx from research it funded, resulting in Robert’s death.

A Texas jury awarded her $26.1 million, though the payout would have been nearly ten times that amount had Texas law not capped punitive damages. But the verdict was vacated on appeal, and the U.S. Supreme Court ultimately decided not to hear the case.

Produced by Joey Rettino
 

According to critics in medicine and academia, the pharmaceutical giant downplayed the cardiovascular risks of Vioxx in studies it funded in its push to introduce a blockbuster medication.

In a 2007 article, Harlan Krumholz, MD, a Yale University professor of medicine with a specialty in cardiology, highlighted conflicts on the purportedly independent safety board that assessed the research.

Krumholz, who participated in litigation against Merck on behalf of plaintiffs, noted that some safety board members were under contract with the company, which made no effort to gauge heart attack risks.

“The study of over 8,000 patients was initiated without a standard operating procedure for collecting information on cardiovascular events and without a cardiologist on the data safety monitoring board,” he wrote.

Documents released during the litigation indicate that Merck knew of the cardiovascular perils but failed to disclose them in scientific studies. The company has paid more than $8.5 billion to settle lawsuits and fines, including a $23 million class-action settlement and $830 million for securities violations.

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Merck, which voluntarily withdrew Vioxx from the market, has long maintained that it did not hide information from the public. To this day, it rebuffs any allegations of misdeeds, stating on a class-action settlement website: “Merck denies any liability for the claims in the lawsuit and makes no admissions of any wrongdoing by agreeing to this Settlement.”

When manufacturers are responsible for testing the safety and efficacy of their goods, the incentives to deliver favorable results can be enormous, say critics. The relationship is fraught with potential for conflicts of interest because researchers are often paid by—or work directly for—industry sponsors.

“There’s a range of ways that companies can manipulate or interfere with the scientific process,” Genna Reed, lead science and policy analyst at the Union of Concerned Scientists’s Center for Science and Democracy, told Tarbell.

Tactics run the gamut from masking or burying sponsorship to selectively highlighting positive results to omitting key data that might alter the outcome. Industry funders are routinely accused of relying on flawed methodologies that deviate from standard scientific procedure.

The roster of companies accused of manipulating science reads like a who’s-who of the Fortune 500. Coca Cola has been pilloried for secretly paying scientists who blame obesity on lack of exercise, not unhealthy eating.

Monsanto teamed with academics willing to issue research supportive of genetically modified foods. Georgia-Pacific has faced accusations that it went to great lengths to downplay the hazards of asbestos.

Ghostwriting, a practice that is legal, but which detractors consider highly unethical, lets corporations influence or write ostensibly independent studies. Research that doesn’t satisfy a sponsor’s goals may never see the light of day.

Industry-sponsored research has its defenders. A leading proponent is the Center for Accountability in Science, an advocacy organization that’s part of the non-profit Center for Organizational Research and Education, which receives funding from the energy, agriculture, and hospitality sectors, among other industries.

“Businesses have an interest in showing that their products are safe,” the center emphasizes on its website. The group, which did not respond to a request for comment, often calls into question research that it argues raises unwarranted concerns about chemicals such as BPA, found in plastics, coffee, and other products.

“Most researchers acknowledge that doing away with industry funding of research is not the answer to criticism about funding bias,” the center says on its website. In a separate article, Tarbell examines how bias favoring the sponsor can be difficult to detect.

For everyday consumers who rely on science to guide purchasing decisions, any co-opting of safety testing can have serious ramifications, say experts.

History is littered with examples of industry-commissioned research that made claims now seen as unfathomable. Newly surfaced documents reveal that in the 1960s, sugar industry studies minimized the health risks of the sweetener while hyping the hazards of fat.

The tobacco industry notoriously challenged and muddled research that linked smoking to cancer and other diseases, dismissing it as anecdotal evidence. Yet internal documents later revealed that Big Tobacco knew in the 1960s that smoking posed health risks.

Environmentalists have unearthed petroleum industry research from the 1950s that drew a link between fossil fuels and climate change, findings largely ignored by Humble Oil, a precursor to ExxonMobil.

Dr. Jerome Kassirer, former editor of the prestigious New England Journal of Medicine and a specialist on conflicts of interest in that field, told Tarbell that drug companies sometimes strike agreements with authors to provide and analyze data and approve the final versions of studies.

Competing interests arise when researchers work for the sponsor of a report, are paid as contractors, hold stock in the company, or have stock options. “All of these conditions create a conflict of interest,” said Kassirer, author of On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health.

Sheldon Krimsky, a humanities and social sciences professor at Tufts University and author of Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?, told Tarbell that researchers often aim to please their corporate benefactors. “They worry if they don’t evaluate the product in a way that satisfies the funder, they will not get another contract.”

Any meddling by corporate interests undermines public trust, warned Reed. “They should be following the research where it leads, instead of messing with the data or messing with the results and coming to a predetermined conclusion,” she said.

Industry Fills Research Void

For the first time since World War II, the U.S. government share of basic research funding has dipped below 50 percent, Science magazine reported last year. “The federal share, which topped 70 percent throughout the 1960s and ’70s, stood at 61 percent as recently as 2004 before falling below 50 percent in 2013.” As of 2015, government agencies accounted for 44 percent of the $86 billion devoted to this form of research.

That means less federal support for research that examines broader scientific issues and is not tethered to a particular product, industry or policy, Reed explained. Basic research is usually conducted by academics with no financial ties to corporate interests.

Instead, companies are funding applied research that seeks to solve immediate problems “because there’s this direct scientific question about a particular product,” Reed said. Those studies can be used to prove a product’s safety, which can help win regulatory approval.

As federal funding wanes, government agencies rely heavily on industry-sponsored studies to make regulatory decisions. Discussing the medical sector, Kassirer recalled that into the early 2000s, the National Institutes of Health (NIH) and independent foundations conducted many clinical trials. “Somewhere along way the balance shifted,” he said, with drug makers now funding most drug testing.

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PhRMA, the leading pharmaceutical trade organization, did not respond to a request for comment on the industry’s research practices.

From 2006 to 2014, the number of industry-funded trials jumped by 1,965, a 43 percent rise, according to JAMA, the peer-reviewed Journal of the American Medical Association. “From 2006 through 2014, there has been a decrease in newly registered NIH-funded trials, whereas industry-funded trials increased substantially,” the article says.

The result is intense pressure to produce results that justify the introduction of new medications, Kassirer said. For some pharmaceutical giants, any fines and recalls after a lucrative drug has been on the market are a mere cost of doing business. “The penalties are trivial compared to the enormous amount of money the company makes,” Kassirer observed.

The EPA, FDA, and USDA are among the agencies that use corporate studies to assess the safety and effectiveness of chemicals, pharmaceuticals and other products, Tufts’ Krimsky said.

He complained that U.S. regulatory agencies routinely accept studies held confidential by corporate sponsors. When he seeks details from agencies on industry reports they’re using, they often decline comment, stating that the information is proprietary. “I don’t think that’s the way we should run government. Everything should be transparent,” he said.

But some industry executives insist that they have no control over research they commission. John Lechleiter, who retired in late 2016 as president and CEO of Eli Lilly and Company, noted that while drug makers fund most clinical trials, they don’t conduct them.

They’re carried out by what he describes as “independent organizations and professionals” who follow agreed-upon protocols approved by “ethical” review boards he wrote in Forbes.com.

“Even though our company may have developed the molecule, and we’re paying for the trial, we don’t see the data until it’s over,” he wrote. “Many times, I’ve experienced the tension of waiting to be ‘unblinded’ on the results of a late-stage trial for one of our experimental medicines.”

Glorified PR campaigns

Industry-backed studies are a form of currency in media and policy circles. The steady stream of headline-grabbing findings is so constant that most people rarely stop to consider how the research came together, or who funded it. Companies keep returning to the model—research, publish, media blitz—because it’s a proven, economical way to reach vast populations with an unfiltered message.

Some industry studies have all the trappings of rigorous science: They were authored by leading academics in a particular field, subject to peer review and published in prestigious medical or scientific journals. But others lack peer review and are published in lesser-known journals that may have looser standards. Or they are not published at all but simply released as fact by corporate PR departments.

The conclusions are grist for a click-bait-driven media universe. Sponsors know that sound-bite-sized summaries of their key findings will ricochet across cyberspace as headlines, tweets, and Facebook posts. Incidentals, such as who financed the project and whether the researchers are truly independent, rarely receive attention.

Those characteristics, critics say, make the bulk of industry-funded studies nothing more than glorified advertising and marketing campaigns thinly veiled as scholarly work.

“Companies fund research for marketing purposes,” Marion Nestle, one of the nation’s foremost specialists on food industry studies, told Tarbell via email. “If they can get evidence that their products reduce heart disease risk or the risk of any other disease, they can market their products with health claims,” she wrote.

“Health claims sell products,” added Nestle, who is professor of nutrition, food studies, and public health, emerita, at New York University. She is publisher of the Food Politics blog and author of Food Politics: How the Food Industry Influences Nutrition and Health.

Companies that produce hazardous chemicals have long “hired researchers to dispute and reanalyze data showing adverse health effects,” David Michaels, author of Doubt is Their Product, wrote in Scientific American. “Their conclusions are almost always the same: the evidence is ambiguous, so regulatory action is unwarranted.”

The coterie of analysts, academics, and consulting firms willing to lend their names and reputations to industry studies for the right price are essential to the corporate research ecosystem. Avalere Health and the Moran Company are two of the Washington, DC-area firms regularly tapped by pharmaceutical and healthcare companies to do their research work.

Neither company responded to Tarbell’s request for comment.

A Moran Company report commissioned by the drug industry association PhRMA in 2017 found that hospitals mark up pharmaceutical prices by an average of 500 percent. The research was neither peer reviewed nor published in a journal. Critics say the study is part of the industry’s well-funded effort to lay the blame for price increases elsewhere.

When Senator Ron Wyden (D-OR) introduced legislation last year that would require Pharmacy Benefit Managers to provide greater transparency about drug company rebates, including how much is passed onto consumers, an industry group pounced with a critical study—again, produced by the Moran Company. The Pharmaceutical Care Management Association warned that the bill would boost federal spending by $20 billion over ten years.

A PCMA spokesman declined to comment on the study in question.

In Defense of Industry Studies

Industry-backed studies routinely stretch the truth, but the dubious conclusions of a December 2016 research paper on sugar consumption were too much for even a corporate sponsor to swallow.

An academic paper published by the Washington, DC-based International Life Sciences Institute, whose funders include Coca-Cola, Hershey, Red Bull, and other major food producers, minimized the importance of limiting sugar consumption.

The findings ran contrary to a wide body of scientific data that directly links sugar to obesity, diabetes, and heart disease. In the rarest of moves, Mars, one of the world’s leading producers of chocolate and snacks, cried foul.

The manufacturer of the iconic M&M, Snickers, and Milky Way brands and an institute funder complained that the report undermined the work of public-health officials and tarnished industry-funded research.

A company spokesman told the Associated Press that the study “creates more doubt for consumers rather than helping them make better choices.”

Mars recently published new science policy guidelines to boost transparency and has announced it will leave ILSI. It’s highly unusual for a report sponsor to break ranks, especially in such a public manner. But the turn-of-events is a reminder that some companies have good intentions regarding research, and that the private sector has the capacity to police itself and take corrective action.

Defenders of industry studies argue that major corporations are often the only entities that can afford costly experiments, and that findings have contributed to life-saving medications, widely used technologies, and other breakthroughs.

PhRMA, the trade organization, notes that a new medicine, on average, takes a decade to develop at a cost of $2.6 billion. (That figure is derived from industry-funded research and has itself been challenged.)

“With strict oversight by institutional review boards, clinical trials provide the U.S. Food and Drug Administration with the scientific information needed to weigh the benefits and risks of a new medication,” the association states. It also insists that that the biopharmaceutical industry is at the “forefront” of efforts to boost access to clinical trial data.

According to a Nature article on the pluses of industry research, a 20-year review of research at nine University of California campuses and three national labs found that corporate-sponsored inventions are licensed more often than federally funded ones.

In fact, companies sometimes fund “exploratory research” into new fields where they have little or no expertise in their quest to generate fresh revenue streams, the article says. They also partner with academics to cultivate and maintain professional relationships.

Corporate sponsors have demonstrated that they are capable of integrity by publishing research that reflects negatively on their products. On her food blog, Nestle highlights a study that received National Honey Board funding that found no difference in blood sugar levels when people consume honey versus sugar and other sweeteners.

Even Coca-Cola wins plaudits from Nestle for not blocking publication of a report it co-funded that links sugar-sweetened beverages with hypertension.

In recent years, the pendulum has swung towards greater transparency, with prominent academic journals and databases requiring greater disclosure about funders and the competing interests of authors.

For Krimsky, the Tuft’s professor, protecting the autonomy of scientific investigators is paramount. He views the production of knowledge that’s free and independent from constraints as a cornerstone of democracy—alongside the right to vote freely in elections and an unfettered press.

“If you cannot retain an independent scientific community to produce credible knowledge and protect it from corporate interests, we’re at a tremendous loss for a democratic society.”

Solutions Database

Big industries skewing science: What you can do

  1. Help Tarbell spot industry-funded studies as we grow a database of phony and biased research backed by corporate money. Email hello@tarbell.org with “#IndustryFunded” in the subject line, or post studies on Facebook and Twitter with #IndustryFunded.
  2. Learn to spot an industry-funded study. It’s not hard. You just need to ask some key questions, like, “Are the results too good to be true?” Find out more here.
  3. The Union of Concerned Scientists offers the Disinformation Playbook, a site that tracks the myriad ways industry uses skewed studies to win policy battles and get potentially unsafe products to market. You can find out more about how to personally address the problem here.
  4. If you are scientist, check out PubPeer, the site that encourages volunteer experts to review newly published studies for errors, omissions and conflicts of interest. Think of it as a crowd-sourced way to keep other scientists honest. Find out more about it here.
  5. Another tool for scientists: The Center for Open Science. The project aims to put science on a free, open source platform to make scientific findings easily reproducible, verifiable and findable. Learn more about them here.
  6. The Reproducibility Initiative is another effort to guarantee study findings through independent testing of key results. Find out more here.
  7. If you’re wondering whether a medicine you take or a medical device in your body has caused harm to other individuals, the law firm of Wilson & Peterson operates Drugwatch.com. Ambulance chasing aside, it is a handy quick reference. Find out more here.

Tarbell is nonpartisan. We do not endorse you taking these actions. But sharing them with you is part of our commitment to helping you find solutions. Email questions to questions@tarbell.org. And learn more about these solutions here