Following a die-in protest outside the Tufts School of Medicine’s Center for the Study of Drug Development (CSDD) on Friday, April 1, protestors continue to demand disclosure from the CSDD on the pharmaceutical companies that fund researcher Joseph DiMasi’s work. At press time, the CSDD has not yet disclosed these companies, which the CSDD says is against the center's policies.
DiMasi’s research focuses on the cost of drug development, and activists argue that the undisclosed pharmaceutical companies that fund his work may encourage him to report a high cost for drug development in order to fit the industry’s agenda, according to a press release from the activists.
“Activists and students are concerned that DiMasi’s figures are paid for by undisclosed pharmaceutical companies and justify exorbitant prices that keep drugs out of reach, and result in unnecessary suffering and death in the [United States] and abroad,” the press release reads.
The protestors included Tufts medical students and members from the Boston chapter of the AIDS advocacy organization ACT UP, Universities Allied for Essential Medicines, the American Medical Student Association and other community activists, according to the press release. The protest was part of a global action campaign led by ACT UP on April 1, protesting against high drug prices with the slogan “Pharma Greed Kills,” according to Chris Noble, the protest organizer and the president of the Boston University chapter of Universities Allied for Essential Medicines.
CSDD Director Kenneth Kaitin and DiMasi both said that the study in question did not receive direct funding from pharmaceutical companies. However, unrestricted grants from pharmaceutical and biotechnology firms comprise 40 percent of the CSDD's operating expenses, according to a financial disclosure statement on its website.
“We provide on our website and every paper that we publish, that we receive unrestricted grants through pharmaceutical companies," Kaitin said. "And [when] we get direct funding [for research], we of course indicate who provided the direct funding.”
When asked why CSDD does not disclose the specific companies that give these unrestricted grants, Kaitin answered that it is against the center's policy.
“This is the way we have done it," he said. "We had made the decision 40 years ago when we were founded, that these unrestricted grants, we would acknowledge the industries that provided them but not the specific companies."
Noble explained that the protestors chose DiMasi and CSDD as their targets because DiMasi’s research showed an example of the potential corruption of the drug industry.
“If [the pharmaceutical] industry is going to be using [DiMasi’s] figure to justify their high prices, which they have been [doing], then we want to know if those same organizations are funding their research, because that is a blatant conflict of interest,” he said. "[Kaitin] needs to publicly declare those conflicts of interests so that anyone who looks at the study knows that it is funded by pharma and should be discarded as evidence to promote pharma's high prices.”
Three weeks after the protest, Tufts medical student Robbie Patterson reiterated the protesters’ unfulfilled demands for the disclosure of the pharmaceutical companies that fund CSDD research.
“We have concerns about threats to the integrity of the research that might impact on the drug industry as a whole,” Patterson said.
Patterson said that the level of financial disclosure the center provides is insufficient.
“We think it's important for an institution that’s publishing really big and important numbers about the cost of drugs, that we are able to evaluate those numbers in light of who is funding their work,” he said.
However, Kaitin noted that knowing which companies funded the center would not necessarily reveal the conflict of interest that the protestors suggest.
“I’m kind of baffled about the idea that knowing the specific companies would make a difference,” Kaitin said. “We’re saying it’s pharmaceutical companies. I’m not sure why you need to know what the specific pharmaceutical companies are, unless there is specific funding to this project.”
Kaitin continued, arguing that the connection the protestors draw between cost of drug development and drug prices is spurious.
“The price for pharmaceuticals is based on perceived cost of doing business; it’s based on the competitive landscape and what the payers will reimburse,” he said. “Those are the three factors, [and they have] nothing to do with R&D costs. In a free market economy, prices are based on what the product will bear and the value of the product to the consumer.”
While Patterson agreed with the logic of Kaitin’s argument, he said there was still a possibility that DiMasi’s findings could be used to justify high drug prices.
“There is this idea that things that you already pay [for] don’t factor into how you price your product," Patterson said. "That makes sense. We think it’s possible that drug companies are using this as a way to raise prices.”
DiMasi also said that not disclosing the pharmaceutical companies that fund the CSDD does not represent a conflict of interest.
“If [one was] doing research about the benefits of a drug being produced by Company A, it’s certainly appropriate to disclose that they are getting funding from Company A…But…we don’t speak or write or research about the benefits or risks of any particular products…We discuss policy trends, effects of innovation,” DiMasi said.
The protestors also described DiMasi’s estimated figure for the new drug development — at $2.9 billion — as “staggering” and cited criticisms of his research, according to the press release.
“DiMasi’s work has long been the subject of controversy, drawing criticism from Doctors Without Borders and even GlaxoSmithKline’s CEO Andrew Witty, who laughed off DiMasi’s 2008 estimate when it was closer to $1 billion per drug developed,” the press release states.
According to DiMasi, this characterization is inaccurate. While he wrote in an email that the $2.87 billion amount represents the total estimated cost, this figure includes post-approval costs which normally are not included when discussing the findings of similar studies, he said.
“The pre-approval cost figure is $2.6 billion," DiMasi told the Daily in an email. "That is what is most commonly cited, and it is what is used to compare to previous estimates (apples-to-apples comparisons).”
DiMasi also said that he has written three different rebuttals to criticisms of his research. He defended his methodology, saying that researchers at the Federal Trade Commission have conducted similar analyses with publicly available data. DiMasi’s study was unique in that his data came from the drug companies, which allowed his estimates to be more accurate but potentially more subject to their interference.
“They are supportive of our results on averages in that, if anything, they suggest that our prior results were conservative (i.e., costs may have been somewhat higher),” DiMasi said.
Patterson qualified the press release’s claim, saying that not all protestors were necessarily challenging the accuracy of DiMasi’s work.
“[DiMasi’s] not the only researcher coming up with big numbers but they have been contested by other people," Patterson said. "And so our intent wasn’t necessarily to say that his numbers are wrong. We think that he probably has a better understanding of the pharmaceutical industry as a whole than we as medical students do, but what we understand is that as medical students it's important for people in the medical profession to be open about their conflicts of interest.”
Patterson said that the protesters plan on meeting again soon, hoping to initiate greater dialogue with Kaitin, DiMasi and the CSDD, while engaging the community of medical students at Tufts.
“I don’t think it’s been publicized widely, and I think that it’s an issue [which is hard] to see its direct effect on patients ... It’s two degrees removed, especially when students are in the middle of finals and have a ton of things to do to keep up,” Patterson said.
Emma Steiner contributed to reporting for this article.
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