FDA Worries More About Companies Than Patients: Professor
New York University journalism professor Charles Seife says that it’s impossible to trust FDA decisions and statements because it “worries more about a drug’s side effect on a company than on a patient.” Writing in a lengthy Scientific American online article, Seife discusses agency efforts to withhold information about Sarepta’s Duchenne multiple sclerosis drug Exondys 51 (eteplirsen).
“FDA is blocking access to very basic information about eteplirsen — censoring side effects, outcome measures, and even possible evidence of misconduct — because releasing that information would hurt Sarepta,” writes Seife, who is suing the agency under the Freedom of Information Act to better understand the eteplirsen approval decision in which CDER director Janet Woodcock overruled agency medical reviewers and approved the drug for marketing. “In the past several weeks, the agency has released thousands of pages of previously undisclosed documents about eteplirsen and its approval, and more are coming before the end of the year. Despite the volume of papers FDA is disclosing, once again, FDA is far from transparent. What’s so striking in those documents is not the information that FDA is releasing, but the information that the agency refuses to release. For example, in several of the documents, frequently encountered adverse events — side effects and other negative consequences that occur during a treatment — are occasionally redacted.”
Seife reports that FDA has said that the redacted sections represent “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” He says that in this case, it tends to mean that release of the information will cause “substantial competitive injury” to the company that turned it over to FDA.
Before FDA released the documents, he writes, it allowed the company to suggest redactions that it felt would cause such harm or are exempt from release for other reasons. And, he says, Sarepta indicates that releasing certain adverse events and trial endpoints will hurt the company and help its competitors.
“If the agency didn’t agree — if it didn’t think that Sarepta was correct — it would still be required by law to release this information, or, at the very least to come up with a different reason for the redactions,” the article says. “So, to all appearances, FDA believes that in these cases releasing this information will hurt Sarepta, and refuses to turn it over.” Seife says FDA refused to answer any questions about its conduct, citing his pending lawsuit as the reason.
“The public’s interest in knowing the truth about a drug is secondary to the interest in protecting a company from harm,” the article concludes. “This is toxic for our confidence in FDA and in the drugs that it allows to come to market. It may well be that there’s no real case for scientific misconduct in the eteplirsen clinical trial. It may well be that we already know all about the drug’s important side effects. Heck, it’s even possible that the censored and missing outcome measures strengthen the case for the drug’s effectiveness rather than weaken it. But FDA’s willingness to consider such basic information about a drug’s performance as a ‘trade secret’ or ‘confidential commercial information’ and block it from public view means that we won’t — and can’t — know. There’s a haze of uncertainty around every single one of FDA’s decisions.”