â€œTrial sponsors can still choose to keep information about some trials confidential, creating serious ethical concerns,â€ Deborah Zarin, the director of ClinicalTrials.gov, tells the paper.
Many experts say the recent Congressional debate underscored a troubling fact: some patients in clinical studies never learn about test results. The problem may be particularly relevant to those implanted with medical devices that stay with them long after a trial is over. For manufacturers and researchers alike, â€œthere is a tremendous incentive to go on, to forget about the old and move on to the new,â€ Drummond Rennie, a deputy editor at The Journal of the American Medical Association, tells the Times.
There are no data available for the number of patients who participate in studies of drugs and devices that never make it to market, but the number is likely to into the thousands. A product may not reach the market for a variety of reasons â€” it may not perform well in trials, for example, or it may be rejected by regulators. Although researchers conducting clinical studies aren't required to disclose test results to study participants, they must alert patients taking part in a test to emerging product dangers.
Companies also have to keep promises made to regulators at the time a trial began, like agreements to follow the health of study patients. Such promises are often required to get approval to begin trials in the first place. But researchers and manufacturers don't always fulfill even those minimal requirements, the Times writes, and such failures may be particularly acute in trials of implanted devices, since those products remain inside patients.
In August, for example, the FDA sent a warning to Boston Scientific after investigators discovered the companyâ€™s diligence in following up with patients faltered around the time it dropped a product under development. The product being tested was an experimental stent intended to prevent the rupturing of an aneurysm in the major abdominal artery.
Among other things, agency investigators found that Boston Scientific, which halted development of the stent last year after a study showed it frequently fractured, had neglected to tell patients in that trial about the problemâ€™s scope. Researchers involved said such a fracture, while not dangerous in itself, could cause a stent device to shift position, thus rendering it useless in treating an aneurysm, a weakening of a blood vessel that can burst with fatal consequences.
Paul Donovan, a spokesman for Boston Scientific, says the device maker was moving to address the FDAâ€™s concerns. While six patients involved in the study have died, he says the company didn't believe the deaths were related to either the stent or burst aneurysms. â€œThere were instances of reporting that was not done in a complete and timely manner, and we are addressing these shortcomings,â€ he tells the Times.
Because of loopholes in the recently passed Congressional bill, device makers like Boston Scientific will still have discretion whether to publicly reveal the results of studies like that of the failed stent. Under the law, device producers will have to report such â€œpremarketingâ€ studies and their results to the F.D.A. But that data will remain in a confidential â€œblack boxâ€ until a product is approved; if a device is rejected or dropped, a company will not have to disclose those results or even publicly acknowledge that the trials occurred.
Device makers lobbied against mandating disclosure for failed products, arguing that releasing such data would be confusing to patients and would give away valuable information to a companyâ€™s competitors about devices under development that might succeed in subsequent trials. â€œSuch disclosures could have the unintended consequence of eliminating many small device makers from the marketplace,â€ Stephen Ubl, ceo of the Advanced Medical Technology Association trade group, testified before Congress in June.
The new bill does allow for a mechanism under which the secretary of the Health and Human Services Department could release trial data about unapproved products if a public health issue exists, but such moves would be argued case by case. â€œThis was a disappointment,â€ says Steve Nissen, the chairman of the cardiology department at the Cleveland Clinic, who helped draft the House version of the bill, tells the paper. â€œThe problem is that if you donâ€™t tell people about failed trials, you can make the same mistake again and again.â€
As a result, patients who were in failed trials may find out about the consequences only by chance. That apparently is what happened last year when two women struck up a conversation at a hospital in Tampa, Fla., and found out that they were both there for the same reason: severe pain, related to their breast implants.
As they talked, the women, Christina Rafsky and Barbara Padgett, learned they had more in common. Both had seen the same doctor in Tampa, who had persuaded them to participate in a clinical trial he was overseeing of a new type of silicone-filled implant made by Inamed Aesthetics, now a unit of Allergan. Next, a curious Ms. Rafsky called Allergan and learned for the first time that Inamed had halted that trial in 2005 because the implant model she had received was rupturing.
â€œI was angry and frustrated,â€ Ms. Rafsky, who lives in Tampa, tells the Times.
A spokeswoman for Allergan, Caroline Van Hove, says that Inamed alerted docs involved in the study in 2005 including the womenâ€™s physician, Gerard Mosiello of Tampa, and suggested that they contact patients about the rupture issue. But when Ms. Rafsky contacted Mosiello, he claimed not to have received the letter. â€œHe said he did not know anything about the product being recalled,â€ she tells the paper.
Rafsky then filed a complaint with a panel at the University of South Florida that oversaw the implant trial, which took place at the H. Lee Moffitt Cancer Center and Research Institute in Tampa. Such panels, which are known as institutional review boards, help ensure, among other things, that trials are properly conducted. After a lengthy investigation, the panel found that Mosiello had failed, among other things, to follow up on the health of study participants like Rafsky and Padgett.
â€œIt was the consensus of the IRB that there was sufficient evidence to support that there were lapses in participant care and follow-up,â€ the group wrote in a July letter that Rafsky made available to the Times. Mosiello declined to be interviewed for this article. Recently, Rafsky and Padgett retained Alan Milstein, a lawyer who specializes in representing patients involved in clinical trials.
As to whether Mosiello received the Inamed letter in 2005, the University of South Florida panel, which interviewed both Mosiello and an Allergan official, found that â€œthere was no documentation or recordkeeping regarding who had been contacted and when,â€ its letter states. Van Hove, the Allergan spokeswoman, says Inamed had followed up to make sure researchers like Mosiello had received the companyâ€™s letter. But she acknowledged that it had not checked back to see what physicians like Mosiello had told patients, if anything.
â€œThe actual communication between a health care provider and his or her patient is left to the physician exercising his or her medical judgment,â€ Van Hove says in a statement.
Source: The New York Times