Share this site! The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.

Q&A on the Fair Access to Clinical Trials Act

Requiring drug companies to register and make public their clinical studies will help improve prescription drug safety

Support the “Fair Access to Clinical Trials Act”

American consumers – and doctors – are bombarded each day by advertisements and marketing for prescription drugs. In fact, the pharmaceutical industry spends $23 billion each year to get us to buy, and doctors to prescribe, their brand-name drugs.

We assume these drugs are safe. After all, prescription drugs are regulated by the Food and Drug Administration (FDA), which requires drug companies to test their products for safety and effectiveness before they are placed on the market. But recent revelations that some drugs may have potential harmful side effects – most notably the painkiller Vioxx and the anti-depressant Paxil – have led many to question whether the pharmaceutical industry is telling us the whole story about the safety of their drugs.

One gaping hole in the current safety process is that the FDA and the drug makers do not have to make these clinical drug trials public – in fact, in most cases the government cannot release this information without the company’s permission. This can lead to situations like Paxil, where study results that found a link to increased suicidal thoughts in teens were known by the drug maker and the FDA, but not released to doctors or consumers. In the case of Vioxx – which was pulled from the market in September after being linked to increased risk of heart attack – the drug maker may have known for years about the risks, but downplayed them.

Doctors are calling for these drug studies to be made public – the American Medical Association supports a comprehensive drug trial registry. And legislation that would require a public registry, the “Fair Access to Clinical Trials Act,” is now pending in the House and Senate. We believe consumers and physicians have a right to know when drug companies discover that their drugs may not be effective or safe for some users – and a public drug trial registry will help ensure that important information is available.

Below are frequently asked questions about the legislation and a mandatory drug trial registry:

Q: What would the “Fair Access to Clinical Trials Act” do?

A: Introduced in both the House and the Senate (HR 5252 and S 2933), the bills would require clinical trial sponsors to register all publicly and privately sponsored trials with the existing government website, Information about the purpose, duration and outcomes to be examined would need to be submitted so they can be made available to the public. Trial sponsors also must disclose drug trial results. Failure to submit required information would be published in the registry, and the government could fine those that do not comply.

Q: Doesn’t a drug trial registry already exist? Don’t the drug companies already have to report their study results to the FDA?

A: Our focus is on public accessibility to this information. Drug companies are required to submit a wide range of clinical trial information to the FDA, but neither the FDA nor the company must make this information public. By requiring all the study information be public and transparent, it would be more difficult for drug makers to put a positive “spin” on potentially damaging study results or for the FDA to delay taking action if a drug may have potential risks.

Q: Isn’t it really the FDA’s responsibility to make sure drugs are safe, so why do we need a public registry?

A: Though the FDA is charged with being the watchdog for consumers on drug safety and efficacy, the FDA often has to rely on companies to tell them when their product is dangerous. Drug companies often conduct trials in an effort to find new ways to market their drug. They may sponsor studies to show that the drug is effective for a new use, or more effective than a competitor’s drug. It is these drug trials where new concerns about safety and effectiveness often appear. We are seeking full disclosure of the information that companies have from these trials, and support more publicly funded safety and comparative trials to gather more information.

Q: The pharmaceutical industry already said it would establish a drug trial registry. Why isn’t this good enough?

A: The industry trade group, PHRMA, recently launched a website, that includes both published articles and summaries of unpublished studies sponsored by PHRMA member companies. However, this is a voluntary registry, so it is up to those who conduct the drug trials to list information. Unlike a mandatory registry, the industry website will not include most phase I & phase II studies, which often include important safety data; sponsors are not required to register their trials before they are begun; there is no enforcement mechanism, and companies are not required to include detailed results of the trials.

Q: How would a mandatory drug trial registry prevent incidents like Paxil and Vioxx?

A: The registry would reduce the likelihood that negative or unfavorable results could be hidden. In addition, information that emerges from clinical trials could be more easily obtained. In the case of Paxil, a full disclosure of information would have made clear to researchers that the drug was not effective in reducing depression among adolescents. And not only was it ineffective, but it also had potential negative side effects – such as suicidal thinking. Vioxx is a more difficult case. Merck, the drug’s manufacturer, apparently was aware of increased heart risks relating to the drug for years. In this case, the FDA required additional warnings to be added to the label in 2002, and information had been available to the public that indicated potential risks. Because there were other products on the market that were as effective with a better safety profile, Merck and the FDA should have acted more quickly to seek removal of the drug from the market. If the details about study results had been available in a centralized database, the information would have been more readily available for public scrutiny, and the heart risks might have been focused on sooner.

Q: Even if a company reports that it held a drug trial, how would we know the results?

A: We believe that companies need to disclose – before they know the outcome – that they are conducting a trial. The information initially made available would include the sponsor of the drug trial, the aspects of the drug that are being studied, and how long the trial is expected to last. If the House and the Senate bills were to become law, after a study is completed, trial sponsors will have a set amount of time to make the results available to the public.

Q: How do you expect consumers to understand the very technical results of a drug trial? Don’t they currently publish results in medical journals that even doctors find hard to understand?

A: One key goal is to improve the transparency of information about treatments. As it stands, this information is not open to public scrutiny of any type. Once the information is publicly available, researchers, public interest organizations, journalists, and others who keep the public informed will have the opportunity to simplify the data and share it with the public.

Q: Won’t requiring drug companies to make test results public make them reluctant to produce new drugs for fear of lawsuits?

A: A clinical trial registry is primarily about helping patients and doctors make safe, appropriate, and effective healthcare decisions by having all relevant information available. No drug on the market is problem-free, and almost all drugs have some risks. The FDA approves a drug when it decides that the risks are outweighed by potential benefits. However, if a drug company has reason to believe that this balance has shifted because new risks have emerged during clinical trials, the public has a right to know. We do not expect more transparency to lead to a reduction in new and improved medicines. Advancements cannot happen without trial and error, and we expect companies to continue to develop new drugs – ones that are safer and more effective than those on the market.