When it comes to the manufacturers of medications, the companies are supposed to report the previously unknown side effects of their medications within 15 days of receiving reports of patient injuries or death. However, a new study is showing that the drug companies are not following the guidelines setup by the Food and Drug Administration. Even more scary, the drug companies are only reporting the side effects to the Food and Drug Administration on time in less than 1 out of 10 cases.
This new study is coming out of the University of Minnesota School of Public Health, and the researchers analyzed 1.6 million side effect reports that were submitted to the Food and Drug Administration between 2000 and 2014. The researchers calculated the number of days that lapsed between when the doctors alerted the drug company of the side effect, and the date when the drug company reported and submitted the documents to the Food and Drug Administration. Keep in mind, the Food and Drug Administration says that the documents need to be submitted to the agency within 15 days of when the drug company receives word that a patient has died or has been injured as a result of side effects of their products that were not previously known or disclosed. The results of the study was published in JAMA Internal Medicine, and it showed how the drug manufacturers did not disclose over 160,000 serious adverse side effects within that 15-day window. Almost 40,500 of the delayed reporting to the Food and Drug Administration involved the patient dying as a result of the adverse side effects. The study had also found out that the manufacturers of the drugs reported 91 percent of the nonfatal side effects and complications as well as 88 percent of the fatal incidence in accordance with the guidelines set by the Food and Drug Administration.
The senior author of the study is Pinar Karaca-Mandic, who is also a researcher at the University of Minnesota School of Public Health. Mandic said that reporting the adverse side effects in a timely manner is important for ensuring that the patients are safe, and also noted that this was the first study to examine the extent of the reporting delays going on by the drug manufacturers. The Food and Drug Administration can get information about the adverse side effects of the drugs by looking through the Adverse Event Reporting System, which is the database that contains the information about the medication error reports. The Food and Drug Administration agents use the database in order to evaluate the drug manufacturers’ compliance with the federal guidelines, and then complete follow-up investigations if needed. Some of the evaluations involve the Food and Drug Administration using the Sentinel System and other such databases to help the agency look into side effects and information about the patient who reported the incident, and then information about what happened to the patient. All of the information that the Food and Drug Administration finds by using the databases is then used to determine what course of action, if any, is needed to inform the consumers about the products to ensure they are safe and educated before using the medication.
The patients and the health care professionals do not have an obligation to report or disclose the side effects to the Food and Drug Administration, but the drug manufacturers have an obligation, and experts say this loophole is risky for everyone involved. An example is that doctors do not have an obligation to tell patients about the adverse side effects of a drug, and don’t have the obligation even when recruiting them to a clinical study. The doctors also could be slow in reporting complications from drugs to the federal health officials or even the drug manufacturers, because they often fear legal recourse. This is a loophole that makes it very difficult in knowing what real adverse side effects could be out there, since the doctors fear legal action, they tend to keep side effects a secret from both the federal agencies and their own patients. Part of this is because if the doctor discloses the risks of a medication but has also prescribed it to hundreds of patients, then there could be a case for negligence down the road, and then you also have the risk of higher malpractice insurance as well. Experts want the doctors to be held to the same legal liability when it comes to reporting known adverse side effects to the government agencies, and even to the patients, because without either side knowing about the side effects, the doctors are putting everyone in a dangerous situation to just possibly save their skin later on down the line.
The researchers proposed that the Food and Drug Administration create a regulation which allows the patients to report side effects to the agency directly, which the wrote about in their study report. Dr. Rita Redberg, who is the JAMA Internal Medicine Editor, called on the Food and Drug Administration to ban drug sales, and to also implement a reverse drug approval when the manufacturers do not report the complications of the drugs in a timely manner. Some researchers disagree on acting against those manufacturers who end up not complying with the reporting guidelines, and one researcher who disagrees with the proposal is Dr. Kenneth Getz. Getz said that it is very “labor-intensive” in terms of reporting and verifying all adverse side effects, which means that drug companies just might not have the staff to report all of these incidents in the 15-day window. Getz said that the manufacturers could be forced to suspend or withdraw medications wrongly, just because they don’t have the reporting done when the Food and Drug Administration wants, and then this could lead to patients being denied medications they need to safely and effectively treat their conditions.
There are other experts that say the Food and Drug Administration needs to be the one held accountable for errors and releasing drugs into the world that could cause serious harm. The Food and Drug Administration needs to be catching the mistakes before the drugs are released, and a lot of experts say this is probably the safest strategy moving forward to ensure efficacy of the medications. The problem with this is that a lot of people believe Big Pharma is too involved in the approval process by the Food and Drug Administration, essentially paying millions or billions to the agency in order to get their drugs approved a little ahead of when they should be, and then this leads to the Food and Drug Administration allowing drugs by certain manufacturers without all of the needed clinical trials and reports that outline the risks of the drugs. So while a lot of people want to see the risks and side effects being reported in a more timely manner, there is a huge debate on who is the most responsible and what or who is to blame for all of the non-disclosure of risks.