The COVID-19 pandemic has sparked an urgent need for development and research of drugs that may aid in the treatment of and recovery from the respiratory illness. Due to a rise in public scrutiny over pharmaceutical product manufacturing, development of new drugs face an uphill battle when it comes to the FDA approval process. Only 9% of drugs submitted to Phase I make it to FDA approval, and only 53 new drugs were approved in 2020.
Despite scrutiny, FDA approval is used as a significant marker to the public in trusting the safety and effectiveness of drugs and medical devices pushed to the market.
There is no doubt that the residual effects of COVID-1 will impact the drug market, both in the short term with COVID-19 treatments and in the long-term with the production and approval over future pharmaceutical products.
Many drugs without FDA approval for COVID-19 treatment have been speculated to be useful in fighting infection. Drugs like Ivermectin, Hydroxychloroquine, and Oleandrin were once widely promoted by a number of political and public figures, but have failed to produce promising results in clinical trials and have since been dismissed by most health authorities.
Other experimental medications and therapies have touted effectiveness. A few types of Monoclonal Antibodies, drugs derived from people who have recovered from COVID-19, have gained emergency authorization from the FDA for high-risk patients infected with the virus. Antiviral pills in development by Merck and Pfizer aim to suppress the virus in its early stages and are also seeking emergency FDA approval.
A momentous & growing public distrust of the pharmaceutical industry ignited during the COVID-19 pandemic ; once unconcerned consumers now question the validity of safety claims of not only COVID-19 treatments, but the safety of all pharmaceutical products. Whether right or wrong, many perceive drug manufacturers as self-serving, financially motivated entities unconcerned with consumer health.
These feelings of distrust have left many wondering, "is my medication safe?".
“Bad Drugs” are medications or devices approved by the FDA that have been known to cause dangerous or even deadly side effects. With the rapid increase in disinformation on emerging treatments, it is important to take the steps below to check whether a medicine could have adverse effects.
Some indicators for drug safety include:
New medicines and treatments seem to carry an inherent risk of unexpected side effects. According to a study of all FDA approved drugs between 2001-2010, nearly one-third of them had problems.
The FDA says that this is due to the testing protocol in clinical trials, where a medication is tested on hundreds and often thousands of participants, but issues arise when the general public, comprised of tens of thousands, use a medication and experience unintended side effects. Regardless, a watchful eye should be applied to news regarding new medicines and devices and their potential side effects.
The creator of a medicine or device should be under consideration when receiving a prescription or recommendation. Although trust is often afforded to brand-names and widely recognized drug manufacturers, even the most well-known pharmaceutical companies have come under public scrutiny and have faced legal ramifications for questionable practices and dangerous side effects.
Recently, three major drug distributors and pharmaceutical giant Johnson and Johnson agreed to a $26 billion settlement for their role in promoting and distributing opioid painkillers across the United States. Pfizer has also previously paid out a $2.3 billion settlement for false marketing.
It is also important to recognize that generic drugs, the bioequivalent of name-brand pharmaceuticals offered at a highly discounted rate, are not subject to the same functionality and safety tests that name-brand pharmaceuticals are required to adhere to.
Generic drug makers are also not held liable for injury to consumers as brand-name pharmaceutical companies are. As ruled in the case “Pliva vs Mensing”, if a generic manufacturer learns of a risk that is not accurately or adequately described in the drug’s written warnings, the generic manufacturer has no duty to warn the public unless the brand-name manufacturer does so first.
In ensuring that a drug or device is safe, it is critical to understand and look into what studies or research have been conducted on a product’s use and efficacy. Different types of research that take years to complete are done to hopefully guarantee that a product can be used safely while minimizing side-effects.
There are tools available on the web for consumers to find clinical studies and trials and their results.
Possible side effects are often found during clinical trials, but many are found after a product has hit the market, either through reporting, like FAERS, or through post-market research. Consult a healthcare professional and consider possible side effects of a medication or device before use, especially if the possible side effects are related to existing health issues.
Possible side effects will be listed on warning labels, safety alerts, and black box warnings.
A drug interaction is a reaction in the body between two or more drugs, or a drug and food/beverage/supplement. Drug interactions can also be caused by a medical condition and the introduction of a new drug. These drug interactions can cause side effects or affect how a drug operates in the body.
There are tools available on the web for consumers to determine drug interactions.
Acknowledging and warning of side effects is an integral and important part of pharmaceutical marketing, but undocumented side effects and adverse events must be taken seriously to reduce harm to yourself and others who may be taking a medication or using a device.
Below are actions to be taken if you find yourself experiencing undocumented side effects or adverse events:
Meet with a healthcare professional to talk about your side effects, possible mitigation, advice on halting use of the medicine or device, and steps going forward.
After meeting with a healthcare professional and gaining advice on what to do, reporting the side effect or adverse event is in your best interest. Be aware that healthcare providers are NOT required to report your condition to the FDA. The FDA provides an online reporting form for these situations.
If the defective or dangerous product resulted in injury or other financial damages, legal action may be a route to compensate for any harm you’ve experienced due to those undocumented side effects or adverse events.
Beasley, Deena. “Pfizer, Merck Launch New Trials of ORAL Covid-19 Drugs.” Reuters, Thomson Reuters, 1 Sept. 2021, https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-starts-dosing-patients-oral-covid-19-drug-trial-2021-09-01/.
Center for Drug Evaluation and Research. “FDA’s Approval OF Veklury (REMDESIVIR) for the Treatment of Covid-19.” U.S. Food and Drug Administration, 22 Oct. 2020, https://www.fda.gov/drugs/news-events-human-drugs/fdas-approval-veklury-remdesivir-treatment-covid-19-science-safety-and-effectiveness.
Center for Drug Evaluation and Research. “New Drug Therapy Approvals 2020.” U.S. Food and Drug Administration, 8 Jan. 2021, https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2020.
“Coronavirus (Covid-19) UPDATE: FDA Authorizes ADDITIONAL Monoclonal Antibody for Treatment of Covid-19.” U.S. Food and Drug Administration, 26 May 2021, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19.
Downing, Nicholas S. “Postmarket Safety Events Among Therapeutics Approved by the FDA.” JAMA, JAMA Network, 9 May 2017, https://jamanetwork.com/journals/jama/fullarticle/2625319.
Hoffman, Jan. “Drug Distributors AND J.&J. Reach $26 Billion Deal to End Opioid Lawsuits.” The New York Times, The New York Times, 21 July 2021, https://www.nytimes.com/2021/07/21/health/opioids-distributors-settlement.html.
“Justice Department Announces Largest Health Care Fraud Settlement in Its History.” The United States Department of Justice, 16 Sept. 2014, https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history.
Landon, Emily. “Which over-the-Counter Medications Are Best for Coronavirus Symptoms?” UChicago Medicine, UChicago Medicine, 7 May 2020, https://www.uchicagomedicine.org/forefront/coronavirus-disease-covid-19/which-otc-medications-are-best-for-coronavirus-symptoms.
“New Drugs Found to Cause Side Effects Years after Approval.” NBCNews.com, NBCUniversal News Group, 10 May 2017, https://www.nbcnews.com/health/health-news/new-drugs-found-cause-side-effects-years-after-approval-n757526.
“New Study Shows the Rate of Drug Approvals Lower than Previously Reported.” Biotechnology Innovation Organization, 14 Feb. 2011, https://archive.bio.org/media/press-release/new-study-shows-rate-drug-approvals-lower-previously-reported. “What Are the Different Types of Clinical Research?” U.S. Food and Drug Administration, FDA, 4 Jan. 2018, https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research.
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