Recent research conducted by the German Institute for Quality and Efficiency in Healthcare (IQWiG) shed some light on how doctors and health care providers decide which drugs are best for a patient. The researchers looked at 216 newly approved drugs in Germany between 2011 and 2017.

This set of drugs includes 152 new drug molecules as well as 64 new applications for existing drugs. Only a quarter of these could show they offered a considerable or major benefit over the standard form of care.

The research indicates that new medicines aren’t necessarily any better than existing options, yet it doesn’t stop doctors from prescribing them. These findings provide insight into the drug development process, how it affects prescribing and also what patients can do to serve as their own advocates.

Drug Discovery and Development Process

The drug development process features several steps. There are often hundreds of thousands of clinical studies going on around the world at any given time, but very few drugs actually make it through and receive approval from the Food and Drug Administration. Only around five out of every 5,000 preclinical drugs will make it through drug development to human testing. Of those, only one of five will be approved by the FDA.

Some of the key steps that occur during drug discovery and development include:

  • During the drug discovery process, a drug development company chooses a molecule that they will then target with a drug. This phase of the process also involves insuring the selected molecule is related to the disease that the drug would aim to treat.
  • After the discovery phase is preclinical testing. There are two main parts of this—one of which is testing in test tubes. The other is testing on animal models or other types of living cells.
  • The third step in the drug development process requires the drug company to submit what’s called an Investigational New Drug Application to the FDA, showing their results in preclinical testing.
  • There are then several steps of clinical studies which involve real patients.
  • The New Application drug filing has to be done, and it can be tens of thousands of pages long. This application includes information and research data about the efficacy and safety of a drug.

The FDA can decide to approve a drug, deny a drug, or ask for additional information. Often even after a drug is approved, the FDA will request ongoing clinical studies to look at long-term safety.

Clinical Drug Development Not Always “Better”

There’s often the misconception that new drugs that have recently gone through preclinical drug development are better than older drugs. What seems to happen following clinical drug development is that you’re often left with drugs that have the same mechanism of action as what already exists. There isn’t as much innovation in clinical drug development as you might think, based on the results of the study.

It’s especially interesting because the research was in Germany, and there was a requirement introduced in 2011 that companies had to prove new treatments are better than existing ones. However, that research often isn’t available or is inconclusive according to the IQWiG researchers. This inconclusive evidence could be the result of improperly operated trials, or no trials at all.

Doctors Use Drug Development Research & Intuition to Prescribe Appropriate Medications

According to ChemistryWorld’s report, when a doctor decides what drugs to prescribe, they usually do so based on a combination of personal experience and intuition. They will often also combine this with interpretations from clinical trial reports, and the information they receive from representatives of pharmaceutical companies.

One study showed that prescribing of new drugs is not just related to critical evaluation, but is instead heavily focused on information from pharmaceutical companies and social influences. These results could indicate why there is so much variation in how doctors prescribe, even with standardized availability of clinical information.

A question people often have is how do doctors get paid for prescribing drugs because the idea of a pharmaceutical company paying a doctor to push their drugs can be troubling. In May of 2019, a federal jury found executives from the Insys Therapeutics company, which manufactures opioids, guilty of racketeering related to the opioid epidemic. The verdict held high-ranking people within the company responsible for bribing doctors to prescribe fentanyl-based Subsys. They were also found guilty of misleading insurers about patients’ needs for the strong and often addictive pain medication.

Dr. Charles Rosen, co-founder of the Association for Medical Ethics, said there is evidence that doctors can be influenced by pharmaceutical companies. Even though doctors can’t be paid cash outright, there are other ways pharmaceutical companies influence doctors’ decisions, such as treating them to meals or hiring them to be consultants. Doctors are influenced to reciprocate the nice gestures, even if they don’t realize it.

In 2010, President Barack Obama signed the Physician Payments Sunshine Act. As a result, medical professionals are required to disclose any payment of more than $10 from pharmaceutical and insurance companies. These disclosures made available data that allowed regulators to see how prescribing patterns might be influenced by payments from pharmaceutical companies, such as paying doctors consulting fees.

These bits of information underscore the importance of advocating for yourself as part of the doctor-patient relationship, and also clearly communicating your symptoms and any side effects you may experience.

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