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FDA, Drug Companies Need to Stop Breaking the Law

FDA, Drug Companies Need to Stop Breaking the Law
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A government report shows how dozens of drugs that received a special “accelerated” approval have no proof of actual clinical benefit to patients, in addition to serious safety issues. Action Alert! 

Taxpayers are spending billions on drugs that have little or no data to support their efficacy. This is the bombshell finding of a report from the Office of Inspector General (OIG) on the failings of the FDA’s accelerated drug approval program. This program allows drugs to be prescribed and sold before there’s any proof they work. That proof is supposed to come later in the form of confirmatory trials that the drug offers a clinical benefit to patients, but the OIG report found that more than a third of drugs approved in this program have not completed these post-approval trials. Another recent report found that 10 percent of all newly approved drugs were based on trials that failed to meet at least one of their goals. This is another egregious example of taxpayers subsidizing the profits of pharmaceutical companies for drugs that are dangerous and often ineffective. It is a crony double-whammy that cannot be allowed to continue. 

The purported purpose of the FDA’s accelerated approval program is to allow the FDA to fast-track drugs that treat serious or life-threatening diseases and offer meaningful therapeutic benefit to patients over existing treatments. The program was developed by the FDA in 1992 in response to the HIV/AIDS crisis and later codified into the law in 2012 with the passage of the FDA Safety and Administration Act. This program allows initial approval of a drug based on less rigorous evidence, such as a surrogate endpoint; drug companies are then supposed to conduct more rigorous clinical trials after approval to confirm the drug’s efficacy.

And herein lies the problem. The OIG reports that drug companies are failing at a high rate to perform these confirmatory trials, meaning dozens of drugs are being sold and prescribed without any actual evidence that they offer any real benefit to patients. More than a third of drugs approved in this pathway (104 of 278) have not completed their trials; four drugs are seriously lagging, ranging from 5 years to nearly 12 years past their scheduled completion dates. As noted by Frank Shallenberger, MD in his February 2023 newsletter, one drug, Hydroxyprogesterone caproate (Makena) is five years past its deadline. It is supposed to reduce the risk of preterm birth but has been shown to increase the risk of pregnancy-related fetal and maternal complications, still births, preterm labor, preeclampsia, gestational hypertension, gestational diabetes, and oligohydramnios (a deficiency of amniotic fluid). 

This should come as little surprise. As the OIG report points out, drug companies don’t have much incentive to complete their trials once they are making money off these drugs. And they are making money, hand over fist: Medicaid and Medicare shelled out $18 billion between 2018 and 2021 on the third of drugs approved under this program that have yet to confirm their clinical benefit. Medicaid programs paid almost $700 million between 2018 and 2021 for Makena, the preterm birth drug mentioned above.

The premise of approving drugs based on surrogate endpoints is deeply problematic. For example, a cancer drug may win approval not because it saves lives or improves patient outcomes, but because it accomplishes a secondary goal such as shrinking tumors. But this often doesn’t translate into improving the lives of patients. A review in JAMA Internal Medicine came to the conclusion that, “Most studies of surrogate endpoints in oncology find low correlations with survival…. The evidence supporting the use of surrogate endpoints in oncology is limited.” An analysis of oncology drug approvals based on surrogate endpoints showed that less than 6% of them use endpoints that are highly correlated with survival.

There are other examples. Glycosylated hemoglobin is a marker of diabetes control. Yet in some clinical trials, patients who achieve lower glycosylated hemoglobin through aggressive medical management have a higher probability of death than those receiving usual care.

The impetus for the OIG report was the 2021 approval of the Alzheimer’s drug Aduhelm, a $56,000 per year therapy. The drug was approved despite the opposition of an FDA expert advisory committee, which overwhelmingly voted that the evidence supporting the drug’s efficacy was inadequate. Three members of the advisory committee resigned in protest over the agency’s decision to approve the drug.

The controversial approval of Aduhelm led another set of researchers to look at how many FDA-approved drugs are based on shaky clinical trial results. They found that 1 in 10 new drugs approved by the FDA between 2018 and 2021 were based on studies that had one or more goals, or end points, that weren’t achieved. Previous research has found that commonly used drugs don’t work for high percentages of people who take them: Crestor (a statin) was found to be effective for only one in eighteen patients, and Nexium (an acid blocker) helped only one in twenty-five.

There doesn’t seem to be any indication that Congress or the FDA have a sense of how wrong this situation is. The 21st Century Cures Act of 2016 doubled down on the idea of accelerating drug approvals. That legislation amended federal law in several ways to speed up the approval of drugs by allowing weaker clinical trial designs, testimonials from patients, and the use of surrogate endpoints in decision-making on drug approvals. This is done in the name of offering patients quicker access to better drugs but amounts to nothing more than subsidizing the profits of Big Pharma for drugs that have no evidence of benefit. This means that patients are being subjected to serious side effects from these drugs without the tradeoff of any benefit. This is shameful.

If we want a better system for ensuring the efficacy of drugs, we cannot rely on the FDA. We took a wrong turn with the Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act and its later add-ons. Prior to that legislation in 1962, the FDA was charged with ensuring safety. Afterward, it had to approve effectiveness as well. This was well intended, but completely unrealistic. Congressional auditors agree that the agency is not competent to decide on effectiveness. It never will be. It relies on outside experts, but these experts are too often bought and paid for by industry—or else they want to preserve their own lucrative medical practices by preventing new drugs, technologies, or procedures. The FDA should concentrate on safety, then let the medical profession work out effectiveness.

The OIG report highlights everything wrong with medicine in America. We rely on dangerous, expensive, and ineffective drugs to treat preventable chronic illnesses. The federal agency charged with protecting public health and ensuring the efficacy and safety of drugs sees the drug industry as its client and protects its interests. The FDA does this by undermining, censoring, and blocking access to natural medicines like dietary supplements, which compete with drugs.

We must clean up this crony mess. 

Action Alert! Write to Congress and FDA and tell them to stop allowing drug companies to break the law. Please send your message immediately. 

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