(April 7, 2020) — It’s a fair question: How does a cancer threat drug like Belviq get FDA approval? Belviq was pulled from the market last month after it was found by FDA to raise the risk of cancer – specifically pancreatic cancer, colorectal cancer, and lung cancer. Something is clearly amiss at FDA when it has to recall an approved drug for a cancer threat. It is one more example which shows how the agency tends to err on the side of drug companies.
Belviq was a very marginal drug, anyway, with minimal benefits. So how did it get approved in the first place? We have to look at the “evolution” (or devolution) of the FDA to understand how.
Every year, the FDA approves more and more pharmaceutical drugs, as well as dubious vaccines – such as Merck’s Zostovax shingles vaccine – which end up being pulled from the market. It is more than fair to ask, “Why does the agency so often err on the side of corporate profit at the expense of the people who take these drugs?”
Magic Bullet Drug Dream
Part of that reason, of course, is our own fault. We all want to believe in a magic bullet drug. We want to believe that we can be saved or “improved” with the latest technology. We have a strange inclination, even a prejudice, to imagine that the latest technology, whatever it is, must be good, if only by “virtue” of its being newer. We are, most of us, oddly wired to believe that what is newer must be improved, must be better than what we had yesterday. And if there’s a lot of money behind the production — and we know there’s a lot of dough behind drugs — then we, most of us, anyway, tend to believe the new thing must be good. As John Lennon said, “Money doesn’t talk, it screams.”
We hope, we believe, often with a strange religious fervor of which we aren’t even consciously aware, that scientific geniuses are working hard to save us, to make something (even us!) better today than yesterday. We know that drug companies spend a lot of money testing drugs, so how could new drugs not be better than old ones, or better than no drugs at all?
Can we Trust Drug Safety Studies?
The only way to get a drug approved is to first study it. But how can we trust the studies when a huge number of the drugs FDA has approved through the years – like the diet drug Belviq – have been later pulled from the market? Even CNN, a steady friend to all things corporate (though the most busted name in news), reported in 2017 on a study that showed 30 percent of FDA approved drugs from 2001-2010 later ran into some type of safety problem.
An author of the study — Dr. Nicholas S. Downing of Brigham and Women’s Hospital in Boston — said, “[W]ith all new drugs and technology (an) ongoing learning process (will) continue through the lifetime of the drug.”
The study noted that most of the drugs were tested on 1,000 or fewer patients before FDA approval. In the real world, drugs hit a wider population, said Downing, which means more problems occur. So scientists need to continuously test drugs to make sure they work with a wide range of variables. [Do you think?]
In plainer language, all these drugs (and vaccines) are experimental, because everyone is different. No two human beings are exactly alike. All are bound to have different reactions in the Faustian bargain we make when we consent to become a part of any drug or vaccine experiment.
Drugs more quickly approved are not “First in Class”
CNN also points to a 2015 independent analysis of drugs approved using the accelerated processing time that drug company lobbyists “coaxed” Congress and FDA into approving. The study found the trend toward faster approval “is being driven by drugs that are not first in class and thus potentially are less innovative.”
In a word, the scandalous drug history we know shows profits are considered to be more important than people where drug approval, as well as the highly lucrative vaccine market, are concerned.
Other studies have showed that some drugs approved using this quicker process had a large number of adverse events that required additional warning labels.
Downing said the new study is a good argument for continuous monitoring of the safety of drugs “throughout their life cycle.”
Indeed. The doctor might have added that fewer of us might consent to be a part of the great big experiment if given all the relevant risk-benefit analysis up front, not after the dubious drug has been pulled from the market.
FDA approves Cures Worse than the Disease
NPR has also shown FDA increasingly approves drugs without conclusive proof that they work.
Nuplazid was a drug approved for hallucinations and delusions associated with Parkinson’s. It failed two clinical trials, then showed minimal benefits in a third trial run under a revised standard for measuring its effect. NPR reported: “Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment.”
Patients who took Uloric for gout suffered more heart attacks, strokes, and heart failure in two out of three trials than did those in a control group who took standard gout meds or no medication at all.
The U.S. FDA approved both those deadly drugs. Uloric’s maker reported in November 2017 that patients on Uloric were 34 percent more likely to die from heart disease than people taking an alternative gout medication. FDA fast-tracked approval of Nuplazid. It hit the market in 2016 for $24,000 a year. About a year later, there were 6,800 reports of adverse events for people on Nuplazid, including 887 deaths as of March 31, 2017.
How does Cancer Threat Belviq get FDA approval?
Today, the FDA increasingly green-lights expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. We know that in the case of Nuplazid, Uloric, Vioxx, and now Belviq, that the “cure” is worse than the disease.
Meanwhile, the FDA increasingly green-lights expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they even curb, much less cure, any disease. It’s not all the agency’s fault. While its funding has been cut, FDA has been roundly attacked for years — by drug company lobbyists and elected politicians loyal to Big Pharma campaign “contributions” – for not approving drugs fast enough.
Responding to that great pressure to increase drug company profits, the FDA today reviews and approves drugs faster than any other regulatory agency in the world. That was also the case even before the orchestrated attacks on the agency’s reputation. On average, from 2011 to 2015, the FDA reviewed new drug applications more than 60 days faster than the European Medicines Agency.