HEALTH

The Fraud Behind Some Of The Most Common Prescription Drugs

HEALTH
Feb 10, 2015 at 12:21 PM ET

“Find fraud.”

That was the vague and intimidating order from my journalism school professor—and, actually, our very first homework assignment. I expected to spend my weekend digging through old FDA databases, hopefully managing to pull one example of real fraud from a mess of redacted, spurious warning letters.

But as it turned out, it was almost too easy.

The problem wasn’t finding fraud—it was deciding which heinous act of straight-up medical chicanery to use. Blatant dishonesty had tainted thousands of medical studies. I found clinical trials with fake patients, doctors who never bothered obtaining consent, forgeries and cover-ups galore. The FDA database was a veritable “who’s who” of dirty researchers.

My former professor, Charles Seife, published a few of my classmates’ findings this week in the Journal of the American Medical Association. My name is buried somewhere near the bottom of the study (no hard feelings, professor). Seife writes that he, too, was blindsided by the sheer volume of fraud in supposedly legit medical studies:

Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wild video. It’s a seemingly endless stream of lurid vignettes. …Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.

In fact, many acts of medical fraud go virtually unreported. The FDA keeps a database of dirty researchers, sends out nasty letters to the guilty parties and occasionally levies a fine or two. But the tainted studies themselves often remain in the medical literature without official retractions. Drugs are approved and prescriptions are filled by unknowing patients, all on the false premise that there’s honest research to back them up.

Seife’s study examines some of the dirtiest cases in detail. Here are three of my personal favorites:

Case 1: An Amputation Cover-Up

The Treatment: A new stem cell therapy that promises to restore blood flow in damaged legs.

The Claim: All 26 patients in the study reported “no significant clinical changes” in either of their legs, beyond those caused by the stem cell treatment.

The Fraud: FDA documents show that one of the patients had an entire foot amputated two weeks into the study. That’s a pretty serious omission, and it definitely constitutes a “significant clinical change” in the leg. No one bothered to correct or retract the faulty study, and the trial was considered a success.

Case 2: “Systemic Discarding of Medical Records”

The Treatment: A new heart medication that promises to help prevent strokes and blood clots.

The Claim: The drug, Xarelto, is safe and effective.

The Fraud: One of the studies behind Xarelto was so rife with fraud that the FDA officially deemed it unreliable. The agency cited falsification, improper randomization and “systemic discarding of medical records.” None of this appears in the medical literature, and Xarelto is currently on the market. (Xarelto clarified that their drug’s approval was based on three other trials — which were presumably less fraudulent.)

Case 3: Criminally Negligent Homicide

The Treatment: An old chemotherapy used to treat multiple new cancers.

The Claim: The chemotherapy, Docetaxel, is effective against several different types of tumors.

The Fraud: Two researchers behind a major Docetaxel trial admitted to falsifying lab results and masking one cancer patient’s deteriorating kidneys and liver. After the patient died mid-trial, one of the scientists had to pay a substantial fine and the other was sentenced to 71 months in prison. None of the subsequent Docetaxel studies mention the fraud, and the chemo is currently on the market.

The FDA’s Role in Scientific Fraud

After reviewing these studies, I remember feeling disenchanted. How could there be so much fraud in the medical literature? For Seife, though, the greatest offense was not that researchers lie—but that the FDA, for all its bluster, does so little to alert the public when fraud strikes.

Usually the FDA justifies its redactions and omissions by arguing that the specific details of fraudulent studies could hurt the drug companies. By law, the FDA is allowed to conduct investigations only on the condition that they ensure, through copious redactions, that trade secrets do not make it to the public. But that doesn’t explain why the FDA hasn’t found a legal way to get the word out. Besides, the FDA is supposed to protect the public. Why, then, does the agency seem to always put the reputations of major drug companies first?

“The FDA has repeatedly hidden evidence of scientific fraud,” Seife writes. “For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.”