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Patients May Die When Doctors Moonlight as Big Pharma’s “Key Opinion Leaders”

Patients May Die When Doctors Moonlight as Big Pharma’s “Key Opinion Leaders”
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Written by Kathleen Sharp, Truthout

As the crimson sun slipped into the gray Pacific Ocean, a multibillion-dollar drug deal took shape. A group of board-certified doctors greeted each other in a private room at a luxury hotel in California. The oncologists were big buyers of an anti-anemia drug called Procrit, sold by Ortho Biotech, a Johnson & Johnson (J&J)  division. That Friday evening, the company toasted its top clients and their wives with bottles of Beaujolais, porterhouse steaks and free weekend accommodations.

The event could have been just another “grin and grip” affair, but there was a catch: J&J wanted to pump the sales of its biotech drug to beat its rival Amgen and its anti-anemia drugs. “The idea,” as J&J drug rep Dean McClellan later explained, “was to get the docs to increase their Procrit dosage to 40,000 units.”

There was just one problem. Regulators had approved a weekly drug dose of 30,000 units, and J&J was prohibited by the Food, Drug, and Cosmetic Act (FDAC) from marketing its drugs in unapproved ways. But the doctors could prescribe in any “off-label” manner they wanted. So, McClellan, a star rep and medical consigliere, led a “discussion” about high-dose experiments. Taking his cue, one physician explained how he routinely injected patients with 40,000 units of Procrit. Another oncologist pumped his people with 10,000 units for ten consecutive days – triple the approved amount. “That seems a little extreme,” said McClellan, frowning.

“Oh no,” the doctor said. “I haven’t seen any side effects so far.”

A few months later, Procrit sales hit the $1 billion mark, beating Amgen by a hair. The resort trip had certainly helped. But it was just one part of an expansive, long-running off-label marketing campaign, according to sales documents. Slowly but surely, oncologists around the country began administering so many high Procrit doses that, in time, the off-label therapy became the “community standard.”

There were problems since insurers don’t always reimburse doctors for off-label use. In fact, when Medicare refused to pay the Arizona Cancer Center, a huge client, for its high-dose Procrit injections, an Ortho manager ghost wrote a letter on behalf of its chief oncologist Daniel von Hoff. After a few more company calls – ipso presto! – the center began receiving more than $1 million in Medicare payments for the illegal therapy. As McClellan claimed in a whistleblowing suit, the cancer market grew so saturated with high doses, that six years later the Food and Drug Administration finally approved them.

The decision might have been defensible had the 40,000-unit regime had been proven to be safe and effective. But independent research later revealed that cancer patients died sooner than expected, and company trials found an alarming number of dialysis patients suffered strokes and heart attacks. Meta-studies showed that 17 percent of patients died from the drug, and stories told of blood counts so high, patients actually spit up blood and choked on their own tumors. Turns out there was little scientific evidence that Procrit, and its cousins Epogen and Aranesp, actually helped people at any dosage.

Last summer, regulators announced that the drugs should be avoided entirely by most patients. “It turns out many people are better off taking placebos,” said Dennis Cotter, president of Medical Technology and Practice Patterns, a nonprofit research institute.

What this illustrates is that drug companies can create entire cultures of over-prescribers for untested, even fatal indications, and that doctors can be easily corrupted. In light of a flurry of recent federal settlements for off-label marketing crimes, it also underlines how you, dear taxpayer, foot the bill for reckless marketing.

In the case of Procrit, the J&J unit formed advisory committees made up of academic physicians and clinical oncologists. These key opinion leaders (KOLs) were paid honoraria of at least $1,000 for every speech they delivered touting off-label use. McClellan selected some pliant clients to be the featured speakers. “Some guys wanted to give three or four speeches a weekend so they can get three or four thousand dollars,” he said. A few actually did. Many talks were delivered at company “conferences” organized for other doctors, who earned hourly credits toward their annual continuing medical education (CME) units, required by state licensing boards. As if that wasn’t enough, Ortho also paid physicians for their rooms, meals and transportation.

Ortho eventually assembled boards of KOLs who specialized in every type of cancer. According to sales documents, the goal was “to build thought leader endorsement [sic] to establish Procrit as standard of care,” not just for approved indications such as AIDs and chemotherapy, but for cancer-related fatigue, depression, and other off-label indications.

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Photo from harveyben via flickr

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25 comments

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5:29AM PST on Feb 14, 2012

This article sure makes you think.
My family doctor never gives samples and double checks all the medications I am already taking before he will prescibe anything new.

2:43PM PST on Jan 29, 2012

Very sad and disturbing indeed. Thx for posting.

2:02PM PST on Jan 29, 2012

In the UK we have a National Health Service (NHS) and for all its drawbacks, there are more checks and balances on this kind of capitalist exploitation. However, we do have similar pressure from pharmaceutical companies who try every trick in the book to push their products. The fact is that 90% of prescribed meds do not work as claimed. As a doctor I am ashamed and very angry at those who follow the same profession and yet betray a patient’s trust by this kind of unprofessional conduct. I hope more information becomes available as to exactly what is going on and those responsible be made an example of. Medicine does not need practitioners who place profit before people.

10:38AM PST on Jan 29, 2012

This has been going on for too long. I worked for private practice doctors for nearly 30 years.
We could not keep the Drug Reps (PIMPS) away. "Free samples, push this drug and we will
give you an all expense paid continuing education (Vacation) weekend in Aruba." Why are there no laws preventing this?

9:16PM PST on Jan 28, 2012

Ever notice how the medical profession has few curea but plenty of treatments?
Jerome Kassirer had it right in his book about doctors like this, who are on the take while denying the fact they sold out to do pharma's bidding.

4:14PM PST on Jan 27, 2012

Very disturbing.

2:03PM PST on Jan 27, 2012

scary...

10:31AM PST on Jan 27, 2012

This is sad. What a horrible breach of patients' confidence and trust. I understand many people become doctors for the money, and it is well-deserved in 99% of cases, but conflicts of interest like this should have to be disclosed on the office/practice door.

However, I will come right out and say that I disagree with the many people that say that they do not trust doctors in general. I agree I have had some doctors that have missed obvious diagnoses and that have generally not been able to treat me well, but there are still some very good people out there that also happen to be doctors.

5:06AM PST on Jan 27, 2012

This only adds to the list of reasons I no longer trust Doctors in general...

12:31AM PST on Jan 27, 2012

they probably sold the patients the drug that made them anemiac in the first place...

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