Roy M. Poses MD Examines Pfizer's $2.3 Billion Pfine

By John Ballard

The aggregator is acting up so I picked a blog at random, Health Care Renewal, a group blog listing nine contributors, one of whom, Roy M. Poses, posts a comprehensive look at Pfizer, recently fined by the US Government over two billion dollars in the largest health care fraud settlement and the largest criminal fine of any kind ever. Dr. Poses is my nominee for Best Medical Muckraker Ever. I did a search and found he's been doing this kind of stuff for years. This guy's a bulldog and does not suffer fools lightly.

(That link to his close scrutiny of NIH and conflicts of interest is worth another post, but it's not timely...yet. I'm saving NIH for later. That's our tax dollars at work, folks, and they are the ones, NOT the drug companies' R&D labs, doing the most the important medical research. There was a time when their discoveries, being tax-supported and all that, were considered public domain. But certain influential people in Washington arranged to have those discoveries "auctioned" at "wholesale" rates so that private companies could patent them to squeeze maximum profits before they could be released to the great unwashed.)

The Pfizer rap sheet is unbelievably long. Dr. Poses refers to the company as recidivist in his headline. Sometimes I think we need a stronger word for people (or, in this case, companies) that stubbornly continue criminal behavior.

The activities for which Pfizer incurred the penalties included
marketing drugs for "off-label" indications for which the company did
not have US Food and Drug Administration (FDA) approval, and other
deceptive marketing practices (from the NYT).

The government charged that executives and sales representatives
throughout Pfizer�s ranks planned and executed schemes to illegally
market not only Bextra but also Geodon, an antipsychotic; Zyvox, an
antibiotic; and Lyrica, which treats nerve pain.

[Acting US Attorney for Massachusetts] Mr. Loucks, the prosecutor, accused Pfizer of aggressive marketing tactics.

'Among other things, Pfizer did the following: Pfizer invited
doctors to consultant meetings, many in resort locations. Attendees
expenses were paid; they received a fee just for being there,' he said.
Such weekend getaways for doctors are still common throughout the drug
and medical device industries.

Also, per the Newark Star-Ledger,

The government said the company promoted four prescription drugs,
including the pain killer Bextra, as treatments for medical conditions
different from those the drugs had been approved for by federal
regulators. Authorities said Pfizer's sales representatives often
created phony doctor requests for medical information in order to send
unsolicited information to doctors about unapproved uses and dosages.
  
The
civil settlement covered Pfizer's promotions of Bextra, blockbuster
nerve pain and epilepsy treatment Lyrica, schizophrenia medicine
Geodon, antibiotic Zyvox and nine other medicines. The agreement with
the Justice Department resolves the investigation into promotion of all
those drugs, Pfizer said.
  
The government said Pfizer also
paid kickbacks to market a host of big-name drugs: Aricept, Celebrex,
Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft and Zyrtec.

I recall the story when it was on the news last week, and the reader can find more details at the link, followed by a review of Pfizer's past violations. This is nothing new.

The meat of Dr. Poses' post is toward the end. 

This begs the question about why no people, save for two relatively low level managers, no individuals paid any penalties. The unethical behaviors listed above must have been implemented by scores of line personnel, lead by mid-level managers. They, in turn, were acting at the behest of a hierarchy of managers and executives, culminating in "C-level" officers, lead by the CEO. Finally, these executives all reported, in theory at least, to the board of directors.

So almost none of the people responsible for the unethical activities paid any penalty. No individuals had to pay fines, or even lose their jobs, much less face criminal proceedings. Maybe the apparent ability of company personnel, starting with those in the trenches, all the way up through levels of management to the CEO, and thence to the board of directors to act with impunity has lead to a culture of amorality.

A Culture of Amorality
Some evidence that the culture of the company is pathologic comes from former Pfizer insiders charged that the comany's culture promotes unethical behavior (from the NYT).

John Kopchinski, a former Pfizer sales representative whose complaint helped prompt the government�s Bextra case, said that company managers told him and others to dismiss concerns about the Neurontin case while pushing them to undertake similar illegal efforts on behalf of Bextra.

'The whole culture of Pfizer is driven by sales, and if you didn�t sell drugs illegally, you were not seen as a team player,' said Mr. Kopchinski

Also, per ABC News,

'At Pfizer, I was expected to increase profits at all costs, even when sales meant endangering lives,' Kopchinski said, in a statement. 'I couldn't do that.'

In light of the list of unethical behaviors documented above, that company leaders deny any big problems itself becomes a problem (from the NYT).

Amy W. Schulman, Pfizer�s general counsel, said that Pfizer had reformed � again.

'The reasons to trust Pfizer are because, as I have walked the halls at Pfizer, you would see that the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner,' she said.

Note that the majority of Pfizer employees may be ethical, but all it takes to accomplish unethical behavior is a few people in key leadership positions willing to direct unethical activities to increase sales and profits, and for their subordinates to be willing to just follow orders.

Hmm...

Where have we seen this before?

Something about "enhanced interrogation," maybe?

But I digress. The reason I hooked this story is a personal discovery last week of waste -- an expensive, avoidable, inexcusable waste. 

?Like hospitals and assisted living facilities, nursing homes go through a lot of prescription medications. I think hospitals, thanks to their size and resources, count pills using only what is needed by patients in accordance with physician orders. But I know from personal experience that assisted living and nursing home environments do not operate that efficiently. In those cases each resident's medication is individually handled and kept separate by nurses assigned to that specific job. Their rolling utility carts have drawers, shelves and storage systems to keep up with all they need to do the job. An assortment of cups, beverages and foods for mixing is available to make the medicine go down, along with a pill smasher, gloves, etc.

Chatting with the nurse in charge of the hall I was working, I mentioned the possibility of several doctors writing prescriptions for patients, often more than they might need.

She rolled her eyes and said "You just don't know. I see so much wasted medicine I can't believe it."

She went on to describe how the routine amount was a thirty-day supply when patients sometimes need only enough for a week. Pain pills are the easiest to get, she said. No doctor wants to make a patient be in pain. And once the need for one or two nebulizers was met with a shipment of five boxes. Of course most of this was billed to Medicare, so no one bothers to go to the trouble to correct it. 

?Last week Morning Edition aired A Medical Mystery: Why Health Care Is So Expensive, yet another piece on the expense of medicine. Chana Joffe-Walt was in a California cardiac surgery watching the doctor going through a variety of expensive medical devices, tossing them away like sponges when they were not perfect. 

The Cost Of Precision

And what happens to the stent that didn't look right? It goes back to the company, which throws it away.

Teirstein's hospital has a special deal with the stent manufacturer � the hospital doesn't have to pay for stents it doesn't use. But from an economic perspective, trashing stents raises the price of all stents, because the manufacturer has to factor in that cost.

In this single operating room, doctors might go through a dozen stents in a day. The rolling metal shelves are stacked with boxes of stents, with what amounts to piles of money.

Teirstein is casual not just with stents but with all his tools. When a tiny wire that looks like it belongs in a piano annoys him during the procedure, he gets rid of it. The wire costs $50.

Then a catheter doesn't sit right in an artery. He calls for another. "You really need a lot of tools to do this procedure," Teirstein says. "They're all kind of expensive. This catheter is probably about $60." It's just a piece of plastic, but it's an FDA-approved piece of plastic that has to bend in the right away and perform its role exactly.

It feels bizarre to stand here not as the patient and not as the doctor but as a sort of accountant. Teirstein goes through five of these $60 plastic tubes in an hour, and three of the $2,000 stents.

You might ask whether the stent needs to cost $2,000. Part of the answer is simply that it's critical to life. It's got to live inside a human being, next to the heart. It needs to be precise, and precision is expensive. Getting a new stent approved by the FDA costs millions of dollars. The $2,000 price lets the manufacturer recoup some of that expense.

The journalist was prudent enough not to mention it, but heart caths is on most lists of over-used procedures, ordered by the dozens instead of much less expensive medicines which in some cases would be more effective and less dangerous to the patient than the the procedure.

People in my peer group can recall when tonsillectomies were all the rage. When I was in elementary school kids getting their tonsils out was almost as common as braces on teeth today. (I say "almost" because I went to one elementary school where braces were a fashion statement. Out of forty or fifty kids, including one of my grandchildren, only two or three were unlucky enough to be born with perfect teeth.)

We are living in a time when most people imagine that everything is affordable. Did I mention living in a Fool's Paradise"?

?Two final anecdotes about waste, both harmless enough.

The Arm and Hammer people had a commercial a few years ago teaching consumers how to use their product for non-cooking applications. First, you put an open box into the refrigerator to help keep down unpleasant odors (this is for those who don't wrap up leftovers, I suppose) then from time to time (when stuff starts stinking anyway) toss it into the commode to balance the chemistry in the sewer! When I saw that commercial my first thought was trying to imagine how to sell more food by inspiring people to raise hogs so they could take more to slop their pigs.

Along the same lines when she was in assisted living my mother always seemed to need a lot more Efferdent tablets than I thought she needed. She only had a partial bridge with two or three teeth and I knew she sometimes even forgot to put them in to eat. When I mentioned this to my wife she said "I know what she's doing with them. She's putting them into the toilet. I showed her once how that was a good way to clean the ring out of the toilet without much work." Mystery solved. That piece of information plus Mom's short-term memory loss may have been costing one or two Efferdent tablets a day.

Don't you wish the nation's medical bills were as cheap and simple to solve as Mom's wasted Efferdent?