Monday, September 07, 2009

Pfour Legal Settlements for Pfizer - Why is the Company "Recidivist?"

We recently posted about Pfizer's $2.3 billion dollar settlement with the US government (here), which we first mentioned six months ago (here). It is worth reviewing what we know about this settlement. We will start with quoted from the article by Gardiner Harris writing in the New York Times. We will also use quotes from other articles listed below:

A Big Settlement

(from the NYT)

The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.

It was the largest health care fraud settlement and the largest criminal fine of any kind ever.
The penalties include a very large criminal fine, an even larger civil fine, and a corporate integrity agreement (from the NYT).

Under the agreement with the Justice Department, Pfizer will pay a $1.3 billion criminal penalty related to Bextra and $1 billion in civil fines related to other medicines. In addition, a Pfizer subsidiary, Pharmacia and Upjohn, will plead guilty to violating the Food, Drug and Cosmetic Act for its promotion of Bextra. The company has agreed to sign another corporate integrity agreement that requires senior company executives to annually certify legal compliance and mandates that Pfizer post on its Web site many of its payments to doctors.
For Specific Unethical and Illegal Activities

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.

Pfizer's Previous Unethical Behavior

Pfizer has previously been charged with unethical conduct, and the penalties it paid for this conduct did not seem to deter it (from the NYT).

It was Pfizer’s fourth settlement over illegal marketing activities since 2002.

'Among the factors we considered in calibrating this severe punishment was Pfizer’s recidivism,' said Michael K. Loucks, acting United States attorney for the Massachusetts district.

Much of the activities cited Wednesday occurred while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin, an epilepsy drug for which the company in 2004 paid a $430 million fine and signed a corporate integrity agreement — a companywide promise to behave.

Some more details of these settlements, from the Philadelphia Inquirer,

Repeat Offender: Previous Pfizer Settlements

April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.

October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.

On Health Care Renewal, we have posted about other instances of unethical behavior by Pfizer. Most recently, these included producing allegedly misleading direct to consumer (DTC) advertising about Lipitor (see post here), and conducting unethical research in Africa (see post here).

So it appears that Pfizer is, as the prosecutor put it above, recidivist. Why has the company repeatedly behaved unethically? One argument is that company executives have learned that the rewards of unethical behavior exceed its costs (thus, are responding to a form of perverse incentives.)

Perverse Incentives Favoring Unethical Behavior

The fines paid by Pfizer were not that large for a company of Pfizer's size (from the NYT).

While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.

In lieu of other punishments, the company's managers may just look upon paying fines as the cost of doing business. Per ABC News,

Industry insiders say drug companies often forgo legal considerations in favor of profit.

If companies, people or entities 'are able to make that decision and determine that there's an economic incentive to break the law, they'll break the law,' said Reuben Guttman, attorney for Glen Demott, a former Pfizer drug representative.

Change in a financially driven industry depends on whether a few billion dollars of penalty will affect the company's net profits or share costs. In 2008, Pfizer earned $48.3 billion in revenue.

Bloomberg commentator Ann Woolner said one reason the penalties have not been stiffer is that somehow the government views the company as too big to fail.

So how does Pfizer get away with civil settlements given its history? The penalties have ranged from hand slaps to a light punch in the gut, none of which have hurt the company enough for things to change. Last year Pfizer earned $8.1 billion on sales of $48.3 billion.

The New York-based company repeatedly winds up as the target of government accusations. Its misdeeds cost federal and state programs hundreds of millions of dollars, says the Justice Department, not to mention the human suffering that comes with taking the wrong drug in the wrong dosage.

But Pfizer is the pharmaceutical equivalent of insurance giant American International Group Inc., which was too interwoven into the global economy to be allowed to fail. Likewise, if Pfizer were convicted of a crime, it would face debarment from federal programs. And that would mean that Medicaid and Medicare patients would have to either somehow pay pocket for vital medicines the company produces or go without.

'You have to balance the desire, an appropriate desire, to punish the company against the harm to patients,' says attorney Kelton.

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 willingo to direct unethical activities to increase sales and profits, and for their subordinates to be willing to just follow orders.

Also, per a report in Bloomberg News, Ms Schulman added,

This gives us a very important opportunity to put final closure on the universe of material open items involving our U.S.-based operations.

This is a significant opportunity because it allows Pfizer to return its attention to the things that really should matter most to a biopharmaceutical company, which is the practice of developing innovative medications and bringing them to market in an appropriate fashion.

Summary: What is to be Done?

So will even a $2,300,000,000 settlement and yet another corporate integrity agreement make Pfizer or any other health care corporation act more ethically? I doubt it.

Remember, Pfizer may be a corporation, and thus be before the law a sort of pseudo-person. However, it is not really a person.

In this settlement, like others before it, it was people who implemented the behavior, made the decisions which lead to the behavior, and condoned the behavior. The people involved ranged from those in the trenches, through layers of management, to C-level executives, to the board of directors. In my humble opinion, until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior.

Finally, I say again that we cannot improve health care until we address this sort of unethical behavior. As reported by ABC News,

'It won't make a dent if the conduct that led to the settlement is not addressed as part of health care reform,' said [Harvard Medical School faculty member Dr Jon]Abramson, who was the expert consultant for the plaintiff attorneys in the Bextra case in 2007.

'The real problem is this behavior is not isolated to Bextra nor Pfizer but in essence is the way the pharmaceutical industry expands the sales of its drugs,' Abramson said. 'Unless health care reform can address misrepresentations, withholding science and control claims made to consumers, Americans will continue to pay too much for health care that is not as effective and is expensive.'

PS - According to Bloomberg commentator Ann Woolner, one of the whistle-blowers in this case was a physician who noticed that a Pfizer drug representative was pushing him to use drugs off-label,

Pfizer Inc. sales folks had one tough customer in psychiatrist Stefan Kruszewski. He didn’t buy their pitch to prescribe the anti-psychotic drug Geodon to children, a use that hadn’t been approved by federal regulators.

Nor did he go for the so-called off-label uses they suggested, such as treating dementia in the elderly.

Kruszewski didn’t just say no. He went and checked the research and saw Geodon could have serious cardiac side effects not mentioned by the salesmen, who boasted of its relative safety, according to his lawyer, Brian Kenney. And he noticed that Pfizer was paying his peers to promote the drug to other psychiatrists.

But the worst for Pfizer was that Kruszewski didn’t keep it to himself. He found a lawyer, Kenney, who specializes in whistleblower cases, and they took what they had to the government.

So to all you physicians out there, this shows that you can succesfully blow the whistle on unethical practices by health care organizations. And you may even make some money doing so. Apparently several of the whistle-blowers in this case will get sizable payments under the US False Claims Act.

ADDENDUM (8 September, 2009) - See also comments by Alison Bass on the Alison Bass Blog, and by Dr Howard Brody on the Hooked: Medicine, Ethics and Pharma blog.


Anonymous said...

Who blew the whistle?

Administrators/executives: 20%
Other Employee: 21%
Unaffiliated auditor/consultant: 12%
Physician: 12%
Other health care provider: 10%
Internal accountant: 10%
Sales rep: 9%
Pharmacist: 3%
Patient 2%

Kesselheim and Studdert, 2008

Anonymous said...

Well stated.

Those listening to sales pitches by the HIT vendors may be able to hunt big game. It is in their sights and range.

Pharma Giles said...

Great article.

Pfizer's problem is a cultural one, of that there is no doubt, and it's a culture that has become the industry norm.

Success in any company activity, be it sales or research, is completely target-driven. If you don't hit your target, you don't get rewarded, simple as that.

Good work that goes nowhere is of no interest to anyone in charge, hence the death of research creativity. It's a system that rewards the ambitious, the plagiarists and the liars - just the sort of folk who become senior managers, in fact - and the ones who set the targets for others.

It's a bean-counting, bottom-line mentality devised by the lawyers and accountants who run the show, and an HR department who have been instructed to use (and take pleasure in using) "low performance" as an easy way to domwnsize staff and cut "headcount" costs.

And of course, anyone who speaks out against the amorality and ultimate futility of it all is punished - after all, those who have profited by the toxic environment they work in are hardly likely to want it to change. It's a self-perpetuating situation.

Fines aren't the answer - companies like Pfizer just regard them as a cost of doing business, as has been shown.

Instead, those responsible for illegal behaviour must be held personally accountable for it. A few reasonable jail terms for middle to senior Pfizer executives (past and present) would soon catalyse a change in corporate culture, maybe even to the extent that the company could start to discover its own drugs again instead of parasitizing smaller companies.

Pfizer executives have enjoyed an era of juicy carrots. Time for the big stick..

Anonymous said...

If Phizer was truly reforming, it would take disciplinary action against those employees who were involved in illegal conduct that gave rise to this 2.3 billion dollar settlement. It would further announce a very specific plan of reform and bring in outside auditors to insure complaince. I have read several of whistleblowers complaints that have been unsealed. They are specific. They name names, dates and very specific illegal acts.
At the time these illegal activities were occuring, Phizer was under a consent decree that required it to report to the federal government any internal reports of illegal activities. The whistleblowers allege that they did report illegal activity that should have triggered mandatory reporting and that Phizer did not comply with the reporting requirements.
Nothing in the news reports that I have read suggests that Phizer is viewing this settlement as anything other than a cost of doing business.

InformaticsMD said...

Pharma Giles wrote:

It's a bean-counting, bottom-line mentality devised by the lawyers and accountants who run the show

And the dishonesty will likely get worse as pipelines inevitably get thinner under the mismanagement inflicted by this culture.