Wednesday, November 10, 2010

"This is Really Going to Set People's Hair on Fire" - the Justice Department Indicts a Pharmaceutical Company Vice President and Associate General Counsel

We have been posting nearly every week about the parade of legal settlements, sometimes including guilty pleas to criminal charges, made by health care organizations.  The settlements have involved charges of kickbacks, fraud, conspiracy, and other colorful offenses. Most of these settlements entailed fines or other payments by the organizations that may seem huge, but were fractions of the amounts made by the practices that lead to the charges that were settled.  Almost never have the cases involved penalties for any individuals who authorized, directed, or implemented the misbehavior.  We have also been saying (seemingly endlessly, but most recently here) that such settlements may be viewed by organizations as merely the costs of doing business, and so until the actual people who were involved in the bad behavior suffer some negative incentive or penalty, expect the behavior to continue. 

Maybe things are changing.  In the New York Times, Duff Wilson wrote:
In a rare move, the Justice Department on Tuesday announced that it had charged a former vice president and top lawyer for the British drug giant GlaxoSmithKline with making false statements and obstructing a federal investigation into illegal marketing of the antidepressant Wellbutrin for weight loss.

The indictment accuses the Glaxo official, Lauren C. Stevens of Durham, N.C., of lying to the Food and Drug Administration in 2003, by writing letters, as associate general counsel, denying that doctors speaking at company events had promoted Wellbutrin for uses not approved by the agency. Ms. Stevens 'made false statements and withheld documents she recognized as incriminating,' including slides the F.D.A. had sought during its investigation, the indictment stated.

An Associated Press story provided more detail about the allegedly false statements:
The Department of Justice alleges that in 2002, Lauren Stevens of Durham, N.C., signed several letters to the Food and Drug Administration denying that her company had promoted an antidepressant drug for unapproved uses. But Stevens knew that the company had paid numerous physicians to give talks touting unapproved uses of the drug, including weight loss,....

In one instance, prosecutors say Stevens withheld slides used by physicians promoting the company's drug, even though the FDA had asked specifically for the materials. Stevens claimed that the company's response to the FDA was 'final' and 'complete,' according to the indictment.

Stevens also falsely denied that Glaxo had paid doctors to attend special sessions where medical experts discussed unapproved uses of Wellbutrin, according to the Department of Justice.

'Attendees were not paid, reimbursed or otherwise compensated to attend these events,' Stevens wrote in a 2003 letter to the FDA. But prosecutors say attendees received gifts, entertainment and other compensation in return for attending the events.

During 2001 and 2002, Glaxo paid two expert physicians to speak about 500 times each about Wellbutrin, including how to use the drug to treat obesity.

In addition, a CBS News story suggested that Ms Stevens was made aware of the nature of the information withheld:
In March of 2003, the indictment alleges, Stevens received a memo from other lawyers at GlaxoSmithKline analyzing the pros and cons of turning over the slides to the FDA. One of the cons listed in that memo was that turning over the slides would provide 'incriminating evidence about potential off-label promotion of [the drug] that may be used against [the corporation] in this or in a future investigation.'

An indictment of an individual, particularly a high-ranking corporate executive, seems to have gotten people's attention, e.g., as Duff Wilson wrote in the Times:

The indictment grabbed the attention of pharmaceutical executives who have been bracing for a long-promised government crackdown on company officials — rather than the corporations themselves — in drug-fraud cases that have resulted in billions of dollars in fines and payments.

'This is absolutely precedent-setting — this is really going to set people’s hair on fire,' said Douglas B. Farquhar, a Washington lawyer who recently presided at a panel on law enforcement during a drug industry conference where federal officials warned they were focusing on individuals. 'This is indicative of the F.D.A. and Justice strategy to go after the very top-ranking managing officials at regulated companies.'

My response is, of course, that the threat of this sort of action is absolutely what is needed to deter future bad behavior by health care organizations. As long as health care leaders could act with impunity, the fraud, kickbacks, conspiracy etc were continuing. Worse, given their impunity, why would anyone but an idealistic fool attempt to swim against the tide of rising sleaze in health care?  How could skeptics and critics of the status quo in health care gain any traction?

Now maybe this sort of action may finally lead self-satisfied, unreflective health care executives to think about what they are doing and its ethical and moral aspects. The NY Times article included this statement in defense of Ms Stevens:
Brien T. O’Connor, a lawyer with Ropes & Gray, said in a statement, 'Lauren Stevens is an utterly decent and honorable woman. She is not guilty of obstruction or of making false statements. Everything she did in this case was consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer specifically because of its experience in working with F.D.A.'

I actually would guess that Ms Stevens believes she did nothing wrong. I would guess that most of the numerous health care leaders who have been caught up in bad behavior also thought they did nothing wrong. After all, they were all very well paid, lived in nice houses in nice neighborhoods, drove fancy cars (when they did not have a paid car and driver), were respected in their communities, did charitable works, etc. How can fine people who look so respectable do anything wrong? But, of course, the veneer of respectability does not prevent unethical or immoral behavior. Making one's numbers, getting one's bonuses, all from doing the big boss' wishes do not certify one's actions as ethical or moral. Perhaps making corporate health care leaders actually accountable for their actions will lead them to think about whether their actions are really as upstanding as their accoutrements of social status make them feel.

My final comment is that it may be significant that this case involved a lawyer. On one hand, attorneys have been at the forefront of what little movement there is to improve the accountability, integrity, and transparency of health care organizations. On the other hand, the leadership of many health care organizations have lawyered up to defend their actions. Organizational lawyers have been known to sweet-talk, obfuscate or intimidate those who dare to criticize the organizational leaders' actions. Anyone who is a vocal skeptic of the powers that be in health care must know there is a constant risk of some corporate counsel or hired firm threatening a libel, slander, or tortious interference action. Any individual who dares to be skeptical must be worried that the leaders of large health care organizations can use a lot of other peoples' money to pay for lawyers to push such actions, while individual skeptics facing threats of suits for huge amounts of damages are not likely to have enough money of their own to keep fighting. So I hope that the current case will also push attorneys who make a lot of money protecting the status quo in health care to reflect on the ethics and morality of what they are doing.

ADDENDUM (10 November) - Also see comments by Prof Margaret Soltan on the University Diaries blog.


Anonymous said...

I have to view this piece from the perspective of pharma’s over riding message: Drugs are good, why are you not taking more drugs?

We see this being played out in the WSJ Health Blog posting:

November 9, 2010, 9:43 AM ET
Prehypertension Sparks Some High-Pressure Debates

The issue raised is should slightly elevated blood pressure be treated with drug therapy?

We then learn:

“August of this year, an article in the British Medical Journal noted that in the wake of the new classification, prehypertension is emerging as a potential goldmine for drug companies, and pointed out that many physicians who were members of the committee have disclosed financial relationships to industry.

One of the committee members named in the article is George Bakris, director of the Hypertension Center at the University of Chicago, who has disclosed consulting arrangements with several drug companies. Bakris, for his part, tells the Health Blog that the committee’s decision had nothing to do with drug-company interests, and was meant to educate and empower patients.

At the time the committee was finalizing its recommendations, he says, new studies were showing that cardiovascular risk starts climbing at blood-pressure readings of 115/75, not 140/90. And starting at 115/75, the risk doubles for each 20 mm Hg increase in systolic pressure and each 10 mm Hg increase in diastolic pressure.”

Once again we find fear mongering for profit in the drug industry. Important to note is that a blood pressure medication will not be prescribed alone. We would also see a statin and an ED drug (wink, wink) given in combination. This will also drive doctor visits as now with a heart condition you simply must be seen every 90 days for a BP reading and have a blood draw due to the statin.

We have recently seen calls for essentially eliminating the FDA for withholding drugs the drug companies felt were necessary for our survival. We have also seen calls for the elimination of all requirements for disclosure of conflicts of interest in the belief all of these people are only doing what is best for us.

My reality is this is an industry out of control and only strong enforcement action will bring some semblance of reliability back to it. This prosecution should only be a first step in this process.

Steve Lucas

Live it or live with in said...

I was hoping you'd mention this story. Lawyers are mostly the problem. They cover for the other bad actors, and claim it is ethical for them to do so using any method because they owe their client the best service. Even apparently if that means lying, destroying evidence, eliminating whistleblowers, cheating, and getting tough with good folk.

It sickened me to watch a health system get taken over by business lawyers.

Lets hope the Obama administration understands that this is what is needed in at least the two years it has left. With some more inditements and even a conviction or two there would be a new support for Obama and his folks.

In some ways, it is the only power he has left.