Princess Health and Questionable Deliberations on the Vagus Nerve Stimulator to Treat Severe Depression. Princessiccia

Princess Health and Questionable Deliberations on the Vagus Nerve Stimulator to Treat Severe Depression. Princessiccia

Cyberonics FDA

Gusty 15:01 Add Comment

The NY Times reports on the curious deliberations by a US Food and Drug Administration (FDA) expert advisory panel on the approval of an implanted vagus nerve stimulator as a treatment for severe depression. The committee was informed about the results of a randomized controlled trial which, as far as I can tell after several PubMed searches, has not yet been published.
The Times reports the trial showed that 17/111 patients who had the stimulator implanted and turned on had improvements in "standard measures of disease severity," while 11/110 who had it implanted, but not turned on also improved. This small increase in the likelihood of improvement was not statistically significant, i.e., could have been due to chance alone, rather than be an effect of the device. Furthermore, the absolute benefit increase implied by these data is at most 4.3%. That is, were 100 people to get the device, this data implies only 4 of them might improve because of it, while the rest would either not improve, or would have improved even without it.
Nonetheless, after hearing some emotional testimonials by patients who claimed that the device helped them, the advisory committee voted to make the device "approvable." The panel's chair, Dr. Kyra Becker, said "the feeling was that anything that gives these people hope is potentially worthwhile." However, one dissenter, Dr. Richard Malone, was bewildered by the panel's decision, "I walked out of there thinking I was nuts. It was stunning, but then I find much of life stunning."
The FDA does not have as rigorous standards to approve devices as those to approve drugs. However, when a device costs $15,000, is invasive, cannot be easily removed, and at best seems as if it may help only a small minority of patients, as is the case for the vagus nerve stimulator, the wisdom of these relatively lax standards comes into question.
Another question is why a scientific advisory committee, staffed ostensibly by medical experts, seemed more attentive to testimonials than to the results of a randomized controlled trial. Perhaps we will get some answers from an investigation by the Senate Finance Committee, which apparently is ongoing.

Princess Health and Questionable Deliberations on the Vagus Nerve Stimulator to Treat Severe Depression.Princessiccia

Princess Health and Questionable Deliberations on the Vagus Nerve Stimulator to Treat Severe Depression.Princessiccia

Cyberonics FDA

Gusty 15:01 Add Comment

The NY Times reports on the curious deliberations by a US Food and Drug Administration (FDA) expert advisory panel on the approval of an implanted vagus nerve stimulator as a treatment for severe depression. The committee was informed about the results of a randomized controlled trial which, as far as I can tell after several PubMed searches, has not yet been published.
The Times reports the trial showed that 17/111 patients who had the stimulator implanted and turned on had improvements in "standard measures of disease severity," while 11/110 who had it implanted, but not turned on also improved. This small increase in the likelihood of improvement was not statistically significant, i.e., could have been due to chance alone, rather than be an effect of the device. Furthermore, the absolute benefit increase implied by these data is at most 4.3%. That is, were 100 people to get the device, this data implies only 4 of them might improve because of it, while the rest would either not improve, or would have improved even without it.
Nonetheless, after hearing some emotional testimonials by patients who claimed that the device helped them, the advisory committee voted to make the device "approvable." The panel's chair, Dr. Kyra Becker, said "the feeling was that anything that gives these people hope is potentially worthwhile." However, one dissenter, Dr. Richard Malone, was bewildered by the panel's decision, "I walked out of there thinking I was nuts. It was stunning, but then I find much of life stunning."
The FDA does not have as rigorous standards to approve devices as those to approve drugs. However, when a device costs $15,000, is invasive, cannot be easily removed, and at best seems as if it may help only a small minority of patients, as is the case for the vagus nerve stimulator, the wisdom of these relatively lax standards comes into question.
Another question is why a scientific advisory committee, staffed ostensibly by medical experts, seemed more attentive to testimonials than to the results of a randomized controlled trial. Perhaps we will get some answers from an investigation by the Senate Finance Committee, which apparently is ongoing.

Princess Health and Jacobi Hospital's Executive Director Fired. Princessiccia

Princess Health and Jacobi Hospital's Executive Director Fired. Princessiccia

Jacobi Hospital Mismanagement

Gusty 14:55 Add Comment

Another quick follow-up on the story about Jacobi Hospital's failure to notify patients about abnormal pap smear results.
The NY Times reports that in an unusually fast response, the hospital's executive director and deputy director of nursing services have been fired. The hospital's chief operating officer (COO) and medical director have received disciplinary warnings.
Coincidentally, the NY Daily News noted that the hospital's executive director was previously employed at Staten Island University Hospital, which has just settled its second big case of Medicaid fraud.

Princess Health and Jacobi Hospital's Executive Director Fired.Princessiccia

Princess Health and Jacobi Hospital's Executive Director Fired.Princessiccia

Jacobi Hospital Mismanagement

Gusty 14:55 Add Comment

Another quick follow-up on the story about Jacobi Hospital's failure to notify patients about abnormal pap smear results.
The NY Times reports that in an unusually fast response, the hospital's executive director and deputy director of nursing services have been fired. The hospital's chief operating officer (COO) and medical director have received disciplinary warnings.
Coincidentally, the NY Daily News noted that the hospital's executive director was previously employed at Staten Island University Hospital, which has just settled its second big case of Medicaid fraud.

Princess Health and Is the adversary model the answer?. Princessiccia

Princess Health and Is the adversary model the answer?. Princessiccia

Gusty 13:13 Add Comment

In his post of Wed 18 May, Roy Poses commented on the PLoS article by former BMJ editor Richard Smith opining that medical journals have been co-opted into Big Pharma's marketing system. Coincidentally, the BMJ reports that the CEO of Merck has resigned, in a move widely seen as a response to the increasingly damaging disclosures about Merck's marketing of Vioxx (though Merck of course denies any connection).

Merck's campaign for marketing Vioxx was clearly a campaign of deliberate deception, with intensive training of detail reps in specific techniques for misleading physicians about the benefits and concealing the risks of the drug. Should we be surprised? No, not really. Consider what is at stake for any drug company marketing a new agent. Hundreds of millions of dollars have gone into its development. Even though the company itself probably hasn't paid for much if any of the actual basic science or discovery, the development of someone else's discovery to marketability costs a bloody fortune. There's no predicting whether it'll be a big seller, a market mediocrity, or a fiasco that proves dangerous but only after all the costs are incurred.

When big money is at stake, people will lie. It's human nature. Are they "bad people"? No, they're people. As the Milgrom experiment and others showed, and WWII gruesomely illustrated, the majority of people can convince themselves that literally anything - no matter how abhorent - is OK. We vastly underestimate in our usual thinking how readily people will believe what's in their interest to believe. Not just a few "bad apples", but the majority of normal people. Further, those few who are squeamish about fibbin' a bit in marketing the product are selected out at low rungs on the corporate ladder in Big Pharma. The upshot is that we just plain have to assume that Big Pharma will lie. Not because they're evil, but because they're humans in a system where extremely strong incentives exist to do so.

So what do we do? Well, we could propose that drug development be placed in the hands of neutral foundations or some similar arrangment that divorces self-interest from the product. Personally, I doubt that will work well though. The nice thing about self-interest is that it really motivates people. Only self-interest will reliably make the majority of people really work hard. Folks just naturally coast a bit if they don't have skin in the game. (You don't need to point to the economic failure of communism to illustrate that point; just check out any organization that has no competitors. Go down to the Secretary of State's office to get your driver's license paperwork, for example.)

So it's time we formally and clearly recognized that doctors and their patients vs. Big Pharma is an adversary relationship. Like prosecutors and defense attorneys, we need each other and society needs us both, but like any good defense attorney we're nuts to trust anything the prosecutor says. (The metaphor is apt, sadly, as the shocking number of falsely convicted men freed from death row or life imprisonment over the last decade demonstrates.) If we want to do the best for our patients, we need to behave adversarially toward Big Pharma. Don't socialize; assume an ulterior motive; if given a paper "proving benefit" look for how it might have been fudged or find out how many negative papers are being kept out of view; never believe industry-funded clinical trials; assume risks are being downplayed and benefits overplayed.

An adversary relationship will put a real crimp in the incomes of quite a few physicians who are used to taking drug money. It'll also raise some serious financing issues for CME, but it's time those came out on the table anyway. Patients deserve much more aggressive protection of their interests than our profession's cozy relationship with Big Pharma has provided. Time to un-cozy.

Princess Health and Is the adversary model the answer?.Princessiccia

Princess Health and Is the adversary model the answer?.Princessiccia

Gusty 13:13 Add Comment

In his post of Wed 18 May, Roy Poses commented on the PLoS article by former BMJ editor Richard Smith opining that medical journals have been co-opted into Big Pharma's marketing system. Coincidentally, the BMJ reports that the CEO of Merck has resigned, in a move widely seen as a response to the increasingly damaging disclosures about Merck's marketing of Vioxx (though Merck of course denies any connection).

Merck's campaign for marketing Vioxx was clearly a campaign of deliberate deception, with intensive training of detail reps in specific techniques for misleading physicians about the benefits and concealing the risks of the drug. Should we be surprised? No, not really. Consider what is at stake for any drug company marketing a new agent. Hundreds of millions of dollars have gone into its development. Even though the company itself probably hasn't paid for much if any of the actual basic science or discovery, the development of someone else's discovery to marketability costs a bloody fortune. There's no predicting whether it'll be a big seller, a market mediocrity, or a fiasco that proves dangerous but only after all the costs are incurred.

When big money is at stake, people will lie. It's human nature. Are they "bad people"? No, they're people. As the Milgrom experiment and others showed, and WWII gruesomely illustrated, the majority of people can convince themselves that literally anything - no matter how abhorent - is OK. We vastly underestimate in our usual thinking how readily people will believe what's in their interest to believe. Not just a few "bad apples", but the majority of normal people. Further, those few who are squeamish about fibbin' a bit in marketing the product are selected out at low rungs on the corporate ladder in Big Pharma. The upshot is that we just plain have to assume that Big Pharma will lie. Not because they're evil, but because they're humans in a system where extremely strong incentives exist to do so.

So what do we do? Well, we could propose that drug development be placed in the hands of neutral foundations or some similar arrangment that divorces self-interest from the product. Personally, I doubt that will work well though. The nice thing about self-interest is that it really motivates people. Only self-interest will reliably make the majority of people really work hard. Folks just naturally coast a bit if they don't have skin in the game. (You don't need to point to the economic failure of communism to illustrate that point; just check out any organization that has no competitors. Go down to the Secretary of State's office to get your driver's license paperwork, for example.)

So it's time we formally and clearly recognized that doctors and their patients vs. Big Pharma is an adversary relationship. Like prosecutors and defense attorneys, we need each other and society needs us both, but like any good defense attorney we're nuts to trust anything the prosecutor says. (The metaphor is apt, sadly, as the shocking number of falsely convicted men freed from death row or life imprisonment over the last decade demonstrates.) If we want to do the best for our patients, we need to behave adversarially toward Big Pharma. Don't socialize; assume an ulterior motive; if given a paper "proving benefit" look for how it might have been fudged or find out how many negative papers are being kept out of view; never believe industry-funded clinical trials; assume risks are being downplayed and benefits overplayed.

An adversary relationship will put a real crimp in the incomes of quite a few physicians who are used to taking drug money. It'll also raise some serious financing issues for CME, but it's time those came out on the table anyway. Patients deserve much more aggressive protection of their interests than our profession's cozy relationship with Big Pharma has provided. Time to un-cozy.

Princess Health and The "Misconduct" of a Leader with "Gravitas,". Princessiccia

Princess Health and The "Misconduct" of a Leader with "Gravitas,". Princessiccia

Mismanagement Staten Island University Hospital

Gusty 11:05 Add Comment

A follow-up on the story of Staten Island (NY) University Hospital's settlement of charges that it had defrauded the state Medicaid program....

According to the NY Times, it turns out that Joseph Pisani, the former Executive Vice President of State Island University Hospital, who was accused of involvement in the scheme to defraud Medicaid, had taken a position as Senior Vice President for financial planning and forecasting at troubled Westchester (NY) Medical Center in 2003, at a salary of $275,000. In 2004 he was promoted to Executive Vice President and Chief Administrative Officer, with a salary of $480,000. At the time, employees and union officials said this salary was excessive given the perilous financial condition of the institution. (The Journal News reported that the hospital has lost $200 million since 2002, and is projected to lose $60 million in 2005.) However, the Chair (in 2004) of the Westchester County Health Care Corporation defended Pisani's salary thus,

• "To get out of this thing, you need good troops, and Joe is really C.E.O material. He has that kind of gravitas and can think outside the box and can think of creative solutions."

Yesterday, when the story of the fraud settlement at Staten Island University Hospital, and Pisani's involvement in it was revealed, Westchester Medical Center fired him. Staten Island University Hospital had announced its regrets over its leaders' "misconduct."
OK, here comes my rant. How many times have we heard about the brilliance of health care leaders (often proclaimed by other health care leaders)? How many times have we heard about their intelligence, their vision, their ability to think outside the box? How many times have we heard about how their brilliant plans will improve care, lower costs, etc., etc.? And how many times do these predictions turn out to be wrong?
My favorite example of the over-hyping of health care leadership: In 1995, Sherif Abdelhak gave the prestigious Cooper Lecture at the American Association of Medical Colleges meeting, later published in the prestigious journal, Academic Medicine. In it he proclaimed how through his brilliant leadership, the Allegheny Health Education and Research Foundation was moving into the brave new world of large-scale integrated health care systems. (Remember, they were all the rage in the 1990's.) In 1997, the ACP Observer reported that Abdelhak was considered a "visionary." By 1998, AHERF was bankrupt, the second largest bankruptcy in the US at that time. Abdelhak was convicted of misappropriating charitable funds, and went to jail. (See my summary of the case here starting on page 5.)
So maybe the next time we hear that some top health care leader is "visionary," has "gravitas," or the ability to "think outside the box" of another, a high degree of skepticism is in order. Maybe we should look for leaders who display some modesty, humility, and realism, for a change.