Ingredients:
2 cups of aloe vera juice
3 cups of coconut water
25 drops of honeysuckle essential oil
Instructions:
Mix all the ingredients together in a spray bottle. Store in a refrigerator until ready for use. (Recipe Source)
Sabtu, 18 Mei 2013
Mixology || Homemade Coconut Aloe Leave-In Conditioner
Ingredients:
2 cups of aloe vera juice
3 cups of coconut water
25 drops of honeysuckle essential oil
Instructions:
Mix all the ingredients together in a spray bottle. Store in a refrigerator until ready for use. (Recipe Source)
Jumat, 17 Mei 2013
Marin General Hospital nurses warn that new computer system is causing errors, call for time out
- Posted on the Healthcare Renewal Blog May 17, 2013 -
Of course, the ever-present euphemism for life-threatening EHR malfunctions and defects, i.e., "glitches" are the cause (http://hcrenewal.blogspot.com/search/label/glitch):
Marin General Hospital nurses warn that new computer system is causing errors, call for time out
By Richard Halstead
Marin Independent Journal
Posted: 05/15/2013 04:07:49 PM PDT
Nurses at Marin General Hospital have asked administrators to put implementation of a new computerized physician order entry system on hold until glitches can be worked out and more training provided to nurses and doctors who use it.
Nearly a dozen nurses attended the regularly scheduled meeting of the Marin Healthcare District board Tuesday night at Marin General to voice their concerns. The district board oversees Marin General, but it does not involve itself in the hospital's day-to-day operations.
"Orders are being inadvertently passed to the wrong patients. People have gotten meds when they've been allergic to them. This is dangerous," said Barbara Ryan, a Marin General registered nurse, who works in pediatrics and the intensive care nursery. "We're not asking you to get rid of it. We're asking you to place it on hold."
Orders passed to wrong patients? No problem, just a glitch! Meds people are allergic to? Just a glitch. Dangerous? No way. It's just a glitch!
But Lee Domanico, who serves as the CEO of both Marin General and the Marin Healthcare District, said, "I'm confident that in spite of the implementation issues, we have a system today that is safer for patients than our old paper system, and it will get even safer as we gain experience with it and work to fix some of the glitches we've experienced."
Where's the data backing up that assertion, I ask? The actual risks of paper records don't seem to be robustly documented anywhere.
Ryan, who serves as the California Nurses Association/National Nurses United representative, was one of four Marin General nurses who spoke during the public comment portion of the meeting. Ryan said the nurses warned in advance of the system's roll-out on May 7 that nurses and doctors had insufficient knowledge of the system. Ryan said due to problems with the software nurses had been unable to open the program at home to practice using it.
And yet the rollout happened anyway? That seems to me to be reckless indifference to the concerns of clinicians.
"Lo and behold the problems that we were worried about have happened," Ryan said. "We're looking at two-hour preps for surgery and two- to three-hour discharges; skilled nursing facilities calling back saying, this really doesn't make sense; the wrong meds ordered on the wrong patients and then given to the wrong patients; the inability for nurses to be able to see what the doctor ordered and double-check it."
Of course, I might add, patient safety was not compromised, the other common refrain of EHR glitch-excusers ... see below.
Ryan said nurses have and will continue to file "assignment despite objection" forms due to the system. Nurses file the forms to document formal objections to what they consider an unsafe, or potentially unsafe, patient care assignment.
"We will take patients but we will object to the assignment because it is unsafe," Ryan said. "This system is making it unsafe."
These will be exceptionally helpful in court to any patients injured or killed as a result of these "glitches" and EHR rollout that occurred despite direct warnings from clinical experts.
Marin General nurse Susan Degan said, "This is not about resistance to change. It's about accountability. My most important role is that of patient advocate. I am held accountable when errors are made."
Domanico acknowledged there have been some technical problems with the Paragon system, including making it possible for nurses to open from home. And he said the software is not faster than the old paper system. [Considering it's acknowledged all the way up to the highest levels of HHS that current EHR's slow physicians down, one wonders if anyone in this organization thought an EHR would actually increase speed? - ed.]
About the "resistance to change" canard, see my essay "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html .
"So yes," Domanico said, "it is causing stress for nurses who have heavy workloads, who are learning how to use it, particularly in areas where we need to speed up the computer."
What? "Speed up the computer?" They've spent tens if not hundreds of millions for an EHR, and the computer's too slow?
Actually, I think what this CEO in an obvious display of health IT ignorance is trying to say is that we have to do something about the system's poor usability, which sort of mimics what the Board Chair of the American Medical Assocation just said (http://hcrenewal.blogspot.com/2013/05/ama-finally-on-board-with-ehr-views.html).
Also - clinician stress promotes error.
But Domanico challenged the suggestion that patient safety at Marin General had been compromised.
In fact, there is no way the issues described above cannot be compromising patient safety, on its face. (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).
"I would have no hesitation about entering this hospital tonight," he said.
As a VIP, of course, this CEO would get special treatment. Thanks a lot.
I would NOT want to be a patient there under these conditions, unless perhaps I had a 24x7 medically-skilled advocate/bodyguard.
Board member Ann Sparkman, who previously served as in-house counsel at Kaiser Permanente, said nurses at Kaiser struggled at first when a new computer system was introduced there.
Sparkman said, "It's just to be expected."
This seems a rather bizarre appeal to common practice (http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html).
The stunning ignorance of this board member about proper mission-critical IT safety testing and implementation, such as performed in pharma, aerospace, etc. is, quite frankly, shocking.
Further, an attitude that life-threatening "glitches" are "just to be expected" by a member of the Board of Directors, with fiduciary responsibilities regarding hospital operations, is grossly negligent in my opinion, and completely ignores patient's rights.
Unbelievable.
One wonders if any formally-trained medical informatics experts were in leadership roles in this project.
-- SS
American Medical Association finally on board with EHR views expressed on this blog since 2004
- Posted on the Healthcare Renewal Blog May 17, 2013 -
It seems to have taken awhile, but organized medicine seems to finally be recognizing that today's commercial health IT is not quite the revolutionizing, transformative, plug-and-play panacea to healthcare's ills it is often touted as:
AMA Wire
May 15, 2013
AMA board chair: HHS should address EHR usability issues immediately
The government needs to act quickly to remedy the impaired usability of electronic health records (EHR) if the technology's touted benefits are to be realized, AMA Board of Trustees Chair Steven J. Stack, MD (left), told officials during a federal hearing last week.
"The AMA and most physicians believe that, done well, EHRs have the potential to improve patient care," Dr. Stack, an emergency physician in Lexington, Ky., said during his 30-minute testimony. "At present, however, these EHRs present substantial challenges to the physicians and other clinicians now required to use them."
He emphasized that many of today's EHR systems require significant changes before they can deliver the promised outcomes. Referring to Medicare's meaningful use program, he pointed to undesired consequences of pushing EHR systems on physicians before the technology was completely ready for prime time.
"Immediately" is strong language.
I note that the phrase "health IT done well" is a term I've been using since 1998 at my now-Drexel-based health IT teaching website at http://www.ischool.drexel.edu/faculty/ssilverstein/cases, as well as at this blog.
Penned by me at my aforementioned Drexel graduate teaching site, originally housed on AOL, in 1998 and still appearing in its main essay:
... While clinical IT is now potentially capable of achieving many of the benefits long claimed for it such as improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth, there is a major caveat and essential precondition: the benefits will be realized only if clinical IT is done well. For if clinical IT is not done well, as often occurs in today’s environment of medical quick fixes and seemingly unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources.Those two short words “done well” mask an underlying, profound, and, as yet, largely unrecognized (or ignored) complexity. This website is about the meaning of "done well" in the context of clinical computing, a computing subspecialty with issues and required expertise quite distinct from traditional MIS (management information systems, or business-related) computing.
(I have more recently switched to the easier-to-parse terminology of "good health IT" vs. "bad health IT" after discussions with Dr Jon Patrick at U. Sydney during my visit Down Under last summer, http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html.)
I've also heard "not ready for prime time" before. It is a phrase I used in speaking with a New York Times reporter that then appeared in the Oct. 8, 2012 NYT article "The Ups and Downs of Electronic Medical Records" (http://www.nytimes.com/2012/10/09/health/the-ups-and-downs-of-electronic-medical-records-the-digital-doctor.html?pagewanted=2) by Milt Freudenheim, October 8, 2012, where I am quoted and this blog cited:
... Critics are deeply skeptical that electronic records are ready for prime time. “The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal. He says testing these systems on patients without their consent “raises ethical questions.”
The AMA Board chair went on to opine:
"Attempting to transform the entire health system in such a rapid and proscriptive manner has compelled providers to purchase tools not yet optimized to the end-user's needs and that often impeded, rather than enable, efficient clinical care," he said.
He noted that physicians are "prolific technology adopters" but that adoption of EHR systems has required federal incentives because the technology still is "at an immature stage of development."
My near-exact terminology has been that the technology is still experimental.
"EHRs have been and largely remain clunky, confusing and complex," he said.
Perhaps he read my ten-part series on the health IT mission hostile user experience at this blog, at http://www.tinyurl.com/hostileuserexper.
According to a recent survey by AmericanEHR Partners, physician dissatisfaction with EHR systems has increased. Nearly one-third of those surveyed in 2012 said they were "very dissatisfied" with their system, and 39 percent said they would not recommend their EHR system to a colleague—up from 24 percent in 2010.
A survey I posted about in Jan. 2010 is here: "An Honest Physician Survey on EHR's", http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html
Dr. Stack spoke at a "listening session" hosted by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), a division of the U.S. Department of Health and Human Services (HHS). The agencies coordinated the session to examine how a marked increase in code levels billed for some Medicare services might be tied to the increased use of EHRs.
Dr. Stack noted that some Medicare carriers have begun denying payment for charts that are too similar to other records.
"In this instance, even when clinicians are appropriately using the EHR, a tool with which they are frustrated and the use of which the federal government has mandated under threat of financial penalty, they are now being accused of inappropriate behavior, being economically penalized, and being instructed ‘de facto' to re‐engineer non‐value‐added variation into their clinical notes," he said. "This is an appalling Catch‐22 for physicians."
"Mandated under threat of financial penalty" has been one of my stated "cart before the horse" issues with HITECH (e.g., http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html).
Dr. Stack advised officials that three key actions are necessary to rectify these issues with EHR systems:The AMA will continue to work with federal agencies to improve EHR systems and the Medicare meaningful use program.
- The ONC promptly should address EHR usability concerns raised by physicians and add usability criteria to the EHR certification process.
- CMS should provide clear and direct guidance to physicians concerning use of EHRs for documentation, coding and billing.
- Stage 2 of the meaningful use program should allow more flexibility for physicians to meet requirements as EHR systems are improved.
I've been calling for usability evaluation to be added to the certification process, including in comments during public comment periods to HHS, for some time.
What the AMA Board Chair is apparently missing, though, is health IT safety. They should perhaps read my post on the recent ECRI Institute Deep Dive Study on health IT risk - itself based on a report in their own AMNews (amednews.com) publication ("Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events", http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).
I don't think any prudent person would consider a 9-week study of 36 hospitals with volunteered reports of 171 health information technology-related problems, where eight of the incidents reported involved patient harm and three may have contributed to patient deaths, information to ignore.
-- SS
Kamis, 16 Mei 2013
Study || Hard Water Impact On Hair
- stiffening of hair strand
- reduction of combing forces
- improvement of ability to hold a style in virgin hair
- reduction of ability to hold a style in bleached hair
Additionally, certain variables affect the uptake of hard water metals by the hair, such as the:
- condition of the hair (e.g., chemically damaged)
- pH of the water
- level of water hardness
ABSTRACTS:
STRUCTURAL IMPLICATIONS OF HARD WATER METALS (2011)
UPTAKE OF HARD WATER METALS BY HAIR (2011)
C R Bard Settles Allegations of Kickbacks to Promote Radiation Treatment for Prostate Cancer
Screening for and aggressive treatment of prostate cancer has become an enormously lucrative business, if not necessarily a life-saving medical strategy. The minimal media coverage of a recent settlement suggests that at least to some degree, it has been fueled by some questionable practices.
The CR Bard Settlement
As reported by the Atlanta Journal Constitution,
Another brief report in the Macon (GA) Telegraph gave a tiny bit more detail about what was given to physicians to get them to use Bard's radiation therapy products,
The story, briefly told as it was, included many of the usual elements of stories of legal settlements of wrong-doing by large health care corporations.
Slow Justice
The settlement, hence justice, as it were, took a long time, about 7 years since the most recent behavior, and 15 years since its start. Per the AJC,
The penalties were not as big as they seemed. There was the seemingly large fine, $48.2 million dollars. However, that should be compared to the company's net sales of over $2.95 billion and net income of $530 million in 2012, according to the company's annual report. It should also be compared to the total compensation of the company's chairman and CEO in 2012, over $8.7 million, and to that of its president and chief operating officer, over $6.0 million, according to the company's 2012 proxy statement. Apparently, the fine came out of the company's treasury, so its impact was diffused among all shareholders, employees, customers, and patients, not directed to those who may have authorized, directed or implemented the kickbacks to physicians.
No Penalties for Individuals, No Acknowledgement of Wrong-Doing
The settlement did not involve any sort of direct penalties to those who authorized, directed, or implemented the kickbacks.
The corporation did not even acknowledge any bad behavior. As per the AJC,
It may not be part of all such settlements, but note that in this case there seemed to be an attempt to shut up the whistle-blower. So, there is reason to think that justice, such as it was, was delayed because the company seemingly tried to punish the whistle-blower, rather than listen to what she had to say. Per the Macon Telegraph,
Nonetheless, the government seemingly trusted C R Bard to fix its own behavior going forward, per the Wall Street Journal,
Summary - the Profitable but Unsubstantiated Aggressive Approach to Prostate Cancer
So its just another day at the office. This was a typical settlement of allegations of unethical behavior by a large health care organization. A large health care company allegedly bribed doctors to use its products. It seemingly tried to shut up a whistle-blower. Seven years later, the company got a financial slap on the wrist, but no one directly involved in the alleged kickbacks, and no one whose compensation may have been enlarged due to such apparently unethical activity paid a price. Never mind that the alleged kickbacks may have induced doctors to use treatments that provided no overall benefit, but could have harmed patients.
Before ending with our usual fulmination, I should note that this case appears to be one small piece in the puzzle of our national infatuation with an aggressive approach to prostate cancer, despite a lack of essentially any good evidence that this approach does any good. Brachytherapy, the treatment pushed allegedly by kickbacks, is one kind of aggressive treatment for prostate cancer. Yet there is no good evidence from randomized controlled trials that is prolongs life. In fact, a recent (and the only major) randomized controlled trial of aggressive treatment of prostate cancer on initial diagnosis failed to show any overall survival benefit.(1) There has been a huge push to screen all men of a certain age for prostate cancer. Yet now two new trials also failed to show any overall survival benefit from screening.(2,3)
But the prostate cancer business is very lucrative. On the Reforming Health blog, a post summarized a lecture given by Dr Otis Brawley, chief medical officer of the American Cancer Society in which Dr Brawley described the financial scheme underlying the aggressive approach to prostate cancer,
Presumably because he was a marketing executive, the manager whom Brawley quoted did not have to feel doubt about all the men subjected to needless procedures, and who would be at risk of serious and unpleasant adverse effects of these procedures, all to make money but not to prolong their lives. Of course, not only the hospitals make money, but also quite obviously the companies that sell them the drugs and devices needed for all this medical aggression make money, as do the doctors who go along with it all.
Now we suspect that one small reason the doctors have gone along with it is that they may have gotten inducements from those companies.
Time to fulminate,...
We will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.
References
1. Wilt TJ, Brewer MK, Jones KM et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012; 367: 203-13. [Link here]
2. Andriole GL, Crawford ED, Grubb RL et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 2009; 360: 1310-9. [Link here]
3. Schroder FH, Gugosson J, Roobl MJ et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med 2009: 360: 1320-8.[Link here]
The CR Bard Settlement
As reported by the Atlanta Journal Constitution,
A medical device company on Monday agreed to pay a $48.2 million settlement to resolve claims by a Georgia employee that it paid kickbacks to doctors and customers who bought radiation treatment for prostate cancer.
C.R. Bard Inc., which is headquartered in New Jersey and has offices in Covington, resolved a whistle-blower suit filed by the employee in 2006. The suit alleged that the company paid off doctors and hospitals to induce them to prescribe brachytherapy seeds, which are implanted in the prostate and deliver a dose of radiation to cancer cells.
Another brief report in the Macon (GA) Telegraph gave a tiny bit more detail about what was given to physicians to get them to use Bard's radiation therapy products,
Customers could order the seeds, used in brachytherapy to deliver a prescribed dose of radiation directly to cancer cells, from multiple companies. But Bard allegedly offered doctors grant money, rebates, free medical equipment and advertising campaigns to entice them to buy their product at inflated prices, according to a news release issued by [whistle-blower Julie] Darity’s legal team....The Usual Elements of Legal Settlements of Allegations of Health Care Corporate Bad Behavior
The story, briefly told as it was, included many of the usual elements of stories of legal settlements of wrong-doing by large health care corporations.
Slow Justice
The settlement, hence justice, as it were, took a long time, about 7 years since the most recent behavior, and 15 years since its start. Per the AJC,
Bard employed its kickback scheme from 1998 to 2006, federal prosecutors said.Penalties Not as Big as They Appeared
The penalties were not as big as they seemed. There was the seemingly large fine, $48.2 million dollars. However, that should be compared to the company's net sales of over $2.95 billion and net income of $530 million in 2012, according to the company's annual report. It should also be compared to the total compensation of the company's chairman and CEO in 2012, over $8.7 million, and to that of its president and chief operating officer, over $6.0 million, according to the company's 2012 proxy statement. Apparently, the fine came out of the company's treasury, so its impact was diffused among all shareholders, employees, customers, and patients, not directed to those who may have authorized, directed or implemented the kickbacks to physicians.
No Penalties for Individuals, No Acknowledgement of Wrong-Doing
The settlement did not involve any sort of direct penalties to those who authorized, directed, or implemented the kickbacks.
The corporation did not even acknowledge any bad behavior. As per the AJC,
Bard is pleased to settle the claims, Scott Lowry, a company spokesman, said in a statement.Suppression of Whistle-Blowing
'This resolution allows the company to put this matter behind it and continue to focus on delivering life-enhancing medical devices and technologies to patients around the world,' he said. 'We remain committed to continuously enhancing and improving our compliance programs in accordance with industry standards.'
It may not be part of all such settlements, but note that in this case there seemed to be an attempt to shut up the whistle-blower. So, there is reason to think that justice, such as it was, was delayed because the company seemingly tried to punish the whistle-blower, rather than listen to what she had to say. Per the Macon Telegraph,
Darity, 56, said she first reported what she suspected as questionable activities to her supervisors.
'I did exactly what was outlined in the company ethics policy,' she said. 'I wanted to think things were being corrected.'
In time, she realized nothing had changed. She filed an internal whistle-blower complaint.
Her job was eliminated in November 2005, soon after an investigation was launched into her whistle-blower complaint, she said.
Darity had worked for Bard, which has an office in Covington, for more than 18 years. When her job was eliminated, she was a manager in the Brachytherapy Contracts Administration division.
Out of a job, Darity filed the lawsuit in U.S. District Court for the Northern District of Georgia in January 2006.
Nonetheless, the government seemingly trusted C R Bard to fix its own behavior going forward, per the Wall Street Journal,
As part of a non-prosecution agreement, C.R. Bard agreed to pay an additional $2.2 million and take remedial steps to enhance compliance. The company had said in a regulatory filing last year that it expected the settlement to include a corporate integrity agreement, which typically require companies to obey restrictions on their sales and marketing practices, but no such agreement was announced Monday.Note that here we discussed a case in which an academic medical institution seemingly tried to punish faculty members who questioned that organization's overly enthusiastic approach to prostate cancer.
Summary - the Profitable but Unsubstantiated Aggressive Approach to Prostate Cancer
So its just another day at the office. This was a typical settlement of allegations of unethical behavior by a large health care organization. A large health care company allegedly bribed doctors to use its products. It seemingly tried to shut up a whistle-blower. Seven years later, the company got a financial slap on the wrist, but no one directly involved in the alleged kickbacks, and no one whose compensation may have been enlarged due to such apparently unethical activity paid a price. Never mind that the alleged kickbacks may have induced doctors to use treatments that provided no overall benefit, but could have harmed patients.
Before ending with our usual fulmination, I should note that this case appears to be one small piece in the puzzle of our national infatuation with an aggressive approach to prostate cancer, despite a lack of essentially any good evidence that this approach does any good. Brachytherapy, the treatment pushed allegedly by kickbacks, is one kind of aggressive treatment for prostate cancer. Yet there is no good evidence from randomized controlled trials that is prolongs life. In fact, a recent (and the only major) randomized controlled trial of aggressive treatment of prostate cancer on initial diagnosis failed to show any overall survival benefit.(1) There has been a huge push to screen all men of a certain age for prostate cancer. Yet now two new trials also failed to show any overall survival benefit from screening.(2,3)
But the prostate cancer business is very lucrative. On the Reforming Health blog, a post summarized a lecture given by Dr Otis Brawley, chief medical officer of the American Cancer Society in which Dr Brawley described the financial scheme underlying the aggressive approach to prostate cancer,
Brawley recounts an experience he had on a site visit to a hospital in 1998 while an Assistant Director at the National Cancer Institute. During the visit a marketing executive explains to Brawley the publicity value and financial rewards of a free prostate screening program offered by the hospital at a local mall. The plan is to screen the first 1,000 men over 50 who come to the mall for testing. I’ve transcribed Brawley’s recollections from the video and they provide a great explanation for the profit-driven practices that continue to occur today, 14 years later:
'If they screen 1,000 men they’re going to have 145 abnormals. They’re going to charge about $3,000 to figure out what is abnormal about these abnormals, that’s how they pay for the free screening. About 10 of the 145 won’t come to this hospital so that’s business for their competitors, but they’ll get 135 times $3,500 on average. Of the 135, 45 are going to die of prostate cancer and the other percentage are going to get radical prostatectomy at about $30-40,000 a case; there’s a percentage that’s going to get seeds at about $30,000 a case; a percentage were going to get radiation therapy that (at the time) was about $60,000. Then [the marketing executive’s] business plan goes further, he knows how many guys are going to have so much incontinence that diapers aren’t going to do it so he had in his business plan how many artificial sphincters urologists were going to implant. And then he was a little apologetic because there was this new thing called Viagra that screwed up his estimates for how many penile implants he was going to sell because guys were upset about impotence related to prostate cancer treatment.'
Brawley says, 'this is 1998, I ask him, if you screen 1,000 people how many lives are you going to save? He took off his glasses and looked at me like I was some kind of fool and said, ‘Don’t you know, nobody’s ever shown that prostate cancer screening saves lives, I can’t give you an estimate on that.’'
Presumably because he was a marketing executive, the manager whom Brawley quoted did not have to feel doubt about all the men subjected to needless procedures, and who would be at risk of serious and unpleasant adverse effects of these procedures, all to make money but not to prolong their lives. Of course, not only the hospitals make money, but also quite obviously the companies that sell them the drugs and devices needed for all this medical aggression make money, as do the doctors who go along with it all.
Now we suspect that one small reason the doctors have gone along with it is that they may have gotten inducements from those companies.
Time to fulminate,...
We will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.
References
1. Wilt TJ, Brewer MK, Jones KM et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012; 367: 203-13. [Link here]
2. Andriole GL, Crawford ED, Grubb RL et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 2009; 360: 1310-9. [Link here]
3. Schroder FH, Gugosson J, Roobl MJ et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med 2009: 360: 1320-8.[Link here]
Selasa, 14 Mei 2013
Six Years Later, Ranbaxy - Oops, Daiichi Sankyo - Pleads Guilty to Adulteration, Pays $500 Million
It only took until 2013, but the US Food and Drug Administration finally secured guilty pleas and fines. The basics are in an Associated Press story (via the Washington Post):
Note that the company pleaded guilty to criminal charges.
Ironies
Note that this resolution has certain ironies.
Lateness
There is a saying that justice delayed is justice denied. Note that it took six years to obtain the guilty pleas. As noted by the AP,
Ambiguities about Responsibility
First, note that while all the headlines are about Ranbaxy, Ranbaxy is not really an independent company. As reported by Reuters (and only by Reuters so far as I can tell at this time),
Second, as per the AP, see the comment made by the Ranbaxy CEO,
Maybe there was something lost in translation, but the CEO certainly spoke as if someone else was responsible for the "conduct of the past." Incidentally, it does not appear that so far any journalist has even sought comment from the people really in charge, at Daiichi Sankyo.
Third, just like many other cases we have reported before, no individual, especially anyone who authorized, directed, or implemented the bad behavior, was held legally responsible. The cost of the fines will no doubt be spread among the corporate structures involved. Since a company pleaded guilty, no individual pays a fine, much less goes to jail.
It does appear that when the settlement was first announced in 2011, a cut in compensation for top executives of Daiichi Sankyo was announced, but the cuts were temporary, and apparently in response to the immediate financial consequences of the settlement, not any larger implications. See Bloomberg's report:
The Contrast with the Case of the Adulterated Heparin
Note that in this case, there have been no allegations that patients were harmed by the admitted adulteration, Per the AP:
In 2008, we began blogging about how US patients started to get sick and die after being infused with heparin, the common anti-coagulant drug. As we have discussed repeatedly (look here, and see the summary at the end of the post), Baxter International was selling contaminated heparin under its label which was made in unregulated workshops in China, and then transmitted through a complex chain of Chinese and US companies.
The AP article stated,
So perhaps this wake up call helped propel the current case against Ranbaxy, that is, Daiichi Sankyo. However, since 2008, if there has been a criminal investigation of the tainted heparin, which appears to have been much more consequential, sometimes fatally so, to patients, the results have not been made public. A cynic might note that the contaminated heparin was sold by a US based manufacturer of branded pharmaceuticals, not a foreign based manufacturer of generic drugs.
Summary
The most fundamental obligation of a drug company is to produce pure, unadulterated drugs. The first attempts to regulate the drug industry in the US were meant to ensure that these companies fulfilled this obligation. Yet now there is increasing evidence that the contemporary pharmaceutical industry has trouble with this most basic responsibility.
As we discussed here, the managers of pharmaceutical companies have been swept up in a dominant business management fad, outsourcing, as a means to cut costs to the bone. (It seems that most health care managers are also caught up in the larger rage for financialization, to emphasize short term revenue over all other concerns, including patients' and the public's health.) As the New York Times reported re the Ranbaxy case,
Again, all pharmaceutical companies, not just generic drug manufacturers, have seen fit to outsource much, if not most of their production.
In our rush to market fundamentalism, we seem to have deregulated, at least de facto, most aspects of health care. We now cannot trust the drugs we take to have been made by the companies whose labels they bear, or to be pure. We now cannot trust that regulators will find that out, or having found that out, will do anything about it in a timely manner.
To repeatedly reiterate, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them.
To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).
- Roy M. Poses MD for Health Care Renewal
Appendix - Heparin Case Summary
- We have posted several times, recently here about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late in 2007, hundreds of such reactions, and 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.
- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. (See posts here and here.)
- We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.
- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."
- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.) Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post here). A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post here).
- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post here.)
- Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post here.) Efforts to make documents to be used in these cases public so far have not succeeded (see post here).
- A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post here.)
- Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post here.)
- In February, 2011, a congressional investigation of the case was announced, but results are so far unavailable (see post here.)
- In June, 2011, a jury returned the first verdict in a civil case about the contaminated heparin, awarding money from Baxter International and Scientific Protein Laboratories to the estate of a man who apparently died due to tainted heparin (see post here).
- If there was a criminal investigation of the case, its results have not yet appeared.
A subsidiary of India’s largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S.
Federal prosecutors say the guilty plea by Ranbaxy USA Inc. represents the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.
Note that the company pleaded guilty to criminal charges.
The subsidiary of Ranbaxy Laboratories Limited pleaded guilty to federal criminal charges and the company separately agreed to resolve civil claims with all 50 states and the District of Columbia. The company had earlier set aside $500 million to cover potential criminal and civil liability stemming from the Justice Department investigation.
It admitted as part of the deal that it sold adulterated batches of drugs — including an antibiotic and generic versions of medications used to treat severe acne, epilepsy and nerve pain — that were developed at two manufacturing sites in India.
Ironies
Note that this resolution has certain ironies.
Lateness
There is a saying that justice delayed is justice denied. Note that it took six years to obtain the guilty pleas. As noted by the AP,
The problems were largely revealed by a whistleblower in a federal lawsuit filed in Maryland in 2007.
Ambiguities about Responsibility
First, note that while all the headlines are about Ranbaxy, Ranbaxy is not really an independent company. As reported by Reuters (and only by Reuters so far as I can tell at this time),
Ranbaxy ... [is] majority-owned by Japan's Daiichi Sankyo.
Second, as per the AP, see the comment made by the Ranbaxy CEO,
'While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy’s stakeholders; the conclusion of the DOJ investigation does not materially impact our current financial situation or performance,' Ranbaxy CEO and managing director Arun Sawhney said in a statement.
Maybe there was something lost in translation, but the CEO certainly spoke as if someone else was responsible for the "conduct of the past." Incidentally, it does not appear that so far any journalist has even sought comment from the people really in charge, at Daiichi Sankyo.
Third, just like many other cases we have reported before, no individual, especially anyone who authorized, directed, or implemented the bad behavior, was held legally responsible. The cost of the fines will no doubt be spread among the corporate structures involved. Since a company pleaded guilty, no individual pays a fine, much less goes to jail.
It does appear that when the settlement was first announced in 2011, a cut in compensation for top executives of Daiichi Sankyo was announced, but the cuts were temporary, and apparently in response to the immediate financial consequences of the settlement, not any larger implications. See Bloomberg's report:
Chief Executive Officer Joji Nakayama and board members will receive 5 percent to 30 percent less compensation for six months in response to the cut in the earnings forecast, Daiichi Sankyo said today. The company has lost about half its market value since agreeing to buy a majority stake in Ranbaxy, India's largest drugmaker, in June 2008.
The Contrast with the Case of the Adulterated Heparin
Note that in this case, there have been no allegations that patients were harmed by the admitted adulteration, Per the AP:
It’s not known whether the problems with the drugs led to any health issues.... The government’s allegations against the company make no claims that the drugs, whose strength, purity or quality differed from the specifications, harmed anyone.
In 2008, we began blogging about how US patients started to get sick and die after being infused with heparin, the common anti-coagulant drug. As we have discussed repeatedly (look here, and see the summary at the end of the post), Baxter International was selling contaminated heparin under its label which was made in unregulated workshops in China, and then transmitted through a complex chain of Chinese and US companies.
The AP article stated,
The case comes as federal regulators and prosecutors focus attention on the quality of ingredients of generics and other drugs manufactured overseas, said Allan Coukell, an expert on drug safety at The Pew Charitable Trusts. He said the 2008 deaths linked to tainted batches of the blood-thinner heparin that were imported from China served as a 'wake up call' about just how much of the nation’s drug supply comes from overseas.
So perhaps this wake up call helped propel the current case against Ranbaxy, that is, Daiichi Sankyo. However, since 2008, if there has been a criminal investigation of the tainted heparin, which appears to have been much more consequential, sometimes fatally so, to patients, the results have not been made public. A cynic might note that the contaminated heparin was sold by a US based manufacturer of branded pharmaceuticals, not a foreign based manufacturer of generic drugs.
Summary
The most fundamental obligation of a drug company is to produce pure, unadulterated drugs. The first attempts to regulate the drug industry in the US were meant to ensure that these companies fulfilled this obligation. Yet now there is increasing evidence that the contemporary pharmaceutical industry has trouble with this most basic responsibility.
As we discussed here, the managers of pharmaceutical companies have been swept up in a dominant business management fad, outsourcing, as a means to cut costs to the bone. (It seems that most health care managers are also caught up in the larger rage for financialization, to emphasize short term revenue over all other concerns, including patients' and the public's health.) As the New York Times reported re the Ranbaxy case,
Others say the company’s problems highlight how little oversight federal drug safety officials have of overseas plants. Studies that have shown the F.D.A. inspects foreign generic manufacturing plants about once every seven to 13 years, compared with once every two years for domestic manufacturers. A law passed last year will eventually require the F.D.A. to apply the same standards when inspecting all manufacturing plants, regardless of location. But some worry that federal budget cuts are slowing the adoption of that law.'They just happened to stumble across the Ranbaxy problem at those two plants in India,' said Joe Graedon, a pharmacologist who runs a consumer Web site, the People’s Pharmacy, which has raised questions about the safety of generic drugs. 'Ranbaxy was the biggest and one of the best in India. What about all the smaller ones? What does that say about them?'
Again, all pharmaceutical companies, not just generic drug manufacturers, have seen fit to outsource much, if not most of their production.
In our rush to market fundamentalism, we seem to have deregulated, at least de facto, most aspects of health care. We now cannot trust the drugs we take to have been made by the companies whose labels they bear, or to be pure. We now cannot trust that regulators will find that out, or having found that out, will do anything about it in a timely manner.
To repeatedly reiterate, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them.
To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).
- Roy M. Poses MD for Health Care Renewal
Appendix - Heparin Case Summary
- We have posted several times, recently here about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late in 2007, hundreds of such reactions, and 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.
- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. (See posts here and here.)
- We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.
- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."
- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.) Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post here). A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post here).
- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post here.)
- Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post here.) Efforts to make documents to be used in these cases public so far have not succeeded (see post here).
- A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post here.)
- Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post here.)
- In February, 2011, a congressional investigation of the case was announced, but results are so far unavailable (see post here.)
- In June, 2011, a jury returned the first verdict in a civil case about the contaminated heparin, awarding money from Baxter International and Scientific Protein Laboratories to the estate of a man who apparently died due to tainted heparin (see post here).
- If there was a criminal investigation of the case, its results have not yet appeared.
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