Conflicts-of-Interest

These findings suggest that private-sector physicians participate as PIs in pharmaceutical clinical trials primarily for financial reasons and see themselves as trial practitioners and businesspeople rather than as scientists. The accuracy of these findings is likely to be limited by the small number of PIs interviewed and by the time that has elapsed since the researchers collected their qualitative data. Moreover, these findings may not be generalizable to other regions of the US or to other countries. Nevertheless, they have potentially troubling implications for drug development. By hiring private-sector physicians who see themselves as involved more with the business than the science of contract research, pharmaceutical companies may be able to exert more control over the conduct of clinical trials and the publication of trial results than previously. Compared to the traditional investigator initiated system of clinical research, this new system of contract research means that clinical trials now lack the independence that is at the heart of best science practices, a development that casts doubt on the robustness of the knowledge being produced about the safety and effectiveness of new drugs.


Fisher JA, Kalbaugh CA. United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study. PLoS Med 2012;9(7):e1001271. PLoS Medicine: United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study

Background - There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities.

Methods and Findings - We conducted a qualitative study in 2003–2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers.

Conclusions - Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies.
 
Some thoughts on general medical moral sets and Big Pharma/Major medical considered.

Many a hospital has had to add windows to doors leading in to small closed private rooms. No to say there is anything wrong with two humans interacting as nature intended, as long as morally sound with consideration to others potentially affected. LOL .. And whether it be a drug rep, nurse, or skank tracing from the bar last night. We are all human, Some able to reallize this more than others. I do give the medical profession credit always from that aspect. There is some sound ration in technical logic...

I have heard the the Hip and knee manufacturers have to keep their Reps rotated well to ensure the docs are happy with the HOOKERS... LOL The lucky ones move on into management once circling the block too many times, and youth and beauty begin to slip.

BUT THERE IS NO DOUBT, and it pisses me off TO NO FUCKING END, that docs are pushing drugs to patients bases on "business social" interactions doctors have with the drug reps. SEE - this is a fine example of where my parents, the school systems, and our society again failed my - IN THAT THEY DID NOT ACCURATELY TRANSLATE HOW THEORY IN THE CLASSROOM TRANSLATES TO REAL WORLD JOB INTEREST. Else I would have been a drug repp'n GIGALO. And a damnd fine one at that with sex as my FAVORITE passtime...:D I guess there is actually still time if I got myself in ultra good shape given men tend to age like fine wine, whereas women... I digress.... Plus I am married and spiritually loyal to that.

Yes, Prozac and Paxil used to be given out as samples as well. They might as well have had a little M&M dish on the receptionist counter with pills in convenient little "go packs". LOL. Too bad that was not occuring in the 1970's.. :eek::rolleyes:

There are also TWO basic premises of docs. Drug Docs, and NON-Drug Docs. There ARE docs out there that just wont prescibe shit until you are purple and flat on the ground - Believe it or not! But this trend has faded and held only by old timers at this time. Really the only reservation docs have today are STILL not even technically or morally based, BUT LEGALLY based with ONLY consideration of what is a hot litigation topic today. Here is another failure and another topic all together. I will never forget how fucking sick it made me to my insides, when my doc was out of service for a while and the one they transferred me too simply did not have the set to write the hydrocodone I need for my arthritis. Keep in mind that even an aspring gives me the shits. Advil is like hot Jalepenos comming out my ass after 5 days of minmal use, and heaven forbid the rest. That doc that did not want to write the pain meds advise he was switching me to Vioxx or something similar for arthritis advising that it was "not harsh on the intestinal tract and that there were no issues". For THE LOVE OF SWEET SHITS SAKE..! Firstly, hydrocodone should just about be over the counter. Quick tolerance, lack of euphoria, and the fact that if you are in pain - it does nothing more than help to mitigate it - should ration the relative safety. Especially for an experienced user. So this gutless little pussy faggot (and he was) would not write me a perfectly safe drug for my needs, and would have me risk loss, of eyesight, internal hemmoraging to the point of anemia, and God knows what else due to THE POLITICAL GUIDELINES OF THE PRACTICE Combine with his "judgement applied". He even had his head CUNT NURSE come in one time ahead of him as a primer to objection as she advised me that the 10mg hydrocodone was a "massive dose" that would lay her out on the floor, and that I should not be taking it - LOL..!!!! And I can say that I have never had an issue with Hydro as who wants to be numb all the time. Ten plus years and all I take is two on most nights. Thats it. Of course Eye tried to abuse it.. But its worthless for pleasure. That is unless you classify being out of pain as PLEASURE.. Cunt... This was supposed to be a "highly qualified Internal Medicine doc". Even in leiu of my latest alcohol related blow out, my doc never hesitates on the Hydo and wrote it again the folowing week. I later relocated to another city and found a DO who was not only very konwledgeable, but practiced amongst solid internals at a large prestigious hospital, and he held mostly internal type philospohy. He stated "You know, I was on every drug that was a hot political topic". He reviewed the precautions with me professionally as we discussed my history and conditions, and then preceded to confidently write the applicable meds. I did offer that I was open to change if he felt so needed and had better ideas. So go figure.

That last paragraph was a bit of a hIJack I confess, but the application to this thread is that not only do pharmaceutical companies influence what docs are writing, So do politics. And when I drug becomes associated with a profile of social stigma in a way that the cost of the issues related outweight the benefit of the drug on a mass social scale, a BUSINESS decision is then made as a facet of politics - which is PEOPLE - Which IS BUSINESS. So BUSINESS only wants to sell you a med as long as it is PROFITABLE, as a FIRST in principle. Strangely, some sociological medical treatments OUTWEIGHT these costs and continue. And really, this boils down to society, the sect that the drug applies to, and what their value to society is. We see this in Psycho/head drugs primarily.. And some cardio related drugs, but only as a true effort to mitigate with failures in medical science more readily addressed from a pharmaceutical standpoint.
A great study point as a suggestion is amphetamines (and not to beat my horse there are other concerns) which have been around "on and off" historically. Accepatance and political protection afforded is on the rise again, as they happen to be the ONLY effective drug for ADD/ADHD. This applies to CONFLICTS OF INTEREST as the alternative as "stimulant free" are truley UNTESTED. To apply a drug like Straterra to an 8 year old child to which we KNOW NOTHING of what it will do to them biophysically and psyhologically resulting down the road is FLAT OUT DISTURBING. Half the docs I have poled wont readily write the SHIT for kids cause they actually have enough moral fortitude to know when to say WHEN IS ENOUGH..! To risk our nations and the worlds CHILDREN to another reason for big Pharma to profit is INSANITY. And I am sure they fetch a much heftier price tag than good old cheap ass amphetamines.!!! Still some moral logic appears to prevail. I wonder if the Pro-Straterra docs" tell the parents of the children switched to non-amphetamine based ADHD drugs that they can cause severe depression and mental disorders.!!! Hell my doc wont write that shit for me in lieu of amphetamines due to this reason....! So there you have an example of Big Pharma influence that not only slaps logic of a tested and truly safe med in the face in in exchange for more money...

I wonder if they have done a study as to the quality of a blowjob given by a drug rep required given the criteria of a given drug pushed..? LOL Would a concamitnt ass eatin followed by full swallow sway the most logical of docs.?! Now If I sound like I have a notion that the medical field is subject the lessened moral fortitue - YOU ARE DAMN RIGHT. I dont know if it is the fact that they deal with the human body as a primary, or that its just that folks driven to the industry have a more liberal approach to SEX as a basic fundamental premise. But it does seem the case. And if you dont believe me - Date a NURSE. But be warned that if you are naive in the WAYS of LOVE, put up your defenses, as this kind of loving can break a man QUICK...! I have been there ONCE...

So I see that there are really (3) main premises to the practive of Big Pharma drug development. Maybe (4).
(1) Pushing new drugs for treatments when there is plenty of room for better and more effective solutions, but handing them out haphazzardly like candy with no warnings of the potential negative effects, as well as skewed and rigged pre-marketing durg trials/studies.
(2) Pushing these same drugs in the face of pre-existing drugs in place KNOWING they are a poorer solution, but there is research money to be recouped. And the actuaries have done the math on the Doll out, payout, and risk of legal Reprecussion$ - You can believe it..!
(3) The general pushing of new drugs to offset the political and financial disaster of the last failed round, and from a skewed incection of the reason for the drugs initial engineering in the first place.
(4) And Finally, and not to be totally negative. The occasional breakthru that really means something to society. But still hampered and conditioned by the political guidelines and agendas of WHAT IS ALLOWED given a MYRIAD of socialogical facets/implications. What makes a drug with a similar success/fail rate acceptible, and the other no etc. So dont even ask why there. These are powers above all of us, including BIG PHARMA that are primary and fundamentally governing in societies. A political Bonfire PENDING the right martyr, but not me for sure....

Did you know that the pharmacies DO have a system for tracking the drugs prescribed by GIVEN DOCS. The data can be corrolated any way you want from there. But it is tracked. And the blowjob just might not include a swallow net time if your numbers are down. Hell, it might end all together if they stay down. But then again, there is always another sale on the horizon..! And who said SEX doesnt sell. Shit! Life is SEX. LIfe IS Business. Therefore - SEX IS BUSINESS. Dont tell me I am not going to hire YOU first if you have a nive big set of valuptuous tits and a smile that melts my heart. Fuck-N-A...!

Yes, Heeeee's baaaa - aick....! But still dry (16 days) and with intent to remain so untile further notice profound... Its funny how alcohol escapes the political wrath and HOW MANY YEARS Have drunks been runing over kids. No I never drank and drove - really. Especially once more mature and older with kids starting about ten years ago. The rammifications are just TOO FUCKING HIGH. I think back in the seventies they gave bonus points for kids under 12. Seriously. Its funny how the blame is so quickly diverted from alcohol to contributing DRUGS. This is one BIG Pharma has taken on the chin from the date of their inception. This is an interesting conundrum as society meets politics and business to never be figured. It seems to be the preferred and tested weapon of choice. Time seem to change a little as I hear you can not even ascertain a license to grown medical marijuana in the state of Colorado. And I never figured in my lifetime, as politically indicated. I think more of our mommies, the baby boomers smoked pot than publicized. I suspect the more ancient witch burning tribe may have died off now only leaving behind a small legacy of followers at best. The only remaining question is how to effectively SELL, and more importantly TAX, and weed that anyone can grow in their back yard. In fact, as a plant (an not sure if techincally a weed), Marijuana does have a strong natural life force. Shit, it wouldnt be long before it was growing everywhere like bahaia grass, and St. Augustine (which is technially a weed FYI). LOL But my PROGESS in mental development is far too important to be impeded at this point.:rolleyes: And I have come so far.!

I now REGRESS to CEASE to DIGRESS...:drooling::D;)
 
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Hospital Chain Inquiry Cited Unnecessary Cardiac Work
http://www.nytimes.com/2012/08/07/b...ernal-reports-found-dubious-cardiac-work.html

August 6, 2012
By REED ABELSON and JULIE CRESWELL

In the summer of 2010, a troubling letter reached the chief ethics officer of the hospital giant HCA, written by a former nurse at one of the company’s hospitals in Florida.

In a follow-up interview, the nurse said a doctor at the Lawnwood Regional Medical Center, in the small coastal city of Fort Pierce, had been performing heart procedures on patients who did not need them, putting their lives at risk.

“It bothered me,” the nurse, C. T. Tomlinson, said in a telephone interview. “I’m a registered nurse. I care about my patients.”

In less than two months, an internal investigation by HCA concluded the nurse was right.

“The allegations related to unnecessary procedures being performed in the cath lab are substantiated,” according to a confidential memo written by a company ethics officer, Stephen Johnson, and reviewed by The New York Times.

Mr. Tomlinson’s contract was not renewed, a move that Mr. Johnson said in the memo was in retaliation for his complaints.

But the nurse’s complaint was far from the only evidence that unnecessary — even dangerous — procedures were taking place at some HCA hospitals, driving up costs and increasing profits.

HCA, the largest for-profit hospital chain in the United States with 163 facilities, had uncovered evidence as far back as 2002 and as recently as late 2010 showing that some cardiologists at several of its hospitals in Florida were unable to justify many of the procedures they were performing. Those hospitals included the Cedars Medical Center in Miami, which the company no longer owns, and the Regional Medical Center Bayonet Point. In some cases, the doctors made misleading statements in medical records that made it appear the procedures were necessary, according to internal reports.

Questions about the necessity of medical procedures — especially in the realm of cardiology — are not uncommon. None of the internal documents reviewed calculate just how many such procedures there were or how many patients might have died or been injured as a result. But the documents suggest that the problems at HCA went beyond a rogue doctor or two.

At Lawnwood, where an invasive diagnostic test known as a cardiac catheterization is performed, about half the procedures, or 1,200, were determined to have been done on patients without significant heart disease, according to a confidential 2010 review. HCA countered recently with a different analysis, saying the percentage of patients without disease was much lower and in keeping with national averages.

At Bayonet Point, a 44-year-old man who arrived at the emergency room complaining of chest pain suffered a punctured blood vessel and a near-fatal irregular heartbeat after a doctor performed a procedure that an outside expert later suggested might have been unnecessary, documents show. The man had to be revived. “They shocked him twice and got him back,” according to the testimony of Dr. Aaron Kugelmass in a medical hearing on the case.

In another incident, an outside expert described how a woman with no significant heart disease went into cardiac arrest after a vessel was cut when a Bayonet Point cardiologist inserted a stent, a meshlike device that opens coronary arteries. She remained hospitalized for several days, according to a person who has reviewed internal reports.

On Monday morning, in a conference call with investors, company executives disclosed that in July the civil division of the United States attorney’s office in Miami requested information on reviews assessing the medical necessity of interventional cardiology services provided at 10 of its hospitals, located largely in Florida, but also two or three hospitals in other states. In the conference call and in a statement on its Web site, the company also referred to inquiries by The Times. HCA’s stock ended nearly 4 percent lower Monday, at $25.55.

In a recent statement, HCA declined to provide evidence that it had alerted Medicare, state Medicaid or private insurers of its findings, or reimbursed them for any of the procedures that the company later deemed unnecessary, as required by law.

“When the company becomes aware of a situation in which we might have a reimbursement obligation, we assess, with outside resources, what our reimbursement obligations might be,” the statement said.

HCA also declined to show that it had ever notified patients, who might have been entitled to compensation from the hospital for any harm.

Some doctors accused in the reviews of performing unnecessary procedures are still practicing at HCA hospitals.

The cardiologists say the reviews of their work did not accurately reflect the care they provided, and HCA says the reviews “are not, by any means, definitive,” according to an e-mailed response by the company. HCA says it took whatever steps were necessary to improve patient care. It also said “significant actions were taken to investigate areas of concern, to bring in independent reviewers, and to take action where necessary.”

Details about the procedures and the company’s knowledge of them are contained in thousands of pages of confidential memos, e-mail correspondence among executives, transcripts from hearings and reports from outside consultants examined by The Times, as well as interviews with doctors and others. A review of those communications reveals that rather than asking whether patients had been harmed or whether regulators needed to be contacted, hospital officials asked for information on how the physicians’ activities affected the hospitals’ bottom line.

HCA denies its decisions at these hospitals were motivated by financial considerations, but rather “demonstrate the strong focus we have on quality patient care.” The company also says that more than 80 percent of its hospitals are in the top 10 percent of government rankings for quality.

Although HCA has hospitals in about 20 states from California to Virginia and Alaska to Texas, Florida, with its large older population, is a critical and growing market for hospital chains and especially for HCA. HCA’s Florida hospitals provide about 20 percent of the company’s revenue.

The need to root out Medicare fraud — billing for unnecessary procedures, for example — is high for all hospitals. In 2003, Tenet Healthcare agreed to pay $54 million to settle allegations that unnecessary cardiac procedures were being performed over six years and billed to Medicare and Medicaid at one of its hospitals in California, Redding Medical Center.

But the pressure is even greater for HCA. In 2000, the company reached one of a series of settlements involving a huge Medicare fraud case with the Justice Department that would eventually come to $1.7 billion in fines and repayments. The accusations, which primarily involved overbilling, occurred when Rick Scott, now the governor of Florida, was the company’s chief executive. He was removed from the post by the board but was never personally accused of wrongdoing.

As part of the settlement with the federal regulators, HCA signed a 97-page Corporate Integrity Agreement that extended through late 2008. It detailed what had to be reported to authorities and provided for stiffer penalties if HCA failed to do so.

If there were intentional violations of such an agreement, it would mean “that a defendant, already caught once defrauding the government, has apparently not changed its corporate culture,” said Michael Hirst, a former assistant United States attorney in California who oversaw the case against Tenet. Mr. Hirst now represents whistle-blowers.

In its statement, HCA said it fulfilled any obligation it had under the agreement to report “substantial overpayment.” The revelations in the documents come at a significant time in the evolution of medical treatment in the United States — from independently owned hospitals to large, corporate chains.

HCA exemplifies the trend. In 2006, HCA was taken private by a group of private equity firms, including Bain Capital, the firm co-founded by Mitt Romney, the presumptive Republican presidential nominee. (By that time, Mr. Romney was no longer a partner in Bain.) By mid-2010, the private equity owners were eager to start cashing out of their investment. While HCA prepared for an initial public offering of its stock that took place in 2011, it borrowed to pay the private equity firms $4.3 billion in dividends.

The ability to take these financial steps hinged on HCA showing continued robust profit growth at its hospitals.

And for that the company turned, in part, to cardiac care.

An Early Sign of Trouble

Two years after the 2000 fraud settlement, company executives uncovered problems in the cardiac catheterization lab at Cedars Medical Center, according to accounts that became public.

An outside consulting group hired by HCA provided a report that raised “questions regarding the medical necessity of some of the procedures,” the company said in a news release in early 2003. HCA said it was suspending eight physicians from doing certain cardiac procedures, was providing the report to a United States attorney and would refund any inappropriately submitted hospital claims.

“This issue at Cedars and the steps taken to investigate and resolve it should be seen and understood in the larger context of HCA’s commitment to quality care and patient safety,” Jack O. Bovender Jr., who was then the company’s chief executive, told investors in a conference call that February.

HCA will not say whether it had ever refunded payments for the unnecessary procedures. Medicare officials said they could not determine whether the agency had received payments, and the United States attorney’s office in Miami declined to comment. The hospital allowed four of the physicians to return under monitoring, according to HCA, and two did so. “We believe the hospital acted appropriately,” the company said in its recent statement. Still, the negative publicity swirling around Cedars worried HCA executives, according to internal e-mails. They wanted to avoid a replay when similar problems were discovered at another HCA hospital — Bayonet Point.

An Outbreak of Stents

Nestled along the west coast of Florida, about 45 miles northwest of Tampa, the town of Hudson, with its winding canals, is largely a quiet fishing community.

Soon after the Cedars episode, HCA executives noticed that the hospital in Hudson, the 290-bed Regional Medical Center Bayonet Point, was implanting an unusually high number of cardiac stents, given the size of the population.

Late in 2003, executives from HCA’s headquarters in Nashville dispatched a group that oversees its hospitals’ cardiac care to investigate. In a confidential memo, the team cited incidents at Bayonet Point where patients were treated for multiple lesions, or blockages, even when “the second lesion (or third) did not appear to have significant disease.” The team went on to note “several cases” in which patients were treated even though their arteries did not have significant blockages.

In a transcript of confidential hearings held later, the lawyers for HCA were blunt. In looking at one physician, Dr. Sudhir Agarwal, Dr. Martin I. Kalish, a physician who served as an outside lawyer for HCA, said the “style of clinical practice leads to unnecessary procedures and unnecessary complications.”

On the team’s recommendation, HCA brought in an external company, CardioQual Associates of Franklin, Mich., in 2004 to examine medical records from Bayonet Point.

In a confidential memo prepared in December 2004 and reviewed by The Times, CardioQual concluded that as many as 43 percent of 355 angioplasty cases, where doctors performed invasive procedures to open up a patient’s arteries, were outside reasonable and expected medical practice.

Worse, the investigation revealed that some physicians had indicated in medical records that the patients had blockages of 80 to 90 percent when a later, more scientific analysis of a sampling of cases revealed the blockages had ranged from 33 to 53 percent.

Cardiologists generally do not operate on any blockage less than 70 percent, said Dr. Rita Redberg, a prominent cardiologist at the University of California, San Francisco. The significant disparities between the magnitude of blockage being cited by the doctors at Bayonet Point and the CardioQual review “raises real concerns that this wasn’t just error, but it was intent” by the doctors, she said.

After receiving the CardioQual report, Bayonet Point suspended the privileges of nine physicians in late 2004. But unlike the Cedars episode, when HCA turned over its findings to regulators and authorities, HCA took steps to withhold details of its conclusions to the media and others, according to internal communications. In January 2005, David Williams, who was then the chief executive of Bayonet Point, wrote in an e-mail: “Clearly, we have protected ourselves under the peer review umbrella and have released very little information.” The recipients of his message included Dan Miller, who then oversaw HCA’s hospitals in western Florida, and Charles R. Evans, a Nashville executive who was president of all of HCA’s hospitals on the eastern side of the country.

In his response, Mr. Evans thanked Mr. Williams for the update and asked for a “summary as to the business impact.”

In a later internal communication, a representative for HCA said the company had successfully used confidentiality rules to withhold the damaging CardioQual report from the Florida attorney general, whose Medicaid Fraud Control Unit had started an investigation of the physicians. In response to questions from The Times, however, HCA said it had provided “substantially all of the information in the report” to state regulators. The attorney general’s office did not return calls seeking comment.

One of the subjects of that investigation was Dr. Agarwal. The CardioQual review of 20 of his cases concluded that fewer than half were within reasonable and expected practice. Dr. Agarwal did not return a call to his office.

Anthony Leon, a lawyer for Dr. Agarwal and the other eight Bayonet Point physicians, said in a statement: “There is absolutely no merit to any allegation that any of these doctors were performing unnecessary procedures or performing procedures that led to unnecessary complications as a style or pattern of practice.” The suspensions of Dr. Agarwal and another physician were found to have been done in error by an outside panel in hearings in 2005 and 2006, Mr. Leon added. A doctor on the panel said Dr. Agarwal’s procedures were found to be within established medical practice, and his full privileges were reinstated in early 2006.

Dr. Agarwal and the other eight physicians have filed defamation lawsuits in county court, claiming the actions and statements of the hospital and HCA ruined their practices. HCA has denied the claims.

HCA would soon discover its problems didn’t end at Bayonet Point.

A Nurse Speaks Out

C. T. Tomlinson said he could not believe his eyes as Dr. Abdul Shadani prepared to insert a stent in a heart patient in the cardiac catheterization lab of HCA’s Lawnwood hospital in the late spring of 2008.

Mr. Tomlinson, a traveling nurse who had worked at more than a dozen cath labs before arriving at Lawnwood, said in a telephone interview that he saw no blockages in the images of the patient’s artery.

“Sir, what are we going to fix?” Mr. Tomlinson recalled asking Dr. Shadani. The doctor responded by asking the nurse if he did not see the 90 percent blockage in the artery. Mr. Tomlinson did not, and looked at the others in the room. They all shrugged, he said, and Dr. Shadani inserted the stent.

Mr. Tomlinson reported his concerns to hospital officials. Shortly after, he was told his contract would not be renewed. An internal memo, however, concluded that Mr. Tomlinson had been retaliated against. Even so, that summer the hospital opened an investigation. Internal communications show that HCA officials in charge of quality were involved in the decision to review a sample of cases from some cardiologists at the hospital.

The reviewer, an outside heart specialist, concluded there were problems with 13 of the 17 cases performed by Dr. Shadani, including unwarranted cardiac catheterizations and patients who were needlessly subjected to multiple procedures.

While it is not clear whether HCA accepted the reviewer’s findings, Dr. Shadani continues to practice at Lawnwood, according to the Web site. Dr. Shadani did not return several telephone calls seeking comment.

The outside reviewer found similar problems with several other cardiologists at Lawnwood. The company declined to say whether it alerted regulators or patients of its findings but it said it established stricter rules governing how cardiologists should document their cases.

A Moneymaking Practice

Cardiology is a lucrative business for HCA, and the profits from testing and performing heart surgeries played a critical role in the company’s bottom line in recent years.

Some of HCA’s busiest Florida hospitals perform thousands of stent procedures each year. Medicare reimburses hospitals about $10,000 for a cardiac stent and about $3,000 for a diagnostic catheterization.

But in recent years, doctors across the country have been less quick to implant stents, instead relying on drugs to treat blockages. Medicare has also questioned the need for patients who receive cardiac stents to stay overnight at the hospital, cutting into the profitability of the procedures at many hospitals.

HCA has more than 100 catheterization labs across the country and the one at Lawnwood was a financial juggernaut. It accounted for 35 percent of the hospital’s net profits, according to financial documents.

In fact, one of the physicians from Lawnwood’s cardiac cath lab, Dr. Prasad Chalasani, was highlighted by the hospital in a 2009 business plan as being the most profitable doctor at the facility. “Our leading EBDITA MD,” the plan described him. (Ebitda, or earnings before interest, taxes, depreciation and amortization, is a measure of corporate earnings.) Just a few months earlier, hospital executives had received an outside review that characterized Dr. Chalasani as too quick to perform catheterizations, often without first doing the stress tests necessary to determine whether a patient needed the invasive and costly test.

When reached by telephone, Dr. Chalasani defended his work, saying the 2008 findings were the result of poor documentation about what had occurred before the patients received the catheterizations. “The tests were done,” he said.

Dr. Chalasani emphasized that he was not paid by the hospital, and had privileges at other hospitals. Since 2008, he said, doctors have improved their documentation. Among the changes, he said, is the use of forms requiring the doctors to indicate that they are following established guidelines.

“To my knowledge, we have made tremendous progress,” he said.

The questions raised by the 2008 incident might have ended there if not for Mr. Tomlinson’s 2010 letter to Alan R. Yuspeh, the head of HCA’s ethics and compliance. HCA undertook another review of Lawnwood and some of its other hospitals in Florida, including Kendall Regional Medical Center, in Miami, and Palms West Hospital, near West Palm Beach. The results showed that some patients without heart disease were receiving questionable treatment, and HCA has responded by conducting still more reviews.
 
These doctors do not hive a shit about their patients. And, it is far worse than what is pictured here. More - The $34-Million Spine Surgeon The $34-Million Spine Surgeon ]

Medtronic Documents Spur New Questions
Medtronic Documents Spur New Questions - WSJ.com

A report by the Senate Finance Committee based on thousands of documents it subpoenaed from Medtronic Inc. MDT +0.34% raises new questions about the integrity of the medical research underpinning one of the medical-device maker's products.

Medtronic was "heavily involved in drafting, editing and shaping the content of medical journal articles" about the product—a bone-growth protein used in spine surgery called Infuse—even as it was paying the physicians who wrote those articles a total of $210 million for unrelated work, the Senate report alleges.

In one instance, a Medtronic employee recommended to one of the physicians not publishing a list of side effects associated with Infuse in a 2005 journal article, company emails show. Medtronic marketing officials also urged inserting language into other journal articles touting the use of Infuse as better for patients than using bone harvested from their pelvises because of the pain associated with the latter, other company documents show.

Medtronic's influence extended to preparing a physician's 2002 speech to a panel advising the Food and Drug Administration on whether to approve the drug, the report alleges. The physician's disclosure to the panel at the time suggested his testimony was independent, but the company had in fact helped him draft it and paid him as a consultant the previous year, company documents show. Medtronic later hired the physician as an executive.

In response to the Senate report, Medtronic issued a statement saying it "vigorously" disagreed with any suggestion that "it improperly influenced or authored any of the peer-reviewed published manuscripts." The company also denied that it "intended to under-report adverse events" associated with Infuse.

Infuse, which is used to spur the fusion of vertebrae to reduce back pain, once brought up to $800 million in annual sales for Medtronic. But the drug has been a source of controversy for the company since 2008, when reports began surfacing of patient deaths linked to its use in the neck.

The FDA approved Infuse in 2002 only for use in one particular type of surgery involving the lower spine. But it became widely used in other types of surgeries, including neck procedures, after a series of medical-journal articles depicted those other uses as safe and effective. Doctors are free to use drugs beyond their official uses, but companies can't promote such "off-label" uses.

Those journal articles have since come under a cloud. Last year, Eugene Carragee, a professor of orthopedic surgery at Stanford University School of Medicine, published a study showing that 13 of the articles failed to report serious complications associated with Infuse and a sister drug called Amplify that hasn't been approved by the FDA. Dr. Carragee's study prompted the Senate inquiry that led to Thursday's report.

Although it was known that Medtronic had financial relationships with some of the physicians who wrote journal articles, the scale of the payments and how far back they went in time had not been fully disclosed until now.

Medtronic says the payments weren't connected to the journal articles. Rather, it said, "the vast majority" were "royalty payments made to compensate physicians for their intellectual property rights and contributions" to other company products.

The documents obtained by the Senate committee show that Medtronic paid four of the article authors—Scott D. Boden, Regis W. Haid, Volker Sonntag and Thomas A. Zdeblick—between $22 million and $34 million each from 1996 to 2010. Medtronic also paid a limited liability company connected to two other authors, John R. Dimar and Steven D. Glassman, nearly $65 million over the same period.

All six are spine surgeons with current or former university affiliations. Drs. Boden and Haid are based in Atlanta, Dr. Sonntag in Phoenix, Dr. Zdeblick in Madison, Wis., and Drs. Dimar and Glassman in Louisville, Ky.

Another 27 physicians who shared authorship of the medical journal articles received payments from Medtronic ranging from a few hundred dollars to $6.4 million over the same 15-year span, the Medtronic documents show.

Dr. Sonntag didn't respond to attempts to reach him for comment.

Dr. Zdeblick said he was "a minor author" on two of the Infuse articles and "saw those manuscripts only in their later stages and have no knowledge of their early preparation." He said the $34 million he received from Medtronic was "related to the spinal implants I have designed and hold 22 patents on." He added that he received no royalties for Infuse itself. However, some of his royalties were for a device that Infuse is encased in when it's inserted in the spine.

Dr. Haid said the $25.5 million he was paid by Medtronic was for patented contributions he made to a variety of Medtronic products, though not Infuse. He said the money didn't influence his judgment with regard to the two journal articles he participated in. "I hold myself to high standards of integrity," he added.

Dr. Boden said he wrote two early articles about Infuse without input from "any Medtronic personnel." He acknowledged receiving consulting payments from the company at the time, but said he disclosed them to his university and took "steps to manage potential conflicts." He added that most of the $28.8 million he received from Medtronic came later and was related to "intellectual property for future biologic products." However, Dr. Boden was also a co-author on a 2007 article about Amplify, by which time he had begun receiving large royalty payments from Medtronic.

Drs. Glassman and Dimar said their journal articles "were edited and published by ourselves" and added that they have reported Infuse's adverse effects "in numerous peer-reviewed publications." They said the money their limited-liability company received from Medtronic was royalties shared with three other surgeons.

In most of the medical journal articles, the authors didn't disclose their extensive financial relationships with Medtronic.

For instance, in the 2007 Amplify article, which was co-authored by Drs. Boden, Glassman and Dimar, the disclosure read in part: "No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript."

That year, Drs. Dimar and Glassman's limited liability company received $9.7 million in royalties for a system of rods, hooks and screws they used in conjunction with Amplify in the study, Medtronic documents show. The study also failed to report a probable link between Amplify and cancer that ultimately led the FDA to decline to approve the drug.

Medtronic's role in shaping the medical journal articles was similarly not disclosed. In June 2004, a Medtronic marketing executive recommended to a surgeon author not listing all the adverse events associated with Infuse in the manuscript of one article. That article was published the following year in the Journal of Bone and Joint Surgery without a table detailing the adverse events.

Dr. Carragee says the omission had serious health implications because the adverse events included instances of inflammation, neurologic problems and bone weakening that could have been forerunners of the problems some patients would later die from when Infuse was used off label in their necks.

In another example of Medtronic's role in molding what was supposed to be independent medical research, another of the company's marketing executives encouraged the authors of two medical journal articles to emphasize the pain experienced by a control group of patients who received pelvic-bone grafts instead of Infuse. A "bigger deal should be made of elimination of donor site pain with Infuse," the executive wrote in a 2001 email to one of the surgeon authors. "I would put that front and center in results, discussion and conclusion so that 'equivalent' results aren't received as a letdown."

In some instances, Medtronic employees drafted responses for the authors to concerns expressed by peer reviewers before publication, the company documents show.

In January 2002, Hallett H. Mathews, a spine surgeon based in Richmond, Va., appeared before an FDA committee tasked with advising the agency about whether to allow Infuse onto the market. Before giving his testimony, which was favorable to Infuse, Dr. Hallett told the committee: "I have no direct financial interest in the product under review here today and am not being paid for my participation in this meeting."

Though technically correct, the disclaimer didn't disclose that Dr. Mathews had been paid consulting fees by Medtronic in 2001 and that Medtronic had worked with the public-relations firm Ketchum to prepare his testimony to the committee that day. Dr. Mathews later went to work for Medtronic as an executive. He left the company last year. Dr. Mathews didn't respond to an attempt to reach him.

In an attempt to address concerns about the science behind Infuse, Medtronic has given a $2.5 million grant to Yale University to oversee two independent reviews of all of its clinical data on the drug. The company expects those reviews to be completed sometime next year.
 
Fiona G. Clinical trial data for all drugs in current use. BMJ 2012;345. Clinical trial data for all drugs in current use | BMJ

Must be made available for independent scrutiny

The drug industry does many good things. It produces medicines that can improve health and save lives. It creates jobs and stimulates economic growth. Sadly it does bad things too. Persistently and systematically over decades it has withheld and misreported data from clinical trials.1 As a result, a whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money. Such wilful distortion is scientific misconduct. It is not something we can forgive because of the good things drug companies do. As Ben Goldacre says in the introduction to his new book Bad Pharma, “Drug companies around the world have produced some of the most amazing innovations of the past fifty years, saving lives on an epic scale. But that does not allow them to hide data, mislead doctors, and harm patients.”

Hats off then to GlaxoSmithKline, which announced last month that it would allow access to anonymised patient level data from its clinical trials. An independent panel will assess all requests, and the company’s chief executive officer, Andrew Witty, says access will be granted on the basis of a reasonable scientific question, a protocol, and a commitment from the researchers to publish their results. Trial data collected since 2007 will be placed on a password protected website. Earlier data, not yet available in standard digitised formats, will be made available on “an ad hoc basis.”

Whether researchers will find it as easy to get past the panel as Witty suggests we will have to wait and see. It will be particularly important to know how many requests are turned down and for what reasons.

And amid the plaudits, a moment of doubt. Surely what this apparently brave and benevolent action really serves to highlight is the rank absurdity of the current situation. Why aren’t all clinical trial data routinely available for independent scrutiny once a regulatory decision has been made? How have commercial companies been allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators? Why should it be up to the companies to decide who looks at the data and for what purpose? Why should it take legal action (as in the case of GlaxoSmithKline’s paroxetine and rosiglitazone), strong arm tactics by national licensing bodies (Pfizer’s reboxetine), and the exceptional tenacity of individual researchers and investigative journalists (Roche’s oseltamivir) to try to piece together the evidence on individual drugs?

Goldacre’s book makes it clear that the reasons are complex and there are no simple solutions. But there is no doubt that medical journals could do more. Rather than no longer publishing industry funded trials, as some have suggested, they could leverage their power and publish only where there is a commitment to make the relevant anonymised patient level data available on reasonable request. The International Committee of Medical Journal Editors has so far declined to take such a step. The BMJwill require this commitment for all clinical trials of drugs and devices—whether industry funded or not—from January 2013.

The BMJ is also intensifying its efforts to help resolve a three year battle to gain access to the full data on oseltamivir (Tamiflu). In 2009 the Cochrane respiratory group, led by Tom Jefferson, was commissioned by the UK government to update its systematic review of neuraminidase inhibitors. Despite a public promise to release “full study reports” (internal company reports) for each trial, each of which can run to thousands of pages, Roche has stonewalled, variously pleading patient or commercial confidentiality, or claiming that sufficient data have already been provided.

In fact the Cochrane group has told the BMJ that about 60% of Roche’s data from phase III trials of oseltamivir have never been published. And although the European Medicines Agency (EMA) could have requested these data from Roche, it did not do so. This means that tax payers in the United Kingdom and around the world have spent billions of dollars stockpiling a drug for which no one except the manufacturer has seen the complete evidence base. Indeed the EMA’s unprecedented infringement proceedings launched against Roche last month suggest that even the manufacturer has never fully evaluated evidence it has collected on the drug’s adverse effects. What has Roche got to hide?

Two weeks ago in an attempt to break the deadlock, the BMJ wrote to one of the UK’s leading academics, John Bell, regius professor of medicine at Oxford University, who is a member of Roche’s board of directors. The letter is published this week. In a response not for publication, Bell said he has referred the matter to Roche and is awaiting a response.

Meanwhile, frustrated by the lack of progress, Jefferson and colleagues have given theBMJ their entire email correspondence with Roche, which is now published at bmj.com/tamiflu, as David Payne explains. They have also shared with us their correspondence with the World Health Organization and US Centers for Disease Control and Prevention. The emails show that none of the Cochrane group’s questions have been answered. All future emails to and from the Cochrane group will be added to the site.

The open correspondence on bmj.com aims to hold specific individuals and organisations to account. Their actions are preventing independent scrutiny of the results of clinical trials and putting patients’ lives at risk. We also hope it will contribute to a sea change in the public mood. Goldacre’s book presents an opportunity to raise awareness of a scandal too long ignored by those in power. We should seize this moment with both hands.
 
How Drug Company Money is Undermining Science
The pharmaceutical industry funnels money to prominent scientists who are doing research that affects its products—and nobody can stop it
How Drug Company Money Is Undermining Science: Scientific American

Many researchers maintain close financial ties to the drug companies that stand to gain from the results of their research.

Congress passed the Physician Payments Sunshine Act, which, starting in 2013, will compel pharmaceutical firms and medical device manufacturers to reveal most of the money that they are putting into the pockets of physicians.

Yet as the case study in this article shows, neither scientific institutions nor the scientists themselves have shown a willingness to police conflicts of interest in research.
 
Conflicted influences
http://www.washingtonpost.com/wp-srv/special/business/NEJM-articles/index.html (New England Journal of Medicine - The Washington Post)

The New England Journal of Medicine is commonly regarded as one of the most esteemed journals in medicine and influences the practice of medicine around the world. But about two-thirds of its articles on new drugs are sponsored by pharmaceutical companies and most of those are co-written by their employees. The journal’s editors have put in place numerous safeguards to prevent bias. In some recent high-profile cases, some of those articles have either overstated the benefits or underestimated the risks of a sponsor’s drugs.
 
Bell SK, Smulowitz PB, Woodward AC, et al. Disclosure, Apology, and Offer Programs: Stakeholders’ Views of Barriers to and Strategies for Broad Implementation. Milbank Quarterly 2012;90(4):682-705. Disclosure, Apology, and Offer Programs: Stakeholders’ Views of Barriers to and Strategies for Broad Implementation - BELL - 2012 - Milbank Quarterly - Wiley Online Library

Context: The Disclosure, Apology, and Offer (DA&O) model, a response to patient injuries caused by medical care, is an innovative approach receiving national attention for its early success as an alternative to the existing inherently adversarial, inefficient, and inequitable medical liability system. Examples of DA&O programs, however, are few.

Methods: Through key informant interviews, we investigated the potential for more widespread implementation of this model by provider organizations and liability insurers, defining barriers to implementation and strategies for overcoming them. Our study focused on Massachusetts, but we also explored themes that are broadly generalizable to other states.

Findings: We found strong support for the DA&O model among key stakeholders, who cited its benefits for both the liability system and patient safety. The respondents did not perceive any insurmountable barriers to broad implementation, and they identified strategies that could be pursued relatively quickly. Such solutions would permit a range of organizations to implement the model without legislative hurdles.

Conclusions: Although more data are needed about the outcomes of DA&O programs, the model holds considerable promise for transforming the current approach to medical liability and patient safety.
 
Malin JL, Weeks JC, Potosky AL, Hornbrook MC, Keating NL. Medical Oncologists' Perceptions of Financial Incentives in Cancer Care. Journal of Clinical Oncology. Medical Oncologists' Perceptions of Financial Incentives in Cancer Care

Purpose The cost of cancer care continues to increase at an unprecedented rate. Concerns have been raised about financial incentives associated with the chemotherapy concession in oncology practices and their impact on treatment recommendations.

Methods The objective of this study was to measure the physician-reported effects of prescribing chemotherapy or growth factors or making referrals to other cancer specialists, hospice, or hospital admissions on medical oncologists' income. US medical oncologists involved in the care of a population-based cohort of patients with lung or colorectal cancer from the Cancer Care Outcomes Research and Surveillance (CanCORS) study were surveyed regarding their perceptions of the impact of prescribing practices or referrals on their income.

Results Although most oncologists reported that their incomes would be unaffected, compared with salaried oncologists, physicians in fee-for-service practice, and those paid a salary with productivity incentives were more likely to report that their income would increase from administering chemotherapy (odds ratios [ORs], 7.05 and 7.52, respectively; both P < .001) or administering growth factors (ORs, 5.60 and 6.03, respectively; both P < .001).

Conclusion A substantial proportion of oncologists who are not paid a fixed salary report that their incomes increase when they administer chemotherapy and growth factors. Further research is needed to understand the impact of these financial incentives on both the quality and cost of care.
 
Fiscal Footnote: Big Senate Gift to Drug Maker
http://www.nytimes.com/2013/01/20/u...ay-is-political-win-for-amgen-drug-maker.html

January 19, 2013
By ERIC LIPTON and KEVIN SACK

WASHINGTON — Just two weeks after pleading guilty in a major federal fraud case, Amgen, the world’s largest biotechnology firm, scored a largely unnoticed coup on Capitol Hill: Lawmakers inserted a paragraph into the “fiscal cliff” bill that did not mention the company by name but strongly favored one of its drugs.

The language buried in Section 632 of the law delays a set of Medicare price restraints on a class of drugs that includes Sensipar, a lucrative Amgen pill used by kidney dialysis patients.

The provision gives Amgen an additional two years to sell Sensipar without government controls. The news was so welcome that the company’s chief executive quickly relayed it to investment analysts. But it is projected to cost Medicare up to $500 million over that period.

Amgen, which has a small army of 74 lobbyists in the capital, was the only company to argue aggressively for the delay, according to several Congressional aides of both parties.

Supporters of the delay, primarily leaders of the Senate Finance Committee who have long benefited from Amgen’s political largess, said it was necessary to allow regulators to prepare properly for the pricing change.

But critics, including several Congressional aides who were stunned to find the measure in the final bill, pointed out that Amgen had already won a previous two-year delay, and they depicted a second one as an unnecessary giveaway.

“That is why we are in the trouble we are in,” said Dennis J. Cotter, a health policy researcher who studies the cost and efficacy of dialysis drugs. “Everybody is carving out their own turf and getting it protected, and we pass the bill on to the taxpayer.”

The provision’s inclusion in the legislation to avert the tax increases and spending cuts that made up the so-called fiscal cliff shows the enduring power of special interests in Washington, even as Congress faces a critical test of its ability to balance the budget.

Amgen has deep financial and political ties to lawmakers like Senate Minority Leader Mitch McConnell, Republican of Kentucky, and Senators Max Baucus, Democrat of Montana, and Orrin G. Hatch, Republican of Utah, who hold heavy sway over Medicare payment policy as the leaders of the Finance Committee.

It also has worked hard to build close ties with the Obama administration, with its lobbyists showing up more than a dozen times since 2009 on logs of visits to the White House, although a company official said Saturday that it had not appealed to the administration during the debate over the fiscal legislation.

Aides to Mr. Hatch and Mr. Baucus, and a spokeswoman for Amgen, said the delay would give the Medicare system and medical providers the time they needed to accommodate other complicated changes in how federal reimbursements for kidney care were determined.

“Sometimes when you try to do too much and too quickly, you screw up,” said Antonia Ferrier, a spokeswoman for Mr. Hatch. The goal, an Amgen spokeswoman said in a written statement, is “to ensure that quality of care is not compromised for dialysis patients.”

But the measure runs counter to a five-year effort in Washington to control the enormous expense of dialysis for the Medicare program by reversing incentives to overprescribe medication.

Amgen’s success also shows that even a significant federal criminal investigation may pose little threat to a company’s influence on Capitol Hill. On Dec. 19, as Congressional negotiations over the fiscal bill reached a frenzy, Amgen pleaded guilty to marketing one of its anti-anemia drugs, Aranesp, illegally. It agreed to pay criminal and civil penalties totaling $762 million, a record settlement for a biotechnology company, according to the Justice Department.

Amgen, whose headquarters is near Los Angeles and which had $15.6 billion in revenue in 2011, has a deep bench of Washington lobbyists that includes Jeff Forbes, the former chief of staff to Mr. Baucus; Hunter Bates, the former chief of staff for Mr. McConnell; and Tony Podesta, whose fast-growing lobbying firm has unusually close ties to the White House.

Amgen’s employees and political action committee have distributed nearly $5 million in contributions to political candidates and committees since 2007, including $67,750 to Mr. Baucus, the Finance Committee chairman, and $59,000 to Mr. Hatch, the committee’s ranking Republican. They gave an additional $73,000 to Mr. McConnell, some of it at a fund-raising event for him that it helped sponsor in December while the debate over the fiscal legislation was under way. More than $141,000 has also gone from Amgen employees to President Obama’s campaigns.

What distinguishes the company’s efforts in Washington is the diversity and intensity of its public policy campaigns. Amgen and its foundation have directed hundreds of thousands of dollars in charitable contributions to influential groups like the Congressional Black Caucus and to lesser-known groups like the Utah Families Foundation, which was founded by Mr. Hatch and brings the senator positive coverage in his state’s news media.

Amgen has sent large donations to Glacier PAC, sponsored by Mr. Baucus in Montana, and OrrinPAC, a political action committee controlled by Mr. Hatch in Utah.

And when Mr. Hatch faced a rare primary challenge last year, a nonprofit group calling itself Freedom Path sponsored advertisements in Utah that attacked his opponent, an effort that tax records released in November show was financed in large part by the Pharmaceutical Research and Manufacturers of America, a trade group that includes Amgen.

In some cases, the company’s former employees have found important posts inside the Capitol. They include Dan Todd, one of Mr. Hatch’s top Finance Committee staff members on health and Medicare policy, who worked as a health policy analyst for Amgen’s government affairs office from 2005 to 2009. Mr. Todd, who joined Mr. Hatch’s staff in 2011, was directly involved in negotiating the dialysis components of the fiscal bill, and he met with “all the stakeholders,” Mr. Hatch’s spokeswoman said, not disputing when asked that this included Amgen lobbyists.

For years, Amgen used its clout in Washington to lobby for generous Medicare payments for its blockbuster drug, Epogen, which fends off anemia in dialysis patients.

The Medicare program covers most costs associated with treating severe renal disease, regardless of a patient’s age, and the dialysis market continues to grow steadily. In 2010, the government’s kidney program was spending $1.9 billion on injectable anti-anemia drugs like Epogen.

But nearly a decade ago, evidence started to surface that questioned the effectiveness and safety of Epogen at the levels being used.

Researchers found that Medicare’s practice of reimbursing providers with separate payments for the drugs and for dialysis treatments encouraged overprescription because the providers made healthy profits with each dose. They also found that high doses posed cardiovascular risks to patients.

Congress reversed the incentive in 2008 by requiring Medicare to pay a single, bundled rate for a dialysis treatment and related medications starting in 2011. With providers potentially profiting more by prescribing less Epogen, use of dialysis drugs dropped by nearly 25 percent.

But the blow was softened for Amgen and other kidney care companies with a few favors from Congress. Among them was a two-year delay in the inclusion of certain oral drugs, Sensipar among them, in the new bundled payment system. That meant demand for Sensipar would not decline and Amgen would maintain control over pricing.

With that two-year exclusion set to expire in 2014, Amgen’s lobbyists began making rounds again on Capitol Hill last fall. In private meetings with staff members of the House Ways and Means and Senate Finance Committees, they argued for another two-year delay, several Congressional aides said.

Committee staff members had been meeting regularly in Room S-124 of the Capitol to negotiate a package of Medicare cuts needed to prevent a large scheduled reduction in doctors’ fees. The kidney program was on the table because a new report by the Government Accountability Office had found that Medicare had overpaid for dialysis by up to $880 million in 2011.

The discussions about cutting dialysis reimbursement began late last fall with little focus on a delay for oral drugs, but it was eventually endorsed by leading staff members for Mr. Baucus and Mr. Hatch, Congressional aides said.

Aides to the senators said the delay made sense because the Government Accountability Office had warned in early 2011 that federal regulators should take care in setting compensation levels for the drugs.

But others on Capitol Hill saw no justification for further delay.

“It is disappointing,” said a Democratic Congressional aide who declined to be named because of the issue’s sensitivity, “since the status quo encourages prescribing of oral drugs based on financial incentives rather than on best clinical practices.”

Mr. Hatch’s spokeswoman, Ms. Ferrier, said the involvement of Mr. Todd, the former Amgen employee, had not been inappropriate and that dozens of staff members on Capitol Hill handled matters that might benefit former employers.

“They have to leave their previous lives behind,” Ms. Ferrier said. “And Dan has done just that.”

After the House was sidelined late in the fiscal negotiations, the Senate gained control of the final bill-writing process, and the provision requested by Amgen was inserted into the legislation by Senate staff members.

Aides to Mr. Baucus and Mr. Hatch emphasized that the White House and Senate leadership, including Mr. McConnell, had the final word on the bill.

A spokesman for Mr. McConnell praised the parts of the legislation related to Medicare, while a White House spokesman declined to comment, saying the matter was decided by players on Capitol Hill.

Many lobbyists and Congressional aides said they first learned of the language when the final bill was posted publicly, only hours before being approved. It called for cutting $4.9 billion over 10 years by lowering Medicare payments for dialysis, but left hundreds of millions on the table by extending the oral drug delay.

At this point, opponents had no way to challenge the provision, as there was a single vote on the entire fiscal package. Mr. Baucus and Mr. Hatch voted in favor.

Aides to the senators said some heavy donors had won and others had lost in the Medicare negotiations — proof that the legislative outcome was based on the merits. “What is the best policy for Montanans and people across the country lies at the heart of every decision Chairman Baucus makes,” said Meaghan Smith, a spokeswoman for Mr. Baucus. “It’s as simple as that.”
 
CLEARLY - Its more like - "BIG gift to unknown congress men - and women...." And in an offshore bank account... LOL:eek:

Fiscal Footnote: Big Senate Gift to Drug Maker
http://www.nytimes.com/2013/01/20/u...ay-is-political-win-for-amgen-drug-maker.html

January 19, 2013
By ERIC LIPTON and KEVIN SACK

WASHINGTON — Just two weeks after pleading guilty in a major federal fraud case, Amgen, the world’s largest biotechnology firm, scored a largely unnoticed coup on Capitol Hill: Lawmakers inserted a paragraph into the “fiscal cliff” bill that did not mention the company by name but strongly favored one of its drugs.

The language buried in Section 632 of the law delays a set of Medicare price restraints on a class of drugs that includes Sensipar, a lucrative Amgen pill used by kidney dialysis patients.

The provision gives Amgen an additional two years to sell Sensipar without government controls. The news was so welcome that the company’s chief executive quickly relayed it to investment analysts. But it is projected to cost Medicare up to $500 million over that period.

Amgen, which has a small army of 74 lobbyists in the capital, was the only company to argue aggressively for the delay, according to several Congressional aides of both parties.

Supporters of the delay, primarily leaders of the Senate Finance Committee who have long benefited from Amgen’s political largess, said it was necessary to allow regulators to prepare properly for the pricing change.

But critics, including several Congressional aides who were stunned to find the measure in the final bill, pointed out that Amgen had already won a previous two-year delay, and they depicted a second one as an unnecessary giveaway.

“That is why we are in the trouble we are in,” said Dennis J. Cotter, a health policy researcher who studies the cost and efficacy of dialysis drugs. “Everybody is carving out their own turf and getting it protected, and we pass the bill on to the taxpayer.”

The provision’s inclusion in the legislation to avert the tax increases and spending cuts that made up the so-called fiscal cliff shows the enduring power of special interests in Washington, even as Congress faces a critical test of its ability to balance the budget.

Amgen has deep financial and political ties to lawmakers like Senate Minority Leader Mitch McConnell, Republican of Kentucky, and Senators Max Baucus, Democrat of Montana, and Orrin G. Hatch, Republican of Utah, who hold heavy sway over Medicare payment policy as the leaders of the Finance Committee.

It also has worked hard to build close ties with the Obama administration, with its lobbyists showing up more than a dozen times since 2009 on logs of visits to the White House, although a company official said Saturday that it had not appealed to the administration during the debate over the fiscal legislation.

Aides to Mr. Hatch and Mr. Baucus, and a spokeswoman for Amgen, said the delay would give the Medicare system and medical providers the time they needed to accommodate other complicated changes in how federal reimbursements for kidney care were determined.

“Sometimes when you try to do too much and too quickly, you screw up,” said Antonia Ferrier, a spokeswoman for Mr. Hatch. The goal, an Amgen spokeswoman said in a written statement, is “to ensure that quality of care is not compromised for dialysis patients.”

But the measure runs counter to a five-year effort in Washington to control the enormous expense of dialysis for the Medicare program by reversing incentives to overprescribe medication.

Amgen’s success also shows that even a significant federal criminal investigation may pose little threat to a company’s influence on Capitol Hill. On Dec. 19, as Congressional negotiations over the fiscal bill reached a frenzy, Amgen pleaded guilty to marketing one of its anti-anemia drugs, Aranesp, illegally. It agreed to pay criminal and civil penalties totaling $762 million, a record settlement for a biotechnology company, according to the Justice Department.

Amgen, whose headquarters is near Los Angeles and which had $15.6 billion in revenue in 2011, has a deep bench of Washington lobbyists that includes Jeff Forbes, the former chief of staff to Mr. Baucus; Hunter Bates, the former chief of staff for Mr. McConnell; and Tony Podesta, whose fast-growing lobbying firm has unusually close ties to the White House.

Amgen’s employees and political action committee have distributed nearly $5 million in contributions to political candidates and committees since 2007, including $67,750 to Mr. Baucus, the Finance Committee chairman, and $59,000 to Mr. Hatch, the committee’s ranking Republican. They gave an additional $73,000 to Mr. McConnell, some of it at a fund-raising event for him that it helped sponsor in December while the debate over the fiscal legislation was under way. More than $141,000 has also gone from Amgen employees to President Obama’s campaigns.

What distinguishes the company’s efforts in Washington is the diversity and intensity of its public policy campaigns. Amgen and its foundation have directed hundreds of thousands of dollars in charitable contributions to influential groups like the Congressional Black Caucus and to lesser-known groups like the Utah Families Foundation, which was founded by Mr. Hatch and brings the senator positive coverage in his state’s news media.

Amgen has sent large donations to Glacier PAC, sponsored by Mr. Baucus in Montana, and OrrinPAC, a political action committee controlled by Mr. Hatch in Utah.

And when Mr. Hatch faced a rare primary challenge last year, a nonprofit group calling itself Freedom Path sponsored advertisements in Utah that attacked his opponent, an effort that tax records released in November show was financed in large part by the Pharmaceutical Research and Manufacturers of America, a trade group that includes Amgen.

In some cases, the company’s former employees have found important posts inside the Capitol. They include Dan Todd, one of Mr. Hatch’s top Finance Committee staff members on health and Medicare policy, who worked as a health policy analyst for Amgen’s government affairs office from 2005 to 2009. Mr. Todd, who joined Mr. Hatch’s staff in 2011, was directly involved in negotiating the dialysis components of the fiscal bill, and he met with “all the stakeholders,” Mr. Hatch’s spokeswoman said, not disputing when asked that this included Amgen lobbyists.

For years, Amgen used its clout in Washington to lobby for generous Medicare payments for its blockbuster drug, Epogen, which fends off anemia in dialysis patients.

The Medicare program covers most costs associated with treating severe renal disease, regardless of a patient’s age, and the dialysis market continues to grow steadily. In 2010, the government’s kidney program was spending $1.9 billion on injectable anti-anemia drugs like Epogen.

But nearly a decade ago, evidence started to surface that questioned the effectiveness and safety of Epogen at the levels being used.

Researchers found that Medicare’s practice of reimbursing providers with separate payments for the drugs and for dialysis treatments encouraged overprescription because the providers made healthy profits with each dose. They also found that high doses posed cardiovascular risks to patients.

Congress reversed the incentive in 2008 by requiring Medicare to pay a single, bundled rate for a dialysis treatment and related medications starting in 2011. With providers potentially profiting more by prescribing less Epogen, use of dialysis drugs dropped by nearly 25 percent.

But the blow was softened for Amgen and other kidney care companies with a few favors from Congress. Among them was a two-year delay in the inclusion of certain oral drugs, Sensipar among them, in the new bundled payment system. That meant demand for Sensipar would not decline and Amgen would maintain control over pricing.

With that two-year exclusion set to expire in 2014, Amgen’s lobbyists began making rounds again on Capitol Hill last fall. In private meetings with staff members of the House Ways and Means and Senate Finance Committees, they argued for another two-year delay, several Congressional aides said.

Committee staff members had been meeting regularly in Room S-124 of the Capitol to negotiate a package of Medicare cuts needed to prevent a large scheduled reduction in doctors’ fees. The kidney program was on the table because a new report by the Government Accountability Office had found that Medicare had overpaid for dialysis by up to $880 million in 2011.

The discussions about cutting dialysis reimbursement began late last fall with little focus on a delay for oral drugs, but it was eventually endorsed by leading staff members for Mr. Baucus and Mr. Hatch, Congressional aides said.

Aides to the senators said the delay made sense because the Government Accountability Office had warned in early 2011 that federal regulators should take care in setting compensation levels for the drugs.

But others on Capitol Hill saw no justification for further delay.

“It is disappointing,” said a Democratic Congressional aide who declined to be named because of the issue’s sensitivity, “since the status quo encourages prescribing of oral drugs based on financial incentives rather than on best clinical practices.”

Mr. Hatch’s spokeswoman, Ms. Ferrier, said the involvement of Mr. Todd, the former Amgen employee, had not been inappropriate and that dozens of staff members on Capitol Hill handled matters that might benefit former employers.

“They have to leave their previous lives behind,” Ms. Ferrier said. “And Dan has done just that.”

After the House was sidelined late in the fiscal negotiations, the Senate gained control of the final bill-writing process, and the provision requested by Amgen was inserted into the legislation by Senate staff members.

Aides to Mr. Baucus and Mr. Hatch emphasized that the White House and Senate leadership, including Mr. McConnell, had the final word on the bill.

A spokesman for Mr. McConnell praised the parts of the legislation related to Medicare, while a White House spokesman declined to comment, saying the matter was decided by players on Capitol Hill.

Many lobbyists and Congressional aides said they first learned of the language when the final bill was posted publicly, only hours before being approved. It called for cutting $4.9 billion over 10 years by lowering Medicare payments for dialysis, but left hundreds of millions on the table by extending the oral drug delay.

At this point, opponents had no way to challenge the provision, as there was a single vote on the entire fiscal package. Mr. Baucus and Mr. Hatch voted in favor.

Aides to the senators said some heavy donors had won and others had lost in the Medicare negotiations — proof that the legislative outcome was based on the merits. “What is the best policy for Montanans and people across the country lies at the heart of every decision Chairman Baucus makes,” said Meaghan Smith, a spokeswoman for Mr. Baucus. “It’s as simple as that.”
 
Published clinical trials shown to be misleading
Comparison of internal and public reports about Pfizer’s drug Neurontin reveals many discrepancies
http://www.sciencenews.org/view/generic/id/347933/description/Published_clinical_trials_shown_to_be_misleading


Vedula SS, Li T, Dickersin K. Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin. PLoS Med 2013;10(1):e1001378. PLOS Medicine: Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin

Using documents obtained through litigation, S. Swaroop Vedula and colleagues compared internal company documents regarding industry-sponsored trials of off-label uses of gabapentin with the published trial reports and find discrepancies in reporting of analyses.
 
Open Data
Open Data | BMJ

Missing clinical trial data are systematically undermining doctors’ ability to prescribe treatment with confidence. A whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money.

It is well documented that researchers and companies often withhold clinical trial results from doctors and patients. Half of all trials are never published. In many cases—such as those of oseltamivir (Tamiflu) and rimonabant—direct requests for information about trials have been refused.

The reporting rules at clinicaltrials.gov have been ignored by four out of five trials . It is common to read in Cochrane Library publications, and other systematic reviews, that strong evidence of publication bias exists, and that companies refused to share information.

This is not a state of affairs that any reasonable person should tolerate.

As of January 2013, the BMJ will no longer publish any trial of drugs or devices where the authors do not commit to making the relevant anonymised patient level data available, upon reasonable request.

On this page we are documenting some of the BMJ’s coverage of adverse outcomes associated with missing clinical trial data. We are also highlighting the extent of the problem, as shown in our missing data special issue, published in 2012.

We are also asking you to help us catalogue drugs, devices, and treatments for which a lack of complete clinical trial data has resulted in a skewed evidence base. Fill in our online form to tell us where and when you have seen this reported.
 
Doctors Who Don’t Speak Out
http://www.nytimes.com/2013/02/17/s...se-shows-why-doctors-often-remain-silent.html

February 15, 2013
By BARRY MEIER

THE note sent by a doctor to several executives at Johnson & Johnson was blunt: an artificial hip sold by the company was so poorly designed that the company should slow its marketing until it understood why patients were getting hurt.

The doctor, who also worked as a consultant to Johnson & Johnson, wrote the note nearly two years before the company recalled the device in 2010. And it was far from the only early warning those executives got from doctors who were paid consultants. Still, the company’s DePuy orthopedic unit plowed ahead, and those consultants never sounded a public alarm to other doctors, who kept implanting the device.

The memos have recently emerged during the trial of the first of more than 10,000 patient lawsuits brought against Johnson & Johnson over the hip implant device, the Articular Surface Replacement, or A.S.R. The company has insisted that it acted responsibly in determining when to halt its sale. But plaintiffs’ lawyers have offered a portrait of executives who put profits ahead of patients, even scuttling a plan to fix the implant because it cost too much.

It might not be surprising to find that executives acted to protect a company’s bottom line. Still, the Johnson & Johnson episode is also illuminating a broader medical issue: while experts say that doctors have an ethical obligation to warn their peers about bad drugs or medical devices, they often do not do so.

“Questioning the status quo in medicine is not easy,” said Dr. Harlan Krumholz, a professor at Yale School of Medicine.

Physicians may remain silent for a variety of reasons, he and other experts said. They may fear that speaking out could get them sued or believe that a product problem was an anomaly or their fault.

Doctors also have an aversion to reporting. For instance, while the Food and Drug Administration relies on physicians to help monitor product safety by alerting the agency to adverse patient reactions, doctors usually do not make such filings, saying they are too busy for the paperwork.

“The standard in the medical community is not to report,” said Dr. Robert Hauser, a cardiologist who, along with a colleague, warned other doctors in 2005 about a defective heart implant.

There is another reason doctors may choose to remain silent, experts say: their financial ties to a drug or device maker.

For years, such consulting payments have raised concerns about the impact of money on a doctor’s decision about which drugs to prescribe or how to interpret research findings. Money can also shift a physician’s sense of loyalty, said George Loewenstein, a professor at Carnegie Mellon University who has studied medical conflict-of-interest policies. “If someone has been paying you or employing you, it is very difficult to blow the whistle,” said Professor Loewenstein, who teaches economics and psychology. “It offends our sense of loyalty.”

Dr. Krumholz said he also believed that such loyalties were between a doctor and a company’s executives, rather than with a company or its brand. Over time, a physician may come to see his relationships with those officials in terms of friendship, while companies see an influential doctor as an asset who helps develop products and boost sales.

For a consultant, breaking those ties can carry a cost. For example, when Dr. Lawrence D. Dorr, an orthopedic specialist, warned fellow surgeons in an open letter in 2008 that a hip implant made by Zimmer Holdings was flawed, he became the subject of a whisper campaign that questioned his skills as a surgeon.

“The first thing that a company does is to put out a campaign that a surgeon does not know how to operate,” said Dr. Dorr, who was a consultant to Zimmer when he wrote the letter. “It hurt my practice for a year.”

TRADITIONALLY, doctors have brought problems to the attention of colleagues by conducting research and publishing their findings in a medical journal. The advantage of that system helps ensure the credibility of study data and protects a researcher from random attack, said Dr. David Blumenthal, the president of the Commonwealth Fund, a group that studies health policy issues.

But getting a study published can take a year or two; some Johnson & Johnson consultants did publish studies about the hip’s flaws, but they largely appeared after it had been recalled.

Dr. Blumenthal said there was probably a need for more immediate ways for doctors to share their concerns, like forums supported by professional medical organizations. Another approach would be to have companies hire doctors as consultants whose sole concern was product safety, Professor Loewenstein said.

The results of not speaking out are playing out in a Los Angeles courtroom, where the first Johnson & Johnson hip case is unfolding. In the years before the implant’s recall, a British physician, Dr. Antoni Nargol, and a colleague were among those who tried to alert surgeons to the problem.

But the silence of other doctors apparently gave company executives the upper hand; in meetings with Dr. Nargol, they said that he seemed to be the only doctor having trouble.

He said recently, “They told me there were no other problems.”
 
Does scientific misconduct cause patient harm? The case of Joachim Boldt
Does scientific misconduct cause patient harm? The case of Joachim Boldt


Zarychanski R, Abou-Setta AM, Turgeon AF, et al. Association of Hydroxyethyl Starch Administration With Mortality and Acute Kidney Injury in Critically Ill Patients Requiring Volume Resuscitation: A Systematic Review and Meta-analysis.JAMA. 2013;309(7):678-688. JAMA Network | JAMA | Association of Hydroxyethyl Starch Administration With Mortality and Acute Kidney Injury in Critically Ill Patients Requiring Volume ResuscitationA Systematic Review and Meta-analysisHydroxyethyl Starch and Outcomes in Criticall

Importance Hydroxyethyl starch is commonly used for volume resuscitation yet has been associated with serious adverse events, including acute kidney injury and death. Clinical trials of hydroxyethyl starch are conflicting. Moreover, multiple trials from one investigator have been retracted because of scientific misconduct.

Objectives To evaluate the association of hydroxyethyl starch use with mortality and acute kidney injury.

Data Sources Randomized controlled trials from MEDLINE, EMBASE, CENTRAL, Global Health, HealthStar, Scopus, Web of Science, the International Clinical Trials Registry Platform (inception to October 2012), reference lists of relevant articles, and gray literature.

Study Selection Two reviewers independently identified randomized controlled trials comparing hydroxyethyl starch with other resuscitation fluids in critically ill patients receiving acute volume resuscitation.

Data Extraction Two reviewers independently extracted trial-level data including population characteristics, interventions, outcomes, and funding sources. Risk of bias was assessed using the risk of bias tool; the strength of evidence was adjudicated using the GRADE methodology.

Results We included 38 eligible trials comparing hydroxyethyl starch to crystalloids, albumin, or gelatin. The majority of trials were categorized as having an unclear risk or high risk of bias. For the 10 880 patients in studies contributing mortality data, the risk ratio (RR) for death among patients randomized to receive hydroxyethyl starch was 1.07 (95% CI, 1.00 to 1.14; I2, 0%; absolute risk [AR], 1.20%; 95% CI, ?0.26% to 2.66%). This summary effect measure included results from 7 trials performed by an investigator whose subsequent research had been retracted because of scientific misconduct. When we excluded these 7 trials that involved 590 patients, hydroxyethyl starch was found to be associated with increased mortality among 10 290 patients (RR, 1.09; 95% CI, 1.02 to 1.17; I2, 0%; AR, 1.51%; 95% CI, 0.02% to 3.00%), increased renal failure among 8725 patients (RR, 1.27; 95% CI, 1.09 to 1.47; I2, 26%; AR, 5.45%; 95% CI, 0.44% to 10.47%), and increased use of renal replacement therapy among 9258 patients (RR, 1.32; 95% CI, 1.15 to 1.50; I2, 0%; AR, 3.12%; 95% CI, 0.47% to 5.78%).

Conclusion and Relevance In critically ill patients requiring acute volume resuscitation, use of hydroxyethyl starch compared with other resuscitation solutions was not associated with a decrease in mortality. Moreover, after exclusion of 7 trials performed by an investigator whose research has been retracted because of scientific misconduct, hydroxyethyl starch was associated with a significant increased risk of mortality and acute kidney injury. Clinical use of hydroxyethyl starch for acute volume resuscitation is not warranted due to serious safety concerns.
 
Comparative [IN]Effectiveness Research on Robotic Surgery

Weissman JS, Zinner M. Comparative Effectiveness Research on Robotic Surgery. JAMA. 2013;309(7):721-722. JAMA Network | JAMA | Comparative Effectiveness Research on Robotic SurgeryComparative Effectiveness and Robotic Surgery

During the last 10 years, the use of robotic-assisted surgery has substantially increased, beginning with urologic procedures and expanding to include gynecologic procedures and many others. Robotic-assisted surgery is a type of minimally invasive procedure that in fact facilitates laparoscopic surgery. Both approaches provide benefits compared with open surgery, including smaller incisions, shorter hospital stays, less postoperative pain, and possibly quicker return to function. As of 2009, more than 200 000 robotically assisted operations had been performed worldwide. The reason for its rapid dissemination in the United States may be linked to a number of converging factors, including better ergonomics for the surgeon, marketing campaigns, and the national fascination with technology and innovation. Under other circumstances, this might be an unparalleled success story of US medical ingenuity. However, critics of robotic surgery claim that it is more expensive without providing a concomitant benefit.

In this issue of JAMA, Wright et al compared the use of robotically assisted hysterectomy for benign gynecologic disease with other approaches. Whereas past research relied on smaller samples in single institutions with limited generalizability, this study used a large national database involving 264 758 women who underwent hysterectomy at 441 hospitals and included detailed clinical variables, comorbidities, and outcomes of perioperative mortality and morbidity. The findings were stark. From 2007 to 2010, overall use of robotically assisted hysterectomy increased from 0.5% to 9.5%, and at hospitals that performed robotic procedures, robotically assisted hysterectomy accounted for 22.4% of all hysterectomies within 3 years. In addition, compared with laparoscopic surgery, robotic surgery was much more expensive—$2000 more per case or nearly a third higher than the median total cost for laparoscopic hysterectomy—without a significant advantage in clinical outcomes.

The study by Wright et al leaves some important unanswered questions. Robotic surgery may have a shorter learning curve than laparoscopic surgery, making it an enabling technology that allows surgeons otherwise unable to perform minimally invasive surgery to offer this benefit to their patients. Because either approach tends to have better outcomes than open laparotomy, in a cost-blind world there may be benefit from the rapid dissemination of a technique that enables access to a minimally invasive procedure for more patients. However, this presumes that laparoscopic surgery is unavailable in areas that offer robotic surgery. The study by Wright et al tracked the apparent replacement of laparoscopic surgery by robotic surgery in hospitals that have machines but did not indicate whether and how often minimally invasive alternatives were available. In addition, training surgeons is expensive. Would it be a better use of resources to train more surgeons in laparoscopic techniques than to spend the money on more robot machines?

A second issue is whether robotic surgery could be valuable for subgroups of patients with select comorbidities or anatomy. It may be necessary to continue to collect detailed registry data to understand if this is the case. Similarly, the results of this study should not be generalized to other clinical conditions for which benefits may accrue from the use of robotic surgery. As always is the case with observational studies, possible selection bias can affect results, although the authors were careful in their analyses by using propensity score methods.

A third issue involves the commercialization of this technology, which has raised eyebrows in the media and elsewhere. Considerable debate surrounded the emergence of direct-to-consumer advertising of prescription drugs in the 1990s. Robotic surgery takes this marketing to a higher level with advanced campaigns not only by industry, but also by surgeons and the hospitals that own the machines. Such consumer-directed advertising is not without merit if it uses consumer awareness to advance underused medical discoveries that benefit the population. However, when the innovation being advertised is of questionable advantage, direct-to-consumer promotion may only fuel unnecessary utilization. Consumer advertising of expensive devices should be subjected to the same scrutiny as that of new and expensive medications.

In the absence of additional research or decreases in price, the path taken by the medical and payer community should be one of caution. At a minimum, manufacturers might begin by voluntarily restricting their promotional activities. Public health entities could consider exercising greater oversight over claims that appear on websites. Meanwhile, physicians and hospitals have a duty to inform their patients of the benefits, risks, and costs of the options. There may also be a role for medical societies, which could join other specialties in the Choosing Wisely initiative of the American Board of Internal Medicine, aimed at identifying services whose “use should be reevaluated by patients and clinicians.”

As reimbursement policies stand today, payments for laparoscopic surgery are the same whether or not the procedures are robotically assisted. Therefore, neither patients, physicians, nor hospitals have the motivation to pursue the less expensive option. The results of this study could inform the development of medical payment policy, that is, the set of decisions made by public and private payers about whether to cover a procedure or service or, if covered, how to manage its utilization. The application of research findings to payment policy can be thought of as a matrix of scenarios depicting value to the health system, with comparative effectiveness (better, equal, worse) on one axis and comparative cost (higher, equal, lower) on the other. Different scenarios suggest different opportunities. For example, in the current US political environment, restricting coverage is difficult when a new technology is more effective, even if it is much more expensive than the technology currently available. Decisions should be more straightforward, however, when a new technology is equally or less effective and more expensive than a current technology. Robotic surgery for conditions such as benign gynecologic disease would seem to fall into the latter category.

Several potential strategies exist. If patient preferences drive the increase in use, it may be appropriate to institute higher copayments or even a reference payment whereby the insurer only covers the cost of the less expensive but equally effective technology. If physicians and hospitals are driving the increase in utilization, they could be asked to justify using the more expensive technology for certain cases. Alternatively, episode-based payments and global contracts promoted under the Affordable Care Act seek to change the payment system so that the incentive to provide high-value care rests with health care organizations, thereby avoiding intrusion by payers into medical decision making. For example, if accountable care organizations or other risk-bearing entities consider robotic surgery a low-value option, they may discourage their surgical groups from making the capital purchase or limit the number of purchases. What is not available cannot be overused.

Inefficiency in health care delivery can trace some of its roots to the use of new and expensive interventions for conditions where other effective treatment options already exist. Evidence-based medicine and comparative effectiveness research (CER) can help ensure the optimal treatment for a given class of patients by reducing the influence of nonclinical factors. By generating evidence comparing the benefits and harms of 2 or more medical interventions, CER can lead to improved patient outcomes, lower cost, or both.

The nation's pursuit of CER will be worthwhile only if the results are used to inform treatment decisions by payers, physicians, hospitals, and patients. The United States is embarking on an unprecedented era in support of evidence-based medicine. The Patient-Centered Outcomes Research Institute was created under health care reform to move the field forward and will have significant resources. The hope is that better and more widely available research will reduce the uncertainty around choosing the optimal intervention, thereby reducing the effect of nonmedical factors such as clinician bias for newer technologies or the profit potential of manufacturers. The medical and surgical community can move more quickly to improved patient outcomes and higher value by not spending scarce resources on less-effective options.
 
The Office of Research Integrity (ORI) Newsletter Addresses the Rise in Retractions
http://ori.hhs.gov/images/ddblock/dec_vol21_no1.pdf

The constant attention to retractions brought forward by RetractionWatch.com along with a steady flow of news regarding research fraud has brought the topic of retractions to the mainstream amongst scientists. Seemingly, more researchers are reading published articles with higher scrutiny not only as learners, but as reviewers.

Dr. John Krueger, ORI scientist-investigator, writes about the consequences of retractions in an article entitled "Why Do Retractions Tell Us?" The article provides thoughtful insight about the extent of the problem, what is causing the rise of retractions, and how can the research community address the rise of retractions.
 
Is Evidence-Based Medicine Only an Illusion?
Is Evidence-Based Medicine Only an Illusion?

In a system where half of all clinical trials never see the light of publication, doctors are merely "imagining that we're practicing evidence-based medicine," says Ben Goldacre, MBBS, a British physician and science journalist.

Goldacre is among the most vocal critics of drugmakers who refuse to hand over complete clinical trial data, making it impossible for doctors and patients to get the full picture on most of the medicines widely used today. He decries the industry's behavior in his new book, Bad Pharma, which in itself is a review of the evidence on evidence review and the stumbling blocks incurred by researchers who try to dig deeper.

He'd like to see all of the clinical study reports ever completed brought out of "dry storage archive...and everywhere else that people stack their old, crinkly, yellow paperwork" and made publicly available -- ideally on his new website, AllTrials.net, which recently signed on GlaxoSmithKline (GSK) to release every study the company has ever done.

During a promotional tour in the U.S., Goldacre answered questions from MedPage Today, in an abbreviated form on camera and in this edited, in-depth Q&A:
 

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