Archive for the ‘Finance and Politics of cancer research and treatment’ Category

Penn’s cancer research institute files lawsuit against former director

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Posted 01 Feb 2012 — by James Street
Category Ethics, Ethics of Science, Finance and Politics of cancer research and treatment, Fraud, General Cancer Research

Craig Thompson allegedly took research he conducted at the Institute to an outside company

Penn’s cancer research institute is suing their former scientific director for $1 billion on charges of stealing intellectual property.

The Leonard and Madlyn Abramson Family Cancer Research Institute filed a $1 billion lawsuit on Dec. 13 against Craig Thompson, the company he co-founded — Agios Pharmaceuticals — and the company that has access to Agios’ drugs, Celgene Corporation.

Thompson, who left the Institute last Oct. 31, is being charged on grounds of intellectual property rights, identifying tangible research property and inventions, fraudulent misrepresentation, breach of fiduciary duty and breach of contract. The plaintiff estimates that reparations for their damages will exceed $1 billion.

In the complaint, the Institute refers to Thompson as “an unscrupulous doctor” who “cheat[ed] future generations of the intended benefits of the … Institute’s intellectual property.”

The nonprofit institute, which is one of the largest in the country, was founded as the Penn Cancer Center in 1973 and was renamed for the Abramson family in 2002.

In the center’s Institutional Agreement, it states that “all Intellectual Property … that is conceived, discovered, developed … in the course of Institute Research Programs whose budgets are funded by multiple sources … will be joint property of the Institute and the University.” The plaintiff now claims that Thompson breached this part of the contract by taking ownership of research that was conducted at the Institute.

When Thompson joined the Institute in 1999 as its scientific director, he managed the Cancer Cell Biology Program. According to the complaint, Thompson allegedly took the cancer cell metabolism research he conducted while at the Institute and brought it to a biotechnology company, Cancer Metabolism Therapeutics, Inc., now known as Agios Pharmaceuticals.

The Institute claims that Thompson concealed his involvement with the company while he was working at the Institute. In addition, Thompson is accused of hiding the fact that the company raised more than $261 million for its “innovative cancer metabolism research platform,” a phrase that the plaintiff says exactly described Thompson’s work at the Institute.

Thompson is also being accused of not informing the Institute that the company was selling all their drugs from this platform to Celgene.

The Institute said they were unaware of Thompson’s involvement with Agios until late last year. They also state that when confronted with the issue, Thompson assured them that his actions did not violate the Institute Agreement.

Susan Phillips, the Institute’s spokesperson, has declined to comment since the suit is still in litigation.

Thompson and his lawyer Allan Arffa have also declined to comment since Thompson has until early February to make an official response to the complaint.

Thompson’s only public statement is that “the allegations in this lawsuit are unfounded and without merit. It is unfortunate that the Abramson Family Cancer Research Institute has chosen to go down this path.”

Last updated January 10, 2012, 10:49 pm

Eighth retraction marks slide of lung cancer work

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Posted 01 Feb 2012 — by James Street
Category Finance and Politics of cancer research and treatment, Fraud, Lung Cancer
Mon, Jan 9 2012

By Ivan Oransky, MD

NEW YORK (Reuters Health) – In a reminder of how much a once-heralded area of lung cancer research has crumbled, a former Duke oncologist and his colleagues issued their eighth study retraction late last week.

On Friday, Dr. Anil Potti and his co-authors formally withdrew a 2008 study in the Journal of the American Medical Association (JAMA) that purported to offer a “genetic signature” that would show which patients with breast cancer would respond to a particular treatment.

The authors write in a statement on the JAMA website — available at bit.ly/AeIufY — that they are retracting the paper because it was based on a method they now believe is unreliable. That approach — which no one has been able to reproduce — was described in a now-withdrawn paper in the journal Nature Medicine in 2006.

The case is yet another example of researchers — some of whom had financial interests in the method — being overly enthusiastic about findings that held great promise for very sick patients, but that did not hold up to scrutiny.

The retraction is the eighth of what Duke officials said this past summer would be about a dozen, along with another dozen corrections and partial retractions. The Duke team had published about 40 papers, many of which have been cited hundreds of times by other scientists, according to Thomson Scientific’s Web of Knowledge.

The now-retracted JAMA study garnered a fair amount of media coverage, too, including a story by Reuters Health on April 1, 2008.

Journals and universities began subjecting the work to intense scrutiny, however, after it emerged that Potti had claimed awards and scholarships that he never received, in biographical sketches for grant applications.

The whole episode has been a “huge setback,” said Dr. Otis Brawley, chief medical officer of the American Cancer Society.

“What happened at Duke is that you have a whole bunch of folks worried that this genomic information is just too complicated, making it too easy for someone to basically create fraudulent science,” Brawley told Reuters Health.

UNDONE BY RESUME ‘INACCURACIES’

Keith Baggerly, who studies genomics at the M.D. Anderson Cancer Center in Houston, has been looking into the Duke team’s data since shortly after the Nature Medicine report came out. A colleague approached him and Kevin Coombes excitedly at the time, hoping he could use the work to improve the treatment of patients at M.D. Anderson.

But Baggerly and Coombes found numerous problems in the research, including mislabeling of data. He began asking the Duke team for their data, but they were slow to provide it. Eventually, some journals began publishing his critiques, often alongside defenses of the work by Potti and his colleagues. Meanwhile, clinical trials making use of the genetic signature continued at Duke.

Baggerly’s questions went largely unheeded until July 2010, when The Cancer Letter, a trade publication, reported that Potti had falsely claimed to be a Rhodes Scholar on an American Cancer Society grant application. Within months, the trials were halted, and Duke returned $729,000 to the cancer organization.

Potti resigned from Duke in November 2010, and has since joined a private oncology practice with offices in North Carolina and South Carolina. He and his colleagues, along with Duke, face two lawsuits from nine patients who took part in the trials. Eleven other such cases have already been settled for at least $75,000 each, according to the North Carolina Medical Board, which reprimanded Potti for the “inaccuracies” on his biographical sketch and CV.

According to the JAMA retraction notice, Potti works at the Myrtle Beach, South Carolina office of Coastal Cancer Center. But a person answering the phone there said he did not work in that office and was unavailable because he was in clinic.

For plaintiffs’ attorneys, proving that patients were actually harmed by being in the trials will be difficult, said Brawley.

“I don’t myself think that patients were harmed by being steered to a particular chemotherapy, at one level,” he said. The choices in the trial were widely accepted therapies that their own doctors would have likely given them.

That wasn’t the only risk, however.

“I’m a little bit concerned that some of the patients may have gone back and had new biopsies, for new analysis in the laboratory,” Brawley said. “If that was purely for this trial, those were unnecessary procedures, with risks. I hope no one was harmed by that.”

MOVING FORWARD

The episode is fueling soul-searching at Federal agencies.

There are “some positive things coming out of this whole mess,” Baggerly said. One potential move being considered as part of a review of cancer genomics studies by the U.S. Institute of Medicine (IOM), for example, is to require genetic tools such as the one the Duke team used to go through the same approvals that a medical device would go through at the Food and Drug Administration.

The IOM’s report is expected out in the next few months, and there are similar changes being considered at the National Cancer Institute — which funded some of the Duke team’s work — and the Food and Drug Administration. Duke itself has created a team to establish new safeguards as genetic research moves into the clinic.

But the dark lessons remain.

“To a certain extent, what I’m worried about is that this may show aspects of how it is becoming increasingly difficult to check the scientific literature and how that difficulty stems at least in part from lack of immediate access to data but also lack of code and documentation,” Baggerly told Reuters Health.

Given the highly technical nature of the work, it’s not surprising that the flaws in the papers weren’t caught before they were published, according to Baggerly.

“That’s actually OK,” he said. “It’s not OK that it took so long for the challenges to be accepted once the research was questioned.”

“The other thing that is not OK is the fact that it made it into guiding clinical trials,” Baggerly added.

Brawley said the story “is a tragedy in a number of different ways.”

“I’m actually more concerned right now with the systemic issue across the country that it’s up to universities to police their researchers,” he said. “But as science progresses, those universities are more and more interested in how many patents they have, and how many licenses they have for those patents.”

“The universities that are responsible for assuring academic integrity actually have a conflict of interest,” said Brawley, pointing out that Duke had an ownership stake in CancerGuide Diagnostics (formerly Oncogenomics, Inc.).

CancerGuide, which cut ties with Potti in July 2010 after the Rhodes misrepresentation came to light, had licensed technology based on Potti’s work from Duke, the student newspaper The Duke Chronicle reported in 2010. Duke has since divested from the company.

‘A 21ST CENTURY DEFINITION OF CANCER’

Despite the setback, cancer treatment will continue to make more and more use of genetic information, Brawley said. Oncologists already use tools such as the OncotypeDX genetic test to tailor treatments for breast cancer and colon cancer.

“Since the 1840s, we’ve been using a light microscope to define cancer,” he said. “Now with all the other advances we have, even the needle biopsy, we often find a one-centimeter tumor, and we’re saying ‘this looks like cancer,’ according to a 19th-century definition. What we need is a 21st century definition of cancer.”

“We’ve got these new tools, and people are very excited about using them,” Baggerly said. “Some of these genetic level screw-ups are indeed what cause the disease, so there is the potential there. That said, some of the initial claims about how quickly we’re going to be able to turn these (findings) into clinically useful assays have been overoptimistic.”

“We’re going to get there, but a number of the early studies thought this would be an easy problem,” he said. “The biology turns out to be quite complex.”

(This story corrects the date in paragraph 12 and adds Kevin Coombes’ name to paragraphs 10 and 11.)

Harm in Hospitals Seldom Reported, OIG Says

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Posted 07 Jan 2012 — by James Street
Category Ethics of Science, Finance and Politics of cancer research and treatment, Hospital Safety, Legal

By Emily P. Walker, Washington Correspondent, MedPage Today
Published: January 06, 2012

WASHINGTON — Most hospital errors that result in harm to Medicare patients go unreported, and even when they are, hospitals rarely change the way they operate in order to prevent similar errors in the future, according to a new report from the Department of Health and Human Service’s Office of the Inspector General (OIG).

The OIG found that hospital staff did not report 86% of adverse events, whether errors or accidents. Hospital administrators interviewed for the report suggested that doctors and nurses are unclear about what constitutes a reportable adverse event.

For their report, investigators selected 420 adverse events from an earlier OIG review on hospital errors and had physicians review the medical records on those cases.

The doctors identified 302 events of preventable harm to patients, 128 of which were considered serious, including a death from septic shock and four deaths from excessive bleeding after administration of anticoagulants.

To determine which of the 302 events were actually reported in hospital error-reporting systems, the OIG requested error reporting data from the hospitals where the selected adverse events occurred.

The OIG investigators also interviewed hospital administrators about the specific events and why they weren’t reported. All of the hospitals involved had reporting systems in place and said they expected staff to report errors that resulted in patient harm, but none had a standardized list of which events should be reported.

The administrators told OIG investigators that the most common reasons that errors went unreported were that no clear error occurred leading up to the adverse event, that the event was thought to be a common side effect to the treatment, and that the event occurred so frequently that it was considered too common to report.

For instance, only one of 17 catheter-related infections — a common event in Medicare beneficiaries — was reported.

In his conclusion, report author Inspector General Daniel Levinson wrote that it is crucial that the adverse event reporting systems do what they’re supposed to and said that the Centers for Medicare and Medicaid Services (CMS) and the Agency for Healthcare Research and Quality (AHRQ) are in the best position to provide hospitals with guidance and incentives to better use reporting systems.

Specifically, AHRQ and CMS should create and promote an adverse event list to be used by hospitals, other healthcare providers, and medical and nursing schools. The list would detail the full range of patient harm that can occur in hospitals so hospital workers would have a clearer idea of what events should be reported.

CMS and AHRQ agreed with the recommendations, according to OIG.

Levinson also recommended that CMS provide guidance to accreditors on how to better assess hospital efforts to track and analyze adverse events. As a condition of participation in Medicare, hospitals must go through an accreditation process that proves they are tracking events that result in patients being harmed.

The OIG report on which the current analysis was based was done in 2010. It found that nearly 14% of hospitalized Medicare beneficiaries experienced a preventable adverse event that resulted in extended hospitalization, required life-sustaining intervention, caused permanent disability, or resulted in death.

An additional 13.5% experienced events that required some sort of additional treatment, but were not life-threatening, the 2010 report showed.

The idea of doing a better job of tracking patient harm as a result of medical treatment gained popularity after the Institute of Medicine’s 1999 landmark report “To Err is Human: Building a Safer Health System.” That report argued that hospitals can only address patient safety problems if adverse events are identified and adequately described.

Federal Judge Tosses Medical Marijuana Case

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Posted 07 Jan 2012 — by James Street
Category Cannabis, Finance and Politics of cancer research and treatment, Legal, Marijuana

By Emily P. Walker, Washington Correspondent, MedPage Today
Published: January 06, 2012

A federal judge has thrown out Arizona governor Jan Brewer’s complaint against the state’s medical marijuana law.

The law, passed in 2010, created a system of marijuana dispensaries that are regulated by the state’s health department. Patients are banned from growing their own marijuana if they live within a 25-mile radius of a dispensary.

Brewer and the state’s attorney general filed the lawsuit just days before the state was scheduled to accept applications from potential dispensary operators. The suit asked for a judgment on whether state officials who administer Arizona’s medical marijuana programs could be at risk for federal prosecution, since marijuana is illegal under federal law.

U.S. District Judge Susan Bolton of Arizona on Wednesday dismissed the complaint, ruling that the Arizona officials failed to show that an imminent threat of prosecution exists for state employees, or that state employees in any of the 16 states with medical marijuana laws have faced prosecution for violating federal laws that make marijuana use and dispensing illegal.

Recently, federal authorities in California began cracking down on the state’s medical marijuana industry, but they are targeting those who are dispensing the drug illegally, and have said those who need marijuana for medical purposes — such as to help ease the effects of cancer or AIDS — will still be able to get it.

Even if the threat of prosecution for state employees in Arizona were imminent, Brewer and the other plaintiffs in the case — the director of the Arizona Department of Health Services and the director of the Arizona Department of Public Safety — didn’t show they would suffer direct harm or immediate hardship if the case wasn’t immediately decided, Bolton wrote, so the case is “not appropriate for judicial review.”

Matthew Benson, director of communications for Brewer’s office, called the ruling a disappointment.

“What this federal court has essentially said is, it won’t hear the state’s lawsuit until a state employee is prosecuted or notified that they imminently face federal prosecution for their part in administering Proposition 203,” he said in an email to MedPage Today.

The American Civil Liberties Union (ACLU) praised the decision.

“It is unconscionable for Governor Brewer to continue to force very sick people to needlessly suffer by stripping them of the legal avenue through which to obtain their vital medicine,” Ezekiel Edwards, director of the ACLU Criminal Law Reform Project, said in a press release. “[The] ruling underscores the need for state officials to stop playing politics and implement the law as approved by a majority of Arizona voters so that thousands of patients can access the medicine their doctors believe is most effective for them.”

In addition to Arizona, 15 other states have medical marijuana laws — Alaska, California, Colorado, Delaware, Hawaii, Maine, Michigan, Montana, Nevada, New Jersey, New Mexico, Oregon, Rhode Island, Vermont, and Washington. Medical marijuana also is legal in District of Columbia.

Cancer Charity Sues Private Firm Over Alleged Research Use

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Posted 03 Jan 2012 — by James Street
Category Finance and Politics of cancer research and treatment, Fraud, Legal Issues

January 3, 2012, 10:41 am

A cancer-research organization is seeking more than $1-billion in damages from a biotechnology company it claims is developing drugs based on work funded by the nonprofit group, according to The Boston Globe.

The suit filed last month by the Leonard and Madlyn Abramson Family Cancer Research Institute accuses Agios Pharmaceuticals of Cambridge, Mass., and its co-founder, Craig B. Thompson, of taking its intellectual property to launch a for-profit business.

Dr. Thompson led the University of Pennsylvania-affiliated institute from 1999 until last year. The charity contends Agios’s work on drugs to suppress cancer cells is based on novel research conducted during his tenure there and that Dr. Thompson did not disclose to the institute that he had started the firm, which has secured tens of millions of dollars in investments and a licensing deal.

Dr. Thompson, who is also the chief executive of New York’s Memorial Sloan-Kettering Cancer Center, denied the allegations, asserting in a written statement that they are “unfounded and without merit.”

An ambitious plan for curing cancer in a businesslike way is in the works

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Posted 28 Dec 2011 — by James Street
Category Bioinformatics, Finance and Politics of cancer research and treatment, General Cancer Research, genetic research, Proteomics, Proteomics, Research Centers, Understanding Cancer

Dec 31st 2011 | NEW YORK | from the print edition

 

Cancer, you have a problem

RON DEPINHO is a man on a mission. Oddly, though, he does not yet know exactly what that mission is. Dr DePinho is the new president of the MD Anderson Cancer Centre in Houston, Texas. (He took over in September, having previously headed the Belfer Institute, part of Harvard’s Dana-Farber Cancer Institute.) Mindful of his adopted city’s most famous scientific role, as home to Mission Control for the Apollo project, he says his own mission is akin to a moon shot. He aims to cure not one but five varieties of cancer. What he has not yet decided is: which five?

That it is possible to talk of curing even one sort of cancer is largely thanks to an outfit called the International Cancer Genome Consortium. Researchers belonging to this group, which involves 39 projects in four continents, are using high-throughput DNA-sequencing to examine 50 sorts of tumour. They are comparing the mutations in many examples of each type, to find which are common to a type (and thus, presumably, causative) and which are mere accidents. (The DNA-repair apparatus in malignant cells often goes wrong, so such accidents are common.)

The consortium’s work is progressing fast, and preliminary results for many tumours are already in. But such knowledge is useless unless it can be translated into treatment. That is where Dr DePinho comes in—for his career has taken him into the boardroom as well as the clinic. He is a serial entrepreneur: he helped found Aveo Pharmaceuticals, which is developing a drug to block the growth of blood vessels in tumours, Metamark Genetics, which works on diagnosing cancers, and Karyopharm Therapeutics, which is trying to regulate the passage of molecules into and out of the cell nucleus, and thus control the nucleus’s activities. His aim in coming to MD Anderson, he says, is to “industrialise” other aspects of biological research in the way that genetics has been pushed forward by high-throughput sequencing.

That will cost billions of dollars. Fortunately, the state of Texas—no pushover when it comes to spending taxpayers’ cash—is creating a $3 billion cancer-research fund to help pay for it. Local philanthropists, including T. Boone Pickens and Ross Perot, are chipping in, too. Their model is the original Human Genome Project, during which the cost of sequencing a single genetic “letter” (a DNA base pair) fell from $10 in 1991 to ten cents in 2001—and is now 3,000 base pairs a cent. They hope their dollars will encourage people working with what are now, essentially, craft technologies to think about how they might industrialise them.

Several techniques look ripe for such industrialisation. Dr DePinho sets great store, for example, by the use of genetically modified mice (he calls them “little patients”) in which mutations found in human cancers can be replicated precisely, but one at a time, to discover the shape of each piece of the jigsaw. If this process can be scaled up it will, as he puts it, allow cancer’s genetic generals to be distinguished from the foot soldiers.

Another field that has great potential is imaging technology—in particular, a combination of positron-emission tomography (which uses radioactive sugar to measure how metabolically active tissue is) and computerised tomography (which uses X-rays to map the body’s internal anatomy). Together these can show whether a treatment is reducing a cancer’s energy consumption, and thus its metabolism. This gives a good indication of how well that treatment is working.

A family business

Dr DePinho himself will have more duties at MD Anderson than just dealing with the five chosen tumours. The donkey work of creating the Institute for Applied Cancer Science, as the new mission control is to be known, will be done by Lynda Chin. Dr Chin, too, worked at the Belfer Institute. She is part of the International Scientific Steering Committee of the cancer-genome project. And she is also Dr DePinho’s wife. Dr Chin will be assisted by some 55 other scientists from the Belfer, who are making the journey to Texas with her and her husband. That sort of team poaching is common in investment banking but rarer in academic research. Dr DePinho refers to it, jokingly, as metastasis, since a clone of his primary creation will be taking root elsewhere in the country.

As to which five cancers to attack, that decision will be made by the middle of 2012. A crucial consideration will be how likely it looks that research into the tumour in question could get rapidly to the “proof of concept” stage—the point at which it could be taken forward by a business that relied on commercial sources of capital, rather than on the sorts of grants that usually propel academic research. At that moment a new firm might be spun out of the institute, or a deal might be done with an established pharmaceutical firm, to try to get a new drug developed.

In recent years many big drug companies have gutted their research departments. This is partly because those departments have failed to come up with new “blockbuster” drugs of the sort that created Big Pharma in the first place, and partly because the big firms’ bosses had hoped that smaller biotechnology companies, of the sort Dr DePinho has helped set up, would do the hard work of drug discovery instead, and then let themselves be bought by the big firms.

Unfortunately, it hasn’t quite worked out like that. The output of the biotech firms has been a trickle, rather than a torrent. They have been one of the worst-performing parts of the private-equity market since 2007, according to Dr DePinho. He hopes to change that—and in the matter of new anti-cancer drugs, the science is looking auspicious. For example, a drug called vemurafenib, which was approved for use in America in August 2011, gives months of extra life to people with metastasising melanoma, one of the deadliest cancers. Vemurafenib is so powerful that some people call it a “Lazarus” drug, after the chap Jesus is said to have raised from the dead.

Crucially for Dr DePinho’s project, the development of vemurafenib was stimulated by the identification of a mutated gene often present in melanomas. He and others like him hope that the cancer-genome consortium will throw up dozens of similar genes, and that they, too, will prove tractable targets for drug development.

Of course, if Dr DePinho had a penny for every time a “cure for cancer” headline proved premature, he wouldn’t need munificent donors. But if his bets on the science and on adopting business methods pay off, the drug industry and millions of patients will benefit. That would be one benign sort of metastasis.

On leaping to conclusions about a neurosurgeon and Dr. Stanislaw Burzynski

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Posted 27 Dec 2011 — by James Street
Category antineoplasms, Complementary and Alternative Medicine, Finance and Politics of cancer research and treatment, Fraud, Medical Blogs, Surgery

Category: Alternative medicine • Cancer • Medicine • Surgery
Posted on: December 27, 2011 10:45 AM, by Orac

Another Christmas is over, and we’re settling in to that strange week between Christmas and New Years when, or so it would seem, most of the world isn’t working except for retail. I’m half taking the week off from work in that I don’t plan on going into the office if I can possibly avoid it, but will be starting up a couple of grants for the February/March NIH cycle and dealing with a couple of nagging issues left over from before the holidays. Regular readers might have noticed that ScienceBlogs had a bit of a glitch beginning sometime in the early morning hours of Christmas morning and not ending until yesterday sometime. In essence, although you could read the blogs, you couldn’t comment, and all the bloggers were locked out of the Movable Type back end. Since that provided me an excellent excuse to take a day off from blogging, I did. I was still recovering from the food and wine coma of the last two days anyway and probably didn’t have anything coherent to say, if I ever do.

But what should await me this morning when I decided to take a look and see if ScienceBlogs were fully up and running again? It’s something I had hoped to be able to ignore until 2012, having blogged enough about it over the last month or so. I’m referring to the “brave maverick” cancer doctor Stanislaw Burzynski and his Burzynski Clinic. Read the links for the full, Orac-ian deconstruction of what Burzynski appears to be doing, but the brief version is that he uses what he calls antineoplastons, which he claims to have originally isolated from urine back in the 1960s and 1970s but now synthesizes chemically, to treat cancer. It turns out that these antineoplastons are nothing more than the metabolic products of a real drug, phenylbutyrate. This is a drug that was initially used to treat urea cycle disorders but has also shown (very) modest promise in treating some forms of cancer and that these days Dr. Burzynski appears to be switching over to using off-label phenylbutyrate but still calling it “antineoplastons” and charging outrageous sums of money to his patients. In addition, these days, seeing a profit opportunity, he’s jumped on the genomic bandwagon–incompetently–and started offering what he calls “personalized, gene-targeted therapy,” which, when looked at more closely, is really nothing more than a simplistic use of a commercially available test to pick out a witch’s brew of chemotherapy, targeted therapies, and antineoplastons phenylbutyrate, put together with little or no thought to synergistic toxicities or whether they interfere with each other’s actions or not. All of this, he sells as being “not chemotherapy” (it is; it’s just incompetently administered chemotherapy) and “natural” (it’s no more natural than taxol, which was originally derived from the bark of the Pacific yew tree and turned into a chemotherapy drug). Through all of this, Burzynski has tried, through his PR flack, to silence bloggers who criticize him and thereby protect the lucrative cult of personality he’s built around his name. Now, it appears that there is another aspect of Burzysnki’s practice I need to comment on, as mentioned on Pharyngula (crossposted here) and Furious Purpose, and that’s physicians who send their patients to Burzynski.

By way of background, I’ve noted before that there is a particularly disturbing aspect of Burzynski’s practice. That’s how his patients, convinced that Burzynski can save them (or, if they’re parents, that he can save their child) will, understandably go to extreme lengths to raise the often hundreds of thousands of dollars Burzynski charges to apply his science-y-sounding woo to cancer. It is not at all uncommon for these families set up charities designed to raise money, or, as I put it a couple of years ago, to harness the generosity of kind-hearted strangers to pay for woo. In fact, it was a couple of high-profile cases, one involving U.K. performer Peter Kay, who did two charity concerts for a Burzynski patient, that originally brought the attention of the skeptical blogosphere on Burzynski. More precisely, it was the reaction of one Marc Stephens, who claimed to represent the Burzynski Clinic and in that claimed capacity issued legal threats against bloggers, that brought the attention (and wrath) of the skeptical blogosphere down on Burzynski. In any case, I thought that that was the worse aspect of Burzynski’s activities, that he seemingly encouraged his patients with terminal cancer to go to such lengths to raise money, the better to enrich himself. There is now, however, another aspect that could be at least as disturbing. I haven’t made up my mind yet, because I don’t know if what I’m learning about this aspect of Burzynski’s activities. If what PZ and Furious Purpose write is accurate, then Dr. Teo is about as unethical as it gets. However, I suspect things are not as simple as what is being written.

Meet Dr. Charles Teo, a neurosurgeon currently in Australia. Apparently, he has a history of funneling patients to Burzynski, although it’s not clear at all to me whether it’s Dr. Teo who promotes Dr. Burzynski or whether he’s just working with patients who have decided to go to Dr. Burzynski. For example, here is one patient description cited:

After much research and the help of many friends we discovered Dr Charles Teo from Prince of Wales Private Hospital in Sydney, who performs surgery on inoperable brain tumors. Dr Teo is a neurosurgeon who has pioneered a method of minimally invasive brain surgery and has successfully performed around 5000 operations. Dr Teo has offered to operate on David and at this stage the operation is scheduled for Friday, 20th September 2002. David, with the support of his family will fly to Sydney on Wednesday, 18th September 2002.This process is not a cure, however, it is designed to relieve the pressure by reducing the size of the tumor, he will need further treatment to kill off any remaining pieces of the tumor. The treatment being researched at the moment is antineoplastons treatment which is administered by the Burzynski Clinic in Houston, USA.

One notes that this is from 2002 and 2003 and that it is not at all clear from the description above that Dr. Teo suggested that this family go to visit Burzynski or that this patient is evidence of Dr. Teo taking advantage of dying patients.

In all fairness, this case is a bit more damning:

However, Braydon’s mother Zoe Cobb hoped the Sebastopol toddler could begin treatment soon at the Burzynski Clinic in Houston, Texas.”We’ll talk more about it with Charlie (Dr Charles Teo) this afternoon,” Zoe said. “We’re just off for the MRI scans now.”

The Burzynski Clinic, named after founder Stanislaw Burzynski, specialises in individual cancer treatments.

Zoe said they had discussed taking Braydon to Texas with Dr Teo, who said he felt it would be a good option for the four-year-old.

However, before you decide, take a look at this video:

And this one as well:

There is a type of surgeon who represents the true “brave maverick” in that he is highly skilled, highly confident, and willing to take on seemingly “hopeless” cases. Surgeons like this will often, as described above, operate on patients who have either been operated on before by other surgeons who couldn’t fix what was wrong or been turned down by other surgeons as “inoperable.” Of course, “inoperable” is not a hard-and-fast word in that what is inoperable to one surgeon might well be operable to another. It’s also a very fine line in that this is an area where science- and evidence-based medicine collide with personal surgical skill. There are surgeons out there who are just so good that they can physically do with their hands what other surgeons, talented and experienced as they might be, cannot. Alternatively, they are far less risk-averse than the typical surgeon in their specialty and are therefore willing to attempt things that other surgeons won’t, such as the resection of “unresectable” brainstem tumors. Where daring ends and recklessness begins is a very fuzzy line with surgeons such as these. When they fail, they fail spectacularly, but when they succeed sometimes the result is the patient described in the video above. Surgeons such as these might very well cause a lot of complications and unnecessary suffering through aggressive–even reckless–pushing of boundaries. However, they also push the envelope (which Dr. Teo even says explicitly that he is trying to do in the second video), which can lead to advances in surgery and can sometimes save patients thought to be unsavable. Where the balance between the harm and good done by such surgones lies is, again, not a trivial thing to figure out.

It probably doesn’t help that Dr. Teo has other aspects of the “brave maverick” doctor. For example, if you search for his name plus “cell phone cancer,” you’ll find a plethora of articles and videos featuring Dr. Teo warning against the dangers of cell phones as a cause of brain cancer:

Brain cancer surgeon Charlie Teo has urged people to put mobile phones on loudspeaker, move clock radios to the foot of the bed and wait until microwaves have finished beeping before opening them.The controversial Sydney specialist told a Melbourne fundraiser that although the jury was still out on mobile phones and other forms of electromagnetic radiation, we should not take risks.

“Even though the jury’s not in, just to err on the side of safety I would try and limit the amount of electromagnetic radiation that you’re exposed to,” he said.

“The American government, for example, recommends that all electrical appliances should be put at the foot of the bed and not the head of the bed.

Then there’s this video:

At around the 3:35 mark, Dr. Teo is featured saying unequivocally that he believes mobile phones can cause brain cancer. Later, the reporter engages in a blatant bit of fear mongering by noting that mobile phones use microwaves and you wouldn’t think of putting your ear up next to a microwave oven.

The stupid in that video, it burns brightly, rather like what would happen if you put metal in a microwave oven.

So, we can see that Dr. Teo is not a very good judge of epidemiology or basic science. Yes, I’ve refused to concede on many occasions that a link between cell phones and cancer is physically impossible, as some physicists have unwisely done based on a Cancer Biology 101 understanding of cancer, but I do consider it incredibly implausible that there is such a link. Maybe not homeopathy-level implausible, but almost. Also, as I (and others) have pointed out time and time again, not only is a link between cell phones and cancer incredibly implausible based on what we know about physics and biology, but the epidemiological evidence is overwhelmingly against such a link existing. There’s no convincing evidence for an increase in the incidence of brain cancers and no good evidence that the laterality of brain tumors correlates with the side of the head people hold their phones to. In brief, there is no good reason, based on prior plausibility informed by basic science or on epidemiological evidence, to think that mobile phone radiation causes brain cancers.

But Dr. Teo believes it does, which makes me think it’s not all that much of a stretch to think that he would be susceptible to the fancy-sounding blandishments of a charlatan like Dr. Burzynski.

And that’s why I think that what’s more likely to be going on here is something way more nuanced than what PZ and Furious Purpose think. Subject to change as more information comes in, I reject, based on what I’ve been able to find out thus far, the contention that Dr. Teo is operating on patients with inoperable brain cancer in order to make money off of them. Certainly neither PZ nor Furious Purpose have made a convincing case for that. A far more likely explanation is that Dr. Teo is one of those “cowboy surgeons” who will operate on risky patients that other surgeons won’t. When he agrees to operate on someone with an “inoperable” brain cancer, from what I can tell he almost certainly believes that he can do what other surgeons can’t: Remove the tumor and possibly cure the patient. It appears that, often enough, he’s right. Based on what I’ve been able to find out, unless there is more information that I’m not aware of, I have little choice but to say that I consider it at best highly irresponsible (and–dare I say?–most unskeptical) and at worse downright scurrilous to leap to the conclusion that Dr. Teo is intentionally operating on inoperable brain tumors just to make money and then to funnel patients to the Burzynski Clinic, as PZ does here (and here):

Teo is an Australian surgeon who has a brilliant scheme for anyone with a bit of surgical skill and a complete lack of conscience. He performs surgery on inoperable brain tumors in kids dying of cancer, and then ships them off to the Burzynski clinic in Texas to get injected with urine and die.You’ve got to admit, marshaling the resources of a hospital, opening up a child’s skull, and diddling about with a knife inside without killing them is an amazing feat of impressive showmanship, sure to make devastated parents think something is being done worth $20-60,000 — even if there is no evidence at all that poking a glioblastoma with a pointy object offers any therapeutic benefit at all. I wouldn’t be at all surprised to learn that Teo is actually a very skilled surgeon. The problem is that brain surgery is not a panacea, and sometimes it is a totally inappropriate approach to deal with some cancers.

Or as Furious Purpose does here:

From reading the stories of those desperate parents of children with inoperable brain tumours, I must conclude that Dr Charles Teo may deliberately choose to operate on children with tumours he knows these kids will die of, because current medical science has no cure to offer them. He then removes the tumour or at least some of it for what is said to be between 20000.- and 60000.- dollars for the surgery at Prince of Wales Hospital in Sydney and the high dependency care required afterwards, and he then recommends to the parents for their child to have additional treatment with “antineoplastons” at the Burzynski clinic in Houston, Texas. Treatment that is not FDA-approved, that has not been shown in trials meeting current scientific standards to be effective, and that is given only in exchange for exorbitant sums of money, and may be refused if the money is not forthcoming.Charles Teo and Stanislaw Burzynski appear to be making money from the desperation of parents of dying children. Teo seems to be offering hope through surgery when there is none, and he then seems to be referring those same desperate folks for more false hope, and more expenses, to the Burzynski clinic in Houston.

Bullshit. Neither Furious Purpose nor PZ has anywhere near enough evidence to justify accusing Dr. Teo of something so vile and despicable.

It’s far more likely that Dr. Teo’s just an aggressive surgeon who thinks he’s doing his best for his patients by trying to remove tumors that other surgeons consider unresectable. Again, there’s a fine line between being surgically aggressive and surgically reckless, and there’s also insufficient evidence in the public record for me to judge whether Dr. Teo has crossed that line.

The second part of the accusation against Dr. Teo is a bit trickier. Is Dr. Teo funneling patients to Dr. Burzynski after having operated on them for in essence no reason? We only have two cases to go on, one of which doesn’t describe Dr. Teo as saying anything about the Burzynski Clinic or antineoplastons, the second of which quotes Dr. Teo as saying that he felt it would be a “good option” for his patient. Whether Dr. Teo suggested it or the patient’s parents latched on to the Burzynski Clinic and Dr. Teo gave his blessing is not known. From what we know, at best we can conclude that Dr. Teo’s grasp of science is not the greatest and that he’s prone to dubious science, as evidenced by his enthusiastic embrace of the “cell phones cause cancer” pseudoscience making the rounds. It’s quite possible that he’s similarly prone to being impressed by bad science and pseudoscience like that promoted by Dr. Burzynski. If that’s true, it’s bad. Very bad. However, it might not be true. We only have two cases that we know about over 8 or 9 years to go on, and Dr. Teo operates on hundreds of patients a year. These two cases could easily be outliers.

It’s clear that Dr. Teo is a controversial figure. He’s wrong on mobile phones and cancer. He also seems to have a bit more of the flamboyant showman in him than is good for a surgeon to have, a point that several of the stories I’ve cited make, and he definitely seems very cocky, perhaps more so than is necessary to be a neurosurgeon. (After all, it takes a certain amount of cockiness to have the confidence in yourself that you can crack open someone’s skull and remove part of his brain without leaving him permanently disabled.) It’s also pretty clear to me that Dr. Teo is the type of surgeon who pushes the envelope, perhaps bordering on recklessness at times. If that’s the case, he should be called out for subjecting patients to operations that can’t help them. However, I’m not convinced that that’s the case. In fact, it is not in the least bit clear to me that Dr. Teo is the sort who operates on patients whom he knows he can’t cure in order to make money, and I wish I didn’t have to point that out. When it comes to whether there’s any sort of relationship between Dr. Teo and Dr. Burzynski, I can only conclude that it’s possible–likely, even–that Dr. Teo is a bit too credulous about Burzynski’s results but that there is nowhere near enough evidence that I’ve been able to find to conclude that Dr. Teo and Dr. Burzynski have some sort of relationship in which Dr. Teo sends patients Dr. Burzynski’s way after operating on them. If there is such a relationship, then I would condemn Dr. Teo in the strongest possible terms–but I need a lot more convincing than either PZ or Furious Purpose has provided before I can come to a conclusion.

Financial Conflicts Taint ‘Ivory Tower’

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Posted 27 Dec 2011 — by James Street
Category Ethics, Finance and Politics of cancer research and treatment, Open Source Drug Discovery
Financial Conflicts Taint ‘Ivory Tower’
By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today
Reviewed by
December 27, 2011
Review
Paul Anderson, MD, an orthopedic surgeon at the University of Wisconsin-Madison, gets so much money from the medical device firm Medtronic that the university put its most stringent oversight on the relationship.

One of the oversight requirements is that Anderson, who has received $225,000 in consulting fees from Medtronic in the last three years, has to meet annually with the department chairman to review the relationship and its potential influence on his university activities.

But the chairman, Thomas Zdeblick, MD, received more than 25 times that amount from Medtronic himself during the same three years.

An accounting by the Journal Sentinel and MedPage Today revealed that he has received more than $25 million in royalties from the company since 2003.

What’s more, UW Hospital spent $27 million for Medtronic spinal products from 2004 to 2010, according to documents obtained through an open records request. And Zdeblick, a renowned spinal surgeon, has co-authored several positive research papers about the company’s spine products.

The Chair Is Conflicted

That ongoing financial relationship has led some academic leaders outside Wisconsin to question whether Zdeblick could objectively serve as a department chairman.

“I really don’t know how you would manage that conflict of interest,” said Jordan Cohen, MD, a former president of the American Association of Medical Colleges. “It (his financial relationship with Medtronic) is bothersome.”

Cohen, a professor of public health at George Washington University in Washington, D.C., said it would be preferable for Zdeblick not to be serving as chairman to avoid the potential for conflicts of interest.

Zdeblick is not alone — other department chairmen across the country get payments from drug companies and device makers. But the ethical grounds may be shifting under their feet. While having a financial tie to industry once was considered a status symbol, more and more critics are questioning those relationships.

Zdeblick declined to comment for this story.

Robert Golden, MD, dean of the UW School of Medicine and Public Health, said Zdeblick is an outstanding chairman who has the enthusiastic support of his faculty, staff, and the leadership of the medical school.

“Dr. Zdeblick is one of the most talented and innovative orthopedic surgeons in the nation,” Golden said in an emailed statement. “We are most fortunate to have him as department chair.”

University records show Zdeblick also received more than $1 million in UW compensation in 2010 — making him UW’s highest paid physician.

Medtronic and UW noted Zdeblick does not receive royalty income for any Medtronic spinal implants used by UW Hospital.

The fact that Medtronic products invented by Zdeblick are implanted in patients at UW Hospital was revealed in 2009, in response to an inquiry by the U.S. Senate Finance Committee, which was investigating payments to doctors by medical companies.

In the letter to U.S. Senate investigators, university officials acknowledged Zdeblick had implanted four kinds of Medtronic devices that he invented, or had a role in inventing, a total of 179 times in the previous three years.

The most implanted device (89 times) was the LT-Cage. It is used in spinal fusion surgery and was part of the clinical trial that helped gain U.S. Food and Drug Administration approval for Medtronic’s bone morphogenetic protein-2 product known as Infuse, or BMP-2.

Documents from the committee indicated Zdeblick’s Medtronic royalties since 2003 totaled $19 million. Since then, UW records obtained by the Journal Sentinel and MedPage Today show his total Medtronic royalties now exceed $25 million.

Prior to 2009, UW doctors only were required to indicate ranges of outside income with the top category being $20,000 or more. That obscured just how much any of the doctors were making.

Also unknown: The annual sales figures for Medtronic spine devices used at UW Hospital.

Through an open records request, the Journal Sentinel and MedPage Today sought spinal products purchasing agreements between Medtronic and UW Hospital. The records were provided only after the university got approval from Medtronic.

The documents were heavily redacted, with officials saying it considers the contracts to be a trade secret, but provide a more complete picture of the relationship between the company and the hospital where Zdeblick and Anderson practice.

Dozens of Medtronic spinal products were included in the records with annual purchases hovering around $4 million.

Managing Financial Entanglements

The type of management plans under which Zdeblick and Anderson must operate are aimed at providing a range of safeguards against undue influence from their financial relationship with Medtronic.

Among the restrictions:

  • They must inform others who may be impacted by the conflict, including students, fellows, and other researchers that they supervise.
  • They can’t serve as the principal investigator for any UW human subjects research without written approval from a committee that examines conflicts.
  • They may not be directly involved in making decisions involving the purchase of items from Medtronic using funding under their control.
  • Their agreements with Medtronic must not limit their ability to publish research.

But critics say Zdeblick’s relationship with Medtronic is so substantial that it calls into question whether he can objectively serve as chairman of the department of orthopedics and rehabilitation.

“Is that the ideal situation?” asked Arthur Caplan, PhD, a professor of medical ethics and health policy at the University of Pennsylvania. “I don’t think so. It is just such a huge sum of money. It’s just too big a connection.”

He said there may be ways to manage the situation, such as disclosing the relationship to others and making sure that an independent conflict of interest committee approves of Zdeblick’s activities. But Caplan said that if the choice were his would discourage someone so heavily conflicted from chairing a department.

A 2003 BMP-2 study by Zdeblick and two non-UW co-authors illustrates the problem.

The study was published in the journal that lists Zdeblick as editor-in-chief. And the study involved another product, the LT-Cage, from which Zdeblick receives royalties.

All three authors had received millions from Medtronic, although none of them received royalty income for the Infuse product.

In the paper, the authors concluded that the product could become “the new gold standard” in spine surgery — and then the authors went on to say the product was being used “exclusively” at their institutions.

The authors did not include information linking the product to serious complications, information that critics say was known to them.

Lisa Brunette, a spokeswoman for UW Hospital, said the “gold standard” comment was not an endorsement of the product by the hospital. She said when the product came on the market, it was the only one of its type that was available. Now, there are several options and UW uses different products.

Several academic experts said that Zdeblick’s financial relationship with Medtronic also is something that can affect his interaction with other faculty as well as his students, residents, and fellows in orthopedic surgery.

“A Farm System”

Another issue is the potential for financial relationships to influence training and mentoring of future physicians and surgeons.

If residents learn how to implant mostly Medtronic products, it can create a “farm system” in which as doctors they may be more inclined to use the company’s products, said David Rothman, PhD, president of the Institute on Medicine as a Profession, part of Columbia University College of Physicians & Surgeons.

In addition, managing other faculty who may have their own financial relationships with Medtronic or competing device companies at the least creates the wrong appearance, said Rothman, who also serves as a consultant to the North American Spine Society, which publishes the Spine Journal.

“What kind of message goes out when the chairman of the department who is going to be evaluating promotions is so deep into the pocket of Medtronic?” he said. “That message, that you can have it all, that you can take millions from Medtronic and still be chairman of the orthopedics department, that’s a message that should make people uncomfortable.”

In his email, Golden, dean of the UW medical school, pointed to several safeguards.

He said the selection of implant devices is done by a review committee, which uses a competitive process after input from surgeons. Zdeblick recused himself from any role in the selection of vendors, Golden said.

In addition, residents and fellows work with multiple surgeons in the department who may have differing views and preferences for various devices, Golden said. They are taught how to critically assess the medical literature and draw conclusions from the evidence.

He also said the students are told about the royalties Zdeblick receives.

And he noted the management plans Zdeblick and Anderson operate within amount to a shared arrangement with the primary responsibility falling to the dean’s office and the graduate school.

“To my knowledge, Dr. Zdeblick has effectively carried out his responsibilities as department chair to review activities of faculty,” Golden said.

A 2007 study in the Journal of the American Medical Association, found that 60% of department chairman at medical schools had some kind of personal relationship with the medical industry, such as being a consultant, paid speaker, or member of an advisory board.

Department chairmen often are influential in their fields of medicine, said Eric Campbell, PhD, lead author of the study and an associate professor of health policy at Harvard Medical School.

And, he said, drug and device companies seek them out as opinion leaders.

“If you have a product, are you not going to want to have the chairman (of orthopedics) at the University of Wisconsin in your corner?” Campbell said. “It’s Marketing 101.”

Without Autopsies, Hospitals Bury Their Mistakes

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Posted 19 Dec 2011 — by James Street
Category Diagnostic, Finance and Politics of cancer research and treatment, Fraud
Thursday 15 December 2011
by: Marshall Allen, ProPublica [3] | Report

When Renee Royak-Schaler unexpectedly collapsed and died on May 22, no one ordered an autopsy.

Not the doctors at Howard County General Hospital in Columbia, Md., where the 64-year-old professor and cancer researcher was pronounced dead.

Not the Maryland Office of the Chief Medical Examiner, which passed on the case because no foul play was involved.

And not Royak-Schaler’s physicians at Johns Hopkins University School of Medicine who had diagnosed cancer in her hip two days beforehand but acknowledged they didn’t know what had caused her unforeseen death.

A half-century ago, an autopsy would have been routine. Autopsies, sometimes called the ultimate medical audit, were an integral part of American health care, performed on roughly half of all patients who died in hospitals. Today, data from the Centers for Disease Control and Prevention show, they are conducted on about 5 percent of such patients.

As Royak-Schaler’s husband, Jeffrey Schaler, discovered, even sudden unexpected deaths do not trigger postmortem reviews. Hospitals are not required to offer or perform autopsies. Insurers don’t pay for them. Some facilities and doctors shy away from them, fearing they may reveal malpractice. The downward trend is well-known — it’s been studied for years.

What has not been appreciated, pathologists and public health officials say, are the far-reaching consequences for U.S. health care of minuscule autopsy rates.

Diagnostic errors, which studies show are common, go undiscovered, allowing physicians to practice on other patients with a false sense of security. Opportunities are lost to learn about the effectiveness of medical treatments and the progression of diseases. Inaccurate information winds up on death certificates, undermining the reliability of crucial health statistics.

It was only because of Royak-Schaler’s connections that her case ended differently. Her colleagues at the University of Maryland School of Medicine urged her husband to authorize an autopsy and volunteered to conduct it for free.

In her case, as in so many, the autopsy revealed a surprise: Royak-Schaler, the renowned cancer researcher, had cancer ravaging her body — in her lungs, kidneys, abdomen and the marrow of her bones. A blood clot, likely related to the tumors, caused her sudden death.

Jeffrey Schaler has wrestled with anger that his wife wasn’t diagnosed sooner but said knowing how she died was better than not.

“There’s a sense of peace that accompanies that knowledge,” he said.

For the last year, ProPublica, PBS “Frontline” and NPR have probed America’s deeply flawed system of death investigation [4], focusing primarily on forensic autopsies, which are conducted by coroners’ offices and medical examiners when there is suspicion of an unnatural death. State laws vary, but the preponderance of deaths that occur in hospitals are considered natural. When deaths are unexplained, unobserved or within 24 hours of admission, hospitals may be required to report them to local coroners or medical examiners, but such  agencies rarely take hospital cases.

Hospital physicians, with consent from patients’ next of kin, may order a clinical autopsy to explore the disease process in the body and determine the cause of death. That was the norm 50 years ago, when the value of the autopsy was considered self-evident.

Fight corporate influence by keeping independent media strong! Click here to make a tax-deductible contribution to Truthout. [5]

“Much of what we know about medicine comes from the autopsy,” said Dr. Stephen Cina, chairman of the forensic pathology committee for the College of American Pathologists. “You really can’t say for sure what went on or didn’t go on without the autopsy as a quality assurance tool.”

Yet, autopsy rates at teaching hospitals, which are typically run on a nonprofit basis and have an educational mission, hover around 20 percent today. At private and community hospitals, which constitute 80 percent of facilities nationwide, rates can be close to zero.

“I know new hospitals are being built these days without a place to do an autopsy,” said Dr. Dean Havlik, the Mesa County, Colo., coroner, who estimated that the overall hospital autopsy rate in his area is less than 1 percent.

Hospitals have powerful financial incentives to avoid autopsies. An autopsy costs about $1,275, according to a survey of hospitals in eight states. But Medicare and private insurers don’t pay for them directly, typically limiting reimbursement to procedures used to diagnose and treat the living. Medicare bundles payments for autopsies into overall payments to hospitals for quality assurance, increasing the incentive to skip them, said Dr. John Sinard, director of autopsy service for the Yale University School of Medicine.

“The hospital is going to get the money whether they do the autopsy or not, so the autopsy just becomes an expense,” Sinard said.

Since a 1971 decision by The Joint Commission, which accredits health-care facilities, hospitals haven’t had to conduct autopsies to remain in good standing. The commission had mandated autopsy rates of 20 percent for community hospitals and 25 percent for teaching facilities, but dropped the requirement. Many hospitals were performing autopsies “simply to meet the numbers” and not to improve quality, said Dr. Paul Schyve, the commission’s senior adviser of health-care improvement.

Doctors, too, have gravitated away from autopsies because of growing confidence in modern diagnostic tools such as CT scans and MRIs, which can identify ailments while patients are still alive.

Still, in study after study, autopsies have revealed that doctors make a high rate of diagnostic errors even with increasingly sophisticated imaging equipment.

A 2002 review of academic studies by the federal Agency for Healthcare Research and Quality found [6] that when patients were autopsied, major errors related to the principle diagnosis or underlying cause of death were found in one of four cases. In one of 10 cases, the error appeared severe enough to have led to the patient’s death.

“Clinicians have compelling reasons to request autopsies far more often than currently occurs,” the agency concluded.

Schyve called the findings of such studies flawed because cases in which autopsies are performed are typically the most complex, making diagnostic errors more likely. The overall error rate is far lower, he said.

But Sinard said so few autopsies are being conducted — one survey found that 63 percent of hospitals in Louisiana performed none in a given year — that doctors and hospitals can’t say for certain how patients are dying. “They’ve never checked,” the Yale pathologist said.

Pathologists interviewed by ProPublica said they often find diagnostic errors. “We often identify things that the imaging study could not,” said Dr. Debra Kearney, director of autopsy pathology at Texas Children’s Hospital.

Autopsies can also be a crucial tool for evaluating and improving medical care.

Dr. Elizabeth Burton, deputy director of the pathology department at Johns Hopkins University School of Medicine, said performing autopsies on patients who have died of hospital-acquired infections helps save others. Infection clusters “go in waves” in hospitals, she said. Physicians have used her findings to change antibiotic regimens, snuffing out the bacterium.

Dr. Renu Virmani, president and medical director of the nonprofit CVPath Institute, has used postmortem examinations to help reform the treatment of heart disease. Virmani and her team have collected about 250 specimens of metal stents removed at autopsy from patients who had procedures to clear blockages from their arteries.

Their work showed that, in certain patients, a type of stent designed to reduce the risk of blood clots was causing delayed healing, inflammation and reactions that could be fatal. As a result, patients who receive these stents are now required to take blood-thinning medication for a year after the procedure.

Sitting in her lab in Gaithersburg, Md., Virmani peers through a microscope at a specimen slide taken from a 61-year-old man who died suddenly in 2004, about four months after receiving a clot-resistant stent. She points out signs of inflammation in the cross-section of his stented artery, describing the swirls and grains, stained pink and purple so they stand out on the slide. The autopsy showed that the stent had led to the patient’s fatal blood clot.

Autopsies should be used to evaluate the effectiveness of other therapies, Virmani said, from chemotherapy to heart-valve replacements. “The only way to learn is through autopsies.”

Hospital autopsies are even rarer when patients older than 60 die in hospitals, representing a lost opportunity to learn about age-related diseases, Burton said. More than 684,000 such patients died in hospitals in 2008 — more than one-quarter of the total deaths in the country — and just 2.3 percent were autopsied, CDC data show.

Without autopsies to confirm patients’ precise causes of death, public health officials say, the health-care system overall suffers. Erroneous information sometimes ends up on death certificates. Broad categories of disease such as cancer are probably accurate, but specifics such as the type of cancer may not be, said Robert Anderson, chief of the mortality statistics branch of the CDC’s National Center for Health Statistics.

“These data are used to set public health priorities, to develop public health programs and allocate resources,” Anderson said. “We do the best that we can given the information we have, but if you put bad information into the system, you’re going to get bad information out.”

In 1999, the Medicare Payment Advisory Commission, or MedPAC, which advises Congress about Medicare, issued a report stating that increasing the rate of clinical autopsies could improve health care and reduce errors.

The report recommended paying pathologists directly for autopsies and giving hospitals bonuses or penalties for hitting or missing target autopsy rates. The advisory group also suggested that Medicare change its hospital regulations to encourage more autopsies and use them as a standard of performance.

But Medicare has not acted upon these recommendations. An official from the Centers for Medicare & Medicaid Services declined ProPublica’s request for an interview, saying the use of autopsies in hospitals “is not within [Medicare’s] bailiwick at all.”

Other organizations that advocate for better medicine, such as the Institute for Healthcare Improvement, National Quality Forum and The Joint Commission, have not pushed for higher levels of autopsies, either, despite the widely held belief  that this could produce improved care.

Raising the rate “is not one of our priorities by any means,” The Joint Commission’s Schyve said.

Dr. George Lundberg, a pathologist and one of the country’s most vocal advocates for increasing the autopsy rate, shakes his head when discussing the medical industry’s apathy about low autopsy rates.  Lundberg, the editor of the journal MedPage Today, said The Joint Commission should re-establish mandatory autopsy rates “like they used to have back in the good old days of quality when we weren’t running away from trying to find the truth [about] our sickest patients.”

One way to shake the complacency, various experts told ProPublica, would be for insurance companies and the government to pay for autopsies. But an official from UnitedHealth Group, the largest health-insurance company in the country, said the autopsy is not reimbursed because it “isn’t a procedure that would prevent or treat a sickness or injury” in a patient.

Virmani called this shortsighted. The cost of an autopsy is small relative to the money spent on drugs, treatment and diagnostic imaging, she said, and the payoff could save lives and money.

“We are letting go of something which we could really use tomorrow to improve the health care of patients,” she said.

Robert Gibbs, founder of Miles For Hope, Inc., loses his seven-year battle with brain cancer – Boston Globe

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Posted 18 Dec 2011 — by James Street
Category Brain, Finance and Politics of cancer research and treatment

Publication Date 17 December 2011

Read this interesting article here: Robert Gibbs, founder of Miles For Hope, Inc., loses his seven-year battle with brain cancer – Boston Globe

Robert Gibbs, founder of Miles For Hope, Inc., loses his seven-year battle with brain cancer

(PR NewsChannel) / CLEARWATER, Fla. / Robert (Bob) Gibbs, co-founder of Miles For Hope, Inc., a nonprofit organization, passed away Saturday December 10th, 2011 at 2:05 a.m., after a seven-year battle with brain cancer. Gibbs, 42, died peacefully with family by his side. Gibbs was a leader in the brain tumor community. His focus through Miles For Hope was to raise awareness and funding for cutting-edge brain tumor research and clinical trials. In July 2011, Miles For Hope partnered with two other brain tumor organizations, in awarding a $100,000 research grant to University of California Los Angeles (UCLA) neurosurgeon Linda Liau, M.D., PhD to begin the clinical trial, Optimizing Dendritic Cell Vaccination for Low Grade Glioma Patients. This is the first trial of its kind for patients that have been diagnosed with low grade gliomas, a common form of brain cancer, which has the potential to improve the lives of brain cancer patients.

This grant reflected Gibbs commitment to increase awareness and funding for potentially life-saving brain tumor research. The next step in carrying out Gibbs vision is to fund a vaccine trial for Pediatric Brain Tumor Patients.

In addition to supporting the latest research, advancements and clinical trials, Gibbs was also dedicated to offering patients and their families much needed support through his organization. This includes providing information about up-to-date treatment options and providing medically necessary flight assistance to patients so they can get the treatment they desperately need.

According to his wife Barb, Bobs mission was not only to find a cure for this devastating disease, but to offer his own brain cancer experiences to others to assist them during their battle. He always put others before himself. He touched many lives while battling his own illness. He always found time to speak with other brain tumor patients or their families, providing hope, information, comfort and support. Although his own treatments exhausted him, he never tired from helping others or turned anyone away. His strength, determination and drive touched and helped so many.

Gibbs, married and father of four, was diagnosed in 2004 with brain cancer at the age of 34. He is survived by his wife, Barb, their four sons Christopher, Justin, Matthew, and Dylan, his parents Clayton and JoAnne Gibbs, and his sister Jackie (Jeff) Tonkel.

A public memorial service will be held Saturday, December 17th, at 3 p.m., at Sylvan Abbey Memorial Park, 2860 Sunset Point Road, Clearwater, FL 33759. In lieu of flowers, the family requests donations to Miles For Hope, Inc., www.MilesForHope.org, to continue Gibbs dedication in Moving Towards a Cure for brain tumors.

About Mile for Hope, Inc: Miles for Hope, Inc. is a 501(3) nonprofit organization dedicated to funding cutting-edge Brain Tumor research, raising awareness and providing medically necessary travel assistance to Brain Tumor patients.

MEDIA CONTACT Barb Gibbs 1684 North Belcher Road Clearwater, FL 33765 (727) 781-4673 Barb@milesforhope.org

Direct link: http://www.prnewschannel.com/2011/12/15/robert-gibbs-founder-of-miles-for-hope-inc-loses-his-seven-year-battle-with-brain-cancer/

SOURCE: Miles for Hope, Inc.

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