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Archive for Politics and Regulation

The 2008-2009 Report of the President’s Cancer Panel: Mostly good, some bad, and a little ugly

Mark Crislip is always a hard act to follow, particularly when he’s firing on all cylinders, as he was last Friday. Although I can sometimes match him (and, on rare occasions, even surpass him) for amusing snark, this time around I’m going to remain mostly serious because that’s what the subject matter requires. I’ve said it before and I’ll say it again: I’m a bit of an odd bird in the world of cancer in that I’m both a surgeon and I run a lab. Sadly, there just aren’t very many surgeons doing basic and translational research these days, thanks to declining NIH funding, increasing clinical burden necessitated by declining reimbursements, and the increasing complexity of laboratory-based research. That’s not to say that there aren’t some surgeons out there doing excellent laboratory research, but sometimes I feel as though I’m part of an endangered species, particularly years like this when grants are running out and I need to renew my funding or secure new funding, the consequence of failure being the dissolution of my laboratory. It’s a tough world out there in biomedical research.

As tough as biomedical research is in cancer, to my mind far tougher is research trying to tease out the relationship between environmental exposures and cancer risk. If you want complicated, that’s complicated. For one thing, obtaining epidemiological data is incredibly labor- and cost-intensive, and rarely are the data clear cut. There’s always ambiguity, not to mention numerous confounding factors that conspire to exaggerate on the one hand or hide on the other hand correlations between environmental exposures and cancer. As a result, studies are often conflicting, and making sense of the morass of often contradictory studies can tax even the most skillful scientists and epidemiologists. Communicating the science and epidemiology linking environment and cancer to the public is even harder. What the lay person often sees is that one day a study is in the news telling him that X causes cancer and then a month later another study says that X doesn’t cause cancer. Is it any wonder that people are often confused over what is and is not dangerous? Add to this a distinct inability on the part of most people, even highly educated people, to weigh small risks against one another (an inability that has led to phenomena such as the anti-vaccine movement), and the task of trying to decide what is dangerous, what is not, how policy is formulated based on this science, and how to communicate the science and the policy derived from it to the public is truly Herculean.
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Posted in: Cancer, Politics and Regulation, Public Health

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Bogus Diagnostic Tests

A few years ago a friend asked me to comment on advice given to her adult daughter by a psychiatrist whom she’d consulted for depression. The psychiatrist had recommended testing samples of saliva and urine for hormone and neurotransmitter levels, the results of which would likely indicate a need for supplements to correct deficiencies or imbalances. According to the psychiatrist, who had an academic appointment at a medical school in New York City, “I have been using these supplements with a great deal of success.” My friend is not medically or scientifically sophisticated, but this made her a little uncomfortable. In that, she was entirely justified.

During our recent panel discussion at the NECSS, a member of the audience identified himself as a clinical pathologist at a major medical center, and wondered what he might do to become involved in the good fight against encroaching pseudoscience in medical schools. Clinical pathology is the medical specialty that concerns itself, in summary, with laboratory tests—their development, their validity, their interpretation, their usefulness and, by implication, their misuse. A topic that we haven’t much featured on SBM (we touched upon it here, here and here, and probably elsewhere) is that of bogus laboratory or other diagnostic tests.

Early in my own education in modern quackery, I found it particularly distasteful not merely that quacks misuse laboratory tests, but that several commercial laboratories market misleading tests. To the untrained eye these laboratories appear to be legitimate, even to the point of their being approved by apparently legitimate certifying bodies. We’ll discuss that below, but first let’s look more closely at the psychiatrist’s recommendations to my friend’s daughter and at other examples of bogus tests.

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Posted in: Health Fraud, Medical Ethics, Neuroscience/Mental Health, Politics and Regulation, Science and Medicine

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Our Visit with NCCAM

Over the past two plus years of the existence of Science-Based Medicine (SBM) we have been highly critical of the National Center for Complementary and Alternative Medicine (NCCAM) – going so far as to call for it to be abolished. We are collectively concerned that the NCCAM primarily serves as a means for promoting unscientific medicine, and any useful research it funds can be handled by other centers at the NIH.

So we were a bit surprised when the current director of the NCCAM, Josephine Briggs, contacted us directly and asked for a face-to-face meeting to discuss our concerns.

That meeting took place this past Friday, April 2nd. David Gorski, Kimball Atwood and I met with Dr. Briggs, Deputy Director Dr. John Killen, Karin Lohman PhD (Director, Office of Policy, Planning, and Evaluation) and Christy Thomsen (Director, Office of Communications and Public Liaison).

Dr. Briggs very graciously began the meeting by telling us that she and her staff have been reading SBM and they find our arguments to be cogent and serious. She shares many of our concerns, and feels that we are an important voice and are having an impact. She then essentially turned it over to us to discuss our primary concerns regarding the NCCAM.

We were prepared for this.

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Posted in: Medical Ethics, Politics and Regulation, Science and Medicine

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My NCCAM Wish List

For a number of reasons, well-argued many times here on SBM, it would be beneficial to American citizens if the National Center for Complementary and Alternative Medicine (NCCAM) were abolished. This does not seem to be in the cards anytime soon. Here, then, are my suggestions for making the Center less dangerous and less of a marketing tool for pseudomedicine than it has been since its inception. Some suggestions might even make the Center somewhat useful. They are listed in order of priority. The Center should:

1. Abandon all unethical trials, beginning with the Trial to Assess Chelation Therapy (TACT, which is under the joint auspices of the NHLBI). This should be done in a very public manner. The reasons for abandoning the TACT, in summary, are as follows.

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Posted in: Medical Ethics, Politics and Regulation, Science and Medicine

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The 2nd Yale Research Symposium on Complementary and Integrative Medicine. Part I

March 4, 2010

Today I went to the one-day, 2nd Yale Research Symposium on Complementary and Integrative Medicine. Many of you will recall that the first version of this conference occurred in April, 2008. According to Yale’s Continuing Medical Education website, the first conference “featured presentations from experts in CAM/IM from Yale and other leading medical institutions and drew national and international attention.” That is true: some of the national attention can be reviewed here, here, here, and here; the international attention is here. (Sorry about the flippancy; it was irresistible)

I’ve not been to a conference promising similar content since about 2001, and in general I’ve no particular wish to do so. This one was different: Steve Novella, in his day job a Yale neurologist, had been invited to be part of a Moderated Discussion on Evidence and Plausibility in the Context of CAM Research and Clinical Practice. This was not to be missed.

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Posted in: Chiropractic, Clinical Trials, Health Fraud, Herbs & Supplements, Homeopathy, Medical Academia, Medical Ethics, Nutrition, Politics and Regulation, Science and Medicine

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Homeopathy Gets a Reality Check in the UK

The House of Commons Science and Technology Committee (STC) has released a report, Evidence Check 2: Homeopathy, in which they recommend that the NHS stop funding homeopathy. The report is a rare commodity – a thoroughly science-based political document.

The committee went beyond simply stating that homeopathy does not work, and revealed impressive insight into the ethical, practical, and scientific problems caused by NHS support for an implausible and ineffective pseudoscience.

The STC formed in October of 2009, and this is their second report. The goals of the STC itself are significant step forward:

The purpose of Evidence Check is to examine how the Government uses evidence to formulate and review its policies.

We certainly can use more of that.

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Posted in: Homeopathy, Politics and Regulation, Science and Medicine

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The Winkler County nurse case and the problem of physician accountability

A MISCARRIAGE OF JUSTICE THAT HAD A (SORT OF) HAPPY ENDING

Back in September and then again last week, I wrote briefly (for me) about an incident that I considered to be a true miscarriage of justice, namely the prosecution of two nurses for having reported the dubious and substandard medical practices of a physician on the staff of Winkler County Hospital in Kermit, Texas. The physician’s name is Dr. Rolando Arafiles, and he happened to be a friend of the Winkler County Sheriff, Robert Roberts, who also happened to have been a patient of Dr. Arafiles and very grateful to him for having saved his life. The nurses, Anne Mitchell and Vickilyn Galle, were longtime employees of Winkler County Hospital, a fifteen bed hospital in rural West Texas. Although some of you may have seen extensive blogging about this before, I thought it very important to discuss some of the issues involved on this blog. Moreover, there is an aspect to this case that the mainstream media reporting on it has missed almost completely, as you will see. Finally, this case showed me something very ugly about my profession, not just because a doctor tried to destroy the lives of two good nurses through his connections to the good ol’ boy network in Winkler County

Let’s recap what happened, a story that reached its climax last Thursday. In 2008, Dr. Arafiles joined the staff of Winkler County Hospital (WCH). It did not take too long for it to become apparent that there were serious problems with this particular doctor. Mitchell and Galle, who worked in quality assurance were dismayed to learn that Dr. Arafiles would abuse his position to try to sell various herbal remedies to patients in the WCH emergency room and the county health clinic and to take supplies from the hospital to perform procedures at a patient’s home rather than in the hospital. No, it wasn’t the fact that Dr. Arafiles recommended supplements and various other “alt-med” remedies, it’s that he recommended supplements and various other “alt-med” remedies that he sold from his own business–a definite no-no both ethically and, in many states, legally. Mitchell reported her concerns to the administration of WCH, which did pretty much absolutely nothing. Consequently, on April 7, 2009, Mitchell and Galle anonymously reported their concerns to the Texas Medical Board (TMB). In June, WCH fired the two nurses without explanation.
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Posted in: Health Fraud, Homeopathy, Politics and Regulation, Science and the Media, Vaccines

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The Dietary Supplement Safety Act of 2010: A long overdue correction to the DSHEA of 1994?

BACKGROUND: A BAD, BAD LAW

One of the themes of this blog has been how, over the last couple of decades, the law has been coopted by forces supporting “complementary and alternative” medicine (CAM) in order to lend legitimacy to unscientific and even pseudoscientific medical nonsense. Whether it be $120 million a year being spent for the National Center for Complementary and Alternative Medicine (NCCAM) or attempts to insert provisions mandating that insurers in the government health care co-ops that would have been created by President Obama’s recent health care reform initiative (which at the moment seems to be pining for the fjords, so to speak), the forces who do not want pesky things like regulation to interfere with their selling of pseudoscience have been very successful. Arguably the crown jewel of their legislative victories came in 1994, when the Dietary Supplement Health and Education Act (DSHEA) was passed. Demonstrating that pseudoscience is a bipartisan affair, the DSHEA was passed, thanks to a big push from the man who is arguably the most powerful supporter of quackery in government and the man most responsible for the creation of the abomination that is NCCAM, Senator Tom Harkin (D-IA), along with his partner in woo, Senator Orrin Hatch (R-UT). It should be noted that Harkin happens to be the recipient of large contributions from supplement manufacturer Herbalife, demonstrating that big pharma isn’t the only industry that can buy legislation related to health.

Dr. Lipson has discussed the DSHEA before (calling it, in his own inimitable fashion, a “travesty of a mockery of a sham“) as has a certain friend of mine. Suffice it to say that the DSHEA of 1994 is a very bad law. One thing it does is to make a distinction between food and medicine. While on its surface this is a reasonable distinction (after all, it wouldn’t make a lot of sense to hold food to the same sorts of standards to which drugs are held), as implemented by the DSHEA this distinction has a pernicious effect in that it allows manufacturers to label all sorts of botanicals, many of which with pharmacological activity, as “supplements,” and supplements, being defined as food and not medicine, do not require prior approval by the FDA before marketing:
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Posted in: Herbs & Supplements, Nutrition, Politics and Regulation

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The legal establishment of Winkler County, Texas conspires to punish whistle blowing nurses

On Science-Based Medicine, several of us have at various times criticized state medical boards for their tolerance of unscientific medical practices and even outright quackery. After all, Dr. Rashid Buttar still practices in North Carolina and the medical board there seems powerless to do anything about it. However, state medical boards have other functions, one of which is to respond to complaints of unethical and dubious behavior about doctors. Key to this function is protection; i.e., if someone reports a doctor, that person needs to be sure that the state will protect her from retaliation from that doctor of the hospital. About five months ago, I reported a true miscarriage of justice, the sort of thing that should never, ever happen. In brief, it was the story of two nurses who, disturbed at how a local doctor was peddling his dubious “herbal” concoctions in the emergency room of the local hospital when he came in to see patients, reported him to the authorities. Moreover, they had gone up the chain of command, first complaining to hospital authorities. After nothing happened for months, they decided to report the physician, Dr. Rolando Arafiles, to the Texas Medical Board because they honestly believed that this physician was abusing his trust with patients and behaving unethically by improperly hawking herbal supplements that he was selling in the rural health clinic and the emergency room of Winkler County Memorial Hospital.

Even though under whistleblower laws the identities of these nurses should have been kept secret, after he learned that a complaint had been filed against him Dr. Arafiles went to his buddy the Winkler County Sheriff Robert L. Roberts, who left no stone unturned in trying to find out who had ratted out Dr. Arafiles:

To find out who made the anonymous complaint, the sheriff left no stone unturned. He interviewed all of the patients whose medical record case numbers were listed in the report and asked the hospital to identify who would have had access to the patient records in question.

At some point, the sheriff obtained a copy of the anonymous complaint and used the description of a “female over 50″ to narrow the potential complainants to the two nurses. He then got a search warrant to seize their work computers and found a copy of the letter to the medical board on one of them.

The result was this:

In a stunning display of good ol’ boy idiocy and abuse of prosecutorial discretion, two West Texas nurses have been fired from their jobs and indicted with a third-degree felony carrying potential penalties of two-to-ten years’ imprisonment and a maximum fine of $10,000. Why? Because they exercised a basic tenet of the nurse’s Code of Ethics — the duty to advocate for the health and safety of their patients.

On Saturday, the New York Times reported on the story, as there have been significant developments since August. Specifically, although the charges against one of the nurses has been dismissed, Anne Mitchell, RN, is going to stand trial beginning today:
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Posted in: Medical Ethics, Politics and Regulation

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The General Medical Council to Andrew Wakefield: “The panel is satisfied that your conduct was irresponsible and dishonest”

BACKGROUND

In my not-so-humble opinion, the very kindest thing that can be said about Andrew Wakefield is that he is utterly incompetent as a scientist. After all, it’s been proven time and time again that his unethical and scientifically incompetent “study” that was published in The Lancet in 1999 claiming to find a correlation between vaccination with MMR and autistic regression in autistic children with bowel symptoms was at best dubious science and at worst fraudulent. For one thing, as investigative journalist Brian Deer found, Wakefield was in the pocket of trial lawyers, who were interested in suing vaccine manufacturers, to the tune of £435,643 in fees, plus £3,910 expenses beginning even before his infamous “study” started accruing patients. Even though the study itself used the typical careful and relatively neutral language that we all expect from scientists, Wakefield himself was not nearly so circumspect. In a press conference announcing the Lancet study, he said:

He told journalists it was a “moral issue” and he could no longer support the continued use of the three-in-one jab for measles, mumps and rubella.

“Urgent further research is needed to determine whether MMR may give rise to this complication in a small number of people,” Dr Wakefield said at the time.

And so began one of the most contentious health stories of this generation.

Wakefield’s Lancet paper, even interpreted as sympathetically as possible, concluded nothing that justified such language. Yet his rhetoric, along with sensationalistic and credulous British journalists, ignited a firestorm of fear over the MMR that has not yet subsided now, over a decade later. Vaccination rates plummeted in the UK, and measles, a disease once thought to be under control, has surged back and become endemic again. It is a feat that Jenny McCarthy and Jim Carrey appear to be trying to replicate right here in the U.S. with their wonderfully Orwellian-named Green Our Vaccines activism and ceaseless promotion of anti-vaccine messages.

More recently, at the Autism Omnibus hearings, we learned from a world expert in the polymerase chain reaction, Dr Stephen Bustin, that the techniques used in the laboratory running PCR on the clinical specimens from Wakefield’s clinical trial were so shoddy, so devoid of routine controls necessary in any PCR experiment, that the measles sequences reported as amplified in Wakefield’s followup to his Lancet study were false positives derived from plasmids with measles sequences in them contaminating the laboratory. Then, in late 2008, Mady Hornig and colleagues at Columbia University published an attempted replication of Wakefield’s study. They failed. There was no association between vaccination with MMR and autistic regression, nor could Hornig find any evidence that measles in the gut was any more common in the autistic children studied than in the neurotypical controls. This study was particularly devastating to Wakefield because it was carried out by a researcher who had previously been sympathetic to the myth that vaccines cause autism, as evidenced by her infamous “rain mouse” study and, even more close to home, using the same laboratory that had performed Wakefield’s PCR, which had apparently cleaned up its act in the years following its work on Wakefield’s specimens.

When it comes to the science, there is no doubt. No reputable scientist has been able to replicate Wakefield’s findings, and there is a remarkable convergence and agreement of findings of major studies looking for a correlation between MMR vaccination and autism: There ain’t one. Indeed, closing out 2009 was the publication of yet another study that failed to find any correlation between MMR and autism, or, as I put it at the time, yet another nail in the coffin of the myth that the MMR vaccine causes autism. Andrew Wakefield’s repeated claims that the MMR can cause or “trigger” autism in some children is deader than dead as a scientific hypothesis and without a basis in scientific or clinical evidence. True, Wakefield tried to counter with a horribly unethical and badly designed primate study that seemed custom-designed to be used in court rather than in the court of scientific inquiry. It didn’t help and only made Wakefield’s Thoughtful House, Wakefield’s Fortress of Solitude in Texas to which he retreated in the wake of the revelations about his conduct, look even worse. Even a credulously “balanced” TV story by NBC news and Matt Lauer couldn’t hide the dubiousness nature of what goes on there.

Of course, while the science refuting Wakefield’s pseudoscience and evidence showing Wakefield to be incompetent and unethical continued to roll in, a little less than a year ago, it got even worse for him. Brian Deer reported that Wakefield very well may have engaged in scientific fraud in the “research” (and I do use the term loosely) that led to the publication of his Lancet paper in 1999. Through it all, the General Medical Council began an inquiry into whether Andrew Wakefield behaved unethically in the “research” that resulted in his 1999 Lancet report. It should be pointed out that the investigation of the GMC began before Deer’s latest revelation of potential fraud; rather it was far more concerned with how Wakefield ran his study and recruited patients. Nonetheless, the revelations nearly a year ago about Wakefield’s playing fast and loose with research methodology could not help but contribute to the sense that the Good Ship Wakefield had been torpedoed below the water line and was taking on water fast.

As the investigation and hearings wound on seemingly endlessly for two and a half years, Wakefield’s supporters intermittently waged an increasingly histrionic and ridiculous propaganda offensive to try to preemptively discredit the GMC’s findings. As it became clear that finally after all this time the GMC was on the verge of announcing its ruling, I noticed that the anti-vaccine crank blog Age of Autism was ramping up an increasingly bizarre and unhinged last minute propaganda campaign, complete with reposting a hilariously inapt post by Mark Blaxill comparing Wakefield to Galileo and the GMC to the Inquisition, complete with references to Stalin and Mao (I suppose I should be relieved that Blaxill refrained from playing the Hitler card); a defense of “that paper” by Wakefield himself; claims that parent witnesses had been “silenced” at the GMC hearings; and a whole series of posts by John Stone trying to discredit the GMC.

And then on Thursday, the GMC ruled.

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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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