The Saatchi Bill, or, How England Could Become Quack Paradise

"Hi. I'm Lord Maurice Saatchi, and I'm trying to help quacks."

The other day, I wrote an open letter to members of the various state legislatures in the United States about so-called "right to try" laws. These laws purport to make it easier for terminally ill patients to seek out and obtain treatment with experimental drugs. The reality is that the laws leave patients in the lurch. State right to try laws simply create false hopes for patients and leave them to take on incredible risks while giving up some of their rights to legal redress. So far, five states have passed right to try laws without any serious critique by legislators. To some degree, I don't blame them. Who wants to deny a patient the right to try anything to prolong their life? Yet those legislators who pass these laws are being far more cruel than any who vote these laws down.

But if you think state right to try laws in the United States are bad, take a look at the United Kingdom's Medical Innovation Bill (HL Bill 48 [full text]), also known as the Saatchi Bill, after its sponsor, Lord Maurice Saatchi. As with right to try laws, the intent of the Saatchi Bill is well-meaning, but the end result is likely to be far more harmful for patients than imagined by the bill's supporters.

An Open Letter to State Congress Members on Right to Try Laws

Dear Members of Congress,

"Right to try" laws, that is, laws designed to purportedly make it easier for terminally ill patients to gain access to unapproved, experimental drugs, have been in the news quite a bit recently. Several state legislatures have overwhelmingly supported these types of bills, with little or no opposition, let alone serious, critical examination. Although advocates of these laws claim to have the rights and interests of terminal patients in mind, much of the legislation, and the long-term consequences, are likely to do more to benefit unscrupulous companies and hucksters while doing little to help, or even increasing the harm to, patients in great need, not to mention legitimate companies.

The driving premise behind right to try laws is that terminally ill patients have nothing to lose by trying unproven treatments, and that they ought to have the right to gain access to those treatments without undue burden. A dominant view among right to try proponents is that the Food and Drug Administration, and the various regulations they enforce, create inappropriate barriers to the timely release of potentially life-saving drugs. Advocates believe that earlier access will save lives, coupled with the belief that the government should not interfere with a patient's right to decide what treatments they wish to pursue.

While right to try laws seem, on their surface, to do nothing but benefit patients, they will very likely fail to do so, and perhaps even harm patients, for a number of reasons.

Mark Geier On His Last Leg

Dr. Mark Robin Geier, about whom I've written about quite a bit, just can't get a break. Geier is the physician who, after reading a single lab study showing that mercury binds with testosterone when in a hot benzene environment (blogger Prometheus has a good write-up of this), thought that this explained how to treat autism. At the time Geier and his son, David (who has gotten in trouble for pretending to be a doctor), latched onto the two ideas that the mercury in thimerosal and testosterone played a role in autism causation. The former is now discredited, after numerous studies comparing autism rates in children who received thimerosal-containing vaccines and those who did not, as well as failed court cases based on this idea. The latter does have some validity to it, but only insofar as the fetus is exposed to high concentrations of testosterone in the womb. The way Geier, père et fils, decided they could treat autism based on this study that bears no resemblance to the environment of the human body, was to use the chemical castrating drug Lupron to lower testosterone levels in kids, followed by dosing with chelating drugs to remove mercury.

It was this treatment protocol that got the Geiers into trouble, first in Maryland. Dr. Geier was found to have been misdiagnosing autistic children with precocious puberty so he could get insurance companies to pay for his treatment, which also happens to be in violation of FDA regulations. Lupron is not approved by the FDA for use in the treatment of autism, so his spurious precocious puberty diagnoses got around this, as well. At any rate, this protocol, among other problems with how he ran his clinic, resulted in his license being suspended. The investigation also turned up that his son, David, practiced medicine without a license by making diagnoses and prescribing various tests and procedures to patients. The original suspension led to nearly every other state in which Mark Geier was licensed to suspend his licenses. Then in September and October ofearlier this year, Maryland, Indiana and Washington went beyond suspension and permanently revoked his license. Hawaii, Illinois and Missouri, however, have been dragging their feet.

Until now.

Making a Lancet Replica

This post is going to be a bit of a departure from my usual writing. You'll be spared my ramblings about vaccines, law, ethics and censorship. Instead, I thought I would put up a post documenting how I went about making a prop for my Halloween costume this year. Hopefully I won't give away too much about what my costume is going to be before it's time to be revealed.

Fleam

Lancet

A good costume is more than just the clothes you wear or a mask. It's also important to pay attention to the details. What kind of props are you going to add on? How accurate are you going to be? What materials are you going to use? For my costume, I really wanted to add on a lancet or fleam, devices that were once used for bloodletting, the belief being that bleeding a patient would balance the humours and heal them of whatever disease they happened to have. In nearly every instance, this was pure nonsense, and frequently dangerous, sometimes fatally so. At any rate, I had a couple options: buy one or make my own. Real lancets were hard to find, fleams a bit easier, and both were rather more than I wanted to spend.

Based on the pictures I was able to find, fleams seemed a bit too complex for me. Not only did I not have the metalworking skills they seemed to required, I just didn't have the tools. The lancet looked much easier, though I did need to do a bit more research on how to add a handle. Some quick googling on how to put handles on knives and I was ready to start. A quick run to the local big box hardware store, then time to get to work.

Washington Joins Indiana and Maryland in Revoking Mark Geier's License

 Washington has become the third state to permanently revoke Dr. Mark Geier's medical license. This comes shortly after Maryland finally revoked Geier's licence. The Washington Medical Quality Assurance Commission had ordered Geier and/or his attorney to appear and to produce certain documents. They did not do so in the time frame specified, so by default, Geier has lost his case.

The Commission ordered (M2012-377) on October 4, 2012, that Mark Geier's license to practice medicine in the state of Washington is permanently revoked. He is ordered to hand over all licenses within 10 days and is fined $5,000, payable within 30 days.

Meanwhile, Missouri, Illinois and Hawaii have yet to do anything to stop this man from preying on autistic children in their jurisdictions. This is, however, very welcome news.
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Related Posts:

• Mark Geier's License Revoked - And It's About Damn Time!
• Mark "Castrate 'Em" Geier's License Suspended - Part 7
• The Fall of the Geiers Continues Apace
• Mark "Castrate 'Em" Geier's License Suspended - Part 6
• Complaint Filed Against Dr. Mark Geier in Florida
• Mark Geier Ordered to Stop Practicing Medicine
• Map of Mark Geier Medical Licenses
• Mark "Castrate 'Em" Geier's License Supsended - Part 5
• Mark "Castrate 'Em" Geier's License Suspended - Part 4
• Mark "Castrate 'Em" Geier's License Suspended - Part 3
• Mark "Castrate 'Em" Geier's License Suspended - Part 2
• Charges Levied Against Mark and David Geier
• URGENT: Please Call the Maryland State Board of Physicians About David Geier
• A Close Look at David Geier
• Mark "Castrate 'Em" Geier's License Suspended

Mark Geier's License Revoked - And It's About Damn Time!

Today, Catherina over at Just the Vax, let me know about a development on a topic that I've been covering for quite some time. And the timing of this is rather fortuitous, as this post marks number 250 for me! I couldn't think of a better subject than to enlighten you all on the latest turn for the infamous Dr. Mark Geier, the physician who inappropriately used the precious puberty and chemical castration drug Lupron to supposedly treat children with autism.

What is this latest development? The Maryland Board of Physicians has (finally!) revoked Dr. Geier's medical license.

File this under: about damn time.

And the order that accompanies this is scathing.

Mark "Castrate 'Em" Geier's License Suspended - Part 7

The bad news just keeps coming for Dr. Mark Geier and his son, David. I recently wrote about the Maryland Department of Physicians finding that David Geier practiced medicine without a license and was fined $10,000 (with, in my admittedly non-expert opinion, the potential for further fines and jail time), as well as Dr. Geier's license being challenged in Hawaii and his application for a license in Ohio rejected.

Catherina at Just the Vax alerted me to some very recent news. Today, she posted some excerpts from meeting minutes of the Florida Board of Medicine. It looks like Florida is the latest state to suspend his license (Final Order here; if the link doesn't work, you can look up the documents here), including administrative and punitive fines. It appears that Dr. Geier entered into a settlement with the state of Florida, agreeing to abide by their suspension of his license and waiving all rights to further appeal or challenge of their decision.

The Fall of the Geiers Continues Apace

A brief break in the posters to bring you some updates on the Geier front. As you have no doubt read by now, David Geier, son of Dr. Mark Geier, has been found by the Maryland Board of Physicians (PDF) to have practiced medicine without a license. His penalty? A $10,000 fine. As Dr. Steven Novella wrote at Neurologica Blog, this is not a huge sum of money, as far as penalties go. The order mentions that the Board took into account:

Mark "Castrate 'Em" Geier's License Suspended - Part 6

[Edited to add: Not sure how I missed this, but when checking out Dr. Geier's listing on the Florida Department of Health's site, it looks like his certification with the American Board of Medical Genetics has been revoked, as well.]

There's been another development in the case of Dr. Mark Geier, the physician who came up with the Lupron Protocol as a purported treatment for autism. Lupron, for those who don't know about it, is a drug that is used in prostate cancer treatment, fertility treatment, to treat precocious puberty and, off-label, to chemically castrate sex offenders. It shuts down production of sex hormones (testosterone in men, estrogen in women). The reason the Geiers use this drug is because they believe that testosterone and mercury bind together, making it more difficult for the body to eliminate the mercury in, for example, thimerosal-containing vaccines. This belief comes from a single study examining testosterone and mercury in hot benzene, which, for those who might be unaware, is a condition never found in the human body. Prometheus wrote about this back in 2006. Never mind that there is no quality evidence showing that in children with autism there is any of this testosterone-mercury binding going on, nor that using lupron (followed by chelation) has any benefit at all.

At any rate, Dr. Geier's erroneously diagnosing children with precocious puberty so he would be able to prescribe lupron, among other ethical and professional lapses, led to his license to practice medicine in Maryland being suspended. This, in turn, resulted in the licensing boards in a number of other states suspending his licenses, too. Which brings us to today.

Cold Space

The other morning, I awoke with my nose deciding it didn't want to function properly and allow me to breathe through both nostrils. The harbinger of a cold, one nostril was stubbornly blocked with the various accumulations of the night. Lovely image, I know. Personally, I blame the exertion and physical stress (particularly the dunking in cold water and subsequent extreme chills) of the zombie run for this state of affairs. I mean, trudging through wet, muddy trails with hundreds of other people in relatively close proximity, dunking in icy water and waiting (soaked) for the better part of an hour in the breezy cool of a spring afternoon can't be all that good for you. Couple that with staying up late and waking early and voilà. A cold.

I actually have a point for relating this. You see, as I commuted to work and noticed my breathing passages start to open, I mused upon what a cold must be like in space. We take for granted that gravity helps our sinuses and nasal cavities drain. But in space, where there is no (or only a weak) gravitational field, would someone with a stuffy nose find absolutely no relief from natural drainage? How would the lack of gravity affect blowing one's nose? Would it be easier or harder?

As I pondered these questions, my mind began to drift toward bigger issues. I might be stepping on Phil Plait's area a bit, but I hope he won't mind. What about more serious medical care in space?

Deception in Research

When is it okay to lie in a study? When someone volunteers to be a research subject, whether it is a psychological study or clinical trial for a new drug, a corporate study or student project, what are the limits on just how much you can deceive the person? What aspects of the deception should be disclosed, and which are okay to keep hidden from the subject? If you do disclose the deception, do you need to be up front about it? Can you wait until after the study is under way or even completed?

The easy answer is that researchers shouldn't lie or mislead study subjects. Lying is wrong, right? Besides, lying could have a very big impact on whether or not the subject participates. And then there are the psychological impacts of being lied to. Just look at the famous (infamous) Shocking Experiment by Stanley Milgram. Most people learn about this in high school social studies, but for those who may be a bit fuzzy or haven't heard about it, a quick summary.

Map of Mark Geier Medical Licenses

UPDATE: I was recently informed that Dr. Geier also has a license in Texas. The map and list have been updated accordingly. He also appears to have a license application pending in Ohio, though the medical board of that state has noted the Maryland action against him and has issued a citation.(Added August 20, 2011)

With all of the various states that have licensed Dr. Mark Geier and the rising tide of suspensions of those license, I thought it may help to provide a map, visualizing which states have suspended Dr. Geier's license to practice medicine and which states still allow him to see and treat patients.

So here we go. Red states are those which have stopped Dr. Geier from misdiagnosing children with precocious puberty and subsequent treatment with the chemical castrator, Lupron, and the green states are those which have yet to take action to bar him from potentially harming any more children.

Mark Geier Medical Licenses by State - Click to Enlarge

Mark "Castrate 'Em" Geier's License Suspended - Part 5

Another brief update on the status of Dr. Mark Geier's licenses to practice medicine in various states. It has come to my attention that a fifth state, California, has now suspended Dr. Geier's license to practice in that state, effective August 3, 2011.

This comes following suspensions (in chronological order) in Maryland (PDF), Washington, Virginia and Indiana (PDF). He still has licenses to practice in Florida, Hawaii, Illinois, Kentucky, Missouri and New Jersey, although it has been reported that his license in Illinois is also under review for possible suspension. There have also been rumors that Missouri will follow suit.

Five dominoes have fallen, six remain.
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Related Posts:

• Mark "Castrate 'Em" Geier's License Suspended - Part 4
• Mark "Castrate 'Em" Geier's License Suspended - Part 3
• Mark "Castrate 'Em" Geier's License Suspended - Part 2
• Charges Levied Against Mark and David Geier
• URGENT: Please Call the Maryland State Board of Physicians About David Geier
• A Close Look at David Geier
• Mark "Castrate 'Em" Geier's License Suspended

Mark "Castrate 'Em" Geier's License Suspended - Part 4

Another brief update for you regarding the status of Dr. Mark Geier's licenses to practice medicine in various states. As you know, his license was first suspended in Maryland. His license was then suspended in Washington and Virginia. Well, it is time to add Indiana to that list. Today, June 24, 2011, when I searched for his license in that state, I found this:

That's 4 out of 11 licenses that have been suspended. His appeal of the Maryland suspension is currently being heard, and the results of that inquiry should be out sometime next week. As it appears that the suspensions in Washington, Virginia and Indiana are based on the actions of the Maryland Board of Physicians, the outcome of the appeal could have a significant impact on the status of his licenses in those states. If his appeal succeeds, his licenses in those three states may be reinstated. If it fails, then there will only be 7 states left in which he can practice his scientifically unfounded protocol of administering the drug Lupron to autistic children.
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Related Posts:

• Mark "Castrate 'Em" Geier's License Suspended - Part 5
• Mark "Castrate 'Em" Geier's License Suspended - Part 3
• Mark "Castrate 'Em" Geier's License Suspended - Part 2
• Charges Levied Against Mark and David Geier
• URGENT: Please Call the Maryland State Board of Physicians About David Geier
• A Close Look at David Geier
• Mark "Castrate 'Em" Geier's License Suspended

If Everyone Else Had Done It, I Didn't Need To - Rachel's Story

I learned about the following story from Phil Plait over at Bad Astronomy. The video is one of many stories you'll find at Shot by Shot.

Mark "Castrate 'Em" Geier's License Suspended - Part 3

I just wanted to provide a brief update on Dr. Mark Geier. Today, I was taking a look at the states in which, last time I checked, Dr. Geier still had a license. If you will recall, his license had been suspended in Maryland and, shortly after that, Washington. He was still licensed to practice medicine in nine states: California, Florida, Hawaii, Illinois, Indiana, Kentucky, Missouri, New Jersey and Virginia. For seven of those, I was able to find laws similar to Washington's, which state that if a licensed practitioner has his or her license suspended in any other state, then it will be suspended in that state as well.

Well, one of those other states has suspended Dr. Geier's license. This is what I found when I went to the licensing board for the state of Virginia:

Only eight states left to step up and take appropriate action. Only eight licenses left that should responsibly be suspended. Another domino has fallen.
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Related Posts:

• Mark "Castrate 'Em" Geier's License Suspended - Part 5
• Mark "Castrate 'Em" Geier's License Suspended - Part 4
• Mark "Castrate 'Em" Geier's License Suspended - Part 2
• Charges Levied Against Mark and David Geier
• URGENT: Please Call the Maryland State Board of Physicians About David Geier
• A Close Look at David Geier
• Mark "Castrate 'Em" Geier's License Suspended

Mark "Castrate 'Em" Geier's License Suspended - Part 2

On April 27, 2011, as you may recall, Dr. Mark Geier's license to practice medicine in the state of Maryland was suspended (PDF). A hearing was scheduled, and on May 12, the MD Board of Physicians upheld its ruling (PDF). I had noted that in addition to his license in Maryland, Dr. Geier also has licenses in California, Florida, Hawaii, Illinois, Indiana, Kentucky, Missouri, New Jersey, Virginia and Washington.

Well, another state has just suspended his license.

Charges Levied Against Mark and David Geier

On April 27, 2011, the Maryland Board of Physicians issued an order for summary suspension of Dr. Mark Geier's license to practice in that state. He was investigated for prescribing Lupron to children with autism, using an unapproved chelating drug, keeping inadequate and incomplete patient records, inappropriately and incorrectly diagnosing patients and so on. Dr. Geier tried and failed to persuade the board to restore his license at a hearing on May 11, 2011. On May 12, the board issued an Order for the Continuation of Summary Suspension for Medical License, meaning that Dr. Geier's license is still suspended. He has until May 22 to file a written appeal.

In the original order, it was also mentioned in passing that Dr. Geier's son, David Geier, may have practiced medicine without a license. From reading the order, it appeared that Mr. Geier performed medical procedures, prescribed tests and made diagnoses. He does not have a medical degree, nor is he licensed to practice medicine in the state of Maryland (or any other state). Mr. Geier was also, inexplicably, appointed as a "diagnostician" in 2009 to Maryland's Autism Commission.

As Kathleen Seidel wrote at the Neurodiversity Blog, charges have been brought against both Dr. Mark Geier and Mr. David Geier.

A Close Look at David Geier

UPDATE: Please click here for an important update to this story.

Medical ethics, health law and policy. Those things are important to me. I can get pretty passionate about them. My interest in them is what drove me to learn about drug and medical device regulations, to actually take formal courses to learn about them beyond merely looking at laws on my own, unguided. The medicines that are offered for our use should be only the best that can be given. I want to be a part of the process, to have an active role in making certain that the medicines that are developed, the clinical trials that are conducted, have the benefit and welfare of patients as the utmost goal.

When I see those values that I so strongly value and hold very highly flaunted or abused, I get mad. I don't much care what a person chooses to do with their own body, money or time, but I get really angry with those who would take advantage of people by cheating them with substandard or even quack treatments. When the victims of that charlatanry are children, I am livid. Quacks and charlatans, those who would prey on others, taking advantage of their emotions and pain, exploiting patients and their children, should face justice. And there is just such a person that I feel is deserving of at least some scrutiny.

Yet before I dive into that, I need to remind myself that it is very, very easy to let my emotions take over, extraordinarily tempting to let the anger or even rage flow forth. And I must remember to breathe, to take a step back and look at the facts. Stick to what is known and avoid the desire to speculate. So that is what I will try to do here, as we take a look at Mr. David Geier.

How Do We Ensure Staff Qualification in Human Subjects Research?

Clinical trials are a human endeavor. They involve humans as subjects and are, necessarily, conducted by humans. (No duh, right?) And, as with all things which we apes undertake, there is potential for error. Clinical trials are generally really, really complex. There are a lot of factors to take into account beyond even the scientific questions under scrutiny. There are logistics of funding and staffing the trials, finding space to carry them out, ensuring adequate supplies, advertising to recruit volunteers, reimbursing subjects for their time and consideration and ensuring that all documents are handled in a timely manner. You have IRB committees reviewing the protocols, consent forms and advertisements. Data Safety Monitoring Boards periodically reviewing data from trials that pose some elevated level of risk to participants. Sponsors may send representatives by to audit the trial sites, not to mention inspections by folks from NIH or FDA. There are lots and lots of people involved.

With so many individuals involved, how can we be sure that they know, at the very least, the basic requirements of human subjects research, like ethics and Good Clinical Practices? How do we ensure that the people running the trials are qualified to do so in a manner that looks out for the well-being of the subjects?