USA Today noted yesterday that Obama's drug czar, Gil Kerlikowske will make curtailing abuse of prescription drugs "one of his top priorities." That's a reasonable position given the overwhelming evidence that pharma abuse is a serious health problem in the United States. It leaves open the question, of course, of whether law enforcement ought to be involved in addressing that health problem.
(Above: Drug Czar Gil Kerlikowske in Nashville Wednesday. Photo by Dipti Vaidya of The Tennessean, taken from website of USA Today.)
Kerlikowske is paraphrased as saying that "he'll push for more states to adopt prescription-monitoring programs,
databases in which doctors and pharmacists log prescriptions for
addictive drugs so law enforcement can track them."
Right problem. Not necessarily the right solution.
Here are the Top 10 Drug Law Blog stories of 2008. Keep in mind that my stories reflect the focus of this blog -- i.e. on changing areas of criminal drug law, with emphasis on California -- and so do not add up to the same list that might be compiled by a lawyer who works on pharmaceutical law, or even a criminal defense lawyer in another state. Prior years' lists are here: 2007, 2006.
10. Salvia divinorum becomes a YouTube celebrity. California passes AB259 to try to crack down on a drug that is not associated with any health problems.
2008 was the year that an obscure, hallucinogenic plant, salvia divinorum, made it onto the radar of many state legislatures not because it was actually causing problems anywhere but because there are lots and lots of YouTube videos of people smoking it and acting silly. You can get a sense of how this typically played out in the clip below: legislator proposes law, local news pulls a bunch of clips off of YouTube, and bingo, you've got a story with some impressive video. Reason enough to start arresting people and putting them in prison? Several state legislatures thought so, including California, which passed a law called AB259 criminalizing the sale of salvia to minors.
(Above: A New York TV news discussion of a proposal criminalize salvia divinorum in that state, drawing heavily on YouTube footage rather than any kind of actual research into salvia. Below: I made a short video about the use of YouTube videos by legislators, encouraging people to push lawmakers to base their policies on science rather than junk pulled off of the internet.)
9. For the second time in two years, Mexico proposes decriminalization of personal use of drugs. Just like the last time, this proposal goes nowhere fast. Meanwhile, Mexico spirals further into extreme, prohibition-related violence.
However, the result of this year's proposal was the same as the result in 2006: absolutely nothing happened. Meanwhile, Mexico was absolutely savaged in 2008 by violence related to an attempt to crack down on drug trafficking. The AP reported in December that more than 5,000 people had been killed in these battles this year. Once-vibrant Places like Tijuana are basically ghost-towns now because of the threat of violence, underscoring the truly terrible human costs created by aggressive prohibition policies.
(Above: A police officer investigates the scene of a "drug-related" shooting in Culiacan, Mexico -- one of more than 5,000 deaths caused this year by a disastrous policy of aggressive prohibition. Photo by Don Bartlett, Los Angeles Times. Below: A TV News segment discusses the extreme impact of these policies on day-to-day life in Mexico.)
8. California's substantive law on medical marijuana evolves: The battle in People v. Kelly is won, but nobody seems to notice, Arnie vetoes a bill for medical marijuana patients' workplace rights, and the Attorney General releases some confusing guidelines around medical marijuana.
There were several important California medical marijuana cases in 2008: Ross v. RagingWire, in which we learned that there is not much workplace protection for medical marijuana users, People v. Mentch, in which we learned that you can't be a "primary caregiver" to a medical marijuana patient simply by providing marijuana to that person, and People v. Kelly, in which we learned that the quantity limits imposed on medical marijuana defenses by the California legislature may be unconstitutional. Also, the United States Supreme Court denied cert in Kha(Garden Grove), the case about return of seized medical marijuana to an individual who has raised a successful medical defense at trial. Some California advocates suggested that this cert denial was a really momentous victory for the prinicple of states' rights. I think that interpretation is, well, incorrect and misleading. But it's still nice that people can get back their medicine.
(Above: The Colbert Report does a segment on Gary Ross and his case in the California Supreme Court.)
People v. Kelly is still on review to the California Supreme Court, but as I noted back in October, the Attorney General has already conceded the argument in that case. That means that strict quantity limits on medical marijuana defenses brought under California's Compassionate Use Act are almost certainly going to be struck down by the Cal Supremes. Seems like a big deal to me, but nobody has picked up on this story.
In August, the Attorney General also released a set of guidelines around medical marijuana. I find them confusing, odd, and of uncertain value for defendants, but some people in the medical marijuana world consider them to be a victory.
Finally, the California legislature passed a bill authored by Mark Leno, AB2279, that would have given workplace protections to medical marijuana users (in response to the defeat in RagingWire, noted above). However, California Gov. Arnold Schwarzenegger vetoed the measure.
(Above: California Representative Mark Leno, who stood up for the workplace rights of California medical marijuana patients. Below: Governor Schwarzenegger, who vetoed Leno's bill.)
7. Federalism follies: San Diego and San Bernardino Counties continue losing their protracted, mean-spirited attempt to overturn California medical marijuana law.
My birthplace of San Diego continued to embarrass itself in 2008 by relentlessly pursuing a case called County of San Diego v. San Diego NORML, which is basically an attempt to argue that California state law can not be modified to allow people to use medical marijuana without prosecution because the federal law of the United States preempts any action in that area. Got that? Federal preemption is so potent a force, according to San Diego County (and San Bernardino County, which is also pursuing this case), that California is literally obliged to continue arresting medical marijuana patients under state law and prosecuting them in state court.
It's a terrible argument, which presumably is why it lost at the trial level and then lost in the court of appeal, and why the California Supreme Court denied review. Nevertheless, San Diego has vowed to seek certiorari in the United States Supreme Court, wasting still of more San Diego County's tax dollars, all in an attempt to argue that local governments should have less power, less flexibility, and should be obliged to spend more money on more prosecutions. If anyone ever wondered whether marijuana can drive people crazy, here is your answer: it's driven the leaders of two California counties completely loco.
(Above: An Aug 12, 2008 protest in San Bernardino County, at which the board of supervisors was urged to drop the NORML lawsuit.)
6. Massachusetts voters pass an initiative making personal possession of marijuana an infraction.
This is not a California story, but it's pretty darn remarkable and could well point the way toward reforms in other states. In the November 2008 election, voters in Massachusetts passed an initiative that makes possession of less than an ounce of marijuana for personal use an "infraction" -- in other words, an offense comparable to a speeding ticket.
Law enforcement in Masschusetts is already moaning that the administration of this law will be a real "headache" for them. Apparently it would be a lot easier --for them, that is -- just to go on arresting and prosecuting people for a nonviolent act that harms nobody.
(On a related point, as Pete of Drug WarRant noted, Arizona's Attorney General stated right at the end of 2008 that he might be willing to consider marijuana decriminalization if a way could be found to administer the process. With any luck, Massachusetts will show the rest of the nation that this is really not that big of a deal.)
(Above: Middlesex District Attorney Gerry Leone spoke at a rally to oppose the marijuana decriminalization initiative. Only problem with this position: Leone and other DAs who took this public stance openly admitted that they themselves were prior users of marijuana, and had somehow managed not to become burnouts, maniacs or deadbeats. AP photo by Bizuayehu Tesafye. )
5. California's Prop. 5 (the Nonviolent Offender Rehabilitation Act) is defeated in California after a massive infusion of cash from the state prison guards' union.
California voters had a chance in the 2008 election to enact really significant drug law reform via an initiative called the Nonviolent Offender Rehabilitation Act. Unfortunately, the initiative was extremely long and technical and very easily distorted by its opponents, including most of the usual suspects in state law enforcement. California's prison guards (the highest paid correctional officers in the nation) threw their weight into the anti-prop. 5 effort, and a chance to reduce the vast prison population of the state was unfortunately lost as a result.
(Above: This cool ad drew attention to the financial motives behind the Prop. 5 opposition, but it didn't manage to persuade voters to pass Prop. 5. Below: Instead, ads like this one, featuring California Senator Dianne Feinstein, scared the public away from reform.)
4. The slow-motion crackdown on California dispensaries continues
Though we finally moved toward what we fervently hope will be a more reasonable federal drug policy (see #3, below), 2008 saw a relentless and depressing parade of federal raids on California medical marijuana dispensaries and prosecutions and convictions of people who have simply tried to operate within the law as passed by California voters and the California legislature. It's as if the Bush administration was determined to waste as much taxpayer money as possible on these crackdowns while it was still holding onto the reigns of the Department of Justice.
One of the most discouraging cases in 2008 was the conviction in federal court of Charles Lynch, the Morro Bay dispensary operator whose story is told in the clips below. When the history of this movement is written, it is folks like Lynch who need to get the credit for bravely putting their own liberty on the line.
3. Barack Obama is elected after having promised to end federal raids on medical marijuana patients. Early indications of Obama's stance on drug policy, however, are not particularly encouraging.
Well, Obama got elected and that felt sort of warm and fuzzy, and it's at least possible that it will mean a more progressive federal stance on medical marijuana. Obama stated during his campaign that "I would not have the Justice Department prosecuting and raiding
medical marijuana users. It's not a good use of our
resources." If he stays true to his word, it will be a dramatic thing, and may well be the change that ushers in medical marijuana on a nationwide basis.
On the other hand, Obama has never seemed to be interested in taking a very progressive stance on drug policy. His nominee for Attorney General, Eric Holder, is a former prosecutor who "proposed legislation to stiffen penalties for the possession of marijuana" while with the Justice Department, according to NORML. Obama is also reportedly considering Jim Ramstad as Drug Czar, despite the fact that Ramstad is reportedly an opponent of both medical marijuana and needle exchange.
All of which means ... well, it's pretty hard to know what it means. But maybe that's the way Obama likes it.
(Above: President-elect Obama. Thumbs up for ... something or other, it's not clear what.)
2. Prescription drugs outstrip street drugs as the drug of choice.
Despite the fact that the policing priorities of the federal government and most other jurisdictions are still heavily skewed toward traditional "street" drugs like marijuana, 2008 was the year when it became entirely obvious that "street" drugs are no longer the growth industry in recreational drug use: that dubious honor belongs, instead, to diverted pharmaceutical drugs, which are now the "drug of choice" for people all over America.
As the Office of National Drug Control Policy noted in its 2008 National Drug Control Strategy Document (see page 17 of the report (pdf)), more 12 and 13-year-olds now use prescription drugs recreationally than use marijuana. The numbers are sufficiently worrisome that some guy named Joe Biden held Senate hearings in March all about what it called "Generation Rx" -- i.e., a generation that has turned away from the drugs that we're sending people to prison for and turning instead to the drugs that are already in the medicine cabinet and being used by mom and dad.
(Below: Vice President-elect Joseph Biden, who convened the hearing on youth use of over-the-counter and prescription drugs.)
1. The chickens come home to roost, as the United States is documented to have the highest drug consumption in the world, the highest incarceration rates in the word, and appalling levels of racial discrimination in drug policing.
Everybody who has a decent head on their shoulders knows that the drug war is a policy that has some shortcomings. 2008, however, was the year in which the statistical evidence of those shortcomings began to pile up to a degree that was totally absurd on every level.
Problems with extreme overincarceration? Check. 2008 saw the release of the Pew Center's report One in 100: Behind Bars in America, officially marking the fact that 1 percent of the entire adult population of the United States is now locked up in jail or prison. As I never tire of repeating, the U.S. is the highest per-capita and overall incarcerator in the world, vastly oustripping every other country, no matter how authoritarian.
Problems with unfair and racist policing patterns around drug use? Check, check and check. 2008 saw the release of not one but three reports documenting in exhaustive detail how extremely skewed drug policing is in terms of the way it targets minorities. (Actually, one of the reports was released in December 2007, but whatever.) The reports are Human Rights Watch: Targeting Blacks: Drug Law Enforcment and Race in the United States (May 2008), The Sentencing Project: Disparity by Geography: The War on Drugs in America's Cities (May 2008), and the Justice Policy Institute: The Vortex: The Concentrated Racial Impact of Drug Imprisonment and the Characteristics of Punitive Counties (December 2007). These three reports all document one basic reality, which is that all people use drugs, no matter whether they are rich or poor, no matter what color their skin might be, and no matter what part of town they live in. Drug policing, drug arrests and drug prosecutions, however, focus overwhelmingly on street-level interdiction in poor, minority neighborhoods, where it takes the least work for cops to make busts. The result is nothing more and nothing less than what can be seen any day of the week by walking into a California Superior Court and checking out who is on trial: it's overwhelmingly poor people and minorities. It's overwhelmingly the hapless and the helpless, people who are just being ground through the mill of of a dysfunctional system and don't have any way to break free.
Problems accomplishing the goals of prohibition? Check. A study released in the summer of 2008 showed that the United States actually leads the world in per capita consumption of marijuana, cocaine and alcohol. Meanwhile, the Office of National Drug Control Policy continued in 2008 to pat itself on the back by referring to the idea that drug use in America is "down by half" -- neglecting to mention one little detail, which is that the decline they are discussing happened more than 15 years ago. So not only are we locking up people like crazy, and not only are we making a mockery of racial justice in the process, we're also failing to accomplish the ostensible goal of our policy. It's absolutely nuts, and it's long past time for the kinds of changes we're finally starting to see in places like Massachusetts.
(Below: a breakdown by race of American incarcerated men, from One in 100, by the Pew Center.)
That's it for 2008 -- kind of a depressing list overall, but it was an election year. Here's hoping that we get a little sanity injected into the process in the year to come!
I've learned by experience to be careful in interpreting reports released by the Center on Addiction and Substance Abuse (CASA) at Columbia University, because it can be difficult to disentangle their empirical claims from their rather strong rhetoric.
So I don't know what weight to give to their latest report on Internet prescription websites, which is called "You've Got Drugs!" V: Prescription Drug Pushers on the Internet," other than to note that they have released it and it's available to read. The most salient detail of the report seems to be that the number of websites offering to sell prescription drugs apparently decreased this year compared to last year, as far as the researchers could tell. But it's hard to know if this number actually reflects any change in the actual availability of drugs online, represents a consolidation in online sellers, or what.
Needless to say, if I'm a consumer looking for drugs online, it hardly matters to me whether I get 400 Google hits or 300 Google hits. I only need one hit that works, and I'm going to ignore the other sites. I'm not sure how else one could assess the availability of online drugs other than by counting websites, but the data that is generated by such a study doesn't actually seem like it tells us very much about drug availability from the consumer's point of view.
Paul Armentano has a post at the NORML blog that addresses my absolute favorite spot in the law: that awkward no-man's-land between criminal drug law and pharmaceutical administrative law, which is where the demonized, criminalized plant marijuana, which will drive you insane and destroy society, turns into a totally legitimate, FDA-approved pharmaceutical drug like Marinol, which can be dispensed by pharmacies and consumed by law-abiding grandmas while watching re-runs of Laverne and Shirley.
Armentano notes:
Big Pharma is busily applying for — and has already received — multiple patents for the medical properties of pot. (The US government has too, but that’s a different story all together.) These include patents for synthetic pot derivatives (such as the oral THC pill Marinol), cannabinoid agonists (synthetic agents that bind to the brain’s endocannabinoid receptors) like HU-210 and cannabis antagonists such as Rimonabant. This trend was most recently summarized in the NIH paper, “The endocannabinoid system as an emerging target of pharmacotherapy,”
which concluded, “The growing interest in the underlying science has
been matched by a growth in the number of cannabinoid drugs in
pharmaceutical development from two in 1995 to 27 in 2004.”
In other words, at the same time the American Medical Association is
proclaiming that pot has no established medical value, Big Pharma is in
a frenzy to bring dozens of new, cannabis-based medicines to market.
Interestingly, Armentano argues against the frequently asserted notion that big pharma is somehow conspiring to keep the plant form of marijuana illegal.
Interestingly, the DEA's webpage only provides a link to the Federal Register instead of linking to the actual text of
the rule. I'll update with a link to the actual text ... if I can find
it!
The introduction to the rule notes the concern around pharma diversion but argues (p. 36726):
However,
with proper controls, the risk of diversion can actually be reduced
through the use of electronic prescriptions. Among the essential
elements of such a system are ensuring that only DEA registrants
electronically sign and authorize controlled substance prescriptions
and that the prescription record cannot be altered without the
alteration being detectable. A system that fails to provide
verification of the signer's identity and authority to issue controlled
substance prescriptions, and/or fails to ensure that alteration of the
record is detectable, would create new routes of diversion that could
be even harder to prevent and detect.
So that's the ostensible rationale for the proposed rule.
The number of Hoosiers who died from drug overdoses increased 147
percent from 1999 to 2004, a trend driven by the growing abuse of
prescription medications, according to a new study.
The problem, experts say, has shown no sign of abating and is expected to worsen.
"This is the new major drug epidemic for the next generation," said
Eric R. Wright, director of the IU Center for Health Policy and one of
the authors of the study "Fatal Drug Overdoses: A Growing Concern in
Indiana."
The Pain Relief Network has filed suit against the state of Washington over that state's guidelines for narcotic prescription, arguing that the guidelines, which set a cap on the amount of painkillers an individual can be given per day, along with intense regulatory scrutiny on doctors, have discouraged doctors from prescribing such medication.
The complaint, filed in federal court, asks the court to declare that the state guidelines "do not constitute enforceable law of any kind and should be stricken and removed from all state publications of every variety," and seeks other additional relief, including an injunction against enforcement. The broad thrust of the argument is as follows:
This action arises from official actions on the part of the senior-most
Washington State Health Officials that has gravely harmed countless
numbers of Washington state citizens. Those officials engaged in
overreaching when, while acting under color of their authority as
state officials, they knowingly crafted ultra vires public health policy,
which they also knowingly passed off as a form of “apparent” law
entitled “Interagency Guidelines on Opioid Dosing for non-Cancer
Pain” [hereinafter “ Dosing Guidelines”]. These Dosing Guidelines
are based on an opiophobic discriminatory animus and are
irreconcilable with the statutory mandate for physicians to provide
effective treatment for chronic, nonmalignant pain. In crafting and
publishing the Dosing Guidelines in contravention of existing law,
those senior-most state health officials completely ignored the limits
of their own statutory authority as well as their fundamental statutory
mission to safeguard the public health. Instead, these officials used
their authority as senior state public health officials to create an
“appearance of authority” that would effectively overrule current explicit statutory and administrative law with which they disagreed.
(Above: Just a little routine monitoring. Nothing to be concerned about.)
Reporter Jeanine Banca of the San Jose Mercury News writes:
If the online system
begins, it would be the largest in the country. Other states with
Web-based drug-monitoring include Kentucky, Maine, Ohio, North
Carolina, Tennessee, West Virginia, Illinois and Virginia.
It
will cost about $3 million to develop and operate the program for three
years, according to a 2007 feasibility study paid for in part by Kaiser
Permanente. Funds have not yet been identified, but supporters are
hopeful health care providers and insurers will foot the bill.
Nationally,
prescription drug fraud costs insurers as much as $72 billion a year,
according to a 2007 study by the Coalition Against Insurance Fraud.
So is this monitoring plan, called the CURES Program, a law enforcement effort to protect public health, or is it a business effort to target insurance abuse? Apparently it's a little of both. Neither one is necessarily a bad idea, particularly because of the serious health risks that prescription drug abuse poses to users, but I'm baffled about how doctor-patient confidentiality fits into this scheme. Banca writes:
Kathy Ellis of the
Department of Justice said details about law enforcement access to
California's system have yet to be worked out. Access likely will be
granted on a case-by-case basis to prevent "fishing" in the system, she
said. "They'd have to identify what their need is. I don't see a patrol
officer having a direct need for that information."
When I read passive sentence constructions like that -- "access likely will be granted" -- I just get a little nervous. A lot turns, as we have seen in connection with the FISA debate on the national level, on who grants access and under what circumstances.
Another year is wrapping up and so it is once again time to consider the most interesting drug law stories of the last 365 days. Keep in mind that I'm a California oriented blogger and my interests have to do primarily with issues that are either in criminal law or in areas of our national regulatory scheme that could potentially shade into criminal law, so my list is not the same list that somebody who is more into pharma law would compile, to say the least.
Barry Bonds was indicted for perjury and obstruction of justice, and the Mitchell Report was released alleging that -- shock! -- Major League Baseball players actually have used steroids. This should have surprised absolutely nobody. Somehow it was a gigantic story. To my mind, it was a gigantic waste of taxpayer resources, even taking into account that the Mitchell report was privately funded. So much effort to police a problem that pales in comparison to the risks of legal drugs like alcohol and cigarettes.
(Above: Former Senator George Mitchell, author of the report on MLB steroid use.)
I've written a few times about the so-called "Ambien Defense," which is the claim a defendant can make that they were under the influence of Ambien and were unexpectedly "sleep-walking" or "sleep-driving" or sleep-whatevering at the time they committed some form of misdeed. At the end of the year, a Massachusetts judge accepted this argument in a case involving vehicular homicide, resulting in a controversial acquittal. At the crossroads between pharma liability issues and challenging theories of diminished culpability, the Ambien defense seems like it is tailor-made for inclusion in law school casebooks. It raises some very difficult questions about who should be held responsible for the rare but potentially very dangerous side effects of a drug.
(Above: The limits of the Ambien defense, from the blog Sid in the City.)
8. ASA Sues the Feds for Putting Out Pseudo-Scientific Gobbledygook.
One of the intriguing things about law is the way formalized and seemingly very "square" tactics can sometimes accomplish surprisingly progressive goals. This year, Americans for Safe Access brought a lawsuit against the Department of Health and Human Services and the FDA based on a law called the Data Quality Act. The basic argument is that under the DQA, these federal agencies have to rely on accurate science in setting their policies, and that their position on medical marijuana manifestly fails to do that. This suit is still working its way through the courts, so we'll see what comes of it....
7. Janice Rogers Brown Tells it Like it Is on the Fourth Amendment.
It's a great thing when a prominent judge cuts through the
circumlocution of legalese and speaks to the realities of the law as it
is actually enforced from day to day. This year, DC Circuit Judge
Janice Rogers Brown, who is generally quite conservative, managed to be
about a million times more candid than the average judge in dissenting
from the majority's June opinion in U.S. v. Goddard. Specifically, Rogers suggested that
prudent
constraints on police conduct have been forgotten in our
frustration over city life plagued with drug trafficking and
violent crime. As a result, what we are now tempted to enforce
is . . . the rule that, in a high-crime neighborhood, being young, male, and black creates reasonable, articulable
suspicion [for police to stop an individual].
(Above: DC Circuit Judge Janice Rogers Brown. Photo by Paul Sakuma, Associate Press, from the website of the New York Times.)
6. Pain Doctors in the Crosshairs.
2007 was a year when the federal government continued to carry out an aggressive campaign of prosecuting doctors for practicing pain medicine, treating what should probably be an administrative matter or an issue of civil negligence as the opportunity to lock doctors up in prison. As the New York Times' John Tierney wrote in July, the message of
these prosecutions for doctors who practice pain medicine was very
simple: "be afraid."
(Above: Law enforcement agents haul evidence out of the office of Dr.
Milton Brindley of Augusta, Kentucky during a June 2007 raid. Photo by
Terry Prather of the Ledger Independent)
5. America Starts to Wonder If Maybe It Has a Prison Addiction.
This year, California taxpayers got the exciting news that they were going to get to spend $7.8 billion dollars to fix their overflowing prisons. They also got to learn that their spending on prisons will soon outstrip their spending on higher education. Meanwhile, despite all this spending, our correctional system is so enormously overcrowded that we might just release 20,000 inmates early. In 2007, dumping billions of dollars into a dysfunctional system started to seem like it might actually be a reason for concern.
More broadly, America continued to be the highest per capita and overall incarcerator in the entire world, giving the lie to the notion that we are the "land of the free." 2007 saw a dawning awareness that this is a problem, not a reason to be proud. Ted Koppel ran a special all about America's addiction to prison, focusing on -- yes, that's right -- California, "where the biggest problems are." 2007 also saw hearings in the Senate entitled Mass Incarceration in the United States: At What Cost? When it comes to our prison addiction, we're in sort of the equivalent of the morning after the DUI car wreck, where we think "hmmm, maybe I'm not in control of this thing after all." ... But it's going to be a long road to recovery.
(Above: A California inmate looks through the door of his cell in a
private Arizona prison, where he was shipped to help relieve the tremendous overcrowding in California's system. Photo from the Los Angeles Times. Photographer:
Luis Sinco.)
4. Medical Marijuana: The Feds Push, and California Pushes Back.
Last year's number 3 story was that a lot of California municipalities had worked to eliminate medical marijuana dispensaries, either by banning them outright or by passing codes that amounted to a de facto ban. That general trend continued this year, and the federal government also conducted a number of raids on dispensaries throughout California. It also started sending letters to the landlords of medical marijuana dispensaries, threatening them that they could lose their property if they didn't terminate the leases. In Oregon, it even tried to subpoena the medical records of medical marijuana patients. In many ways, it seemed like the federal crackdown that could have started in 2005 after the Supreme Court decided Gonzales v. Raich was finally coming to pass.
At the same time, 2007 saw some really interesting California court cases on medical marijuana and some signs that the courts were taking a line on our Compassionate Use Act that would vigorously defend the autonomy of our own laws against the federal perspective. In November, the Fourth District Court of Appeal decided City of Garden Grove v. Superior Court, a case that was all about whether an individual should be able to get back medical marijuana that was seized by police if the marijuana was legally possessed under California law. We also saw the oral argument in the California Supreme Court in the employment law case of Ross v. RagingWire, which was about whether an employee could be fired for using physician-approved medical marijuana. Though it's tough to know how that one will ultimately come out, at least some of the comments from the justices suggested that they were sympathetic to the state's position on medical marijuana.
(Below: Medical marijuana protesters in Los Angeles. Photo by Ric Francis/AP, from the website of ABC News.)
(Above: Joe Elford argues before the California Supreme Court in Ross v. RagingWire. Below: Protestors at a DEA raid in Los Angeles, where the LAPD assisted in the raid, chant "Uphold State Law.")
3. Substantive Due Process Arguments Fail in Abigail Alliance and Gonzales v. Raich.
Last year a panel of the DC Circuit Court of Appeals had reached an exciting conclusion in a case called Abigail Alliance v. Eschenbach: it suggested that there was a due process right for terminally ill patients to access certain drugs that had been approved for human testing but had not yet received full FDA approval. That decision, depending on how you read it, might suggest that federal drug regulatory schemes were not the be-all and end-all of the law around drug control, and that some fundamental rights could trump the FDA's control of this area. This year, however, the DC Circuit reconsidered that opinion en banc and rejected it. It's not the end of the road, though, because the case could well go to the Supreme Court. (Update: In Jan 2008, the US Supreme Court declined to grant cert, rendering the DC Circuit's en banc opinion the last word on this issue.) I did an interview with Scott Ballenger, the attorney for the Abigail Alliance, which is here. A related argument also failed in the follow-up to the Supreme Court's big 2005 decision in Gonzales v. Raich.
2. Bong Hits for Jesus: The First Amendment "Drug Exception."
This year the Supreme Court gave us Morse v. Frederick and the "Drug Exception" to the First Amendment, another in a series of decisions that erode constitutional protections for the sake of the war on drugs. Last year we saw the Fourth Amendment getting carved up for the sake of the drug war in Hudson v. Michigan. This year, the Supreme Court concluded that it was just fine for schools to create content-based restrictions on student speech if "a reasonable observer would interpret [that speech] as advocating illegal drug use." The Bong Hits case is just one more sad illustration of the way the drug war is chipping away at the American Constitution, one more example of how we try to "send a message" about drug use but instead send a message about a country that would rather tear itself apart than deal forthrightly with the fact that individuals use drugs for pleasure.
(Above: The infamous "Bong Hits" banner, so extremely subversive that the Supreme Court found it necessary to develop an exception to the First Amendment just to suppress it.)
1. America Kicks Crack, Sort Of.
In a surprising one-two punch of Supreme Court jurisprudence and Sentencing Commission reforms, the federal government decided both to retroactively apply reforms to the preposterously harsh sentencing guidelines around crack cocaine and, in Kimbrough v. United States, suggested that federal trial court judges could take into consideration the wide disparities between crack and powder cocaine in the federal sentencing guidelines in deciding to sentence a crack defendant below the guideline. The result is hardly a revolution in the way America handles crack cocaine, but it's a modest step toward a more humane policy. In a field that is dominated by decisions that are made primarily on the basis of fear, ignorance and pandering to the public, these simple steps in the right direction were a major victory. At the end of the year, a few apparently insane legislators actually sought to pass a law reversing this reform, but they seemed unlikely to succeed.
PLUS 1. Mainstream Politicians Speak Up in Favor of Drug Policy Reform.
The most striking development of 2008, from my point view, is that drug policy reform started to creep with increasing frequency into the mainstream political discourse. In part, I think, this has to do with the role of the Internet in spreading ideas, and particularly the ability of YouTube to capture candidates reacting to situations. But we also saw comments from individuals like San Francisco Mayor Gavin Newsom, who went ahead and proclaimed that the war on drugs was a "total failure." And we saw every single Democratic presidential candidate pledging to end federal raids on medical marijuana patients. We also saw the intriguing campaign of Republican candidate Ron Paul, a man who (as the YouTube clip below illustrates) unapologetically calls for the end of the war on drugs.
We have a ways to go before drug policy reform is a reality, but the fact that this subject is on the lips of serious politicians is an encouraging sign.
Naïve as I was, I found myself astonished at the level of detail that drug companies were able to acquire about doctors’ prescribing habits. I asked my reps about it; they told me that they received printouts tracking local doctors’ prescriptions every week. The process is called “prescription data-mining,” in which specialized pharmacy-information companies (like IMS Health and Verispan) buy prescription data from local pharmacies, repackage it, then sell it to pharmaceutical companies. This information is then passed on to the drug reps, who use it to tailor their drug-detailing strategies. This may include deciding which physicians to aim for, as my Wyeth reps did, but it can help sales in other ways. For example, Shahram Ahari, a former drug rep for Eli Lilly (the maker of Prozac) who is now a researcher at the University of California at San Francisco’s School of Pharmacy, said in an article in The Washington Post that as a drug rep he would use this data to find out which doctors were prescribing Prozac’s competitors, like Effexor. Then he would play up specific features of Prozac that contrasted favorably with the other drug, like the ease with which patients can get off Prozac, as compared with the hard time they can have withdrawing from Effexor.
The American Medical Association is also a key player in prescription data-mining. Pharmacies typically will not release doctors’ names to the data-mining companies, but they will release their Drug Enforcement Agency numbers. The A.M.A. licenses its file of U.S. physicians, allowing the data-mining companies to match up D.E.A. numbers to specific physicians. The A.M.A. makes millions in information-leasing money.
The Pharmalot blog has a post up today on the prosecution of pharma companies for encouraging off-label prescribing practices. The key bit:
Since 1997, when the Justice Department began receiving funding
earmarked for fighting health care fraud, the AP notes the federal
government has collected $11.87 billion in fines for various violations
and returned the money to Medicare, Medicaid and other health care
programs. The effort has largely been led by the US Attorney's office
in Boston.
Whether law enforcement is having much effect is unclear. One could
argue the recent spate of cases actually reflects older activity, and
that companies have moved to take corrective steps by improving
compliance procedures, implementing new policies and, in some cases,
hiring an exec with a compliance background.
On the other hand, the recent episodes in which anonymous
AstraZeneca and Pfizer employees have leaked material to various blogs,
including this one, also suggests that off-label practices are alive
and well, and industry compliance is either ineffective, incomplete or
a sad example of 'saying one thing, but doing another.'
Last year I linked to coverage of a study that suggested that 20% of all prescriptions were for off-label purposes -- many of which were poorly supported by scientific research. If those numbers are even somewhat accurate, it's a striking thing to consider.
Much of the criticism of the medical marijuana movement, for example, is premised on the idea that the scientific support for the use of marijuana is lacking. Propoponents of medical marijuana often reject that criticism, and the debate goes round and round. Whatever one's take on that issue, the prevalence of off-label prescribing suggests another line of argument: that in fact the scientific support for the use of "legitimate," FDA-approved drugs is actually surprisingly slim in about a fifth of all prescriptions. In other words, consumers may not be all that well justified in feeling safe using prescription meds, depending on the circumstances in a particular case.
The New York Times had an article Tuesday (3/27/07) on the prosecution of pain doctors, and the prosecution in particular of Virginia pain specialist William Hurwitz. I worked on Dr. Hurwitz' case when I was an intern with the Drug Policy Alliance's Office of Legal Affairs, and I think it's a very challenging case. The argument can certainly be made that Dr. Hurwitz did not use the best judgment with respect to some of his patients. On the other hand, as the Times article notes, the legal standards around the prescription of pain medication have been quite unsettled and were particularly unclear in the time immediately before the prosecution of Dr. Hurwitz.
Dr. [Russell] Portenoy, the chairman of the pain medicine department at Beth Israel Medical Center,
was one of the researchers who worked with the D.E.A. four years ago to
draw up guidelines on pain medication for doctors and law enforcement
officials. The guidelines assured doctors that they would be safe
unless they “knowingly and intentionally” prescribed drugs for
illegitimate reasons, and cautioned narcotics agents not to investigate
doctors just because they prescribed large quantities.
The
D.E.A. published the guidelines, and then abruptly withdrew them on the
eve of Dr. Hurwitz’s trial, just after his defense had indicated that
it planned to use the document at the trial. The D.E.A., which said the
document had not been properly vetted, went on to repudiate some of the
guidelines and warned that it intended to keep targeting doctors deemed
suspicious because they prescribed large quantities and ignored certain
red flags.
I've been bending over backwards to ignore the Anna Nicole Smith story, even though rumors have been circulating that her death was related to methadone, because it doesn't seem to have any particular legal significance.
But there is an interesting element in today's news stories on the subject: the doctor who prescribed methadone for Smith reportedly prescribed it to an alias that she used: Michelle Chase. A spokesman for the California Medical Board is paraphrased in today's article as saying "the board is looking into, among other things, whether it is illegal for a doctor to prescribe medication to someone using an alias." TMZ.com has a few items about this issue.
The alias thing isn't new: Radio commentator Rush Limbaugh was arrested last June for having painkillers that had been prescribed in another person's name. In that case, though, the drugs had been prescribed in the name of Limbaugh's doctor for privacy reasons -- a practice that was legal under Florida law as long as all the parties involved were aware of what was happening.
BusinessWeek has a piece up today discussing the willingness of some doctors to prescribe drugs online, facilitating a bustling Internet trade in prescription meds. A few graphs:
An accomplished
"doc-in-a-box," as the hired hands of online "pharmacies" are known,
typically approves Internet prescriptions at a rate of more than 1,000
a day—without communicating with the purchaser or, in many cases,
reading the questionnaire. Such work may be less challenging than the
average medical practice—and can be swiftly rewarding. For each
prescription, a "doc-in-a-box" typically earns up to $10, and sometimes
even more. An ambitious doctor can earn over $1 million a year.
Some shady online pharmacies don't even bother with
prescriptions or doctors at all, they just respond to orders. Others
hire doctors to approve prescriptions, generally required by law, for
controlled pharmaceuticals. But without a physical exam, discussion of
symptoms, consideration of medical history, and a diagnosis, a person
can suffer unexpected consequences from medication they believe can
help alleviate their condition. In Schmidt's case, he nearly died and
has been left permanently impaired.
How easy is it to get prescription drugs online? In 2004,
private investigators at Beau Dietl & Assoc., hired by the drug
industry group Pharmaceutical Research & Manufacturers of America,
easily obtained a range of prescription medicines by lying on
questionnaires. Among them: antidepressants Zoloft and Paxil, muscle
relaxant Zanaflex, and weight-loss drugs Meridia and Bontril. In a
June, 2006, report for Columbia's National Center on Addiction &
Substance Abuse, the same investigators noted that "it was rare for an
online pharmacy to reject an order or even follow through with a phone
call."
The interesting legal wrinkle, according to Keith Epstein, who wrote the article, is that a prescription is only valid if issued by a doctor "in the usual course of his professional practice." And of course what passes for "usual" is changing these days, simply because the Internet is such a ubiquitous tool and because people don't have much time for face-to-face meetings.
Even the lawmakers aren't clear on what's legal or not. By complying with federal law which requires prescriptions—but then having doctors approve them without seeing or speaking with a patient—"some rogue sites operate in a legal gray area," noted a legislative attorney for the Congressional Research Service in a May, 2005, report to Congress. "This practice, though potentially unsafe for patients who may be diagnosed incorrectly, is not necessarily illegal," the attorney added.
The Ninth Circuit today upheld the conviction under 21 U.S.C. § 841(a) of an Arizona doctor who prescribed excessive quantities of drugs to patients in U.S. v. Feingold, No. 05-10037. The case is interesting because, as in the Eighth Circuit case of U.S. v. Katz decided in May, it explores the boundary between mere professional negligence and outright criminal activity.
In Feingold, the appellant, who was a naturopathic physician, didn't give much scrutiny the claims of patients to need pills and was also willing to prescribe very large quantities of drugs. In one case, for example, he prescribed 2,000 Oxycontin per month to an individual who should not have been taking more than 186 per month. Feingold argued that this might have been professional negligence but was not in itself criminal. The trial court gave the jury the following instruction on this issue:
A practitioner may not be convicted of unlawful
distribution of controlled substances when he distributes
controlled substances in good faith to patients in
the regular course of professional practice. Only the
lawful acts of a practitioner, however, are exempted
from prosecution under the law. A controlled substance
is distributed by a practitioner in the usual
course of his professional practice if the substance is
distributed by him in good faith in medically treating
a patient. Good faith is not merely a practitioner’s
sincere intention towards the people who come to
see him, but, rather, it involves his sincerity in
attempting to conduct himself in accordance with a
standard of medical practice generally recognized
and accepted in the country. Thus, good faith in this
context means an honest effort to prescribe for a
patient’s condition in accordance with the standard
of medical practice generally recognized and
accepted in the country. However, practitioners who
act outside the usual course of professional practice
and prescribe or distribute controlled substances for
no legitimate medical purpose may be guilty of
unlawful distribution of controlled substances.
Feingold first argued that this instruction relieved the jury of the burden of finding that he had distributed the drugs with the intent to do so in a manner beyond the accepted bounds of medicine. This argument did not gain much traction with the Ninth:
We are
satisfied that the district court’s instructions did require the
jury to find that he intentionally acted outside the usual course
of professional practice. Although the district court did not
explicitly use the word “intent” in instructing the jury on this
aspect of the offense — that the defendant “prescribed or distributed
the controlled substance other than for a legitimate
medical purpose and not in the usual course of professional
practice” — the instructions as a whole made clear that the
jury had to make a finding about Dr. Feingold’s state of mind.
Feingold additionally suggested that the jury instructions conflated professional negligence with criminal wrongdoing. The Ninth Circuit summarized the issue as follows:
[C]an a defendant who intentionally
exceeds a generally recognized “standard of medical practice”
still be engaged in “the usual course of professional practice,”
Moore, 423 U.S. at 124, such that he could escape criminal
liability? The question is a difficult and important one, and it
implicates the conduct of any health care professional whose
judgment about the appropriate standard of medical care may
conflict with what a jury determines to be the generally
accepted standard.
The threat, Dr. Feingold argues, is that
doctors could be prosecuted and perhaps convicted as criminals
whenever the Attorney General disapproves of a course
of treatment, or whenever they step outside of conventional
medical protocols in order to provide some sort of special
treatment for uniquely needy patients. (Emphasis supplied.)
In attempting to avoid this risk, the Court of Appeals came to the following conclusion:
We hold that an instruction is improper if it allows a
jury to convict a licensed practitioner under § 841(a) solely on
a finding that he has committed malpractice, intentional or
otherwise. Rather, the district court must ensure that the
benchmark for criminal liability is the higher showing that the
practitioner intentionally has distributed controlled substances
for no legitimate medical purpose and outside the usual
course of professional practice. . . . Nonetheless, we reaffirm that it is appropriate in cases
such as this for the jury to consider the practitioner’s behavior
against the benchmark of acceptable and accepted medical
practice. Just how that benchmark is expressed to the jury —
here, the district court defined that benchmark in terms of the
“standard of medical practice generally recognized and
accepted in the country” — is a matter within the district
court’s discretion.
Here, the court said, the standard for criminal liability was correctly articulated by the trial court.
The LA times has an article today on so-called "off-label" prescribing, which is the prescription of a drug for a purpose other than the one for which it was approved. According to the Times:
Millions of Americans each year are prescribed drugs that are not
approved for their specific medical condition, a practice that is legal
and logical in many cases. But a new study has found that fully 20% of
all prescriptions are written for such nonapproved uses and that most
of these — three-quarters — are not well-supported by scientific
studies.
This
widespread use of medications "off-label" could threaten patients'
safety while escaping the attention of federal regulators, some experts
suggest.
The Eighth Circuit today upheld the conviction of a Missouri doctor who improperly prescribed Xanax, Vicodin and other prescription drugs to patients in U.S. v. Katz, No. 05-2940.
The doctor, Harry Katz, had been convicted of 176 counts of attempted or actual distribution of Schedule III and IV controlled substances outside of the scope of medical practice and not for a legitimate medical purpose in violation of 21 U.S.C. §§ 846 and 841(a)(1). Without going through an endless recitation of the facts, it sounds like Dr. Katz did not give much scrutiny to the reasons that patients requested drugs, prescribing them in one case because someone said they wanted to "chill out."
There are some interesting elements to this case, including: that it was okay for the trial court to instruct on "willful blindness" to the probable motives of the patients, that it was okay to introduce evidence of hundreds of prescriptions that Dr. Katz wrote that did not lead to any indictment, and -- probably most importantly -- that it was acceptable to introduce expert testimony suggesting "that a doctor who did not follow the standards of care in diagnosis could not have a legitimate medical purpose to write a prescription." Dr. Katz challenged this last point because he argued that the testimony "in effect, lowered the government's burden of proof to a mere negligence standard, giving the jury license to convict him if it found his prescription methodology differed from Dr. Parran's methodology."
The Eighth Circuit rejected that argument because:
The district court instructed the jury that they must find beyond a reasonable doubt that Dr. Katz wrote prescriptions outside the scope of medical practice and not for a legitimate medical purpose. Further, the jury was specifically instructed that mere negligence could not support a conviction for criminal conduct. As a result, the district court did not abuse its discretion in admitting Dr. Parran's expert testimony.
There seems to be some fuzziness to the logic there. If the jury was convinced beyond a reasonable doubt that Katz did not follow accepted standards of care in diagnosis, the expert's testimony would logically lead the jury directly to the conclusion that Katz was practicing outside the scope of medical practice. So in effect the government's burden was reduced to establishing the simple question regarding standards of care in diagnosis. Or at least that's my quick take.
Lastly, the court of appeals rejected the idea that prosecutorial misconduct occurred when the DA unleashed the following bizarre rebuttal closing argument, which the court neverthless said was "improper" and had "little or no probative value on any issue at trial":
There's a war on drugs and the DEA fights it every day. Think about that for a minute with me. It has a history of its own, going all the way back to post World War II, the heroine scourge. And it hit big cities like New York and it rooted in the ghettos, places like Harlem. And think about the history of what heroine did to Harlem in post World War II and then fast forward a decade or so to the 60s and the counterculture movement; sex, drugs, and rock and roll. Tune in, turn on, and drop out. It became the mantra of an entire generation. It was rooted in the Height Ashbury District in San Francisco in the 70s and early 80s in cocaine, powder cocaine. That war was fought in the discotheques and the nightclubs and it reached all the way up to the social elite and the famous and the wealthy. Still, movie actors and rock stars. And then came the 80s and the retardation of cocaine, crack cocaine. And it became a poor man's addiction. And then the 90s with methamphetamine and designer drugs like Ecstacy. There's a crazy logic to it all. They all start out in some exotic locale, the coca fields of Afghanistan for heroine or for cocaine in Brazil—I'm sorry. The poppy fields in Afghanistan for heroine. Mexican superlabs for the methamphetamine that makes it across the border. The tropics of the world for the world's strongest and most potent marijuana. And it all comes to America through some port city. It's Miami, it's New York, it's L.A., it's San Francisco or it sneaks across the border across the Rio Grande and they make it to America. And from there, from those port cities, it hopscotches its way across the United States to the big cities, to the medium cities, to the small towns. And that war is fought on a daily basis by DEA special agents. And it's probably easy to be amember of that chain somewhere down the line where either the farmer in the poppy field or the cartel leader in Brazil or the smuggler that gets it into the United States or the mule that transports it to the Midwest or the distributor on the street corner who sells it. Because no one along that chain has to see the entire picture in carnage that's left behind. No one has to stand face-to-face with that.
[Dr. Katz objected at this point; the district court overruled the objection, but instructed the government to "get back on track."]
But what do we have here? What do we have here? This man is different than the war on drugs you're familiar with from TV. He is licensed, his [sic] is educated, he is trained, and he is experienced. And for all of that he is trusted by all of us who are not those things. He is doctor. But when Mike Otten, Dawn Molkenbur, Cindy Scott, Mr. And Mrs. Marlow, Charles Beck, Dan Seay, the Ashers, Bill Bradley, Danny Turman, and all four of the Bowen family walk into the office and need something from the doctor, they tell him what they want, he does not tell them what they need. When you tell the doctor what you want and he gives it to you without questions asked, that's Doctor Feel Good, that's not Dr. Katz. This doctor is no more than a drug dealer. He has an office instead of a street corner. Do we put a DEA diversion agent in every doctor's office now? We can't. How do we fight convenience doctors, drug dealers? You do. It's not good faith. There is not one scintilla of evidence that this man was acting in good faith. It's more of this. I don't care, here's your prescription . . . .
Laws are pending in several states that would restrict the ability of drug companies to collect data on the prescribing practices of doctors, the New York Times reports. The practice is controversial not so much because of privacy concerns -- patients are not identified in the records handed over to the drug companies -- but because of the belief that the data gives the companies too much lobbying leverage over doctors.
