DEAsucks is an advocate for the rights of chronic pain patients and their doctors to be free from DEA interference and intimidation tactics. The (US Drug Enforcement Administration) DEA sucks because its campaign to reduce the abuse and diversion of prescription drugs is denying millions of Americans adequate pain relief.

Wednesday, May 20, 2020

The DEA War on Chronic Pain Patients

The DEA's intimidation tactics against doctors causes billions of dollars of additional healthcare expenses for patients, billions of dollars in lost productivity because of untreated pain, and is actively destroying or severely limiting the quality of life for tens of millions of people in America every single day.
  • According to the American Academy of Pain Medicine, seventy-six million Americans suffer from chronic, daily pain, and at least nine million have daily pain that is severe enough to interfere significantly with their jobs and relationships. 
  • An estimated 20% of American adults (61.5 million people) report that pain or physical discomfort disrupts their sleep a few nights a week or more. 
  • The annual cost of chronic pain in the United States, including healthcare expenses, lost income, and lost productivity, is estimated to be $100 billion. 
  • More than half of all hospitalized patients experienced pain in the last days of their lives and although therapies are present to alleviate most pain for those dying of cancer, research shows that 50-75% of patients die in moderate to severe pain. 
  • In a recent survey, 50% of chronic-pain patients had, at one time or another considered suicide to escape the unrelenting agony of their pain. There are no statistics on the number of suicides attributable to untreated pain, but various studies carried out over the past decade have found that fear of pain is what lies behind the majority of requests for doctor-assisted death. 
  • Untreated pain also raises blood pressure, and researchers have found that every 10mm increase in systolic blood pressure results, on the average, in a 40 percent increase in risk of stroke and a 30 percent increase in risk of heart attack.
The DEA campaign against prescription drug abuse has stigmatized patients in need of pain medication. DEA intimidation tactics and sting operations against doctors have created a climate of fear, with the predictable result that many doctors now won't prescribe opiates at all or are only willing to prescribe amounts that are totally inadequate. As a result, many more people die from not having the prescription pain medications they need, than die from the drug abuse the government is trying to prevent. The DEA is actually killing chronic pain patients by intimidating their doctors.
 
One of the major causes of those deaths is the overuse of OTC NSAIDS like acetaminophen (Tylenol) and ibuprofen (Advil, Motrin) by people who are desperate for pain relief. The Food and Drug Administration estimates that 200,000 cases of gastric bleeding occur each year, resulting in nearly 20,000 deaths. 
 

Background

Americans are a generous and compassionate people. But they have been brainwashed their entire lives by the constant drumbeat of anti-drug propaganda coming from drug warriors, law enforcement and the criminal justice system, and endlessly parroted by self-serving politicians and the media. 
 
Twenty years ago, the DEA made prescription drug abuse its primary mission after its survival was threatened because of its failure to have any measurable impact on the availability of street drugs. The DEA ginned-up a lot of bogus statistics about deaths supposedly due to prescription drugs by blaming deaths on prescription drugs if there were any narcotics involved, even if the drugs weren't the actual cause of death. Then they cranked-up their propaganda machine in concert with their allies in various public and private agencies who all have one thing in common; they owe their existence to the war on drugs. The media accepts press releases from these agencies and does stories on them without any critical examination of the claims being made. Mothers who lost their children to drug abuse are invited to testify before Congress, giving our representatives an opportunity to exploit their grief in a national spotlight for political gain.  
 
The DEA has focused on doctors who prescribe a lot of pain medications to chronic pain patients because they are easy targets. Doctors keep good records and they have a lot of assets that can be seized. And the DEA is far more interested in seizing assets than they are in seizing illegal drugs. Doctors who prescribe narcotics are now living under the constant threat that they will be arrested by the DEA and prosecuted as if they were running a drug cartel.

Once arrested and stripped of all his assets, a doctor will be charged with tens, if not hundreds of individual crimes, so that they will be under tremendous pressure to plead guilty to lesser charges in order to avoid a lengthy prison sentence. Many doctors who are totally innocent cave-in and accept a plea bargain because they know the odds are stacked against them.

In a criminal trial, a jury of ordinary people are asked to decide whether a doctor's care was appropriate, based on the testimony of competing experts on both sides. Prosecutors who want to portray a compassionate doctor as a common drug dealer will hold up bags of pills and argue that the doctor was operating "outside the bounds of legitimate practice." One way they do that is by trying to confuse the jury about what the legal definition of "Standard of Care" really means.

"Standard of Care" aka Reasonable Physician Standard of Care is legally defined as being based on what the science (as reflected in the medical texts and journals) indicates is appropriate care.

But prosecutors and their hired-gun experts attempt to use "Community Norms" to show that the doctor is operating way out on the fringes -- beyond what "most doctors" would do. Community Norm is defined as what most doctors would do, but most doctors are afraid to do the right thing because of the chilling effects of DEA intimidation tactics.

Doctors who aggressively treat the patients who need the most pain relief are actually doing the right thing, based on any reasonable interpretation of the science. That puts those doctors outside the norm, and in the DEA's crosshairs, because most doctors won't prescribe ANY narcotics for chronic pain. Only a small percentage are willing to prescribe narcotics for the treatment of chronic pain, and the overwhelming majority of those will only prescribe to their comfort level, rather than their patient's. The tiny percentage of doctors who are courageous enough to put their patients welfare first are under constant surveillance by the DEA and routinely subjected to DEA sting operations.

You can make a difference, and you should try, because you and everyone you care about is at risk for having their life destroyed by untreated pain. Do not accept without question what is being spoon-fed to you daily by those who profit from denying pain medications to people who need it the most.


News:

Wikileaks Cables Portray Expanded Reach of Drug Agency

The Drug Enforcement Administration has been transformed into a global intelligence organization with a reach that extends far beyond narcotics, and an eavesdropping operation so expansive it has to fend off foreign politicians who want to use it against their political enemies, according to secret diplomatic cables. In far greater detail than previously seen, the cables, from the cache obtained by WikiLeaks and made available to some news organizations, offer glimpses of drug agents balancing diplomacy and law enforcement in places where it can be hard to tell the politicians from the traffickers, and where drug rings are themselves mini-states whose wealth and violence permit them to run roughshod over struggling governments.   

Report finds DEA Losing More Guns 

The Drug Enforcement Administration is losing more guns than it was about five years ago, the Justice Department's inspector general said. Auditors said the DEA lost 22 firearms and had an additional 69 stolen over the 5½-year period. The stolen weapons included pistols, rifles, shotguns, and a submachine gun.

The majority of stolen guns had been left in an official's car, despite a policy prohibiting leaving a weapon unattended in a vehicle. The report cited examples of guns stolen from cars parked outside restaurants, hotels, schools and gyms. Some agents had their guns taken from their cars while they were shopping or getting coffee. One firearm was stolen while the car was at the body shop.
 

Audit Faults DEA Mishandling of Cash Seizures

U.S. Department of Justice
Office of the Inspector General
"For most seizures we tested, we found no documentation indicating that a witnessing agent or task force officer was present at critical stages of the cash handling process. Further, we found many instances in which agents and task force officers generally did not count the seized currency; did not provide a receipt to the subject from whom the currency was taken; did not complete documents transferring custody of the currency to an evidence custodian; and did not record the receipt, transfer, or disposal of the currency in a temporary or permanent control ledger."   


DEA Follies:

The Prescription Drug Rap From a DEA web site aimed at teens

What's up with Prescription and
Over-the-Counter Drugs?


Prescription drugs, they treat the pain,
If you use too much, they will give you no gain.
Con-cen-tra-tion - a thing they can do,
Some help you think and feel better too.
"Don't abuse them," that's the prescription.
"Don't abuse them," the right decision!

DEA agent shoots himself in the foot

 DEA agent shoots himself in the foot
"I'm the only one in this room professional enough,
that I know of, to carry a Glock 40." BLAM!
Update - Lee Paige, the DEA agent who shot himself in the foot while demonstrating gun safety to schoolchildren was only suspended for five days. This real-life "Barney Fife" then sued the DEA over release of the video that made him famous. His law suit was dismissed by a federal judge.

The DEA, Diversion and the War on Drugs:

The DEA War on Hydrocodone
The DEA wants to classify hydrocodone the same way it does Oxycodone. If hydrocodone became less available, we could expect potentially 8,000 more deaths from stroke and heart attack every year. And, although there's no way to reasonably estimate the number of people who will suffer bouts of depression, thoughts of suicide and actually commit suicide after being denied adequate pain medication because of the DEA's increasingly draconian measures, it's safe to assume that number will be in the millions...
 
Reefer Madness: The Federal Response to California's Medical Marijuana Law
Marijuana is unique among illegal drugs in its political symbolism, its safety, and its wide use. California's law seems to have engendered a uniquely harsh federal response because California is a large, trend-setting state; because its new marijuana law is very broad as compared with others; and because the law was passed by popular referendum...
 
The Pain Crisis in America
There is a Pain Crisis in America. Its primary manifestation is the routine and widespread under-treatment of pain, especially chronic, non-cancer pain. Other manifestations include a severe and growing shortage of physicians willing to prescribe morphine and related opioid analgesics, the widespread use of more toxic and less efficacious classes of medications in an effort to avoid opioids, and the profound distortion of medical education and of the doctor-patient relationship...
 
Victimized Doctors
Doctors throughout the country are being targeted by the DEA for helping patients manage crippling pain with prescription drugs. There is no presumption of innocence. Collateral damage to patients and physicians' families is the norm. "Our office will try our best to root out (certain doctors) like the Taliban" boasted US Attorney Gene Rossi..
 
American Medical Association (AMA) Policy Statement on Pain Management Using Opioid Analgesics
Preventing drug abuse remains an important societal goal—it should not hinder patient’s ability to receive the care they need and deserve or discourage physicians from prescribing pain medications when medically appropriate. The AMA is committed to the goal of protecting the legitimate use of prescription drugs for patients in pain...


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Sunday, May 3, 2020

The Pain Crisis in America


There is a Pain Crisis in America. Its primary manifestation is the routine and widespread under-treatment of pain, especially chronic, non-cancer pain. Other manifestations include a severe and growing shortage of physicians willing to prescribe morphine and related opioid analgesics, the widespread use of more toxic and less efficacious classes of medications in an effort to avoid opioids, and the profound distortion of medical education and of the doctor-patient relationship.


How large a problem is under-treated pain in America? In a 2001 article in the Journal of the American Medical Society (JAMA), Brian Vastag reports on the work of Richard Brown and colleagues who stated, at a National Institute on Drug Abuse (NIDA) symposium in April 2001, that there was widespread acknowledgment that both acute and chronic pain are under-treated. Brown estimated that more than 17% of Americans have serious chronic pain and that many go untreated and many more are under-treated. This is the pain crisis in America.


In an attempt to gauge the extent of the problem, these researchers developed a survey that measured the prescribing practices for benzodiazepines (Valium and related sedatives) and for opioid analgesics by different groups of physicians in response to variations of a single presented case. The physicians' prescribing decisions were then compared with recommendations from a panel of pain management experts. The findings were stark:


While the expert panel recommended that virtually all patients with [common idiopathic back pain] who do not respond to other treatments be given an opioid analgesic, only 20% of physicians said they would actually write that prescription... "It suggests there's a lot of unnecessary suffering," said Brown. To combat the problem, he called for increasing the amount of medical school education devoted to pain management, from the typical 2 to 4 hours to 16 or 20. 


None of this is new. For decades, researchers have noted this discrepancy between how chronic pain should be treated and the dismal state of the art as practiced in the U.S., and they commonly call for more and better education of physicians. But is the pain crisis in America simply a problem of the acquisition and application of medical knowledge? And if so, why have the impressive and consistent educational campaigns directed at this problem in recent decades failed to yield the expected changes in medical practice in the U.S.? 


The historical record strongly suggests a deeper and far more disturbing root cause of our current pain management predicament. In the years after 1914, the Narcotics Division of the Treasury Department, progenitor of today's Drug Enforcement Agency (DEA), brought a series of test cases against physicians under the Harrison Act. Through the courts, drug prohibitionists achieved the criminalization of drug users and of the doctors who would treat them as patients and as human beings worthy of the same individualized medical care as any other sufferer in a free society. This wide scope of law enforcement responsibility was far beyond that legislated by Congress when it passed what appeared to be a tax act in 1914. 


This historical period marks the invention of a perpetual national drug crisis which has ever since been claimed as the special national interest justifying the regulation of opioid analgesic medications and other dangerous drugs' by a federal law enforcement agency. In so doing, this agency has usurped the right constitutionally reserved to the states to otherwise license and regulate medical practice in that most fundamental, archetypal, and timeless of all the medical arts: the skillful application of opioid analgesia towards the relief of human pain and suffering. 


While opium and its derivatives are among the most ancient and well understood and safest pharmaceuticals mankind has ever developed, problematic use has been a source of personal tragedy in the lives of individuals throughout recorded history. However, before about 1920, there was no domestic drug subculture, no drug problem, no criminal black market, no drug cartels, no state-sponsored hounding and jailing of drug users and pain patients and of their physicians, no public outcry for the politicians of the day to "get tough on drugs." In fact, there is no credible record of a domestic drug problem prior to the perversion of the Harrison Act in the courts in the years after 1914 although there were many more opiate dependent people, both in absolute numbers and as a percentage of the population, than there are today. It has been estimated that in the 1880s some 4 per cent of the population of the United States used some kind of opiate for non-medicinal purposes.  


For a sense of perspective, consider that modern heroin use peaked in the late 1980's at approximately 326,000 (past month) users, or about 0.1 percent of the population, according to National Household Survey on Drug Abuse data. It is notable that, in the decades around the end of the Nineteenth Century, America supported large and powerful popular social movements against alcohol and tobacco use which were widely (and correctly) perceived as true national public health scourges. There is no record of any anti-opioid movement or opioid prohibition movement of similar significance because this class of substance was not viewed (again correctly) to be a social scourge or significant public health menace. 


The root cause of the widespread under-treatment of pain can be traced directly to the systematic, nationally coordinated, relentless harassment, arrest, and prosecution of thousands of American physicians, many of whom had been engaged in nothing other than the standard care of pain and addiction of the day. This pogrom has continued, unabated, for almost ninety years. 


The proximate cause of the pain crisis arises from what is known as the "chilling effect," a phrase which describes the grotesque distortion of the norms of medical practice and the violation of the doctor-patient relationship that results from the withdrawal of physicians from the appropriate treatment of pain due to fear of litigation, loss of livelihood, and incarceration. 


In a 2003 press release entitled "The Myth of the Chilling Effect," the DEA denied the possibility that its actions against physicians could have such an effect, arguing that DEA only brings actions against a miniscule proportion of doctors, therefore actions against doctors for violations of the Controlled Substances Act (CSA) cannot be causing other doctors to seek to avoid such actions by failing to use opioid analgesics appropriately or by refusing to prescribe them at all. We will analyze this document very carefully later in this paper and reveal it to be so much dissembling gibberish.


What each of us as members of a free and democratic society, governed by our own consent under the Constitution and the Bill of Rights, with an understanding of the meaning of federalism, States rights, the Fourth Amendment right to privacy, and the separation of powers, has to decide is:


Was there ever, or is there now, a national problem caused by domestic licit and illicit drug use of such dire import and magnitude that it might justify placing medical doctors and researchers under the direct regulatory control of adversarial federal law enforcement officers with no medical training? Should the DEA, a federal law enforcement agency with a Fiscal Year 2004 Office of Management and Budget (OMB) rating of ZERO, have the power to prescribe and proscribe the medical behavior of individual physicians, down to the level of judging individual patient medication regimens, and to grossly distort the norms of medical practice in entire specialties of medicine? 
 
If there is a national drug problem that does warrant eighty years of a war on drugs / war on doctors and the systematic state sanctioned abuse of pain patients, drug users, and their families, what exactly is the nature of the problem and how severe is it? Compared to what? 3. Where do we go from here? Does the DEA have a legitimate role in making policy on issues which are considered to be medical and public health matters by the vast majority of the nations of the world? Is negotiating towards achieving consensus with such people possible? Is it strategically, morally and ethically advisable? There have been several "Pain Summits" over the years and grand "consensus documents" and "clinical guidelines" have been proclaimed, and yet the war on doctors continues unabated. So we ask, does the DEA negotiate in good faith?

Saturday, May 2, 2020

Reefer Madness: The Federal Response to California's Medical Marijuana Law

Marijuana is unique among illegal drugs in its political symbolism, its safety, and its wide use. More than 65 million Americans have tried marijuana, the use of which is not associated with increased mortality.  Since the federal government first tried to tax it out of existence in 1937, at least partly in response to the 1936 film Reefer Madness, marijuana has remained at the center of controversy. Now physicians are becoming more actively involved. Most recently, the federal drug policy against any use of marijuana has been challenged by California's attempt to legalize its use by certain patients on the recommendation of their physicians. The federal government responded by threatening California physicians who recommend marijuana to their sick patients with investigation and the loss of their prescription privileges under Drug Enforcement Administration (DEA) regulations. The editor-in-chief of the Journal suggested that prohibiting physicians from helping their suffering patients by suggesting that they use marijuana is "misguided, heavy-handed, and inhumane." He recommended that marijuana be reclassified as a Schedule II drug and made available by prescription without the usual requirement of controlled clinical trials. Many states, including Massachusetts, had previously passed laws that permitted their citizens to use marijuana for medicinal purposes under some circumstances. 

California's law seems to have engendered a uniquely harsh federal response because California is a large, trend-setting state; because its new marijuana law is very broad as compared with others; and because the law was passed by popular referendum. In this article I will discuss the new California law and its implications for physicians. 
 
The California Proposition  
In the fall of 1996, California voters approved the Medical Marijuana Initiative (Proposition 215) by a vote of 56 to 44 percent. The act is entitled the Compassionate Use Act of 1996, and its purpose is to give Californians the right to possess and cultivate marijuana for medical purposes "where that medical use is deemed appropriate and has been recommended by a physician who has determined that the person's health would benefit from the use of marijuana in the treatment of cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, migraine, or any other illness for which marijuana provides relief." Nothing in the act permits persons using marijuana for medical purposes to engage in conduct that endangers others (such as driving while under its influence), condones "the diversion of marijuana for nonmedical purposes," or permits the buying or selling of marijuana.  The two operative sections of the law are as follows: 
 
Notwithstanding any other provision of law, no physician in this state shall be punished, or denied any right or privilege, for having recommended marijuana to a patient for medical purposes.  [Existing California law] relating to the possession of marijuana [and the] cultivation of marijuana, shall not apply to a patient, or to a patient's primary caregiver [the person who has consistently assumed responsibility for the patient's housing, health, or safety] who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician. (5)  The primary purpose of this law is to provide a specified group of patients with an affirmative defense to the charge of possession or cultivation of marijuana, the defense of medical necessity. To use this defense, the patient must be able to show that his or her physician recommended or approved of the use of marijuana, either orally or in writing. Obviously, a note from a physician is better evidence than a simple assertion that "my doctor said this would be good for me," and most patients will want a written statement to help protect them from problems with the police.
 
Nothing in this law changes current law against buying or selling marijuana or affects federal law; it merely provides that qualified patients and their primary care givers can possess and cultivate their own marijuana for personal medicinal purposes, without violating state drug laws.  

Compassion and the Use of Unapproved Drugs
The federal government has been in the business of regulating drugs for almost a century, and few exceptions have ever been made to the basic rules of the Food and Drug Administration (FDA), even for patients with cancer or AIDS. In 1979, for example, the FDA was successful in convincing a unanimous U.S. Supreme Court that Congress intended no exception for terminally ill patients who sought to take laetrile, an unapproved drug, for cancer. The FDA's primary rationale was that the use of this unapproved and useless drug could prevent patients from seeking conventional treatments for cancer that offered them at least some chance of a cure.  Under President Ronald Reagan, however, the FDA responded with a great deal more flexibility to the AIDS epidemic and permitted the use and sale of drugs not yet approved (but in use in ongoing clinical trials) if, among other things, "the drug [was] intended to treat a serious or immediately life-threatening disease."  More surprisingly, the FDA also permitted individual patients to import unapproved drugs from other countries for their personal, medical use. These regulations were almost purely political, had no scientific basis, and tended to conflate treatment and research and to undermine the very purpose of clinical trials.  The theory used to justify these exceptions to federal drug laws was the very one rejected by the Supreme Court: terminally ill patients have "nothing to lose" and should not be deprived of the hope (even the false hope) that they might escape death.  
 
Given this history, it is not surprising that the advocates of the medicinal use of marijuana concentrate their reform efforts on helping patients with cancer ameliorate the adverse effects of chemotherapy and helping patients with AIDS counteract weight loss and fight their disease. Virtually no one thinks it is reasonable to initiate criminal prosecution of patients with cancer or AIDS who use marijuana on the advice of their physicians to help them through conventional medical treatment for their disease. Anecdotal evidence of the effectiveness of smoked marijuana abounds. Perhaps the most convincing is the account of Harvard professor and author Stephen Jay Gould, one of the world's first survivors of abdominal mesothelioma. When Gould started intravenous chemotherapy, he writes: 
Absolutely nothing in the available arsenal of anti-emetics worked at all. I was miserable and came to dread the frequent treatments with an almost perverse intensity. I had heard that marijuana often worked well against nausea. I was reluctant to try it because I have never smoked any substance habitually (and didn't even know how to inhale). Moreover, I had tried marijuana twice [in the 1960s]... and had hated it.... Marijuana worked like a charm.... The sheer bliss of not experiencing nausea -- and not having to fear it for all the days intervening between treatments -- was the greatest boost I received in all my year of treatment, and surely the most important effect upon my eventual cure.   
 
Similarly, in patients with AIDS, marijuana has been credited with counteracting such side effects of treatment as severe nausea, vomiting, loss of appetite, and fatigue, as well as with stimulating the appetite to help prevent weight loss.  
 

The White House Press Conference
Had the California proposition been limited to the use of marijuana for terminal illnesses such as cancer and AIDS, it would probably have caused much less concern. Arizona passed a much broader initiative that permitted physicians to prescribe any drug on Schedule I, but in April 1997, the Arizona legislature amended the law to apply only to drugs approved by the FDA, thus effectively repealing it. The California law applies only to marijuana but makes it available for a wide range of medical conditions, including anorexia, pain, spasticity, glaucoma, arthritis, migraine, "or any other illness for which marijuana provides relief." This very broad definition of the potential medicinal uses of marijuana seemed an explicit endorsement of the drug itself, which the Clinton administration and others believed to be sending the wrong message to America's youth. After thinking about the issue for approximately two months, the Clinton administration announced that it would vigorously oppose the implementation of the California proposition and the Arizona law. Barry McCaffrey, director of the Office of National Drug Control Policy, announced at a White House news conference on December 30, 1996, that "nothing has changed. Federal law is unaffected by these propositions." McCaffrey expressed concern about marijuana as a "gateway drug" and about the potential impact of the law on children. As for the potential medicinal uses of marijuana, he said: 
 
This is not a medical proposition. This is the legalization of drugs that we're concerned about. Here's what the medical advisor in the state of California saw as the potential uses of marijuana. [Here McCaffrey showed a slide.]... It includes recalling forgotten memories, cough suppressants, Parkinson's disease, writer's cramp. This is not medicine. This is a Cheech and Chong show. And now what we are committed to doing is to look in a scientific way at any proposition that would bring a new medicine to the assistance of the American medical establishment.   
 
Secretary of Health and Human Services Donna Shalala said that the initiatives reinforced the growing belief among Americans that marijuana is not harmful, whereas the administration remained "opposed to the legalization of marijuana [because] all available research has concluded that marijuana is dangerous to our health." Nonetheless, she did say that the National Institutes of Health (NIH) would continue to support and review "peer-reviewed" and "scientifically valid" research on "the possible usefulness of smoked marijuana in the limited circumstances where available medications have failed to provide relief for individual patients."  
 
Finally, Attorney General Janet Reno announced that physicians who followed the terms of the California law would be the new targets of federal law enforcement (instead of drug dealers) and threatened physicians with loss of their registrations with the DEA and with exclusion from participation in Medicare and Medicaid. She stated: 
 
Federal law still applies.... U.S. attorneys in both states will continue to review cases for prosecution and DEA officials will review cases as they have to determine whether to revoke the registration of any physician who recommends or prescribes so-called Schedule I controlled substances. We will not turn a blind eye toward our responsibility to enforce federal law and to preserve the integrity of medical and scientific process to determine if drugs have medical value before allowing them to be used. 
 

Doctor-Patient Conversations
Two basic issues are raised by the administration's position. One involves government regulation of doctor-patient conversations, and the other the quality of evidence necessary to make marijuana available by prescription. A group of California physicians filed suit against McCaffrey, Reno, and Shalala, arguing that the threats of prosecution against physicians for talking to their patients violate their First Amendment rights and interfere with their ability as physicians to use "their best medical judgment in the context of a bona fide physician-patient relationship." In the only comparable case to reach the U.S. Supreme Court, the Court narrowly upheld a gag rule related to discussing abortion in a federally funded Title X family-planning clinic. The Court upheld the gag rule because Congress could reasonably limit the types of medical services available at a federally funded facility. The Court was able to sidestep the First Amendment issue because patients (at least in theory) had access to other doctors who had an obligation to furnish them with full information, and the doctor-patient relationship in a Title X clinic was characterized as not "all-encompassing" but, rather, as limited only to preconception counseling: 
 
The Title X program regulations do not significantly impinge upon the doctor-patient relationship. Nothing in them requires a doctor to represent as [his or her] own any opinion that [he or she] does not in fact hold. Nor is the doctor-patient relationship established by expectation on the part of the patient of comprehensive medical advice. The program does not provide post-conception medical care, and therefore a doctor's silence with regard to abortion cannot  reasonably be thought to mislead a client into thinking that the doctor does not consider abortion an appropriate option for her.  
 
Even if one accepts this unconvincing rationale, it is impossible to apply it to California physicians who believe that marijuana would be beneficial for their patients and who are providing their overall health care. Patients receiving care for cancer or AIDS rightfully and reasonably expect and are entitled to full disclosure and discussion of available treatment options. The California physicians are on strong legal ground with their lawsuit, and they should prevail. In early April,  U.S. District Court judge Fern M. Smith granted a preliminary injunction prohibiting the DEA from carrying out its threats against California physicians and encouraged the litigants to try to work out a settlement of the dispute. 
 
In response to the lawsuit and the growing opposition to its threats to physicians, the administration issued a clarifying letter, essentially stating that physicians may discuss marijuana with their patients so long as they do not recommend its use. This provides no guidance at all. Of course doctors can talk to patients; the question is what they can tell them. The real subject of dispute remains whether physicians can "recommend" marijuana (and thereby grant their patients immunity from state prosecution), as the California proposition provides. Would, for example, telling a patient with cancer that other physicians have reported that marijuana has given their patients relief from nausea constitute a "recommendation"?  Judge Smith made it clear that the First Amendment protects physician-patient communications and that the government has no authority to determine the content of physicians' speech. She also concluded that the federal statements regarding threatened prosecution were vague and thus could lead to physicians' censuring  their own speech to avoid possible federal prosecution. On the other hand, she noted (correctly) that the First Amendment does not protect "speech that is itself criminal because [the speech is] too intertwined with illegal activity." Under federal drug laws, which cannot be affected by legislation in California, it remains a crime for physicians to aid, abet, or conspire -- by speech or action -- to  violate federal criminal statutes. Thus, it is not a violation of the First Amendment for the federal government to prosecute or threaten to prosecute physicians who specifically intend to aid, abet, or conspire with their patients to violate federal drug laws.
 
Judge Smith could have added that to prevail in such a case the government will have to prove more than simply that the physician recommended marijuana as worth trying for a medical condition. The "more" will include evidence that the physician "associated himself with the venture" of illegally purchasing marijuana "as something he wished to bring about and sought by his actions to make succeed." This should require at least that the physician identify a source of the marijuana, and some connection between that source and the physician. It is only speech short of this that the injunction covers. Of course, this formulation still leaves it uncertain exactly how far physicians may go in recommending marijuana use before the federal government is justified in prosecuting them for criminal behavior.Judge Smith concluded with an understatement: "This injunction does not provide physicians with the level of certainty for which they had hoped." 
 

Marijuana as Medicine
Attempts to have marijuana reassigned from Schedule I to Schedule II began almost immediately after Congress passed the Uniform Controlled Substances Act of 1970, which established the current system of drug classification. The following findings must be made to place a drug on Schedule I: "(A) The drug... has a high potential for abuse; (B) The drug... has no currently accepted medical use in treatment in the United States; and (C) there is a lack of accepted safety for use of the drug under medical supervision." Part A for Schedule II drugs is identical; the other requirements are "(B) The drug... has a currently accepted medical use in treatment in the United States... and (C) Abuse of the drug... may lead to severe psychological or physical dependence." 
 
In 1988, after two years of hearings, DEA administrative-law judge Francis Young recommended shifting marijuana to Schedule II on the grounds that it was safe and had a "currently accepted medical use in treatment." Specifically, Judge Young found that "marijuana, in its natural form, is one of the safest therapeutically active substances known to man.... At present it is estimated that marijuana's LD-50 [median lethal dose] is around 1:20,000 or 1:40,000. In layman's terms... a smoker would theoretically have to consume 20,000 to 40,000 times as much marijuana as is contained in one marijuana  cigarette... nearly 1500 pounds of marijuana within about fifteen minutes to induce a lethal response." As for medical use, the judge concluded, among other things, that marijuana "has a currently accepted medical use in treatment in the United States for nausea and vomiting resulting from chemotherapy treatments." The administrator of the DEA rejected Young's recommendation, on the basis that there was no scientific evidence showing that marijuana was better than other approved drugs for any specific medical condition. Further attempts to get the courts to reclassify marijuana have been unsuccessful.
 
Reacting to a DEA suggestion that only a "fringe group" of oncologists accepted marijuana as an antiemetic agent, a survey of a random sample of the members of the American Society of Clinical Oncology was undertaken in 1990. More than 1000 oncologists responded to the survey, and 44 percent of them reported that they had recommended marijuana to at least one patient. Marijuana was believed to be more effective than oral dronabinol (Marinol) by the respondents: of those who believed they had sufficient information to compare the two drugs directly, 44 percent believed marijuana was more effective, and only 13 percent believed dronabinol was more effective. Of course, nothing in the FDA regulations requires a drug to be more effective than an existing one for it to be approved. Nonetheless, in the current anti-marijuana climate, the NIH has consistently refused to fund research on marijuana. In the wake of the California proposition, this position is no longer tenable. 
 
An NIH panel, after a two-day workshop in February, recommended research on marijuana in the areas of wasting associated with AIDS, nausea due to cancer chemotherapy, glaucoma, and neuropathic pain. This list seems reasonable, especially since objective criteria such as weight gain, intraocular pressure, and the frequency of vomiting can be used to determine the drug's effectiveness.
 
Such research may be difficult to do, but it is possible to compare orally administered dronabinol with smoked marijuana. Some argue that because the symptoms of nausea are so subjective and "extremely difficult to quantify in controlled experiments," marijuana should be available as a prescription drug on a compassionate basis. In fact, current FDA regulations provide the authority for making marijuana available on a compassionate basis while such studies are proceeding. Other support for its compassionate use would appear to come from the Clinton administration's solicitor general, Walter Dellinger, who argued before the Supreme Court less than two weeks after the McCaffrey-Reno press conference that the administration believed that Americans had a weak constitutional right "not to suffer." Although Dellinger said he did not believe this right was broad enough to prohibit the states from making physician-assisted suicide for terminally ill patients a crime, it should certainly be broad enough to prohibit the federal government from denying patients with cancer and AIDS access to drugs that could help them withstand potentially life-saving treatments.
 

What About the Children?
The final argument that the administration makes against any medical use of marijuana is that this would send the "wrong message" to children, who would then use this "gateway drug" and get hooked on much more harmful substances, such as cocaine and heroin. There are two responses to this argument. The first is provided by Boston Globe columnist Ellen Goodman, who asks, "What is the infamous signal being sent to [children]?... If you hurry up and get cancer, you, too, can get high?" The second response relates to the "gateway" issue itself. A 1994 survey found that 17 percent of current marijuana users said they had tried cocaine and only 0.2 percent of those who had not used marijuana had tried cocaine. One way to interpret these data is that children who smoke marijuana are 85 times as likely as others to try cocaine; another is that 83 percent of pot smokers, or five out of six, never try cocaine. Honesty is likely to make a greater and more lasting impression on our children than political posturing and hysteria. Many people want to make marijuana legal for everyone. But opposition to the legalization of marijuana generally is not a good reason to keep it from patients who are suffering. Making marijuana a Schedule II drug does not make it widely acceptable or available any more than classifying medicinal cocaine as a Schedule II drug made it acceptable or available. 
 

Conclusions
Doctors are not the enemy in the "war" on drugs; ignorance and hypocrisy are. Research should go on, and while it does, marijuana should be available to all patients who need it to help them undergo treatment for life-threatening illnesses. There is certainly sufficient evidence to reclassify marijuana as a Schedule II drug. Unlike quack remedies such as laetrile, marijuana is not claimed to be a treatment in itself; instead, it is used to help patients withstand the effect of accepted treatment that can lead to a cure or amelioration of their  condition. As long as a therapy is safe and has not been proved ineffective, seriously ill patients (and their physicians) should have access to whatever they need to fight for their lives. 


An article by George J. Annas, published August 7, 1997 in the New England Journal of Medicine


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Friday, May 1, 2020

The DEA War on Hydrocodone


The DEA wants to classify hydrocodone the same way it does oxycodone, a more powerful analog that is the active ingredient in the long-lasting painkiller Oxycontin. Oxycontin prescriptions cannot include refills. Oxycontin or hydrocodone alone are rarely the sole cause of a drug-induced death. More than 95 percent of these deaths are caused by "polypharmacy," the ingestion of multiple illicit compounds, usually laced with a lot of quite legal booze.

Picking on one drug won't do the trick, but picking on hydrocodone is a particularly bad idea, because the DEA's proposals could well kill more people from pain than they save from abuse.

How much pain and suffering does hydrocodone mitigate? There were 100 million new prescriptions for the drug last year in the United States, given to 38 million patients. (This doesn't even count in-hospital use.) Hydrocodone is by far the most prescribed drug in the nation.

Because there will be no more refills, DEA's proposal means at least 300 million office visits per year (figuring that most chronic pain prescriptions are refillable twice). Nowadays, one just doesn't walk in and out of a doc's office. Most pain doctors are so busy that appointments must be made months in advance, and appointment, travel and waiting easily burn half a day. That's 150 million worker days lost. Based upon average annual wages, employers will pay ( and you and I will shoulder ) about $13 billion in wages for doctor-visit induced absenteeism. And the office visits will add another $20 billion in cost, payable through the patient's insurance or someone else's taxes.

Add this to the fact that, according to Katherine Foley, a pain expert at Sloan-Kettering Cancer Center, pain already costs Americans $100 billion per year in treatment costs and labor-related losses. Making pain relief harder to get will only make it more expensive.

How risky is hydrocodone? According to the Drug Abuse Warning Network, a systematic effort to procure objective information on drug-related deaths, hydrocodone showed up in 46 bodies last year in Las Vegas, a town surely prone to a bit of drug abuse. The number of hydrocodone pills prescribed there in 2001 was around 27 million, and this doesn't even count the huge number that fly in with tourists, gamblers and others who engage in risk-taking behavior every weekend. I'd say it's a good bet that more people die in legal casinos and brothels in southern Nevada from heart attacks than are killed by hydrocodone.

Some other state data can be used to make fuzzy estimates of abuse-related deaths. In 2002, there were 150 findings of fatal concentrations of hydrocodone in postmortem examinations in Florida. Assuming conservatively that this may catch half the deaths, and way too conservatively that "Miami Vice" Florida is typical, this would maximize the number of deaths per year associated with fatal concentrations of this drug at around 6,000 nationwide.

Given the problem of polypharmacy, it's charitable to assume that the DEA's proposal may prevent half those deaths. Are 3,000 deaths pretty high overhead for pain relief? Well, consider NSAIDs. About 16,000 people who use these medications for arthritis alone die each year, due to the drugs' propensity to enhance internal bleeding. It would seem from this that DEA would save a lot more lives if it made ibuprofen harder to get, so that those with pain would have to switch to hydrocodone or oxycodone.

But that may be just one tip of the iceberg. Pain raises blood pressure and researchers have found that every 10mm increase in systolic blood pressure results, on the average, in a 40 percent increase in risk of stroke and a 30 percent increase in risk of heart attack for your age class. 
So if hydrocodone became less available, we could expect potentially 8,000 more deaths from stroke and heart attack every year. And, although there's no way to reasonably estimate the number of people who will suffer bouts of depression, thoughts of suicide and actually commit suicide after being denied adequate pain medication because of the DEA's increasingly draconian measures, it's safe to assume that number will be in the millions.
Compare that with about 3,000 deaths that can prevented by the DEA's proposal. Those deaths are very unfortunate, but any "solution" that punishes the 38 million pain patients who use hydrocodone safely is not a reasonable solution.
Adapted from an article by Patrick Michaels, a senior fellow in environmental studies at the Cato Institute.


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