New Evidence on Smoking Marijuana and Lung Function; Update on New Jersey’s Nascent Medical Marijuana Program

This week’s JAMA includes an article reporting on new evidence that smoking marijuana does not negatively affect lung function. Smoking tobacco has long been known to harm the lungs and to increase the risk of developing chronic obstructive pulmonary disease and lung cancer, both leading causes of death. The risks posed by smoking marijuana, on the other hand, have largely been assumed, based on the fact that “[m]arijuana smoke contains many of the same constituents as tobacco smoke[.]”

The authors of the JAMA article analyzed data from a 20-year longitudinal study of 5,115 people in 4 American cities who “comprise a broad cross-section of typical tobacco and marijuana use patterns” and found that “[w]ith up to 7 joint-years of lifetime exposure (e.g., 1 joint [a day] for 7 years or 1 joint [a week] for 49 years)” there was no evidence of an adverse effect on the lungs. Very heavy marijuana use in excess of 7 joint-years of lifetime exposure could prove harmful, but there were not enough heavy users in the study to demonstrate this.

High-quality epidemiological evidence like this latest JAMA study will be key to filling in the gaps in our knowledge about marijuana’s safety profile. While double-blinded randomized controlled trials are considered the gold standard for evaluating the safety and efficacy of drugs, they are not always an option, particularly where the goal is to gather data over many years. Marijuana’s classification as a Schedule 1 controlled substance adds to the difficulty of mounting clinical trials. Given this, it is (or will be) a very good thing that New Jersey’s still-nascent medical marijuana program will include a registry of de-identified patient treatment and outcomes data that will allow researchers to learn more about the drug’s safety and efficacy.

The statute authorizing New Jersey’s medical marijuana program was passed two full years ago, in January 2010, but the road to implantation has been a long and rocky one. (My previous posts on the subject are here, here, here, and here.) While the Christie Administration is now on board, local towns have proved resistant to efforts to site alternative treatment centers that would grow and/or dispense marijuana there. In the Associated Press earlier this week, Geoff Mulvihill writes that “[s]o far, only one [of the six groups authorized by the state to operate alternative treatment centers] has announced that it has secured local approvals. … Three others have been shut out of their chosen locations by local government bodies, despite assurances that security at the dispensaries would be tight and that pot would be given only to patients who are truly sick.”

The state may be fighting back. Nina Rizzo reports in the Asbury Park Press that Assemblyman Declan O’Scanlon has announced “that he will introduce legislation next week that would prohibit counties and municipalities from interfering with the development of medical marijuana cultivation and distribution centers by extending their protections under the Right to Farm Act.”

Such a heavy-handed approach may be necessary in the short term, to ensure that all six authorized alternative treatment centers can get off the ground. If the New Jersey Compassionate Use Medical Marijuana Act and its regulations work as they are intended to, however, public confidence in the program should grow.

High School Just Says No to Medical Marijuana

Remember the “Just Say No” and D.A.R.E. anti-drug campaigns way back in the day?  I do.  That’s when the high school kids would come to my elementary school, put on a play, and divide us into small groups for a talk on how we shouldn’t use drugs.  I think there was even a song in there somewhere.  Remember those bizarre zero-tolerance policy stories too?  The ones about a middle school student who was suspended for touching and refusing a proffered Adderall pill or a little kid who was suspended for bringing a camping utensil to school and then required to attend an alternative school for 45 days?

So what should parents and teachers do when a high school student may legally take medical marijuana lozenges to treat diaphragmatic and axial myoclonus, a rare condition which causes him to suffer seizures that can last for 24 hours, but may not legally do so when the seizures occur at school?  As The Colorado Independent reports, that’s the question facing a Colorado Springs teenager who needs to take such lozenges for seizures that can happen without warning and a high school that doesn’t want him to have the lozenges on its property.

You see, 15 states - Alaska, Arizona, California, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Jersey, New Mexico, Oregon, Rhode Island, Vermont, and Washington — and the District of Columbia have legalized medical marijuana.  Nine states — Connecticut, Delaware, Idaho, Illinois, Maryland, Mississippi, New Hampshire, New York, and Oklahoma — have similar legislation pending.  In November 2000, 54% of Colorado voters approved the legalization of medical marijuana through Ballot Amendment 20.  The law went into effect on June 1, 2001.  (Nine years later, Governor Bill Ritter signed House Bill 1284 and Senate Bill 109 into law, providing a regulatory framework for dispensaries and addressing potential fraud and abuse.)

The Colorado Department of Public Health and Environment (CDPHE) maintains the Medical Marijuana Registry program which accepts and processes applications for Registry Identification cards.  The registration process is fairly straightforward.  Under 5 CCR 1006-2, an adult patient/applicant (over the age of 18) must submit a notarized application which includes name, address, date of birth, Social Security number, name and address of primary-care giver (if applicable), written documentation from the applicant’s physician confirming his or her debilitating medical condition, name and address of the applicant’s physician, and a copy of an identity document.  For a minor patient/applicant (under the age of 18), a parent residing in Colorado must submit written consent and the applicant’s name, address, date of birth, Social Security number, written documentation from two of the applicant’s physicians confirming his or her debilitating medical condition, the name and address of the two physicians, consent from the applicant’s parents residing in Colorado, and documentation from one of the physicians about the risks/benefits of the medical marijuana treatment.

In June 2010, CDPHE reported that 95,477 Coloradan patients possess valid Registry Identification cards… and only 24 of those patients — a mere 0.0251%  — are minors.  However, if you read the fine print in C.R.S.A. § 25-1.5-106(12)(B)(IV), you’ll note that “[a] patient or primary caregiver shall not: possess medical marijuana or otherwise engage in the use of medical marijuana in or on the grounds of a school or in a school bus.”  What should minors do if they’re still in school and need to take their medicine?

So maybe the Colorado Springs high school isn’t without reason for prohibiting this student from bringing his lozenges onto its property.  It’s an oversight on the part of the legislature to be sure and I wonder if any of the other 23 registered minors have experienced similar problems.  The obvious compromise would be to allow the student to go home and take his medicine as needed — The Colorado Independent reports that he switched schools last year to be closer to home for this very reason — and then return to school.  Yet until this past week the school told the student that this wasn’t an option.  Besides, it’s not a wholly satisfactory compromise if the student has to walk home while having a seizure.

New Jersey’s Long-Awaited (and Controversial) Proposed Medicinal Marijuana Program Rules

Last week, New Jersey’s Department of Health and Senior Services released long-awaited proposed regulations implementing The Compassionate Use Medicinal Marijuana Act and they have already proved controversial.  Generating the most debate is the Department’s determination that the entities authorized to grow marijuana will not be authorized to dispense it to patients and vice versa.  As the Department explained in a press release, “[s]ix Alternative Treatment Centers (ATCs) will be selected through a competitive process.  Two of the ATCs will be cultivators and four will be dispensaries. … The ATCs selected for dispensing medicinal marijuana will also have the ability to apply to the Department for satellite locations in their region.”

According to the New Jersey Law Journal, Assemblyman Reed Gusciora (D-Mercer), one of the Act’s primary sponsors, called the regulations “a departure from the legislative intent” to authorize six ATCs — two each in northern, central, and southern New Jersey — all of which would both grow and dispense medical marijuana.  Senator Nicholas Scutari (D-Union), another primary sponsor, agrees, arguing that: “the regulations are a problem.  I’m not happy because they do not comport with the statute.  It’s insulting and agitating.”  The Law Journal reports that “Scutari and Gusciora say they will try to persuade [DHSS Commissioner Poonam] Alaigh to change the regulations to conform to the statute.  ‘You can’t change a statute through the regulatory process,’ says Scutari, adding that he will pursue changes through litigation if the rules are not amended to the Legislature’s satisfaction.”

A careful reading of the Act reveals that the provision addressing the function of ATCs is less than crystal clear, however:

“An alternative treatment center shall be authorized to acquire a reasonable initial and ongoing inventory, as determined by the department, of marijuana seeds or seedlings and paraphernalia, possess, cultivate, grow, harvest, process, display, manufacture, deliver, transfer, transport, distribute, supply, sell, or dispense marijuana, or related supplies to qualifying patients or their primary caregivers[.]”

The Department obviously reads this in the disjunctive, to mean that ATCs shall be authorized to do (at least) one of the things listed, but need not be authorized to do all of them.  This reading is supported by the “or” between “sell” and “dispense.”  On the other hand, reading the sentence in the disjunctive allows for absurd results that clearly would thwart the Legislature’s intent.   (For example, under this reading, the Department would be within its rights to authorize six ATCs to grow marijuana but none to dispense it.)

Leaving further statutory analysis to others, I will say that I do not think that the Department’s decision to separate growing and dispensing will necessarily thwart the Legislature’s directive that there be “a sufficient number of alternative treatment centers throughout the State, pursuant to need, including at least two each in the northern, central, and southern regions of the State,” particularly given that the regulations provide for both home delivery and the possibility of satellite ATC locations.  More likely to limit access is the expense to patients, both of participating in the program ($200 for the patient, unless they qualify for Medicaid or other assistance programs, and another $200 if the patient needs a caregiver to assist with their marijuana use) and of paying for medical marijuana, which of course is not covered by any insurance plan.  The proposed regulations provide that prospective ATCs will be judged based on a number of criteria, including “ability to meet overall health needs of qualified patients”; within that rubric, the selection committee should consider prospective ATCs’ plans to make medical marijuana affordable to those who need it.

“The alternate approach to medical marijuana distribution,” an op-ed by Kate Greenwood featured in The Record

[Ed. Note: This op-ed piece was featured in The Record's Sunday Editorial Page and on North Jersey.com. It was written by Center for Health & Pharmaceutical Law & Policy Research Fellow and regular Health Reform Watch blogger, Kate Greenwood]

WE FEEL there is no question about it: The careful, legal distribution of medicinal marijuana to those in need is a good thing. The New Jersey Legislature agreed and passed legislation permitting distribution last January. Then-Gov. Jon Corzine signed the measure before leaving office.

But Governor Christie has requested a delay in its implementation, and a proposal to modify the system of distribution is cause for concern.

More than a year ago, Seton Hall Law’s Center for Health and Pharmaceutical Law and Policy distributed a position paper to New Jersey lawmakers urging passage of the marijuana measure, called the “New Jersey Compassionate Use Medical Marijuana Act.” The center did so citing the inclusion of “multiple measures designed to reduce the risk of abuse or diversion” and noting that “the medical literature supports the conclusion that smoked marijuana can provide relief to patients suffering from debilitating medical conditions for whom conventional treatments have failed.”

Implementation delayed

The act was to have taken effect this month, but, in response to a request from Christie, the Legislature pushed back the effective date to October.

As passed, the act provides that medical marijuana be grown and distributed by six not-for-profit “alternative treatment centers.”

But now, the New Jersey Council of Teaching Hospitals has proposed that the act be amended — before it is even implemented to provide that medical marijuana instead be grown by Rutgers University and distributed by the state’s teaching hospitals.

While hospitals are, as the Council of Teaching Hospitals points out, experienced dispensers of medicine, the act should not be rewritten to require them to dispense medical marijuana.

The passage of the act affects the rights and responsibilities of patients and providers of medical marijuana under New Jersey law; it does not change the fact that distribution and use of marijuana are illegal under federal law.

Although Attorney General Eric Holder has pledged not to prosecute patients and providers who comply with applicable state laws, and hospitals could thus dispense medical marijuana without fear of criminal prosecution, they would still be violating federal law.

Condition of participation

This is a problem because compliance with federal law is a condition of participation in the Medicaid and Medicare programs. Hospitals depend heavily on Medicaid and Medicare funding; the Compassionate Use Act’s alternative treatment centers would not.

Read More

Medical Marijuana Act Signed Into Law: Some Chronically Ill New Jerseyans Rejoice While Others Continue to Wait

As expected, on January 18, 2010, Governor Jon Corzine signed the New Jersey Compassionate Use Medical Marijuana Act into law, making New Jersey the 14^th state to legalize marijuana for medical use.  Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy endorsed the Act in a position paper distributed to key lawmakers in June 2009.

The Act’s backers celebrated its passage with “hugs and tears,” while its opponents expressed continued concerns, including that the for-profit “alternative treatment centers” that the Act will allow to grow and distribute marijuana will have negative effects on the neighborhoods where they are established.  An interesting abcnews.com article by Susan Donaldson James highlights a third constituency: New Jerseyans with chronic illnesses that are responsive to treatment with marijuana but who are not considered to have debilitating medical conditions under the Act.

The article profiles Jack O’Brien of Laurel Lake, New Jersey who was born without fingers and toes and suffers from “crushing neuropathic pain.”  He wakes up to shooting pain in his arms and legs and can only walk short distances on his deformed feet.  According to O’Brien, smoking marijuana is “like having a valve on the forearm, turning it and having the coolness of relief through my extremities. … I try to walk on these feet and I can go four or five blocks, with my wife. With marijuana, I can go forever.”  State Assemblyman Reed Gusciora, who was a prime sponsor of the Act, explained that while he had empathy for O’Brien and others in his position, the legislature “had to do a measured approach,” citing fears that New Jersey could become another California, where medical marijuana “seemed to be spiraling out of control.”   Assemblyman Gusciora promised that in two years the legislature would “revisit the issue and add ailments.”

Addendum:

While Jack O’Brien’s case provides only anecdotal evidence of marijuana’s efficacy against neuropathic pain, as the Center noted in its position paper, “in the past two years, three placebo-controlled, randomized, double-blind clinical trials published in the medical literature have demonstrated that smoked marijuana is effective against neuropathic pain, including for patients who have tried the available conventional treatments and are still in pain.”   The existence of this evidence is remarkable because, as recent articles in the New York Times and Wall Street Journal explain, researchers must surmount formidable hurdles to study marijuana’s potential medical uses.

For those who are curious, under the compromise version of the Act which was signed into law January 18^th, “debilitating medical condition” is defined to include the following:

• Seizure disorder, including epilepsy, if resistant to conventional medical therapy;
• Intractable skeletal muscular spasticity, if resistant to conventional medical therapy;
• Glaucoma, if resistant to conventional medical therapy;
• HIV or the treatment of HIV, if it causes severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome;
• AIDS or the treatment of AIDS, if it causes severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome;
• Cancer or the treatment of cancer, if it causes severe or chronic pain, severe nausea or vomiting, cachexia, or wasting syndrome;
• Amyotrophic lateral sclerosis;
• Multiple sclerosis;
• Terminal cancer;
• Muscular dystrophy;
• Inflammatory bowel disease, including Crohn’s disease; and
• Terminal illness, if the physician has determined a prognosis of less than 12 months of life.

New Jersey Legislature Passes Medical Marijuana Bill

Yesterday, the last day of its 2008-2009 legislative session, the New Jersey legislature voted to legalize the use of medical marijuana by New Jersey residents suffering from debilitating medical conditions.

The version of the New Jersey Compassionate Use Medical Marijuana Act passed yesterday represents a compromise between the version that the state Senate passed in February of 2009, which Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy endorsed in a position paper distributed to key lawmakers, and the Assembly version, which included a number of amendments intended to bolster the Act’s already strict safeguards against abuse and diversion.  (The differences between the Assembly and Senate versions are outlined here; a summary of the changes made in the final legislation is posted here on the Legislature’s website.)   Governor Corzine is expected to sign the Act into law before he leaves office next week.

Among other changes, the final legislation:

• revises the definition of “debilitating medical condition” to specify that severe or chronic pain, severe nausea or vomiting, and cachexia or wasting syndrome qualify a patient to use medical marijuana if they are symptoms of cancer, HIV/AIDS, “or the treatment thereof.” The new definition also adds inflammatory bowel disease, including Crohn’s disease, muscular dystrophy, and terminal illnesses expected to cause death in 12 months or less to the list of debilitating conditions;

• deletes the Assembly provision that allowed patients to designate an individual to transport marijuana to them in an emergency, and reverts to the Senate language allowing patients to designate a primary caregiver to assist them with their use of medical marijuana on an ongoing basis; and

• preserves the Assembly version’s requirement that patients obtain their marijuana from “medical marijuana alternative treatment centers,” i.e., that they not be allowed to grow their own, but increases the amount of marijuana that patients can be dispensed in a 30-day period from one ounce to two ounces.

Interestingly, the final legislation also requires that the system the Division of Consumer Affairs in the Department of Law and Public Safety establishes to monitor the dispensation of marijuana for medical use must “serve the same purpose as, and be cross-referenced with” the Division’s system for monitoring the dispensation of certain prescription drugs with the potential for abuse.  This is further evidence that marijuana is slowly but surely, as Fordham Law Professor Kimani Paul-Emile writes, “migrating from the criminal regulatory regime into the public health regulatory regime.”

New Jersey Medical Marijuana Legislation Update: Poised to Pass?

Supporters are hopeful that before Governor-Elect Chris Christie takes office next month, the New Jersey legislature will pass — and current Governor Jon Corzine will sign — medical marijuana legislation.  In February 2009, the “New Jersey Compassionate Use Medical Marijuana Act,” which would allow patients suffering from “debilitating medical conditions” to treat their symptoms with marijuana without fear of state criminal reprisals, passed the state Senate.

In June 2009, Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy issued a position paper calling on the full legislature to pass the Act, arguing that it would “allow New Jersey residents with debilitating medical conditions access to marijuana to ease their suffering without creating an undue risk of abuse or diversion.”  Soon thereafter, the Act cleared the Assembly Health, Human Services and Senior Citizens Committee, albeit with a number of amendments, including several bolstering the Act’s already strict safeguards against abuse and diversion.  (For a detailed summary of the differences between the Senate and Assembly versions of the Act, see below.)

According to an article in the New Jersey Law Journal, a legislative aide “says they are trying to get the [Act] posted for a floor vote on Dec. 7, Jan. 7 or Jan. 11, the remaining voting sessions in the current term.  The Assembly is expected to pass it.”  Due to the amendments added by the Assembly Committee, the Senate would need to pass the Act again before it would reach the Governor’s desk.  Even if the Act is not passed during the current lame-duck session, however, there is hope for its passage in sessions to come. Governor-Elect Christie has indicated that, with sufficient restrictions in place, “he would be supportive of such legislation.”

Summary of Differences between Assembly and Senate Versions

Change to definition of “bona fide physician-patient relationship.”

The Senate’s version of the Act (S119) requires that patients who wish to use medical marijuana obtain a “written certification” from a physician with whom they have a “bona fide physician-patient relationship.”  Such a relationship is said to exist whenever a physician has completed a full assessment, including a physical examination, of a patient.  The Assembly’s version (A804) includes a significantly narrower definition, providing that only the physician with “ongoing primary responsibility” for treating a patient’s “debilitating medical condition” can approve that patient to use marijuana.  Such a physician must be “board-certified, if available” in the specialty appropriate for caring for the condition which qualifies the patient to use marijuana.

Changes to list of eligible “debilitating medical conditions.”

• Whereas S119 would have granted eligibility for marijuana to patients suffering from “severe and persistent muscle spasms, including, but not limited to, those characteristic of multiple sclerosis or Crohn’s disease,” A804 limits eligibility to those with “intractable skeletal muscular spasticity,” which would, it would seem, include some patients with multiple sclerosis, but exclude those with Crohn’s disease.
• Whereas S119 made all patients with cachexia or wasting syndrome, severe nausea, or severe or chronic pain eligible, under A804 patients with those conditions are only eligible if their symptoms are the result of AIDS or cancer. Concomitantly, neither AIDS nor non-terminal cancer render a patient eligible unless they cause cachexia or wasting syndrome, severe nausea, or severe or chronic pain.
• A804 adds to the list of those eligible for marijuana, patients suffering from amyotrophic lateral sclerosis and multiple sclerosis. Patients with cancer that is “terminal” and glaucoma that is “resistant to conventional therapy” are also eligible; under S119 all cancer and glaucoma patients were eligible.
• Notably, both versions include a provision allowing for additional medical conditions to be added by regulation.

Changes to rules governing “medical marijuana alternative treatment centers.”

Under A804, eligible patients will no longer be permitted to grow marijuana.  The statute’s protection will only apply to patients who obtain marijuana from New Jersey Department of Health and Senior Services-approved “medical marijuana alternative treatment centers.”  A804 adds as a requirement of approval that such centers be operated on a nonprofit basis.  They do not have to be recognized as such by the IRS but they do need to comply with all state nonprofit laws.  Perhaps in an effort to mitigate hardship that might arise as a result of these, more restrictive, provisions, A804 exhorts DHSS to “seek to ensure the availability of alternative treatment centers throughout the State, including, to the maximum extent practicable, at least two each in the northern, central, and southern regions of the State.”

Other potentially-significant changes.

• Unlike S119, A804 does not protect patients and others from arrest or prosecution; its protection is limited to waiver of applicable “civil or administrative penalties.”
• A804 also eliminates protection for caregivers who assist patients with medical marijuana use. Instead, it provides that “[t]he commissioner shall adopt regulations to: (1) provide for the use by a registered qualifying patient of a designated individual in an emergency situation to transport marijuana to the patient who is otherwise unable to obtain marijuana from an alternative treatment center[.]“

Position Paper In Support of the “New Jersey Compassionate Use Medical Marijuana Act”

[Ed. note: mpp.org: "On February 23, the New Jersey Senate voted 22-16 to pass S119, also known as the New Jersey Compassionate Use Medical Marijuana Act. The Assembly health committee voted 8-1 to pass an amended version of the bill on June 4. It must now pass the full Assembly [If the amended bill clears the Assembly, it would return to the Senate for a second vote because of the changes] before it goes to Gov. Jon Corzine (D), who has said that he will sign the bill if it makes it to his desk.”]

Seton Hall University School of Law

Center for Health & Pharmaceutical Law & Policy

Statement In Support of the “New Jersey Compassionate Use Medical Marijuana Act”

The Center for Health & Pharmaceutical Law & Policy supports the passage of the New Jersey Compassionate Use Medical Marijuana Act (the “Act”) because the legislation has been carefully drafted to allow New Jersey residents with debilitating medical conditions access to marijuana to ease their suffering without creating an undue risk of abuse or diversion.

• Medical Evidence. Available medical evidence supports the use of marijuana to treat each of the debilitating medical conditions set forth in the Act: AIDS/HIV; cachexia (wasting syndrome); cancer; glaucoma; severe and persistent muscle spasms; severe nausea; severe or chronic pain; and seizures.
• Need for Access to Marijuana Despite Availability of Cesamet and Marinol Pills. While smoking carries with it certain health risks, smoked marijuana has meaningful advantages over the Cesamet and Marinol pills, which contain synthetic compounds that mimic marijuana’s primary active ingredient. Smoked marijuana is faster-acting, allows for more reliable dosing, and has fewer psychoactive side effects than the pills. In addition, smoked marijuana can be the only option for patients who can not swallow pills due to severe nausea and vomiting as a result, for example, of treatment for cancer.
• Abuse and Diversion. No state that has passed a medical marijuana law has subsequently experienced an increase in recreational marijuana use among its children and youth. The Act’s multiple safeguards against abuse and diversion of medical marijuana provide further reassurance. If passed, the Act would be among the most restrictive of all the states’ medical marijuana laws.

Below please find a brief position paper setting forth the medical evidence and policy arguments in support of the Act.

Seton Hall University School of Law

Center for Health & Pharmaceutical Law & Policy

Position Paper In Support of the “New Jersey Compassionate Use Medical Marijuana Act”

Medical Evidence

Medical evidence supports the use of marijuana to relieve symptoms or ameliorate the side effects of primary treatments of each of the debilitating medical conditions set forth in the Act: AIDS/HIV; cachexia (wasting syndrome); cancer; glaucoma; severe and persistent muscle spasms; severe nausea; severe or chronic pain; and seizures.  While conventional treatments are available for some of these conditions for some patients, smoked marijuana has the potential to help those individuals who do not benefit from, or can not tolerate, currently available therapies.[1]

AIDS/HIV and Cachexia (Wasting Syndrome)

Marijuana is an effective treatment for cachexia, also known as wasting syndrome, an involuntary loss of appetite and weight linked to disease progression and death in patients with AIDS/HIV.  The American College of Physicians has concluded that abundant support exists for the use of the cannabinoid delta-9-tetrahydrocannabinol (”THC”), one of the primary active ingredients in marijuana, as an appetite stimulant.[2] The FDA concurs, as evidenced by its approval of Marinol, a pill containing a synthetic version of THC, to treat “anorexia associated with weight loss in patients with AIDS.”[3]

Marijuana is also an effective treatment for AIDS/HIV-associated sensory neuropathy, a condition characterized by excruciating pain in the nerve endings that afflicts over a third of patients with AIDS/HIV.[4] In the past two years, three placebo-controlled, randomized, double-blind clinical trials published in the medical literature have demonstrated Read more