An Insite-ful Decision

Canadian Supreme Court clears the way for Vancouver’s safe-injection facility.

Insite, the controversial supervised injection site for addicts in Vancouver, has won its case before the Supreme Court of Canada for a permanent exemption from the nation's drug laws. CBC News reports that, in a unanimous decision, “The court ordered the federal minister of health to grant an immediate exemption to allow Insite to operate.”

Written by chief justice Beverley McLachlin, the ruling said in part: "Insite saves lives. Its benefits have been proven. There has been no discernable negative impact on the public safety and health objectives of Canada during its eight years of operation." A member of Parliament told the CBD: "The Conservative government has been relentless in their opposition so today's decision by the court just feels like an incredible victory. It feels like a great day."

The Supreme Court of Canada was forced to determine the fate of Insite, where addicts use clean needles with a nurse on the premises, after numerous governmental attempts to shutter the facility led to lawsuits. Numerous studies have demonstrated the benefits of such programs, but Insite remains the only long-term injection facility in North America. The eight-year old clinic has increasingly won both professional and popular support as a workable method of harm reduction in high-risk drug areas. As the Vancouver Sun sensibly notes: “It is increasingly mainstream thinking in Canadian health care as reflected by other interveners in the Supreme Court case--Canadian Nurses Association, Association of Registered Nurses of British Columbia, Registered Nurses Association of Ontario, Canadian Medical Association, and Canadian Public Health Association.” You can’t get much more mainstream than that. 

As The Fix recently reported, Insite has reduced drug overdose deaths by 35% in its notorious Downtown Eastside headquarters in a neighborhood housing the highest population of needle addicts in Canada. A recent study found  that drug overdoses do occur at Insite—but among its recorded 2,000 ODs, there has not been a single fatality (doctors are on hand with a ready supply of the anti-OD drug Naloxone). Injection centers offer other public health benefits, including steering addicts into treatment and reducing hepatitis C and HIV infections. Opposition in the U.S. has centered on the notion that safe injection facilities will encourage the use of injectable narcotics by somehow sanctioning the activity.

The Globe and Mail editorialized that when the Supreme Court of Canada convened in May to take evidence on Vancouver’s supervised injection site, it heard “detailed arguments that hinge on the fine print of the Canadian Constitution. But besides being a landmark showdown between federal and provincial powers, the hearing also sets the stage for a ruling expected to affect not only the daily lives of injection drug users on Vancouver’s Downtown Eastside but drug policy across the country and potentially farther afield.”

This was a big one, a verdict much awaited, because it will be widely seen as playing a crucial role in determining whether facilities like Insite will be allowed to operate in North America. Technically, a court ruling against Insite would not have automatically put the operation out of business, but would have left it in the twilight zone of operating under a federal government exemption that could be pulled at any time—and the current Canadian government has broadly hinted that it would do so.

The Supreme Court victory means that Insite can operate without benefit of any kind of federal government legal exemption from drug laws, a situation that has always put Insite at the mercy of political posturing.

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FDA Reports Critical Drug Shortages

Delays put EMTs on alert for dextrose, naloxone, epinephrine.

It’s the kind of thing most people take for granted: You’re suddenly taken seriously ill—a heart attack, dehydration, asthma, shock, perhaps even a heroin overdose—and in the ambulance or the emergency room, medical professionals immediately go to work, using the right drugs and medications for the job.

Imagine lying in the back of an ambulance, in cardiac arrest, or experiencing an episode of acute schizophrenia, or turning blue from a heroin OD—and the EMTs and nurses and other medical staff have only a precariously minimal supply of what you need. You might expect such a thing in wartime, or in parts of the developing world.  But drug shortages already plague health care, and may worsen as drug suppliers run the risk of cutting back production too aggressively on vital drugs used in emergency medical procedures.

At present, according to the Food and Drug Administration (FDA), shortages exist for the following drugs, among others:

Injectable Dextrose 50%: unanticipated increased demand. Full recovery by mid-September. Used in IV solutions.

Injectable ephedrine: manufacturing delays, increased demand. Full recovery by late August. Used as a brochodilator.

Injectable epinephrine: Unanticipated increased demand. Recovery by late September. Used in the treatment of cardiac arrest, shock and anaphylaxis.

Injectable haloperidol decanoate: On back order from major suppliers, estimated recovery by November.  Used for schizophrenia.

Injectable naloxone: manufacturing delays. Recovery by mid-September. Used for heroin overdose.

Writing for the New England Journal of Medicine online, Valerie Jensen and Bob A. Rappaport demonstrate that shortages of certain drugs in sterile injectable form have been increasing. Data from the Drug Shortage Program at the FDA show that, while 35% of the drugs experiencing supply shortages in 2008 were sterile injectables, that number rose to 46% in 2009.  “Reduction in the supply of these drugs can have dramatic effects on medical practice,” they write, “ultimately keeping patients from receiving the level of care they deserve and have come to expect.”

How do these shortages happen? For perspective, the authors lay out the case history of the injectable drug propofol, a fast-acting sedative commonly used to induce and maintain sedation or anesthesia. In 2009, three pharmaceutical manufacturers serviced the market for propofol—Hospira, Teva, and APP. In October of 2009, Hospira recalled “multiple batches of its propofol owing to the presence of particulate matter in the vials.” A few weeks later, Teva issued a recall on several lots of propofol due to “possible microbial contamination.” In June of 2010, Hospira had still not returned to the market, and Teva had chosen to exit the market for good. That left a single company as sole supplier of propofol for the entire U.S.—“an unrealistic expectation, given anesthesiologists’ reliance on the drug.”

Drug shortages can occur in other ways. Producers often abandon older drugs for newer, higher margin offerings. Free market policies can and do lead to supply shortages, particularly in the case of complex injectable products with long manufacturing lead times. Such drugs are most efficiently manufactured in amounts that leave little excess supply in inventory channels. As a result, “a sudden change in either the supply of or the demand for the drug can have catastrophic clinical consequences,” the authors write.

The FDA, say the authors, “cannot require a company to start or to continue manufacturing a drug or dictate how much of a drug must be manufactured…” The free market paradox is always part of medicine: competition drives down the price of drugs, making them more affordable and accessible to patients. But if prices go too low, manufacturers may choose to stop producing a given drug, thereby limiting competition and making the drug vulnerable to supply shortages.

However, the FDA does have the authority to temporarily allow the importation of drugs certified to be of similar formulation and quality, if there is a serious shortage. In the case of propofol, the FDA allowed the importation of a similar but unapproved drug, Fresenius Propoven 1%, which is used in other countries.

Shortages of sterile injectable drugs like propofol create special hazards. For example, they are commonly used in ambulances and emergency rooms for treating shock and heart attack. We are not talking about a shortage of cotton swabs here. In addition, the FDA warns of numerous adverse effects resulting from “multiple entries into single-use vials of the drug,” a common method of dealing with shortages. The authors cite a case in a Nevada endoscopy clinic, where the practice of obtaining multiple doses from a single-dose vial “led to an outbreak of hepatitis C infection, and approximately 40,000 patients were advised to be tested for potential infection of hepatitis B, hepatitis C, and HIV.”

Jensen, V., & Rappaport, B. (2010). The Reality of Drug Shortages -- The Case of the Injectable Agent Propofol New England Journal of Medicine DOI: 10.1056/NEJMp1005849

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White House Pushes Cautiously Forward on Needle Exchange

Clean syringes become part of federal AIDS strategy.

As most people know, addicts who inject drugs have played a major role in the HIV epidemic. In the U.S. alone, there are an estimated one million “injection drug users,” as the government calls them. They are linked to almost 20% of new HIV infections each year. (Roughly 56,000 new HIV infections occur in the United States annually, according to CDC estimates.)

And in black and white, on page 16 of the July 2010 position paper titled “National HIV/AIDS Strategy for the United States”, the White House made it official. In a list of “proven biomedical and behavioral approaches that reduce the probability of HIV transmission,” the report has this to say:

 “Among injection drug users, sharing needles and other drug paraphernalia increases the risk of HIV infection. Several studies have found that providing sterilized equipment to injection drug users substantially reduces risk of HIV infection, increases the probability that they will initiate drug treatment, and does not increase drug use.”

That relatively mild statement represents a bold departure from the AIDS/HIV policies of previous administrations--when such policies existed at all. The White House has bolstered its contention with citations:

Latkin, C, Davey, M, and Hua, W. Needle Exchange Program Utilization and Entry into Drug User Treatment: Is There a Long- Term Connection in Baltimore, Maryland? Subst Use Misuse, 41(14):1991-2001.

Vlahov D, Junge B. The role of needle exchange programs in HIV prevention. Public Health Rep. 1998;113 (Suppl 1):75-80.

Put simply, clean needles save lives. Needle exchange programs put more addicts in contact with social services, thereby easing their entry into drug treatment programs.

“Comprehensive, evidence-based drug prevention and treatment strategies have contributed to reducing HIV infections,” the report states. “In 1993, injection drug users comprised 31 percent of AIDS cases nationally compared to 17 percent by 2007. Studies show that comprehensive prevention and drug treatment programs, including needle exchange, have dramatically cut the number of new HIV infections among people who inject drugs by 80 percent since the mid-1990s.”

By the end of this year, the report pledges, “Centers for Disease Control and Prevention (CDC)  and the  Substance Abuse and Mental Health Services Administration (SAMHSA) will complete guidance for evidence-based comprehensive prevention, including syringe exchange and drug treatment programs, for injection drug users.”

One question not answered in the White House document—how to pay for new treatment initiatives of this kind.

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