As the world’s largest professional society concerned with the causes and treatment of blood disorders, many of our more than 16,000 members are on the front lines of dealing with the country’s severe shortage of methotrexate, a drug critical in the treatment of children with acute lymphocytic leukemia (ALL).

The Food and Drug Administration (FDA) reported that two manufacturers plan additional releases within the week of February 20th, at the end of February, and continuing into March, which it anticipates will meet all patient needs.

While the Society is pleased with this announcement, we realize the shortage is still critical at many sites throughout the country and urge the FDA to ensure that once supplies are available, hematologists can have information on how to access this therapy for their critically ill patients.

ASH has been working hard to address the shortage, including reporting shortages to the FDA and Congress and urging the FDA to take immediate action to identify other manufacturers to meet demand, import supplies from overseas, and establish an emergency supply once there is a release so that supplies can be easily accessed.

Over the past year the Society has led collaborative efforts with the FDA, Congress, and senior health officials in the Administration to resolve not only this shortage, but also shortages of more than 200 other drugs, many of which are used to treat patients with hematologic diseases, that have become critical and life-threatening.

This week the Society sent a letter of support to Representatives Larry Buscon (D-IN) and John Carney (D-DE) who introduced bipartisan legislation (H.R. 3839, the Drug Shortage Prevention Act) that would provide expedite FDA review of drugs in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration (DEA) quotas for medications in short supply.

The Society is also submitting comments this week to the FDA concerning its Interim Final Rule, issued in response to the President’s Executive Order of Oct. 31, 2011, to enable the FDA to improve its collection and distribution of drug shortage information.

The steps the Society has taken over the past year have had impact. Following the introduction of bills in the House and Senate last year (S. 296/H.R.2245, the Preserving Access to Life-Saving Medications Act) mandating early notification by manufacturers of drugs in short supply, ASH was the first medical society to call on Congress to conduct hearings and has made recommendations on ways to prevent and mitigate drug shortages that are being incorporated into legislative and regulatory proposals.

ASH will continue to monitor all hematologic drug shortages closely and will continue to work with policy makers to protect the health of Americans.

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The U.S. federal government ruled last week that marijuana has no accepted medical use, despite the growing body of evidence suggesting otherwise. Proponents of medical marijuana have advocated for nine years that the drug be declassified. Instead, the D.E.A. decided to leave marijuana in the same class as heroin, classifying marijuana as a “highly dangerous drug.”

This is the third time that the federal government has rejected appeals to reclassify marijuana. The first was filed in 1972 and denied 17 years later. The second was filed in 1995 and denied in 2001. Both decisions were appealed, but the courts sided with the federal government.

Worldwide research has suggested that marijuana has a number of medical uses, including treating devastating diseases like multiple sclerosis. Research has suggested that marijuana also helps ease symptoms of chemotherapy. Advocates for marijuana were critical of the ruling. However, they were pleased that the Obama administration has finally acted, allowing them to appeal to the federal courts.

The FDA’s decision came less than two months after advocates asked the U.S. Court of Appeals to force the administration to respond to their petition.”We have foiled the government’s strategy of delay, and we can now go head-to-head on the merits,” said Joe Elford, the chief counsel for Americans for Safe Access and the lead attorney on the lawsuit.

Elford and other proponents were not surprised by the decision. “It is clearly motivated by a political decision that is anti-marijuana,” he said.

In a June 21 letter to the organizations that filed the petition, DEA Administrator Michele M. Leonhart said she rejected the request because marijuana “has a high potential for abuse,” “has no currently accepted medical use in treatment in the United States” and “lacks accepted safety for use under medical supervision.” The letter and 37 pages of supporting documents were published Friday in the Federal Register.

The Coalition for Rescheduling Cannabis filed its petition in October 2002. In 2004, the DEA asked the Department of Health and Human Services to review the science. The department recommended in 2006 that marijuana remain classified as a dangerous drug. Four and a half years then elapsed before the current administration issued a final denial.

“The regulatory process is just a time-consuming one that usually takes years to go through,” said Barbara Carreno, a spokeswoman for the Drug Enforcement Administration.

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A well-known Miami-Dade criminal lawyer and former mayor was sentenced to 40 months in jail on March 3 after he pleaded guilty to using his illegal Internet pharmacy site to sell tens of millions of dollars worth of pharmaceutical drugs to individuals without prescriptions throughout the United States.

Robert Smoley, 59, is the owner of the online pharmacy United Mail Pharmacy Services.  He admitted that his medical distributions were outside the scope of professional medical practice and without legitimate medical purpose.  This was no revelation, it could easily be assumed that the lawyer/mayor had no place in the realm of medical practice.  He and others (doctors who apparently cared little about the possibly of losing their license) distributed approximately $48 million worth of drugs.  This included selling over seven million pills through more than 17 online pharmacy sites.  He established an elaborate distribution network based out of a warehouse in Florida.  He used call centers in Costa Rica and the Dominican Republic to take orders for United States-based individuals.

“The Smoley drug trafficking organization fed the habits of drug seekers while its members chose profits over the health and well-being of those customers,” DEA special agent Anthony Williams said.

Smoley took online orders from “customers” who filled out forms.  Smoley made no effort to check the accuracy of any of the information on the forms.  These order forms were given to a group of doctors who would do rubber-stamp approval of the orders and fill them.  Smoley encouraged his network of doctors to review as many orders as possible.  These doctors would approve upwards of 500 orders per day making between $2 and $5 per order.  The doctors never conducted any physical exams on these “patients” nor saw any medical paperwork.  Smoley admitted he was well aware of this.

The one-time mayor was caught in early 2008 when he ordered more than half a million drugs from an undercover DEA agent.  He has been under investigation by federal agents in California since then.  He pleaded guilty in November 2008 before a federal judge in San Francisco to conspiracy to distribute schedule III and IV controlled substances, which includes narcotic medicines, and conspiracy to launder money.

Miami lawyer Richard Sharpstein represented Smoley in March before United States District Court Judge Jeffrey White.

Sharpstein said his client opened his Internet pharmacy fully believing it was legal.  (Really?  A lawyer running a pharmacy to dole out mass numbers of prescription medicines to unknown buyers with little documentation was legal at one time?)  “Unfortunately for him, over the past five years, the government has reversed its position and he was caught in the web.”

The Smoley investigation led to the dismantling of more than five Internet pharmacies that illegally distributed more than 80 million doses of medicine.  Law enforcement agents seized more than $40 million in cash and assets, including high value homes and luxury vehicles.  Smoley was left with nothing but his not-so-luxurious jail cell.

Smoley will have ample time in jail to think about how he put the health and welfare of so many Americans at risk.  Now, what about the doctors who were reviewing all of these prescription orders without knowing a drop about any of the “patients?”  Will they be exposed, caught, charged and sentenced?  This is unknown.  It can only be hoped, however, that these immoral doctors are not spread widely throughout the U.S. practicing their special brand of medicine on patients that are none the wiser.

There were 27 individuals convicted on federal criminal charges along with Smoley.  There is no word about whether these were in fact the doctors or if it was the call center and warehouse workers.

Should Smoley be considered a criminal lawyer (a possibly redundant title) or a lawyer criminal who was caught breaking the law.  Either way, we’ll see you in 40 months, Smoley, with hopefully a new and improved set of morals.

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