U.S. Food and Drug Administration • Center for Drug Evaluation
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U.S. Food and Drug Administration • Center for Drug Evaluation
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CDER News Along the Pike
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By Jackie Barber
A total of 80 individuals and 49 groups from the Center received honors at ceremonies held by CDER and FDA in May.
At the Center's Spring Honor Awards ceremony May 31 in Gaithersburg, 76 individuals and 29 groups were recognized. The number included 25 Commissioned Corps officers who responded to the Sept. 11 terrorist attack or the anthrax crisis.
At the FDA ceremony held the same day in Rockville, four Center employees and 10 groups with CDER representatives were recognized.
At CDER's patriotically themed ceremony, Center Director Janet Woodcock, M.D., along with senior management presented the awards. The Montgomery County Police Color Guard presented the colors, and Kevin Barber sang the national anthem.
"Many of you provided support to the rescue and recovery efforts in New York City and at the Pentagon, while others worked diligently to strengthen our counterterrorism program," Dr. Woodcock said. "The heightened risk of such an attack has brought out the best in us as a nation and in CDER as a public health organization."
Rita Thompson, the director of the Division of Management Services in the Office of Management, introduced each award. Office directors provided an explanation of individual achievements, and Thompson read the citations for the group and team achievements.
Jackie Barber is the Center's incentive awards officer.
On Aug. 21, FDA announced a significant new initiative to enhance the regulation of pharmaceutical manufacturing and product quality and to bring a 21st century focus to this FDA responsibility.
The initiative, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, focuses on FDA's current good manufacturing practice program and will cover veterinary and human drugs, including human biological drug products such as vaccines.
"Americans expect that their medicines will be of the highest quality, and assuring that quality is one of FDA's core missions," said FDA Deputy Commissioner Lester M. Crawford, DVM, Ph.D. "FDA's regulatory and quality control systems for pharmaceutical products have become a gold standard for the world, and we Americans should be proud that the quality of the medicines we have available to us and our animals is second to none.
"Any system can be improved upon, however; and, with this risk-based, highly integrative cGMP initiative we intend to do just that. We know we can make even a very good system better."
More than 40 years ago, Congress instructed FDA to require that all drugs be produced according to current good manufacturing practice. This requirement came in response to significant concerns about substandard drug manufacturing practices at that time, and it brought modern quality assurance and control principles to drug manufacturing.
In a memorandum to FDA employees, Dr. Crawford noted that the last comprehensive revision to the regulations are nearly a quarter of a century old. "Now, as we approach the 25th anniversary of the last major revisions to the drug cGMP regulations, it is time to step back and evaluate the currency of both the cGMP program and the pre-market review of chemistry and manufacturing issues," Dr. Crawford said.
"The initiative announced today is intended to build on the many successes of these two programs and help them continue to be successful in the future by keeping pace with advances in pharmaceutical science and manufacturing technologies."
The major goals of the initiative are to make sure that:
FDA cannot accomplish these goals alone. Given the global nature of pharmaceutical production, FDA will work in close concert and consultation with its regulatory counterparts internationally.
The success of this initiative will be strongly dependent on active participation and input from manufacturing quality control experts from industry, academia, government and consumer groups.
CDER is the lead center for the initiative. A steering committee overseeing the effort includes representatives from the Office of Regulatory Affairs, CDER, the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine and the Office of the Commissioner.
A concept paper published by the steering committee outlines five principles that will guide implementation of the reappraisal:
The Center's representatives on the steering committee are:
Project manager for the steering committee is Maureen Hess in the Office of Executive Programs.
FDA released four documents about the initiative on its Web site. The documents and their locations are:
By Karen Zawalick
The Committee for Advanced Scientific Education kicks off the fall semester with the State of the Center address and a rousing game of CDER Jeopardy.
Janet Woodcock, M.D., and Steven Galson, M.D., the Center's director and deputy director, will give the annual talk, restricted to an internal audience, in the auditorium at the University of Maryland Shady Grove campus, Sept. 4, 1:30 p.m. to 3:30 p.m. Light refreshments are planned prior to the presentation. Continuing education credit will not be offered.
Sept. 18, we welcome David Slavin, M.D., head of risk technology at Pfizer who will speak on the tolerability of risk and quantitative risk analysis. Watch office directors and review staff match wits at CDER Jeopardy Sept. 25, 1:30 p.m. to 3:30 p.m., in Parklawn Conference Rooms D and E.
Watch the weekly calendar of events for upcoming programs.
Karen Zawalick is an educational specialist in DTD and CASE executive secretary.
By Jim Morrison
On the heels of every rash of overblown promises by companies or individuals touting panaceas for the world's ills, comes the day of reckoning. In the day of reckoning for promising drugs comes the epiphany that FDA thinks they don't work-or at least haven't been shown to work. The day of reckoning is soon followed by the day of deflection and the conspiracy theory.
Now, I'm not thinking of any specific case, because there are more than enough examples in the media. It has become commonplace for the beleaguered company, whose stock price rocketed on whispered results of testing for a new drug that would cure cancer, stroke or hangnails, to blame FDA when it all falls apart.
The Web chat rooms are then soon filled with speculation about how big competitors and FDA conspired to block the drug. When the conspiracy theorists get really going, they may include the AMA in the cabal, since if all diseases were cured, doctors would be out of business. Sometimes the conspiracy is given credence by the news media, usually through less than thorough fact gathering.
Face it-we all believe what we want to or are conditioned to believe. We need our heroes and we need our villains. Heroes should be individuals acting in the face of insurmountable odds. Villains should be powerful people or organizations over which the public has virtually no control. That is where FDA comes in. If you are sick, it is more comforting to think that a cure for your illness is out there. It is just FDA that stands in the way of your survival. That leaves the door open for individuals to fight FDA and its co-conspirators, to get the drug released and the patient cured. That allows the helpless to take hope and to take action. It is not comforting to find that the company or people pushing the drug company stock lied, that there isn't any cure and that the patient will die (or that the investors were scammed out of their money).
FDA gets blamed either way. If we approve a drug that is later found to have unexpected side effects, we are criticized as being too fast and sloppy, in the hip pocket of industry or worse. If we fail to approve a drug, we are accused of being overly bureaucratic, stupid and causing the financial markets to collapse.
We in FDA should accept as inevitable that our organization and we as individuals will occasionally be painted as villains. It's the price we pay for taking action in the arena of public health. But it is necessary for all of us to be careful about what we say and to whom.
Further, if we see a drug that is yet to be approved but is being promoted by the sponsoring company far beyond its therapeutic value, we should convey that information to CDER's liaison with the Securities and Exchange Commission-Debbie Henderson, director of the Office of Executive Programs. The SEC has the authority to take action if the promotion is coming from the company and if the company has not truthfully informed stockholders. We should also alert DDMAC, because, if the promotion is coming from the company, it may be illegal.
Patients, patients' families, investors, stock analysts and reporters should do their homework and not believe pie-in-the-sky promises of a breakthrough drug that is just around the corner if only FDA would get out of the way. True breakthroughs do happen. Unfortunately, they happen far less often than people hope for. When they do occur, FDA is usually willing and able to speed them through the review process. Everyone should recognize that FDA cannot legally disclose information about pending applications.
What are purported by rumor mills to be leaks from FDA almost always come from within the company, the researchers or elsewhere. If anyone has substantial evidence of an FDA employee leaking information, report it to the FDA's Office of Internal Affairs (7-0243). It is a crime, punishable by dismissal and perhaps prison for FDA staff to leak such information. Conspiracy to break the law is a crime, and, fortunately, is also one rarely committed by FDA employees.
Jim Morrison is the Center's ombudsman.
By Ron Wilson
CDER along with other FDA representatives conducted one-on-one sessions with attendees of the fourth annual National Institutes of Health's Small Business Innovation Research Conference in June.
The conference supports NIH's Small Business Innovation Research Program, a competitive, three-phase system that provides qualified small businesses with opportunities to propose innovative ideas that meet the specific research and development needs of the federal government. The most worthwhile ideas receive NIH development grants.
The program was established by the Small Business Research And Development Act of 1992. Under this law, federal agencies are required to reserve 2.5 percent of their extramural budgets for small businesses to conduct research and development. A small business is one with fewer than 500 employees.
With the growth of the NIH budget, small businesses are showing an increased interest in the program. This year, for example, there is almost $500 million reserved by NIH for the small business grant program. Because FDA's extramural budget is much smaller, funds for the Agency's program are more limited. This fiscal year, FDA had $580,000 available for grants.
Many businesses that attend the annual NIH conference are small pharmaceutical firms, and the products that emerge from the NIH funds have to obtain FDA's approval. NIH invites us to attend the meeting and conduct one-on-one sessions with the attendees.
This is an important opportunity to provide guidance to small businesses at an early stage of their planning and research. More than 800 people attend the conference each year, and many require guidance. The one-on-one sessions with FDA representatives are quite busy.
OTCOM's Ron Wilson heads the Center's Small Business Assistance Program and assisted with the one-on-one sessions.
By Don Duggan
If you use a CDER computer on the road or from home, you will soon be using a different but more secure system to access the Center's internal network.
Background: In 1999, Congress mandated that all HHS provide a secure means by which government employees could remotely access internal information resources by the close of calendar year 2002. FDA's Office of Information Resources Management assembled a team of engineers, contractors and center representatives to discuss and evaluate technology available to achieve the task.
In 2000, the working groups completed the task of procuring hardware and software necessary to permit secure access as well as installing and testing the new system. Now referred to as Secure Remote Access Service, or SRAS for short, this system will replace the existing dial-up Remote Access Service. The current system will be in use until the end of 2002.
New secure service: The new system uses technology permitting authorized government employees and contractors to connect to internal information resources through conventional analog dial-up.
In brief, a Windows-based application program, Cisco Virtual Private Network, will be installed on your government-owned computer. This program is responsible for encryption (scrambling) and decryption (unscrambling) of the information being transmitted over public telephone lines. Finally, in order to add additional security, you will have an electronic token and personal identification number to synchronize a unique password that changes each time you log into the CDER network.
Analog dial-up: The conventional dial-up connection over analog telephone lines is the most common type of connection used by CDER employees. Plans to incorporate DSL and cable modem connections will be addressed at a later date. Dial-up uses the software application Cisco VPN described above. You will be required to schedule a service date with OIT for SRAS installation and instruction. We foresee the rollout to CDER beginning in mid-September. The new Secure Remote Access Service is different from what you are used to, but it is far more secure than the conventional non-secure system being phased out.
By Scott E. Zeiss
A one-stop intranet site now exists for FDA's records management policies and procedures. Sections on the site include:
Electronic forms are available in PDF format for transferring records to the Federal Records Center. There are links to various records management standards, guidances and training courses. Recent additions to the site include FAQs on general records management and e-mail messages as records. More operational tools will be added in the future.
The site can be accessed through the OITWeb at http://oitweb. Click on Policy on the main page. On the next page, under FDA Policy click on FDA's Records Management Site. The direct link is http://intranet.fda.gov/oirm/records/.
If you have questions about FDA's or CDER's records management policies and procedures, contact me (ZEISSS).
By Tim Mahoney
The Electronic Document Room is receiving hundreds of electronic submissions a month. What do you do when you get that e-mail stating that the submission is available for your review in the Electronic Document Room?
If you have the necessary skills to use Adobe Acrobat, Microsoft Office, Windows and statistical applications like JMP, you get to work using the advantages of electronic submissions over paper-based documents. If you have these skills, you can quickly and efficiently use electronic tools to navigate, annotate, search, and copy and paste text, tables and graphics from an electronic submission. If you have not developed that skill set, you need training.
OIT offers NDA Electronic Submissions Training, NDA Electronic Data Analysis Training and Introduction to JMP classes regularly. These classes provide instruction on how to use the electronic tools that make electronic submissions review more efficient than paper review. The Training section of the OITWeb (http://oitweb) offers class descriptions, calendars and online registration for these courses for CDER reviewers.
But what can you do if you just got the e-mail and the next class is a few weeks away? There is no reason to wait. Contact Lana Kostecka (KOSTECKAL) or me (MAHONEYT) to set up Just-in-Time training classes for your review team. These classes are highly successful in delivering the necessary tools to review staff at the necessary time and are customized to your individual group's needs.
But don't take our word for it. Read the comments below from reviewers who have attended the courses.
The authors work in the Office of Information Technology: Don Duggan in the Division of Infrastructure Management and Services; Scott E. Zeiss in the Division of Data Management and Services; and Tim Mahoney on the Technology Support Services Staff.
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12 Access Intro and Tables (C) 9:00-12:00Access Queries (C) 1:00-4:00 |
13 Access Form Design (C) 9:00-12:00Access Report Design (C) 1:00-4:00 |
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By Patrick E. Clarke
The Division of Drug Risk Evaluation, one of the three divisions in the new Office of Drug Safety (Jan.-Feb. Pike), will have more premarket work as a result of the Prescription Drug User Fee Act III, according to Julie Beitz, M.D., the division's director. (See the July Pike for a story on the Division of Mediation Errors and Technical Support.)
"PDUFA III won't change our mission, but it will cause increased interaction with the review divisions regarding safety data before the drug is marketed. That's a real change, consulting before the drug is marketed," Dr. Beitz said.
"It's a challenge for us to figure out how to get the right people involved in reviews. No one person is a risk management expert."
Providing consultations on drug safety questions is just one of DDRE's activities. The 42-member division conducts epidemiological analyses, detects and assesses drug safety signals, disseminates important drug safety information and helps formulate risk management programs.
The safety evaluators and epidemiologists in the division distribute findings on adverse drug reactions by:
The division's staff comment on the various approaches used to formulate risk management strategies including:
"We're particularly proud of our consult record," Dr. Beitz said. Last year 56 percent of the consults came from the Office of New Drugs, 23 percent from other offices within CDER, the Center for Biologics Evaluation and Research and other government agencies, and 21 percent were self-generated, the percent her division is proudest of.
Self-generated consults are accomplished by reviewing the Adverse Events Reporting System database, literature review and epidemiological studies. DDRE staffers were published more than 20 times in 2001 on a variety of drug-related adverse event subjects. The publications include The New England Journal of Medicine, JAMA, Lancet and Pharmacoepidemiology and Drug Safety.
Division members design, conduct and publish studies using automated medical claims databases. For example, studies conducted under the Cooperative Agreements Program can look at the effect of labeling changes. "We can look in a claims database before and after a major labeling change," Dr. Beitz said. "So, if a drug is marketed and later on liver function tests are recommended for persons taking that drug, we can check and see if testing is being done."
Dr. Beitz anticipates that her group of 23 safety evaluators, 10 epidemiologists, three project managers and other staff members will grow as a result of PDUFA III.
"One priority for us will be the hiring and training of new staff," Dr. Beitz said. "Of course, we hope to do more self-generated reports and publish more."
Dr. Beitz stresses the need for improved communication between her division and review divisions.
"When divisions send us consults, it is critical that they communicate their needs and priorities," she said. "We ask for as much specificity as possible. In fact, we welcome conversations and meetings prior to doing the actual consults to define expectations and the specifics of the data that are needed."
Patrick Clarke is a public affairs specialist in the OTCOM's Division of Public Affairs.
By Sherunda Lister
"Let's roll," seemed to be Betsy Bretz's rallying cry as she led the June 26 open house meeting for CDER employees on the development of FDA's White Oak campus. Bretz is co-chair and one of the consumer representatives on Labquest, a community-based group that acts as a liaison for the parties involved in the consolidation.
Labquest, now in its seventh year, has representatives from the community, FDA, the General Services Administration, and county and state elected officials. About 45 people including Labquest members attended the open house at WOC II. The meeting was a chance for CDER employees to meet the group, get an update on the White Oak construction and ask questions.
The meeting provided updates on funding, legislative, transportation, construction and recreation matters.
Phase I-construction of the laboratory building for CDER and the Center for Devices and Radiological Health-has begun. The lab is expected to be completed and ready for occupancy in 2003.
Phase II-office space for most of CDER-is expected to be completed and ready for occupancy in 2005.
Funding for Phase III of the construction appears forthcoming pending final authorization. Phase III construction includes the CDRH lab building and the completion of the third and fourth floors of the CDER lab building as laboratories. Because CDRH is expected to occupy part of the CDER lab building, the structure is expected to be named the Life Sciences Building.
Labquest addressed issues of concern to most CDER employees like parking and public transportation. The group has worked with Montgomery County to provide busses from the Silver Spring Metro station onto the campus. Portions of New Hampshire Avenue and Powder Mill Road are expected to be widened to help accommodate the additional traffic flow.
On-site parking is still being finalized. The plan calls for several single- and multi-level parking lots to be built on the site but the final ratio of parking spaces to employees is still be negotiated with the appropriate licensing department.
The large deer population on the campus grounds may come as a surprise to many FDA employees. For animal and people safety, Labquest is looking at available options.
When asked about Maryland Sen. Paul Sarbanes' hopes for the consolidated campus, Jeanie Lazerov a field representative for his office responded: "We're looking forward to having a first-class facility for the efficient operation of a world-class agency with world-class scientists and employees."
Within the next few months, Labquest plans to hold a meeting to brief all FDA employees on recent changes to the plans for the consolidated campus.
Sherunda Lister is a public affairs specialist in OTCOM.
By Chris Nguyen
The Faculty Recognition Awards Ceremony for the 2001-2002 academic year was held on May 14 to recognize and honor FDA employees who planned, developed and taught courses to their colleagues. They provided subject matter knowledge, conducted research and developed lesson plans on their own time and without compensation in addition to performing their current jobs. Their efforts support CDER's mission by providing training and orientation to CDER staff.
To say "thank you" to CDER faculty for their hard work, the Division of Training and Development in the Office of Training and Communications holds an annual recognition ceremony. The education and training mission of the Center cannot be fulfilled without their support.
Opening remarks were provided by Nancy D. Smith, Ph.D., OTCOM's director, and .Janice Newcomb, DTD's director. The awards were presented by DTD's project managers.
Read the courses and faculty . . .
Chris Nguyen is a training specialist in DTD.
By Elizabeth Hausner, DVM
The Center's semi-annual retreat for pharmacology/toxicology reviewers included regulatory updates from standing subcommittees of the Pharm/Tox Coordinating Committee, a scientific update on drug-device combinations and an entire afternoon session devoted to pediatric issues during pre-clinical assessment.
These retreats focus on regulatory issues, new technology and integrated education in areas impacting the drug review process. The June 19 retreat was organized and arranged by Fred Alavi, Ph.D., Hanan Ghantous, Ph.D., Pat Harlow, Ph.D., Wafa Harrouk, Ph.D., Elizabeth Hausner, DVM, Tom Papoian, Ph.D., Adele Seifried, M.S., Jui Shah, Ph.D., William Taylor, Ph.D., and Suzanne Thornton, Ph.D.
Dr. Ghantous, the retreat planning committee chair, gave the opening remarks. Dr. Ghantous is from the Division of Anti-Inflammatory, Analgesic and Ophthalmic Drug Products. Supervisors introduced new reviewers. After a team building exercise, Robert Osterberg, Ph.D., the acting deputy associate director for pharmacology/toxicology, gave an update of the current pharm/tox issues. The search for a new associate director is ongoing and hopefully will be completed in a few months.
The pharm/tox group is also trying to be proactive about the projected retirement within the next five years of many senior reviewers. The Education Committee and the associate director are designing multi-faceted programs to mitigate the effects of losing so much historical and institutional memory. Dr. Osterberg also discussed the status of several guidances, MAPPs and the good review practices format.
Read more about the retreat . . .
Elizabeth Hausner is a pharmacologist in the Division of Cardio Renal Drug Products
By Mary Jane Mathews
Last year's anthrax attacks, fears of other biological attacks and the potential for attacks on nuclear facilities or the explosion of radioactive dirty bombs have focused public health concerns on medical countermeasures.
In support of national counterterrorism activities, the Center's laboratories in the Office of Testing and Research conducted studies on two important drugs in the nation's emergency drug stockpile.
These studies, requested by the Center's Office of Counterterrorism and Pediatric Drug Development, evaluated two drugs, doxycycline and potassium iodide, to determine if the stockpiled tablets could be dissolved in common foods or drinks for use by children.
Doxycycline
Because of the unprecedented anthrax-mailing incident last fall, OTR evaluated doxycycline, one of the stockpiled antibiotics that can be used for the post-exposure prevention of anthrax.
Although doxycycline is available and is stockpiled as a suspension, in an emergency, the tablets may be needed for pediatric dosing. OTR began the study in October.
Scientists evaluated the effect of crushing the doxycycline tablets into various foods and drinks. Many questions needed prompt answers, such as:
OTR completed the initial lab work to determine the stability and dosing uniformity of doxycycline in a variety of foods and drinks over the next few weeks.
A subsequent study, done with FDA volunteers, tested palatability of the drug. The results ranked chocolate pudding, chocolate milk, low-fat chocolate milk, and simple syrup with sour apple flavor as the top choices for palatability. The study took less than three months to complete.
The results of the stability and palatability studies were made public on FDA's Web site and shared with CDC and other government agencies responsible for homeland security. The instructions for crushing and mixing the tablets are being finalized for consumer-friendly language. This information will also be posted on our Web site.
Potassium iodide
This spring, OTR began a study on potassium iodide, a drug substance that is used to help protect the thyroid gland after exposure to radioactive iodine.
While the tablets are scored for division into smaller doses for children, they may crumble when split. Also, children and infants will not be able to swallow the bitter tablets.
Mixtures of the tablets dissolved in various foods or drinks needed to be tested so directions could be written for administration to children.
The OTR laboratory in St. Louis tested the stability and dose uniformity of the tablets when mixed with commonly available household foods and drinks.
For the next step, the University of Tennessee helped with palatability studies.
Study results allowed FDA to make recommendations for:
The studies took about two months to complete.
Results of the palatability and stability studies showed that raspberry syrup masked the taste of potassium iodide the best, followed by low-fat chocolate milk, orange juice and flat soda (such as cola). These results and instructions for home preparation of the mixtures were posted on FDA's Web site and shared with CDC and other government agencies responsible for homeland security.
Details of all the studies are available on CDER's Drug Preparedness and Response Internet site at: http://www.fda.gov/cder/drugprepare/default.htm.
Mary Jane Mathews is a writer-editor in the Office of Pharmaceutical Science.
By Tony Chite
1. Tall erect plant with large oblong leaves splotched with ivory markings. When chewed, its poisonous leaf produces immediate intense pain and swelling of the mouth. This common houseplant is the:
a. Diffenbachia (or mother-in-law's tongue)
b. Chrysanthemum
c. Lucky bamboo
d. Aloe vera
2. Large green stem leaves and smaller but showy red, pink or yellow leaves surround the flowers. Fruit is a three-celled, three-lobed capsule. When leaves, stem or milky sap are touched, they cause irritant dermatitis. Ingestion causes gastritis. This houseplant is the:
a. Coleus
b. Venus fly trap
c. Poinsettia
d. African violet
3. Climbing vines with aerial roots. Leaves are large and variable, the most common being heart-shaped. Ingesting the leaves of this plant causes painful burning of the lips, mouth, tongue and throat. Contact dermatitis is common. This houseplant is the:
a. Rhododendron
b. Philodendron
c. Easter lily
d. Lily of the valley
Key: 1a;2c;3b
Tony Chite is a pharmacist and consumer safety officer in the Division of Information Disclosure.
On Aug. 12, FDA announced approval of oxaliplatin (Eloxatin injection) for use in combination with infusional 5-fluorouracil (5-FU) and leucovorin for the treatment of patients with colorectal cancer whose disease has recurred or become worse following initial therapy with a combination of irinotecan with bolus 5-FU and leucovorin. The drug was shown to shrink tumors in some patients and delay resumed tumor growth. There are as yet no data on the effects of the combination on survival.
FDA reviewed the marketing application in seven weeks, the fastest review to date for a cancer drug. FDA used the "rolling review" procedures available for new drug applications designated as "fast track."
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Tegaserod maleate (Zelnorm tablets) received approval July 24 for short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation. The safety and effectiveness of the drug in men have not been established.
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FDA on July 17 approved sodium oxybate or gamma hydroxybutyrate also known as GHB for treating a small population of patients with narcolepsy who experience episodes of cataplexy, a condition characterized by weak or paralyzed muscles. To be marketed under the trade name Xyrem, the drug will be tightly restricted. In the early 1990s, GHB was also abused as a recreational drug and is well-known for use in date rape. The drug has been designated as a Schedule III controlled substance.
Jack Morin in the Division of Training and Development has a suggestion that he hopes will be to his benefit and may benefit other readers of the Pike. If there is reader response, we'll run your ads each month.
If you want to hook up, contact Jack directly. To place an ad, e-mail it to Patrick Clarke (CLARKEP).
Anticipating my 40th high school reunion caused some trepidation around the Oliver household. My wife, who knew I had studied Latin and Greek at a small boys' school in Northeast D.C., feared it would be a "geek reunion."
She graphically described to me how "Greek - R = geek."
"Not to worry," I said, "there were only two of us who studied Greek. The other was David Cooper. Sadly, he died not long after we graduated. Plus, we don't want to offend Greeks."
In the meantime, the fellows didn't do much to allay her anxiety when they settled on the Latin phrase "nunc est bibendum" for the reunion motto.
"Not to worry," I said, "it's an old Roman way of saying 'Let's party!'"*
At the reunion, we took time to reflect on the short life of our departed classmate. David was better known for his mathematical genius than partnering with me in Greek. He carried his own pack of colored chalks to graph mathematical equations and kept his watch set to GMT, "the only true time." We frequently didn't understand him, but we watched and listened politely.
The year we graduated, we took a class trip to the beach. We were chaperoned, of course. One evening, we were at the beach house playing cards. ("Geeks to the core!" my wife whispered. "We were underage," I replied.)
To play cards, you have to shuffle them. Some of us could riffle them, sometimes known as a New Orleans or riverboat shuffle. "Suppose you could perform a perfect shuffle," one of us asked. "How many shuffles would it take for the deck to return to its original order, if ever?" We thought about it but went on playing.
David took a piece of paper and a pencil and left. Two hours later, he returned and announced: "Eight."
"Eight what?" we asked.
"Eight shuffles to return the deck to its original order," David said. He then went on to describe the method he used to solve the problem. Our eyes glazed over. We don't recall if he arrived at a general or specific solution.
"That's a hypothesis," one of us said. "We can test it empirically."
So we manually interleaved cards. Sure enough, David was correct.
("True geeks!" my wife said. Was our test influenced by science news of the era? Perhaps. Among other 1962 events was passage of the Kefauver-Harris amendments to the Food, Drug and Cosmetic Act requiring drug manufacturers to provide empirical evidence of the effectiveness of their products.)
My classmate George Wright, now a professor of computer science at a college in Baltimore, was able to put David's math genius in perspective. Several years ago, S. Brent Morris, the chief mathematician at the National Security Agency, gave a recruiting lecture at his school. NSA is the country's largest employer of mathematicians. Morris described how his youthful interest in card tricks led him to work on the mathematics of the perfect shuffle in graduate school. Morris likes to say he has the only doctorate in card shuffling.
The perfect shuffle, it turns out, is a very hard math problem. While one answer, eight, had been discovered empirically early in the 20th century, it wasn't until much later that Morris and other groups were able to solve the math. One group of three mathematicians took six months to solve the general problem in the early 1980s (Science, 216:505-506). By the end of the century, solving the math turned out to be important for managing computer memory.
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*Literally: "Now is the time for drinking." This isn't smart-alecky school-boy Latin. It has an impeccably ancient pedigree and is found in an ode by Horace celebrating Octavian's naval victory over Marc Antony and Cleopatra at the Battle of Actium off the west coast of Greece in 31 B.C.
The Pike is published electronically approximately monthly on the World Wide Web at: http://www.fda.gov/cder/pike.htm
Photocopies are available in the Medical Library (Parklawn Room 11B-40) and its branches (Corporate Boulevard Room S-121 and Woodmont II Room 3001).
Views and opinions expressed are those of the authors and do not necessarily reflect official FDA or CDER policies. All material in the Pike is in the public domain and may be freely copied or printed.
Rose Cunningham
Bonnie Dunn
Pam Fagelson
Elaine Frost
Edward Miracco
Melissa Moncavage
Jim Morrison
Ellen Shapiro
Ted Sherwood
Tony Sims
Nancy Smith
Wendy Stanfield
Gloria Sundaresan
Marcia Trenter
Jennifer Wagner
Diane Walker
Grant Williams
Pamela Winbourne
Have ideas, news or comments to contribute? Please contact a member of the Editorial Board or:
News Along the Pike
CDER Office of Training and Communications (HFD-210)
Parklawn Building, Room 12B-45
Editor: Norman "Joe" Oliver (OLIVERN)
Associate Editors: Patrick Clarke, Christine Parker
Phone: (301) 827-1695; Fax: (301) 827-3055
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FDA/Center for Drug Evaluation and Research
Last Updated: January 19, 2006
Originator: OTCOM/DPA
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