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Results Promising for Computational Methods For Drug Development

New research, led by a Virginia Tech chemist, may someday help natural-products chemists decrease by years the amount of time it takes for the development of certain types of medicinal drugs. The research by T. Daniel Crawford, associate professor of chemistry, involves computations of optical rotation angles on chiral—non-superimposable—molecules. The research titled, "The Current State of ‘Ab Initio’ Calculations of Optical Rotation and Electronic Circular Dichcoism Spectra," appeared recently as the cover article in The Journal of Physical Chemistry A.

Many chiral molecules are important for medical treatment for illnesses ranging from acid-reflux to cancer. The term “chiral” means that two mirror images of a molecule cannot be superimposed onto each other. In other words, some are “left-handed” and some are “right-handed.”

“Most drugs have this handedness property,” Crawford says, “and for many of these drugs, even though both hands can cause a reaction, it is a situation where one hand does a good thing and one does a bad thing.” He used thalidomide as an example. A mixture of both hands of the drug was used in the late 1950s and early 1960s to treat morning sickness in pregnant women. Later studies revealed that, while one of the two hands acted as the desired sedative, the other hand was found to cause significant birth defects. Thalidomide was never approved by the FDA in the United States and was eventually taken off the market in Europe.

For chemists, therefore, it is often vital to determine which hand of a molecule they are using. In other words, when you have a sample of a chiral molecule, how do you distinguish between the left and right hand"

This is where a technique called polarimetry comes in to play. By shooting plane-polarized light through a sample of one hand, the chiral molecule in question will rotate to a characteristic angle either clockwise or counterclockwise, and the two hands of a chiral molecule produce opposite rotations.

“So if we figure out the direction and rotation of the light or each hand, we have a frame of reference for determining whether we have the left or right hand of a molecule,” Crawford says.

The problem with this method is that synthesizing the two hands of chiral molecules is often extremely time consuming. “It can take anywhere from weeks to years,” Crawford says.

Crawford’s research applies the theory of quantum mechanics to devise computational methods in order to eliminate having to create a synthetic molecule. “The hope is that this will allow us to calculate things like optical rotation very accurately,” he says. “So when an organic chemist has a molecule and doesn’t know if it is left- or right-handed, we can calculate that directly on the computer.”

Crawford says the ultimate goal in his research is to be able to provide organic chemists with computational tools to determine the handedness of a particular molecule they are working with. He said that such tools could speed up the drug development process by years.

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Drug Dosages Often Incorrect for Obese Patients

As if severely overweight people didn’t already have enough health concerns, experts are raising another red flag – the possibility that some of their prescription medications, especially antibiotics, may not be prescribed at the appropriate dosage and could be ineffective.

Because most adult antibiotics are produced in a “one size fits all” dosage and some doctors are not attuned to this issue, the societal trend towards severe obesity is resulting in more individuals who get inappropriate drug therapies for infectious disease, a new study in the journal Pharmacotherapy suggests.

“The number of individuals with the highest body mass index, very obese people, is up 600 percent between 1986 and 2000,” says David Bearden, a clinical associate professor in the College of Pharmacy at Oregon State University.

“Very obese individuals in some cases, even those with severe infections, may be getting only half the necessary dose of a prescription drug such as an antibiotic,” Bearden said. “That’s a problem. It could lead not only to antibiotic failure but also an increase in antibiotic resistance, another serious issue.”

The problem is somewhat less of a concern with dosages of medications that patients take for extended periods, such as blood pressure or cholesterol medications, because the results of taking those medications are more routinely monitored and dosages can be increased as necessary. It’s a particular concern with antibiotics, Bearden says, because they are often used to treat severe or even life-threatening infections, and “bad things can happen quickly if the drug is ineffective.”

Drug companies are just now becoming more aware of this issue and beginning to test and recommend dosages more appropriate for adults of varying weights, Bearden says. But with older drugs that are commonly used, there often is very little or no data for adjusting dosages. In actual practice the issue is often ignored outright, or “educated guesses” are made with whatever data is available.

Without more attention, the issue may only get worse, and it’s not just a U.S. phenomenon. The World Health Organization estimates that 400 million people were obese in 2005 and that the total will increase to 700 million by 2015. It considers these numbers a “global pandemic” that is affecting low, middle and high-income nations around the world. Obesity is also considered an independent risk factor for surgical site infections and is associated with higher mortality rates in critically ill patients.

Even if the problem is carefully considered, Bearden says, it’s not simple.

“It would be nice if we could just use a simple multiplier to adjust drug dosages for overweight people,” Bearden says. “But it’s not that easy. There are a lot of factors that affect drug distribution in the body, including age, weight, kidney function, other disease problems and the type of antibiotic or other drug.”

Adipose tissue, or body fat, affects how the human body interacts with drugs. With some drugs it absorbs large amounts of a prescription medication, but with others, it doesn’t. And sometimes there is a very fine line between a drug being effective at one dose, ineffective if the dose is too low, and toxic if it’s too high. All of these issues affect appropriate dosages, and in many situations, the data needed to evaluate the problem simply doesn’t exist.

The issue of adjusted drug dosages has been known and addressed in children for decades, experts say, because of the obvious distinction between a 30-pound toddler and a 120-pound youngster. But with adults, far less attention has been given the problem. The medical and pharmaceutical industries often just assume that everyone weighs about 150-170 pounds.

“This is enough of an issue that if I were a very obese person being given an antibiotic, I would discuss it with my doctor,” Bearden says. “Hopefully the doctor will already have considered it and will be able to address your concerns. If not, then it’s a conversation you need to have, and more medical specialists, including pharmacists, may need to be consulted.”

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Video: Pain Medication in U.S. Nearly Doubles

An Associated Press analysis shows that pain medication use in the United States has nearly doubled. Meanwhile, physicians are facing increased scrutiny from federal drug agents looking to crack down on drug abusers.

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Outsourcing to Biotechs Is the Answer for Many Pharma Companies' Development

Small, mid-sized and large pharmaceutical companies are turning to outsourcing to free up cash for more early-stage marketing endeavors, according to a new study from Cutting Edge Information.

Early-stage development and commercialization resources can be hard to come by, as most pharmaceutical executives can attest to. Cutting Edge Information's study found that companies that focus their limited early-stage resources on commercialization have a distinct advantage once their products reach the market.

"Uniting R&D and Marketing for Integrated Early-Stage Market Preparation" is Cutting Edge Information's latest study. The report reveals that pharmaceutical companies are looking towards the biotech sector to outsource development of new drugs. In doing so, the company can free up resources to market drugs currently in their pipelines.

"It is no secret that the top pharmaceutical products each year are backed by hundreds of millions in marketing dollars," says Elio Evangelista, research team leader at Cutting Edge Information."Pharma-biotech partnerships have become a more popular method for pharmaceutical companies to outsource drug development and fill pipeline gaps."

One profiled company is in favor of shrinking business unit departments and creating small internal teams to handle deals with small biotechs to outsource most of the early-stage pre-clinical work. The idea is based on the biotech industry's capability to develop innovative products morequickly than slow-moving, large pharmaceutical companies. The company invests almost as much in early-stage research as it would for an in-house compound, but it outsources the work to smaller, faster-moving biotechs, which assume some of the risk that the company would otherwise retain.

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Drug Study Looks at Cost-Saving Step That Could be Used by Millions

Slicing certain pills in half could slice a hefty amount off of America’s prescription drug costs. While only some types of pills can be split safely, the practice could be used by millions of Americans – including many of those who take popular cholesterol-lowering drugs.

Now, a new University of Michigan study adds more evidence that splitting a high-dose pill and swallowing half of it, rather than taking a whole low-dose pill each time, doesn’t change those medicines’ impact on cholesterol levels. It is also the first prospective randomized controlled trial of pill-splitting, and the first to look at the impact of out-of-pocket costs on patients’ willingness to take the time to split pills.

The study is published in the June issue of the American Journal of Managed Care by a team from the UM Health System and the UM College of Pharmacy.

“This study was done in part to see what the impact would be of having some of the cost savings go back to the patient,” says first author Hae Mi Choe, PharmD, CDE, clinical assistant professor in the college and a UMHS clinical pharmacist.

While the study did not find that out-of-pocket costs had an impact on the participants’ tendency to split and take their pills in the six-month study, most participants said that reduced co-pays would be needed to entice them to continue splitting pills.

The findings have already had an impact on one large employer’s prescription drug plan: UM used them to justify a pill-splitting program that launched in early 2006. In its first full year, the program saved the University $195,000, and saved more than 500 employees and retirees a total of more than $25,000 in drug co-pay costs.

Pill-splitting relies on the fact that many medicines are manufactured in tablet formulations that contain different doses of the active ingredient. Some of the higher-dose tablets can be cut in half with a blade to produce two lower-dose tablets – for example, 80 milligram tablets can be cut to produce two 40-mg tablets.

Because drug manufacturers and wholesalers don’t usually charge twice the price for twice the dose, the cost of half of a high-dose pill is far lower than the cost of buying a whole pill containing the same dose of medicine. So, pill-splitting can save money for the insurance plan or pharmacy-benefit manager that buys the pills for a group of insured patients -- and for the employer or government agency that pays for the plan.

But few prescription plans currently structure their benefits to encourage pill-splitting, by charging lower co-pays to patients who buy high-dose pills they intend to split.

Patients have been splitting pills on their own for years. Some do it without their doctors’ knowledge, to try to save money. But others do it with help from physicians who write prescriptions for a higher dose and instruct patients on how to make one month’s supply last two months. However, this can result in potentially dangerous confusion, and skew the patient’s and doctor’s records.

In recent years, pharmacists have worked to determine which tablets can be safely split, and which — such as drugs that exit the body quickly, or that have time-release coatings — cannot.

Cholesterol-lowering drugs called statins are among the most widely-used classes of medicines, with tens of millions of Americans taking the drugs. They’re also good candidates for splitting because they linger in the body for a relatively long time, and because small day-to-day dose fluctuations that can happen when pills are split don’t make a major difference in cholesterol levels.

The UM study involved patients who were taking atorvastatin, pravastatin, or simvastatin, which are sold commercially as Lipitor, Pravachol, and Zocor or genetic simvastatin, respectively. The patients were all being treated by physicians at a single UMHS health center. They were also better educated and more likely to be white and female than the general U.S. adult population.


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Researchers Find Deadly Prescription Drug Effects Six Years Before FDA

Northwestern University's Charles Bennett, M.D., is a super sleuth of potentially deadly prescription drug reactions. He leads a national SWAT team of doctors called RADAR (Research on Adverse Drug Events and Reports) based out of Northwestern's Feinberg School of Medicine.

They swoop in to investigate early signs of trouble years before the Food and Drug Administration (FDA) takes notice.

A new study by Bennett, the A.C. Buehler professor in Economics and Aging at Northwestern's Feinberg School of Medicine, and a hematologist and oncologist at Northwestern Memorial Hospital, found RADAR identified serious drug reactions six years earlier than the FDA and drug companies.

RADAR's proactive safety efforts and reports also were much more comprehensive than those from the FDA or drug companies, according to the study. RADAR's reports provided doctors with important medical insights as well as guidance for prevention, diagnosis and treatment.
The study will be published in Archives of Internal Medicine.

Since Bennett launched RADAR in 1998, his research has resulted in black box warnings on billion dollar drugs like Plavix that may have saved thousands of lives. He has also provided guidance to help physicians more safely administer drugs. More than 100,000 people die each year from reactions to medications. The FDA is under attack for its passive and inefficient methods of learning about these problems.

Why is RADAR so nimble" Bennett's network includes hematologists and oncologists around the country and the world. His phone rings weekly with calls from concerned doctors alerting him to possible new trouble. After such a call, Bennett probes for clues that led to a life-threatening reaction to a drug. ‘What's the age and weight of the patient, x-rays, details of the physical exam and blood tests"' he'll ask. He'll canvas doctors to see if they've seen similar cases. If a vital piece of evidence is missing, Bennett even will track down a doctor at home on a Sunday and ask her to drive back to her office to check a chart. Then Bennett and his team fit all the puzzle pieces together to figure out what happened and how to prevent it in the future.

The new study also shows, however, that the FDA and drug companies were faster than RADAR to spread the word about serious adverse drug reactions. RADAR relies on publishing its studies in peer-reviewed medical journals, a process that takes longer than the FDA's warning letters to doctors and the drug companies' package inserts.

Thus, it's time for a formal collaboration between RADAR and the FDA to wed their strengths, said Bennett, who also is co-director for cancer control of the Robert H. Lurie Comprehensive Cancer Center.

"We need to work together as partners," Bennett says of the FDA. "Pharmaceutical side effects are one of the top five causes of death in this country. We want to move it out of the top five. This is the way to start that process and save thousands of lives."

Bennett envisions a formal partnership with the FDA in which he would share RADAR's investigations on safety issues, arrive at a joint insight on drug problems and have the FDA distribute the information to doctors.


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Pharmacists' Workload Contributes To Errors

High workloads for pharmacists increase the potential for medication errors, says a new study by University of Arizona College of Pharmacy researchers published in the May issue of the journal Medical Care.

The study was conducted by a team of researchers led by College of Pharmacy professor Daniel Malone, who is also a member of the Arizona Center for Education and Research on Therapeutics at the Critical Path Institute.

Researchers reviewed data submitted to insurance companies from 672 pharmacies in 18 metropolitan regions. The pharmacies filled an average of 18,000 prescriptions from January to March 2003, or 1,375 prescriptions per week. During that time, the average number of potentially harmful drug-drug interactions dispensed by each pharmacy was 32.1.

The pharmacies employed an average of 1.2 pharmacists for each hour the store was open, and each pharmacist filled an average of 14.1 prescriptions per hour. The risk of dispensing potentially harmful combinations of medications that could result in a drug interaction increased by 3 percent for each additional prescription filled per hour.

The study also found that computerized interaction alerts and telephone, Internet, and fax systems—which are intended to decrease pharmacist workload and increase the efficiency of prescription receipt and filling—also were associated with an increase in the number of prescriptions dispensed for medications that could interact.

“It appears that prescription volume is exceeding capacity and that automation and other pharmacy staffing may not sufficiently compensate for the increased pharmacist workload,” Malone says. “Additional research is needed to confirm and clarify this study, but our findings are consistent with other reports concerning workload and medication errors. We need to take a closer look at what we can do better in community pharmacies to reduce potentially dangerous interactions between dispensed medicines.”

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