Pharmaceutical heists in the U.S. have quadrupled since 2006, a coalition of industry and law enforcement estimates. And experts say the reasons include spotty security and high drug prices that can make such thefts extremely lucrative.

While some stolen pills wind up overseas, others show up on pharmacy shelves in the U.S. with fake labels and lot numbers.

The theft from an Eli Lilly & Co. warehouse early Sunday is the largest of its kind on record and attests to the growing sophistication of those who pull off such crimes.

Authorities say the thieves cut a hole in the roof, lowered themselves into the building on ropes, disabled the alarm system and stole enough drugs to fill a tractor-trailer. The stolen pharmaceuticals included best-selling antidepressants Prozac and Cymbalta.

“The people that target the pharmaceutical industry are an organized criminal element,” said Charles Forsaith, director of supply chain security for drugmaker Purdue Pharma. “This isn’t a couple of guys walking by a warehouse and saying, `I’m going to hit that place.’”

Forsaith heads a coalition of drug companies, distributors and law enforcement officials who have been working to prevent such thefts since 2006.

In the past four years, reported thefts of prescription drug shipments have quadrupled from 11 to 46, according to FreightWatch International, a security firm. Last year, roughly $184 million in pharmaceuticals were stolen in the U.S., up from $96.6 million the year before. Most of the heists involve cargo stolen from trucks or cargo containers, though company warehouses have also been hit.

Widely abused drugs like morphine and codeine are often peddled on the street, but federal officials say drugs like those stolen from Lilly are often sold back to medical suppliers.

Major drugstore chains say they purchase pharmaceuticals only from manufacturers or wholesalers that certify the source of their product.

But with layers of drug wholesalers, distributors and online pharmacy businesses across the U.S., experts say stolen prescription drugs can easily be resold.

“Some of these thieves completely redo labels, and they pass muster if no one’s looking too closely,” said Food and Drug Administration spokesman Tom Gasparoli.

The danger to the public comes if the thieves decide to hold onto the product until it expires and becomes unsafe.

“If they flood the market with this stuff now they’re going to get caught. If they hold on to them too long, you’re going to have shelf-life issues,” said Steve Brozak, president of WBB Securities, an investment firm focused on the drug industry.

A year ago, a refrigerated truck of insulin worth more than $10.9 million was stolen from Novo Nordisk in North Carolina. Months later the FDA reported several cases of diabetics showing up in emergency rooms with unsafe blood sugar levels; the cases were traced to the stolen insulin, which was not properly refrigerated.

Security experts say the incentives behind pharmaceutical theft are largely confined to the U.S. and unlikely to change anytime soon.

“Whenever you have a health care system where drugs are very expensive and there’s a fragmented supply chain, you’re going to have a means to profit from stolen drugs,” said Ron Greene, a spokesman for FreightWatch.

According to Greene, pharmaceutical theft is virtually nonexistent in Europe, where government controls keep drug prices low and most people have health care coverage.

Drugmakers are taking steps to protect their products. FreightWatch advises companies to hire security personnel to protect major shipments. In other cases they can install electronic tracking systems to monitor where their trucks are at all times.

The FDA has stepped up its own efforts, issuing alerts to the public, working with manufacturers, wholesalers, pharmacies and law enforcement, and publishing lot numbers of stolen drugs on a Web site.

“FDA stresses that it is everyone’s responsibility in the supply chain to look closely, to care about the quality of the products they sell,” Gasparoli said. “If there is not a solid market for these stolen goods, the thieves will do something else.”

Technorati Tags: cymbalta, online pharmacy, pharmaceuticals, pharmacies, prescription drug, Prozac

In an editorial published in the British Medical Journal, microbiologists at the University of Hong Kong said the number of reported acupuncture-related infections worldwide was the tip of an iceberg and they called for tighter infection control measures.

“To prevent infections transmitted by acupuncture, infection control measures should be implemented, such as use of disposable needles, skin disinfection procedures and aseptic techniques,” wrote the researchers, led by Patrick Woo, microbiology professor at the University of Hong Kong.

“Stricter regulation and accreditation requirements are also needed,” they added.

Acupuncture is one of the most widely practiced strands of alternative medicine and is based on the theory that inserting and manipulating fine needles at specific points in the body helps to promote the flow of “Qi” or energy.

It has its origins in ancient China and has become widely accepted in the West in recent decades particularly in the treatment of pain. It is also used for conditions like obesity, constipation and arthritis, among others, although documented scientific evidence for these are patchy.

Woo and his colleagues said acupuncture may be risky as needles are inserted up to several centimeters beneath the skin and they warned of a new syndrome — acupuncture mycobacteriosis — in the 21st century.

“This is an infection caused by mycobacteria that rapidly grow around the acupuncture insertion point as a result of contaminated cotton wool swabs, towels and hot-pack covers. There is a long incubation period but the infection usually leads to large abscesses and ulcers,” they wrote.

“So far, more than 50 cases have been described globally. In most cases … bacteria were transmitted from the patient’s skin flora or the environment because of inadequate skin disinfection before acupuncture,” they wrote.

While most patients recover from these bacterial infections, 5 to 10 percent of the reported bacterial infections end up with serious problems including joint destruction, multi-organ failure, flesh-eating disease and paralysis.

There have been at least five outbreaks of hepatitis B virus infection that are linked to acupuncture.

In most of these cases, the sources were infected patients and the virus was transmitted through dirty needles, although in one case, it was the acupuncturist who was the source, they said.

The paper also laid out the possibility of transmission of hepatitis C and HIV via acupuncture.

“Although no clear evidence exists to support a link between acupuncture and HIV infection, there are reports of patients with HIV who had no risk factors other than acupuncture,” it said.

Technorati Tags: acupuncture and HIV infection, alternative medicine, Bacterial infections, hepatitis, HIV, infection control, prevent infections

The American Academy of Family Physicians offers these medication guidelines for breast-feeding mothers:

• If you must take medications orally, take them just after breast-feeding, to give the medications time to travel through your system.
• Generally, acetaminophen and NSAIDs are safe pain relievers for nursing women, but always check first with your doctor.
• Don’t take aspirin while breast-feeding, as it may lead to bleeding and skin rash in babies.
• Don’t take antihistamines long-term while breast-feeding.
• Carefully monitor your baby for any side effects from your medications. Be especially aware of symptoms such as trouble breathing or skin rash.

Technorati Tags: Breast Feeding, medication guidelines, Medications and Breast Feeding, pain relievers

Their 14-week study of 170 patients found that 54 percent of those who received the combined treatment were able to stop drinking, compared with 21 to 28 percent for patients who received a placebo, Zoloft only, or naltrexone only.

The patients who received the combined treatment also went for a longer period of time before they started drinking again — 61 days compared with 15 days for patients in the other groups.

The findings may prove an important advance in the treatment of patients with alcohol dependence and depression, said the University of Pennsylvania researchers.

“When depression and alcohol dependence occur together, each condition has a negative influence on the outcome of the other, so not only does this pairing of illnesses affect a lot of patients, it also makes the individual disorders worse,” study author Helen Pettinati said in a news release. “Combining sertraline and naltrexone could be a practical approach for these patients because both have (U.S. Food and Drug Adminstration) approval.”

The study was published March 15 in the The American Journal of Psychiatry.

Technorati Tags: Combination Treatment, depression and alcohol dependence, naltrexone, sertraline, stop drinking, zoloft

They found that salsalate — an atypical non-steroidal anti-inflammatory drug, chemically similar to aspirin but easier on the stomach — helps control glucose levels.

The finding came from a three-month clinical trial of 108 people, 18 to 75 years old, who had type 2 diabetes. Those who took salsalate, the study found, had a 0.5 percent drop in levels of hemoglobin A1C, a measure of blood glucose levels. The decrease was in the range of several recently released diabetes treatments, according to the study, led by Joslin Diabetes Center researchers.

The findings are published online March 16 in Annals of Internal Medicine.

“These results are exciting,” Dr. Allison Goldfine, director of clinical research at Joslin and an associate professor at Harvard Medical School, said in a news release from the center. “They indicate that salsalate may provide an effective, safe and inexpensive new avenue for diabetes treatment.”

She stressed, however, that the findings were preliminary. “At this time we do not recommend patients use this medication for their diabetes treatment until further studies are completed,” Goldfine said.

Goldfine added that salsalate also could help combat atherosclerosis (narrowing of the arteries). The study found that people who took the drug had lowered triglycerides and higher levels of adiponectin, a protein believed to help protect against heart problems.

Technorati Tags: Arthritis Drug, diabetes treatment, fight diabetes, salsalate

Patients with a certain genetic variation can’t convert the blood thinner into its active form, which puts them at risk for heart attack and stroke, the U.S. Food and Drug Administration warned.

“If the patient makes less of the active form, there is less antiplatelet effect in the blood, and the patient may not receive the full benefit of Plavix treatment,” Mary Ross Southworth, FDA’s deputy director for safety in the division of cardiovascular and renal products at the Center for Drug Evaluation and Research, said during an afternoon press conference.

These patients are called poor metabolizers, she said.

Clopidogrel (Plavix) is generally prescribed after a heart attack, stroke or a procedure to open blocked coronary arteries. It usually makes platelets less likely to form blood clots, thus reducing the risk of heart attack, unstable angina, stroke and cardiovascular death in patients with cardiovascular disease.

For the drug to do its work, liver enzymes, especially one called CYP2C19, must convert the drug to its active form. In patients with low levels of the enzyme, the drug may be less effective in preventing heart attack, stroke and cardiovascular death, according to the FDA.

About 2 percent to 14 percent of people fall into this category, with the percentages varying by race. About 2 percent of whites have the variation, while 4 percent of blacks and 14 percent of Chinese people do, Southworth said.

But patients should not stop taking Plavix without consulting their doctor, the FDA said, noting a test to assess the CYP2C19 genotype can determine if a patient is a poor metabolizer.

In May 2009, the FDA required mention of the problem on the bottle label, but additional data from a recent study has caused the agency to call for the “black box” alert, its strongest warning.

That study, which the FDA asked Plavix’s makers to conduct, found less antiplatelet activity in people who were poor metabolizers than in patients who had no problem converting the drug.

However, when Plavix was given at higher-than-usual doses, the poor metabolizers showed more active drug in their blood than when they received lower doses, the researchers noted.

Patients who cannot convert Plavix well should use another anti-clotting drug or try an alternate strategy, such as a dosage increase, the FDA advised. Anti-clotting drugs that might be substituted for Plavix include ticlopidine (Ticlid) and prasugrel (Efient), the FDA said.

>”Efient doesn’t need this enzyme as much to form its active metabolite so it does not have the primary problem, and we know some people will consider using that,” Dr. Robert Temple, director of the FDA’s Office of Drug Evaluation, said during the press conference.

On the other hand, “ticlopidine was the first member of this class and has a fairly high frequency of some unpleasant hematologic problems, so it has lost popularity considerably,” he said.

Another recent study found that heart attack patients taking Plavix plus a proton pump inhibitor, such as Prilosec or Nexium, may be at increased risk of death or another heart attack, because this combination also prevents Plavix from being fully metabolized. The FDA is conducting a safety review about potential interactions of these commonly prescribed medications.

Plavix is made in partnership by two pharmaceutical giants, Bristol-Myers Squibb and Sanofi Pharmaceuticals. A Bristol-Myers spokesperson told the Associated Press that the new labeling would be added to Plavix during the next two months.

Technorati Tags: Nexium, Plavix, Plavix treatment, Plaxix prescription, Prilosec

A military-backed government in 2006 suspended patent protections for expensive cutting-edge treatments for AIDS, cancer and heart disease, giving Thais access to cheap copycat versions.

Activists against AIDS and poverty hailed Thailand as a global leader, but the kingdom has faced heavy pressure and threats of legal action from Western pharmaceutical firms.

Trade Representative Kiat Sittheeamorn told the American Chamber of Commerce in Thailand that the government was in talks with all sides and hoped for an eventual solution under the World Trade Organization.

“What we would like to see is US engagement with the WTO in order to come up with a multilateral regime that is good for all,” Kiat said in remarks videocast in Washington.

“It is a very sensitive issue, but we also recognize that we don’t want to violate any patent rights,” he said.

“I think the final goal for all is to be able to have affordable drugs for all the Thai people while recognizing the ownership rights” of patent holders, he said.

Campaigners voiced outrage last year when they said they obtained a letter showing Prime Minister Abhisit Vejjajiva’s government would not license more generic drugs as the issue was holding up free trade talks with the United States.

In its last annual report in March 2009, the US Trade Representative’s office said Thailand was within its WTO rights to approve generic drugs but called for “transparency and due process.”

Major pharmaceutical firms argue that generic drugs ultimately hurt patients by depriving the companies of funding for research and development.

Former US president Bill Clinton in 2007 struck a deal with two generic drug makers in India that now provides lower-cost AIDS treatment to more than two million people in developing countries, including Thailand.

Technorati Tags: affordable drugs, generic drug makers, generic drugs, Thailand

Researchers found that among more than 75,000 Massachusetts patients given drug prescriptions over one year, 22 percent of the prescriptions were never filled. The rate was even higher — 28 percent — when the researchers looked only at first-time prescriptions.

Such “non-adherence,” the study found, was common even among patients prescribed drugs for chronic conditions that can have serious health consequences.

Between 28 percent and 31 percent of new prescriptions for diabetes, high blood pressure and high cholesterol, for example, went unfilled, according to findings published in the Journal of General Internal Medicine.

Exactly why many patients did not fill their prescriptions is unclear. One possibility is that, when health problems cause few or no symptoms — as with high blood pressure or high cholesterol — people may not see the need for a medication.

“If they do not fully understand the reason that they are being prescribed the medication, they may be less likely to take it,” lead researcher Dr. Michael A. Fischer, of Brigham and Women’s Hospital in Boston, told Reuters Health in an email.

Cost could also be an issue, Fischer added — particularly when people are unsure of why a drug is being prescribed.

All of the patients in the study had health insurance. But even with coverage, people may have high co-payments for medications or may be prescribed a drug not covered by their plan, Fischer and his colleagues note.

For their study, the researchers used a database of electronic drug prescriptions for patients in two Massachusetts health plans, along with pharmacy claims records to verify whether the prescriptions were filled.

The study found that of almost 196,000 “e-prescriptions” written between 2004 and 2005, about 78 percent were filled. Of the more than 82,000 prescriptions for new drugs, just under 72 percent were filled.

Patients were least likely to pick up prescriptions for pain drugs, with only 45 percent of new prescriptions being filled. Between one- quarter and one-third of new prescriptions for conditions like depression, asthma and gastrointestinal ills also went unfilled.

More studies, according to Fischer, are needed to weed out the reasons why many people never fill their prescriptions — whether cost, worry over side effects, a desire to avoid medications or other issues.

For now, he said, people with questions about their new prescriptions should not hesitate to bring them up with their doctors.

“If you are not sure why you are being prescribed a medication, ask your doctor directly,” he said. “One of our jobs as physicians is to educate and advise our patients, and being sure that they understand their medication regimen is a big part of that job.”

Fischer added that in cases where people have left their prescriptions unfilled, they should not be “afraid” to tell their doctors. “Then they can talk with you about why you are not taking the medication and work with you to find a medication that you can use.”

SOURCE: Journal of General Internal Medicine, online February 4, 2010.

Technorati Tags: prescriptions, prescriptions for diabetes drugs, prescriptions for pain drugs

Ratiopharm could stay in takeover talks with two or even three bidders, as some bids, which had been due by the end of Friday, are seen within a close range of 3 billion euros ($4.11 billion), said the people, who are familiar with the procedure.

That would make the deal the biggest generics takeover since Teva’s $7.5 billion purchase of U.S. rival Barr, announced in July 2008.

The world’s largest drug company Pfizer, previously seen as an unlikely candidate, has re-emerged, defying a relatively unfavorable impression it left with regional law-makers in southwestern Germany, where Ratiopharm is headquartered, according to the people.

Industrial heir Ludwig Merckle is selling Ratiopharm as part of concessions made to creditor banks by his late father Adolf Merckle, who committed suicide in January 2009 after losing control over his business empire to lenders during the financial crisis.

Industry analysts said Teva, the world’s largest generics company, has deeper pockets and stands to gain more from potential cost cuts at family-owned Ratiopharm than does Actavis/EQT.

The Nordic consortium, however — which has enlisted former Ratiopharm Chief Executive Claudio Albrecht for advice — has improved its chances after pledging to protect jobs in the region.

“Teva seems to have a better financial position and the infrastructure to capture cost synergies. However, the smaller size of Actavis may appeal to the family-owned seller,” analysts at Jefferies said in a note. “Also, an Actavis acquisition may be somewhat more job friendly.”

Pfizer has already struck a string of collaborations and acquisitions to bolster its range of generics, particularly off-patent injectable drugs. An alliance with India’s Strides Arcolab Ltd last month marked the latest step.

For its part, Teva has said it plans to more than double total revenue and almost triple sales in Europe by 2015, a venture analysts say would require acquisitions worth $15 billion.

Ratiopharm could become Teva’s fast track to the No. 1 spot in Germany’s generics market, the world’s second-biggest, where Teva now trails Novartis, Ratiopharm, and Stada.

The acquisition would also make Teva the largest generics player in Europe, where its presence has been below Teva’s global average.

A spokesman for Ratiopharm declined to comment, as did spokespeople for Teva, Pfizer and EQT. Ratiopharm previously said a deal would be closed in the first quarter at the earliest.

Sources have said that debt-laden Actavis sought backing from EQT for the takeover bid in an aggressive move to boost the Icelandic firm’s market value after it failed to find a new owner last April.

(Reporting by Ludwig Burger, Frank Siebelt, Philipp Halstrick and Alexander Huebner in Frankfurt, Quentin Webb in London; Editing by Keiron Henderson)

Technorati Tags: Actavis, generic drug maker, injectable drugs, Pfizer, Ratiopharm

Those who are allergic to live evergreens may choose to decorate with artificial plants, but both live and artificial trees can trigger symptoms, experts say. They offer the following hints to help people avoid allergy and asthma symptoms over the holiday season:

• Some allergies are triggered by terpene, which is found in the oil or sap of live evergreen trees, wreaths and garlands. Other allergy sufferers may react to mold or pollen on trees and natural decorations. The ACAAI suggests washing pollen and mold off live trees, especially the trunk, with a garden hose and leaving the tree in a bucket of water in the garage or a covered porch while it dries. Wear gloves when handling the tree to protect against contact with sap.
• For those who are allergic to dust and mold, even artificial trees can be a problem if they haven’t been stored properly. Because dust and mold can accumulate on these items, it is a good idea to wash the tree outside before setting it up inside the house for decorating. The best way to store an artificial tree is to place it in an air-tight bag or container.
• Ornaments and other decorations can also gather dust and mold and are best stored in air-tight containers. Thoroughly clean each item before putting it on display.
• Artificial snow spray shouldn’t be used indoors because it can trigger asthma and allergy symptoms. Other potential triggers include scented candles, potpourri and other scents, and wood-burning fireplaces, the ACAAI warns.
• Food allergies are another potential problem during the holidays. Those with food allergies should ask party or dinner hosts about the ingredients used in each dish. It is also a good idea to prepare a dish you know is “safe” for you to eat and bring it along to share. When hosting a gathering, talk to guests in advance about food allergies.
• When traveling, remember to pack your asthma and allergy medications. If the trip requires air travel, keep those items in a carry-on bag. Bringing a pillow and mattress cover is recommended for those affected by dust mites.

Stress doesn’t cause allergies or asthma but can weaken your immune system. Make sure you take time in your busy holiday schedule to stay on top of your allergy and asthma symptoms so that illness doesn’t ruin your holiday plans. People with asthma should talk with their doctor about getting a flu shot, the ACAAI recommends.

Technorati Tags: allergies, asthma, food allergies, prevent alergies, prevent asthma