Pharma Blog Online

We know that physicians meet a parade of drug company sales representatives from their first days of medical school to retirement and that they see drug ads every time they pick up a medical journal.
At least that is represented as the advertising it is.
But a study in this week’s issue of the Annals of Internal Medicine provides extensive detail about how drug companies push their products in far more subtle ways.
Some drug makers pay key leaders in a field of medicine, such as chairs of departments in medical schools, tens of thousands of dollars if they are saying the right things about their product. They manipulate medical education sessions, lectures, articles in medical journals, research studies, even personal conversations between physicians to get their product message across.
“It is very disturbing,” says lead author Dr. Michael Steinman of the University of California, San Francisco and the San Francisco VA Hospital. “It really does a disservice to patient care.”
Reliable estimates put the drug industry’s expenditure on promotion to doctors at $18.5 billion — that’s about $30,000 a year for every physician in the U.S. Companies conceal the specifics of those efforts with a jealousy worthy of a state secret.
Now a huge collection of drug company internal documents — revealed as part of a lawsuit —offers a wealth of detail online pharmacy shipp international.
In 1996, Dr. David Franklin, an employee of the drug company Parke-Davis, filed the lawsuit under federal whistleblower statutes alleging that the company was illegally promoting an epilepsy drug called Neurontin for so called “off-label” uses. Under federal law, once the FDA approves a drug, a doctor can prescribe it for anything. But the law specifically prohibits the drug company from promoting the drug for any unapproved uses.
In 2004, the company, by then a division of Pfizer admitted guilt and agreed to pay $430 million in criminal and civil liability related to promoting the drug for off-label use.

Widely used heartburn and ulcer drugs such as Nexium, Pepcid and Prilosec can make people more susceptible to pneumonia, probably because they reduce germ-killing stomach acid, Dutch researchers found in a study of more than 300,000 patients.
The highest risks occurred with more powerful acid-fighting drugs called proton pump inhibitors, which are sold in the United States under such brand names as Nexium, Prevacid and Prilosec. Over nearly three years, users of these drugs faced almost double the risk of developing pneumonia compared with former users.
Users of another class of acid-fighting drugs that includes cimetidine and famotidine — sold in the United States as Tagamet and Pepcid — also faced an elevated risk.
The study was led by researcher Robert J.F. Laheij at University Medical Center St. Radboud in Nijmegen, Netherlands, and appears in Wednesday’s Journal of the American Medical Association.
Less germ-killing stomach acid
The acid in normal stomach fluids generally kills harmful bacteria; suppressing it with drugs to treat heartburn and ulcers may make the body more hospitable to such germs, which may then infect the lungs and cause pneumonia, the researchers said.
These heavily promoted medicines are among the most widely prescribed drugs worldwide, with almost $13 billion in sales in 1998 alone, according to a JAMA editorial. Millions of Americans take these drugs, which are heavily advertised in “ask your doctor about …” TV commercials.
Older patients and those with asthma and other chronic lung ailments are especially vulnerable to pneumonia. In light of the latest findings, the researchers said such patients should use these medicines “only when necessary and with the lowest possible dose.”
Among the 364,683 patients whose medical records were studied, 5,551 cases of pneumonia were diagnosed — 185 of them in people taking acid-suppressing drugs.
The researchers said their findings translate to about one case of pneumonia for 226 patients treated with the more potent acid-fighting drugs and one case per 508 patients treated with the other drugs.
Users of the more potent drugs were 89 percent more likely than former users to develop pneumonia. Patients using the less potent drugs were 63 percent more likely to develop pneumonia than former users of those drugs.
Nevertheless, the findings are reassuring because the apparent increase in the risk of pneumonia was small, said Dr. James Gregor of the University of Western Ontario.
Moreover, the study does not actually prove that the drugs cause pneumonia, said Gregor, who wrote the JAMA editorial and was not involved in the research. Regardless of which medication a patient is taking, heartburn, or acid reflux disease, can cause a person to accidentally inhale regurgitated stomach acid, increasing the risk of pneumonia, he said.

The possibility of a link with blindness was raised publicly earlier this year, when Dr. Howard Pomeranz of the University of Minnesota reported in an ophthalmology journal seven patients who reported NAION vision loss occurring within 36 hours of a Viagra dose.
“A definite causal relationship cannot be established at this time,” Pomeranz wrote.
Viagra and its competitors work by slightly dilating arteries so that blood flow in the penis increases. Whether it affects blood flow to the eye isn’t known, but Pomeranz argued that some effect on the optic nerve is plausible.
So he urged that ophthalmologists ask NAION patients whether they use impotence drugs, and report any additional cases. Also, Viagra users who suffer NAION in one eye should be cautioned that continued use might raise the risk of vision loss in the other eye, Pomeranz wrote.
The loss of vision is permanent.
Pomeranz told MSNBC Friday that “the drug is doing something to alter the circulation of blood to the optic nerve and in turn causing an injury to the nerve resulting in a loss of vision.”
The patients in the study had a history of high blood pressure and an anatomical risk factor involving the optic nerve.
“If a patient takes the medication and 45 minutes later suddenly notices the onset of vision loss, to me that’s certainly some evidence there is a connection between the two,” Pomeranz told MSNBC.
Because the drugs affect blow flow a connection “makes sense,” NBC’s chief science correspondent Robert Bazell told MSNBC Friday. He added that the condition is rare and there isn’t yet cause for widespread concern.
But publicity over the FDA investigation could result in more cases coming forward, said Bazell, noting that a bigger study examining the link is needed.

When used judiciously, pharmacy Web sites can play an important educational role for consumers, but they never should be used for ordering new prescriptions, according to a professor of pharmacy at the University at Buffalo.
Karl Fiebelkorn, UB clinical assistant professor of pharmacy practice, says legitimate online pharmacies, such as those run by reputable community pharmacies, including Drugstore.com owned by Rite Aid and Soma.com owned by CVS, can be good sources of information for patients on their disease state and their drug therapies. They also can be good sources of referrals to other sites or information sources, such as drug companies, government agencies or patient-help organizations.
“Consumer education is critical to the success of a treatment,” says Fiebelkorn, who for 16 years supervised a major community pharmacy. “But, as they say, ‘A little bit of knowledge can be dangerous.’ That’s why it is always important for the patient to see a health professional face-to-face.”
Some pharmacy Web sites, Fiebelkorn says, such as those that operate offshore and send to consumers prescription drugs without a prescription, are patently illegal and obviously should be avoided.
Reputable sites can be useful when a consumer is ordering a refill by email and picking it up at a local pharmacy, he says. Moreover, prescribers can email prescriptions directly to a pharmacy to be picked up, so long as the email system is secure.
But even ordering new pharmaceuticals from seemingly reputable sites can pose problems, like those that arise from using mail-order pharmacies.
According to Fiebelkorn, a trained pharmacist can glean quite a lot of information from an in-person conversation with a patient that is just not possible in cyberspace.
“Can you monitor a patient’s success with their drug therapy online?” he asks. “Can you check the patient’s blood pressure or blood sugar online or over the phone? Of course not. Real pharmacists in community pharmacies can do all these things. We can actually see the skin rash for which the patient is seeking treatment.”
Case in point: a few years ago, while Fiebelkorn was working in a community pharmacy, a diabetic patient called to say that, according to her blood-glucose meter, her blood-sugar level was “out of control.” Fiebelkorn asked her to come to the pharmacy and bring her glucose meter with her. It turned out she was getting inaccurate readings because the sensors in the meter needed to be cleaned.
In another instance, Fiebelkorn recalls, a patient told him she was using her inhaler more times during the day than was recommended and that she was having her medication refilled (through a mail-order pharmacy) about twice as often as is usually necessary. When Fiebelkorn asked her to show him how she used her inhaler, he saw at once that she was using it incorrectly, and he showed her how to use it properly.
It’s also important for a pharmacist to be able to observe a patient’s body language because it provides insight into a patient’s mindset and whether something is bothering him or her.
“And what if the patient isn’t telling you everything?” he asks. “Online, you can’t know whether or not the patient is telling you all the facts.”
For example, he describes a hypothetical patient who wants a prescription for Viagra. That patient could state in an email message to an online pharmacy that he weighs 150 pounds and is in perfect health, when in fact he is extremely overweight and has a heart condition, which normally would be contraindications for the drug. But in the online environment, the prescribing pharmacist would never know.
In addition, he says, there is no way for online pharmacies to comply fully with state regulations that require patients to receive detailed information about the drugs they are receiving.
“In New York State, for example, how would an online pharmacy counsel you?” he asks. “By sending you an email or putting you in a chat room?”
Confidentiality also is an issue, he adds. “Someone with AIDS or asthma, for example, may not want other people, like their employers, to know about their disease. But email is not secure. And with an online pharmacy, you don’t know who the Webmaster is, and what they will do with that information.”
Just last semester, a UB pharmacy student doing his internship in a community pharmacy saved a woman’s life because he correctly suspected that the bad headache she described was actually a subarachnoid hemorrhage. Instead of selling her a bottle of painkiller, he insisted that she go to the doctor right away; she was admitted to a hospital, where she was treated.
“There are dozens of these examples,” says Fiebelkorn, “and any pharmacist could give you similar accounts. But each of them did it only when they interacted with the patient. Face-to-face.”

Examples
candesartan cilexetil Atacand eprosartan mesylate Teveten irbesartan Avapro losartan Cozaar Hyzaar olmesartan Benicar telmisartan Micardis valsartan Diovan
How It Works
These medications block the action of a hormone that causes blood vessels to narrow. As a result, blood vessels may relax and open up. This makes it easier for blood to flow through the vessels, which reduces blood pressure. Additionally, these drugs increase the release of sodium and water into the urine, which also lowers blood pressure.
Why It Is Used
Angiotensin II receptor blockers (ARBs) may be used alone or combined with other medication-often a diuretic-to treat high blood pressure.
How Well It Works
Angiotensin II receptor blockers (ARBs) reduce blood pressure as effectively as angiotensin-converting enzyme (ACE) inhibitors but without some of the side effects (such as a cough) associated with ACE inhibitors.1

Eprosartan mesylate (Teveten) is a recently approved ARB that is combined with a diuretic.

Side Effects
Side effects include diarrhea, stomach problems, muscle cramps and back and leg pain, dizziness, insomnia, nasal congestion, cough, sinus problems, and upper respiratory infection.

See Drug Reference for a full list of side effects. (Drug Reference is not available in all systems.)

What To Think About
ARBs do not cause a cough, which is a common side effect of ACE inhibitors and a reason many people stop taking ACE inhibitors. ARBs therefore are often substituted for an ACE inhibitor when a person develops a cough.
Studies show that ARBs may have fewer side effects than beta-blockers, and that the ARB losartan is more effective than the beta-blocker atenolol in reducing fatal and nonfatal stroke and heart attack in people who are at high risk for complications of high blood pressure.2
Another study showed that losartan is more effective than the beta-blocker atenolol for treating people with isolated systolic hypertension and left ventricular hypertrophy.3 Left ventricular hypertrophy is enlargement and thickening of the heart due to high blood pressure.
Losartan has also been shown to be more effective than atenolol for preventing fatal and nonfatal stroke and heart attack in diabetics.4
Pregnant women should not take angiotensin II receptor blockers.

Call it the Year of the Panda. In 2006 a record 31 pandas were born in captivity in China, triple the number in 2000. Zoo Atlanta welcomed a baby panda too: Mei Lan (Chinese for “Atlanta Beauty”) was born Sept. 6. “The giant panda’s safe,” said Zhang Hemin, head of the China Conservation and Research Center for the Giant Panda.
Zhang’s team plans to raise the captive-bred population from 120 to 300 within 10 years. That would guarantee the species’ survival for at least 100 years, increase the number of pandas that can be reintroduced into the wild and provide more specimens for lucrative loans to zoos around the world.
How did the experts get these love-shy mammals to mate? Mei Lan was a product of artificial insemination. But conservationists are using other methods to encourage natural breeding. Unpopular females have been scented with the urine of popular rivals, so that a male thinks he’s mating with a more attractive female. Zhang has shown them videos of pandas breeding in the wild–basically, panda porn. He even gave one male Viagra–which didn’t work so well. “We’ll never do that again,” he said. “The panda was excited for 24 hours.”

The anti-impotence drug Viagra will be available on the High Street without a prescription from 14 February.
Boots the chemist is introducing a trial scheme at three of its branches in Manchester.
Men aged between 30 and 65 will be able to buy four pills for £50 after a consultation with the pharmacist.
But Dr Jeff Hackett, chairman of the British Society for Sexual Medicine, said many men were entitled to the drug on the NHS, without paying.
“We have some regulations at the moment that allow a large number of patients to get the drug free on the National Health Service,” he said.
“One of the problems for pharmacists will be to identify these patients who actually shouldn’t be paying who are legally entitled to get it free and that’s quite a challenge.”
Hour-long consultation
Men seeking the drug from the pharmacist will have to undergo some basic medical tests, and anyone wanting a repeat prescription would have to consult a doctor.
Boots pharmacist James Longdon said the men would have an hour-long consultation, including blood pressure, blood sugar and cholesterol checks.
He added that they would also be made aware that men with certain medical conditions could obtain the drug free of charge with a prescription from their GP.
Boots claims that only 10% of the three million men who suffer from impotence are being treated.
It said offering Viagra without a prescription could help to improve those figures.
The chemist also claimed the move would be a good way to monitor men’s health, as erectile dysfunction was often a marker for a more serious underlying medical condition. About Kamagra Oral Jelly

Many adults could be short of Vitamin D, putting them at greater risk of developing conditions such as diabetes, research suggests. In a review of research into diabetes and Vitamin D, three separate studies showed that breastfeeding mothers and children who received Vitamin D supplements were 60% less likely to develop Type 1 diabetes.
More black and Asian people may be getting Type 2 diabetes because if you have darker skin you are less able to make your own Vitamin D from the sun.
Phil Casey, Care Advisor for Diabetes UK stressed more research is needed before we know for sure whether a lack of vitamin D can trigger diabetes. Scientists need to rule out the chance that something else - rather than Vitamin D - is raising the risk of diabetes in these people.
“Diabetes UK does not recommend that people take supplements unless clinically diagnosed with a deficiency,” he added.
“The safety of taking various dosages of supplements, such as vitamin D, and taking them for a prolonged period of time must be rigorously tested.”

Tokyo (JCNN) - Sumitomo Pharmaceuticals, Co, Ltd. announces that it has concluded a license agreement with Novo Nordisk A/S (Denmark) for the anti-diabetic agent, Repaglinide (generic name) which will enable Sumitomo Pharmaceuticals to develop and market the drug in Japan.
Repaglinide is an anti-diabetic agent currently marketed by Novo Nordisk A/S in more than 80 countries in the world with the brand name “Prandin” in the USA “Gluconorm” in Canada and “NovoNorm” in other countries. The product is one in a group of anti-diabetic agents known as meglitinides, a rapid acting insulin secretagogue, which improves post-prandial blood glucose levels, an important parameter in the treatment of type 2 diabetes. This is achieved by increasing insulin secretion after meals.
With this agreement, Sumitomo Pharmaceuticals now takes over the development of Repaglinide in Japan, previously initiated by Novo Nordisk Pharma Ltd., the Japanese subsidiary of Novo Nordisk A/S.
Type 2 diabetes is a lifestyle-related disease, with the number of people affected by it going up worldwide. This therapeutic area is an important R&D target for Sumitomo Pharmaceuticals, which has “Glucophage” (metformin), licensed from Merck Sante s.a.s., in the development stage and several other development candidates in the R&D pipeline. Sumitomo Pharmaceuticals also has “Melbin”, a metformin product in the market already and an application has been filed for the introduction of a smaller size tablet.
Sumitomo Pharmaceuticals has planned to conduct all necessary clinical studies to achieve early launch of Repaglinide, and wishes to contribute to better treatment of diabetic patients by adding Repaglinide to its product pipeline.
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Results of new analyses found that ACTOS(R) (pioglitazone HCl), an oral antidiabetic medication, significantly reduced the risk of recurrent stroke in high-risk patients with type 2 diabetes. The findings were presented today in a late-breaker session at the World Congress of Cardiology in Barcelona.
“These results are very encouraging news for people with type 2 diabetes because they demonstrated that ACTOS reduced the incidence of strokes in patients who had already experienced a stroke from 10.2 percent down to 5.6 percent, translating to a risk reduction of almost 50 percent,” said Robert Wilcox, M.D., professor in the Department of Cardiovascular Medicine at Queen’s Medical Centre, University Hospital, Nottingham, United Kingdom.
These new analyses from the landmark PROactive Study examined the effects of ACTOS on the risk of stroke and other cardiovascular (CV) outcomes in high- risk patients with type 2 diabetes with and without prior stroke. Pre-specified study endpoints included all-stroke and CV disease death, myocardial infarction (MI, excluding silent MI) or stroke.
According to the results, there were statistically significant benefits of ACTOS in patients who had suffered a prior stroke. The incidence of recurrent stroke was reduced by 47 percent (P=0.008) and the combined risk of death, MI or stroke was reduced by 28 percent (P<0.05). There was no effect of ACTOS on subsequent strokes in patients who had never experienced a stroke.
Patients with diabetes are at an increased risk of stroke. In fact, the risk is two to four times higher for people with diabetes than the general population. Results from the PROactive Study demonstrated that an oral glucose-lowering medication could substantially impact the risk of some CV events, including the combined risk of death, MI and stroke in high-risk patients with type 2 diabetes.