Pharma Blog Online

WHITEHOUSE STATION, N.J. - Merck & Co. Inc. said Thursday its first-quarter profit jumped 12 percent, with the drugmaker crediting higher sales and one-time gains from product divestitures.
The maker of Fosamax for osteoporosis and Singulair for asthma and allergies posted net income of $1.7 billion, or 78 cents per share, up from $1.52 billion, or 69 cents per share, in the first quarter of 2006.
Excluding a charge of 6 cents per share for its ongoing global restructuring program, Merck said income was 84 cents per share. That matched the forecast of analysts surveyed by Thomson Financial, who had bumped up their estimates last Thursday when Merck raised its earnings forecast.
In the year-ago quarter, Merck took a charge of 9 cents per share for the restructuring.
Sales totaled $5.77 billion, up nearly 7 percent from $5.41 billion a year earlier. Analysts had expected revenues of $5.36 billion.

WASHINGTON - A major U.S. AIDS treatment group plans to file a lawsuit Monday that accuses drug giant Pfizer Inc. of illegally promoting recreational use of its blockbuster impotence pill Viagra.
The AIDS Healthcare Foundation (AHF) told Reuters it wants Pfizer to be barred from marketing Viagra as a lifestyle or sexual enhancement drug. The nonprofit organization said Pfizer’s actions had led to risky behavior by men and an increase in HIV and other sexually transmitted diseases.
“Pfizer has created and contributed to the perception of Viagra as a safe, sexy, lifestyle, recreational drug, to be frequently used regardless of the degree, or even existence of” erectile dysfunction, the group said in draft legal documents.

Until late last year, Hi-Tech Pharmaceuticals of Norcross, Ga., appeared to be a thriving business with a hot-selling line of natural dietary supplements. But in a bizarre case quietly unfolding in federal court in Atlanta, prosecutors allege that it was really a criminal enterprise that sold dangerous “spiked” products and was run by executives who considered assassination and blackmail to quash a federal investigation.
The allegations are the most far-ranging ever leveled against a major player in the loosely regulated dietary supplement industry, and include activities more at home in the Mob hangouts of television’s Tony Soprano than a corporate boardroom. Among other things, prosecutors allege in court filings that some or all of the defendants:
Discussed killing a U.S. Food and Drug Administration agent and blackmailing an assistant U.S. attorney. Neither plot was carried out, but a Hi-Tech co-founder was subsequently jailed after being convicted of being a felon in possession of a “firearm silencer.”
Used the herbal stimulant ephedra in Hi-Tech diet products after the U.S. Food and Drug Administration banned its use on April 12, 2004, finding it presented “an unreasonable risk of illness or injury.”
Sold “herbal” supplements that actually contained the active ingredients of prescription drugs that could interact dangerously with other medications.
Illegally imported and sold banned steroids.
Manufactured phony ecstasy tablets that were sold on U.S. streets.
Created a muscle-building drink that was later marketed as a cleaning solution in an effort to mislead investigators.
The shocking allegations spring from the Sept. 7 indictment of the company and 11 executives, employees and associates for allegedly operating an illegal Internet pharmacy in Belize.
Belize lab ‘substandard and unsanitary’
The defendants used numerous Web sites to advertise and sell what were described as generic prescription drugs from Canada but were actually products that they were manufacturing in “substandard and unsanitary conditions” in Belize, according to the indictment.
Among the substances were the steroids Oxymethelone and Stanozolol, controlled drugs Ambien, Valium and Xanax, and prescription drugs Viagra, Cialis, Lipitor and Vioxx, it said.

Taking such popular heartburn drugs as Nexium, Prevacid or Prilosec for a year or more can raise the risk of a broken hip markedly in people over 50, a large study in Britain found.
The study raises questions about the safety of some of the most widely used and heavily promoted prescription drugs on the market, taken by millions of people.
The researchers speculated that when the drugs reduce acid in the stomach, they also make it more difficult for the body to absorb bone-building calcium. That can lead to weaker bones and fractures.
Hip fractures in the elderly often lead to life-threatening complications. As a result, doctors should make sure patients have good reason to stay on heartburn drugs long term, said study co-author Dr. Yu-Xiao Yang of the University of Pennsylvania School of Medicine.
“The general perception is they are relatively harmless,” Yang said. “They often are used without a clear or justified indication for the treatment.”
Some people find relief from heartburn with over-the-counter antacids such as Tums, Rolaids and Maalox. For others, these medicines do not work well. Moreover, heartburn can be more than a source of discomfort. People with chronic heartburn can develop painful ulcers in the esophagus, and in rare cases, some can end up with damage that can lead to esophageal cancer.
Dr. Sandra Dial of McGill University in Montreal, who was not involved in the study but has done similar research, said patients should discuss the risks and benefits with their doctors and taper off their use of these medicines if they can.
Nexium, Prevacid and Prilosec are members of a class of drugs known as proton pump inhibitors. The study found a similar but smaller risk of hip fractures for another class of acid-fighting drugs called H2 blockers. Those drugs include Tagamet and Pepcid.
The study, published in Wednesday’s Journal of the American Medical Association, looked at medical records of more than 145,000 patients in England, where a large electronic database of records is available for research. The average age of the patients was 77.
The patients who used proton pump inhibitors for more than a year had a 44 percent higher risk of hip fracture than nonusers. The longer the patients took the drugs, the higher their risk.

TOKYO: Japan’s largest drugmakers are on a biotechnology shopping spree, raising the cost of takeovers and new products in the global pharmaceuticals industry.
Takeda Pharmaceutical and Eisai spent $500 million last month for acquisitions, almost five times as much as all Japanese companies paid in the two previous years for biotech. The deals came after Japan’s government cut prescription-drug prices 6.7 percent and companies failed to produce medicines with the potential to reach $1 billion in sales.
The new competition means American and European companies, including Merck and Novartis, may need to pay more as they pursue the same strategy. The top four Japanese drugmakers had more than $21 billion in cash last year, double the combined amount disclosed by Pfizer, GlaxoSmithKline, Sanofi-Aventis and Novartis in their annual reports.
“Prices could go up as a result of Japanese buying,” said Leslie Pryce, a former Glaxo executive who heads the pharmaceutical consulting group New Business Horizons in Nagoya, Japan. “They have a lot of cash.”
Biotech companies were targets in mergers and acquisitions worth $68 billion over the past seven years, based on data compiled by Bloomberg. Half the buyers were from the United States, a fourth were European and fewer than 2 percent were based in Japan. Last year the number of biotech deals in North America rose 32 percent to 232, and the average premium over the price of traded shares rose to 33 percent from 23 percent, based on data compiled by Bloomberg.

Nobody likes being sick. But feeling sick down there can add embarrassment to the misery.

Here’s a list of a few common problems of the genital and surrounding areas in case you were too embarrassed to ask about them.

MALE CONDITIONS

_Enlarged prostate: The condition is seen in men as they age, but not all men show symptoms, said Dr. Neyssan Tebyani, urologist at Saddleback Memorial Medical Center.
An enlarging prostate is a natural process that occurs as a result of testosterone, which stimulates the prostate gland to grow. As the prostate enlarges, it blocks the flow of urine out of the bladder, which can cause symptoms.
Symptoms can start in the 40s and include weak urine stream, frequent urination and an increase in urgency to urinate.
Treatment can include taking saw palmetto for milder symptoms, and taking medications like alpha blockers (which treat symptoms) Proscar and Avodart (which can decrease the size of the prostate) for moderate or severe cases. If those don’t help, there are more invasive surgical options available.
_Prostate cancer: A cancerous growth of the prostate gland, this condition is the most common non-skin cancer affecting men in the United States, said Tebyani.
The majority of patients show no symptoms, but some may suffer from urinary frequency and difficulty. Risk factors include increased age and a family history of prostate cancer. African-American men are more at risk.
Screening for prostate cancer includes a rectal exam and blood test.
Treatment includes radiation, surgery, lowering testosterone levels via injections, and freezing the prostate gland (cryotherapy).
Prevention tip: Avoid eating excessively fatty foods, since high-fat diets have been linked to prostate cancer.
_Erectile dysfunction: This refers to the inability to initiate or maintain an erection, said Dr. Aaron Spitz, urologist at UCI Medical Center. Most of the time, the underlying cause of ED is poor circulation because of elevated cholesterol, hypertension, diabetes, etc.
Younger men who are otherwise healthy probably suffer from psychological causes leading to anxiety.
Treatment includes oral medications like Viagra, Cialis and Levitra, injected medications, vacuum devices, and surgical implants.

Most men experience occasional erectile dysfunction (ED) at some time in their lives as a result of fatigue, stress or excessive alcohol consumption. However, when it occurs consistently or for a long period of time, causing significant distress to the sufferer or to his relationship, then it starts to be considered a serious problem.

Here are some treatment options starting with self help:

Share your concerns - it is particularly important that you communicate with your partner by being open and honest and asking for their support. The lines of communication need to be opened.
Start by placing less emphasis on intercourse and more on developing other forms of sexual intimacy. Spending time cuddling, kissing, licking and massaging can still be pleasurable and will help keep you emotionally close to your partner.

Sex therapy - many men could benefit from a course of counseling or therapy. Sex therapy is particularly necessary if the ED has psychological causes which cannot actually be cured with physical treatments. Sex therapy can help to restore self esteem and sexual confidence. Involve your partner in sex therapy too.

Practice a healthy lifestyle by cutting down on the drinking and quitting the smoking. Take moderate-intensity exercise - brisk walking for example - for half an hour on most days of the week. Eat a balanced diet rich in fruit and vegetables and low in fat. Reduce the stresses in your life.

In recent years, pharmaceutical companies have been developing ED treatments as they have realized the extent of the problem. There are now 3 different brands of tablets known as phosphodiesterase type-5 inhibitors. Cialis and Levitra work in a similar way to Viagra (the first drug of this type) but take effect more quickly. A 4th drug Uprima comes as a tablet to be dissolved under the tongue and it brings about an erection in about 20 minutes. Prior to such research, men who sought help and medical advice from their doctor were prescribed such treatments as testosterone or penile injections or even penile implants.

Traditional natural healing products for the treatment of ED were not always readily available in the western world. Now you can chose a natural rather than a man-made solution for ED as a safe alternative. With a natural healing product, you retain the power to control your erection as opposed to some oral and man-made drugs which induce an erection for a longer period of time but do not give you the control. A natural healing product will help boost your self esteem and confidence by allowing you to get an erection and to maintain it for as long as desired.

Many men used to feel embarrassed when they sought medical advice for an ED problem but fortunately, the problem has been discussed so openly in the media in recent years, that they are starting to feel more confident about getting help.

Amoils offers all natural treatments for common conditions and ailments using essential oils. Visit our Erectile Dysfunction page for more information.

Until late last year, Hi-Tech Pharmaceuticals of Norcross, Ga., appeared to be a thriving business with a hot-selling line of natural dietary supplements. But in a bizarre case quietly unfolding in federal court in Atlanta, prosecutors allege that it was really a criminal enterprise that sold dangerous “spiked” products and was run by executives who considered assassination and blackmail to quash a federal investigation.
The allegations are the most far-ranging ever leveled against a major player in the loosely regulated dietary supplement industry, and include activities more at home in the Mob hangouts of television’s Tony Soprano than a corporate boardroom. Among other things, prosecutors allege in court filings that some or all of the defendants:
Discussed killing a U.S. Food and Drug Administration agent and blackmailing an assistant U.S. attorney. Neither plot was carried out, but a Hi-Tech co-founder was subsequently jailed after being convicted of being a felon in possession of a “firearm silencer.”
Used the herbal stimulant ephedra in Hi-Tech diet products after the U.S. Food and Drug Administration banned its use on April 12, 2004, finding it presented “an unreasonable risk of illness or injury.”
Sold “herbal” supplements that actually contained the active ingredients of prescription drugs that could interact dangerously with other medications.
Illegally imported and sold banned steroids.
Manufactured phony ecstasy tablets that were sold on U.S. streets.
Created a muscle-building drink that was later marketed as a cleaning solution in an effort to mislead investigators.
The shocking allegations spring from the Sept. 7 indictment of the company and 11 executives, employees and associates for allegedly operating an illegal Internet pharmacy in Belize.

Belize lab ‘substandard and unsanitary’
The defendants used numerous Web sites to advertise and sell what were described as generic prescription drugs from Canada but were actually products that they were manufacturing in “substandard and unsanitary conditions” in Belize, according to the indictment.

Among the substances were the steroids Oxymethelone and Stanozolol, controlled drugs Ambien, Valium and Xanax, and prescription drugs Viagra, Cialis, Lipitor and Vioxx, it said.
The indictment also charged Hi-Tech President and CEO Jared R. Wheat, 35, with operating a “continuing criminal enterprise” — a violation of an anti-organized-crime statute that carries a minimum penalty of 20 years in prison. In court filings, prosecutors describe Wheat as a “lifelong drug dealer,” citing a conviction for dealing ecstasy at the age of 19 in addition to the current allegations.
Wheat has pleaded not guilty to all charges and Hi-Tech said in a statement that it is “appropriately conducting its business and there is no basis for the indictment.”
The case raises concerns about the safety of the company’s line of dietary supplements, which remain available through many major U.S. retailers, and more generally about a loosely regulated industry that supplies nutrition products consumed by millions of Americans.
But it remains unclear to what extent the government’s charges involve Hi-Tech products manufactured and sold in the United States versus those made in Belize for sale over the Internet.
The U.S. Food and Drug Administration has not issued any safety advisories for Hi-Tech products since the indictment. Representatives of the FDA and the U.S. Attorney’s Office in Atlanta said they could not discuss the ongoing criminal case.

Nexium, Prilosec may make it harder for body to absorb calcium, study says.
CHICAGO - Taking such popular heartburn drugs as Nexium, Prevacid or Prilosec for a year or more can raise the risk of a broken hip markedly in people over 50, a large study in Britain found.
The study raises questions about the safety of some of the most widely used and heavily promoted prescription drugs on the market, taken by millions of people.
The researchers speculated that when the drugs reduce acid in the stomach, they also make it more difficult for the body to absorb bone-building calcium. That can lead to weaker bones and fractures.
Hip fractures in the elderly often lead to life-threatening complications. As a result, doctors should make sure patients have good reason to stay on heartburn drugs long term, said study co-author Dr. Yu-Xiao Yang of the University of Pennsylvania School of Medicine.
“The general perception is they are relatively harmless,” Yang said. “They often are used without a clear or justified indication for the treatment.”
Some people find relief from heartburn with over-the-counter antacids such as Tums, Rolaids and Maalox. For others, these medicines do not work well. Moreover, heartburn can be more than a source of discomfort. People with chronic heartburn can develop painful ulcers in the esophagus, and in rare cases, some can end up with damage that can lead to esophageal cancer.
Dr. Sandra Dial of McGill University in Montreal, who was not involved in the study but has done similar research, said patients should discuss the risks and benefits with their doctors and taper off their use of these medicines if they can.
Nexium, Prevacid and Prilosec are members of a class of drugs known as proton pump inhibitors. The study found a similar but smaller risk of hip fractures for another class of acid-fighting drugs called H2 blockers. Those drugs include Tagamet and Pepcid.
The study, published in Wednesday’s Journal of the American Medical Association, looked at medical records of more than 145,000 patients in England, where a large electronic database of records is available for research. The average age of the patients was 77.
The patients who used proton pump inhibitors for more than a year had a 44 percent higher risk of hip fracture than nonusers. The longer the patients took the drugs, the higher their risk.

Clearly, the advertisement for Flomax — a prescription medication designed to alleviate uncontrollable male urination—was the true winner of Super Bowl XLVXIV. But apparently, you were too busy urinating to notice!
The “Flomax” ad was a gut-wrenching, emotional plea to end those constant trips to the restroom, while learning to live with possible side effects such as “runny nose,” “fainting” and “decrease in semen.” But you wouldn’t know that, would you? Because you were too busy dashing back and forth to the toilet, and laughing with your callous friends at the expense of a poor mouse being brutally attacked for your entertainment.
This is NOT the America I signed up for, Americans. That’s why the scientists here at MSNBC.com have decided to give our readers two choices: either retract your vote for the Blockbuster “pets of perversion,” or we will be forced to instigate a very nasty online petition. We’re not exactly sure what we’ll be petitioning against—but mark our words, it’ll make what happened to Sodom and Gomorrah look like a cupcake party.