Tuesday, April 29, 2008

Osteoporosis drug linked to irregular heart beat

I found this to be a real shocker. I don't see any reason to make any significant changes in clinical decisions -- yet. But it's fascinating that these types of adverse events can be discovered years after the introduction of a medication. And there is no clear connection between the mechanism of action of the drug and atrial fibrillation in any way. I suspect more research will be conducted to follow up on this.

From CTV News:
Women who take popular osteoporosis drug alendronate, known more commonly as Fosamax, are twice as likely to develop a common form of irregular heartbeat compared to those who have never taken it, a new study suggests.

Researchers analyzed data from more than 700 women who had been diagnosed with atrial fibrillation, or irregular heartbeat, in a three-year period and compared them to a control group of more than 900 randomly selected women.

They found a nearly two-fold increase in risk for developing atrial fibrillation among those women who had ever taken alendronate.

The findings were compiled by researchers from Group Health and the University of Washington by analyzing records of patients enrolled in Group Health, a Seattle-based non-profit health-care centre. The study was published Monday in the journal Archives of Internal Medicine. ...more

Pharmaceutical drugs overshadowing heroin

From the National Post:
Heroin is fast being replaced by legal pharmaceutical drugs such as OxyContin and morphine among street users of opioids, suggests a national survey of addicts that underscores the challenges and opportunities of the changing drug trade.

Users of pharmaceutical opioids are less likely to inject their narcotics, which is good for curbing infectious disease, but they are also more likely to mix them dangerously with cocaine, crack and other street drugs, the newly published study indicates.

Meanwhile, experts are struggling to understand a supply system that includes retirees peddling painkiller prescriptions and pharmaceutical company employees selling purloined stock. With Canada one of the world's biggest medical consumers of opioids, which provide users with an anesthetizing release, the abundance of legal supplies has undoubtedly fed the illicit street market, researchers say.

There is an "urgent need" to more closely investigate and comprehend the new opioid scene, says the study published this month in the journal Drug and Alcohol Review by researchers in B.C. and Toronto. ...more

Shoppers Drug profit up 19 pct on chain expansion

From Reuters:
Profit at Shoppers Drug Mart (SC.TO) rose about 19 percent in the first quarter, Canada's largest pharmacy chain said on Tuesday, helped by an aggressive expansion campaign, cost cuts and a tax reduction.

The company also announced a dividend of 21.5 Canadian cents per common share, payable in July.

Shoppers said it earned C$101.3 million ($100.1 million), or 47 Canadian cents a share, in the period ended March 22, up from C$85.3 million, or 39 Canadian cents a share, in the comparable period a year earlier.

Revenue in the quarter was up 10 percent at C$2.02 billion, continuing to climb as the company expands both the size and number of its stores. ...more

U.S. drug arm pushes Jean Coutu into the red

From the Financial Post:
Jean Coutu Group Inc., Canada's second-biggest pharmacy chain, reported a third-quarter loss after losing money on its holdings in U.S. drug retailer Rite Aid Corp.

The net loss was $269.2-million, or $1.08 a share, in the three months through March 1, compared with net income of $232.1-million (89 cents) a year earlier, the Longueuil, Que.-based company said on Tuesday in a statement.

Profit excluding Jean Coutu's (PJC.A/TSX) stake in Rite Aid missed analysts' estimates by 1 cent.

Rite Aid reported April 10 it had a loss of US$952.2-million on an income-tax charge and costs to integrate the Brooks and Eckerd pharmacies it bought from Jean Coutu. The Canadian company holds a 30% stake in Camp Hill, Penn.- based Rite Aid that it acquired as part of its US$4-billion sale of the U.S. pharmacy chains last year. ...more

Health Canada warns against use of Vigoureux

From CTV News:
Health Canada is warning consumers not to use an unauthorized product promoted for the treatment of erectile dysfunction.

In a release issued Friday, officials said the product, Vigoureux, may pose serious health risks, as it was found to contain the prescription drug sildenafil which is not indicated on the product label and should only be used under the supervision of a health-care professional.

Patients with pre-existing medical conditions, including those with heart problems, taking heart medications or at risk for strokes, may be at an increased risk of serious health effects associated with the use of Vigoureux.

Use of sildenafil by patients with heart disease can result in serious cardiovascular side-effects such as sudden cardiac death, heart attack, stroke, low blood pressure, chest pain and abnormal heartbeat. ...more

New HIV finding could prevent drug resistance, toxic side-effects

From CBC News:
Researchers have discovered a new method of attacking the HIV virus which may offer a solution to drug resistance.

Their method involves targeting the proteins of human cells, which bind with the virus. Many of the antiretroviral drugs that are used to fight HIV, the virus that causes AIDS, attack the proteins that exist on the surface of the virus, rendering it incapable of infecting healthy cells.

But as the virus can mutate, these targets can change and render these medications useless, even when physicians prescribe multi-drug "cocktails" that attack the virus on different fronts. ...more

Monday, April 28, 2008

Expensive colorectal cancer drug to go on sale

From the Globe and Mail:
A pharmaceutical company that refused to market one of the world's most expensive cancer drugs due to a cost dispute will sell its medicine to Canadians after all – at a price lower than it had wanted.

Marc Osborne, spokesman for Bristol-Myers Squibb Canada, confirmed that cetuximab will be marketed some time this year at a price agreed to by the Patented Medicine Prices Review Board.

But he said the decision to launch had largely to do with studies showing the drug can prolong the lives of metastatic colorectal cancer patients, in addition to patients with certain head and neck cancers.

“The price issue is behind us,” Mr. Osborne said in a telephone interview from Montreal. “We're going to work at making sure it's available to Canadians beyond the special access program.”

Bristol-Myers Squibb Canada took the unusual move about two years ago of deciding not to launch the drug because the price it wanted to charge was found to be too high by the federal board that regulates the cost of patented medicines to ensure they are not excessive. ...more

Sunday, April 27, 2008

Tough rules coming for cough medicine

From the Batemans Bay Post Star (NSW, Australia)
Children younger than two years will soon have to see a doctor if they need cough syrup.

The National Drugs and Scheduling Committee has decided sedating antihistamines, found in medicines like Demazin and Dimetapp, will be classified as prescription medicines from September 1.

The decision follows reports of bad reactions like agitation, insomnia, hallucinations and oversedation in children in the US and UK.

At the moment, the medicines could only be bought under pharmacist supervision, Surf Beach Pharmacy pharmacist in charge Renee Hall said. ...more

New Psoriasis Pill Appears Effective

From the Washington Post:
A new drug for patients with moderate to severe psoriasis appears to be safe and effective, a Canadian trial shows.

The results indicate higher doses of ISA247, which is a calcineurin inhibitor, significantly improve symptoms of psoriasis. Calcineurin is a protein that helps regulate inflammation.

"This is the first oral medication in 20 years to show promise for the treatment of moderate to severe plaque psoriasis," said lead researcher Dr. Kim Papp, from Probity Medical Research in Waterloo, Ontario.

The new drug is safer and easier to use than current treatments for psoriasis, the researchers said. ...more

News Focus: Doctors or pharmacists?

From the New Straits Times (Malaysia):
Complement each other, not fight. This is the advice given by Health Minister Datuk Liow Tiong Lai to doctors and pharmacists who have been arguing over the right to dispense medicines.
"We are talking about two professional bodies. They should complement each other and not be competing with each other."

He said it could not be denied that both were specialised in their respective fields of work.

Right now, Liow said, the system was such that doctors handled all the functions.

On the issue of separation of duties in the dispensing of medicine, he said: "I had a meeting with the Malaysian Medical Council last week and I will be meeting representatives from the Malaysian Medical Association tomorrow. I will meet representatives from the pharmaceutical industry next week."
Liow said he would decide on the matter after the meetings.

For almost 20 years, pharmacists have been fighting for the return of their right to dispense medications but have been unsuccessful for various reasons. ...more

How some Asian nations handled dispensing split

From the New Straits Times (Malaysia):
Dispensing of medicine by pharmacists and not doctors is not just a western practice. It is the norm in several Asian countries, including India, Korea, the Philippines and even Indonesia.
It became legal in Indonesia in 1964, the Philippines in 1969, India in 1988, and in South Korea in 2000.

It is common to find 24-hour pharmacies in these countries.

Besides 24-hour pharmacies, the Philippines' 72 public hospitals also render 24-hour pharmaceutical services, said Romeo L. Manalo, assistant secretary of the Office of Standard Pacific Affairs at the Philippines' Department of Health. ...more

Plan B pill proposal worries pharmacists

From the National Post:
Canadians could have the most liberal access to the morning-after pill in the Western world, according to critics of proposed changes to how the drug is sold here.

An expert advisory committee has urged that the single-dose version of Plan B be available off the shelf at pharmacies, without women having to consult a pharmacist first. The recommendation would mean people could buy emergency contraceptives much the way they can Aspirin or vitamins.

A women's group has applauded the recommendation as a way to increase access to the pill, but pharmacists are objecting, saying Plan B customers would miss out on the invaluable information and advice druggists currently provide.

"Emergency contraceptives would be more readily available here [under the proposal] than in any developed country," said Janet Cooper of the Canadian Pharmacists Association. ...more

Thursday, April 24, 2008

Woman can now buy cancer drug at cost

From the Halifax Chronicle Herald:
A Guysborough County woman will now be able to buy Avastin at cost from an Antigonish hospital, saving about $400 per dose compared to what she originally paid for the cancer drug.

She and her husband hope others will get the same benefits and that Nova Scotia will eventually pay for the pricey treatment.

Marlene George, 47, was diagnosed with advanced colon cancer a year ago and has been taking Avastin and having chemotherapy for 10 months.

Her husband Blair George said that in getting the drug at cost they’ve won a battle but not the war.

"We’re not special people here," he said Friday. "This has got to be something for everybody for the short term, and in the long term, my fight is for the government to pay for it."

The late Jim Connors, a lawyer, former Dartmouth city councillor and cancer patient, led a strong lobby urging the province to fund the colorectal cancer treatment which he could afford but others could not. ...more

Rexall embraces mosaic with Chinese signage

From the Calgary Herald:
Rexall has opened its first bilingual drug store in Alberta in Calgary's Harvest Hills neighbourhood, its second location in Canada with Chinese signage throughout the store.

Also, the company is catering to the large Chinese community in the area by making available prescription drug labels and instructions for those prescriptions in Chinese.

"What we're trying to do here is be part of the community," said Scott Morrow, vice-president operations for Rexall's western division, of the new 10,870-square-foot store on Harvest Hills Boulevard. ...more

Risk of depression dims hopes for new anti-addiction pills

From the Canadian Press:
Two years ago, Scientists had high hopes for new pills that would help people quit smoking, lose weight and maybe kick other tough addictions like alcohol and cocaine.

The pills worked in a novel way, by blocking pleasure centres in the brain that provide the feel-good response from smoking or eating. Now it seems the drugs may block pleasure too well, possibly raising the risk of depression and suicide.

Margaret Bastian of suburban Rochester, N.Y., was among patients who reported problems with Chantix, a highly touted quit-smoking pill from Pfizer Inc. that has been linked to dozens of reports of suicides and hundreds of suicidal behaviours. The product is sold as Champix in Canada and other countries.

"I started to get severely depressed and just going down into that hole ... the one you can't crawl out of," said Bastian, whose doctor took her off Chantix after she swallowed too many sleeping pills and other medicines one night. ...more

Wednesday, April 23, 2008

Heart tests urged before children take ADHD drugs

From the Ottawa Citizen:
Every child prescribed Ritalin or other ADHD drugs should first get heart tests to check for conditions that could put them at risk of sudden unexpected death, U.S. experts are recommending.

The drugs --among the most widely-prescribed pills to Canadian children -- can increase blood pressure and heart rate, side effects that could be dangerous for children with known heart problems or heart defects.

But some children can have undiagnosed heart conditions without showing any symptoms.

"They might get a little bit dizzy when they exercise or they might feel fluttering heartbeats or a near fainting spell that they don't bother to worry about," says Dr. Catherine Webb, professor of pediatrics at Northwestern University Feinberg School of Medicine in Chicago and chair of the council on cardiovascular disease in the young at the American Heart Association. ...more

Friday, April 18, 2008

Alberta unveils health 'action plan'

From the Calgary Herald:
Health Minister Ron Liepert unveiled an "action plan" for reforming the provincial medical system Wednesday morning, but he suggested the sizeable shortage of doctors in Alberta is far from being the only problem facing health care.

Liepert outlined proposals government will consider during a nine-month overhaul of the $13-billion health system, ranging from a new governance model for the province's health regions to monitoring infection control standards.

The plan also moves to address shortages of nurses and doctors, a problem that is so acute in Calgary that an estimated 200,000 people don't have a regular family physician. But Liepert also expressed doubt about the "so-called shortage of doctors."

"Let's not just jump to the conclusion that we have to run out there and hire 1,500 doctors. There are other ways of addressing this problem," Liepert said at the legislature, referring to plans to add physician assistants and give pharmacists more power to manage chronic diseases. ...more

Thursday, April 17, 2008

Ontario urged to cover cancer drug

From the Toronto Sun:
Alain Gourd lives on the other side of the Ottawa River in Quebec -- and for him it has been the difference between life and death.

Gourd, a former deputy minister of communications for the federal government, was diagnosed with advanced colorectal cancer in March 2003. It had spread to his liver and lungs, and the resident of Gatineau was told he had six months to live.

"I had 14 metastasized cancer nodules on two lungs and I could not go for surgery. I was cooked. I started chemotherapy with Avastin and after two years of treatment the tumours diminished from 14 to three," he said yesterday.

Saskatchewan, Newfoundland, British Columbia and Quebec have made Avastin available through public funding. Ontario has not. ...more

Wednesday, April 16, 2008

Studies allege Merck manipulated Vioxx data; journal calls for ethics overhaul

From the Canadian Press:
Two new studies suggest drugmaker Merck and Co. manipulated data on its withdrawn drug Vioxx, was slow to disclose adverse events associated with the painkiller and used academic researchers to enhance the credibility of scientific studies largely written by Merck employees.

The articles were based on company documents made public as a result of thousands of lawsuits levelled against Merck and Co. after it withdrew the former blockbluster medication from worldwide markets in September 2004 because studies revealed people who used it were at higher risk of heart attacks and strokes.

They were published Wednesday in the Journal of the American Medical Association, which also ran a damning editorial calling on everyone in the business of clinical research to pull up their socks, starting with doctors.

"The profession of medicine in every aspect - clinical, education and research - has been inundated with profound influence from the pharmaceutical and medical device industries," editor Dr. Catherine DeAngelis and deputy editor Dr. Phil Fontanarosa wrote. ...more

When an orphan drug is a patient's only hope

From the Globe and Mail:
Denise Halpenny's biggest fear is losing use of her left hand when she quits taking the drug for multiple sclerosis that she can no longer afford.

She and her husband Scott, a high school teacher, have struggled with the possibility. They've decided that if her hand goes, the mother of three will have to leave their family home here and move into a long-term care facility.

Multiple sclerosis, which struck Halpenny in 1986, has already robbed her of her ability to walk and taken away use of her right arm.

"Things will change dramatically for me," she said, fighting to hold back tears.

What frustrates the 49-year-old as much as the disease are bureaucratic rules that mean she has to come up with the money for the drug Zenapax, although the cost is equivalent to other MS drugs that are covered by the province. ...more

Monday, April 14, 2008

Medical marijuana users more than $500,000 in arrears with Health Canada

From the Canadian Press:
Medical marijuana users are on the hook for more than $500,000 in unpaid bills for government-certified weed, raising questions about the effectiveness of Health Canada's troubled dope program.

Newly disclosed statistics show that Health Canada has sent final notices - and sometimes dispatched a collection agency as well - to 462 registered users since government marijuana first became available in 2003.

"Most of the 462 individuals who have received a letter regarding their accounts in arrears have had their shipment ceased," department spokesman Paul Duchesne said in an e-mail.

The unpaid bills, totalling $554,255 as of Dec. 31, have tripled in value in the last two years and have resulted in some seriously ill citizens returning to the black market for their medication. The marijuana distribution service was specifically designed to give patients a legal alternative to street dope. ...more

Health Canada looking for firm to grow its medical marijuana

From the Canadian Press:
Health Canada is looking for someone to grow its weed.

The department served notice Monday it will soon invite firms to bid on a contract to cultivate and distribute medical marijuana, which is now being done in Flin Flon, Man., by Prairie Plant Systems Inc.

The winning firm will be expected to deliver a steady stream of government-approved dope to certified medical, users starting in the fall.

Health Canada posted a notice on a government tenders website saying it would put out a formal request for proposals in the spring of 2008, without specifying a date. ...more

Loophole clears path for direct-to-consumer drug ads, critics charge

From the Globe and Mail:
A Conservative amendment leaves open a loophole that could allow pharmaceutical companies to directly advertise drugs to consumers.

It's a move critics say could drive up health-care costs and influence which drugs people take.

Under an amendment to the federal Food and Drugs Act, the government could authorize companies to promote drugs and their benefits directly to consumers through television, radio and print commercials, as they do in the United States.

The change was included in sweeping updates to food, drug and consumer product safety laws that Prime Minister Stephen Harper introduced at a news conference earlier this week.

A Canadian expert on direct-to-consumer advertising condemned the change and said it could have wide-reaching consequences on the health-care system and the treatment Canadians receive. ...more

Sunday, April 13, 2008

Scientists pop Ritalin to sharpen thinking

From the Calgary Herald:
One-fifth of the world's professional scientists and university science students have used "cognition-enhancing" prescription drugs to help them concentrate, according to a survey by a top research journal.

The most common of these "steroids for scientists" is the amphetamine Ritalin, says the journal Nature.

And while some officials at Canadian universities expressed surprise at the finding, others said the practice is well-known, usually using drugs to keep awake and alert.

A student diagnosed with attention deficit disorder, which is treated with Ritalin, can become very popular at exam time or when essays and lab work are due, they say. ...more

New drug rules: life-saver or safety risk?

From the Globe and Mail:
The pharmaceutical industry, health experts and patient groups across Canada are strongly divided over whether the federal government's proposed new system for approving and monitoring drugs will result in harm or benefit to Canadians.

Under the proposed new "progressive licensing" system, Health Canada "will shift the focus from pre-market assessment to continuous assessment" of drugs, according to an article written by departmental officials and published last June in the Canadian Medical Association Journal.

The new system will "support timely access to drugs and provide a mechanism for the continuous monitoring and reassessment of a drug's safety" throughout its life cycle, states the article.

Some advocacy groups say the move is a much-needed development that will improve access to breakthrough, live-saving drugs or treatments for rare diseases. ...more

Heparin probe highlights challenges of regulating global drugs market

From CBC News:
On a dusty lane in east China, a small factory sitting amid strawberry and vegetable fields processes chemicals from pig guts into heparin, a commonly used blood thinner linked to 62 deaths and hundreds of allergic reactions in the U.S. and Germany.

The mysterious problems with heparin from the factory and others like it - China's deadliest product quality scandal since Chinese cough syrup killed 93 people in Central America a year ago - dramatically illustrate the perils of shifting drug production offshore.

With recalls of heparin products now in six countries, it is an issue that regulators are scrambling to address. Some specific heparin products and certain lots from B. Braun Medical Inc. that were distributed in Canada are among those recalled in recent weeks. ...more

Pharmacies to withdraw from drugs scheme

From Irish Business News:
Several hundred pharmacists plan to pull out of community drugs schemes in a dramatic escalation in the row over drug payments.

Up to 400 pharmacies have told the Health Service Executive (HSE) of plans to suspend services or terminate their contracts with the state from May 1, according to sources close to the stand-off between pharmacists and the HSE.

In some counties, including Mayo and Donegal, almost all pharmacies have contacted the HSE about ceasing current arrangements. This could leave medical card patients without access to medicine in some areas, although the HSE has drawn up contingency plans to deal with this scenario. ...more

Friday, April 11, 2008

'Suicidal' urges among reactions to stop-smoking pill

From the Ottawa Citizen:
Nearly half of reported suspected drug reactions in people taking the popular anti-smoking pill Champix involve psychiatric reactions, including seven people who became suicidal while on the drug, a new federal report shows.

In the first eight months after Pfizer Inc. began marketing its smoking cessation drug last April, Health Canada received 107 reports of adverse drug reactions suspected of being associated with Champix.

Of these, 46 involved psychiatric reactions including aggression, depression and suicidal thinking. Others involved amnesia, abnormal dreams, anxiety, insomnia, and abnormal thinking. 'Suicidal' urges among reactions to stop-smoking pill

NDP questions Williams over PR role in cancer drug approval

From CBC News:
Newfoundland and Labrador's governing Tories were focused on public relations, not just health, while approving a new cancer drug, the New Democratic Party says.

In October 2005, then Health Minister John Ottenheimer solicited cabinet support for subsidizing Herceptin, an expensive but effective drug offered to breast cancer patients in the early stages of the disease.

The briefing document, which has been tabled as an exhibit at the judicial inquiry now examining how a St. John's pathology lab produced hundreds of inaccurate hormone receptor test results, included arguments in favour of approving the drug. ...more

Wednesday, April 09, 2008

Experts sound alarm on drug-approval plan

From the Globe and Mail:
The federal government moved yesterday to meet intense pressure to get new drugs on the market faster while maintaining rigorous safety requirements, but health experts warned that Canadians could be exposed to medicines that are approved too quickly to ensure safety.

The government introduced sweeping changes to the way drugs are approved and monitored such that they will require safety checks before and after they reach the market. The changes are among consumer-product safety measures unveiled in Ottawa.

Health Minister Tony Clement said the rules won't water down safety requirements for new drugs, and the continued monitoring will improve the government's ability to spot problems.

"I can assure you we are not going to change our standards or change our stringent review," Mr. Clement said in an interview. "Our work is going to remain as intense." ...more

Possible link between flu drugs, deaths and hallucinations

From the Calgary Herald:
Health officials are investigating whether Relenza - a drug provinces have stockpiled in case of a pandemic flu outbreak - can be linked to fatal reactions or abnormal behaviour in children.

Dr. Patricia Huston, interim director of pandemic preparedness for the Public Health Agency of Canada, confirmed Monday that pandemic flu experts are studying the matter with Health Canada.

The investigation is a response to recently updated safety warnings issued by the U.S. Food and Drug Administration (FDA) or Relenza. In March, pharmaceutical giant GlaxoSmithKline updated Relenza's safety labels after children in Japan were reported to suffer from delirium, hallucinations. Some died after injuring themselves. ...more

Mixed reactions to Ottawa's new drug safety proposals

From CBC News:
Federal government proposals to change the way drug safety is monitored in Canada have drawn a mixed response.

On Tuesday, consumer safety legislation was tabled in the House of Commons that includes requirements for health-care institutions to report adverse drug reactions, demands continuing surveillance of drugs after they've been approved and raises fines for unsafe drugs from $5,000 to a minimum of $5 million.

While some experts say the new rules will improve the government's ability to protect the public, critics say it has the potential to expose Canadians to more risk.

Dr. Joel Lexchin, a York University professor in Toronto, says he's concerned that the bill would give the federal health minister the ability to fast-track drug approvals. ...more

Druggist takes on province

From the Toronto Star:
Toronto pharmacist Chaim Wrightman took his fight with the Ontario health ministry to Superior Court yesterday, in a case with potential impact on how the elderly receive medication.

The battle started over pill packs, those cases with individual compartments for medication prescribed by a doctor and divided by the pharmacist into daily and weekly doses. In Ontario, most users of the packs are covered under the Ontario Drug Benefit Program.

While the battle started over pill packs, it has now escalated into a fight over the pharmacist's right to bill under the massive drug benefit plan that costs Ontario $3 billion a year.

Wrightman had wanted to keep dispensing the packs and being paid for it. The Ontario government first tried to stop him in 2007 by ordering him to reimburse $250,000 in dispensing fees on pill packs over seven years. ...more

High cost of living

From the Welland (Ont.) Tribune:
Kevin Bigford feels the province’s health system has let him down.

Its decision to not fund a drug that could extend his life caught the former Port Colborne resident completely by surprise when his oncologist laid out the cold facts about the cancer-fighting drug Avastin.

Because Avastin is still before the province’s committee to evaluate drugs, the Ministry of Health won’t fund it – even though four other provinces will.

“While they won’t come right out and say so, it’s about money,” Bigford said in a recent telephone interview from his home in Kitchener.

Avastin has a proven track record in extending the lives of patients with colorectal cancer, but the treatment comes with a crippling financial cost. One treatment of Avastin costs Bigford just under $3,000. He needs two treatments per month – about 20 in total.

In 2007, the Canadian Cancer Society estimated that 20,800 Canadians would be diagnosed with colorectal cancer and 8,700 people would die from the disease. One in 14 men is expected to develop colorectal cancer in their lifetime. It is currently the second leading cause of death. ...more

Tuesday, April 08, 2008

Pfizer Wins Canadian Order Blocking Generic Version of Lipitor

From Bloomberg:
Pfizer Inc., the world's biggest drugmaker, won a Canadian appeals court ruling blocking regulatory approval of Ranbaxy Laboratories Ltd.'s generic version of the cholesterol pill Lipitor.

Canada's Federal Court of Appeal yesterday reversed a lower-court ruling that Ranbaxy could seek approval for its competing version of Lipitor before Pfizer's patent expires in 2010, Pfizer spokeswoman Vanessa Aristide said in a phone interview.

Ranbaxy, India's largest drugmaker, also challenged Lipitor patents in the Netherlands. Pfizer said in February it would appeal a Dutch ruling invalidating one of its patents covering Lipitor, the world's best-selling medicine with ales of $12.7 billion last year. Ranbaxy can appeal yesterday's ruling to Canada's Supreme Court. The order doesn't apply to litigation in other countries, including the U.S., Aristide said. ...more

FDA cites 62 reports of possible heparin deaths

From Reuters:
U.S. regulators have received 62 reports of deaths during the last 15 months of patients who were treated with the blood-thinner heparin and suffered allergic reactions or low blood pressure, the Food and Drug Administration said on Tuesday.

Those are the problems that prompted Baxter International Inc to recall most of its heparin products in February. ...more

Monday, April 07, 2008

Drug warning linked to less help, more suicides

From CTV News:
A new study has found that fewer young people received treatment for depression and suicides rose among children and adolescents following a Health Canada warning about the use of antidepressants.

Researchers from the University of Manitoba analyzed data on prescription and health care use by almost 3 million children, adolescents and young adults. They looked specifically at the nine years before the warnings were issued in 2004 and the two years after. ...more

Rated Rx

From the Globe and Mail:
The first time, Allard Gee popped the little blue pill in secret and then slipped into bed. At 59, after a three-year dry spell, he couldn't be sure it was going to work. Better not to start the night with big expectations.

"It was a very unexpected pleasure," giggles his wife, Joyce, taking over the story. "Afterwards, we got up and had a drink and made a toast to good health. Had we known, we would have gone to the doctor sooner."

Ten years ago this month, wine glasses were clinking in bedrooms across North America, as men joined Mr. Gee in hustling to their doctors for a brand-new sex elixir called Viagra — named for "the vigour of Niagara" and promising to get the job done without the dreaded stab of a needle or the drastic step of an implant.

The Gees, who live in the Eastern Ontario village of Gilmour, enjoyed an early supply as part of a clinical trial. Many of their fellow Canadians, forced to wait one more year for Health Canada approval, scampered across the border. In the first six months, American doctors wrote 5.3 million prescriptions for the drug, which works by increasing blood flow to the penis within about an hour of being ingested.

The blue pill rivalled Monica Lewinsky's notorious blue dress as the story of the year for 1998 — and together, arguably, they took the blush off the public discussion of sex once and for all. ...more

Experts unfazed by drugs in water

From the Toronto Star:
Painkillers and other drugs that are flushed down toilets will inevitably pour out of household taps in trace amounts around the world, a University of Toronto expert says.

Civil engineer Ron Hofmann, who specializes in drinking-water toxins, says a recent report finding painkillers, antibiotics and cholesterol-lowering drugs in the water coming from 15 southern Ontario treatment plants was "not surprising at all" to people in the field.

"There's a raft of studies that show these (drugs) are coming through the waste water treatment plants." he said.

Hofmann said the drugs enter the water supply when people pass trace amounts of unmetabolized medications through their urine, or throw unused pills down the sink or toilet. ...more

Sunday, April 06, 2008

The pharmacist will see you now

From the Los Angeles Times:
Twice a week, Stephen Inns sees patients with high blood pressure at his office in a medical practice in southern England. Usually he conducts a few quick tests, asks them how they're doing and adjusts their medicines if necessary.

Inns isn't a doctor; he's a pharmacist.

He is one of fewer than 100 pharmacists across Britain recently given permission to prescribe drugs for patients and provide basic care, without relying on a doctor. The move is part of Britain's attempt to expand its healthcare system by allowing medical professionals such as nurses and pharmacists to treat patients.

Though many countries are slowly loosening the rules on non-doctors giving out medicines, none has given pharmacists as much power as Britain has in its effort to increase services and cut costs in a financially overburdened health system.

In 2006, Britain expanded the powers of pharmacists to treat patients once they took a training course. Though the number of prescribing healthcare professionals other than doctors remains small, their ranks are growing -- and the government hopes they will someday become the norm. ...more

Regina business changing owners after 55 years

From the Regina Leader Post:
After 55 years of ownership by the Ast family, Hill Avenue Drugs has been sold.

But don't mention retirement to Dean Ast.

"Please do not say that I'm retiring," said the 46-year-old pharmacist with a laugh. "It was time for a change but I'm not retiring. Obviously pharmacy and health care are still interests."

Andrew Gilbertson became the store's new owner on April 1 but he's not a new face behind the dispensary. The pharmacist has worked with Ast for almost four years.

"We had talked about a buyout and some time last year it felt right to sell," Ast said. ...more

Bogus pharmacist case scrutinised

From BBC News:
The medicines regulator is re-examining how a bogus pharmacist bought large quantities of slimming pills and got funding from a pharmaceutical giant.

Robin Huxley, a salesman from Barnsley, was jailed last month for 14 months for illegally prescribing Xenical.

Roche, which markets Xenical, believed Huxley was a pharmacist running a group of slimming clinics alongside a doctor.

The company says it was simply the victim of crime, but an ex-employee has raised concerns about its practices.

Dr. Ryta Kuzel, the former head of regulatory affairs, said: "I feel strongly Roche's business practices have put people's lives at risk and they haven't been called to account." ...more

New prescription law to take effect

From the Charleston (SC) Post and Courier:
Prescription cheaters beware. As of April 1, all Medicaid prescriptions must be written on tamper-resistant pads.

The move could save taxpayers up to $355 million in the next decade, according to the Congressional Budget Office.

After a six-month delay of the initial enforcement date, Oct. 1 2007, most in the medical community seem well-prepared for the switch.

"There's no indication they're not ready for the change," said Jeff Stensland, director of public information for the state's Medicaid agency.

Judi Bucknam, manager of Medical University of South Carolina's 20 adult medical surgical clinics, said that the whole hospital will go over to the tamper-resistant prescription pads Tuesday.

Before, prescriptions were written on regular laser jet printer paper, she said. A ream of regular paper runs about $6, she said. The new paper costs $64 a ream. ...more

City chemists go back to school to study international standards

From Viet Nam News:
About 300 pharmacies will be invited to training courses after representatives from 150 of HCM City’s major pharmacies attended the city’s first Good Pharmacy Practice (GPP) programme.

The next courses – intended to help pharmacists standardise their stores – will be held in July and August.

The programme, organised by the HCM City Health Department, follows a Health Ministry announcement that all the country’s pharmaceutical chemists will have to meet GPP standards by 2011.

GPP requires pharmacy owners to have a pharmacist’s certificate, drugs to be stored at below 30 degree Celsius and medicines to show both their origin and clear instructions for their use. ...more

Coles's pharmacy role in doubt after court ruling

From the Sydney (Australia) Morning News:
Wesfarmers-owned Coles's back-door entry into the $9 billion pharmacy sector appears under threat after a court ruled that its purchase of a Sydney-based cut-price pharmacy chain may have breached laws restricting ownership to qualified pharmacists.

The threat comes after the NSW Supreme Court judge Peter Young ruled yesterday that because Pharmacy Direct, a mostly online chemist that Coles bought two years ago, is not owned by a pharmacist, it has breached the pharmacy act.

Justice Young is yet to make his final orders, but when the case resumes later this month he could force Wesfarmers to transfer or sell Pharmacy Direct to a pharmacist or pharmacist-owned corporation.

The retailer, which Coles bought for $56 million, is one of only 30 pharmacies in NSW that operates under a corporate licence. It claimed it had been acting lawfully since Coles bought the business in 2006 from the founder and pharmacist Peter Brown. However, Coles was widely criticised by the industry as having used a loophole to encroach on the territory held by mostly independently owned chemists. ...more

Database puts the squeeze on addicts who rob pharmacies

From the Seattle Post Intelligencer:
Just weeks before last Christmas, Nicholas A. Dent fed his addiction to painkillers through a relentless show of force. In 10 days, he robbed a dozen pharmacies for OxyContin pills before stepping in front a security camera that revealed his identity to police.

Dent, 28, is one of many drug addicts over the past few years behind a spike of violence against pharmacies.

Federal authorities went after the pharmaceutical company making the painkiller, Purdue Pharma, for misleading doctors about the drug's addictiveness. The company was made to pay more than $600 million in fines.

But Purdue has also joined police and crime-prevention groups to stop addicts with a heavy dose of information technology.

Early last month, police officers and pharmacists in the Seattle area were introduced to RxPatrol, a nationwide database of robberies, break-ins and forged prescriptions at pharmacies. ...more

More layoffs, cuts as U.S. drug makers face generics, other woes

From CBC News:
U.S. drugmakers beset by growing generic competition, few new blockbusters, drug safety concerns and pressure from insurers and government health programs to discount prices are cutting tens of thousands of jobs.

Nearly all of the 10 largest pharmaceutical companies in the U.S. are restructuring, with some, such as Schering-Plough Corp., announcing plans to trim 10 per cent or more of the work force.

Since 2007, eight of the world's biggest drugmakers have announced the elimination of more than 42,000 jobs; two other major companies have eliminated another 12,200 jobs in the last few years.

"There are a lot of things going on making this the perfect storm for the industry," said Argus Research health-care analyst Martha Freitag. "My sense is maybe we're halfway through" the cost-cutting.

Today's struggles come after the industry's golden era in the 1990s, when a slew of new drugs quickly became blockbusters, fuelling almost routine double-digit quarterly profit increases and rising stock prices and dividends. ...more

Drug Makers Near Old Goal: A Legal Shield

From the New York Times:
For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted. ...more

Thursday, April 03, 2008

MD: ‘So far, so good’ on Pharmacare

From the Halifax Chronicle Herald:
A Halifax doctor says the province’s month-old family Pharmacare program has helped some of her patients get the drugs they need.

"So far, so good," rheumatologist Dr. Dianne Mosher said Wednesday.

Nova Scotia has the highest prevalence of arthritis in Canada.

Earlier this year, Arthritis Consumer Experts, a national education organization for people with the inflammatory joint disease, gave the province a C-minus grade for access to medically necessary treatments.

But the family drug program, which began March 1, is meant to help the 30 per cent of Nova Scotians who have no private drug insurance afford the medications they need. ...more

Spring clean your medicine cabinet

From the Calgary Herald:
Cleaning out the medicine cabinet is like cleaning out the fridge, but with a lot less "ewwws!"

The expired medications and health stuff you find may be years past the best-before date, but at least it's not leftovers covered in fuzzy green mould or foul-smelling, stomach-turning black slime.

The worst thing Kory Sloan of St. Albert, Alta., encountered while cleaning out his grandfather's cupboards was a bottle of really old pain-relieving tablets that smelled like vinegar. The smell is a sign the medication has gone bad.

Not that you should stick your nose into an expired container before deciding to chuck it out.

"The first thing they teach you in pharmacy school is don't put your nose into anything," says Edmonton pharmacist Ali Damani.

"If it's toxic, you could pass out from it." ...more

New Brunswick to set up online drug-control program

From CBC News:
The New Brunswick government has awarded the contract for development of an online drug control program to Medavie Blue Cross of Moncton.

Health Minister Mike Murphy made the announcement Tuesday afternoon in the provincial legislature in Fredericton.

The program will allow the province to track the use of prescribed narcotics like OxyContin, which is a group of drugs similar to morphine, and Dilaudid, a derivative of morphine.

The program will also monitor the prescribing patterns of doctors and drug patterns of patients, Murphy said.

Pharmacists will be taught how to use the new online program, Murphy said.

"All of the province's approximately 190 community pharmacies will be linked in the system, and pharmacists trained over a period of about one year," Murphy said. ...more

Program to teach docs new options

From Surrey (BC) Now:
n a bid to stem the soaring cost of prescription drugs, the province has launched a new program aimed at educating doctors about new therapies.

Under the academic detailing program, a pharmacist will visit physicians one-on-one and educate them on the latest information and research findings on various medications.

Research shows that a key source of information on prescription drugs for doctors after medical school is drug manufacturers, who have a vested interest in promoting their products.

Health Minister George Abbott says doctors need an independent source of information.

Abbott said putting people on the best drug regime at the start of their treatment is better for patients and will ultimately curb the rising cost of PharmaCare. ...more

Natural remedies, drugs may pose danger

From the National Post:
A surprisingly large number of children are taking combinations of natural-health products and drugs that could trigger harmful reactions in the young patients, new Canadian research suggests.

A false sense among some parents that natural remedies are completely safe seems to underlie the problem, said one of the study's authors.

Researchers found that nearly one in five children who showed up at a B.C. emergency ward had been given natural remedies and other medicines that could have negative -- and sometimes serious -- interactions, the study found.

The natural products ranged from common vitamins to ginger, echinacea and St. John's wort.

The research, just published in the Journal of Pediatrics, did not delve into whether the combinations of products did, in fact, cause such harm. ...more

MDs marvel at blood pressure drug combo

From the Toronto Star:
An international drug trial that could change the way high blood pressure is controlled has shown a combination of two common hypertension medications can bring the often-lethal condition under control, even in the most dangerous cases.

In the trial, which was stopped early because the results were so positive, researchers found patients who took a so-called ACE-inhibitor and CCB combination pill suffered 20 per cent fewer major cardiac events, including death from heart attack and stroke.

The drug combination also effectively controlled blood pressure levels for 80 per cent of patients with the most serious hypertensions.

The interim results, which doctors say should "shake the foundations" of current treatment, were presented yesterday at a meeting of the American College of Cardiology in Chicago.

Study leader Dr. Kenneth Jamerson, professor of internal medicine at the University of Michigan, said an independent monitoring board recommended ending the trial after only 60 per cent of the data had been collected because the results were so conclusive and could potentially benefit millions of patients. ...more

Teen fears he may die without test drug

From the Globe and Mail:
An Alberta teenager fears he could die within six months if he cannot get an experimental drug for an extremely rare disease.

Seventeen-year-old Trevor Pare suffers from Pompe Disease and has been taking the drug Myozyme for the past four years as part of a clinical trial.

But the trial runs out at the end of May, leaving his family on the hook for the nearly $500,000 annual cost.

Pompe is a hereditary disease caused by a mutation in the gene that produces the enzyme alpha-glucosidase, which the body needs to break down glycogen. ...more

Tuesday, April 01, 2008

Take a clean pill

From the Halifax Chronicle Herald:
BRENT FAY has helped make chocolate trays and winter tires, and all that experience came in to play developing a brand new product that prevents potentially deadly reactions in people who are taking medicine.

Mr. Fay and his partner Michael Jarvis are making the world’s first self-cleaning pill dispensing system, and they’re doing it out of their machine shop in Chester.

It’s been tested by the National Research Council, where scientists have proven it is a drastic improvement over the traditional plastic trays pharmacists use to dispense pills.

The two men recently incorporated their business under the name Clean Count Inc. and are awaiting the patent for their system. ...more

Psychiatric drugs causing weight gain: doctors

From the Vancouver Sun:
The very drugs millions of Canadians are taking to get through their day can cause dramatic weight gain, doctors are warning.

Psychiatric drug-related weight gain "is a huge problem," says Dr. David Lau, chair of the diabetes and endocrine research group at the University of Calgary and president of Obesity Canada.

"You can see patients gaining 10, 20, 30, 40 pounds," Lau says.

Not everyone taking antidepressants, mood stabilizers or newer generation antipsychotics will gain weight, he stressed. What's more, he said new antipsychotics, so-called "atypical antipsychotics" have been "tremendous in terms of bringing back the functionality of people with schizophrenia, bipolar disorders and depression." ...more