Steve Anthony: True Canadian Pharmacy

In every instance, the published article made the drug look better than it would have. We cannot be certain that selective reporting was a decision made by employees of Pfizer and Parke-Davis, since the authors of the published reports included nonemployees, the researchers wrote. 3 billion US — including an unprecedented $1. According to the report, when a company-funded study’s primary finding wasn’t favorable, that result was usually buried  and something else positive was highlighted, without disclosing the switch. This results in harm. Sidney Wolfe, head of health research at consumer group Public Citizen, called it the first comprehensive look at studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was. In eight of the 12 published studies, the main outcome listed in internal documents differs from the one later given in the published report. Experts believe most Neurontin sales were for off-label uses — the ones in the reviewed studies.

The documents used in the review were obtained by lawyers suing Pfizer for refunds on prescriptions paid for by insurers and consumers.
— Dr. The study descriptions also list their primary and secondary outcomes. By last year, Neurontin sales fell to $387 million US due to cheaper generic versions sold as gabapentin. gov, to be eligible for publication. Pfizer disputes the report’s conclusions, saying the company never attempted to mislead the medical community about the effectiveness of the drug for certain uses. While doctors can prescribe drugs for unapproved, or off-label uses, drug companies are legally barred from promoting their products for such uses. The report appears in Thursday’s New England Journal of Medicine. 2-billion US criminal fine — for illegally marketing other blockbuster drugs. In every instance, the published article made the drug look better than it would have, said Wolfe, a member of the Food and Drug Administration’s drug safety advisory committee. We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research, Pfizer said in a statement. Sales peaked at $2. But they don’t always seek approval for those new uses, particularly if the new findings aren’t convincing.

Drugmakers often test drugs for additional conditions and publicize the results. Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics, called the report one of the most ethically disturbing papers I’ve read in some time and an indication that people have been playing fast and loose with studies, particularly industry ones. epilepsy drug found that reporting of the results was often misleading, indicating the medicine worked better than internal company documents showed. Medical journals in recent years have required that studies be listed on a federal website, called ClinicalTrials. Its potential side-effects include suicidal tendencies and depression. In half the cases, a new primary outcome was substituted and in others, the original main outcome was instead reported as a secondary measure or wasn’t disclosed at all. One of the report’s authors is an expert witness for the plaintiffs; another has received fees from the lawyers. The studies were published in medical journals or presented at conferences, mostly over the last decade. Wolfe said there should be bigger fines and jail terms for manipulating study data, plus tougher rules for studies being published in journals. Dr. For the new review, the researchers examined 20 patient studies funded by New York-based Pfizer and its Parke-Davis unit on use of Neurontin for preventing migraines or treating nerve pain or bipolar disorder. The lawyers, who are seeking class action status for the cases, claim Pfizer concealed evidence the epilepsy drug Neurontin didn’t work for those unapproved uses, including nerve pain, migraines and bipolar disorder. Caplan said the FDA should have the power to audit industry drug studies. That move was made partly to make it harder for industry to hide studies on products that don’t pan out and only publish those with good results. Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. The report, by researchers at the University of California at San Francisco and the Johns Hopkins Bloomberg School of Public Health comes two months after Pfizer was fined a record $2. Pfizer said it now has 1,245 company-sponsored studies listed on the website.

Neurontin was approved by the FDA a decade ago for treating seizures and later for pain caused by shingles — but not for other conditions. The authors cited some limitations to their review, including not knowing who made the changes. 7 billion US in 2004, when Pfizer paid $430 million US in government fines to settle allegations it improperly marketed the epilepsy drug for unapproved uses.

p The scandal-plagued agency, tasked with electronically filing the province’s health records, caused public outrage and raised the ire of the opposition after a CBC News report uncovered millions of dollars worth of untendered contracts and expense abuses by consultants being paid $2,700 a day. Premier Dalton McGuinty has already apologized for the spending scandal at the agency, but the governing Liberals have thus far rejected calls for a full !–more– all-party review. The opposition parties in the legislature have renewed their call for a review of eHealth. At a special meeting of the government agencies subcommittee on Thursday, the opposition parties recommended an all-party review of the troubled Ontario health agency. The agency is on its third CEO in three months after the original CEO, Sarah Kramer, was shown the door on June 7 after seven months on the job. But last month, Health Minister David Caplan agreed to a request from eHealth to drop the outside review, saying it would duplicate the work of Ontario’s auditor general, who is set to release a report on the agency in September. The public wants to know that MPPs are taking this scandal seriously, and they want to make sure the government is doing everything in its power to get to the bottom of all that is wrong with eHealth, MacLeod said. The onus is now on the McGuinty Liberals to do the right thing and use their majority to give us the green light when the legislature resumes, MacLeod said. In June, the government said PriceWaterhouseCoopers would look into procurement practices at the agency. The recommendation now moves on to the Liberal-dominated main committee, which will decide whether or not to proceed. Progressive Conservative MPP Lisa MacLeod requested the special meeting on Thursday, with the support of the NDP.

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p I. , says the province’s chief health officer. E. certainly has very high rates of skin cancer. might impose. E. Heather Morrison
The Island government is reviewing its Public Health Act, and Dr. That prompted the World Health Organization to upgrade its health warning for the devices to the highest level, along with cigarette smoke. I.
Tanning beds were the subject of an article published in the medical journal Lancet Oncology this week. !–more– Morrison said it was too early to say what kinds of regulations P. It concluded tanning beds and sun lamps are carcinogenic. We have had concerns about tanning beds, so we have already asked that tanning beds be included in that review of the radiation safety regulations, Morrison told CBC News Thursday. The Canadian Cancer Society asked the New Brunswick government this week for an explanation of how that ban is enforced. E. E. New Brunswick is the only province in Canada that restricts the use of tanning beds. Those under the age of 18 aren’t allowed to use them. Heather Morrison wants tanning beds included in regulations that cover the use of devices that emit radiation, such as X-ray machines. ‘We know that P. I. We know that P. certainly has very high rates of skin cancer. ‘
— Dr. I. Tanning beds could soon be regulated on P.

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p Food and Drug Administration say Aspirin is indicated for primary prevention to reduce the risk of a first non-fatal heart attack in people deemed at risk by their physicians, which the packaging also suggests. In the secondary prevention studies among people who had already had a stroke or heart attack and were at high risk for another, Aspirin reduced the risk of serious vascular events by about a fifth — a benefit that clearly outweighed !–more– any small extra risk of bleeding. They stressed the importance of making lifestyle changes such as quitting smoking, eating a healthy diet and getting regular exercise, in addition to considering drugs like Aspirin or cholesterol-lowering statins. 57 per cent to 0. But the value of its long-term use by healthy people is uncertain, given the increased risk of internal bleeding. In a commentary accompanying the review, Prof. Colin Baigent of the University of Oxford in London and his colleagues performed a review of studies documenting serious vascular events like heart attacks and strokes, and major bleeds in six trials involving 95,000 people at low to average risk, and 17,000 people at high risk. 10 per cent year). For primary prevention, Baigent and his colleagues found no significant difference in risk of serious vascular events (risk of serious vascular events dropped from 0. Ale Algra and Dr. Prof. S. Aspirin and ASA are generally recommended to prevent non-fatal heart attacks among people who already had a heart attack or stroke. 07 per cent to 0. 51 per cent per year with the use of Aspirin), but the small risk of internal bleeds increased by about a third in those taking Aspirin (from 0. Their findings appear in this week’s issue of the medical journal The Lancet. Jacoba Greving of the University Medical Centre in Utrecht, Netherlands, agreed that in most cases, Aspirin is not justified for primary prevention. Healthy people shouldn’t take Aspirin to prevent heart disease, a new review suggests. That finding backs current guidelines for Aspirin’s use. Aspirin is generally recommended to prevent non-fatal heart attacks among people who have already had a heart attack or stroke. The currently available trial results could well help inform personally appropriate judgments by individuals about their own use of long-term Aspirin, they do not seem to justify general guidelines advocating the routine use of Aspirin in all healthy individuals above a moderate level of risk for coronary heart disease, the study’s authors concluded. Health Canada and the U. Patients might not wish to be medicalised — such considerations are important in the decision to take Aspirin or not, the pair wrote. There is no good evidence that the benefits of long-term use of Aspirin exceed the risks by an appropriate margin for tens of millions of healthy men and women of all ages worldwide who could potentially be affected, Baigent said.

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Eating vegetables raw or lightly steamed is a healthier option than boiling. To rank the foods, Anand’s team used criteria developed by Sir Austin Bradford Hill, the late British scientist who helped establish the link between smoking and lung cancer. Starchy carbs such as white bread, white rice and white potatoes that are high on the glycemic index were also linked to an increased risk of heart disease. Fish. Vegetables. They found little strong (more…)

Health Minister Glenn Hart said that decision is heavily dependent on what residents want. “Why did this government make a major health-care decision before completing the health-care consultations? The Yukon Hospital Corp. Hart said the town of Dawson will host public meetings on the Dawson hospital, seeking views from health-care workers, the local First Nation and the community as a whole. ”
The Yukon government announced in September that (more…)

In this week’s edition of the medical journal The Lancet, Dr. Michael Kochen of the department of general practice at the University of Göttingen in Germany, agreed that patient expectations need to be addressed, since exposure to radiation doses from X-rays or CT scans is an issue. “We need to identify back pain assessment and educational strategies that meet patient expectations and increase satisfaction, while avoiding unnecessary imaging. (more…)

A class of antidepressants thought to raise the risk of suicide among teens may significantly reduce the risk in adults, a review suggests.
In Tuesday’s issue of the Canadian Medical Association Journal, researchers from Italy and the World Health Organization reviewed eight studies involving more than 200,000 patients with moderate or severe depression who took selective serotonin reuptake inhibitors (SSRIs).
“Data from observational studies (more…)

The federal government will spend more to monitor the safety of drugs already on the market, Health Minister Leona Aglukkaq announced Wednesday.
“The Drug Safety and Effectiveness Network complements Canada’s rigorous pre-testing of new drugs by studying how Canadians respond over time to already-approved drugs,” Aglukkaq said at a Toronto hospital during her first major news conference as health minister.
“The results will help in decision-making (more…)