Thursday, 27 June 2013

Canada unveils new labeling initiative to enhance drug safety

Canada has rolled out the plain language labeling initiative to improve the safe use of medicines by making drug labels and safety information easier to read and understand for all health care practitioners and Canadians.

Canada health minister Leona Aglukkaq said that millions of Canadians rely on drugs to maintain and improve their health and vague labeling carries some risks.

The government will be making plain language a requirement on drug packages in order to help prevent adverse drug reactions, medication errors and protect Canadian patients, Aglukkaq added.

It was found that one in nine emergency rooms visits were related to drug adverse effects, and 68% of such cases are preventable, but occur due to limited access to products' information printed on the labels.

Under the new proposal, key safeguards such as a 'Drug Facts' table should be imprinted on the label to standardize the format of non-prescription drug labels and assist users to locate important information.

Drug manufactures will have to maintain contact information on labels so that users can report problems and adverse drug reactions, to provide mock-ups of labels and packages for review, and cater evidence.

The new plan will be implemented in phases starting with prescription and followed by non-prescription drugs.

Canadá acusa a Nestlé y Mars de manipular el precio del chocolate

La autoridad de competencia canadiense acusó ayer al gigante de la alimentación Nestlé y a los grupos estadounidenses Mars y Hershey de haber fijado los precios del chocolate en el país, mediante un sistema de colusión (un pacto entre dos organizaciones con el fin de perjudicar a un tercero) un que implicaría también a la firma de distribución Itwal.

Nestlé, el grupo Mars y la canadiense Itwal se enfrentan a una multa de 10 millones de dólares canadienses (7,35 millones de euros), según dijo en un comunicado la Oficina de Competencia, que pidió «clemencia» para Hershey por haber cooperado con la investigación.

«La fijación de precios es un delito grave y los cargos hoy (por ayer) presentados muestran que la Oficina de Competencia está decidida a poner fin a las actividades de carteles en Canadá», afirmó John Pecman, directo del regulador del mercado.

Además, la agencia canadiense presentó cargos contra Robert Leonidas, expresidente de Nestlé, Sandra Martínez, exdirectora de la división de golosinas de Nestlé y David Glenn Stevens, presidente ejecutivo de Itwal, informó el comunicado.

Los acusados se exponen a una multa máxima de 7,35 millones de dólares (unos 5,6 millones de euros), y además una pena de cárcel de hasta cinco años.

Las autoridades dijeron que Hershey Canada Inc, acusada como como parte de la trama, cooperó con las investigaciones y aceptó declararse culpable en la audiencia del 21 de junio a cambio de ser perdonada.

Por su parte, las filiales canadienses de Nestlé y de Mars han afirmado en sendos comunicados que no comparten esas acusaciones y que están dispuestas a defenderse de «manera vigorosa» contra esas acusaciones.

Fuente

Gwen Olsen: confessions of an ex-pharmaceutical sales representative (I)


Highlights

"We were been trained to misinform people"

"I was encouraged to minimize side effects when I talked to doctors"

"A large number of psychiatrists are dishonest because I see them 
giving people drugs that they know are brain damaging
therapeutics that they know you don't have positive lantern outcomes"

"The symptoms are listed and called a mental illness or mental disorder and this are voted upon by psychiatrists. We can define people as being mental ill and therefore we can sell more drugs for the pharmaceutical industry"

"There's no scientific data that's required for a psychiatrist diagnosed mental illness"

EMA decision to release drug data sparks controversy

A decision by Europe's drug regulator to release detailed data on drugs once a medicine is approved could discourage critical investment in crisis-hit Europe, Sanofi's chief executive said.

Chris Viehbacher, who took over as president of the European Federation of Pharmaceutical Industries and Associations (Efpia) on Monday, said companies would invest in regions where they felt welcome.

"If you, on the other hand, say, 'you guys are bad actors, we want to cut your prices, we want to take your confidential data and share it with any one of your competitors', you don't get the same feeling of encouragement," he told reporters.

The controversy over clinical data transparency compounds a situation where drugmakers are already reluctant to invest in Europe because of a wave of austerity-driven cuts in drug prices.

"If I was to say where would I put the next euro of investment, I would say either the next euro of investment would go to the United States or to emerging markets," Viehbacher said, speaking specifically as the head of France-based drugmaker Sanofi.

2 MILLION PAGES

Since November 2010, the European Medicines Agency (EMA) has released some 2 million pages of detailed information about drugs it has assessed - an approach it says reflects growing public demands for more openness to ensure that drugmakers cannot conceal adverse drug effects.

The idea behind it is to make drug companies more transparent, and help researchers pool information to fight disease better.

The problem, Viehbacher said, was that the data included details on things such as manufacturing processes that could allow a competitor to step in.

"The manufacturing process is often where the know-how of the company is, and this is particularly true of biological processes," he said.

"If all of this stuff is laid out, then we could have competitors from any country, particularly outside of Europe, suddenly start looking at our manufacturing process and we could suddenly find ourselves with some non-European competitors."

In April, U.S. companies AbbVie and InterMune used the courts to stop their clinical data being released, prompting the European regulator to appeal.

The EMA's plans to release clinical trial data have been slammed as irresponsible by the Pharmaceutical Research and Manufacturers of America lobby group - the U.S. equivalent of Efpia - which fears it could harm business and undermine incentives for research.

Still, some drug companies reckon the clamour for greater openness won't go away, given past drug safety scares. That has prompted Britain's GlaxoSmithKline to take a more conciliatory stance and decide to release a large amount of detailed data from its own clinical trials.

Le patron de Sanofi élu à la tête du syndicat de l’industrie pharmaceutique européenne

Chris Viehbacher, le directeur général de Sanofi, vient d’être nommé pour deux ans président de la Fédération Européenne des Industries et Associations Pharmaceutiques (EFPIA).


Le directeur général de Sanofi, Chris Viehbacher, a été élu ce lundi 24 juin et pour deux ans président de la Fédération Européenne des Industries et Associations Pharmaceutiques (EFPIA). Il était jusqu’à présent le vice-président de cette association qui représente l'industrie pharmaceutique en Europe (31 associations nationales regroupant 38 entreprises pharmaceutiques).

Dans le communiqué de l'EFPIA, Chris Viehbacher souligne le rôle que doit jouer l'industrie pharmaceutique pour contribuer au redressement de l'économie européenne. Le dirigeant a fixé trois axes prioritaires : l'information des patients, la recherche et développement et la compétitivité.

Januvia User Says Side Effects Worse Than High Blood Sugar

Against his doctor’s advice, Don, age 47, stopped taking Januvia, saying he would rather deal with high blood sugar than kidney stones, blood in his urine and severe abdominal pains.

“As soon as I started taking Januvia, my stomach started burning, and about a year ago, I started to urinate blood clots,” says Don, who was on Januvia for about two years. “Then my urine turned a brownish color and I passed some kidney stones - the pain was so bad I wound up in hospital. They x-rayed my abdomen and found a sharp kidney stone that I hadn’t passed. By January, I could barely urinate at all and my toes went numb - not pleasant.”


Don adds that, after researching the side effects, he is worried about Januvia pancreatitis and Januvia cancer. His doctor advised him to stay on the diabetes drug to keep his blood sugar levels in check, but Don decided to stop taking it anyway. “I didn’t have any of these problems before I took Januvia,” he says, “and nobody could tell me why I was getting these symptoms. I wasn’t on any other meds so it was too much of a coincidence. But I did take antibiotics for a urinary tract infection because the kidney stone I passed was sharp as a razor blade.

“Before I took Januvia, my blood sugar was about 400, and after I took the pill, it ran up to 490 for an hour or two, then went back down to 400. ‘You aren’t worried that you could destroy your kidneys and your heart could shut down?’ my doctor asked me. I would rather live with high blood sugar and take my chances than possibly develop Januvia side effects. Now I’m afraid to take any drug now. Instead I just watch my diet and exercise, and I’m feeling a lot better since I stopped Januvia - it just made things worse.”

Don adds that his health issues first started when he was prescribed Seroquel: he developed diabetes from the drug, filed a lawsuit against AstraZeneca and settled in federal court.

Don is hopeful that he can join other patients who have filed Januvia lawsuits against Merck, and whose cases have now been consolidated to a special federal multi-district court in California. 

The Problem With Pain Pills

In the new e-book “A World of Hurt: Fixing Pain Medicine’s Biggest Mistake” the New York Times reporter Barry Meier explores the murky world of prescription pain medicine. He makes a strong case that opioid drugs used to treat chronic pain, like OxyContin, not only are addictive and deadly but often don’t work for many people who use them and lead to a range of additional health problems.

It’s Mr. Meier’s second foray into the complicated world of pain relief. His first book, “Pain Killer: A ‘Wonder’ Drug’s Trail of Addiction and Death,” focused on the potential for abuse of OxyContin, particularly by teenagers. In the new, shorter e-book, Mr. Meier focuses on the long-term consequences of widespread use of opioid drugs to treat pain. I recently spoke with Mr. Meier about the problems associated with painkillers, why doctors and patients resist giving them up and some of the surprising side effects of these drugs. Here’s our conversation:

Why did you decide to revisit the topic of opioid painkillers?

I wrote a book 10 years ago about the rise of OxyContin and the pain management industry. That book was focused on abuse. The prevailing medical notion was that there was this bright line involving the opioids — that they were great for patients but the problems happened when they went out on the streets and were abused by kids and others. But today it’s clear that the long-term use of these drugs can not only be ineffective for chronic pain, but they also create bad side effects for patients. Not just addiction but powerful psychological dependency, depression of hormone production, lethargy and listlessness and sleep apnea, among others. These drugs do work well for some patients, but for many other patients, they’re not working well at all.

What made you realize that more needed to be written about the consequences of these drugs?

There were two powerful factors. The number of annual overdose deaths from narcotic painkillers has grown four times higher than it was a decade ago. The current statistic is that about 16,000 people a year die of overdoses involving prescription narcotics. The thing that was even more powerful for me was the growing realization that there are risks of these drugs for patients themselves, not just for people who are out-and-out abusing these drugs. People taking these drugs as directed have far more significant negative consequences than have been previously appreciated. It became of question of, “How are we treating chronic pain over the long term and are these drugs really the answer?”

Given these concerns, why are opioid pain relievers like OxyContin the drug of choice for doctors and patients?

Insurers and government agencies seized on opioids much like the use of antidepressants for psychological problems. Drugs are cheaper than talk therapy. Drugs are cheaper than a multidisciplinary approach to chronic pain. Doctors get reimbursed to treat people quickly, so funding for other approaches is cut out. These drugs became the treatment method of choice.

Are doctors beginning to question the use of these drugs now?

There is probably a real shift going on in the medical community. There have been increasing questions raised, even among those who once promoted the drugs, that they are not the panacea to treating chronic pain. One leading expert said: “We thought the big problem with these drugs is addiction. Now we realize the problem is with patients who take them and basically opt out of life.” There is a general realization that while they do work for some patients, using them on a massive scale to treat chronic pain has had really disastrous consequences.

What is it about these drugs that creates such concern?

You look at things like disability statistics — one of the biggest indicators of disability is use of these drugs. For instance, back pain is probably the leading workplace injury. What insurers and workers’ comp agencies are discovering is that when workers are treated with high doses of opioid drugs fairly soon after these injuries, it’s the leading predictor for them not coming back to work for long periods of time, or ever.

These drugs have a very powerful impact on our production of sexual hormones — testosterone in men and estrogen in women. Lower hormone production is not just about growing hair or sexual performance; it’s about your entire energy level. These drugs are depleting people of energy. There are even data showing that the more powerful opioids, the long-acting OxyContin, methadone, fentanyl, which is sold as Duragesic, have an even more powerful effect on depressing hormone production than short-acting opioids. These drugs are not just blocking pain receptors so you don’t feel pain; they are having powerful systemic effects on people,

You also make the point that these drugs can actually lead to more pain. How does that happen?

When you take a narcotic painkiller it sets off a natural reaction called tolerance, which means your body adjusts to it. You have to take more of the drug to get the same painkilling effect. Patients would come back to doctors and say, “This drug was working really well for me, but now I’m feeling pain again.” The doctor would increase the dose. The prevailing ideology during the war on pain was that these drugs had no ceiling dose. You could keep increasing them. The doctors kept boosting them every six months. People started taking higher and higher doses of these drugs. At a certain point it appears they create a change in the neurological system where people develop hyperalgesia and they become far more sensitive to pain than when they started out on these drugs.

So what is a person who has chronic pain supposed to do?

There was an interesting German research study earlier this year that looked at what happened when people are weaned off these drugs to a nondrug treatment plan. When they are weaned off high levels of opioids, they experienced less pain than when they were on high doses.

Part of the reason for writing this book is there is an antidote to dependence on these drugs. There are plenty of data suggesting that a multidisciplinary approach to chronic pain works as effectively as high-dose opioid treatment. Patients experiencing chronic pain for whatever cause will be put through a program where they receive intensive physical therapy, behavioral counseling, intensive psychological counseling.

One of the problems with chronic pain – there’s a lot of catastrophizing around it. People think this is the way it’s going to be for the rest of their life, and that they are trapped in this horrible pain and it’s only going to get worse. There is tremendous anxiety associated with that. They not only end up taking pain drugs and strong narcotics, but they take a lot of anti-anxiety medications as well.

The whole focus on multidisciplinary programs is to get people functioning again. One of the big drawbacks of long-term opiate use is many people who take these drugs over a long period of time lose physical function. The goal is to restore physical function and to help people learn if they do have chronic pain conditions, they may experience pain for the foreseeable future, but that is not necessarily a barrier to prevent them from living a full, active life.