Comparación de precios de fármacos entre Colombia y España

Fuente

Dr. Joan Corbella, respecto a la sobremedicalización

Destacados:

"Actualmente, hay más enfermos sobremedicalizados que antes"

"Es importante ver a los enfermos con cierta frecuencia"

"Hay que atreverse a dar la mínima dosis necesaria"

"Los estados de ánimo colectivos afectan inevitablemente a la población en general"

"El enfermo agradece que se le trate bien y con normalidad. 

Inspirar pena no gusta a nadie"

Ciclo vital de un medicamento en España

Las estructuras de evaluación que intervienen en el proceso son:

• La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
• La Dirección General de Cartera Básica del Servicio Nacional de Salud y Farmacia (DGCBSF)
• Direcciones de Farmacia de Comunicades Autónomas (CCAA)

1. En la Asesoría prestan las agencias reguladoras tiene en cuenta los aspectos de desarrollo dirigidos a la autorización del medicamento. Incorporar esta visión por parte de las autoridades competentes en precio y financiación desde el inicio del desarrollo de un medicamento permitiría también dirigir este desarrollo a lo que posteriormente le va a ser exigido por dichas autoridades. ¿Esto implica más participación por parte de las autoridades sanitarias en el desarrollo de un nuevo medicamento?
2. En el desarrollo clínico, se produce con frecuencia un acceso precoz a los medicamentos en investigación mediante el uso compasivo (utilización de un medicamento antes de su comercialización) amparado por el Real Decreto 1015/2009 de uso de medicamentos en situaciones especiales que de nuevo tiene impacto en el sistema. Este impacto varía desde lo excepcional y único (generalmente en fases precoces del desarrollo) a un acceso precoz de cohorte en aquellas situaciones próximas a la autorización. Desarrollar estos aspectos conjuntamente tiene un doble interés, la racionalización por una parte y la obtención de información importante sobre el uso en condiciones reales desde las fases iniciales del uso de un medicamento.
3. En la autorización de comercialización sólo debe fijarse en los aspectos relacionados con el beneficio-riesgo del medicamento con exclusión de cualquier otra consideración, inmediatamente después todas estas consideraciones deben ser tenidas en cuenta para el posicionamiento, la decisión de financiación/precio, la incorporación y el uso del medicamento.
4. El marco de la autorización de medicamentos en Europa es relativamente complejo estableciendo tres procedimientos para obtener una autorización de comercialización: centralizado (una única autorización válida para todos los países de la Unión Europea; obligatorio para medicamentos biotecnológicos, terapias avanzadas, medicamentos para el VIH/SIDA, cáncer, diabetes, enfermedades neurodegenerativas, autoinmunes, inmunológicas, o enfermedades virales; y medicamentos designados huérfanos), reconocimiento mutuo y descentralizado (una autorización válida para múltiples países de la UE con una evaluación compartida entre estos países), y nacional puro (una autorización válida en un solo país de la UE). Además, la legislación europea contempla la posibilidad de autorizaciones condicionadas (sometidas a la realización de estudios ulteriores) y bajo condiciones excepcionales (cuando no es posible obtener datos adicionales), así como establecer planes de minimización de riesgos que condicionan la autorización de comercialización.
5. Los medicamentos, especialmente en sus primeros años de comercialización, sufren cambios en el grado de conocimiento sobre el mismo, se desarrollan nuevas indicaciones o se generan alertas de seguridad que no estaban incluidas en la autorización. El uso en la práctica clínica también produce un aumento en el conocimiento del medicamento. Sin embargo, regulación y uso en práctica diaria se mantienen a veces como compartimentos estancos con muy poca influencia del uno en el otro. Hasta que un medicamento no está comercializado ni es utilizado en la práctica clínica, se desconoce el nivel de riesgo y seguridad ¿No es posible saber el nivel de seguridad durante los ensayos clínicos durante su desarrollo?¿Hemos de esperar a que esté en el mercado y haya una alerta para conocer su eficiacia, por un lado, y su nivel de seguridad, por el otro? La regulación debe buscar (y encontrar) formas de acercarse a la práctica real salvaguardando el rigor en la evaluación y sin contaminar los mecanismos de evaluación. Pero también la práctica clínica, la prescripción en concreto, debe comportar por parte del profesional un acto delegado de responsabilidad en la eficiencia. De nuevo la integración del sistema debe ayudar en la consecución de estos dos objetivos.
6. Una vez en el mercado, la legislación posibilita el uso de medicamentos fuera de indicación, lo cual tiene también un impacto sobre el sistema, pero pocas veces se regula este uso a la luz de los conocimientos disponibles y que pueden aportar cada una de estas partes, y se pierde la oportunidad de generar conocimiento compartido que, a su vez, sirva para tomar decisiones relevantes.
7. Finalmente, las re-evaluaciones de cualquiera de los aspectos importantes del medicamento (nuevas indicaciones o cambios en la seguridad del medicamento, por ejemplo) no siempre son compartidas.

Fuente

GSK: no evidence of China bribes, staff under house arrest

GlaxoSmithKline says it has found no evidence of its employees in China paying bribes to doctors and hospitals, despite claims made by the country's Public Security Bureau.

The last couple of weeks has seen the drugs giant's activities in China come under the spotlight and the PBS issued a statement talking about bribes being paid through travel agencies or as "project sponsorships". GSK is also suspected of being involved in tax-related crime, according to the ministry, which says that the offences have been occurring "for some time, involving a large number of people and significant amounts of money".

The PSB also claimed that some employees at GSK have already confessed to the offences. A GSK spokesperson told PharmaTimes World News that "we are aware of the statement from the PSB [and] we are willing to cooperate with the authorities in this inquiry".

The spokesperson noted that "this is the first official communication that has been published by the PSB in relation to the specific nature of its investigation. We take all allegations of bribery and corruption seriously. We continuously monitor our businesses to ensure they meet our strict compliance procedures".

However, "we have done this in China and found no evidence of bribery or corruption of doctors or government officials", said the spokesperson, noting that "if evidence of such activity is provided we will act swiftly on it".

Constant surveillance

Meantime, this morning, the Daily Telegraph has reported that at least 30 GSK employees, including five or six executives, are currently under house arrest and constant surveillance, quoting an unnamed source familiar with the situation.

Those held include the company's legal counsel in China, who has been cut off from communication with GSK's head office, the source claims. The newspaper says that GSK is locked in emergency meetings with its advisors over the situation and has hired Jun He, one of Beijing's leading law firms.

Source

What's in your milk?

Source

5 undeniable reasons your prescription drug costs are so ridiculously high

Americans spend a little less than $1,000 annually per person on average for prescription drugs. That's the average, which means that many spend a lot more. Why are prescription costs so ridiculously high? You might not like the answers, but here they are.

1. You're paying for other drugs that you don't use.
When you put your money down at the pharmacy for Lyrica, the nerve and muscle pain drug from Pfizer , you're really paying for your Lyrica prescription plus a whole host of other drugs. How's that possible? The answer lies in the realities of the drug development process.

Dr. Josh Bloom with the American Council on Science and Health estimates that it takes a drugmaker an average of 14 years to bring a drug to market -- at a total cost of around $1.3 billion. However, only one out of every 50 drugs that start down the development path actually make it to market. And, of those that do, typically only two out of 10 will make a profit.

Pfizer spent around $890 million on cholesterol drug torcetrapib, only to cancel the drug's development program in 2006 after serious safety concerns. The big pharmaceutical company wrote off $2.8 billion on inhalable insulin Exubera after consumers simply didn't like it.

How did Pfizer make up for those and other losses? Like all the other drugmakers, it added to the cost of the drugs that did succeed -- so Lyrica and others cost more than they would have otherwise.

2. You're paying for the world.
The weight of the world might not be on your shoulders, but the weight of subsidizing the world's drugs is. Prescription drug costs are higher in the U.S. than in any other country. Per-capita pharmaceutical spending in Canada, the second-highest nation, is a whopping 33% lower than in the U.S.

Two words explain why: price controls. Most other countries establish fixed price limits that they will pay for prescription drugs. What this means, though, is that pharmaceutical companies raise their prices for prescription drugs sold in the U.S. to make up for charging lower prices throughout the rest of the world.

You might think the simple solution is to implement price controls in the U.S., too. Such a move probably would lower prices for the drugs currently available.

The problem, though, is that it would provide financial disincentives for pharmaceutical companies to develop as many new drugs as they do now. If that happened, it could end up actually increasing overall health care costs, since taking prescription drugs is frequently much less expensive than other medical treatments.

3. You're paying for others to find out about the drug you use.
Marketing is king in the world of pharmaceuticals. And it demands a king's ransom. Unfortunately, you ultimately pay that ransom every time you buy a prescription drug.

Pfizer's advertising budget last year totaled more than $622 million. Over half of that budget was spent promoting three drugs -- Celebrex, Viagra, and Lyrica.Eli Lilly wasn't far behind with an ad budget topping $433 million. Nearly 94% of that amount was spent on only two drugs, in this case Cymbalta and Cialis.

Nielsen's tracking found that the top 10 pharmaceutical companies spent $2.7 billion last year on direct-to-consumer advertising. However, that figure doesn't include online advertising or physician promotions, so the actual marketing budgets for the big pharma companies is even larger. Research firm Cegedim estimates that total pharmaceutical industry spending on promoting drugs was around $28 billion in 2010.

You're also likely picking up part of the tab for the companies mistakes in how they promote their products. For example, Abbott Labs settled federal and state lawsuits accusing the company of inappropriate promotion practices for epilepsy drug Depakote for a cool $1.6 billion last year.

At the time of the settlement, the Justice Department said that the case demonstrated that "those who put profits ahead of patients will pay a hefty price." A hefty price was surely paid, but Abbott's profits for 2012 were more than 26% higher than either of the previous two years.

4. You're paying Uncle Sam.
Don't forget your good friends at the IRS. The passage of the Affordable Care Act brought new fees for large drugmakers totaling $80 billion. That amount is spread over multiple years, though. "Only" $2.8 billion was paid by pharmaceutical companies last year.

Technically, the big pharma companies pay these fees, which basically are excise taxes. However, those companies can't pay the IRS unless it first gets the money from its customers. Ultimately, you're paying Uncle Sam.

5. You're paying for profits.
Regardless of what product you purchase, you're paying for the maker of those products to make money. It's no different with prescription drugs. The concern is over whether prices paid by consumers contribute to excessive profits.

Most pharmaceutical companies generate nice profits. Despite Lilly's woes from losing patent protection for some of its big drugs, the company still had a profit margin of over 20%. Even though Abbott paid a steep fine last year for a legal settlement, its profit margin was 13% -- better than a lot of companies.

Pfizer ranks first among all Dow index stocks in terms of profit margin, with a margin of nearly 27%. The other two pharmaceutical companies in the Dow have profit margins higher than the average Dow company. However, of the top 10 Dow stocks ranked by profit margin, four are technology firms. Pharmaceutical companies generate high profit margins, but they're not always the highest among all industries.

A little good news
You're paying ridiculously high prices for prescriptions, but there is a little bit of good news. In 2012, Americans actually spent less on prescription drugs than the prior year for the first time on record. It was only 1% less -- but that's still better than spending more.

I figure this improvement amounts to maybe having an extra $10 in the wallet for the average American. You might want to hold on to that money. You'll probably need it soon enough.

Source

Pharma payments to doctors stay behind closed doors … for now

Patients will remain in the dark about whether their treating doctors receive payments from pharmaceutical companies that could influence prescribing habits, after a bill aimed at increasing transparency ground to a halt on Monday. The payments may be indirect (though conference sponsorship or funds to travel to or attend conferences) or direct (though consultation fees).

The Senate Finance and Public Administration Legislation Committee rejected the bill, agreeing with government, industry and the Australian Medical Association (AMA) that self-regulation is the preferred approach.

The rejection of legislative approach means that achieving transparency across the therapeutics goods industry will require up to nine industry associations to reform their disparate codes of conduct. Currently, only one (Medicines Australia) has commenced work in this area and at best, it will be 2016 before it reports to the public.

What did the bill propose?

Greens Senator (and medical doctor) Richard Di Natale sponsored the bill – an amendment of the Therapeutic Goods Act 1989 – to restrict the interaction between pharmaceutical companies and medical practitioners. Payments made by pharmaceutical companies to individual doctors would also have to be reported. The aim was to minimise industry inducements that could unduly influence prescribing behaviour.

There is increasing concern that industry-practitioner interaction can result in uncritical uptake of newer, expensive and less-well-evaluated products and the underutilisation of more cost-effective drugs and medical devices. The cost and safety implications of these influences can be significant.

The bill was referred to the committee for review on March 21, 2013. The committee received 25 submissions, held a public meeting in Melbourne and tabled its report on Monday.

Submissions to the committee by the Department of Health and Ageing (DoHA), pharmaceutical companies, industry and health professional bodies generally opposed the bill and supported self-regulation.

But a number of submissions argued that the current self-regulation model could be strengthened by co-regulation – by requiring companies to adhere to an industry code as a condition of product registration, for instance.

Government reviews

Improving the transparency of financial relationships between pharmaceutical companies and clinicians has been on the government’s agenda for a number of years.

A 2010 government position paper supported industry self-regulation but acknowledged inconsistency among various codes within the therapeutic goods sector. It also noted the inapplicability of codes to non-members of industry associations, such as the Indian generic company Ranbaxy. A Working Group on the Promotion of Therapeutic Products was set up.

A 2011 report of the working group produced a set of high-level principles to assist strengthening and aligning industry codes (and those of health professionals). The working group recommended that, as a condition of product registration, all applicants, including those not a member of an industry association, be required to nominate the relevant code of practice to which it will subscribe.

The government rejected this recommendation, stating its preferred position was to maintain the self-regulatory framework. However, it did concede that legislative measures might be required if voluntary participation failed to deliver the outcomes desired.

In 2013, the government set up a Therapeutic Goods (Codes of Conduct) Advisory Group to assess the uptake of the Working Group’s recommendations and provide an independent evaluation of the effectiveness of the self-regulatory framework.

Industry reforms

Alongside these government reviews, other influences have been at work.

In 2012, the Australian Competition and Consumer Commission (ACCC) urged Medicines Australia to include the disclosure of payments made by pharmaceutical companies to individual health-care professionals in its next code of conduct revision.

In response, Medicines Australia established a Transparency Working Group. The group has developed transparency principles applicable to all therapeutic goods companies and all health professions and is currently finalising a draft reporting model for consultation. This consultative document is expected to be published in the next few days and then be open for debate until mid 2014.

The final model agreed by Medicines Australia members will be added to the 18th code revision to be put to the ACCC in late 2014. If authorised, data collection would start in 2015 with public reporting in 2016.
International examples

The Senate committee reviewed overseas experience. The US Physician Payment Sunshine Act requires pharmaceutical and device companies to report to the Centers for Medicare and Medicaid Services (CMS) all payments, or other transfers of value, made to individual doctors and teaching hospitals that total more than US$100 per year.

Data is to be collected by therapeutic goods manufacturers from August 2013, with reporting to CMS in March 2014 and reporting to the public in September 2014.

The Dutch are already reporting financial arrangements exceeding €500 per year.

Why the bill failed

Many submissions argued that the timing of the bill was inappropriate, given that Medicines Australia’s Transparency Working Group and the government’s Codes of Conduct Advisory Group are currently underway.

The limited application of the bill was also noted: it only addressed pharmaceutical companies and registered medical practitioners, not all therapeutic goods companies and all health professionals.

There was concern that the bill proposed the publication of reports on individual company websites, whereas a single public repository was preferred by consumers and others.

The AMA, industry and others argued the bill would preclude valuable interactions between companies and medical practitioners such as medical education and the conduct of research. Given support for self-regulation by government, industry and the AMA, there was never a doubt the bill would be rejected.

Regardless, numerous questions remain. While Medicines Australia members may vote to include additional transparency in the 18th edition of their code (with public reporting in 2016) there is no compulsion on other industry associations to do so, let alone non-members.

And it remains to be seen what persuasive impact the latest government Codes of Conduct Advisory Group can have. In addition, the question of who will house and pay for a transparency register that is applicable to all therapeutic goods companies and all health practitioners is not yet on anyone’s agenda.

Source

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.

Source

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"

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.

Source

Drug Known to Cause Suicidal Thoughts Results in Death of 16-Year-Old Boy

Some drugs help. Other drugs, like Cymbalta, have the potential to kill, as they did in this case.

“Wrongful death, defective product lawsuits involving the suicide of a young teen are particularly hard to deal with. The family is distraught and in shock. They want to know that what happened to their son will never happen to anyone else. The drug Cymbalta is at the center of the storm in this lawsuit and eventual settlement,” indicated Austin injury lawyer Brooks Schuelke, with Perlmutter & Schuelke, L.L.P.

Cymbalta was approved for use in the U.S. in 2004, and was usually prescribed for depression. Over time, physicians used it for other off-label purposes and the drug maker, Eli Lilly and Co., started to promote its use for other conditions. In 2012, Lilly made $5 billion on this one drug alone. As ironic as it may seem, this drug, prescribed for depression, actually perpetuated it and was well known to cause suicidal thoughts in younger individuals.

“The 16-year-old in this shocking case was given the drug to take in November 2004. One month later, he shot himself,” said Schuelke. The parents elected to file a wrongful death lawsuit against Eli Lilly and their marketing partner, Quintiles Transnational. The suit alleged that neither company adequately warned patients that the drug could cause suicidal thoughts —- often acted upon —- in some users.

Evidence that would have been presented at trial, had the case not been settled out of court, showed the drug maker hid the fact that during a patient trial of the drug, a 19-year-old male hung himself. Furthermore, the Food and Drug Administration recommended a “black box warning” about the drug’s dangerous side-effects. It was not added to the drug packaging until 2005.

This is not the only drug with dangerous side-effects that Eli Lilly has been sued over. Consider the mass tort litigation involving Prozac. A large number of those cases were also settled out of court, as the company did not want to deal with its dirty laundry in the legal arena in a public manner.

“Those facing the death of a loved one as the result of a dangerous drug need to reach out and discuss their situation with an experienced injury attorney,” stated Schuelke. “You need a voice in court on your side to obtain not only justice, but to be able to send a message to drug makers that their actions are not acceptable and they must take responsibility for them.”

Source

Gwen Olsen: Pharma Not in Business of Health, Healing, Cures, Wellness

Highlights

"Pharmaceutical industry are not in the business to cure cancer, to cure Alzheimer, to

cure heart disease because if they were, they will be onthe business putting themselves:

OUT  OF BUSINESS"

"Pharmaceutical industry doesn't want to cure people"

"Psychiatric drugs: these drugs encourage people to

remain customers of the pharmaceutical industry"

"Cholesterol drugs are lowering cholesterol excessively and causing other diseases states as a consequence"

"The drugs are always trailed against the placebo and clinical trials. Placebo is a sugar pill.

In fact, many drugs are not found to be much more efficaces than a sugar pill"

"Antidepressants are not more effective than placebo as per clinical study"

"Pharmaceutical industry makes 5 to 6 times the amount of

money as any of the others companies in United States of America"

Drug prescriptions in U.S. often dangerous and inappropriate

Two recent reports highlight costly and widespread use of prescription medication in the United States that raise concern. Recently, the Department of Health and Human Services, Office of Inspector General, launched an investigation into prescribing practices among doctors. What they found was questionable practices for prescription drugs that include pain medications and antipsychotics that are paid for under Medicare part D and Medicaid.

The finding suggests many physicians are writing potentially dangerous medications for the elderly and disabled.

The report, published by the inspector general of the Health and Human Services Department uncovered more than 700 physicians with questionable prescribing practices writing prescriptions for drug that have a high potential for addiction and abuse.

"The review found more than 2,200 doctors whose records stood out in one of five areas: prescriptions per patient, brand name drugs, painkillers and other addictive drugs or the number of pharmacies that dispensed their orders," wrote ProPublica reporters in a press release.

The reporters are urging Medicare officials to take a closer look at physician prescribing practices. In response to the investigation and ensuing recommendations, Medicare officials say they have been working to monitor the overuse of narcotics.

Yet, CMS officials also note the importance of Medicare beneficiaries having access to the medication they truly need. A past study shows many elders skip needed prescriptions due to cost.

Source

AMA declares obesity a disease in USA

The American Medical Association (AMA) voted Tuesday to declare obesity a disease, a move that effectively defines 78 million American adults and 12 million children as having a medical condition requiring treatment.

In the end, members of the AMA's House of Delegates rejected cautionary advice from their own experts and extended the new status to a condition that affects more than one-third of adults and 17% of children in the United States.

"Recognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately 1 in 3 Americans," said Dr. Patrice Harris, an AMA board member.

Tuesday's vote is certain to step up pressure on health insurance companies to reimburse physicians for the time-consuming task of discussing obesity's health risks with patients whose body mass index exceeds 30. It should also encourage doctors to direct these patients to weight-loss programs and to monitor their often-fitful progress.

The AMA's decision essentially makes diagnosis and treatment of obesity a physician's professional obligation. As such, it should encourage primary care physicians to get over their discomfort about raising weight concerns with obese patients. Studies have found that more than half of obese patients have never been told by a medical professional they need to lose weight — a result not only of some doctors' reluctance to offend but of their unwillingness to open a lengthy consultation for which they might not be reimbursed.

"As things stand now, primary care physicians tend to look at obesity as a behavior problem," said Dr. Rexford Ahima of University of Pennsylvania's Institute for Diabetes, Obesity and Metabolism. "This will force primary care physicians to address it, even if we don't have a cure for it."

The new designation follows a steep 30-year climb in Americans' weight — and growing public concern over the resulting tidal wave of expensive health problems. Treatment of such obesity-related illnesses as cardiovascular disease, Type 2 diabetes and certain cancers drives up the nation's medical bill by more than $150 billion a year, according to the Centers for Disease Control and Prevention.

Projected increases in the obesity rate could boost that figure by an additional $550 billion over the next 20 years, a recent Duke University study concluded.

In laying out the case for and against the redefinition of obesity, the AMA's Council on Science and Public Health argued that more widespread recognition of obesity as a disease "could result in greater investments by government and the private sector to develop and reimburse obesity treatments."

The Food and Drug Administration, which has approved just two new prescription weight-loss medications since 1999, would probably face increased pressure to approve new obesity drugs, spurring new drug development and more widespread prescribing by physicians, the council noted.

"The greater urgency a disease label confers" also might boost support for obesity-prevention programs such as physical education initiatives and reforms to school lunch, the council added. In addition, it speculated that "employers may be required to cover obesity treatments for their employees and may be less able to discriminate on the basis of body weight."

But the council also said that making obesity a disease could deepen the stigma attached to being overweight and doom some patients to endless nagging — even if they were otherwise healthy or had lost enough weight to improve their health.

It might also shift the nation's focus too much toward expensive drug and surgical treatments and away from measures to encourage healthy diets and regular exercise, the council wrote in a background memo for AMA members.

Dr. Daniel H. Bessesen, an endocrinologist and obesity expert at the University of Colorado Anschutz Medical Campus, called the AMA's shift "a double-edged sword." Though the semantic change may reflect "a growing awareness that obesity is not someone's fault," he worried that "the term disease is stigmatizing, and people who are obese don't need more stigmatizing."

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Ben Goldacre: What doctors don't know about the drugs they prescribe

Ben Goldacre, physician, academic and author of Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, explains in TED Talk his views about research studies published in medical journals among other interesting points. Here it goes!

Highlights

"In the academic literature, we'll see a biased sample of the true

picture of all of the scientific studies that have been conducted"

"People do lots and lots and lots of different studies, and the occasions when

it works they will publish, and the ones where it doesn't work they won't"

"Over 100.000 people died unnecessarily in America from

the prescription of anti-arrhytmic drugs (20-30 years ago)"

 "You can see what a staggering difference there was between reality and

what the doctors, patients, commissioners of health services, and

academics are able to see in the peer-reviewed academic literature"

"We cannot know the true effects of the medicines that we

prescribe if we do not have access to all the information"

"We need to force people to publish all trials conducted in human,

including the older trials, for all drugs in current use"

Fish on Prozac: Anxious, anti-social, aggressive

When fish swim in waters tainted with antidepressant drugs, they become anxious, anti-social and sometimes even homicidal. New research has found that the pharmaceuticals, which are frequently showing up in U.S. streams, can alter genes responsible for building fish brains and controlling their behavior. Antidepressants are the most commonly prescribed medications in the United States; about 250 million prescriptions are filled every year. And they also are the highest-documented drugs contaminating waterways, which has experts worried about fish. “At high doses we expect brain changes” said scientist Rebecca Klaper. “But we saw the gene expression changes and then behavioral changes at doses that we consider environmentally relevant” Male minnows exposed to a small dose of Prozac in laboratories ignored females and took more time capturing prey. When the dose was increased, but still at levels found in some wastewater, males became aggressive, killing females in some cases.

Exposure to fluoxetine, known by the trade name Prozac, had a bizarre effect on male fathead minnows, according to new, unpublished research by scientists at the University of Wisconsin-Milwaukee.

Male minnows exposed to a small dose of the drug in laboratories ignored females. They spent more time under a tile, so their reproduction decreased and they took more time capturing prey, according to Rebecca Klaper, a professor of freshwater sciences who spoke about her findings at a Society of Environmental Toxicology and Chemistry conference last fall. Klaper said the doses of Prozac added to the fishes’ water were “very low concentrations,” 1 part per billion, which is found in some wastewater discharged into streams.

When the dose was increased, but still at levels found in some wastewater, females produced fewer eggs and males became aggressive, killing females in some cases, Klaper said at the conference.

The drugs seem to cause these behavioral problems by scrambling how genes in the fish brains are expressed, or turned on and off. The minnows were exposed when they were a couple of months old and still developing.

There appeared to be architectural changes to the young minnows’ brains, Klaper said at the toxicology conference. Growth of the axons, which are long nerve fibers that transmit information to the body, was disrupted.

When the dose was increased, but still at levels found in some wastewater, females produced fewer eggs and males became aggressive, killing females in some cases.

The new findings build on Klaper’s previous research, which tested minnows with the gene changes to see how well they avoided predators. They swam longer distances and made more directional changes, which suggests that the drugs induced anxiety.

The drugs used in the study were among the most common in sewage: Prozac, Effexor and Tegretol. The researchers tested each drug alone and in combination.

“At high doses we expect brain changes,” Klaper said. “But we saw the gene expression changes and then behavioral changes at doses that we consider environmentally relevant.”

However, there is too little evidence to know whether pharmaceuticals are having any impacts on fish populations in the wild, said Bryan Brooks, an environmental science professor at Baylor University who has extensively studied pharmaceuticals in streams and fish.

Any changes in reproduction, eating and avoiding prey can have devastating impacts for fish populations, Klaper said.

The most vulnerable fish populations are those downstream of sewage treatment plants, where prescription drugs consistently show up in higher levels than in other waterways. It’s only within the past decade that technology has allowed plants to test for the chemicals in their wastewater and in waters downstream, though most still don’t, said Steve Carr, supervisor of the chemistry research group at the Los Angeles County Sanitation Districts.

One of the antidepressants tested in the fish – Tegretol – comes into the treatment plants and goes out at near constant levels, said Eric Nelson, a senior chemist with the Los Angeles County Sanitation Districts.

That means the county’s treatment technology does not seem to have any effect on the drug. It comes in and leaves in a very tight range, about 150 to 400 parts per trillion, Nelson said.

Nelson said the two other drugs tested on the fish – Prozac and Effexor – are discharged in effluent at even lower levels: between about 20 and 30 parts per trillion. In comparison, the levels that altered behavior of the lab fish were 50 times higher.

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