Obama Orders FDA to Double Down on Drug Shortage Crisis

By Robert Lowes

October 31, 2011 — President Barack Obama today put the US Food and Drug Administration (FDA) in red-alert mode about a drug shortage crisis that has endangered patients, delayed clinical trials, and triggered price gouging.

The number of drugs deemed in short supply by the FDA has nearly tripled, from 61 in 2005 to 178 in 2010, with roughly 200 shortages reported so far in 2011. Scarce drugs are mostly sterile injectables such as cancer medications, anesthetics, and antibiotics. Many of them are generics.

The president's executive order directs the FDA to broaden its reporting of potential drug shortages to give the agency enough time to prevent or reduce them. With early notification, the FDA can work with manufacturers to more quickly address quality issues that shut down production, as well as find other manufacturers to help increase their output. In a press conference today, US Department of Health and Human Services Secretary Kathleen Sebelius said that such advance notice has helped the FDA avert 137 shortages during the last 21 months.

The president's order also requires the FDA to grease its regulatory wheels by speeding up the review of new manufacturing sites, manufacturing changes, and drug suppliers that could prevent a shortage from occurring.

Obama's new initiative seeks to go beyond the narrow requirement now in place that sole-supplier manufacturers of critical medications inform the FDA if they intend to stop making them; bipartisan legislation pending in the Senate and House would extend this requirement to all manufacturers. Sebelius said the administration is urging Congress to pass the legislation to maximize the authority that the FDA has to require drug shortage reporting. The executive order is the next best thing to Congressional action, Sebelius said.

"We can't stand by and watch Americans go without medicines they count on," she said.

In addition, the executive order directs the FDA to work with the Department of Justice to investigate whether secondary drug wholesalers or other market players have illegally raised drug prices to gouge hospitals and physicians, or hoarded medications to exploit potential drug shortages. Sebelius said the price of one hypertensive medication in short supply has shot up from $26 to $1200 per dose.

The Obama administration also announced other steps it was taking to address shortages that have delayed surgeries, disrupted chemotherapy regimens, and forced clinicians to rely on less effective less familiar medications: It is roughly doubling the staff at the FDA's Drug Shortage Program, and today the administration sent a letter to manufacturers reminding them of their responsibility to report the discontinuation of some medications, and encouraging them to voluntarily disclose all potential shortages.

A Department of Health and Human Services report released today attributes the drug shortage crisis largely to demand outstripping manufacturing capacity. An unusually high rate of brand-name drugs going off-patent beginning in 2008, the report states, has left producers of generic versions unable to meet the need.

Obama Commended for Adopting Physician Recommendations

The president's decision to push the FDA harder on reducing drug shortages immediately garnered applause from several of the healthcare organizations that are most affected by the problem.

"On behalf of our physicians and patients, we praise President Obama for his bold action in addressing the growing drug shortages pandemic," said Jerry Cohen, MD, president of the American Society of Anesthesiologists, in a press release. Dr. Cohen noted that Obama's executive order incorporates several recommendations made by a coalition of groups that includes the American Society of Anesthesiologists.

Likewise, the American Society of Clinical Oncology said in a statement that it is "pleased the Administration is taking action to help ensure patients with cancer receive the life-saving treatments on which they rely." The society added that it hoped the executive order will put additional pressure on the Senate and House to act on the shortage notification legislation.

Similar commendations came from the American Hospital Association and the American Society of Health-System Pharmacists.

Divorce Oncologist Revenue From Drug Sales, Write NEJM Authors

Two articles published online today in the New England Journal of Medicine suggest additional and more far-reaching solutions to the drug-shortage crisis. In one piece, Bruce Chabner, MD, from the Massachusetts General Hospital Cancer Center, Boston, recommends that the federal government require manufacturers of generic drugs to establish "redundant" manufacturing capacity and revoke marketing licenses of companies that fall short of minimal production goals.

"A license to market lifesaving products should entail public obligation to meet demand," writes Dr. Chabner.

In addition, the government should increase Medicare reimbursement of generic medications to motivate manufacturers to boost production, as well as improve quality, according to Dr. Chabner. He writes that Medicare currently limits reimbursement for injectable generics to no more than 6% above the average sales price during the preceding quarter.

Such a formula also minimizes profits for oncologists who purchase chemotherapy drugs and resell them. In their New England Journal of Medicine article, Mandy Gatesman, PharmD, and Thomas Smith, MD, write that oncologists naturally would rather earn their 6% margin on brand-name Abraxane (Celgene), priced at $5824, rather than generic paclitaxel, which is priced at $312, under this reimbursement scheme.

Dr. Gatesman and Dr. Smith argue that oncologist revenue should not hinge on chemotherapy sales. This payment system not only favors higher-priced brand-name drugs, which is unsustainable, but also "puts oncologists in potential ethical conflict with patients, since it hides revenue information that might influence drug choices and thus affects costs and patients' copayments," the authors write.

To get away from the dependence on medication sales, the authors recommend adopting clinical pathways that specify preferred chemotherapy combinations and sequences, and paying disease-management fees to oncologists who follow such pathways. Another option that would eliminate conflict of interest, they write, is putting oncologists on salary.

"The only good news," write Dr. Gatesman and Dr. Smith, "is that the drug shortages may catalyze a shift from a mostly market-based system to one that rewards provision of high-quality cancer care at an affordable cost."

More information on drug shortages is available on the FDA Web site.

Dr. Gatesman and Dr. Smith have disclosed no relevant financial relationships. Dr. Chabner reported that he sits on the board of directors of 2 pharmaceutical companies and serves as a consultant to a number of others.

Extraído de: http://www.medscape.com/viewarticle/752604?src=mp&spon=30

Three-Pronged Attack on Obesity

October 7, 2011 (Orlando, Florida) — Physicians who specialize in treating obesity are conceding that education to promote prevention and lifestyle improvements will not be sufficient to reverse the obesity epidemic. So at Obesity 2011, three experts staged a debate on the future roles of behavior modification, drugs, and surgery in treating obesity.

"We really need a Manhattan Project for medical treatment in the field of obesity--we need prevention, we need behavioral modification, we need more drugs, and we need to look at better indications for bariatric surgery," surgeon Dr John Morton (Stanford University, CA) said. Because of the negative social stigma attached to obesity, there is still a lot of reticence among patients, physicians, and the general public to support obesity treatments other than diet and exercise. That must change if the problem is going to be solved, Morton argued. "We need to mainstream the treatment of obesity. That's really the big thing here. We wouldn't be having this conversation around oncology or cardiology. It would just happen. Those patients would get treated."

Exercise More, Eat Less?

In the staged debate, Dr Patrick O'Neil (Medical University of South Carolina, Charleston) was tasked with defending the importance of behavioral modification in preventing and treating obesity. "We all accept that in order to lose weight and keep it off it's going to require changes in caloric changes, changes in eating and drinking habits, and changes in physical activity, including exercise and general lifestyle activity," he said.

We wouldn't be having this conversation around oncology or cardiology

He conceded that "we all know that for a variety of reasons, many physiological and otherwise, it's a lot harder to do than to say. . . . The environment that we live in really does encourage a lot of the wrong things from a weight-control standpoint." However, O'Neil pointed out that lifestyle modification complements the more expensive and perhaps risky measures such as bariatric surgery or pharmaceuticals.

"This is not an either-or recommendation. The [National Heart Lung and Blood Institute] very explicitly recommends that there be a foundation of diet, physical activity, and behavioral activity, or lifestyle changes, even though the patient may in addition be considered for drugs or surgery," because behavioral therapy enhances the impact of surgery or drugs. O'Neil cited studies of several drugs, including sibutramine (Meridia, Abbott Laboratories), showing that although the drug can produce weight loss in obese patients by itself, patients taking the drug while also undergoing behavioral-modification therapy lose even more weight.

Morton, who debated in favor of surgical and device interventions for obesity, said that even surgical patients must be receptive to lifestyle change first. "You need to say that this is a big deal, to change how you live, how you work, how you eat, and how you sleep. And you've got to have those patients on board. I wouldn't offer surgery to somebody who is not ready."

Thinner Living Through Chemistry?

Dr Caroline Apovian (Boston University, MA) is pessimistic about the ability of behavior therapy alone to treat obesity in the majority of patients. "Right now, when you require diet and exercise interventions for at least six months prior to using drugs or surgery, you know the patient is going fail most of the time," she said. "You're just waiting for failure so you can then give them an intervention that is going to work."

Intensive behavior-modification therapy "improves weight loss, but it's not practical on a long-term basis," she said. Apovian cited a 1988 randomized study that showed that although patients who stayed involved in weight-maintenance therapy after six months of weight-loss therapy did not gain back as much as patients who had only six months of weight-loss therapy, the patients in the maintenance-therapy group also started to gain weight again after about a year [1]. She also pointed out that the Institute of Medicine's guidelines on maintenance of weight loss recommend 90 minutes of exercise a day, which is just not practical for most severely obese patients, she said.

We've created a society where it's easy to gain weight. . . . How are we going to change it? Tear down all of the fast-food restaurants?

"We've created a society where it's easy to gain weight, and we can't change it right now," Apovian said. "How are we going to change it? Tear down all of the fast-food restaurants? It's very easy to eat 3000 calories a day or more, so why are we torturing people? Some people really can't make lifestyle changes in this environment, and if we really think that obesity is a disease, let's treat it like one."

Drugs intended to treat obesity are having a difficult time reaching the US market lately. The FDA recently declined to approve Contrave (Orexigen Therapeutics), a combination of naltrexone and bupropion HCL, despite the favorable vote by the FDA's advisory panel. Lorcaserin (Arena Pharmaceuticals) and phentermine/controlled-release topiramate (proposed name: Qnexa, Vivus) were not favored by the advisory panel.

Despite the recent setbacks, Apovian, who is involved with research on several obesity drugs, argued that pharmaceuticals will play an important role in the treatment of obesity in the near future and could eventually even supplant the surgical options, which "just aren't appealing to most patients," she said. "The majority of obese Americans need something in between diet and exercise and gastric bypass or the Lap-Band [Allergan]," she said.

Current surgery and device-based techniques are designed to alter patient's perceptions of satiety and appetite. Eventually, better understanding of endogenous signaling of appetite-regulating hormones and neurotransmitters will allow drug therapy to accomplish the same goal safely, she predicts.

"But in the interim, as we develop drug combinations and new drugs for obesity, we will have devices that are safer and less aggressive than surgery, like the Lap-Band and the EndoBarrier endoluminal barrier [GI Dynamics], to bridge the gap until we figure out which drug combinations simulate what we see with surgery," she said. "Right now, surgery is the only option we have for severe obesity."

Apovian cautioned that although drugs and surgery can kick-start the weight-loss process, ultimately the patient must change his or her lifestyle. "There are combinations of drugs or surgery to help the patients suddenly be able to make lifestyle changes," she said.

O'Neil, Morton, and Apovian support a staged approach to treating obesity. It is hoped that people headed toward severe obesity can be identified early and treated with lifestyle changes alone, but for the foreseeable future, there will be severely obese people in need of more intensive therapy, they agreed. Morton said that, for example, a very small percentage of people who could benefit from weight-loss surgery are currently undergoing the procedure.

"Too many people who need help don't get it," he said. "What we really need is better access to care and to try to make some of those changes earlier rather than later and find out what works and doesn't work."

O'Neil has research relationships with Arena Pharmaceuticals, Orexigen Therapeutics, Weight Watchers International, South Carolina Research Authority, Novo Nordisk, and Shire Development and is an advisor to Orexigen Therapeutics. Apovian is on the scientific advisory board for GI Dynamics, Gelesis, Zafgen, Orexigen, Arena, and Amylin; receives research support from Amylin; and consults for Vivus. Morton reports grants from Ethicon Endosurgery and advises Vibrynt.

http://www.medscape.com/viewarticle/751220?sssdmh=dm1.724644&src=nldne

Liga da Saúde: Fitoterapia e Obesidade...

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O paradoxo do Cromo: um dos nutrientes mais importantes e mais esquecidos

O Paradoxo do Cromo: Um dos Nutrientes mais Importantes e Esquecidos...

Sabe aquela vontade incontrolável de comer aquele docinho no meio da tarde ou o dia todo? Ou então níveis aumentados de glicose, colesterol e triglicerídeos no sangue, mesmo jovem? E ainda dificuldades em perder peso? Se você apresenta um destes sintomas, você pode estar com deficiência de cromo.

Diferentemente do cálcio, magnésio, zinco, potássio, fósforo, selênio, manganês, cobre e do ferro, que possuem inúmeras funções e é sabido que a deficiência de qualquer um destes nutrientes pode provocar diversas desordens bioquímicas, disfunções de tecidos e surgimento de sintomas e doenças (como osteoporose, gripes e resfriados e depressão), até então só se conhece uma única função do cromo: regular o metabolismo de carboidratos. Não parece ser algo tão grave, afinal é apenas uma única função. Porém, esta é uma das funções mais importantes do ponto de vista do metabolismo humano, pois é a responsável por gerar energia adequada para o funcionamento das células. E o paradoxo está justamente no fato de ser um elemento tão importante e, ao mesmo tempo, tão esquecido por grande parte dos médicos e nutricionistas, por não darem importância às dosagens de cromo. A conseqüência disto é a utilização de medicamentos conhecidos como “hipoglicemiantes orais”, tais quais Metformina, Glibenclamida, Rosiglitazona e Arcabose, para auxiliar no controle da glicemia. Porém, se o paciente estiver em estado de carência de cromo, bem, poderia ser mais lógico do que lançar mão de imediato destes fármacos, simplesmente a suplementação nutricional deste mineral. Esta é mais uma missão da Liga da Saúde.

É preciso então entender o processo de formação de energia: a glicose é a forma elementar de utilização de energia pelas células. Porém, por se tratar de uma molécula hidrossolúvel, ela não é capaz de atravessar a membrana plasmática celular, que possui característica lipossolúvel. Existe então um sistema de transporte da glicose para dentro da célula e a insulina é a responsável pelo início desta operação, conforme mostrado na figura 1. Ao se ligar ao seu receptor, a insulina promove uma cascata de reações (do tipo fosforilação), que no final das contas, estimula estruturas conhecidas como GLUTs, que são proteínas transportadoras de glicose, a se deslocarem para a membrana plasmática, que por sua vez captam a glicose que está no meio externo. Pois bem: toda esta dinâmica celular para “seqüestrar” a glicose para dentro da célula, que é um conjunto de reações bioquímicas, é extremamente dependente de cromo, pois este elemento é co-fator destas reações.

Na deficiência de cromo, este processo não acontece perfeitamente, os níveis de glicose no sangue permanecem elevados, elevando o risco de diabetes, e o organismo tratará de buscar outros nutrientes para geração de energia, como proteínas e gorduras, o que aumenta o risco de níveis sanguíneos elevados de colesterol, triglicerídeos, e a longo prazo, doenças renais, da microcirculação, hipertensão, retinopatias, hepatopatias e obesidade.

Para que isso não ocorra, é importante que o médico ou nutricionista esteja atento aos níveis de cromo, que no sangue, devem estar entre 0,7 a 2,2 μg/L. Maus hábitos alimentares, como o consumo de açúcares refinados, podem reduzir os níveis de cromo, o que por sua vez, aumenta o desejo por alimentos doces, criando-se aí um ciclo vicioso.

Alimentos fonte de cromo são: cereais integrais, levedura de cerveja, carnes bovinas, de aves e de peixe. Se não for suficiente, pode-se optar pela suplementação nutricional do cromo, na forma de cromo picolinato (forma de melhor biodisponibilidade), em dosagens que variam de 50 a 1.000mcg ao dia, em cápsulas. Estudos clínicos mostram que a suplementação do cromo auxilia no controle da glicemia de pacientes pré-diabéticos ou diabéticos, que utilizam ou não medicamentos hipoglicemiantes orais, reduzindo os níveis de glicose, de insulina, bem como colesterol, triglicerídeos e substâncias resultantes do estresse oxidativo (como substâncias reativas ao ácido tiobarbitúrico), além de auxiliar na perda de peso e no tratamento da síndrome dos ovários policísticos (que tem como base fisiopatológica a resistência insulínica e como co-morbidade a pré-diabetes / diabetes).

http://ligadasaude.blogspot.com/2011/06/o-paradoxo-do-cromo-um-dos-nutrientes.html#comment-form

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