Política de saúde (aids ) e política industrial (medicamentos)

Uma pausa no caso Avandia. Agora, voltando ao caso efavirenz que motivou uma reportagem de Valor Econômico (25/05/07) que conseguiu ir no âmago da questão: a contradição do progama da aids. Excelente na assistência, deficiente na sustentação econômica. O Estado brasileiro está correto em desenvolver sua política de saúde pública com autonomia para reduzir dano a sua população. Fez isso de forma no caso da aids. Por outro lado, o Estado brasileiro foi incorreto ao não desenvolver a política industrial na área de medicamentos. Com isso, o "Estado brasileiro que está correto" foi penalizado pelo "Estado brasileiro que foi incorreto". Aí entram, os pescadores de águas turvas com soluções para hoje que foram as causas do erro do passado. Qual erro? Considerar três nuncas: (1) nunca poderíamos competir com a Big Pharma. (2) nunca desenvolveríamos um programa de genéricos. (3) nunca teríamos um programa de saúde pública competente. Essa inapetência pelo poder global (e, claro conflito imenso de interesse com a Big Pharma) fez com a Índia passasse na nossa frente e, conseguisse dar muita dor de cabeça à Big Pharma. Por outro lado, a política indiana para aids é pífia.

A solução agora, não é comprar remédios de indianos, não é xingar a indústria farmacêutica multinacional (nem adulá-la) mas sim desenvolver a rede de incorporação de tecnologia na área de medicamentos, oferecendo muitas vantagens para entrada no Brasil do capital da........Big Pharma acoplado a incentivos a indústria local desde que tenha perspectiva do mercado mundial. Insisto muito, que o Brasil pode ser a plataforma da Big Pharma na área não só de genéricos como de química fina.

Tratamento da aids: Abbott se acerta com a Tailândia.

The Wall Street Journal noticia acerto entre a Abbott e o governo da Tailândia nos preço do Kaletra, para tratamento da aids. Tudo isso depois da represália da empresa em registrar e vender nos medicamentos àquele país, por causa da possibilidade de entrada de genéricos para aids. O novo preço é inferior ao dos genéricos. Abaixo, trecho da matéria, onde destaco em negrito que os países emergentes são fundamentais para manter a lucratividade da Big Pharma, cujas vendas estão em queda nas economias centrais.

Abbott's Thai Pact May Augur Pricing Shift
By NICHOLAS ZAMISKA in Hong Kong and JAMES HOOKWAY in BangkokApril 23, 2007
Abbott Laboratories has backed away from a confrontation with the Thai government over patent protection for a popular AIDS treatment, a concession that could embolden other developing countries pushing big drug makers to lower the price of their products.
Abbott is offering to sell the latest version of its AIDS drug Kaletra in Thailand at a discounted rate, according to Miles D. White, Abbott's chief executive. The move reverses Abbott's decision in February to withhold the new form of Kaletra, called Aluvia in some countries, from Thailand following a Thai government announcement it would allow sales of generic versions of the drug and other branded medicines to cut patients' costs. "In this particular case, in the name of access for patients, we offered to resubmit Aluvia at our new price, which is lower than any generic, provided they wouldn't issue a compulsory license," Mr. White said. He said the initial decision was driven by "concern that compulsory licensing would be abused ever-more widely, using HIV as an excuse." Jennifer Smoter, a spokeswoman for Abbott, said Thailand's health ministry has expressed interest in the offer, but a resolution hasn't been reached. Abbott's move doesn't affect its decision to withhold six other drugs from Thailand. Abbott Laboratories in February withheld an AIDS drug from sale in Thailand after the government said it would allow sale of generic versions of drugs. • What's New: Backing down, Abbott is offering to sell the drug in Thailand at a discounted rate. • The Significance: Other developing nations may push for lower drug prices.
• The Background:Abbott's turnabout could crimp growth of global drug makers, which rely on emerging markets to compensate for slowing growth in home markets. Gustav Ando, an analyst for Global Insight, an economic-forecasting firm in Waltham, Mass., said, "If one country does it...any country can do it.... It's not going to stop there." Abbott, of Abbott Park, Ill., in February, refused to sell the country seven of its newest drugs. The move appeared to backfire, prompting consumer boycotts in Thailand, bringing human-rights advocates out in support of Thailand's policy and provoking protests from some Abbott shareholders, who argued Abbott should sell its latest drugs in Thailand. Thailand generated about $30 million a year in sales for Abbott, said a person familiar with the company's sales.
In backing down, Abbott is joining Merck & Co. and Sanofi-Aventis SA, which already have cut the prices of their AIDS and heart-disease drugs in the hope of dissuading Thailand from switching to less-expensive alternatives. Thailand still could choose to import generic drugs to replace Abbott's, however, just as it is now using generic versions of Merck's AIDS drug Efavirenz, despite Merck's own move to lower prices. Big drug companies have been pushing sales in emerging markets like Thailand, in part, because of a backlash against expensive brand-name drugs in the U.S. and other Western markets. Merck expects revenue in emerging markets to double by 2010 to more than $2 billion a year. Abbott's international pharmaceutical sales totaled $1.68 billion in the first quarter of this year -- nearly as much as its $1.69 billion in U.S. sales. In 2006, Abbott's total sales in the U.S. dropped 7.5% to $11.5 billion, while the company's international revenue rose nearly 11% to $10.9 billion.

Um caso de corrupção na China: exceção ou regra na aprovação de medicamentos?

The Wall Street Journal relata um caso de corrupção na China relacionado à regulamentação de medicamentos. A empresa local estava para aprovar o sal da claritromicina, um antibiótico, no equivalente da ANVISA. Ao invés de enviar o próprio sal, remeteu a formulação original da Abbott americana para o órgão fiscalizador. A empresa teve seu pedido aprovado e, desde então continua vendendo o seu sal (que não foi testado de fato). Recentemente, investigação do partido comunista confirmou o pagamento de propinas por parte da empresa.

Casos como esse abalam a credibilidade de tudo que foi e continua sendo feito na China e seu órgão regulador.

Abaixo, trecho da matéria.

In 1995, a Chinese drug maker was developing a version of clarithromycin, a popular antibiotic used mainly to treat respiratory infections. But to begin selling the medication, the company, Zhongxiang Kangshen Medicine Co., needed approval from China's drug regulator. So Luo Yongqing, director of Zhongxiang's research department, called his top employees to a meeting. According to Gao Chun, a research scientist who attended, Mr. Luo tossed a box of antibiotics made by Abbott Laboratories on the table and told the scientists to use the American drug maker's pills in their application for approval from the country's drug watchdog. Zhongxiang's own drug wasn't ready yet, Mr. Gao says, but the company didn't think that should get in the way. Some of the researchers agreed to substitute the pills, Mr. Gao says, but he refused. "I thought it was immoral and against the law," he says. A short time later, Mr. Gao stopped working for Zhongxiang and launched a decade-long fight against the drug and against government regulators, whom he accuses of taking bribes from his former employer to look the other way. The company won approval for the drug and has been selling it ever since. Mr. Gao's case failed in the courts, but the picture he painted of a system gone wrong has received surprising vindication. A major corruption probe has targeted China's former top drug regulator, a man with whom Mr. Gao had an angry confrontation as he pursued his case. The Central Commission for Discipline Inspection, the Communist Party's anticorruption watchdog, began investigating the regulator, Zheng Xiaoyu, in December and announced his expulsion from the party on March 1, alleging that he abused his power by taking bribes from drug companies. It is unclear whether he will face criminal prosecution. Mr. Zheng couldn't be reached for comment.

Genérico, não necessariamente o mais barato.

Como os consumidores brasileiros já aprenderam, em vários momentos o preço do genérico se aproxima ou mesmo supera o do equivalente de marca. Agora, esse fenômeno foi detectado nos EUA, onde a venda de genéricos está crescendo muito nos últimos dois anos. Abaixo, trecho de reportagem do The Wall Street Journal.

Why Generic Doesn't Always Mean Cheap
Zocor Case Shows DrugstoresMay Offer Only Small SavingsOver Brand-Name Drug Prices
By SARAH RUBENSTEINMarch 13, 2007; Page D1
The great promise of cheap generic drugs is taking a bumpy road to arrival.
Case in point: Zocor, one of the most commonly prescribed pills in the U.S., which lost patent protection last June. Multitudes of patients have switched to generic versions of the cholesterol-lowering drug, lured by lower insurance co-payments or the promise of a significant price drop for those who pay out-of-pocket.
As predicted, the price that many insurers pay for generic Zocor has dropped dramatically. But the price that pharmacies charge patients who pay cash remains high in many locations, with wide variations by vendor. At online pharmacy walgreens.com, for instance, the price for 30 tablets of a 20-milligram dose of Merck & Co.'s Zocor is $149.99, compared with $89.99 for simvastatin, the generic version. And last week, the same dose of simvastatin cost $108.99 at CVS's Web site, compared with $154.99 for Zocor. After a call from a reporter, CVS said it would drop its simvastatin price to $79.99, as part of an "ongoing price analysis."
At a time when policy makers are searching for ways to cut health-care costs, generic drugs are often viewed as one of the most straightforward solutions. But as the situation with generic Zocor illustrates, prices can vary wildly, and may not be nearly as cheap as expected. Generics of a number of other notable drugs that came off patent recently -- including the antidepressant Zoloft, the antibiotic Zithromax and allergy drug Flonase -- have also so far failed to deliver big savings in many cases.
"We're not seeing that sharp a drop-off" in price among generic drugs that have come out in the past couple of years, says Jim Yocum, executive vice president of DestinationRx Inc., a Los Angeles pharmacy data and software company. "We're just not seeing it."
To be sure, even for the uninsured, generics still typically cost less than their branded counterparts. And at big clubs such as Costco Wholesale and Sam's Club, out-of-pocket prices for generics do generally plummet. Simvastatin costs $6.97 for 30 pills of the 20-milligram dose at a Sam's Club for which the company provided price information.
But just how far -- and how fast -- generic prices fall depends on a number of factors. Among them: how many generics makers sell the drug; how much competitive pressure pharmacies feel; whether there is another alternative, such as a different generic in the same class of drugs; and whether a particular generics maker gets an initial exclusivity period. By law, the first generics maker to challenge a patent on a branded drug and prevail wins six months of exclusive sales.
For the more than 46 million Americans without health insurance -- plus perhaps millions more whose insurance plans don't cover drugs -- the lesson is to shop carefully. Some pharmacies list prices online, and certain Web sites will compare prices from a number of competitors. If your pharmacy doesn't list prices, a few phone calls to some competitors can mean big savings. If you're willing to travel, try pharmacies that aren't very close to each other and are less likely to react directly to each other's prices.
The growing variety of outlets for prescription drugs -- with wholesalers and online vendors joining the chains and mom-and-pops -- brings a range of business models that affect how generics are priced. At sellers where drugs are a significant driver of revenues, prices may remain high. Sometimes, as with generic Zocor, prices stay high even after a six-month exclusivity period ends, when additional generics makers start fueling supply.
Stores say they regularly review prices. At drugstore.com, generic simvastatin until recently had been at $125 for the common 30-tablet dose, compared with $135.99 for Zocor, even after the six-month exclusivity period ended in late December. After a reporter called to inquire about the price, drugstore.com on Friday dropped simvastatin to $27.99, which the company said was part of a regular review. Zocor now costs $139.99. On walgreens.com, simvastatin's price hadn't fallen after the six-month period's end. After a reporter inquired about it in late February, it dropped to $89.99 from $129.99. A spokeswoman said the price had already been under review.

Genéricos em alta no Brasil, mas a indústria faturou bem em 2006.

A indústria farmacêutica não pode reclamar: aumentou o faturamento em reais que quase 10% em 2006 quando comparado a 2005. Os genéricos tiveram aumento de faturamento bem maior:26,3%. Apesar do aumento no último ano, a participação dos genéricos no mercado total foi de 9,4%

Genéricos em alta nos EUA.

A prescrição e compra de medicamentos genéricos aumentou nos Estados Unidos, principalmente entre os idosos. Tudo isso apesar da propaganda intensa dos medicamentos de marca. Abaixo, reportagem do The Wall Street Journal.

Use of Generic Drugs Is Rising,Especially Among the Elderly
By DEAN TREFTZFebruary 8, 2007; Page D3
WASHINGTON -- Government data to be released today show that almost two-thirds of prescriptions filled for Medicare beneficiaries are for generic, rather than brand-name, drugs, a proportion that is higher than in the under-65 age group and that is helping to lower the projected costs of the Medicare drug benefit.
The Centers for Medicare and Medicaid Services, which runs the federal program for the elderly and disabled, found 61% of seniors' prescriptions were for generic medications in the third quarter, the third consecutive quarter of growth in using generics.
The National Association of Chain Drug Stores also will announce today that the use of generic drugs rose to almost 53% of privately insured Americans, from 48% in 2005. Increased use of generics has been cited as one reason why growth in U.S. health-care spending has slowed from its earlier torrid rate.
Generic alternatives to more expensive brand-name drugs allow seniors to delay reaching the drug benefit's coverage gap, also known as "the doughnut hole," or to avoid it altogether, Medicare officials said. The agency encourages the use of generic drugs.