Nota C&T:
Caros leitores,existem detalhes que merecem muita atenção das autoridades competentes para o assunto medicamentos novos e a ganância por dinheiro de muitos. Não só as Indústrias Farmacêuticas são alvos desta atenção, os órgãos reguladores também têm seus interesses.
O médico tem o papel fundamental durante o ato médico de escolher o melhor para o paciente, ele deve ser racional e não se empolgar com o que chamam de novidades terapêuticas.Há uma corrida louca por novas drogas ou extensão de patente, principalmente quando a patente de um *blockbuster está próxima de expirar, como são os casos de Glivec, Lipitor, Plavix, Diovan, entre muitos outros.
* 'blockbuster' é geralmente definido como um único medicamento que trata uma doença e gera receita de mais de US $ 1 bilhão por ano (€ 664.000.000).
Nota postada por Teófilo Fernandes.
Comparative Effectiveness: Hope Or Hype?
(Eficácia comparativa: esperança ou campanha publicitária?)
With Democrats controlling the Senate and the White House, the failure of congressional efforts to repeal ObamaCare was hardly a surprise. So what can we expect? Well, the U.K.’s arbiter of reimbursement for prescription drugs, the National Center for Clinical Excellence, offers a window into the kind of drug rationing that may ultimately be in store for us.
For example, NICE’s recent decisions include rejecting coverage under the National Health Service for two cancer drugs — not because they aren’t safe or don’t work but because they are perceived to cost too much for the benefits they offer. In November, NICE denied payment for a higher-than-standard dose of Glivec (Gleevec in the U.S.) for gastrointestinal stromal tumors, although some patients (14%, according to the manufacturer of the drug) would benefit from the higher dosage.
Why is this relevant to American health care? In no small part because Center for Medicare & Medicaid Services head Donald Berwick — among others in Congress and the administration — is completely gaga over the British health care rationing system. He gushed, “I am romantic about the NHS. I love it.” Rationing — a politically charged term that Berwick himself uses — is a primary reason Berwick much prefers the “politically accountable” British system. “NICE is not just a national treasure,” he said, “it is a global treasure.”
But NICE is not considered all that nice by everyone. Without question, it denies British citizens access to breakthrough drugs for debilitating and life-threatening conditions like cancer, multiple sclerosis, Alzheimer’s disease and macular degeneration because those medicines are not judged to be sufficiently cost-effective. Karol Sikora, a professor of oncology at Imperial College School of Medicine in London, believes that “The real cost of this penny-pinching is premature death for thousands of patients.”
An essential part of the kind of decision-making done by NICE is “comparative effectiveness” — a rigorous test of a given treatment, such as a new medicine, against other available treatments. To gain regulatory approval of a potential new medicine, a pharmaceutical company usually has to demonstrate only that its candidate outperforms a placebo in clinical trials. (Cancer drugs are an important exception: Clinical studies compare new drugs to standard care.) Comparative effectiveness research is more ambitious because it pits two or more drugs (or other kinds of interventions) that are already on the market against each other. Such studies therefore often require much larger numbers of human subjects to show that one drug is either superior to the alternatives – especially if the differences are small — or that it offers equivalent therapeutic benefits for less money.
Because such head-to-head trials are so expensive to conduct, pharmaceutical makers seldom foot the bill, most often leaving governments to pick up the tab, in spite of the fact that the results can be a bonanza for the makers of the superior drug. (Again, cancer drugs are a frequent exception.)
The 1994-2002 ALLHAT trial of competing blood pressure medicines is a textbook example of important comparative effective research. The study showed that for most patients with hypertension, an inexpensive generic diuretic, sometimes called a “water pill” (because it stimulates urination), was just as effective at lowering blood pressure and preventing heart attacks and strokes as pricey name-brand calcium channel blockers or ACE (angiotensin-converting enzyme) inhibitors. The last biannual follow-up study of ALLHAT’s 33,357 participants bolstered the original findings. Patients were followed for an average of 8.8 years after their participation in the ALLHAT trial had ended. Those who had been taking the diuretic actually suffered fewer heart-failure hospitalizations and deaths than those who had been taking the up-market calcium channel blocker. Also, people on the diuretic had fewer fatal strokes than those who had been taking the ACE inhibitor.
The ALLHAT researchers were careful to point out that for certain subpopulations, a diuretic was not the best treatment for hypertension, and that still other patients would need to take a diuretic in combination with other blood pressure drugs. Without any government mandate, ALLHAT has quietly changed the way many American doctors treat hypertension — and has reduced spending on drugs.
Another more recent example of the usefulness of comparative effectiveness is found in a study published on Dec. 14 of the use of a new interventional heart technology –fractional flow reserve, or FFR — that can help patients avoid the insertion of unnecessary coronary artery stents by providing sophisticated measurements of blood flow in the vessels to the heart. Used diagnostically in patients with coronary artery disease to determine which arteries should receive a stent, it involves inserting a guide wire that measures pressure into the artery instead of relying solely on the traditional coronary angiogram. By reducing the number of stents inserted (compared to the standard angiogram), FFR saved an average of $2,000 per patient.
Thus, comparative effectiveness studies can be useful, at times both improving patient care and reducing medical costs. But they are unlikely to have a significant impact on America’s skyrocketing medical expenses, because the cost of performing the requisite number of studies would be prohibitive.
Comparative effectiveness research began in the late 1970s and, until the recent health care debate, for the most part enjoyed bipartisan political support. The Medicare Modernization Act of 2003, passed at a time when Republicans occupied the White House and controlled Congress, authorized the federal Agency for Healthcare Research and Quality to perform comparative effectiveness research.
The new ObamaCare law prohibits the U.S. Department of Health and Human Services from using “a dollars-per-quality adjusted life year (or similar measure that discounts the value of a life because of an individual’s disability) as a threshold to establish what type of healthcare is cost effective or recommended.” In other words, Medicare administrators appear to be precluded from taking cost concerns into account when making coverage decisions. Another provision of the law prohibits federal bureaucrats from using such research “in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.” In addition, there is an older statute that appears to bar Medicare officials from taking cost into account, but a government press officer dodged my request for specific information about it.
Although Medicare administrators are not permitted to make coverage decisions based on economic considerations, the new law does preserve their longstanding ability to deny payment for a drug if persuasive evidence suggests that it is not clinically effective for a particular condition.
In spite of the anti-rationing provisions in the healthcare law, many critics (including this writer) believe that Medicare administrators will push the envelope to find a way to avoid reimbursement for drugs they regard as too expensive. Dr. Berwick’s paeans to NICE bolster that conviction. And U.S. bureaucrats’ emulating the British approach would be ironic in view of the recent announcement from the U.K.’s Conservative-led government that NICE will no longer have the power actually to reject drugs and that decisions on how much the national health-care system will pay for new treatments will be made through “a new system of value-based pricing.”
There is no simple or satisfactory answer to how we can develop and provide cutting-edge treatments at a cost that society can afford. University of North Carolina School of Medicine Professor Joel E. Tepper captured the conundrum this way, “Many so-called advances in fact provide trivial advantage for the patient despite huge costs, and there is a total disconnect on the part of many people who demand full access to any and every medical intervention while not wanting to pay for it (either through society or the individual).”
Reconciling those contradictions will be difficult in an atmosphere of increasingly divisive and partisan politics.
Henry I. Miller, a physician and a fellow at Stanford University’s Hoover Institution, was the founding director of the FDA’s Office of Biotechnology. He is the author of To America’s Health: A Proposal to Reform the FDA.
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