FDA DISCOURAGES DEVELOPMENT OF NEEDED DRUGS

Amid all the buzz about a possible avian-flu pandemic (and more noise soon as another season of West Nile virus infections begins), America is already ex periencing another perilous epidemic. The Centers for Disease Control and Prevention report that as many as 2 million patients nationwide contract bacterial infections in hospitals each year - and 90,000 die. The death rate in such cases is alarmingly high not because the patients are initially very ill, but because hospital germs increasingly are resistant to multiple antibiotics. Thus, the infections are difficult to treat.

But antibiotic resistance in hospital germs is merely a worst-case version of what is happening in the broader community in non-hospitalized patients - in common lung, skin and sinus infections, for example. That is, germs are becoming more resistant to the antibiotics we have - which means that we need new ones.

Federal health officials have adopted four main strategies - prevent infection, diagnose and treat infection, use antimicrobials sparingly and prevent transmission - but they have paid little attention to the shortage of new antibiotics. For decades we've relied largely on slight variations on old drugs to combat rapidly evolving pathogens. The last 37 years have brought just two new antibiotics with truly novel modes of action - Zyvox in 2000 and Cubicin in 2003 (and Cubicin is only used for skin infections).

Right now, the prospects for more are bleak. Over the last decade or so, all the major drug makers have dramatically trimmed or eliminated their antibacterial research programs, to focus instead on drugs that treat chronic ailments and lifestyle issues. Research costs are equally high - it now costs more than $800 million to bring an average new drug to market - and these other drugs are more likely to repay the investment. Whereas antibiotics cure a patient in days, and may not be required again for years, someone taking Lipitor for high cholesterol or Levitra for erectile dysfunction might pop these expensive pills every day for decades.

Congress hasn't managed a remedy. Legislation was proposed last year to create tax incentives for companies that develop new antibiotics, limit their liability for side effects (as has been done for childhood vaccines) and extend patents to compensate for time lost while awaiting FDA approval. But the bill also included an added feature, "wild-card exclusivity" - that turned out to be too wild. This would allow a firm that markets a new antibiotic to extend the patent on any product in its portfolio by up to two years, with the approval of federal officials.

The idea was to give, for example, Pfizer the incentive to discover an important new antibiotic, and so win more time to market Viagra before generic manufacturers could legally produce the drug. But, as written, it might have let companies reap such lucrative gains even for antibiotics little different from existing ones. Better policy - and politics - dictates that "wild card" antibiotics both be intended for treatment of serious or life-threatening conditions and address unmet medical needs.

We need also to adopt the kinds of critical FDA reforms suggested by the Infectious Diseases Society of America - to speed up clinical trials, goose regulators and encourage more innovative research.

The two novel antibiotics introduced since 2000 won't be enough to keep rapidly mutating pathogens at bay for long - and once a resistant bug appears, it will spread rapidly. Soon, there might not be any more "routine," easily treated infections.

Unless we create economic incentives for companies to develop antibiotics, it's unlikely that we'll see many more wonder drugs in the near future. Think about that the next time you or a loved one is hospitalized with a flesh-eating bacterial infection - or even if you've recently taken an antibiotic for bronchitis or a skin infection as an outpatient.

Source







NHS targets are the real waste

Once again the NHS is in crisis. Essential staff are sacked, beds closed, GPs are scolded for "over production" because they have exceeded their targets. When will the mandarins realise that patients are not widgets on a production line for which targets can be imposed and delivered? If a patient needs a half hour of a doctor's time to help him/her come to terms with an unexpected cancer diagnosis, that is what the doctor will do because the professional ethos demands it.

All targets do is waste valuable time. Already nurses spend 40% of their time on computers, much of it designed to capture data needed for targets which also encourage managers to be deceitful and massage figures and make desperate efforts to rob Peter to pay Paul.

The alarming rates of hospital acquired infections that we now suffer (and die of) could be more easily avoided if staff had the time to practise the aseptic techniques that prevent HAIs.

This government is too fond of suggesting useless ideas to improve patient care; I don't know whether to be horrified or amused at the appointment of "dignity nurses" given that treating patients with dignity should be central to the job of a nurse. Unfortunately, some modern nurses have not been properly trained in the skills needed to treat elderly patients with dignity. I fear for the existence of a once superb institution which I have always been passionate about.

Source

***************************

For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

***************************