Archive for December, 2009

Problems after Lasik Surgery

Wednesday, December 30th, 2009

The FDA has received persistent complaints about outcomes and “quality of life” following LASIK (laser-assisted in situ keratomileusis) eye surgery. Even though the total number of patients reporting problems is relatively low, about 5% one has to keep in mind that reporting rates of complications resulting from a variety of medical causes such as drug reactions, etc. is less than 10%. Even without taking this into account, with 750,000 procedures annually in the U.S. (13.5 million procedures total  performed in the U.S., and only 16.3 million worldwide!) the total number reporting problems amounts to 675,000 patients.

Complaints reported include poor distance vision, dry eye, redness and pain, glare, and halos.  According to the JAMA, Dec. 9, 2009, advocacy groups opposing LASIK surgery have added other complications, including depression and suicide ideation.

See LASIK Surgery watch for discussion of other potential problems with LASIK surgery that are becoming the source of controversy among ophthalmologists. Among these are problems with accuracy of intraocular pressure (IOP) measurements used routinely to screen for glaucoma. “Permanent changes in corneal thickness and biomechanical properties following LASIK result in inaccurate IOP measurement, exposing patients to risk of undiagnosed glaucoma and associated vision loss.” Also mentioned is the problem of measuring the corneal surface in cataract surgery to calculate the power of in intraocular lens implantation.(IOL). Changes to the cornea after LASIK can  cause inaccurate measurement of IOL power, which may result in a poor visual outcome after cataract surgery.

In May of this year the FDA and CDC began reviewing reports of fungal keratitis-a serious infection which can cause destruction of the cornea-  in over 90 patients wearing contact lenses using cleaning/disinfecting solutions, ReNu and MoistreLoc by Bausch and Lomb.

The FDA plans three studies, culminating in a survey of quality of life following LASIK surgery in about 2500 patients from the general population.This may not take place for 1-3 years.  According to this site, LASIK eye Surgery is the procedure of choice and can be elected to be done for a person who is dependent on glasses or contact lens for a prolonged period.”  It seems to me that one should consider carefully whether his desire not to wear glasses or contacts supercedes the possible immediate and long-term risks of undergoing surgery on his cornea.

I wonder, in other words, the true percentage of 750,000 patients a year who really Need or benefit from LASIK surgery. See this American Academy of Ophthalmology site.for more information.

Cancer Chemo: Unaffordable?

Thursday, December 10th, 2009

Could you afford over $30,000 a month for a newly approved chemotherapy drug? It’s called “Folatyn” an “improved” form of an old drug, Methotrexate; yet no one yet knows if it will prolong life in certain rare cancers. Then why was it approved without evidence of effectiveness? Genzymes’ Clolar for pediatric leukemia costs $68,000 for a required two weeks treatment. As reported in the New York Times GlaxoSmithKline is charging $98,000 for a six-month treatment course for Arzerra, to treat chronic lymphocytic leukemia which strikes 15,000 Americans a year. That adds up to about $1.5 billion a year.

Treating a lung cancer patient with Erbitux, marketed by Eli Lilly and Bristol-Meyers costs $80,000 for an 18 week regimen, and reportedly prolongs survival by only 36 days. In how many patients is that measured, and how are they matched-what are the biases? The Journal of the National Cancer Institute reports that the life of each American who dies of cancer could be extended by one year at the cost of about half a trillion dollars. The authors went on to question the cost benefit analysis of other big sellers such as Avasgin, and Nexavar,” both drugs costing more than $34,000 for a single course of treatment citing poor survival data.”

The authors, quoted in the Wall Street Journal, Tito Fojo and Christine Grady, both of the NIH National Cancer Institute, called for changes in both the testing and and practice of oncology, noting that more than 90% of chemotherapeutic drugs approved for cancer treatment in the past four years in the U.S. cost more than $20,000 for a 12-week course.

They add, the high cost and relatively low benefit of these drugs points to “one of the thorniest questions facing lawmakers working on the overhaul of the U.S. health-care system”: reducing growing health care spending in the last months of patient’s lives. “Some countries, like the United Kingdom, agree to pay for expensive drugs only if they meet a certain threshold of efficacy, but no such rationing exists in the U.S.,” the Journal reports.

Stay tuned.