Category: Bioethics

The Seattle Times: Health: Lawsuit won over doctor’s undisclosed drug problem

A Washington hospital and a malpractice insurer have successfully sued a Louisiana hospital and two doctors who wrote glowing letters of recommendation for a colleague without disclosing his drug problem.

The jury award of more than $4 million for fraud and negligent misrepresentation marks the first time one hospital has successfully sued another for failing to disclose adverse information about a doctor being considered for privileges to practice there, liability experts said.

The case was brought by Seattle-based Western Professional Insurance and Kadlec Medical Center, the Richland hospital that later hired Dr. Robert Lee Berry, unaware of his history.

In 2002, one of Berry’s patients, Kim Jones of Richland, then a 31-year-old mother of three, sustained severe brain damage during a routine procedure. Jones is in a nursing home in Michigan unable to care for herself.

Two years later, Berry, an anesthesiologist, and Kadlec agreed to an $8.5 million settlement in a lawsuit brought by Jones’ family.

During that lawsuit, Jones’ family learned that Berry had been diverting the narcotic painkiller Demerol from his patients. They also learned he had been asked to leave the Louisiana hospital and his practice for being impaired on the job ”” a fact neither had disclosed to Kadlec.

“Had we known, we wouldn’t have hired him,” Kadlec spokesman Jim Hall said.

Ron Perey, Jones’ lawyer, said “a case like this has never been won before.” He predicted it would bring about positive changes in “honesty in the medical industry.”

Well, it’s certainly a change – here’s hoping it’s a positive one.

New Scientist Breaking News – UK drug trial disaster — the official report

The final report into a catastrophic drug safety trial that left six men fighting for their lives in the UK in March 2006 has severely criticised Parexel, the firm that carried out the trial.

Parexel’s catalogue of errors, listed in the report issued by the Medicines and Healthcare products Regulatory Agency, include failing to complete proper patient medical records and not providing 24-hour medical cover.

However, the report concludes that the serious adverse reactions experienced by the healthy volunteers were the result of an “unpredicted biological action of the drug in humans” — echoing an interim report issued in April 2006.

Why, for all it’s flaws, the FDA (or some sort of regulatory agency) is a good idea. Granted, it does sound like it was simply a problem with the drug itself – which is why we do clinical trials – but there were enough flaws within Parexel’s protocol that it highlights why we need oversight agencies.

This is becoming an even worse problem in the third world countries, or upcoming ones such as India, where drug companies are fleeing at alarming rates to do their trials – no FDA, no regulatory agency, no institional review boards, nothing. Just free reign and the money to buy people who’re desperate enough for the cash that they’ll do just about anything – especially with trials, where you have a chance of placebo and walking away with money and no side effects.

Of course, this British disaster shows the problem with that logic – it’s a Big Pharma version of Russian roulette.

Gabon has taken the unusual step of bringing in bioethics experts to educate their government about drug trials, and to insist that all trials done in their country follow US FDA protocols and procedures. This insures greater safety for their citizens, and Big Pharma still goes there, cuz it’s still cheaper. It’s almost a win-win situation; I wonder, and should dig, on just what FDA rules are for accepting clinical trials run outside the USA. And I think I have just the book to do it,…

New Scientist Breaking News – Rhythm method criticised as a killer of embryos

The range of birth control choices may have become narrower for couples that believe the sanctity of life begins when sperm meets egg. The rhythm method, a philosopher claims, may compromise millions of embryos.

“Even a policy of practising condom usage and having an abortion in case of failure would cause less embryonic deaths than the rhythm method,” writes Luc Bovens, of the London School of Economics, in the Journal of Medical Ethics.

With other methods of contraception banned by the Catholic church, the rhythm method has been one of the few options available to millions.

In using the rhythm method, couples avoid pregnancy by refraining from sex during a woman’s fertile period. Perfect adherents claim it is over 90% effective — i.e. one couple in 10 will conceive in an average year. But, typically speaking, effectiveness is estimated at closer to 75%.

Now Bovens suggests that for those concerned about embryo loss, the rhythm method may be a bad idea. He argues that, because couples are having sex on the fringes of the fertile period, they are more likely to conceive embryos that are incapable of surviving.

You can read the rest of the article by following the above link, but I think this snippet nicely summarizes the entire piece – and the problems that could be facing the Catholic Church and fundamentalist Protestants. If the rhythm method kills more embryos than other forms of contraception, or is the cause of noted miscarriages (and the article does note devout Catholics seem to have a higher rate of miscarriage), then the Church/churches are going to have to change their view of even this method of “contraception”.

Frankly, I’ve never understood why this is okay and other forms of contraception are not – the intent, after all, is the same. Especially if you’re comparing it to non-barrier method forms of birth control; it seems to me that if the argument is that, in the case of the rhythm method, God can choose to cause impregnation, should He so desire, you’re either implying God isn’t all powerful and can’t overcome a small thing like hormones, or that God would be so pissed at you using contraception he wouldn’t bless you with a child…which is sort of playing into the point of contraception to begin with.

In the case of barrier methods, at least there is some consistency, since there is an actual barrier in place to prevent the sperm from ever meeting the egg. Although, again – God isn’t powerful enough to cause the barrier to fail, if he so wanted a pregnancy?

Yeah. Eight years of exposure, and I still don’t get the mindset.