Getting Away With Murder — Cheaply
This is one of those stories that I find very difficult to write. My anger is great and clouds my mind. Yet if I do not, there may be some kind of eruption – tears, shouts, or pounding on the wall.
The headline in the Philadelphia Inquirer read, “4 ex-pharma execs face possible jail time.”
“Possible” jail time? This is murder.
Synthes received FDA approval bone cement for use only to fill bony voids or defects in some parts of the body, but not in the spine.
In 2003 and 2004, the company is accused of having its representative train surgeons to use this cement for the very thing they were forbidden by the government to do.
For those who don’t know, many surgeries are performed by people who aren’t technically allowed to practice medicine. A lot of times, people who didn’t complete medical school or people who have had their medical licenses taken away for various disciplinary reasons can get employment with a manufacturer of pharmaceuticals or medical appliances (like replacement hip joints) and will train doctors on how to utilize these new products.
This isn’t widely discussed and is shady, at best. It’s probably criminal, but that’s another column.
Synthes executives are charged with conducting illegal clinical trials in which 200 patients were treated for ways not approved by the FDA.
Of those 200, three died.
The original 52 felony counts from the 2009 trial were melted down into a single misdemeanor through the “responsible corporate officers” doctrine, which seems to be another way corporations have used their influence in government to make things easier on them than they are for us regular citizens.
Now, more than two years later, sentencing has been announced. There will be jail time – seemingly minor for such serious infractions, but at least the executives have been named. According to the newspaper, it is rare for pharmaceutical executives to do jail time.
They somehow just skipped trials of this new bone cement on humans, and decided to teach an elite group of surgeons and three patients died while on the operating table having bone cement injected between their vertebrae to shore up their fractures.
In my subscription-only newsletter, I just wrote about this last week. If you aren’t a subscriber, you can opt-in for free by filling in the little box in the upper right-hand corner of this page — and of course, opt-out any time you find it boring. I try awfully hard to NOT be boring.
Immediately after applying the cement, people had a sudden and significant drop in blood pressure.
Now these things occasionally happen during major surgery, mind you. A decent nurse-anesthetist or anesthesiologist knows how to handle this kind of stuff, and I have personally seen this handled intelligently and well a number of times. Here, nobody was fast enough, so this was very serious stuff. Three people died as certainly as if a gun had been pointed at their head.
The lapsus here (if I may inject some Freudian jargon) is not a simple “whoopsie.”
Any product that is going to be used on – or in –humans has to be tested on humans first (after years of being proven safe by use on animals ). This is federal law as well as having been established internationally. This procedure with new devices or substances or medications has been done innumerable times, by Synthes, as well as their parent company Johnson and Johnson.
What mad rush to make money faster made people do this? The patients surely did not know. They wouldn’t sign an informed consent to be guinea pigs on something the government wouldn’t allow.
How about the surgeons? Were they willing to take risks in doing forbidden procedures? To them, there wasn’t the monetary incentive. Were they modern day Victor Frankensteins, wanting to play God?
Doctors are not usually brave pioneers. We are usually ultra-conservative when it comes to patient care and looking out for our own malpractice exposure and licensing status.
Starting way back when I was a medical student, I personally used to ask companies for the official pamphlets on devices and products provided. It made sense because the devices and products were often too new to be in textbooks or anywhere else.
Did these surgeons not do this? Were there special honoraria (monetary, vacation trips, other perks) to the “elite” surgeons chosen by Synthes? Is risking your career and your freedom to live outside a prison worth vacations to Hawaii and the like?
What about the drug rep who got friendly with the surgeons, pumped up their egos somehow and convinced them to do this? What kind of pressure were the reps under to sell this stuff? How stupid did the doctors have to be to go for it?
For a good look at what pharmaceutical sales representatives go through (and what they do) as well as how doctors treat them, there is a surprisingly realistic movie called “Love And Other Drugs” which is now playing on pay-cable networks and will probably be available in the rental outlets by the time you read this.
Like the Penn State child molesting scandal, there are attempts at a “cover-up,” I think, by the drug company. Cover-ups make things worse and are often more serious infractions than the original crimes. The executives directly involved should go to prison. They were sentenced after a couple of years of dragging around in various courts, but only for a few months.
I think they should be imprisoned until the end of their days, as they are murderers.
A lot of people down the way may have had complicity in these murders. They should be sentenced as accessories.
The sad widow or widower pictured in the article holding a portrait of the deceased for the news photographer has a right to ask for just punishment of this kind of thing, for it is murder for certain. Here there is no recompense, no just desserts, as the executives who did not follow the law and test this product seem to be somehow having their guilt mitigated by being part of a “corporation.”
I remember hearing that President Obama was going to get people to crack down on “medical fraud.” This may be fraud initially, but it is murder at the outcome — and nothing less. I am not ever sure how you as a patient can protect yourself from this. I’ve written before about people who were entered into risky experimental treatments without their knowledge.
You should be offered a written “Informed Consent” form, and you should have a person to explain each part of it to you – not just shove it at you on a clip-board and tell you “Sign here.”
You are also allowed to hand-write any additional conditions on that form that you feel are important. Something like, “No non-FDA approved substances or procedures can be utilized in my treatment.” If the staff or the doctor objects to this – you need to get help from higher up — Some hospital administrator who specializes in “risk management” (their term for malpractice lawsuits), or a patient advocate – which most hospitals have on staff, but I’m not sure if it is required by law.
However, I realize that a patient cannot go through all of this when one is sick, in pain or otherwise injured. This is how such breeches in law and ethics slip through the cracks.
Another thing that annoys me about this story is that it was not easy for me to find. Maybe somebody in the corporate structure tried to limit publicity, or perhaps I am projecting because I am angry. I do realize that newspapers often shield their big advertisers from adverse publicity, and also that corporations have lots of lobbyists that can be very effective in “softening” the news.
A company that makes medical substances or devices generally has the public trust. In fact, most spend a lot of money on positive PR to create this trust. Just the fact that a company is big and you see their name on TV, in magazines and on products in the stores can have a comforting, positive effect.
I have not had any Synthes prostheses installed in my body, but I do remember seeing the name on boxes, and probably assisted in the installation of such devices.
Of course, “Johnson and Johnson” is part of plenty of lives. My first thought here is of my Mother-Of-Blessed-Memory “Band-Aid” bandages on my little “owies” when I was a tiny child. The company also does a land-office business with mainstream stuff like Listerene mouthwash, StayFree sanitary napkins, Tylenol, Rolaids, Pepcid – well, you get the idea. They are BIG.
What were these people trying to do? Make more money? Rush a product into production to increase the lining of their pockets with silver?
This one should be the headline on every news service, and it isn’t.
These four people who authorized or at least knew about this mess will probably not do anything with human research or treatment for the rest of their lives. Any monetary sanctions to the company are written off as the “cost of doing business.”
Murder minimally punished, scapegoated by a company that broke international and federal laws, numerous accomplices and aiders and abettors ignored; three innocent people dead in perhaps the worst medical injustice known to me.
This is why I weep for the United States of America.
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Tags: back surgery, blood pressure, bone cement, clinical trials, cover-upmurder, criminal, doctors, Drug Companies, FDA, Frankenstein, informed consent, Johnson & Johnson, lapsus, lobbyists, Love and Other Drugs, malpractice, medical appliance, patient advocate, Penn State, pharmaceutical companies, pharmaceutical executives, pharmaceutical sales rep, risk management, surgeons, Synthes.