Category Archives: Legal Side of Medicine

Pharma Companies that Can’t Handle Comments Should Get Off Facebook, Good Riddance!

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Jonathan at Dose of Digital talks about pharma’s fear of Facebook pages centering around 2 issues that pharma thinks require 24/7 monitoring: Adverse Events and negative publicity.

I hear the same excuse on why pharma companies are so scared to look at patient comments on blogs: adverse events.

I’m sorry, but adverse events are happening whether pharma companies are monitoring or not, and this is different from monitoring whether someone’s posting something “bad” about your company (newsflash: not everyone’s going to like you, better to expect it and have rules to address it than bury your head in the sand).

Adverse events are crucial for patient adherence and avoiding Facebook comments for fear of posts on AE is a missed opportunity for pharma to engage with patients in an issue that they all care about.

Patients expect drugs to work — rarely will patients want to get on a pharma page to thank the company for making a product that works. You may have a cancer patient who will do this if the company has gone above and beyond the call of duty to help the patient gain access to the drug that the patient otherwise cannot afford. But for the most part, patients have a “love-hate” relationship with pharma companies that is more “hate” than “love”, and I can’t blame patients for feeling this way.

What patients gripe about, and fear, and dread, are the adverse events.

Adverse events chip away a patient’s hope of getting better.

Adverse events erode a patient’s quality of life.

Adverse events make patients wonder, “would I rather stay ill, or deal with this horrible side effect?”

Then they look at companies avoiding discussion about something that is so key to their treatment experience, they naturally assume “profits before patients”. Never mind the realities of bureaucracy in adverse event reporting, I know it’s a bitch… the FDA knows it too.

That’s how pharma companies come across in their being so scared about Facebook.

Funny… I rarely recall pharma companies coming across scared when some of their sales and marketing teams find creative ways to fly under the radar to promote off-label. Somehow these companies are fine with breaking the law to “expand” usage of their drugs, but now they’re claiming they can’t deal with lack of guidance where Facebook pages are concerned.

Better companies pull their pages off Facebook if they are hard-headed about not allowing comments. Leave those who are more enlightened to get those patients’ eyeballs and possibly gain some goodwill.

Companies who want to control the message and behave hypocritically are doing the right thing by leaving Facebook: they aren’t adding value on the social network anyway.

Stop Pretending You Don’t Know, Pharma Companies!

I remembered years ago I was speaking to a Forest employee who told me how proud she was to be working at Forest because of how ethical the company and the CEO was.

That same employee was critical of me for talking to the WSJ about some of the less ethical practices that pharma companies have been using medical science liaisons – especially when all other quotes were positive – mine was the only one dealing with the abuse and misuse of the role. She felt that I should have used the media opportunity to “talk up” the profession.

I said that “talking up” the profession was what I’d done for all those years that I was running the MSL Institute. It’s time to “talk honestly” about what ails the profession so change can actually proceed.

I find what has happened with Forest Labs part of a lot of denial that some companies’ employees and executives experience when they see one thing but are told what they should be seeing.

If they oust the CEO, it will send a message to other CEOs at other pharma companies: “you’d better start hiring people underneath you who are capable of producing profit within the law, or you’ll pay for your bad hiring decisions.”

While it would be more poetically just to oust those who directly violated – firing the CEO is also part of the solution. The CEO’s job is to ensure that the people s/he has hired know how to create that ethical culture, not just talk a good talk but walking a different way when the feds aren’t watching.

After a while investors, who are always interested in protecting their investments, will catch on with the reality that golden parachutes are no longer a good deal.

Or is this too vicious of a cycle to ever catch up with the investors and the Street’s pocketbooks?

Would You Cancel a Surgery if Your Surgeon is Getting a Kick-Back?

The specific question is about getting kickbacks as a surgeon using a medical device, and was originally asked on Quora. The explanation to the question (posted by the asker) said,

“The department of justice has investigated conflicts of interest, and the Pittsburgh Post Gazette has published on the topic. To quote from the gazette:

Payments to other Pittsburgh area physicians include:
• The Orthopaedic Group of Pittsburgh received $75,000 to $100,000 this year from Smith & Nephew, and two of its doctors, Ari Pressman and Allan Tissenbaum, received individual fees. Smith & Nephew reported paying the same range of fees to Carnegie Mellon University, and to Carnegie Mellon professor Dr. Jeffrey O. Hollinger, a bone tissue regeneration expert.

• Biomet has a relationship with the University of Pittsburgh Medical Center’s Department of Orthopaedic Surgery, through Dr. Freddie H. Fu and Dr. Christopher Harner, paying $75,000 to $100,000.

• DePuy’s largest payment went to Dr. Lawrence Crossett, a UPMC surgeon who has received $250,000 to $275,000. On Dec. 6, he’s scheduled to perform two knee replacement surgeries, which will be broadcast over the Internet by DePuy and viewed by doctors.

• Zimmer, the largest of the joint manufacturers, paid out the most to Pittsburgh doctors, $1.16 million through Oct. 31.”

Regrettably, this is a relatively small fraction of the total physicians, giving the impression that most physicians have these conflicts of interest. Fortunately, the department of justice’s investigation has helped curtail these conflicts of interest. Having said that, if you discovered the night before your procedure that your surgeon has such a conflict, would you proceed with your surgical procedure or would you cancel it? Assume that the procedure is elective, not emergent.

I think there are various caveats to the question being asked, and perhaps, a different way of asking the question that can help the patient make better decisions about whether to stay with the surgeon or find another doctor:

Questions that came to my mind were:

Does the surgeon opt to cut when there is no clear benefit to surgery or when another therapy would give as good of a result?
Does the surgeon opt for one device over another device and is this decision based on a kickback or is it based on clinical data that suggests a benefit for the patient’s profile?
Is the surgeon an inventor or co-inventor of the device?*

Conflict of interest comes to light when surgeon has mostly a financial incentive to choose one device or another or to recommend surgery over nonsurgical alternative if there is no clear clinical benefit or if the recommendation introduces new side effects to the patient.

The last point that I marked with * warrants discussion because this is not so “clear cut” a conflict of interest as the first 2 bullets. In devices the physician may be an inventor or coinventor and then licenses the technology or device to a company.

Even though the physician may have a conflict of interest – by receiving royalty payments for example – the physician is also the best expert on the technology that s/he has invented, so the choice to go for one’s own device may have less to do with a kickback and more to do with the physician’s belief in the invention’s efficacy/benefit.

Here’s a link to an article a while back (and how I got the “mostly royalties” impression) from WSJ when device companies had to post what they’d paid to orthos – although the asker rightly pointed that that the medical device company engineers are probably the majority of inventors to the technology rather than the MDs themselves.

Yet there’s also the argument made by Andy Lemke on Quora (in the comments section) that a doctor who serves as consultants to several companies must know his/her stuff since s/he is so sought after by device companies, so it’s not necessarily going to hurt that physician’s integrity in the eyes of the patient.

FDA Has to Slow Down to Keep Up with Drug Companies

Steve Woodruff is hopping mad with the apparent gross inefficiency and indecision of the “guidance process” for pharma company promotional practices when it comes to social media, and I can’t blame him!

But I’m on the FDA’s side this time.

Let me say up front that I never liked how the FDA remains vague and slow in the past, it sucked when I was a pharma employee trying to figure out just what the FDA “wants”, but the FDA had long acted like a tripped out lover who has something in mind but we’re supposed to guess or better yet – read his mind.

But today I am much more forgiving of the FDA than I am of pharma company management.

I was looking at a recent run down of 2010′s lawsuits settled by drug companies and to say that I’m disappointed with industry’s continual hypocrisy is a gross understatement.

It’s one thing when you can say that you’re working toward implementation of compliance practices. It’s another when you take one step forward and 3 steps back as an industry in something as “common sense” as “don’t mislead the public” (in every which way that can be done via old media/new media).

For so many years whether as employee or consultant, I have heard company management say “Patients are our #1 concern! People are our greatest asset! We want to do the right thing!” in public forums and company meetings. Then I look at the actions that are motivated by incentives and hidden rules at companies.

I’m not surprised why the government keeps ramping up its prosecution arm. I get that pharma changes are slow, but this looks almost as if pharma wants to test how slow it can change.

I’m not surprised the FDA has to “slow down to keep up”.

I have read some of the recent untitled warning letters sent to pharmacos, and the violative actions from pharmacos. HAVE YOU READ THESE? Look at the list growing from year to year. And how the SAME CITATIONS KEEP COMING UP, AGAIN AND AGAIN.

If I had to cull through the sheer amount of garbage that pharmacos continue to churn out as sales aid, my resources would come up short as well.

It’s like, pharma companies can’t learn!

It makes me want to say, “come on pharmaco people, you guys come armed with MBAs and doctorate degrees, you have teams of lawyers…. SERIOUSLY? THIS TYPE OF VIOLATION – STILL?”

Or more accurately, maybe they just don’t want to learn.

Maybe it’s still a game to see how much money you can make when you push the envelope and offset the profits with FDA imposed penalties and fines.

Even when you slapped with a huge lawsuit costing you hundreds of millions of dollars, well you can act like this is the stock market and say if you earned more revenue than lose it as a liability of “market fluctuation or market conditions” you’ll still come out on top.

Meanwhile, patients lose, healthcare loses, and pharma employees who actually want to do the right thing when earning their keep lose.

OIG’s Top 10 Most Wanted Fugitives

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John Walsh probably isn’t going to be featuring these on his “Most Wanted” show, but these criminals are on OIG’s Most Wanted for defrauding the government (and tax payers like you and me) out of millions of dollars by submitting false claims for services or goods (motorized wheelchairs seem to be a popular vehicle).

These people look like very unhappy people, maybe all that stealing and defrauding make one a sour puss in life. Not to mention in prison.

Read more from the Washington Post: Health care fraud: Not a faceless crime any longer.