Ends and Means, Means and Ends

Especially at this time of year, when people are so crazed by the spirit of love and charity that they will get into fistfights over parking spaces at the shopping mall, it's important to review some ethics basics.

For instance: Do the ends ever justify the means?

I don't like to say, "Never". Mostly because whenever I say I'd "never do X", within approximately 30 seconds I'm doing X. Always for the best of reasons, of course.

So I'll just answer my question with a little wriggle-room: Almost never.

Here's a great example from today's New York Times:

As Abby Goodnough writes in her article, "On its face, it seemed reasonable enough: a bone marrow registry sending recruiters to malls, ballparks and other busy sites to enlist potential donors."

What a worthy enterprise! Who could argue against having more people sign up to help those suffering from formerly-incurable diseases?

The devil, as they say, is in the details.

If you were a young man, hanging out at the mall with some friends, would you be more likely to respond positively to a request to "be a hero" if those words were said to you by a paunchy middle-aged guy in floods, or by a pretty young model in a short skirt and high heels?

I thought so.

You could argue that this was smart marketing (assuming there were some attractive young men in the model pool too, preferably not in short skirts and heels).

But models aren't free, of course. The donor registry, Caitlin Raymond International, apparently hired them at a cost of about $60,000 per week, according to Goodnough's article.

The registry is a nonprofit subsidiary of UMass Memorial Medical Center in Worcester, MA. An estimated 185,000 potential donors were recruited in New England.

The hospital "said Thursday that it had stopped seeking donors in New Hampshire and using models altogether."

Why no New Hampshire donors? Because the registry's practices are being investigated by the New Hampshire state attorney general's office. The AG is interested, not just because of questionable marketing tactics, but also because of extremely questionable billing procedures: those who agreed to the DNA cheek swab were not told that their insurance companies would be billed for the test, to the tune of $4,300 each.

Goodnough notes that "New Hampshire passed a law in 2006 requiring insurers to pay for tissue-typing tests for potential bone marrow donors. But at the time, ... proponents told lawmakers that each test would cost $100 or less." Oops. All of a sudden, we understand why New Hampshire seemed like such a good recruiting arena, don't we?

There's no question that more of us should learn about donation -- of blood, of marrow, of organs -- and that more of us should donate all of these.

But: isn't there a more transparent way of getting information out than by hiring sweet-talking high-heeled models, and by hoping no one will notice that the insurers are being billed, big-time?

Did the hospital really have that little confidence in the worth of the work it was doing that it needed to resort to these kind of tactics?

When this many people are being enlisted, do the tests really cost $4,300 a shot, and if so, how could New Hampshire legislators have been given a figure almost 98% lower?

Not to mention: don't you think there was a better use for $60,000 per week?

Who Writes Medical Textbooks? You Might be Surprised.

Last week, I wrote a post about dental products manufacturers underwriting articles, and even entire issues, in dental practice journals. This week, I get to write about pharmaceutical companies writing whole books.

This does not make me happy.

Today's New York Times carries an article by Duff Wilson about a 1999 textbook on the treatment of psychiatric disorders that was apparently written by GlaxoSmithKline (then SmithKline Beecham).

Pharmaceutical companies and medical instrument manufacturers have in the past been accused of playing too important a part in the writing of articles, but "to ghostwrite an entire textbook is a new level of chutzpah," to quote Dr. David A. Kessler, a former FDA commissioner.

The book ("Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care") was "written" by Dr. Charles B. Nemeroff (who was at Emory University's medical school at the time) and Dr. Alan F. Schatzberg (then at Stanford's medical school). In the book's preface, the "authors" thanked SmithKline Beecham for an "unrestricted educational grant."

According to Wilson's article, Drs. Nemeroff and Schatzberg insist that SmithKline "had no involvement in content."

But a 1997 letter from the associate editorial director of Scientific Therapeutics Information suggests a somewhat different scenario. The letter was attached to a "complete content outline", notes that "we have begun development of the text", names the primary technical writer (not either Dr. Nemeroff or Dr. Schatzberg), and presents a proposed timeline, which includes dates for drafts to be submitted to "co-authors / APPI / sponsor".

"APPI" is the publishing arm of the American Psychiatric Association, and was the publisher of the book.

Guess who "sponsor" is.

Peer-reviewed medical journals now require full disclosure -- as Wilson put it, "whose idea it was, who wrote the first draft, and who edited."

Don't you think medical textbooks should meet those same standards? Of course you do.

Full Disclosure is Better than Full-Body Scans

Pretend, for a moment, that you are a dentist.

If you read an article in the Journal of the American Dental Association that tells you that a "cone-beam CR scanner" would provide a safe and effective way to identify tooth and jaw problems earlier and more effectively than older methods like X-rays, you might consider investing in such a gizmo for your office, right?

In fact, there's an entire issue in the JADA dedicated to the wonders of this new technology. Sounds even better, right?

Now ... what if I tell you that the entire issue is underwritten by a cone-beam scanner manufacturer. Still as interested?

I thought not.

Today's New York Times has a long article by Walt Bogdanich and Jo Craven McGinty on this new technology, and about concerns that children, who are particularly vulnerable to the pernicious effects of radiation, are being exposed to excessive levels of radiation in their dentists' chairs.

Individual scans, properly administered, are not dangerous, but the effects are cumulative, so children (and adults) should not be scanned unless there's a genuine need.

An expert in 3-D technology like the cone-beam scan is quoted as saying that "a cone-beam scan produces no more radiation than a whole-body scan at the airport," while another expert argues that "cone-beam scanners can be several hundred times as powerful." (Never mind that there are questions being raised about the radiation levels to which frequent travelers may be exposed.)

The real question is, Why are we exposing children and adolescents to radiation if it isn't necessary?

According to the Times, cone-beam CT scans produced "significantly higher" levels of radiation than traditional dental imaging techniques, without sufficient scientific data to prove that it provides better results.

That's not to say that traditional techniques are perfectly safe. Dentists have been advised not to use old, slow "D-speed" X-ray film "because it requires more radiation than faster film". But about 70 percent of dentists are still using D-speed film.

The Times offered its readers an important sidebar: "What Patients Might Want to Ask the Dentist about X-Rays". It is important to know why a particular technique is being recommended, and that a proper lead shield is being used to protect you (or your child) from unnecessary exposure.

But an even more important question to ask might be why obvious conflicts of interest keep getting by us.

At the end of their lengthy article, Bogdanich and McGinty point to the continuing education credits that dentists can earn "by reading about cone-beam technology in a new magazine, Orthodontic Practice - US, and then answering 10 simple questions appended to the end."

The article is credited to Dr. Edward Y. Lin, a Wisconsin orthodontist, who is a strong supporter of cone-beam scanning. That's fine; different dentists certainly have different opinions about the value of the technology, and Dr. Lin said that "the company did not pay him to write the article or to appear in its full-page advertisement in the same issue."

What company would that be? Imaging Sciences, a scanner manufacturer. For whom Dr. Lin has been a paid lecturer.

In other words: How many lectures paid for that article?

Illegal vs Unethical vs Stupid

Imagine this situation: you have a conflict with your boss. It's not a huge deal, but it's been simmering away for a while, and you're ticked off about it. You're convinced that you're not getting a fair deal -- after all, your boss is your boss, right? So you vent a little to your co-workers in the lunchroom, or around the water-cooler.

Or on Facebook.

Is this a firing offense?

Here's the actual situation: An ambulance service company had asked an EMT employee to prepare a response to a customer complaint about her work, but denied her representation by her union. Later that day (from home), the employee posted a derogatory comment about her supervisor on her personal Facebook page; some of her friended colleagues piled on. She was suspended and later fired for those postings, which violated company Internet policies.

According to the National Labor Relations Board, that was a violation of workers' rights: your right to complain about your boss does indeed extend to social media sites.

"The labor relations board announced last week that it had filed a complaint against an ambulance service, American Medical Response of Connecticut, that fired an emergency medical technician, accusing her, among other things, of violating a policy that bars employees from depicting the company 'in any way' on Facebook or other social media sites in which they post pictures of themselves," writes Steven Greenhouse in an article in today's New York Times.

In addition, the NLRB found "that the company’s blogging and internet posting policy contained unlawful provisions, including one that prohibited employees from making disparaging remarks when discussing the company or supervisors and another that prohibited employees from depicting the company in any way over the internet without company permission." (The complete board release is here.)

I'm not going to rehash all the public details of the case, but it does seem as though everyone involved behaved badly.

And while I agree with the NLRB position, the employee's behavior strikes me as, well, dumb.

Yes, the EMT is ticked off right now and wants to vent with her friends. I understand that, and empathize. That's what water coolers and (after hours!) the neighborhood bar are for. But what happens when she applies for another job, and the prospective employer, in conducting the background check, comes across this posting?

Now put yourself in that employer's shoes: You don't know all the circumstances of the dispute (any more than I do). Maybe the employee is right; maybe her boss is right. But wouldn't her response (the posting) strike you as a little intemperate? Could such behavior escalate? While she may have all the qualifications you are looking for, in an environment of high unemployment, what are the chances you can't find someone who hasn't been posting negative comments about her boss?

How many articles do we have to read about people posting embarrassing pictures or comments about themselves or others before it sinks in that the Internet is forever.

Is $750 Million Enough to Get Your Attention?

In the largest criminal (and civil) payment for the manufacture of adulterated drugs, GlaxoSmithKline yesterday agreed to pay $750 million to settle complaints that it had knowingly sold contaminated and/or ineffective products.

The complaints all stem from a plant in Cidra, Puerto Rico, since closed. (News articles from the New York Times here, The Guardian here, National Public Radio here; there are many, many more.)

In a statement, a GlaxoSmithKline (GSK) senior vice president said, "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice (cGMP) requirements and with GSK's commitment to manufacturing quality. GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes."

This is an apology? And what is "cGMP" anyway -- not making people sick when they use your product?

So ... just how serious were those "manufacturing issues"? NPR's Scott Hensley termed some of the "sobering":

• Nausea medicine Kytril and antibiotic ointment Bactroban could have been contaminated with bacteria.
• A special coating on Paxil CR pills cracked, leading to medicine that wasn't effective.
• Tablets of Avandeamet, a diabetes drug, were sometimes too strong or too weak.
• Different medicines were mixed up in the same bottles.
  

How were these "sobering" issues first uncovered?

Following a Food and Drug Administration (FDA) warning letter in 2002, Cheryl Eckard, then a GSK global quality assurance manager, was sent to the Puerto Rico plant to lead a team of 100 experts to fix the cited problems.

According to Gardiner Harris and Duff Wilson's article in the New York Times,

[Cidra] was GlaxoSmithKline's premier manufacturing facility, producing $5.5 billion of product each year. But Ms. Eckard soon discovered that quality control was a mess: the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles.

Ms. Eckard complained to her supervisors, and was ignored. Instead, she was fired. A ten-year GSK employee, she turned to the FDA and sued the company. The complete complaint can be found online here; it does not make for pleasant reading. Ms. Eckard will receive $96 million, one of the highest whistle-blower awards for health care fraud.

The three-quarters of a billion dollars that GlaxoSmithKline is paying to settle the charges is the largest ever paid for the manufacture of adulterated drugs, but is only the third highest that drug companies have paid in the last two years. Pfizer agreed to pay a total of $2.3 billion in September 2009 to settle charges relating to Bextra, Zyvox, Lyrica, and other drugs (I wrote about that settlement, here), and Eli Lilly agreed to pay a total of $1.4 billion in January 2009 to settle charges related to its Zyprexa drug.

The key difference in the GSK case is that nearly all prior settlements dealt with illegal marketing issues (e.g., in the Pfizer case, a government investigation showed that Pfizer actively promoted off-label use of Bextra, by providing all-expenses-paid trips, and even kickbacks, to doctors). As the Times article noted, this GSK case "is the first successful case ever to assert that a drug maker knowingly sold contaminated products." (emphasis added)

It should also be noted that 2009 profits were up 20% over the previous year (Financial Channel article here), to 5.5 billion pounds (some $8 billion). At which point $0.75 billion doesn't sound so bad. According to Market Watch, third-quarter 2010 sales and profits are down, larger due to lower sales of Avandia (a troubled diabetes drug) and Valtrex (used to treat certain herpes infections). The company had in July set aside $750 million in anticipation of reaching an agreement with the government regarding the Cidra manufacturing complaints.

I have written before that the starting point of business ethics is contractual: I agree to provide a fair product (or service), and you agree to pay me a fair price. After that, the arguments can start.

When it comes to pharmaceuticals, the floor below which we must not go is: It's safe; it's effective; it's not contaminated; it's what I say it is.

GSK went down to the sub-basement on this one. Very senior heads should roll.

My Back Hurts -- Pass Me One of Your Vicodins Please

If you're taking illegal drugs at work, and test positive on a random drug test, you'll be fired. What if you're taking prescribed drugs for pain or anxiety?

Should you be fired for testing positive for those prescription painkillers?

It's actually a more complicated issue than it might sound.

What if you're taking prescription painkillers so that you can get back to work? What if you're taking painkillers as a result of injuries sustained on the job? What if you're taking a painkiller that was prescribed to one of your colleagues, who offered you one of his pills because your back hurts, and you forgot to bring your medication with you? What if ...

I'll stop here -- there are endless variations possible, but you get the picture.

Katie Zezima and Abby Goodnough have a long article in today's New York Times about how prescription drug testing may pose a new kind of "quandary" for employers, some twenty years "after the Supreme Court first upheld the right to test for drugs in the workplace."

It used to be that companies only tested for illegal drugs, but more and more companies are testing for prescription painkillers, anxiety medication, and more.

In one example in the Times story, a 22-year employee (not a 22-year-old, but someone who had been with the company for 22 years) was fired for taking a medication which had been prescribed by her doctor for back pain because she had tested positive for that drug, which the company, "which makes car parts, had suddenly deemed unsafe."

Now trimming car window molding, which was this woman's job, is not an office job. There is far more dangerous equipment around the factory floor than staplers. Employees may be working in closer proximity than the next cubicle, and if someone on the line has an accident or is impaired, there is substantial risk to those nearby. (Note: this particular employee is suing for discrimination and invasion of privacy, and her company would not comment for the article, citing the ongoing lawsuit.)

But how impaired is too impaired? In this tough economy, a lot of people who have jobs will do anything to keep those jobs. If it means popping a bunch of pain pills to keep working on the line, they will do that.

The employee who was fired said that "she understood [the company's] safety concerns but believed the company should have worked with employees who take prescription drugs rather than fire them. She said,

If the medicine they're taking is not good for them or the workplace, then there should be some sort of program where they can teach us how that affects you or see if something can be worked out. But that was not an option for us.

The automotive parts manufacturer decided that it wanted to "provide a safe environment" and would consider all drugs "unsafe if its label included a warning against driving or operating machinery, but doctors say many users function normally despite such warnings."

I can understand that the manufacturer preferred to have a blanket policy: All drugs of this type will be banned. Such a policy is easier to explain, easier to administer, and should be easier to defend in a court of law (although we'll have to wait and see whether it can be successfully defended). But is it ethically better?

In general, I don't like hard-and-fast rules for how to treat people because people themselves aren't "hard and fast". Some people respond better to "carrots" and some react better to "sticks". In the case of medications, different people react to different medications differently. Some people get "up" on "downers"; some people get slow and logy on "uppers".

Moreover, the Times article points out that setting rules about prescription drug use at work can easily run afoul of the Americans with Disabilities Act which "prohibits asking employees about prescription drugs unless workers are seen acting in a way that compromises safety or suggests they cannot perform their job for medical reasons."

Other employees at the plant said in interviews that there were some people there who used illegal drugs, and that some passed around prescription drugs (along the lines of, "Sorry, I don't have any Tylenol for your headache, but I'll give you one of my OxyContins.").

With an employee who has been working for you for 22 years -- assuming you're really worried about line safety ... don't you think you could have found a different, non-line position for her?

I wouldn't mind a "no illegal drugs" blanket rule, and I wouldn't mind a "no prescription drug sharing" blanket rule. But firing people for using a properly-prescribed drug properly, without any evidence that it's affecting their ability to perform their job?

That's going too far.

Fool Me Once...

I'm not a health-care industry analyst, so why am I writing about Johnson & Johnson for the fourth time this year?

It's to say, "I told you so."

And I'm not happy about it.

Back in January (here), I wrote about how long it took McNeil Consumer Healthcare, a J&J division, to respond to consumer complaints about odd smells in some bottles of over-the-counter medications. At that time, I wrote,

As a consumer, I have plenty of generic non-branded choices for pain relief. Unless I have a good reason to trust J&J to provide me with a higher level of product quality, why would I pay extra for Tylenol or Motrin?

I wrote again about McNeil in March (here), about the steps the company was taking to address the funny-smell problem (traced to chemicals leaching from wooden pallets that were used to transport and store product packaging materials), and contrasted the company's behavior with the "gold standard" comments J&J got in 1982 for its Tylenol recall.

And then in August, news broke of more problems, this time at the DePuy Orthopaedics unit and Acuvue contact lens. It was the ninth product recall for J&J this year. In that post (here), I quoted an investment banker who follows the company:

No. 1, is there a systemic issue at J&J? No. 2, is this [the DePuy hip-replacement recall] reflective of that systemic issue? And, No. 3, is there more to come?

I also noted that all these recalls were starting to affect J&J's bottom line.

And now it seems to be affecting consumer behavior.

Andrea Gardner, for American Public Media's Marketplace program today, reports that more and more parents are realizing that "there is no boogieman in the [generics] bottle", which could have a huge, long-term impact on companies like J&J.

Gardner notes (full story here) that she usually bought generics for herself, but bought branded products to care for her infant. With the recall of Infant Tylenol in April, she turned to generic acetaminophen. Will she go back when production ramps up again?

Gardner quotes a pharmaceutical industry analyst, who thinks that she, and other mothers like her, will return to the fold. There will be "a barrage of ads from J&J in 2011 and '12, with a message of trust, and changes made in the wake of the recall," he believes.

But: today's New York Times reports that McNeil is now voluntarily recalling eight-hour Tylenol caplets made at its Fort Washington PA plant, before that plant was closed.

Can a massive advertising campaign really make consumers forget everything they've heard this year? Fool me once.... Fool me twice.... Fool me thrice....

At some point, consumers can't be fooled anymore.