As reported by DrugStoreNews.com, there has been a lot of discussion in the biotechnology world over the appropriate names of follow-on biologics.  “Follow-on biologics,” also known as “biosimilars,” are “biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods” (Wikipedia).

Because generic pharmaceutical drugs are by law chemically identical to branded drugs, brand name drugs and generic drugs carry the same name.  As such, companies that manufacture biosimilars demand this standard and practice to be used for their products.  For example, Enbrel is an autoimmune drug made by the company Pfizer and Enbrel’s generic name is etanercept.  Generic drug companies in Europe have openly said that the use of the same generic name has not been a problem over the past six years of their availability.

However, some biotech companies assert that biosimilars are actually made from different cell lines, and are therefore chemically unique, thus requiring separate nomenclature and review.

Over the past week, half a dozen US senators have taken concern over the recent development regarding biosimilar naming, as Biotechnology Industry Organization is a trade group that is at risk for losing billions in sales if biosimilars are allowed to use the same names as the drugs to which they are similar.  The Organization is worried about the competition these biosimilars will bring and possible confusion for American citizens.

In the end, what is most relevant here is the risk for confusion among consumers and the medical community.  If doctors believe in a certain case that a biosimilar ought to be avoided in clinical use, but the desired generic or branded drug carries the same name as the biosimilar, it isn’t unreasonable to believe that there may be problems.  Any drug that is chemically unique ought to have a unique name, regardless of how similar it is to another chemical.

Can you trust your advocacy organization to disclose their ties to big pharma? Looks like there’s only a one-in-four chance that you can.

The study analyzed data from Eli Lilly & Co. from the first half of 2007 and found that only 25 percent of 161 organizations disclosed funding from the drug giant on their Web sites. Just 18 percent acknowledged Lilly’s grants in their annual reports, and 1 percent listed Lilly on a corporate sponsors page.

Source: Advocacy groups fail to disclose drug company funding, a new study finds – chicagotribune.com

I see disturbing parallels between modern-day pharmaceutical practices regarding sponsorships and what asbestos companies used to do.  For decades, asbestos companies doled out funding to organizations that would produce scientific research that was in line with the interests of asbestos companies.  They then used this secretly corporate-funded research to defend themselves in court.

I’m glad more pharmaceutical companies are starting to disclose who they give money to, but I’m saddened that so many advocacy groups don’t want their members to know whose money the organizations take.

Pharmaceutical companies use cheesy marketing gimmicks to help train their sales people.  Rhymes and limericks are perennial favorites.

Someone sent me a few of the ones used for Ortho Evra.  Get a load of these:

The patch contains hormones you knew;
E
E and NGMN are impregnated in glue.
It blocks eggs from a poppin;
Changes mucus for sperm blockin.
After one try, women will ask to renew!

Ortho-Evra – it works like a charm,
whether it’s placed on the butt or the arm.
It works largely by stoppin
those eggies from poppin,
Whether you live where it’s cold or it’s warm!

Move over pill, ring, and injectable.
Introducing a patch quite delectable.
The woman decides
On which cheek it resides.
It’s discreet and not too detectable!

If I were unethical, I’d go on about how limericks like these show that the company disregarded safety and focused only on sales, made jest of risks, etc.  But I’m sure that the science and safety guys weren’t spending their days writing limericks. 

Instead, I look at these and try to figure out who wrote them.  I figure it was either the most vapid airhead you’ve ever met in your life, or an English major whose life did not turn out the way he or she planned.

I also wonder if there was some lame training class in which all the reps had to sing these out loud.  If so, I imagine that all of the sales reps but one just gritted their teeth and went through it, but there was one rep who was really into it.  I also imagine that no one else liked that rep.

Anyway, I thought I’d share these because I know I’m not the only one who enjoys glimpses into big pharma.  If you’ve got any other limericks or gimmicks to share, shoot them my way.

I’ve had the opportunity to email Dr. Elliott several times since interviewing him and he’s just an all-around good guy.  That sentiment was amplified today when I saw this column on CNN:

(CNN) — If you want to understand the way prescription drugs are marketed today, have a look at the 1928 book, "Propaganda," by Edward Bernays, the father of public relations in America.

For Bernays, the public relations business was less about selling things than about creating the conditions for things to sell themselves. When Bernays was working as a salesman for Mozart pianos, for example, he did not simply place advertisements for pianos in newspapers. That would have been too obvious.

Source: How to brand a disease — and sell a cure – CNN.com

Just as some believe the worst thing that happened to the legal profession was lawyer advertising, I believe the worst thing that happened to the medical profession is pharmaceutical advertising.  While I don’t know if Dr. Elliott feels that way, you can tell by reading his post that he is not a fan of the way in which pharmaceutical companies hype diseases.

This is promising:

Drugmaker executives whose companies promote unauthorized uses of their medicines may be targeted by U.S. regulators for misdemeanor prosecutions, Food and Drug Administration Deputy Chief for Litigation Eric Blumberg said.

* * * *

‘“It’s clear we’re not getting the job done with large, monetary settlements,” Blumberg said. “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.”

Source: Drugmaker CEOs May Be Targets for U.S. FDA in Off-Label Cases, Lawyer Says – Bloomberg

However, I would go one step further.  As a matter of public policy, I would prevent pharmaceuticals from paying for the legal defense of anyone who is charged with criminal off-label promotion.  Let’s face it – the DOJ doesn’t have the best track record in the world in complicated prosecutions.  And the reason the DOJ isn’t winning more cases is because multibillion-dollar companies are able to provide the best defense money can buy.

If pharma executives had to pay the cost of their own defense, two things would happen.  First, executives would be less likely to engage in conduct that might get them criminally prosecuted.  Second, the DOJ wouldn’t be outgunned by multimillion-dollar dream teams.

As I’ve mentioned before, the game plan for most pharmaceutical companies these days seems to be to (a) get a drug approved for a limited indication, and then (b) promote it as a cure for every ailment known to man.  I thought the figures below were interesting:

The Justice Department on Tuesday joined a whistle-blower lawsuit against Pfizer and its subsidiary Wyeth Pharmaceuticals that accuses Wyeth of illegal off-label marketing of Rapamune, a drug used to prevent rejection of kidney transplants.

* * * *

The filing continued a crackdown on drug industry fraud. Over the last three years, the government has also settled false claims suits against Bristol-Myers Squibb for $515 million, AstraZeneca for $520 million, Eli Lilly for $1.4 billion, and last week, a unit of Forest Laboratories for $313 million.

Source: U.S. Joins Whistle-Blower Suit Against Pfizer – NYTimes.com

Over the last three years, the government recovered over $2 billion dollars.  If that’s what was actually recovered, one wonders how  much hasn’t yet been recovered.

Drug marketing 101: The FDA approves drugs for specific ailments.  Drug companies may not market the drug to treat any other type of ailment.  If they do, it’s called off-label marketing and it is illegal.

Drug marketing 201: It’s often very profitable to engage in off-label marketing, because the fines you pay are less than the money you make doing it:

Allergan, the maker of Botox, agreed on Wednesday to pay $600 million to settle charges that it illegally promoted and sold the drug through 2005 for unapproved uses like treating headaches.

Source: Maker of Botox Settles Inquiry on Off-Label Marketing – NYTimes.com

Now, I don’t know for sure that off-label marketing netted Allergan more than $600 million dollars.  But, I do know that Allergan made several billion dollars selling Botox over the last few years.  $600 million is definitely a large fine, but it’s only effective if it is more money than they made by promoting it off-label.

An analogy I often use: If you only had to give back half of the money you got from robbing a bank, how many banks would you rob?

A little skepticism is a healthy thing:

Many patients taking prescription drugs believe that pharmaceutical companies have too much influence over their physicians’ prescribing practices, according to a new survey.

* * * *

About half of the medication users believed that their doctors were too eager to write a prescription when other non-pharmacological options are available.

Source: Consumer Reports Survey: Patients Think Doctors Too Cozy With Pharma – ABC News

Some people don’t understand why pharmaceutical companies shouldn’t be allowed to engage in off-label marketing.  Here’s one reason:

Peetz was diagnosed with the autoimmune disorder thrombotic thrombocytopenia purpura in 1995, at age 11. According to the lawsuit, by 2003 Genentech and Biogen Idec were marketing Rituxan as an off-label treatment for Peetz’ condition, meaning the Food and Drug Administration had not approved it for that use.

* * * *

Peetz took Rituxan for two years before developing a near-fatal viral infection that left him "a ventilator-dependent flaccid quadriplegic," the lawsuit said. Peetz’ court filing said the drug puts all users at risk, not just those taking it for off-label conditions

Source: Omaha man sues makers of drug Rituxan – San Jose Mercury News

I haven’t had a chance to take a look at the label for Rituxan, so I can’t comment on whether I think there’s a valid failure-to-warn claim there or not.

I’ll be honest with you. I don’t trust pharmaceutical sales reps.  Few of them are medical doctors, but they tell doctors which drugs should be prescribed for which patients.  Traditionally, their compensation is based in part upon how many drugs the doctors they visit prescribe.  This leads to a gigantic incentive to engage in off-label marketing and other unethical practices.

Perhaps this is going to stop at GSK.

Starting next year, bonuses will be determined “in part, by customer feedback, and by a sales professional’s adherence to the company values of transparency, integrity, respect and patient-focus,” the company said earlier this week. (Here’s the Dow Jones Newswires story.)

Source: Bonuses For GSK Pharma Sales Reps Won’t Be Tied to Sales – Health Blog – WSJ

Time will tell.