Genetic Test Firms Steal Marketing Ideas from Pharma

Dr. Michael S. Wilkes of UC-Davis (and NPR), who has been eloquent in addressing issues around the ethics and professionalism of drug marketing, widened his gaze in an editorial a while back:
http://www.springerlink.com/content/0798016272844307/

He commented on another article in the journal on the marketing of genetic screening tests. It is generally agreed that while genetic testing can be very valuable for individuals or families known to be at high risk for an inherited disease, genetic screening tests aimed solely at showing a patient's statistical risk of developing multi-gene diseases such as diabetes or heart disease are seldom clinically useful and often quite misleading. Despite this a firm called Navigenics will very happily sell you one of this fishing-expeditiona genetic screening tests for a modest $999. What the research focused on was the fact that a national primary-care practice group, MDVIP, entered into a marketing agreement with Navigenics to promote this test to their patients, and that as part of this relationship, the company offered a free genetic screening test to these primary physicians, 1/3 of whom accepted the offer.

I'll pick up the commentarty from here in Dr. Wilkes's own words:

An offer of an incentive (in this case a free genetic test) from a new “collaborator” should clearly have raised questions for every one of the doctors. Even if any given doctor genuinely believed the test was in the best interest of a patient, it would be difficult to argue that the test ordering wasn’t influenced by a favor provided by Navigenics with an implicit expectation of reciprocity (“we did you a favor, now it is expected you will do us a favor by ordering this test on your patients”)....Is this type of social influence any different than offer of free drugs to doctors by pharmaceutical companies in an attempt to build loyalty?...

I wonder if any MDVIP physicians ever told their patients that they received a free gift by the very company that profited from the test the doctor was about to order—a test that has no proven value to the patient? Similarly, prior to testing, did the physicians include in their conversations with patients a discussion around informed consent? ...

It seems we have been round this issue before with pharmaceuticals and medical devices. As a profession, haven’t we decided that education developed by a company with a vested interest in the physician’s practice outcomes is not ethically or educationally appropriate? ...

Primary care doctors can either be part of the problem or we can be part of the solution by being vigilant and by self policing to avoid any actual or perceived conflicts of interest in order to maintain the trust of our patients and society. We also need to be informed consumers when it comes to our own education and avoid all commercial influence that seeks to promote profit at the expense of patient well being.

The usual hat tip to Rick Bukata and Jerry Hoffman's Primary Care Medical Abstracts for calling my attention to this article.

Bipartisanship in Congress, in Support of Pharma and Device Industries

It's often said today that Congress is totally dysfunctional and cannot agree on anything due to the huge partisan culture war. Well, the good news is that there's bipartisan cooperation on at least one issue. The bad news is that it's all in favor of handing the foxes at the pharmaceutical and medical device industries the key to the FDA henhouse.

The estimable Merrill Goozner: http://gooznews.com/?p=3914--has blogged about the latest renewal round of the Prescription Drug User Fee Act, where drug firms agree to pay a lot of the freight for running the FDA's drug approval process, and almost always manage to wring out favorable concessions in exchange for their largesse. Among the Christmas list the industry wants this time, and that Congress, well primed by the lobbyists, is apparently ready to hand them, are:

• More use of surrogate markers to approve new drugs, without demanding proof that the actual diseases that affect people get any better (e.g., a drug that lowers blood sugar but does nothing to prevent heart attacks or strokes or blindness from diabetes)
• Complete gutting of the reforms called for in the recent Institute of Medicine report to toughen requirements for testing new devices for safety

Gooz reports that consumer advocacy groups are incensed over these concessions but are getting nowhere with Congress.

The solution, as we have known for a good while, is to stop depending on the drug industry to fund the FDA--though replacing drug bucks with taxpayer bucks won't make that army of lobbyists go away (meaning that at some point or other, campaign finance reform is desperately needed as well).

NOTE ADDED 5/18: A kind colleague at Consumers Union just sent me two links that are very useful in relation to this issue-- first, a Public Citizen fact sheet regarding device regulation:
http://www.citizen.org/documents/30-things-you-need-to-know-about-medical-devices-approvals-the-industry-and-safety.pdf
--and next, a Twitter discussion from the Safe Patient Project at Consumers Un ion regarding the pending legislation in Congress and how it fails to protect patients:
http://twitter.com/#!/cusafepatient

Abbott Labs, Again--More on Recent $1.6 Depakote Settlement

Okay, I admit that I'm confused. Last November I posted this about a $1.3B legal settlement paid by Abbott Laboratories over off-label marketing of its drug, valproic acid (Depakote):
http://brodyhooked.blogspot.com/2011/11/back-to-standard-form-letter-abbott.html

Now I learn from our friends at the Health Care Renewal blog that Bloomberg News just announced a $1.6B settlement from Abbott over the same drug for the same reason:
http://hcrenewal.blogspot.com/2012/05/abbott-pleads-guilty-settles-for-16.html
http://www.businessweek.com/news/2012-05-07/abbott-to-pay-1-dot-6-billion-to-settle-depakote-marketing-claims

So I have to assume that the article last November was a preliminary announcement and that this recent notice is the final announcement--otherwise Abbott would have paid a total of $2.9B over this one drug which would set a new record and would no doubt have been remarked on in the news media. The amount paid is of interest as previous reports of Pharma settlements often showed that the settlement sum, while in the hundreds of millions of dollars, was still only about 10% or 15% of the annual sales of the offending drug. In this case, $1.6B is the total annual sales figure for Depakote before it became generic. (But don't worry about Abbott, as the company proudly announced that they'd already set aside the funds needed to pay the settlement. Presumably, big drug companies find that sort of loose change under their sofa cushions.)

The settlement is also different from most in that Abbott was forced actually to admit wrongdoing, pleading guilty to a misdemeanor charge. As piddly as that may sound, in past settlements the company has usually been allowed to escape any admission of guilt.

Dr. Roy Poses over at Health Care Renewal focuses (as is his wont) on one aspect of this, which is the responsibility of the company and its CEO for this admitted wrongdoing. The settlement lets Abbott off the hook merely with being on probation for the next 5 years and promising not to do it again. Dr. Poses helpfully gives us Abbott's recent track record that presumably earned it this degree of lenience:

• Obstructing Justice - In 2003, an Abbott subsidiary settled civil allegations and pleaded guilty to obstructing a federal criminal investigation of its marketing practices, resulting in fines of $614 million ...
• Suppressing Reports of Drug Contamination - In 2009, the FDA charged that an Abbott subsidiary failed to report bacterial contamination of an optic product ....
• Blocking Generic Competition - In 2010, Abbott settled with the New York state Attorney General allegations that the company conspired to block generic competition for its lipid lowering drug TriCor ...
• Inflating Charges - In 2010, Abbott also settled with the US Justice Department for $421 million charges that it defrauded Medicare and Medicaid ....
• Paying Kickbacks to Doctors - In 2010, an Abbott subsidiary also settled with the US government charges it paid kickbacks to physicians to prescribe other cholesterol lowering drugs...
• Anti-Competitive Pricing Practices - In 2011, Abbott settled lawsuits alleging that its anti-competitive practices inflated prices of anti-viral drugs...

 Somehow I have the impression that if your typical petty criminal went before the judge with a guilty plea, and had this track record, that he'd be unlikely to get only a few years' probation.

 

 Dr. Poses is also very concerned about whether the CEO of a company that engages in this sort of illegal behavior ever suffers any penalties. I am very pleased to report that the Abbott CEO has indeed taken a hit, unlike most of his predecessors in similar circumstances. In 2010 his salary was $25,564,283. His 2011 salary was trimmed all the way down to $24,010,902.

 

Sort of gives new meaning to the term "making out like a bandit."

The Things that You're Liable to Hear from Pharma Marketers, It Ain't Necessarily So

I just finished listening to the latest issue of Primary Care Medical Abstracts from my friends Rick Bukata and Jerry Hoffman, which means that I have some more recent articles from the medical literature to comment on. This time the theme is: stuff practitioners believe to be true based on the way that Pharma marketing has flooded the medical airwaves, that may actually not be true at all.

• Chapter 1: Even if the Prozac class of antidepressants are not necessarily more effective than the older tricyclic antidepressants, at least they're a lot safer. A team from Nottingham, England looked at a database of about 60,000 patients 65 or older being treated for new-onset depression. They compared the outcomes for patients on the new-generation (SSRI) vs. older (tricyclic) drugs. They found in virtually every category a higher incidence of adverse reactions among those taking the SSRI-type drugs. The risk of dying within 1 years was 8.1% for people taking the tricyclics vs. 10.6% for the SSRI patients. This is an observational study and not a controlled trial, so you can't exclude the possibility that somehow the sicker patients were given the SSRI drugs and that explains why they had worse outcomes. Still, the huge number of patients included in the study certainly suggests that the safety of SSRIs may have been greatly exaggerated. (Coupland C, Dhiman P, Morriss R, et al. "Antidepressant Use and Risks of Adverse Outcomes in Older People: Population Based Cohort Study." BMJ 343:d4551, 2011)
• Chapter 2: Alprazolam (Xanax) has unique properties as a drug for panic disorder. While alprazolam is a member of the benzodiazepine class (minor tranquilizers like Valium), company marketing has been highly successful in associating it in physicians' minds specifically with panic disorder, so that if you have a patient with that diagnosis, or who even gets excited once in a while, and you try to treat that patient with any other benzo besides alprazolam, you're an idiot. An international team of folks did a systematic review of 8 studies that compared alprazolam to other benzodiazepines in the treatment of panic disorder. They found no evidence that Xanax is superior to any other drug in that class. They did find, however, that Xanax had a worse addiction profile and many additional adverse reactions compared to its benzo cousins. (Moylan S, Staples J, Ward SA, et al. "The Efficacy and Safety of Alprazaolam versus Other Benzodiazepines in the Treatment of Panic Disorder." Journal of Clinical Psychopharmacology 31:647-652, 2011)
• Chapter 3: If you want to prevent Type 2 diabetes, reach for a bottle of pills. There's been a huge interest, almost entirely driven by Pharma marketing, in diagnosing the condition "prediabetes" and then throwing medications at it.  This group from NIH utilized a database of over 200,000 patients who were surveyed for lifestyle factors in 1994-96 when none of them had diabetes, and then compared follow-up data in 2004-6 to see which ones ended up developing diabetes. They looked at smoking, body weight, diet, exercise, and alcohol consumption. Every single one of the healthy lifestyle factors was a significant predictor of not developing diabetes later on, with lean body mass being the single most powerful one. Basically, for every additional healthy lifestyle factor that you had, you reduced your risk of diabetes by about 1/3 compared to what it was previously. The main point here is the immensity of the effect--drug companies would kill to be able to announce a drug that reduced future risk of diabetes by 5-10%. The take home message seems to be that if it takes time and energy to counsel patients on lifestyle instead of reaching for ther prescription pad, it's well worth the effort. (Reis JP, Loria CM, Sorlie PD, et al."Lifestyle Factors and Risk for New-Onset Diabetes: A Population-Based Cohort Study." Annals of Internal Medicine 155:292-299, 2011.)

Avastin Continues to Impress for Eye Use

A while back I posted on the controversy about the drugs Avastin and Lucentis:
http://brodyhooked.blogspot.com/2007/10/retinal-specialists-get-integrity-award.html

Quick recap: Eye specialists found out almost by accident that a drug intended for cancer, Avastin, was really good for a particular eye condition, wet macular degeneration, and was also quite inexpensive. The maker, Genentech, then marketed a newer cousin of Avastin, called Lucentis, which of course they priced up the wazoo, and tried every trick in the book to get doctors to use it instead of the cheaper Avastin, which remains officially off label for eye use. (To their great credit, the retinal community refused to go along.)

In the earlier post away back in 2007, I noted that a trial was just beginning that would provide the definitive scientific answer to whether Avastin was as good as Lucentis for eye use, contrary to the interested claims of Genentech that Lucentis was superior. Genentech, quite naturally, refused to fund a head-to-head comparison trial of the two drugs to find out the answer, so an NIH-funded study was launched.

The first results of that study showed that the two drugs worked equally well, as did a more definitive follow-up report from the same study, as now helpfully summarized at Merrill Goozner's blog:
http://gooznews.com/?p=3892

So in case you wondered, we now have sound evidence for what the retinal specialists had all along believed based on the older evidence plus their impressive clinical experience--a cheaper version of the drug works just as well as the much more expensive version.

If the world were just, the FDA would now revise the labeling for Avastin to make it clear that it's indicated for wet macular degeneration, removing Genentech's claim that Lucentis is the only drug so approved. But to the best of my understanding, the world is not fair, and only Genentech can initiate such a label change at the FDA, which of course they would only do over their dead bodies. (If others know the FDA rules better please chime in.)

Barbara Roberts, "The Truth About Statins"

I recently had the privilege of attending the very important conference in Boston called Avoiding Avoidable Care (about how to both improve quality and reduce costs by avoiding the use of nenbeneficial tests and treatments), and there met Dr. Barbara H. Roberts, a cardiologist who heads the Women's Cardiac Center at Miriam Hospital in Providence, RI. I therefore learned about her new book, The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs (New York: Pocket Books, 2012).

I've not yet had time to read the entire book but zeroed in first on Chapter 7, which is titled, "Big Pharma, the FDA, and the Medical Profession: An Unholy, Very Lucrative Alliance" (for reasons readers of this blog can imagine). Dr. Roberts does a nice job of explaining her own personal experiences with the pharmaceutical industry (she did sponsored talks for a while until the managers decided she was actually telling the audience about the science rather than peddling drugs), and especially in revealing the extent to which organizations in her field, especially the American Heart Association, are in bed with industry and rolling in industry cash--and how that influences the supposedly objective guidelines and food approvals they issue.

I also reviewed what Dr. Roberts had to say about the JUPITER trial, about which I blogged extensively (for a summary see http://brodyhooked.blogspot.com/2010/06/more-on-cholesterol-statins-and-jupiter.html). Her analysis to my inexpert eye is both detailed and cogent.

In short this appears to be a great book for both physicians and patients about how statins for cholesterol have been way too aggressively marketed, and why old-fashioned lifestyle changes are probably a more potent and certainly safer way to reduce one's risk of heart disease.

The Wages of Sin Are Considerable

In an earlier post, I discussed the implications of Kenneth Frazier, CEO of Merck and former company general counsel, serving on the Board of Trustees of Penn State at the time of their recent coaching scandal:
http://brodyhooked.blogspot.com/2011/11/what-could-penn-state-scandal-have-to.html

In that post, I sumarized Mr. Frazier's career at Merck as follows: "So Penn State wants to put its investigation into the hands of a guy who first, did his best (in company with all the corporate leadership) to conceal the truth to assure that a favored brand continued to make profits; and second, once the truth came out, fought like heck to make sure that the human beings who were harmed by those corporate actions didn't get a penny. Sounds like a great plan to restore trust in the university."

The results of Frazier's leadership at Merck thus far have been roughly as follows, as nicely summarized by our good friend Roy Poses over at Health Care Renewal:
http://hcrenewal.blogspot.com/2012/04/spoils-of-scorched-earth-defense-merck.html

Frazier, he tells us, saved Merck megabucks by aggressively fighting all the Vioxx lawsuits. But Merck has since had to pay huge criminal fines for the way it marketed Vioxx,  most recently, a $950M settlement. Merck stock has been in the doldrums as a result.

So how has Merck treated their CEO? According to Dr. Poses (quoting the Dow Jones News Service), "Merck & Co.'s ... leader received compensation valued at $13.3 million for 2011, up 41% from the year before, reflecting his ascension to the drug maker's top post and Merck's ability to exceed certain internal performance targets."

As Dr. Poses has gone blue in the face reminding his readers, this is the norm for corporate America nowadays. Companies are not run for the benefit of their customers, or even necessarily for the benefit of their shareholders, but for the benefit of their top executives, with the full complicity of pliant boards of directors. When this sort of thing happens in the less-developed countries, we call it corruption. As both Dr. Poses' and this site have also blogged about in the past, until individual execs start to suffer real consequences (like how about jail time) for serious misdeeds, we can expect this behavior to continue. (See for instance: http://brodyhooked.blogspot.com/2010/04/cnn-pfizer-too-big-to-prosecute-shadow.html)