Without Free Gifts from Pharma to Docs, Would Research be Useless?

Without Free Gifts from Pharma to Docs, Would Research be Useless?

In a recent blog post (here), PhRMA said "Without Promotion Research will be Useless." To support its case, PhRMA cited "an interesting opinion editorial" in the latest edition of the Annals of Emergency Medicine – the medical journal of the American College of Emergency Physicians (ACEP). In the op-ed, entitled "Limiting Gifts, Harming Patients," Emory University economist Paul Rubin, Ph.D. expressed concern that ACEP policy regarding Gifts to Emergency Physicians from Industry "could have the unfortunate effect of limiting the exchange of critical information between medicine makers and physicians about the benefits and risks of new medicines, how to use them properly and how best to diagnose the right candidates for particular treatments."

Basically, Rubin and PhRMA are saying that gifts to physicians are an integral part of promoting new discoveries to physicians and without these gifts and promotion, medical research would be "useless."

I haven't read the op-ed piece because it cost about $32 to download the pdf file for 24 hours! Highway robbery is all I have to say about that! I did, however, request a complimentary copy, but haven't received any response yet. No matter. The op-ed piece obviously is attacking ACEP policy on the subject of free gifts to emergency physicians. You can find that policy here.

What's so onerous about the ACEP policy that an op-ed piece would attack it as "harmful to patients" and PhRMA would claim it renders research useless?  I looked at the policy to learn first hand why it's research Agamemnon.

First, the ACEP policy does NOT make ALL gifts to physicians from pharma unacceptable by their members. Here are gifts ACEP says are perfectly acceptable:

Emergency physicians may accept educational gifts that are not of substantial value ($100 or less). Examples include:

• Occasional modest meals in an office, clinic, or hospital setting that accompany an educational presentation 
• Evidence-based clinical care guidelines or pocket handbooks 
• Anatomical models designed for patient education 
• Informational materials to facilitate patient understanding of a disease or treatment

This sounds familiar. The PhRMA Code on Interactions with Healthcare Professionals says essentially the same thing. Code #11 states "It is appropriate for companies, where permitted by law, to offer items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities. For example, an anatomical model for use in an examination room is intended for the education of the patients and is therefore appropriate..."

The ACEP policy, however, cites examples of gifts that should NOT be accepted. These include:

• Meals provided for physicians or their family members, staff, or guests (other than modest meals accompanying educational presentations, as noted above)
• Personal or recreational items, such as tickets to theatrical or sporting events
• Direct subsidy of any expenses (such as registration, travel, lodging, meals) incurred in attending CME events or other educational or professional meetings (All industry support for such activities should be provided directly to the activity provider to offset program costs or to a general fund for continuing education programs.)
• Cash or cash equivalents such as gift certificates or vouchers
• Gifts offered in exchange for prescribing or using a product
• Medical equipment, such as stethoscopes or otoscopes
• Payment for token consultant or advisory arrangements
• Medical products for the personal use of the physician, the physician's staff, or family members

Again, PhRMA takes a similar stance. Code #3 states: "To ensure the appropriate focus on education and informational exchange and to avoid the appearance of impropriety, companies should not provide any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare professional who is not a salaried employee of the company."

It seems tio me that Dr. Rubin could just as well criticized the PhRMA Code, which limits gifts to physicians, as being "harmful to patients." So, I am confused why PhRMA would cite Rubin's op-ed piece in defense of promotion being necessary for research success.

Of course, the drug industry is free to promote drugs to emergency and other physicians. There's nothing in the ACEP policy that limits access to physicians for promotional purposes. In fact, the policy states:

"The College also recognizes that emergency physicians should be free to interact with industry representatives if they choose, and that physicians may receive useful information about particular products from industry representatives. Emergency physicians may receive compensation at fair market value from pharmaceutical and biomedical device companies for legitimate professional services rendered, including participation in research and service as faculty in continuing education programs."

What PhRMA and Dr. Rubin should have focused on is the role of "promotion" in general and not the free gifts to physicians straw man. Rubin, for example, says that "Research and promotion are merely 2 sides of the same coin," which is a more rational point of view that deserves a bit more analysis.

What PhRMA and Rubin are claiming is that pharmaceutical companies need to have the freedom to promote new medicines to physicians (and "maybe" consumers too, says Rubin) in order for research to have a successful commercial outcome. I can agree with that. But are gifts to physicians really necessary to achieve that outcome? I don't think so.

There are many other ways for pharmaceutical companies to reach physicians with promotional messages, including social media (eg, Twitter posts). If a gift is required to get the message out about research, then pharma is in deep doo doo.

What's needed is NOT promotion. What's needed is true two-way communication. Without that kind of communication, research truly is useless.

The Pharma Marketing News article "Physician Participation in Peer-to-Peer Social Media Sites," which will be published on October 12, 2011 (free to subscribers; available here to everyone else for $4.95) speaks about what physicians want from pharma: users of online physician peer-to-peer communities want open and transparent participation by pharma and non-promotional information: “Give us the data, let us make up our minds, don’t try to spin me, I’ve got a rep who does that,” is a typical physician comment. “Make dialogue two-way, respect us, and focus on scientific exchange,” is another. Physicians are looking for negative findings also!

Some other information physicians want from pharma companies include:

• Drug pipeline information. 
• New information about product—not interested in being detailed, however. 
• Focus on topics like re-imbursement, patient education materials, etc.

So there's a lot more to "promotion" than detailing physicians after gaining access made possible by free gifts!

P.S. I finally did get a copy of Dr. Rubin's Op-Ed piece from ACEP. Thanks very much. The Annals of Emergency Medicine will publish a "rebuttal" to Dr. Rubin in the next few weeks. Meanwhile, here's my rebuttal:

After reading just the first three paragraphs of Dr. Rubin's op-ed, I am bowled over by his cherry picking of "the best evidence" (eg, 3 citations of the same author). Dr. Rubin also said that "the best evidence" indicates that ACEP's policies are "likely to lead to worse outcomes for patients." He did not cite any references to "the best evidence." 

Dr. Rubin's naivete regarding the FDA approval process is breathtaking. According to Dr. Rubin,  the FDA drug approval is "restrictive"; ergo "this means that we would expect that newer drugs would be better than older drugs. Because this is so [my emphasis], actions that lead to increased sales of newer drugs [eg, free gifts for physicians] would be expected to improve patient health." Whaaa? Dr. Rubin offered no proof -- eg, clinical outcomes -- that this is so. That did not stop him, however, from criticizing studies that find fault with pharma advertising because they too offered no real proof; ie, "clinical outcomes."

It doesn't take a PhD in economics to rebut Dr, Rubin's shoddy analysis. Even so, I can't wait to see the rebuttal to be published in the Annals of Emergency Medicine!

Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster.

Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster.

The Brits have won the race to issue social media guidance for the drug industry! (OK, it's NOT a race. Still, everyone says the EU regulators FOLLOW FDA's lead. Here's a case where the horse is following the cart!)

The Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), just published "informal guidance" providing the drug industry advice on how to use online communications.

You can access the PMCPA "informal guidance" here.

While the US FDA (PhRMA too!) twiddles and delays, the British PMCPA tweets and delivers!

Most of the advice, however, is merely to follow the existing ABPI Code of Practice, which "applies irrespective of the method of communication." NOTE: In contrast to the British industry code, US PhRMA's DTC Guidelines specifically excludes online communications.

Regarding Twitter, PMCPA has this to say:

"If a company wanted to promote a medicine via twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code. In addition companies would also have to ensure that recipients had agreed to receive the information. Given these restrictions and the character limit on twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code.

"Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine."

I interpret that to mean that Tweets such as the following from Boehringer Ingelheim (BI) may not pass muster with the Brits:

Back in October, 2009, I criticized tweets like this, which I thought violated FDA regulations (see "Boehringer's Branded Tweet Violates FDA Regulations Just Like Those 14 Paid Search Ads Did"). So far, however, FDA has not issued any NOV letters to companies who post such tweets. Maybe BI is out of the FDA's jurisdiction because the tweet was meant for an EU audience and not a US audience? And since BI is not a British Pharmaceutical industry, it is not obligated to comply with the ABPI Code.

While many industry pundits fault the FDA for not issuing social media guidance in a timely fashion, no one has put any blame on PhRMA (the US industry equivalent of ABPI) for not issuing its own voluntary industry guidelines regarding Internet and social media pharmaceutical promotion. No one but me, of course (see, for example, "PhRMA Finalizes DTC Principles").

New Lipitor Ads Dis Exercise & Healthy Diet. Are You Kidding Me?

New Lipitor Ads Dis Exercise & Healthy Diet. Are You Kidding Me?

In its most recent TV and print ads for Lipitor, Pfizer highlights a middle-aged man working out in a gym. In bold text and voice overs, the ad asks "Are You Kidding Yourself?" The print ad -- an example from this week's Time Magazine is shown here (click for an enlarged view) -- goes on to say "A lot of people think exercise and healthy diet are enough to lower cholesterol. For 2 out 3, it may not be."

Damn! You mean that the odds of me lowering my cholesterol via exercise and diet are only 1 in 3?

This is the first time I have ever seen a DTC (direct to consumer) ad that so blatantly "disses" exercise and diet. At least, that's what it sounds like to me.

Older Lipitor ads featured active people -- mostly men -- such as "doctors" rowing and guys skiing or biking, etc. These ads only hinted that lifetstyle changes may not be enough. Recent ads, however, appear to be CRITICAL of those among us who are trying to change our lifestyles.

In fact, IMHO, the new Lipitor ads come very close to violating PhRMA's "Guiding Principles for Direct to Consumer Advertisements About Prescription Medicines"; especially principle #12, which states "DTC television and print advertising should include information about the availability of other options such as diet and lifestyle changes where appropriate for the advertised condition."

Yes, the new Lipitor ads do say "When healthy diet and exercise are not enough.." and "Along with diet, Lipitor....[blah, blah]. Pfizer, therefore, obeys the letter of the guidelines, but maybe not the spirit. Should I report this ad to PhRMA's "Office of Accountability?" I didn't have much luck the last time I did that (see "Adventures of PhRMA Intern!", a Pharma Marketing Blog "Classic").

The other criticism I have is in regard to the "2 out 3" claim. What's the basis for that statement of fact? I can find no reference to any data in support of that claim in the ad. The LIPITOR.com site attempts to "prove" the claim with even more unsubstantiated claims: "Only about 25% of cholesterol comes from the foods you eat. The other 75% is made by the body. Factors such as age and family history affect how much cholesterol your body makes. That’s why, for 2 out of 3 people with high cholesterol, diet and exercise alone aren’t enough and a cholesterol-lowering medicine, like LIPITOR, may be necessary."

Maybe factors such as amount of exercise ALSO affect how much cholesterol your body makes or affect how cholesterol is disposed of in your body. Maybe exercise helps stop the build up of plaque in your arteries due to high cholesterol. Etc.

Perhaps Pfizer is trying to counteract "Non-prescription Cholesterol Lowering" advice from physicians on the Internet (see here, for example) or is getting desperate as Lipitor sales continue to tank around the world (see "Pfizer Sales Lag, Hurt by Generic Lipitor, Effexor").

Whatever. I think it's the wrong message when a DTC ad leads off with "dissing" healthy lifestyle options with the phrase "Are You Kidding Yourself?" Perhaps it was meant to be just a way to capture my attention (which it did), but it SOUNDS to me like its challenging my decision to exercise and eat healthy, which directly conflicts with the advice of my doctor. Talk about interfering with the patient-doctor relationship!

"Reasonable" $600 MILLION Fine for Misbranding BOTOX: I Guess Allergan's Suit Against FDA Paid Off!

"Reasonable" $600 MILLION Fine for Misbranding BOTOX: I Guess Allergan's Suit Against FDA Paid Off!

Allergan -- the company that markets Botox legally for wrinkles and illegally for other things -- agreed to pay $600 million in fines, including $375 million to the government as part of a Botox “misbranding” charge. Allergan admitted that its marketing of Botox from 2000 to 2005 led to intended use in treating headache, pain, muscle stiffness and juvenile cerebral palsy. Read the media stories and press releases here.

Considering that Eli Lilly paid $1.41 billion to settle charges that it had improperly marketed  Zyprexa for elderly patients with dementia and that Pfizer paid $2.3 billion to settle charges that it had illegally marketed the painkiller Bextra, the $600 million Allergan has to pay seems "reasonable," which is exactly how  Larry Biegelsen, an analyst at Wells Fargo Securities in New York, described it: “The $600 million settlement amount appears reasonable based on industry standards.”

Why such a "reasonable" settlement for a drug company that, IMHO, is an unethical marketer and the the drug industry poster boy for off-label promotion? Allergan, for example, has refused to abide by PhRMA's DTC Guidelines as well as PhRMA's Guidelines for Interactions with Healthcare Professionals (see "Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway"). Allergan has also been cited by the FDA for other violations such as a misleading Latisse Web site (see "FDA Reads My Blog: Declares Latisse Web Site Misleading").

You must read a bit further down in the media articles about this to learn that Allergan "is required as part of the agreement to drop the lawsuit it filed against the FDA in October challenging a government rule that prohibits marketing drugs for unapproved uses."

There's a lot to ponder when reading that statement.

I ponder, for example, whether Allergan got off much easier because it agreed to drop its suit? Which was probably frivolous to begin with!

BTW, I've written about Allergan's off-label migraine shenanigans previously. See Allergan's "Eye-popping" Migraine Botox Study: Freedom of Expression or Off-Label Promo Tool?

Allergan is currently seeking FDA approval of Botox for the treatment of migraine. In the above post I reviewed a clinical study that Allergan is doing to support its case. The drug was so ineffectual that the researchers admitted they “have searched for patient characteristics that may predict a favorable treatment response.” Of course, they ultimately were successful in winnowing down the migraine population that is responsive to treatment: ie, those people who suffer from "imploding" or "eye-popping" headaches but NOT "exploding" headaches.

This would all be a joke if Botox was not such a dangerous drug, which includes a black box warning on its label. But I won't get into that -- you can read what other people have to say about the dangers of Botox here.

P.S. As part of the agreement with the Justice Department, Allergan also will be required to publish information about its payments to doctors. I am not anticipating that Allergan's physician payment information will be easy to analyze considering that much more ethical drug companies have failed to be transparent in this regard (see "Transparency Vs. Translucency in Reporting Physician Payments").