CCFA Webcast assists IBD drug makers

[Note: This has been written to help explain the "New Webcasts on Crohn's Disease!" announcement put up on the front of the CCFA website. In the process of assembling this information I engaged in what may be considered ungentlemanly conduct for personal gain. A full disclosure appears in the footnotes.1]

Imagine you're a smaller pharmaceutical company and you want to include the one million plus IBD patients in your revenue stream. You gaze longingly at the balance sheets of others: backed by Johnson and Johnson's "marketing might", 2001 Remicade sales hit $721 million dollars2 while Proctor and Gamble's Asacol brings home $300 million a year.3 You want to get into the IBD action too. But it's not easy. You have a drug but you don't have the unlimited advertising budget of the big guys. Your drug is in the third round of clinical trials, but you need to recruit more participants. A few years remain before your product hits the market, but you want to start getting the name out and cast doubt on your competitors. What do you do? Where will the money come from? There must be a simpler way . . .

Have no fear! The CCFA can help you advertise directly to IBD patients and interest them in participating in your clinical trials. All you have to do is put up a tax-deductible website for "educational" purposes, donate tax-deductible money to the CCFA, and they'll use their name and extensive doctor/patient network to direct traffic to your website. The latest example may be seen on the Crohn and Colitis Foundation of America homepage where a link reads "Currently running: Crohn's Disease Education Network."

Following the link brings you to http://www.healthtalk.com/crohns, a site sponsored by educational grants from Elan Pharmaceuticals & Biogen Pharmaceuticals.4 The site contains information such as "Defining Crohn's Disease", explanations about different types of medications, and how IBD is diagnosed--information already covered in CCFA pamphlets as well as nearly every IBD book at the local Barnes and Noble. How does this help your new drug? Remember what the head of a company once said:

"When you're trying to sell something radical, you want to look as normal as possible, you don't want people to be put off or get nervous. You want them to relate to what you're saying while gradually introducing your ideas . . ."5
 

The "normal" is most of the information on the site, all the stuff veteran IBD patients have heard dozens of times. The "something radical" appears when following the boldfaced link titled:

Promising Advances in Crohn's Disease6

This link goes to a section of the webcast transcript which talks about Antegren, a new Crohn's drug. As might be predicted, a quick google.com search shows that development of this drug is a joint effort by Elan Pharmaceuticals and Biogen Pharmaceuticals.

As explained below, this website helps a pharmaceutical company get into the IBD "action" by accomplishing four goals:

  1. Promotes a yet to be approved, experimental drug.

  2. Recruits people for clinical trials of the new drug
  3. Casts doubts on competing IBD products.
  4. Acts as a tax-deductible expense for the company by being labeled as an "educational site."

1. Promotes a yet to be approved, experimental drug

The web videos feature a minimum cast of an enthusiastic narrator, a "prominent" doctor, and an IBD patient. This is an excellent vehicle for introducing a new product. In the webcast (and transcript) "Promising Advances in Crohn's Disease",7 after talking about the downsides of using antibiotics and fish oil to treat the condition, the discussion moves onto "Biologic therapy". First comes the narrator:

Rick [narrator] :Let's move now to some biologic therapies currently being investigated. Dr. Enns, Tell us first about biologic therapies—how they provide new hope for people with Crohn's disease. Let's begin with Antegren. What makes Antegren different from other biologic therapies currently being studied?8 [emphasis added]

Note the positive framing of the drug with the word "hope". In response to the question, Dr. Robert Enns of Vancouver's St. Paul's Hospital explains how Antegren acts as an anti-inflammatory.

Dr. Enns: . . . Now, Antegren is a medication, which works as an anti-inflammatory essentially. The white cells in the body traverse through the bloodstream, and they traverse through the bloodstream much like if you look at the branches of a tree, the nutrients are brought up through the trunk and into the branches. In a similar fashion, white cells traverse through the body in blood vessels. To get out of those blood vessels to reach the bowel, or in a tree it's to reach the leaves, there has to be a transport mechanism out of the circulatory system into the bowel, and that transport mechanism requires the white cell to stick or stop and subsequently, to make it through the endophilial cell, which is a method of getting out into the bowel. What Antegren does is essentially it inhibits the little grabbers that grab the white cell and move it through the endophilial cell into the bowel. This is a method of stopping inflammation. It's kind of a very fancy specific anti-inflammatory method that does appear to hold significant promise.9 [emphasis added]

In the paragraph above, Dr. Enns explains Antegren in terms of a 'tree", "branches", and "leaves"--simple nature images which hold "significant promise". He doesn't mention that inhibiting "the little grabbers" may be detrimental to a patient's immune system. Dr. Enn currently receives payment for enrolling patients in Antegen's clinical trials.10 As part of this process, he must have them sign a form which states:

Because natalizumab [scientific name for Antegren] affects the concentration of white blood cells in the body (cells important in fighting infection), another possible side effect that has not been reported or observed, but which might occur, is an increased likelihood of infections in general.11 [emphasis added]

Stopping "the little grabbers" mentioned in Dr. Enn's interview essentially means suppressing the immune system by inhibiting white blood cells from reaching the bowel. This has led to another effect with unknown consequences:

Increases of certain types of white blood cells and platelets (cells important in blood clotting) and an increase in a blood marker of inflammation (C-reactive protein) have been seen in people treated with natalizumab, but no apparent symptoms have been associated with these laboratory findings. [emphasis added] 12

What does increasing number of "cells important in blood clotting" mean in the long term? Does it mean more clotting? A potential for stroke? But why dwell on the long term? The 1,000 to 3,000 people enrolling for Phase III clinical trials which lasts three years will help answer some of those questions. But first they have to sign the consent form which also lists the side effects experienced by the 600 Antegren patients who have been tested during the Phase I and Phase II trials.13 The side effects listed below are presented on the consent form for the Crohn's patients.

"Most common" side effects:

"Headache, pain, sore throat, colds, diarrhea, bladder and kidney infection, back pain, runny/stuffy nose, sinus infection, dizziness, tiredness, eye infection (conjunctivitis), chest pain, abscesses associated with pain and swelling in the anal/rectal region and abscesses that may open in the perirectal (rectum) and perianal (anal) region". [An abscess is a localized collection of pus due to an infection.]

"Side effects less commonly seen":

Fever, numbness, an urgent need to pass urine, inflammation of the stomach and intestines, intestinal gas, hair loss, rash, muscle weakness, and vomiting.

Allergic reactions observed:

"Allergic reactions can range from mild (for example, skin rash, itching, swelling, numbness) to severe (for example,low blood pressure, difficulty breathing, shock, or even cardiac arrest)"

Don't become pregnant while on the drug:

"This is because the effect of natalizumab on the fetus has not been studied and there is a risk that it could cause spontaneous abortion or affect fetal development." 14

However, the website never mentions any of these items. Saying that it's a common side effect for anal and rectal abscesses to open up and that allergic reactions may include shock and cardiac arrest doesn't place the drug in a positive light. But of course, Elan and Biogen aren't paying for an educational website which gives more than one side of the story. By creating an "educational program [which] is produced in partnership with the Crohn's and Colitis Foundation of America" 15 these companies pay to advertise. Luckily, it's "educational" advertising so we are spared lists of side effects which are mandatory for real pharmaceutical commercials.

So the goal of getting the drug's name out to the IBD population has been met by prominently placing links under blurbs such as "Promising advances" and "latest advances in biologic therapy may help you". These links go to interviews and webcasts about Antegren's "very exciting [clinical] trials".16 But in the excitement they leave out the side effects. Good job.

2. Recruits people for clinical trials of the new drug
Following the introduction of "Antegren" into the vocabulary of IBD drugs, the webcasts/transcripts also include an interview with "Diane", a Crohn's disease patient in the Antegren clinical trial program. She's a good find. First she eases the fear people may have about putting their bodies on the line to test a powerful drug:

Well, Dr. Enns was very encouraging in entering the trial. I did do a previous trial medication and had good results with it while I was on it and eventually developed a delayed allergic reaction. So I was a bit leery about trying something new again, but I'd reached a point where the next option would probably have been surgery again for me. I've had two major surgeries over the years, so Dr. Enns was really good about helping me through deciding that this was something that I should do.17

(Well of course he was really good at it, he was getting paid!18 ) Sorry about the outburst. So patient Diane had a poor experience with another clinical trial but with the kind Dr. Enns by her side she's going for another one--and she's not getting paid--except perhaps by the webcast program. But she has more to say, including the following quotes:

"I had my first infusion three-and-a-half weeks ago, and I expect to have another one this coming Tuesday. For me, the results are quite incredible. My pain has decreased, and the pain is a big thing. You know, it's very real. It's very harsh, and when it goes away for a little bit, you forget how bad it has been. "
 

"I guess I would encourage people to try it. Like I say, I was leery and I'm very glad that I went ahead in taking part in the trial, and it's made a world of difference for me, even at this early point. I would just hope that it continues, and it's encouraging for people with Crohn's disease, I think—very encouraging." 19

On the web page with the transcript from Diane appears a helpful link to click so that you can see if you're eligible to participate in Antegren clinical trials. After the webcast, Antegren sounds like winning a trip to Disney World. Many people will want to check out the clinical trials: "Feel great, participate in the Antegren clinical trials. If you qualify, all you have to do is sign this consent form. No don't worry, those common side effects probably won't happen to you, we just have to say that. You know (wink, nudge), for the legal department."

So Biogen and Elan made a good move with their web program, they've put the name of their drug into the IBD lexicon and now they're enticing people to join the clinical trials program. It sure saves time. As a company, instead of making costly visits to doctors you can have the patients contact you directly.

3. Casts doubts on competing IBD products.
An example of casting doubt on a current medication appears in the webcast and transcript of "Promising Advances in Crohn's Disease". At one point, the narrator, asks the following question to Dr. Robert Enns of Vancouver's St. Paul's Hospital. There is no disclosure that Dr. Enn is being paid to test Antegren, which when approved, will compete with Remicade.

Rick [narrator]: Let's talk a little bit about Remicade. And it's, I understand, the only approved [biologic] drug for severe Crohn's, right?
 

Dr. Enns: Remicade as an anti-TNF agent is approved. It has a track record and has been used significantly throughout the world now, and it certainly does work. There are probably two significant concerns with it. One is allergic reactions that develop as there is a mouse component to the antibody. The other that has been raised is a concern of lymphoma. The concern of lymphoma with recurrent Remicade infusions is not settled. It appears to be a small risk, and it's not even sure if it's a real risk. So those are still being evaluated. But the allergic reaction certainly for some patients caused some problem. A lot of patients can receive medication to avoid the allergic reactions, but other patients may have to stop the medication. So Remicade has been around the last few years and certainly is a medication, which does work, even though it is relatively expensive. [emphasis added] 20

Go Dr. Enns, hit the competitor where it hurts: "significant concerns", "allergic reactions", "expensive". These are all true concerns with Remicade. Expense is a concern as noted in these New York Times quotes from an April 11, 2002 article:

  • "Remicade is a good drug," Dr. April said, "but it is being overused because there is money to be made by using it."
  • Kathleen McDermott, a former assistant United States attorney who works at Blank Rome Comisky & McCauley law firm, said Centocor's marketing statements in the Web site document could invite scrutiny from federal health care fraud investigators. "Are doctors only going to prescribe what benefits their pocketbook, or will they prescribe what benefits the patient?" she said. "That is the core issue." [Centocor is owned by Johnson and Johnson.]
  • According to the federal government, Medicare's payments for Remicade skyrocketed last year [2001]. Medicare paid at least $141 million for Remicade last year—almost three times the $48 million the government paid for the drug in 2000.21

The webcast also takes other potshots at Remicade. Here's a quote from Dr. Hanauer:

This treatment [Remicade] is very expensive and does have some potential side effects, including the reactivation of infections such as tuberculosis in patients who have been exposed to tuberculosis.22

Not to be outdone, here's a webcast quote from Page Byers, a Crohn disease patient:

I went back out of the hospital and I tried Remicade, which is a biologic. That worked terrific the first time. It was like a miracle. It was as though I had regained my full ability to live my life with two small children and a lot of activities.



I went back in for my second infusion and it didn't work as well. I think at this point, I had had my diagnosis for about ten months, and I was in pain all of the time and I was so disheartened. My doctor began to bring up again the fact that I might need surgery. 23

(Note: the consent form for Remicade's clinical trials is similar to Antegen but, perhaps since it's been tested longer, includes even worse side effects, such as lupus.24)

So that's the Remicade experience from a patient point of view, condensed by a competing pharmaceutical company: Remicade works ("miracle"), but then it fails, patient has "pain all the time", and may need "surgery". The doctors' quotes and patient experience highlight that Remicade doesn't work too well, casting doubt on the product. Mission accomplished, Elan and Biogen, with the help of the CCFA, have introduced their new product, recruited for clinical trials, cast doubt on a competitor, and it's all tax deductible.

Of course, this raises some questions, how much money would the users of the Specific Carbohydrate Diet have to raise in order to get their own webcast. Notwithstanding that there is no official SCD group to donate money, the CCFA's main objections to the SCD, as stated in an e-mail to me dated October 2, 2002, are as follows:

  1. "We are familiar with the claims about the Specific Carbohydrate diet, but . . . its efficacy is purely anecdotal."

  2. ". . . investigating alternative therapies in a scientific manner has its own set of concerns. You can find some information about that in the article at: www.ccfa.org//medcentral/library/adjunct/wkly0129.htm.

After reviewing the Biogen/Elan webcast, I see that these objections may be overcome by money. They point out that SCD efficacy is anecdotal. However the clinical trial and Remicade experiences of patients Diane and Page respectively are also purely anecdotal, yet the CCFA placed a link in the middle of their site to this information.

The CCFA's second point links to an article on alternative therapies and how they are untested so you cannot tell if they work and may even be dangerous. However, the SCD has no side effects. The nutrition of the diet is sound. In contrast, the CCFA sponsored program produced in partnership with Biogen and Elan tells people to participate in trials for an experimental drug which has shown numerous side effects--not the least of which is impairing the body's immune system. These side effects are not mentioned in the CCFA advertised webcast. If followed properly, the SCD has no side effects except to make you healthy. Therefore, I predict that a generous donation to the CCFA site, on par with that of Elan, Biogen, or Proctor & Gamble could result in a link on the site. But I need my money for mortgage, food, red wine, etc.

Oh, well. Sometimes I feel obligated to criticize the "latest news" on the CCFA site. It's frustrating to watch an organization steer IBD sufferers and doctors away from alternatives such the SCD. Similarly, with "educational" tax deductions for advertising as well as pending IBD legislation, I don't want even a fraction of a penny from my tax dollars supporting it. On the other hand, after a while it feels bad picking on an organization founded for a decent purpose which now shamelessly prostitutes itself. Eh!! But while the pickings good, someone has to do it:) Cheers!


Footnotes

1 Disclosures of ungentlemanly conduct:
While researching Remicade on the web, I signed up for Remicare at www.remicare.com and in the process received a coupon for a free magazine subscription which I redeemed (I chose Discover magazine, they had several magazines to choose from including Reader's Digest). In order to sign up, I misrepresented myself as being a Crohn's disease patient who takes Remicade (I have UC and eat homemade yogurt). This is how it happened:

  • At the Remicare site I was presented with a web registration form. www.remicare.com/gateway/registration1.jsp.

  • I answered 'yes' to the question, "Are you currently taking REMICADE® (infliximab)?"
  • Remicade mailed a Remicare binder filled with glossy information on how getting a pet and taking Remicade will make you healthy. The binder also included directions on how to get a free magazine subscription, 15% off of a Franklin Covey planner, and other assorted information.
  • I called and redeemed the free magazine subscription. (Johnson & Johnson kindly pays people to staff the Remicare phones from 8am to midnight.)

2 Barrett, Amy. "Johnson & Johnson: A Shopping Spree Waiting to Happen",Business Week Online , June 17, 2002.
2001 remicade sales were $721 million dollars, up from $116 million in 2000 due to Johnson and Johnson's "marketing might" after it bought Centocor Inc. Business Week Online

However, an April 11, 2002 New York Times article reported Remicade sales as lower in 2001, at $658 million, and much higher in 2000, $256 million.
Petersen, Melody. "Methods Used for Marketing Arthritis Drug Are Under Fire", The New York Times, April 11, 2002.


Reprint of New York Times article. I think it's now archived on the nytimes.com site, this link is a free source on a lawyer's site--and in no way an endorsement for ambulance chasers.

3 Baker, Don. Once a stepchild, P&G's drug business grows up. Cincinatti Post. April 19, 2002.

4 The sponsorship statement may be seen on the bottom of these pages:

5 Quote from the head of a software company which I once worked for.

6 http://www.healthtalk.com/crohns/

7 "Promising Advances in Crohn's Disease" http://www.healthtalk.com/crohns/interviews/enns/

8 Antegren link in webcast: http://www.healthtalk.com/crohns/interviews/enns/02.html#bio

9 same link as Footnote number 8 (above).

10 Form titled "Consent to be a Research Subject: A Phase III, International, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy and Tolerability of Intravenous Antegren (natalizumab) in Subjects with Moderately to Severely Active Crohn's Disease Protocol No. AN100226-CD301G."


From page 2 of the consent form:

PAYMENT
I will not be paid for participating in this study. My study doctor will be reimbursed by the Sponsor for the work that he or she and the medical staff has to do as part of this study, and for the use of the site's facilities.[emphasis added]

Full Antegen consent document available at http://gi.ucsf.edu/pdf/clin_antegren.pdf

11 Side effects are listed on pages 3 and 4 of the consent form described in Footnote 10 (above).

12 Side effects are listed on pages 3 and 4 of the consent form described in Footnote 10 (above).

13 An overview of the different phases of clinical trials may be found here http://www.allp.com/drug_dev.htm

14 Side effects are listed on pages 3 and 4 of the consent form described in Footnote 10 (above).


Of the 600 people tested so far, 26 were healthy (Phase I trials), 244 had Crohn's disease (Phase II), and approximately 350 had multiple sclerosis (Phase II)--another potential use for the drug.

15 "From our studio in Seattle, and from all of us at HealthTalk and our partner, the Crohn's and Colitis Foundation of America, we wish you and your family the best of health." [emphasis added]
http://www.healthtalk.com/crohns/interviews/hanauer/18.html (blurb appears at the bottom of the page)

16 http://www.healthtalk.com/crohns/interviews/enns/02.html

17 http://www.healthtalk.com/crohns/interviews/enns/03.html#advice

18 See footnote 10 about paying doctors who participate in clinical trials.

19 Same transcipt as footnote 17.

20 http://www.healthtalk.com/crohns/interviews/enns/04.html

21 See New York Times article in Footnote 2.

22 http://www.healthtalk.com/crohns/interviews/hanauer/07.html

23 http://www.healthtalk.com/crohns/interviews/hanauer/16.html

24 Remicade's patient consent form, in PDF format, may be found at this link http://gi.ucsf.edu/pdf/clin_infliximab.pdf