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I expected Patient Recruitment and Retention in India in the Drug Information Association Global Forum magazine to provide insights into the special factors confronting sponsors of clinical trials in India. India is a crucial place for drug development and since I’ve never been there (Thailand is the closest I’ve gotten) I don’t have firsthand experience. But if the author, Dr. Deepti Sanghavi, is correct, there seems to be essentially no difference between India and the US.

These are the barriers she cites:

• Protocol-related barriers including tight inclusion/exclusion criteria, invasive procedures, frequent medical visits, use of placebos, shortage of patients for orphan indications
• Disease-related barriers including the patient getting much better or worse and becomes less interested in the trial
• Medicine-related barriers, such as the medicine tasting or smelling bad.
• Investigator or site-related barrier such as competitive studies happening at the same site, lack of time or motivation to recruit, and poor communications or trust between doctor and patient.
• Subject related barriers such as lack of awareness about clinical research, lack of awareness of disease status, age, social circumstances, inconvenient appointment times, lack of understanding of informed consent, and inadequate compensation.

Everything I read in the above applies equally to the US. The only India-specific points I saw in the article were:

• Female subjects only participate after gaining consent of a male member of the family
• There is less advertising than in the West
• Lack of literacy is an issue

In any case I would have liked to read some more details about the barriers or at least have a couple of anecdotal examples. For instance:

• Are there different ideas about bad tastes or smells that trip up Western sponsors in India, whose products don’t elicit objections at home?
• How do typical inclusion/exclusion criteria affect the Indian population compared with those in the US or Western Europe?
• How does India compare with other “alternative” places trials are done, such as Eastern Europe, China, and Brazil?

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Among the pharmaceutical industry challenges is that’s it hard to recruit patients for clinical trials. This is especially true in therapeutic areas such as oncology where there are lots of drugs in development and the need for clinical trial participants is high relative to the supply of patients. The Center for Information and Study on Clinical Research Participation (CISCRP), which is sponsored by a variety of clinical trial sponsors and research organizations, works to improve the public perception of clinical trials to increase the willingness of patients to participate. From the Drug Information Association’s Global Forum magazine:

“The ‘Medical Heroes’ campaign is designed to rebrand the clinical research industry,” explains Diane Simmons, CISCRP President and CEO. “We’re very clear on the level of public distrust in the clinical research enterprise — a really high level of distrust”

The magazine printed Patient Perspective, comprising five vignettes about “medical heroes,” aka patients who participated in clinical trials. To boil it down:

1. Alexandra Scott got neuroblastoma as a baby. By age 3 1/2 chemo wasn’t working and she was told she was out of options. She participated in a trial and lived to be 8.
2. Brennen Teel was diagnosed with acute lymphocytic leukemia at age 6. He entered a trial and was cured. Now he’s 27.
3. Jean Burns got Parkinson’s at 51. She enrolled in a trial but the drug didn’t work and the trial was eventually halted. She’s not cured but she’s still a fan of trials.
4. John Cleland had testicular cancer at 22. The cancer spread to his lungs. He entered a trial for cisplatin and was cured. Now he’s 58 and healthy.
5. Barbara Holtz had invasive ductal carcinoma in 2001. She enrolled in a Herceptin trial –against the urgings of her family– and it worked great. She says, “The whole thing was a positive experience for me… My message to others would be, have an open mind to being a clinical trial subject. Learn all you can about the trial’s purpose and requirements and go for it!”

These are all nice stories. Note almost all are about cancer –and all of those results are either quite successful (#1) or extremely successful. The only trial that didn’t work is the Parkinson’s example –and hey Parkinson’s isn’t so bad anyway, right?

I think these stories are nice and I believe they’re true. But I am a bit concerned if CISCRP intends to present these results as representative of the patient experience in clinical trials, when the reality is much more mixed. Yes, many clinical trials are necessary and important, and those who participate are potentially generating benefits for other patients as well as the trial sponsors. But that really doesn’t mean that every patient should participate in a trial or that the results are likely to be dramatic.

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Sonia Sotomayor, President Obama’s pick to be the next Supreme Court justice, is a solid choice. Female, Puerto Rican family, childhood hardships, Princeton, Yale, distinguished career, appointed by a Republican President, solid legal record, not too old and not too young –she’s 54. What’s not to like? One topic people are talking about is that Sotomayor is a Type I diabetic. Obama mentioned it in his introduction, so it’s certainly not being hidden. And diabetics (especially Type I’s) are cheering the nomination as a teachable moment and an affirmation that people with Type I can do anything. I agree.

It is reasonable, though, to at least discuss whether her diabetes will affect her longevity on the Court. Supreme Court appointees are one of the main ways a President can establish a lasting legacy. Justice John Paul Stevens was appointed by President Ford way back in 1975. Anton Scalia and Anthony Kennedy were appointed by President Reagan in the mid-80s. Sitting Justices were mainly appointed in their early to mid 50s. The exception: Clarence Thomas, who was appointed when he was 43.

Most of the articles I’ve seen raise the question about whether her Type I diabetes will affect her performance and longevity, and they mostly say it won’t. The Wall Street Journal article (Sotomayor’s Type 1 Diabetes Is ‘Non-Issue,’ Say Docs) is a case in point:

“I think that’s a non-issue,” said Zachary Bloomgarden, a clinical professor at Mount Sinai School of Medicine in New York City.

Type 1 diabetics can’t metabolize sugar because their disease has killed off the insulin-producing cells that normally perform that function. As a result, they must monitor their blood-sugar levels and take insulin several times a day to manage their conditions. By keeping their blood-sugar levels within an acceptable range, sufferers can decrease their risks for heart attacks and other side effects, say experts.

“There’s absolutely no reason why the fact that she has diabetes should be a factor in her longevity or should affect her ability to serve” on the Supreme Court, said Christopher Saudek, director of the Johns Hopkins Diabetes Center in Baltimore.

However, in the comments section Anne offers a perspective that might be more on the mark

Sotomayor and I are almost the same age and I’ve had Type 1 diabetes a year longer. Trust me, people who were diagnosed that long ago have begun to experience problems to varying degrees. I wish her well, but know she’s had much to overcome, and it’s not going to get easier as time goes on. The disease is quietly and slowly destructive to the circulatory system which affects everything else – and long timers like us won’t be likely to see any benefit from stem cell research…although we’re very optimistic for the children being diagnosed today. Keep a good thought for all.

In considering longevity on the Court, however, there are other factors to keep in mind besides her diabetes. Consider:

• Women in the US live about 7 years longer than men (perhaps a good reason to appoint only women to the Court!)
• Just because Justices can serve until death doesn’t mean they will. Sandra Day O’Connor retired in her mid-70s. David Souter is retiring at 69.

All in all I don’t see that her diabetes should be a major consideration in her appointment, but it should be a minor consideration.

There is another interesting aspect to her appointment: As someone who likely would be uninsurable in a purely free-market health care system, she may be a sympathetic voice on the Court when/if challenges to an eventual health care reform law are entertained.

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In Big Pharma and Twitter = Big joke! I demonstrated that big pharma’s presence on Twitter is pathetic. Few of the top 10 companies even maintain the Twitter address with their company’s name. If anything, the situation is even worse when it comes to the top-selling drugs. Big pharma expends considerable effort and dollars to produce and promote slick product-specific websites for its brands. Look at Lipitor.com for example. All the big drugs have sites like that.

By contrast the Twitter presence is a real horror show. Let’s have a look at the top 10 drugs by sales and their presence on Twitter:

1. Lipitor: http://www.twitter.com/Lipitor “has been suspended due to strange activity.” In other words, the same characters who sell fake Lipitor via Spam had probably also registered the Lipitor site on Twitter until Twitter put a stop to it. (The Twitter Viagra site http://twitter.com/Viagra is suspended, too.)
2. Advair: http://twitter.com/advair The name on this one is “CUSTOMER CARE,” following no one, and with two followers. “This person has protected their updates” –not sure why.
3. Plavix: http://twitter.com/plavix has two followers and a single one-word update: “Eating” from October.
4. Nexium: http://twitter.com/nexium is maintained by Rui Manuel Fonseca, who describes himself as “Newly graduated photographer looking fo his way…”
5. Norvasc: http://twitter.com/norvasc is maintained by Jason Lovett, whose bio reads “Viva La Revolucion”
6. Remicade: http://twitter.com/remicade is maintained by someone you know who decided to babysit until the owner wakes up
7. Enbrel: http://twitter.com/enbrel is registered to someone named Dave Allingham who hasn’t posted any updates. He is following one person: Consumer Reports.
8. Zyprexa: http://twitter.com/zyprexa is registered to MaryAnn Hutchinson who’s posted one update, “Listening to KTAR and getting pissed regarding imigration and cigarette prices.”
9. Diovan: http://twitter.com/diovan has one update from way back in 2007, a classic piece of spam, “Buy Diovan Purchase Diovan (Valsartan) Online Diovan, Order Diovan at Canadian pharmacy.” It links to 1canadameds.com, which seems to have been shuttered.
10. Risperdal: http://twitter.com/risperdal is held by Benjamin Blevins. His one update, from April, is an offer to sell this name. He lists his gmail address.

I understand that it’s not totally obvious what pharma companies should do with product sites on Twitter. But I find it pretty lame that not a single one of these top 10 drugs –each with marketing budgets in the millions or more– has paid any attention to this element of brand identity.

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In  Why Drug Companies Prefer Twitter Over Blogs BNET Pharma points out that there are only four big pharma blogs, including GSK’s brand new site.

Drug companies thus far have been far more interested in Twitter than blogging. Check out AstraZeneca’s Twitter stream: 420 updates! They’re addicted! There’s a reason for that … which I’ll get to below.

I agree that there’s not much blog activity from big pharma. But the Twitter presence is even more pathetic. Let’s have a quick look at the top 10 pharma companies and their presence on Twitter.

• Pfizer: http://twitter.com/pfizer is about Pfizer but maintained by someone else who doesn’t seem to be affiliated with the company
• J&J: http://twitter.com/jandj appears to be two friends or sisters, http://twitter.com/j&J has not been registered (until someone reads this and does it), and neither has http://twitter.com/johnson&johnson
• Bayer: http://twitter.com/bayer exists and is maintained in German
• GSK: http://twitter.com/gsk is maintained by Mark, http://twitter.com/glaxo is maintained by Tinus, http://twitter.com/glaxosmithkline looks to be held by a squatter who’s made no updates. (Update: As of May 18, GSK is using http://twitter.com/GSKUS to point people to posts on its new blog.)
• Novartis: http://twitter.com/novartis is used to pump out press releases by Novartis. This is probably the top of the heap for big pharma
• Sanofi-Aventis: http://twitter.com/sanofi-aventis is not registered, http://twitter.com/sanofi is owned by a person named Sanofi, http://twitter.com/sanofiaventis is just like http://twitter.com/glaxosmithkline, i.e., blank
• Roche: http://twitter.com/roche appears to be run by someone in Japan, http://twitter.com/hoffman-laroche is not registered, and http://twitter.com/hoffmanlaroche looks like http://twitter.com/sanofiaventis and http://twitter.com/glaxosmithkline
• AstraZeneca: This is BNET’s big example. I could be wrong but it doesn’t look like the site they cite  http://twitter.com/AstraZenecaUS is actually run by the company. http://twitter.com/AstraZeneca looks a lot like the US site, and the bio refers to the company as “they,” so I think it’s just a hobbyist like the Pfizer site.
• Merck: http://twitter.com/merck is like the other blank, squatted sites
• Abbott: http://twitter.com/abbott is run by Bruce

Twittersquatting isn’t exactly like the old cybersquatting. It should be easy for these companies to at least claim their Twitter URLs, so why haven’t they even done that? It doesn’t seem like much to expect.

PS –I’ve posted a new entry showing the status of the top 10 branded drugs and the story is similar.

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President Obama is doing a pretty good job rallying the troops on health reform. Between working the Congress, bringing health care players to Washington to promise savings, and inserting key “down payments” into the stimulus bill, he’s done a lot already. It’s not to say that health care reform will be easy or even that it will happen, but it’s not looking like Hillarycare II.

A key component of the Obama strategy is to lean on the grassroots organization built up during the campaign. Yesterday everyone on the mailing list received an “I need your voice on health care” email from the President.

The chance to finally reform our nation’s health care system is here. While Congress moves rapidly to produce a detailed plan, I have made it clear that rea reform must uphold three core principles –it must reduce costs, guarantee choice, and ensure quality for every American…

When our opponents spread fear and confusion about the changes we seek, your support for these core principles will show clarity and resolve. When the lobbyists for the status quo tell Congress to hold back, your personal story will give them the courage to press forward.

The email then links to a website where people can show their support and tell their personal stories about their encounters with the health care system. Obama then tells such a story of his own and promises to “personally [review] many of these signatures and stories.”

It’s a clever message and approach. It helps anyone who’s reasonably well informed keep in mind the salient points about health reform, and opens the floor up to anyone who’s had an issue with the health care system. Obama’s principles and approach also don’t run into any of the problems Drew Altman describes in his column highlighting differences among experts and the public, which I blogged about yesterday. Experts and the public are in favor of cost reduction, quality, and care for all. Everyone has a personal story. Choice is in there as a defensive tactic for when the plan’s foes talk about a government takeover, but the truth is most people don’t have that much choice in their health care today and won’t in the future.

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Drew Altman, who heads the Kaiser Family Foundation, writes an excellent series on health care policy called Pulling it Together… But I don’t think his latest column, The Experts vs. The Public on Health Reform is on the money. According to Altman:

In repeated Kaiser polls, we see a divide between what experts believe and what the public believes about some of the key issues in health reform. They don’t disagree on everything; far from it. But there is a wide gulf on basic beliefs about what is behind the problems in the health care system and key elements of reform, especially delivery reform…

These differences between experts and the public matter because key elements of health reform which elected officials expect to resonate with the public could get a decidedly less enthusiastic reception than expected if more is not done to close the gap in basic premises and beliefs between experts and the public. Most fundamentally, the challenge is to educate the public about why health costs are rising as fast as they are in the U.S. As long as people think we can solve the problem of rising health care costs simply by eliminating waste, fraud and profiteering, the hard choices they hear experts and leaders talking about will not make much sense to them.

There’s a certain logic to this argument, but I don’t find the examples in his table particularly compelling:

I’ll examine his points one by one:

• Unnecessary care: Experts would probably agree that there are a lot of people who don’t get the tests and treatment they need. (However, it is probably true that people don’t realize they receive unneeded care.)
• Why costs are so high: Drug and insurance companies certainly have made a lot of money –and that is a part of the reason costs are high. Even when insurance companies don’t make a lot of profit they do contribute to administrative costs for providers, themselves and ultimately purchasers. People really are paying too much now, considering our health care costs are so much higher than anywhere else in the world.
• Quality: The public isn’t right that there’s no big difference in quality among doctors in their area. However, this is probably attributable to lack of good quality information rather than a rigid view that everyone is the same.
• Health IT: The public might be right about this one, especially over the first few years of reform.
• Comparative effectiveness research: Experts probably feel the same way as the public when they are patients themselves.
• Ratings: I’m with the public on this one. Patient experience is an important part of the quality equation. I’d prefer a doctor I have a good relationship with to someone who happens to have a high rating –especially since the rating may be unreliable, outdated, or unrelated to the procedure I’m receiving. Also, a doctor I know may pay more attention when working on me, thereby improving quality.
• Prudent purchasing: Consumers are just learning to deal with cost information. One reason they don’t ask is no one seems to have good answers when they do.
• The health cost problem: It’s certainly reasonable for individuals to look at this issue on a personal level while experts view it on a macro level. But the two are linked: if individuals pay too much then the nation is paying too much. I think there actually is another issue here, that this table doesn’t bring out. It’s that many people think the country should spend more on health care –by expanding Medicaid and Medicare and placing restrictions on managed care practices– rather than less.

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This year’s Boston Globe 100 issue, published today, is a lot gloomier than normal. Certainly the economy is way down but the tone of the issue seems even more depressing, perhaps having something to do with the Globe’s own fragile finances.

Cubist Pharmaceuticals is listed as the number one company this year, based on return on equity (ROE) among public companies during 2008. Its ROE was 83 percent. Number 50 on the top list, Cynosure, managed an ROE of 7.8 percent. (If they’d done a top 100 they probably would have ended in negative territory.)

Cubist is an interesting number one, and it’s somewhat emblematic of companies in the Boston area. It’s a successful biotech company, but it’s not in a position to control its own destiny. For example:

• The company has just one drug on the market, Cubicin, which was approved in 2003. The drug came from Lilly, which abandoned development.
• Revenues are growing fast but are still under half a billion. Market cap is under $1 billion.
• The drug is mainly used for MRSA infections –an indication that wasn’t anticipated when the drug came to market.
• Although the patents are not expected to expire until 2016, Teva Pharmaceuticals is already preparing to challenge their validity. A generic entrant could come along and wipe Cubist out.
• Cubist is taking a number of steps to become a “real” company: co-promoting a drug with a big pharma company and developing some earlier stage products, but don’t hold your breath for the next Cubicin

Cubist is a nice company and I wish them continued success, but if it’s the #1 company in the Boston area that’s kind of sad.

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Check out the latest edition of Grand Rounds at Healthcare Technology News.

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In January I wrote about Designing for Better Health,  a collaboration between Ashoka’s Changemakers and the Robert Wood Johnson Foundation to search globally for:

“nudges” – innovative little pushes that help people make better decisions for their own health and the health of others.

In all, 281 entries were received from 29 countries. The judges announced 10 finalists, and everyone is invited to vote for their three favorites. Each of the three winners will receive $5000 to help put their idea into practice. My four favorites (and their own one sentence descriptions) are as follows:

• Just an idea (US) –To remind millions of women to complete their monthly breast self-examination, put a symbol in birth control pill packages on the optimal exam day.
• Room Makeover Award (US) -Creative Strokes establishes peer-driven “Home Energy Action Teams” to improve the environments and lives of people with mental health challenges.
• Just a cloth piece? (India) -Opening up the most taboo & ignored subject of menstrual hygiene; a female health hazard by involving masses in generating an affordable cloth napkin
• Child promoters on Oral Health. An alternative to achieve wellbeing (Venezuela) –Children become responsible for providing oral health at their schools

Votes must be cast by May 28, 2009 to be counted. What are you waiting for?

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