As promised, today I would like to take a look at how a drug like thalidomide, which was first created and distributed over forty years ago, could still be controlled by drug maker Celgene.
Why isn’t this very expensive anti-myeloma drug available in generic form?
The answer to the last question is simple. It is sold in generic form–and at a much lower cost–in other parts of the world. I started this series, addressing the high cost of chemotherapy drugs used to treat multiple myeloma, two weeks ago. Lets wrap things up where we started: Examining a seven year old Wall Street Journal article, written by Geeta Anand.
Geeta answers all of these questions in a few, short paragraphs:
Thalidomide is inexpensive to make. Fundacao Ezequiel Dias, a government laboratory in Brazil, sells 100-milligram capsules to the Brazilian government health system for seven cents. The pills are given to leprosy and cancer patients free of charge. A Netherlands pharmacy sells the same dose for about $2.60…
The company devised a system for dispensing the drug that requires, among other things, regular pregnancy tests for patients of childbearing age. Since thalidomide had been around for decades and the composition couldn’t be patented, Celgene would eventually patent this system of controlling distribution.
In theory a generic-drug company could sell thalidomide in the U.S., since the patent on the drug’s composition expired long ago. However, it would need to get the FDA’s approval for a distribution system to keep the drug out of the hands of pregnant women. Such a system would be difficult to devise without violating Celgene’s five patents on its own system. And the FDA might hesitate to approve an alternative system because Celgene’s system has worked well to prevent birth defects from thalidomide. Celgene says no other company has attempted to bring thalidomide to market in the U.S.
Interesting. Call it ingenious. Call it sneaky or opportunistic. Praise Celgene for re-inventing and recycling a drug which had been banished 25 years earlier for causing birth defects.
But the bottom line is this: By patenting the distribution system and then conducting clinical trials, Celgene resurrected thalidomide, re-named it Thalomid, and profits soared.
Think you know where I am going with this? You might be surprised. In deference to our free market readers, let’s examine what Celgene did–and does with profits from Thalomid–which now sells for over $4000 for some month long cycles. Here is more from Geeta:
Each year, as thalidomide revenue grew, Mr. Jackson plowed more money into research and development of new medicines. By 2003, the R&D budget at Celgene had reached $123 million, which amounted to nearly half of the company’s revenue of $271 million. Part of the research budget funded three clinical trials of Revlimid, a drug the company believes could be more effective than thalidomide in certain cancers without the potential to cause birth defects.
As revenue grew, the company raised pay for top officers. In 2003, Mr. Jackson earned $1.8 million in salary and bonus, compared with $365,000 in 1998.
There you have it. The yin and yang. The good and bad in our capitalist system, all outlined in two simple paragraphs.
Yes, profits from Thalomid financed research for the new, improved and more effective version of thalidomide, Revlimid. The mastermind of the Thalomid project, Mr. Jackson, certainly deserved a raise. But from $365,000 to 1.8 million in just five years? Over $4000 per month per patient. Come on, man! Pricing like this is unfair and impossible for all but the most far right capitalists to justify.
Interestingly, Geeta goes on to describe the attitude of multiple myeloma related organizations to the high price of Thalomid:
The two biggest advocacy groups for multiple myeloma haven’t made lower drug prices a priority. “I try to focus on the positive rather than coming after them on price,” says Kathy Giusti, president of the Multiple Myeloma Research Foundation.
Susie Novis, president of the International Myeloma Foundation, says taking on drug companies over pricing is a losing battle. “They won’t even discuss it. They say, ‘It is what it is,’ ” she says.
This article was written seven years ago. Kathi Giusti and Susie Novis are still running the MMRF and IMF. Have their attitudes changed?
Certainly not publicly. This, too is complicated. Both the IMF and MMRF have dependent relationships with Celgene, Millennium, Onyx and other companies which manufacture and distribute multiple myeloma related drugs. If I didn’t know about all of the great work the IMF and MMRF do for myeloma research and patients, I might be tempted to call their relationships incestuous.
Best I can tell, the IMF and MMRF have decided to focus on helping push research development, turning a blind eye to soaring drug costs. Why? So not to alienate companies which produce life saving medications for multiple myeloma patients–even if they do cost too much.
This has all gotten very complicated. Drug company profits finance new research and non-profit organizations dedicated to advancing research and helping patient. But someone pays for all of this. Insurance companies? Sure. But who pays the premiums? All of us–especially the patients.
What about those patients who can’t afford sky high co-pays–or who don’t have insurance at all? Let’s ask Geeta:
Celgene’s free drug program, generous by industry standards, helps patients who earn less than $38,000 a year and also have assets of less than $10,000. It doesn’t apply to people whose insurance is paying part of the bill. Dr. Comenzo’s nurse, Alice Ford, says she sees many patients who struggle to pay for thalidomide and don’t qualify for Celgene’s free drug program. For that reason, she says, “I discourage the doctor from putting people on it.” Velcade, though more expensive, has been covered by Medicare.
Just when you thought things couldn’t get any more complicated! Celgene’s Patient Assistance Program is awesome! When I was initially denied insurance coverage for Revlimid by my Blue Cross/Blue Shield policy for Revlimid, prescribed by Mayo Clinic docs in 2007, Celgene’s Patient Assistance stepped in and payed for my first month’s cycle–at a cost of nearly $7000–and helped me fight my insurance company to extend coverage.
We were successful. My next month’s cycle was covered by insurance. Sure, I had a $3000 deductible. But that wasn’t even one half the cost for one month’s treatment. (Remind me why 21 capsules are that expensive again?)
So how does one describe our drug research and distribution system in this country? Complicated. Incestuous. Innovative. Compassionate. Greedy. Pick one. Heck, pick them all!
In one way or another, all apply.
Can anything be done to improve the system? Proponents argue against single payer systems like in Canada or the UK. Critics point to ridiculously high executive salaries and the unreasonable burden put on patients and their families here now. Is there a middle ground?
I argue YES! Just because it has become increasingly difficult and unpopular to compromise in politics and among corporations, doesn’t mean we should stop trying.
Why can’t reason and moderation be applied for the common good?
The ultimate question is this: Are we going to continue to rely on government intervention and imposed solutions–or can a coalition of patients, medical professionals and groups like the IMF and MMRF nudge drug and insurance companies in the right direction?
I’m approaching my “43 month anniversary.” That was the median life expectancy for a Stage 2 multiple myeloma patient in the spring of 2007. I write a lot about how that discussion with my Mayo Clinic oncologist changed my life in my first book, Living with Multiple Myeloma. (Hey–a guy has to sell a few books to help pay the bills, right?) 43 months. That’s how long I was expected to live.But I’m going to blow by that number! Better keep taking my Revlimid. Better keep supporting the IMF and MMRF. Better keep living my complicated, wonderful, interdependent life.
Feel good and keep smiling! Pat