Slinkerwink's most recent diary, which has been on the rec list all day, suggests, amongst other things, that the Eshoo Amendment could cost lives for cancer patients.
As a former cancer patient myself, this had me very upset from yesterday evening on.
However, Rep. Anna Eshoo has now issued a response to Jane Hamsher's allegations that her Amendment, co-authored by the late Senator Ted Kennedy, would harm anyone, stating that,
"Ms. Hamsher attributes nefarious motives to this effort and the legislation. I fiercely disagree. It was carefully shaped and guided by Senator Kennedy and myself with the highest purposes of bringing life-saving biologics to include biosimilars, to save lives and to bring down the costs to every human being in our country who needs them."
For those who are confused, biologics are pharmaceuticals made from combining plant and animal proteins. I'm sure a biochemist could deliver a much more refined definition than I might. Basically, they're designed to treat patients dealing with serious immune system disorders.
Now everyone has a right to trust politicians to whatever degree they care to. This isn't a diary to in any way question the hard work of various people associated with FDL. This diary is intended only to put on record the statement of Rep. Eshoo (CA-14) about her inclusion of an Amendment that initially read to me as a utterly draconian, giving me serious ethical pause about much of the health care reforms proposed.
Slinkerwink's diary, based off of the article "House Health Care Bill: A Death Sentence For My Fellow Breast Cancer Survivors" from Jane Hamsher on FDL, states:
The Eshoo amendment is one that will bring a high cost to the lives of patients like those with breast cancer. It's a bad provision that should be addressed, and one we need to CALL our lawmakers about today. We all should be very aware about the high costs to the deal made with PhRMA, and ask ourselves---are we okay with this deal?
Of course, who would be okay with a deal that dealt a death sentence out to those struggling with cancer or HIV? Not many. So many of us took action, as requested, including myself.
However, Rep. Eshoo responded to Jane Hamsher's various allegations in the Huffington Post today. Obviously, it's up to you to decide whether her arguments, or Jane Hamsher's, are more compelling. I strongly recommed you read both in full, since I can only provide select portions here in my diary.
I do think it's important for those who are currently concerned about biologics and the Eshoo Amendment to be aware of Ms. Eshoo's response to Ms. Hamsher's concerns.
Rep. Eshoo states the following:
Ms. Jane Hamsher related some heartbreaking stories on HuffPost about breast cancer survivors and their struggles to overcome this devastating disease. I've heard dozens of similar stories and each one has moved me to do everything I possibly could throughout my public service to help breast cancer victims, and I have been a leader in the House of Representatives in promoting women's breast health. The National Breast Cancer Coalition, a group representing hundreds of organizations and millions of women who dedicate their lives to curing breast cancer has honored me with their prestigious 'Perfect Voting Record' honor. I've fought tirelessly to make it a federal crime for insurance companies to kick women out of their hospital beds right after they've had a mastectomy (the Breast Cancer Patient Protection Act). I fought for increased access to breast cancer screening so millions of women can catch the cancer before its too late (MRI and Mammogram Availability Act).
In 1997, I successfully authored and saw into law the Reconstructive Breast Surgery Benefits Act, which banned the practice of private insurers treating breast reconstructive surgery following a mastectomy as cosmetic surgery. In 2000, I was a leading sponsor of the Breast Cancer and Cervical Treatment Act, which allows states to use Medicaid dollars to provide health treatment coverage for low-income women diagnosed with breast or cervical cancer. I also serve as Chair of the Cancer Care Working Group, a coalition of members in the House who are dedicated to improving the care and treatment of cancer patients.
Rep. Eshoo continues...
Having put so much into these critical issues, I'm quite frankly outraged by the falsehoods and misrepresentations in Ms. Hamsher's column.
Honestly, I initially had the same read as Ms. Hamsher, since I struggled with costly childhood cancer that left me with a mere 5% odds of living. After multiple surgeries and long, painful, and drawn out treatments, I beat the odds and am thus daily inspired to help others get good treatment for even the most horrific and painful of diseases. I've laid in a hospital bed, I've lost my hair the same month I got my first period, and I'm very empathetic with the plight of those who wrestle with illness and insurance issues both. For all those who have been sick, the terror of an illness returning, and the desire to ease the struggle of others similarly afflicted, can hit an awesome xenith from time to time.
But please, for the record, back to Rep. Eshoo:
My amendment to create a new pathway for approval of 'follow-on' versions of innovative biotechnology products, or 'biosimilars,' will not deny patients access to these miraculous treatments. In fact, my legislation, sponsored by the late Senator Edward Kennedy, will create for the first time in our country's history an FDA approval process for biosimilars to compete with innovative biologics.
Well that doesn't sound too bad. Ted Kennedy, hmm... he went through cancer as well...
Rep. Eshoo continues on to explain how biologics will provide a pathway to the development of biosimilars in "an accelerated approval process."
She repudiates the notion that the 12-year patent exclusivity would hurt the process, saying that:
"Biotechnology products cost billions of dollars to develop, test and bring to market, and in order to ensure that competitors aren't immediately allowed to free-ride on the costly safety and efficacy data produced by innovators, some period of 'data exclusivity' is necessary to allow some period of time to recoup the investment in developing the drug. Without such a 'data exclusivity' period, there would be no reason to invest in new biologics. We would see the flow of research funds going to traditional pharmaceuticals, medical devices, semiconductors, green technology or other more promising innovations."
That's kind of a mouthful for me, but she goes on to say, "The Kennedy-Eshoo legislation brings this exclusivity down from forever to 12 years, in essence laying the groundwork for the creation of the biosimilar industry, new competition for the biotechnology industry, and reduced prices for patients."
Now that's interesting to me.
Specific points of Jane Hamsher's that Rep. Eshoo takes issue with are:
- 12 year wait periods on generic drugs -- Rep. Eshoo responds that, "Since the vast majority of the most popular biologics treatments were approved at least 12 years ago, this means that they would have virtually no data exclusivity protection."
- evergreening clauses, granting drug monopolies -- Rep. Eshoo says, rather pointedly, that "There is in fact an 'anti-evergreening' clause... My amendment prohibits by its plain language exactly what Ms. Hamsher alleges it would encourage...Ms. Hamsher seems to be describing an alternative outcome which is pure fiction.
"
Perhaps the most compelling point Rep. Eshoo makes is the following:
I'm proud to have this legislation endorsed by: The AIDS Institute, ALS Association, Alliance for Aging Research, American Autoimmune Related Diseases Association, Association of American Universities, Candlelighters Childhood Cancer Foundation, former Vermont Governor Howard Dean, M.D., Immune Deficiency Foundation, the National Alliance on Mental Illness and many other patient advocacy groups.
I've always really liked Howard Dean and I've personally worked with one of these groups as well.
So there you go.
I think it's important to be very careful about what we believe, and equally, what we throw out. I completely understand how Jane Hamsher may have misread this Amendment. It's exactly what I did initially. But it's also hard to argue with the AIDS Institute, the ALS Association, or the other various endorsing agencies here. It's hard to argue with the data in general.
I know. People will go berzerk attacking FDL here. Please. This may well have been an honest mistake, but before running off to your phone calling in outrage against the Eshoo Amendment, try to understand what's at stake. Human Life. Not the reputations of bloggers or politicians. Human Life. That is the topic of this diary: attempting to make sense of the Hamsher-Eshoo debate.
I'm generally appalled at the state of this Health Care Reform Bill for multiple reasons that are worth another diary completely, but the Eshoo Amendment seems to be one of the less noxious parts of it.
At any rate, if you do have something to say to your Representative, by all means, do so. You should! You should tell them what you want from them, since they work for you. This isn't an insult to their competence. It's a statement of their integrity as someone sworn to vote in your stead in our Representative Democracy.
So whatever's on your mind today, like Harry Reid, I encourage you to KNOW WHAT YOU WANT and SAY IT POLITELY BUT FIRMLY.
Even if you think it's "too late" or your idea isn't "politically viable."
You should speak Truth to Power. Always. Otherwise you're not providing a voice of reason, your educated, individual voice that creates our Democracy. You're abstaining from participating in the same system that ultimately benefits you. It's a little like refusing to eat dinner at the family table, in my humble opinion. And for this, I thank all those who are active in this fight, be they FDL, OFA, DFA, and all other groups trying to make sense of this issue, trying to push for a better future for those most in need.
Hell, even Harry Reid agrees that you should contact someone. Not that I'm Harry Reid's B.F.F. but hey... to each their own:
To find your Representative, click here.
To find your Senator, click here.
To contact the White House, click here.
Bless up to all today!
h/t to sherijr, who suggested I add this comment of mine to the body of the diary:
I'm wrestling with an exhaustion with the reforms myself, but trying to let that stay out of my psychic state here. Basically, I brought this up because I was arguing fiercely along with Jane Hamsher: this Bill, if it comes to pass, will KILL people! I think I shouted that all evening. But then I read what Rep. Eshoo said today and thought, wow, there's some strong language. She says, no, it will kill more people if this amendment doesn't come to pass.
That's a giant ethical quandary, being asked who to believe about who is going to die if we're for, or against, something. It deserves SERIOUS consideration because both sides are claiming that this is life, or death, for HIV and Cancer patients.
Also, h/t to MotherofZeus for pressing on my to bother writing, and to gchaucer2 for fixing my tags.
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Update #3 - Kossacks in the Biotechnology Industry Offer Their Perspectives
asilomar writes in the comments:
First, you should know that I'm in the business - biotechnology, that is. Not in developing biologics per se, but enough to know what's involved. Both the costs, and the difficulty of developing these drugs.
I also happen to be a patent holder, as in, one familiar with the patenting process.
Second, you should know that I have and have had dear, close friends with cancer.
One of them is alive right now because of a so-called biologic drug.
I am acutely aware, on the most personal level, of the issues surrounding pricing and access for those who cannot afford $50,000 per month.
Unlike generic pricing for pills, about 10% of the proprietary cost, IMHO the cost of biosimilars is probably not going to drop too much.
Third, you should know that I have been watching this issue over years. In August I corresponded - politely, but with Gov. Dean's strong "let me tell you why" kind of pushback - on the 12 year extension for "generic biologic drugs."
To my concerns, Eshoo responded, thoughtfully and in detail, just as strongly, about her and late Sen. Ted Kennedy's thinking on the 12 years.
I disagree with Eshoo. I agree with Obama.
I agree with Hamsher's concern, but not with some of her conclusions. In the real world, lack of access to a key drug is not always about pricing.
So this diary is not about views, but about respect.
In the 12 years I have been Eshoo's constituent, I have become a Deaniac and Kossack. This is the only time in years that I have disagreed with Rep. Eshoo. I can and will respect her thinking and logic on this point. I cannot and will stand by when poorly-informed people just rant. I will ask that all citizens, but particularly Kossacks, do their homework.
I ask that we all agree to respectfully disagree.
And I will continue to write to President Obama to ask him for his help in shortening the time to his suggested compromise.
On a final note, Eshoo has been pro-healthcare reform since the mid-1980s. She has been a rock solid and consistent voice for the public option. She spoke out often and early against the Iraq War. In town hall meetings about Iraq in 2007, she made it clear, in the face of constituents' disagreements, that she objected to many of Bush's policies.
Perhaps you know that in the past ten years, Eshoo and Kennedy were the lone voices trying to bring a "generics" clause to biologics for years. The Bush administration blocked this.
I believe that Eshoo should be congratulated and thanked for bringing this legislation to a reality that while a compromise, and a disappoinment to some, represents a major and hugely important step forward in bringing "generic pricing" to biologic drugs.
and yuriwho states:
As a Ph.D. Biochemist who designs proteins I can tell you that this is a very important amendment. The problem with biologics and patenting is that for any protein that is patented as a drug, you patent the composition of matter, i.e. the sequence of the protein. The existing patent law prevents others from making variations on that sequence that improve the drugs characteristics unless it is by adding substantial changes to the basic sequence. However with these changes to the law it would allow many companies to create improved versions of protein based drugs and get 12 years of exclusivity on their sequence and or close variations thereof. This will result in several companies competing with similar but distinct versions of a biologic drug resulting in improved drugs and cost competition which will bring down the outrageous prices that pharma's are charging for biologics. As it happens, biologics are the future of the drug industry. There have been relatively few new small molecule drugs developed in the last 15 years compared with the number of new biologics. Also the technology to develop biologics has advanced greatly in the last 10 years making it relatively easy to generate improved variants of any existing biologic.
This will transform pharmaceutical research for the better if it is adopted.