[Ip-health] Doctors rebut Eshoo's false claims re biogenerics secn in health bill

[Sarah Rimmington]

http://seminal.firedoglake.com/diary/19160

UCSF Physicians Respond to Rep. Eshoo on Evergreening Loophole in
Biologics Bill
By: atsai Tuesday December 15, 2009 11:59 pm


By: Alexander C. Tsai, M.D., Ph.D. and Nicholas Rosenlicht, M.D.

As psychiatrists who provide critical psychological counseling and
support for many patients living with HIV/AIDS in San Francisco, we have
observed firsthand how =91evergreening=92 by the pharmaceutical industry ha=
s
adversely affected our patients. Prompted by the passing of another
World AIDS Day, we wrote an op-ed in the San Jose Mercury News outlining
our concerns with Representative Anna Eshoo=92s (D-California)
co-sponsorship of the biologics legislation now under consideration as
part of the overall health care reform package weaving its way through
Congress ("Eshoo needs to close loophole in biologics legislation", Dec.
2). Rep. Eshoo responded with an op-ed several days later ("Biologics
bill will help make breakthrough drugs more widely available", Dec. 6).
Given the space limitations of the newspaper "letter to the editor"
format, the purpose of this blog posting is to respond to her remarks in
detail.

-

Eshoo: "As Congress has moved to overhaul the health care insurance
industry in America, I=92ve been struck by some of the myths put forward
by opponents of the effort that have gained traction: death panels,
government takeovers of health care, free care for illegal aliens and so on=
.

Response #1: Rep. Eshoo=92s argumentum ad hominem is an attempt to lump
our position together with views traditionally espoused by Republicans.

We are disappointed in Rep. Eshoo=92s use of ad hominem. As physicians,
our primary concerns about her biologics bill have to do with its
adverse effects on our patients and how it will diminish access to new
lifesaving biologics both now and in the long run. Our Dec. 2 op-ed was
reasonably worded and dispassionately argued. We did not, for example,
characterize Rep. Eshoo as an industry pawn even though it is documented
that she has received more than $600,000 in campaign finance
contributions from the pharmaceutical and health care industries over
the past decade.

In contrast, it is ad hominem for Rep. Eshoo to cite emotionally charged
material such as "death panels" and anti-immigration activists. Clearly
our op-ed had nothing to do with "death panels" and anti-immigration
activists, so there is no need to introduce these concepts into a debate
about biologics policy. However, we do observe that these positions have
been conventionally espoused by Republican policymakers and activists.
The effect of Rep. Eshoo=92s ad hominem is to link our concerns with
theirs, psychologically, in the eye of the reader. Nothing could be a
falser accusation.

-

Eshoo: "But I=92ve been particularly troubled by misrepresentations about
legislation I sponsored to reduce costs and increase availability of
biologic treatments =97 drugs produced from human or animal cells through
biotechnology."

Response #2: Rep. Eshoo=92s bill will actually preserve high prices on
branded biologics and undercut incentives for drug manufacturers to
develop truly innovative new biologics.

Rep. Eshoo=92s proposed 12 years of data exclusivity ensure that biologics
manufacturers can charge whatever prices the market will bear for as
long as data exclusivity remains in effect. The Federal Trade Commission
(FTC) recently studied the potential effects of proposed follow-on
biologics legislation ("Emerging Health Care Issues: Follow-on Biologic
Drug Competition", June 2009) and arrived at the recommendation that
such a regulatory pathway should be characterized by zero years of data
exclusivity. Furthermore, Rep. Eshoo=92s bill contains an evergreening
loophole (see Response #7 below) that could generate additional delays
for generic biologics manufacturers attempting to bring their products
to market =97 meaning that our patients would be paying high prices for
branded biologics for years and years to come.

With regards to availability, our criticism of Rep. Eshoo=92s bill takes a
long view of our patients=92 ability to access lifesaving medications. As
physicians, we frequently rely on medicines developed by a
pharmaceutical industry that relies on research funded by the federal
government, and consequently we believe that legislation affecting the
pharmaceutical and biologics industries should preserve their incentives
to produce truly innovative new medicines. This is why it would likely
be to our patients=92 detriment for Rep. Eshoo=92s bill to be adopted as
currently worded. The FTC, in the aforementioned report, also described
how granting market exclusivity to branded biologics in addition to
their patent terms would lead biologics manufacturers to "direct scarce
[research and development] dollars toward developing low-risk clinical
and safety data for drug products with proven mechanisms of action
rather than toward new inventions to address unmet medical needs" =97 thus
stifling future development of truly innovative new medicines.

-

Eshoo: "The bill secured overwhelming support in the House and Senate,
as well as endorsements from the Association of American Universities,
the California Institute for Regenerative Medicine, and more than 70
patient and industry groups, including the AIDS Institute, the ALS
Association and the Alliance for Aging."

Response #3: While Rep. Eshoo=92s list of industry and industry-funded
supporters is impressive, we would be interested in seeing a list of her
non-industry affiliated supporters.

We attempted to set aside the measuring stick of endorsements in our
initial op-ed so that we could focus on enumerating reasons to oppose
Rep. Eshoo=92s bill. However, we understand that her description of her
list of endorsers is a critical component of her argument. Therefore, it
may be instructive and more transparent for voters to understand who
endorses her endorsers. The three disease-based advocacy organizations
she lists in her rebuttal op-ed are documented to have received
corporate funding from Pfizer (AIDS Institute, ALS Association, Alliance
for Aging Research); Novartis (ALS Association, Alliance for Aging
Research); Wyeth (ALS Association, Alliance for Aging Research); Tibotec
(AIDS Institute); Abbott, Amgen, Biogen Idec, Mylan, Novartis, Roche,
Sanofi-Aventis, Unilever (ALS Association); and AstraZeneca, Edwards
Lifesciences, and Eli Lilly (Alliance for Aging Research). These
corporate funding sources are consistent with Rep. Eshoo=92s list of
industry endorsers, which includes the Biotechnology Industry
Organization and the Pharmaceutical Research and Manufacturers of
America, as well as numerous state biotechnology associations.

Industry seeding of patient and disease-specific advocacy organizations
may generate potentially fruitful collaboration but can also distort the
agendas of these advocacy organizations. This phenomenon is particularly
well-characterized in the field of psychiatry ("Giving Legs to Restless
Legs", PLoS Medicine, 2006; "Drug Makers are Advocacy Groups=92 Biggest
Donors", New York Times, Oct. 21). Senator Charles Grassley (R-Iowa) has
long expressed concern that industry funding of patient and disease
advocacy organizations may create conditions for the pharmaceutical
industry to exert undue influence over them to lobby on behalf of
industry, rather than on behalf of patients ("Senator Grassley Seeks
Financial Details from Medical Groups", New York Times, Dec. 7). Given
that Rep. Eshoo=92s bill has been described in a recent page one San
Francisco Chronicle article as "a multimillion-dollar bonanza" for the
biotechnology industry ("Eshoo Bill Huge Boon for Silicon Valley
Biotech", Dec. 6), it comes as no surprise to us that Rep. Eshoo=92s bill
has such a long list of industry champions.

In contrast to Rep. Eshoo=92s long list of pharmaceutical industry
supporters, many non-industry affiliated consumer, health, and patient
groups have recorded their opposition to her bill. The list of opposing
groups, recently assembled and posted online by Essential Action,
includes the American Medical Student Association, Consumers Union,
Public Citizen, National Physicians Alliance, U.S. PIRG, Service
Employees International Union, and many others. The full list is
available online here, and more information is available here:
http://www.AffordableMedsNow.org.

-

Eshoo: "Currently, competitors are free to create products that are
similar to innovative biologics, so long as they don=92t infringe on any
patents. To obtain Food and Drug Administration approval, however,
generic manufacturers would have to generate their own safety and
efficacy data as though the product were a new drug. Under no
circumstances may they rely on the safety and efficacy data of the
innovator. This "data exclusivity" protection is essentially infinite
under current law. The Kennedy-Eshoo language would bring this period of
protection down to 12 years, concurrent with existing patent protections."

Response #4: Rep. Eshoo favorably compares the current "infinite"
duration of data exclusivity to her proposed 12 years, when in fact her
proposal compares unfavorably to the zero years of data exclusivity
supported by experts.

Rep. Eshoo is right to point out that, under the current policy regime,
data exclusivity is "infinite" because no regulatory pathway for
biologics exists. However, we view this as an unnecessary appeal to the
"anchoring bias" that is a well documented phenomenon in psychology and
behavioral economics ("Judgment under Uncertainty: Heuristics and
Biases", Science, 1974). When compared to "infinite", certainly Rep.
Eshoo=92s proposed 12 years of exclusivity may actually seem reasonable to
the na=EFve reader.

However, Rep. Eshoo neglects to name the other anchoring points that are
also available. The 12 years of market exclusivity provided by her bill
is more than double the five years that conventional pharmaceutical
drugs (i.e., new molecular entities) currently receive. The FTC, as
noted previously, recommended zero years of data exclusivity for branded
biologics. Rep. Henry Waxman (D-California) and colleagues, and Sen.
Charles Schumer (D-New York) and colleagues, have proposed legislation
to grant branded biologics manufacturers five years of data exclusivity,
comparable to what conventional pharmaceutical drugs currently receive.
President Barack Obama has recommended a "generous compromise" of seven
years of data exclusivity ("Costly Drugs Known as Biologics Prompt
Exclusivity Debate", New York Times, Jul. 21). When compared to these
alternative anchoring points, Rep. Eshoo=92s proposed 12 years of
exclusivity is more appropriately viewed as an unnecessarily lengthy
duration of protection.

Finally, irrespective of whether a final biologics bill contains 12
years vs. zero years of exclusivity, it is important to note that Rep.
Eshoo=92s bill contains a glaring evergreening loophole that we already
described in our Dec. 2 op-ed: simple, inexpensive modifications to drug
structure can trigger additional years of data exclusivity. We develop
this argument further below.

-

Eshoo: "[The twelve years of proposed data exclusivity] is the typical
amount of time all drugs now receive under patent protection following
FDA approval, so the actual period of protection will remain the same in
most cases."

Response #5: Rep. Eshoo obfuscates the difference between patent
protection and data exclusivity, which obscures the fact that experts
have recommended zero years of data exclusivity given the adequacy of
existing patent protections for biologics.

In comparing her proposed period of data exclusivity for biologics with
the average duration of effective patent protection for conventional
drugs, Rep. Eshoo is comparing apples to oranges. The duration of patent
protection and the duration of data exclusivity are two different
issues, and Rep. Eshoo=92s prior writings on this issue clearly
demonstrate her understanding of the difference between the two. The
patent system already provides adequate market protection for branded
biologics. As discussed extensively in a paper published in the New
England Journal of Medicine ("Balancing Innovation, Access, and Profits
=97 Market Exclusivity for Biologics", Oct. 14), biologics already receive
adequate patent protection under the current regulatory apparatus. As an
example, these experts describe how Amgen, the maker of Epogen=AE (a
biologic used to treat anemia), has invoked patents to prevent
competitors from importing into the U.S. similar drugs that have already
received European regulatory approval. Because of the adequacy of the 20
year patents that biologics already receive, FTC experts have
recommended that branded biologics receive zero years of data
exclusivity rather than the 12 years that Rep. Eshoo has proposed.

-

Eshoo: "Contrary to the claims of insurers, the generic drug industry
and its supporters, the bill does not provide innovators additional
years of exclusivity if they make slight changes to their products, a
practice known as evergreening."

Response #6: Rep. Eshoo=92s second ad hominem attack is an attempt to lump
our position together with those taken by the health insurance and
generic drug industry.

We are again disappointed that Rep. Eshoo has resorted to ad hominem
attacks, which are quite unnecessary in the context of a policy debate.
Similar to her opening ad hominem attempting to link us with "death
panels" and anti-immigration activists (see Response #1 above), it is ad
hominem for her to lump us in with "insurers, the generic drug industry,
and its supporters". In contrast to the more than $600,000 in campaign
finance contributions Rep. Eshoo has received from the pharmaceutical
and health care industries over the past decade (and unlike most
physicians nationally), over the past decade neither of us has accepted
any food, gifts, or payments from pharmaceutical/biologics (branded or
generic) or health care industry representatives in return for attending
educational seminars or professional meetings, consulting, giving
lectures, or enrolling patients in drug trials.

Furthermore, many of the organizations that have documented their
opposition to Rep. Eshoo=92s bill =97 including the American Medical Studen=
t
Association, Consumers Union, Public Citizen, National Physicians
Alliance, U.S. PIRG, Service Employees International Union, and many
others (full list available online here) =97 do not accept funding from
either the insurance industry or the generic drug industry, and they
would likely characterize their positions in the biologics debate as
being more closely aligned with patients than with either industry.

-

Eshoo: "The plain language of the legislation provides that new
indications, new routes of administration, new dosage schedules, new
dosage forms, new delivery systems, new delivery devices, and new
strengths for an original product would get zero years of extended data
exclusivity."

Response #7: Rep. Eshoo=92s appeal to the "plain language" of the
legislation ignores the evergreening loophole that we described in our
initial op-ed.

We are pleased that Rep. Eshoo has recorded her opposition to the
practice of evergreening. If in fact she is opposed to evergreening, all
that remains is for her to change the wording of her proposed bill to be
more consistent with the position that she has just described. It is
true that, under the language Rep. Eshoo introduced, changes to an
already approved biologic that result in "new indications, new routes of
administration, new dosage schedules, new dosage forms, new delivery
systems, new delivery devices, and new strengths" in the absence of a
change in drug structure are specifically exempted from receiving 12
additional years of data exclusivity. However, this does not mean her
bill would actually limit the practice of evergreening (which she has
attempted to argue). Under this language, if a branded biologics
manufacturer performs "a modification to the structure of the biological
product" that results in one of the enumerated changes, they are in fact
not exempt from receiving 12-years of data exclusivity on the modified
product. As Ethan Guillen, Chris Manz, and Sarah Rimmington have pointed
out, this language creates an evergreening loophole by permitting a
branded biologics manufacturer to implement easily performed and
inexpensive structural modifications just as the original protection
period is about to expire =97 and receive another 12-year data exclusivity
protection period on the modified product.

As psychiatrists who advocate fiercely on behalf of our patients, we
dislike the practice of evergreening and are intimately familiar with
its adverse effects. For example, Johnson & Johnson, facing expiration
of its patents on the blockbuster drug Risperdal=AE (commonly used to
treat psychotic thought disorders), took the active metabolite and
marketed it as Invega=AE =97 thereby extending its patent shelf life. To th=
e
body it is the same drug, but it now carries a higher price tag: a
one-month supply of a typical dose of Risperdal=AE costs $300, whereas a
one-month supply of Invega=AE costs four times as much. Based on our
experience with the behavior of conventional pharmaceutical
manufacturers like Johnson & Johnson, we have strong reason to believe
that brand-name biologics manufacturers will attempt to do the same
under Rep. Eshoo=92s legislation. Indeed, it is quite likely that in many
or most cases this prospect will deter generic biologics manufacturers
from entering the biogenerics market at all.

Fortunately for our patients, it would be quite simple for Rep. Eshoo to
narrow this problematic loophole by removing the bracketed language in
section 7(C) of the biologics provision in the House health care bill,
which reads "(not including a modification to the structure of the
biological product)." Removing this bracket would allow the provision to
operate as she claims, by exempting modified versions of existing
products from receiving another 12 year period of data exclusivity. If
Rep. Eshoo is truly committed to "zero years of extended data
exclusivity", she can to demonstrate that commitment by making this
simple language change. We strongly encourage her to do so.

-

Eshoo: "I=92m disappointed that the mischaracterizations and falsehoods of
insurance companies and generic drug manufacturers who oppose the
Kennedy-Eshoo bill continue to surface, but I=92m committed to seeing that
this critical legislation is enacted into law for the benefit of
patients across the country."

Response #8: This is Rep. Eshoo=92s third ad hominem in the span of 600 wor=
ds.

We reiterate our disappointment in how Rep. Eshoo has chosen to attack
us (rather than addressing the substance of our arguments) by lumping
our position together with those espoused by insurance companies and
generic drug manufacturers. This is an unnecessary rhetorical tool and
has no place in a policy debate.

Summary Response: In sum, we find Rep. Eshoo=92s rebuttal op-ed
unconvincing. She ignores our concerns about how her bill would undercut
branded biologics manufacturers=92 incentives to produce new, truly
innovative medicines. Her rhetorical tools do little to refute our
argument that her proposed 12 years of data exclusivity is too lengthy a
period of protection given the adequacy of the current patent protection
regime for conventional drugs. She resorts to ad hominem attacks three
times in the span of 600 words. And finally, she sidesteps our frank
discussion of the evergreening loophole in her bill. We outline concrete
steps that Rep. Eshoo can take to demonstrate her commitment to closing
the evergreening loophole, for the sake of our patients. Ultimately, we
hope that she reconciles her priorities with those of the poor and excluded=
.

=96

Alexander C. Tsai, M.D., Ph.D. is a psychiatrist at the Langley Porter
Psychiatric Institute, University of California at San Francisco (UCSF)
and a resident of San Francisco. Nicholas Rosenlicht, M.D. is a clinical
professor of psychiatry at UCSF and maintains a private practice in
Berkeley, where he resides.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/

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