Better to Best: Thoughts on Global Health Care Systems

Sorry for the extra-long hiatus.

Posted in Medical School (General), PharmFree by reshmagar on April 15, 2012

This year has been something else. It’s been fun, devastating, satisfying, frustrating, and more all at once. I can safely say that I am confident I chose the right career path. As sad as this may sound, I really love working at the hospital. I love saying hello and good morning and smiling to everyone who walks by and talking to patients who most of the time think I’m in high school. I love working with the whole team to figure out what’s going on with our patients. I even love the cafeteria…especially now because post-call, chocolate chip pancakes really hit the spot. So all in all, that’s good. I’m pretty relieved about all of this. Hopefully, this love will be reciprocated and my patients one day will enjoy having me as their provider.

Anyhow, I’ve neglected this blog for way too long. It’s been a very busy year and during my free time, when I had hoped to update this, I instead decided to sleep, catch up with friends, or do non-productive things like watching way too much television on my computer or go to websites like this.

But I’ll be back in two weeks. I will be officially done with third year and taking a couple years off to serve as the American Medical Students Association PharmFree Fellow and then go to grad school. I’ll definitely be updating this with various things I’m working on or the many articles/emails in my inbox that I’ve archived for later. 

In the meantime, see how your medical school did on the 2011-2012 PharmFree Scorecard in terms of their conflict of interest policies.

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Why I’m even more skeptical about a Novartis exec joining the Gates Foundation

Posted in Health Rights, Human Rights, PharmFree by reshmagar on October 19, 2011

From MSF India – still unclear as to why a executive coming from a company that is trying very hard to deny access to an affordable version of a key life-saving leukemia drug is joining the Gates Foundation, an organization that prides itself in providing inexpensive vaccines and other drugs to developing countries worldwide.

WHAT NOVARTIS SAYS…AND WHY IT’S WRONG

Médecins Sans Frontières briefing note, 4 October 2011

Swiss pharmaceutical company Novartis issued a press statement last week in
response to the growing concerns regarding its latest legal challenge
against the Indian government. Ahead of the next hearing of the case in the
Indian Supreme Court set for 17 October 2011, Médecins Sans Frontières
addresses the issues Novartis raised in its statement.

BACKGROUND: The Supreme Court case is the final act in a legal battle over
the patentability of the salt form of the anti-cancer drug imatinib and
section 3(d) of the Indian patent law that stretches back over five years.
In 2006, the Indian patents office ruled that Novartis did not deserve a
patent for imatinib mesylate, a salt form of a life-saving cancer drug, on
the grounds that the application claimed a new form of a drug too old to be
patentable in India (see notes below). The company then embarked on a series
of lawsuits against the Indian government including the one that is
currently pending before the Supreme Court. In this case Novartis is
challenging a part of India’s patent law – Section 3(d) – which read with
other provisions of the patent law and the Madras High Court decision says
that a new form of a known medicine can only be patented if it is not
obvious and shows significantly improved therapeutic efficacy over the known
substance.

*What Novartis says: “price doesn’t affect access to medicines”.*

In its statement, Novartis writes “Acknowledging innovation by granting a
patent is unrelated to the access to medicines issue. Improving access to
medicines is a matter of making medicines available.”

This is not the entire truth. MSF has found, during its field experience in
working in many developing countries, that granting a patent has had a
direct bearing on access to affordable essential medicines. Granting a
patent on a medicine provides the patent holder with a monopoly on that
medicine, which in turn allows the company to charge a high price in the
absence of any generic competition. In fact, improving access to medicines
is a matter of not simply making the medicine available but also making it
affordable for patients and governments to buy. This is well documented.
When AIDS treatment first became available in the late 1990s, the price of
first line patented AIDS medicines was – even after discounts – US$10,439
per patient per year. Millions died in developing countries, particularly in
Africa, as prices were too high. Generic competition brought prices down
making treatment possible. In MSF’s experience, patents on medicines are a
key barrier to making medicines affordable, as it prevents access to those
who cannot afford it.

*What Novartis says: “this case will in no way impact access to medicines
to poor countries”. *

This is not true. If Novartis succeeds in weakening the interpretation of
section 3(d) for the purpose of obtaining a patent on imatinib mesylate, the
Indian Patent Office would have to apply the same standards of intellectual
property protection as wealthier countries like the US, granting far more
patents than required under international trade rules or envisioned by
India’s lawmakers.

It is not only about this particular medicine. The interpretation of the
clause has a direct bearing on the examination of patent applications
claiming salt forms, pediatric formulations and other improved formulations
of AIDS drugs, the generic versions of which are currently used by MSF in
its medical projects. This case would set a precedent in this regard.

This could lead to generic competition on many essential drugs ending
entirely and prices for these in both India and developing countries
increasing. This would have a devastating impact on not only people MSF
treats, but also on people the world over who rely on affordable medicines
manufactured in India. MSF buys 80% of the ARVs it uses to treat 170,000
people for HIV across the developing world from Indian generic
manufacturers, and donors rely on Indian sources in similar proportions.

It is crucial to preserve the public health safeguards of Indian patent law
– particularly Section 3(d). The future of generic production is largely
dependant upon the outcome this case.

Imatinib mesylate is a crucial anti-cancer drug sold by Novartis in India
for Rs.120,000 (US$ 2,400) per patient per month. Indian generic companies
sell generic versions for Rs. 8 – 10,000 ($160 – 200) per patient per month.

*What Novartis says: “Section 3(d) – as it relates to evergreening – is not
applicable at all to Glivec”. *

Novartis is seeking a patent in India on the salt form of imatinib (Glivec).
Claiming a patent on a salt form of an existing drug is a common and
well-known form of evergreening by pharmaceutical companies to extend the
patent life – and monopoly – of their drugs. And companies do this routinely
to prevent generic competition. An example of this is the AIDS drug
abacavir. Although the abacavir molecule was first developed and patented in
the 1980s, pharmaceutical company GSK applied for a patent in 1997 on
abacavir sulphate (salt form) in developing countries, with the intention of
obtaining a patent monopoly until 2017. Where the patent was granted this
has blocked access to affordable generic forms of abacavir in many
developing countries.

*What Novartis says: “Glivec has been granted a patent in nearly 40
countries and India should also follow suit”*.

This is a mistaken interpretation of international intellectual property
rules. Although the TRIPS Agreement obliges all members of the World Trade
Organization to grant patents on medicines, nothing obliges developing
countries like India to replicate patent systems of wealthy countries. An
important flexibility in this respect is the right of WTO Member States like
India to define the patentability criteria in accordance with their
particular national priorities. This is precisely what India did when it
amended its Patents Act in 2005. At the time of implementing TRIPS, India
felt that many countries were granting a large number of patents on new uses
and new forms of known medicines, which was becoming a key reason for
creating longer patent barriers and high prices in developing countries. So
along with patent protection for new innovative medicines, Indian lawmakers
introduced a specific provision, section 3(d), in its patent law that
excludes from patentability new uses and new forms of known medicines. The
system India has is not perfect, but it does prevent drug companies from
getting unjustified 20 year monopolies every time they come up with a new
use or a new form of a known medicine.
.

*What Novartis says: “medicines can be made available through access
safeguards in international agreements and, in the case of essential and
life-saving medicines, special pricing arrangements in developing
countries”. *

While this is correct – countries have the legal flexibility to issue
compulsory licences to generic producers on patented drugs where it hinders
access to essential medicines – measures like tiered pricing in our
experience are not the most effective way to make medicines affordable.

Novartis also seems to imply that countries can only act once patents are
granted. However, a lesser known key TRIPS flexibility is the right of a
country to take steps before a patent is granted to ensure that patent
applications on routine and obvious improvements of medicines are not
granted so that they do not disrupt supply of affordable generic medicines
to patients. India has chosen to adopt this safeguard with the introduction
of Section 3(d) in its patent law, while allowing patents to be granted on
new medicines from 2005.

*Notes for the editor: *
The basic molecule imatinib was first patented (US 5521184) in 1993. India
signed the WTO TRIPS agreement in 1995 and opened up filing of product
patent applications in India. In 1998, Novartis filed an application
1602/MAS/1998 on the mesylate salt of Imatinib. This case relates to the
1998 application.

Financial Times: Novartis executive to join Gates foundation

Posted in Health Rights, PharmFree by reshmagar on September 14, 2011

This makes me slightly uncomfortable…

September 13, 2011 9:03 pm

Novartis executive to join Gates foundation

By Andrew Jack in London

A top executive at Novartis is to join the Bill & Melinda Gates Foundation, cementing strong co-operation between leading pharmaceuticals companies and the world’s largest philanthropic organisation.

Trevor Mundel, 51, who heads of global development at the Swiss-based drug manufacturer, will in December take over as head of global health at the Seattle-based Gates Foundation, responsible for its $1.5bn annual budget, funding the development of new drugs, vaccines and diagnostics.

The decision is likely to herald fresh support for the drug companies’ commitment to tough intellectual property laws and support further Gates funding of their research, including for Novartis, which is already one of the most active in researching drugs and vaccines for diseases of the developing world.

However, it may antagonise some health advocates who have criticised patents – fiercely defended by drug companies – as providing a barrier to affordable access to medicines for the poor. Novartis has been in the forefront of the clash, as it gears up for a fresh defence of its patents in India for Glivec, a costly cancer drug.

Tido von Schoen-Angerer, director of Medecins sans Frontieres’ essential medicines campaign, said: “It is worrisome to see yet another industry executive in this powerful global health position. While he brings important skills to the Gates Foundation’s product development work, his new role is broader and includes shaping access and other health policies. The foundation will likely alienate many in the global health community, given Novartis’s relentless attacks on the Indian patent system to weaken access to affordable medicines.”

Mr Mundel becomes the second incumbent at the Gates Foundation with a background in the pharmaceuticals sector following Tachi Yamada, the former head of research at GlaxoSmithKline, who stepped down from his role as head of global health in June after five years.

Novartis is one of the drug companies with the most relevant experience for the Gates Foundation. It sells at cost large quantities of Coartem, the pioneering and highly effective malaria treatment, and donates drugs for other illnesses, including leprosy.

Mr Mundel said he had had little direct experience on drugs for the poor, stressing instead his past work on medicines, including Gilenya for multiple sclerosis and Ilaris for a rare inflammatory disease. But he highlighted his work in operating a research centre in Hyderabad in India.

“The Gates Foundation has a somewhat pharmaceutical [industry] problem or opportunity: a large portfolio of projects,” he said. “You have to accept there will be a certain attrition, find a way to focus your resources and [impose] data-driven milestones.”

AMSA Response to USTR Proposal for Trans-Pacific Partnership Agreement

Posted in Health Rights, PharmFree by reshmagar on September 14, 2011

On Tuesday, the US Trade Representative Office released a white paper with a proposal towards the Trans-Pacific Partnership Agreement. Document is attached below:

White Paper

Highlights and summary:

As part of this initiative, the Office of the United States Trade Representative (USTR) has
presented a variety of trade proposals to TPP partners that are aimed at promoting access to
medicines in TPP partner markets. These proposals are the product of a new strategic initiative,
Trade Enhancing Access to Medicines (TEAM), which is designed to deploy the tools of trade
policy to promote trade in, and reduce obstacles to, access to both innovative and generic
medicines, while supporting the innovation and intellectual property protection that is vital to
developing new medicines and achieving other medical breakthroughs.

The TEAM initiative reflects fresh thinking about trade and access to medicines. It is about
more than allowing access to medicines. It is about working with trading partners to develop
strong and common standards to help drive access – propelling the TPP countries to the front of
the line for important innovative medicines and for generic competition, while promoting U.S.
jobs and exports.

The paper goes on to list a set of goals the United States along with the countries under the TPP would address. Great goals, but not really a clear sense of how the goals would be achieved.

Knowledge Ecology International commented:
One has to read between the lines, and guess what the White House is trying to say (or avoid saying plainly). It appears as though USTR will demand TPPA partners agree to several years of exclusive rights in regulatory test data for new medicines, including biologic drugs. What we don’t know is how many years, when the clock starts to run, or how iron clad the protection is expected to be.

The Wall Street Journal published an article about this as well with an excellent comment from Peter Maybarduk, Public Citizen (+1.202 588 7755, +1. 202 390 5375, pmaybarduk@citizen.org
It is insulting that USTR has released this paper on ‘access to medicines’ on the same day that it has tabled its most controversial and access-restricting provisions at the Trans-Pacific FTA negotiations — and then failed entirely to address those provisions, or the other access-restricting elements of its aggressive intellectual property proposal, in this paper. The Obama administration is heading rapidly in the wrong direction, at the expense of global public health. This paper is primarily window dressing for USTR’s pro-Big Pharma, anti-access to medicines status quo.

Another set of comments I quite enjoyed:

Sean Flynn, American University
The statement of the administration today continues its practice of actively thwarting the release of meaningful information about its positions in closed door international law making. The statement says little about what the administration’s actual trade policy on medicines issues is or what justifies it.
It does not explain any of the positions it has taken in the leaked intellectual property proposal;
It does not explain what its position is in the bracketed text on data exclusivity, patent term extensions or patent-pharmaceutical linkage;
It does not answer whether it has abandoned the May 10th agreement between the Bush administration and Congress safeguarding some TRIPS flexibilities in developing countries;
It does not include any evidence supporting how its policy positions promote access to medicines.
Thanks to leaked proposals, we know what the administration’s actual position is. This administration has endorsed a set of policy proposals in its trade negotiations with developing countries that is much worse for access to medicine concerns than those of any other past administration.
The administration is proposing to:
Grant patent rights on substances that are already discovered,
Increase in-transit seizures on medicines,
Extend monopoly rights through data protection that operate independent of patent rights,
Get rid of the so-called “May 10th” deal between the Bush Administration and Congress protecting key access to medicines flexibilities in developing countries,
Add a first ever restriction on the operation of pharmaceutical reimbursement programs as a cost saving mechanism in developing countries.
Calling this an “access to medicine” policy is Orwellian.

AMSA also released a response as well:
Hon.Ron_Kirk_Letter_091311

The American Medical Students Association (AMSA) appreciates the opportunity to offer comments on the proposed Trans Pacific Partnership Agreement (TPPA). As the nation’s oldest and largest independent organization for physicians-in-training representing more than 35,000 members, AMSA supports global health equity through international agreements that secure patients’ rights to life-saving medications in resource-poor settings and encourage investment in public health as outlined in the Doha Declaration.

AMSA strongly urges a revision of the proposed TPPA to ensure access to essential, affordable medicines for patients living in TPPA negotiating nations including the United States. It is critical countries be permitted to engage in parallel importation to ensure citizens’ access to inexpensive medications. Therefore, we recommend that the TPPA refrain from granting copyright holders the right to prohibit importation of their works. Consistent with President Obama’s 2012 budget proposal request, AMSA strongly urges that the term for data protection be limited to 7 years for biologic products. Similarly, pharmaceutical companies should not be eligible for new 20-year patents based on minor modifications to existing products that do not meaningfully benefit patients. Such provisions would allow for timely access to generic medications for suffering patients that could save lives.

When will governments and even pharmaceutical companies realize that their responsibilities should be for their constituents/clients rather than profits?

Pharm Stuff. In ze news.

Posted in Human Rights, PharmFree by reshmagar on July 26, 2011

Read this:

The Bin Laden vaccine: Yes, vaccinations are a CIA plot | The Economist.

Then, read this:

KENYA: People Dying Because of Lack of Anaesthetics

And this:

Companies Shut Down HIV Drug Discount Programmes In Middle-Income Countries, Where Prices Can Be Over Ten Times Higher

Finally, read this:

Pfizer Breaks Psychological Need To Always Seek FDA’s Approval
(Thanks Alissa!)

And because the above stuff is mostly depressing, you should listen to this to cheer you up. It’s cheering me up from studying for my shelf! YAY!

http://8tracks.com/mixes/283103/player_v3

The State of Pharmaceuticals (in pictures!)

Posted in Medical School (General), PharmFree by reshmagar on June 19, 2011

Last week, I was sent this awesome infographic via AMSA PharmFree regarding the incentives that doctors receive from drug companies to prescribe expensive brand-name drugs. I agree with the first statement here that drug costs were not really brought up during the healthcare reform debate. In fact, when Dr. Ezekiel Emanuel came to Brown this past year to talk about how healthcare reform would impact our current system in terms of costs, he glossed over the issue of rising brand-name drug costs and the newly (and sneakily) added evergreening legislation that extend patents for brand-name biologics stalling the entry of cheaper generics into the market. When asked further about this, Dr. Emanuel called the legislation “unfortunate”. Womp womp.

Needless to say, it is true that doctors do have the power to decide what to prescribe to their patients. Working in the psychiatry unit, this was very apparent as there was a Walmart $4 prescription list available throughout. We had one patient who was prescribed brand-name antipsychotics by his PCP. The patient was on Medicare and when he went to the pharmacy, he was told that the medication was not covered and he would have to pay a full price of around $1000. Needless to say, after a month the patient stopped taking his medications, became again psychotic and was admitted. Now he’s on the $4 brand but suffers from some motor side effects. On the list, there’s only one anti-psychotic available so we didn’t really have a choice in the matter and can only hope that his outpatient provider will keep an eye on him to see that these side effects don’t get worse. We wondered why his outpatient provider prescribed him this brand-name medication, especially as it was the most expensive one available. Perhaps, they just didn’t realize he was on Medicare…or perhaps, they were getting some nifty kickbacks from Big Pharma. While there have been laws passed banning pharmaceutical companies from even giving out pads and pens to doctors, we see them in offices all the time. The incentives are still there and unfortunately, there’s little to no regulation of them.

In JAMA this past week, an article was printed stating that while two-thirds of medical students think that drug companies’ educational materials are biased, at least one-third find the information used and half or more would like to receive ADDITIONAL materials from manufacturers. The most shocking finding, I think, is that as medical students advance from their preclinical to clinical years, they are more likely to find the incentives from pharmaceutical companies to be “ethically permissible”. Seriously? Yikes.

Clearly, this shows that these incentives and the biases of doctors as a result are not just a policy issue but also a cultural one. So long as medical schools in their curriculum and practice do not preach or practice to their students the importance of being independent and unbiased in their prescription practices and have a discussion about the impact their decisions will have on drug costs and in turn, the healthcare system, this issue will continue in the eyes of many students to be ethically ambiguous.

Medical Students’ Paradox: Drug Company Materials Biased Yet Helpful, They Say

Rebecca Voelker

Medical students appear to be a paradoxical lot in their views of pharmaceutical companies. A new review shows that at least two-thirds of students surveyed think the companies’ educational materials are biased. But at least one-third say the information is helpful, and half or more would like to receive additional materials from drug makers (Austad KE et al. PLoS Med. 2011;8[5]:e1001037). The findings also show that as medical students advance from preclinical to clinical training, they are more likely to view gifts from pharmaceutical manufacturers as ethically permissible.

The study’s authors say they conducted the review in response to ongoing controversies about the role of pharmaceutical companies in undergraduate medical education. With an understanding of how physicians’ attitudes toward the pharmaceutical industry develop during their training, the researchers say, medical schools would be better equipped to teach students about interactions with pharmaceutical companies and to develop institutional policies on industry contact with students.

The review is based on 32 studies of 9850 students at 76 medical schools in the United States, Canada, Australia, Russia, and several countries in Europe and the Middle East. The data show that by the time medical students reach their clinical training years, up to 90% have received some form of educational materials from pharmaceutical companies. Students who had contact with pharmaceutical sales representatives were more likely than those who did not to have positive perceptions of industry marketing practices. Students exposed to more marketing were less likely to view promotions as inappropriate or an attempt to influence prescribing patterns.

“Interventions that decrease students’ contact with industry and eliminate gifts may have a positive effect on building the ‘healthy skepticism’ that evidence-based medical practice requires,” the authors wrote.