В Бр Мед Ж опубликован комментарий, приведенный ниже полностью. В нем,
конечно, не открывается ничего принципиально нового, но размеры
поразительны.
Только американское правительство на свиной грипп выделило на лекарства
3 и на вакцины 7 млрд долл. Жилеад, который разработал тамифлю, только
за три летних месяца получил отчислений от продаж 52 млн. А продавец
тамифлю - Рош - за последний квартал 590 млн. И такую прибыль удавалось
получать последние годы за средство от вируса, которого в то время еще не
было (2005 г.).
Правительства напирают на закупки тамифлю, поскольку таким образом
создается иллюзия деятельности.
В Англии тамифлю стал практически безрецептурным, и выдается бесплатно,
если пациент описывает гриппозные симптомы - так делают, чтобы люди не
перегружали своих врачей ненужными явками за рецептом.
На тамифлю патент еще до 2016 г.
В догон заметим, что МЗСР России рекомендует прежде всего арбидол с
кагацелом...
ввв
BMJ 2009;339:b3811
Feature
Pandemic Flu
Flu's unexpected bonus
Andrew Jack, pharmaceuticals correspondent
1 Financial Times, London
Andrew.Jack@ft.com
doi:10.1136/bmj.331.7527.1277
With over 96 countries stockpiling oseltamivir, Andrew Jack assesses who
has benefited from pandemic flu
Former US defence secretary Donald Rumsfeld was talking about weapons of
mass destruction and the war in Iraq when he referred to "unknown
unknowns" in 2002, but he could just as easily have been explaining why
drug companies have been able to make money out of the global flu
pandemic. Within a few months of his comments, a series of events began
to fuel growing international concern about a new pandemic. The mixture
of fear and ignorance over its timing, nature, and severity soon sparked
an unexpected bonanza for the manufacturers.
Since the emergence of swine flu in Mexico this spring finally triggered
the first pandemic in four decades, J P Morgan, the investment bank,
estimates that governments have made fresh orders for antiviral drugs of
$3bn (?1.8bn; {euro}2bn) and that recent or potential sales of vaccines
are $7bn.1 All that despite signs that the virus is proving relatively
mild, with potentially less impact than a standard seasonal flu outbreak.
One beneficiary has been Gilead, a fast growing US biotech business that
initially developed the antiviral medicine oseltamivir (Tamiflu). In the
three months to June this year alone it reported $52m in royalties on
its drug. Another who gained was Rumsfeld, Gilead's former chairman and
continuing shareholder, who stressed that he disqualified himself from
decisions that could have caused conflicts of interest.2
Roche, the Swiss giant that licensed, commercialised, and manufactured
the drug from Gilead, has benefited most of all. In its most recent
financial quarter, it generated SFr609m (?350m; {euro}200m; $590m) in
sales on the drug. For the full calendar year, it expects that it will
contribute SFr2bn to revenues.
Oseltamivir had already become an important product for the company,
generating SFr1.6bn in 2005, long before the pandemic began. In fact,
the drug became the world's first "virtual" blockbuster, earning ten
digit revenues to treat a virus that did not yet exist.3
Such commercial success was far from inevitable. When the drug was
launched to treat seasonal flu in 1999, it---and the slightly older, first
in class sister drug zanamivir (Relenza)---flopped. Zanamivir was judged
not cost effective by the UK's National Institute for Health and
Clinical Excellence, ruling out its use in the National Health Service.
Japan was among the few large countries to prescribe oseltamivir on any
scale. Elsewhere, seasonal flu was widely dismissed as little more
harmful than the common cold, although it kills up to 500 000 people
globally each year. But in 2003, the mood began to change. Severe acute
respiratory syndrome (SARS) reminded people how fast and far lethal new
viruses could spread with plane travel. Then the spread of H5N1,
including to birds across Europe and human deaths in Turkey, switched
attention to flu.
Being seen to act
Broader political factors were also at work. In the US, then President
George Bush was keen to pledge resources after criticism of his
administration over its botched handling of Hurricane Katrina. In
France, President Jacques Chirac sought to ensure no repetition of the
disproportionate deaths of elderly people during summer heat waves.
In the UK, which has amassed stockpiles of oseltamivir to cover a
greater proportion of its total population than almost anywhere in the
world, there was the spectre of foot and mouth disease. Already in 2004,
the government's exercise to assess security threats had identified flu
as a greater risk than terrorism.
Furthermore, in the wake of the trillions of dollars paid out by
government during the global financial bailout in late 2008, even the
hundreds of millions allocated by some richer countries on pandemic
preparations suddenly seemed relatively modest.
Oseltamivir provided only a partial solution to a pandemic, offering a
modest reduction in the length and severity of flu symptoms. But it was
far more effective than the older class of antiviral drugs, now rendered
largely obsolete by resistance. And it was far easier to take than
zanamivir, which patients have to inhale.
And while the lengthy production of a flu vaccine could not even begin
until the specific pandemic strain emerged, oseltamivir allowed
politicians to show that they were doing something.
There was a chance for the first time to treat and even potentially
prevent a flu pandemic. At the least, a containment strategy to slow the
spread of the virus and reduce its intensity would ease pressure on
overworked general practitioners and hospital intensive care units while
buying time for vaccine production.
Roche has traditionally worked closely with public relations advisers to
stoke media interest, adding to political pressure. As its pubic adviser
Edelman wrote at the time of initial US launch of oseltamivir for
seasonal flu in 1999, it worked with the company to create "a hybrid
network of twelve local public relations agencies to take advantage of
flu as a breaking news story and launch Tamiflu in the top 100 local
markets when flu was in the area . . . The Roche local business units
and sales force identified local physicians who were interested in
participating in our media campaign to add the clinical angle to the
Tamiflu story . . . We partnered with consumer and professional
organizations in an effort to educate their members and constituents on
influenza and Tamiflu . . . We leveraged these relationships by
enlisting our third-party partners to serve as spokespeople and increase
awareness of Tamiflu and its benefits."
Earlier this year, research supported by Roche showing the widely varied
levels of stockpiles in different countries put pressure on the laggards
to catch up.4 As a pandemic of conferences got underway, drug stockpiles
were an easy box to tick in efforts to show that governments were doing
something. To date, Roche has provided more than 270 million doses to 96
governments.
Exploiting opportunity
Over time, Roche has expanded the uses of the drug, winning regulatory
approval for its use in children and pregnant women and providing lower
dose and easier to swallow liquid paediatric versions. Today, it is
studying oseltamivir's use in combination with other medicines, over
longer durations, and in intravenous form.
It has offered to reprocess older stocks of the drug. Even a highly
unusual recent extension by regulators of the shelf life from five to
seven years, which postpones any need to replace expired stock, may
perversely tempt some governments to add to their stockpiles, knowing
that they will now last longer.
With the pandemic underway, it was soon clear that using oseltamivir as
a "fire blanket" to prevent localised flu outbreaks escalating into a
global pandemic would not work. Some doctors raised concerns about side
effects of taking the drug. The most recent recommendations from the
World Health Organization are that people who are not considered at high
risk need not be treated.
Yet orders continue to grow. In the UK, oseltamivir has practically
become an over the counter drug, with one distinction: it is handed out
free after callers provide a simple description of their flu symptoms by
telephone, bypassing the need to see a doctor.
Even so, in the UK and elsewhere, concern that limited health system
supplies or distribution problems have spurred many private sector
employers---and international organisations---to buy their own private
prescription stocks directly from Roche.
Oseltamivir's rise has not been without problems. Japanese regulators
suspended its use in teenagers after suggestions of a link with suicidal
feelings. A number of seasonal flu viruses in circulation began to show
resistance to the drug. The enormous gap between demand and supply, and
its relatively high cost for the poor, triggered calls to overturn the
patents and let rival companies make it more cheaply. But Roche defended
its brand, expanding production capacity while donating 11 million
treatments to WHO; offering to license manufacturing to generic rivals;
waiving patent rights in the poorest countries; and providing deeper
discounts and deferred payment terms to others.
Future directions
The peak may soon be over. Today, Roche's former dominance is under
threat. Biota, the Australian biotech company which first developed
zanamivir, and GlaxoSmithKline, which commercialised it, have seen more
modest sales, partly because the drug is more difficult to take. But as
governments have sought to diversify from a single drug, and some
resistance has emerged, they have complemented their oseltamivir
stockpiles with supplies of zanamivir. The drug contributed A$45m (?23m;
{euro}26m; $39m) in the past year to Biota; and ?60m in the second
quarter of this year alone to GlaxoSmithKline---up from just ?3m in the
second quarter last year.
Oseltamivir's patents expire in 2016, and newer experimental antiviral
drugs pose a competitive threat even before then. These include
peramivir, which is being developed by BioCryst with Green Cross
Pharmaceuticals and Shionogi and laninamivir, by Biota and Daiichi Sankyo.
Although antiviral drugs have provided a stop-gap for prevention,
government planners hope that vaccination will provide still greater
reassurance against a returning, second pandemic wave. Vaccine
manufacturers have been much more coy about providing figures on their
pandemic sales, partly because they have yet to produce, test, and
deliver the vaccines. There are still regulatory hurdles over the use of
adjuvants and other antigen sparing techniques.
But more than a dozen companies---including Sanofi-Aventis,
GlaxoSmithKline, Novartis, Baxter, CSL, and AstraZeneca---all stand to
gain and are already receiving substantial funding from governments to
reserve scarce capacity, invest in research, and launch production. Many
are already indulging in a public relations war stressing the relative
advantages of their vaccines.
Despite the sales now being generated by the pandemic, neither the main
flu drugs nor the vaccines have become a primary source of profits for
the large companies. As William Burns, Roche's head of pharmaceuticals,
said in a presentation in early September, Tamiflu was a "hidden
surprise," but even now it is only the fourth bestselling medicine.
Other companies also stress that they have risked substantial sums in
development---$2bn so far for GlaxoSmithKline alone. And the head of
Sanofi-Aventis asserts that although pandemic vaccine orders represent a
"nice one-off," they are not sustainable.5 What the current response is
doing is creating a stronger future range of tools for tackling seasonal
flu.
There is little doubt that several drug companies and their shareholders
have benefited strongly from flu. But they have also contributed to
easing its ill effects. Whether the money has been justified will
ultimately depend on the final toll once the pandemic has passed, and
how far its impact could have been known in advance.
Cite this as: BMJ 2009;339:b3811
doi:10.1136/bmj.331.7527.1277
Competing interests: None declared.
References
1. Jack A. Drug groups to reap swine-flu billions. Financial Times
2009 Jul 20. www.ft.com/cms/s/0/375dde06-7559-11de-9ed5-00144feabdc0.html.
2. Schwartz N. Rumsfeld's growing stake in Tamiflu. CNN Money 2005
Oct 31. http://money.cnn.com/2005/10/31/news/newsmakers/fortune_rumsfeld.
3. Jack A. How Tamiflu became a global blockbuster. Financial Times
2009 Sep 6. www.ft.com/cms/s/0/cd89a424-9aec-11de-a3a1-00144feabdc0.html.
4. Roche. Tamiflu media briefing. 2009. www.roche.com/mb_090907.pdf.
5. Jack A. Sanofi warns of flu vaccine shortage for developing
world. Financial Times 2009 Jul 29.
www.ft.com/cms/s/0/5b2e0bbc-7c3e-11de-a7bf-00144feabdc0.html.
--
Vasiliy V. Vlassov, MD
e-mail: vlassov[a t]cochrane.ru
snail mail: P.O.Box 13 Moscow 109451 Russia
FAX: USA +1-215-2611492; Russia +7(495)6549353