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Getting it to the streets

Drug development flourishes despite medicinal failures, says Laurie Wiegler

PHARMACEUTICAL makers know was simply too busy.

Worldview, practices that getting a drug approved is an

endeavour littered with difficulties
The FDA also declined to comment
on allegations that it may be unduly
Andrew Penman, vice-president of drug and pitfalls. Not only do you have to influenced by the interests of ‘big
development at Southern Research in identify your drug candidate, prove it pharma’. Some critics fear that such
Birmingham, AL, US, points out that the drug works and show it’s safe, you then have interfererence could have allowed drug
approval process in Europe has the advantage to get it past the regulator. For most companies to hide negative test results
that for such things, Europe is considered as pharmaceuticals, approval by the US Food and bribe doctors and scientists on the
“one state.” For example, if a drug is approved and Drug Administration (FDA) is the FDA panel.
in the UK it will also be saleable in Italy. final and most important step in getting For example, in a recent case the
The European Medicines Agency (EMEA) tomorrow’s blockbuster to market. Massachusetts anaesthesiologist Scott
regulates drugs, as it conducts the final But any ideas that once a drug’s Reuben was accused of fabricating
scientific evaluation of applications for launched, pharmaceutical companies can 21 studies that purportedly show the
European marketing authorisation for just concentrate on marketing and rely benefits of painkillers such as Merck’s
medicines. Companies submit what is called a on the money coming in are far from the Vioxx and Pfizer’s Bextra, which have
“single marketing authorisation application“ truth. Recent years have seen a flurry since been withdrawn. Reuben called on
to the EMA; once granted, the European of drug recalls – for Heparin, Fen-Phen, the FDA not to restrict the use of these
Commission makes that authorisation valid Baycol, Ephedra, Vioxx and hundreds drugs, citing his own data as evidence.
in all EU and EEA-EFTA states, with the more – over safety concerns with drugs At the same time, Reuben was being paid
exceptions of Iceland, Liechtenstein and that were previously approved by the as a corporate speaker by Pfizer, and
Norway, which are European Free Trade FDA. the company also supported some of his
Association (EFTA) members. The question is, then: is the FDA research financially.
The EMEA draws on its six scientific approving drugs too hastily? Have efforts Frost & Sullivan research analyst Sylvia
committees, composed of members of all EU to ease the development and approval Miriyam Findlay, says that while she
and European Economic Area-European Free process helped shareholders while risking regards such accusations as “baseless”,
Trade Associations states (EEA-EFTA) as well as patient’s lives? With an arduous review the FDA needs to address the perception
some doctors and other concerned parties – to process that involves a series of pre- that it is doing less than it could. “It’s
conduct its main scientific work: committees clinical and clinical trials that consist high time that the FDA looks into its
for medicinal products for human use, of carefully-monitored phases, first with processes and reduces the approval of
veterinary use, orphan medicines (drugs used unsafe drugs.”
rats and then with humans, the answer
to treat more rare diseases), herbal medicinal
would appear to be no. Yet, that hardly An impartial observer, a corporate
products, paediatrics and for advanced
calms the families of those who’ve lost communications expert who’s followed
loved ones to bad drugs. pharmaceuticals for years – and asked to
In Canada, drugs must be approved by
remain anonymous – pointed out that in
Health Canada, monitored by the country’s rooting out the problem light of current bad press, the FDA may
Minister of Health. Also, in 2004 the SARS Asked to comment for this article, the indeed be trying to control the story.
crisis prompted the formation of a new FDA first said it must be allowed to
government body, the Public Health Agency review quotes and later, that questions still the only game in town
of Canada, which largely functions to control be sent in advance. Ultimately, an However, one would have to look no
disease outbreak. interview was not granted because, a further than disease-stricken Third
spokesperson claimed apologetically, it World countries to find good reasons to

44 tce june 2009 www.tcetoday.com


continue supporting the FDA. After all,

the agency approves hundreds of drugs
there’s a bit of conflict in the whole drug
development process.”
“Even in a country where they may
annually, all of which must be proven Merkatz points out that the not make the same amount of profit
both safe and efficacious. The road pharmaceutical companies have a limited
to approval is a long and bumpy one, time to recoup their investment and to
from drugs as they do in the US, they
though, and the outcome is that most turn a profit, which is their responsibility still will make something and will still
drugs are not approved. if they are a publicly-traded company.
Drugs research has to pass through “So because of patents, the sooner they have exclusivity in the marketplace
three formal phases of human research
before the FDA can put a stamp of
can get their drug approved while it’s
on patent, the longer they will have to
until the generics can come in”
approval on a new treatment. But be able to own the marketplace for that
before they even get to the three particular drug.” Ruth Merkatz, Center for
phases, researchers must be awarded
an investigational new drug application
As Frost & Sullivan’s Findlay says,
though, oftentimes drug approval
Biomedical Research, New York
(IND). This proves that tests on can actually be held up despite best
laboratory animals indicate that it’s safe intentions. “Pharma companies are of these messages. She even draws a
to move forward on humans – or at least facing huge delays for drug approvals link between the Vioxx recalls of 2004
to the best of researchers’ knowledge. from the FDA, which can be attributed and direct marketing. Going forward,
If FDA issues the green light, an IND to various factors [such as] staff “DTC marketing should undergo serious
must pass the following rounds: shortage[s] and delays at the [FDA’s] changes, especially from advertising
• Phase 1 studies are conducted with advisory committee.“ drugs to promoting disease awareness,”
healthy volunteers. FDA literature states she says.
that “the goal here is to determine what
marketing the message
the drug’s most frequent side effects are Yet another conflict is occurring in generic prevalence major
and, often, how the drug is metabolised prime time. Turn on the US TV, and one difference
and excreted. The number of subjects is immediately struck by the multitude While a thorough examination of the
typically ranges from 20 to 80.” of commercials for all manner of drugs. entire drug development industry would
Lipitor, Humira, Cymbalta, Levitra, take several months, a briefer glimpse
• Phase 2 studies begin only if Phase
Treximet and Nexium – pharmaceuticals punctuates some of the similarities
1 doesn’t reveal unacceptable toxicity.
tackling high cholesterol, arthritis, between US drug development and that
“While the emphasis on Phase 1 is on
depression, erectile dysfunction, of the UK, Europe and Canada.
safety, the emphasis in Phase 2 is on
migraines and heartburn – were just A marked difference in the UK and
effectiveness.” This phase is designed to
a few of the drugs advertised within a
prove whether the drug works in humans Canada versus the US, at least, is the
few hours on two separate US television
with a certain disease or condition. prevalence of generic drug use. “The
stations during prime-time one February
Researchers use about 300 subjects in majority of the medicines in the UK
these types of studies. would be generic medicines provided by
According to Merkatz, it’s not an
• Phase 3 studies begin only once generic manufacturers,” says Mike Murray,
accident that Americans may notice
Phase 2 has shown the drug works for manager of technical services with
more commercials. “Back in the mid
the given indication. These studies London-based ABPI. The reason would
to late 90s the FDA changed its ruling
gather more information about safety appear to be fairly straightforward: both
and permitted the advertising of drugs
and effectiveness, studying different nations enjoy free national healthcare,
[on television]. Before it was just in
populations and different dosages and which puts pressure on healthcare
periodicals – in journals and magazines.”
using the drug in combination with professionals to prescribe the cheapest
other drugs. The number of subjects Nowadays the ads are infiltrating
effective treatment.
usually ranges from several hundred to the airwaves – from TV to radio to,
However, a prevalence of generics
about 3000 people. no doubt, the myriad forms of mobile
does not equal free: one in five people in
broadcasting. Even so, she points out:
Andrew Penman, vice president of the UK pay a flat fee of £7.20 ($10.99)
“They [advertisers] have to disclose
drug development for Southern Research, per item for their medicines.
safety risks. All advertisements have to
who has worked on developing medical “The majority of medicines in the UK
devices and other areas of discovery be reviewed very carefully in the US. It’s
a division within the FDA called DDMAC are dispensed free of charge because
throughout the world, points out that there are a number of exempted
unmet medical need is a key driver (Division of Drug Marketing, Advertising
and Communications.)” categories of patients: the elderly, people
for drug development. “If you develop
Of course, it would take psychologists on income benefit/income support,
a drug to cure lupus, for example, or
and sociologists, perhaps, to accurately people suffering from various disease
multiple sclerosis, you would have a
address the issue of whether clever types and categories, and children
license to print money.”
marketing – couples running through a obviously,” says Murray.
conflicts of interest meadow to advertise erectile-dysfunction One should not jump to conclusions,
Yet pharmaceutical companies can spend improving drugs or supermodels popping though, and assume that socialised
millions delivering drugs that we strictly cholesterol-lowering meds – contributes medicine means a socialised
speaking don’t need, while others are to a rise in recalls. pharmaceuticals industry. As Merkatz
approved too hastily. Yet, Findlay isn’t shy in says: “Even in a country where they may
Ruth Merkatz, director of clinical acknowledging the problem, stating not make the same amount of profit as
development and reproductive health that direct-to-consumer (DTC) marketing they do in the US from drugs, they still Laurie Wiegler
with the Population Council at the has an impact on the patient-physician will make something and will still have is a US-based
Center for Biomedical Research in New relationship since patients aren’t fully exclusivity in the marketplace until the freelance
York, says: “There’s no question that able to understand the implications generics can come in.” tce journalist

www.tcetoday.com june 2009 tce 45