[PAA-Discuss] Fwd: [wildestcolts] The New Scientist - When big pharma breaks the law, prosecute the CEO
rebelljb at aol.com
rebelljb at aol.com
Tue Oct 19 18:40:59 EDT 2010
-----Original Message-----
From: Jim Moore <mofunnow at swbell.net>
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Sent: Tue, Oct 19, 2010 5:24 pm
Subject: [wildestcolts] The New Scientist - When big pharma breaks the
law, prosecute the CEO
http://www.newscientist.com/article/mg20827826.900-when-big-pharma-breaks-the-law-prosecute-the-ceo.html
When big pharma breaks the law, prosecute the CEO
19 October 2010 by Paul Thacker
Magazine issue 2782.
Patient safety will remain at risk until
big pharma's top executives are brought to book for their
companies' actions, says Paul Thacker THERE have been
so many stories about pharmaceutical companies promoting the
misuse or abuse of their drugs that the names seem to merge
- Zyprexa, Seroquel, Paxil and more. The latest
case concerns GlaxoSmithKline's Avandia (rosiglitazone), an
anti-diabetes drug linked to heart attacks. Last month, the
European Medicines Agency recommended its suspension from
the market, while the US Food and Drug Administration made
it all but impossible for doctors to write prescriptions for
the drug. With sales worth over $3 billion in 2006,
Avandia was the world's best-selling diabetes drug until May
2007, when The New England Journal of Medicine published a
study linking it to heart attacks. Reporters circled, and
the finance committee of the US Senate investigated, forcing
GSK to hand over internal documents. As the main investigator
into Avandia for the Senate committee for the past three
years, I looked closely at the documents. I was appalled.
From 2000, GSK pulled out all the stops to keep the drug on
the market. Not all studies were provided to regulators, and
it intimidated a doctor who criticised the drug. Even though
GSK is in the middle of multibillion-dollar lawsuits brought
by thousands of patients, it still has hundreds of documents
hidden from public view under court seal - a feature of the
US system that leaves documents provided under discovery
accessible only to the parties involved in the litigation.
How can we stop this? One way is to slash what pharma
can spend on encouraging doctors to prescribe their drugs.
Companies spend billions wining and dining doctors. For
instance, Forest Laboratories' 2004 marketing plan for its
antidepressant Lexapro notes it planned to spend $34.7
million to pay doctors to give lectures to their peers, and
$36 million on lunches for doctors to create "an extended
amount of selling time for representatives". In legal
settlements reached with the US government, several
companies have been forced to publish databases listing
monies they provide to doctors. A provision in the Health
Reform Bill passed this year will from 2013 require
companies to disclose payments above $10 made to doctors,
and explain why. This will be available in a searchable
public database. This will help, and may shame doctors into
not taking handouts, but we also need professional societies
to tighten ethical requirements to stop doctors accepting
pharma gifts. A second route is to reform the continuing
medical education (CME) courses doctors must take every
year. Of the $2 billion spent on CME in the US, pharma funds
almost half. Companies claim this has no influence on
prescribing practices, but internal company documents made
public by the Senate finance committee contradict this. For
example, Forest Laboratories' marketing material on Lexapro
discussed how CME courses could be used to push sales of the
drug. Several universities have revised rules on
industry funding. Stanford University in California now
requires companies to pool their money and fund a number of
activities instead of funding individual courses, as is
still allowed in most medical schools. The Memorial
Sloan-Kettering Cancer Center in New York has ended all
commercial support for CME in 2007, without ill effects.
Third, we need to penalise executives when companies are
caught committing illegal acts. Since 2004, pharma has paid
over $7 billion in fines and penalties, but even these
figures barely dent profits. The $2.3 billion fine Pfizer
paid in September 2009 for the way one of its subsidiaries
marketed Bextra, the non-steroidal anti-inflammatory drug,
and three other drugs, was the biggest ever paid by a
corporation in the US. Yet the fine was just 14 per cent of
$16.8 billion revenue from the drugs from 2001 to 2008,
little more than the price of doing business. Only
pursuing executives through the courts will make CEOs think
twice about unethical behaviour. The government has
threatened to bring more criminal charges against executives
for breaking the law, but most are never punished. Take
Tachi Yamada, head of research at GSK when negative studies
on Avandia were being downplayed to keep sales high. He left
in 2006 to become president of the Global Health Program at
the Bill & Melinda Gates Foundation. Using internal GSK
documents, the Senate committee assembled a report, released
in 2007, that cited Yamada as part of GSK's intimidation of
a doctor who spoke up about Avandia's health risks soon
after it came on the market. In 2008, Yamada was awarded an
honorary doctorate from Warwick Medical School in the UK, a
leader in medical education.
Pursuing executives through the
courts will make CEOs think twice about unethical
behaviour
Last, we must reform the legal process itself.
Major problems with drugs usually go public only during
litigation, when company documents become part of the legal
discovery process. That can take years. In February 2009,
for example, a case brought by a whistleblower resulted in
AstraZeneca being forced to release more than 100 documents
on its psychiatric drug Seroquel, out of view for almost
four years. They showed that marketing managers discussed
cherry-picking favourable data from one trial and burying
results of unfavourable trials that linked the drug with
obesity and diabetes. Permanent staff in the Senate want
reforms compelling public disclosure of documents that come
to light during discovery, where they show evidence of a
product's potential to harm public health. All these reforms
should be made as soon as possible. While they may not
completely prevent industry misbehaviour, they will set us
on the right path.
Paul Thacker is an investigator at the Project On
Government Oversight, a non-profit organisation exposing
waste, fraud and abuse in federal government. He was
congressional investigator for the US Senate's finance
committee, where he was Senator Chuck Grassley's lead
investigator on Avandia
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