On April 1st, 60 Minutes did a special on doctors taking money from drug
companies to test risky drugs on people. Taking huge kick backs many
doctors found working for drug companies much more lucrative than accepting
payments from insurance companies.

When lacking enough patients with specific symptoms, doctors would often
order bacteria and specimens and falsify results in order to assist drug
companies in bringing their products to market.

To see details of this show, including how to order a transcript, go to:
http://www.cbsnews.com/now/section/0,1636,3415-412,00.shtml

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Subject: [medicalerrors-solutions] A washingtonpost.com article from
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Date: Fri, 30 Mar 2001 15:51:35 -0500 (EST)

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Drug Giant's Spin May Obscure Risk


HONG KONG -- When pharmaceutical giant Glaxo Wellcome Inc. came to this
crowded Asian city several years ago to test a new drug for hepatitis B,
researcher Nancy Leung was pleased with the early results. In a short course
of treatment, the drug showed positive effects on many liver patients at her
university hospital.

But over time, she began detecting mutant viruses in the blood of
participants who stayed on the drug longer than a year. She promptly
reported the disturbing development to Glaxo.

"Most virologists," Leung said, "do not want to create a new virus."

Glaxo assured her that the new viruses, though drug-resistant, appeared to
be relatively benign, she said.

Then, in the summer of 1997, a 36-year-old patient, She Yun-Ki, fell
mortally ill while taking the drug. Glaxo listed his cause of death as
peritonitis, but Leung said that was misleading. He had developed mutant
viruses, she said, and his liver failed. The peritonitis was the last in a
cascade of deadl!
y ailments that followed, she said.

The death left her shaken, and she took a more critical view of the rapidly
spreading mutant viruses among patients receiving long-term treatment,
joining a growing number of liver specialists who say the drug should not be
used for more than a year.

But that view is on a collision course with Glaxo's efforts to promote more
and longer use of the drug, lamivudine, which is now sold in 60 countries
and last year accounted for $108 million in sales. Glaxo officials say
long-term treatment is safe and effective for most patients.

Leung said Glaxo has tried to suppress concerns about the drug, attaching
her name to upbeat research reports that she didn't approve and churning out
data that mask the drug's problems. Glaxo's failure to adequately
acknowledge lamivudine's problems has led to a "mood of mistrust and
discontent" among Asian liver specialists, she said.

Fraser Gray, who leads Glaxo's lamivudine development team, said he was not!
aware of any unhappiness among Asian researchers over the company's
interpretation of their data. Glaxo works closely with all outside
researchers to make sure they agree with the company's scientific claims of
success, he said.

Leung sees it differently. "We are too much controlled by them," she said.
"I feel like I've been constantly, positively spun."

The mutant virus controversy illustrates a new global twist in an ongoing
debate in U.S. scientific circles over whether drug companies with massive
research budgets exert too much control over human testing and the
publication of findings in medical journals.

Academic researchers who rely on industry money to stay afloat are being
pressured by drug companies to put a favorable spin on clinical trial
results, said Marcia Angell, former editor in chief of the New England
Journal of Medicine.

Lamivudine is prescribed for chronic hepatitis B, a potentially fatal liver
disease that infects 350 million people around the wo!
rld. In the United States, the virus spreads largely through illegal drug
use and unprotected sex. In Asia, where three-quarters of the hepatitis B
population resides, the disease is primarily passed from mother to baby.
Chronic carriers may live normal lives, but they suffer periodic attacks
that can eventually cause liver failure or cancer.

Glaxo, now GlaxoSmithKline, began worldwide lamivudine testing in the
mid-1990s and is still studying its long-term usefulness. The FDA approved
lamivudine for hepatitis B in 1998, based on one-year results from research
carried out by Leung and others in Asia, Europe and the United States.

Since then, there has been good and bad news on lamivudine. While there is
evidence that long-term treatment produces lasting improvement in some
patients, the mutant virus risk rises dramatically over time -- infecting
one-fourth of study participants after one year of treatment and 67 percent
after four years.

Patients with the mutant viruses h!
ave suffered relapses and several have died. Some have had to forgo liver
transplants, because the risk of complications is higher. On the other hand,
many appear no worse off initially and continue to show improvement on
lamivudine, leading Glaxo to recommend they stay on the drug. The long-term
consequences of the mutant viruses are not yet known.

A recent study by Liaw Yun-San, a leading Taiwan hepatologist, uncovered
more frequent and severe liver attacks in lamivudine patients with the
mutant than Glaxo had been reporting. He said his own and other studies led
him to conclude that the mutant viruses should be avoided until an effective
treatment is developed.

Yet Glaxo has portrayed Liaw's research as an endorsement of lamivudine,
citing the improvement seen in some of his patients after their serious
liver attacks.

"They always want to look on the bright side," Leung said. "It's a milestone
drug. But it's not a perfect milestone. That is where we part ways."

Earl!
y on in her dealings with Glaxo, Leung said, there was a puzzling incident
that set the tone for her relationship with the company.

It occurred in 1998, after Glaxo applied for U.S. marketing approval, when
an FDA inspector conducted a routine spot check of clinical trial records in
Hong Kong. She said Yun-Ki's death was mentioned in a memo that the
inspector wanted to review. But the copy of the document that Glaxo gave the
inspector was missing the reference to the dead patient, according to Leung
and an FDA official. The alteration was discovered after Leung's hospital
provided the inspector with an unaltered version of the document, they said.

It is unclear why the document was altered, since Glaxo had reported the
death to the FDA at the time it happened. A Glaxo spokeswoman said its Hong
Kong staff did it to protect patient privacy, but Leung said the FDA
inspector had free access to patient names.

Subsequent incidents haven't been as ambiguous, she said. The slide!
s Glaxo gave her for an international science meeting presented misleading
information about her findings, she said. Some lamivudine patients had shown
dramatic spikes in liver inflammation. Yet the company's chart showed a
flat, steady line that hovered near normal liver enzyme levels. The company
flattened the spikes by using averages rather than individual readings,
arguing that approach was easier to understand.

Last summer, Leung said she received an e-mail with several study abstracts
that Glaxo had written under her name, without her input, for distribution
at a conference at the National Institutes of Health in Bethesda. Her
reservations about long-term treatment weren't reflected in Glaxo's upbeat
conclusions.

Leung said she tried to correct the written record in her oral presentation,
but the damage had been done, because the abstracts are read and cited
internationally. "It doesn't matter if Nancy creates a fuss at a
presentation, because the whole world reads t!
he abstract," she said.

Glaxo spokeswoman Nancy Jo Pekarek said there may have been a "breakdown in
the process" in the rush to get the abstracts done for the NIH conference.
"This unfortunate incident has not disrupted the good working relationship
we have with her," Pekarek said.

In December, Glaxo sought Leung's signature for this year's updated research
report for the FDA. She read the report and, four days later, fired back a
dozen questions. Later the same day, she said, the company informed her that
it was too late to address her concerns, because the report had already been
"signed off internally" and submitted.

Pekarek confirmed that the company had given the FDA the long-term treatment
data on lamivudine, including the Asian study results.

Other lamivudine researchers described varying degrees of company influence.
Another Hong Kong researcher said Glaxo routinely writes abstracts and
scientific papers under his name, although he usually reviews them first. A!
Taiwan scientist said he has asked Glaxo to remove his name from a paper
that he considered too positive. In the United States, one researcher said
he does his own analyses, while another said the company often writes the
first draft of papers but he revises them.

"Some people work better doing a draft on their own, and some prefer that we
do it," said Gray of Glaxo, who called Leung's experience a "rare
occurrence."

Pekarek said the company doesn't skew research data in its favor. The
company conducts symposia and distributes treatment guidelines addressing
the mutant virus risk, she said. Potential problems are disclosed in all
scientific and marketing materials, she said.

Leung said she gets those materials but disagrees that the risks are
adequately presented. A Glaxo flier last month promoted a four-year regimen
of lamivudine, with favorable statistics superimposed on a Pacific island
scene.

"And only small print on drug resistance," Leung said. "Do we as a medic!
al profession need to dress up in bikinis to counter them?"



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