Alliance for Human Research Protection (AHRP)
Advancing Honest and Ethical Medical Research
www.ahrp.org
FYI
In their compelling Op Ed article in The New York Times,
Drug Data
Shouldn't Be Secret, Peter Doshi and Tom Jefferson, take their
case advocating for clinical trial data disclosure to the wide
public. They describe how pharmaceutical companies like Roche,
manufacturer of the drug, Tamiflu, get away with generating false
claims about the safety and effectiveness of their products when
published in medical journals whose peer-review process is
supposed to ensure scientific honesty. Pharmaceutical companies do
so, by concealing the data from their trials, which they alone
control--thereby undermining the integrity of the peer-review
process and the credibility of the published reports.
Despite evidence exposing corrupted peer-review process,
company-generated assertions in medical journals about safety and
efficacy of drugs, vaccines, and medical devices, journal reports
are presumed to be science-based. Indeed, those largely
unsubstantiated assertions in journals form the basis for medical
practice guidelines and public health policies which may--and
often have--proven harmful to our health and also to our fiscal
policies.
The authors sought Tamiflu data which Roche promised, but did not
honor. They sought access to data from 10 clinical trials, 8 of
which had not been published a decade after completion,
representing more than 4,000 patients from every continent except
Antarctica.
But, as the authors correctly note, by law, companies are required
to disclose to the FDA all clinical trial data pertaining to drugs
for which they seek a license to market. But the FDA has never
required drug or medical device manufacturers to share their data
with independent researchers or academics. In fact, the FDA
treats the company data as secret and proprietary. In effect, the
FDA collaborates in the concealment of vital drug safety
information.
FDA's assessment of the data submitted by Roche shows that Tamiflu
is of minimal benefit--no more than aspirin. In adults, the label
states, "there was a 1.3 day reduction in the median time to
improvement in influenza-infected subjects receiving TAMIFLU
compared to subjects receiving placebo." In geriatric patients
there was a 1 day reduction, and in children 1.5 days compared to
placebo. The label states that "Tamiflu has not been shown to
prevent serious bacterial infections" (for instance, pneumonia).
As a result of data secrecy, the public interest--both health and
fiscal--is ill served when government agencies, lacking access to
the scientific data, make public health policy decisions based on
the false assertions in medical journal reports because they put
their trust in the integrity of the peer- review process.
So why, did the US government stockpile this drug paying more than
$1.5 billion at taxpayer expense? Because officials of the US
Centers for Disease Control, the Dept. of Health and Human
Services, and the World Health Organization disregarded FDA's
efficacy assessment. They issued pronouncements--without
supporting data--declaring that the drug was effective in reducing
the duration of hospitalizations, reducing serious complications
(such as pneumonia), cutting transmission of the virus. Roche
didn't need sales reps to convince doctors to use their
drug--authoritative public health agencies were Tamiflu's best
emissaries.
Company controlled clinical trial data has been accessible during
legal litigation in the US many years after the drugs have been
marketed and have caused harm. Invariably, the data has
contradicted safety and efficacy assertions in journal reports,
which explains why manufacturers routinely conceal the data.
Although the authors focus on their experience in trying to obtain
Tamiflu data from Roche, they make the case that public trust in
public health policies can only be won if the scientific basis
informing those policies--namely, the data documenting the risks
and benefits--are made public and open to independent analysis.
Human beings who volunteer to serve as research subjects have been
led to believe that their sacrifice--undertaking risk and
discomfort--will serve a humanitarian purpose. If sponsors of
research are not compelled by law to disclose the data from those
trials--the integrity of the research is thrown into doubt. Absent
the humanitarian raison d'etre for enrolling in a clinical trial,
no human being should be put at any--even minimal risk--without
adequate compensation as a laborer and the protection of Workmen's
Compensation insurance.
Vera Sharav
read more:
http://www.ahrp.org/cms/content/view/843/9/
THE NEW YORK
TIMES
Drug Data Shouldn’t Be Secret
April 10, 2012
By PETER DOSHI and TOM JEFFERSON
In the fall of 2009, at the height of fears over
swine flu, our research group
discovered that a majority of clinical trial data for the
anti-
influenza drug
Tamiflu — data that proved,
according to its manufacturer, that the drug reduced the risk
of hospitalization, serious complications and transmission —
were missing, unpublished and inaccessible to the research
community. From what we could tell from the limited clinical
data that had been published in medical journals, the
country’s most widely used and heavily stockpiled influenza
drug appeared
no more
effective than aspirin.
After we published this finding in the British Medical Journal
at the end of that year, Tamiflu’s manufacturer, Roche,
announced that it would release internal reports to back up
its claims that the drug was effective in reducing the
complications of influenza. Roche promised access to data from
10 clinical trials, 8 of which had not been published a decade
after completion, representing more than 4,000 patients from
every continent except Antarctica. Independent verification of
the data seemed imminent. But more than two years later, and
despite repeated requests, we have yet to receive even a
single full trial report. Instead, the manufacturer released
portions of the reports, most likely a very small percentage
of the total pages. (One of us, Tom Jefferson, has been
retained as an expert witness in a lawsuit relating to some of
these issues.)
This is entirely within Roche’s rights. After all, regulators
have never required drug or medical device manufacturers to
share their data with independent researchers or academics.
They are required to show the information only to the
regulators themselves, who treat the data as secret....xxx cut
xxx
http://www.nytimes.com/2012/04/11/opinion/drug-data-shouldnt-be-secret.html
Peter Doshi is a postdoctoral fellow in comparative
effectiveness research at Johns Hopkins University
School of Medicine.
Tom Jefferson is an independent epidemiologist with the
Cochrane Collaboration, an international nonprofit
research organization.
See also, PLos Medicine, 2012:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001201
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