Bad pharma - A Fraud in Clinical Trail Data

Presented By –
Riddhi Mhatre (MP09) 72891119009
Chinmay Thakur (MP06) 72891119006
Introduction

► The topic is based on a book by Ben Goldacre,

published in 2012.
► The book emphasis on repeatedly the harm to
patients resulting from the biased and incomplete
reporting of trials data, and other failures of drug
regulation and marketing.
► There are total six chapter in book , of which first
few chapter explain about missing data and fraud
in clinical trails.
► Final chapter tells about unethical practices in
marketing of drugs.
The main source to identify the
effectiveness of medicine?

Clinical trials:
But as our parents tend to hide the
bad qualities of their son/daughter
over the good qualities
► Clinical Trials are the foundation of modern medicine, but
regulators, doctors and patients often do not get to see the full
picture about how safe and effective drugs and treatments are.
► As Goldacre says, that when companies test their shiny new drug
against other treatments, they don't always play fair.
► The vital comparison may be made against a placebo or against
unusually low or abnormally high doses of the drug – to ensure
suitable conclusions as to efficacy.
► Pharma Industry also does what your
parents does, hides the bad records of
their off-springs.
► As we all know that negative or
unfavorable clinical trials results are
much less likely to be published than
positive findings by big pharma.
But is it safe to have a medicine without
knowing it completely?

► Goldacre emphasizes repeatedly the harm to patients resulting

from the biased and incomplete reporting of trials data, and
other failures of drug regulation and marketing
► The ALL-Trials campaign was initiated by author
► In which 747 organisations have signed the petition.
 Big Pharma
► World’s Largest Pharmaceutical Industries.
► The trillion-dollar pharmaceutical industry.
► Big pharma profits for prescription drugs are
expected to reach $610 billion.

► In a 24 year period , big pharma companies has

paid 373 settlements for marketing fraud. Which
was totaled $34.7 billion.
► The largest health care fraud settlement in U.S
history was GlaxoSmithKline (GSK) Agreed to a
$3 billion.
 Modi Warns Pharma Industry

► Met Zydus Cadilla, Torrent & Wockhardt on 2nd Jan 2020.

► Not to use unethical marketing
► Took action on basis of report submitted by NGO Sathi.
► Application of Voluntary Code

► Indian Pharmaceutical Ministry is drafting laws for

pharmaceutical marketing
► Types of Relation to be maintained with doctors.
Bad Pharma because of Big Pharma
Influencing clinical Trial Results
► Fund the trials.
► Design the trials.
► Handpick trial results.
Putting patients at risk.

As we all know:
► Clinical trials can be expensive.
► Drug company influence a clinical trial by providing the
funds.

For example, new medicines that treat illnesses affecting the

respiratory system are the most expensive trials to run and
 THERAPEUTIC AREA Clinical trails
expense
Respiratory Area $115.3 Million

Cost of clinical Pain and $105.3 Million

trails for different Anesthesia

Oncology $78.6 Million
segments: Ophthalmology $69.4 Million

Cardiovascular $65.2 Million

Endocrine $59.1 Million

Gastrointestinal $56.4 Million

Anti Infectives $54.2 Million

Dermatology $49.3 Million

What Happens When Big Pharma
Influences Trial Results?
► Unreliable data on drugs.
► No proper information for doctors.
► Question on the safety of the medications.
► Miracle curing drug Dangerous and life-
threatening drug
Example:
Antidepressant : Reboxetine
One trial out of seven was published
This one published trial was done with placebo
The rest six trails were showing less effective, and had worse adverse
effects.

Depression rate in India 15%

 Some Examples of Bad pharma

Sr no Drugs Used for Manufactured by

Avandia Used for type 2 diabetes. GlaxoSmithKline 

1. (rosiglitazone)

2. Vioxx Painkiller  Merck

(Rofecoxib)

3. Seroquel Antipsychotic drug AstraZeneca

4. Tamiflu anti-retroviral drug Roche

 Case study of medical devices
❑ INFUSE Bone Graft
► Synthetic Fragment which mimics bone.
► INFUSE Bone Grafts are made by Medtronic.
► Protein (RhBMP-2) and Bovine Collagen as scaffold from cows.
Use:
1.To heal the bone fractures which is not healing on its own.
2. To heal diseased joint.
3.To regenerate the lost bone and growth .
DEGENERATIVE DISC DISEASE
The U.S. Food and Drug Administration (FDA) approved INFUSE
Bone Graft in 2002 for the treatment of degenerative disc disease
in the lumbar region, or the spine in the lower area of the back
 COMPLICATIONS:
► Such as allergic reactions, bone fractures, abnormal bone formation
and growth, tissue damage, infections, pain,, paralysis or
neurological problems, spinal cord damage, or nerve damage.
► The bone graft may also fail, break, bend or loosen, which may
require additional surgery.
► Controversial trail data:
► Nearly ten years after the INFUSE Bone Graft came on the market,
information started to come that Medtronic may not have been
completely transparent about the risks posed by
rhBMP-2(protein)used in the graft. 
► It was also uncovered that several researchers involved in early
studies of INFUSE, which did not disclose all the side effects
►  The Spine Journal published this review to warn doctors and patients
about the risks that was 50 times high than reported in studies
sponsored by Medtronic.
Warning:
► the FDA issued a warning in 2008 that INFUSE Bone Grafts should not
 Case study of medical devices
❑ De-Puy Hip Replacement
► De-Puy ASS and De-Puy Pinnacle Implant
► Metal on Metal devices.
FDA approval:
► FDA approval for the ASR and Pinnacle was approved through the fast-
track 510(k) approval process, which means they never had to perform
clinical trials on the devices to prove its safety.
► They only had to prove that the components were similar to other hip
components already on the market.
Complication:
► Bone loss, premature loosening, and early implant failure, metal
contamination in the hip joint and surrounding tissue.
► Implant could also allegedly cause shedding of small shards of cobalt
and chromium into the surrounding hip joint which also lead to
pockets of swelling
 DePuy hip replacement lawsuits:
► By 2007 : 100 report were filed
► By the end of 2008: 300 reports.
► The surgeon who designed the device, Dr. Thomas Schmalzried, admitted
that DePuy had known since 2008 that the ASR cup may have problems.
Events lead to DePuy ASR recall :
► In 2009 FDA send notice for not provided adequate clinical data to
demonstrate the safety of the ASR hip resurfacing system.
► DePuy withdrew the ASR from the Australian market in December 2009
because the Australian National Joint Replacement Registry which
showed that 5.4 percent of all ASR hip implants had to be replaced within
three years or less after the initial surgery.
J&J offers settlement for ASR hip lawsuits:
► J&J paid $2.5 billion as remuneration to settle 8000 claims.
How to achieve clinical trails
transparency:
The theoretical framework is based on the All Trials campaign’s three key solutions:
1. Trial registration. All clinical trials should be registered, with a
full trial protocol, before
the first participant is recruited.
2. Results posting. A summary of results, including information on
the primary and any
secondary outcomes measured and statistical analysis, should be
posted where a trial was
registered within one year of completion of a trial.
3. Trial reports. All trial reports (Clinical Study Reports or their
equivalent in non-commercial settings) should be posted online in
full, with only minimal reactions.
Recommendations by Author

Some of the recommendations he has to improve regulation

includes:
1. Requiring companies to compare new drugs against the
current “standard of care” rather than placebo
2. Raising the evidence bar to demand trials that answer
more relevant questions useful for patients and physicians
3. Dramatically increasing the transparency of drug
evaluation process, so that the evidence supporting
decisions can be evaluated
4. Improving the way we share information on the risks and
benefits of drugs
FDAAA 801 and the Final Rule
► Summarizes the clinical trial registration and results
information submission requirements described in Section
801 of the Food and Drug Administration Amendments Act
of 2007, known as FDAAA 801.
► The Final Rule clarifies and expands the regulatory
requirements and procedures for submitting registration
and results information for certain trials to ClinicalTrials.
gov, in accordance with FDAAA 801.
► The regulation became effective on January 18, 2017,
► Responsible parties have been required to be in compliance
starting April 18, 2017.
Some things to keep in mind before
taking drugs include:

► Big Pharma has been influencing medicine for decades,

but there are a few ways in which people might be able to
protect themselves. 
► Research a Drug or Device
► History of Lawsuits.
► Changing law.
 Links for reference:
1. https://www.forbes.com/sites/arleneweintraub/2016/08/17/why-big-pharma-gets-a-failing-
grade-on-clinical-trial-transparency/#118c19716cbd
2. https://www.quanticate.com/blog/ben-goldacre-clinical-data-transparency-video
3. https://www.bbc.com/news/health-11521873
4. https://thesandersfirm.com/defective-medical-devices/depuy-hip-recall-lawsuit/
5. https://www.recallreport.org/dangerous-drugs-products/infuse-bone-graft/#:~:
text=FDA%20Adverse%20Events&text=For%20the%20INFUSE%20Bone%20Graft,
back%20pain%2C%20and%20breathing%2
Thank
you!