Transcript Deceit of Big Pharma?

Deceit of Big Pharma?
Lošinjski dani bioetike
Darko Polšek
[email protected]
Literature:
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Marcia Angell. 2004. The Truth About the Drug Companies. How They Deceive Us and What to do
About It.
Marcia Angell. 2004. The Truth About the Drug Companies, New York Review, July 15.
Marcia Angell. 2006. Your Dangerous Drugstore, New York Review, June 8
Marcia Angell. 2005. The Body Hunters, New York Review, October 6.
Jerome Kassirer. 2005. On the Take. How Medicine’s Complicity With Big Business Can Endanger
Your Health
Generic Drug Entry Prior To Patent Expiration. 2002. Federal Trade Commission Study
http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf
David Willman. 2000. How a New Policy Led to Seven Deadly Drugs, LA Times, Dec. 20.
Ben Kage. 2005. The truth about medical journals, and how drug companies exert heavy influence
over published scientific articles, http://www.NewsTarget.com/010315.html
Dani Veracity. 2005. The great direct-to-consumer prescription drug advertising con: how patients
and doctors alike are easily influenced to demand dangerous drugs
Alexis Black. 2006. Silencing public health advocates: Outspoken Vioxx critic loses job after
testimony against Merck in federal trial
Alexis Black. 2006. Fraud in medical research: A frightening, all-too-common trend on the rise
How Big Pharma was made
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Bayh-Dole Act (enabled universities and small
businesses to patent discoveries made by research
sponsored by National Institutes of Health) 1980.
Until then, taxpayer-financed discoveries were in
the public domain, available to anyone.
That means that drug companies no longer have to
rely on their own research for new drugs, and only
few do.
Researchers become part owners of patents and
small companies, or receive stock options in
companies – conflicts of interest
This act transformed the ethos of medical schools
and hospitals. (“Technology transfer”)
How Big Pharma was made
• 1984. Hatch-Waxman Act. In a series of
laws, monopoly rights for brand-name
drugs was extended from 8 years (in
1980) to about 14 years (in 2000)– billions
of dollars surplus in drug sales.
• Two forms of monopoly rights:
– USPTO (Patent and Trademark Office)
– FDA (Food and Drug Administration)
• Shortening of testing period, shortening of
aproval period – more money cashed
• Medicaid is not allowed to negotiate drug
prices
Buying researchers their conflict of interests (Kassirer)
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Researchers and physicians are “on the
take”
Researchers become part owners of
patents and small companies, or receive
stock options in companies – conflicts of
interest
Researchers and physicians do not
disclose financial ties to big companies
Since 1980’s companies sponsor
meetings of physicians in resorts, foreign
countries, cruise ships. Sometimes it is an
excuse to go playing golf, see sights etc.
Sponsorship entitles them to influence the
content of the program
Scientific meetings as a marketing
opportunity
In 1999. revenues for sponsoring
scientific meetings by big pharma was
600 million dollars (Public Citizen)
Buying researchers and physicians
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“More than 40% of life science researchers at
50 universities had accepted gifts,
discretionary funds, trips to meetings…”
(Kassirer, 18)
At SAGES (Gastrointestal surgeons society)
surgeons volontarily disclosed: 60% of senior
surgeons and 40% of junior surgeons had at
least one conflict of interest. The average
number of conflicts per surgeon was
approximately two, and two individuals had
ties to five companies. (Kassirer 19) (# of
conflict = # of ties to Pharma companies).
“Consulting fees” to researchers, physicians,
members of NIH and FDA
Appointment to the speaker’s bureau (of Big
Pharma company) is used as a “payback” for
participation in clinical drug trials.
Doctors are used as marketing promotors
Buying physicians II
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For helping Big Pharma finding appropriate subjects for drug
experimentation
For prescribing experimental drugs
For prescribing drugs for off-label purposes
For ghostwriting (for instance in editorials – blaming competing
drugs etc.)
By giving “free samples” of drugs which may be refunded in
cash by the patient or Medicaid
For helping companies avoid lawsuits
By profiting from a class-action lawsuits
For influencing NIH and FDA decisions
For “shadowing” (marketing representative influencing patient’s
decisions in doctor’s offices)
For tainting information to patients
Buying authors and reviewers in
scientific journals (Kassirer, 22)
• Journal of American Medical Association and New England
Journal of Medicine in 1990’s abandoned peer-review policy
which required an author and a reviewer to disclose financial
conflict of interests. Rationale given: “It is extremely difficult to
find authors who were free of conflicts”.
• “Conflicts were so extensive that medical journals were
unwilling to use valuable space in the paper pages of the
journal to print them. On Web pages authors’ financial
conflicts encompassed three single-spaced typewritten
pages”
Buying political influence
http://www.citizen.org/congress/campaign/special_interest/articles.cfm?ID=6537
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The drug industry spent $262 million on political influence in the 1999-2000 election cycle: $177 million on
lobbying, $65 million on issue ads and $20 million on campaign contributions.
The industry hired 625 different lobbyists last year to buttonhole lawmakers – or more than one lobbyist for
every member of Congress. Unlike data on contributions and campaign ads, this comprehensive information
on lobbying has recently become available (most lobbying details for the second half of 2000 didn’t become
available from Congress until May 2001 and no organization has analyzed the data as thoroughly as Public
Citizen).
The bill for this team of lobbyists in 2000 alone: $92.3 million – a $7.2 million increase over what the industry
spent for lobbying in 1999. Brand name drug companies spent $90.0 million, generic drug companies spent
$2.3 million.
Drug companies took advantage of the revolving door between Congress and other branches of the federal
government and the industry. Of the 625 lobbyists employed in 2000, more than half were either former
members of Congress (21) or others who previously worked in Congress or in other federal government
positions (295).
The drug industry spent more (based on available data) on lobbying and other political persuasion than any
other industry in 1999-2000.
The drug industry lobbyists were well-connected: 33 served as Chief of Staff to members of Congress; 11
others worked for the powerful House Ways and Means Committee, which has jurisdiction over a Medicare
drug bill; eight others worked for the key Senate Judiciary Committee, where drug patent law is crafted.
In addition, six worked for the Bush I administration; five worked for former House Speaker Newt Gingrich
(R-Ga.); four worked for former Senate Judiciary Chairman Orrin Hatch (R-Utah); five worked for current
Senate Health, Education, Labor and Pensions Committee Chairman Edward Kennedy (D-Mass.); four
worked for former Senate Majority Leader Trent Lott (R-Miss.); and three worked for current Senate Finance
Committee Chairman Max Baucus (D-Mont.).
Buying approval (at NIH, FDA and
White House)
• David Willman (LA Times) disclosed major conflicts of interest among the
most prestigious scientists at the NIH. Since 1995 scientists in NIH may
have financial relations with Pharma industry.
• Conflicts of interest at drug advisory committee meetings for the U.S. Food
and Drug Administration (FDA) are common and often of considerable
monetary value, finds a study (JAMA. 2006;295:1921-1928) conducted by
Public Citizen and published in The Journal of the American Medical
Association. The study details financial conflicts of interest between drug
advisory committee members and the companies producing the drugs
they evaluated; it also examines conflicts with competing companies. The
study exposes statistically significant relationship between certain conflicts
and votes in favor of the drug under consideration.
• In 2006. President G. Bush tried to enact a law stripping the legal
liability of Big Pharma for injuries by the drugs approved by the FDA
(so far not successfully)
Marcia Angell: The Truth about the
Drug Companies
• In 2001, about 2,3 million Americans served as
human subjects in experiments and drug tests. (29)
• Contract research organizations routinely offer
doctors large bounties (averaging about $7000 per
patient in 2001). In one trial physicians were paid
$12000 per patient, plus $30000 for the enrollment
of the sixth patient. Risk: it induces doctors to
enroll patients who are not really eligible. (31)
Marcia Angell: The Truth about the
Drug Companies
• In 2001. FDA had only 30 people to review 34000 patent
claims. Now it has 9.000 people to oversee industry =
95.000 businesses (food, drugs, vaccines, blood products,
medical devices) worth more than a trillion dollars.
• Total time from testing to marketing drugs ranged from 610 years. In 2002. it was 16 months and is getting shorter.
Marcia Angell: The Truth about the
Drug Companies
• Big Pharma claims it spends $800 million dollars on each
new drug (some claim $1,7 billion). That is false: By
calculating industry’s own R&D costs divided by # of
drugs – it comes to $175 million after taxes.
• However, R&D costs are tax deductable and R&D costs
include all sorts of marketing gimmics. So, a realistic
figure is $100 million.
• All sorts of promotional activities (including soft-money)
are filed as R&D costs (as to be tax deductable)
Marcia Angell: The Truth about the
Drug Companies (innovation)
• Is the industry really inovative? Between 1998 and 2002, 415 drugs
were approved, 83 per year. Of those 133 were new molecular
entities. Of those 133, only 58 were priority review drugs, i.e. 12
innovative drugs per year.
• In 2001 and 2002, only 7 innovative drugs were approved per year.
“And that’s it – the five-year grand total of innovative drugs from
this mighty industry” (55)
• But the real scandal is the fact that the few innovative drugs that do
come to market nearly always stem from publicly supported
research. (56) At least a third of Big Pharma drugs are acquired
from outside sources, small countries.
• Big drug companies are competing not so much to find new drugs
but for the limited number of drugs to licence.
Marcia Angell: The Truth about the
Drug Companies (generics)
• 77% of registered drugs are me-too drugs or generic ones.
To get approved, they just have to show they are more
effective than placebo. On the basis of placebo-controlled
trials, drugs can be approved that are actually worse than
drugs already on the market. (74)
• People with uncommon diseases are not of much interest
to drug companies because the market is small.
• Once upon a time, drug companies promoted drugs to
treat diseases. Now, they promote diseases to fit their
drugs. (86) Especially interesting is psychiatry.
Marcia Angell: The Truth about the
Drug Companies
• New drugs are patented and FDA approved
solely by
– changing their terms of use
– changing their diagnostic span
– changing their quantities
– changing their coating (???)
Marcia Angell: The Truth about the Drug
Companies (drug effectiveness)
• ALLHAT trial of the treatment of high blood pressure tested: 1.
calcium channel blocker Norvasc (Pfizer) 2. alpha-adrenergic
blocker – Cardura (Pfizer), 3. ACE inhibitor - Zestril (AstraZeneca)
and Prinivil (Merck) 4. generic diuretic (water pill). Diuretic turned
out to as good for lowering blood pressure, and better for preventing
devastating complications like heart disease.!!! ALLHAT study
shows that diuretics are the best choice to treat hypertension,
medically and economically!!! (96)
• Researchers do not control clinical trials anymore; sponsors do.
(100)
Marcia Angell: The Truth about the
Drug Companies (bias and deceit)
• One survey of seventy articles about their safety found that 96% of authors who
were supportive of the drugs had financial ties to the companies that made them,
and only 37% of authors who were critical had such ties. (107)
• Authors of industry-funded studies were more than five times as likely to
recommend the company drug as authors of studies funded by nonprofit
organizations – regardless of actual results.
• Handbook for trials of Big Pharma drugs:
– Enroll only young subjects in trials even if the drugs tested are for use of elderly
people.
– Compare the new drug with an old drug given a too low a dose.
– Administer the old drug incorrectly.
– Design trials that are too brief to be meaningful.
– Present only part of the dana (ignore unfavourable results)
– Suppress negative results
• In antidepressant drug testing, on average placebos were 80% as effective as the
drug tested!!!
Marcia Angell: The Truth about the Drug
Companies (masking bribes by “education”)
• “It is crucial for big pharma to maintain the fiction that these
expenditures ($19 billion promotion + $35 billion “education”) are
for education, not promotion, because by doing so it can evade legal
constraints on its marketing activitis. And it is also good public
relations. (136) If drug companies can convince doctors to prescribe
drugs for off-label uses, sales go up. That is where “education”
comes in. If drug companies pretend they are merely informing
doctors about other potential uses, they can circumvent the law. And
that is what they do.
Consequences:
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No new drugs in pipeline
– Of 78 drugs approved by FDA in 2002, only 17
contain new ingredients, and only 7 are classified by
FDA as improvements over older drugs.
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No fundamental research from the Big Pharma
People are buying drugs from Canada (and
elsewhere – Internet)
“Constant gardener business”
Comment on “Constant Gardener” by Marcia Angell (NYRev
October 6, 2005)
“The story is based on the premise that a pharmaceutical
company would be so threatened by disclosures of its
activities that it would have someone killed. That is what is
fantasy. In fact, many of the practices that so horrified le
Carré's heroine are fairly standard and generally well
known and accepted. They seldom provoke outrage, let
alone murder. A company like KDH would not kill someone
like Tessa even if it were willing to do so; it wouldn't have to.
Her concerns would have seemed isolated and futile, and
the companies would hardly have taken notice of them.”