Deceit of Big Pharma?

1
Deceit of Big Pharma?
Lošinjski dani bioetike Darko Polšek dpolsek_at_publ
ic.srce.hr
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Literature

• 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
  Medicines 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.NewsTarg
  et.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

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How Big Pharma was made

• 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)

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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

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Buying researchers -their conflict of interests
(Kassirer)

• 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 1980s 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)

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Buying researchers and physicians

• 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 speakers bureau (of Big
  Pharma company) is used as a payback for
  participation in clinical drug trials.
• Doctors are used as marketing promotors

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Buying physicians II

• 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 patients decisions in doctors
  offices)
• For tainting information to patients

8
Buying authors and reviewers in scientific
journals (Kassirer, 22)

• Journal of American Medical Association and New
  England Journal of Medicine in 1990s 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

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Buying political influence http//www.citizen.org
/congress/campaign/special_interest/articles.cfm?I
D6537

• 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 didnt 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.).

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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. 20062951921-1928) 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)

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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)

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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 6-10 years. In 2002. it was 16 months and is
  getting shorter.

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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 industrys own RD costs
  divided by of drugs it comes to 175 million
  after taxes.
• However, RD costs are tax deductable and RD
  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 RD costs (as to be tax
  deductable)

14
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 thats 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.

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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.

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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 (???)

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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)

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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!!!

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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.

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Consequences

• 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.
• No fundamental research from the Big Pharma
• People are buying drugs from Canada (and
  elsewhere Internet)

21
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.