Vol. 29 September 15, 2010 Big Pharma and $$$

September 15, 2010

“Doc, you say I’m too heavy?

You want me to exercise more and go on a diet?

Hey, I’m an American. Give me a pill!”

This is my short form of the more nuanced statement by Daniel Callahan noting that one secret of pharmaceutical companies’ success is to designate life’s problems as diseases and then aggressively market a treatment (usually a pill) for them. Obesity, ADHD, acne, aging, and “low” testosterone are just some of the examples. (1) One study counted up the number of people designated as “sick”, and therefore could benefit from a particular drug, in all the drug ads and arrived at the fantastic total of 1.5 billion sick people in the U.S, or five times our population. (2) A growing volume of “neuroenhancer” drugs to fight memory loss of dementia (Aricept) or improve your academic performance (Ritalin, Concerta, Adderall, Provigil) is an another example of life’s problems being given disease status. In 2007 more than 1.6 million people in U.S. used prescription stimulants (Ritalin, Adderall, Provigil) for “non-medical” purposes. On some college campuses 25% of students reported using them.  One rationale is that “cognitive enhancement through drugs is just like improving vision by wearing glasses.” (3)

Only the U.S. and New Zealand permit direct-to-consumer advertising by drug companies. In 2009 drug companies spent $4.8 Billion on direct consumer advertising alone. (4) Drug companies spend more on all forms of marketing than they do on research and development of new drugs. (Some say it is 50-50). The FDA has 57 employees to monitor over 75,000 drug advertisements per year, and that does NOT include  the internet with its Facebook banners, widgets, and now Twitter. Online ads are increasingly aimed at teenagers with musical themes and flashy, MTV-like editing; methods that drug companies refer to as “informational tactics”. The FDA did succeed in shutting down “Tupperware parties” for women during which certain IUD’s were promoted as a surer route to “carefree happiness”. Direct-to-consumer advertising works because 1) companies say they are “informing” the patient, 2) no doctor wishes to take time to discuss one of several effective drug options if the patient has already asked for one of them, and 3) “patient-centered care” has become the new Holy Grail of medical care quality.

FDA regulations require that a new drug has to be compared only to a placebo (no drug) in order to be approved. No proof of superiority over existing drugs is required. This has spawned many “me too” drugs which may differ in small biochemical and clinical ways from an existing drug whose patent protection is about to expire. Nexium, the purple pill antacid, is the classic example of this as it differs only slightly in chemical orientation (“racemic” is the chemical term)  from Prilosec that was about to have its patent protection expire. The health care reform law under its section of Comparative Effectiveness Research (CER) will require new drugs to show some advantage over existing ones through direct comparison studies.

In 2004 $73 million was spent by the pharmaceutical industry lobbying at the federal level. Another $49 million was spent on the state level and about $5 million was spent just lobbying a single agency, the FDA. In just the first quarter of 2009 $66 million was spent on lobbying at the federal level. (5) The drug company organization, PhRMA (Pharmaceutical Research an Manufacturers of America), has successfully blocked the importation of drugs from Canada and Medicare’s ability to negotiate drug prices with manufacturers; a sizable cost savings to many state’s Medicaid programs.

If there is any doubt that big money is involved, just take a look at Genzyme. In one week the same newspaper reported that Genzyme was laying off 1,000 workers (10% of its total) to cut costs in order “to stay competitive” AND another drug company, Sanofi-Aventis SA, had offered to buy Genzyme for $18 Billion. Much of Genzymes fortunes have been made on two drugs for two different rare diseases, Fabry and Gaucher diseases. What the prospective buyer sees are three new drugs that Genzyme has “in the pipeline” for other two other uncommon diseases. They may bring in new revenue of $1 Billion per year.(6)  Such drugs for rare diseases are called “orphan drugs” and have their own “special economics.

Next Post: “Fake Pharma and an orphan drug gone wild, Botox.”

References:
1.Taming the Beloved Beast, How Medical Technology Costs are Destroying Our Health Care System, Daniel Callahan,, 2009
2. Critical Condition: How Health Care in America Became Big Business – and Bad Medicine, Bartlett and Steele, 2004
3. Brain Gain: The Underworld of Neuroenhancers, Margaret Talbot, New Yorker Magazine, April 27, 2009
4. Outgunned FDA, Rueters, September 2010
5. Center for Responsive Politics, http://www.opensecrets.org
6. Boston Globe Sept. 11 and 13, 2010

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Vol. 18 April 1, 2010 APRIL FOOL’S ISSUE

April 1, 2010

APRIL FOOLS DAY (according to one theory that ignores the 13th century literature references to “april fools”) was created around 1582 when the Gregorian calendar moved the first day of the New Year from April 1 to January 1. Those who persisted in calling April 1 “New Year’s Day” were often sent phony invitations to  New Year’s parties. Other pranks to fool people, usually performed in the morning, were soon added to the phony party invitations. Someone who pulled a prank after noontime on that day was also called a “fool”.

THE TRADITION CONTINUES.

NIH REPORTS THAT ONLY 20% OF AMERICANS ARE ACTUALLY OBESE.
The NH discovered an error in its formula for calculating Body Mass Index  (BMI), a widely used standard of obesity which is posted on their website. The calculation error results in a grossly overstated BMI which negates decades of provocative research on obesity. The White House spokesperson for Michelle Obama declined comment by saying, “We have other more important health care issues on the front burner right now”. The NIH regrets any inconvenience that this may have caused, reassures researchers that study grant funds will not be reclaimed,  and states, “Hey, we can’t be right about everything.”

LAST SUPPER PORTIONS HAVE INCREASED 69.2% OVER THE LAST MILLENNIUM.
In a related study, and a timely one at that, two researchers studied 52 paintings of the Last Supper and concluded that the size of the main course in the paintings had increased by nearly 70% over the centuries. Plate size increased by 66% and bread size by 23%. The authors of this study published in the International Journal of Obesity just in time for Easter speculate that the increasing sizes reflect the increasing abundance and affordability of food over the years. (Apparently there is nothing new about “Super Size Me”.) (1)

H1N1 (SWINE) FLU PROGRAM A BIGGER STIMULUS THAN THE BANK BAILOUTS
The Government Accounting Office (GAO), the federal government’s premier watchdog agency, reports that the H1N1 (swine flu) epidemic efforts created more of an economic stimulus than the bank bailouts. The amount of money pumped into media outlets by the educational efforts was exceeded only by the amount paid to pharmaceutical companies for manufacturing and distribution of the vaccines, now readily available in excess supply due to underuse. More importantly, much of the trickle down economic benefits occurred in the offices of pediatricians, internists, and family physicians; our lowest income bracket health care providers. When asked by the GAO for comments, the CDC replied, “Hey, we can’t be right about everything.”

VIDEO GAME EXPERIENCE MORE BENEFICIAL THAN HONOR GRADES.
Army recruits with a history of prolonged play on video games have better success records as tank commanders and drone pilots than the valedictorians from the same schools. The study speculates that the better hand-eye coordination and enhanced perception of spatial relationships of the video game players accounts for the large discrepancy in skills between the two groups of students. The study authors speculate that these findings could be generalized to include endoscopic, laparoscopic, angioplastic, and other “minimally invasive”  procedures. “Perhaps it is time we altered our application standards for medical school and post-graduate clinical training.”

VEGETABLES CAN LOWER IQs.
Organic vegetables are suspected of  lowering the IQ in young children by at least 10 points. This result of a study of children in Western Massachusetts, Southern California, Oregon, and other tree-hugging communities surprised the authors who had received funds for the study from the National Association of Vegetable Investors (NAVI). A parallel study in rabbits revealed that carotene (the color in yellow and green vegetables) has a strong affinity for nerve synapse proteins in the brain. The carotene  binds tightly with the nerve protein, slowing the response time, EXCEPT in the occipital lobe which is responsible for vision. (Your grandmother was right after all. Eating carrots can help your eyesight.)

WEARING GALOSHES (OR RUBBERS) IN THE MOVIES DOES NOT HARM YOUR VISION.
This small study revealed no change in vision between children who removed their galoshes while in the movie theater and those who did not. The study authors concluded that “Mothers and grandmothers can’t be right all the time, either”, but admitted that the study result was weakened by its small size since they had trouble finding enough kids who still went to a movie theater to watch movies.

OLIVES IN A MARTINI ARE AS GOOD AS OLIVE OIL IN REDUCING CHOLESTEROL.
“You just have to drink enough of them” say the study’s authors.

PASSAGE OF HEALTH CARE REFORM BILL CAUSES MASSIVE SHIFT OF LOBBYISTS.
Lobbyists for bankers, business groups, hedge funds, insurance firms, Wall Street brokers, and others in the  financial sector are poised to reclaim their historical position as the number one group in expenditures to influence Washington policy now that the health care bill has been passed. The Committee for Truth in Politics, its membership and financing still a secret, has already spent $5 million in advertising opposing proposed financial reforms. The Center for Responsive Politics, which tracks spending by lobbyists, speculates that the financial sector lobbyists want to get back to its spending level of the past decade of $3.9 Billion. (2)

CELL PHONE USAGE MAY INCREASE FERTILITY.
In the midst of the scientific controversy about whether or not the low-level radio frequency (RF) coming from cell phones can cause brain tumors, one study has unexpectedly shown an increase in the birth rate in those women using the cell phone more than an hour a day. The mechanism of enhanced fertility is not known. “We compared the actual time spent on voice calls, texting, twittering, and Facebook and found no fertility differences among them, so we don’t think it is associated with just an increase in social intercourse. Likewise, we found no differences between heavy daytime users and heavy nighttime users.” Dr. Siegal Sadetski, a researcher at Israel’s Gertner Institute, stated, “Scientifically speaking, we don’t have proof yet, but as a public health concern, I’m saying we definitely should adopt precautions.” (3)

References:

1. Believe or not, this fun fact is actually true. Wansink and Wansink from Cornell and VWI are the authors. Look it up!
2. Actually some of these names and amounts are true. Check out Center for Responsive Politics website.
3. This quote is true too, but is wildly out of context. 


Volume 3 August 1, 2009 Health Care Lobbyists, Things That Can Threaten Life or Limb

August 1, 2009

Amount spent nationally in 2008 for all healthcare lobbying: $484 million    Amount per day: $1.3 million                                                                          Amount per each congressman and senator per day: $2,600

Number of health care lobbyists in 2008 and increase since 1998:  3,627 / x2

Number of health care organization in the top ten spenders for Massachusetts lobbyists: 5  Which?: MHA, BC/BS, SEIU 1199, Mass Assoc. of Health Plans, Partners Health Care

Per cent of total health care lobbying money attributed to pharmaceutical interests:  > 50

Amount spent by pharmaceutical companies for lobbying in just the first quarter of 2009: $66 million

Per cent increase that is over last year’s amount: +25

Rank of pharmaceutical industry spending on lobbyists of 121 industries monitored since 1998: 1

Number of years new drug patents are “exclusive” which prohibits generic manufacture: 12

Amount contributed this year by Amgen to the Edward M. Kennedy Institute for the United States

Senate at the University of Massachusetts: $1 million

Rank of health professionals lobbying and spending level compared to pharmaceutical: 12 and 1/2

Top five health professional organizations making political contributions in 2008 and amount spent:

Am Med Assoc./ $20.1 million; Am Coll. of Radiology/ $3.4 million; Am. Acad. of Family Practice/

$3.1 million; Am. Assoc. of Orthopedic Surg./ $1.7 million; Am Coll. of ER Physicians/ $1.6 million

Amount of money paid for “No.9” electronic cigarettes in the past two years: $100 million

No. 9 is an E-cigarette that dispenses propylene glycol and liquid nicotine and the plastic tip

glows when you inhale. It dispenses 1/5 as much nicotine and costs about one-half as much as a

real cigarette. One scientist has stated, “There is simply no evidence at this time that electronic

cigarette use poses any significant risk to non-smokers (emphasis added).”

Per cent of Massachusetts registered drivers over 75 and per cent of all auto accidents involving a

driver over 75 respectively: 7 / 3.6

Per cent change since 2004 of Massachusetts accidents involving over 75 year old drivers: -18

This is heartening to those of us who have noticed the recent spurt of stories about the

over 75 year old drivers who have confused the accelerator pedal with the brake pedal.

Ratio of fatalities in accidents at intersections for over 75 and those aged 26 to 64 yrs.:  2:1

Factor by which a driver using a cell phone is more apt to cause an accident: 4x

Chance of reducing that increased risk of an accident by use of a hands-free cell phone: 0

Per cent alcohol level in drivers having the same risk of an accident as a cell phone user: .08

Per cent of 50 states that define drunk driving as a blood alcohol level of .08 or more: 100

Conclusion: If you meet an over 75 year old on a cell phone at an intersection, get out and walk.

Number of Massachusetts soldiers killed in action between 2002 and 2007:  78

Number of Massachusetts  residents dying of a drug overdose in the same period:  3,265

Increased chance of having a blood clot develop in your leg during a long sedentary trip: x3

Per cent increase in risk for each two hour interval of travel: 18 (26% for air travel)

Absolute risk of developing a blood clot during an airplane trip: 1 in 4,600 flights


Quotable Quote

“Confidence is what you have before you understand the problem. Woody Allen

Seton Hall University Law School; http://www.healthreformwatch.com/2009/06/27/

Center for Responsive Politics, http://www.opensecrets.org

Boston Globe July 18, 2009,   Mass Secretary of State’s office statistics

Boston Globe, Biotech Firms Push Hard to Protect Profits, July 21, 2009, p.A1

Boston Globe, July 21, 2009, p. G22, Alex Beam

Boston Globe, July 19, 2009, p. B1, David Abel; Mass RMV; US Government Accounting

Office;Insurance Institute for Highway Safety

Boston Globe, July 19, 2009, p. A9, Matt Richtel

Massachusetts Oxycontin and Heroin Commission

Annals of Internal Medicine, Vol. 151: Issue 3, 2009, D. Chandra, et al.


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