[lou_lou]

BMJ 2002;324:886-891 ( 13 April )

http://www.bmj.com/cgi/content/full/324/7342/886#art

Education and debate
Selling sickness: the pharmaceutical industry and disease mongering

Commentary: Medicalisation of risk factors

Selling sickness: the pharmaceutical industry and disease mongering
Ray Moynihan, journalist a, Iona Heath, general practitioner b, David Henry, professor of clinical pharmacology c.

a Australian Financial Review, GPO Box 506, Sydney, 2201, Australia, b Caversham Group Practice, 4 Peckwater Street, London NW5 2UP, c School of Medical Practice and Population Health, Faculty of Health, University of Newcastle, NSW 2308, Australia

Correspondence to: R Moynihan ray_128@hotmail.


A lot of money can be made from healthy people who believe they are sick. Pharmaceutical companies sponsor diseases and promote them to prescribers and consumers. Ray Moynihan, Iona Heath, and David Henry give examples of "disease mongering" and suggest how to prevent the growth of this practice

There's a lot of money to be made from telling healthy people they're sick. Some forms of medicalising ordinary life may now be better described as disease mongering: widening the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments. 1 2 Pharmaceutical companies are actively involved in sponsoring the definition of diseases and promoting them to both prescribers and consumers. The social construction of illness is being replaced by the corporate construction of disease.

Whereas some aspects of medicalisation are the subject of ongoing debate, the mechanics of corporate backed disease mongering, and its impact on public consciousness, medical practice, human health, and national budgets, have attracted limited critical scrutiny.

Within many disease categories informal alliances have emerged, comprising drug company staff, doctors, and consumer groups. Ostensibly engaged in raising public awareness about underdiagnosed and undertreated problems, these alliances tend to promote a view of their particular condition as widespread, serious, and treatable. Because these "disease awareness" campaigns are commonly linked to companies' marketing strategies, they operate to expand markets for new pharmaceutical products. Alternative approachesemphasising the self limiting or relatively benign natural history of a problem, or the importance of personal coping strategiesare played down or ignored. As the late medical writer Lynn Payer observed, disease mongers "gnaw away at our self-confidence."2

Although some sponsored professionals or consumers may act independently and all concerned may have honourable motives, in many cases the formula is the same: groups and/or campaigns are orchestrated, funded, and facilitated by corporate interests, often via their public relations and marketing infrastructure.


Summary points


--------------------------------------------------------------------------------
Some forms of "medicalisation" may now be better described as "disease mongering"extending the boundaries of treatable illness to expand markets for new products

--------------------------------------------------------------------------------
Alliances of pharmaceutical manufacturers, doctors, and patients groups use the media to frame conditions as being widespread and severe

--------------------------------------------------------------------------------
Disease mongering can include turning ordinary ailments into medical problems, seeing mild symptoms as serious, treating personal problems as medical, seeing risks as diseases, and framing prevalence estimates to maximise potential markets

--------------------------------------------------------------------------------
Corporate funded information about disease should be replaced by independent information



A key strategy of the alliances is to target the news media with stories designed to create fears about the condition or disease and draw attention to the latest treatment. Company sponsored advisory boards supply the "independent experts" for these stories, consumer groups provide the "victims," and public relations companies provide media outlets with the positive spin about the latest "breakthrough" medications.

Inappropriate medicalisation carries the dangers of unnecessary labelling, poor treatment decisions, iatrogenic illness, and economic waste, as well as the opportunity costs that result when resources are diverted away from treating or preventing more serious disease. At a deeper level it may help to feed unhealthy obsessions with health,3 obscure or mystify sociological or political explanations for health problems,4 and focus undue attention on pharmacological, individualised, or privatised solutions.3 More tangibly and immediately, the costs of new drugs targeted at essentially healthy people are threatening the viability of publicly funded universal health insurance systems.5

Recent discussions about medicalisation6 have emphasised the limitations of earlier critiques1 of the disabling impact of a powerful medical establishment. Contemporary writers argue that the lay populace has become more active, better informed about risks and benefits, less trusting of medical authority, and less passively accepting of the expansion of medical jurisdiction into their bodies and lives. Although these views may herald a more mature debate about medicalisation, the erosion of trust in medical opinion reinforces the need for wide public scrutiny of industry's role in these processes.

In this paper we do not aim for a comprehensive classification or definitive description of disease mongering, but rather we draw attention to an important but under-recognised phenomenon. We identify examples, taken from the Australian context but familiar internationally, which loosely represent five examples of disease mongering: the ordinary processes or ailments of life classified as medical problems; mild symptoms portrayed as portents of a serious disease; personal or social problems seen as medical ones; risks conceptualised as diseases; and disease prevalence estimates framed to maximise the size of a medical problem. These groups are not mutually exclusive and some examples overlap.

http://www.bmj.com/cgi/content/full/324/7342/886#art

[lou_lou]

Commentary: Medicalisation of risk factors
Peter C Gøtzsche, director.
http://www.bmj.com/cgi/content/full/324/7342/886#resp1

Nordic Cochrane Centre, Rigshospitalet, 2100 Copenhagen Ø, Denmark

pcg@cochranedk go to original page for email address:

A middle aged man with pneumonia may wonder why the attending doctor is inserting a finger into his rectum. This is a screening testit has nothing to do with the patient's disease. The physician may find a localised prostate cancer, and the patient may subsequently undergo radical prostatectomy, although no evidence from randomised trials shows that this operation is effective. The patient with pneumonia cannot be sure that the prostatectomy will increase his chance of living longer, but his life will probably feel longer, because the operation renders most men impotent.1 This disastrous consequence has received too little attention, but when properly informed, many men will decide not to have a screening test.2

The man's risk factor for prostate cancer was his age. Increased age leads to other unanticipated interventions. In some countries, women are invited for mammography in a letter in which the date and time of the appointment have already been fixed. This puts pressure on these women, who must actively decline the invitation if they don't want to be screened. Sometimes, women are asked to give reasons for not attending appointments, as if it were a civic duty. In leaflets, women get simple messagesthat cancer detected early can be cured, and early cancers can often be treated with breast conserving surgery. The data tell another story: no reliable evidence shows that breast screening saves lives; breast screening leads to more surgery, including more mastectomies; and estimates show that more than a tenth of healthy women who attend a breast screening programme experience considerable psychological distress for many months. 3 4

Senior scientists argue that this debate should not be taking place in public.5 This misguided paternalism makes us wonder why health professionals are so eager to intervene in healthy people's lives and about those people's own perspectives on risks. In Denmark, the most common cause of death from cancer among women is no longer breast cancer but is now lung cancer, which is mainly self inflicted.

It seems that every person aims to balance the rewards of taking risks against perceived hazards.6 This can probably explain why laws on wearing safety belts have not reduced deaths from road crashes. Such deaths now happen to those outside rather than inside the vehicleprobably because drivers who wear safety belts feel safer and drive faster or more carelessly than those who do not.6

Another important consideration is the reliability of studies of risk. Increased risks are often reported in case-control studies, which do not reliably identify moderate increases in risk. A much quoted and carefully done meta-analysis of case-control studies claimed to show a 30% increase in the risk of breast cancer after induced abortion,7 but this was later refuted by a large cohort study.8 Most epidemiologists interviewed by Science said they would not take seriously a single study reporting a new potential cause of cancer unless it increased the risk by at least a factor of three; some even noted that the lower limit of the confidence interval should exceed 3.9 Nevertheless, lay people are influenced by increases in risk of 50-100%, and this leads to much public anxiety and many negative changes in lifestyle. Some people, for example, will follow unappealing diets or quit sports when told that their bone mineral density is low, even though these diets may not affect bone mineral density and inactivity increases the risk of fractures.

Mass intervention on a fragile basis may lead to mass harm. The main outcome of cancer screening trials disease specific mortalityis unreliable and biased in favour of screening. 3 4 10 It therefore seems prudent to show an effect of a screening programme on total mortality in good randomised trials and to inform the public fully about the adverse effects before the programme is implemented. The biggest risk for the population right now may be the uncritical adoption of screening tests for cancerfor example, for cervical, breast, prostate, colon, and lung cancer, 1 3 10 11 despite lack of evidence of an effect on total mortality. Precursors to cancer can be seen in most healthy people above middle age, and the potential for screening to cause harm and lead to a diagnosis of "pseudo-disease" is frightening. Whether risk factors should be turned into diseases also needs careful reflection for other screening testsfor example, detection of mild hypertension or mild hypercholesterolaemia.

Perhaps it is time to rethink what life is all about and remind ourselves that most people are willing to run substantial risks in their ordinary life to preserve their joy and autonomy.

In Out of Africa, Karen Blixen wrote that the European wants to get insured against fate, whereas the African takes it as it comes. She also wrote: "Frei lebt wer sterben kann" [Those who can die live freely].
Footnotes


Competing interest: None declared.


References

1. Stanford JL, Feng Z, Hamilton AS, Gilliland FD, Stephenson RA, Eley JW, et al. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the Prostate Cancer Outcomes Study. JAMA 2000; 283: 354-360[Abstract/Free Full Text].
2. Wolf AM, Nasser JF, Wolf AM, Schorling JB. The impact of informed consent on patient interest in prostate-specific antigen screening. Arch Intern Med 1996; 156: 1333-1336[Abstract].
3. Olsen O, Gøtzsche PC. Systematic review of screening for breast cancer with mammography (http://image.thelancet.com/lancet/extra/fullreport.pdf).
4. Gøtzsche PC. Screening for breast cancer with mammography. Lancet 2001; 358: 2167-2168[ISI][Medline].
5. Horton R. Screening mammographysetting the record straight. Lancet 2002; 359: 441-442[CrossRef].
6. Richens J, Imrie J, Copas A. Condoms and seat belts: the parallels and the lessons. Lancet 2000; 355: 400-403[CrossRef][ISI][Medline].
7. Brind J, Chinchilli VM, Severs WB, Summy Long J. Induced abortion as an independent risk factor for breast cancer: a comprehensive review and meta-analysis. J Epidemiol Community Health 1996; 50: 481-496[Abstract].
8. Melbye M, Wohlfahrt J, Olsen JH, Frisch M, Westergaard T, Helweg Larsen K, et al. Induced abortion and the risk of breast cancer. N Engl J Med 1997; 336: 81-85[Abstract/Free Full Text].
9. Taubes G. Epidemiology faces its limits. Science 1995; 269: 164-169[Free Full Text].
10. Black WC, Haggstrom DA, Welch HG. All-cause mortality in randomized trials of cancer screening. J Natl Cancer Inst 2002; 94: 167-173[Abstract/Free Full Text].
11. Raffle AE, Alden B, Mackenzie EF. Detection rates for abnormal cervical smears: what are we screening for? Lancet 1995; 345: 1469-1473[CrossRef][ISI][Medline].



--------------------------------------------------------------------------------
© BMJ 2002
Related Articles
Waking up from the DREAM of preventing diabetes with drugs
Victor M Montori, William L Isley, and Gordon H Guyatt
BMJ 2007 334: 882-884. [Extract] [Full Text]

Female genital mutilation: whose problem, whose solution?
Ronán M Conroy
BMJ 2006 333: 106-107. [Extract] [Full Text]

Reform of investigation of deaths
Richard Baker and Stephen Cordner
BMJ 2006 333: 107-108. [Extract] [Full Text]

How NICE may be outflanked
R E Ferner and Sarah E McDowell
BMJ 2006 332: 1268-1271. [Full Text]

The pharmaceutical industry and disease mongering
Richard Tiner, Linda Edwards, Adam Jacobs, Philip Sambrook, Judy Stenmark, Jan Karmali, Matthew Anderson, Alison Karasz, Peter Lurie, Sheila McKechnie, Joanna Moncrieff, Phil Thomas, Ray Moynihan, Iona Heath, and David Henry
BMJ 2002 325: 216. [Extract] [Full Text]

Action is needed to stop "disease mongering"
BMJ 2002 324: 0. [Full Text]

Postmodern medicine
BMJ 2002 324: 0. [Full Text]

This article has been cited by other articles:
(Search Google Scholar for Other Citing Articles)

Herndon, M. B., Schwartz, L. M., Woloshin, S., Welch, H. G. (2007). Implications Of Expanding Disease Definitions: The Case Of Osteoporosis. Health Aff (Millwood) 26: 1702-1711 [Abstract] [Full text]
Paccaud, F. (2007). Implausible diseases and public health. Eur J Public Health 17: 410-410 [Full text]
Davies, P (2007). The predictability of research in chronic illness. J. Epidemiol. Community Health 61: 467-467 [Full text]
Khosla, S., Melton, L. J. III (2007). Osteopenia. NEJM 356: 2293-2300 [Full text]
Montori, V. M, Isley, W. L, Guyatt, G. H (2007). Waking up from the DREAM of preventing diabetes with drugs. BMJ 334: 882-884 [Full text]
Conroy, R. M (2006). Female genital mutilation: whose problem, whose solution?. BMJ 333: 106-107 [Full text]
Ferner, R E, McDowell, S. E (2006). How NICE may be outflanked.. BMJ 332: 1268-1271 [Full text]
Busfield, J. (2006). Pills, Power, People: Sociological Understandings of the Pharmaceutical Industry. Sociology 40: 297-314 [Abstract]
Khan, M. M. (2006). Murky waters: the pharmaceutical industry and psychiatrists in developing countries. Psychiatr. Bull. 30: 85-88 [Full text]
Gilbody, S, Wilson, P, Watt, I (2005). Benefits and harms of direct to consumer advertising: a systematic review. Qual Saf Health Care 14: 246-250 [Abstract] [Full text]
Brodkey, A. C. (2005). The Role of the Pharmaceutical Industry in Teaching Psychopharmacology: A Growing Problem. Acad. Psychiatry 29: 222-229 [Abstract] [Full text]

http://www.bmj.com/cgi/content/full/324/7342/886#resp1

[lou_lou]

NewsTarget.com printable article
Originally published June 29 2006

The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity (opinion)
by Mike Adams

June 30, 2006 is a day that will be long remembered as a dark milestone in the history of FDA and its campaign against health consumers. On June 30, an FDA "Final Rule" goes into effect, establishing a regulatory power grab of such scale and scope that it attempts to bypass all laws, the will of Congress and fundamental protections for consumers. This "Final Rule," which may as well be called a "Final Solution" for drug consumers, claims that consumers can no longer sue drug companies for the harm caused by any FDA-approved drug, even if the drug's manufacturer intentionally misled the FDA by hiding or fabricating clinical trial data.
In one blatantly illegal act, the FDA is attempting to pull off the greatest Big Pharma coup of all: The outright elimination of any responsibility whatsoever for the suffering and death caused by deadly pharmaceuticals.

In the preamble of the FDA's new "Final Rule" to take effect on June 30, the agency asserts that FDA approval of prescription drugs -- and their implied safety -- may no longer be second-guessed by consumers or organizations of any kind. The FDA's stamp of approval, the agency claims, is an absolute declaration of safety of all such drugs, for any use whatsoever, including off-label use (the use of drugs on health conditions that were never tested in clinical trials).

But such a position has no basis in law. During a June 6, 2006 hearing, a New Jersey state court judge Carol E. Higbee characterized the FDA's preamble as, "a political statement by the FDA" and explained that the ploy has, "...nothing to do with science. ...It is contrary to the U.S. Supreme Court's decisions. It is contrary to all the law on preemption. ... In addition to being contrary to the law of the land, it is also contrary to the Constitution of the United States."


The FDA is dangerous to America
That this outrageous assertion by the FDA would take place at a time when so many Americans are routinely killed by the harmful side effects of prescription drugs only contributes to the arrogance and absurdity of this rogue agency that has now become the No. 1 threat to the health and safety of the American people. Even a terrorist nuclear attack on a major U.S. city would not equal the number of Americans who have already been killed by the negligent actions of the FDA.
FDA-approved prescription drugs injure 2.2 million and kill approximately 100,000 Americans each year, according to peer-reviewed published studies, and more realistic estimates put the number of deaths at over 200,000 people annually in the United States alone (see Death By Medicine for detailed statistics). Vioxx, according to senior FDA drug safety researcher Dr. David Graham, appears responsible for the deaths of over 60,000 Americans, and further deaths due to beta blockers, antidepressant drugs, statins and other medications continue to mount by the hour.

The resulting FDA body count of American casualties makes the casualties of war look small in comparison. The Vietnam War claimed the lives of approximately 50,000 Americans (plus many more Vietnamese), and a memorial in Washington D.C. honors those who died. But FDA-approved prescription drugs have killed well over a million Americans, yet no memorial will be built, no honors bestowed, and now the FDA would deny the families of those victims their legal right to fight for any sort of compensation.

It's not like these consumers were killed by enemy gunfire in a foreign land; they were killed by American companies, on American soil, with the full permission and approval of an American regulatory agency! The enemy from within is, indeed, far more dangerous than any foreign threat to the lives of American citizens. Not since World War II have so many Americans died from a single, common, preventable cause, and it almost seems that the FDA has declared war on the American people and is using chemical weapons to win that war.

The scourge of dangerous prescription drugs, combined with willful collusion at the FDA, has now created a chemical holocaust on U.S. soil that will continue to claim the lives of mothers, fathers, daughters and sons until the American people demand that justice be served and that the FDA / pharmaceutical industrial complex be dismantled and condemned through some modern-day equivalent of the Nuremberg Trials. How many millions more have to die from this chemical holocaust before this reign of medical terror is brought to an end?


The ramifications of the FDA's Final Rule
The FDA's new "Final Rule" would allow drug companies to operate with impunity, shouldering absolutely no responsibility for the harmful (even fatal) side effects of their prescription drugs, many of which we are now learning were only approved under highly suspicious circumstances that smack of fraud, corruption and outright criminal intent. Consumers harmed or killed by toxic prescription drugs -- even drugs that their manufacturers knew were extremely dangerous -- would have no recourse whatsoever.
If such a rule were to go unchallenged, the degree of profiteering by Big Pharma would be unprecedented. Free to charge monopoly prices thanks to the FDA-enforced domestic drug racket that outlaws international competition, and unburdened by the financial risk of lawsuits from consumers harmed by their drugs, Big Pharma would be emboldened to unleash a dystopian era of unprecedented disease mongering, bribery of doctors, false advertising and the mass drugging of children, adults and seniors alike... with absolutely nothing to hold them in check.

This result may, in fact, have been the intention all along. This "Final Rule" appears to be little more than a thinly-veiled attempt to establish wide-ranging authority where none exists by burying it in the language of a drug labeling rule. A more detailed legal criticism is offered by Karen Barth Menzies, an attorney at Baum Hedlund in Los Angeles:

On Wednesday, Jan.18, 2006, the Food and Drug Administration issued new regulations regarding the labeling of prescription drugs, including regulations aimed at providing doctors and patients with clearer information about the risks associated with prescription drugs. However, in the preamble to these new regulations, the FDA inserted conclusory and legally unsupported statements that tort lawsuits alleging a failure to warn of known or reasonably knowable safety risks are preempted by federal law. This attempted power-grab by the FDA wholly ignores the prerogative of Congress, contradicts both statutory and case law precedent, disregards the parallel but distinct roles played by FDA and tort liability law, fails to provide an avenue through which consumers may be compensated for drug-induced injury, neglects any federal replacement of applicable state policing and enforcement procedures, and shirks constitutionally established principles of federalism which protect the jurisdiction granted to states in matters involving public safety and health. By inserting preemption language into the Final Rule without an official consultation with state and local government groups concerning the preemption language, the FDA also violated Executive Order (E.O.)13132. (When an Executive department or agency proposes to act through adjudication or rule-making to preempt State law, the department or agency shall provide all affected States notice and an opportunity for appropriate participation in the proceedings. Exec. Order No. 13132, [[4(e), 64 Fed.Reg. 43255, 43257 (1999). According to the National Conference of State Legislatures (NCSL), the preemption language inserted into the preamble of the Final Rule is a thinly veiled attempt on the part of FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling. The NCSL called FDA s action an abuse of agency process and a complete disregard for our dual system of government.


The fallout of the FDA's "Final Solution"
The ramifications of this "Final Rule" action by the FDA cannot be overstated. If this rule is allowed to stand, it represents the end of health justice, the end of the power of Congress, and the surrender of absolute power to an agency of such arrogance and evil that it has conducted armed raids on vitamin clinics, organized the raid of a church, and even ordered the destruction of recipe books it didn't want to see published. (Supporting documents are available for all of these statements).
The FDA, through its willful negligence, is indirectly responsible for the deaths of more Americans than all terrorists, murderers and drunk drivers combined. As the deaths continue to mount, and drug companies become even more aggressive with outlandish disease mongering and advertising efforts, the FDA rears up to unleash a new wave of corporate terrorism upon the American people by emboldening drug companies to care even less about the safety of their synthetic chemical products, most of which cause harm by their very nature of being foreign to the human body.

As Menzies explains:

Pharmaceutical industry lobbying efforts and zealot tort reformers have sired a new wave of brazen attempts to shield drug manufacturers from tort liability. The preemption language in the preamble to the Final Rule is but the latest attempt. Preemption has become the argument du jour and politically appointed regulatory officials the mouthpieces. The crafty messages sound of consumer protection, but are just the opposite. Limiting the liability of drug companies will not improve public safety. The FDA's purported position on preemption assumes that the FDA is infallible and that negligent misconduct by pharmaceutical companies should be the sole purview of FDA. Recent regulatory failures demonstrate that FDA is neither infallible nor does it have the capability of policing drug manufacturers negligent misconduct.

Want to see the real FDA at work? Read the story of Rezulin, and you'll be shocked to learn the truth about the real agenda that drives this rogue agency.


The end is near for the Big Pharma / FDA racket
Why would the FDA engage in such an obviously unlawful power grab? Because Big Pharma co-conspirators have realized that lawsuits threaten to bankrupt the drug companies. The products of these companies are so universally harmful, and their ability to hide this truth is slipping away so rapidly, that the financial burden of settling lawsuits (or defending them in court) threatens to crush the entire pharmaceutical empire.
Merck alone is defending itself against literally thousands of lawsuits from just one drug: Vioxx. As the truth emerges about the dangerous side effects from the long-term use of other widely-prescribed drugs, class action lawsuits will reach a momentum that will make the Big Tobacco settlements seem like a friendly game of Friday-night poker.

Truth be told, there is not enough money in the world to pay for all the pain, suffering and death that has already been caused by prescription drugs, and if drug companies are held responsible for even a small fraction of the patients their products have harmed and killed, they will rapidly fall from the most wealthy corporations in the world to the most bankrupt, both financially and morally.

And so the FDA is jumping in with one last, desperate attempt to cast a spell of immunity over all drug companies in order to preempt the coming flood of class action lawsuits. But even this effort will fail, as the truth about the dangers of prescription drugs can no longer be censored. Through a tidal wave of new books, documentaries and health websites, consumers are learning the shocking truth about Big Pharma and the FDA, and the beginning of the end of the age of chemical medicine is already under way.

Reading suggestions: The Truth About the Drug Companies by Marcia Angell, M.D., Psyched Out by Kelly Patricia O'Meara, or Death by Prescription by Ray Strand.

You see, the arrogance and greed of drug companies will ultimately be their downfall. They have pushed too hard, too far, and they have landed themselves in a realm of such obvious scientific fraud and criminal negligence that the backlash is inevitable. The rampant disease mongering, the mass drugging of schoolchildren with amphetamines, the false claims of drug ads, the bribery of doctors, the collusion at the FDA... it's all coming to the surface now, and by the time this house of cards comes tumbling down, the resulting criminal trials against drug company executives and FDA officials will make the Enron trials sound like a high school debate.

It is not only inevitable that drug company executives and FDA senior officials will do prison time for their crimes against humanity, it is important that they be loudly condemned via such punishments for knowingly defrauding, harming and ultimately killing countless Americans in exchange for one thing: Corporate profits.

American medicine is now the shame of the world, and the conduct of senior officials at the FDA is nothing less than criminal. There is now no greater threat to the health and safety of the American people than the U.S. Food and Drug Administration.

"As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent." - Dr. David Graham, senior drug safety researcher at the Food and Drug Administration, and Vioxx whistleblower

Editor's Note: This opinion piece is authored solely by Mike Adams, the Health Ranger. In contrast to what is being misreported at some websites, this opinion piece was not authored by Dr. David Graham. Dr. Graham is only the author of the quotes for which he is clearly attributed here.




All content posted on this site is commentary or opinion and is protected under Free Speech. Truth Publishing LLC takes sole responsibility for all content. Truth Publishing sells no hard products and earns no money from the recommendation of products. Newstarget.com is presented for educational and commentary purposes only and should not be construed as professional advice from any licensed practitioner. Truth Publishing assumes no responsibility for the use or misuse of this material. For the full terms of usage of this material, visit www.NewsTarget.com/terms.shtml

[tonyd92236]

The only FDA item in the January 18, 2006, Federal Register relates to labeling of cosmetics, not prescription drugs.

A "Final Rule" should also include the section of the CFR that is being modified. Do you have that reference?

[olsen]

One Judge's response to this "law":
Judge Criticizes FDA's Preemption Position

The FDA's position was sharply criticized recently by a New Jersey state court judge, the Honorable Carol E. Higbee. During a June 6, 2006 hearing, she called the Final Rule's preamble "a political statement by the FDA." She complained that the FDA's position that lawsuits should be federally preempted and that the FDA should be the final word has "nothing to do with science. ... It is contrary to the U.S. Supreme Court's decisions. It is contrary to all the law on preemption. ... In addition to being contrary to the law of the land, it is also contrary to the Constitution of the United States." She concluded by telling the defendant's in the case: "And I am not going to allow you to use it." Doherty v. Merck & Co., Ind., Docket No. ATL-L-0638-05MT, in Superior Court of New Jersey, Atlantic County Civil Division. (For more information on preemption, see: http://www.baumhedlundlaw.com/Attorn...AFinalRule.pdf

[lou_lou]

dear tony -welcome to the forum, you have a great question -but I can not answer it, I am not a lawyer, just a PD patient of 15 years, that doesn't understand the ethics of the FDA, US Government, BigPharma, the curent
President, etc...
however -thank you!


dear olsen,
that was a great link -however lawyer speak -
it could say one thing and be interpreted many many different ways by lawyers? or judges..
thank you

___________________
however all I can find is the powers that be are corrupt...

here is a quick summize of Dr. Marcia Angell's book ~

The Truth About the Drug Companies

Browsing Options:

During her two decades at The New England Journal of Medicine Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes.

She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book,
Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become-and argues for essential, long-overdue change.

Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers.

Zeroing in on hugely successful drugs like AZT (the first drug to treat HIV/AIDS), Taxol (the best-selling cancer drug in history), and the blockbuster allergy drug Claritin, Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective.

ie: TAXOL is a chemotherapy drug - owned by Bristol Meyers Squibb

[lou_lou]

MotherJones.com

The Truth About Drug Companies

The author calls the pharmaceutical industry a “vast marketing machine” that thrives on monopoly rights and public-sponsored research but produces few innovative drugs.

Peter Meredith
September 07 , 2004

The high price of prescription drugs has put -- and kept -- U.S. pharmaceutical companies in the news recently, but Dr. Marcia Angell argues that problems with the industry run even deeper. In her new book, The Truth About Drug Companies: How They Deceive Us and What to Do About It (reviewed in the current issue of Mother Jones), the former editor of the New England Journal of Medicine contends that the industry has become a marketing machine that produces few innovative drugs and is dependent on monopoly rights and public-sponsored research.

Angell disputes the industry’s reputation as an “engine of innovation,” arguing that the top U.S. drug makers spend 2.5 times as much on marketing and administration as they do on research. At least a third of the drugs marketed by industry leaders were discovered by universities or small biotech companies, writes Angell, but they’re sold to the public at inflated prices. She cites Taxol, the cancer drug discovered by the National Institutes of Health, but sold by Bristol-Myers Squibb for $20,000 a year, reportedly 20 times the manufacturing cost. The company agreed to pay the NIH only 0.5 percent in royalties for the drug.

The majority of the new products the industry puts out, says Angell, are “me-too” drugs, which are almost identical to current treatments but “no better than drugs already on the market to treat the same condition.” Around 75 percent of new drugs approved by the FDA are me-too drugs. They can be less effective than current drugs, but as long as they’re more effective than a placebo, they can get the regulatory green light.

Finally, Angell attacks major pharmaceutical industry -- whose top ten companies make more in profits than the rest of the Fortune 500 combined -- for using “free market” rhetoric while opposing competition at all costs. She discusses Prilosec maker Astra-Zeneca, which filed multiple lawsuits against generic drug makers to prevent them from entering the market when the company’s exclusive marketing rights expired. The company “obtained a patent on the idea of combining Prilosec with antibiotics, then argued that a generic drug would infringe on that patent because doctors might prescribe it with an antibiotic.”

Angell, who is a doctor and a lecturer at Harvard Medical School, wants to see the industry reformed. She recently sat down with MotherJones.com to talk about how to “ensure that we have access to good drugs at reasonable prices and that the reality of this industry is finally brought into line with its rhetoric.”

MotherJones.com: Pharmaceutical companies say higher prices are necessary to pay for heavy R&D investment.

Marcia Angell:These companies are justifying extremely high prices by saying they need this money to cover their high R&D costs, and they’re very innovative, and that we should be willing to spend the money in return for the innovation. In the book, I question those premises. I say that, yes, they spend a lot on R&D, but still they make more in profits, and they spend two to two-and-a-half times as much on what they call “marketing and administration.” If you want to argue that they need the high prices to cover R&D, it would make more sense to argue that they need the high prices even more to cover their marketing costs. I just want to put that in perspective. Also, their profits are enormously high. Until last year, [they were] the number one industry in the U.S. in terms of profits. In 2002, the top 10 American [pharmaceutical] companies in the Fortune 500 made 17 percent of their sales in profits, whereas they spent only 14 percent on R&D. The median for the other Fortune 500 companies was between 3 percent of sales. So, you can’t make an argument that they’re just eking out a living, just managing to cover their R&D costs.

MJ.com: Your numbers for how much companies spend to bring drugs to market are very different from the industry’s. How come?

MA: The industry arrives at that $802 million [per drug] figure by looking at a tiny handful of the most costly drugs. Those are drugs that were developed entirely in-house, and that are new molecular entities. That’s a very tiny handful of the drugs that come to market each year. They’re the most expensive drugs. Second, even for those drugs, they come up with a figure of $403 million per highly selected drug. They then double that to $802 million simply by adding in what they call the “opportunity costs” — what they could have made if they’d spent the same money on investments. Third, the figure is inflated by not including the tax deductions and tax credits. They get very large tax deductions and credits. So the figure is highly inflated. That gets buried in the reporting of it. When you hear the figure, you hear it given with the implication that for any random new drug, that’s what it costs to develop it. And that’s just simply not so.

MJ.com: In your book, you charge that even some of what the industry calls R&D is actually marketing. Can you elaborate on that?

MA: Well, no one knows for sure what goes into the R&D budget, because the companies aren’t telling. It’s been estimated that about a quarter of it is spent on Phase IV clinical trials, many of which are just excuses to pay doctors to prescribe the drug. They don’t yield any real scientific information. But no one knows for sure.

MJ.com: So should the pharmaceutical industry be making its books public?

MA: Yes, because it’s an industry that is so dependent on the public for special favors. This industry, despite its free-market rhetoric, is on welfare big-time. It lives on taxpayer-funded research to a very great extent, and it lives on government-granted monopoly rights in the form of patents and FDA-conferred exclusivity. An industry that is so beholden to the public has some obligation in return. That includes opening their books. We ought to know more about their business. We ought to know whether the claims they make can really be justified.
MJ.com:Why should the industry have to open its books — or be asked to charge less for its products, for that matter — when other industries aren’t held to those standards?

MA: The public is absolutely dependent on this industry for drugs that people need to take for their health and even their lives. So, I think there are some special obligations.

MJ.com: In the past you’ve written that “there can be no better example of something that does not belong in the market [than prescription drugs],” but you don’t address that in the current book. Do you still think so?

MA: I don’t think I’ve ever said that they should come off the market, but there need to be reforms that accomplish several things. [Pharmaceutical companies] have too much influence over the education of physicians in this country. They have too much control over the evaluation of their own products, and that’s a conflict of interest. I think the industry needs to be regulated, but I’ve never suggested taking it out of the market altogether. It’s now a funny mix of free enterprise and welfare. On the one hand, it is free to choose to make whatever drugs it wants to make. If it wants to make one more me-too drug, it’s free to do that instead of making an antibiotic that may really be needed. It’s free to charge whatever the market will bear in this country. And at the same time, it claims all sorts of special favors. It claims that Americans should not be allowed to purchase drugs in any other country. It claims the right to license taxpayer-funded research. It not only claims the right to very long patents, but extends them in all kinds of quite dubious ways. Now, this is hardly free enterprise.

MJ.com: In terms of licensing drugs from publicly-funded institutions, how much do companies generally pay? Is it relative to how much they charge?

MA: I don’t know. I know in the case of Taxol, it was very little. In general, when companies license a drug from universities, it’s not all that much compared with the profits. They’re licensing now from small biotechs as well. The industry likes to portray itself as the engine of innovation, but in fact its major products are me-too drugs—minor variations of drugs already on the market. For example, we have six cholesterol-lowering statins on the market right now; we have five SSRI anti-depressants; we have nine ACE inhibitors to treat high blood pressure. If you look at the top-selling drugs on the market right now, most of them are me-too drugs, and the original of these drugs came on the market back in the ‘80s, or even earlier. The companies have been stringing out variations on the themes ever since. The original drugs were usually based on government university research.

MJ.com: Regarding me-too drugs, can’t one make the argument that there should be as many different variations of a drug as possible on the market? Shouldn’t the market decide?

MA: We have an FDA because what drugs to sell isn’t something for the markets alone to decide. It’s also a technical decision that requires scientific evidence. The companies don’t want to provide that evidence. They don’t test their me-too drugs against other me-too drugs at comparable doses for the same conditions. The companies also make the case that there need to be several me-too drugs on the market because if one doesn’t work, maybe another one will. But until they test that, it’s just an assertion. They don’t test their me-too drugs in people who have not done well with an earlier drug of the same class. They have to do that in order to prove that assertion. I suspect that in most cases, a second drug will not work any better, since me-too drugs are so similar, but no one can know until it’s tested.

MJ.com: Speaking of the FDA, you characterize the agency as one that facilitates new drugs, rather than regulating them. To what degree is the agency controlled by the industry it’s supposed to regulate?

MA: Too much. The FDA now gets “user fees” from drug companies—about a half a million dollars for any drug that the FDA reviews. Those user fees are small for the companies, but it’s a substantial part of the FDA budget. In fact, it’s more than half [the budget for] the Center for Disease Evaluation and Research, which is responsible for approving new drugs. In return, the FDA is supposed to review drugs faster.

MJ.com: So you would propose getting rid of those user fees?

MA: Absolutely. I think that the FDA should be funded adequately by taxpayers, and it should see taxpayers as the “users.” It should not be funded by the industry it’s supposed to be regulating.

MJ.com: One of the changes you propose in this book is that the NIH -- and not drug companies -- be responsible for clinical research. But you propose that drug companies help pay the NIH to do this. Couldn’t this lead to a similar problem?

MA: No, because instead of paying user fees by drug, companies would be levied a very small percentage of their revenues. It wouldn’t be tied to research on any particular drug. This would be only for clinical trials, not the early development stage. The NIH would put out contracts to universities and medical centers to actually design and carry out the clinical trials, but the NIH would have oversight.

MJ.com: FDA commissioner Lester Crawford recently warned against buying drugs from Canada, citing potential terrorist threat if drugs are tampered with. Is there a valid concern there?

MA: There’s no reason to think that drugs that are imported from Canada are any more likely to be unsafe than drugs that one gets right here. In fact, the cases of counterfeiting that I know of have all occurred in this country. So there’s some reason to think that maybe it’s safer to get your drugs from Canada [laughs]. The drugs that an American would purchase from Canada are going to be the drugs that they ordinarily pay much more for here—that is, FDA-approved drugs. They’re not going to be buying just something in a bottle; they’re going to be buying FDA-approved drugs that were shipped to Canada from European and American companies which have manufacturing plants all over the world. We have to remember that drugs are crossing borders all the time. Pfizer, for example, said on its website last year that it had 60 manufacturing plants in 32 countries. That right there constitutes a lot of borders. There’s nothing about the Canadian border that’s going to render these drugs poison. It’s a scare tactic. What the industry does not want people to realize is the great price disparities between the United States and every other advanced country.

MJ.com: In the past, you’ve criticized the U.S. health care system, saying that “if we had set out to design the worst system we could imagine, we couldn’t have imagined one as bad as this.” Do you still believe that?

MA: The market-based pharmaceutical industry is one problem in the larger problem of a market-based health care system. We spend twice as much per person on health care as the average of all the other advanced countries, and that gap is growing. Yet, we get less for our money. We have over 40 million people with no insurance at all. Most of the rest of us are under-insured. The usual indices of health, like life expectancy and infant mortality, are toward the bottom in the U.S. compared with other advanced countries. So, something’s wrong, and it’s the system. A market-based system distributes health care as a commodity according to the ability to pay, instead of as a social service distributed according to need. Yet, there’s an inverse relationship between one’s ability to pay for health care and one’s medical needs. The situation gets crazier when you allow competing, investor-owned insurance companies to insure Americans, because they have learned that the best way to compete is to keep costs down by skimping on health services. We have the only health care system on the world that’s based on dodging sick people. [Insurers] do everything they can to avoid covering people at high risk of getting ill, and when they do get ill, [companies] fight paying for it. They exclude certain expensive conditions as much as possible. They pass those costs back to the patient or another insurer. And that takes a lot of paperwork, and a lot of overhead.

MJ.com: In the book, you mention that every other developed nation regulates prescription drug prices—

MA: Yes, but they have different ways of doing it. If you look at Canada, it’s a very mild form of regulation, really. They have a national board, and when a me-too drug comes on the market, they say it can’t be priced any higher than the highest-priced drug for that condition already on the market. Nor can it be priced any higher than the median in seven advanced countries, and these countries include the U.S. Then they say the prices cannot rise any faster than the inflation rate. So, that’s not too onerous. Drug companies make profits in Canada.

MJ.com: Is that an example of a system you’d like to see in the U.S.?

MA: Yes. Importing drugs from Canada is not a very sensible solution, because Canada can’t possibly supply the U.S., and the drug companies are now retaliating against Canada and squeezing their supplies. So, importation is not a long-term solution. It’s just a symptom of the real problem of price-gouging in this country. We should be looking at the Canadian system, and maybe import that rather than importing the drugs.

MJ.com: Realistically, do you think a system of price controls like that could ever be instituted in the U.S.?

MA: Well, something’s going to have to happen, because there’s no one around any longer who can afford the drug company prices. Not only are individuals having problems, but states are having problems. They feel these prices through the Medicaid system. The federal government is going to find that this fairly open-ended Medicare drug benefit is going to be completely outpaced by the rising prices.

MJ.com: If pharmaceutical manufacturers were forced to lower prices, couldn’t it backfire if they cut back on research as a result, rather than marketing?

MA: Well, they might choose to do that, but they wouldn’t have to. They could cut their marketing instead, or they could cut into their profits. Their R&D very often comes from the NIH or other publicly sponsored research. Most of their R&D expenditures go for clinical testing after the creative work is already done. This is true for the most innovative drugs, as well as for cancer and HIV/AIDS drugs.

MJ.com: You say that there’s “palpable” discontent among seniors and others about drug prices. Do you see this as having an effect on the problems you described in the book?

MA: I think that there are political effects, and I think that’s what you’re seeing right now with the importation issue. Congress has passed a law saying that you can import drugs from Canada, but that the administration must certify that it not add any risks. Both the Clinton and Bush administrations have refused to do that. It’s giving Congress an opportunity to play both sides of the street.

MJ.com: Given that Congress is torn between seniors and the pharmaceutical lobby, do you think change will ever occur?

MA: I think that the public doesn’t seem to be buying the argument that drugs from Canada are dangerous. If it comes down to choosing between the money that drug companies provide and the votes that citizens provide, I think members of Congress are going to go with votes. That’s what I hope will happen.

MJ.com: In the conclusion of the book, you stress that citizens should grill their doctors regarding drugs they’re prescribing. Why do you recommend that type of action most heavily?

MA: The other reforms will take time, but in the meantime, doctors are too willing to provide drugs for very minor conditions. Those drugs are too often the very most expensive, heavily advertised, me-too drugs. I think that patients have to get a little savvier about that. Instead of just grabbing that sample and thinking they’ve gotten something for free, they ought to think about what it means. Nearly every drug has side effects. I do think that we are an overmedicated society.

Peter Meredith is an editorial fellow at Mother Jones



.Progress, the Investigative Fund of Mother Jones, and gifts from generous readers like you.

© 2004 The Foundation for National Progress

[Howardh]

Wow Tena, don't hold back girl, say what you really mean. Reading through all that stuff about the criminal minds operating the FDA and pharmaceauticals, makes Al Capone and his Mafia mates look like the tooth fairy. Even El Queda despots and those that managed the Enron scam, pale into insignificance compared to the outright Government Death Machine that is the FDA. IT is clear from these reports, the FDA is not operating under the rationalization of protection, altruism, the social "good" and higher causes, but as destructive machines of dishonesty, crime and death.

The genocide is not only happening in Darfore but it is happening by stealth in the U.S.

It's Time to clean up Dodge City, send in Wyatt Earp, round em up, re-open Alcatraz and ostracize the lot. GOOD STUFF. Heads will roll on this one.

In the meantime.

GO HARD......SCIENCE

[lou_lou]

hey howard,

I tried to spit it out -hahahaha?
Was I not blunt enough...

take care -dear Aussie man!

[Howardh]

the extraordinary powerful data again, it is easy to conclude why there has been no significant breakthrough in Parkinson medication for forty years. Corrupt quisling business charlatans associated with controlling the giant pharmaceutical industry, combined with the criminal ways of those in decision making positions in the FDA has led too a complete stagnation in innovation, and the probable scrapping of many promising research programs, while dishonest greedy lazy and manipulative snake oil charmers have lined their pockets, along with the pharmaceutical companies they control.

This giant fraud of all frauds is akin to me starting up a business and lobbying my government for exclusive rights, until such time I have recouped all of my initial investment and some, thus ensuring uncompetitive advantages. and the lack of free market initiatives. Oh, and while you're at it could you (government) puleeze subsidize me with some of the loot you take off taxpayers and I'll cut you in on the deal. This is not the competitive free market at work folks, and once these Enron type execs have been convicted and sent to the same exclusive retirement resort as Jeffrey Skilling, then we will see the innovation and business vision of Andy Grove's "cultural revolution" explode into the stratosphere of exponential growth not too dissimilar to Intel. http://clinpharm.blogspot.com/2007/1...rom-intel.html



GO HARD>>>>SCIENCE