Do you know anybody harmed by Big Pharma?

My best friend has diabetes. In December, he became so ill I feared for his life. He had a yet undiagnosed pneumonia-type sickness which did not respond to antibiotics of the strongest kind. He went through test after test and, thankfully, recovered to a great degree although in the past few weeks he has been complaining because his ankles and feet are swelling. This has never happened to him before.

I turned on the TV last night and I hear that this drug Avandia is being recalled because GlaxoSmithKline noted a greater incidence of fractures of the upper arms, hands and feet in female diabetics taking the drug and another article in the June issue of New England Journal of Medicine tied the use of rosiglitazone/Avandia to a 45% increased risk of heart attack.

I talked to my friend last night and, hearing that medicine was prescribed for diabetics, I asked if he had ever taken Avandia. "Yes", he answered. His doctor prescribed the drug Avandia to the tune of 4 pills a day and he took them for TWO YEARS!!!

He still has some of the medicine. I told him to hold onto it to sue the m*()*()*_&()*(*&*. I am no doctor but I know that swelling the feet and ankles is an indication of congestive heart failure.


My mother, from 1990 to 2000--was prescribed estrogen and progestin pills manufactured by Wyeth under the name Prempro. In 2000 she developed breast cancer. Nobody in my family has ever had breast cancer. She is alive and well today after undergoing partial masectomy, chemo, and other side effects of the drugs taken to counter the estrogen induced breast cancer.

Wyeth is petitioning to sell more than the $2 billion worth of the poison derivative of horse urine as I write this.
http://query.nytimes.com/gst/fullpage.html?sec=health&res=9503E5DA1230F932A25754C0A9649C8B63



Two of the people that I love most in the entire universe have been harmed by Big Pharma. We talk about the dangers of drug companies here but their misdeeds are personal to me. I hope Sicko touches on this important topic--the release of drugs without really knowing what harm they may do to the general public or, even knowing what harm they may cause and releasing them anyway. It is a crime.

I've only had my life saved thanks to big pharma, so I can't help you.

You do it every single time without fail.

I hope you take prescription drugs at every opportunity -- you need to find out the hard way.

I hope you refuse prescription drugs and every opportunity. Then YOU'll find out the hard way.

:rofl:

They are one of the top causes of death in the United States.

Before prescription drugs.

disorders. Nearly 50% of all children result in either miscarriage or a less than healthy child.

http://www.hsph.harvard.edu/press/releases/press11072006.html

and

http://books.nap.edu/catalog.php?record_id=9871

Quoting the disproven "Death by Medicine" article doesn't count.

is open for "debate." I thank you for your comment. I am not here to debate on the topic as some seem to be. It's an open and shut case as far as I am concerned and I am glad that my loved ones escaped with their lives. I only post this as a warning to others.

Your friend was sick. Big pharma invented a medicine that he was taking. Then this questionable study shows up and suddenly there's a big problem with big pharma.

I'm reminded of a Simpsons episode. The townspeople, angry at science, raid a museum. Moe the bartender attacks a mammoth fossil, which collapses and crushes his spine. He then shouts, "Oh God! I'm paralyzed! Well, I'll guess I'll have to wait for medical science to cure me."

according to an article published in JAMA -- the Journal of the American Medical Association.

(see: Lazarou J., Pomerantz, B., Corey, P., Incidence of Asverse Drug Reactions in Hospitalized Patients, A Meta-analysis of Prospective Studeis, JAMA, April 15, 1998, 279(15): 1200-1205).

That article also states that at least 106,000 U.S. citizens die and over 2,000,000 suffer from severe reactions every year from drugs prescribed in hospitals.

The true magnitude of the problem are grossly understaed because people outside of hospitals often die from adverse drug reactions but the causes of death are never determined.

It sounds like pretty serious stuff.

Drugs have side effects and you take calculated risks getting treatment.

There was a time when drugs were tested and were truly safe for human consumption. That time has passed. Today, pharma rushes drugs into the publics' hands despite the serious risks that they are aware of. People should not be used as guinea pigs.

Then that should be a great big warning sign to pass. And when the insert has pages and pages of legal boilerplate language to protect the pharmaceutical company -- PASS.

There are some problems with the drug approval process right now, but overall it's pretty damn good compared to the rest of the world.

Pharmaceutical companies are absolutely greedy, rather soulless corporations whose primary goal is to make money.

That said, their research and drug development has *without question* saved millions of lives and improved the quality of life for millions of others.

Drugs are mostly (unfortunately, often not well enough) tested as well as they can be. It is an unfortunate impossibility to not be able to foresee large-scale population wide side effects ahead of time. For instance, in your example, it would not be possible to create a properly controlled clinical trial to test whether Avandia causes a higher incidence of cardiovascular disease--the only way to determine this is to follow a cohort of patients who take it over an extended period of time and watch to see what sort of outcomes they have.

Drug research is certainly a cost-benefit analysis. On the whole, as a medical professional myself, I'd argue that they have been a net benefit. Do I like them as entities? No. Would I take any sort of favor from any of them? No. Will I prescribe their drugs if in my opinion--with the best evidence based medicine available to me at the time--that it will benefit my patients? Of course.

today are not being tested as they should be before being released to the public. I disagree that it is impossible to foresee serious side effects like those with Avandia. Drugs companies are supposed to run tests in control groups over an extended period for this very reason. The shame is that they now value money more than human life and their cost benefits and risk assessments are increasingly akin to the Ford Pinto school of thought--sell damaged goods, make money and pay the few who die from known risks.

ON EDIT: Are you saying that you would have prescribed Avandia?

that the pharmaceutical companies far too often have their bottom line in mind, I am not sure you know enough about epidemiology or molecular biology to make the claim that it is possible to foresee all side effects of drugs. We simply know too little about the biochemistry of human beings to be able to adequately predict the total effects of drugs, and that's simply the truth. Medicine is, for better or worse, largely an art of trial and error.

All that said, I do wish there were stricter controls on FDA approval of certain drugs.

say that drug companies are supposed to test drugs in control groups for extended periods to monitor effects. IF this is done, long enough, without rushing to market, then the probability is high that serious side effects will surface as I am sure they did with Advantia. Still, they sold the drug with the known side effects to people who trust the physicians who prescribe poisons to them--physicians often bought off by pharmaceutical companies themselves.

You clearly have no idea what you're talking about. Of course all drugs are tested in control groups--there are very strict laws designed for exactly that purpose and having been involved in many clinical drug trials myself, I can assure you that everyone involved takes them extremely seriously. It is literally impossible to run a trial long enough to rule out all possible side effects, even serious ones--this is basic biostatistics. There is a cost benefit analysis involved. With any new drug, a physician knows that there may end up being some previously unknown side effect, but he or she has to decide whether to prescribe it based on its known potential benefits for his or her patients.

Your blanket description of doctors as bought off by drug companies is both wrongheaded and insulting. The vast, vast, majority of physicians are altruistic people who try their very best to make the best medical decisions they can for their patients.

Whether you choose to believe that or not is your business, but as a purported progressive, I'd suggest you try not to be so closed-minded. Nothing in life is nearly as black and white as you seem to want to make it out to be.

While it may be insulting to hear the truth, that many doctors do prescribe inadequately-tested medications to the trusting, unsuspecting and poor without reviewing the side effects and without even scheduling follow up visits to monitor them when there are high risks such as with Advantia--it is the truth. That's not altruistic in my eyes.

which you'd know, if you knew anything about statistics.

I'm sorry your friends got hurt--that's really awful. Try not to let it make you so closed-minded. Realize that your personal opinions about how the medical profession works may not be based on very much, any more than what I would know about what you do. I mean this entirely earnestly.

Anyway, it's about time for me to get back to pocketing some money from pharmaceutical companies and HMOs and drive home in my mercedes to my victorian mansion paid for with blood money. :eyes:

Cheers.

except maybe the military industrial complex. They are similar in important ways.

Let's please mention up front that top FDA officials regularly go to work for Big Pharma, and are rewarded handsomely for decisions made while they "regulating" Pharma's products.

I don't call it BigPharma, but rather the Chem/ Pharm industry, because every pharma company I've researched also manufactures, or has subsidiaries that manufacture, highly toxic chemicals.

Chem/Pharm is extremely powerful -- and regularly destroys the reputations of scientists, doctors and researchers who attempt to bring chemical injury into the forefront of public discussion.

This industry has been extremely aggressive in corrupting science and the medical profession in general, so that at this point it is seen by many as a criminal enterprise.

See a long list of titles below that are a partial listing of the documentation of corruption in this industry -- with tentacles in every area of science, politics and medicine.

The links here are partial because I don't have time to click on each one and post the URL separately (mine are all hyperlinks). The titles of the articles and reports are highly searchable by title and can be found in major medical / science journals, the Wall St. Journal, Alliance for Human Research Protection, The Lancet, and others:


Conflict of Interest: Profits vs Safety Congressional Investigations -- http://www.ahrp.org/ethical/CongInvestigation.php

US Senators Pharmaceutical industry holdings, 2004: http://www.consumerwatchdog.org/resources/SenPharma.pdf


Oct 12: How Did the Vioxx Debacle Happen? USA Today / Lancet -- http://www.ahrp.org/infomail/04/10/12.php

Oct 4: Op Ed: Psychiatry on the Ropes--WP / Evidence-based Psychiatry -- http://www.ahrp.org/infomail/04/10/04.php

Oct 3: BBC PANORAMA TONIGHT - Taken on Trust - 13 years-Medical Deception -- http://www.ahrp.org/infomail/04/10/03.php

Sep 30: GSK Sales Reps told NOT to Divulge Paxil Data / Merck Withdraws Vioxx -- http://www.ahrp.org/infomail/04/09/30.php

Sep 28: SEC Focusing on Drug Makers Disclosure_ Continuing Medical Ed Changes http://www.ahrp.org/infomail/04/09/28.php

Sep 16: Black Box Warnings for Antidepressants - What's Next? http://www.ahrp.org/infomail/04/09/16.php

Sep 16: Tell the Truth About Antidepressants On Drug Labels & in Medical Journals http://www.ahrp.org/infomail/04/09/16a.php

Sep 14: AHRP Press Briefing Re: Antidepressant Drug Risks http://www.ahrp.org/infomail/04/09/12.php

Sep 8: FDA Forced Wyeth to REMOVE Suicide Warning from Effexor Label http://www.ahrp.org/infomail/04/09/08.php

Sep 2: Antipsychotic Drug Use Doubled since 1996 in Tennessee Children - Why? http://www.ahrp.org/infomail/04/09/02.php

Aug 13: Time for a Drug Test Registry_Marcia Angell_Why NIH is Not Up to the Task http://www.ahrp.org/infomail/04/08/13.php

Aug 13: Bradshaw cancels appearance after SSRI-Citizen Press Release Announced Protest http://www.ahrp.org/infomail/04/08/13a.php

Aug 5: Spitzer Expands drug Probe: Johnson & Johnson / New FDA analysis Confirms SSRI Risks to Kids - WSJ http://www.ahrp.org/infomail/04/08/05a.php

Aug 4: FDA Approves Lilly's Cymbalta for Depression Despite Risk of Suicide http://www.ahrp.org/infomail/04/08/04.php

Aug 3: Drug safety Hearings-Sept-Congress/ FDA - Lilly Plans to Disclose Data http://www.ahrp.org/infomail/04/08/03.php

Jul 27: Bill Moyers: the Real Show...Congressional hearing was abruptly cancelled http://www.ahrp.org/infomail/04/07/27a.php

Jul 26: Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits - NYT -- http://www.ahrp.org/infomail/04/07/26.php

Jul 22: Concealed Drug Trial Results Mislead Doctors & Put Children's Lives at Risk - NYT http://www.ahrp.org/infomail/04/07/22.php

Jul 21: Cong Greenwood's version http://www.ahrp.org/infomail/04/07/21a.php

Jul 21: Hearing on Antidepressants Canceled - Washington Post http://www.washingtonpost.com/wp-dyn/articles/A106-2004Jul20.html

Jul 20: Corruption of Cong by Pharma: Greenwood offered job / drops Pharma hearing http://www.ahrp.org/infomail/04/07/20.php

Jul 19: Clinical Trials Controversy Spotlights Flawed System - Psychiatric News http://pn.psychiatryonline.org/cgi/content/short/39/14/1

Jul 14: Statin-Cholesterol Guidelines--Industry influenced? http://www.ahrp.org/infomail/04/07/14.php

Jul 9: FDA Squelches an Article Raising Doubts on Safety Of Device to Repair Artery - WSJ http://www.ahrp.org/infomail/04/07/09.php

Jul 9: Paxil for Children: Safety, Efficacy Aren't Established - Letter WSJ http://www.ahrp.org/infomail/04/07/09a.php

July 7: Pharma Influence: Penn Psychiatrist Files Whistleblower Lawsuit - Investigtion Confirms Medicare Chief Lied to Congress

http://www.ahrp.org/infomail/04/07/07.php

Jul 6: FDA Failed to Enforce Law Requiring Drugmakers to Disclose Test Data - WashPost http://www.ahrp.org/infomail/04/07/06.php

June 30,2004: NYS AG Expands Pharmaceutical probe - Forest Labs http://www.ahrp.org/infomail/04/06/30.php

June 30, 2004: Response to Washington Post Editorial "Missing Drug Data" http://www.ahrp.org/infomail/04/06/30a.php

Jun 28. 2004: Scientists Decode Secret of Getting NIH Grants - WSJ http://www.ahrp.org/infomail/04/06/28.php

Jun 27, 04: NIH Under Fire: Longtime Favorite of Congress - Wash Post / WSJ http://www.ahrp.org/infomail/04/06/27.php

Jun 26: Forest Labs Admits Concealment of data - Congressional Probe Expands http://www.ahrp.org/infomail/04/06/26.php

Jun 23: AHRP: Published NIMH Funded Prozac Trial Report Concealed Suicide Attempts by Teens http://www.ahrp.org/cms/content/blogcategory/0/105/9/369/

Jun 21: Antidepressants - USA Today Editorial / AHRP OpEd/ WSJ Editorial Bashes Spitzer

Jun 20: HMO physician applauds Spitzer's focus on information bias / NYT blind spot

Jun 7: Paxil induced suicides in US quantified - Glaxo Faces criminal action in UK over "suicide"
pills - Times

Jun 6, 2004: NY Times Editorial Gets it Right: When Drug Companies Hide Data

Jun 5: "Black Hole" of medical research--Negative Results Don't get Published - JAMA, WSJ

Jun 2, 2004: NYS Attorney General files suit against GlaxoSmithKline

Jun 2: NY Times Does it Again - Drug Advertisers Get Front Page Coverage to Boost SSRI Market

May 25, 2004: FDA role in suppressing damaging data - WSJ

May 24, 2004: More than 100 top regulatory officials represented industry as lobbyists, lawyers - Denver Post

May 18, 2004: Lawmakers accused leaders of the NIH of encouraging "the option of corruption."

May 17, 2004: Paxil Sales Plummet in UK (372K PDF)

May 16: Pfizer Admits Guilt in Promotion of Neurontin--Agrees to Pay $430 Million

May 7, 2004: NIH Panel Recommendations Fail to Resolve Conflicts of Interest

May 6, 2004: Interview with Shannon Brownlee (NPR)

Apr 13: Doctors Without Borders: Why you can't trust medical journals anymore

Mar 25: Antidepressant Controversy: Media Conflicts of Interest - New York Times

Mar 2, 2004: Ethics Policy Announced for NIH Officials - LAT

Jan 29, 2004: Antidepressant Makers Withhold Data on Children - Washington Post

Jan 25, 2004: ACNP Summary Report Criticized as "Junk Science"

Jan 21: ACNP - a pharmaceutical industry funded association of psychiatrists - claims SSRI Antidepressants don't increase suicidal behavior

Jan 7, 2004: FDA Sham Conflicts of Interest Policy

Dec 7, 2003: Stealth Merger: Drug Companies and Medical Research at NIH - LAT

Aug 15, 2003: Almost 1/2 of faculty on IRBs have ties to industry - Harvard Partners

Aug 3, 2003: Psychiatrist's Undisclosed Financial Ties Prompt Reproval - NYT

June 20, 2003: Time to put drug giants on trial - Scotsman (UK)

April 5, 2003: AHRP Comments: DHHS COI Guidance for Human Subject Protection

March 30, 2003: CNN: Drug Argument Embroils Psychiatrists, Pharma Companies

March 19, 2003: Conflicts of Interest Taint UK Gov panel investigating SSRI

November 22, 2002: Tonight PBS Is Science for Sale?

September 30: Ritalin Outrage: Congress_ Big Media Under the Influence of Big Drugs

August 25, 2002: Integrity in Scientific Research : Peer review ineffective - Institute of Medicine / Lancet / Science

August 1, 2002: Randomized Controlled Trials: Evidence Biased Psychiatry, an original article by David Healy MD, MRCPsych in which he challenges the scientific assumptions about the value of evidence obtained from randomized controlled clinical trials.
July 15, 2002: The Emperor's New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration. By Irving Kirsch, Thomas J. Moore, and Alan Scoboria and Sarah S. Nicholls.

A meta-analysis of efficacy data submitted to the U.S. Food and Drug Administration for approval of the six most widely prescribed antidepressants approved between 1987 and 1999. They report that, although the difference in drug versus placebo response was statistically significant, approximately 80% of the medication response was duplicated in the placebo control. The accompanying expert commentaries reflect the broad range of reactions that such findings provoke. http://journals.apa.org/prevention/volume5/pre0050023a.html

Response to the commentaries Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions http://journals.apa.org/prevention/volume5/pre0050033r.html

July 15, 2002: Short Drug Tests, Fatal Flaws. Thomas J. Moore. Op Ed. Boston Globe

July 14, 2002: Corporate influence on medicine, budgets & investors

June 13, 2002: When Money Corrupts Medicine - Deaths Occur

June 13, 2002: In 1984 the NEJ M became the first of the major medical journals to require authors of original research articles to disclose any financial ties with companies that make products discussed in papers. In accordance with the NEJM policy, editorial reviewers could have no financial ties to the companies. In 2002, Dr. Jeffrey Drazen, the journal's new editor, abandoned the Journal's policy of containing conflicts of interest, claiming "it is becoming tough to find doctors to write such articles." The change, Drazen wrote in the June 13, 2002 issue of the Journal, is designed "to enhance the depth and breadth of the journal's content while ensuring that the articles we publish are not influenced by financial interests.'' The Boston Herald indicated that Drazen claimed: "We're strengthening the journal.'' But Dr. Jerome Kassirer, former editor of the NEJM, blasted the new policy.

http://www.bostonherald.com/news/local_regional/nejm06132002.htm

June 8, 2002: Fraudulent Conduct that Takes Lives: Why Criminal Prosecution of Medical Researchers with Financial Conflicts, Who Fabricate Safety Data, has Become an Essential Component of Regaining the Integrity of Device and Drug Research in the United States
By James J. Neal, Copyright 2002

"Giant corporations are locked in a life and death struggle to provide one of a kind instrumentation with which a given operation 'must' be done." Editor, Michael Baggish M.D., Journal of Gynecologic Surgery.

"Rare is the disinterested researcher. It is a phenomenon found in every medical treatment using devices." "If you can't trust the studies, what happens to the profession and what happens to patients." John Wasson, M.D., Dartmouth, New York Times.

"We've lost our way. We've terribly, terribly lost our way. Science has been lost in the rush for money." Steven Nissen, M.D., Cleveland Clinic, New York Times.

"Organs punctured include bile ducts, bowel, small intestine, liver and arteries and veins. Data shows high morbidity." Pennsylvania Medical Society, comments on "hi tech" surgical devices.

Summary: In recent years, surgical instrument companies working through surgeons with concealed equity interests in devices, have created new procedures, to promote the sale of equipment. Corporations have created demand for new surgical procedures "through massive advertising campaigns to convince the public of necessity." Rutkow, IRA,

The Socioeconomic Tyranny of Surgical Technology. Archives of Surgery. Leading surgical researchers, with equity interests have fabricated surgical research to demonstrate the safety and efficacy of new procedures with device costs of $2,000-$5,000 per operation. One sales rep described his companies' philosophy as "dollars per procedure." Although the device industry has generated tens of billions of dollars in revenue using these tactics, serious surgical morbidity from many new device dependent operations has multiplied. Treating MD's and patients need law enforcement's assistance in deterring fabricated research data published by research surgeons with concealed equity interests in expensive medical devices, and new drugs. The question raised in this analysis is whether fraudulent medical research is taking lives, and if so, how many. For complete article go to:
http://www.redflagsweekly.com/new_frontiers/2002_june08.htm

June 5, 2002: APA Under the Influence of PhaRma

June 13, 2002: Vermont to Require Drug Makers to Disclose Payments to Doctors
By MELODY PETERSEN The New York Times. Vermont follows Minnesota in its efforts to contain the cost of medicine by requiring public disclosure of conflicts of interest. A law will require drug companies to disclose the gifts and cash payments they make to doctors. We have not heard of similar moves by states that have major medical centers such as: New York, Massachusetts, Maryland or California.
http://www.nytimes.com/2002/06/13/business/13DRUG.htm

May 30, 2002: Bitter Medicine: Pills, Profit & the Public Health - ABC News

May 23, 2002: FDA -Conflicts of Interest to be expanded - Washington Post

May 21, 2002: Bitter Pill for David Healy: academia under pharma influence

May 6, 2002: "Conflicts of Interest in Clinical Trials", a presentation by Vera Hassner Sharav before the U.S. Army Medical Department and Henry M. Jackson Foundation for Advancement of Military Medicine on Conflicts of Interest in Medical Research.

September 24, 2001: The American Prospect.
Pharma Buys a Conscience By Carl Elliott, MD, PhD

The issue of corporate money has become something of an embarrassment within the bioethics community. Bioethicists have written for years about conflicts of interest in scientific research or patient care yet have paid little attention to the ones that might compromise bioethics itself. Arthur Caplan, the director of the University of Pennsylvania Center for Bioethics, counsels doctors against accepting gifts from the drug industry. "The more you yield to economics," Caplan said last January, "the more you're falling to a business model that undercuts arguments for professionalism." Yet Caplan himself consults for the drug and biotech industries, recently coauthored an article with scientists for Advanced Cell Technology, and heads a bioethics center supported by Monsanto, de Code Genetics, Millennium Pharmaceuticals, Geron Corporation, Pfizer, AstraZeneca Pharmaceuticals, E.I. du Pont de Nemours and Company, Human Genome Sciences, and the Schering-Plough Corporation.

By no means does Caplan's center stand alone in its coziness with industry. The University of Toronto houses the Sun Life Chair in Bioethics; the Stanford University Center for Biomedical Ethics has a program in genetics funded by a $1-million gift from SmithKline Beecham Corporation; the Merck Company Foundation has financed a string of international ethics centers in cities from Ankara, Turkey, to Pretoria, South Africa. Last year the Midwest Bioethics Center announced a new $587,870 initiative funded by the Aventis Pharmaceuticals Foundation. That endeavor is titled, apparently without irony, the Research Integrity Project.

Bioethics appears set to borrow a funding model popular in the realm of business ethics. This model embraces partnership and collaboration with corporate sponsors as long as outright conflicts of interest can be managed. It is the model that allows the nonprofit Ethics Resource Center in Washington, D.C., to sponsor ethics and leadership programs funded by such weapons manufacturers as General Dynamics, United Technologies Corporation, and Raytheon. It also permits the former president of Princeton University, Harold Shapiro, to draw an annual director's salary from Dow Chemical Company while serving as chair of the National Bioethics Advisory Commission. Dow, of course, has been the defendant in a highly publicized lawsuit over the Dow Corning silicone breast implants as well as in numerous legal actions involving disposal of hazardous waste.

Part of the problem is aesthetic. It is unseemly for ethicists to share in the profits of arms dealers, industrial polluters, or multinationals that exploit the developing world. But credibility also is an issue. How can bioethicists continue to be taken seriously if they are on the payroll of the very corporations whose practices they are expected to assess?

Read complete article (free): http://www.prospect.org/print/V12/17/elliott-c.html

May 18, 2000. The New England Journal of Medicine. Is Academic Medicine for Sale?

By Marcia Angell, MD - Vol. 342, No. 20

Finding an editorialist to write about the article presented another problem. Our conflict-of-interest policy for editorialists, established in 1990, ( ) is stricter than that for authors of original research papers. Since editorialists do not provide data, but instead selectively review the literature and offer their judgments, we require that they have no important financial ties to companies that make products related to the issues they discuss. We do not believe disclosure is enough to deal with the problem of possible bias. This policy is analogous to the requirement that judges recuse themselves from hearing cases if they have financial ties to a litigant. Just as a judge's disclosure would not be sufficiently reassuring to the other side in a court case, so we believe that a policy of caveat emptor is not enough for readers who depend on the opinion of editorialists.

In this editorial, Angell discusses the extent to which academic medicine has become intertwined with the pharmaceutical and biotechnology industries, and the benefits and risks of this state of affairs. Bodenheimer, in his Health Policy Report elsewhere in this issue of the Journal, provides a detailed view of an overlapping issue -- the relations between clinical investigators and the pharmaceutical industry.

The ties between clinical researchers and industry include not only grant support, but also a host of other financial arrangements. Researchers serve as consultants to companies whose products they are studying, join advisory boards and speakers' bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company-sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the companies.

Read complete article (for pay) : http://www.nejm.org/content/2000/0342/0020/1539.asp

May 18, 2000. The New England Journal of Medicine.
"Uneasy Alliance -- Clinical Investigators and the Pharmaceutical Industry"
By Thomas Bodenheimer, MD, MPH. Vol. 342, No. 20

How much influence does industry have over the work and products of the research community? Can practicing physicians trust the information they receive about the medications they are prescribing? Does the shift from the academic to the commercial research sector give industry too much control over clinical drug trials?

In this report, I discuss some of the problems raised by pharmaceutical-industry funding of drug trials, problems that may deepen as trials are increasingly conducted by commercial organizations. I interviewed 39 participants in the process: 6 pharmaceutical executives, 12 clinical investigators, 9 people from university research offices, 2 physicians with CROs, 8 people who have studied the process of clinical drug trials, and 2 professional medical writers. Each interview consisted of standard questions plus an opportunity for the interviewees to discuss the industry-investigator relationship in a general way. Several interviewees preferred not to allow the use of their names in the article.
Read complete article (for pay): http://www.nejm.org/content/2000/0342/0020/1539.asp

May 22, 1999: This smashing NY Times editorial (below) should awaken the public and its elected policy makers to the need for reform our Federal human subject protection regulations so that patients don't become unwitting commodities.

THE NEW YORK TIMES EDITORIAL May 22, 1999 Patients for Hire, Doctors for Sale
People go to doctors because they assume the doctor will tell them what they need to do to stay healthy or get well. But in articles published in The Times on Sunday and Monday, the reporters Kurt Eichenwald and Gina Kolata have opened the door on a practice of medicine that few of us knew existed - a warped world in which patients have become commodities, lured into research projects for the profit of their doctors.

In pushing to create a supermarket of new pills, the pharmaceutical industry has created a frantic competition for patients on whom new drugs must be tested before they can be approved. A bounty system has evolved in which doctors are paid by drug companies to enroll research subjects with certain kinds of problems: $1,200 from Bayer for a patient with vaginitis; $2,955 from Merck for one with hypertension; $4,410 from SmithKline Beecham for a willing diabetic.

The devil's bargain is that the doctor knows that enrolling the patient is worth money, but the patient does not. It is a recruiting system with the potential to corrupt either the drug companies, because they are forced to outbid each other for patients, or the doctors, because they are tempted to enroll patients who may not be medically appropriate.

The articles reveal a whole research universe slipping out of control. A review by The Times of more than 300 recent drug studies, and more than 200,000 government research request files, found hundreds of thousands of patients involved and indications that some doctors make $500,000 to $1 million a year in recruitment bounties.

One Southern California doctor now in prison forged his patients' medical records and test results on a massive scale to boost his income.

In the past, most clinical trials of drugs were conducted by doctors at medical research institutions. But that system proved too slow at recruiting patients, so the drug companies and their contractors turned to doctors in private practice, tripling their number since 1990.

Meanwhile, the monitoring systems to protect patient welfare, already under fire for past performance, have shown no interest in the ethical conflict of doctors being paid to recruit their own patients.

Dr. Nancy Dickey, president of the American Medical Association, says that the bounty system is unethical by A.M.A. standards and that the organization will work with Federal regulators to try to end the practice.

They need to act expeditiously. The patient search has now begun to tap the poor populations of South America, threatening to corrupt the practice of medicine even more widely. © The New York Times

"drugs today are not being tested as they should be before being released to the public"

I dunno. People gripe & moan when the FDA takes too long to approve a new treatment, and they get rightly upset when an approved substance then shows problems. Very easy to criticize with 20/20 hindsight.

Both of them used to have trouble with ankles/feet swelling (well--until the one had both legs amputated). If I remember right, it was just fluid retention from bad kidneys not being able to filter things fast enough. If they stayed off their feet for awhile, they usually went back down.

Aggression and Suicidality

Preventive Psychiatry E-Newsletter # 287

by Donna Young

BETHESDA, MD, 16 March 2006 — Signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors at usual dosages of any of the drugs approved in the United States to treat attention deficit/hyperactivity disorder (ADHD), according to the Food and Drug Administration (FDA).

But current approved labeling for ADHD medications lack information about the risks of drug-induced signs or symptoms of psychosis or mania, drug safety reviewers said in a document posted on FDA's Web site this week.

The labeling for these drugs, the reviewers added, does not clearly state the importance of stopping drug therapy in any patient who has hallucinations or other signs or symptoms of psychosis or mania during drug treatment of ADHD.

"We recommend that these issues be addressed," the reviewers said.

Regulators issued the review document this week in preparation for the March 22 meeting of FDA's Pediatric Advisory Committee, which is expected to discuss how best to communicate risk information about ADHD medications to prescribers and parents.

The panel will also discuss adverse-event reports received during the first year of marketing of four drugs granted pediatric exclusivity under the Best Pharmaceuticals for Children Act.

The Psychopharmacologic Drugs Advisory Committee is scheduled to meet the next day to discuss the sleep disorder drug modafinil (Cephalon’s Provigil), which is under review for marketing approval to treat ADHD.

The Drug Safety and Risk Management Advisory Committee stunned regulators on Feb. 9 when the panel voted 8–7 to add a black-box warning to the labeling of stimulants used to treat ADHD to alert prescribers about cardiovascular risks associated with use of the drugs. At that meeting, regulators said that the agency had received reports of more than 20 deaths associated with use of ADHD drugs.

In the document issued this week, FDA said that its ADHD psychiatric review team analyzed post-marketing reports of psychiatric adverse events associated with ADHD medication use received since January 2000 from drug sponsors and identified from the agency's adverse event reporting system (AERS).

FDA received 18 reports from Shire of suicidal thoughts or behavior, known as suicidality, associated with the use of amphetamine salts, or Adderall. The company also reported 84 reports of psychosis or mania and 83 reports of aggression or violent behavior.

FDA's review team identified 77 reports from AERS of psychosis or mania associated with Adderall use.

Shire reported 33 occurrences of suicidality associated with use of its extended-release form of amphetamine salts, marketed as Adderall XR. The company also reported 92 occurrences of psychosis or mania and 95 reports of aggression.

McNeil, which markets methylphenidate under the brand name Concerta, reported 121 occurrences of suicidality. The company also reported 160 cases of psychosis or mania and 219 reports of aggression.

Novartis, which markets methylphenidate as Ritalin, reported 67 cases of suicidality. The company, which also markets dexmethylphenidate as Focalin, reported a combined 130 occurrences of psychosis or mania for the two drugs. However, FDA noted, because of the relatively limited use of Focalin, those figures represent very few reports for that drug.

FDA reviewers identified 148 reports from AERS of psychosis or mania associated with Concerta and Ritalin.

The largest number of reports of suicidality associated with the use of an ADHD drug came from Eli Lilly and Co., which markets atomoxetine, or Strattera, a selective norepinephrine-reuptake inhibitor.

The company reported 399 cases of suicidality associated with Strattera’s use.

Eli Lilly last fall added a black-box warning to Strattera’s labeling to warn prescribers about an increased risk of suicidality in children and adolescent users of the drug.

The company also reported 360 occurrences of psychosis or mania in patients using the drug and 992 reports of aggression or violent behavior. FDA reviewers identified 292 reports from AERS of psychosis associated with the drug's use.

Although Provigil is not approved for ADHD use, Cephalon, which markets the drug as Provigil for sleep disorders, reported 18 cases of suicidality. The company also reported 94 cases of psychosis or mania and 22 occurrences of aggression. FDA reviewers identified 43 reports from AERS of psychosis or mania associated with the drug's use.

http://www.ashp.org/news/ShowArticle.cfm?cfid=11587059&CFToken=10876124&id=14536

She had rheumatoid arthritis and had to take anti-inflamatories. After she had a run in with an ulcer her doctor thought Vioxx would be a better choice than a regular NSAID plus a separate acid reducer. Doctors were never advised that Vioxx had an increased risk of blood clots. Her doctor testified by deposition that if he'd been given that information he would never have prescribed it for my neighbor.

They were gored. It was terrible.

PHARMA because they couldn't afford their overpriced medicine and were prevented from buy affordable pharmaceuticals from Canada. Thank big PHARMA for Medicare Part D as well, which is screwing grandpa and grandma at a time in their lives that they can least afford to be screwed.

Apparently pharmaceuticals are being thrown out on the market these days without sufficient testing, which is why people are getting bad results down the line. I could have gotten breast cancer too, because I was given Prempro, which the doctors said would prevent cancers like cervical cancer and breast cancer. Apparently this was what the PHARMAS sold the doctors on. It's when I found out that the way they got the drug was from the urine of pregnant horses that I refused to take it.

I thought if I got cancer, so be it. I wasn't going to be party to animal abuse to save my worthless skin. It looks like I saved my life instead.

It's almost essential that individuals do that now since doctors won't. I still cringe at a doctor that I saw on Oprah about two months ago who, during a discussion of controlling menopause, stated that it's perfectly safe to take hormone replacement therapy (ie, Prempro). It is not safe. An extensive five year study by the National Institute of Health concluded that hormone replacement therapy not only did not prevent heart disease or osteoarthritis, it increased the risk of cancer. We are not safe from lies.

I could live very comfortably in some parts of the world for what I hand over to "Big Pharma."

Does that count?

This too: in Canada or Mexico my drugs cost only a third of what they cost here. But I'm never going to stop taking them. Emergency rooms are no fun, and I stopped my futile quest to live without meds a long time ago.

Before modern meds I would have simply been a crazy guy who died young, probably out on the streets from pneumonia. So Big Pharm is not all bad in my book, even though I find much of what they do to be utterly loathsome and despicable, especially here in the United States where they apparantly own a much bigger chunk of the government than ordinary citizens.

I am sorry that it costs so much to save your life--especially when it is due to governmental policies bought and paid for by greedy monopolies.

was on the big pharma merry-go-round. He wound up in the hospital a couple of times because of the drugs the docs had him on.

forewarned about side effects as we should be, there are virtually no studies on the interactions of these new drugs with other drugs.

I certainly do see a lot of evil in pharmaceutical companies. They are very Western and often try to stifle any competition from alternative medicine. Still, to be fair, if they don't deliver drugs fast enough we bitch because people are dying while the drugs are taking years and years to test. If they push the drugs out too fast we bitch when tragedies like thalidomide happen.

I wouldn't want to be in that business.
Lee