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Hot Topics - Big pharmaHot Topics - Big pharma - includes drug development, funding, FDA oversight, PR/advertising, and research conduct FREEDOM OF CHOICE IS NOT FREE Vaccination News, A Non-Profit Corporation All the News (includes Breaking News) - a running tab of everything posted on this website since October 29, 2003 Return to Vaccination News Home Page (for best results, right click to "open in new window") View past & current Scandals (columns by Sandy Gottstein aka Mintz) Subscribe to Scandals Search This Site using keywords click here to download Adobe Reader
The Topics: *Alternatives *Big pharma *Big trouble *Conferences *Conflict of interest *Diseases and their vaccines *Legal/political *Miscellaneous *Research *Vaccine-related issues Big pharma - includes drug development, funding, FDA oversight, PR/advertising, and research conduct March 1-7, 2004 ►March 4, 2004 -
Group Seeks Ban of Anti-Cholesterol Drug - AP via Yahoo! ►March 4, 2004 - Animal instincts - Duluth-based Merial invents drugs, vaccines - The Atlanta Journal-Constitution - "Other companies have file cabinets. Merial has freezers...Make that deep-freeze freezers. Where else would you stash the creepiest infections known to the world of fur and feathers?..." ►February 28, 2004 - Genuine concern or corporate greed? - opinion - Broomfield Enterprise via The Daily Camera - "Does Senate Bill 139 represent genuine concern or corporate greed? Follow the money...SB 139 will set forth a statewide database of all Colorado's children. The system will be used to call parents and coerce them to have their children "fully" vaccinated. This means the child must have every single recommended vaccine...When I was a child I only had two immunizations: polio and smallpox. These shots were for serious diseases that affected large populations. I am truly grateful for advances in modern medicine that have eradicated deadly diseases. Today, though, Colorado's children are required to receive 29 vaccinations by the age of 4. The risk of children contracting some of these diseases is miniscule." ►February 21, 2004 - GlaxoSmithKline staff told not to publicise ineffectiveness of its drug - journal article (BMJ) ►March 2, 2004 -
U.N.: Drug
Producers Target Middle-Class - AP via Yahoo! ►March 8, 2004 - FDA
boosts efforts to find fake drugs - Electronic "track and trace" methods are
examined as a way to halt the growing problem of counterfeit pharmaceuticals. -
www.ama-assn.org ►March 2, 2004 - MedImmune Looks to Boost FluMist Sales - Company Hopes New Version Will Fix Problems Faced by Nasal Vaccine in Its Debut (requires registration) - The Washington Post ►March 1, 2004 - Troubled
FluMist Vaccine to Remain in Production - Status of Saatchi on $40 Million
Account Still Unknown - www.adage.com - "MedImmune
today said it will continue producing troubled nasal flu vaccine FluMist,
despite slumping sales and the possibility of a $75 million write-off if Wyeth
bows out of a co-marketing agreement on the drug." ►March 1, 2004 - MedImmune Plans to Keep FluMist Alive - MedImmune to Keep FluMist Alive Despite Dismal Sales, Lowering Outlook for the Coming Year - AP via ABC News ►March 1, 2004 - Injecting New Life into the Vaccine Industry - Harvard Business School - "Vaccines for preventable diseases save millions of lives every year, yet as an industry, the vaccine business suffers a host of ailments, the CEO of Merck & Co. contends...Speaking at a Harvard Business School forum recently, Raymond V. Gilmartin (HBS MBA '68) said the vaccine industry needs to overcome hurdles that include a feeble distribution infrastructure, a thin pipeline of competition to inspire more innovation, and a poor diet of incentives for the development of vaccines for which there is no natural market such as vaccinations against anthrax or ricin." ►February 29, 2004 - Dirty tricks drug firms use to get publicity - The Scotsman - "SHOCKING tactics including bribery, fabrication and plagiarism are being used by unscrupulous drug companies to get their research published in influential medical journals, according to a damning new report...Only a week after controversial research on the MMR vaccine was discredited by the journal which published it following a 'fatal conflict of interest', an influential committee has revealed the widespread use of underhand tactics by researchers." ►February 28, 2004 - Only 6% of drug advertising material is supported by evidence - journal article (BMJ) ►February 28, 2004 - Panel Urges Stricter Limits on Acne Drug - Reuters via Yahoo! News ►February 29, 2004 - Is Biotechnology Losing Its Nerve? (requires registration or subscription) - The New York Times - "AS a founder of four biotechnology companies, Dennis A. Carson can practically write an encyclopedia entry on risk. After all, his first start-up, a gene therapy and vaccine company called Vical, still does not have a product on the market after 16 years and more than $100 million spent...But now Dr. Carson, who is also the director of the cancer center at the University of California at San Diego, is playing it safe, or at least safer. Rather than develop radical new technology or invent new medicines, his latest venture, Salmedix, plans to sell drugs licensed from other companies - drugs that are already on the market or that have at least gone through some clinical trials." February 23-29, 2004 ►February 24, 2004 - FDA's new status quo - The Boston Globe ►February 22, 2004 - FDA, States at Odds Over Drugs - Minnesota Web Site Points Way to Canadian Pharmacies (requires registration) - Washington Post ►February 27, 2004 - FDA Debates More Restrictions on Accutane - AP via The Herald-Sun ►February 26, 2004 - Vaccine Program Remedies Must Be Exhausted Before Filing Suit - The Legal Intelligencer via www.law.com - "A couple whose son suffers from autism because of an alleged adverse reaction to thimerosal, a mercury-based preservative once present in vaccines for newborns, may not file suit in Pennsylvania against a group of pharmaceutical companies until they exhaust administrative remedies available through the National Vaccine Injury Compensation Program, the Pennsylvania Superior Court has ruled...According to the Superior Court opinion, the federal Vaccine Act of 1986 requires that before commencing any state or federal claims, vaccine claimants must first file a petition with the "no-fault" compensation program, a special tribunal of the Federal Court of Claims known as the Vaccine Court and located in Bethesda, Md." ►February 17, 2004 - Faint Warning - Generation RX - CBC News Disclosure ►March 2004 - Death by Medicine - by Gary Null, PhD, Carolyn Dean, MD, Martin Feldman, MD, Debora Rasio, MD, and Dorothy Smith. PhD - LE Magazine - "Natural medicine is under siege, as pharmaceutical company lobbyists urge lawmakers to deprive Americans of the benefits of dietary supplements. Drug-company front groups have launched slanderous media campaigns to discredit the value of healthy lifestyles. The FDA continues to interfere with those who offer natural products that compete with prescription drugs…These attacks against natural medicine obscure a lethal problem that until now was buried in thousands of pages of scientific text. In response to these baseless challenges to natural medicine, the Nutrition Institute of America commissioned an independent review of the quality of 'government-approved' medicine. The startling findings from this meticulous study indicate that conventional medicine is 'the leading cause of death' in the United States.” February 16-22, 2004 ►February 19, 2004 - Pfizer Cuts Supplies to Canadian Drugstores - Sales Are Halted To Reimporters Of Bargain Drugs (requires registration) - Washington Post ►February 19, 2004 - FDA Looks to Chips to Thwart Drug Counterfeiters - Voluntary Plan Envisions Manufacturers Adopting Electronic Track-and-Trace Technology by 2007 (requires registration) - Washington Post ►February 13, 2004 - FDA boss rumored to be in line for new post - San Diego Union-Tribune via SignOnSanDiego.com - "The head of the Food and Drug Administration, who has been on the job for a little over a year, appears to be the Bush administration's front-runner to lead the agency that runs Medicare...The speculation is being met with mixed emotions by many in the drug industry who recall waiting about two years for President Bush to fill the FDA post...During that leaderless period, drug companies complained bitterly that the lack of FDA leadership resulted in slower approval times for experimental drugs and unexpected rejections of some new drug applications." ►February 18, 2004 - DynPort Vaccine Company Selects Finjan's Mirage Solution to Provide Precise Control over FDA Regulated Processes and Documentation - Digital Rights Management Tool to be Used for Conducting Research, Studies and Clinical Trials - press release - Finjan Software via PRNewswire via Yahoo! ►February 17, 2004 - The future of drug development - Public Library of Science via www.eurekalert.org ►February 17, 2004 -
Two for Whom? - Combo Pills May Help Patients -- and Are Sure
To Help Drug Firms (requires registration) - Washington Post - "Two,
two, two drugs in one... February 9-15, 2004 ►February 12, 2004 - MedImmune thinking twice about staying in vaccine business - CNS via www.sunherald.com - "The research chief of Gaithersburg-based MedImmune told a House committee Thursday that the company may get out of the vaccine-production business, following disappointing sales of its nasal-spray vaccine this flu season." Comment: "BL Fisher Note (from the NVIC newsletter): When America's free enterprise system is allowed to work properly, without government coercion, then those products the public needs and wants will be purchased and consumed and those the public does not need or want will not be purchased and consumed. That leaves the way open for other manufacturers to build a better mousetrap and persuade the public to use that better mousetrap, which is as it should be...A good example is the Prevnar vaccine. The Prevnar vaccine, without any government mandates, was the best selling new drug/biological in 2001. Wyeth can't make the product fast enough to satisfy public demand...In any given year, only about one quarter of the US population has voluntarily chosen to purchase and consume flu vaccine of any kind. Only when government interferes and mandates use of a vaccine or subsidizes manufacturers of vaccines is America's free enterprise system not allowed to work as it should. At the end of the day, the public should not be forced to use a product it does not want...There were very good reasons why the FDA did not approve FLUMIST for use in children under five or adults over 50. MedImmune and Wyeth both know why. MedImmune is wise to read the writing on the wall rather than ask for government bailout of a vaccine that the public, for whatever reasons, obviously does not want." ►February 9, 2004 - Drug Company Attacks Developing Nations' Diseases - AP via The Tampa Tribune - "Victoria Hale is chief executive of the ultimate oxymoron: a nonprofit drug company...From her office in San Francisco, she hopes to wipe out diseases that plague developing nations but are ignored by Western drug companies for lack of profit possibilities...Hale's prescription is to gain marketing rights to promising drug candidates that are owned by drug companies but sit undeveloped in labs." ► Vaccines and Related Biological Products Advisory Committee - FDA/CBER - meeting alert - February 18 - 19, 2004►February 11, 2004 - Network of NHS watchdogs launched - An independent network of NHS watchdogs is to be launched aimed at giving the public a greater say over healthcare. - BBC ►February 10, 2004 - WHO Issues Herbal Medicine Guidelines - AP via The Herald-Sun ►February 10, 2004 - Seniors Given Dangerous Drugs, CDC Warns - AP via The Herald-Sun ►February 9, 2004 - Study examines inappropriate medication prescribing for elderly patients - JAMA and Archives Journals Website via www.eurekalert.org - "Medications considered 'inappropriate' were prescribed at approximately eight percent of outpatient visits by elderly patients, with pain relievers and central nervous system drugs accounting for a large share, according to an article in the February 9 issue of The Archives of Internal Medicine, one of the JAMA/Archives journals...According to the article, inappropriate medication use in patients 65 or older has been linked to many adverse drug reactions, poor physical functioning, and excess health care utilization." ►February 12, 2004 - Pop That Pill - PopMatters via AlterNet.org - "Around 20 years ago, the word 'patient' began evaporating eerily – like the photo of Michael J. Fox in 'Back to the Future' – from the dictionaries of the drug companies. And in its place came the term, 'medical consumer.' Twenty years ago. That's when drug manufacturers began marketing prescription medications directly to the lay public...It used to be that drug ads were directed only toward physicians, mostly in the dry pages of medical journals. And for good reason. Prescription drugs are complex things; each has risks and benefits. There is no such thing as a harmless medicinal drug. In Hebrew, the word for medicine is samim, or poison. Every drug is a poison." ►February 10, 2004 - FDA on Drug Ads: Less Is More - (requires registration) - Washington Post ►February 9, 2004 - Helping the less fortunate - Company advances drugs to cure little-known diseases, not to make a profit - AP via The Buffalo News ►February 8, 2004 - Medicine Hunter Tracks Promising Plants - AP via The Herald-Sun January 26 - February 8, 2004 (2 weeks combined due to illness) ►January 25, 2004 - Fears Grow as Drug Firms Quit Antibiotic Research - Reuters - "With 'superbugs' stalking hospitals and old killers such as tuberculosis re-emerging, the world badly needs more powerful antibiotics...Yet the pipeline of new treatments is drying up as drug firms -- citing poor financial returns -- focus instead on chronic conditions, such as high cholesterol, where medicines are taken for years rather than curing patients in one or two weeks...The shrinking of the medical armory is a growing worry for healthcare officials and has sparked a debate between regulators and pharmaceutical companies over ways to kick-start investment." Comment: Is it really poor financial returns which are keeping the pharmaceutical industry from developing new antibiotics? Or is it the knowledge that we will make it worth their while if they balk at doing so? ►February 4, 2004 - Frightful find a boon for one firm - Word that ricin, a poison, had been found in a senator's office, gives a big boost to DOR BioPharma. But one expert warns investors to be cautious. - The Miami Herald ►February 2, 2004 - FDA Panel to Weigh Safety Of Mood Drugs for Children - Some Data Link Use of Antidepressants, Suicidal Thoughts - The Washington Post - "A government panel of doctors will meet today to weigh disturbing but ambiguous evidence that widely used antidepressants may make some children suicidal, concerns that peaked in December when British authorities warned doctors not to prescribe the drugs to children...Clinical trials conducted by the drug industry in recent years have produced a steady drumbeat of data suggesting that suicidal thoughts and behavior are slightly more likely to develop in depressed children who take antidepressants such as Paxil, Zoloft and Effexor than in children who get dummy pills, according to several scientists who have analyzed many of the studies."
►February 3, 2004 -
FDA
Links Antidepressants, Youth Suicide Risk (requires registration) -
Washington Post ►February 5, 2004 - Proposed Changes to Ad Rules (requires registration or subscription) - The New York Times - "THE Food and Drug Administration is asking the makers of prescription drugs to shun the obfuscation, so to speak, by proposing revisions of its regulations on advertising directly to consumers. The proposals encourage the ads to describe significant risks the drugs may pose in language that is clearer and easier for patients to understand...The most notable aspect of the proposed changes, among several announced yesterday after months of study by the F.D.A., is the potential replacement of full-page advertisements for prescription medications in newspapers and magazines that now detail, in small type, information about effects and effectiveness." ►February 3, 2004 - Spanish scientist cleared - Scientific freedom of speech seen as winner in suit between drug firm and pharmacologist - The Scientist - "David has beaten Goliath again, this time in Spain. Joan-Ramon Laporte, the Spanish pharmacologist who was taken to court on January 16 by the giant Merck Sharp and Dohme (MSD) for an article in which he commented on the irregularities surrounding the company's VIGOR trial has been cleared of wrongdoing." ►January 26, 2004 - Miracle In A Bottle - Dietary supplements are unregulated, some are unsafe—and Americans can’t get enough of them. - The New Yorker ►January 24, 2004 - F.D.A. Begins Push to End Drug Imports - The New York Times ►February 1, 2004 - Making Drugs, Shaping the Rules (requires registration or subscription) - The New York Times - "But to sell medicines that treat schizophrenia, the companies focus on a much smaller group of customers: state officials who oversee treatment for many people with serious mental illness...For Big Pharma, success in the halls of government has required a different set of marketing tactics. Since the mid-1990's, a group of drug companies, led by Johnson & Johnson, has campaigned to convince state officials that a new generation of drugs - with names like Risperdal, Zyprexa and Seroquel - is superior to older and much cheaper antipsychotics like Haldol. The campaign has led a dozen states to adopt guidelines for treating schizophrenia that make it hard for doctors to prescribe anything but the new drugs. That, in turn, has helped transform the new medicines into blockbusters." ►February 7, 2004 - Adventist was human guinea pig for military during Vietnam War - Sarasota Herald-Tribune - "Ken Cobb was drafted into the Army during the height of the Vietnam War. Instead of fighting in the jungles of Vietnam, the Seventh-day Adventist member volunteered as a human guinea pig in a top-secret biological weapons program...He was one of a select group of soldiers who volunteered from 1954 to 1973 to expose themselves to deadly viruses and bacteria as human guinea pigs. The Army used the soldiers to test vaccines and equipment against biological weapons and diseases and to develop treatments for these diseases. All of the volunteers were members of the Seventh-day Adventist Church." January 19-25, 2004 ►January 23, 2004 - FDA: Misusing Painkillers Can Be Deadly - AP via The Herald-Sun ►January 25, 2004 - Many Surprised by Bold Moves at the F.D.A. (requires registration or subscription) - The New York Times ►January 24, 2004 - Whistleblower vows to fight on - journal article (BMJ) - "A Canadian haematologist at the centre of a cause célèbre over academic freedom and research funded by a drug company vowed this week to continue her crusade after failing in her attempt to challenge the European marketing authorisation granted for the thalassaemia drug deferiprone." ►January 23, 2004 - Pfizer sets aside $403m for possible settlement - 4th-quarter charge is aimed at closure in drug fraud cases - The Boston Globe - "If Pfizer settles the criminal and civil cases for close to that amount, it would be one of the largest settlements for drug fraud in US history. In June, drug maker AstraZeneca Pharmaceuticals agreed to pay $355 million to resolve criminal and civil allegations that the company inflated the price of its prostate cancer drug and bribed doctors to prescribe it."►December 2003 - Prescription Drugs - OxyContin Abuse and Diversion and Efforts to Address the Problem (pdf) - GAO ►January 21, 2004 - From Mad Cow to mercury, agencies watch for our welfare - The Record-Courier ►January 17, 2004 - Anti-Counterfeit Steps By Drugmakers Sought - Legislators' Goal Is to Halt Illegal Sales - Washington Post - "Congressional lawmakers asked five of the nation's largest drugmakers yesterday to explain what they are doing to stop counterfeit drugs from entering the marketplace. The letters are part of a widening effort in Congress and among federal agencies to crack down on the illegal distribution of prescription drugs." January 12-18, 2004 ►January 17, 2004 - Shooting up on hype - The chief executive has a chequered past. The biggest shareholder is elusive. Ben Hills investigates a company that claims it has found the Holy Grail. - The Sydney Morning Herald - "Alan Shortall plunges a hypodermic into an orange and injects it with one millilitre of water. He then carefully extracts it and releases the plunger, to demonstrate how the needle automatically retracts into the transparent barrel of the syringe and flips to one side so it can't be reused...'This is the Holy Grail of syringe technology,' he recites for the thousandth time, 'Of course, it's different when you are injecting a person, but you can see that it works. This is not a rort, this is not a scam, we are building a legitimate business.' Comment: The irresponsible use of re-usable needles has done untold harm in developing nations. For more on this, go to Scandals: "But Faith, fanatic Faith, once wedded fast To some dear falsehood, hugs it to the last." - Thomas Moore (Scandals - update and "flashback") ►January 14, 2004 - Biotech's Babies: Doing Well by Doing Good - As Big Pharma pulls out of the low-margin vaccine business, upstart outfits are exploiting new technologies to tap niche markets - Business Week Online ►January 13, 2004 - Putting a Price on a Good Night's Sleep (requires registration or subscription) - The New York Times - "Americans are about to be reminded again how much they need sleep — and sleeping pills...A new effort appears to be developing to expand the use of sleeping pills, which because of their potential for abuse have long had a reputation as being in some ways more dangerous than the insomnia they are meant to treat." ►January 13, 2004 - VaxGen gets big boost - Government gives firm $80.3 million anthrax contract - www.sfgate.com ►January 12, 2004 - Crackdown on GPs who tout bogus cures - www.smh.com.au Comment: And when will there be a crackdown on the false claims of the drug companies and their merchants, the medical profession? Even they know their drugs often do not work, yet where is the outrage, the clamping down, over that? For a recent article on this, go to The drugs don't work. ►January 16, 2004 - FDA Sees Rebound In Approval Of Innovative Drugs In 2003 - FDA via www.intelihealth.com ►January 5, 2004 - Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review - FDA/HHS via the Federal Register Online via GPO Access ►January 14, 2004 - U.S. rethinking rules on importing bovine tissues - Abilene Reporter-News - "Now that the United States has mad-cow disease, federal regulators are reconsidering long-held policies aimed at prohibiting importation of products or ingredients with bovine tissue or blood from countries with documented cases of the illness...The products include vaccines, nutritional supplements and cosmetics, all of which can contain ingredients derived from cows." Comment: Interesting dilemma. If the ban is continued, we now would be unable to use our own products (at least, theoretically). ►January 7, 2004 - The Political Economy of FDA Drug Review: Processing, Politics and Lessons for Policy - (requires registration) - Health Affairs www.medscape.com ►January 13, 2004 - FDA Advances Consumer Health and Safety in 2003 - PharmaLive - "At the heart of the Pharmaceutical Industry" - "The Food and Drug Administration (FDA) today released a white paper highlighting some of FDA's priorities and major initiatives to protect and advance consumer health and safety in 2003, and describing how the agency intends to build on many of these initiatives in 2004...The major consumer achievements noted in the paper, "Protecting and Advancing Consumer Health and Safety," include efforts to: bolster consumer safety through major industry regulations and risk communications; combat new forms of terrorism and emerging diseases; crack down on false products and false claims; reduce preventable medical errors; speed access to safe and affordable medicines; and help consumers improve their health through better information and greater 'health literacy.'" January 5-11, 2004 ►January 5, 2004 - The Ephedra Ban Is Not Enough (requires registration or subscription) - The New York Times ►January 10, 2004 - New Zealand moves to ban direct advertising of drugs- journal article (BMJ) - "New Zealand’s health minister, Annette King, will seek final approval from the cabinet later this month for the adoption of common standards with Australia on drug marketing, as a way of instituting a ban on advertising prescription only drugs directly to consumers...New Zealand medical and consumer groups have cautiously welcomed the move as likely to result in the adoption of the Australian standard, which bans such advertising of prescription drugs but allows general campaigns raising awareness of disease." ►January 7, 2004 - Strategic Perspectives: Commercial Opportunites in Depression - Generating Revenue Growth In Symptoms And Comorbidities - "Introduction:The growth of the antidepressant market over the last decade has been built upon increasingly sophisticated marketing strategies. This has not only made the depression market highly competitive, but also produced an expanded patient potential as manufacturers move their products into non-traditional markets."Comment: And this report can be yours for a mere $6,400.00.►January 10, 2004 - Immunologist accused of misconduct is allowed to relocate - journal article (BMJ) - "The leading Sydney specialist in immunology, Bruce Hall, who was accused of scientific misconduct, will escape any punishment after a controversial decision by his university to allow him to relocate his laboratory and staff." ►January 10, 2004 - Three journals raise doubts on validity of Canadian studies - journal article (BMJ) - "Suspicions about the validity of research by Professor Ranjit Kumar Chandra, a prominent Canadian researcher, have been raised by three journals, including the BMJ." ►January 6, 2004 - Judge Says Maker of OxyContin Misled Officials to Win Patents (requires registration or subscription) - The New York Times - "Purdue Pharma, the maker of the highly profitable painkiller OxyContin, deliberately misled federal officials to win patents protecting its drug, a federal judge ruled yesterday. The ruling helps clear the way for a cheaper generic version and could lead to more lawsuits." December 29, 2003 - January 4, 2004 ►December 29, 2003 - Healthy Defence - Contrary to what the US Institute of Medicine suggests, economic realities such as low profits and costly R&D are not barriers to vaccine innovation for pharmaceutical companies. In fact, Merck chief Raymond Gilmartin argues that the development of vaccines is a profitable venture. ANNA TEO reports - The Business Times ►December 29, 2003 - Pharmaceutical companies find new ways to reach anxious parents -- go direct (Editorial) - www.sfgate.com December 22-28, 2003 ►December 26, 2003 - Schneider: Drug industry uses 'blackmail' - Wisconsin Rapids Daily Tribune - "An area lawmaker has asked a state legislative committee to hold hearings on efforts by American pharmaceutical companies to prevent governments from buying less expensive drugs in Canada...State Rep. Marlin Schneider, a Democrat from Wisconsin Rapids, said he has asked the Republican chairmen of the Assembly's Public Health Committee to investigate what he called "blackmail" by the drug industry...'At a time when senior citizens, businesses and state and local governments are facing ever-increasing health-care costs and insurance premiums, it is outrageous that these drug companies should be able to force Canada into denying cheaper drugs to American consumers,' Schneider said in a news release." ►December 25, 2003 - Drug industry political victory doesn't mute underlying problems - AP via Newsday - "Pharmaceutical company executives breathed a collective sigh of relief when the Medicare reform bill excluded two ideas they abhorred: imports of low-priced drugs and government price controls...Industry lobbyists had swarmed the capital before the bill's late-year approval, pressing aggressively against both measures. They emerged victorious _ but it doesn't mean they can relax. The issue of prescrition drug costs will rage into 2004." ►December 27, 2003 - Medicine industry fights bad image - Even a miracle pill might not improve the perception of pharmaceutical giants. - Gannett News Service via StatesmanJournal.com - "Yet, even though drug companies make products that help people feel better and live longer, the industry’s image is on life support...Fewer than half of Americans surveyed in a Gallup Poll in August had a positive view of the drug industry. Drug companies ranked below the federal government and airline companies and just above the legal profession in the public’s eyes." ►December 23, 2003 - Vaccine options - The Washington Times - "An alternative approach involves the application of option theory to ensure adequate supply of vaccine. Financial options are widely used to address uncertainty in markets. Call options give the holder the right, but not the obligation, to purchase a particular asset (the underlying asset, in this case, being additional vaccine doses) at a predetermined price, on or before a given date." Comment: Note the advertisers for the Washington Times Editorial/Op-Ed. ►December 21, 2003 - Merck will not have to submit environmental study - AP via www.wcnc.com - "The incentives bill designed to bring a Merck & Co. plant to Treyburn Corporate Park here contains more than just monetary enticements...Merck will not have to submit an extensive environmental study required for projects that involve taxpayers' money...Officials with the N.C. Department of Commerce say they inserted the exemption from the State Environmental Policy Act into the bill so the mandated study wouldn't endanger the company's March construction plans." ►December 22, 2003 - Pharmacists warning on ibuprofen - www.news.com.au - "Pharmacists said the wider availability of the medicine gave the false impression it was safe for everybody...'The only winners are the manufacturers of ibuprofen who have lobbied long and hard to make their products available everywhere, to everyone.'...Currently available only at chemists, ibuprofen is commonly used for headaches, period pain, backaches and other muscular pain." Comment: Isn't that fascinating. Ibuprofen was not sold over-the-counter in Australia until recently..... December 15-21, 2003 Issues 2004 - A Net of Control - Unthinkable: How the Internet could become a tool of corporate and government power, based on updates now in the works - Newsweek via MSNBC - "Picture, if you will, an information infrastructure that encourages censorship, surveillance and suppression of the creative impulse. Where anonymity is outlawed and every penny spent is accounted for. Where the powers that be can smother subversive (or economically competitive) ideas in the cradle, and no one can publish even a laundry list without the imprimatur of Big Brother. Some prognosticators are saying that such a construct is nearly inevitable. And this infrastructure is none other than the former paradise of rebels and free-speechers: the Internet." December 14, 2003 - Let it flow, let it flow? - by Molly Ivins - Star-Telegram - "I can't tell whether this administration is flaunting its cynicism, its contempt for science or its conviction that, when in power, you help your contributors and fry your enemies -- although how millions of small children and unborn fetuses came to be enemies of George W. Bush & Co. is beyond my political or theological understanding...We are talking about the rollback announced last week in regulating mercury pollution. Except, of course, that it wasn't announced as a rollback -- it was announced as a great step forward." December 18, 2003 - Violative Advertising and Promotional Labeling Letter -Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine, Comvax (Merck & Co, Inc) - FDA/CBER December 2001 - Pharma Buys a Conscience - Provincial Health Ethics Network - "Why pharmaceutical companies want the goodwill of doctors is no great mystery. The surprise is why they want the goodwill of someone like me. I am a philosophy professor, and I work at a bioethics center...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." December 15, 2003 - Not-So-Public Relations - How the drug industry is branding itself with bioethics - http://slate.msn.com - " To promote the drug, Lilly has hired a public relations agency; the PR campaign they've created is called 'The Ethics, the Urgency and the Potential,' and its premise is that it is 'unethical not to use the drug.'...It is a brilliant strategy. There is no better way to enlist bioethicists in the cause of consumer capitalism than to convince them they are working for social justice."December 13, 2003 - Taking your medicine - Gary Hughes and Liz Minchin follow the big pharmaceutical money trail to reveal who is really behind the health advice we are getting. - The Age - "Many of us with chronic health problems rely on advocacy groups and peak medical bodies for independent advice and support. But just how independent is that advice and are we being given the full picture?...The Age has found that many advocacy groups are becoming hooked on sponsorship dollars from drug companies and these international corporations are in turn using them to promote their products in Australia's booming $5 billion drug market." December 12, 2003 - Big Pharma's influence on the rise - www.malaysiakini.com/ December 15, 2003 - Drugs industry is accused of putting wealth before health - The Telegraph, UK December 13, 2003 - The drugs don't work - journal article (BMJ) December 8-14, 2003 December 13, 2003 - Drug firms fund disease awareness - www.smh.com.au - via Spin of the Day @ PR Watch.org - "Pharmaceutical companies are pouring millions of dollars into patient advocacy groups and medical organisations to help expand markets for their products...They are also using sponsorships and educational grants to fund disease-awareness campaigns that urge people to see their doctors." December 8, 2003 - Even giants like Merck struggling with hard times - AP via Buffalo News - "The problems besetting pharmaceutical giant Merck & Co. also plague most of its competitors: falling profits, patent expirations, generic competition, the lack of new blockbuster drugs and pressures to make medicines more affordable...But the contrast to the heady days and double-digit profit growth of the 1990s is particularly striking at Merck, which has fallen in just a few years from the world's biggest drugmaker to No. 3 as competitors merged and leapfrogged ahead...'Size is not important in this industry. (Revenue) growth is'...." December 11, 2003 - Rules on medicines 'need big shake-up' - Anti-depressant ban for children reveals flaws in system, says Mind - The Guardian, UK - "'It is totally unacceptable that for a significant period 50,000 children and adolescents in the UK have been prescribed anti-depressant drugs that were not licensed for use but it is only now being demonstrated that they do not help and can indeed cause harm,' said Richard Brook, Mind's chief executive." December 9, 2003 - Merck to submit 5 vaccines, drugs over next 3 yrs - Reuters via Forbes December 9, 2003 - Merck Talks Up New Drugs To Address Research Doubts (requires subscription) - Wall Street Journal - "In the shorter term, Merck's strongest area is vaccines. It said it plans to submit an application to the Food and Drug Administration in the second half of 2005 for a vaccine against the human papilloma virus, which research chief Peter Kim called "the predominant cause of cervical cancer death" in women. Other vaccines that Merck expects to market in the next few years would prevent shingles, a painful viral infection of the nerve roots, and infection with rotavirus, which is a serious problem especially in less-developed countries." December 4, 2003 - N.C. special session incentives designed to lure Merck plant - AP via The Miami Herald - "State lawmakers will consider plans next week to provide millions of dollars in tax breaks and incentives to pharmaceutical giant Merck & Co. to bring a manufacturing plant to Durham County." December 1-7, 2003 December 2, 2003 - Merck, GSK need new drugs - Troubled pharmaceutical giants need new drugs - CBS Market Watch November 24-30, 2003 November 29, 2003 - Drug companies succeed in keeping payments to doctors secret - journal article (BMJ)
November 25, 2003 - Study Questions New Schizophrenia Drug - Study Says Newer Schizophrenia Drug May Not Be Much Better Than Older and Cheaper Medication - AP via ABC News
For more on this, go to: Up to 20% of drugs may cause unexpected problems and Safety of New Drugs Cannot Be Known for Many Years November 25, 2003 - MedImmune Seeks Help In Relaunching FluMist - New Plan to Be Rolled Out in January - The Washington Post November 25, 2003 - Drug Makers Move Closer to Big Victory- The New York Times - "As Congress edged closer to passing a Medicare drug benefit that prohibits the government from using its buying clout to win discounts, one thing was clear: the drug industry appeared on the cusp of an enormous victory, gained in part by millions in political donations and an expensive lobbying campaign." November 23, 2003 - The Doctors and the Drug Makers (6 Letters) - The New York Times - "Arnold S. Relman portrays how the pharmaceutical industry influences drug costs through its sponsorship of education programs for doctors (Op-Ed, Nov. 18). But as long as health care in this country remains primarily pharmaceutically based, these problems will continue regardless of what program is being financed." November 25, 2003 - Drug Makers Move Closer to Big Victory- The New York Times - "As Congress edged closer to passing a Medicare drug benefit that prohibits the government from using its buying clout to win discounts, one thing was clear: the drug industry appeared on the cusp of an enormous victory, gained in part by millions in political donations and an expensive lobbying campaign." November 17-23, 2003 November 21, 2003 - FDA Now Urges Caution On SSRI Use in Children - The U.S. FDA appears to have backpedaled a bit, preferring to urge "caution" rather than advising physicians to stop prescribing SSRIs for children. - Psychiatric News Comment: Who does this "backpedaling" benefit? Who does the FDA protect, business or the consumer?November 21, 2003 - Drugmakers Protect Their Turf - Medicare Bill Represents Success for Pharmaceutical Lobby - The Washington Post - "No industry in negotiations over the $400 billion Medicare prescription drug bill headed to the House floor today outpaced the pharmaceutical lobby in securing a favorable program design and defeating proposals most likely to cut into its profits, according to analysts in and out of the industry." November 17, 2003 - FDA advisory committee member on silicone gel breast implants may have major conflict of interest - Public Citizen November 18, 2003 - Your Doctor's Drug Problem - Editorial, The New York Times - "The rising costs of pre scription drugs are driving the current debate about Medicare reform. Yet Republicans and Democrats alike may be unaware of a primary reason for this inflation: doctors are taught about drugs by agents of the pharmaceutical industry, which works hard to persuade them to select the newest and most expensive medications — even in the absence of scientific evidence that they are any better than older, less costly ones." November 10-16, 2003 dangerous prescription - More than a dozen dangerous drugs have been pulled off the market since 1997. Why were they approved in the first place? An investigation of America's drug safety system. - Frontline/PBS - includes: The FDA - Hazardous to Your Health? AND Politics, Profits and Pharma Is the FDA Really Protecting Us? Nope...Opinion by IAHF President John Hammell - Millions of Health Freedom Fighters Newsletter FDA's McClellan, `Loved by Industry,' Seeks Fast Drug Reviews - Bloomberg - Hmmm, does this mean the FDA is dropping any pretense that its job is to protect the consumer?
Investigators Find Repeated Deception in Ads for Drugs - The New York Times (requires fee)
Debate Over Meningitis Vaccine Tainted by Aggressive Lobbying - AAPS Pharmaceutica - "One factor driving some of the new legislation is aggressive lobbying by Aventis, which makes a vaccine that is effective for most strains of meningococcal disease. The pharmaceutical company has hired firms in various states to make legislators aware of the life-threatening disease and promote its vaccine. The laws Aventis advocates go far beyond the recommendation of the CDC..." Drug Makers Pressed to Upgrade Plants - AAPS Pharmaceutica - "No longer a secret is the shocking revelation that the drug industry has, for a very long time, ignored the upgrading of its manufacturing facilities. The industry’s production techniques lag far behind those of potato-chip and laundry-soap makers [The Wall Street Journal Online, 3 September 2003]." Pill seeker - The Guardian, UK - "Selling amphetamines to children is a career that normally ends in jail. But not for Matthew Emmens, the chief executive of Shire Pharmaceuticals, the UK's third largest drug company." Neurontin Sales Soared on Dubious and Misleading Promotion - AAPS Pharmaceutica - "The Parke-Davis division of Warner-Lambert, which was acquired by Pfizer in 2000, was able to greatly expand sales of its anticonvulsant Neurontin (gabapentin) by manipulating study results as part of a campaign to promote the medication for unapproved uses." Merck Stops Depression Drug Development - AP via The Herald-Sun Cancer drugs' side effects often identified late after FDA approval - Reuters Health - And what, pray tell, of other drug side effects? For instance, what of drugs (i.e., vaccines) which are pushed on healthy children by the government and medical profession prior to proper study (i.e., long-term studies using never-vaccinated children as controls)? What's the chance they are even particularly followed up on, given that there are 35,688 VAERS reports for which it is apparently "Unknown" whether or not the person RECOVERED. (Note estimates of under-reporting that may or may not be applicable to VAERS.)
Drugmakers' paths of influence need to be less hidden - The Wall Street Journal (requires subscription) via www.healthleaders.com - "Wall Street Journal columnist Alan Murray says that although drugmakers should be allowed to lobby for influence with the federal government, their tactics should be public knowledge." November 3-9, 2003 Waiting for Wyeth - Motley Fool - "But yesterday, the drug maker announced a "temporary delay" in Prevnar shipments as it works to make some changes to its quality-control processes...In Wyeth's press release on the matter, the company sought to comfort investors with assurances that this will not result in a shortage, and that this development does not imply any questions about the safety or effectiveness of the vaccine...However, the delay does make one wonder: Why is this upgrade happening now instead of prior to the manufacturing ramp-up months ago?"
Gel Implants a Concern for Advisory Panel - AP via FindLaw - "In a highly unusual move, the chairman of a government advisory panel that reluctantly backed resuming sales of silicone gel breast implants now is urging federal health officials and lawmakers to disregard that advice." - Highly unusual, indeed. Well, good for Dr. Whalen. Talk about a man with integrity.
Drug Companies Settle 7 Suits for $1.6 Billion - The New York Times
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