The Pharmaceutical "Business with Disease"

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March 7, 2005

Safety Vs. Efficacy
Last week, investors in biotech Biogen Idec got a taste of the biggest risk in the pharmaceutical business: unexpected side effects. After one death due to an apparent side effect, Biogen and partner Elan pulled their multiple sclerosis drug Tysabri, which had been approved with rapid speed by the Food and Drug Administration only four months before. It was the most recent of several drug safety dilemmas.
>> Read article at Forbes.com

Pfizer Stirs Concern With Plans to Sell Heart Drugs Only as Pair
A drug that could be one of the most promising new heart treatments in a decade is generating controversy even before it is approved, because its maker, Pfizer, plans to sell it only in combination with the company's best-selling cholesterol treatment, Lipitor. At a cardiology conference in Orlando, today, researchers sponsored by Pfizer are expected to present positive new results about the drug, which has been shown in preliminary studies to substantially raise levels of what is known as good cholesterol, a novel approach to preventing heart disease.
>> Read article at NYTimes.com

March 5, 2005

F.D.A. Panel Weighs Fate of a Drug for Cancer?
A federal advisory panel began wrestling yesterday with whether to remove from the market a lung cancer drug that was rapidly approved for use by desperate patients but has now failed to prolong lives in a large clinical trial. The advisory panel to the Food and Drug Administration was not asked to vote on the fate of the drug, Iressa, which is made by AstraZeneca. Agency officials said they would await more data before making any decision.
>> Read article at NYTims.com

March 4, 2005

Pfizer launches freezer pops for cough relief
The taste of liquid remedies or the sight of pills often send children burrowing beneath their covers and can be messy or difficult for children to take. Children's PediaCare Medicated Freezer Pops, however, provide parents with an easy new way to give their children cough relief, lasting up to eight hours.
>> Read article at Pharmaceutical-Business-Review.com

Experts and the Drug Industry
When a government advisory panel concluded that the painkillers Celebrex, Bextra and Vioxx could all be safely marketed despite evidence of cardiac risks, the decisive votes were cast by experts who had financial ties to the drugs' manufacturers. That disturbing fact was revealed last week in a Times article, based on data compiled by the Center for Science in the Public Interest, an advocacy group.
>> Read article at NYTimes.com

Boy's Cancer Prompts FDA to Halt Gene Therapy
The Food and Drug Administration has suspended several U.S. gene therapy experiments after learning that a third child who underwent treatment in France has developed cancer as a result, a development that has cast a pall over the struggling research field.  Adding to the gloom, researchers are due to report today that a monkey has died of cancer caused by a gene therapy experiment six years ago. That suggests the treatments may carry long-term as well as near-term risks, said scientists who will be discussing the issue at an FDA meeting.
>> Read article at WashingtonPost.com

March 3, 2005

Crestor May Pose Risk of Muscle Damage
The popular new cholesterol-lowering drug Crestor may cause an increased risk of potentially life-threatening muscle damage, especially in people of Asian ancestry, the Food and Drug Administration said yesterday. In a formal advisory, the agency said the risk is small and was largely identified and understood when the drug was approved in 2003. But because of new post-market studies that underscored the concerns, the agency concluded that the public should be informed and that warnings on the product label should be strengthened.
>> Read article at WashingtonPost.com

Senate bill takes away power from states and shields drug companies
from accountability for vaccine injuries
They are at it again. Those determined federalists and lobbyists for big Pharma, who view informed consent advocates and vaccine victims as an impediment to exercising more control over and making more money off of America's forced vaccination system. This time, they are using the public's memory of September 11, 2001 to push a Senate bill (S.3) deceptively entitled "Protecting America in the War on Terror Act of 2005."
>> Read article at RedFlagsWeekly.com

March 2, 2005

Tamoxifen Raises Endometrial Cancer Risk
Doctors often prescribe the drug tamoxifen to breast cancer patients over the long term, to help reduce the chances of cancer recurrence. But a new study confirms tamoxifen can also boost the risk of endometrial cancer in both pre-menopausal and postmenopausal women, with that risk increasing the longer a woman takes the drug.
>> Read article at RedNova.com

Securities Lawsuit Filed Against AstraZeneca Over Exanta
A class action lawsuit was filed on behalf of all persons who purchased American Depository Receipts ("ADRS") of AstraZeneca, PLC between April 2, 2003 and October 11, 2004. The lawsuit alleges that the drug maker AstraZeneca and certain of its officers and directors issued materially false statements concerning the results of clinical trials of the Company's investigational oral anticoagulant Exanta, and the status and likelihood of the approval of the New Drug Application for Exanta.
>> Read article at LegalNewsWatch.com

F.D.A. Official Admits 'Lapses' on Vioxx
After the Food and Drug Administration insisted for months that it did nothing wrong in its oversight of the withdrawn pain pill Vioxx, a top agency official acknowledged "lapses" in the agency's actions before a Senate panel onTuesday. Dr. Kweder said the agency took too long to get information about Vioxx's heart risks into the prescribing label that is provided to physicians. More than a year passed between an advisory panel's conclusion that those risks should be highlighted and the label changes, she said.
>> Read article at NYTimes.com

March 1, 2005

AIDS Drugs Might Combat Bird Flu - Reuters
The anti-HIV drugs known as protease inhibitors may be effective against the bird flu virus, according to an Italian researcher.
>> Read article at Reuters.com

FDA Seeks Drug-Warning-Label Authority
The Food and Drug Administration asked Congress on Tuesday for authority to dictate label changes for drugs to end the type of haggling with pharmaceutical companies that delayed warnings to Vioxx users about potential heart problems.
>> Read article at InteliHealth.com

February 28, 2005

FDA drug approval times likely to grow
The withdrawal of a multiple sclerosis treatment is likely to lead to even longer product approval times for pharmaceutical companies as pressure mounts on the Food and Drug Administration to improve drug safety, experts say. The news Monday that one patient died and another developed a serious disease while taking the MS treatment Tysabri, made by Biogen Idec Inc. and its Irish partner Elan Corp., is the latest in a series of negative revelations about drugs' safety and effectiveness.
>> Read article at SeattlePI.NWSource.com

February 27, 2005

Hard sell: how marketing drives the pharmaceutical industry
The painkillers Vioxx, Celebrex and Bextra may go down in history as a classic example of the danger posed by aggressive industry promotion of prescription drugs to both patients and doctors.
>> Read article at SFGate.com

February 26, 2005

Senator Questions FDA Panellists' Ties to Industry
An advisory panel's recommendation that the Food and Drug Administration allow two painkillers to stay on the market despite cardiac risks was marred by its members' ties to drug makers, a senior lawmaker said Friday. But two doctors who served on the panel suggested another explanation for close votes on the painkillers Bextra and Vioxx: a difference of perspective between physicians on the committee.
>> Read article at LATimes.com

FDA's safety reform is greeted with scepticism
The US consumer watchdog group Public Citizen has described the creation of a new safety body at the Food and Drug Administration as a "desperate" and "cynical" attempt to respond to public alarm about the harms of prescription drugs.
>> Read article at BMJ.com

February 25, 2005

U.S. health spending is expected to double in decade
The Bush administration has predicted that government will account for nearly half of all U.S. health care spending by 2014. Further, the administration said on Wednesday, total health spending will double in a decade, to $3.6 trillion in 2014 from $1.8 trillion last year, while gross domestic product, the total output of goods and services, will grow more slowly.
>> Read article at IHT.com

FDA panellists with ties to industry vital in getting Cox-2 drugs back on market
Ten members of the U.S. Food and Drug Administration advisory panel who voted that a group of powerful pain killers should continue to be sold had ties to the drugs makers, a new analysis shows. Their votes were crucial in keeping two of the three drugs in question on the market. A study by the Center for Science in the Public Interest indicates that 10 of the 32 panel members had ties to either Pfizer Inc., or Merck & Co., ranging from consulting fees and speaking honoraria to receiving research support from the companies.
>> Read article at MedBroadcast.com

Influenza Vaccination Programmes For Children
in USA and Canada Based on Little Evidence
Children in the USA and Canada are being vaccinated against influenza without adequate proof that it will work, concludes a study published in this week's issue of The Lancet. Most immunisation campaigns target people aged 65 years or older. The USA and Canada have recently started vaccinating children, including those aged 6 to 24 months, in the hope of reducing disease spread, admissions and visits to hospitals, deaths of elderly relatives, complications (such as ear infections and pneumonia), absences from school, and parental loss of workdays and over-prescribing of antibiotics. However, there is no evidence that vaccinating children can achieve these goals.
>> Read article at MedicalNewsToday.com

Poll Shows Americans Value Drugs, But Say Drug Makers Put Profits First
Americans believe prescription drugs are improving their lives, but most also say that the drug industry cares more about profits than people, according to the latest Kaiser Health Poll Report issued by Kaiser.
>> Read article at KFF.org

February 24, 2005

Heart Attack Risk with HIV Drugs a Concern
The risk of having a heart attack for HIV-positive people increases the longer they're on anti-HIV drug therapy, according to the latest results of a large multi-center study. However, the overall absolute risk of a heart attack is still "modest," Dr. Jens Lundgren of the University of Copenhagen told an audience at the 12th Annual Retroviral Conference on Wednesday.
>> Read article at Reuters.com

February 22, 2005

Pharmaceutical and biotechnology industry in the new EU countries
presents considerable potential
In contrast to subdued growth in the pharmaceutical markets of the former 15-state European Union (EU), pharmaceutical markets in the 'new' EU accession markets are expanding vibrantly. While the former has been increasing at eight per cent annually, the latter has been growing at the rate of 16.5 per cent over the past five years, offering exciting growth opportunities to pharmaceutical and biotechnology companies.
>> Read article at News-Medical.net

Clampdown on misleading drug ads
Companies who use misleading advertising to promote drugs and other medical products will be "named and shamed" the (UK drug) regulator has announced. The Medicines and Healthcare products Regulatory Agency (MHRA) plans to clampdown on poor advertising. It will target inflated claims about a product's effectiveness, and the use of confusing information. As well as pursuing legal action where appropriate, the MHRA will publish advert reviews on its website.
>> Read article at BBCNews.com

February 21, 2005

Novartis to become world's biggest generic drugs maker
The Swiss drugs firm Novartis today agreed to buy German firm Hexal and most of US company Eon Labs in deals worth €5.6bn (£3.8bn). The acquisitions will make it the world's largest generic drugs manufacturer. Novartis will gain a leading position in the major markets for generic drugs, which are chemically identical to more expensive branded rivals, in Germany and the US. It is buying 100% of Hexal and 67.7% of Eon Labs from the Struengmann family, of Germany.
>> Read article at Guardian.co.uk

FDA Policy Adviser Says More Agency Collaboration With Pharmaceutical Industry
Would Help Restore Confidence in Medication Safety
Amit Sachdev, deputy commissioner for policy at FDA, on Wednesday said that increased collaboration with the pharmaceutical industry would help restore public confidence in the agency's prescription drug approval process and the safety of medications on the market.
>> Read article at MedicalNewsToday.com

February 20, 2005

FDA Safety Official Testifies COX-2 Inhibitors
Have Cardiovascular Risks Similar to Smoking
COX-2 inhibitors increase risk for cardiovascular events at about the same rate as cigarette smoking, hypertension and diabetes, FDA Office of Drug Safety Officer David Graham told an agency advisory committee on Thursday.
>> Read article at MedicalNewsToday.com

February 19, 2005

AIDS Case in N.Y. May Not Be a Harbinger of Supervirus
The virulent and highly drug-resistant case of AIDS recently found in a New York City man is similar in some ways to two Canadian cases that appeared in 2001 and did not lead to the spread of a "supervirus," as some fear may happen in New York.
>> Read article at WashingtonPost.com

A Reminder That No Drug Is Risk-Free
When a federal panel of doctors and scientists recommended allowing the sale of arthritis medicines from Pfizer and Merck despite acknowledging their heart risks, it did more than just give new life for Celebrex, Bextra and possibly Vioxx - three drugs some analysts had viewed as doomed. The panel's recommendations backed the pharmaceutical industry's stance that no medicine is risk-free and that patients should sometimes be allowed to choose medicines that have serious risks even for conditions that are not life-threatening.
>> Read article at NYTimes.com

Activists sue Merck and Pfizer
Healthcare activists in Massachusetts sued Merck & Co. Inc. and Pfizer Inc. in separate lawsuits over marketing campaigns for their arthritis pain medications, alleging the companies misled consumers by advertising benefits of the drugs while not disclosing the full range of risks and shortcomings.
>> Read article at Boston.com

FDA panel supports return of Vioxx drug
A Food and Drug Administration advisory panel yesterday recommended that Merck & Co. could resume selling the painkiller Vioxx, but must include stringent warnings of the heart problems it can cause and restrictions on its use. The panel also decided that, like Vioxx, the drugs Celebrex and Bextra pose cardiovascular risks but offer enough benefits that they should remain available -- with warnings and limits similar to those for Vioxx.
>> Read article at Boston.com

February 18, 2005

Bush Signs Landmark Bill On Class-Action Lawsuits
President Bush on Friday signed a bill that he says will curtail class-action lawsuits against companies and "marks a critical step toward ending the lawsuit culture in our country." The legislation aims to discourage multimillion-dollar class-action lawsuits by having federal judges take them away from state courts, a victory for conservatives who hope it will lead to other lawsuit limits. The president has described class-action suits as often frivolous, and businesses complain that state judges and juries have been too generous to plaintiffs.
>> Read article at WSJ.com (Subscription needed)

Alzheimer's Drug Fears
A drug prescribed to treat dementia in elderly patients actually accelerates their mental decline, a shocking new study of Alzheimer's sufferers in the North of England claims today. More than eight million people have used Seroquel since 1997 and it is given to about 45pc of dementia patients in care homes to control agitation.
>> Read article at RedNova.com

European warning on Cox-2 painkillers as fears grow
European watchdogs issued a warning yesterday about the use of Cox-2 type painkillers amid growing concerns about their health risks. The European Medicines Agency said doctors should be cautious about giving the drugs to patients with risk factors for heart disease, and should not prescribe them to people who have heart disease or have had strokes. It also advised that the lowest dose and shortest course should in any case be prescribed.
>> Read article at Netdoctor.co.uk

SSRIs and suicide: evidence supports the association
People taking selective serotonin reuptake inhibitors (SSRIs) are more likely to attempt suicide than people taking placebo or a non-SSRI drug.
>> Read article at BMJ.com

America approves bill to limit class action lawsuits
Landmark legislation aimed at curbing class action lawsuits against big business in America overcame Democratic opposition yesterday to win approval in Washington. The measure transfers most class action suits from state to federal courts. The US house of representatives approved the bill by 279 votes to 149. It now needs only the president's signature.
>> Read article at Guardian.co.uk

February 17, 2005

Merck May Consider Selling Vioxx Again
Merck will consider selling its arthritis pill Vioxx again if the U.S. Food and Drug Administration decides the cardiovascular risks are similar to those of related prescription pain relievers, a company official said on Thursday. New information on competing pain drugs presented to a U.S. advisory committee over two days at a public hearing has changed the company's evaluation of Vioxx, Merck Research Labs President Peter Kim told an FDA advisory panel.
>> Read article at Boston.com

Hormone therapy controversy raises drug safety issues
"The hormone therapy debate is one more example of a larger issue: are the medications that doctors prescribe safe, and do the benefits outweigh any risks?" said Michelle Naughton, Ph.D., lead author of an article in the current issue of Journal of Social Issues.
>> Read article at MedicalNewsToday.com

February 16, 2005

Party may be over for Big Pharma
Reynold Panettieri Jr. is sitting pretty, flush with drug-company money for his research on asthma at the University of Pennsylvania. Edward Garvey, on the other hand, is miffed, having lost his pharmaceutical marketing job in New Jersey because of corporate cost cutting. These are the clashing realities of the global pharmaceutical business today, with the Philadelphia region one of its hubs. Companies are gambling ever bigger sums of money on blockbuster products, with painful consequences when they falter.
>> Read article at Philly.com

Merck Says Heart Risk Not Limited To Vioxx
Researchers at Merck now say that the cardiovascular effects that caused Vioxx to be pulled from the market were part of a "class effect," which may extend at least two other similar medicines.
>> Read article at Forbes.com

February 15, 2005

Drug sales in the US head for stagnation
The rate of growth in America’s massive drugs market is set to grind to a halt over the next three years amid mounting safety fears, a leading consultant has revealed. In a forecast that is closely watched by the pharmaceuticals industry, IMS Health, the industry research firm, is predicting that US sales growth in prescription medicines will flatten out at just 7.5 to 8.5 per cent a year for each of the next three years.
>> Read article at TimesOnline.co.uk

FDA to Create New Drug Safety Board
The U.S. Food and Drug Administration said on Tuesday it was creating a new drug safety board to improve the monitoring of medicines already in the marketplace, a response to charges the agency has failed to protect the public from dangerous side effects. The announcement comes on the eve of a three-day FDA meeting called to discuss the safety of painkillers like Merck & Co. Inc.'s now-withdrawn Vioxx that have been linked to an increased risk of heart disease and stroke.
>> Read article at Reuters.com

Drug Industry's Longtime Critic Says 'I Told You So'
Dr. Wolfe, a director at Public Citizen, a consumer advocacy group, has been angry with the Food and Drug Administration and talking himself hoarse about it for nearly 34 years. He has condemned dozens of high-priced medicines and denounced their makers. He has castigated state medical boards and railed about rates for Caesarean sections. He has sought to ban unpasteurized milk and some herbal supplements.
>> Read article at NYTimes.com

Truth in Advertising
Investigators reviewed pharmaceutical ads in American medical journals and found that nearly one-third contained no references for medical claims; while the majority of references to published material were available, only a minority of company data-on-file documents were provided upon request; and the majority of original research cited in the ads was funded by or had authors affiliated with the product's manufacturer.
>> Read article at MedicalNewsToday.com

More Pain For Pfizer
One the eve of a crucial Food and Drug Administration hearing, the New England Journal of Medicine is releasing damning new details from studies indicating that the Pfizer painkillers Celebrex and Bextra may cause the same sorts of heart problems that led to the recall of Merck's Vioxx last fall. The top-line results of the studies were announced last fall, but this is the first publication of the full details. In one study of Bextra and its injected cousin parecoxib, heart bypass patients treated for as little as ten days with the drugs had nearly quadruple the risk of having a heart attack or other cardiovascular-adverse events in the next month.
>> Read article at Forbes.com

February 12, 2005

Health Agency Chief Seeks Conflict Summit
The head of the U.S. National Institutes of Health said he wants government and academic leaders to meet to address conflicts of interest in medical research, the Los Angeles Times reported on Saturday. "We need to have a summit discussion to say, 'Look, what is the interest of the public?' The interest of the public is to make sure the science that's done is not tainted," the Times quoted NIH Director Dr. Elias Zerhouni as saying.
>> Read article at Reuters.com

Rare and Aggressive H.I.V. Reported in New York
A rare strain of H.I.V. that is highly resistant to virtually all anti-retroviral drugs and appears to lead to the rapid onset of AIDS was detected in a New York City man last week, city health officials announced on Friday. It was the first time a strain of H.I.V. had been found that both showed resistance to multiple drugs and led to AIDS so quickly, the officials said. While the extent of the disease's spread is unknown, officials called a news conference to say that the situation is alarming.
>> Read article at NYTimes.com

A Dismal Class-Action Finale
Senator Joseph Biden, the Delaware Democrat, got it exactly right when he pronounced the limits on class-action lawsuits approved on Thursday by the Senate a bad idea whose time has come.
>> Read article at NYTimes.com

Wyeth rheumatoid arthritis drug causes fatal side effects in 134 users
Rheumatoid arthritis drug Rheumatrex Capsule caused fatal side effects in 134 people between March 1999 and November 2004, according to a manufacturer's report. Wyeth K.K., the Japanese subsidiary of U.S. drug manufacturer Wyeth, said in its annual survey that the side effects were caused by methotrexate. An estimated 100,000 people nationwide are taking the drug.
>> Read article at Japantimes.co.jp

Novartis to Pay $49.2 Million in Civil, Criminal Penalties
A unit of Novartis agreed to pay $49.2 million in civil and criminal fines and be excluded from federal healthcare contracts to resolve a probe into its marketing of nutritional products to Medicare and Medicaid.
>> Read article at LATimes.com

February 11, 2005

Bush vows veto of any tampering with Medicare plan
President George W. Bush warned Congress on Friday he would veto any legislation that would take away prescription drug coverage for senior citizens, a new Medicare benefit whose rising costs are causing heartburn in Washington.
>> Read article at ReutersHealth.com

Drug regulators are trying to quash study, senator says
The tension and intrigue surrounding a crucial federal drug advisory committee meeting next week, already high, reached a boil on Friday when Senator Charles E. Grassley charged that top federal drug regulators intended to suppress an important study. The panel has been convened to discuss whether Celebrex and Bextra, heavily selling arthritis pills from Pfizer, hurt the heart and are worth their potential risks. But top officials of the Food and Drug Administration have forbidden Dr. David Graham, a drug-safety officer at the agency, to discuss before the panel a large study of that very question, said Dr. Gurkirpal Singh of Stanford University School of Medicine, Dr. Graham's co-author.
>> Read article at NYTimes.com

Amgen Says Trial Halted on Safety Concern
Amgen Inc. confirmed Friday that it halted a clinical trial of an experimental treatment for Parkinson's disease because the drug could cause permanent brain damage.
>> Read article at WashingtonPost.com

FDA had concerns about Vioxx for years
U.S. drug regulators had serious concerns about Vioxx more than two years before Merck & Co. pulled the popular painkiller over safety concerns. The Food and Drug Administration knew Alzheimer's studies showed older people taking the drug were more likely to die than those in a placebo group but did not order Merck to warn doctors about such concerns.
>> Read article at BigNewsNetwork.com

Marketing of Vioxx: How Merck Played Game of Catch-Up
At times, it is necessary to "neutralize" the opposition, or at least Merck & Company executives seemed to think so. In 1999, the company's new pain drug, Vioxx, was beaten to pharmacy shelves by a competing drug, Celebrex. Merck apparently hoped that nationally known rheumatologists like Dr. Roy Altman could help it catch up.
>> Read article at NYTimes.com

February 10, 2005

Regulator sought curbs on high dose of cholesterol drug
Experts at the UK's medicine regulator expressed serious worries over high doses of controversial cholesterol-lowering drug Crestor just two months before it went on the market, confidential documents seen by the Guardian reveal. Their concerns were overruled by a European-wide decision to allow the high dose, 40mg, on the market.
>> Read article at Guardian.co.uk

Medicare Prescription Drug Benefit To Cost $720 Billion Over First 10 Years, CMS Says
The new Medicare prescription drug benefit will cost more than $720 billion over its first 10 years, with costs reaching $100 billion annually by 2015, according to new estimates released Tuesday by CMS Administrator Mark McClellan.
>> Read article at MedicalNewsToday.com

February 9, 2005

Bioterror Bill Would Increase Drug Costs
The Generic Pharmaceutical Association (GPhA) today issued a strong warning to the Senate that biodefense legislation (S. 3) in its current form would effectively extend patents for marketed drugs and delay access to more affordable generic medicines - unnecessarily increasing prescription drug costs to consumers, businesses, and government purchasers by tens of billions of dollars a year.
>> Read article at MedicalNewsToday.com

Savings in US President's Budget Undercut
By Reductions in Disease Prevention And Health Promotion
The American Public Health Association (APHA) says that proposed savings as outlined today in President Bush's budget are severely undercut by the administration's failure to adequately invest in disease prevention and health promotion activities. "While controlling federal spending is critical, the administration's failure to adequately invest in prevention means that any perceived short-term savings will result in greater health and medical expenditures in the long-term," says Georges C. Benjamin, MD, FACP, executive director of APHA. "It's like owning a car, but never taking it in for service. Without prevention, catastrophic failure is imminent."
>> Read article at MedicalNewsToday.com

February 8, 2005

Illinois Joins Other States Suing Drug Makers
The Illinois attorney general accused 48 major drug makers of fraud for overcharging government health care programs, joining several other U.S. states filing similar suits, authorities said on Tuesday. The lawsuit filed in Cook County Circuit Court in Chicago by state Attorney General Lisa Madigan "alleges that the people of Illinois overpaid hundreds of millions of dollars over the last decade or so," said her spokeswoman, Melissa Merz.
>> Read article at Reuters.com

Merck Cancelled an Early Study of Vioxx
Merck & Company executives have long insisted that they never pursued a clinical trial to directly study the heart risks of the pain drug Vioxx because other tests they were conducting would supply those answers just as quickly. But previously undisclosed company documents show that the drug maker was poised to begin a major cardiovascular study of the drug in 2002, and abruptly dropped the project just before it was set to start. The trial was scheduled to produce data by March 2004 but may have provided answers about Vioxx's risks even earlier if patients had shown ill effects.
>> Read article at NYTimes.com

Vaccine maker's '91 memo suggests mercury-level risk
A memo from Merck & Co. shows that, nearly a decade before the first public disclosure, senior executives were concerned that infants were getting an elevated dose of mercury in vaccinations containing a widely used sterilizing agent. The March 1991 memo, obtained by the Los Angeles Times, said 6-month-old children who received their shots on schedule would get a mercury dose as much as 87 times higher than guidelines for the maximum daily consumption of mercury from fish.
>> Read article at SanFransiscoChronicle.com

Will your vitamins be banned from the shelves after August?
If you are among the 43 per cent of the population who take vitamins, minerals or other food supplements, you may well be feeling a little alarmed and confused. On August 1, the European Food Supplements Directive takes effect. From then, the only vitamins and minerals that can be sold in Britain will be those on a list of permitted substances, or those for which an application to be added to this "positive" list has been made.
>> Read article at Telegraph.co.uk

February 6, 2005

Guiding a company in the midst of a crisis
Merck & Co. Inc. has been in crisis since Sept. 30, when the company pulled its prescription painkiller Vioxx off the market after a study confirmed the drug increased the risk of heart attack and stroke. Merck chief Raymond Gilmartin is grappling with multiple product-liability and shareholder lawsuits. Scheduled to retire in April 2006 under a plan in place before the Vioxx disaster, Gilmartin spoke with Globe reporter Christopher Rowland during a visit to Boston last week.
>> Read article at Boston.com

Lilly's Boss Says American Health System is Unhealthy to the Core -
Offers Principles for Reform
America's health care system is hurting, and fixing it requires the urgent attention of elected officials, Eli Lilly and Company's Chairman, President and Chief Executive Officer Sidney Taurel said today.
>> Read article at MedicalNewsToday.com

February 4, 2005

Merck CEO Rejects Bankruptcy, Merger Talk
There is no way Merck & Co. will have to declare bankruptcy over pending Vioxx litigation, nor is it considering a major merger, the company's chief declared Thursday. In an interview with MarketWatch, Chairman and Chief Executive Raymond Gilmartin contended the strength of Merck's cash flow, coupled with conservative management, will keep the pharmaceutical giant financially sound.
>> Read article at SmartMoney.com

Novartis drug risk seen similar to Vioxx
A clinical trial for Novartis AG's experimental painkiller Prexige showed the risk of heart attack, stroke and death was "similar" to Merck & Co. Inc.'s now withdrawn Vioxx, U.S. regulatory staff said in documents released on Friday.
>> Read article at Alternet.org

FDA staff questions heart risks of Merck's Arcoxia
Merck & Co. Inc.'s painkiller Arcoxia offers a "marginal" advantage in gastrointestinal safety but seems "worse than" other pain drugs in terms of deaths and serious cardiovascular problems, U.S. regulatory staff said in documents released on Friday. Merck conducted studies on Arcoxia comparing it to a placebo, naproxen and other medicines known as nonsteroidal anti-inflammatory drugs.
>> Read article at Alertnet.org

Glaxo demands China, India, Brazil respect patents
GlaxoSmithKline, Europe's biggest drug maker, is calling for Britain to use its presidency of the G7 to ensure the world's emerging economic powerhouses respect patents and clamp down on counterfeiting. "Globally, the UK must work to deliver a level playing field by demanding respect for intellectual property rights in the countries that benefit the most from globalisation -- India, China, Brazil," GSK Chief Executive Jean-Pierre Garnier said on Friday.
>> Read article at Reuters.co.uk

Newborns at Risk of Antidepressant Withdrawal
Newborn babies could be at risk of suffering withdrawal symptoms if their mothers are prescribed antidepressants during pregnancy, researchers said on Friday. The drugs known as selective reuptake inhibitors (SSRIs) can cause convulsions, irritability, abnormal crying and tremors.
>> Read article at Reuters.com

February 3, 2005

Bush's Calls for Tort Overhaul Face Action in Congress
With President Bush pressing Congress for a swift overhaul of the nation's civil liability system, action in the Senate Judiciary Committee this week is quickly turning into the political laboratory for what will be doable and what will be difficult. In his State of the Union address on Wednesday evening, Mr. Bush once again urged lawmakers to rewrite the tort law rules to do away with what he has called frivolous and costly lawsuits, which he has repeatedly said have become a significant drag on the economy.
>> Read article at NYTimes.com

FDA Warns Glaxo on Hypertension Drug Marketing
The U.S. Food and Drug Administration warned GlaxoSmithKline Plc on Thursday about misleading advertisements touting its hypertension drug called Coreg. The company presented the marketing information at a conference last June, using posters that omitted risk information and overstated how well the drug worked, the FDA said in a letter posted on its Web site.
>> Read article at Reuters.com

NIH Workers Angered by New Ethics Rules
National Institutes of Health Director Elias A. Zerhouni stood before hundreds of NIH employees yesterday to explain why it had become necessary for him to impose, in his words, "drastic" restrictions on stock ownership and other forms of outside income, which take effect today for all agency employees.
>> Read article at WashingtonPost.com

Gift for drug industry?
As anyone who watches Sunday's Super Bowl will note, the demand for erectile-dysfunction drugs has not emerged in a vacuum. The manufacturers of Viagra, Levitra and Cialis have been bombarding sporting-event telecasts with advertising for their highly profitable drugs.
>> Read article at SFGate.com

Liver alert on hyperactivity drug
A drug used to treat behaviour problems in children has been linked to liver damage, say experts. Strattera was licensed for the treatment of attention deficit hyperactivity disorder (ADHD) last year.
>> Read article at BBCNews.com

AstraZeneca facing class action suits over Iressa
AstraZeneca’s Japanese subsidiary is facing the threat of a class action lawsuit over the fatal side-effects of Iressa, its lung cancer treatment. The 29 Japanese lawyers representing the families of Iressa victims are also mulling cases against the London-based parent company and are planning a fact-finding trip to the UK.
>> Read article at TimesOnline.co.uk

February 2, 2005

Pushing Risky Drugs
Even as expert advisers to the Food and Drug Administration prepare to take a closer look at a potentially risky class of painkillers, the COX-2 inhibitors, disturbing new evidence has emerged that these drugs have been prescribed primarily to patients who do not need them. If an analysis just published in The Archives of Internal Medicine holds up under further scrutiny, it will provide a telling example of how an avalanche of marketing can propel the use of new drugs far beyond reason, posing needless risks to patients they are unlikely to help.
>> Read article at RedNova.com

Jobs not a priority as companies repatriate foreign profits
When the U.S. Congress passed a one-time tax break on corporate foreign profits last year, lawmakers said their main purpose was to encourage American companies to build new operations and hire more workers at home. But as corporations are gearing up to bring tens of billions of dollars back to the United States this year, adding jobs is far from their highest priority. Some, in fact, say they might end up cutting their work forces.
>> Read article at IHT.com

Half of Bankruptcy Due to Medical Bills
Half of all U.S. bankruptcies are caused by soaring medical bills and most people sent into debt by illness are middle-class workers with health insurance, researchers said on Wednesday. The study, published in the journal Health Affairs, estimated that medical bankruptcies affect about 2 million Americans every year, if both debtors and their dependents, including about 700,000 children, are counted.
>> Read article at Reuters.com

Class-Action Lawsuits
Tort reform is in the eye of the beholder. In the name of reforming the nation's civil justice system, and with scant public debate, President Bush and Congressional Republicans are racing to reward wealthy business supporters by changing the rules for class-action lawsuits. Their real objective is to dilute the impact of strong state laws protecting consumers and the environment and to make it harder for Americans to win redress in court when they are harmed by bad corporate behavior.
>> Read article at NYTimes.com

UK should help build African drug industry
The country’s national academy of science is calling for the government to help build a drug industry in Sub-Sahara Africa by providing long-term investment.
>> Read article at BlackBritain.co.uk

February 1, 2005

4 Networks Reject Ad Opposing Bush on Lawsuits
An advocacy group, USAction, said on Monday that four television networks had turned down its request to run an advertisement opposing President Bush's effort to clamp down on medical malpractice lawsuits.  The group wanted to run the spots just before Mr. Bush's State of the Union address on Wednesday. But networks said the advertisement violated their standards for advertising on controversial issues.
>> Read article at NYTimes.com

NIH to Ban Deals With Drug Firms
Under a far-reaching reform to be announced today, all staff scientists at the National Institutes of Health will be banned from accepting any consulting fees or other income from drug companies, and the employees must also divest industry stock holdings, officials said.
>> Read article at LATimes.com

Pfizer Says 1999 Trials Revealed Risks With Celebrex
Celebrex, the popular arthritis and pain medicine from Pfizer, sustained another blow yesterday when the company acknowledged that a 1999 clinical trial found that elderly patients taking the drug were far more likely to suffer heart problems than patients taking a placebo.
>> Read article at NYTimes.com

Popular painkiller to be withdrawn
Twenty years after doctors were warned that a painkiller taken by 1.7m people a year was linked to suicides and accidental deaths, the government announced yesterday it was to be withdrawn. Co-proxamol, also known by the trade names Distalgesic, Cosalgesic and Dolgesic, is involved in between 300 and 400 deaths every year. About a fifth of those are accidental, sometimes involving alcohol.
>> Read article at Netdoctor.co.uk

US government list of cancer-causing agents grows
The Department of Health and Human Services released its Eleventh Edition of the Report on Carcinogens today, adding seventeen substances to the growing list of cancer-causing agents, bringing the total to 246.
>> Read article at MedicalNewsToday.com

January 31, 2005

FDA Reinstates Military Anthrax Vaccination Program
The Food and Drug Administration has invoked the Project BioShield Act of 2004 for the first time to partly overturn a judge’s ruling that anthrax vaccine adsorbed (AVA) was approved in violation of FDA regulations and could not be administered to troops against their will.
>> Read article at Mealeys.com

January 30, 2005

Class-action lawsuit claims antipsychotic drug led to diabetes
A B.C. man has launched a class-action lawsuit against drug maker Eli Lilly over its medication Zyprexa, claiming the company "minimized" the heath risks of taking the anti-psychotic drug. The suit filed in the B.C. Supreme Court alleges Vancouver's Marc Estrin developed diabetes as a result of taking the drug to treat schizophrena.
>> Read article at MedBroadcast.com

January 28, 2005

Merck Slumps On SEC Vioxx Investigation
The pharmaceutical giant said Friday that the U.S. Securities and Exchange Commission has started a formal inquiry into the company's handling of the withdrawal of Vioxx. Previously, Merck said the SEC was conducting an informal investigation.
>> Read article at Forbes.com

January 26, 2005

Merck sets aside $675m to pay for arthritis drug lawyers
The US drugs company Merck is to spend at least $675 million on lawyers and other legal fees to defend itself against writs from patients who suffered side-effects from the arthritis drug Vioxx. The district attorney in Munich, Germany, has started a criminal inquiry into the company over the drug, Merck admitted yesterday.
>> Read article at Netdoctor.co.uk

January 25, 2005

Novartis chief admits pharmaceutical industry has lost public trust
Daniel Vasella, chief executive of Novartis, has warned his peers that ‘big pharma’ has lost the trust of consumers and regulators in the midst of product recalls and clinical data controversies.
>> Read article at EthicalCorp.com

Doctor cuts Wall Street, drug maker ties
A prominent Cleveland Clinic researcher has stopped working as a paid consultant for a Wall Street fund and has broken ties to many drug companies to avoid any potential conflicts of interest.
>> Read article at Boston.com

Medical journal prints controversial study of Vioxx; had withheld the report
A medical journal published a study Tuesday of coronary disease related to the anti-inflammatory drug Vioxx after withholding the report because the researcher said he had been threatened by superiors at the U.S. Food and Drug Administration. The Lancet, which originally planned to publish the paper on Nov. 17, released the study online.
>> Read article at MedBroadcast.com

January 24, 2005

Group Calls on FDA to Pull Pfizer Pain Drugs
U.S. regulators should pull Pfizer Inc.'s arthritis drugs Celebrex and Bextra from the market because they are too risky, U.S. consumer watchdog group Public Citizen said in a letter on Monday. In a formal petition to the U.S. Food and Drug Administration, Public Citizen said the two drugs' potential to cause heart attacks and strokes outweighed any possible benefit.
>> Read article at Reuters.com

Avoiding Another Vioxx
"Too cozy" is how Senator Charles Grassley of Iowa referred to the relationship between the U.S. Food and Drug Administration and pharmaceutical companies in the aftermath of the Vioxx debacle. Although the FDA admits no substantive lapse in vigilance, congressional pressure and consumer outrage are forcing officials to rethink the agency's role and perhaps even the drug approval process itself.
>> Read article at SciAm.com

January 23, 2005

Vioxx, Celebrex overprescribed?
Millions of Americans who were prescribed Vioxx or Celebrex in the drugs' first few years on the market could have safely taken older, cheaper painkillers such as ibuprofen, a new study says. The drugs' main selling point was that, theoretically at least, they were less likely to cause bleeding and other serious stomach complications than older nonsteroidal anti-inflammatory drugs, or NSAIDs. But patients at low risk for such problems accounted for two-thirds of the growth in Vioxx and Celebrex use from 1999 — when the drugs came on the market — to 2002, researchers report today in the Archives of Internal Medicine.
>> Read article at USAToday.com

January 22, 2005

UK Drug Regulator Planning to Get Tough on Sales Pushes
The UK drugs regulator is considering plans to "name and shame" pharmaceuticals companies that engage in aggressive or misleading marketing. The organisation is also looking at tightening rules on company- sponsored entertainment and hospitality for doctors, and on "disease awareness" campaigns that implicitly promote a particular drug to people. It may also step up prosecutions for the most serious breaches by drug companies.
The Medicines and Healthcare Products Regulation Agency (MHRA) is to ask for public comments on possible "get tough" policies, after taking private soundings from the drug industry over the past weeks.
>> Read article at RedNova.com

Safety Concerns Reported on J & J. Alzheimer's Drug
Regulators are reviewing the safety of the Alzheimer's disease drug Reminyl after data from two clinical trials indicated that people taking the drug had a much higher death rate than those taking a placebo. The review was announced yesterday by Johnson & Johnson, which said it was in discussions with the Food and Drug Administration and regulators in Europe and Canada.
>> Read article at NYTimes.com

January 21, 2005

AstraZeneca cancer drug could be banned in Japan
Japan’s Ministry of Health and Welfare is considering banning Iressa, AstraZeneca’s controversial lung cancer drug, after accepting a report that linked the medicine to 588 deaths in the country — more than four times the number previously thought. An official spokesman for the ministry told The Times last night that the findings would raise the “possibility” that Iressa would be now be withdrawn. The report, compiled by a panel of scientists, concludes that 1,473 patients suffered side effects after taking Iressa and that the drug was linked to 588 deaths.
>> Read article at TimesOnline.co.uk

Novartis sucked into Serious Fraud Office inquiry
The Serious Fraud Office is investigating a division of Novartis, one of the world's largest pharmaceutical firms, for alleged criminal marketing practices as part of its investigation into alleged price-fixing by drugs companies. Novartis's generic drug division, Sandoz, is being investigated to find out if it broke criminal or competition law while selling its products. Sandoz makes a wide range of drugs in the UK, from the breast cancer treatment tamoxifen to diazepam and ibuprofen.
>> Read article at Guardian.co.uk

January 20, 2005

WHO backs AIDS drug despite FDA warning
The World Health Organisation (WHO) said it would continue recommending use of the Viramune drug in AIDS patients despite a U.S. regulatory warning, as the benefits were greater than toxicity problems. "We don't think at the moment to change our policy ...," Charles Gilks, director of WHO's AIDS treatment and prevention scale-up team, told Reuters on Thursday. "We are aware of the toxicity profile, but at the moment we believe the benefits outweigh any problems," he said.
>> Read article at Alertnet.org

Lawyers Plan Attack on Merck Over Vioxx
Most of the roughly 250 lawyers assembled in the Wyndham Philadelphia hotel ballroom listened intently Thursday as fellow attorney Barry Hill showed off an extensive collection of trinkets and product samples emblazoned with the logo of the now-withdrawn drug Vioxx. "Maybe you can use them (the samples) as evidence," joked Hill, a Wheeling, W.V., trial lawyer who bears a resemblance to the actor William Holden.
>> Read article at Forbes.com

Study Shows Plavix Has Higher Ulcer Risk
Plavix, a heart drug recommended by medical groups as an easy-on-the-stomach substitute for aspirin, instead showed a much higher risk of recurrent ulcers in a small but provocative study. The study could upend the treatment guidelines for tens of thousands of Americans who must take anti-clotting drugs for their hearts but are prone to gastrointestinal problems.
>> Read article at Philly.com

January 19, 2005

Cancer Now the Leading Killer of Americans
Cancer has displaced heart disease as the leading killer of Americans under the age of 85, according to the American Cancer Society's latest projections released Wednesday. Even though the mortality rates are higher relative to heart disease, according to the latest report, the mortality from many types of cancer is actually declining. Cancer now accounts for about 23 percent of all deaths among Americans regardless of age, the annual report found.
>> Read article at HealthScout.com

U.S. Warns of Safety Risks of Boehringer AIDS Drug
An important AIDS drug can cause sometimes deadly liver damage but remains a key option for many patients, U.S. health officials warned on Wednesday. The Food and Drug Administration said doctors should weigh benefits and risks before prescribing the drug, Boehringer Ingelheim's Viramune, also known by the generic name nevirapine.
>> Read article at Reuters.com

Pfizer's Celebrex Risk Gets Worse
In an earnings statement issued by Pfizer recently it revealed, for the first time, that there may have been other, inconclusive data that could be used to argue that Celebrex poses a heart risk.
>> Read article at Forbes.com

NIH Halts Use of COX-2 Inhibitor in Large Cancer Prevention Trial
The National Institutes of Health (NIH) announced today that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute. The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo.
>> Read article at MedicalNewsToday.com

January 18, 2005

More Evidence of Heart Risks from Bextra
Combining aspirin with the painkiller Bextra may magnify the heart-related risks associated with Bextra and similar drugs. Two new studies offer new clues about the role of Bextra in heart disease. They suggest that combining Bextra with aspirin may increase the risk of blood clots that could trigger a heart attack or stroke.
>> Read article at WebMD.com

January 17, 2005

Public to view drug side effects
Patients will be able to examine data on the safety of different medicines, the UK government has announced. Anonymised data on suspected adverse drug reactions will be published on the Medicines and Healthcare products Regulatory Agency website. Researchers will be able to access more detailed information.
>> Read article at BBCNews.co.uk

Lilly Launches Public Outreach Initiative to "Correct" Allegations About Company and Prozac
Eli Lilly and Company today announced its plans to correct “inaccurate statements” circulating in the news media based on a collection of random papers anonymously sent to the British Medical Journal (BMJ). Lilly has posted a detailed explanation of those papers in question on its website and has published an open letter to patients in leading U.S. newspapers to state its case.
>> Read article at MedicalNewsToday.com

Drug advertising: FDA warning may return to haunt Pfizer
Pfizer has withdrawn advertising of its COX-2 products in view of the FDA's concerns and the wider controversy surrounding the safety of COX-2s. Whether intentional or not, the 'misleading' advertisements will have benefited sales as the general public will mostly be unaware of the violations against the FDA's rulings. The immediate future does not look good for either the COX-2 class or Pfizer.
>> Read article at CommentWire.com

Protests over US bill to shield drug firms from court
Patients in the US who suffered severe side-effects from revolutionary new drugs may be denied recourse to the courts under a new law being drawn up by President Bush's second administration. The move would shield the world's major drug companies from waves of expensive litigation, in effect capping the costs associated with controversial drugs such as Vioxx, Merck's arthritis painkiller which the manufacturer withdrew after several users suffered heart attacks or strokes.
>> Read article at Guardian.co.uk

January 16, 2005

Another cholesterol drug seeks OTC status
Although a Food and Drug Administration advisory panel has recommended against selling one cholesterol-lowering statin drug over-the-counter (OTC), the maker of another is moving forward with plans to seek the agency's permission to make the switch.
>> Read article at USAToday.com

January 15, 2005

Insurers cut cover to drug firms amid fear of lawsuits
Insurance companies are cutting the amount of cover they are prepared to offer big drug manufacturers against litigation amid fears of a surge in new lawsuits from patients.
>> Read article at TimesOnline.co.uk

Amgen Issues Warning on Drug
Amgen Inc. sent a letter to doctors warning that high doses of anemia drugs, including the company's Aranesp, might be dangerous for cancer patients. Amgen said it issued the letter after studies of similar drugs sold by Roche Holding and Johnson & Johnson showed a higher death rate in patients whose red-blood cell levels exceeded targets.
>> Read article at LATimes.com

FDA Announces Dates for Public Meeting on Non-Steroidal Anti-Inflammatory Drugs
The Food and Drug Administration (FDA) has announced a joint public meeting of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to be held February 16, 17 and 18, 2005. The committees will discuss the overall benefit-to-risk considerations (including cardiovascular and gastrointestinal concerns) for COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines.
>> Read article at MedicalNewsToday.com

FDA Panel says 'No' to making Mevacor an OTC drug
An FDA advisory panel said ‘no' to Merck's request that its statin, Mevacor, become an OTC (over-the-counter) drug. The panel voted 20 against and 3 in favour of the request. What the advisory panel recommends is usually accepted by the FDA.
>> Read article at MedicalNewsToday.com

January 14, 2005

Europe's Officials Grill Drug Firms on Painkillers
Officials from Pfizer Inc, Merck & Co Inc and Novartis AG will appear next week before a panel of European drug experts, who are meeting to consider curbs on the use of COX-2 painkillers.
>> Read article at Reuters.com

Drugs early-warning system 'not working'
The UK's biggest pharmaceutical companies have called on the Government to do more to ensure that doctors report side effects from new drugs, in an attempt to head off growing public concern about the side effects of blockbuster drugs.
>> Read article at NetDoctor.co.uk

A Push in States to Curb Malpractice Costs
As state legislative sessions open across the country this week, Republican governors and lawmakers in many states are mounting major campaigns to control medical malpractice insurance premiums by limiting civil litigation. In Georgia, Missouri, Washington and more than a dozen other states, Republican legislators have made malpractice premiums a priority this year, groups that track such legislation said. In Kentucky, Maryland and Mississippi, Republican governors have already waded into the fray.
>> Read article at NYTimes.com

A Gift for Drug Makers
With all the problems and the bad publicity that drug companies have been facing recently, you might think that this would not be a good time for the Bush administration to toss yet another bonanza their way. But the administration is like an ardent lover in its zeal to shower the rich and powerful with every imaginable benefit. So tucked like a gleaming diamond in proposed legislation to curb malpractice lawsuits is a provision that would give an unconscionable degree of protection to firms responsible for drugs or medical devices that turn out to be harmful.
>> Read article at NYTimes.com

Exporting Cures, Importing Misery
In the heavily polluted region of Patancheru, the production of pharmaceuticals to save lives in the West may be cutting lives short in India.
>> Read article at Alternet.org

January 13, 2005

FDA Warns Pfizer About 2 Drugs' Ads
The Food and Drug Administration has warned Pfizer Inc. that television and print advertisements for its painkillers Celebrex and Bextra misled consumers, according to a letter made public Wednesday. Five advertisements did not disclose side effects and other risk information and made "unsubstantiated effectiveness claims," the F.D.A. said in a letter dated Jan. 10 that was posted on its Web site.
>> Read article at NYTimes.com

FDA Considers Sales for Cholesterol Drug
The US government is considering whether a drug for a serious chronic condition, high cholesterol, should sit on drugstore shelves alongside medicines for headaches, allergies and athlete's foot.
>> Read article at ABCNews.com

January 12, 2005

Watchdog Group: Avoid 181 Prescription Drugs
There are 181 popular prescription drugs on a "Do Not Use" list issued by the watchdog group Public Citizen on Wednesday. The drugs, including the cholesterol-lowering drug Crestor, the birth control pill Yasmin, and controversial pain relievers Celebrex and Bextra, are condemned by the group because their potentially dangerous side effects far outweigh their benefits or because there are safer alternatives that work just as well
>> Read article at WebMD.com

Statins: A risk to your baby?
Some birth-defects specialists say they are concerned about the possibility of a cholesterol-lowering statin drug going over the counter, a move to be considered today and Friday by a Food and Drug Administration advisory committee.
>> Read article at USAToday.com

January 10, 2005

Pfizer to Pull Its Ads for Arthritis Painkiller
Pfizer has said that it will immediately stop advertising Celebrex, an arthritis pain reliever, to consumers after a study showed that high doses were associated with an increased risk of heart attacks. Pfizer appears to have had little choice in deciding to end the advertising campaigns. The U.S. Food and Drug Administration said Friday that it was considering regulatory measures that could include severe label warnings or even requiring that the drug be withdrawn in the United States.
>> Read article at RedNova.com

AstraZeneca Reports Death of Crestor Drug Patient
AstraZeneca Plc's cholesterol-lowering drug Crestor has been linked to the death of a patient, Europe's third largest drugmaker said on Monday. The death, possibly due to the severe muscle-wasting condition rhabdomyolysis, has been reported to regulators worldwide, company spokesman Steve Brown said.
>> Read article at Reuters.com

January 8, 2005

Equality in the 1990s would have saved 900,000 black Americans
Eliminating racial inequality in health care in the United States would have saved the lives of almost 900 000 black people from 1991 to 2000, says a report published in the American Journal of Public Health. Equality of care would have saved five times the number of lives saved by new technologies and treatments, the investigators say.
>> Read article at BMJ.com

Rejecting political correctness
Known for his outspoken views on NHS reform and private medicine, Karol Sikora, professor of cancer medicine and honorary consultant oncologist at Imperial College London's School of Medicine, is now grappling with medical education. After being approached by Buckingham University's vice chancellor, Terence Kealey, himself a doctor, Professor Sikora was appointed dean elect of Britain's first private medical school at Buckingham University, the only UK university not directly funded by the government. He finds the challenge of implementing a new medical course appealing.
>> Read article at BMJ.com

January 6, 2005

Drug tests: too speedy - or safe enough?
Prescription drugs pulled from the market. Drug ads voluntarily yanked from TV and print. "Black box" warning labels placed on some medicines, and safety doubts raised about others. As Americans try to figure out how suspect drugs got into their medicine cabinets - and who is to blame - two startling facts are coming to the fore: 1) The consumption of all medications involves some risk and 2) The bar for establishing their safety is set much lower than many people think.
>> Read article at CSMonitor.com

Gefitinib (Iressa™) Marketing Authorisation Application Withdrawn In EU
AstraZeneca today announced that it is withdrawing the European Marketing Authorisation Application (MAA) for IRESSA™ (gefitinib) in treating patients with non-small cell lung cancer (NSCLC) from the European Medicines Agency (EMEA).
>> Read article at MedicalNewsToday.com

Drug research openness promised
The world's leading drug companies have promised to publish more data about clinical trials into new medicines to reassure the public about their safety. Results of all industry clinical trials will be published on the internet later this year under plans drawn up by pharmaceutical trade associations.
>> Read article at BBCNews.com

January 5, 2005

Malpractice Bill Shields Drugmakers
The medical malpractice bill backed by President Bush would prevent consumers from seeking punitive damages from the makers of Vioxx and Celebrex, two popular pain medications recently linked to increased risks of heart attacks and strokes, according to legal experts on both sides of the issue. While Bush often touts the medical malpractice proposals as a prudent way to stop frivolous lawsuits against doctors, the bill's less-discussed liability protections for pharmaceutical companies such as Merck & Co., the manufacturer of Vioxx, is generating controversy this week.
>> Read article at WashingtonPost.com

Bush promotes plan to limit medical liabilityl lawsuits
President George W. Bush said Wednesday in Collinsville that he wanted Congress to pass medical malpractice reform, and do it this year. Speaking before a backdrop of about 125 doctors in white lab coats, Bush said that trial lawyers are filing frivolous lawsuits that add billions of dollars to health care costs while forcing doctors to curtail vital care. "What I'm here to do is say as clearly as I can - the United States Congress needs to pass real medical liability reform this year," Bush said. The cornerstone of that reform plan is a $250,000 cap on "pain and suffering" damages.
>> Read article at Kentucky.com

January 4, 2005

Statin Use May Slightly Impair Brain Function
The results of a new study suggest that treatment with a cholesterol-lowering statin called simvastatin (Zocor) may have small negative effects on brain function. The effects on cognitive function were "too small" to have any immediate implications for the way the statin is prescribed, but they do suggest the possibility that the drug may harm the brain
>> Read article at Reuters.com

Lilly and Novartis schizophrenia drugs may increase diabetes risk
Researchers have found that patients treated with the anti-psychotic agents clozapine and olanzapine, marketed as Novartis's Clozaril and Eli Lilly's Zyprexa respectively, may be at an increased risk for insulin resistance, a major risk factor for diabetes.
>> Read article at Pharmaceutical-Business-Review.com

NIH whistleblower says government bungled AIDS study in Uganda
Federal officials involved in a U.S.-funded study in Uganda endangered the lives of hundreds of patients testing an AIDS drug because of careless and negligent research practices, a government whistleblower said Tuesday. Dr. Jonathan Fishbein said officials at the National Institutes of Health overlooked safety problems with the drug, which was being used to protect babies in Africa from HIV infection during birth.
>> Read article at MedBroadcast.com

Bush Administration pressures Canada to eliminate drug importation
Canadian mail-order drug importation may become illegal soon due to new regulations proposed by the Liberal Government. After quietly supporting the practice for four years, the Liberals made a conspicuous about face after President Bush's November visit to Canada. Health Minister Ujjal Dosanjh confirmed that the president conferred with Canadian Prime Minister Paul Martin on the matter.
>> Read article at News-Medical.net

Michigan law makes drug suits difficult
Michigan is the only state in the country with a law that shields drug makers from liability if the drug was approved by the Food and Drug Administration, according to the Michigan Trial Lawyers Association. Plaintiffs can win damages only if they prove a company withheld or misrepresented information about a drug that would cause the FDA to not give or withdraw its approval.
>> Read article at freep.com

January 3, 2005

Long-Term Use of Non-Steroidal Anti-Inflammatory Drugs
May Cause Severe Intestinal Damage
According to a study published today chronic users of non-steroidal anti-inflammatory drugs (NSAIDs) have an increased risk of bleeding and visible damage to their small intestine. "We have always known that NSAIDs can cause potentially deadly stomach complications, but the extent of the impact on the small intestine was largely unknown until now," said David Graham, MD, lead study author. "The introduction of video capsule endoscopy gave us an opportunity to examine the small intestine and learn that NSAIDs can cause severe damage to this organ."
>> Read article at DocGuide.com

Drug firms under fire over secrecy on 1,096 trials
More than 1,000 drug trials have taken place in Ireland over the last seven years, with little or no public knowledge. Although the Irish Medicines Board (IMB) authorises all trials, it does not provide any public information on drugs being tested, the number of patients involved in trials, the drug firms concerned or the results of such studies.
>> Read article at IOL.ie

January 1, 2005

Indicting Big Pharma
Is the pharmaceutical industry a dangerous and crooked business that federal and state authorities need to bring to heel? Should those who develop market or prescribe drugs hang their heads in shame when faced with the stark reality of what they do to earn a living? Is Big Pharma in fact the moral equivalent of the tobacco industry?
>> Read article at AmericanScientist.org