Pharmaceutical / Drug / Biotech
Articles and Resources
Date Fairness.com Resource Read it at: Dec 11, 2012 Scientists Propose Central Database for Disclosing Conflicts of Interest
QUOTE: a lack of standardization in COI disclosures increases the administrative burden on physicians and increases the chances of being accused of incomplete and misleading statements. As a solution, their committee — facilitated by the Institute of Medicine — recommends the creation of a centralize database for the disclosure and reporting of interests.
Scholarly Kitchen Nov 24, 2012 As drug industry’s influence over research grows, so does the potential for bias
QUOTE: What only careful readers of the article would have gleaned is the extent of the financial connections between the drugmaker and the research.Whether these ties altered the report on Avandia may be impossible for readers to know. But while sorting through the data from more than 4,000 patients, the investigators missed hints of a danger that, when fully realized four years later, would lead to Avandia’s virtual disappearance from the United States: The drug raised the risk of heart attacks....
Washington Post Mar 20, 2012 Generic Drugs Proving Resistant to Damage Suits
QUOTE: Across the country, dozens of lawsuits against generic pharmaceutical companies are being dismissed because of a Supreme Court decision last year that said the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the risks of taking their drugs. Now, what once seemed like a trivial detail — whether to take a generic or brand-name drug — has become the deciding factor in whether a patient can seek legal recourse from a drug company.
New York Times Mar 19, 2012 A Drumbeat on Profit Takers
QUOTE: Their joint crusade, stated repeatedly in editorials for the journal and since expanded in books and dozens of articles in the lay press, is against for-profit medicine, especially its ancillary profit centers of commercial insurance and drug manufacture — in Dr. Relman’s words, “the people who are making a zillion bucks out of the commercial exploitation of medicine.”
New York Times Dec 22, 2011 In Treating Disabled, Potent Drugs and Few Rules
QUOTE: psychotropic medications, which alter the brain’s chemistry, are often dispensed sloppily, without rigorous or regular review, by general practitioners with little expertise in the area. And low-level workers at state group homes are frequently given discretion to increase the medication “as needed,” despite their lack of significant training.
New York Times Jul 28, 2011 Useless Studies, Real Harm (Op-Ed)
QUOTE: In an age of for-profit clinical research, this is the new face of scandal. Pharmaceutical companies promote their drugs with pseudo-studies that have little if any scientific merit, and patients naïvely sign up, unaware of the ways in which they are being used.
New York Times Jul 07, 2011 How Bright Promise in Cancer Testing Fell Apart
QUOTE: as patients and their doctors try to make critical decisions about serious illnesses, they may be getting worthless information that is based on bad science. The scientific world is concerned enough that two prominent groups, the National Cancer Institute and the Institute of Medicine, have begun examining the Duke case; they hope to find new ways to evaluate claims based on emerging and complex analyses of patterns of genes and other molecules.
New York Times Jul 04, 2011 Think Inside the Box
QUOTE: Bombarded with pharmaceutical ads listing what seems like every conceivable side effect, American consumers might think they are already getting too much information. But they — and their doctors — are not getting what arguably matters most: independent, plain-English facts about the medication. Fortunately, there is a simple model for getting such information across.
New York Times Jun 23, 2011 High Court sides with generic drug makers in narrow ruling
QUOTE: The justices in a 5-4 ruling said generic drug companies do not share the same level of responsibility as makers of brand-name equivalents, to update their warning labels when significant new risks emerge.
CNN (Cable News Network) Jun 04, 2011 Drug Makers’ Feared Enemy Switches Sides, as Their Lawyer
QUOTE: a year and a half ago, Mr. Loucks, a Republican, left the United States attorney’s office in Boston after he was passed over for the top post and President Obama appointed a Democrat. Instead, Mr. Loucks joined Skadden, Arps last July, and has startled former allies by emerging in recent months as zealous a corporate defender as he was a prosecutor, complete with proposals seeking more lenient treatment for the medical companies he once vilified.
New York Times May 13, 2011 Google Is Said to Have Broken Internal Rules on Drug Ads
QUOTE: Google allowed rogue online pharmacies to advertise on its site in violation of its own advertising policies, according to one of the companies subpoenaed in the federal investigation of Google’s drug ad sales.
New York Times Mar 10, 2011 U.S. Regulators and J.&J. Unit Reach a Deal on Plant Oversight
QUOTE: Federal regulators reached an agreement on Thursday with a unit of Johnson & Johnson that would impose greater federal oversight at three manufacturing plants responsible for recalls of children’s Tylenol and many other popular over-the-counter medicines... Last year, the company’s (Johnson & Johnson) DePuy unit recalled two different hip implants, affecting tens of thousands of patients worldwide. Its Animas unit recalled tens of thousands of insulin pump cartridges last month because they had the potential to leak and deliver too little insulin, the company said.
New York Times Oct 27, 2010 Glaxo to Pay $750 Million for Sale of Bad Products
QUOTE: GlaxoSmithKline, the British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant — the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines.
New York Times May 27, 2010 F.D.A. Weighs Penalties in Drug Recall
QUOTE: [The FDA] is considering further actions against McNeil Consumer Healthcare, the Johnson & Johnson unit, after a pattern of violations in manufacturing and quality control practices led to a number of recent recalls...
New York Times May 27, 2010 Safety Rules Can’t Keep Up With Biotech Industry
QUOTE: the estimated 232,000 employees in the nation’s most sophisticated biotechnology labs work amid imponderable hazards. And some critics say the modern biolab often has fewer federal safety regulations than a typical blue-collar factory.
New York Times Mar 21, 2010 When drug makers' profits outweigh penalties
QUOTE: As large as the penalties are for drug companies caught breaking the off-label law, the fines are tiny compared with the firms' annual revenue. The $2.3 billion in fines and penalties Pfizer paid for marketing Bextra and three other drugs cited in the Sept. 2 plea agreement for off-label uses amount to just 14 percent of its $16.8 billion in revenue from selling those medicines from 2001 to 2008.
Bloomberg News Nov 21, 2009 Growth of counterfeit drugs sparks international response: Authorities in the U.S. and across the globe conduct raids this week to intercept fake medications.
QUOTE: Counterfeit drugs are the latest -- and potentially most dangerous -- front in the long-running battle against intellectual-property crimes
Los Angeles Times Nov 18, 2009 DNA Testing Firm Goes Bankrupt; Who Gets the Data? (Threat Level)
QUOTE: An Icelandic firm that offers private DNA testing to customers has filed for bankruptcy in the U.S., raising privacy concerns about the fate of customer DNA samples and records, according to the Times of London.
Wired Nov 14, 2009 In House Record, Many Spoke With One Voice: Lobbyists’
QUOTE: Statements by more than a dozen lawmakers were ghostwritten, in whole or in part, by Washington lobbyists working for Genentech, one of the world’s largest biotechnology companies.
New York Times Oct 27, 2009 A dubious alternative: There's no evidence that homeopathic products can prevent flu
QUOTE: Unlike vaccines or prescription or over-the-counter drugs, homeopathic medicines, which account for annual U.S. sales of more than $200 million, do not need to demonstrate safety or effectiveness...
Washington Post Oct 22, 2009 Research Uproar at a Cancer Clinic
QUOTE: community [research] centers may not always be adhering to the rigorous protocols of research medicine that the National Cancer Institute expects them to follow.
New York Times Oct 08, 2009 How to Stop the Counterfeit-Medicine Drugs Trade
QUOTE: According to the World Health Organization (WHO), more than 50% of drugs sold online have either been falsified or altered in some way.
Time Magazine Oct 07, 2009 Personal genomics firms must come clean
QUOTE: Companies that offer analyses of future health risks based on basic genetic tests should be more transparent about the limitations of their predictions, says genomics pioneer Craig Venter.
New Scientist Oct 01, 2009 Bayer Labels’ Cancer-Fighting Claim Draws Suit
QUOTE: A nonprofit group in Washington has filed a lawsuit against Bayer Healthcare charging that the company’s labels and commercials falsely claimed its One A Day multivitamins for men may reduce the risk of prostate cancer.
New York Times Sep 24, 2009 F.D.A. Reveals It Fell to a Push by Lawmakers
QUOTE: The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.
New York Times Sep 21, 2009 Benefit and Doubt in Vaccine Additive
QUOTE: Are Americans obligated to use an unproven vaccine to help protect people in other countries from the flu pandemic?
New York Times Sep 15, 2009 Where Cancer Progress Is Rare, One Man Says No (Forty Years' War)
QUOTE: cancer has proven difficult to crack, leading to frustration among executives and advocates who wonder why the Food and Drug Administration is not approving more drugs.
New York Times Sep 10, 2009 Ghostwriting Is Called Rife in Medical Journals
QUOTE: In the scientific literature, ghostwriting usually refers to medical writers, often sponsored by a drug or medical device company, who make major research or writing contributions to articles published under the names of academic authors. The concern... is that the work of industry-sponsored writers has the potential to introduce bias...
New York Times Sep 04, 2009 Awareness: Clinical Trial Rule Is Widely Ignored (Vital Signs)
QUOTE: Many researchers are ignoring a 2005 requirement that they register proposed clinical trials in a government database as a condition for publishing their results in medical journals.
New York Times Sep 04, 2009 Ethics scrutiny needed for Chinese–European projects: Panel calls for joint advisory body to monitor research.
QUOTE: Biomedical research collaborations between Europe and China need greater ethical oversight to combat unregulated stem-cell therapies and prevent the exploitation of clinical-trial participants.
Nature Sep 03, 2009 Academic researchers receive on average $33k a year from the medical industry (60-Second Science Blog)
QUOTE: researchers in the ivory towers—and labs—of U.S. universities receive an average of $33,417 of funding a year from medical device, pharmaceutical and other medical industry companies...
Scientific American Sep 02, 2009 High Stakes for Merck in Litigation on Fosamax
QUOTE: Drug executives, product liability lawyers and Wall Street analysts are closely watching a jury trial in New York over medical problems associated with Fosamax, a drug from Merck... It is the first of about 900 state and federal cases pending against Merck in which plaintiffs claim that taking Fosamax caused them to develop a rare problem called osteonecrosis of the jaw.
New York Times Aug 31, 2009 Keeping genes out of terrorists' hands: Gene-synthesis industry at odds over how to screen DNA orders.
QUOTE: A standards war is brewing in the gene-synthesis industry. At stake is the way that the industry screens orders for hazardous toxins and genes
Nature Aug 26, 2009 Study Finds Radiation Risk for Patients
QUOTE: At least four million Americans under age 65 are exposed to high doses of radiation each year from medical imaging tests, according to a new study...
New York Times Aug 24, 2009 Research Trove: Patients’ Online Data
QUOTE: Several private companies are now collecting patient data and genetic information online to use in recruiting patients for clinical trials, conducting research internally or to sell to drug and biotechnology companies.
New York Times Aug 19, 2009 Report: HPV vaccine may be going to the wrong women
QUOTE: some doctors now question whether the [HPV] vaccine has been overpromoted to affluent women who need it least instead of patients most at risk of dying from the disease.
USA TODAY Aug 19, 2009 Obama endangering developing countries' access to affordable drugs, activists charge
QUOTE: [activists] say the problem may lie in the administration's reluctance to confront the giant pharmaceutical companies at a time when the companies are crucial allies in President Obama's struggle to revamp the U.S. healthcare system.
Aug 18, 2009 Senator Moves to Block Medical Ghostwriting
QUOTE: A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies...
New York Times Aug 18, 2009 Live From the O.R.: The problems with broadcasting surgeries as they happen.
QUOTE: Combining education with entertainment and patient care with promotion, live telesurgery is a fixture at surgical conferences and marketing campaigns by hospitals and medical device manufacturers
Slate Aug 17, 2009 Diabetes Case Shows Pitfalls of Treatment Rules
QUOTE: setting [healthcare] guidelines that are good for every patient, it turns out, can get messy, with some experts warning that a big national plan of this sort poses risks.
New York Times Aug 13, 2009 Senators Investigate Hospital Purchasing
QUOTE: Senators from committees like finance, judiciary and aging are investigating the practices of companies that represent big networks of hospitals, nursing homes and other institutions. These group purchasing organizations select “preferred” manufacturers and negotiate the prices of medical products, which are a closely held secret.
New York Times Aug 13, 2009 Privacy Regulations Bedevil Medical Social Media Efforts
QUOTE: To truly participate in social media, healthcare organizations need to allow other people to leave comments on the organizations' content. But that's difficult to reconcile with HIPAA and other government privacy regulations...
InformationWeek Aug 11, 2009 Salvia on Schedule: Law, Medicine and a Hallucinogen: Scheduling the mind-altering herb as a controlled substance could slow medical research
QUOTE: As the source of the most powerful natural hallucinogen known, salvia is drawing scrutiny from U.S. authorities who want to restrict this Mexican herb... But neuroscientists worry that controlling it before studies have determined its safety profile is premature and could hamper research of the drug's medicinal value.
Scientific American Aug 05, 2009 Studies Question Using Cement for Spine Injuries
QUOTE: Two new studies cast serious doubt on a widely used and expensive treatment for painful fractures in the spine.
New York Times Aug 04, 2009 Medical Papers by Ghostwriters Pushed Therapy
QUOTE: Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.
New York Times Aug 02, 2009 Lack of Study Volunteers Hobbles Cancer Fight ("Forty Years' War" part 4)
QUOTE: There are more than 6,500 cancer clinical trials seeking adult patients, according to clinicaltrials.gov... But many will be abandoned along the way. More than one trial in five sponsored by the National Cancer Institute failed to enroll a single subject, and only half reached the minimum needed for a meaningful result Dr. [Scott] Ramsey and his colleague John Scoggins reported...
New York Times Aug 01, 2009 Adaptive Evolution: A once-rare type of clinical trial that violates one of the sacred tenets of trial design is taking off, but is it worth the risk?
QUOTE: in an increasingly common approach, a trial can be altered in various ways while it’s still in progress... Such modifications are based on a peek at interim data—which of necessity means unblinding the data before the trial’s completion.
Scientist, The (TS) Jul 30, 2009 Does your child need ADHD drugs? (Empowered Patient)
QUOTE: Does my child really need drugs for ADHD, and if so, is there a point when he or she should stop taking them?...Because drug companies tend to give samples for only the most expensive drugs, once the samples run out, you'll end up paying more than if your child had been prescribed a generic drug.
CNN (Cable News Network) Jul 28, 2009 Perils of the professional lab rat
QUOTE: Now some health researchers and bioethicists are expressing concern at the way socially and financially vulnerable people are being drawn to careers... as guinea pigs in phase I clinical trials.
New Scientist Jul 26, 2009 Lawmakers Seek to Curb Drug Commercials
QUOTE: For some legislators and consumer advocates, the [drug] ads are a daily reminder of a health care system run amok. Critics contend that drug ads are intended to prompt people to diagnose themselves with chronic quality-of-life problems like insomnia or restless leg syndrome; lead people to pressure their doctors for prescriptions for expensive brand-name drugs to treat these conditions; and steer people away from cheaper generic pills.
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