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December 31, 2004

Editor claims drug companies have a "parasitic" relationship with journals
The relationship between medical journals and the drug industry is "somewhere between symbiotic and parasitic," according to the editor of the Lancet, Richard Horton. But at the moment it has swung too much towards the parasitic, he told the House Commons select committee on health last month in his oral evidence on the role of the industry.
>> Read article at BMJ.com

Intimidation, Politics and Drug Industry Cripple U.S. Medicine
While the U.S. Food and Drug Administration (FDA) is supposed to safeguard the nation's medical products, drawing upon the substantive expertise of its drug scientists in vigilant dedication to the public's health, that is not the case today. Documentation, interviews and recent drug debacles depict a brutally different reality, with the Vioxx scandal alone estimated to have resulted in 30,000-55,000 U.S. deaths. "You have an agency in denial -- the FDA still maintains it made no mistake in the approval or regulation of Vioxx," says the agency's associate safety director, Dr David J Graham.
>> Read article at CommonDreams.org

Direct to consumer advertising is at the crossroads
of competing pressures from industry and health needs
Direct to consumer advertising increases the use of drugs and medical services and increases wealth for pharmaceutical, advertising, and media companies. It increases prescribers' workloads and increases expenditure by patients, taxpayers, insurers, and large employers.
>> Read article at BMJ.com

FDA to review "missing" drug company documents
The US Food and Drug Administration has agreed to review confidential drug company documents that went missing during a controversial product liability suit more than 10 years ago. The documents appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence.
>> Read article at BMJ.com

December 30, 2004

FDA doctors defend agency's Vioxx moves
Two US regulators defended the Food and Drug Administration's handling of the withdrawn painkiller Vioxx, disputing the contention of heart researcher Dr. Eric Topol that the agency could have forced Merck & Co. to do more safety testing.
>> Read article at Boston.com

December 29, 2004

Has FDA become Big Pharma pawn?
After a year filled with stories of dangerous painkillers and questionable flu shots, critics say pro-industry forces have eroded the FDA's regulatory prowess. They charge the FDA yields to political pressure to speed drugs through the approval process, and is reluctant to yank a suspect medication off the market once approved.
>> Read article at CBS.MarketWatch.com

Lessons learned from troubles with COX-2 inhibitors
One of the nation's leading cardiovascular medical researchers has issued a call for less aggressive direct-to-consumer advertising and better safety assurances of medications in a special article posted online today by JAMA because of its relevance to the recent withdrawals and warning labels on the pain-relieving drugs known as COX-2 inhibitors.
>> Read article at MedicalNewsToday.com

Lawsuit Alleges Children's Motrin Causes Stevens-Johnson Syndrome
A lawsuit filed Tuesday against Johnson & Johnson alleges that Children's Motrin causes Stevens-Johnson Syndrome, a harmful reaction resulting in severe burning, blistering, blindness or death in some cases. The Plaintiff, Sabrina Brierton Johnson, age 7, claims that an allergic reaction to taking Children's Motrin (Stevens-Johnson Syndrome) caused her to become blind and photosensitive.
>> Read article at LegalNewsWatch.com

U.S. family files suit after woman dies during experimental AIDS drug regimen
The family of a pregnant woman who died while taking experimental AIDS drugs to protect her baby from getting the disease is suing the doctors, drug makers and hospitals involved in the study for $10 million US.
>> Read article at MedBroadcast.com

Gilmartin: Merck Says CEO May Testify In Vioxx Lawsuits
Merck Chief Executive Raymond V. Gilmartin may testify in some of the many lawsuits filed over the Vioxx recall, a company lawyer said.
>> Read article at Forbes.com

December 28, 2004

Chemotherapy lowers levels of antioxidants and micronutrients
Children undergoing chemotherapy for acute lymphoblastic leukemia (ALL) have significant changes in their antioxidant and micronutrient status which are related to their treatment outcomes, according to the results of a novel prospective study.
>> Read article at News-Medical.net

December 27, 2004

Over-the-counter cholesterol drug coming?
Merck next month will make its second try for approval to sell cholesterol drug Mevacor without a prescription. If the Food and Drug Administration approves, cholesterol drugs would become the third type of drug to switch from prescription to over-the counter status in the USA. Bristol-Myers Squibb said this month that it also intends to seek non-prescription status for cholesterol drug Pravachol.
>> Read article at USAToday.com

December 26, 2004

Big Pharma's Dirty Little Secret
The American healthcare system is the best in the world. Or so we are often told. But is it really true? It is certainly the best system for drug companies, which can charge the highest prices in the world to some U.S. consumers. The Congressional Budget Office has estimated that average prices for patented drugs in 25 other top industrialized nations were 35% to 55% lower than in the United States.
>> Read article at LATimes.com

December 24, 2004

FDA Statement on Iressa
The Food and Drug Administration (FDA) learned yesterday from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival benefit from taking Iressa.
>> Read article at ScienceDaily.com

December 23, 2004

FDA too dependent on drug money
The troubles surrounding a major class of painkillers may ultimately help cure what has long ailed the U.S. Food and Drug Administration. Despite research showing that high doses of Celebrex more than double the risk of heart attack, Pfizer has kept the medicine on the market, where it makes the company billions each year. The company has, however, pulled all advertising for the painkiller, which arguably helped create the problem in the first place.
>> Read article at Hamptonroads.com

Are Drug Makers Influencing Your Doctor?
When patients visit their doctor for medical care and advice, most believe they are getting unbiased medical attention that puts the patient's well-being first. But most patients are unaware that some doctors' advice might be affected by expensive gifts, lavish trips to luxury resorts, gourmet dinners and high-priced tickets to Broadway shows and sporting events.
>> Read article at ABCNews.com

FDA orders review of studies involving COX-2 pain drugs
The Food and Drug Administration on Thursday ordered a review of all prevention studies involving drugs such as Celebrex and Bextra, which have been associated with increased risk of heart problems. The agency also urged the public to limit use of over-the-counter pain medications.
>> Read article at SFGate.com

Drug risks raise doubt about ads
As the list of prescription drugs raising concern about possible harmful side effects grows, new questions are being asked about the wisdom of inundating consumers with a blizzard of ads for medicines whose safety or effectiveness may later be called into question.
>> Read article at CSMonitor.com

Substantial Bone Loss Seen With Depo-Provera Use
The results of a new study confirm that using the contraceptive Depo-Provera is associated with bone loss. Depo-Provera, also known as DMPA, is a long-lasting contraceptive hormone that is injected every three months.
>> Read article at Reuters.com

December 22, 2004

Rethinking over-the-counter drugs
A government finding that Aleve, the widely used pain reliever, appears to increase the risk for heart problems underscores how little is known about possible side effects of some common older medicines.
>> Read article at SFGate.com

F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and Misleading'
AstraZeneca's recent full-page newspaper advertisements defending the safety of its cholesterol-lowering pill, Crestor, are "false and misleading," in part because serious concerns remain about the safety of the drug, federal drug regulators said Wednesday. The advertisements stated that "the F.D.A. has confidence in the safety and efficacy of Crestor" and that the agency "as recently as last Friday publicly confirmed that Crestor is safe and effective." Neither is true, said a letter from the Food and Drug Administration to AstraZeneca.
>> Read article at NYTimes.com

Good Pill, Bad Pill: Science Makes It Hard to Decipher
In one of the great examples of the mixed messages of science, the same study that killed the blockbuster arthritis drug Vioxx after showing that it had heart risks also found that the drug had a significant benefit: it prevented precancerous colon polyps in some patients, one of the study's principal researchers said.
>> Read article at NYTimes.com

The National Institutes of Health: Public Servant or Private Master?
For 15 million Americans, it is a daily ritual: gulping down a pill to reduce cholesterol. They do it because their doctors tell them to. Their doctors, in turn, rely on recommendations from the National Institutes of Health and its scientists, such as Dr. H. Bryan Brewer Jr. Brewer, as a leader at the NIH, was part of a team that gave the nation new cholesterol guidelines that were expected to prompt millions more people to take the daily pill. He also has written favorably of a specific brand of cholesterol medication, Crestor, which recently proved controversial. What doctors were not told for years is this: While making recommendations in the name of the NIH, Brewer was working for the companies that sell the drugs. Government and company records show that from 2001 to 2003, he accepted about $114,000 in consulting fees from four companies making or developing cholesterol medications, including $31,000 from the maker of Crestor.
>> Read article at LATimes.com

Doctors told to stop using painkiller
Doctors were yesterday advised to switch all patients taking the painkillers known as Cox-2 inhibitors on to other drugs following revelations that they increase the risk of heart attack. At least a million people are thought to have been on the drugs which were widely prescribed for arthritis before the first of the two market leaders, Vioxx, was withdrawn by the manufacturer Merck at the end of September. Four days ago Pfizer, which makes Celebrex, said it too had new data showing an increased heart attack risk.
>> Read article at TheGuardian.com

Safety Issue May Change Pill Culture
Safety questions about popular pain-killing medications may give people pause over the nation's pill-popping culture, analysts say, and that would give the beleaguered drug industry something else to worry about. The tendency to take prescription pills for everyday aches and pains, shyness, allergies, impotence, and other "lifestyle" concerns have helped prop up pharmaceutical company revenue. Now analysts say safety concerns may prompt a consumer backlash.
>> Read article ate WashingtonPost.com

AP Poll: Confidence in Drug Safety Remains
Consumers remain confident in the safety of prescription drugs sold in the USA at a time when some popular ones have been linked to health threats, an Associated Press poll found. They also expressed confidence in the Food and Drug Administration, the federal agency responsible for ensuring drug safety. But some indicated their confidence is limited.
>> Read article at RedNova.com

December 21, 2004

Bush Administration's Effective Denial of Drug Importation from Canada
Appears to be Due to Power of Drug Money
The findings released today by the Bush administration’s Drug Importation Task Force are highly suspect because of: 1) the task force’s makeup; 2) an intense lobbying campaign by the pharmaceutical industry, which included many former senior officials from the Bush administration; and 3) the industry’s financial support of Bush’s re-election, according to a report released today by Public Citizen.
>> Read article at Citizen.org

NHS Scotland launches Ritalin probe
The NHS Scotland health watchdog has launched an inquiry into the treatment of the childhood behavioural condition attention deficit hyperactivity disorder (ADHD) after new figures revealed a tenfold increase in the use of the psychoactive drug Ritalin.
>> Read article at NursingTimes.net

Potentially fatal toxicities occur with off label use of cancer drugs
Food and Drug Administration policies prevent pharmaceutical manufacturers from informing patients about potentially fatal toxicities that occur with some cancer drugs -- policies that should be revised immediately, according to Northwestern University researchers who have called for an immediate revision of these FDA policies, particularly because the drug thalidomide, which was approved by the FDA as an off-label cancer treatment in 1998, has been reported to have caused potentially fatal blood clots in the legs and the lungs in over 190 cancer patients.
>> Read article at MedicalNewsToday.com

A Fourth Painkiller Is Linked to Increases in Heart Problems
A new study has found that Aleve, a popular over-the-counter painkiller made by Bayer, could increase heart problems, and federal officials are warning patients not to exceed the recommended dose of two 200-milligram pills a day or continue therapy for more than 10 days without consulting a physician. It was the fourth big-selling pain medicine in recent months to be suspected of hurting the heart, and federal drug officials said that similar drugs, like Advil, might also increase heart risks.
>> Read article at NYTimes.com

Overdosed and Oversold
In the early 1960's, Congressional hearings on skyrocketing drug prices went nowhere. But the political logjam was broken when a eagle-eyed doctor at the Food and Drug Administration averted a potential disaster by advising the agency not to let thalidomide into the United States market. While the final legislation back then had little to do with prices or safety, the new law ushered in efficacy testing and led to the withdrawal of hundreds of drugs of no medical benefit from the market.
>> Read article at NYTimes.com

FDA Chief: Keeping Options Open on Naproxen
The head of the U.S. drug safety agency said on Tuesday the United States was keeping "all regulatory options open" as it studied data showing increased heart risks from some painkillers.
>> Read article at Reuters.com

December 19, 2004

White House official praises drug agency
The federal drug safety agency is doing a "spectacular job" of protecting the public, the White House chief of staff said Sunday. The assessment drew an immediate outcry from a Senate critic who charged that government oversight under the Bush administration has proved "a catastrophic failure."
>> Read article at SeattlePI.NWSource.com

Pfizer CEO Defends Celebrex, Won't Recall It
Pfizer Chief Executive Hank McKinnell said on Sunday doctors should be made aware of the health risks in prescribing Celebrex to their patients, but the company does not plan to recall its popular arthritis drug.
>> Read article at RedNova.com

Medicine Fuelled by Marketing Intensified Trouble for Pain Pills
In the mid-1990's, the medical community reached an inescapable conclusion. Researchers at the Stanford University Medical School and elsewhere who had long been monitoring arthritis and rheumatism patient records had found that thousands of patients, perhaps as many as 16,500, were dying annually from bleeding ulcers and other problems caused by widely used painkillers like ibuprofen. Within a few years, a new class of pain relievers, the so-called COX-2 inhibitors, burst onto the market with the promise they might reduce that toll.
>> Read article at NYTimes.com

December 18, 2004

American Consumers Suffer As More New Drugs Debut in U.S., Analysis Shows
Thousands of Americans are getting sick and many are dying each year from prescription drugs that were pushed onto the U.S. market ahead of the rest of the world. A Knight Ridder analysis shows that as the number of new drugs given first to Americans has increased, the reports of drug-induced ailments have soared. Yet, even as the deaths and damage have increased, the Food and Drug Administration has never instituted an aggressive system to track the safety of drugs once they're on the market.
>> Read article at RedNova.com

Bad news about Celebrex, Strattera, Iressa fuel criticisms of FDA
A string of negative reports about medications has the media buzzing with questions about the job FDA is doing and the public asking pharmacists and physicians questions about whether the drugs they are taking are really safe and effective.
>> Read article at MedicalNewsToday.com

December 17, 2004

Drug doubts
First Vioxx, now a new study alerts people to possible problems with fellow painkiller Celebrex. These are just one class of drugs. There have also been concerns raised recently about other prescription drugs, including the use of antidepressants for teenagers. Will this trigger a backlash?
>> Read article at CNN.com

US House panel asks Pfizer for Celebrex records
The U.S. House Energy and Commerce Committee said on Friday it requested documents from Pfizer Inc. related to painkillers Celebrex and Bextra, two drugs that have been linked to heart risks. The committee, in a letter to Pfizer Chief Executive Hank McKinnell, said it had concerns about Pfizer's statements in recent weeks about the safety of Celebrex.
>> Read article at Reuters.com

S. Africa Rips U.S. on AIDS Drug Debacle
President Thabo Mbeki's African National Congress party carried an article in its online journal Friday accusing top U.S. officials of treating Africans like guinea pigs and telling lies to promote the sales of a key AIDS drug. The article, published in ANC Today, was responding to Associated Press reports this week that U.S. health officials withheld concerns about a key nevirapine study before President Bush launched a 2002 plan to distribute the drug in Africa to protect newborns from catching HIV from their infected mothers.
>> Read article at APWire.com

Jesse Jackson calls for investigation into AIDS drug
The Reverend Jesse Jackson says the US government should immediately halt distribution in Africa of an AIDS drug that reportedly poses serious risks. The civil rights leader is calling for a congressional investigation into reports that US health officials withheld research from the White House that showed problems with the drug (nevirapine).
>> Read article at EyewitnessNewsTV.com

Pfizer Celebrex Trial Stopped After Heart Attacks
Pfizer Inc. on Friday said patients taking its blockbuster arthritis drug Celebrex in a long-term cancer-prevention trial had more than twice the number of fatal or non-fatal heart attacks as those taking a placebo.
>> Read article at Reuters.com

December 16, 2004

Woman Died During U.S. AIDS Drug Study; Family Never Told of Likely Cause
A pregnant Tennessee woman who enrolled in federally funded research in hopes of saving her soon-to-be-born son from getting AIDS died last year when doctors continued to give her an experimental drug regimen despite signs of liver failure, government memos say.
>> Read article at ABCNews.com

Bribes Alleged in Sales Policy for AIDS Drug
A New York sales representative for a Swiss biotechnology company was charged Tuesday by federal prosecutors with bribing doctors to write prescriptions for an expensive AIDS drug.
>> Read article at RedNova.com

Many FDA Scientists Had Drug Concerns, 2002 Survey Shows
Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality. The survey of almost 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency's ability to assess the safety of a drug.
>> Read article at WashingtonPost.com
>> Read also the article at UCSUSA.org
>> Read also the article at Peer.org

Busting Big Pharma
What happens when a slick sales force of 87,000 is set loose with billions of dollars to wine and dine, entertain and educate the US's 600,000 doctors? The short answer is that six years ago Americans spent $US89 billion on prescription drugs. Last year the amount exploded to $US149 billion. In the year to March 2004, Australia spent $5.8 billion on prescription drugs. The US accounts for half of all global profits for Big Pharma, as the pharmaceutical corporations are known.
>> Read article at TheAustralian.com

House's Author of Drug Benefit Joins Lobbyists
Representative Billy Tauzin, a principal author of the new Medicare drug law, will become president of the Pharmaceutical Research and Manufacturers of America, the chief lobby for brand-name drug companies, the trade group announced Wednesday.
>> Read article at NYTimes.com

December 15, 2004

Drug Induced Liver Injury Expected to Increase With Almost Half of All Americans Now Using Prescription Drugs
HepaLife Technologies, Inc, a development stage biotechnology company focused on the research, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease, today announces its expectations of increased drug induced liver injuries and adverse drug reactions due to a dramatic rise in prescription drug usage amongst Americans, with almost half of the population now taking at least one prescription drug and one person in every six taking three or more (Centers for Disease Control and Prevention, December 2, 2004).
>> Read article at RedNova.com
>> The CDC report can be found here

AIDS Research Chief Rewrote Safety Report
The government's chief AIDS researcher removed some negative safety conclusions from a subordinate's report on a U.S.-funded drug experiment, then ordered the research to resume over objections from his staff, memos show.
>> Read article at ABCNews.com

December 14, 2004

NIH Officials Warned of Nevirapine Risks But Did Not Inform White House, 2002
Although NIH officials were warned that a Ugandan clinical trial using the antiretroviral drug nevirapine was "flawed" months before President Bush announced an initiative to reduce mother-to-child HIV transmission in Africa and the Caribbean, they did not inform the White House of the risks associated with the drug's use in pregnant women.
>> Read article at MedicalNewsToday.com

Vioxx Lawsuits Swamp Merck
Merck Tuesday said that 475 personal injury lawsuits have been filed against the company relating to its withdrawal of Vioxx from the market on Sept. 30. Kenneth C. Frazier, senior vice president and general counsel, said the company will vigorously defend against the lawsuits, seeking to try the lawsuits on a case-by-case basis because each patient taking the drug has a different set of circumstances and medical conditions.
>> Read article at TheStreet.com

If Bush Needs a Cholesterol Drug, Do You?
If the county's top doctors say President Bush, an avid exerciser they describe as being in "excellent" health, needs a cholesterol-lowering statin drug, do you, too?
>> Read article at WebMD.com

Merck increases job cuts amid earnings decline
Merck & Co. Inc. whose earnings are being hurt by the withdrawal of its arthritis drug Vioxx, said on Tuesday it has increased the number of jobs it expects to cut by the end of this year to 5,100 from an original target of 4,400.
>> Read article at Reuters.com

Drug Czars
India's pharmaceutical tycoons are getting richer, thanks to growing international demand for their generic drugs. No surprise, then, that pharmaceuticals are the source of wealth for nine of India's richest people, who together have a collective net worth of $6.5 billion.
>> Read article at Forbes.com

Prescriptions to Combat Depression Raise Concern
A senior Government adviser on mental health has expressed concern that doctors are over-prescribing anti- depressants with little evidence of any public health benefit. Dr Dermot Walsh, the former Inspector of Mental Hospitals, told The Irish Times the increase in prescription of anti-depressants was also accompanied by a worrying rise in suicide rates. "There isn't any public health evidence that widespread increase in anti-depressants has resulted in a decrease in the incidence of depression," he said.
>> Read article at RedNova.com

This Is Your Country on Drugs
Don't steroids carry dangers? Of course they do. But so do the enhancement drugs we get from our doctors. Fen-Phen, the popular weight-loss drug that was linked to pulmonary hypertension and heart disease, has killed and harmed so many people that Wyeth, its manufacturer, has put aside more than $16 billion to compensate victims. Hormone replacement therapy, promoted in the 1960's as an anti-aging drug for women, has been linked to an increased risk of heart disease, strokes, pulmonary emboli and breast cancer. Antidepressants like Prozac, Paxil and Zoloft were described as "cosmetic psychopharmacology" a decade ago; today they are embroiled in a public controversy over their links to suicide and homicide.
>> Read article at NYTimes.com

Doctors link common chemotherapy drug to jawbone necrosis
Doctors at Long Island Jewish (LIJ) Medical Center recently discovered a link between a common chemotherapy drug and a serious bone disease called osteonecrosis of the jaw (ONJ).
>> Read article at MedicalNewsToday.com

Valdecoxib gets contraindication, boxed warning, USA
In addition to a contraindication for use of valdecoxib (Bextra-Pfizer) for the treatment of postoperative pain immediately following coronary artery bypass graft (CABG) surgery, FDA has added a boxed warning to the drug's labelling stating that serious, potentially fatal skin reactions-including Stevens-Johnson syndrome and toxic epidermal necrolysis-have been reported.
>> Read article at MedicalNewsToday.com

We Love Them. We Hate Them. We Take Them.
There were eight of us crowded into the exam room as an exasperated patient and I tried to figure out why he was feeling weak and tired and itchy and nauseated and almost fainted in the subway Thursday night. Two of us, the patient and I, were human beings. The rest had no voices, bodies or personalities in the ordinary sense of the word, but they played a role in the discussion that was just as vigorous and important as if they did. They were, of course, my patient's pills.
>> Read article at NYTimes.com

December 13, 2004

New study shows early ritalin may cause long-term effects on the brain
A new study conducted in rats by the National Institutes of Health (NIH) and McLean Hospital/Harvard Medical School suggests that the misdiagnosis of attention-deficit hyperactivity disorder (ADHD) combined with prescription drug use in children may lead to a higher risk of developing depressive symptoms in adulthood.
>> Read article at MedicalNewsToday.com
>> The DEA information about methylphenidate can be found here

December 10, 2004

US officials move toward drug safety independence
U.S. lawmakers and health officials are moving to give more independence to an office that reviews drug safety, but some experts say ensuring medicines are studied after they hit the market is more important than the bureaucratic pecking order. Health and Human Services Secretary Tommy Thompson is expected to announce changes as early as next week to give the U.S. Food and Drug Administration's Office of Drug Safety more autonomy from the Office of New Drugs, which approves new therapies. "I'm working on how I'm going to set that up," Thompson told reporters Wednesday, adding that a review group outside the FDA was a consideration.
>> Read article at Reuters.com

Rep. Stupak Calls on FDA to Assure Whistleblower Keeps his Job
The Food and Drug Administration asked a whistleblower, drug safety expert Dr. David Graham, to leave his position and move elsewhere in the agency, according to Congressman Bart Stupak. In a letter to the FDA Acting Commissioner Lester M. Crawford, Stupak and 21 congressional members have demanded assurance Dr. Graham will keep his job. The members also asked the Commissioner that he investigate the smear campaign conducted by some within the agency against Dr. Graham.
>> Read article at LegalNewsWatch.com
>> Read Rep. Stupak's press release on the subject here

Why doctors don't read research papers
I find the same when trying to read medical papers. Sometimes it is the austere formulaic style of the prose that seems a bit dishonest. The authors affect the scientific style of the disinterested observer when in truth they are advocates of their idea. I find myself wanting to say: "Hey! If you want to persuade me to your view that this is important—be honest about it. Tell me what you think and then, honestly, why you think it."
>> Read article at BritishMedicalJournal.com

Prozac is risky for children too
European drug regulators are concerned that Prozac, like its sister antidepressants, is unsafe for children, contrary to UK advice. The Committee for Medicinal Products for Human Use (CHMP) reviewed all of the available data. It said there was an increased risk of suicidal behaviour and thoughts with all antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs). UK regulators say the benefits of Prozac in under-18s outweigh any risk.
>> Read article at BBCNews.co.uk

A Top Republican to Offer Drug Data Bill
A top Senate Republican on health care issues, Charles E. Grassley of Iowa, plans to introduce legislation early next year that would require pharmaceutical companies to register drug trials and report their results in a public database, an aide said yesterday. Several Democrats have introduced similar proposals in the Senate and the House. But the involvement of Mr. Grassley, who led recent hearings involving the drug industry and federal drug regulation, may be a significant advance because it signals some bipartisan support for such a bill.
>> Read article at NYTimes.com

December 9, 2004

Drug Maker Withheld Paxil Study Data
New documents uncovered by ABC News suggest GlaxoSmithKline, the maker of the popular antidepressant Paxil, failed to disclose important information about the possibility of an increased risk of suicidal behaviour in some children taking the drug, as well as serious withdrawal symptoms when some patients stop taking Paxil. The new documents obtained by the ABC News program "Primetime Live" have never before been made public. Earlier this year, the Food and Drug Administration ordered manufacturers to place a warning in bold print on antidepressants, alerting consumers that the drugs can cause suicidal tendencies in children and teenagers.
>> Read article at ABCNews.com
>> The previously covered-up GSK internal memo touting the "remarkable efficacy and safety in the treatment of adolescent depression" of Paxil can be found here

Bextra Found to Pose Risks After Heart Bypass Surgery
The government is warning of potential heart problems associated with the use of the painkiller Bextra in people who have recently had heart bypass surgery. The Food and Drug Administration said Thursday that it was adding the warning to the label of Bextra, as well as strengthening the label warnings on the possibility of severe skin reactions with the drug, which is made by Pfizer.
>> Read article at NYTimes.com

Baxter Ends Flu Vaccine Trial; Cites Side Effects
Baxter International Inc. on Thursday said it halted a late-stage European trial of a flu vaccine because of higher-than-expected rates of fever and other symptoms. The health-care products company said it has put further clinical studies for the vaccine, dubbed Preflucel, on hold while it analyzes data from the trial.
>> Read article at Reuters.com

CHMP meeting on Paroxetine and other SSRIs, European Medicines Agency
The European Medicines Agency scientific committee, the Committee for Medicinal Products for Human Use (CHMP), held an extraordinary meeting in London on 8 December 2004 and took two actions relating to paroxetine and to other SSRIs.
>> Read article at MedicalNewsToday.com
>> The EMEA press release can be found here

December 8, 2004

Lilly launches publicly available clinical trial registry
Eli Lilly and Company today will announce the launch of its publicly available clinical trial registry which will post the results from all Phase I through Phase IV clinical trials of Lilly's marketed products. Results that do not support the hypothesis being tested or that are contrary to the expected outcome will be disclosed.
>> Read article at NewsMedical.net
>> The Lilly clinical trials website can be found here

Medical Students Declare ‘Pharmfree Day' to Combat Biased Industry Temptations
The American Medical Student Association (AMSA), the nation's largest, independent medical student organization, with nearly 50,000 members, today announces National PharmFree Day, the first annual day of action where medical students, residents and physicians will speak out against the pharmaceutical industry's biased marketing practices.
>> Read article at MedicalNewsToday.com
>> Details of AMSA's PharmFree Campaign can be found here

How To Prevent Another Vioxx
In the U.S. drug industry, it often takes a disaster to bring change. Not until thousands of European babies were deformed by thalidomide in the late 1950s and early 1960s did Congress raise standards for approvals. Now the Food & Drug Administration and Congress are grappling with what FDA whistle-blower David Graham says "may be the single greatest drug-safety catastrophe in the history of this country" -- the use by millions of people of a painkiller, Vioxx, that raises the risk of heart attacks.
>> Read article at BusinessWeek.com

Doctors not influenced by pharmaceutical marketing tactics
Pharmaceutical drug companies spend upward of $25 billion per year in the USA on promoting new drugs and distributing free samples to doctors, but new research shows such marketing devices have little impact on physicians and their prescribing behavior.
>> Read article at MedicalNewsToday.com

Industry Distortion of the F.D.A.
Twelve years ago, the White House and Congress made an agreement with the pharmaceutical industry that seemed eminently reasonable at the time. The industry would supply substantial sums - reaching $200 million a year at latest count - to help the Food and Drug Administration hire more reviewers to speed the approval process for new drugs that might otherwise be held up solely by administrative logjams. The quid pro quo was that the government had to meet tight deadlines for reviewing drugs and had to keep steady its own financing for new-drug reviews, adjusted for inflation.
>> Read article at NYTimes.com

Merck's Board Appoints Panel to Investigate Handling of Vioxx
The directors of Merck, the giant drug maker, have opened an independent investigation into whether the company acted properly regarding Vioxx, the arthritis treatment that it withdrew from the market in September.
>> Read article at NYTimes.com

December 7, 2004

U.S. Imports 1.2 Million More Flu Shots
The United States has procured another 1.2 million foreign doses of influenza vaccine under an investigational new drug (IND) application. All of the doses are expected to be available this month. The new vaccine, Fluarix, was made by GlaxoSmithKline in its German plant. Under a protocol worked out with the U.S. Food and Drug Administration, Glaxo has agreed to make up to 4 million doses total available.
>> Read article at MedicalNewsToday.com
>> Details of Bush's campaign funding can be found here

Go East, Big Pharma
Drugmakers are expanding in China, but patents are still a worry
>> Read article at BusinessWeek.com

Vioxx three times as dangerous as Celebrex, study indicates
An independent study carried out at the University of Pennsylvania has shown that your risk of having a heart attack is three times greater with Vioxx than with Celebrex. Celebrex and Vioxx are both arthritis pain medications (prescription drugs).
>> Read article at MedicalNewsToday.com

Arava: the 'sixth drug' that may soon be under fire
At a recent hearing into the Vioxx affair, the FDA's Dr David Graham named five drugs that he considers too dangerous to be on the market. However, in his testimony, Dr Graham also cited Sanofi-Aventis' Arava as a drug he has recommended be withdrawn. Unlike the other five drugs, Arava has largely escaped the media spotlight, but there may yet be some tough questions asked about its safety.
>> Read article at BioPortfolio.com

A.M.A. Seeks More Openness in Drug Trials
The nation's largest group of doctors called yesterday for an end to restrictions in drug trial contracts that prevent academic and other researchers from freely discussing test data and results. In a unanimous vote, the policy-making board of the American Medical Association adopted a resolution yesterday that called for the development of guidelines to eliminate confidentiality clauses that can prevent researchers who have worked on a drug trial from discussing its results with other researchers and doctors.
>> Read article at NYTimes.com

December 6, 2004

FDA Mulls Easier Access to Cholesterol Drugs
Four years ago, advisory committees of the Food and Drug Administration rejected requests by several companies to turn their prescription cholesterol drugs into over-the-counter medications. Next month, at least one of the drugs will get another chance.
>> Read article at TheStreet.com

German lawmakers warns drug firms over price suits
Germany's ruling Social Democrats may oppose plans to cut a compulsory discount on patented drugs if drug companies go ahead with plans to sue over the main pricing system, a lawmaker was quoted in a German newspaper as saying on Sunday. The government has been locked in a battle with drug companies such as Pfizer Inc. and Altana AG over its drug pricing system, which the companies claim is unfair, but which Berlin says is needed to keep health-care costs under control.
>> Read article at ReutersHealth.com

Lipitor - Vioxx: Discovering the Statin - Painkiller Chain Reaction
Is there an obvious but overlooked connection between statin drugs, their side effects and the new-generation painkillers of the Vioxx class? An intriguing question for anyone interested in drug safety, one would think - except the FDA does not seem overly concerned.
>> Read article at NewMediaExplorer.org

Bayer to slash 560 jobs, with HQ hard hit
German drugmaker Bayer last week put an end to speculation that it is planning swingeing job cuts by confirming that it is planning to axe 560 positions in Germany and the US as part of restructuring its global pharmaceutical R&D operations.
>> Read article at InPharma.com

FDA Commissioner agrees to meet top Republican Charles Grassley
Lester Crawford, Acting Commissioner for the FDA, has agreed to meet Charles Grassley about the FDA's handling of safety concerns regarding Vioxx. Crawford wrote to Charles Grassley, Chairman of the Senate Finance Committee and said he took his concerns ‘very seriously'.
>> Read article at MedicalNewsToday.com

GPs get new anti-depressant rules
Doctors are to be issued with new guidelines on the prescription of anti-depressants, amid concerns too many people are taking them. The National Institute for Clinical Excellence guidelines cover drugs such as Prozac and Seroxat used by hundreds of thousands of people in the UK. The guidelines are set to say people with mild and moderate depression should seek alternative treatments.
>> Read article at BBC.co.uk

With or Without Vioxx, Drug Ads Proliferate
Just seven years after the Food and Drug Administration ended decades of restrictions by allowing drug makers to advertise prescription products directly to consumers, spending on such ads has reached $3.8 billion. To put that sum in perspective, it is more than companies like Coca-Cola, Pepsi-Cola and Cadbury Schweppes spend combined each year to sell their soft drinks. It even exceeds what one of the very largest marketers, Unilever, spends annually on global campaigns for all its brands, including Dove, Knorr, Lipton, Lux, Pond's, Slim-Fast and Wish-Bone.
>> Read article at NYTimes.com

At F.D.A., Strong Drug Ties and Less Monitoring
When federal drug officials suspected in 1992 that a popular allergy pill might cause heart problems, they turned to their own scientists. Their trial confirmed the danger, and the drug was pulled from the market. Eight years later, similar worries surrounded the arthritis pill Vioxx. But by then, the Food and Drug Administration had shifted gears, slashing its laboratories and network of independent drug safety experts in favor of hiring more people to approve drugs, changes that arose under an unusual agreement that has left the agency increasingly reliant on and bound by drug company money. Discovering Vioxx's dangers would take four more years.
>> Read article at NYTimes.com

December 5, 2004

Sleeping pills can kill, drug firm warns
A warning is to be issued about the widely used tranquilliser Ativan, which has been shown to have a rare but potentially fatal impact on patients' breathing. Ativan, one of the benzodiazepine-class drugs taken by more than one million Britons each year, is prescribed for people suffering from anxiety, panic attacks and resulting insomnia. Campaigners have accused the drugs companies for years of withholding information on the addictiveness of benzodiazepines, as well as their long-term side effects.
>> Read article at Guardian.co.uk

UN pricks pharma's conscience
The United Nations special rapporteur on the “right to health” says better policing is needed to ensure the pharmaceutical industry fulfils its social responsibilities.
>> Read article at NZZ.ch

December 4, 2004

Glaxo faces threat of UK class action over Seroxat
Lawyers acting for 1,700 people in the UK have issued a pre-action letter of claim against GlaxoSmithKline alleging serious side-effects have been suffered by their clients taking one of its best-selling drugs, the anti-depressant Seroxat.
>> Read article at TheIndependent.co.uk

December 3, 2004

Malpractice, Medicaid Shaping 2005 Congress Agenda
Republicans' long-sought curbs on medical malpractice awards are likely to top the congressional health care agenda when lawmakers return in January, even as Democrats prepare for a clash over potential cuts to Medicaid, aides said Friday. An aide to Senate Majority Leader Bill Frist of Tennessee told reporters Wednesday that capping doctors' liability in lawsuits will be at the top of his boss's list when the 109th Congress convenes in early 2005. The caps were a cornerstone of President Bush's domestic agenda in his re-election campaign, though the Senate has so far balked at passing them over strong opposition from Democrats.
>> Read article at Reuters.com

Politics, spin, and science
A US National Academy of Sciences panel made a remarkable recommendation last month, remarkable not for its content but that it had to be made at all. In the report the panel recommends: "When a federal advisory committee requires scientific or technical proficiency, persons nominated to provide that expertise should be selected on the basis of their scientific and technical knowledge and credentials. It is inappropriate to ask them to provide non-relevant information, such as voting record, political-party affiliation, or position on particular policies." The panel apparently felt compelled to make this recommendation after reports that scientists under consideration for advisory board appointments were being questioned about their political views by the Bush administration.
>> Read article at TheLancet.com

Crisis deepens at the US Food and Drug Administration
The US Food and Drug Administration, rocked by controversy in recent months, has now admitted that a senior management official secretly contacted a whistleblower group. That official attempted to discredit Dr David Graham, the FDA's scientist who criticised the agency during US Senate hearings, saying that the FDA failed to protect the public when it approved rofecoxib - despite evidence suggesting that the drug caused heart attacks and strokes.
>> Read article at BMJ.com

Tighter controls are needed to root out bogus patient groups
Patient organisations need to be more tightly regulated to protect the public from bogus groups and undue influence from the pharmaceutical industry and other funding bodies, UK MPs heard last week. Setting standards on transparency and accountability would help to distinguish legitimate patient groups from those set up by drug companies to promote awareness of a specific condition and drugs to treat it, said witnesses at the fourth public hearing of the health committee’s inquiry into the influence of the pharmaceutical industry.
>> Read article at BMJ.com

Two out of every three Americans know someone stricken by lung cancer
Two out of every three Americans know someone stricken by lung cancer, yet more than half of Americans don't realize that lung cancer is among the most lethal of cancers, according to a nationwide survey conducted on behalf of The Lung Cancer Online Foundation. The survey highlights the impact this deadly disease has on Americans.
>> Read article at News-Medical.net

New 20 year patients threaten to end AIDS drugs for developing countries
Efforts to bring antiretroviral treatment to AIDS patients in developing countries are threatened by the looming implementation of new World Trade Organisation’s patent rules, the charity Médecins Sans Frontières warned this week. The organisation’s TRIPS (trade related aspects of intellectual property rights) agreement comes into force for most signatories on 1 January 2005. It requires the organisation’s members to grant 20 year patents to new pharmaceutical products. Only the least developed countries can postpone implementation until 2016.
>> Read article at BMJ.com

US threatens Australia over plan to block exptensions to drug patients
The US government has warned Australia that legislative provisions seeking to ensure generic drugs are not blocked by frivolous patent extensions to branded drugs could trigger a trade dispute between the two countries. The warning comes as the Australian minister for trade, Mark Vaile, plans to push through what he describes as "minor changes" to legislation implementing the Australia-US Free Trade Agreement in the final parliamentary sitting for 2004.
>> Read article at BMJ.com

UK patients seek compensation after taking rofecoxib (Vioxx)
British lawyers are gearing up to launch a mass compensation claim in the British courts on behalf of hundreds of patients who had strokes or heart attacks after taking the arthritis drug rofecoxib (Vioxx). Two law firms, Leigh, Day & Co and Irwin Mitchell, investigated the possibility of suing the manufacturer, Merck, in the United States, but have decided to sue in the British courts instead under the Consumer Protection Act, which covers defective products.
>> Read article at BMJ.com

Americans Relying More on Prescription Drugs, Report Says
More than 40 percent of Americans take at least one prescription drug and 17 percent take three or more, the government said Thursday in a comprehensive report on the nation's health. The report documented the growing use of medications in the last decade, a trend that it attributed to the growth of insurance coverage for drugs, the discovery and marketing of new products, and clinical guidelines that recommend greater use of drugs to treat high cholesterol, high blood pressure, diabetes and other conditions.
>> Read article at NYTimes.com

December 2, 2004

'Female Viagra' fails to win FDA panel's approval
A Food and Drug Administration advisory committee voted Thursday not to recommend approving the first prescription treatment for female sexual dysfunction until more studies are done to determine the drug's risks. Procter & Gamble had urged approval of the testosterone patch, called Intrinsa, which has been nicknamed the "female Viagra." The company presented data to the panel that showed that women who tried the patch in clinical trials had improvements in sexual arousal and orgasms and had more satisfying sexual experiences. But the committee decided that Intrinsa should not be approved before researchers conduct additional studies to measure long-term health risks.
>> Read article at USAToday.com

December 1, 2004

Safety of American Drugs Is Questioned
In a sharp pivot, many medical authorities are questioning the fundamental safety guarantees for American drugs, threatening to dull the national appetite that has demanded and devoured pharmaceuticals at a faster clip for nearly a generation. In a challenge unthinkable even two months ago, Dr. Catherine DeAngelis, editor of the Journal of the American Medical Association, now compares the drug safety system to a dangerous building: "This building is on very shaky ground. Would I condemn it? No, but I would tell people, 'You go in at your own risk.'"
>> Read article at ABCNews.com

Britain backs HIV vaccine studies
Britain will work with other countries to speed up the development of an Aids vaccine, Chancellor Gordon Brown said on World Aids Day. He added Britain would buy up stocks to guarantee a market for vaccines being developed by researchers.
>> Read article at BBCNews.com

Celebrex safe, says Pfizer
The drug company that manufactures the anti-arthritic drug celecoxib has released evidence which it says proves its safety. Pfizer said this week that a review of studies involving nearly 40,000 patients shows that celecoxib, marketed under the trade name Celebrex,  was no more likely to cause heart problems than traditional painkillers.
>> Read article at NursingTimes.net

November 30, 2004

Brazil Plans to Break Patents on Foreign AIDS Drugs
Brazil will break the patents next year on between three and five foreign drugs used in the anti-AIDS cocktail central to its innovative program to fight the illness, the government said on Tuesday.
>> Read article at Reuters.com

Merck Demands Specific Proof in Vioxx Suits, Court Records Show
Keith Stubblefield took Merck & Co.'s Vioxx painkiller for six weeks before he had a fatal heart attack while washing his car. His widow sued Merck, saying that Vioxx killed him and that the company hid the drug's risks. Merck, which recalled Vioxx on Sept. 30 after a company study found it doubled heart attack and stroke risk after 18 months of daily use, denied the drug caused Stubblefield's death in March 2001. The No. 2 U.S. drugmaker argued in court papers that Stubblefield, 37, was an overweight smoker with high blood pressure and heart disease.
>> Read article at Bloomberg.com

FDA Responds to JAMA Studies on Cholesterol Drug Baycol, Reviews Records
FDA has launched a review of its records of the August 2001 withdrawal from the market of Bayer's statin Baycol in light of allegations made last week that the pharmaceutical company was aware of the risks associated with the drug but failed to inform FDA of its findings in a timely manner.
>> Read article at MedicalNewsToday.com

Free the Academic Drug Tests
Academic medical centers represent the top rung of medical research in this country and are widely thought to be impartial and independent. So it is disheartening to find them signing restrictive contracts with pharmaceutical companies that allow the companies to dictate what drug testing data can be openly discussed and published. The manufacturers of drugs and medical devices are already under increasing pressure to list all of their clinical trials and results in public databases. Now academic medical centers will need to clean up their own practices to help prevent suppression of information about the safety and efficacy of drugs.
>> Read article at NYTimes.com

Merck sued by New York Fund over Vioxx
The New York state comptroller sued Merck & Co., claiming the drug maker hid certain risks associated with the painkiller Vioxx. The company has been the subject of several investor lawsuits since it pulled Vioxx off the market, mostly because its stock has lost well over a third of its value since the recall. One of the losers has been New York state's pension fund, which has recorded $171 million in paper losses related to Merck, according to state Comptroller Alan G. Hevesi.
>> Read article at ABCNews.com

Pfizer outlines plan for combining cholesterol drugs
On Tuesday, Pfizer Inc., the world's largest drug-maker, outlined its plans to combine its best-selling Lipitor cholesterol-lowering drug with another drug that boosts the "good" type of cholesterol. In early trials, the combination pill significantly lowered bad cholesterol, known as LDL, while raising the desirable HDL that acts as a scavenger, scouring arteries of fatty deposits.
>> Read article at MenaFM.com

Warning over long-term HRT use
Hormone Replacement Therapy should only be used for the short-term relief of menopausal symptoms, say experts. The new guidance suggests that if a woman has taken HRT for around five years, she should consider if it is in her best interest to continue.
>> Read article at BBCNews.com

Merck Offering Top Executives Rich Way Out
With its stock plunging and its ability to thrive as an independent company uncertain, the drug giant Merck has adopted a plan that could give its top executives big bonuses if the company is taken over. Merck has been reeling since it withdrew its arthritis treatment Vioxx from the market on Sept. 30 after acknowledging that studies have found a higher incidence of heart problems in people taking the drug.
>> Read article at NYTimes.com

November 29, 2004

US FDA may reassign Vioxx whistleblower - lawyer
A U.S. Food and Drug Administration reviewer who criticized the agency's handling of Merck & Co. Inc.'s now-withdrawn Vioxx painkiller may be forced to another position at the agency, a lawyer for the scientist said on Monday. FDA efforts to move David Graham, the associate director for science in the Office of Drug Safety, have stepped up since he accused the agency at a Nov. 18 Senate hearing of failing to protect the public, said his lawyer, Thomas Devine.
>> Read article at Reuters.com

Uncle Pharma's Mischief in a Bottle
A major pharmaceutical CEO gets hauled up in front of Congress to do the congressional version of a perp walk. The executive's company stands accused of one of the worst drug screw-ups in recent history. Meantime, an FDA official, a scientist with an impeccable scientific track record who had managed to predict almost all of the major drug recalls, testifies that the drug should have been targeted for intense study and possible withdrawal up to three years earlier. The CEO is lauded on the business page for his affability and straightforwardness. The Food and Drug Administration is nailed on the front page for not doing its job. The scientist is profiled as a "devout Catholic," a "loner" and being against RU-486. To ask the obvious: What is that all about?
>> Read article at LATimes.com

Glaxo tells Blair to press G8 for patents reform
GlaxoSmithKline, the UK's largest pharmaceuticals company, has written to Tony Blair to demand new tax credits and patent concessions to encourage the development of medicines for the world's poorest countries. The company is also urging the Prime Minister to use Britain's presidency of the G8 group of industrialised nations to strengthen global agreements on intellectual property rights.
>> Read article at NetDoctor.co.uk

Contracts Keep Drug Research Out of Reach
Academic institutions and researchers are widely viewed as the impartial, independent heart of the system this country uses to test drugs and medical devices. But that independence often comes with strings attached, sometimes making those institutions and their researchers obstacles to the exchange and discussion of test results. The upshot is that doctors may not get all the information they need. In the wake of revelations about unpublished test data showing the potential risks of pediatric antidepressants, some doctors have stopped prescribing them. And even doctors who continue to prescribe the drugs question why they were kept in the dark.
>> Read article at NYTimes.org

Here, Kiddie, Here
How drug companies are pushing ADHD drugs for children by funding researchers and advocacy groups – and ignoring the studies which question their claims.
>> Read article at Alternet.org

November 28, 2004

GSK linked to trials forcing Aids drugs on deprived US children
GlaxoSmithKline will be accused this week of backing drug trials in the US in which underprivileged children were forced to test Aids treatments against their will. The trials have been taking place in New York under the auspices of the Administration for Children's Services, the body that looks after the welfare of children in New York City.
>> Read article at Independent.co.uk
>> The website of the Paediatric Aids Clinical Trials Group can be found here
>> The website of the New York city Administration for Children's Services can be found here

Big Brother in Your Medicine Cabinet
Have you ever heard of the “New Freedom Initiative”? No, it doesn't have anything to do with freedom, unless you count the freedom of the drug companies to sell more of their high-priced drugs to treat mental illness. For Americans on the home front, this is the scariest plan yet to come out of the Bush Administration.
>> Read article at InterventionMag.com
>> The website of the New Freedom Initiative can be found here

New cancer drugs to cost NHS £50m
The NHS faces a £50 million increase in its drugs bill next year to pay for a new generation of anti-cancer drugs that will allow millions more people to survive with the disease for many years. A special Observer investigation reveals that by 2010 there will be thousands more drug compounds to treat cancer, dramatically improving patients' survival rates.
>> Read article at Observer.Guardian.co.uk

November 27, 2004

Looking for Adverse Drug Effects
As the Food and Drug Administration continues to draw fire for its handling of various drugs and the flu vaccine crisis, one lesson is inescapably clear: the agency lacks enough power to ensure the safety of drugs after they are approved and on the market. That defect needs to be corrected before countless Americans are killed or hurt by dangerous side effects that did not show up in the original clinical trials and only became apparent when the drugs were in widespread use.
>> Read article at NYTimes.com

November 26, 2004

Pfizer pulls Celebrex in Turkey
Pfizer has temporarily stopped selling its COX-2 arthritis and pain drug Celebrex in Turkey due to disputes with health authorities, according to reports. The dispute is reported to be over restrictive language on cardiovascular issues to be used on the product's warning label.
>> Read article at Datamonitor.com

Feed your head
Monty Python had a phrase for it: "And now for something completely different." "That's what it's like for me addressing an education conference," says Alex Richardson. The Oxford University scientist gets plenty of practice at public speaking. Recently she has given the keynote speech at the York festival of food and drink, talked about fish at London's Royal Institution, and briefed Scottish MPs on autism.
>> Read article at TES.co.uk

When New Drugs Go Wrong: Role of the FDA Debated
Federal officials responsible for ensuring that medications are safe face a major limitation of drug research: Although a new drug is often tested on a few thousand patients, a serious side-effect may not be fully recognized until its users number in the hundreds of thousands. "To a real degree, the people who get the drug in the first few years after its approval are being experimented on," said Dr. Brian L. Strom, a professor of biostatistics and epidemiology at the University of Pennsylvania.
>> Read article at LATimes.com

Is drug regulation failing?
Something is rotten at the heart of the FDA. The United States Food and Drug Administration, mired in controversy over the last 12 months, now faces an extraordinary charge of attempting to discredit a whistleblower. As this week's issue reveals, David Graham, the FDA's associate director of drug safety, was so bothered about the difficulties of presenting his data on rofecoxib (Vioxx) in the Lancet that he took his case to the Government Accountability Group, a public interest group that protects whistleblowers.
>> Read article at BMJ.com

November 25, 2004

From bad to awful
However intense the pain, the troubles of the world’s big pharmaceutical companies has hardly seemed unusual. Half a dozen other industries in America have also been feeling the lash of energetic state regulators, a hostile business press, political scrutiny and the unwanted attentions of plaintiffs' lawyers. Rumours that Michael Moore plans to make a film about the drug industry (whose employees are under strict instructions to keep their mouths shut) had simply added one more item from what is fast becoming a standard list of business headaches in the new century. Yet, over the past week, the drug firms' crisis has appeared to morph into something uniquely dark and dangerous. Suddenly its American regulator, the Food and Drug Administration (FDA), finds itself under attack. And if public confidence in the regulator goes, worried industry executives and company shareholders are asking, what then?
>> Read article at Economist.com

Cholesterol drug faces review
Health Canada is reviewing the safety of Crestor, a popular drug used to lower cholesterol. Since early 2003, at least 14 Canadians who have taken the drug have developed serious muscle problems that can lead to kidney failure. Thursday's announcement comes on the heels of a warning from the U.S. Last week, a safety reviewer at the U.S. Food and Drug Administration called Crestor and four other drugs the most worrisome drugs on the market.
>> Read article at MSN.CBC.ca

Drug Firms Accused of Holding Back Addiction Information
Pharmaceutical giants deliberately suppressed information showing how addictive their drugs were, it was claimed today. Roche and John Wyeth and Brother were accused of withholding information showing their benzodiazepines were much more addictive than stated in prescription guidelines. The claims were made by Labour MP Phil Woolas. Mr Woolas, who is a trustee of the “Beat the Benzos” campaign, was giving evidence to the House of Commons health committee which is investigating the influence of the pharmaceutical industry.
>> Read article at News.Scotsman.com

Plan for first shelf antibiotic
The first antibiotic to be sold by pharmacies without a prescription may get the go-ahead under plans being considered by the (UK) drugs regulator. The Medicine and Healthcare products Regulatory Agency is consulting on whether to make chloramphenicol eye drops available over-the-counter.
>> Read article at BBCNews.com

AstraZeneca in big ads drive
Drugs giant AstraZeneca has launched a massive marketing offensive in the US to convince consumers its cholesterol-lowering drug, Crestor, is safe, as the pharmaceuticals industry finds itself in the firing line after the withdrawal of Merck's Vioxx painkiller. The company, headed by Sir Tom McKillop, is rolling out advertisements in newspapers across the nation with the headline: 'You can be assured that at AstraZeneca patient safety is our number one priority.'
>> Read article at ThisisMoney.com

Flu pandemic threatens billions
An influenza pandemic is likely to affect every country leaving millions dead and make more than a quarter of the world's population ill with no vaccines available until at least next March, the World Health Organisation says. An outbreak of bird flu that has killed 32 people in Thailand and Vietnam this year is the most likely cause of an inevitable pandemic but it was not clear if it would start in the "next week or the next years", said Dr. Klaus Stohr of the WHO global influenza programme.
>> Read article at SundayTimes.co.za

November 24, 2004

AstraZeneca to fight 'false promotion' lawsuit
AstraZeneca declared last night that it would vigorously contest a lawsuit accusing the Anglo-Swedish drug maker of falsely promoting its new ulcer drug as a more powerful medicine than an older version that is available at a cut-price rate.
>> Read article at TimesOnline.co.uk

You Want A Moral Issue? How About Drugs That Don't Kill?
As Democrats continue to search heaven and earth for a moral values issue they can call their own, I have just the prescription: Why not start with the immoral behavior of giant drug companies such as Merck that continue to sacrifice the health of the public on the altar of higher and higher profits?
>> Read article at AriannaOnline.com

How drug approval woes crept up on FDA
For many Americans, opening up the medicine cabinet may seem far more perilous than it did just a few months ago. Revelations about potentially deadly problems with government-approved drugs - from Merck's painkiller Vioxx to Bayer's cholesterol-fighter Baycol - have prompted even the conservative Journal of the American Medical Association (JAMA) to charge that the Food and Drug Administration's system for protecting consumers is broken.
>> Read article at CSMonitor.com

AstraZeneca Should End Crestor Ad Campaign, Group Tells FDA
AstraZeneca Plc, the U.K.'s second- largest drugmaker, is making misleading statements in the advertising campaign for its Crestor cholesterol-lowering medicine, the Public Citizen consumer group said in Washington. The ads, which appeared in newspapers including the Washington Post and the New York Times, contend that the U.S. Food and Drug Administration isn't concerned about Crestor's safety, Sidney Wolfe, director of Public Citizen's health research group, wrote today in a letter to FDA acting Commissioner Lester Crawford. That contradicts statements from FDA officials including David J. Graham.
>> Read article at Bloomberg.com

Senator calls for FDA probe
A U.S. lawmaker called Wednesday for a probe of reports that Food and Drug Administration officials tried to discredit a veteran scientist who testified over Merck & Co. Inc.'s withdrawal of Vioxx. In a letter to the Department of Health and Human Services, Senate Finance Committee Chairman Sen. Charles Grassley asked whether FDA managers contacted a whistle-blower protection group to file false charges in an attempt to tarnish the reputation of David Graham, the associate director for science in the Office of Drug Safety.
>> Read article at Money.CNN.com

Biogen gets the first FDA approval in 8 years for a multiple sclerosis drug
Today was a day of good news for multiple sclerosis patients: FDA granted approval to a new anti-multiple sclerosis drug Antegren developed by Biogen Idec Inc. after a priority review including one-year data from two Phase III studies. This is the first anti-MS drug approved by the FDA in eight years.
>> Read article at FinanceGates.com

CDC admits obesity stats flawed - pharmaceutical and weight loss industry at fault
A Wall Street Journal bombshell report that the U.S. Centers for Disease Control and Prevention (CDC) has admitted to serious statistical errors in calculating that obesity kills 400,000 Americans each year is only the tip of the iceberg of gross exaggerations and miscalculations, according to The Center for Consumer Freedom (CCF).
>> Read article at News-Medical.net

House Panel Joins Vioxx Inquiry
An influential House committee has joined in the congressional investigation of U.S. prescription drug safety, issuing extensive records requests Tuesday to the Food and Drug Administration and the drug manufacturer Merck & Co. The House Energy and Commerce Committee said it was seeking to understand how the heart risks of Merck's painkiller Vioxx were not addressed before the FDA approved the drug in 1999.
>> Read article LATimes.com

F.D.A. Employee Seeks Legal Help From Whistle Blowers' Group
Dr. David J. Graham, the drug safety reviewer who denounced his employer, the Food and Drug Administration, before a Congressional panel last week, said yesterday that he feared being fired and had sought legal help from a group that protects whistle-blowers. "My concern is retaliation from these people," Dr. Graham said in a telephone interview.
>> Read article at NYTimes.com

November 23, 2004

Glaxo says don't break up drug approval process
Splitting up the drug approval process by hiving off safety monitoring to a separate agency would be foolhardy, the research head of the world's second-largest drug maker, GlaxoSmithKline said on Tuesday. Tachi Yamada, chairman of research and development at Glaxo, urged caution before tampering with the existing system. "It would be very, very difficult and hazardous to consider the notion of separating out the review of efficacy from the review of safety, because all drug decisions are based upon the balance of risk to benefit," he told reporters during an R&D seminar.
>> Read article at Reuters.com

U.S. FDA Adds Restrictions to Acne Drug
Roche's acne drug Accutane and its generic versions will face tighter prescription controls to prevent harm to unborn children, U.S. health regulators said on Tuesday. The measures include a new joint database shared by all manufacturers of the drug to monitor patients, doctors and pharmacies, the Food and Drug Administration said.
>> Read article at NYTimes.com

Bayer says Baycol report 'unscientific'
Bayer on Tuesday rejected as "unscientific" a U.S. report alleging that it may have known its Baycol drug caused a high rate of a serious muscle condition more than a year before it warned of the risk. The authors of the report in the Journal of the American Medical Association (JAMA) were biased, Bayer said, highlighting that they were being paid to work with lawyers pursuing U.S. product liability claims over cholesterol-lowering Baycol.
>> Read article at Money.CNN.com

Millions still taking risky heart drug without warnings promised by FDA
A highly toxic heart drug continues to be prescribed to millions of patients nationwide without the detailed consumer warnings promised by the U.S. Food and Drug Administration more than a year ago. Each bottle of the drug, amiodarone, is supposed to include a new advisory that warns of its many risks and symptoms of fatal side effects and explains how the medication is supposed to be used. But the advisory, planned since October 2003, remains in draft form, bouncing back and forth between the FDA and the drug maker assigned to write it.
>> Read article at RealCities.com

AstraZeneca Faces U.S. Suit Over Nexium
A U.S. law firm has announced a class action lawsuit against AstraZeneca Plc accusing the Anglo-Swedish drugmaker of deception in its promotion of ulcer pill Nexium. Goodkind Labaton Rudoff & Sucharow said in a statement late Monday that AstraZeneca had falsely promoted Nexium as a more powerful and more effictive drug than its previous ulcer pill Prilosec, which is now subject to cheap generic competition. The law firm said that as of 2003, Prilosec was on sale at 46 U.S. cents a pill compared to $4 a pill for Nexium.
>> Read article at Reuters.com

Possible conflits of interest to influence look at suspected adverse drug reactions
A review of the published literature and of internal company documents from the manufacturer of cerivastatin (Baycol) a cholesterol lowering drug removed from the market in 2001, suggests that information about serious adverse effects of this medication was known to the company within months after this drug was launched, and that company analyses showing substantially increased risk of rhabdomyolysis were apparently not published or disseminated to physicians and patients.
>> Read article at MedicalNewsToday.com

Medical Journal Calls for a New Drug Watchdog
The United States needs a better system to detect harmful effects of drugs already on the market, and it should be independent of the Food and Drug Administration and the drug industry, medical researchers and journal editors said yesterday. Arguing that it was unreasonable to expect the same agency that approves drugs to "also be committed to actively seek evidence to prove itself wrong," the editors of The Journal of the American Medical Association (JAMA) recommended that the nation consider establishing an "independent drug safety board" to track the safety of drugs and medical devices after they were approved and in widespread use.
>> Read article at NYTimes.com

November 22, 2004

Arthritis Pills Little Use in Beating Cancer
Painkillers taken by millions of arthritis sufferers worldwide are actually of limited use in relieving symptoms, Norwegian scientists said on Tuesday. Researchers from the University of Bergen said their findings suggested the drugs should be used only on a short-term basis and be prescribed much more critically in future.
>> Read article at Reuters.com

Antidepressants May Increase Risk of Abnormal Bleeding
New users of selective serotonin reuptake inhibitors (SSRIs, a type of antidepressant) have an increased risk of being admitted to the hospital for abnormal bleeding. Case reports and observational studies have shown a relationship between SSRI use and abnormal bleeding. It is believed that serotonin plays a role in blood clotting, and because SSRIs affect serotonin levels, they may be associated with an increased risk of bleeding.
>> Read article at DocGuide.com

Report Faults Bayer on Baycol Withdrawal
New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks. This time it's Baycol, a cholesterol-lowering statin that Bayer AG withdrew in 2001 after some who took it developed a severe and sometimes fatal muscle disorder. A new study found that the risks were far greater than had been believed.
>> Read article at Yahoo.com

Roche consumer health sale cleared by EU
Bayer’s acquisition of the Roche consumer health business, a major player in the vitamin supplements market, has been approved by the European antitrust authorities, giving way to the creation of the region’s biggest consumer health business.
>> Read article at inPharma.com

November 21, 2004

Business View: Big pharma haunted by the spectre of Pinto
Remember the Ford Pinto? It was a small car with a poorly located fuel tank, which happened to explode if someone went into the back of it. Ford had lobbied US regulators against making changes to the car, producing a cost/benefit analysis that said "only" 180 people were likely to be killed by the Pinto's faults. And that was not worth the $137m (about £330m in today's money) that would have been needed to sort out the problem. The regulators were not impressed. Nor were the courts. Nor were the public. Ford's reputation went through the floor. Is the same thing happening in pharmaceuticals?
>> Read article at Independent.co.uk

Merck Steps Up PR Campaign After Recall
Merck & Co.'s campaign to defend itself in the wake of the recall of the pain reliever Vioxx intensified as it placed a package of three full-page ads in seven prominent newspapers beginning last Friday. That follows several television appearances as well as testimony before Congress by the company's chief executive. But public relations experts are calling the campaign predictable and said it lacks a crucial element necessary to bolster Merck's claims that it acted responsibly and timely in removing Vioxx from the market: Parties with no self interest or financial ties to the company coming to its defense.
>> Read article at ABCNews.go.com

Shades of the Vioxx Case for Another Drug
At a hearing Thursday on Capitol Hill, senators excoriated top federal drug regulators for failing to realize three years ago that Vioxx, a pain pill that Merck withdrew in September, was dangerous. But the Food and Drug Administration today faces almost exactly the same situation with another arthritis drug, Bextra, that it did with Vioxx three years ago. And just as with Vioxx, it is far from clear what the agency should do. In a sign that they believe they acted appropriately in the Vioxx case, top agency officials are handling the Bextra situation exactly the same way.
>> Read article at NYTimes.com

November 20, 2004

AIDS, Industry, Congress Put FDA on a Fast Track
In the 1990s, after decades of taking a slow, skeptical approach to approving new medicines, the Food and Drug Administration responded to pressures from patient advocacy groups, private industry and Congress by streamlining the way it did its job. Instead of acting as a suspicious cop, the FDA began to embrace a philosophy of working with the pharmaceutical industry as a trusted partner. It is that sea change, critics say, that has led to the controversy over Vioxx and to charges that in recent years the agency has too often allowed unsafe drugs to reach the market — with sometimes catastrophic results.
>> Read article at LATimes.com

Survey shows need for conservative, drug-free options
A new survey showing that nearly half of all Americans are concerned about the safety of the medical care they receive should send a strong signal to the health and insurance industries that safer non-drug, non-surgical treatments should be considered whenever possible, according to the American Chiropractic Association (ACA).
>> Read article at News-Medical.net

UK drug firms deny safety doubts
British drug firms have defended the safety of two products which were deemed unsafe by an American expert - Crestor, a cholesterol-lowering drug from AstraZeneca, and GlaxoSmithKline's Serevent, used by asthma patients.
>> Read article at BBCNews.com

November 19, 2004

Mutual medicine
From developing strategy for a product at the earliest pre-launch phase to promoting older, established products the pharma industry has always worked closely with clinical advocates. These experts, who are often referred to as key opinion leaders (KOLs) provide valuable input and feedback to the pharma industry to support the marketing process. In fact, the industry could not supply the right products, information or educational materials to the medical profession and patients without a close working relationship with them.
>> Read article at inPharm.com

US fears knock £3bn off AstraZeneca value 
Nearly £3bn (€4.2bn) was wiped off the value of pharmaceuticals giant AstraZeneca today after a US safety official raised concern over one of its key drugs. David Graham, of the US Food and Drugs Administration (FDA), told the US Senate Finance Committee that a closer review of anti-cholesterol drug Crestor was needed amid fears that it causes acute kidney failure.
>> Read article at IrishExaminer.com

FDA Vioxx fiasco raises questions about AIDS drug approvals for developing world
AIDS Healthcare Foundation today noted that the current "FDA fiasco" involving the agency's initial approval and subsequent recall of Merck's troubled arthritis drug, Vioxx, raises serious questions about the FDA's ongoing parallel role in the approval of generic AIDS drugs for widespread use in Africa and the developing world. At present, the President's Emergency Plan for AIDS Relief (PEPFAR) which pays for, or provides AIDS drug treatments for patients in developing world countries stipulates that if cheaper generic drugs are to be used, they must be approved for 'bio-equivalency' to their branded drug counterpart by the FDA.
>> Read article at NewsMedical.net
>> The AHF website can be found here

Two Vioxx Critics Allege Pressure
Two leading scientists said in Senate testimony yesterday that they were pressured to back off criticism of the painkiller Vioxx after warning that it might cause heart attacks and strokes in some patients. Gurkirpal Singh, a professor at Stanford University's medical school, said a senior executive of Merck & Co. Inc., the maker of Vioxx, contacted his superiors and suggested that Singh would have career problems if he continued to raise concerns. "I was warned that if I persisted in this fashion, there would be serious consequences for me," Singh said.
>> Read article at PhiladelphiaEnquirer.com

FDA will increase postmarketing surveillance of drugs
After controversies about the possible increased risk of suicide in children taking antidepressants and the increase in heart attacks and strokes in patients taking rofecoxib (Vioxx), the US Food and Drug Administration has announced plans to strengthen its surveillance of drugs on the market. The agency's Center for Drug Evaluation and Research will hire the Institute of Medicine to assemble a committee to review the effectiveness of the US drug safety system with emphasis on the FDA's postmarketing surveillance. Steven Galson, acting director of the centre, said, "Our current drug approval system has demonstrated that we don't always understand the full magnitude of drug risks prior to approval of drug products."
>> Read article at BMJJournals.com

November 18, 2004

Anti-Cholesterol Drug Launched
A new drug, Lipitor, formulated to checkmate coronary heart disease and other associated ailments, was launched in Lagos last week by the multi-national pharmaceutical company, Pfizer Specialties Limited. Speaking at the launch ceremony, Dr. Bimbola Ogunkelu, former minister of cooperation and integration in Africa, who was chairman of the occasion, stated that coronary heart disease was a major killer in Nigeria.
>> Read article at AllAfrica.com

Study Suggests How COX Drugs Cause Heart Disease
Painkillers suspected of causing fatal heart disease may act by starting the process of hardening the arteries, researchers proposed on Thursday. The drugs, known as COX-2 inhibitors, include Merck and Co.'s Vioxx, which earned the company $2.55 billion a year but was pulled off the market on Sept. 30 after a study showed it doubled the risk of heart attack and stroke. Tests on mice suggest COX-2 inhibitors might be especially dangerous to younger women, who are normally protected by biology from heart disease.
>> Read article at Reuters.com
>> An abstract of the study can be found here

Grassley Calls for Independent Review of Drugs on Market
U.S. Senate Finance Committee Chairman Charles Grassley called for independent reviews of drugs on the market at a hearing in which he called the recall of Merck & Co.'s Vioxx painkiller a ``disaster.'' The U.S. Food and Drug Administration's relationship with drugmakers is ``too cozy,'' Grassley, an Iowa Republican, said as he opened the hearing on Capitol Hill. He said the FDA failed to heed its own scientist's warning about Vioxx, which Merck withdrew Sept. 30 after the drug was linked to heart attacks and strokes.
>> Read article at Bloomberg.com

F.D.A. Failing in Drug Safety, Official Asserts
Federal drug regulators are "virtually incapable of protecting America" from unsafe drugs, a federal drug safety reviewer told a Congressional panel on Thursday, and he named five drugs now on the market whose safety needs "to be seriously looked at." In testimony before the Senate Finance Committee, Dr. David Graham, the reviewer in the Food and Drug Administration's Office of Drug Safety, used fiery language to denounce his agency as feckless and far too likely to surrender to demands of drug makers.
>> Read article at NYTimes.com

FDA Is Flexing Less Muscle - Some Question Its Relationship With Drugmakers
In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects, records show, leading some lawmakers, academics and consumer advocates to c