Big Pharma Under Fire for Reverse Plagiarism

The pharmaceutical industry is coming under fire for allegedly hiring ghostwriters (writers who work for pay, but not a byline) to write positive reports/analysis of clinical tests on drugs with possible efficacy issues - and then recruiting notable doctors to stick their names on it. This issue has been bandied about for months and suspected for longer, but now U.S. Senator Charles Grassley from Iowa is renewing the fight.

Is the fact that this possibility has surfaced doesn’t surprise me troubling? Even before I declared my concentration in health/medicine reporting, I was aware of the corruption and rampant abuse of power by what is referred to as Big Pharma. Government deregulation and regulation on a slew of business and healthcare policy issues end up benefiting these corporate entites, whether allowing unapproved drugs and drugs with possible side effects to go on the market before they are fully vetted by the FDA or removing/weakening price caps on prescription drugs so that Pharma can charge more for less and profit from donations of life-saving drugs to Third World countries. And of course there are the deceptive drug ads that have had varying levels of regulation over the last two decades.

Journal articles are an important “first draft” introducing new developments in medicine to the public and are among the sources used by health professionals and medical reporters in their story research. Doctors and reporters already look at journal articles with a wary eye, and the likely possibility of journal articles being fabricated can be even more detrimental to the trust people place in such written work.

And that doctors would sign on to put their names on these works they haven’t written - even if they agree with what is being written - is egregious and says they condone this deceptive practice. Like the regulations placed on drug advertisements, all that would be needed is for the doctors to acknowledge that this IS NOT their work. It would be better if it were, but if this is the way they want to roll, then disclose your affiliations.

It is tantamount to plagiarism.

NYC HEALTH: Health Department Targets Deadly Cosmetics

By Heather J. Chin
September 25, 2008
(originally published at the CUNY Graduate School of Journalism blogs)

New York – City health officials stepped up their efforts to alert residents that some imported cosmetics threaten them with lead and mercury poisoning.

While federal and state standards already prohibit lethal cosmetics from entering the country, consumer demand keeps the supply steady, according to officials at the Board of Health during their quarterly meeting on Wednesday.

“The problem with global … products [is] that they are falling through the cracks,” said Dr. Nancy Clark, Assistant Commissioner of the department’s Bureau of Environmental Disease Prevention.

Specific deodorants, skin creams, aphrodisiacs and herbal remedies used by residents of Dominican, Indian and Chinese communities are on the list of products with poisonous ingredients. These cosmetics are imported from Asia, Latin America, Africa and the Middle East.

Tests done by NYC’s health department and by others around the country have shown these products to have lead and mercury levels as much as 6,000 times higher than limits recommended by the U.S. Food and Drug Administration (FDA). The FDA limit for lead levels is 10 parts per million; for mercury, it is 1 part per million.

At last month’s meeting, the board authorized the health department to find and remove dangerous cosmetics from store shelves, just as tainted food or drugs are.

These tools will come in the form of signs and fact sheets in the languages spoken by consumers, explained Ms. Paromita Hore, a risk assessment coordinator. “They’re often not aware” of the danger, she said, adding that use of the unhealthy products “is longstanding in their culture.”

At least in the Chinese community, such awareness efforts are welcome, says Gary Lee, the owner of a pharmacy in Chinatown that offers both U.S. name brands and popular Chinese medicines and herbs.

“[Officials] usually want to put pressure on the importer, not putting pressure on the shop,” he said. He notes that if a store has non-FDA approved drugs in stock, it is because they sell. “What [the consumer] wants, they make a request.”

For Indian Americans, kohl and surma – two skin products listed by the Health Department as being laced with high levels of lead – pose a great threat because they are so embedded in the culture.

“Loving kohl is one of the commandments for being desi,” writes Anu, an Indian American freelance writer on her blog, The Indian Make-Up Diva.

When ingested or absorbed through the skin, high levels of lead and mercury can pose a danger to brain function, as well as to blood and renal system function. These effects are particularly dangerous in children and pregnant women.

MEDICAL NEWS: First Treatment For Huntington's Approved By FDA

(previously published here at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

08/19/2008

A drug called Xenazine (tetrabenazine) has been approved by the U.S. Food and Drug Administration as the first treatment for chorea, the involuntary jerking movements that are a symptom of Huntington's Disease.

The drug addresses only specific symptoms, however, and does not target the complete condition. It is also not without major side effects, notes the FDA, such as suicidal thoughts and depression, especially in patients already predisposed to those conditions. Other side effects include drowsiness, insomnia, nausea and restlessness.

Xenazine works by suppressing the ability of dopamine - a neurotransmitter responsible for improving nerve conduction - to communicate with certain nerve cells in the brain, resulting in an over-active system.

Huntington's Disease, or chorea major, is a rare inherited neurological disorder that affects physical, cognitive and behavioral ability - a person's coordination, speech, thought processes and muscle control. Patients with chorea are at higher risk of fall-related injuries.

About 30,000 Americans are currently affected and another 200,000 are at risk of developing the genetic disorder. Symptoms usually manifest between the ages of 30 and 50.

Xenazine should be available by prescription by the end of the year and given the FDA-approval, it is likely (although uncertain) that Medicare and other government or private insurance plans would cover the drug's cost.

The medication is already available in Australia, Canada and Europe and is manufactured by the Washington, D.C.-based Prestwick Pharmaceuticals.

Heather J. Chin can be reached at hchin@thebulletin.us.

©The Evening Bulletin 2008

Some Antibiotics Could Damage Tendons, FDA Says

(for original article and comments, see www.thebulletin.us
As of this reprint, the statistics are under second review.)

By: Heather J. Chin, The Bulletin

07/14/2008

Some antibiotic drugs such as Bayer AG's Cipro and Avelox as well as Merck & Co. Inc's Noroxin will be required to have a stronger "black box" warning about the risk of tendonitis and ruptured tendons, according to new Food and Drug Administration regulations issued Tuesday.

In addition, an FDA-approved medication guide must be provided to individuals upon the filling of their prescriptions. Other drugs affected by the new requirements include Oscient Pharmaceuticals Corp.'s Factive, Depomed Inc.'s Proquin XR, and Ortho-McNeil's (a Johnson & Johnson subsidiary) Levaquin and Floxin.

Cipro and Levaquin, two leading drugs included in the warning, have other uses as well. Cipro is commonly used to treat urinary tract infections and is also effective against deadly bacteria, anthrax, being one of the drugs stockpiled by the government should a bio-attack occur. Levaquin is used to treat respiratory infections.

When sold by generic manufacturers, Cipro is referred to as ciprofloxacin and Floxin as ofloxacin. All of the drugs affected fall under a drug class known as fluoroquinolones.

Tendons are the tough, fibrous connective tissue joining muscles and bones. Also called sinew, they are essential to body movement and receive a lot of tension. Overuse can lead to inflammation and tendonitis, and excess pressure, some diseases and steroids can lead to snaps or ruptures. Such issues are normally thought of as sports injuries in young men or men in their mid-30s.

FDA studies indicate that the risk of tendon ruptures is estimated at about three to four times higher than normal rate (about one in 100,000) for those taking fluoroquinolones, notes Dr. Renata Albrecht, head of the FDA's division focusing on infectious microbes and transplant issues. Also, the risk is greater in patients ages 60 and older, particularly those who have had certain organ transplants or are using steroid therapy.

With this in mind, doctors are advised to restrict use of the drugs to confirmed bacterial conditions, and patients with tendon pain should immediately stop taking the drug, halt all exercise and call their doctor.
Patients who do experience a rupture may recover without surgery, but if surgery is needed to repair a torn tendon, full recovery may not be possible.

The regulation comes in the wake of a January 2008 lawsuit by consumer group Public Citizen, which had petitioned for the "black box" warnings two years ago and is still pushing for a warning letter to be sent to physicians describing the possible adverse reactions, such as tendon pain, that could be caused by the drugs.

"If the doctor is left out of the loop, it just doesn't make any sense," Sidney Wolfe, head of Public Citizen's Health Research Group said to Reuters UK.

Current labels for all the drugs involved already contain cautions about tendon problems, but Edward Cox, director of the FDA's antimicrobial products office, said, "The FDA believes that these labeling changes will better inform health care providers and patients about the risk."

Also, since the presence of several hundred "continued reports" of tendon-related problems indicated that these warnings were not reaching some doctors and patients, "additional steps are warranted to better manage the risk of tendon rupture," said Dr. Albrecht.

The specific number of reported cases were not available from the FDA, but Public Citizen's Mr. Wolfe lists government data as noting the numbers as 407 ruptures and 341 tendonitis cases through 2007 and 262 tendon ruptures, 258 tendonitis and 274 other tendon disorders through 2005.

Ortho-McNeil and their parent company Johnson & Johnson will add the new warning to both Levaquin and Floxin, as will Merck & Co. for its drug Noroxin, according to spokeswomen for the two companies.
Oscient released a statement saying it would review the issue and the remaining companies were not available for comment.

Heather J. Chin can be reached at hchin@thebulletin.us

FDA Approves A New Insulin Pump

(previously published at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

07/03/2008

At the same time that a wireless insulin pump for diabetics has been approved for marketing and public use by the U.S. Food and Drug Administration (FDA), its regulators are reconsidering the standards they use to approve diabetes medications.

The FDA began hearing from a panel of outside diabetes experts, cardiologists and statisticians on Tuesday as to whether the agency should require pharmaceutical companies to prove, through extensive long-term clinical research studies, that their drugs reduce heart problems and do not increase risk of death in order to gain FDA approval.

Diabetes is a disease where the body either does not produce or properly use insulin, a hormone that converts food into energy. Prescription drugs used to treat type 2 diabetes - the most common form, where a person's body either produces too little insulin or rejects insulin - are currently evaluated on the basis of whether they are proven to control blood-sugar levels.

The wireless insulin pump that has been approved is known as the OneTouch Ping glucose management system and is produced by Animas Corp., a medical device company from West Chester, that is a subsidiary of Johnson & Johnson Corp. in New Brunswick, N.J. It makes it easier for individuals with diabetes to calculate and inject themselves with the proper dose of insulin.

This reconsideration of regulatory standards is the result of questions that arose last year after an analysis of a popular diabetes drug, Avandia, showed that although taking it lowered blood-sugar levels, its use also increased the risk of heart attack in individuals.

FDA research into the issue yielded no actionable results, and additional trials by Avandia's manufacturer, GlaxoSmithKline, which has operations in the Philadelphia area, will likely not be ready until 2014.

The panel's opinions may influence and affect that approval of both new diabetes drugs and those that are already on the market.

However, there are some scientist even from within the FDA, who are skeptical of the value of tying risk of a side effect (heart attack) to the approval and availability of a drug whose target goal is to treat [low blood sugar and] diabetes.

Still, consumer advocates, lawmakers and diabetes organizations express concern over the risk of possible side effects.


Heather J. Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008

New Vaccines Approved For Kids

(previously published at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

06/30/2008

Pentacel and Kinrix, two new combination vaccines that immunize infants and children against multiple diseases with fewer injections, received federal approval this week and will be available for distribution to U.S. health care providers by this summer.

Kinrix is produced by GlaxoSmithKline, a UK company with operations and research and development sites throughout Philadelphia, Upper Merion and King of Prussia. Likewise, Pentacel has a Pennsylvania connection, as it is the product of Sanofi Pasteur of Swiftwater. It is a division of Sanofi Aventis Group, a French company that creates vaccines protecting against infectious diseases.

The two vaccines were approved by the Advisory Committee on Immunization Practices, which voted to recommend adding both combination vaccines to the federal government's Vaccines for Children program. The program which provides free vaccinations for all children, regardless of ability to pay.

For the 6 weeks to 4-5 year (before the fifth birthday) age group, the FDA has approved Pentacel, a five-in-one vaccine manufactured by Sanofi Aventis, to protect infants and children against diptheria, tetanus, pertussis (also known as whooping cough), polio and Haemophilius influenzae type b (Hib).

It is administered as a four-dose series, one-a-time at 2, 4, 6 and 15-18 months of age. It is the first four-dose combination vaccine licensed in the U.S. that includes both poliovirus (IPV) and Hib vaccine antigens.

For children 4 to 6 years of age, GlaxoSmithKline will release Kinrix, a four-in-one booster vaccine that uses only one shot and is geared for use to protect against diptheria, tetanus, pertussis and polio. Kinrix is recommended for use by children who have already taken Infanrix or Pediarix vaccines.

Infanrix covers DPT, diphtheria, tetanus, and pertussis (whooping cough).
Pediarix is a multiple vaccine that covers DPT, hepatitis B and polio, and has had over 30 million doses used in younger children since 2003.

Clinical studies into Pentacel and Phase III trials into the safety of Kinrix have shown that the new combination vaccines offer similar safety benefits as previous vaccines.

Both vaccines seek to remedy the problem of multiple doctor visits where young children, their parents and their doctor must deal with the stress of frequent needle jabbing. The U.S. Centers for Disease Control and Prevention (CDC) currently recommend up to 23 single shots by the time a child reaches 18 months of age.

Using combination vaccines "reduces the number of shots by 6 shots in the first year of life, with the same degree of efficacy and no[ne or fewer] side effects," said Dr. Gary Emmett, professor of pediatrics at Jefferson University Hospital and member of the Board of Health in the city of Philadelphia.

Fewer shots can also have a positive effect on the child's health.

"When I started practicing, we gave DTP, which had almost 200 separate antigens in it, " said Dr. Emmett. "Now we give DTaP, which is more refined and has less than 30 antigens, so even though... the [earlier ones] were effective, they gave more side effects. Now we have less sore arms, less fevers, making the [children and the] pediatricians happy."

Combination vaccines can also help to fulfill both school and CDC immunization requirements, says Jennifer Armstrong, a GlaxoSmithKline spokewoman, while also creating less need to experience painful finger or arm pricks, especially when young children are involved.

"Four- to six-year-olds are a particularly challenging group," said Ms. Armstrong. "They are old enough to [know what's coming and] say no right off the bat."

Heather J. Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008

MEDICINE: FDA Expands Anti-Psychotic Drug Warning

(published and archived at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

06/18/2008

The U.S. Food and Drug Administration (FDA) will soon be increasing the number of prescription anti-psychotic drugs to carry a special warning label.

The label will warn against side effects, particularly for those over 65 based on recent studies suggesting the elderly are susceptible.

Several older or "conventional" antipsychotic medications used to treat behavioral and dementia-related problems are scheduled to join other newer drugs in carrying a "black box" warning.

The FDA's Web site lists Navane, Haldol and Moban among 11 conventional drugs affected by the new regulations.

Pharmaceutical manufacturers will have 30 days to submit either the wording for the new labels or a reason to dispute the FDA's labeling requirement. After that point, the FDA will have authority to enforce the legal requirement.

Although antipsychotic drugs are not approved to treat dementia, and are primarily utilized for schizophrenia, studies found that patients with dementia who take these drugs can exhibit violent behavior.

The decision whether or not to prescribe these medications is and will remain up to the prescribing doctor on a case-by-case basis.

Symptoms of dementia range from forgetfulness and diminished memory to an inability to recognize familiar objects, sounds or people.

In 2005, the FDA first announced requirements for black box warnings for the newer, or "atypical" antipsychotic drugs. These drugs with existing warning labels include Abilify, Clozaril, Risperdal, Seroquel and Zyprexa. These drugs tend to cause a lower incidence of side effects, such as involuntary tics and parkinsonism. Parkinsonism is the display of symptoms similar to, but not necessarily symptomatic of Parkinson's disease, including tremors slow movement, impaired speech or muscle stiffness.

In a news conference on Monday, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, said that the warning is intended to help doctors and families understand and balance the risks and benefits of anti-psychotic medication.

"It is important that health care professionals and consumers have the most up-to-date drug safety information," said Dr. Laughren.

In the two studies on which the box warnings are now based, researchers found patients taking the older drugs had a 4.5 percent risk of death, versus a 2.6 percent risk for those taking a placebo.

Dr. Laughren speculated however, that as the patients in the studies were elderly and many were already ill, its findings might be biased.

©The Evening Bulletin 2008