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health news roundup: focus on D R U G S
By | November 16, 2009
The average premium [Medicare beneficiaries] pay for stand-alone drug plans will rise 11% to $38.94 a month in 2010… Changes are even greater for seniors receiving drug coverage as part of Medicare Advantage… The average monthly premium for those beneficiaries will rise by an average of 32%, to $48 a month… Advantage plans cost the federal government 14% more on average per beneficiary than traditional Medicare. [for details, tips, and links, including rx drug coverage search engine, see here and here.]
Current U.S. Food and Drug Administration regulations require that any mention of a drug’s benefits must also reveal its risks… But drug makers and Web companies attending a two-day hearing this week on online marketing of medical products said the rule hampers them… [They] are proposing new types of ads – ones that would carry links to detailed drug information [rather than the drug information itself, thus leaving more room, suggests dr leigh, for bigger photos of women looking sad and men in bathtubs].
A new study shows that drug ads are not doing a good job at helping consumers improve decisions about their health… “American television viewers see as many as 16 hours of prescription drug advertisements each year…” The study authors also suggest getting rid of video and audio distractions.
Pharma Will Fight House Health Reform Bill… The Senate version includes an $80 billion discount drugmakers agreed with the White House would be offered; the House version says that should be $140 billion. Brennan says the industry will fight if the House version survives. ["discount" means price controls on drugs covered by government health programs, which might reduce drug company profits by the amounts mentioned.]
The health care reform bill passed by the House would force drugmakers to disclose how much they spend on continuing medical education classes for docs, although the Senate version doesn’t include such a requirement.
Eli Lilly’s publication of a registry revealing all payments to doctors has opened up an overdue conversation. Is it ethical for a doctor to become a member of a drug company speaker’s bureau? Or is it inherently deceptive for a doctor to pose as being an independent source of information while at the same time being under contract to speak for specific drugs?
from the registry, jan-june 2009:
one drug company, one state (oregon), one 6-month period: how much doctors were paid to promote lilly drugs (in economically distressed communities), individual amounts:
portland/beaverton (11.7% official september unemployment rate, vs. 9.8% nationwide*): $32,025 – $27,125 – $27,150 – $18,450 – $16,450 – $15,050 – $13,350 – $12,638 – $12,150 – $11,063 – $8,750 – $5,813 – $5,550 – $5,400 – $4,450 – $4,800 – $3,000 – $2,500 – $675 – $638 – $188
eugene (12.2% official unemployment rate): $19,900 – $9,400 – $3,600 – $3,300
bend (15.9%): $35,113 – $29,269
salem (11.6%): $1,800
corvallis (7.6%): $16,950 – $5,700
ashland (11.5%): $525
*sept unemployment rates from oregon employment dept
[note: to date, lilly is the only company that publishes their 'speaker's bureau' list.]
The Food and Drug Administration on Friday took the first step toward banning alcoholic beverages that contain caffeine, sending letters to nearly 30 manufacturers of such products giving them a month to prove that the products are safe… The caffeine in the drinks tends to mask the impairment produced by alcohol.
Stainless steel fragments, non-latex rubber and fiber-like material have been found in some drugs made by Genzyme Corp… Viral contamination forced the company to close its Allston Landing plant in Boston in June.
[The Food and Drug Administration] is considering “outsourcing” the efficacy analyses of older marketed antibiotics to a nonprofit standards-setting group ["CLSI"], whose 2,000 members include numerous drugmakers.
…The FDA said it is facing the enormous task of ensuring that drug labeling for older antibiotics, which are mostly made by generic manufacturers, many of them foreign firms, is updated… Many antibiotics have become resistant to certain bugs, but the product labeling does not reflect that information.
…The FDA is facing a choice of requiring generic drugmakers to conduct clinical trials to establish the current efficacy of the older antibiotics in combating pathogens – which regulators have expressed is an unfeasible option, given the expense to do so – or force the drugs off the market, which also would not be feasible given the need for the drugs. The other option is to use the data already collected and analyzed by CLSI or another standards group.
…But Diana Zuckerman, president of the National Research Center for Women & Families, who testified at the October advisory meeting, argued that the FDA should evaluate antibiotic resistance using “the gold standard” of clinical trials.
[let me get this straight: what "outsourcing" means, is that the FDA is funded too poorly to test generic antibiotics to see if they still work, or is too spineless to require generic manufacturers to do the testing, so they plan to just buy data compiled by drug manufacturers in the past? that's "outsourcing"?]
U.S. Senator Benjamin L. Cardin (D-MD) today [11/10/09] sent a letter to Defense Secretary Robert Gates requesting an accounting of how many troops serving in Iraq and Afghanistan have been prescribed antidepressant medications while deployed. Senator Cardin expressed his concern that there may be a connection between the reported use of such prescription medications and the record high suicide rate among active-duty soldiers.
Antidepressants get to work immediately to lift mood, contrary to current belief, UK researchers say… The action is rapid, beginning within hours of taking the drugs, and changes negative thoughts, according to the Oxford University researchers… [One author] said: “We found the antidepressants target the negative thoughts before the patient is aware of any change in feeling subjectively… Over time, this will affect our mood and how we feel because we are receiving more positive information.”
A regular antidepressant combined with an intensive treadmill training program can help people with partial spinal injuries walk better and faster, a study by the Rehabilitation Institute of Chicago found.
A new analysis of a dozen studies in The New England Journal of Medicine examined possible new uses for [Neurontin, a.k.a. gabapentin,] and found the published results were often fudged, indicating the pill worked better than internal company documents showed. In essence, when the primary finding of a company-funded study wasn’t favorable, the study authors usually buried the result and found something else positive to highlight, without disclosing the change… The analysis comes two months after Pfizer was fined a record $2.3 billion, including an unprecedented $1.2 billion criminal fine, for illegally marketing other drugs.
Eight prescription drug-making companies are paying Iowa $4.3 million to settle allegations that they purposefully reported false and inflated drug prices which serve as the basis for Medicaid reimbursements paid by taxpayers. Medicaid is the state-federal health care program for the poor… The suit alleged that the price for drugs paid by the State, based on fraudulently-reported Average Wholesale Prices… can exceed 40-50%, 100%, 200% or even 1000% or more of the real prices.
headlines at a glance:
A drug for people with a form of leukemia holds promise as a possible treatment for ovarian cancer.
A drug used to treat pneumonia might serve as an effective treatment against a type of muscular dystrophy.
Two drugs used to treat breast cancer and osteoporosis eliminated cervical cancer in mice.
Birth Control Pill May Reduce Asthma Symptoms
German Company Develops Female Viagra
Researchers are now inching closer to discovering a contraceptive pill for men. Men will soon have the options of a daily oral pill, a patch or gel to be applied to the skin, an injection given every three months or an implant placed under the skin every 12 months as birth control methods.
Since 1997, the American Medical Association has taken a hard line against [medical marijuana], endorsing its classification as a Schedule 1 controlled substance – the most restrictive category – and asserting its lack of medical value… [But] at its annual meeting Tuesday, the country’s largest physicians’ organization adopted a policy that urges the federal government to reclassify, or “reschedule,” the drug.
11/4/9 – Voters approved a referendum making Maine the fifth state to allow retail pot dispensaries… California, Colorado, New Mexico and Rhode Island allow for places where medical marijuana patients can legally buy pot… Fourteen states have laws allowing some use of marijuana for medical purposes.
The Cannabis Cafe in Portland, Oregon, is the first to give certified medical marijuana users a place to get hold of the drug and smoke it – as long as they are out of public view.
Police raided four large marijuana-growing operations in Eugene and West Linn [Oregon] this week that were tied to a registered medical marijuana grower whose crop far exceeded legal limits… [and who] is registered as a legal grower for one patient under the Oregon Medical Marijuana Program. He is permitted to possess only six mature marijuana plants [and] 18 seedlings… In all, police seized 1,127 marijuana plants.
Abusing prescription drugs is an alarming new trend… National statistics show teens are three times more likely to overdose on prescription pills rather than illegal ’street’ drugs… In a national survey, 64 percent of teens 12-17 say they didn’t have to look farther than their own home, often getting pills from their own medicine cabinet, or from friends and relatives. [dr leigh's opinion: the most dangerous drug overdose: calcium-channel blockers (for high blood pressure). next most dangerous: tylenol. next most dangerous, but most prevalent: alcohol. estimated number of teenagers who overdose yearly, on plain old marijuana: zero.]
A few weeks ago I walked into the pharmacy of one of those “we sell everything and cheaper” places to fill a 14-pill prescription for a cancer patient… I asked the pharmacist what the price would be without the insurance. She looked at me and smiled and said in a very low voice, “$4,100.” “Excuse me. Did I hear four thousand one hundred dollars for 14 pills – almost $300 for one?” my voice becoming shriller with each word. “Yes,” she replied at an even lower decibel, glancing nervously over at the line of customers waiting to be served.
For more than a few minutes I was utterly incoherent… The patient took me by the arm and led me out of the store and said smilingly, “They don’t leave much alternative do they? Either one can afford them or one can’t…” When I related the story of the 14 pills to a congressman the other morning at a press breakfast, he was stunned for only a second and then began the standard defense about how much it took the pharmaceutical companies to research and produce such special medicine. He said nothing about how many billions in profits these companies have made over the years, or the fact that very few new medicines are being produced, or that stockholder demands that the research costs be recaptured quickly are a problem.
Some of my colleagues stopped me after the meeting to ask what kind of pills they were and who was the person who needed them? My daughter, I replied, for a brain tumor. “Wow!” one of them said. “Yeah, wow!” I replied.
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