An Interesting Read
November 12, 2009
Still Waiting for Health Care by Ralph Nader « Dandelion Salad
The victims of medical malpractice – estimated by the Institute of Medicine and the Harvard School of Public Health to be about 100,000 deaths a year – escaped having to overcome more hurdles before they have their full day in court. Helping to beat back the Republicans, who define “medical malpractice reform” as letting the negligent perpetrators get away with their lethal consequences, was Congressman Bruce Braley (D-IA).
Rising on the House floor he delivered a factual plea for patient safety. Hardly had he started to speak with Republicans started shouting “trial lawyer, trial lawyer” referring to his previous profession of representing wrongfully injured people before local juries in Iowa. This rare display of shouting by opponents was punctuated by one of their unleashed members rushing down the aisle shouting “You’ll pay for this.”
During this overall debate on the bill, Republicans stood up one by one, as prevaricatory dittoheads, to often scream and howl (like coyotes) that this is “a government takeover of one sixth of the economy,” “would destroy the economy,” “put 5.5 million people out of work,” “destroy the doctor-patient relationship,” “be a steamroller of socialism,” “force millions of seniors to lose their current health coverage” (meaning, Medicare?) and, in a passionate appeal to the Almighty, Congressman John Fleming (R-LA) declared “God help us as the government takes over your day-to-day life.”
Never mind that this bill is just an expansion, however misdirected, of government health insurance designed to increase corporate profits and increase the corporate grip over the day-to-day decisions regarding who, when and how people get their health care or get their bills paid.
To top off the madness, Senator Joe Lieberman (I-CT), an ever maturing political hermaphrodite, reneged on his assurance to Senate Majority Leader Harry Reid and imperiously announced on Fox News Sunday that “if the public option plan is in there, as a matter of conscience, I will not allow this bill to come to a final vote.”
For media-centric Joe, his motto seems to be “L’Senat c’est moi.”
The Young and the Old – Different Risk with H1N1 Virus
November 12, 2009
Young People More Likely to Get H1N1 Flu, Study Reaffirms
A Mexican study has confirmed that younger people were more likely to become infected with the pandemic H1N1 influenza virus but that older people were more likely to die from it.
The majority of confirmed infections (56%) occurred in individuals 10 to 39 years old, with only 10.2% occurring in people 40 and older, according to Victor Borja-Aburto, PhD, of the Mexican Institute for Social Security in Mexico City, and colleagues.
“The high incidence of infection in young people could show not only their different exposure related to their daily activities but also that people older than 60 years might have some immunity against the H1N1 virus,” they wrote online in The Lancet.
However, the death rate was highest among those 70 and older, at 10.3%. The death rate was 2% or less for all age groups younger than 40.
The findings are consistent with previous epidemiological studies of the ongoing pandemic.
Public Option is Still Alive… So It Seems.
October 19, 2009
Senator Says Public Plan Is In, SGR Gets Attention
When the healthcare reform bill comes up for a vote in the Senate, it will contain a public plan, the chairman of the Health, Education, Labor and Pensions (HELP) Committee said today.
“Yes, we’ll have a good strong, public option,” Sen. Tom Harkin (D-Iowa) told reporters Friday.
Harkin has been one of the main proponents of the public plan in the Senate, but Sen. Max Baucus (D-Mont.), chairman of the Finance Committee, has said he doesn’t think the public option has enough votes to pass in the Senate.
H1N1 – Swine Flu Epidemic
September 21, 2009
Medical News: CDC Spells Out Process to Get Pandemic Vaccine to Patients
A minimum of 3.4 million doses of vaccine against H1N1 pandemic flu will be available in the first week of October, the CDC said.
Those doses — all in the form of a live attenuated nasal spray vaccine — may be supplemented by some injectable vaccine, according to Jay Butler, MD, the chief of the agency’s 2009 H1N1 vaccine task force.
“Additional vaccine may be available as well,” Dr. Butler told reporters, “but 3.4 (million) is the hard number that we have right now.”
After the first week of October, additional vaccine will become available, he said, eventually reaching 20 million doses delivered each week until the end of the year.
Butler cautioned that getting the vaccine to patients is likely to be logistically challenging, especially in the first days. “The flow of vaccine the first week or two may be slower than what we would like,” he said.
The U.S. has ordered 195 million doses of pandemic flu vaccine from five companies, and four of the vaccines have now been licensed by the FDA. (See FDA Approves H1N1 Vaccines)
To get them out, the government will use the same process employed by the Vaccine for Children program, which distributes medications to about 40,000 healthcare providers across the country, he said.
That network will be expanded by adding another 50,000 providers of various types.
But not all of those providers will have vaccine available for all patients immediately, he said. “There’s not a sudden appearance of vaccine in 90,000 refrigerators around the country,” Butler said.
The ordering process, he said, will begin with a request from a provider to the state health department, which will know from day to day how much vaccine is allocated to that state.
State allocations will be based on population.
Their Lawyer Says Corporate Integrity is Their No. 1 Goal.
September 3, 2009
Medical News: Pfizer Settles Fraud Charges for $2.3 Billion
Pfizer will pay the government $2.3 billion to settle criminal and civil charges that it promoted off-label uses for the disgraced painkiller valdecoxib (Bextra) and three other drugs.
The Justice Department said it was the largest healthcare fraud settlement in history.
More than half the settlement — $1.3 billion — involves Pfizer’s efforts to promote valdecoxib, a COX-2 inhibitor withdrawn from the market in 2005 because of cardiovascular and other risks.
Pfizer’s sales staff had urged doctors to prescribe the drug for surgical pain and to prevent deep vein thrombosis, according to court records from a criminal trial of a Pfizer manager earlier this year.
The other $1 billion covered charges that Pfizer improperly promoted the antipsychotic drug ziprasidone (Geodon), the antibiotic linezolid (Zyvox), and pregabalin (Lyrica), approved for epilepsy, fibromyalgia, and neuropathic pain.
The settlement will be shared between the federal government, state Medicaid programs, and whistleblowers. The latter include a Pennsylvania psychiatrist and at least one former Pfizer employee whose allegations helped launch the investigation.
Their complaints, which had been sealed until the settlement was reached, provided details on Pfizer’s alleged transgressions.
For example, according to one complaint, Pfizer pushed linezolid for several types of infections not named on its FDA-approved labeling, and also claimed it was superior to vancomycin without FDA approval.
Similarly, Pfizer was said to have promoted ziprasidone — approved only for schizophrenia or acute manic or mixed episodes associated with bipolar disorder — for depression, obsessive-compulsive disorder, autism, and a host of other conditions.
In addition to promoting the off-label uses, Pfizer was also accused of paying kickbacks to doctors who prescribed the drugs.
Sales of ziprasidone, pregabalin, and linezolid in 2008 totaled about $2.5 billion, according to the consulting firm SDI Health.
Come See My Show
August 21, 2009
Evanston artist to show photos at ‘THREE’
August 20, 2009
SRO: PEOPLE TO WATCH“THREE,” the third annual fall show by artists at Margin Gallery and Collective, co-founded by Nima Taradji of Evanston, will open Sept. 4 at 1915 S. Halsted St., Chicago. Taradji also co-founded Hello Artichoke, another cooperative gallery in Los Angeles, where he worked as a commercial photographer, shooting celebrities in art, music and modeling. He later took a break from commercial photography to attend law school in Chicago. Besides the photographs of Taradji and others, “THREE” will include paintings, drawings, ceramics and metalwork. An artists’ talk will be held at 7 p.m. Sept. 4 and an opening reception between 6-10 p.m. Sept. 11. Gallery hours are 5-9 p.m. Fridays, 12-7 p.m. Saturdays and 12-5 p.m. Sundays. Visit www.margingallery.org.
I Will Believe it When I See It.
August 7, 2009
FDA Chief Promises Tougher Stance on Food and Drug Safety
FDA Commissioner Margaret Hamburg, MD, vowed that the agency would be more aggressive in enforcing food and drug safety regulations and quicker to act when a company breaks the law.
In a speech at the Food and Drug Law Institute, Hamburg said that some FDA enforcement actions over the past several years have been “hampered by unreasonable delays” and that there has been a “steep decline in enforcement.”
“In some cases, serious violations have gone unaddressed for far too long,” Hamburg said. “These include violations involving product quality, adulteration, and misbranding, false, misleading, or otherwise unlawful labeling, and misleading advertising.”
The new FDA — the one Hamburg took the helm of just eight weeks ago — will be much more aggressive and visible. “The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” she said.
Specifically, she said, the agency will do the following:
* Create a clear timetable for companies to respond to FDA inspection findings, generally no more than 15 days after the inspection. If the company fails to respond, the agency will issue a warning letter or take other enforcement action.
* Streamline the warning letter process by limiting legal review of letters to those that might actually present major legal issues, and prioritize the follow-up process on warning letters.
* Rely more on local, state, and international officials in food safety situations that require quick action.
* Be prepared to act “swiftly and aggressively” when dealing with significant public health concerns, possibly even before a formal warning letter is issued. The agency will no longer issue multiple warning letters before dealing with a violation, Hamburg said.
* If a company has corrected whatever issues were raised in a warning letter, the FDA will publicly clear the company on its Web site. Hamburg called it a “close out process.”By beefing up its enforcement efforts, Hamburg said the FDA will ensure that “violations are taken seriously, that warning letters and enforcement actions occur in a timely manner, and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.”
Since Hamburg took the helm of the FDA, the agency has been aggressive in cracking down on the makers of misleading or potentially dangerous products.
For instance, the FDA recently issued 65 warning letters to Web sites hawking phony products that supposedly prevent, diagnose, or treat the H1N1 (swine flu) virus — including a “virus killing” shampoo. According to Hamburg, 80% of the Web sites contacted by the FDA have removed the products.
Where 10 such products were popping up every day, the FDA is now aware of about two new ones a week.
Also, the FDA last week sent warning letters to companies that sell dietary supplements containing anabolic steroids, and posted a public health advisory warning consumers to avoid body-building supplements that contain androgen, estrogen, and progestin-related ingredients.
Free Drugs for A Year to Unemployed
May 15, 2009
Pfizer Offers Year of Free Meds to Unemployed
Drug giant Pfizer said unemployed people who have been taking its branded products could receive them free for up to a year in a new program — with some exceptions.
The program, called MAINTAIN, will provide access to more than 70 Pfizer drugs including atorvastatin (Lipitor), celecoxib (Celebrex), pregabalin (Lyrica), and sildenafil (Viagra).
But the program excludes biologics, most cancer drugs, and other of Pfizer’s most expensive products.
Individuals who became unemployed after Jan. 1 of this year are eligible for the program and may sign up through Dec. 31.
Other eligibility requirements include having taken the branded Pfizer drug for at least three months prior to losing a job, having no other prescription drug coverage, and being able to attest to financial hardship.
Income prior to becoming unemployed is not a factor, Pfizer said. But participants who regain employment or prescription drug coverage will have to start paying again.
A stock analyst quoted by the Associated Press pointed out that the program is likely to prevent some current Pfizer drug customers from switching to generic equivalents.
The company said it was taking signups today, although the program would not be fully operational until July 1.
Pfizer said signups and additional information on the MAINTAIN program would be available at Pfizer Helpful Answers or by calling 866-706-2400 toll-free.
