August 10, 2009 by mike
Filed under NWO
August 9, 2009
New York Times
By Milt Freudenheim
More than 10 years after she tried without success to have a baby, Marcy Campbell Krinsk is still receiving painful reminders in her mail. The ads and promotions started after she bought fertility drugs at a pharmacy in San Diego.
Marketers got hold of her name, and she found coupons and samples in her mail that shadowed the growth of an imaginary child — at first, for Pampers and baby formula, then for discounts on family photos, and all the way through the years to gifts suitable for an elementary school graduate.
“I had three different in vitro procedures,” said Ms. Krinsk, now 55, a former telecommunications executive who lives with her husband in San Diego. “To just go to the mailbox and get that stuff, time after time after time, it was just awful.”
Like many other people, Ms. Krinsk thought that her prescription information was private. But in fact, prescriptions, and all the information on them — including not only the name and dosage of the drug and the name and address of the doctor, but also the patient’s address and Social Security number — are a commodity bought and sold in a murky marketplace, often without the patients’ knowledge or permission.
That may change if some little-noted protections from the Obama administration are strictly enforced. The federal stimulus law enacted in February prohibits in most cases the sale of personal health information, with a few exceptions for research and public health measures like tracking flu epidemics. It also tightens rules for telling patients when hackers or health care workers have stolen their Social Security numbers or medical information, as happened to Britney Spears, Maria Shriver and Farrah Fawcett before she died in June.
“The new rules will plug some gaping holes in our federal health privacy laws,” said Deven McGraw, a health privacy expert at the nonprofit Center for Democracy and Technology in Washington. “For the first time, pharmacy benefit managers that handle most prescriptions and banks and contractors that process millions of medical claims will be held accountable for complying with federal privacy and security rules.”
The law won’t shut down the medical data mining industry, but there will be more restrictions on using private information without patients’ consent and penalties for civil violations will be increased. Government agencies are still writing new regulations called for in the law.
Ms. Krinsk was never able to find out who sold her information, but companies that have been accused in lawsuits of buying and selling personal medical data include drugstore chains like Walgreens and data-mining companies like IMS Health and Verispan. CVS Caremark, which handles prescriptions for corporate clients, has also been accused of violating patients’ privacy.
These companies all say that names of patients are removed or encrypted before data is sold, typically to drug manufacturers.
But as Ms. Krinsk’s case shows, there are leaks in the system.
Before the changes, privacy regulations mainly applied to hospitals and doctors. Enforcement was weak, and there were lots of loopholes.
Privacy experts cite research by Latanya Sweeney, director of the Data Privacy Lab at Carnegie Mellon University in Pittsburgh, which shows that a computer-savvy snooper can easily match names, addresses, Social Security numbers and so on to “re-identify” information that had supposedly been rendered anonymous.
“Our biggest concern is the complete lack of protection against re-identifying data that was supposed to be anonymous and secure,” Ms. McGraw said.
Tracking prescriptions has been a big business for decades. Data miners say their research is valuable because gathering and analyzing information from thousands of people helps identify trends and provides indications of potentially dangerous side effects of drugs.
Click here to continue reading at the New York Times
Tags: CVS, drug manufacturers, epidemics, federal health privacy, federal stimulus law, flu, hackers, IMS Health, pharmacy, prescription, privacy, prohibits, sale of personal health information, social security numbers, tracking, Verispan, Walgreens
July 2, 2009
New York Times
by Gardiner Harris & Duff Wilson
WASHINGTON — Federal drug regulators warned Wednesday that patients taking two popular drugs to stop smoking should be watched closely for signs of serious mental illness, as reports mount of suicides among the drugs’ users.
But officials emphasized that fear should not stop patients from taking the smoking-cessation medicines, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline, which also sells it under the brand name Wellbutrin, for depression.
“Stopping smoking is a goal we should all be working towards,” said Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration. “We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”
Pfizer will add a so-called black box warning — the F.D.A.’s most serious caution — to the packaging information for Chantix.
The Pfizer drug, introduced in 2006, has about 90 percent of the market for prescription smoking-cessation drugs, according to IMS Health, a health care information company. Even so, Chantix sales — $846 million in 2008 — had been less than Pfizer had hoped because of previous warnings of its side effects.
Glaxo will expand its existing black box warning on Wellbutrin, citing suicidal thoughts by patients who use it for depression, to include Zyban, which has had only modest sales in the smoking cessation market.
Both companies will also be required to conduct clinical trials to assess the mental health risks associated with the drugs’ uses. Pfizer is already enrolling schizophrenia patients in a trial.
Because smokers and people trying to quit are statistically more likely to be depressed and suicidal, officials for both companies said it was difficult to identify the specific impact of the drugs on those risks. “Nicotine withdrawal itself can be very difficult for people to endure,” Dr. Steve Romano, a Pfizer vice president, said Wednesday.
Analysts said the F.D.A. action would have little effect on sales because of previous indications of the drugs’ psychiatric risks.
“I think the market and physicians have already been sensitized to this,” said Catherine J. Arnold, an analyst for Credit Suisse.
“I’m not panicking,” said Jami Rubin, an analyst for Goldman Sachs, “Sales are already down a lot. It is and will remain a small niche product.”
Chantix had already experienced a slight sales decline last year from the $883 million achieved in 2007. And this year’s first-quarter sales of $177 million were 36 percent below the corresponding period last year.
Ms. Arnold predicted that sales would probably continue falling to around $740 million for all of 2009, but that demand for smoking-cessation treatments would enable it to grow modestly after that — to perhaps half of the $2 billion in annual sales Pfizer had originally hoped for the drug.
European officials first alerted the F.D.A. in 2007 to problems associated with Chantix. In September of that year, Jeffrey Carter Albrecht, a keyboard player from the pop-music group Edie Brickell and New Bohemians, was killed by a neighbor who had complained that Mr. Albrecht was banging on his door, ranting. Mr. Albrecht’s girlfriend blamed Chantix, which she said had made him hostile.
The widely publicized event led to a cascade of similar reports and scrutiny by F.D.A. safety officials, who have now received 98 reports of suicides and 188 reports of suicide attempts among those taking Chantix.
As officials looked more closely, they found to their surprise that Zyban has similar associated risks. The agency received 14 reports of suicides and 17 reports of suicide attempts among those taking Zyban.
No one knows why the drugs are associated with mental problems. In some cases, patients could be experiencing nicotine withdrawal, but some of the reports involved patients who had yet to stop smoking. And many of the events happened just as patients began or stopped therapy, officials said.
“If this is nicotine withdrawal, it really doesn’t matter,” said Dr. Robert Temple, an F.D.A. official. “You need to pay attention to them.”
The agency’s action requires the drugs’ makers to mention the risk of suicide in advertising, and it prevents the companies from using “reminder” ads, during which consumers are encouraged to talk to their doctors about a health issue but the product’s name is not mentioned.
Click here for the full report from the New York Times.
Tags: black box warning, Chantix, clinical trials, Credit Suisse, depression, FDA, Food and Drug Administration, GlaxoSmithKline, Goldman Sachs, IMS Health, mental health, mental illness, Nicotine withdrawal, patients, Pfizer, psychiatric risks, schizophrenia, smoking, smoking cessation, suicidal thoughts, Wellbutrin, Zyban
