It's too early to celebrate -- who knows what will happen on appeal, and I have not doubt that this decision will be appealed -- but US District Court Judge (Southern District of New York) Robert W. Sweet is my hero for the day.
In a 152-page ruling Judge Sweet struck down seven patents currently held by Myriad Genetics for genes associated with a greater risk for breast and ovarian cancer, as reported by John Schwartz and Andrew Pollack in today's New York Times, and by many other news channels. The suit had been filed last May by a group of women with breast cancer, several medical research organizations, the American Civil Liberties Union, and others.
I think that many of us, who are not genetic scientists, find it hard to understand (and more than a little ambiguous morally) that a corporate entity could own genes that come from our own bodies. And that was the crux of the suit.
The patents had been used in the development of a test that looks for mutations in the BRCA 1 and 2 genes. The only way to know whether you have the mutations is to pay up to $3000 for the Myriad Genetics test; Myriad has refused to license the test to other companies. The suit charged that by doing so, Myriad kept prices artificially high and prevented woman from getting a second opinion from another testing company.
Moreover, the suit asserted that the "patenting of human genes, the concept of looking at or comparing human genes, and correlations found in nature between certain genes and an increased risk of breast and/or ovarian cancer violates long established legal principles that prohibit the patenting of laws of nature, products of nature, and abstract ideas." (More background on the case can be found here, in a March 2010 E-Commerce Times article by C. Douglas Brown, and here, in Turna Ray's piece for Pharmacogenomics Reporter) The patenting of genes, the plaintiffs argued, "stifle[s] research that could lead to cures and limit women's options regarding their medical care."
Companies like Myriad have argued that without the potential for significant financial gain that the patents represent, there would be no incentive to invest in potentially life-saving research.
Some legal experts had expected that the case would be dismissed -- after all, as Schwartz and Pollack reported in the Times, "the Supreme Court upheld patents on living organisms in 1980."
But Judge Sweet agreed with the plaintiffs, ruling that the patents had been "improperly granted".
This is hardly the end of the story. As I said above, appeals can be expected. Moreover, Myriad holds 23 patents for its BRCA analysis, so there are still 15 not addressed by this suit.
Note that at present, about one-fifth of all human genes have been patented. Hello?!? Note also that this is a US problem; most other countries do not permit gene patenting.
Tuesday, March 30, 2010
Friday, March 26, 2010
Honoring the Triangle Shirtwaist Fire victims
Did you know that yesterday was the 99th anniversary of the Triangle Shirtwaist Factory fire? I didn't either, until reminded yesterday by Jezebel.com and the New Yorker, and today by the New York Times. Some of the nearly 150 workers who died in that fire were suffocated by the smoke; others died as they leapt from the ninth floor to the street below; still others were killed when the single, flimsy exterior fire escape broke (there was no audible alarm on the affected floors; doors locked to prevent unauthorized cigarette breaks then prevented many workers from escaping the flames; fire department ladders could reach no higher than the sixth floor).
As labor activist Rose Schneiderman said at the time, "The life of men and women is so cheap and property is so sacred! There are so many of us for one job, it matters little if 140-odd are burned to death."
There are memorial observances every year at the site and around New York. Why? It was a tragedy, of course, but Americans are generally speaking not very good at history, so why does this historical event still resonate?
The fire played a critical role in tougher safety regulations, of course. Since its victims were largely young immigrant women, it also played a key role in the founding of the International Ladies' Garment Workers Union (ILGWU, now a part of UNITE HERE!). And the fire launched the political career of Frances Perkins, the first female cabinet member (Labor, under FDR), a staunch progressive voice for the minimum wage and unemployment insurance.
Maybe we remember the Triangle Shirtwaist Fire so well because those issues are, alas, still with us.
Just a month ago, as reported by LaborNotes and others, 21 Bangladeshi garment workers were killed in a fire because they had been locked in for their own "security". Astonishingly enough, such things still happen, even here in the United States: Only a few years ago that it was revealed that Wal-Mart / Sam's Club in the U. S. were routinely locking overnight workers into the stores, ostensibly to keep robbers out (and to prevent employee theft -- click here for a 2004 New York Times article on the practice). So there's still a lot of work to be done to guarantee people's safety in their workplaces. Since companies obviously cannot be trusted to police themselves on this matter, we need tougher laws and tougher enforcement.
Labor unions have lost ground for years, but stagnating middle-class salaries and rapidly growing economic inequality should tell us how smart that has been for America. I still believe, with Schneiderman, that the single best one-word solution to poverty is: organize. To steal a tagline from LaborNotes, it's time to put "the movement back in the labor movement."
And while Frances Perkins should be praised for her pioneering work on unemployment insurance and the minimum wage, can anyone really say that this work is done? The federal minimum wage, since July 2009, is $7.25 / hour. Multiply that by 40 hours, and figure out how you would get by on $290 a week, or $15,080 for a 52-week year (on that salary, are you going to take a two-week vacation? I didn't think so.).
So a moment of silence for the Triangle Shirtwaist victims. But honor them by changing workers' lives for the better.
As labor activist Rose Schneiderman said at the time, "The life of men and women is so cheap and property is so sacred! There are so many of us for one job, it matters little if 140-odd are burned to death."
There are memorial observances every year at the site and around New York. Why? It was a tragedy, of course, but Americans are generally speaking not very good at history, so why does this historical event still resonate?
The fire played a critical role in tougher safety regulations, of course. Since its victims were largely young immigrant women, it also played a key role in the founding of the International Ladies' Garment Workers Union (ILGWU, now a part of UNITE HERE!). And the fire launched the political career of Frances Perkins, the first female cabinet member (Labor, under FDR), a staunch progressive voice for the minimum wage and unemployment insurance.
Maybe we remember the Triangle Shirtwaist Fire so well because those issues are, alas, still with us.
Just a month ago, as reported by LaborNotes and others, 21 Bangladeshi garment workers were killed in a fire because they had been locked in for their own "security". Astonishingly enough, such things still happen, even here in the United States: Only a few years ago that it was revealed that Wal-Mart / Sam's Club in the U. S. were routinely locking overnight workers into the stores, ostensibly to keep robbers out (and to prevent employee theft -- click here for a 2004 New York Times article on the practice). So there's still a lot of work to be done to guarantee people's safety in their workplaces. Since companies obviously cannot be trusted to police themselves on this matter, we need tougher laws and tougher enforcement.
Labor unions have lost ground for years, but stagnating middle-class salaries and rapidly growing economic inequality should tell us how smart that has been for America. I still believe, with Schneiderman, that the single best one-word solution to poverty is: organize. To steal a tagline from LaborNotes, it's time to put "the movement back in the labor movement."
And while Frances Perkins should be praised for her pioneering work on unemployment insurance and the minimum wage, can anyone really say that this work is done? The federal minimum wage, since July 2009, is $7.25 / hour. Multiply that by 40 hours, and figure out how you would get by on $290 a week, or $15,080 for a 52-week year (on that salary, are you going to take a two-week vacation? I didn't think so.).
So a moment of silence for the Triangle Shirtwaist victims. But honor them by changing workers' lives for the better.
Thursday, March 18, 2010
Fixing Specific Problems; Fixing General Procedures
Another day, another update. This one from Johnson & Johnson's McNeil Consumer Healthcare unit.
Back in mid-January, I wrote about complaints -- including an FDA warning letter -- about some moldy-smelling bottles of McNeil's over-the-counter medications. McNeil apparently waited nearly two years from receiving its first complaints to recall batches of the products. The problem was eventually traced to "the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials. The health effects of this chemical have not been well studied but no serious events have been documented in the medical literature." (This from a company press release at the time; my full blog post can be found here.)
My concern at the time was about trust, and how easily it can be lost and how hard to regain. Would I ever feel the same way about McNeil's branded products, like Motrin? (I have some back trouble, and trust me, I love my Motrin.) If I can't trust J&J completely, why not just buy a generic? (The answer to that question can be found in this Times story re manufacturing violations at a major generic manufacturer's Indian and New Jersey plants.)
Today's New York Times carries a piece by Natasha Singer (who also reported on the initial problem) in which McNeil seeks to reassure consumers that they have taken the steps necessary to prevent such incidents in the future. In a letter dated 5 February 2010 and posted on the FDA's website, McNeil's president Peter Luther wrote that the company "recognizes the seriousness of this situation" and outlined a "corrective action plan" involving "enhancements to the quality system," "organizational changes", and "senior management oversight".
It's not just the specific problems with chemicals leaching from pallets to products that are being addressed, the McNeil letter asserted, but company-wide complaint review processes and complaint handling processes are being changed. That's good news, as the next problem -- and there will inevitably be a next one -- will be something quite different.
But I still don't feel quite the same way about McNeil and J&J as I did before.
Back in mid-January, I wrote about complaints -- including an FDA warning letter -- about some moldy-smelling bottles of McNeil's over-the-counter medications. McNeil apparently waited nearly two years from receiving its first complaints to recall batches of the products. The problem was eventually traced to "the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials. The health effects of this chemical have not been well studied but no serious events have been documented in the medical literature." (This from a company press release at the time; my full blog post can be found here.)
My concern at the time was about trust, and how easily it can be lost and how hard to regain. Would I ever feel the same way about McNeil's branded products, like Motrin? (I have some back trouble, and trust me, I love my Motrin.) If I can't trust J&J completely, why not just buy a generic? (The answer to that question can be found in this Times story re manufacturing violations at a major generic manufacturer's Indian and New Jersey plants.)
Today's New York Times carries a piece by Natasha Singer (who also reported on the initial problem) in which McNeil seeks to reassure consumers that they have taken the steps necessary to prevent such incidents in the future. In a letter dated 5 February 2010 and posted on the FDA's website, McNeil's president Peter Luther wrote that the company "recognizes the seriousness of this situation" and outlined a "corrective action plan" involving "enhancements to the quality system," "organizational changes", and "senior management oversight".
It's not just the specific problems with chemicals leaching from pallets to products that are being addressed, the McNeil letter asserted, but company-wide complaint review processes and complaint handling processes are being changed. That's good news, as the next problem -- and there will inevitably be a next one -- will be something quite different.
But I still don't feel quite the same way about McNeil and J&J as I did before.
Wednesday, March 17, 2010
Winner Declared!
Yesterday I was still pondering who best "deserved" the prize in the Lehman fiasco. Today, there's no question.
The winner is ... (envelope please) ... former CEO Richard S. Fuld Jr.
According to a published reports in today's New York Post, Fuld is apparently "feeling vindicated" by the bank examiner's report on Lehman's fall. This despite being called "at least grossly negligent" (emphasis added) in the 2200-page report.
The Post's Mark DeCambre writes, "Fuld privately believes that the report by examiner Anton Valukas provides proof that he did nothing illegal as he steered Lehman through a financial mess that ultimately led the firm to file the largest bankruptcy in US history..."
There may indeed not be enough evidence for criminal charges, although I suspect a civil suit would be harder to beat. Still, Mr. Fuld appears to be, um, ethically challenged. He denied having any knowledge of the highly-questionable Repo 105 accounting tricks (and yet was able to certify with his signature the financial statements), and he did admit to telling his underlings to reduce the firm's debt levels. Apparently, he didn't care how they went about doing so.
Sorry, Mr. Fuld: the buck stops at your desk. Congratulations on your "prize".
The winner is ... (envelope please) ... former CEO Richard S. Fuld Jr.
According to a published reports in today's New York Post, Fuld is apparently "feeling vindicated" by the bank examiner's report on Lehman's fall. This despite being called "at least grossly negligent" (emphasis added) in the 2200-page report.
The Post's Mark DeCambre writes, "Fuld privately believes that the report by examiner Anton Valukas provides proof that he did nothing illegal as he steered Lehman through a financial mess that ultimately led the firm to file the largest bankruptcy in US history..."
There may indeed not be enough evidence for criminal charges, although I suspect a civil suit would be harder to beat. Still, Mr. Fuld appears to be, um, ethically challenged. He denied having any knowledge of the highly-questionable Repo 105 accounting tricks (and yet was able to certify with his signature the financial statements), and he did admit to telling his underlings to reduce the firm's debt levels. Apparently, he didn't care how they went about doing so.
Sorry, Mr. Fuld: the buck stops at your desk. Congratulations on your "prize".
Tuesday, March 16, 2010
And the Prize Goes To....
... really, there are so many here in the Lehman Brothers mess that it's hard to know whom to honor first.
Like many of you, I suspect, I've been wallowing in the report from court-appointed bank examiner Anton R. Valukas over the past several days. I haven't waded through all nine volumes, 2200 pages plus appendices (which is, thanks to the New York Times' DealBook, all available online here), but I've read some of it, as well as articles and blog posts in the Times and elsewhere.
"Lehman was more the consequence than the cause of a deteriorating economic climate," Valukas writes in the executive summary, "[But] Lehman's financial plight, and the consequences to Lehman's creditors and shareholders, was exacerbated by Lehman executives, whose conduct ranged from serious but non-culpable errors of business judgment to actionable balance sheet manipulation; by the investment bank business model, which rewarded excessive risk taking and leverage; and by Government agencies, who by their own admission might better have anticipated or mitigated the outcome."
There's a lot of good ammunition in the report, based on what I've seen so far, for plaintiffs planning civil lawsuits against Lehman executives. Former CEO Richard S. Fuld Jr., who certified the financial statements, is called "at least grossly negligent".
Accounting gimmicks, chiefly one known internally as Repo 105, used by Lehman to reduce its net leverage ratio are termed "materially misleading" by Valukas. "Unbeknownst to the investing public, rating agencies, government regulators, and Lehman's board of directors, Lehman reverse engineered the firm's net leverage ratio for public consumption," the report states. Questions could be asked here: How is it that the board knew nothing? Isn't that what audit committees are there for? How could the government regulators, who saw it all, have been so blind?
As Andrew Ross Sorkin reports in today's Times, "Almost two years ago to the day, a team of officials from the Securities and Exchange Commission and the Federal Reserve Bank of New York quietly moved into the headquarters of Lehman Brothers. They were provided desks, phones, computers -- and access to all of Lehman's books and records.... [The] mystery is why it took this long for anyone to raise a red flag...."
And serious questions have been raised about how Ernst & Young, Lehman's accounting firm, could have certified accounting results. Still, it seems unlikely that E&Y will go the way of Enron's accountants, the late Arthur Andersen. In a Financial Times article published Sunday, Rachel Sanderson wrote, "Accounting experts do not believe the fallout from the Lehman report will damage E&Y’s reputation in a life threatening way, although damage from litigation costs could be significant as could the longer- term impact on the credibility of the profession particularly among the Big Four."
Like many of you, I suspect, I've been wallowing in the report from court-appointed bank examiner Anton R. Valukas over the past several days. I haven't waded through all nine volumes, 2200 pages plus appendices (which is, thanks to the New York Times' DealBook, all available online here), but I've read some of it, as well as articles and blog posts in the Times and elsewhere.
"Lehman was more the consequence than the cause of a deteriorating economic climate," Valukas writes in the executive summary, "[But] Lehman's financial plight, and the consequences to Lehman's creditors and shareholders, was exacerbated by Lehman executives, whose conduct ranged from serious but non-culpable errors of business judgment to actionable balance sheet manipulation; by the investment bank business model, which rewarded excessive risk taking and leverage; and by Government agencies, who by their own admission might better have anticipated or mitigated the outcome."
There's a lot of good ammunition in the report, based on what I've seen so far, for plaintiffs planning civil lawsuits against Lehman executives. Former CEO Richard S. Fuld Jr., who certified the financial statements, is called "at least grossly negligent".
Accounting gimmicks, chiefly one known internally as Repo 105, used by Lehman to reduce its net leverage ratio are termed "materially misleading" by Valukas. "Unbeknownst to the investing public, rating agencies, government regulators, and Lehman's board of directors, Lehman reverse engineered the firm's net leverage ratio for public consumption," the report states. Questions could be asked here: How is it that the board knew nothing? Isn't that what audit committees are there for? How could the government regulators, who saw it all, have been so blind?
As Andrew Ross Sorkin reports in today's Times, "Almost two years ago to the day, a team of officials from the Securities and Exchange Commission and the Federal Reserve Bank of New York quietly moved into the headquarters of Lehman Brothers. They were provided desks, phones, computers -- and access to all of Lehman's books and records.... [The] mystery is why it took this long for anyone to raise a red flag...."
And serious questions have been raised about how Ernst & Young, Lehman's accounting firm, could have certified accounting results. Still, it seems unlikely that E&Y will go the way of Enron's accountants, the late Arthur Andersen. In a Financial Times article published Sunday, Rachel Sanderson wrote, "Accounting experts do not believe the fallout from the Lehman report will damage E&Y’s reputation in a life threatening way, although damage from litigation costs could be significant as could the longer- term impact on the credibility of the profession particularly among the Big Four."
Sanderson also quoted Steven Thomas, a trial attorney with Thomas Alexander & Forrester LLP, saying that continued disclosures are eroding confidence in the profession “and leaves us asking why do we have auditors”?
It appears as though, as a Times headline put it on Friday (12 March), "findings on Lehman take even experts by surprise."
Thursday, March 4, 2010
The FDA is Growing Some Teeth, Finally
I've written before about misleading labels on food products, from the "Smart Choice" checkmark on Fruit Loops cereal (41% sugar) to Kellogg's agreement in December of last year to remove "now supports your child's IMMUNITY" labels on Rice Krispies.
This stuff makes me CRAZY. And it makes me wonder, as many of you no doubt do too, how the FDA, which is, after all, responsible for regulating food labeling, lets companies get away with such nonsense.
Well, the FDA seems finally to be growing teeth. Little ones, to be sure, but teeth nonetheless.
Yesterday, as reported by the New York Times, the Wall Street Journal, and many others, the FDA sent warning letters to 17 food manufacturers regarding their labels. For example, the agency objected to Dreyer's label for "Dibs Bite Sized Ice Cream Snacks Vanilla Ice Cream with Nestle Crunch Coating" which trumpets its "no trans fat" recipe ... but neglects to point out that it has "significant" amounts of saturated fat and total fat. In fact, the fine print of the Dibs label shows that one serving has 20 grams of saturated fat, 99% of the suggested daily value.
Similarly, Diamond Food was cited for claiming in its "California Shelled Walnuts" packaging that walnuts can "treat, prevent, or cure diseases such as heart disease, arthritis and cancer." (Click here for the FDA's chart of all firms, products, and product claims that were involved, and here for the FDA's accompanying press release.)
The warning letters give companies 15 business days to inform the FDA of the steps they plan to take to bring their labels in line with agency regulations.
Why the action now? Agency commissioner Dr. Margaret Hamburg has made nutrition labeling a priority, but the timing is no doubt related to a new report issued by the Center for Science in the Public Interest, which has been urging the FDA to crack down on "false and misleading food labeling" for some time, and just released a comprehensive report on what the center terms "Food Labeling Chaos" (full report here; accompanying letter to Dr. Hamburg here)
According to the Times' William Neuman, food manufacturers seem to be surprised:
This stuff makes me CRAZY. And it makes me wonder, as many of you no doubt do too, how the FDA, which is, after all, responsible for regulating food labeling, lets companies get away with such nonsense.
Well, the FDA seems finally to be growing teeth. Little ones, to be sure, but teeth nonetheless.
Yesterday, as reported by the New York Times, the Wall Street Journal, and many others, the FDA sent warning letters to 17 food manufacturers regarding their labels. For example, the agency objected to Dreyer's label for "Dibs Bite Sized Ice Cream Snacks Vanilla Ice Cream with Nestle Crunch Coating" which trumpets its "no trans fat" recipe ... but neglects to point out that it has "significant" amounts of saturated fat and total fat. In fact, the fine print of the Dibs label shows that one serving has 20 grams of saturated fat, 99% of the suggested daily value.
Similarly, Diamond Food was cited for claiming in its "California Shelled Walnuts" packaging that walnuts can "treat, prevent, or cure diseases such as heart disease, arthritis and cancer." (Click here for the FDA's chart of all firms, products, and product claims that were involved, and here for the FDA's accompanying press release.)
The warning letters give companies 15 business days to inform the FDA of the steps they plan to take to bring their labels in line with agency regulations.
Why the action now? Agency commissioner Dr. Margaret Hamburg has made nutrition labeling a priority, but the timing is no doubt related to a new report issued by the Center for Science in the Public Interest, which has been urging the FDA to crack down on "false and misleading food labeling" for some time, and just released a comprehensive report on what the center terms "Food Labeling Chaos" (full report here; accompanying letter to Dr. Hamburg here)
According to the Times' William Neuman, food manufacturers seem to be surprised:
A spokesperson for POM (cited by the FDA for making claims that its POM pomegranate juice "will treat, prevent, or cure diseases such as hypertension, diabetes, and cancer") said that "'all statements made in connection with POM products are true' and supported by scientific research."
The POM response also said that the company, "as strong advocates of honest labeling and fair advertising" is "looking forward to working with the agency to resolve this matter."
Doesn't that sound like Casablanca's Captain Renault being "shocked, shocked to find that gambling is going on here" (as he's being handed his winnings)?
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