Colorado Business Litigation Lawyer Blog

An analysis by Canadian researchers of over 4,000 studies conducted from 1950-2009 concludes that drinking light to moderate amounts of alcohol (1 drink per day for women and 2 drinks for men) reduces by as much as 25% the risk of multiple cardiovascular outcomes, including incidence of and mortality from coronary heart disease and stroke, compared with persons who don't drink at all.

A separate review found that moderate imbibing increases the levels of "good" cholesterol in the body.

The researchers emphasize that a careful balance should be made between the concepts of drinking large amounts of alcohol being bad for overall health, while moderate drinking can have health benefits.

Of course, the message remains clear that overconsumption of alcohol causes numerous societal problems, including domestic and other violence, various kinds of criminal activity, child abuse and neglect, injuries and death caused by impaired driving and many other serious adverse consequences.

In a recent article [click here], we wrote about Dan Flanagan, a Colorado Vietnam vet undergoing treatment for bone marrow cancer, whose health insurance was canceled over a two cent shortage in a premium payment.

On January 26, after public outcry resulting largely from Denver's NEWS7's coverage on the issue, Ceridian,--the administrator for the vet's claim-- asked the fiduciary, a former employer, to reinstate the health coverage. Thankfully, the fiduciary agreed to the reinstatement.

The action taken by Ceridian and the fiduciary was the decent thing to do, even though it may not have been legally required.

We are pleased to observe that large business organizations are not always without compassion and concern for the individual in need.

A tip of the hat to Denver NEWS7 for its timely coverage of the story. And the best of luck to Dan Flanagan and his family.

Colorado's Channel 7NEWS reports that Ron Flanagan, a Vietnam vet's health insurance was canceled because of a $.02 (yes, that's two cents) premium underpayment.

Frances Flanagan, the veteran's wife, mistakenly paid $328.67 for the monthly premium payment instead of the $328.69 that was due. She says that when making the online payment for November, she hit the 7 key instead of the 9 key. A check for the full December premium was received and cashed by Ceridian Cobra Services, the Flanagan's Florida-based insurance administrator; nevertheless, Ceridian canceled the Flanagans' health insurance policy.

Here's the rub: the Flanagans say they first found out about the cancellation on January 13, just as Ron was being prepped for a bone biopsy at a Broomfield medical center in connection with his struggle with multiple myeloma--bone marrow cancer-- that was diagnosed in September 2008 and is believed to have been caused by Ron's exposure to Agent Orange in Vietnam..

Ron has had two surgeries for stem cell transplants and needs another by February. A donor is available, but Ceridian will not pay for the procedure. The transplant can be done by the VA hospital, but would require Ron to travel to Seattle. In the meantime, Ron may start oral chemotherapy to help manage his condition.

A Ceridian spokesperson told 7NEWS that the company canceled the policy because of the insufficient payment and that the Flanagans were sent several notices of the shortage, together with more than one grace period reminder notice, all consistent with COBRA regulations. The Flanagans say that nothing they received clearly informed them that they could be dropped; otherwise, they would have just added the two cents to the December payment.

Don't you think a simple telephone call probably would have solved the problem? Ceridian says they "simply do not have the capacity to be able to personally call continuants and remind them of the status of their COBRA benefits."

You be the judge.

Continue reading "Business as Usual?" »

Bloomberg.com reports that a former officer and general counsel for GlaxoSmithKline (GSK), a London-based drug manufacturer, was indicted on November 8, 2010, for making false statements to the FDA and with obstructing an FDA investigation.

In 2002-2003, the FDA was investigating the promotion of Wellbutrin SR, an antidepressant drug, for possible uses not approved by the FDA. The attorney, Lauren Stevens, now residing in North Carolina, is charged with making false statements in a series of correspondence with the FDA and with withholding documents that could have proved that Wellbutrin SR was being promoted for uses such as weight loss, which had not been approved by the FDA.

Among other things, Stevens had sent letters to various doctors and had learned about the improper and illegal promotion of the drug. GSK had paid at least two doctors to give about 1,000 promotional talks to other doctors promoting the off-label (non-approved) use of the drugs. The indictment alleges that Stevens knew about the off-label promotions but concealed such materials from the FDA and made false statements concerning her knowledge of the off-label promotion activity.

If convicted on each of the six counts of the indictment, Stevens could be sentenced to a total jail term of up to sixty years. Stevens’ attorneys say that she is innocent of all charges and that she relied on the advice of a nationally prominent law firm that had expertise in working with the FDA.

We wait with bated breath to see whether or not any other officers of GSK will be charged or indicted. And of course, under our law, Stevens is presumed to be innocent of all charges.

Continue reading "GlaxoSmithKline in Spotlight Again" »

In a September 23, 2010 news release, the FDA announced that it will “significantly restrict” the use of the diabetes drug Avandia to Type 2 diabetics who cannot control their diabetes on other medications, and who are unable to take Actos, the only other drug in the thiazolidinedione class. These restrictions are a result of study data that suggests an elevated risk of heart attack and stroke in patients using Avandia, manufactured by GlaxoSmithKline.

Under the restrictions, doctors will be required to certify and document their patients’ eligibility for access to Avandia, and patients who desire to continue to use the drug must acknowledge that they have been informed of and understand the risks.

The FDA is continuing to study the drug and may take additional action as warranted.

More Avandia related postings:

"Between a Rock and a Hard Place," Colorado Business Litigation Lawyer Blog, posted 09/21/10

"Avandia Health Concerns Crosses the Pond," Colorado Business Litigation Lawyer Blog, posted 09/08/10

"Update on the Avandia/Actos Saga," Colorado Business Litigation Lawyer Blog, posted 09/02/10

"An Introduction to Business Ethics," Colorado Business Litigation Lawyer Blog, posted 08/18/10

Type II diabetics are now being told that the drug Actos, manufactured by Takeda Pharmaceutical Co., may be linked to a higher risk of bladder cancer. The information comes from preliminary results of a 10-year study sponsored by Takeda following over 193,000 Actos users.

This unsettling news comes on the heels of study results by the manufacturer of Avandia, an Actos competitor, that there may be a connection between Avandia and an increased risk of heart attacks and strokes.

The Actos study appears to show that the bladder cancer risk is higher among those who have used Actos for more than two years.

The FDA has both drugs under study. It is unknown when a decision will be made. In the meantime, those who use either drug have been advised to follow the advice of their physicians.

And whose advice should the physicians follow?

More Avandia postings:

"An Introduction to Business Ethics," Colorado Business Litigation Lawyer Blog, posted 08/18/10

"Update on the Avandia/Actos Saga," Colorado Business Litigation Lawyer Blog, posted 09/02/10

"Avandia Health Concerns Crosses the Pond," Colorado Business Litigation Lawyer Blog, posted 09/08/10

We previously wrote here and here concerning increased heart attack and heart failure risks to those taking the prescription drug Avandia (Rosiglitazone). The drug, manufactured by GlaxoSmithKline (GSK), is prescribed to Type II (non-insulin dependent) diabetics. The FDA has taken under advisement the issue of whether or not to increase warnings and precautions of taking the drug or to completely remove the drug from the U.S. market.

A September 5, 2010 article by BBC Panorama disclosed that the drug was recommended for withdrawal in the UK two months ago by an expert panel of the UK Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s equivalent of the FDA. In July, clinicians at the Commission on Human Medicines (CHM), the MHRA’s advisory body, recommended unanimously that Avandia be withdrawn from the UK. This recommendation was not made public. MHRA has sent letters to healthcare officials, suggesting they should “consider alternative treatments where appropriate.”

Avandia has been prescribed to tens of thousand of patients in the UK over the last ten years, earning GSK billions of pounds. The European Medicines Agency, in a Europe- wide review of Avandia, will announce later this month whether or restrict Avandia’s prescription or to withdraw it completely. Meanwhile, GSK said its research proved the drug was “safe and effective when it is prescribed appropriately,” and that “patient safety is our first priority.”

Actos, a competitor drug to Avandia, is being widely prescribed in the U.S., although some studies claim to show that Actos is no more safe for Type II diabetics than Avandia.

The drug choice facing prescribing physicians and patients at this time is a difficult one and appears to be little more than a roll of the dice.

A Colorado Business Litigation Lawyer Blog posted August 18, 2010 (click here for entry) reported on the SmithKline study that clearly showed that Avandia (a diabetes drug) had a significantly higher heart attack and death risk than its competitor drug Actos.

Along comes a new study funded by WellPoint, Inc. that claims to show that the increased risk of heart problems linked to either drug is exactly the same at 4%. This latest study reported on subjects whose age averaged 54 years, while the earlier study’s subjects averaged 74.4 years young (a politically correct word). Some scientific observers commented that the age difference may have skewed the WellPoint results, since younger persons would likely be in better overall health than older persons.

One diabetes researcher from Australia suggested that it appears that both drugs may be risky, since the 4% heart attack and death increase is “pretty high” given the short study periods.

The FDA is expected to make a decision on whether Avandia should be taken off the market or perhaps change its warnings to reflect the risks involved. It is unclear (a word used by journalists when they don’t have the answer) when the decision will be made. Given the fact that our government sometimes (almost always) moves at less than a snail’s pace, and given the fact of the new, conflicting study results, we should not hold our collective breath.

While we wait, let’s think about the dilemma our prescribing doctors have until the FDA acts.

Here’s an article I wrote back in July. Before a decision was made whether or not to post it, the FDA advisory panel (a group of scientists) recommended by a split vote that Avandia be left on the market, pending a decision by the head of the FDA, which should be forthcoming. When her decision is made, I will write a follow-up.

How often have we read or watched media stories about greedy trial lawyers filing spurious class action lawsuits against big tobacco and other giants of American industry? And don’t we sometimes enjoy it immensely when we hear that some jury somewhere stiffed the dying-of-cancer plaintiff with a verdict in favor of the huge corporate defendant? After all, the person harmed should have known better than to have been suckered by the massive advertising campaign touting the safety of a deadly product.

Just when people felt they had reached a comfortable level of complacency on this issue, along comes SmithKline Beechman. Documents recently obtained by the New York Times allegedly show that SmithKline (now known as GlaxoSmithKline) actively hid from regulators and the public the fact that Avandia, a SmithKline diabetes drug known as rosiglitazone, was riskier to the heart than Actos, a competing drug manufactured by Takeda.

In 1999, SmithKline completed a secret study comparing the heart risk of the two drugs. The results clearly showed that Avandia was not safer and in fact may actually cause heart attacks. Researchers began discovering Avandia’s risk in 2007. Shortly thereafter, SmithKline admitted that it had known of the heart attack risk at least since 2005.

Instead of reporting their findings to drug regulators as they should have done, SmithKline apparently suppressed the results for eleven years. A recently-discovered 2001 email discloses that a SmithKline executive wrote that the study “was done for the U.S. business, way under the radar. Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.” A GSK spokesperson recently said the study’s results were not disclosed because they “did not contribute any significant new information.”

Do you get the picture now?

A Colorado Springs woman undergoing chemotherapy treatments for leukemia four times a week almost lost her health insurance coverage over an alleged one cent shortage in her premium payment. Yes, you read that right: one cent.

La Rosa Carrington, the single mother of two teenage daughters lost her job in May. Under COBRA, she was allowed to keep her insurance coverage, but was required to pay a part of the premium. When she calculated the premium, using the discount she was entitled to under the 2009 American Recovery and Reinvestment Act, she sent in a check for $165.15. She soon received a notice from Discovery Benefits, a North Dakota benefits administrator, telling her that her premium was one cent short and that she would lose her insurance coverage.

Dumfounded, Carrington called Discovery and spoke with two customer service reps. Both told her that it was company policy not to waive even one cent of the premium due. She then spoke with a supervisor, who told her the same thing. Carrington threatened to take the issue to the media. Shortly thereafter, she received a call from the supervisor, saying that the supervisor had done the calculation and got the same figure as Carrington.

An executive vice-president for Discovery gave yet another excuse. She said the COBRA software rounded the calculation of $161.1545 up to the nearest penny. Carrington had rounded down, using commonly accepted rounding principles such as those used by the Internal Revenue Service. Needless to say, Carrington’s insurance was reinstated.

This incident not only exposes the grossly impersonal nature of huge corporations, but also makes one wonder if common sense plays even a miniscule part in business transactions.

Continue reading "Something to Make Your Day Just a Little Drearier" »

In May 2009, the American Civil Liberties Union (ACLU) and the Public Patent Foundation filed a lawsuit against Myriad Genetics and the University of Utah Research Foundation. The lawsuit challenged patents granted to Myriad on two genes related to breast and ovarian cancer. U.S. District Court Judge Robert Sweet in New York invalidated the seven patents in his March 29, 2010 ruling.

Myriad and its founder, Mark Skolnick, were granted patents on the BRCA1 and BRCA2 genes. Mutations of these genes have been linked to breast and ovarian cancer. With the patents, Myriad had exclusive rights to perform diagnostic testing on the genes, the power to prohibit outside research, and the discretion to decide the cost for the preventative tests.

ACLU, joined by individual patients and medical organizations, charged in the lawsuit that the patents restrict scientific research and patients’ access to medical care. The union of plaintiffs also asserts that genes are products of nature and, therefore, are not subject to patents. Judge Sweet agreed, ruling the patents were “improperly granted.”

As reported by John Schwartz of the New York Times, Myriad and companies like it that hold patents on approximately 20% of human genes argue that the patent system rewards the considerable investment required for research by providing a temporary monopoly. In response to being a product of nature, Myriad contests that isolating the DNA makes it patentable.

The ACLU believes that a patent should not be granted until a company or individual develops a test or drug based on a gene, not when the gene has been isolated.

The decision is likely to be appealed. Watch for updates in the future.

Comment: The dictionary definition of a patent is “a grant made by a government that confers upon the creator of an invention the sole right to make, use, and sell that invention for a set period of time.” In other words, patents are intended to protect ideas or knowledge, not things created by nature. Last time I checked, genes were not inventions.

Continue reading "Gene Patents – Rewarding Innovation or Inhibiting Research?" »

Dbtecno.com reports on June 14, 2010 that a 41-year old Michigan woman shot herself in the shoulder in an attempt to obtain health care for that same shoulder for injuries incurred a month earlier when she tried to prevent her dogs from fighting.

Being without health care, the woman said she couldn’t afford to see a specialist for her previous shoulder injury. After the shooting, the woman’s neighbors banded together to raise funds for the treatment of her pre-existing, painful condition.

Let me see if I understand this story. She can’t afford to see a specialist for her shoulder, but apparently she can afford hospital and medical care for the gunshot wound to her shoulder.

Is this an argument for or against health care reform?