Colorado Business Litigation Lawyer Blog

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?