Chapter 8
Why Haven’t You Heard This Opinion of Sleeping Pills From Every Expert?

“The treatment of insomnia by drugs is always to be avoided as much as possible.” - H.C. Woods, 1893

The idea that sleeping pills have a dark side is nothing new.  Indeed, generations of physicians have shared my opinion, based on their own clinical experiences. Probably, the majority today agree.  They are a silent majority, with little to be gained by making their opinions public.

The sleeping pills industry has over two billion dollars of yearly sales, and it has thought of many subtle ways of keeping its products popular. To be frank, the manufacturers of sleeping pills have often given the leaders of sleep research large monetary grants to test their products. These colleagues are very nice people who are not the sort to bite the hand which feeds them. Some of the most prominent leaders of sleep research have been supported mainly by drug company grants. The drug companies have used many subtle free offers and not-so-subtle methods of influencing the wider group of sleep clinicians to mute their critical attitude towards sleeping pills.

For example, a few years ago, manufacturers offered free chocolate cream pie at a national sleep meeting for attendees to watch a bizarre comic session in which leaders of the sleep community mocked the Food and Drug Administration for its efforts to regulate sleeping pills.  I suppose a good deal of money was spent for those free chocolate cream pies and the advertising of that clowning.

For several years, the National Sleep Foundation has launched a yearly publicity campaign about the dangers of insomnia, encouraging everybody to sleep 8 hours.  Scientific evidence to support 8 hours sleep is almost nonexistent:  for example, people live longer who sleep less (see above).  Could this campaign be influenced by the fact that much of its money comes from sleeping pill manufacturers?  The public relations firm for Ambien bragged that National Sleep Foundation publicity was effective in increasing sleeping pill sales.[57]

Unfortunately, nobody advertises for behavioral treatments, or for hypnotic abstinence.  The advertising for bright light treatment is minuscule compared to pharmaceutical advertising.

8.A. Why haven’t you heard from the FDA?

When we reported that people who took sleeping pills died 4.6 times faster and suffered more cancer,[58] I thought the FDA would ban the drugs studied or warn people. Forgive my naivety. Ignoring, now, 21 studies showing that people who take sleeping pills die sooner or suffer more cancer, and might be as dangerous as cigarettes, the FDA still claimed (in August, 2012) that sleeping pills are safe and effective. I had made quite certain that the FDA had reviewed the new studies, but the FDA decided to require no black box warnings about these risks and to require no further studies to confirm whether the mortality and cancer risks are so serious.

Look at the spring, 2012 product labeling for Ambien CR (zolpidem), for example. You will find no warning that Ambien is associated with excess deaths. No studies reporting excess human cancer risk are mentioned. The word cancer does not appear, despite some euphemisms. Similarly, the Lunesta labeling in the spring of 2012 does not disclose that some FDA scientists thought that Lunesta had so much cancer risk in animals that it should not be sold. Incidentally, Lunesta labeling did not disclose the new British study showing clearly that Lunesta impairs next-day performance even in young adults.

Perhaps we should not have expected the FDA to protect the public. A 2009 report of the Congressional Government Accountability Office questioned the FDA’s ability to protect Americans from unsafe medical products.[59] A 2012 National Institute of Medicine report found that the FDA’s current oversight was not adequately assuring the safety of marketed drugs.[60] The FDA Amendments Act of 2007 gave the FDA authority to require additional safety studies on marketed drugs when needed. The Act provided authority to require risk evaluation and mitigation strategies, but the FDA disclosed no such strategy to deal with cancer and mortality risks of sleeping pills. In July, 2012 we learned that not only had the FDA fired scientists for trying to protect the public from health risks, but FDA allegedly invaded the computer systems of Congressional offices to catch whistleblower leaks about the risks of industry products. In a September, 2012 law suit and press release, Public Citizen alleged that the FDA was acting unlawfully in failing to protect the public from an Alzheimer’s Disease drug, because it had “chosen to support the profit interests of a large pharmaceutical company.”[61]

Given their health impact, the National Institutes of Health (NIH) should clarify the risks of sleeping pills (see Chapter 9). NIH has made no effort. With planned budget cuts, one cannot anticipate that NIH sleeping pill research will expand. The medical insurance companies can tell from their own medical data bases whether hypnotic users are developing more cancers or dying sooner. Medical insurance companies and Medicaid might ask themselves why they are paying for sleeping pills which are increasing medical costs. They might warn their clients. Unfortunately, private insurance companies have a conflict of interest. The higher medical costs become, the more profits these companies can make. Oddly, drugs which shorten life span might decrease Medicare and Department of Veterans Affairs costs. Medicare and the VA also fail to warn.

8.B. What if your family was injured?

If somebody in your family died or developed cancer after taking sleeping pills, you may have an entitlement to reimbursement for injury, but equally important, perhaps injured families could spread the warnings. When the medical community was no match for the cigarette companies, lawyers and law suits helped disclose cigarette risks. We may now need law suits for failure to disclose sleeping pill risks. If your family member died while regularly taking sleeping pills, and the risk was not disclosed, consult your attorney. If your family member developed a cancer while taking sleeping pills, especially esophageal or lung cancers or lymphoma, and the risk was not disclosed, consult your attorney. In Wyeth v. Levine[62], the U.S. Supreme Court ruled that drug manufacturers are liable if failing to warn patients, even when the FDA has not required a warning in the labeling. If the drug companies, the many doctors taking gifts and money from drug companies, the FDA, and the insurance systems will not alert the public to the risks of sleeping pills, injured families might have to give the warnings with legal assistance. You may contribute to better warnings if injured patient families and whistle blowers file enough law suits, recovering damages like the $4.85 billion which one company paid to settle Vioxx claims.[63] You might help save hundreds of thousands of lives.

Endnotes for Chapter 8

57. Kripke, DF.  Chronic hypnotic use: Deadly risks, doubtful benefit.  Sleep Medicine Reviews.2000;4:5-20. [return]

58. Kripke DF, Langer RD, Kline LE. Hypnotics’ association with mortality or cancer: a matched cohort study. BMJ Open. 2012;2:e000850Link to a website outside this eBook. [return]

59. United States. Comptroller General. General Accounting Office. FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs, GAO-09-581, Jun 19, 2009, available as a PDF document at the GAO website, www.gaonet.gov/products/GAO-09-581Link to a website outside this eBook. [return]

60. IOM (Institute of Medicine). 2012. Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Washington, DC: The National Academies Press. Available as a PDF from the IOM at www.iom.edu/Reports/2012/Ethical-and-Scientific-Issues-in-Studying-the-Safety-of-Approved-Drugs.aspxLink to a website outside this eBook. [return]

61. Bradbery, Angela. Public Citizen Sues FDA for Failing to Act on Request to Ban Dangerous Dose of Alzheimer’s Drug Aricept. Public Citizen, Inc. September 5, 2012. Text of press release available online at www.citizen.orgLink to a website outside this eBook. In November 2012, the FDA decided it had not made a mistake in approving the drug and rejected Public Citizen's petition. Wolfe, Sydney. FDA Rejects Petition to Ban Aricept 23: Did Drug Companies, FDA Collude in Approving Dangerous Alzheimer’s Drug? Public Citizen, Inc. November 6, 2012. Statement of Dr. Wolfe available online at www.citizen.orgLink to a website outside this eBook. [return]

62. Wyeth v. Levine, 555 U.S. 555 (2009). The full text of the majority opinion by Justice John Paul Stevens, as well as the concurrences and dissent, are available at Cornell University Law School's online Legal Information Institute, at www.law.cornell.edu/supct/html/06-1249.ZS.htmlLink to a website outside this eBook, while a summary of its holdings may be found at Wikipedia, en.wikipedia.org/wiki/Wyeth_v._LevineLink to a website outside this eBook. [[return]

63. See Wikipedia's summary of the Vioxx case history, as part of its article on Merck and Co., Inc., available online at en.wikipedia.org/wiki/Merck_%26_Co.#VioxxLink to a website outside this eBook. [return]