From the monthly archives:

October 2009

Gardasil, a Good Idea?

by Jerry Meyers on October 30, 2009

Gardasil is a HPV vaccine produced by Merck.  HPV, Human Papilloma Virus, has clearly been demonstrated to increase the risk of a woman developing cervical cancer so it would seem to be a good idea to provide young woman, even as teenagers, with a vaccine that would guard against the virus and prevent the development of  invasive cervical cancers which would otherwise be produced by the virus.

In 2006 Merck Pharmaceuticals received the go ahead.  The FDA approved the distribution of Gardasil, a Human Papilloma Virus vaccine manufactured by Merck Pharmaceuticals and Merck promptly began the distribution of the vaccine.

Later in the same month the distribution began, the advisory committee on immunization practices recommended routine vaccination of girls 11 to 12 years old.  Remarkably, these recommendations were issued before completion of the so-called phase III trials demonstrating whether advanced pre-cancerous lesions of the cervix are prevented by the use of the vaccine.

In fact, only two of the fifteen types of HPV known to have a cancer-producing potential have been shown to be affected by the vaccine.

Merck has seen to it that the public has been provided with a favorable view of the vaccine.  In a report by Rothman and Rothman published in the Journal of the American Medical Association this year, Marketing HPV vaccine: implications for adolescent health and medical professionalism, JAMA 2009 Aug 19; 302(7):781-786  the author shows how Merck employed the assistance of various important medical associations by providing the associations with ready-made presentation slide sets, emails and letters to promote the product.  All this publicity in favor of the use of the vaccine began before important trials had even been concluded.

Now, in the same issue of the Journal of the American Medical Association in which the report of Rothman and Rothman appears, there is an article from the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration reporting adverse events occurring in the two and a half years following administration of Gardasil, Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine,  Slade, B.A., Leidel, L.,Vellozzi, C.; et al. JAMA 2009 Aug 19; 302(7): 750-757.    There were 752 adverse reports.  6.2% of the adverse reports involved serious adverse effects, including 32 reports of death but the system of depending on voluntary reports of adverse events risks underreporting and there is no real evidence that the adverse events reported resulted from the vaccine.  Such adverse events reports are based solely on an event occurring after the administration of the vaccine and not because of any other evidence proving the vaccine caused the event.

So, we don’t really know the extent of any benefit a young woman will receive as a consequence of being vaccinated and we also don’t know the risk.

What a nightmare for a parent with a decision to make about a teenager receiving Gardasil.  Cervical cancer continues to kill thousands of women every year. If the leading cause of the cancer is a virus that can be prevented by vaccination, how does one decide to not offer the vaccination?  If, as some have suggested, the chances are less than six adverse events per thousand doses distributed and only 6.2% of those represent serious adverse effects, that means that one serious adverse event would be associated with every three thousand doses distributed.  But even with a risk this small, has there been a sufficient benefit demonstrated to justify that risk?

In a completely different context, many years ago Jonas Salk pointed out to me the importance of focusing on the numerator.  If the chance is 1 in 10,000,000 and you are the one, it is little comfort that 9,999,999 other doses were administered safely.

Perhaps it was easier long ago when we knew little and simply did what we were told.  If not better, perhaps it was just a lot simpler.  What do you think?

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A Patient Should Have a Right to Legal Advocacy

by Jerry Meyers on October 13, 2009

In 1998 the United States Advisory Commission on Consumer Protection and Quality in the healthcare industry adopted a Patient Bill of Rights. The same year Pennsylvania enacted a Patient Bill of Rights allegedly for the purpose of providing quality healthcare accountability and protection under Act 68 of 1998.

It is interesting that the legislature of Pennsylvania elected to call the Act a Patient Bill of Rights. It in fact bears no similarity to what the founding fathers of this country called a Bill of Rights. First, it doesn’t apply to healthcare directly but rather regulates how managed care organizations such as HMOs interact with their insureds. Since the relationship between an insurance company and its insured is defined by contract, the few items regulated by the so-called Patient Bill of Rights in Pennsylvania and in other states where similar bills have been enacted do little to enhance patient safety. Indeed, one does not have a right if one lacks the power to secure enforcement of that right. Enforcements provisions under the typical “Patient Bill of Rights” is, for example, limited in the case of a patient being denied access to a particular procedure being paid that sum which the insurance company had refused to pay. There are no other penalties and no provision for a patient to be represented by anyone in the appeals process.

Patients who cannot seek enforcement of rights have no right and the rights I have discussed thus far are trivial compared to those rights which most would consider fundamental with respect to the provision of healthcare.

A patient certainly should have a right to receive medical care at a level consistent with the principals of practice accepted by accredited institutions of learning and certifying boards of medicine. Everyone feels more comfortable if they are being treated by a physician who has received appropriate training and especially if a physician has been certified by a specialty board of medicine. Physicians are certified only after having been examined usually both in writing and orally. During the course of these examinations, everyone accepts that there are answers which are right and answers which are wrong as in any test.

A patient might therefore assume that the care provided them by a board certified physician would be consistent with those principles of practice which are taught in medical schools and residency training programs and which are the subject of certifying exams. Regrettably, this is often not the case.

Any medical resident who performed an initial assessment of a patient at the beginning of a hospitalization without taking a comprehensive history from that patient would be reprimanded by their supervisor in training. Such a reprimand would depend upon the supervisor becoming aware that such an error was made.

Improper histories and inadequate physical examinations and, most importantly, failed diagnostic process occur with frequency in every healthcare setting and when such errors are made often patients suffer harm. Diagnoses are incorrectly made or made too late for effective treatment to be given.

It is widely acknowledged that this is so. In fact in November of 1999 the report of the Institute of Medicine entitled, “To Err is Human: Building A Safer Health System,” reported as many as 98,000 people die in hospitals each year as a result of medical errors.

Part of the current healthcare reform debate concerns now 10 years after the IOM report a continued search for how to make patients safer, no one currently believing that fewer people are dying today than were dying in 1999 as a result of medical errors.

It is therefore, I think, ironic that we hear news commentators talking about limiting patient’s rights to have legal advocates as a means of somehow making patients safer.

It defies common sense that drivers would operate vehicles more carefully if they were immunized in whole or in part from being held accountable for their carelessness. Patients who suffer severe and unexpected adverse consequences of a healthcare experience in the hospital or elsewhere cannot depend on their doctors, nurses or other healthcare providers to inform them honestly and openly of the causes of the unexpected consequences. It just doesn’t happen. A patient or a patient’s family must be free to consult with lawyers experienced in the management of medical malpractice claims. Such lawyers know how to readily and, usually at their own expense, obtain such information by family interviews or by examination of records as permit the lawyers to honestly advise a patient or their family of whether a bad outcome of medical care was preventable or should have been prevented. Lawyers through their research have access to the principles about which physicians are tested for certification and are taught in schools and through their residency training. Patients in fact have no other satisfactory means of obtaining such information.

In most hospitals, at the time of a patient’s admission, they will be informed of the existence of a bill of rights. They may even be given a paper enumerating these rights. Most hospitals now also have persons who they refer to as patient advocates. The hospital employee who is given the title “patient advocate” is truly powerless to obtain the information a patient requires to learn whether an unexpected injury or outcome was preventable or should have been prevented or not and if the advocate by chance believed the patient was mistreated and harmed as a result of carelessness, such a patient advocate wouldn’t have the power to do anything about it.

The function of a hospital employed patient advocate is to make patients feel better about the care they have received whether that care has harmed the patient or not. Independent patient advocates who have the power to conduct an investigation into the circumstances of a patient’s care and secure for the patient compensation for harms needlessly suffered do not exist outside of our legal system. Only lawyers have the power to be true patient advocates.

It is unfortunate that in so many states in our country rather than increasing patient rights and safety, there has been a relentless effort largely endorsed by medical societies and insurance companies to limit a patient’s access to legal representation or to limit the rights of a patient to be compensated when they have suffered needless harms. The imposition of such limitations is done under the title, “Tort Reform”.

Tort Reform advocates cause patients to believe that Tort Reform and patient safety are somehow related. Tort reformers have many justifications that they give for why reform is needed. They will talk about frivolous lawsuits but they don’t talk about the fact that most tort reform measures limit patients who have been seriously injured by clear carelessness from being compensated for their injuries. Patients will never be made safer by tying the hands of the only true advocates they have.

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