The inadequate FDA medical device safety surveillance system: a case study

January 25, 2012 By Steven Greer, MD

I have worn contact lenses for more than twenty years without any problems. But recently, my eyes began to disagree with them. In the course of investigating the possible reasons why, I uncovered some shocking inadequacies of the FDA reporting system meant to detect safety problems in medical devices, and also discovered ongoing problems in the way that Johnson and Johnson (JNJ) deals with medical device safety problems.

In October of 2011, I received a new batch of JNJ-made Acuvue Advance contact lenses (Silicone hydrogel lenses meant to be worn for two weeks), purchased from Utah supplier “1-800-CONTACTS”, which is now affiliated with Walmart in an “alliance” of distribution. I have used Read more »

Oh my god, I have a disease!

March 21, 2014- This DTC TV drug ad medicalizing a non-disease really struck us as egregious

Medical Tip: How to get special glasses for computer screen distances, for cheap

March 14, 2014- By Steven E. Greer, MD

With remarkable regularity across all populations, the inner lens of the eye loses flexibility after age 45 and people begin to have trouble reading up close (presbyopia). So, to compensate, people push the book or computer screen away. Then, as the eyes worsen, people start to have trouble reading computer screens even when they are three feet away.

The solution is Read more »

The new hybrid career as doctor/corporate-lobbyist

Update: February 22, 2012

An FDA advisory committee of doctors voted to approve the Vivus drug Qnexa despite the unknown risk to heart valves and know risk of birth defects. David Letterman’s doctor, Lou Aronne, internist and weight loss expert, had visited the FDA as a hybrid lobbyist/doctor.

Update: May 27, 2011

The Senate Finance Committee is investigating the conflicts of interests between medical societies and individual doctors paid millions of dollars by drug companies, who then double as lobbyists and petition the FDA for causes favoring the branded drugs. The Healthcare Channel was the first to recognize this as pure lobbying, in our April 29th story, below.

April 29, 2011

Steven Greer, MD for The Healthcare Channel

Medical societies have long been officially-registered lobbyist organizations with offices in Washington, DC. However, what seems to be an alarming new trend is now for individual doctors, receiving industry funding, to visit The Hill or The FDA to lobby on behalf of those companies’.

The Wall Street Journal reported that an epidemiologist, Emily Gower, PhD, of the Johns Hopkins Bloomberg School of Public Health, was funded by Roche/Genentech to create a retrospective study comparing the safety of Lucentis versus “generic” Avastin for the treatment of wet macular degeneration. This study was commissioned to offset the negative effects of the NIH-funded CATT trial that showed the much more expensive Lucentis, at an 8000% premium to Avastin, was no more effective and equally safe to Avastin. Dr. Gower’s study claims that Lucentis is safer, justifying the huge expense and $1.6 Billion in revenue to Roche.

According to the WSJ, Dr. Gower was taken along with Roche executives to The Hill to lobby for maintaining reimbursement of Lucentis in the wake of the CATT results. Roche characterized her discussions as “scientific” rather than lobbying.

Dr. Gower is yet to present or publish the aforementioned Roche-funded study. If she discussed these data and conclusions with anyone, including congress, CMS, or the FDA, it would be violating most medical journal and medical society rules.

Dr. Gower did not reply to our calls or emails.

Something similar to the Dr. Gower lobbying described above occurred in 2007 when Cleveland Clinic cardiologist Steve Nissen went to The Hill to push his agenda: that the diabetes drug made by GlaxoSmithKline, Avandia, was unsafe. Like Dr. Gower, he had a “smoking gun” white paper set to be published that concluded Avandia was unsafe, and he revealed the results to numerous groups prior to publication. This is according to some members of congress who questioned him before an oversight hearing.

More recently, David Letterman’s doctor, Lou Aronne, internist and weight loss expert based in Cornell’s New York Presbyterian Hospital, went to the FDA to lobby on behalf of several small struggling biotechnology companies that have suffered regulatory setbacks with their weight loss pills. Dr. Aronne has a lengthy list of financial disclosures indicating that he receives payments from the companies for which he was lobbying on their behalf (Orexigen, Vivus, Arena Pharmaceuticals).

As state and federal budgets are running with significant deficits, and the states unable to print money to survive as the federal government does, the lucrative funding from industry has become more powerful within state-funded medical centers. The biggest controversies twenty years ago might have been whether a doctor received too many free meals or trips from a healthcare company. Now, it seems that it is acceptable for active faculty members to double as paid lobbyists for the industries.

Philip Rosenfeld, MD, PhD: The history of intravitreal Avastin for AMD

Dr. Rosenfeld discusses the series of events that led him to begin using off-label intravitreal Avastin to treat wet AMD rather than use the more expensive Lucentis.

Philip Rosenfeld, MD, PhD: The Lucentis v Avastin CATT trial

Dr. Rosenfeld discusses the ongoing CATT trial (Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial) that is testing whether cheaper off-label intravitreal Avastin is as effective as Lucentis, and whether fewer as-needed doses are as effective as current dosing.

Doctor violates embargo rules

April 28, 2010

The CATT trial data (Lucentis v Avastin in wet AMD) were surprisingly released from embargo today ahead of schedule. It has the press world “In a tizzy” according to one media relations person. The NEJM confirmed that they made this move as a result of the data being leaked to the New York Times yesterday.

The doctor who leaked these data on the CATT trial demonstrated poor judgment. He/she is apparently unaware of what happened to a famous cardiologist when he leaked COURAGE trial data to press. That doctor was banned from the NEJM for many years. Also, in the news now are doctors who have been arrested for leaking trial data via “expert networks”.

The doctor in this case likely took the risk because he/she was leaking to the press rather than an expert network. However, the SEC is even clamping down on that after decades of major M&A deals being leaked to the financial press and the stocks involved moving ahead of the official news.

All doctors in possession of clinical trial data should be advised to not speak to the press or anyone about those data prior to the official presentation. Practices that have been borderline legal but commonplace in the past are no longer acceptable to the SEC and DOJ.

The 8000% price premium to Lucentis over Avastin

July 15, 2009, the Healthcare Channel

The 8000% price premium to Lucentis over Avastin

The Healthcare Channel previously exposed a 1000% price increase on a generic drug made by Actavis and how it was a case example for healthcare reform. The United States spends approximately $300 Billion or more annually on prescription drugs. Branded drugs have high prices that translate into 85% gross profit margins in many cases. The pricing for drugs is established by the pharmaceutical companies with little control from Medicare or private insurance. Moreover, drug companies raise prices 10% or more annually, far exceeding inflation.

The various healthcare reform bills in the House and Senate have all met with resistance due to their trillion-dollar estimated costs. As a result, congress is now exploring ways to fund the bill resorting to once taboo methods, such as allowing The HHS to negotiate drug prices. Being a large purchaser of drugs, The HHS or Medicare would be able to demand steep price cuts. The drug industry is adamantly opposed to this option.

How much fat could be trimmed from drug expenditures by cutting prices? In addition to our Actavis example, an expensive eye medication sold by Roche, Lucentis, is another example of a huge price premium on a drug, 8000% in this case, compared to alternative treatments. The HCC interviewed Philip Rosenfeld, MD, PhD, Professor of ophthalmology at the University of Miami, to discuss how he innovated an alternative therapy to Lucentis that he estimates has saved $6 Billion in drug costs globally since 2005.

The drug industry argues that high prices on drugs in the United States are necessary because of the cost involved in developing drugs and the high failure rate in clinical trials. The HCC estimates that drug prices could be trimmed by as much as 50% and the companies would still be profitable. Using Wall Street sell-side models, the average gross profit margin (revenue minus the cost of manufacturing the drug) exceeds 80%. After deducting the clinical development costs, marketing costs, and research costs, the companies still post operating profit margins of 40%. If an industry-wide 10% cut in drug prices were instituted, more than $30 Billion would be saved in the U.S. alone. This is based on global drug revenues of more than $700 Billion (source IMS) and half of that derived from the U.S. markets.

Senate committees are considering drug price cuts as an option to fund healthcare reform, according to the Pink Sheet and our own sources. At this point, it is unlikely that any measure would survive to the final bill. However, the situation is very dynamic.

Tips for an optimal annual physical exam

Many people schedule their annual physical for either the end of the year or the start of the year. Your doctor undoubtedly delegates most of the tests and data collection to the staff, and they are often improperly performed. Some common mistakes to keep an eye out for are the following:

• Make sure all of the staff washes their hands.
• Make sure the nurse actually measures your height and weight. You likely lie to yourself about both and the nurse should not take your word for it.
• Make sure the ECG leads are actually placed on the ankles and not on the abdomen. Nurses and most doctors often do not understand the artifacts caused by improper leads and they only glance at the ECG to look for obvious rhythm disorders. For an ECG to be of use in identifying old infarcts, the leads have to be properly placed across the chest, both arms, and both legs.
• When they draw the blood, have them penetrate the vein at a 90-degree right angle, not close to parallel to the skin at an acute angle. A right angle works better and is less painful.
• Make sure the doctor checks the soles of your feet the pulses in ankles. Ask your doctor to measure the “Ankle/brachial index” to pick up peripheral vascular disease in the legs.
• Make sure the doctor looks in your ears. You probably have cerumen (wax) and you will hear those iPods better if the canals are clean. Use hydrogen peroxide dipped in Q-tips to gently clean your ears without compacting the wax deeper, or see an ear doctor if you have the luxury.
• Particularly if you are Caucasian, make sure the doctor looks for nevi (moles) and signs of skin damage from the sun, particularly if you are over age 40 or are younger with fair skin. Have the doctor chart the lesions found. If you have any doubt, just go to a dermatologist and have the lesion removed. For widespread skin damage, photodynamic therapy works well.
• If you are over age 50, go to an eye doctor to have a real eye exam where your pupils are dilated by drops. Your primary care doctor is just going through the motions by looking in your undilated eyes and cannot see much at all other than cataracts. Signs of early eye disease that will lead to blindness can only be seen when the pupils are dilated.
• Ask about adult vaccinations for diseases such as shingles, flu, pneumonia, etc. Financial reasons have caused most primary care offices to stop administering vaccines.
• If your doctor recommends any form of medication to prevent a cardiology problem, such as high cholesterol or high blood pressure, get a second opinion and search http://www.currentmedicine.tv/ for the topic. In general, get a second opinion before starting any new therapy.
• Weeks later, if the laboratory testing company tries to bill you, do not pay. They are not allowed to bill you for the balance of what insurance does not pay as long as your doctor is “in network”. Be generous with your doctor, however. Most primary care doctors are underpaid.