Building the “better mouse trap” sometimes means producing a product that simply does not work the way it is designed to work. It is a process, sometimes, of trial and error.
If someone (other than the mouse) is seriously injured by that product, it is called negligence.
Building the “better mouse trap” and then hiding or concealing that you know the new mouse trap actually can cause great harm to other than just the mouse is called reckless disregard for the safety of others.
A recently discovered e-mail sets forth what seems to be pretty clear intentions on the part of Johnson & Johnson and its subsidiary, DePuy, to appreciate a dangerous product and not tell anyone about it until they absolutely had to and until they were able to squeak out as much profit as possible.
The problem? Insufficient testing; inadequate reporting of complications; and continued distribution of a product the manufacturer knew or should have known was defective.
Johnson & Johnson, through its subsidiary Depuy, produced a “metal-on-metal” hip implant that they knew:
By mid-2009 the FDA refused approval of the implants because studies “showed it had failed prematurely in ‘significant’ numbers, requiring repeat surgeries for patients”.
They were receiving increasing complaints in the US and abroad of the implants or “companion” implants failing at rising rates.
That patients were requiring replacement or revision of the devices after only a few years as compared to as many as 15 years or more with other hip implants.
Failure rates could not have been physician caused, since studies run by surgeons were hand-picked by DePuy (Johnson) and still demonstrated failures.
Australian medical device regulators were seeing higher failure rates in the device than was acceptable.
The genesis of the problems with devices like the DePuy MOM implants is really two-fold.
First, corporations are answerable to their shareholders on a bottom line profit basis. This motivates any corporation to maximize those profits. As a result, corporations are often motivated in favor of decisions that preserve or increase their bottom line and, sometimes, even if it results in harm to others.
Second, the agency charged with the oversight of products such as metal-on-metal hip implants is the Food & Drug Administration (FDA). Out of necessity, the majority of funding for the FDA comes from the very industries it regulates and it must necessarily cut a fine line between regulation and mediation.
The regulation of medical devices is an important responsibility and the protection of consumers should be the foremost goal; caution should be exercised, even when that caution may cost a manufacturer considerable cost in holding off the marketing of a product.
The reality, however, is the FDA regularly walks a tightrope between consumer protection and biting the hand that feeds you.
Sadly, it is only after 30,000 patients in the US and an unknown number overseas have fallen victim to MOM implants, that the truth is finally seeing the light of day as a result of ongoing litigation.
Has it simply become all about bean counters and number crunching for some drug companies?
If you can generate over $1.5 billion in sales for (5) years, for a drug you know is defective, can you afford to pay the claims that result from people being hurt or killed?
If you can generate $7 billion in sales and your profit margin is 40%, you show a $2.8 billion in the black.
If you are sued by 10,000 people and 30% are people who die and 70% are people who were hurt, what would the average claim payment have to be to still call the drug a “success”?
Based on these sales projections, the company who might go through these grisly computations could still show a billion dollars in profit and have available $180,000 to handle each claim. Since some number of the victims will not be able to prove their case or will give up before anything is paid, maybe that is enough to buy everyone off?
When reading about the recent developments in the Yaz, Yasmin and Ocella debacle, it increasingly seems like bean counting and “business decisions” were made with the marketing of the drug, Yaz (Yasmin, Ocella).
As I have written before, like it or not, the Food & Drug Administration simply can not independently test every drug or medical device submitted for approval. The FDA must rely on the apparent completeness of the testing data submitted by the maker of a drug in order to assess its viability and safety. So, the FDA needs drug makers and medical device manufacturers to be honest.
Yes, balancing profits and safety, that does not always work well when we are talking about “billions and billions” of dollars in sales numbers. Even when manufacturers intentions are honorable that balance can be thrown off; when manufacturers simply do not care enough about patient safety, the danger levels can rise to dangerous levels.
Today, we find out the following about Bayer’s drug, Yaz (Yasmin):
Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin’s safety provided to the agency.
The report also didn’t include an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives.
Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin. The company also promoted the oral contraceptive for unapproved uses, particularly for treatment of premenstrual syndrome.
Bayer unit withheld information about Yasmin’s risks of clots before the drug was approved by the FDA in 2001.
In 2003, the FDA told Bayer it was “very concerned” about the number of adverse events reported in Yaz and Yasmin users. Those “adverse events” included strokes and deaths in relatively young girls and women. Bayer responded by assuring the FDA that its data did not show a higher risk for Yasmin (Yaz).
In a draft of the report that has recently been uncovered, a Bayer investigator set forth:
“Compared to the three other OCs, Yasmin has a several fold increase in the reporting rates for DVT, PE, ATE and confirmed VTEs.”
When considering only serious AEs (adverse events), the reporting rate for Yasmin was 10 fold higher than with the other products.” The total rate of confirmed VTEs per year was three or four times higher than the other three oral contraceptives reviewed, according to the data in the draft, Kessler said. The raw numbers were 6.9 per year for Yasmin and 1.5 for two of the other pills, according to the draft.
Holding back on the “bad news” about these drugs was not enough for Bayer. Bayer launched a marketing campaign to balloon all other marketing efforts. You remember, balloons, lots of pretty balloons; and highly successful, intelligent and attractive women touting the incredible advantages of Yaz and Yasmin. Bayer also consciously decided it would ignore regulation designed to prevent undue influence on consumers by drug companies. Bayer marketers designed a marketing approach that specifically circumvented FDA restrictions on marketing because Bayer saw those regulations as a threat to the monumental commercial success of the drugs that Bayer so very much wanted.
In October, the FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. The FDA examined data on 835,826 women who took pills containing the hormone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report.
The Food & Drug Administration intends to hold hearings beginning on December 8, 2011 and hopefully more withheld information will come to light. When trading consumer health in favor of profits, perhaps the federal government needs to deliver the message that “bean counting” consumer’s lives will not be tolerated.