A US appeals court has overturned a conviction of a former drug rep for encouraging doctors to prescribe a drug “off label”. The court ruled this violated the First amendment rights and that the federal government had failed to show his comments were false.
I am no constitutional lawyer and it is likely armies of lawyers will dissect this ruling. In addition a further appeal would be almost certain. “Off label” prescribing pertains to prescribing a medication for purposes for which it is not “approved”. It is important to point out that not being approved is not the same as not being useful. Drugs may have multiple uses but only be officially approved for one of them.
As usual the arguments are less about health and more about money.
Insurers, including the government will pay or reimburse patients for drugs if they are approved. However unless an audit is done nobody except the doctor and patient knows the reason a drug is prescribed.
When drugs are marketed to doctors, sales reps are only allowed to discuss approved uses. But it should come as no surprise to learn that this is routinely ignored. A number of pharmaceutical companies have had to pay large fines for promoting drugs for off label use so this ruling could be a real blow to the FDA if it is confirmed.
At its core the question is whether laws pertaining to marketing are inherently a restriction of free speech. They are. Companies are not allowed to make false claims about products to entice people to buy them. If I sell a product claiming it will enable you to live to 150, I will be prosecuted for false advertising. This is notwithstanding my rights to freedom of speech. The same goes for companies selling vitamins or natural health products that have to be careful with claims they make.
So should the pharmaceutical industry be treated differently? Short answer is no!
I am a passionate advocate of free speech. Freedom of speech includes the right to offend and the right to tell lies. However if a product is licensed for a particular use then that license includes a restriction on how that product can be promoted. In accepting the license the restriction is accepted. This is even more the case when the end user is not paying for the product but someone else is. And especially when that someone is the taxpayer.
Big Phrama’s reputation is not great. In India doctors have been given coffee makers and vacuum cleaners as a “reward” for prescribing certain drugs. A big company settled charges that it paid kickbacks in various European countries.
In the last month or so Pfizer settled two cases for over US$500 million. And its CEO has been ordered to appear in a trial where the stop smoking drug Champix (Chantix) is claimed to have caused psychiatric illness.
There are the ongoing issues about dubious research, the non-publishing of unhelpful studies and the payment of doctors as “key opinion leaders”.
Plus as I discussed recently with Paul Murray on my regular segment on 6PR the asthma drug Seretide (Advair) is being subjected to a review due to safety concerns. The drug has been associated with higher rates of deaths in asthmatics. This is from the salmeterol component. Seretide combines salmeterol, which is a long acting beta agonist with fluticasone, a steroid.
Approved as a second line drug, which means it can be used when others have not worked, its market share suggests it is being used first line. Some two thirds of asthmatics in the USA are using it. In Australia that figure may be around 50%.
It is alleged the drug was promoted as first line therapy in an off label manner. Sales since 2007 are in excess of $4 billion per annum.
And here is the real corker. A panel, which recommended use of the drug, had 15 out of 18 members with financial ties to the manufacturer. Another academy which endorsed the drug has received $US 4.7 million from drug companies.
The chairman of the panel was from the University of Wisconsin. This tweaked my interest because this is the same university where “research” supporting Oxycontin was done. There may well be a governance issue at this institution.
Having laws against off label marketing has not stopped it but at least there have recently been some bigger penalties. The maker of Seretide (GSK) was fined over $US3 billion in July for inappropriate marketing of drugs. The asthma drug was not part of this settlement.
Weakening regulations will make off label marketing even easier resulting in more cost to the system and more people being prescribed drugs they do not need. I am loath to argue against free speech but this issue is about marketing not an individuals right to express a personal opinion.
Big pharma together with some universities, researchers and doctors have been allowed to get away with too much. They need to be held accountable, not let further off the hook!