This post continues a series of Bruce Willis unintended consequences posts, of which there will be two more. There is a degree of truth in all of them.
As outlined in last week’s Osama Saves Millions, Yusuf Hamied stepped in at a critical point in the unfolding global AIDS story and in offering Triple Therapy at a dollar a day decisively shifted the storyline. His company, Cipla, was an Indian pharmaceutical company dealing primarily with generic drugs.
The link between Hamied and Bill Haddad that led to Hamied’s Triple Therapy proposal was embedded in politics. The generic pharmaceutical industry in the United States was closely linked to the Democratic Party. In 1964, Haddad had stood for Congress as a Democrat with the price of drugs as his main campaign platform. He had run the Kefauver 1956 vice-presidential campaign and later Kefauver hearings on the pharmaceutical industry. He was involved in the 1960 and 1968 Kennedy campaigns.
When he approached Hamied, he was the Chair of the GPIA – the generic pharmaceutical industry association. The generic version of PhARMA. As early as 1984, he had said that if the branded industry didn’t bring drugs like AZT on the market the generic industry would – and AZT was the first drug licensed under the Orphan Drugs Act, of which Haddad was a leading instigator.
The Clinton administration efforts in the 1990s to get healthcare reform through Congress were closely tied to the fortunes of the generic pharmaceutical industry. The irony was that Republicans, not Democrats, were supposed to favor markets and dismantling monopolies as the best way to deliver better quality and cheaper products but when it comes to pharmaceuticals things often turn inside out.
Once Hamied cut the Gordian knot holding back Triple Therapy, Bill Clinton, then the former president, became the biggest promoter of Cipla and soon afterwards all Indian pharmaceutical companies, including Ranbaxy. He made many visits to India, with Indian politicians and executives apparently dazzled by their new fellowship with a political superstar.
Apparently. Pretty quickly Ranbaxy and some other companies smelt a killing. They began filing for generic approval in US and European markets for drugs about to come off patent. Not just filing but filing for first generic approval as this was worth substantially more than later approvals.
To get there first required either a very swish technical operation or fraud. Fraud was a lot easier, and cheaper and more reliable. The FDA essentially didn’t have an inspection system for Indian pharmaceutical companies. Companies didn’t have to do the experiments. They could make up the data.
There were one or two FDA operatives in the field in India and China who despite having to announce their arrival to companies beforehand and having to be escorted around plants began to raise concerns – they were fired.
What was happening came to light because of whistle-blowers within Ranbaxy, especially Dinesh Thakur.
As the evidence of problems came to light, FDA were caught in a dilemma. The Obama government had come to power and a supply of cheaper drugs was essential to proposals for healthcare reform. The findings of fraud were so egregious and the consequences of inaction for the health of patients exposed to Ranbaxy drugs so serious that doing nothing was not an option but bankrupting Ranbaxy with the kind of fines that seemed called for would be a serious blow to the Affordable Care Act. After many twists and turns, Ranbaxy ended up with a relatively small fine.
Efforts to put a proper inspection system in place for the Indian and Chinese generic companies were quietly shelved.
Bottle of Lies
The story is vividly told in Katherine Eban’s Bottle of Lies.
I keep track of books like this for any light they might shed on aspects of the history of the pharmaceutical industry. I was skeptical about the promotional blurbs, figuring this might well be another written in the branded-industry con-job, aimed at discrediting the generic industry.
If it is, its a very sophisticated one as Eban makes clear that brand name American companies are now moving their production operations to India and China where oversight is minimal to non-existent and we are likely at just as much risk from brand name products as generics as a result.
(And of course the most high profile price gougers of recent years have been generic companies like Mylan and Turing – a hedge fund in generic clothing).
Does this story make a difference to any of us. Yes it does. Pretty well every working week now I come across people with convincing stories of being given a generic drug made by a different company to their prior supplier and having a completely different response – or no response. This can be very serious in the case of a patient on a diuretic whose drug stops working.
Two decades ago if a patient switched from a branded drug to a generic, and complained there were differences, most doctors rolled their eyes to heaven and dismissed the complaint. But these problems are now being reported by people switching from one generic drug to another and are pretty gross and consistent.
Given that close to 85% of drugs used in the USA are now generics and 40% of the drugs used in Britain’s NHS are generics from India, this is not a minor issue.
Patients in the West are the lucky ones. Eban’s book makes it clear that if you are a child with a life-threatening infection in Africa, the chances are the antibiotic you are given will be a dud and you will die. A decade ago, there were concerns about Fake Medicines in Africa and elsewhere cooked up in bath-tubs but the bigger concern now is medicines from big name companies, where one batch might be okay but the next ineffective or dangerous.
This almost certainly applies to vaccines also. There are no placebo-controlled trials of vaccines. All we have are trials of adjuvant against adjuvant plus vaccine. The adjuvants are mostly compounds with an Aluminium component whose role is to trigger a more vigorous reaction to the proteins of the vaccine.
But there is another component to vaccines – fluid. The vaccine and adjuvant are dissolved in fluid. If this fluid contains a scrap of anything else, a protein, a metal, or anything, then the adjuvant can trigger a response to that also. And if any of the vaccine batches are made up in India and China then it is almost for certain, the fluid will contain other materials.
In this way even a vaccine with a clear bill of health from controlled trials could cause significant damage.
As Clinton’s story decades earlier made clear, sometimes politics requires you to execute a mentally handicapped person. Chances are Obama’s healthcare efforts may have led to the death and disablement of millions.
Are Generic Drugs Safe?
These money-saving alternatives may not always be as effective as brand names, according to an alarming new study. Prevention’s exclusive, must-read report will give you all the facts you need to protect your health.
https://www.prevention.com/life/a20460151/find-out-how-to-use-generic-drugs-safely/
By Joe Graedon, MS, and Teresa Graedon, PhD
Nov 3, 2011
The generic manufacturer doesn’t have to prove all over again that the drug works. In fact, drug testing is generally required only on 24 to 36 people for a brief period of time. As long as the pills contain the same active ingredient as the brand-name version, in roughly the same amount, and it gets into the bloodstream in a comparable manner, the meds are good to go.
USFDA chief supports generics made in India
The Indian drug makers are finally seeing a recovery with most of their factories being cleared by the US watchdog.
,
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/usfda-chief-supports-generics-made-in-india/articleshow/68161844.cms
By DIVYA RAJAGOPAL
Feb 26, 2019
Mumbai: Indian drug companies have got a shot in the arm with the US Food and Drug Administration (USFDA) chief coming out in support of generics manufactured in India and the US to dispel fears over such medicines.
Generic drugs were just as safe and much less expensive but this is no longer the case. Katherine Eban in her book had extensive input from the Graedon’s and The Peoples’ Pharmacy. And its highly likely Indian and Chinese companies try to ensure the supply to developed countries is as good as they can make it – for business reasons – but their attitudes to what they are willing to send to other countries is not the same. This is an area in which some excellent FDA people have been frustrated, perhaps even sabotaged, by their bosses.
David
Unbelievable, and how further inhumanely people and children in Africa and other countries are considered.
I was given a generic version of Lexapro, one of many unexpected Seroxat follow ups when already in withdrawal from Lexapro whilst still on the drug (only realising this later: the vivid violent “foreign” nightmares and thoughts, agitation and flashes of jumping in front of buses should have be the typical initial signs for me). Definitely made matters worse – and when your head has been rendered away already.
The Stewart Dolin Case and outcome (along with a link to MISSD) should be on the box of all generics with regards to patient’s rights.
We should be standing outside pharmacies with illuminous markers regarding “Black Box Warnings” and slapping “Rights Box” sticker warnings on medicines for patients.
(ie. you nor you upon behalf of your child or elderly parent, cannot possibly have had Informed Consent if a brand drug – and contrary to and incompatible with both Human Rights legislation which may have been incorporated into your country and Medical Council Directives.
If a generic drug and you, your child or your elderly parent, die a horrific death by a long known ADR with no warning, or you are rendered disabled, you and your struggling or bereaved family may have no rights at all).
Off topic a little, but can I ask under what law or legal means have companies been able to get away with not allowing doctors access to data or raw data?
(A message to me as a Seroxat victim regarding Informed Consent and my rights as a patient etc from the Irish Health Minister’s Office was laughable to the point of utter deafness and insult. They’d likely send the same blah off to a Thalidomide victim and already treated disgracefully by the Irish State).
I’ve been reading cases in Ireland in the last few years where Irish people have been able to sue the Irish State for Human Rights Breaches under European Human Rights (which, not least, for patients, amongst other howlers, includes Informed Consent. Also recognised by the Irish Supreme Court).
Leonie Fennel would know more about this perhaps but if there did exist any Achilles heel in legislation or which may hold more weight over other leglislation which may allow pharmaceutical companies to get away with this **** or if case was taken up in a country with the best chance of such a case succeeding, it would at the very least raise awareness. And get people, especially parents, to refer to independent evidence studies themselves etc.
There simply must be something.
Pillars of Society
How thousands of British patients may have taken tainted NHS drugs sold by the mafia, as it emerges health chiefs KNEW about the scandal and didn’t warn the public
https://www.theguardian.com/us-news/2018/nov/19/sackler-family-members-face-mass-litigation-criminal-investigations-over-opioids-crisis
Opioid crisis: Johnson & Johnson hit by landmark ruling
By Russell Hotten BBC News, New York
3 hours ago
https://www.bbc.co.uk/news/business-49452373
Drugmaker Johnson & Johnson must pay $572m (£469m) for its part in fuelling Oklahoma’s opioid addiction crisis, a judge in the US state has ruled.
The company said immediately after the judgement that it would appeal.
The case was the first to go to trial out of thousands of lawsuits filed against opioid makers and distributors.
Earlier this year, Oklahoma settled with OxyContin maker Purdue Pharma for $270m and Teva Pharmaceutical for $85m, leaving J&J as the lone defendant.
Judge Thad Balkman of Cleveland County District Court in Norman, Oklahoma, said prosecutors had demonstrated that J&J contributed to a “public nuisance” in its deceptive promotion of highly addictive prescription painkillers.
Sackler family are set to pay $3bn of their OWN money and turn Purdue Pharma over to the government in settlement over opioid epidemic
Sackler family would pay £3bn of own money in settlement over opioid epidemic
They are also set to turn over Purdue Pharma to the government to free up funds
Representatives held confidential meetings last week in Cleveland, Ohio
Purdue Pharma is among several drug makers and distributors which are being held accountable for the opioid epidemic crisis that has killed thousands
They reached a settlement in March for $270m to resolve a lawsuit by Oklahoma
https://www.dailymail.co.uk/news/article-7402011/Sackler-family-set-pay-3bn-money-settlement-opioid-epidemic.html
The firm is offering to settle the lawsuits against them for $10billion to $12billion.
The majority of the funds would come from transforming the company from private to a ‘public beneficiary trust’ under a Chapter 11 bankruptcy filing.
https://www.statnews.com/2019/08/28/purdue-pharma-government-attorneys-settlement-talks/
Purdue Pharma is owned by members of the Sackler family, who have given money to cultural institutions around the world, including the Smithsonian Institution, New York City’s Metropolitan Museum of Art and London’s Tate Modern.
Purdue’s drugs are just a slice of the opioids prescribed, but critics assign a lot of the blame to the company because it developed both the drug and an aggressive marketing strategy.
Sackler family ‘funnelled $1bn into different bank accounts’
BBC News
US and Canada
14 September 2019
https://www.bbc.co.uk/news/world-us-canada-49702413
Vectura provides update on GSK Litigation
https://www.globenewswire.com/news-release/2019/09/13/1915332/0/en/Vectura-provides-update-on-GSK-Litigation.html
Judge Andrews denied the following motions: GSK’s motion for judgment of non-infringement, GSK’s motion for judgment of obviousness, GSK’s motion for a finding of no wilful infringement, GSK’s motion for a new trial, GSK’s motion for a reduction in the amount of damages awarded by the jury, Vectura’s motion for enhanced damages, and Vectura’s motion for attorney’s fees.
Purdue Pharma files for bankruptcy in the US
3 hours ago
BBC News
Business
https://www.bbc.co.uk/news/business-49711618
US drug-maker Purdue Pharma has filed for bankruptcy protection, as part of efforts to deal with thousands of lawsuits that accuse the firm of fuelling the US opioid crisis.
The company’s board approved the Chapter 11 filing on Sunday.
The move is designed in part to resolve more than 2,600 lawsuits filed against Purdue over its alleged role in the opioid epidemic.
Last week, the firm reached a tentative deal to settle most of those lawsuits.
Purdue ‘reaches agreement’ to settle opioid cases
Sackler family ‘funnelled cash into Swiss banks’
It is hard enough to sue, Branded Drugs, without Generics, muddying the waters..
https://strongsidesolutions.com/news/blog/40-states-sue-generic-drug-makers-for-collusion/
Patients in Two States Can Sue Brand-Name Drugmakers Over Generics
https://www.drugwatch.com/news/2018/03/20/patients-two-states-can-sue-brand-name-drugmakers-generics/
Betrayed by the medical profession and government oversight agencies, the public must rely on trial lawyers to stop the irresponsible marketing of toxic drugs that have triggered lethal behavior–including suicide–in young children. There is probably no greater crime than knowingly putting a child’s life in danger for financial gain.
Below a press release from the lawfirm, Baum Hedlund, announces it has filed a class action lawsuit against GlaxoSmithKline charging the company with fraud, negligence, strict liability, and breach of warranty in its marketing of Paxil (Seroxat) by concealing the risk of suicide.
https://ahrp.org/national-class-action-filed-against-drug-maker-for-paxil-induced-suicides-in-youths/
Glaxo Fights Against Public Paxil Trials
http://www.laleva.org/eng/2008/04/glaxo_fights_against_public_paxil_trials.html
By Evelyn Pringle
April 7, 2008
Washington – Government attorneys appointed by the Bush Administration have been supporting GlaxoSmithKline in a number of courts across the country in an effort to convince the courts that lawsuits filed by victims of Paxil-induced injuries should be dismissed before ever making it to a jury.
Not particularly surprising to hear the producers of generic versions of drugs don’t have to prove that their product works. On the other hand, with the SSRIs and SNRIs not having been proven to work much better than placebo, I don’t feel much more confident about US produced, brand name drugs.