There’s a new war raging in health care, with hundreds of millions of dollars at stake and thousands of lives in the balance. The battle, pitting drug companies against doctors and patient advocates, is being fought over the unlikeliest of substances: human excrement.
The clash is over the future of fecal microbiota transplants, or F.M.T., a revolutionary treatment that has proved remarkably effective in treating Clostridioides difficile, a debilitating bacterial infection that strikes 500,000 Americans a year and kills 30,000.
The therapy transfers fecal matter from healthy donors into the bowels of ailing patients, restoring the beneficial works of the community of gut microbes that have been decimated by antibiotics. Scientists see potential for using these organisms to treat diseasesfrom diabetes to cancer.
At the heart of the controversy is a question of classification: Are the fecal microbiota that cure C. diff a drug, or are they more akin to organs, tissues and blood products that are transferred from the healthy to treat the sick? The answer will determine how the Food and Drug Administration regulates the procedure, how much it costs and who gets to profit.
In the category of saying the quiet parts out loud, consider this statement by Nirmal Mulye, the chief executive of drug company Nostrum Laboratories:
“I think it is a moral requirement to make money when you can … to sell the product for the highest price.”
Mulye was responding to questions posed by the Financial Times about his quadrupling the price of an essential antibiotic to $2,392 per bottle. The drug, nitrofurantoin, is used to treat urinary tract infections. It has been on the market since 1953 and is listed by the World Health Organization as an essential medicine for “basic healthcare systems.”
In his interview with the Financial Times published Tuesday, Mulye defended Martin Shkreli, the former drug company CEO who became the face of the industry’s profiteering in 2015 when he jacked up the price of a generic anti-parasitic drug needed by HIV patients by more than 5,000%.
So which definition of moral were you referring to, Mr. Mulye? I think the moral response would be for the federal government to start regulating the price of drugs such as this one.
The 23rd Commissioner of the U.S. Food and Drug Administration, Scott Gottlieb, responded
1/2 Regarding @FT story today @bydavidcrow; there’s no moral imperative to price gouge and take advantage of patients. FDA will continue to promote competition so speculators and those with no regard to public health consequences can’t take advantage of patients who need medicine
The Food and Drug Administration has not licensed phage therapy, keeping it out of pharmacies and hospitals. Few physicians have used it even experimentally, and most civilians have never heard of it. But phages are a natural phenomenon, frequently deployed in the former Soviet Union. When used properly, they can save lives.
To understand how phage therapy works, it helps to know a little biology, starting with the distinction between bacteria and viruses. Most of the drug-resistant superbugs that cause medical havoc are bacteria, microscopic single-celled organisms that do most of the things that other living things do: seek nutrition, metabolize it into energy, produce offspring. Viruses, which are much smaller than bacteria, exist only to reproduce: They attach to a cell, hijack its reproductive machinery to make fresh viruses, and then, in most cases, explode the cell to let viral copies float free.
Phages are viruses. In the wild, they are the cleanup crew that keeps bacteria from taking over the world. Bacteria reproduce relentlessly, a new generation every 20 minutes or so, and phages kill them just as rapidly, preventing the burgeoning bacterial biomass from swamping the planet like a B-movie slime monster. But phages do not kill indiscriminately: Though there are trillions in the world, each is tuned evolutionarily to destroy only particular bacteria. In 1917, a self-taught microbiologist named Félix d’Herelle recognized phages’ talent for targeted killing. He imagined that if he could find the correct phages, he could use them to cure deadly bacterial infections.
That was a gleaming hope, because at the time, nothing else could. (Sir Alexander Fleming wouldn’t find the mold that makes penicillin, the first antibiotic, until 1928.) Treatments were primitive: aspirin and ice baths to knock down fever, injections of crude immunotherapy extracted from the blood of horses and sheep, and amputation when a scratch or cut let infection burgeon in a limb and threaten the rest of the body with sepsis. Phages—whose full name, bacteriophages (or “bacteria eaters”), was given by d’Herelle in 1916—did something that medicine had never before been able to accomplish: They vanquished the infections for which they were administered without otherwise harming patients. A medical sensation and a cultural phenomenon, they provided the key plot device in the novel Arrowsmith, about an idealistic doctor, that won the Pulitzer Prize in 1926, and they saved the life of the Hollywood cowboy actor Tom Mix, a 1930s superstar.
D’Herelle was a restless researcher who seems to have felt undervalued despite being awarded jobs in Paris and Vietnam and at Yale. That insecurity made him vulnerable to an offer he received in 1933 to relocate to Tbilisi in Georgia, home territory of Soviet dictator Joseph Stalin. With a protégé, Georgi Eliava, d’Herelle co-founded the Eliava Institute of Bacteriophages, Microbiology and Virology. Stalin showered the institute with attention and money because it offered something he badly wanted: a scientific achievement that he could portray as a pure product of communism. Antibiotics became the basis of infectious-disease medicine in the West, but behind the Iron Curtain, phages took their place.
Eliava was murdered in a political purge in 1937, and d’Herelle died in 1949. Their institute dwindled, but it survived the collapse of the Soviet Union in 1991 and the Georgian civil war the following year. When the former USSR opened up to the West, physicians in the United States and Europe learned the Eliava Institute was one of the few places in the world where researchers were still studying and administering phages. That was fortunate timing, because antibiotics in the West were losing their power under the onslaught of antibiotic resistance.
Will phage therapy ever catch on in the US? Maybe, but our medical system is dependent upon the profit motive, thus pharmaceutical corporations are less interested in phage therapy because the resultant drugs won’t be so easily monetized. Plus the FDA’s bureaucratic infrastructure impedes studying these kinds of medicines.
Brief fu1, I bet footage of this tearful speech would be worth a lot to many, many news organizations…
A federal judge on Friday sentenced Martin Shkreli, the notorious former hedge fund manager, to seven years in prison for defrauding his investors.
U.S. District Judge Kiyo Matsumoto roughly split the difference between the 15 years prosecutors asked for and the 18 months sought by Shkreli’s defense team. Shkreli, 34, who delivered a tearful speech to Matsumoto apologizing for his conduct and pleading for leniency, did not react to the sentence.
Almost as if the healthcare industry (doctors, hospitals, pharmaceutical corporations, insurance corporations) have a vested interest in making profits before healing people. Not that they are trying to harm people, rather that making money is the first motive.
A low-carbohydrate diet was in fact standard treatment for diabetes throughout most of the 20th century, when the condition was recognized as one in which “the normal utilization of carbohydrate is impaired,” according to a 1923 medical text. When pharmaceutical insulin became available in 1922, the advice changed, allowing moderate amounts of carbohydrates in the diet.
Yet in the late 1970s, several organizations, including the Department of Agriculture and the diabetes association, began recommending a high-carb, low-fat diet, in line with the then growing (yet now refuted) concern that dietary fat causes coronary artery disease. That advice has continued for people with diabetes despite more than a dozen peer-reviewed clinical trials over the past 15 years showing that a diet low in carbohydrates is more effective than one low in fat for reducing both blood sugar and most cardiovascular risk factors.
The diabetes association has yet to acknowledge this sizable body of scientific evidence. Its current guidelines find “no conclusive evidence” to recommend a specific carbohydrate limit. The organization even tells people with diabetes to maintain carbohydrate consumption, so that patients on insulin don’t see their blood sugar fall too low. That condition, known as hypoglycemia, is indeed dangerous, yet it can better be avoided by restricting carbs and eliminating the need for excess insulin in the first place. Encouraging patients with diabetes to eat a high-carb diet is effectively a prescription for ensuring a lifelong dependence on medication.
At the annual diabetes association convention in New Orleans this summer, there wasn’t a single prominent reference to low-carb treatment among the hundreds of lectures and posters publicizing cutting-edge research. Instead, we saw scores of presentations on expensive medications for blood sugar, obesity and liver problems, as well as new medical procedures, including that stomach-draining system, temptingly named AspireAssist, and another involving “mucosal resurfacing” of the digestive tract by burning the inside of the duodenum with a hot balloon.
Have we reached a tipping point for drug pricing yet? Seems close, at least, to a public consensus that pharmaceutical companies cannot set prices so high they shock the conscience. We have to weigh public health against private profits.
The attorney general of Massachusetts said on Wednesday that she had opened an inquiry into whether Gilead Sciences had violated state consumer protection laws by charging too much for its hepatitis C drugs.
The notification, which was contained in a letter to the company from the attorney general, Maura Healey, is the latest challenge to the practices of Gilead, which has become the largest and most profitable biotechnology company by dominating the market for drugs used to treat both H.I.V. and hepatitis C.
On Tuesday, the AIDS Healthcare Foundation, a nonprofit organization that treats patients with H.I.V. and AIDS, filed a lawsuit seeking to invalidate patents covering the new version of Gilead’s mainstay H.I.V. drug, tenofovir. The lawsuit also says that Gilead, to maximize product life span but to the detriment of patients, delayed the introduction of the new, safer version of tenofovir until the old version was about to lose patent protection.
The hepatitis C drugs, Sovaldi and Harvoni, are widely considered breakthroughs — curing most patients in 12 weeks with few side effects. But Sovaldi has a list price of $1,000 per daily pill, or $84,000 for 12 weeks, and Harvoni costs $94,500. Those prices, and the great demand for the drugs, have strained the budgets of state Medicaid programs and prison systems, forcing many of them to restrict treatment to those most seriously ill.
In her letter to Gilead’s chief executive, John C. Martin, Ms. Healey said her office was examining whether Gilead’s pricing would be an “unfair trade practice,” in violation of Massachusetts law.
“Because Gilead’s drugs offer a cure for a serious and life-threatening infectious disease, pricing the treatment in a manner that effectively allows H.C.V. to continue spreading through vulnerable populations, as opposed to eradicating the disease altogether, results in massive public harm,” she wrote, referring to the hepatitis C virus by its initials.
One motivation for Ms. Healey’s letter was a class-action lawsuit filed against Massachusetts’ Department of Correction asking for more inmates to be treated for hepatitis C. Ms. Healey’s letter said that treating everyone at the list price of Sovaldi would “easily exceed our entire budget for prisoner health care.”
Hard to imagine another pharmaceutical that receives so much resistance to even being studied. Perhaps the problem is that cannabis is not patented by Pfizer, anyone can grow their own, in pretty much the entire world. Hard for Big Pharma to realize profits on a medically significant weed.
while the medical marijuana movement has been generating political news, some researchers have been quietly moving in new directions — testing cannabis and its derivatives against a host of diseases. The scientific literature now brims with potential uses for cannabis that extend beyond its well-known abilities to fend off nausea and block pain in people with cancer and AIDS. Cannabis derivatives may combat multiple sclerosis, Crohn’s disease and other inflammatory conditions, the new research finds. Cannabis may even kill cancerous tumors.
Many in the scientific community are now keen to see if this potential will be fulfilled, but they haven’t always been. Pharmacologist Roger Pertwee of the University of Aberdeen in Scotland recalls attending scientific conferences 30 years ago, eager to present his latest findings on the therapeutic effects of cannabis. It was a hard sell.
“Our talks would be scheduled at the end of the day, and our posters would be stuck in the corner somewhere,” he says. “That’s all changed.”
A bigger revelation came in 1992: Mammals make their own compound that binds to, and switches on, the CB1 receptor. Scientists named the compound anandamide. Researchers soon found its counterpart that binds mainly to the CB2 receptor, calling that one 2AG, for 2-arachidonyl glycerol. The body routinely makes these compounds, called endocannabinoids, and sends them into action as needed.
“At that point, this became a very, very respectable field,” says Mechoulam, now at Hebrew University of Jerusalem, who along with Pertwee and others reported the anandamide discovery in Science. “THC just mimics the effects of these compounds in our bodies,” Mechoulam says. Although the receptors are abundant, anandamide and 2AG are short-acting compounds, so their effects are fleeting.
In contrast, when a person consumes cannabis, a flood of THC molecules bind to thousands of CB1 and CB2 receptors, with longer-lasting effects. The binding triggers so many internal changes that, decades after the receptors’ discovery, scientists are still sorting out the effects. From a biological standpoint, smoking pot to get high is like starting up a semitruck just to listen to the radio. There’s a lot more going on.
Though the psychoactive effect of THC has slowed approval for cannabis-based drugs, the high might also have brought on a serendipitous discovery, says neurologist Ethan Russo, senior medical adviser for GW Pharmaceuticals, which is based in Porton Down, England. “How much longer would it have taken us to figure out the endocannabinoid system if cannabis didn’t happen to have these unusual effects on human physiology?”
A Senate report that revives concerns about a GlaxoSmithKline PLC diabetes drug’s link to heart attacks is putting pressure on the Food and Drug Administration to make changes to its drug-safety program.
People familiar with the situation say agency leaders held calls over the weekend to discuss how to address complaints from Sens. Max Baucus (D., Mont.) and Chuck Grassley (R., Iowa), who released a new report Saturday on the Glaxo drug, called Avandia.
The FDA is trying to assemble a timeline of what the FDA knew of risks associated with Avandia, these people say, and plans to call a meeting of an outside advisory committee in the next few months to look at recent information on the drug, which Glaxo reported as having global sales of £771 million ($1.2 billion) in 2009.
According to a two-year investigation by the Senate Finance Committee, Glaxo knew about data linking Avandia to elevated risk of cardiovascular events for several years, but played down the information and tried to suppress doctors who raised concerns. Starting in 1999, Glaxo executives complained to superiors about researchers who questioned Avandia’s safety, the report says.
and the FDA is certainly not blameless in this mess
Some critics of the FDA cited the Avandia report in renewing calls for an independent safety unit at the agency to track problems with drugs after they go on the market. Currently the section that does “post-market surveillance” is subordinate to the division that approves new drugs. As a result, there is an inherent conflict of interest because the approval officers are judging their own previous decisions, critics say.
The question is: will public outrage be sufficiently heated to force some structural changes in the FDA? Jury is still out…
In other corrupt-Washington-business-as-usual news, the pharmaceutical corporations have successfully protected their profits against generic drugs by convincing Washington to underfund the department of government regulators who approves generics. If they have no staff and no budget, generics can’t be brought to market, causing consumers and Medicare to spend more on non-generic drugs.
American consumers are waiting nearly a year longer for government regulators to approve new lower-priced generic drugs than they did in 2005.
The delays, caused by a growing backlog of applications at the Food and Drug Administration, may be costing consumers and the federal government hundreds of millions of dollars a year as they continue in some cases to pay for name-brand drugs even after their patents expire, industry analysts said.
Currently, approvals are taking over 2 years to wade through. Obviously, this office of the FDA is not a priority.
With lawmakers preparing to meet at the White House next week to discuss ways to give more Americans access to health insurance, generic makers say that underfunding of the F.D.A.’s generics office is denying consumers access to more affordable drugs. The agency’s office of generic drugs has a budget of $51 million for fiscal year 2010, up from $41 million in fiscal 2009.
Executives at the generics meeting joked that government was spending less per year on reviewing applications for new generic drugs than the New York Yankees spend on the payroll of the left side of their infield. (Alex Rodriguez and Derek Jeter between them earned $54.6 million last year, according to ESPN).
but if Washington was serious about being cost-sensitive and fiscally responsible, they’d act already. Ultimately, delaying generic drugs ends up costing taxpayers more money
While accounting for the majority of drug prescriptions in the United States, generics represent just a fraction of the total cost of drugs. Generics accounted for 70.4 percent of the 2.9 billion prescriptions in the United States last year, according to IMS Health, a health information company. But they accounted for only about 15 percent of the $300 billion spent on prescription drugs in this country last year, IMS said.
The slowdown in new generic drug approvals ultimately hurts consumers — and government payers like Medicare — because prices stay higher when there are no or only a few generic alternatives to a branded drug, industry analysts said.
Sad state of affairs: almost as if pharmaceutical corporations like GlaxoSmithKline set national policy. Hmmm, maybe they do?
Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.
The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.
“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.
The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.
GSK is more interested in resurrecting their cash cow:
Driven in part by a multimillion-dollar advertising campaign, sales [of Avandia] were $3.2 billion in 2006
despite the US Senate suggesting the process itself was/is flawed:
In a letter sent Thursday to Dr. Hamburg, the Food and Drug Administration commissioner, Mr. Baucus and Mr. Grassley asked “what steps the F.D.A. has taken to protect patients in the TIDE trial” and said the trial’s patients had never been told about the concerns raised by the agency’s own safety officers.
Mr. Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. Graham and Dr. Gelperin over their counterparts who approve medicines and deal more directly with drug makers.
“It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,” Mr. Grassley said. “The Avandia case may be the most alarming example of the problem with this setup.”
The question of when and how to communicate possible drug risks has long bedeviled drug makers and regulators. Hints are common that drugs may cause injuries; thousands of drug injury reports pour into the Food and Drug Administration every week. For example, Avandia ranked first among all prescribed drugs in the number of serious, disabling and fatal problems — including 304 deaths — reported to the agency in the third quarter of 2009, according to an analysis done by the Institute for Safe Medication Practice, a drug safety oversight group.
The Senate investigation — the result of years of digging through more than 250,000 internal company documents — concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.
Don’t forget that the FDA’s coziness with the pharmaceutical corporations is part of the problem too. Unless there are some drastic structural changes in the FDA, these sorts of issues are going to come up repeatedly.
Allegations of corruption and conflict of interest at the FDA? Really? How novel
The inspector general of the Department of Health and Human Services is investigating a conflict-of-interest allegation involving the official in charge of drug approvals at the Food and Drug Administration, the FDA said.
The investigation of Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.
In its complaint, Amphastar alleges that its competitor had special access to Dr. Woodcock at critical times in the prolonged approval process, which is ongoing. Amphastar points out that Dr. Woodcock co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. while both companies were battling to win FDA approval of their generic blood thinners.
Just a little corruption, nothing to pay attention to
Health reporters may become entangled in the same kinds of ethical conflicts they often expose when accepting industry-sponsored awards and relying on corporate public relations offices, three researchers warn.
Journalism awards consisting of cash prizes and all-expense-paid trips given out by drug companies are among the more “astonishing” financial ties between journalists and drug companies, the authors said. The paper appears in the online edition of the British medical journal BMJ.
Among the prizes cited are the Embrace Award for reporting on urinary incontinence — consisting of trips to Washington, D.C., and Paris — offered by pharmaceutical firms Eli Lilly and Boehringer Ingelheim, as well as another Eli Lilly award for cancer treatment stories that includes a weeklong international trip for two.
The authors also point a finger at journalism training and education programs sponsored by the health care industry and to professorships funded by drug company grants. The writers go on to criticize reporters’ reliance on drug company press officers for referrals to experts or to patients, whose views may have been carefully screened.
Drug companies are fretting that their huge advertising budgets won’t be large enough to sell their expensive drugs at the expense of cheaper generics, so are ramping up lobbying efforts.
U.S. drugmakers led by Merck & Co. and Biogen Idec Inc. are stepping up their fight against President Barack Obama’s move to encourage cheaper medical care.
Already the biggest spender on influencing policy, the drug industry is hiring well-known individuals, some with stories of personal battles against disease. They include Tony Coelho, a former House Democratic leader who has epilepsy; Andrea LaRue, counsel to Tom Daschle when he was Senate Democratic leader; and the firm of Democratic fundraiser Tony Podesta, brother of Obama adviser John Podesta.
The firepower shows the drug industry’s resolve to stop Obama from using comparisons of medical treatments to force cuts in health costs. More than half of medical care may be based on insufficient evidence of effectiveness, the Congressional Budget Office said in March. Meantime, the Health and Human Services Department says all medical spending will probably rise this year to $2.5 trillion, or 18 percent of the economy.
“The companies fear that older generic drugs might very well turn out to be better than the newer advertised drugs, which bring in much more of a profit,” said Julian Zelizer, a history and public affairs professor at Princeton University in Princeton, New Jersey. “In difficult economic times, the drug companies don’t want to take any risks, so they are bringing out the biggest lobbyists in the business.”
Nigerian families can sue the Pfizer drugs giant in the US over its alleged role in the deaths of children, a US appeals court has ruled. The decision overturns ruling by a lower court that the case must be heard in Nigeria.
Pfizer is accused of killing 11 children and injuring 181 others when an antibiotic was tested on them during a meningitis epidemic in 1996.
Pfizer denies the claims, saying they were victims of the outbreak.
The epidemic killed 12,000 children in Nigerian in six months.
The families say that Pfizer tested out an oral antibiotic called Trovan on some 200 ill children in hospital in Kano, without first getting the consent of their parents.
They say the drug killed 11 children and caused blindness, deformities and brain damage in others
No social networking for Big Pharma, probably because they are worried that people might realize that the latest and greatest new pharmaceutical has some nasty side effects, or worse, is just ineffective.
Although a majority of marketers have embraced online social media and user-generated content efforts, one industry is conspicuously not taking advantage of the gold rush: pharmaceuticals.
Drug brand Web sites almost never carry the features that marketers usually are desperate to give their customers: bulletin boards, chat rooms, blogs and Web-page hosting.
The reason: Marketers fear that user-generated content will include complaints about injuries caused by their drugs’ side effects. The law requires these “adverse events” to be reported to the FDA. The FDA’s adverse-event databases are regularly combed by lawyers looking for potential class-action suits
On the other side are brand managers, whose every published word must survive a thicket of in-house lawyers, some of whom aren’t Internet savvy.
Dori Stowe, chief digital strategist at Grey Healthcare Group, New York, recalls speaking with a pharma company’s legal team about a campaign, “and somebody raised their hand and asked, ‘What’s Google?
Anecdotal, sure, but how McCain-esque to you have to be to have avoided learning the name of Google? I’ve been using Google as my web search tool since 1998, so that’s ten years, plus Google is a hugely successful publicly traded company.